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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
| | | | | |
☒ | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
For the quarterly period ended September 30, 2024
OR
| | | | | |
☐ | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from __________ to __________
Commission File Number 001-38547
AUTOLUS THERAPEUTICS PLC
(Exact name of registrant as specified in its charter) | | | | | | | | | | | |
England and Wales | | Not applicable |
(State or other jurisdiction of incorporation or organization) | | (I.R.S. Employer Identification No.) |
| |
The Mediaworks |
191 Wood Lane |
| London | W12 7FP | United Kingdom |
(Address of principal executive offices) |
| | | |
| (44) 20 | 3829 6230 |
| (Registrant's telephone number, including area code) |
Securities registered pursuant to Section 12(b) of the Act: | | | | | | | | |
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
American Depositary Shares, each representing one ordinary share, par value $0.000042 per share | AUTL | The Nasdaq Global Select Market |
| Ordinary shares, nominal value $0.000042 per share* | * | The Nasdaq Stock Market LLC* |
| | | | | | | | |
* | | Not for trading, but only in connection with the listing of the American Depositary Shares on The Nasdaq Stock Market LLC. |
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Yes ☒ No ☐
Indicate by check mark whether the registrant has submitted electronically, every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☒ No ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and “an emerging growth company” in Rule 12b-2 of the Exchange Act:
| | | | | | | | | | | |
| Large accelerated filer | ☐ | Accelerated filer | ☐ |
| Non-accelerated filer | ☒ | Smaller reporting company | ☐ |
| | Emerging growth company | ☐ |
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Yes ☐ No ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes ☐ No ☒
As of November 8, 2024, the registrant had 266,121,689 ordinary shares (including shares in form of ADSs), par value $0.000042 per share, outstanding.
EXPLANATORY NOTE
Autolus Therapeutics plc (the “Company”) qualifies as a “Foreign Private Issuer,” as defined in Rule 3b-4 under the Securities Exchange Act of 1934 (the “Exchange Act”) and is exempt from filing quarterly reports on Form 10-Q by virtue of Rules 13a-13 and 15d-13 under the Exchange Act. The Company has voluntarily elected to file this Quarterly Report on Form 10-Q for the quarter ended September 30, 2024.
TABLE OF CONTENTS
GENERAL INFORMATION
Unless context otherwise requires, all references in this Quarterly Report on Form 10-Q to “Autolus,” the “Company,” “we,” “us” and “our” refer to Autolus Therapeutics plc and, where appropriate, its consolidated subsidiaries.
Autolus, AUCATZYL® and our other trademarks or service marks appearing in this Quarterly Report on Form 10-Q are our property. Solely for convenience, the trademarks and trade names in this Quarterly Report on Form 10-Q are referred to without the ® and TM symbols, but such references should not be construed as any indicator that their respective owners will not assert, to the fullest extent under applicable law, their rights thereto. Products or service names of other companies mentioned in this Quarterly Report on Form 10-Q may be trademarks, trade names or service marks of their respective owners.
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q contains forward-looking statements about us and our industry that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this Quarterly Report on Form 10-Q, including statements regarding our strategy, future financial condition, future operations, research and development costs, plans and objectives of management, are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “design,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “predict,” “positioned,” “potential,” “seek,” “should,” “target,” “will,” “would” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. Although we believe that we have a reasonable basis for each forward-looking statement contained in this Quarterly Report on Form 10-Q, we caution you that these statements are based on a combination of facts and factors currently known by us and our expectations of the future, about which we cannot be certain.
The forward-looking statements in this Quarterly Report on Form 10-Q include, among other things, statements about:
•the therapeutic potential and expected clinical benefits of AUCATZYL/obe-cel (obecabtagene autoleucel) for adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (“r/r B-ALL”);
•our ability to generate revenues from AUCATZYL which is dependent upon maintaining significant market acceptance among physicians, patients and healthcare payers;
•our ability to maintain regulatory approval of AUCATZYL in the United States (“US”), to obtain and maintain regulatory approval for obe-cel for adult r/r B-ALL in additional territories and the timing thereof, and to obtain and maintain regulatory approval of our other product candidates in the indications for which we plan to develop them, and any related restrictions, limitations or warnings in the label of an approved drug or therapy;
•our expectations regarding the commercialization and marketing of AUCATZYL for adult r/r B-ALL, including expanding into additional territories and the related timing of reaching patients in such territories;
•the development of our commercial product and product candidates, including statements regarding the initiation, timing, progress and the results of clinical studies or trials and related preparatory work, the period during which the results of the trials will become available and our research and development programs;
•our estimates regarding expenses, future revenue, capital requirements and needs for additional financing;
•our commercialization, marketing and manufacturing capabilities and strategy for AUCATZYL, including our ability to successfully recruit and retain sales and marketing personnel and to successfully build the market for AUCATZYL;
•our expectations about the willingness of healthcare providers to recommend AUCATZYL to people with adult r/r B-ALL;
•the impacts of public health crises and their effects on our operations and business, including interruption of key clinical trial activities, such as clinical trial site monitoring, access to capital, and potential disruption in the operations and business of third-party manufacturers, clinical sites, contract research organizations (“CROs”), other service providers and collaborators with whom we conduct business;
•our expectations regarding our ability to obtain and maintain intellectual property protection and our ability to license additional intellectual property relating to our product candidates from third parties and to comply with our existing license agreements;
•our plans to research, develop, manufacture and commercialize our product candidates;
•the potential benefits of our commercial product and product candidates;
•the timing or likelihood of regulatory filings and approvals for our product candidates, along with regulatory developments in the US, European Union (“EU”), the United Kingdom (“U.K.”) and other foreign countries;
•the size and growth potential of the markets for our commercial product and product candidates, if approved, and the rate and degree of market acceptance of our commercial product and product candidates, including reimbursement that may be received from payors;
•our need for and ability to obtain additional funding, on favorable terms or at all, including as a result of worsening macroeconomic conditions, including changes inflation and interest rates and unfavorable general market conditions, and the impacts thereon of the war in Ukraine, the conflicts involving Israel, and global geopolitical tension;
•our plans to collaborate, or statements regarding our current collaborations with BioNTech SE (“BioNTech”) and others;
•our license and option agreement with BioNTech, including our potential to receive milestone payments and royalties under the agreement;
•our ability to attract collaborators with development, regulatory and commercialization expertise;
•our ability to identify, recruit and retain qualified employees and key personnel;
•our ability to contract with third-party suppliers and manufacturers and their ability to perform adequately;
•the scalability and commercial viability of our manufacturing methods and processes;
•the success of competing therapies that are or may become available;
•whether we are classified as a Passive Foreign Investment Company (“PFIC”), for current and future periods;
•additional costs and expenses related to our decision to voluntarily comply with certain U.S. domestic issuer reporting obligations before we are required to do so; and
•any other factors which may impact our financial results or future trading prices of our American Depositary Shares (“ADSs”), and the impact of securities analysts’ reports on these prices.
Although we believe that the expectations reflected in these forward-looking statements are reasonable, these statements relate to our strategy, future operations, future financial position, future revenue, projected costs, prospects, plans, objectives of management and expected market growth, and involve known and unknown risks, uncertainties and other factors including, without limitation, risks, uncertainties and assumptions regarding the impact of worsening macroeconomic events, including changes in inflation and interest rates and unfavorable general market conditions and the impacts of the war in Ukraine, the conflicts involving Israel, and global geopolitical tensions, on our business, operations, strategy, goals and anticipated timelines, our ongoing and planned preclinical activities, our ability to initiate, enroll, conduct or complete ongoing and planned clinical trials, our timelines for regulatory submissions and our financial position that may cause our actual results, levels of activity, performance or achievements to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. You are urged to carefully review the disclosures we make concerning these risks and other factors that may affect our business and operating results in this Quarterly Report on Form 10-Q. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this document. Except as required by law, we do not intend, and undertake no obligation, to update any forward-looking information to reflect events or circumstances.
PART I - FINANCIAL INFORMATION
Item 1. Financial statements
AUTOLUS THERAPEUTICS PLC
Unaudited Condensed Consolidated Balance Sheets
(In thousands, except share and per share amounts)
| | | | | | | | | | | | | | | | | | | | |
| | Note | | September 30,
2024 | | December 31,
2023 |
Assets | | | | | | |
Current assets: | | | | | | |
Cash and cash equivalents | | | | $ | 657,067 | | | $ | 239,566 | |
Restricted cash | | | | 1,470 | | | 769 | |
Prepaid expenses and other current assets | | 7 | | 59,577 | | | 34,967 | |
Total current assets | | | | 718,114 | | | 275,302 | |
Non-current assets: | | | | | | |
| Property and equipment, net | | 8 | | 44,258 | | | 34,862 | |
| Prepaid expenses and other non-current assets | | | | 193 | | | 380 | |
| Long-term deposits | | | | 1,033 | | | 983 | |
| Operating lease right-of-use assets, net | | | | 60,503 | | | 60,791 | |
| Deferred tax asset | | | | 3,389 | | | 3,063 | |
| | | | | | |
Total assets | | | | $ | 827,490 | | | $ | 375,381 | |
Liabilities and shareholders’ equity | | | | | | |
Current liabilities: | | | | | | |
Accounts payable | | | | $ | 1,418 | | | $ | 103 | |
Accrued expenses and other liabilities | | 9 | | 47,488 | | | 39,581 | |
| Operating lease liabilities, current | | | | 3,568 | | | 5,053 | |
Total current liabilities | | | | 52,474 | | | 44,737 | |
Non-current liabilities: | | | | | | |
| Operating lease liabilities, non-current | | | | 48,661 | | | 47,914 | |
Liabilities related to future royalties and milestones, net | | 12 | | 248,943 | | | 170,899 | |
| Other long-term payables | | | | 447 | | | 357 | |
Total liabilities | | | | 350,525 | | | 263,907 | |
| | | | | | |
| Commitments and contingencies | | 14 | | | | |
| | | | | | |
Shareholders’ equity: | | | | | | |
Ordinary shares, $0.000042 par value; 490,909,783 shares authorized as of September 30, 2024 and 290,909,783 as of December 31, 2023; 266,117,277 and 174,101,361, shares issued at September 30, 2024 and December 31, 2023, respectively; 266,119,252 and 174,158,985, shares outstanding at September 30, 2024 and December 31, 2023, respectively | | | | 12 | | | 8 | |
Deferred shares, £0.00001 par value; 34,425 shares authorized, issued and outstanding at September 30, 2024 and December 31, 2023 | | | | — | | | — | |
Deferred B shares, £0.00099 par value; 88,893,548 shares authorized, issued and outstanding at September 30, 2024 and December 31, 2023 | | | | 118 | | | 118 | |
Deferred C shares, £0.000008 par value; 1 share authorized, issued and outstanding at September 30, 2024 and December 31, 2023 | | | | — | | | — | |
Additional paid-in capital | | | | 1,549,351 | | | 1,018,902 | |
Accumulated other comprehensive loss | | | | (898) | | | (28,992) | |
Accumulated deficit | | | | (1,071,618) | | | (878,562) | |
Total shareholders’ equity | | | | 476,965 | | | 111,474 | |
Total liabilities and shareholders’ equity | | | | $ | 827,490 | | | $ | 375,381 | |
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
AUTOLUS THERAPEUTICS PLC
Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss
(In thousands, except share and per share amounts)
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | | | Three Months Ended September 30, | | Nine Months Ended September 30, | |
| | Note | | 2024 | | 2023 | | 2024 | | 2023 | |
| | | | | | | | | | | |
| License revenue | | 3 | | $ | — | | | $ | 406 | | | $ | 10,091 | | | $ | 1,698 | | |
| | | | | | | | | | | |
| Operating expenses: | | | | | | | | | | | |
| Research and development | | | | (40,323) | | | (32,318) | | | (107,606) | | | (92,938) | | |
| General and administrative | | | | (27,330) | | | (10,611) | | | (67,410) | | | (31,017) | | |
| Loss on disposal of property and equipment | | | | (223) | | | — | | | (223) | | | (3,791) | | |
Impairment of operating lease right-of-use assets and related property and equipment | | | | — | | | (382) | | | (414) | | | (382) | | |
| Total operating expenses, net | | | | (67,876) | | | (42,905) | | | (165,562) | | | (126,430) | | |
| | | | | | | | | | | |
Other income, net | | | | 54 | | | 136 | | | 161 | | | 109 | | |
Foreign exchange losses | | | | (11,884) | | | (1,733) | | | (12,368) | | | (442) | | |
| Interest income | | | | 8,320 | | | 3,646 | | | 24,908 | | | 10,495 | | |
| Interest expense | | 4 | | (10,686) | | | (5,014) | | | (40,129) | | | (14,939) | | |
Total other expenses, net | | | | (14,196) | | | (2,965) | | | (27,428) | | | (4,777) | | |
| Net loss before income tax | | | | (82,072) | | | (45,870) | | | (192,990) | | | (131,207) | | |
Income tax (expense) benefit | | | | (22) | | | 21 | | | (66) | | | (5) | | |
Net loss | | | | (82,094) | | | (45,849) | | | (193,056) | | | (131,212) | | |
Other comprehensive income (loss): | | | | | | | | | | | |
| Foreign currency exchange translation adjustment | | | | 27,010 | | | (5,837) | | | 28,094 | | | 5,104 | | |
| Total comprehensive loss | | | | $ | (55,084) | | | $ | (51,686) | | | $ | (164,962) | | | $ | (126,108) | | |
| | | | | | | | | | | |
| Basic and diluted net loss per ordinary share | | 5 | | $ | (0.31) | | | $ | (0.26) | | | $ | (0.77) | | | $ | (0.75) | | |
| Weighted-average basic and diluted ordinary shares | | 5 | | 266,084,589 | | | 173,984,101 | | | 251,480,521 | | | 173,890,666 | | |
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
AUTOLUS THERAPEUTICS PLC
Unaudited Condensed Consolidated Statements of Shareholders’ Equity
(In thousands, except share amounts)
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Ordinary Shares | | Deferred Shares | | Deferred B Shares | | Deferred C Shares | | Additional Paid in Capital | | Accumulated other comprehensive loss | | Accumulated deficit | | Total Shareholders’ Equity |
| Shares | | Amount | | Shares | | Amount | | Shares | | Amount | | Shares | | Amount | | | | |
| | | | | | | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | | | | | | |
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| | | | | | | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | | | | | | |
| Balance at June 30, 2024 | 266,045,468 | | | $ | 12 | | | 34,425 | | | $ | — | | | 88,893,548 | | | $ | 118 | | | 1 | | | $ | — | | | $ | 1,545,146 | | | $ | (27,908) | | | $ | (989,524) | | | $ | 527,844 | |
| | | | | | | | | | | | | | | | | | | | | | | |
| Share-based compensation expense | — | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | 4,020 | | | — | | | — | | | 4,020 | |
| | | | | | | | | | | | | | | | | | | | | | | |
| Vesting of restricted stock unit awards net of shares withheld to cover tax withholding | 3,721 | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | — | |
| | | | | | | | | | | | | | | | | | | | | | | |
| Exercise of share options | 68,088 | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | 185 | | | — | | | — | | | 185 | |
| Unrealized gain on foreign currency translation | — | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | 27,010 | | | — | | | 27,010 | |
| Net loss | — | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | (82,094) | | | (82,094) | |
| Balance at September 30, 2024 | 266,117,277 | | | $ | 12 | | | 34,425 | | | $ | — | | | 88,893,548 | | | $ | 118 | | | 1 | | | $ | — | | | $ | 1,549,351 | | | $ | (898) | | | $ | (1,071,618) | | | $ | 476,965 | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Ordinary Shares | | Deferred Shares | | Deferred B Shares | | Deferred C Shares | | Additional Paid in Capital | | Accumulated other comprehensive loss | | Accumulated deficit | | Total Shareholders' Equity |
| Shares | | Amount | | Shares | | Amount | | Shares | | Amount | | Shares | | Amount | | | | |
| | | | | | | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | | | | | | |
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| | | | | | | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | | | | | | |
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| | | | | | | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | | | | | | |
| Balance at June 30, 2023 | 173,680,872 | | | $ | 8 | | | 34,425 | | | $ | — | | | 88,893,548 | | | $ | 118 | | | 1 | | | $ | — | | | $ | 1,012,709 | | | $ | (27,957) | | | $ | (755,542) | | | $ | 229,336 | |
| | | | | | | | | | | | | | | | | | | | | | | |
| Share-based compensation expense | — | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | 2,864 | | | — | | | — | | | 2,864 | |
| | | | | | | | | | | | | | | | | | | | | | | |
| Vesting of restricted stock unit awards net of shares withheld to cover tax withholding | 253,851 | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | — | |
| | | | | | | | | | | | | | | | | | | | | | | |
| Exercise of share options | 2,071 | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | 4 | | | — | | | — | | | 4 | |
| Unrealized gain on foreign currency translation | — | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | (5,837) | | | — | | | (5,837) | |
| Net loss | — | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | (45,849) | | | (45,849) | |
| Balance at September 30, 2023 | 173,936,794 | | | $ | 8 | | | 34,425 | | | $ | — | | | 88,893,548 | | | $ | 118 | | | 1 | | | $ | — | | | $ | 1,015,577 | | | $ | (33,794) | | | $ | (801,391) | | | $ | 180,518 | |
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
AUTOLUS THERAPEUTICS PLC
Unaudited Condensed Consolidated Statements of Shareholders’ Equity
(In thousands, except share amounts)
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Ordinary Shares | | Deferred Shares | | Deferred B Shares | | Deferred C Shares | | Additional Paid in Capital | | Accumulated other comprehensive loss | | Accumulated deficit | | Total Shareholders' Equity |
| Shares | | Amount | | Shares | | Amount | | Shares | | Amount | | Shares | | Amount | | | | |
| Balance at December 31, 2023 | 174,101,361 | | | $ | 8 | | | 34,425 | | | $ | — | | | 88,893,548 | | | $ | 118 | | | 1 | | | $ | — | | | $ | 1,018,902 | | | $ | (28,992) | | | $ | (878,562) | | | $ | 111,474 | |
| Issuance of ordinary shares, net of issuance costs | 91,666,669 | | | 4 | | | — | | | — | | | — | | | — | | | — | | | — | | | 520,613 | | | — | | | — | | | 520,617 | |
| Share-based compensation expense | — | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | 9,241 | | | — | | | — | | | 9,241 | |
| | | | | | | | | | | | | | | | | | | | | | | |
| Vesting of restricted stock unit awards net of shares withheld to cover tax withholding | 134,849 | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | — | |
| | | | | | | | | | | | | | | | | | | | | | | |
| Exercise of share options | 214,398 | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | 595 | | | — | | | — | | | 595 | |
| Unrealized gain on foreign currency translation | — | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | 28,094 | | | — | | | 28,094 | |
| Net loss | — | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | (193,056) | | | (193,056) | |
| Balance at September 30, 2024 | 266,117,277 | | | $ | 12 | | | 34,425 | | | $ | — | | | 88,893,548 | | | $ | 118 | | | 1 | | | $ | — | | | $ | 1,549,351 | | | $ | (898) | | | $ | (1,071,618) | | | $ | 476,965 | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Ordinary Shares | | Deferred Shares | | Deferred B Shares | | Deferred C Shares | | Additional Paid in Capital | | Accumulated other comprehensive loss | | Accumulated deficit | | Total Shareholders' Equity |
| Shares | | Amount | | Shares | | Amount | | Shares | | Amount | | Shares | | Amount | | | | |
| Balance at December 31, 2022 | 173,074,510 | | | $ | 8 | | | 34,425 | | | $ | — | | | 88,893,548 | | | $ | 118 | | | 1 | | | $ | — | | | $ | 1,007,625 | | | $ | (38,898) | | | $ | (670,179) | | | $ | 298,674 | |
| | | | | | | | | | | | | | | | | | | | | | | |
| Share-based compensation expense | — | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | 7,948 | | | — | | | — | | | 7,948 | |
| | | | | | | | | | | | | | | | | | | | | | | |
| Vesting of restricted stock unit awards net of shares withheld to cover tax withholding | 860,213 | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | — | |
| | | | | | | | | | | | | | | | | | | | | | | |
| Exercise of share options | 2,071 | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | 4 | | | — | | | — | | | 4 | |
| Unrealized loss on foreign currency translation | — | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | 5,104 | | | — | | | 5,104 | |
| Net loss | — | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | (131,212) | | | (131,212) | |
| Balance at September 30, 2023 | 173,936,794 | | | $ | 8 | | | 34,425 | | | $ | — | | | 88,893,548 | | | $ | 118 | | | 1 | | | $ | — | | | $ | 1,015,577 | | | $ | (33,794) | | | $ | (801,391) | | | $ | 180,518 | |
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
AUTOLUS THERAPEUTICS PLC
Unaudited Condensed Consolidated Statements of Cash Flows
(In thousands)
| | | | | | | | | | | |
| Nine Months Ended September 30, |
| 2024 | | 2023 |
Cash flows from operating activities: | | | |
Net loss | $ | (193,056) | | | $ | (131,212) | |
Adjustments to reconcile net loss to net cash used in operating activities: | | | |
Depreciation and amortization | 5,639 | | | 4,790 | |
| Share-based compensation net of amounts capitalized | 9,239 | | | 7,929 | |
Interest expense including cumulative catch-up adjustments on liabilities related to future royalties and milestones, net | 39,709 | | | 14,878 | |
| Foreign exchange differences | (13,166) | | | (366) | |
| Non-cash operating lease expense | 3,480 | | | 2,963 | |
Loss on termination of operating lease | 176 | | | 95 | |
| Loss on disposal of property and equipment | 223 | | | 3,812 | |
| Impairment of operating lease right-of-use assets and related property and equipment | 414 | | | 382 | |
| Deferred income tax | (326) | | | (520) | |
| | | |
Changes in operating assets and liabilities: | | | |
Increase in prepaid expenses and other current assets | (21,851) | | | (7,655) | |
| Decrease in prepaid expenses and other non-current assets | 288 | | | 1,932 | |
Decrease in long-term deposits | — | | | 937 | |
Increase in accounts payable | 1,259 | | | 69 | |
Increase (decrease) in accrued expenses and other liabilities | 3,713 | | | (6,823) | |
Decrease in operating lease liability | (4,078) | | | (11,965) | |
Net cash used in operating activities | (168,337) | | | (120,754) | |
Cash flows from investing activities: | | | |
Purchases of property and equipment | (10,963) | | | (9,509) | |
Net cash used in investing activities | (10,963) | | | (9,509) | |
Cash flows from financing activities: | | | |
| Proceeds of issuance of ordinary shares | 549,977 | | | — | |
Payments of equity issuance costs | (29,360) | | | (910) | |
Proceeds from the exercise of share options | 595 | | | 4 | |
Proceeds from liabilities related to future royalties and milestones, net | 40,000 | | | — | |
Payments of issuance costs related to the liabilities related to the sale of future royalties and milestones, net | (1,665) | | | — | |
Net cash provided by (used in) financing activities | 559,547 | | | (906) | |
Effect of exchange rate changes on cash, cash equivalents and restricted cash | 37,955 | | | 5,257 | |
Net increase (decrease) in cash, cash equivalents and restricted cash | 418,202 | | | (125,912) | |
Cash, cash equivalents and restricted cash, beginning of period | 240,335 | | | 382,761 | |
Cash, cash equivalents and restricted cash, end of period | $ | 658,537 | | $ | 256,849 | |
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| | | | | | | | | | | | | |
| Nine Months Ended September 30, |
| 2024 | | 2023 | | |
Unaudited supplemental cash flow information | | | | | |
Cash paid for income taxes | $ | 1,263 | | | $ | — | | | |
| | | | | |
Unaudited supplemental non-cash flow information | | | | | |
Property and equipment purchases included in accounts payable or accrued
expenses | $ | 2,889 | | | $ | 1,389 | | | |
| Leased assets terminated and obtained in exchange for operating lease liabilities, net | $ | (975) | | | $ | (1,110) | | | |
| Leased assets obtained in exchange for operating lease liabilities | $ | 1,640 | | | $ | 41,211 | | | |
| Capitalized share-based compensation, net of forfeitures | $ | 2 | | | $ | 19 | | | |
Capitalized implementation costs included in accrued expenses | $ | 204 | | | $ | 74 | | | |
| | | | | |
| | | | | |
| | | | | |
| | | | | |
| Reconciliation of cash, cash equivalents and restricted cash reported within the consolidated balance sheets: | | | | | |
| Cash and cash equivalents | $ | 657,067 | | | $ | 256,415 | | | |
| Restricted cash | 1,470 | | | 434 | | | |
Total cash, cash equivalents and restricted cash | $ | 658,537 | | | $ | 256,849 | | | |
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
AUTOLUS THERAPEUTICS PLC
Notes to the Unaudited Condensed Consolidated Financial Statements
Note 1. Nature of the Business
Autolus Therapeutics plc (with its subsidiaries, collectively, “Autolus” or the “Company”) is an early commercial-stage biopharmaceutical company developing next-generation programmed T cell therapies for the treatment of cancer and autoimmune diseases. Using its broad suite of proprietary and modular T cell programming technologies, the Company is engineering precisely targeted, controlled and highly active T cell therapies that are designed to better recognize target cells, break down their defense mechanisms and attack and kill these cells. The Company believes its programmed T cell therapies have the potential to be best-in-class and to offer patients substantial benefits over the existing standard of care, including the potential for cure in some patients. On November 8, 2024 the Company was notified by the U.S. Food and Drug Administration (“FDA”) that the Company’s biologics license application (“BLA”) was approved, allowing for the marketing of AUCATZYL (obecabtagene autoleucel, also known as obe-cel) in the US for the treatment of adult patients (18 years and older) with r/r B-ALL. Obe-cel is under regulatory review in both the European Union (“EU”) and the United Kingdom (“U.K.”) for the treatment of r/r adult B-ALL, with marketing authorization submissions accepted by the European Medicines Agency (“EMA”) in April 2024, and the UK Medicines and Healthcare products Regulatory Agency (“MHRA”) in August 2024.
Autolus Therapeutics plc is registered in England and Wales. Its registered office is The MediaWorks, 191 Wood Lane, London, W12 7FP, United Kingdom.
The Company is subject to risks and uncertainties common to companies in the biotechnology industry, including, but not limited to, development by competitors of new technological innovations, dependence on key personnel, protection of proprietary technology, compliance with government regulations and the ability to secure additional capital to fund operations. The Company’s product candidates currently under development will require significant additional research and development efforts, including preclinical and clinical testing and regulatory approval, prior to commercialization. Although AUCATZYL has been granted marketing approval in the US by the FDA, the Company will continue to incur significant additional costs to commercialize it. These efforts will require significant amounts of capital, as well as additional personnel, infrastructure, and compliance capabilities. Even if the Company’s product development efforts for obe-cel and its other product candidates are successful, it is uncertain when, if ever, the Company will realize revenue from its product sales.
BioNTech Agreements
On February 6, 2024 (the “Execution Date”), the Company concurrently entered into a (i) Securities Purchase Agreement (the “BioNTech Securities Purchase Agreement”), (ii) a Registration Rights Agreement (the “BioNTech Registration Rights Agreement”), (iii) a Letter Agreement (the “BioNTech Letter Agreement”) and (iv) a License and Option Agreement (the “BioNTech License and Option Agreement”), collectively called the “BioNTech Agreements”, with BioNTech. The BioNTech Agreements were entered into and in contemplation of one another and, accordingly, the Company assessed the accounting for these agreements in the aggregate. The following descriptions of the BioNTech Agreements do not purport to be complete and are qualified in their entirety by reference to the full text of such agreements.
(i) BioNTech Securities Purchase Agreement
Pursuant to the BioNTech Securities Purchase Agreement the Company sold to BioNTech ADSs, each representing one ordinary share with a nominal value of $0.000042 per share, of the Company (the “Ordinary Shares”) in a private placement transaction (the “Private Placement”). On February 13, 2024, the Company completed the Private Placement of 33,333,333 ADSs (the “Initial ADSs”), representing 33,333,333 Ordinary Shares at an offering price of $6.00 per Initial ADS. Aggregate net proceeds to the Company, after underwriting discounts and offering expenses, were $193.8 million.
In the event that BioNTech and the Company enter into a Manufacturing and Commercial Services Agreement (as defined below) within 18 months of the initial closing of the Private Placement, BioNTech will purchase additional ADSs (the “Subsequent ADSs” and, together with the Initial ADSs, the “Private Placement ADSs”), not to exceed 15,000,000 ADSs, for an aggregate purchase price of up to $20.0 million. The total number of Subsequent ADSs that may be issued is subject to additional limitations and restrictions.
The BioNTech Securities Purchase Agreement contains customary representations, warranties, and covenants of each of the Company and BioNTech.
(ii) BioNTech Registration Rights Agreement
Pursuant to the BioNTech Registration Rights Agreement the Company agreed to file a registration statement with the SEC to register the resale of the Private Placement ADSs.
AUTOLUS THERAPEUTICS PLC
Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued
(iii) BioNTech Letter Agreement
The BioNTech Letter Agreement provides BioNTech with certain additional rights and subjects BioNTech’s investment in the Company to certain restrictions. BioNTech received the right to nominate a director to the Company’s board of directors. If BioNTech acquires beneficial ownership of at least 30% of the issued and outstanding Ordinary Shares of the Company (including in the form of ADSs) within five years of the Execution Date, BioNTech will have the right to designate an additional director who shall be independent. BioNTech’s director nomination rights shall automatically terminate upon BioNTech’s ownership of Ordinary Shares dropping below certain specified percentages. Additionally, BioNTech has the right to purchase equity securities sold by the Company in bona fide financing transactions in amounts that are based on BioNTech maintaining specified ownership thresholds following such financing transactions.
Subject to specified exceptions, BioNTech may not sell the Private Placement ADSs without the Company’s approval for a period of six months following the applicable closing date for such ADSs.
The BioNTech Letter Agreement terminates upon the earlier of (a) the later of (i) February 6, 2027 and (ii) such time as no securities of the Company are held by BioNTech or its affiliates and (b) the consummation of a change of control transaction involving the Company.
(iv) BioNTech License and Option Agreement
License and Options
The Company, through its wholly owned subsidiaries, Autolus Limited and Autolus Holdings (U.K.) Limited, entered into the BioNTech License and Option Agreement with BioNTech pursuant to which the Company granted to BioNTech:
•an exclusive, worldwide, sublicensable license (the “Binder License”) to certain binders and to exploit products that express in vivo such binders (collectively, the “Binder Licensed Products”), and
•several time-limited options (the “Options”) to acquire additional rights to specified clinical-stage product candidates, binders and technologies of the Company, described in more detail below:
◦an option to obtain exclusive rights to co-fund development costs of the Company’s development-stage programs AUTO1/22 and AUTO6NG (“Product Options”), in return for agreed upon economic terms, including an option exercise fee, milestone payments and a profit-sharing arrangement for each such product candidate, with additional options to co-promote or co-commercialize each such product candidate;
◦an option to obtain an exclusive worldwide license to exploit products that express certain additional binders in vivo or, with respect to certain binders, in an antibody drug conjugate (the “Binder Option”);
◦an option to obtain a co-exclusive worldwide license to exploit products that express in vivo the Company’s modules for activity enhancement, with a non-exclusive right, in certain agreed instances, to exploit products that include Company’s modules for activity enhancement but do not express in vivo such modules (the “Activity Enhancement Option”); and
◦an option to obtain a non-exclusive worldwide license to exploit products that contain the Company’s safety switches (the “Safety Switch Option” and, together with the Binder Option and the Activity Enhancement Option, the “Technology Options”).
In consideration for the Binder License and the Technology Options, BioNTech made an initial payment to the Company of $10.0 million. In the event that all Options are fully exercised, the Company would be eligible to receive maximum aggregate payments of up to $582.0 million pursuant to the License Agreement. This maximum amount includes the potential milestone payments for the Binder Licensed Products described below, all option exercise fees and potential milestone payments for licenses to optioned products and technologies, and additional payments that BioNTech may pay to the Company for an increased revenue interest with respect to the Company’s product candidate obe-cel as described below.
The option exercise fee for each Technology Option is a low seven-digit amount. Each of the Activity Enhancement Option and the Safety Switch Option must be exercised with respect to a given biological target or combination of targets. There is a cap on the total option exercise fee if multiple options are exercised with respect to a given target. There is also a cap on milestone payments across all agreements entered into as the result of BioNTech exercising one or more of the Technology Options and a cap on the royalty rate payable on any given product for which multiple Options are exercised.
AUTOLUS THERAPEUTICS PLC
Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued
Obe-cel Product Revenue Interest
BioNTech has also agreed to financially support the expansion of the clinical development program for, and planned commercialization of obe-cel. In exchange for the grant of rights to future revenues from the sales of obe-cel products, BioNTech made an upfront payment to the Company of $40.0 million. The Company will pay BioNTech a low single-digit percentage of annual net sales of obe-cel products, which may be increased up to a mid-single digit percentage in exchange for milestone payments of up to $100.0 million in the aggregate on achievement of certain regulatory events for specific new indications upon BioNTech’s election.
Manufacturing and Commercial Services Agreement
Under the terms of the BioNTech License and Option Agreement, the Company has agreed to grant BioNTech the option to negotiate a joint manufacturing and commercial services agreement pursuant to which the parties may access and leverage each other’s manufacturing and commercial capabilities, in addition to Autolus’ commercial site network and infrastructure, with respect to certain of each parties’ CAR T products, including BioNTech’s product candidate BNT211 (the “Manufacturing and Commercial Services Agreement” or “MCSA”). The MCSA, if entered into, would also grant BioNTech access to the Company’s commercial site network and infrastructure.
The Company concluded there were four freestanding financial instruments arising from the execution of the BioNTech Agreements, comprising:
1.the Initial ADSs representing ordinary shares purchased pursuant to the BioNTech Securities Purchase Agreement;
2.the potential Subsequent ADSs representing ordinary shares that may be purchased pursuant to the BioNTech Securities Purchase Agreement;
3.the BioNTech License and Option Agreement, and
4.the MCSA.
The Subsequent ADSs are classified as a forward instrument contingent on the MCSA being executed. As of September 30, 2024, the MCSA had not been entered into. The forward instrument has an inconsequential market value as the exercise price approximates the Company’s stock price on the last trading day prior to the signing date of the MCSA. Consequently, the initial proceeds arising from the purchase of Initial ADSs pursuant to the BioNTech Securities Purchase Agreement will not be separately allocated to this freestanding financial instrument at inception of the BioNTech Agreements. Furthermore, as the MCSA has yet to be entered into no consideration will be allocated to this freestanding financial instrument at inception of the BioNTech Agreements.
Within the BioNTech License and Option Agreement, there are a number of embedded features which have each been assessed for freestanding financial instrument accounting in accordance with Accounting Standards Codification (“ASC”) 480 – Distinguishing Liabilities from Equity. Although these embedded features are separately exercisable, they lack legal detachability and, therefore, the BioNTech License and Option Agreement is accounted for as one freestanding financial instrument. However, each embedded feature is assessed for derivative accounting in accordance to ASC 815 – Derivative and Hedging (“ASC 815”).
The Company analyzed how it should account for the host contract (i.e., the BioNTech License and Option Agreement) as the Binder License represents an agreement with customer for goods and services and therefore should be accounted for under ASC 606 – Revenue from Contracts with Customers (“ASC 606”). However, as the other embedded features of the BioNTech License and Option Agreement fall under the scope of other topics that specify how to initially measure the contract (i.e., ASC 470 – Debt (“ASC 470”)), the Company determined that the host contract should not be accounted for and initially measured pursuant to ASC 606. Furthermore, the Company determined the host contract (the BioNTech License and Option Agreement) met the scope exception of ASC 815-10-15-59(d) and therefore should not be accounted for as a derivative under ASC 815 but instead be accounted for as a debt financial instrument in accordance with ASC 470.
AUTOLUS THERAPEUTICS PLC
Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued
The four units of accounting were recorded at fair value upon initial recognition and will not be subsequently measured at fair value. The Company allocated the total gross proceeds arising from the BioNTech Securities Purchase Agreement (i.e. the Initial ADSs representing ordinary shares), and the BioNTech License and Option Agreement among the four units of accounting on a relative fair value basis at the time of the transaction as follows:
| | | | | | | | | | | | | | | | | | | | | | | | | | |
| Units of Accounting | | Gross proceeds (in millions) | | Initial fair value (in millions) | | Allocated consideration based on relative fair value (in millions) | | Net allocated consideration based on relative fair value after transaction costs* (in millions) |
Initial ADSs, representing ordinary shares | | $ | 200.0 | | | $ | 200.0 | | | $ | 200.0 | | | $ | 193.8 | |
Subsequent ADSs, representing ordinary shares | | $ | — | | | $ | — | | | $ | — | | | $ | — | |
BioNTech License and Option Agreement | | $ | 50.0 | | | $ | 50.0 | | | $ | 50.0 | | | $ | 47.9 | |
Liabilities related to future royalties and milestones, net (Obe-cel Product Revenue Interest) | | $ | 40.0 | | | $ | 40.0 | | | $ | 40.0 | | | $ | 38.3 | |
License Revenue (Binder License) | | $ | 10.0 | | | $ | 10.0 | | | $ | 10.0 | | | $ | 9.6 | |
MCSA | | $ | — | | | $ | — | | | $ | — | | | $ | — | |
| Total | | $ | 250.0 | | | $ | 250.0 | | | $ | 250.0 | | | $ | 241.7 | |
* In addition, the total shared transaction costs of $8.3 million, relating to the BioNTech Agreements have been allocated to the four units of accounting on a relative fair value basis. |
Note 2. Summary of Significant Accounting Policies
Basis of Presentation
The accompanying unaudited condensed consolidated financial statements of the Company have been prepared in accordance with generally accepted accounting principles in the US (“US GAAP”) and are presented in US dollars. All intercompany accounts and transactions between the Company and its subsidiaries have been eliminated upon consolidation.
The significant accounting policies used in the preparation of these unaudited condensed consolidated financial statements are consistent with those discussed in Note 2, “Summary of Significant Accounting Policies” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023 as filed with the Securities and Exchange Commission on March 21, 2024 (the “Annual Report”).
Certain information and footnote disclosures have been condensed or omitted as permitted under US GAAP. The information included in these unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and the related notes thereto as of and for the year ended December 31, 2023, included in the Annual Report. However, these interim financial statements include all adjustments, consisting only of normal recurring adjustments, which are, in the opinion of management, necessary to fairly state the results of the interim period. The interim results are not necessarily indicative of results to be expected for the full year ending December 31, 2024, any other interim periods, or any future year or period.
Going Concern
The Company has incurred recurring losses since its inception, including net losses of $82.1 million and $45.8 million for the three months ended September 30, 2024 and 2023, respectively and $193.1 million and $131.2 million for the nine months ended September 30, 2024 and 2023, respectively. The Company had an accumulated deficit of $1,071.6 million and $878.6 million as of September 30, 2024 and December 31, 2023, respectively. The Company expects to continue to generate operating losses in the foreseeable future. The Company’s inability to raise additional capital as and when needed could have a negative impact on its financial condition and ability to pursue its business strategies. There can be no assurances, however, that the current operating plan will be achieved or that additional funding will be available on terms acceptable to the Company, or at all. The Company expects that its cash and cash equivalents at September 30, 2024 of $657.1 million will be sufficient to fund the Company’s operations for at least twelve months from the issuance date of these unaudited condensed consolidated financial statements and accordingly they have been prepared on a going concern basis. As the Company continues to incur losses, the transition to profitability is dependent upon the successful development, approval and commercialization of its product candidates and achieving a level of revenues adequate to support its cost structure. Even if the Company’s planned regulatory submissions for its products are approved, and the Company is successful in its commercialization efforts, additional funding will be needed before the Company is expected to reach cash breakeven.
AUTOLUS THERAPEUTICS PLC
Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued
Foreign Currency Translation
The reporting currency of the Company is US dollars. The Company has determined that its functional currency of the ultimate parent company, Autolus Therapeutics plc, is British Pound Sterling. The functional currency of each subsidiary’s operations is the applicable local currency. Monetary assets and liabilities denominated in currencies other than the Company’s functional currency are translated into the functional currency at rates of exchange prevailing at the balance sheet dates. Non-monetary assets and liabilities denominated in foreign currencies are translated into the functional currency at the exchange rates prevailing at the date of the transaction.
The Company recorded foreign exchange losses of $11.9 million and $1.7 million for the three months ended September 30, 2024 and 2023, respectively, and foreign exchange losses of $12.4 million and $0.4 million for the nine months ended September 30, 2024 and 2023, respectively, which are included in foreign exchange losses in the unaudited condensed Consolidated Statements of Operations and Comprehensive Loss.
For financial reporting purposes, the financial statements of the Company have been translated into US dollars. Assets and liabilities have been translated at the exchange rates at the balance sheet dates, while revenue and expenses are translated at the average exchange rates over the reporting period and shareholders’ equity amounts are translated based on historical exchange rates as of the date of each transaction. Translation adjustments are not included in determining net income (loss) but are included in foreign currency translation to other comprehensive loss, a component of shareholders’ equity.
Segment Information
The Company’s chief operating decision maker (the “CODM”), its Chief Executive Officer, manages the Company’s operations on an integrated basis for the purpose of appropriately allocating resources. When evaluating the Company’s financial performance, the CODM reviews total revenue, total expenses and expenses by function and makes decisions using this information on a global basis. The Company and the CODM view the Company’s operations and manage its business as a single operating segment, which is the business of developing and commercializing CAR T therapies.
Use of Estimates
The preparation of consolidated financial statements in conformity with US GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of income and expenses during the reporting periods. Significant estimates and assumptions reflected in these consolidated financial statements include, but are not limited to, the accrual for research and development expenses, share-based compensation including assessing the probability of meeting performance conditions, income taxes, initial fair value of warrants, and interest expense on liabilities related to future royalties and milestones, net and related cumulative catch-up adjustment, lease term of the Company’s new manufacturing facility (“The Nucleus”), incremental borrowing rates related to the Company’s leased properties and allocation of transaction price using the relative standalone selling price. Estimates are periodically reviewed in light of changes in circumstances, facts and experience. Actual results could differ from those estimates.
Allocation of transaction price using the relative standalone selling price
Upfront payments are allocated between performance obligations using the Company’s best estimate of the relative standalone selling price of the performance obligation. The relative standalone selling price is estimated by determining the market values of development and license obligations. As these inputs are not directly observable, the estimate is determined considering all reasonably available information including internal pricing objectives used in negotiating the contract, taking into account the different stage of development of each development program and consideration of adjusted-market data from comparable arrangements. Where performance obligations have been identified relating to material rights, the determination of the relative standalone selling price of these performance obligations also includes an assessment of the likelihood that the options will be exercised and any payments by the customer that are triggered upon exercising the right. This assessment involves significant judgment and could have a significant impact on the amount and timing of revenue recognition.
An assessment of the allocation of transaction price using the relative standalone selling price was required for the three and nine months ended September 30, 2024 and 2023 for the BioNTech License and Option Agreement and the Option and License Agreement with Cabaletta Bio Inc. (“Cabaletta”), respectively. See Note 3 for additional information on the allocation of the transaction price for those agreements.
AUTOLUS THERAPEUTICS PLC
Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued
Liabilities related to future royalties and milestones, net and cumulative catch-up adjustments
The Company accounted for each of the Blackstone Collaboration Agreement (See Note 12) (“Blackstone Collaboration Agreement Liability”) and the BioNTech Obe-cel Product Revenue Interest (“BioNTech Liability”) as liabilities measured at amortized cost based on an effective interest rate determined at the outset of the Blackstone Collaboration Agreement Liability related to future royalties and milestones, net is measured based on the Company’s current estimates of the timing and amount of expected future royalties, milestone payments to be paid and the milestones receivable upon the achievement of certain specified clinical, manufacturing and regulatory milestones (each such payment, a “Blackstone Development Payment” and collectively, the “Blackstone Development Payments”) expected to be received over the estimated term of the agreement. Similarly, the BioNTech Liability related to future royalties is measured based on the Company’s current estimates of the timing and amount of expected future royalty expected to be paid over the estimated term of the agreement. Milestone payments pursuant to the BioNTech License and Option Agreement (“BioNTech Milestone Payments”) are payable upon BioNTech’s election, and therefore have not been included in the determination of the effective interest rate or in the measurement of the liability.
The liabilities are amortized using the effective interest rate, resulting in recognition of interest expense over the estimated term of the agreement. Each reporting period the Company assesses the estimated probability, timing and amount of the future expected royalty, milestone payments, the Blackstone Development Payment over the estimated term. If there are changes to the estimates, the Company recognizes the impact to the liability’s amortization schedule and the related interest expense using the cumulative catch-up method.
The Company’s estimate of the probability, timing and amount of expected future royalties and milestones to be paid by the Company and the expected Blackstone Development Payment to be paid to the Company, considers significant unobservable inputs. These inputs include regulatory approval, the estimated patient population, estimated selling price, estimated sales, estimated peak sales and sales ramp, timing of the expected launch and its impact on the royalties as well as the overall probability of a success. Additionally, the transaction costs associated with the liability will be amortized to interest expense over the estimated term of the agreements.
The carrying amount of the Blackstone Collaboration Agreement Liability and BioNTech Liability is based on the Company’s estimate of the future royalties, milestones to be paid to Blackstone by the Company and the expected Blackstone Development Payment to be received over the life of the arrangement as discounted using the initial effective interest rate. The excess estimated present value of future royalties, milestone payments and the future Blackstone Development Payment received over the carrying amount is recognized as a cumulative catch-up adjustment within interest expense using the effective interest rate.
Recent Accounting Pronouncements Not Yet Adopted
In November 2023, the Financial Accounting Standards Board, (“FASB”), issued Accounting Standards Update, or (“ASU”), 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures, or (“ASU 2023-07”), which expanded the disclosures for reportable segments made by public entities. These amendments within ASU 2023-07 retained the existing disclosure requirements in ASC 280 - Segment Reporting (“ASC 280”) and expanded upon them to require public entities to disclose significant expenses for reportable segments in both interim and annual reporting periods, as well as items that were previously disclosed only annually on an interim basis, including disclosures related to a reportable segment’s profit or loss and assets. In addition, entities with a single reportable segment must provide all segment disclosures required in ASC 280, including the new disclosures for reportable segments under the amendments in ASU 2023-07. The amendments did not change the existing guidance on how a public entity identified and determined its reportable segments. A public entity should apply the amendments in ASU 2023-07 retrospectively to all prior periods presented in the financial statements. Upon transition, the segment expense categories and amounts disclosed in the prior periods should be based on the significant segment expense categories identified and disclosed in the period of adoption. The amendments in ASU 2023-07 are effective for annual periods for all public entities in fiscal years beginning after December 15, 2023, and in interim periods within fiscal years beginning after December 15, 2024. The Company will comply with any new applicable disclosures in its Annual Report on Form 10-K for the year ending December 31, 2024. The Company does not expect the adoption to have a material effect on its financial statements and related disclosures.
In December 2023, the FASB issued ASU 2023-09, Improvements to Income Tax Disclosures. This ASU improves the transparency of income tax disclosure by requiring consistent categories and greater disaggregation of information in the rate reconciliation, and income taxes paid disaggregated by jurisdiction. This guidance is effective for the Company for the year beginning January 1, 2025, with early adoption permitted. The amendments should be applied on a prospective basis, with retrospective application permitted. The Company intends to adopt the guidance in the fiscal year beginning January 1, 2025. The Company does not expect the adoption of ASU 2023-09 to have a material effect on its financial statements and related disclosures in this Quarterly Report on Form 10-Q or in its Annual Report on Form 10-K for the full year ending December 31, 2024.
Unless otherwise discussed, the impact of recently issued standards that are not yet effective are not expected to have a material impact on the Company’s consolidated financial statements and disclosures.
AUTOLUS THERAPEUTICS PLC
Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued
Note 3. License Revenue
License revenue for the three and nine months ended September 30, 2024, and 2023, is presented in the table below by geographical location (in thousands):
| | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Three Months Ended September 30, | | Nine Months Ended September 30, |
| | 2024 | | 2023 | | 2024 | | 2023 |
| License revenue | | | | | | | | |
| United Kingdom | | $ | — | | | $ | 346 | | | $ | — | | | $ | 346 | |
| United States | | — | | | 60 | | | — | | | 1,352 | |
Germany | | — | | | — | | | 10,091 | | | — | |
| Total license revenue | | $ | — | | | $ | 406 | | | $ | 10,091 | | | $ | 1,698 | |
Major customers
During the nine months ended September 30, 2024, 100% of the Company’s license revenues were generated from BioNTech. For the nine months ended September 30, 2023, 80% and 20% of the Company's license revenues were primarily generated from Cabaletta and an investee of Syncona Portfolio Limited, respectively.
License and Option Agreement with BioNTech
See Note 1 for a description of the BioNTech License and Option Agreement, under which the Company recognized revenue during the nine months ended September 30, 2024. For further details on the terms and accounting treatment considerations for the BioNTech Agreement, refer to following notes to these interim condensed consolidated financial statements:
•Note 1, “Nature of the business”
•Note 2, “Summary of significant accounting policies”
•Note 10, “Shareholders’ equity”
•Note 12, “Liabilities related to future royalties and milestones, net”
•Note 14, “Commitments and contingencies”
As the BioNTech License and Option Agreement has been accounted for as one freestanding financial instrument with various embedded features, including the Binder License and related transfer of know-how, Technology Options, and Product Options, the Company is required to consider if the embedded features are required to be bifurcated from the host contract and therefore accounted for as a separate derivative. The Company concluded the Binder License and related transfer of know-how, Technology Options, and Product Options meet the scope exception set out in ASC 815-10-15-59(d) and therefore not accounted for as derivatives under ASC 815.
Binder License
The Company applied ASC 606 to account for the Binder License and related know-how as functional intellectual property. The Binder License and related transfer of know-how were not distinct from one another and must be combined as a performance obligation, as BioNTech requires the know-how to derive benefit from the license. Based on these determinations, the Company identified one combined distinct performance obligation at the inception of the BioNTech License and Option Agreement.
The Company further determined the consideration received included in the transaction price at contract inception, is to be allocated to the one combined performance obligation. The Company determined that the performance obligation was recognized at a point-in-time, upon the delivery of the transfer of know-how and Binder License to BioNTech. The Company recognized total license revenue of $10.1 million (net of foreign exchange differences), related to the BioNTech License and Option Agreement during the three months ended March 31, 2024. No license revenue was recognized during the three months ended September 30, 2024.
The Company is eligible to receive milestone payments of up to $32.0 million in the aggregate upon the achievement of specified clinical development and regulatory milestones for each Binder Licensed Product that achieves such milestones. The Company is also eligible to receive a low single-digit royalty on net sales of Binder Licensed Products, subject to customary reductions, which are subject to specified limits. The royalty will be increased if BioNTech, its affiliates or sublicensees commercialize a Binder Licensed Product in an indication and country in which the Company or its affiliates or licensees also commercializes a product containing the same binders. Under the BioNTech License and Option Agreement, BioNTech is solely responsible for, and has sole decision-making authority with respect to, at its own expense, the exploitation of Binder Licensed Products. Milestone payments and royalty payments are regarded as variable consideration and will be evaluated under the most likely amount method. Milestone payments and royalty payments were not included in the transaction price, as these amounts were fully constrained as of September 30, 2024.
AUTOLUS THERAPEUTICS PLC
Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued
Technology Options
As the Technology Options are outside the scope of ASC 815, the Company considered other relevant accounting guidance to apply to this component of the BioNTech License and Option Agreement. The Company therefore applied ASC 606, considering particularly the accounting guidance related to any options granted to customers to purchase additional goods or services at a future date as this could provide a material right to the customer. A material right is a promise embedded in a current contract that should be accounted for as a separate performance obligation. The Company determined the Technology Options were not offered at a significant and incremental discount. Accordingly, the Technology Options granted to BioNTech do not represent a material right and, therefore, were not a performance obligation at the outset of the arrangement. The Technology Option exercise fee equates to the standalone selling price of the technologies underlying each option and consequently, the transaction price of $10.0 million was not allocated to the Technology Options’ performance obligation. No Technology Options were exercised during the three and nine months ended September 30, 2024.
Product Options
As the Product Options are precluded from being accounted for under ASC 815 due to the scope exception, management considered the terms of the Product Options and concluded that they should be accounted for as a gain contingency under the scope of ASC 450 - Contingencies (“ASC 450”). The Product Options, unlike the Technology Options, are 1) still subject to negotiation as to the specific activities to be performed by each party, which will be determined and agreed before the Product Options can be exercised, and 2) have not been exercised upon signature of the BioNTech License and Option Agreement. As a result, Product Options are not accounted for under to ASC 606, and no recognition is required under ASC 450, until the Product Options are exercised. No Product Options were exercised during the three and nine months ended September 30, 2024.
Option and License Agreement with Cabaletta
On January 9, 2023, the Company entered into an Option and License Agreement (the “Cabaletta Agreement”) with Cabaletta, pursuant to which the Company granted to Cabaletta a non-exclusive license to research, develop, manufacture, have manufactured, use, and commercialize products incorporating the Company’s safety switch technology (the “RQR8 technology”). Upon the execution of the Cabaletta Agreement, the Company made available the RQR8 licensed know-how to Cabaletta for a non-refundable license fee of $1.2 million. The Company has no further material performance obligations related to the Cabaletta Agreement.
The Company further granted to Cabaletta the option to expand the rights and licenses granted under the Cabaletta Agreement to include the research, development, manufacture, use, or commercialization of licensed products up to a predetermined number of target options upon payment of an option exercise fee.
The Company identified the following material promises relating to the granting of a non-exclusive license for research, development, manufacturing and commercialization activities as well as the initial transfer of know-how and information to Cabaletta. The Company determined the option exercise fee is not offered at a significant and incremental discount. Accordingly, the option granted to Cabaletta does not represent a material right and, therefore, is not a performance obligation at the outset of the arrangement. The Company determined that the granting of the research license and the initial transfer of know-how were not distinct from one another and must be combined as a performance obligation, as Cabaletta requires the know-how to derive benefit from the license. Based on these determinations, the Company identified one distinct performance obligation at the inception of the contract.
The Company further determined that the license fee payable constituted the entirety of the consideration included in the transaction price at contract inception, which was allocated to the one performance obligation. The amount of the transaction price allocated to the performance obligation is recognized as or when the Company satisfies the performance obligation. The Company determined that the performance obligation was recognized at a point-in-time, upon the delivery of the transfer of know-how and research license to Cabaletta. The Company recognized total license revenue of $1.2 million related to the Cabaletta Agreement for the nine months ended September 30, 2023. No license revenue was recognized related to the Cabaletta Agreement for the three and nine months ended September 30, 2024.
Upon execution of the Cabaletta Agreement, the transaction price included only the $1.2 million non-refundable license fee payable to the Company. The Company may receive further payments upon the exercise of the options for licensed targets, the achievement of certain development and sales milestones, as well as royalty payments based on net sales of each product covered by the licensed intellectual property.
AUTOLUS THERAPEUTICS PLC
Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued
Research, Option and License Agreement with an Investee of Syncona Portfolio Limited
The Company entered into a license agreement with an investee of Syncona Portfolio Limited on September 2, 2020. The terms of the agreement include a non-refundable license fee, payments based upon achievement of clinical development and regulatory objectives, and royalties on product sales. During the three and nine months ended September 30, 2023, Company received variable consideration arising from the achievement of a development milestone amounting to $0.4 million. Consequently, the Company recognized license revenue of $0.4 million (net of foreign exchange differences) for the three and nine months ended September 30, 2023.
The future milestones, which represent variable consideration, will be evaluated under the most likely amount method, and were not included in the transaction price, as these amounts were fully constrained as of September 30, 2024. For the three and nine months ended September 30, 2024 and 2023, the Company has not recognized any variable consideration with regards to the development milestones and sales-based milestones with its customers as they are deemed not probable.
Note 4. Interest expense
Interest expense consisted of the following (in thousands):
| | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Three Months Ended September 30, | | Nine Months Ended September 30, |
| | 2024 | | 2023 | | 2024 | | 2023 |
Interest expense on liabilities related to future royalties and milestones, net (refer to Note 12) | | $ | 10,280 | | | $ | 5,014 | | | $ | 28,839 | | | $ | 14,878 | |
Cumulative catch-up adjustment arising from the liabilities related to future royalties and milestones, net (refer to Note 12) | | — | | | — | | | 10,870 | | | — | |
Other interest expense | | 406 | | | — | | | 420 | | | 61 | |
Total interest expense | | $ | 10,686 | | | $ | 5,014 | | | $ | 40,129 | | | $ | 14,939 | |
Note 5. Net loss per ordinary share
Basic and diluted net loss per ordinary share was calculated as follows (in thousands, except share and per share amounts):
| | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, | | Nine Months Ended September 30, |
| 2024 | | 2023 | | 2024 | | 2023 |
| Numerator | | | | | | | |
| Net loss | $ | (82,094) | | | $ | (45,849) | | | $ | (193,056) | | | $ | (131,212) | |
| Net loss - basic and diluted | $ | (82,094) | | | $ | (45,849) | | | $ | (193,056) | | | $ | (131,212) | |
| | | | | | | |
| Denominator | | | | | | | |
| Weighted-average number of ordinary shares used in net loss per share - basic and diluted | 266,084,589 | | | 173,984,101 | | | 251,480,521 | | | 173,890,666 | |
| Basic and diluted net loss per ordinary share | $ | (0.31) | | | $ | (0.26) | | | $ | (0.77) | | | $ | (0.75) | |
For all periods presented, outstanding but unvested restricted stock units, share options and warrants have been excluded from the calculation, because their effects would be anti-dilutive. Therefore, the weighted average number of ordinary shares used to calculate both basic and diluted loss per share is the same for all periods presented.
AUTOLUS THERAPEUTICS PLC
Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued
The following potentially dilutive securities have been excluded from the calculation of diluted net loss per share due to their anti-dilutive effect:
| | | | | | | | | | | |
| Three and Nine Months Ended September 30, |
| 2024 | | 2023 |
Unvested restricted stock units | 36,186 | | | 264,326 | |
Share options | 20,382,429 | | | 14,074,842 | |
| Warrants | 3,265,306 | | | 3,265,306 | |
Total potentially dilutive securities | 23,683,921 | | | 17,604,474 | |
Note 6. Fair value measurements
The Company uses valuation approaches that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible. The Company determines the fair value based on assumptions that market participants would use in pricing an asset or liability in the principal or most advantageous market. When considering market participant assumptions in fair value measurements, the following fair value hierarchy distinguishes between observable and unobservable inputs, which are categorized in of the following levels:
• Level 1 — Quoted prices in active markets for identical assets or liabilities.
• Level 2 — Inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly.
• Level 3 — Unobservable inputs that reflect the Company’s own assumptions about the assumptions market participants would use in pricing the asset or liability.
The carrying amounts reported in the balance sheet for cash and cash equivalents, restricted cash, prepaid expenses and other assets, accounts payable and accrued expenses and other liabilities approximate their fair value because of the short-term nature of these instruments.
The following tables present information about the Company’s financial assets measured at fair value on a recurring basis and indicate the level of the fair value hierarchy utilized to determine such fair values (in thousands):
| | | | | | | | | | | | | | | | | | | | | | | | | | | |
| September 30, 2024 | | |
| Total | | Quoted Prices in Active Markets for Identical Assets (Level 1) | | Significant Other Observable Inputs (Level 2) | | Significant Unobservable Inputs (Level 3) | | | | |
| Financial assets | | | | | | | | | | | |
Cash and cash equivalents: | | | | | | | | | | | |
Money market funds | $ | 596,387 | | | $ | 596,387 | | | $ | — | | | $ | — | | | | | |
| Total | $ | 596,387 | | | $ | 596,387 | | | $ | — | | | $ | — | | | | | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | |
| December 31, 2023 | | |
| Total | | Quoted Prices in Active Markets for Identical Assets (Level 1) | | Significant Other Observable Inputs (Level 2) | | Significant Unobservable Inputs (Level 3) | | | | |
| Financial assets | | | | | | | | | | | |
Cash and cash equivalents: | | | | | | | | | | | |
Money market funds | $ | 184,635 | | | $ | 184,635 | | | $ | — | | | $ | — | | | | | |
Total | $ | 184,635 | | | $ | 184,635 | | | $ | — | | | $ | — | | | | | |
During the three and nine months ended September 30, 2024 and the year ended December 31, 2023, there were no transfers between fair value levels.
AUTOLUS THERAPEUTICS PLC
Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued
Note 7. Prepaid Expenses and Other Current Assets
Prepaid expenses and other current assets consisted of the following (in thousands):
| | | | | | | | | | | |
| September 30, | | December 31, |
| 2024 | | 2023 |
| Research and development claims receivable | $ | 34,766 | | | $ | 19,209 | |
Prepayments | 14,057 | | | 8,638 | |
| VAT receivable | 3,140 | | | 2,771 | |
| Deferred cost | 2,237 | | | 1,787 | |
Other taxes receivable | 1,678 | | | — | |
Accrued interest income | 1,409 | | | 999 | |
Lease deposit receivable | 993 | | | 938 | |
Corporate tax receivable | 699 | | | — | |
Other receivables | 598 | | | 516 | |
| Accounts receivable | — | | | 109 | |
| Total prepaid expenses and other current assets | $ | 59,577 | | | $ | 34,967 | |
Note 8. Property and Equipment, Net
Property and equipment, net consisted of the following (in thousands):
| | | | | | | | | | | |
| September 30, | | December 31, |
| 2024 | | 2023 |
Lab equipment | $ | 42,857 | | | $ | 32,232 | |
Office equipment | 5,571 | | | 3,777 | |
Furniture and fixtures | 2,519 | | | 2,360 | |
Leasehold improvements | 15,055 | | | 12,728 | |
Assets under construction | 13,513 | | | 12,539 | |
Less: accumulated depreciation | (35,257) | | | (28,774) | |
Total property and equipment, net | $ | 44,258 | | | $ | 34,862 | |
Depreciation expense for the three months ended September 30, 2024 and 2023 was $1.9 million and $1.4 million, respectively, and for the nine months ended September 30, 2024 and 2023 was $5.6 million and $4.8 million, respectively.
Note 9. Accrued Expenses and Other Liabilities
Accrued expenses and other liabilities consisted of the following (in thousands):
| | | | | | | | | | | |
| September 30, | | December 31, |
| 2024 | | 2023 |
Research and development costs | $ | 20,093 | | | $ | 19,825 | |
Compensation and benefits | 15,444 | | | 14,757 | |
Professional fees | 7,584 | | | 4,466 | |
VAT accrual | 3,964 | | | — | |
| | | |
Other accrued liabilities | 403 | | | 533 | |
Total accrued expenses and other liabilities | $ | 47,488 | | | $ | 39,581 | |
AUTOLUS THERAPEUTICS PLC
Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued
Note 10. Shareholders’ Equity
Ordinary Shares
Each holder of ordinary shares is entitled to one vote per ordinary share and to receive dividends when and if such dividends are recommended by the Company’s board of directors and declared by the shareholders. As of September 30, 2024, the Company has not declared any dividends.
Restricted Stock Units
At September 30, 2024, restricted stock unit awards for 1,975 ordinary shares had vested but the underlying shares had not been issued. However, these vested restricted stock unit awards have been included in the calculation of the Company’s outstanding shares at September 30, 2024 as they are considered issuable for little or no cash consideration. Subsequent to September 30, 2024, all of the underlying ordinary shares were issued.
February 2024 Underwritten Offering
On February 12, 2024, the Company completed an underwritten offering of 58,333,336 ADSs representing 58,333,336 ordinary shares at an offering price of $6.00 per ADS. Aggregate net proceeds to the Company, after underwriting discounts and offering expenses, were $326.8 million.
BioNTech Securities Purchase Agreement
Concurrently with the execution of the BioNTech License and Option Agreement (see Note 1 and Note 3), the Company and BioNTech entered into the BioNTech Securities Purchase Agreement pursuant to which the Company sold ADSs, each representing one ordinary share, to BioNTech in a Private Placement transaction. On February 13, 2024, the Company completed the Private Placement of 33,333,333 ADSs representing 33,333,333 ordinary shares at an offering price of $6.00 per ADS. Aggregate net proceeds to the Company, after underwriting discounts and offering expenses, were $193.8 million.
In the event that BioNTech and the Company enter into the MCSA within 18 months of the initial closing of the Private Placement, BioNTech will purchase up to 15,000,000 ADSs for an aggregate purchase price of up to $20.0 million, subject to additional limitations and restrictions.
Note 11. Share-based Compensation
The following table summarizes the total share-based compensation expense included in the unaudited condensed consolidated statements of operations and comprehensive loss (in thousands):
| | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, | | Nine Months Ended September 30, |
| 2024 | | 2023 | | 2024 | | 2023 |
| Research and development | $ | 1,218 | | | $ | 1,525 | | | $ | 2,716 | | | $ | 4,982 | |
| General and administrative | 2,802 | | | 1,335 | | | 6,525 | | | 2,947 | |
| Capitalized | — | | | 4 | | | (2) | | | 19 | |
Total share-based compensation expense | $ | 4,020 | | | $ | 2,864 | | | $ | 9,239 | | | $ | 7,948 | |
AUTOLUS THERAPEUTICS PLC
Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued
Share Options
The table below summarizes Company’s share option activity during the nine months ended September 30, 2024: | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Number of
Options | | Weighted-
Average
Exercise
Price per share | | Weighted-
Average
Remaining
Contractual
Term
(Years) | | Aggregate Intrinsic Value (1) (in thousands) |
| | | | | | | | |
| | | | | | | | |
| | | | | | | | |
| | | | | | | | |
| | | | | | | | |
| | | | | | | | |
| | | | | | | | |
| | | | | | | | |
| | | | | | | | |
| | | | | | | | |
| | | | | | | | |
| | | | | | | | |
| | | | | | | | |
| Outstanding as of December 31, 2023 | | 17,956,385 | | | $ | 5.64 | | | 8.35 | | $ | 48,968 | |
| Granted | | 3,797,650 | | | 4.19 | | | | | 268 | |
| Exercised | | (214,398) | | | 2.77 | | | | | 480 | |
| Forfeited | | (902,906) | | | 3.30 | | | | | 857 | |
| Expired | | (254,302) | | | 9.41 | | | | | 5 | |
| Outstanding as of September 30, 2024 | | 20,382,429 | | | $ | 5.45 | | | 7.98 | | $ | 13,411 | |
| Exercisable as of September 30, 2024 | | 8,879,183 | | | $ | 8.13 | | | 6.88 | | $ | 4,561 | |
| Vested and expected to vest as of September 30, 2024 | | 20,382,429 | | | $ | 5.45 | | | 7.98 | | $ | 13,411 | |
| | | | | | | | |
(1) Aggregate intrinsic value is calculated as the difference between the exercise price of the underlying options and the fair value of ordinary shares for those options in the money as of September 30, 2024 |
During the nine months ended September 30, 2024, the Company modified the exercise period of 571,352 share options resulting in the recognition of incremental share-based compensation expense of $0.4 million.
The total intrinsic value of options exercised was $0.5 million for the nine months ended September 30, 2024.
The weighted average grant-date fair value of share options granted was $3.02 per share option for the nine months ended September 30, 2024.
As of September 30, 2024, the total unrecognized compensation expense related to unvested share options without performance conditions was $13.5 million, which the Company expects to recognize over a weighted average vesting period of 3.04 years.
As of September 30, 2024, the total unrecognized share-based compensation expense related to unvested share options with performance conditions was $2.9 million, which the Company expects to recognize when the performance condition becomes probable.
Restricted Stock Units
The table below summarizes Company’s restricted stock unit (“RSU”) awards activity during the nine months ended September 30, 2024:
| | | | | | | | | | | | | | |
| | Number of
restricted
units | | Weighted average
grant date
fair value |
| | | | |
| | | | |
| | | | |
| | | | |
| | | | |
| | | | |
| | | | |
| | | | |
| | | | |
| | | | |
| | | | |
| | | | |
| Unvested and outstanding at December 31, 2023 | | 116,436 | | | $ | 3.43 | |
| | | | |
| Vested | | (79,200) | | | 2.94 | |
| Forfeited | | (1,050) | | | 6.20 | |
Unvested and outstanding at September 30, 2024 | | 36,186 | | | $ | 4.43 | |
As of September 30, 2024, there was less than $0.1 million of unrecognized share-based compensation expense related to unvested RSUs without performance conditions, which is expected to be recognized over a weighted average period of 1.44 years.
AUTOLUS THERAPEUTICS PLC
Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued
Note 12. Liabilities related to future royalties and milestones, net
| | | | | | | | | | | |
| | | Amount in thousands |
Balance at 1 January, 2023 | | | $ | 125,900 | |
Interest expense on liability related to future royalties and milestones, net | | 4,905 | |
Balance at March 31, 2023 | | | $ | 130,805 | |
Interest expense on liability related to future royalties and milestones, net | | 4,959 | |
Balance at June 30, 2023 | | | $ | 135,764 | |
Interest expense on liability related to future royalties and milestones, net | | 5,014 | |
Balance at September 30, 2023 | | | $ | 140,778 | |
Interest expense on liability related to future royalties and milestones, net | | 5,014 | |
Cumulative catch-up adjustment | | 25,107 | |
Balance at December 31, 2023 | | | $ | 170,899 | |
| Initial recognition of BioNTech liability | | 38,335 | |
Interest expense on liability related to future royalties and milestones, net | | 8,390 | |
Cumulative catch-up adjustment | | 10,870 | |
Balance at March 31, 2024 | | | $ | 228,494 | |
Interest expense on liability related to future royalties and milestones, net | | 10,169 | |
Balance at June 30, 2024 | | | $ | 238,663 | |
Interest expense on liability related to future royalties and milestones, net | | 10,280 | |
| | |
Balance at September 30, 2024 | | | $ | 248,943 | |
During the three months ended September 30, 2024 and 2023, interest expense on liabilities related to future royalties and milestones, net amounted to $10.3 million and $5.0 million, respectively. During the nine months ended September 30, 2024 and 2023, interest expense on liabilities related to future royalties and milestones, net amounted to $28.8 million and $14.9 million, respectively.
During the three months ended September 30, 2024 and 2023 and nine months ended September 30, 2023, there was no cumulative catch-up adjustment (included in interest expense). During the nine months ended September 30, 2024, the cumulative catch-up adjustment amounted to $10.9 million.
Blackstone Collaboration Agreement
On November 6, 2021, the Company concurrently entered into the following agreements with BXLS V - Autobahn L.P, (“Blackstone”): (i) Strategic Collaboration Agreement (the “Blackstone Collaboration Agreement”), (ii) Securities Purchase Agreement (the “Blackstone Securities Purchase Agreement”), (iii) Warrant Agreement (the “Blackstone Warrant”) and (iv) a Registration Rights Agreement (the “Blackstone Registration Rights Agreement”). The Blackstone Collaboration Agreement, the Blackstone Securities Purchase Agreement, the Blackstone Warrant and the Blackstone Registration Rights Agreement are collectively referred to as the “Blackstone Agreements”. The Blackstone Agreements were entered into and in contemplation of one another and, accordingly, the Company assessed the accounting for the Blackstone Agreements in the aggregate.
For further details on the terms and accounting treatment considerations for these contracts, please refer to following notes to the Company’s consolidated financial statements contained in the Company’s Annual Report:
•Note 2, “Summary of significant accounting policies”
•Note 11, “Liability related to future royalties and milestones, net”
•Note 12, “Warrants”
•Note 13, “Shareholders’ equity”
AUTOLUS THERAPEUTICS PLC
Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued
In November 2021, the upfront payment of $50.0 million was paid by Blackstone upon execution of the Blackstone Collaboration Agreement. In December 2022, two Blackstone Development Payments were paid by Blackstone of $35.0 million each as a result of (i) the joint steering committee’s review of the Company’s interim analysis of pivotal FELIX Phase 2 clinical trial of obe-cel in r/r B-ALL and (ii) achievement of a pre-agreed manufacturing milestone as a result of completion of planned activities demonstrating the performance and qualification of the Company’s obe-cel’s manufacturing process. On November 8, 2024, the Company was notified by the FDA that the Company has been granted marketing approval for AUCATZYL for the treatment of adult patients (18 years and older) with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (r/r B-ALL). The remaining $30.0 million of Blackstone Development Payments are now payable to the Company as a result of such approval.
BioNTech Agreements
On February 6, 2024, the Company concurrently entered into the BioNTech Agreements.
For further details on the terms and accounting treatment considerations for these contracts, refer to following notes to these interim condensed consolidated financial statements:
•Note 1, “Nature of the business”
•Note 2, “Summary of significant accounting policies”
•Note 3, “License Revenue”
•Note 10, “Shareholders’ equity”
•Note 14, “Commitment and contingencies”
Obe-cel Product Revenue Interest
Under the BioNTech License and Option Agreement, BioNTech has agreed to financially support the expansion of the clinical development program for, and planned commercialization of obe-cel. In exchange for the grant of rights to future revenues from the sales of obe-cel products, BioNTech made an upfront payment to the Company of $40.0 million. The Company will pay BioNTech a low single-digit percentage of annual net sales of obe-cel products, which may be increased up to a mid-single digit percentage in exchange for milestone payments of up to $100.0 million in the aggregate on achievement of certain regulatory events for specific new indications upon BioNTech's election.
As the BioNTech License and Option Agreement has been accounted for as one freestanding financial instrument with various embedded features, (e.g. the Obe-cel Product Revenue Interest, milestone payments and royalties), the Company is required to consider if these embedded features are required to bifurcated from the host contract and therefore accounted for as a separate derivative. The Company determined the host contract to be debt-like and therefore the embedded features were analyzed pursuant to a debt host contract. The Company concluded the BioNTech License and Option Agreement (the host contract) should not be accounted as a derivative in accordance with ASC 815-10-15-59(d) but rather as a debt instrument under ASC 470.
The Company has accounted for the Obe-cel Product Revenue Interest as a liability primarily due to the Company’s significant continuing involvement in generating the royalty stream. The Company initially recognized the BioNTech Liability at $38.3 million being the face value less debt issuance costs. Once the Company commences commercial sales of AUCATZYL that generate royalties, the Company will recognize the portion of royalties paid to BioNTech as a decrease to the liability with a corresponding reduction in cash.
The carrying amount of the BioNTech Liability is based on the Company’s estimate of the future royalties to be paid to BioNTech to be received over the life of the arrangement as discounted using an effective interest rate. The excess or deficit of estimated present value of future royalties over the initial carrying amount, is recognized using the cumulative catch-up method within interest expense using the initial effective interest rate. The imputed rate of interest on the unamortized portion of the BioNTech Liability was approximately 28.70% as of February 6, 2024, the execution date of the BioNTech Agreements and September 30, 2024.
On a quarterly basis, the Company assesses the amount and timing of expected royalty using a combination of internal projections and forecasts from external sources. To the extent the present value of such payments is greater or less than its initial estimates or the timing of such payments is materially different than its original estimates, the Company will adjust the amortization of the BioNTech Liability using the cumulative catch-up method.
AUTOLUS THERAPEUTICS PLC
Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued
Note 13. Leases
Operating leases - Lessee
The Company leases certain office space, laboratory space, and equipment. At the inception of an arrangement, the Company determines whether the arrangement is or contains a lease based on the unique facts and circumstances present.
Since September 2017, the Company has had an arrangement with Cell Therapy Catapult Limited to lease manufacturing suites at the Cell and Gene Therapy Catapult manufacturing center in Stevenage, United Kingdom. In August 2024, one of the leased manufacturing suites ended and the Company exited the suite. In September 2024, the Company extended the lease term from August 2024 to March 2025 for the remaining manufacturing suite.
On September 19, 2023, the Company entered into a 20-year lease agreement with the landlord of The Nucleus. The Company made fit-out costs in other areas of the building which may be required to be removed at the end of the lease term. On September 10, 2024, the Company completed a variation of the lease for the manufacturing facility, related to additional works at the site. The landlord will provide funding for certain specified improvements to the facility (the “Works”), which the Company commits to undertake on a mutually agreed schedule. Funding received for the Works done are deemed lease incentives in accordance to ASC 842. Once the Works are complete, the rental payments under the lease will be increased according to a specified formula for the remainder of the lease term. The deed of variation does not affect the lease term, which continues to run for 20 years from September 19, 2023.
The Company’s costs as a lessee for the three and nine months ended September 30, 2024 and 2023 were as follows (in thousands):
| | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Three Months Ended September 30, | | Nine Months Ended September 30, |
| | 2024 | | 2023 | | 2024 | | 2023 |
| Operating lease costs | | $ | 2,155 | | | $ | 2,061 | | | $ | 6,340 | | | $ | 5,235 | |
| Variable costs | | 157 | | | 573 | | | 1,186 | | | 657 | |
| Short term lease costs | | 72 | | | 227 | | | 276 | | | 451 | |
| Total lease costs | | $ | 2,384 | | | $ | 2,861 | | | $ | 7,802 | | | $ | 6,343 | |
| | | | | | | | |
| | | | | | | | |
| | | | | | | | |
| | | | | | | | |
| | | | | | | | |
| | | | | | | | |
| | | | | | | | |
| | | | | | | | |
| | | | | | | | |
Supplemental cash flow information for the nine months ended September 30, 2024 and 2023 were as follows (in thousands):
| | | | | | | | | | | | | | | | | | | | |
| | | | Nine Months Ended September 30, |
| Other information | | | | 2024 | | 2023 |
| Cash paid for amounts included in the measurement of lease liabilities: | | | | |
Operating cash outflows from operating leases | | $ | 7,067 | | $ | 7,817 |
| | | | |
The weighted average remaining lease term and weighted average discount rate of operating leases at September 30, 2024 and 2023 were as follows:
| | | | | | | | | | | | | | | | | | | | |
| | | | Nine Months Ended September 30, |
| | | | 2024 | | 2023 |
| | | | |
| | | | |
| | | | |
| | | | | | |
Weighted-average remaining lease term - operating leases | | 15.6 years | | 15.9 years |
| Weighted-average discount rate - operating leases | | 8.14 | % | | 7.44 | % |
AUTOLUS THERAPEUTICS PLC
Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued
The maturities of operating lease liabilities as of September 30, 2024 were as follows (in thousands):
| | | | | | | | | | | | | | |
Remainder of 2024(1) | | | | $ | (1,941) | |
2025(1) | | | | (2,952) | |
2026(1) | | | | 8,514 | |
2027 | | | | 8,912 | |
| 2028 | | | | 8,156 | |
| Thereafter | | | | 88,819 | |
| Total lease payments | | | | 109,508 | |
| Less: imputed interest | | | | (57,279) | |
| Present value of lease liabilities | | | | $ | 52,229 | |
(1) Includes lease incentives from the Nucleus lease variation amounting to $4.5 million, $11.3 million and $0.9 million, for the year ended December 31, 2024, 2025 and 2026, respectively. |
Operating leases - Lessor (sublease agreements)
The Company subleases two manufacturing spaces in Enfield, U.K. to third parties. The annual lease payments to be received for each of the subleased units are £97,000 and £109,000, over lease terms from October 2021 to February 2029 and October 2021 to October 2026, respectively.
The following table shows the sublease rental income for the three and nine months ended September 30, 2024 and 2023 (in thousands):
| | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Three Months Ended September 30, | | Nine Months Ended September 30, |
| Sublease rental income | | 2024 | | 2023 | | 2024 | | 2023 |
Sublease rental income (included in other income (expense), net) | | $ | 63 | | | $ | 61 | | | $ | 186 | | | $ | 181 | |
| Total sublease rental income | | $ | 63 | | | $ | 61 | | | $ | 186 | | | $ | 181 | |
Future fixed receipts for non-cancellable operating subleases in effect as of September 30, 2024 are receivable as follows (in thousands):
| | | | | | | | |
Remainder of 2024 | | $ | 69 |
2025 | | $ | 276 |
2026 | | $ | 215 |
2027 | | $ | 130 |
| 2028 | | $ | 112 |
| | |
| Total lease payments receivable | | $ | 802 |
Note 14. Commitments and Contingencies
License Agreements
The Company has entered into an exclusive license agreement, as amended (the “UCLB License Agreement”), with UCL Business Ltd (“UCLB”). In connection with the UCLB License Agreement, the Company is required to make annual license payments and may be required to make payments to UCLB upon the achievement of specified milestones, including upon regulatory approval for obe-cel. During the three and nine months ended September 30, 2024, less than $0.1 million was paid or payable to UCLB by the Company, relating to the income allocable to the value of the sublicensed intellectual property rights. The BLA approval for AUCATZYL in the fourth quarter of 2024, resulted in the Company now being obligated to make a £10.0 million ($13.4 million translated at the balance sheet date spot rate) regulatory milestone payment in accordance with the UCLB license agreement, which the Company expects to pay in the first quarter of 2025.
AUTOLUS THERAPEUTICS PLC
Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued
In September 2023, the Company entered into a non-exclusive sublicense agreement with Miltenyi Biotech B.V. & Co. KG (“Miltenyi”) under which the Company received a sublicense related to the use of certain Miltenyi products in the Company’s development, manufacture and sale of its products. Under the agreement, the Company is obligated to make specified payments to Miltenyi upon the achievement of certain regulatory and clinical milestones. The Company recognized $0.4 million of expense in aggregate relating to an upfront license payment and milestone payments that were deemed probable during the year ended December 31, 2023. The Company recognized milestone payments of less than $0.1 million during the three and nine months ended September 30, 2024.
Contractual obligations
In July 2022, the Company renegotiated a master services agreement (the “Adaptive Master Services Agreement”) with Adaptive Biotechnologies Corporation (“Adaptive”), under which Adaptive's assay is used to analyze patient samples from r/r B-ALL patients. Under the agreement, the Company is obligated to make specified payments to Adaptive upon the achievement and receipt of certain regulatory approvals and achievement of commercial milestones in connection with the Company’s use of the Adaptive assay. During the year ended December 31, 2023, the Company recognized all contractual milestones relating to this contract, and as a result no contractual milestones were recognized during the three and nine months ended September 30, 2024.
In previous periods, the Company has entered into agreements with certain advisory firms. The Company is obligated to make specified payments upon the achievement of certain strategic transactions involving the Company. During the three and nine months ended September 30, 2024, the Company paid a fee under these agreements.
The Company has estimated the probability of the Company achieving each potential milestone in relation to the agreements with UCLB, Miltenyi and its agreements with certain advisory firms in accordance with ASC 450. The Company considers the regulatory approval, commercial milestones and execution of collaboration agreements probable when actually achieved. Furthermore, the Company recognizes expenses for clinical milestones when their achievement is deemed probable. The Company concluded that, as of September 30, 2024, there were no other milestones for which the likelihood of achievement was currently probable.
Capital Commitments
As of September 30, 2024, the Company’s unconditional purchase obligations for capital expenditures totaled $27.1 million and included signed orders for capital equipment and capital expenditures for construction and related expenditures relating to its properties in the United Kingdom and the United States. The Company expects to incur the full amount of these obligations within one year.
Master Supply Commitments
As of September 30, 2024, the Company’s unconditional purchase obligations with Miltenyi Biotec GmbH for reagents and consumables totaled $0.6 million, which the Company expects to incur within one year.
Distribution Commitments
The Company entered into an Exclusive Distribution Agreement, effective as of April 25, 2024 (the “Effective Date”), with Cardinal Health 105, LLC (“Cardinal Health”). Pursuant to, and subject to the terms and conditions of, the Exclusive Distribution Agreement, the Company engaged Cardinal Health as its exclusive third-party logistics distribution agent for sales of AUCATZYL in the US. The Exclusive Distribution Agreement runs for an initial term of three years following commercial launch and automatically renews for additional terms of one year each, unless either party elects not to renew. Under the terms of the Exclusive Distribution Agreement, the Company must pay to Cardinal Health a one-time start-up fee, and if the Company proceeds with commercialization of obe-cel, upon its launch, a monthly account management fee, and other fees for various services, including post-launch program implementation, information systems, warehouse operations and financial services.
Blackstone and BioNTech Agreements
Refer to Note 12, “Liabilities related to future royalties and milestones, net” for further details about the BioNTech Agreements and Blackstone Agreements.
AUTOLUS THERAPEUTICS PLC
Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued
BioNTech License and Option Agreement - Product Options gain contingency
As the Product Options within the BioNTech License and Option Agreement were an embedded feature within a freestanding financial instrument, the Company assessed if the Product Options should be accounted for as a derivative under ASC 815. However, the Company determined the Product Options met the scope exception for derivative accounting under ASC 815 and therefore should be accounted for a gain contingency under the scope of ASC 450. As of September 30, 2024, Product Options were not exercised and therefore no amounts were recognized.
Legal Proceedings
From time to time, the Company may be a party to litigation or subject to claims incident to the ordinary course of business. Regardless of the outcome, litigation can have an adverse impact on the Company because of defense and settlement costs, diversion of management resources and other factors. The Company was not a party to any litigation and did not have contingency reserves established for any liabilities as of September 30, 2024 and December 31, 2023.
Indemnification Agreements
In the normal course of business, the Company enters into contracts and agreements that contain a variety of representations and warranties and provide for general indemnification. The Company’s exposure under these agreements is unknown because they involve claims that may be made against the Company in the future. To date, the Company has not paid any claims or been required to defend any action related to its indemnification obligations. However, the Company may record charges in the future as a result of these indemnification obligations.
In accordance with the indemnification agreements entered into with relevant individuals in accordance with the Company’s Articles of Association, the Company has indemnification obligations to its directors, officers and members of senior management for certain events or occurrences, subject to certain limits, while they are serving at the Company’s request in such capacity. There have been no claims to date under these indemnification agreements, and the Company has director and officer insurance that may enable it to recover a portion of any amounts paid for future potential claims.
Note 15. Related party transactions
Blackstone Agreements
In November 2021, the Company concurrently entered into the Blackstone Agreements. As of the execution of the Blackstone Agreements, Blackstone became a related party of the Company, as Blackstone became the owner of more than 10% of the Company’s outstanding voting securities. In addition, Blackstone received and exercised its right to nominate one director to the board of directors of the Company and is therefore considered to be one of the principal owners of the Company.
As of September 30, 2024, the carrying amount of the Blackstone Collaboration Agreement Liability was $203.4 million which included aggregated cumulative non-cash interest expense and cumulative catch-up adjustment of $32.5 million. As of December 31, 2023, the carrying amount of the Blackstone Collaboration Agreement Liability was $170.9 million which included aggregated cumulative non-cash interest expense (including cumulative catch-up adjustments), of $45.0 million. Refer to Note 12, “Liabilities related to future royalties and milestones, net” for further details.
BioNTech Agreements
In February 2024, the Company concurrently entered into the BioNTech Agreements. Upon the execution of the BioNTech Agreements, BioNTech became a related party of the Company. BioNTech owns more than 10% of the Company’s outstanding voting securities and is therefore one of the principal owners of the Company. In addition, BioNTech has the right to nominate one director to the board of directors of the Company which BioNTech has not yet exercised.
As of September 30, 2024, the carrying amount of the BioNTech Liability was $45.5 million which included aggregated cumulative interest expense and cumulative catch-up adjustment of $5.5 million. Refer to Note 12, “Liabilities related to future royalties and milestones, net” for further details.
AUTOLUS THERAPEUTICS PLC
Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued
Note 16. Subsequent Events
The Company evaluated subsequent events through November 12, 2024, the date on which these unaudited condensed consolidated financial statements were issued.
On November 8, 2024 the Company was notified by the FDA that the Company has been granted marketing approval for AUCATZYL (obecabtagene autoleucel) for the treatment of adult patients (18 years and older) with r/r B-ALL.
As described in Note 12, the approval of the Company's BLA for obe-cel triggered the remaining $30.0 million of Blackstone Development payments payable to the Company in accordance with the terms of the Blackstone Collaboration Agreement. The Company expects to receive such amounts during the fourth quarter of 2024. The Company is also obligated to make a £10.0 million regulatory milestone payment in accordance with the UCLB License Agreement, also expected to occur in the first quarter of 2025, resulting in a net increase to cash and cash equivalents of $16.6 million (based on the spot rate at balance date as of September 30, 2024) following approval. These net proceeds are expected to be utilized as part of the Company's resources deployed to support commercialization of AUCATZYL.
Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations
The following discussion and analysis of our financial condition and results of operations should be read together with the unaudited condensed consolidated financial statements and the related notes to those statements included in this Quarterly Report on Form 10-Q. We also recommend that you read our discussion and analysis of financial condition and results of operations together with our audited financial statements and the notes thereto, which appear in our Annual Report as filed with the SEC.
We maintain our books and records in pounds sterling, our results are subsequently converted to U.S. dollars, and we prepare our consolidated financial statements in accordance with U.S. GAAP, as issued by the FASB. All references in this Quarterly Report on Form 10-Q to “$” are to U.S. dollars and all references to “£” are to pounds sterling. Our unaudited condensed Consolidated Statements of Operations and Comprehensive Loss and Cash Flows for the three months ended September 30, 2024 and 2023 have been translated from pounds sterling into U.S. dollars at the rate of £1.00 to $1.3008 and £1.00 to $1.2657, respectively. Our unaudited condensed Consolidated statements of Operations and Comprehensive Loss and Cash Flows for the nine months ended September 30, 2024 and 2023 have been translated from pounds sterling into U.S. dollars at the rate of £1.00 to $1.2768 and £1.00 to $1.2439, respectively. Our unaudited condensed Consolidated Balance Sheet as of September 30, 2024 and audited Consolidated Balance Sheet as of December 31, 2023 have been translated from pounds sterling into U.S. dollars at the rate of £1.00 to $1.3387 and £1.00 to $1.2730, respectively. These translations should not be considered representations that any such amounts have been, could have been or could be converted into U.S. dollars at those or any other exchange rate as of those or any other dates.
The statements in this discussion and analysis of our financial condition and results of operations regarding our expectations regarding our future performance, liquidity and capital resources and other non-historical statements are forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These risks and uncertainties include, but are not limited to, the risks and uncertainties set forth in the “Risk Factors” section of our Annual Report, this Quarterly Report and any subsequent reports that we file with the SEC.
Autolus, AUCATZYL and our other trademarks or service marks appearing in this report are our property. Solely for convenience, the trademarks and trade names in this report are referred to without the ® and TM symbols, but such references should not be construed as any indicator that their respective owners will not assert, to the fullest extent under applicable law, their rights thereto. Products or service names of other companies mentioned in this report may be trademarks, trade names or service marks of their respective owners.
Overview
We are an early commercial-stage biopharmaceutical company developing next-generation programmed T cell therapies for the treatment of cancer and autoimmune diseases. Using our broad suite of proprietary and modular T cell programming technologies, we are engineering precisely targeted, controlled and highly active T cell therapies that are designed to better recognize target cells, break down their defense mechanisms and attack and kill these cells. We believe our programmed T cell therapies have the potential to be best-in-class and to offer patients substantial benefits over the existing standard of care, including the potential for cure in some patients.
Since our inception, we have incurred significant operating losses. For the three months ended September 30, 2024 and 2023, we incurred net losses of $82.1 million and $45.8 million, respectively, and net losses of $193.1 million and $131.2 million for the nine months ended September 30, 2024 and 2023, respectively, and had an accumulated deficit of $1,071.6 million and $878.6 million as of September 30, 2024 and December 31, 2023, respectively.
As of September 30, 2024, we had cash and cash equivalents of $657.1 million. Based on our current clinical development and commercialization plans, we believe our existing cash and cash equivalents will be sufficient to fund our current and planned operating expenses and capital expenditure requirements through at least the next twelve months from the date of issuance of our unaudited condensed consolidated financial statements included in this report.
Recent Developments
Approval of obe-cel in the United States for adult relapsed / refractory (“r/r”) adult B-cell Acute Lymphoblastic Leukemia (“B-ALL”) under the brand name AUCATZYL
On November 8, 2024 we were notified by the U.S. Food and Drug Administration (“FDA”) that we have been granted marketing approval for AUCATZYL/obe-cel (obecabtagene autoleucel) for the treatment of adult patients (18 years and older) with r/r B-ALL. AUCATZYL/obe-cel for adult r/r B-ALL is also under regulatory review in both the EU and the U.K, with marketing authorization submissions accepted by the EMA in April 2024, and the U.K. MHRA in August 2024.
The approval of our Biologics License Application (“BLA”) for AUCATZYL triggered a $30.0 million milestone payment due to us from Blackstone in accordance with the terms of the Blackstone Collaboration Agreement as detailed under Note 12 to the financial statements included in this report. We are also obligated to make a £10.0 million regulatory milestone payment in accordance with the UCLB License Agreement, resulting in a net increase to cash and cash equivalents of $16.6 million (based on the spot rate at balance date as of September 30, 2024) as a result of the approval. These net proceeds are expected to be utilized as part of our resources deployed to support commercialization of AUCATZYL.
Obe-cel in r/r adult B-ALL – The FELIX Study
•We presented updated data from the FELIX trial at the Society of Hematologic Oncology (“SOHO”) meeting in August 2024 which supported our rationale for tumor burden-guided dosing by analyzing the impact of bone marrow blast percentage in patients treated with obe-cel. The data showed the importance of administering a split dose and highlighted the differentiation of obe-cel based on its binding properties and tumor burden-guided approach.
•In October 2024, we presented data at the 2024 Lymphoma, Leukemia & Myeloma Congress which suggested adult patients with r/r B-ALL can achieve comparable outcomes irrespective of the timing of stem cell transplant (“SCT”) either before or after infusion of obe-cel, suggesting no further benefit of consolidative transplant based on this post-hoc analysis. Additionally, obe-cel given as a sole treatment to patients with lower tumor burden at lymphodepletion was associated with better outcomes.
Obe-cel in B-cell mediated autoimmune diseases
•The Phase 1 dose confirmation trial (“CARLYSLE”) in refractory systemic lupus erythematosus (“SLE”) patients is ongoing. We expect to complete enrollment and patient dosing, as well as present initial data in first quarter of 2025. We anticipate that full data with adequate follow-up will be available for presentation in the second half of 2025 at a medical conference.
Pipeline programs in collaboration with University College London
•Clinical programs AUTO8, AUTO6NG and AUTO1/22 are progressing as expected and we are planning data updates for all programs in 2025.
Components of Our Results of Operations
Revenue
We account for our revenue pursuant to the provisions of ASC 606, Revenue from Contracts with Customers. Prior to the approval of AUCATZYL on November 8, 2024, we had no products approved for commercial sale, and we have not generated any revenue from commercial product sales as of September 30, 2024. The total revenue to date has been generated principally from out-licensing agreements. As of September 30, 2024, we had entered into various license agreements which included non-refundable upfront license fees, options for future commercial licenses, payments based upon achievement of clinical development and regulatory objectives, payments based upon achievement of certain levels of product sales, and royalties on licensed product sales.
In determining the appropriate amount of revenue to be recognized in relation to each license agreement, we perform the following steps: (i) identify the promised goods or services in the contract; (ii) determine whether the promised goods or services are performance obligations, including whether they are distinct in the context of the contract; (iii) measure of the transaction price, including the constraint on variable consideration; (iv) allocate the transaction price to the performance obligations based on estimated selling prices; and (v) recognize of revenue when (or as) we satisfy each performance obligation.
License Fees and Multiple Element Arrangements
If a license to our intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, we recognize revenues from non-refundable, upfront fees allocated to the license at such time as the license is transferred to the licensee and the licensee is able to use, and benefit from the license. For licenses that are bundled with other promises, we utilize judgment to assess the nature of the combined performance obligations to determine whether the combined performance obligations are satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue from non-refundable, upfront fees. We evaluate the measure of progress at each reporting period and, if necessary, adjust the measure of performance and related revenue recognition.
Appropriate methods of measuring progress include output methods and input methods. In determining the appropriate method for measuring progress, we consider the nature of service that we promise to transfer to the customer. When we decide on a method of measurement, we will apply that single method of measuring progress for each performance obligation satisfied over time and will apply that method consistently to similar performance obligations and in similar circumstances.
Customer Options
If an arrangement is determined to contain customer options that allow the customer to acquire additional goods or services, the goods and services underlying the customer options that are not determined to be material rights are not considered to be performance obligations at the outset of the arrangement, as they are contingent upon option exercise. We evaluate the customer options for material rights, or options to acquire additional goods or services for free or at a discount. If the customer options are determined to represent a material right, the material right is recognized as a separate performance obligation at the outset of the arrangement. We allocate the transaction price to material rights based on the relative standalone selling price, which is determined based on any identified discount and the probability that the customer will exercise the option. Amounts allocated to a material right are not recognized as revenue until, at the earliest, the option is exercised.
Contingent Research Milestone Payments
ASC 606 constrains the amount of variable consideration included in the transaction price in that either all, or a portion, of an amount of variable consideration should be included in the transaction price. The variable consideration amount should be included only to the extent that it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved. The assessment of whether variable consideration should be constrained is largely a qualitative one that has two elements: the likelihood of a change in estimate, and the magnitude thereof. Variable consideration is not constrained if the potential reversal of cumulative revenue recognized is not significant, for example.
If the consideration in a contract includes a variable amount, we will estimate the amount of consideration in exchange for transfer of promised goods or services. The consideration also can vary if our entitlement to the consideration is contingent on the occurrence or non-occurrence of a future event. We consider contingent research milestone payments to fall under the scope of variable consideration, which should be estimated for revenue recognition purposes at the inception of the contract and reassessed ongoing at the end of each reporting period.
We assess whether contingent research milestones should be considered variable consideration that should be constrained and thus not part of the transaction price. This includes an assessment of the probability that all or some of the milestone revenue could be reversed when the uncertainty around whether or not the achievement of each milestone is resolved, and the amount of reversal could be significant.
U.S. GAAP provides factors to consider when assessing whether variable consideration should be constrained. All of the factors should be considered, and no factor is determinate. We consider all relevant factors.
Royalty Revenue
For arrangements that include sales-based royalties, including milestone payments based on the level of sales, and the license is deemed to be the predominant item to which the royalties relate, we recognize revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied).
Research and Development Expenses
Research and development expenses (“R&D”) consist of costs incurred in connection with the research and development of our product candidates, which are partially offset by research and development tax credits, including tax credits arising from the U.K. small and medium enterprise (“SME”) regime and research and development expenditure credit (“RDEC”) regime provided by HMRC. We expense research and development costs as incurred. These expenses include:
•expenses incurred under agreements with CROs, as well as investigative sites and consultants that conduct our clinical trials, preclinical studies and other scientific development services;
•manufacturing scale-up expenses and the cost of acquiring and manufacturing preclinical and clinical trial materials;
•employee-related expenses, including salaries, related benefits, travel and share-based compensation expense for employees engaged in research and development functions;
•expenses incurred for outsourced professional scientific development services;
•costs for laboratory materials and supplies used to support our research activities;
•allocated facilities costs, depreciation and other expenses, which include rent and utilities; and
•upfront, milestone and management fees for maintaining licenses under our third-party licensing agreements.
We recognize external development costs based on an evaluation of the progress to completion of specific tasks using information provided to us by our service providers.
Our direct research and development expenses are tracked on a program-by-program basis for our product candidates and consist primarily of external costs, such as fees paid to outside consultants and CROs in connection with our preclinical development, manufacturing and clinical development activities. Our direct research and development expenses by program also include fees incurred under license agreements. We do not allocate employee costs or facility expenses, including depreciation or other indirect costs, to specific programs because these costs are deployed across multiple programs and, as such, are not separately classified. We use internal resources primarily to oversee research and development as well as for managing our preclinical development, process development, manufacturing and clinical development activities.
Research and development activities are central to our business model. Product candidates in later stages of clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials. As a result, we expect that our research and development expenses will increase substantially over the next few years as we increase personnel costs, initiate and conduct additional clinical trials and prepare regulatory filings related to our product candidates. We also expect to incur additional expenses related to milestone, royalty payments and maintenance fees payable to third parties with whom we have entered into license agreements to acquire the rights related to our product candidates.
After consultation, we have been advised by His Majesty Revenue and Customs (“HMRC”)that any sale of our obe-cel CAR T therapy to U.K. customers in the future will be considered an exempt supply from a U.K. VAT perspective. Consequently, we have assessed and restricted the amount of U.K. VAT we have historically reclaimed and will continue to do so in the future. The restriction will be based on the estimated U.K. market turnover as a percentage of global turnover. We currently expect revenue from U.K. customers to only represent a small proportion of our overall activity. If the proportion of revenue from U.K. customers increases this would further restrict the amount of U.K. input VAT recovered. Included in research and development expenses is historical irrecoverable input VAT previously claimed on research and development expenses and subsequently reversed.
The successful development and commercialization of our product candidates is highly uncertain. At this time, we cannot reasonably estimate or know the nature, timing and costs of the efforts that will be necessary to complete the clinical development of any of our product candidates or when, if ever, material net cash inflows may commence from sales of any of our product candidates. This uncertainty is due to the numerous risks and uncertainties associated with development and commercialization activities, including the uncertainty of:
•the scope, progress, outcome and costs of our clinical trials and other research and development activities, including establishing an appropriate safety profile with IND-directed studies;
•successful patient enrollment in, and the initiation and completion of, clinical trials;
•the timing, receipt and terms of any marketing approvals from applicable regulatory authorities;
•establishing commercial manufacturing capabilities or making arrangements with third-party manufacturers;
•development and timely delivery of commercial-grade drug formulations that can be used in our clinical trials and for commercial manufacturing;
•obtaining, maintaining, defending and enforcing patent claims and other intellectual property rights;
•significant and changing government regulation;
•launching commercial sales of our product candidates, if and when approved, whether alone or in collaboration with others;
•maintaining a continued acceptable safety profile of the product candidates following approval; and
•significant competition and rapidly changing technologies within the biopharmaceutical industry.
We may never succeed in achieving regulatory approval for any of our product candidates. We may obtain unexpected results from our clinical trials. We may elect to discontinue, delay or modify clinical trials of some product candidates or focus on others. Any changes in the outcome of any of these variables with respect to the development of our product candidates in clinical development could mean a significant change in the costs and timing associated with the development of these product candidates. For example, if the European Medicines Agency (“EMA”), the FDA, or another regulatory authority were to delay our planned start of clinical trials or require us to conduct clinical trials or other testing beyond those that we currently expect or if we experience significant delays in enrollment in any of our planned clinical trials, we could be required to expend significant additional financial resources and time on the completion of clinical development of that product candidate. Commercialization of our product candidates will take several years and millions of dollars in development costs.
U.K. Research and Development Tax Credits
The U.K. operates R&D tax incentive regimes. Under these regimes qualifying R&D expenditure incurred by U.K. companies can be included within R&D claims via the corporate tax return, resulting in reimbursable tax credits from the U.K. government.
As a company that carries out extensive R&D activities, we make claims under the U.K. R&D tax credit regime. This regime provides companies with a similar tax profile with a tax rebate at an effective rate of between 18.6% (for SME) and 27% (for intensive regime) of qualifying R&D expenditure in an accounting period. The regime’s rules are complex, and if a tax authority were to challenge or seek to disallow our claims (in whole or in part), for example by asserting that the relevant expenditure does not meet the technical conditions to be granted tax credits, then such challenge or disallowance could have a material impact on our cash-flow and financial performance. In addition, future legislative changes to the U.K. R&D tax credit regime may mean that we no longer qualify for it or have a material impact on the extent to which we can make claims (or benefit from them).
The SME regime has been particularly beneficial to us, as under this regime the trading losses that arise from our qualifying R&D activities can be surrendered for a cash rebate of up to 18.6% of qualifying expenditure incurred after April 1, 2023. Qualifying expenditures largely comprise employment costs for research staff, consumables, outsourced contract research organization costs and utilities costs incurred as part of research projects for which we do not receive income. A large proportion of costs in relation to our pipeline research, clinical trials management and manufacturing development activities, all of which are being carried out by our subsidiary Autolus Limited, are eligible for inclusion within these tax credit cash rebate claims.
On April 1, 2023, the headline rate under the RDEC regime increased from 13% to 20% and can generate cash rebates of up to 15% (increased from 10.5%) on qualifying R&D expenditure incurred from this date.
The benefit from U.K. RDEC and U.K. SME programs is recognized as income in the Consolidated Statement of Operations and Comprehensive Loss and is subject to tax at the prevailing rate (RDEC only).
Amendments to the current SME and RDEC programs that are contained in the Finance Act 2024 which was enacted on February 22, 2024 will take effect from periods on or after April 1, 2024 and will (i) (unless limited exceptions apply) introduce restrictions on the tax relief that can be claimed for expenditure incurred on subcontracted R&D activities or externally provided workers, where such sub-contracted activities are not carried out in the U.K. or such workers are not subject to U.K. payroll taxes, and (ii) merge the SME and RDEC programs into a single scheme which would generate net cash benefit of up to 15% of the qualifying expenditure for profit making companies and up to 16.2% for loss making companies. Nevertheless, the higher rate of 27% for R&D intensive SME companies will still be in effect from periods on or after April 1, 2024.
We currently meet the conditions of the SME regime, but we also can make claims under the RDEC regime to the extent that our projects are grant funded. We do not expect to qualify for the SME regime after December 31, 2024 due to an expected increase in employee headcount. If we cease to qualify under the SME regime, we may make a claim under the RDEC regime for periods ending December 31, 2024, or the merged R&D regime for the period ending December 31, 2025. It should be noted, however, that in some instances the types of qualifying expenditure which we may make claims under the RDEC regime differ to those under the SME regime (for example, it may be the case that certain subcontracted costs in respect of which claims may be made under the SME regime do not qualify for relief under the current RDEC regime).The subcontracted rules under the merged regime are more aligned to the current SME regime.
General and Administrative Expenses
General and administrative expenses consist primarily of salaries, related benefits, travel and share-based compensation expense for personnel in executive, finance, legal and other administrative functions. General and administrative expenses also include allocated facility-related costs, patent filing and prosecution costs and professional fees for marketing, insurance, legal, consulting, accounting and audit services. Included in general and administrative expenses is historical irrecoverable input VAT previously claimed on general and administrative expenses and subsequently reversed.
We anticipate that our general and administrative expenses will increase in the future as we increase our headcount to support the planned development of our product candidates. We anticipate an increase in salaries and related benefits as a result of our preparation for commercial operations, especially as it relates to the sales and marketing of AUCATZYL and our other product candidates.
We have experienced, and expect to continue to experience, increased expense with being a public company, including increased accounting, audit, legal, regulatory and compliance costs associated with maintaining compliance with Nasdaq listing rules and SEC requirements, director and officer insurance premiums, as well as higher investor and public relations costs. Additionally, should we fail to maintain our status as a foreign private issuer, we would expect to incur increased expenses to remain compliant with applicable SEC and Nasdaq requirements.
Loss on disposal of property and equipment
Loss on disposal of property and equipment primarily consists of losses arising from the disposal of all categories of property and equipment.
Impairment of operating lease right-of-use assets and related property and equipment
Impairment of operating lease right-of-use assets and related property and equipment consists primarily of impairment losses arising from the impairment of leased properties and leasehold improvements that are currently not be utilized by us.
Other income (expense), net
Other income (expense), net consists primarily sublease income and gains or losses arising from the termination of leases.
Foreign exchange (losses) gains
Foreign exchange (losses) gains consists primarily of foreign currency transaction gains and losses arising from transactions denominated in foreign currencies.
Interest Income
Interest income consists primarily of interest received from banks and money market funds on our cash and cash equivalents balances. We invest funds in a variety of short-term interest-bearing instruments.
Interest Expense
Interest expense consists primarily of interest expense arising from amortization of the liability related to future royalties and milestones, pursuant to our collaboration agreements with Blackstone and BioNTech, using the effective interest rate method. On a quarterly basis, we assess the expected present value of the future Blackstone and BioNTech payments under the Blackstone Collaboration Agreement and BioNTech Agreements which may be received by us and future royalties and sales milestone payments to Blackstone and BioNTech which may be paid by us. To the extent the amount or timing of such receipts or payments is materially different than our previous estimates we record a cumulative catch-up adjustment to the liability related to future royalties and milestones. The adjustment to the carrying amount is recognized as an adjustment to interest expense in the period in which the change in estimate occurred.
Income Tax (Expense) Benefit
We are subject to corporate taxation in the United Kingdom, United States, Germany and Switzerland. Due to the nature of our business, we have generated losses since inception. Our income tax benefit (expense) recognized represents the sum of the research and development tax credits recoverable in the U.K. and offset by income tax payable in the United States.
Un-surrendered U.K. losses may be carried forward indefinitely to be offset against future taxable profits, subject to numerous utilization criteria and restrictions. The amount that can be offset each year is limited to £5.0 million plus an incremental 50% of U.K. taxable profits. After accounting for tax credits receivable, we had accumulated tax losses for carry forward in the U.K. of $418.1 million at December 31, 2023. A valuation allowance has been recognized against our deferred tax asset relating to our U.K. losses. We carried a $3.4 million deferred tax asset balance related to the U.S. entity at September 30, 2024 for which there is no valuation allowance. At September 30, 2024, we recorded a full valuation allowance against the net deferred tax asset in the U.K., as the recoverability due to future taxable profits was uncertain. On April 1, 2023, the main rate of the U.K. corporation tax was increased to 25% for companies with profits in excess of £250,000, or the small profits rate of 19% for companies with profits of £50,000 or less (with marginal relief from the main rate available to companies with profits between £50,000 and £250,000).
In the event we generate revenues in the future, we may benefit from the U.K. “patent box” regime that allows profits attributable to revenues from patents or patented products to be taxed at an effective rate of 10%.
Results of Operations
Comparison of Three Months Ended September 30, 2024 and 2023
The following table summarizes our results of operations for the three months ended September 30, 2024, and 2023 (in thousands):
| | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, | | Change | | Change |
| 2024 | | 2023 | | (in thousands) | | (in percentage) |
| | | | | | | |
| License revenue | $ | — | | | $ | 406 | | | $ | (406) | | | (100) | % |
Operating expenses: | | | | | | | |
Research and development | (40,323) | | | (32,318) | | | (8,005) | | | 25 | % |
General and administrative | (27,330) | | | (10,611) | | | (16,719) | | | 158 | % |
Loss on disposal of property and equipment | (223) | | | — | | | (223) | | | 100 | % |
| Impairment of operating lease right-of-use assets and related property and equipment | — | | | (382) | | | 382 | | | (100) | % |
Total operating expenses, net | (67,876) | | | (42,905) | | | (24,971) | | | 58 | % |
| | | | | | | |
Other income, net | 54 | | | 136 | | | (82) | | | (60) | % |
Foreign exchange losses | (11,884) | | | (1,733) | | | (10,151) | | | 586 | % |
Interest income | 8,320 | | | 3,646 | | | 4,674 | | | 128 | % |
Interest expense | (10,686) | | | (5,014) | | | (5,672) | | | 113 | % |
Total other expense, net | (14,196) | | | (2,965) | | | (11,231) | | | 379 | % |
Net loss before income tax | (82,072) | | | (45,870) | | | (36,202) | | | 79 | % |
Income tax (expense) benefit | (22) | | | 21 | | | (43) | | | (205) | % |
Net loss | $ | (82,094) | | | $ | (45,849) | | | $ | (36,245) | | | 79 | % |
License Revenue
No license revenues were recognized for the three months ended September 30, 2024. License revenue amounting to $0.4 million for the three months ended September 30, 2023 primarily relates to revenue recognized arising from an existing license agreement with an investee of Syncona Portfolio Limited, which is a holder of more than 10% of our share capital.
Research and Development Expenses
The following tables provide additional detail on our research and development expenses (in thousands):
| | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, | | Change (in thousands) | | Change (in percentage) |
| 2024 | | 2023 | | |
Direct research and development expenses |
| |
| |
| | |
B cell malignancies (Obe-cel, AUTO1/22 & AUTO3) | $ | 7,729 | |
| $ | 4,779 | |
| $ | 2,950 | | | 62 | % |
Other projects (AUTO4, AUTO5, AUTO6, AUTO7 & AUTO8) | 132 | | | 761 | | | (629) | | | (83) | % |
Total direct research and development expense | $ | 7,861 | | | $ | 5,540 | | | $ | 2,321 | | | 42 | % |
| | | | | | | |
Indirect research and development expenses and unallocated costs: |
| |
| |
| | |
Personnel related (including share-based compensation) | $ | 23,129 | | | $ | 15,603 | | | 7,526 | | | 48 | % |
Indirect research and development expense* | 9,333 | | | 11,175 | | | (1,842) | | | (16) | % |
Total research and development expenses | $ | 40,323 | |
| $ | 32,318 | |
| $ | 8,005 | | | 25 | % |
* Indirect research and development expense is net of U.K. research and development tax credits | | |
Research and development expenses increased by $8.0 million to $40.3 million for the three months ended September 30, 2024 from $32.3 million for the three months ended September 30, 2023 primarily due to:
•an increase of $7.5 million in salaries and other employment related costs including share-based compensation expense, which was mainly driven by an increase in the number of employees engaged in research and development activities,
•an increase of $2.8 million in general office expenses primarily relating to historical irrecoverable input VAT due to a change in VAT treatment,
•an increase of $1.8 million in clinical costs primarily relating to our research and development activities, including transport costs of manufacturing consumables,
•an increase of $0.8 million in depreciation and amortization related to property and equipment, and
•an increase of $0.1 million in information technology infrastructure maintenance cost, offset in part by:
•a decrease of $3.5 million in professional consulting and legal fees in relation to our research and development activities,
•a decrease of $1.2 million in facilities costs, and
•an increase of $0.3 million in U.K. R&D tax credits (decrease in R&D expense) due primarily to an increase in qualifying research and development expenditures related to the SME scheme.
General and Administrative Expenses
General and administrative expenses increased by $16.7 million to $27.3 million for the three months ended September 30, 2024 from $10.6 million for the three months ended September 30, 2023 primarily due to:
•an increase of $9.1 million in salaries and other employment related costs including share-based compensation expense, which was mainly driven by an increase in the number of employees engaged in general and administrative activities,
•an increase of $7.2 million in costs related to commercial-stage readiness activities,
•an increase of $1.2 million in costs related to general office expenses, primarily relating to historical irrecoverable input VAT due to a change in VAT treatment, partially offset by:
•a decrease of $0.7 million in legal and professional fees related to our general and administrative activities, and
•a decrease of $0.1 million in depreciation and amortization related to property and equipment.
Loss on disposal of property and equipment
For the three months ended September 30, 2024, a loss on disposal of $0.2 million was recognized related to a manufacturing facility in Stevenage, U.K that we exited. There were no such disposals during the three months ended September 30, 2023.
Impairment of Operating Lease Right-of-use Assets and Related Property and Equipment
For the three months ended September 30, 2023, we recognized an impairment loss on operating lease right-of-use assets and related property and equipment of $0.4 million related to a leased property in Stevenage, United Kingdom. There was no similar impairment recognized for the three months ended September 30, 2024.
Foreign exchange losses
Foreign exchange losses increased to $11.9 million for the three months ended September 30, 2024 from $1.7 million for the three months ended September 30, 2023. The increase of $10.2 million was primarily due to the strengthening of the pound sterling exchange rate relative to the U.S. dollar resulting in a net foreign exchange loss.
Interest income
Interest income increased to $8.3 million for the three months ended September 30, 2024, as compared to $3.6 million for the three months ended September 30, 2023. The increase in interest income of $4.7 million primarily related to increase in yield and also higher account balances associated with our cash and cash equivalents during the three months ended September 30, 2024 as compared to the three months ended September 30, 2023.
Interest expense
Interest expense increased to $10.7 million for the three months ended September 30, 2024 as compared to $5.0 million for the three months ended September 30, 2023. Interest expense increased by $5.7 million primarily due to an increase in the balance of the liabilities for future royalties and milestones, net associated with our Collaboration Agreement with Blackstone and the BioNTech License and Option Agreement which was executed in February 2024.
Comparison of Nine Months Ended September 30, 2024 and 2023
The following table summarizes our results of operations for the nine months ended September 30, 2024, and 2023 (in thousands):
| | | | | | | | | | | | | | | | | | | | | | | |
| Nine Months Ended September 30, | | Change (in thousands) | | Change (in percentage) |
| 2024 | | 2023 | | |
| | | | | | | |
| License revenue | $ | 10,091 | | | $ | 1,698 | | | $ | 8,393 | | | 494 | % |
Operating expenses: | | | | | | | |
Research and development | (107,606) | | | (92,938) | | | (14,668) | | | 16 | % |
General and administrative | (67,410) | | | (31,017) | | | (36,393) | | | 117 | % |
| Loss on disposal of property and equipment | (223) | | | (3,791) | | | 3,568 | | | (94) | % |
| Impairment of operating lease right-of-use assets and related property and equipment | (414) | | | (382) | | | (32) | | | 8 | % |
Total operating expenses, net | (165,562) | | | (126,430) | | | (39,132) | | | 31 | % |
| | | | | | | |
Other income, net | 161 | | | 109 | | | 52 | | | 48 | % |
Foreign exchange losses | (12,368) | | | (442) | | | (11,926) | | | 2698 | % |
Interest income | 24,908 | | | 10,495 | | | 14,413 | | | 137 | % |
Interest expense | (40,129) | | | (14,939) | | | (25,190) | | | 169 | % |
Total other expense, net | (27,428) | | | (4,777) | | | (22,651) | | | 474 | % |
Net loss before income tax | (192,990) | | | (131,207) | | | (61,783) | | | 47 | % |
Income tax expense | (66) | | | (5) | | | (61) | | | 1220 | % |
Net loss | $ | (193,056) | | | $ | (131,212) | | | $ | (61,844) | | | 47 | % |
License Revenue
License revenue amounting to $10.1 million for the nine months ended September 30, 2024 related to license revenue recognized pursuant to the License and Option Agreement with BioNTech. License revenue of $1.7 million for the nine months ended September 30, 2023 primarily related to the execution of the Cabaletta Bio Inc. (“Cabaletta”) Option and License Agreement, which included recognition of a non-refundable license fee and license revenue from an investee of Syncona Portfolio Limited, which is a holder of more than 10% of our share capital.
Research and Development Expenses
The following tables provide additional detail on our research and development expenses (in thousands):
| | | | | | | | | | | | | | | | | | | | | | | |
| Nine Months Ended September 30, | | Change (in thousands) | | Change (in percentage) |
| 2024 | | 2023 | | |
Direct research and development expenses |
| |
| |
| | |
B cell malignancies (Obe-cel, AUTO1/22 & AUTO3) | $ | 19,750 | |
| $ | 12,933 | |
| $ | 6,817 | | | 53 | % |
Other projects (AUTO4, AUTO5, AUTO6, AUTO7 & AUTO8) | 1,176 | | | 2,304 | | | (1,128) | | | (49) | % |
Total direct research and development expense | $ | 20,926 | | | $ | 15,237 | | | $ | 5,689 | | | 37 | % |
| | | | | | | |
Indirect research and development expenses and unallocated costs: |
| |
| |
| | |
Personnel related (including share-based compensation) | 56,604 | | | 46,485 | | | 10,119 | | | 22 | % |
| | | | | | | |
Indirect research and development expense | 30,076 | | | 31,216 | | | (1,140) | | | (4) | % |
Total research and development expenses | $ | 107,606 | |
| $ | 92,938 | |
| $ | 14,668 | | | 16 | % |
* Indirect research and development expense is net of U.K. research and development tax credits | | |
Research and development expenses increased by $14.7 million to $107.6 million for the nine months ended September 30, 2024 from $92.9 million for the nine months ended September 30, 2023 primarily due to:
•an increase of $10.1 million in salaries and other employment related costs, including share-based compensation expense, which was mainly driven by an increase in the number of employees engaged in research and development activities,
•an increase of $6.9 million in clinical costs primarily relating to our research and development activities including transport costs of manufacturing consumables,
•an increase of $2.7 million in general office expenses primarily relating to historical irrecoverable input VAT due to a change in VAT treatment,
•an increase of $1.2 million in facilities costs related primarily to our new manufacturing facility, The Nucleus, in Stevenage, U.K. as well as increases in costs related to maintaining our current leased properties, and
•an increase of $1.0 million in depreciation and amortization related to property and equipment, offset in part by:
•a decrease of $5.0 million in professional consulting and legal fees in relation to our research and development activities,
•an increase of $1.6 million in U.K. R&D tax credits (decrease in R&D expense) due primarily to an increase in qualifying research and development expenditures related to the SME scheme, and
•a decrease of $0.6 million in information technology infrastructure maintenance costs.
General and Administrative Expenses
General and administrative expenses increased by $36.4 million to $67.4 million for the nine months ended September 30, 2024 from $31.0 million for the nine months ended September 30, 2023 primarily due to:
•an increase of $20.4 million in salaries and other employment related costs, including share-based compensation expense, which was mainly driven by an increase in the number of employees engaged in general and administrative activities,
•an increase of $12.0 million in costs related to commercial-stage readiness activities,
•an increase of $1.7 million in legal and professional fees related to our general and administrative activities,
•an increase of $1.2 million in costs related to general office expenses, primarily relating to historical irrecoverable input VAT due to a change in VAT treatment,
•an increase of $0.9 million related to information technology infrastructure and support for information systems related to the conduct of corporate and commercial operations, and
•an increase of $0.2 million in facility costs due to the increase in space utilized for general and administrative activities and related to general office expense,
Loss on disposal of property and equipment
For the nine months ended September 30, 2024, a loss on disposal of $0.2 million was recognized related to a manufacturing facility in Stevenage, U.K that we exited. For the nine months ended September 30, 2023, we recognized a loss on disposal of property and equipment of $3.8 million related to fixed assets no longer being utilized in the manufacturing facility exited in Stevenage, United Kingdom.
Impairment of Operating Lease Right-of-use Assets and Related Property and Equipment
For the nine months ended September 30, 2024, respectively, we recognized an impairment loss on operating lease right-of-use assets and related property and equipment of $0.4 million related to a leased property in Enfield, United Kingdom. For the nine months ended September 30, 2023, we recognized an impairment loss on operating lease right-of-use assets and related property and equipment of $0.4 million related to a leased property in Stevenage, United Kingdom.
Foreign exchange losses
Foreign exchange losses increased to $12.4 million for the nine months ended September 30, 2024 from $0.4 million for the nine months ended September 30, 2023. The increase of $12.0 million was primarily due to the strengthening of the pound sterling exchange rate relative to the U.S. dollar resulting in a net foreign exchange loss.
Interest Income
Interest income increased to $24.9 million for the nine months ended September 30, 2024, as compared to $10.5 million for the nine months ended September 30, 2023. The increase in interest income of $14.4 million primarily related to increase in yield and also higher account balances associated with our cash and cash equivalents during the nine months ended September 30, 2024 as compared to the nine months ended September 30, 2023.
Interest expense
Interest expense increased to $40.1 million for the nine months ended September 30, 2024 as compared to $14.9 million for the nine months ended September 30, 2023. Interest expense increased by $25.2 million primarily due to an increase in the balance of the liabilities for future royalties and milestones, net associated with our Collaboration Agreement with Blackstone and the BioNTech License and Option Agreement which was executed in February 2024.
Liquidity and Capital Resources
Since our inception, we have not generated any commercial product revenue and have incurred operating losses and negative cash flows from our operations. We expect to incur significant expenses and operating losses for the foreseeable future as we market AUCATZYL and advance our other product candidates through preclinical and clinical development and seek regulatory approval and pursue commercialization of any additional approved products. As a result, we will need significant additional capital to fund our operations until such time as we can generate significant revenue from sales of AUCATZYL or other products.
As of November 8, 2024, we have one product approved for commercial sale in the United States, AUCATZYL, but have not yet generated any revenue from commercial product sales. We have funded our operations to date primarily with proceeds from government grants, sales of our equity securities, through public offerings and pursuant to our at-the-equity market facility, through U.K. research and development tax credits and receipts from the SME and RDEC schemes, out-licensing arrangements and strategic collaboration and financing agreements. From our inception in 2014 through September 30, 2024, we have raised an aggregate of $1.7 billion from these capital sources.
As of September 30, 2024, we had cash and cash equivalents of $657.1 million.
Cash Flows
The following table summarizes our cash flows for each of the periods presented (in thousands):
| | | | | | | | | | | |
| Nine Months Ended September 30, |
| 2024 | | 2023 |
Net cash used in operating activities | $ | (168,337) | | | $ | (120,754) | |
Net cash used in investing activities | (10,963) | | | (9,509) | |
Net cash provided by (used in) financing activities | 559,547 | | | (906) | |
Effect of exchange rate changes on cash, cash equivalents and restricted cash | 37,955 | | | 5,257 | |
Net increase (decrease) in cash, cash equivalents and restricted cash | $ | 418,202 | | | $ | (125,912) | |
Net Cash Used in Operating Activities
During the nine months ended September 30, 2024, operating activities used $168.3 million of cash, resulting from our net loss of $193.1 million and net cash used resulting from changes in our operating assets and liabilities of $20.7 million, partially offset by non-cash charges of $45.4 million. The non-cash charges related to interest expense including cumulative catch-up adjustments on liabilities related to future royalties and milestones, net of $39.7 million, share-based compensation of $9.2 million, depreciation and amortization of $5.6 million, non-cash operating lease expense of $3.5 million, impairment of operating lease right-of-use assets and related property and equipment of $0.4 million, loss on disposal of property and equipment of $0.2 million and loss on termination of operating lease of $0.2 million, which was offset by foreign exchange differences of $13.1 million and deferred income tax movement of $0.3 million. Net cash used in operating activities resulting from changes in our operating assets and liabilities for the nine months ended September 30, 2024 consisted primarily of a net increase of $21.6 million in prepaid expenses and other current and non-current assets and a decrease of $4.1 million in our operating lease liability, offset by an increase in accrued expenses and other liabilities of $3.7 million and an increase in accounts payable of $1.3 million.
During the nine months ended September 30, 2023, operating activities used $120.8 million of cash, resulting from our net loss of $131.2 million, and net cash used resulting from changes in our operating assets and liabilities of $23.5 million, partially offset by non-cash charges of $33.9 million. The non-cash charges related to interest expense including cumulative catch-up adjustments on liabilities related to future royalties and milestones, net of $14.9 million, share-based compensation of $7.9 million, depreciation and amortization of $4.8 million, loss on disposal of property and equipment of $3.8 million, non-cash operating lease expense of $2.9 million, impairment of operating lease right-of-use assets and related property and equipment of $0.4 million and loss on termination of operating lease of $0.1 million, which was offset by deferred income tax movement of $0.5 million and foreign exchange differences of $0.4 million. Net cash used in operating activities resulting from changes in our operating assets and liabilities for the nine months ended September 30, 2023 consisted primarily of a $12.0 million decrease in current and non-current operating lease liabilities, a decrease in accrued expenses and other liabilities of $6.8 million, net of operating lease right of use assets, and a net increase of $5.7 million in prepaid expenses and other current and non-current assets, offset by a decrease in long-term deposits of $0.9 million and an increase in accounts payable of $0.1 million.
Net Cash Used in Investing Activities
During the nine months ended September 30, 2024 and 2023, we used $11.0 million and $9.5 million, respectively, of cash in investing activities, all of which consisted of purchases of property and equipment.
Net Cash Provided by (Used in) Financing Activities
During the nine months ended September 30, 2024, net cash provided by financing activities of $559.5 million related to net aggregate proceeds raised from the BioNTech Agreements and our underwritten offering of ADSs. During the nine months ended September 30, 2023, net cash used in financing activities of $0.9 million was primarily for payments of issuance costs relating to a prior equity financing.
Funding Requirements
We expect our expenses to increase substantially in connection with our ongoing activities, particularly as we begin to market and sell AUCATZYL, operate our new commercial manufacturing facility and advance the preclinical activities and clinical trials of our other product candidates. Our expenses will increase as we:
•establish and expand our sales, marketing and distribution infrastructure in connection with commercializing AUCATZYL and other product candidates for which we may obtain marketing approval and intend to commercialize on our own or jointly;
•seek regulatory approvals for any other product candidates that successfully complete preclinical and clinical trials;
•hire additional clinical, medical and development personnel;
•expand our infrastructure and facilities to accommodate our growing employee base; and
•maintain, expand and protect our intellectual property portfolio.
Our primary uses of capital are compensation and related expenses, clinical costs, external research and development services, laboratory and related supplies, legal and other regulatory expenses, and administrative and overhead costs. Our future funding requirements will be heavily determined by the resources needed to support the development of our product candidates and commercialization of AUCATZYL. We also expect to incur significant commercialization expenses related to product manufacturing, sales, marketing and distribution, depending on where we choose to commercialize. We may also require additional capital to pursue in-licenses or acquisitions of other product candidates.
Based on our current clinical development and commercial plans, we believe our current cash and cash equivalents will be sufficient to fund our current and planned operating expenses and capital expenditure requirements for at least the next twelve months from the date of the issuance of these unaudited condensed consolidated financial statements. We have based these estimates on assumptions that may prove to be wrong, and we could utilize our available capital resources sooner than we expect.
Because of the numerous risks and uncertainties associated with research, development and commercialization of pharmaceutical product candidates, we are unable to estimate the exact amount of our working capital requirements. Our future funding requirements will depend on and could increase significantly as a result of many factors, including:
•our ability to continue to execute our commercialization strategies for AUCATZYL and, if approved, our other product candidates;
•the scope, progress, outcome and costs of our clinical trials and other research and development activities;
•the costs, timing, receipt and terms of any marketing approvals from applicable regulatory authorities;
•the costs of future activities, including product sales, medical affairs, marketing, manufacturing and distribution, for AUCATZYL or any of our product candidates for which we receive marketing approval;
•the revenue, if any, received from commercial sale of AUCATZYL or our other product candidates, should any receive marketing approval;
•the costs and timing of hiring new employees to support our continued growth;
•the costs of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending intellectual property-related claims; and
•the extent to which we in-license or acquire additional product candidates or technologies.
Until such time, if ever, that we can generate product revenue sufficient to achieve profitability, we expect to finance our cash needs through a combination of public or private equity offerings, reimbursable U.K. research and development tax credits and receipts from the SME and RDEC schemes, out-licensing agreements, or strategic collaboration agreements. To the extent that we raise additional capital through the sale of equity, the ownership interest of existing shareholders will be diluted. If we raise additional funds through other third-party funding, collaborations agreements, strategic alliances, out-licensing agreements or marketing and distribution arrangements, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds when needed, we may be required to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market products or product candidates that we would otherwise prefer to develop and market ourselves.
Critical Accounting Policies and Significant Judgments and Estimates
Our management's discussion and analysis of our financial condition and results of operations is based on our unaudited condensed consolidated financial statements, which we have prepared in accordance with U.S. GAAP. The preparation of our unaudited condensed consolidated financial statements and related disclosures requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, costs and expenses, and the disclosure of contingent assets and liabilities in our unaudited condensed consolidated financial statements. We base our estimates on historical experience, known trends and events and various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. We evaluate our estimates and assumptions on an ongoing basis. Our actual results may differ from these estimates under different assumptions or conditions.
Below we have included an update to our significant judgments and accounting estimates from those included in our Annual Report.
Allocation of transaction price using the relative standalone selling price
Upfront payments are allocated between performance obligations using our best estimate of the relative standalone selling price of the performance obligation. The relative standalone selling price is estimated by determining the market values of development and license obligations. As these inputs are not directly observable, the estimate is determined considering all reasonably available information including internal pricing objectives used in negotiating the contract, taking into account the different stage of development of each development program and consideration of adjusted-market data from comparable arrangements. Where performance obligations have been identified relating to material rights, the determination of the relative standalone selling price of these performance obligations also includes an assessment of the likelihood that the options will be exercised and any payments by the customer that are triggered upon exercising the right. This assessment involves significant judgment and could have a significant impact on the amount and timing of revenue recognition.
An assessment of the allocation of transaction price using the relative standalone selling price was required for the nine months ended September 30, 2024 and 2023 for the BioNTech License and Option Agreement, the Research, Option and License Agreement with Cabaletta and Research, Option and License Agreement with an investee of Syncona Portfolio Limited, respectively.
Liabilities related to future royalties and milestones, net and cumulative catch-up adjustments
We accounted for the Blackstone Collaboration Agreement and the BioNTech Obe-cel Product Revenue Interest, (“BioNTech Liability”) as liabilities measured at amortized cost based on an effective interest rate determined at the outset of the arrangement. The Blackstone Collaboration Agreement Liability related to future royalties and sales milestones, net is measured based on our current estimates of the timing and amount of expected future royalty and milestone payments to be paid and the Blackstone Development Payments expected to be received over the estimated term of the agreement. Similarly, the BioNTech Liability related to future royalties is measured based on our current estimates of the timing and amount of expected future royalty expected to be paid over the estimated term of the agreement. Milestone payments (“BioNTech Milestone Payments”) pursuant to the BioNTech License and Option Agreement are payable upon BioNTech's election, and therefore have not been included in the determination of the effective interest rate or in the measurement of the liability.
The liabilities are amortized using the effective interest rate, resulting in recognition of interest expense over the estimated term of the agreement. Each reporting period we assess the estimated probability, timing and amount of the future expected royalty, milestone payments, the Blackstone Development Payment over the estimated term. If there are changes to the estimates, we recognize the impact to the liability’s amortization schedule and the related interest expense using the catch-up method.
Our estimate of the probability, timing and amount of expected future royalties and milestones to be paid by us and the expected Blackstone Development Payment to be paid to us, considers significant unobservable inputs. These inputs include regulatory approval, the estimated patient population, estimated selling price, estimated sales, estimated peak sales and sales ramp, timing of the expected launch and its impact on the royalties as well as the overall probability of a success. Additionally, the transaction costs associated with the liability will be amortized to interest expense over the estimated term of the agreements.
The carrying amount of the Blackstone Collaboration Agreement Liability and BioNTech Liability is based on our estimate of the future royalties, milestones to be paid to Blackstone by us and the expected Blackstone Development Payment to be received over the life of the arrangement as discounted using the initial effective interest rate. The excess or deficit of estimated present value of future royalty, milestone payments and the future Blackstone Development Payment received over the carrying amount is recognized as a cumulative catch-up adjustment within interest expense using the effective interest rate.
Contractual Obligations
As of September 30, 2024, other than disclosed within Notes 12 to 14 to our unaudited condensed consolidated financial statements included in this report, there have been no material changes to our contractual obligations and commitments from those described under “Management’s Discussion and Analysis of Financial Condition and Results of Operations” included in our Annual Report.
Recent Accounting Pronouncements Not Yet Adopted
A description of recently issued accounting pronouncements that may potentially impact our financial position and results of operations is disclosed in Note 2, “Summary of Significant Accounting Policies,” to our unaudited condensed consolidated financial statements included in in this Quarterly Report.
Item 3. Quantitative and Qualitative Disclosures about Market Risk
We are exposed to market risks in the ordinary course of our business, which are principally limited to interest rate fluctuations and foreign currency exchange rate fluctuations. We maintain significant amounts of cash that are in excess of federally insured limits in various currencies, placed with one or more financial institutions for varying periods according to expected liquidity requirements.
Interest Rate Risk
Our exposure to interest rate sensitivity is primarily impacted by changes in the underlying U.S. and U.K. bank interest rates. As of September 30, 2024 and December 31, 2023, we had cash and cash equivalents of $657.1 million and $239.6 million, respectively. Our surplus cash has been invested in interest-bearing savings and money market funds. We have not entered into investments for trading or speculative purposes. An immediate hypothetical one percentage point change in interest rates would have resulted in a $1.8 million increase in interest income on our unaudited condensed Consolidated Statements of Operations and Comprehensive Loss for the nine months ended September 30, 2024.
As of September 30, 2024 the Blackstone Collaboration Agreement Liability has a fixed effective interest rate and is not subject to any fluctuations due to interest rates. However, the effective interest rate for the BioNTech Liability may be subject to fluctuations due to the discretionary nature of certain contractual payments to us. We have no other debt outstanding that is subject to interest rate variability. The carrying amount of the Blackstone Collaboration Agreement Liability and BioNTech Liability is based on our estimate of the future royalties, milestones to be paid to Blackstone by us and the expected Blackstone Development Payment to be received over the life of the arrangement as discounted using the initial effective interest rate. The excess or deficit of estimated present value of future royalty, milestone payments and the future Blackstone Development Payment received over the carrying amount is recognized as a cumulative catch-up adjustment within interest expense using the effective interest rate.
Foreign Currency Exchange Risk
Foreign currency risk is the risk that the fair value or future cash flows of a financial instrument will fluctuate because of changes in foreign exchange rates. Our exposure to the risk of changes in foreign exchange rates relates primarily to fluctuations in value of foreign currency cash and cash equivalent balances held by our main operating subsidiary in the United Kingdom, our operating activities in the United States, and outsourced supplier agreements denominated in currencies other than pound sterling. We minimize foreign currency risk by maintaining cash and cash equivalents of each currency at levels sufficient to meet foreseeable expenditure to the extent practical.
As of September 30, 2024, substantially of our cash and cash equivalents were held by one of our U.K. subsidiaries, of which approximately 29% were denominated in pound sterling and approximately 71% were denominated in U.S. dollars, with immaterial amounts denominated in euros and Swiss francs. The significant remainder of our cash and cash equivalents are held by our U.S. subsidiary and denominated in U.S. dollars.
Changes in exchange rates had a material impact on U.S. dollar balances held by our main operating subsidiary in the U.K., which resulted in material foreign exchange gains and losses in the Consolidated Statements of Operations and Comprehensive Loss due to the appreciation and depreciation of the subsidiary’s U.S. dollars in pounds sterling terms. Further movements in exchange rates or returns to previous exchange rate levels have caused, and may continue to cause, material fluctuations or equivalent losses in the Consolidated Statements of Operations and Comprehensive Loss.
We maintain our accounting records in pounds sterling, our functional currency, and present our consolidated financial statements in U.S. dollars for financial reporting purposes. Monetary assets and liabilities denominated in currencies other than the functional currency are translated into the functional currency at rates of exchange prevailing at the balance sheet dates. Non-monetary assets and liabilities denominated in foreign currencies are translated into the functional currency at the exchange rates prevailing at the date of the transaction. Exchange gains or losses arising from foreign currency transactions are included in the determination of net income (loss) for the respective periods. We recorded foreign exchange losses of $11.9 million and $1.7 million for the three months ended September 30, 2024 and 2023, respectively, and foreign exchange losses of $12.4 million and $0.4 million for the nine months ended September 30, 2024 and 2023, respectively, which are included in other income (expense), net in the unaudited condensed Consolidated Statements of Operations and Comprehensive Loss.
Assets and liabilities are translated at the exchange rates at the balance sheet dates and revenue and expenses are translated at the average exchange rates and shareholders’ equity is translated based on historical exchange rates. Translation adjustments are not included in determining net income (loss) but are included in foreign exchange adjustment to accumulated other comprehensive income (loss), a component of shareholders’ equity.
We do not currently engage in currency hedging activities in order to reduce our currency exposure, but we may begin to do so in the future. These instruments may be used to selectively manage risks, but there can be no assurance that we will be fully protected against material foreign currency fluctuations.
Item 4. Controls and Procedures
Evaluation of Disclosure Controls and Procedures
We maintain “disclosure controls and procedures,” as defined in Rule 13a-15(e) and Rule 15d-15(e) under the Exchange Act, that are designed to ensure that information required to be disclosed by us in the reports that we file or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms, and is accumulated and communicated to our management, including our principal executive and principal financial officers, as appropriate to allow timely decisions regarding required disclosure. In designing and evaluating our disclosure controls and procedures, management recognizes that disclosure controls and procedures, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the disclosure controls and procedures are met. Additionally, in designing disclosure controls and procedures, our management applied judgement in evaluating the cost-benefit relationship of possible disclosure controls and procedures.
The design of any system of controls also is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions; over time, controls may become inadequate because of changes in conditions, or the degree of compliance with policies or procedures may deteriorate. Because of the inherent limitations in a control system, misstatements due to error or fraud may occur and not be detected.
Our management, with the participation of our Chief Executive Officer and Chief Financial Officer, has evaluated the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e)) under the Exchange Act as of September 30, 2024. Based on such evaluation, our Chief Executive Officer and Chief Financial Officer have concluded that, as of September 30, 2024, our disclosure controls and procedures were not effective due to control deficiencies in our internal control over financial reporting which constituted a material weakness.
In connection with the review of our unaudited condensed consolidated financial statements for the quarter ended March 31, 2024, we identified a material weakness in relation to accounting for complex transactions. The material weakness did not allow us to identify, understand and evaluate the impact of certain key aspects of the accounting for the BioNTech Agreements. Our process as designed was inadequate to deal with the complexity of the accounting for the transaction and did not allow for an effective and timely evaluation of key aspects of the agreements and their impact on the financial statements.
Our remediation plan includes a redesign of the process for dealing with complex accounting transactions which will allow us to identify, understand and evaluate the impact of any key judgements, estimates or other factors which might have a material impact on the financial statements. Our plan for remediation will encompass: (i) structured project plans allowing us to manage multiple stakeholders, including any specialists we use in our work on complex accounting transactions; (ii) the use of summary outputs allowing for earlier review of key judgements, estimates and other factors which impact the financial statements; and (iii) enhancing our review process and controls, including building in more time to allow for their effective operation.
Changes in Internal Control over Financial Reporting
Except as described above, there were no changes in our internal control over financial reporting (as defined in Rule 13a-15(f) of the Exchange Act) that occurred during the three months ended September 30, 2024 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
PART II - OTHER INFORMATION
Item 1. Legal Proceedings.
From time to time, we may become involved in legal proceedings arising in the ordinary course of our business. We are not currently a party to any material legal proceedings, and we are not aware of any pending or threatened legal proceeding against us that we believe could have an adverse effect on our business, operating results or financial condition.
Item 1A. Risk Factors.
Our business is subject to numerous risks. You should carefully consider and evaluate each of the following factors as well as the other information in this Quarterly Report on Form 10-Q, including our financial statements, and related notes, the risk factors discussed in our Annual Report on Form 10-K, which we filed with the SEC on March 21, 2024, in evaluating our business and prospects. The risks and uncertainties described below are not the only ones we face. Additional risks and uncertainties not presently known to us or that we currently consider immaterial may also impair our business operations. If any of the following risks actually occur, our business and financial results could be harmed. In that case, the trading price our ADSs could decline. You should also consider the more detail description of our business contained in our Annual Report on Form 10-K.
Risks Related to Our Financial Position and Need For Capital
We are an early commercial stage biopharmaceutical company and have incurred significant losses since our inception. We expect to continue to incur losses for the foreseeable future.
We are an early commercial stage biopharmaceutical company with a limited operating history, and we have incurred significant net losses since our inception in 2014. We have incurred losses of $208.4 million, $148.8 million and $142.1 million for the years ended December 31, 2023, 2022 and 2021, respectively. As of December 31, 2023, we had an accumulated deficit of $878.6 million. We have funded our operations to date primarily with proceeds from the sale of our equity securities, including ADSs, licensing and collaboration arrangements and strategic financing.
We currently have one product, AUCATZYL (obe-cel), approved for commercial sale, and while we have generated revenue from licensing, we are devoting substantially all of our financial resources and efforts to manufacturing and commercializing AUCATZYL and for the research and development of our other programmed T cell product candidates and T cell programming technologies. Investment in biopharmaceutical product development is highly speculative because it entails substantial upfront operating and capital expenditures and significant risk that any potential product candidate will fail to demonstrate adequate effect or an acceptable safety profile, gain regulatory approval and become commercially viable.
Should we be unsuccessful in our commercialization efforts for AUCATZYL or if the rates of market acceptance do not meet our expectations, we may not generate sufficient revenue. We expect that it could take several years until any of our other product candidates receive marketing approval and are commercialized, and we may never be successful in obtaining marketing approval and commercializing any of our other product candidates, including obe-cel in additional indications. We expect to continue to incur significant expenses and increasing operating losses for the foreseeable future. These net losses will adversely impact our shareholders’ equity and net assets and may fluctuate significantly from quarter to quarter and year to year. We anticipate that our expenses will increase substantially as we:
•expand our sales, marketing and distribution infrastructure to commercialize AUCATZYL/obe-cel and any other product candidate for which we may obtain regulatory approval;
•make required milestone, royalty and revenue sharing payments to third parties under license and collaboration agreements;
•continue to scale up internal and external manufacturing capacity with the aim of securing sufficient quantities to meet our capacity requirements for commercialization of AUCATZYL and clinical trials of our other product candidates;
•continue our ongoing and planned research and development of our current programmed T cell product candidates for the treatment of hematological cancers, solid tumors and autoimmune diseases;
•seek to discover and develop additional product candidates and further expand our clinical product pipeline;
•initiate preclinical studies and clinical trials for any additional product candidates that we may pursue in the future, including our planned development of additional T cell therapies for the treatment of hematological cancers, solid tumors and autoimmune diseases;
•seek regulatory approvals for any product candidates that successfully complete clinical trials;
•develop, maintain, expand and protect our intellectual property portfolio;
•acquire or in-license other product candidates and technologies;
•hire additional clinical, quality control and manufacturing personnel;
•add clinical, operational, financial and management information systems and personnel, including personnel to support the commercial development of AUCATZYL, as well as our other product development and future commercialization efforts;
•expand our operations in the United States, Europe and other geographies; and
•incur additional legal, accounting and other expenses associated with operating as a public company.
To become and remain profitable, we must succeed in commercializing AUCATZYL and developing and eventually commercializing other products that generate significant revenue. This will require us to be successful in a range of challenging activities, including marketing and selling AUCATZYL and any future products for which we may obtain regulatory approval, completing preclinical studies and clinical trials of our product candidates, preparing a satisfactory filing package for regulatory authorities, obtaining regulatory approval, manufacturing, marketing and selling any products for which we may obtain regulatory approval, as well as discovering and developing additional product candidates. We may never succeed in these activities and, even if we do, may never generate revenues that are significant enough to achieve profitability.
Because of the numerous risks and uncertainties associated with the development, manufacturing, delivery and commercialization of complex autologous cell therapies, we are unable to accurately predict the timing or amount of expenses or when, or if, we will be able to achieve profitability. If we are required by regulatory authorities to perform studies in addition to those currently expected, or if there are any delays in the initiation and completion of our clinical trials or the development of any of our product candidates, our expenses could increase and profitability could be further delayed.
Even if we achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis. Our failure to become and remain profitable would depress the value of our ADSs and could impair our ability to raise capital, expand our business, maintain our research and development efforts or continue our operations. A decline in the value of our ADSs could also cause you to lose all or part of your investment.
We will need additional funding to successfully commercialize AUCATZYL and to complete the development of and commercialize our other product candidates, which may not be available on acceptable terms, if at all.
Unless and until we are able to successfully commercialize AUCATZYL and achieve significant revenue from sales, we will require substantial additional funding to meet our financial needs and to pursue our business objectives. If we are unable to raise capital when needed, we could be forced to delay, reduce or altogether cease our product development programs or commercialization efforts.
Since our inception, we have devoted substantially all of our resources to fund the operating expenses and capital expenditure requirements associated with the research and development of AUCATZYL and our other product candidates. Even once we begin to generate revenue from sales of AUCATZYL, we will need to raise additional capital to reach profitability as well as to complete the development and commercialization of our other programmed T cell product candidates, and in connection with our continuing operations, strategy and other planned activities. Our future capital requirements will depend on many factors, including:
•our ability to execute our commercialization strategies for and generate revenue from sales of AUCATZYL and, if approved, our other product candidates;
•the progress, results and costs of laboratory testing, manufacturing, and preclinical and clinical development of our current and future product candidates;
•the timing and amounts of any milestone, royalty payments or revenue sharing payments we may be required to make under current or future license or collaboration agreements;
•the costs of leasing, building out, equipping, and operating the facilities necessary to research, develop, manufacture and commercialize our product candidates, as well as to support our continuing operations;
•the costs of hiring additional clinical, quality control and manufacturing personnel;
•the costs, timing and outcome of regulatory review of our product candidates;
•the costs and timing of commercialization activities, including product manufacturing, marketing, sales and distribution, for any future product candidates for which we receive marketing approval;
•the costs and timing of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending any intellectual property-related claims; and
•the costs of operating as a public company.
Identifying potential product candidates and conducting preclinical testing and clinical trials is a time-consuming, expensive and uncertain process that takes years to complete, and we may never generate the necessary data or results required to obtain regulatory approval and achieve product sales. In addition, AUCATZYL, or our other product candidates, if approved, may not achieve commercial success. Our product revenues in the near term will be derived primarily from sales of AUCATZYL in the US, as we that we do not expect to generate material revenues from obe-cel in other jurisdictions or from other pipeline programs, for up to several years, if at all. Accordingly, we will need to continue to rely on additional financing to achieve our business objectives. Adequate additional financing may not be available to us on acceptable terms, or at all. In addition, we may seek additional capital due to favorable market conditions or strategic considerations even if we believe we have sufficient funds for our current or future operating plans.
To the extent that we raise additional capital through the sale of equity or convertible debt securities, our shareholders may experience substantial dilution. We may sell ordinary shares or ADSs, convertible securities or other equity securities in one or more transactions at prices and in a manner we determine from time to time. If we sell ordinary shares or ADSs, convertible securities or other equity securities in more than one transaction, investors may be materially diluted by subsequent sales. These sales may also result in material dilution to our existing shareholders, and new investors could gain rights superior to our existing shareholders. In February 2024, we issued an aggregate of approximately 91.7 million ADSs in an underwritten offering and a private placement, resulting in substantial dilution for existing shareholders. Debt financing and preferred equity financing, if available, could result in fixed payment obligations, and we may be required to accept terms that restrict our ability to incur additional indebtedness, force us to maintain specified liquidity or other ratios or restrict our ability to pay dividends or make acquisitions.
If we raise additional funds through collaborations, strategic alliances or marketing, distribution or licensing arrangements with third parties, we may be required to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates or to grant licenses on terms that may not be favorable to us. In addition, we could also be required to seek funds through arrangements with collaborators or others at an earlier stage than otherwise would be desirable. If we raise funds through research grants, we may be subject to certain requirements, which may limit our ability to use the funds or require us to share information from our research and development. If we are unable to raise additional funds through equity or debt financings when needed, we may be required to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to a third party to develop and market product candidates that we would otherwise prefer to develop and market ourselves. Raising additional capital through any of these or other means could adversely affect our business and the holdings or rights of our shareholders and may cause the market price of our ADSs to decline.
We have incurred substantial obligations under license and collaboration agreements, which could impair our flexibility and access to other capital and adversely affect our financial position, and our business would be adversely affected if we were unable to meet our obligations under these and similar future agreements.
In November 2021, we entered into a collaboration agreement with Blackstone (the “Blackstone Collaboration Agreement”) pursuant to which Blackstone agreed to pay us up to $150 million to support the continued development and commercialization of AUCATZYL/obe-cel and next-generation product candidates (collectively, the “Collaboration Products”) in exchange for our agreement to make substantial payments to Blackstone following approval of such Collaboration Products. These payments include a single-digit percentage payment on worldwide net sales of (i) the Collaboration Products in any indication and (ii) AUTO3 for the treatment of B-cell leukemias and lymphomas, by us and any of our licensees, as well as sales milestone payments relating to such net sales. Such payments to Blackstone could increase our cash requirements and could impair our liquidity. Through December 31, 2023, Blackstone paid $120 million to us under the terms of the Blackstone Collaboration Agreement. Following the approval of AUCATZYL, we expect to receive the remaining $30 million in the fourth quarter of 2024.
In connection with the Collaboration Agreement, Blackstone was granted a security interest in substantially all of our assets. The Collaboration Agreement also contains negative covenants that restrict us from (a) granting liens on certain of our assets, including liens on the intellectual property relating to the Collaboration Products, except for certain permitted liens, (b) making distributions or dividends, except for certain permitted distributions, (c) entering into development or commercialization license transactions with respect to the Collaboration Products, except that we are permitted to enter into any such development or commercialization license transactions with certain pharmaceutical companies, including those companies that have annual sales in excess of an agreed threshold, (d) consummating certain change in control transactions, (e) selling royalties or entering into similar financials transactions involving the sale of revenues or royalties, or (f) acquiring subsidiaries without joining such subsidiary as a party to the Blackstone Collaboration Agreement. These restrictions could inhibit our ability to pursue our business strategies and may limit our ability to, among other things, incur secured indebtedness, encumber assets, pay dividends or make other distributions to holders of our capital stock, license-out the Collaboration Products, complete mergers or acquisitions, or sell royalties. However, the security interest and negative covenants will expire upon the first commercial sale of AUCATZYL.
If we default under our obligations under the Blackstone Collaboration Agreement, we will be obligated to pay Blackstone liquidated damage payments in excess of the development payment paid by Blackstone. If we fail to make such payments, Blackstone could elect to exercise its remedies in respect of the security interest, which would seriously harm our business and ability to continue as a going concern.
Under the BioNTech License Agreement with BioNTech entered into in February 2024, we also agreed to pay BioNTech a low single-digit percentage of annual net revenue of AUCATZYL/obe-cel, which may be increased up to a mid-single digit percentage, in exchange for milestone payments of up to $100 million in the aggregate on achievement of certain regulatory events for specific new indications upon BioNTech's election. Such payments to BioNTech could increase our cash requirements and could impair our liquidity.
Risks Related to the Commercialization of AUCATZYL and Our Other Product Candidates
AUCATZYL and any other product candidates, if approved, may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for commercial success, thereby limiting our potential to generate revenue.
AUCATZYL and any other product candidates, if approved, may not achieve market acceptance among physicians, patients, hospitals, including pharmacy directors, and third-party payors and, ultimately, may not be commercially successful. If these products do not achieve an adequate level of acceptance, we may not generate significant product revenue and may not become profitable. FDA’s investigation into secondary malignancies associated with CAR T cell therapies and other similar actions could result in increased government regulation, unfavorable public perception and publicity, stricter labeling requirements for AUCATZYL and those product candidates that are approved, and a decrease in demand for AUCATZYL or any such product candidates. The degree of market acceptance of AUCATZYL, and any other product candidates, if approved for commercial sale, will depend on a number of factors, including:
•the timing of market introduction of those products compared to competitive products;
•the continued safety and efficacy of those products;
•the clinical indications for which our product candidates are approved;
•physicians, hospitals, cancer treatment centers, and patients considering our product and product candidates as a safe and effective treatment;
•hospitals and cancer treatment centers establishing the infrastructure required for the administration of redirected T cell therapies;
•the potential and perceived advantages of our product and product candidates over alternative treatments;
•the prevalence and severity of any side effects;
•product labeling or product insert requirements of the FDA, the European Commission or other regulatory authorities;
•limitations or warnings contained in the labeling approved by the FDA or the European Commission;
•the cost of treatment in relation to alternative treatments;
•the amount of upfront costs or training required for physicians to administer our product and product candidates;
•the availability of coverage, adequate reimbursement, and pricing by third-party payors and government authorities;
•the willingness and ability of patients to pay out-of-pocket in the absence of comprehensive coverage and adequate reimbursement by third-party payors and government authorities;
•relative convenience and ease of administration, including as compared to alternative treatments and competitive therapies; and
•the effectiveness of our sales and marketing efforts and distribution support.
Our efforts to educate physicians, patients, third-party payors and others in the medical community on the benefits of AUCATZYL and our other product candidates, if approved, may require significant resources and may never be successful. Such efforts may require more resources than are typically required due to the complexity and uniqueness of our product candidates. Because we expect sales of AUCATZYL and any future products, if approved, to generate substantially all of our product revenue for the foreseeable future, the failure of those products to find market acceptance would harm our business and could require us to seek additional financing.
In addition, although we are not utilizing embryonic stem cells or replication competent vectors, adverse publicity due to the ethical and social controversies surrounding the therapeutic use of such technologies, and reported side effects from any clinical trials using these technologies or the failure of such trials to demonstrate that these therapies are safe and effective, may limit market acceptance our product candidates.
Even if our products achieve market acceptance, we may not be able to maintain that market acceptance over time if new products or technologies are introduced that are more favorably received than our products, are more cost effective or render our products obsolete.
If we are unable to fully develop our sales, marketing and distribution capability on our own , or enter into sales, marketing and distribution agreements with third parties, we may not be successful in commercializing AUCATZYL, or our other product candidates, if and when approved.
We have spent significant resources to build our global commercialization capabilities in anticipation of the commercial launch of AUCATZYL. To achieve commercial success for AUCATZYL or any other product candidate for which we may obtain marketing approval, we will need to maintain a sales and marketing organization and establish logistics and distribution processes to commercialize and deliver our product candidates to patients and healthcare providers. The development of sales, marketing and distribution capabilities has required and will continue to require substantial resources, will be time-consuming and could delay any product launch. We currently have limited resources compared to some of our competitors, and the continued development of our own commercial organization to market our medicines and any additional medicines we may acquire will be expensive and time-consuming. In addition, none of the members of our sales force have promoted any medicine for treatment of adult r/r B-ALL prior to the launch of AUCATZYL. We have spent and will continue to expend significant time and resources to train our sales force to be able to educate physicians on the benefits of prescribing and pharmacists dispensing AUCATZYL. Furthermore, we must train our sales force to ensure that a consistent and appropriate message about AUCATZYL is being delivered to our potential customers. We may experience turnover of the sales representatives that we hired or will hire, requiring us to train new sales representatives. If we are unable to effectively train our sales force and equip them with effective materials, including medical and sales literature to help them inform and educate physicians about the benefits of AUCATZYL and its proper administration and label indication, as well as our patient assistance programs, our efforts to successfully commercialize AUCATZYL could jeopardize, which could have a material adverse effect on our financial condition, share price and operations.
If we are unable or decide not to establish internal sales, marketing and distribution capabilities, in any territory, we would have to pursue collaborative arrangements regarding the sales and marketing of our products. However, we may not be successful in entering into arrangements with third parties to sell, market and distribute AUCATZYL/obe-cel or our other product candidates or may be unable to do so on terms that are favorable to us, or if we are able to do so, that they would be effective and successful in commercializing our products. Our product revenues and our profitability, if any, would likely be lower than if we were to sell, market and distribute AUCATZYL/obe-cel and any other product candidates that we develop ourselves. In addition, we would have limited control over such third parties, and any of them may fail to devote the necessary resources and attention to sell and market AUCATZYL/obe-cel and any of our other product candidates effectively.
The incidence and prevalence for target patient populations for AUCATZYL and our other product candidates have not been established with precision. If the market opportunities for AUCATZYL and our other product candidates are smaller than we estimate, our revenue and ability to achieve profitability will be adversely affected, possibly materially.
The total addressable market opportunity for AUCATZYL and our other product candidates will ultimately depend upon, among other things, acceptance by the medical community and patient access, product pricing and reimbursement as well as expansion into additional markets. The number of patients who may benefit from AUCATZYL or our other future products may turn out to be lower than expected, patients may not be otherwise amenable to treatment with our products, or new patients may become increasingly difficult to identify or gain access to, all of which would adversely affect our results of operations and our business. We may not be successful in our efforts to identify additional product candidates. Due to our limited resources and access to capital, we must prioritize development of certain product candidates, which may prove to be the wrong choice and may adversely affect our business.
We operate in a rapidly changing industry and face significant competition, which may result in others discovering, developing or commercializing products before or more successfully than we do.
The development and commercialization of new biopharmaceutical products is highly competitive and subject to rapid and significant technological advancements. We face competition from major multi-national pharmaceutical companies, biotechnology companies and specialty pharmaceutical companies with respect to our current and future product candidates that we may develop and commercialize in the future. There are a number of large pharmaceutical and biotechnology companies that currently market and sell products or are pursuing the development of product candidates for the treatment of cancer. Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large, established companies. Potential competitors also include academic institutions, government agencies and other public and private research organizations.
Due to their promising clinical therapeutic effect in clinical exploratory trials, engineered T cell therapies, redirected T cell therapies in general and antibody-drug conjugates are being pursued by multiple biotechnology and pharmaceutical companies, including Novartis AG (“Novartis”), Gilead Sciences, Inc. (“Gilead”), Bristol-Myers Squibb (“BMS”), Janssen Biotech Inc., TwoSeventy Bio Inc., Legend Biotech Corp., GSK plc, AstraZeneca Plc, Pfizer Inc., BioNTech, Astellas Pharma Inc., ADC Therapeutics SA, Roche Holding AG, Seattle Genetics, and Amgen Inc. Our competitors may succeed in developing, acquiring or licensing technologies and products that are more effective, more effectively marketed and sold or less costly than any product candidates that we may develop, which could render our product candidates non-competitive and obsolete.
We have received marketing approval from the FDA for AUCATZYL for the treatment of adult r/r B-ALL. Novartis, Gilead and BMS have also received marketing approval for anti-CD19 CAR T cell therapies. Gilead's therapy was approved for the treatment of adult ALL in October 2021. AUCATZYL is expected to compete directly with these companies and therapies. In addition, some companies, such as Cellectis, Inc., Les Laboratoires Servier SAS, Allogene Therapeutics Inc., Lyell Immunopharma, Cargo Therapeutics and Crispr Therapeutics AG are pursuing allogenic T cell products that could compete with our programmed T cell product candidates.
Novartis, Gilead and BMS may be successful in establishing a strong market position for their CD19-targeted CAR T cell products, and we may not be able to compete effectively against these therapies once they have been established.
Our commercial opportunity could be reduced or eliminated if our competitors develop and commercialize products that are safer, more effective, have fewer or less severe side effects, are more convenient or are less expensive or better reimbursed than any products that we may commercialize. Our competitors also may obtain FDA, European Commission or other regulatory approval for their products more rapidly than we may obtain approval for ours, which could result in our competitors establishing a strong market position for either the product or a specific indication before we are able to enter the market.
Many of our competitors, either alone or with their strategic collaborators, have substantially greater financial, technical and human resources than we do. Accordingly, our competitors may be more successful than we are in obtaining approval for treatments and achieving widespread market acceptance, which may render our treatments obsolete or non-competitive. Mergers and acquisitions in the biotechnology and pharmaceutical industries may result in even more resources being concentrated among a smaller number of our competitors.
These competitors also compete with us in recruiting and retaining qualified scientific and management personnel and establishing clinical trial sites and patient registration for clinical studies, as well as in acquiring technologies complementary to, or necessary for, our programs. Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies.
Coverage and adequate reimbursement may not be available for AUCATZYL or our current or any future product candidates, which could make it difficult for us to sell profitably, if approved.
Market acceptance and sales of our product and any product candidates that we commercialize, if approved, will depend in part on the extent to which reimbursement for these products and related treatments will be available from third-party payors, including government health administration authorities, managed care organizations and private health insurers. Third-party payors decide which therapies they will pay for and establish reimbursement levels. Third-party payors in the United States often rely upon Medicare coverage policy and payment limitations in setting their own coverage and reimbursement policies. However, decisions regarding the extent of coverage and amount of reimbursement to be provided for our product or any product candidates that we develop, once approved, will be made on a payor-by-payor basis. One payor’s determination to provide coverage for a drug does not assure that other payors will also provide coverage for the drug. Additionally, a third-party payor’s decision to provide coverage for a therapy does not imply that an adequate reimbursement rate will be approved. Third-party payors are increasingly challenging the price, examining the medical necessity and reviewing the cost-effectiveness of medical products, therapies and services, in addition to questioning their safety and efficacy. We may incur significant costs to conduct expensive pharmaco-economic studies in order to demonstrate the medical necessity and cost-effectiveness of our product, and product candidates, once approved, in addition to the costs required to obtain FDA approvals. Our product and product candidates, once approved, may not be considered medically necessary or cost-effective by third-party payors.
Each payor determines whether or not it will provide coverage for a therapy, what amount it will pay the manufacturer for the therapy, and on what tier of its list of covered drugs, or formulary, it will be placed. The position on a payor’s formulary, generally determines the co-payment that a patient will need to make to obtain the therapy and can strongly influence the adoption of such therapy by patients and physicians. Patients who are prescribed treatments for their conditions and providers prescribing such services generally rely on third-party payors to reimburse all or part of the associated healthcare costs. Patients are unlikely to use our products, and providers are unlikely to prescribe our products, unless coverage is provided and reimbursement is adequate to cover a significant portion of the cost of our products and their administration. Therefore, coverage and adequate reimbursement is critical to new medical product acceptance.
A primary trend in the U.S. healthcare industry and elsewhere is cost containment. Third-party payors have attempted to control costs by limiting coverage and the amount of reimbursement for particular medications. We cannot be sure that coverage and reimbursement will be available for our product or any product candidates and, if reimbursement is available, what the level of reimbursement will be. Even if favorable coverage and reimbursement status is attained for our product or any product candidates for which we receive regulatory approval, less favorable coverage policies and reimbursement rates may be implemented in the future. Inadequate coverage and reimbursement may impact the demand for, or the price of, any drug for which we obtain marketing approval. If coverage and adequate reimbursement are not available, or are available only to limited levels, we may not be able to successfully commercialize our current and any future product candidates that we develop.
Additionally, we are developing a proprietary diagnostic test for use with our product and certain of our product candidates. We will be required to obtain coverage and reimbursement for this test separate and apart from the coverage and reimbursement we seek for our products and product candidates, if approved. There is significant uncertainty regarding our ability to obtain coverage and adequate reimbursement for this proprietary diagnostic test for reasons similar to those applicable to our product and product candidates, if approved.
Product liability lawsuits against us could cause us to incur substantial liabilities and to limit commercialization of AUCATZYL or any other products that we may develop.
We face an inherent risk of product liability exposure related to the testing of our product and product candidates in human clinical trials and will face an even greater risk if we commercially sell any products that we may develop. If we cannot successfully defend ourselves against claims that our product candidates or products caused injuries, we will incur substantial liabilities. Regardless of merit or eventual outcome, liability claims may result in:
•reduced resources of our management to pursue our business strategy;
•decreased demand for any product candidates or products that we may develop;
•injury to our reputation and significant negative media attention;
•withdrawal of clinical trial participants;
•initiation of investigations by regulators;
•product recalls, withdrawals or labeling, marketing or promotional restrictions;
•significant costs to defend the resulting litigation;
•substantial monetary awards paid to clinical trial participants or patients;
•loss of revenue; and
•the inability to commercialize any products that we may develop.
We currently hold £10.0 million in product liability insurance coverage in the aggregate, with a per incident limit of £10.0 million, which may not be adequate to cover all liabilities that we may incur. We may need to increase our insurance coverage as we expand our clinical trials or if we commence commercialization of our product candidates. Insurance coverage is increasingly expensive. We may not be able to maintain insurance coverage at a reasonable cost or in an amount adequate to satisfy any liability that may arise.
Risks Related to the Development of Our Product Candidates
Our product candidates are in clinical development or in preclinical development. If we are unable to advance our product candidates through clinical development, obtain regulatory approval and ultimately commercialize our product candidates, or experience significant delays in doing so, our business will be materially harmed.
Other than AUCATZYL, the rest of our product pipeline is in clinical or preclinical development. We have established clinical proof-of-concept for only one of our products, AUCATZYL, which recently received FDA approval in r/r adult B-ALL. There is no assurance that our current or any other future clinical trials of our product candidates will be successful or will generate positive clinical data. Although we received marketing approval from the FDA for AUCATZYL in the US, and have submitted MAAs to the MHRA and EMA, we may not be successful in receiving marketing approval from these regulatory agencies, including the European Commission, for obe-cel or for any of our other product candidates. In order to commence a clinical trial in the United States, we must submit an IND to the FDA and have the IND application go into effect. Trials in the United States must be conducted pursuant to an active IND. An investigator may not administer a drug candidate to human subjects until the IND goes into effect. Similar requirements apply to our conduct of trials in the UK and EU. We are sponsoring active, recruiting clinical trials for obe-cel in additional indications and AUTO4. We are also collaborating with our academic partner UCL to support clinical trials sponsored by them of obe-cel in additional indications, AUTO1/22, AUTO6NG and AUTO8. In addition, patients who have received an investigational product developed by us will be evaluated for long-term safety and disease response in a long-term follow-up protocol. There can be no assurance that the FDA, the competent authorities of EU Member States or other regulatory agencies will permit any future clinical trial application to go into effect for our product candidates in a timely manner or at all.
U.S. and EU regulations require parties seeking regulatory approval for product candidates in adult indications to define a development plan for such candidate in pediatric indications, commonly referred to as a PSP in the United States. and a PIP in the EU. Similar requirements apply in other jurisdictions. If these requirements are not met, a submission for marketing authorization cannot be submitted. A pediatric development plan must be approved by U.S., EU and other regulators, and the conduct of the respective pediatric studies, typically in parallel with the adult clinical development, must be conducted in the time frame described in the plan. Failure to comply with these requirements can lead to penalties and reputational damage. There can be no assurance that the FDA, EMA or other regulatory agencies will permit a pediatric development plan to go into effect in a timely manner, or at all.
If we are unable to agree upon appropriate pediatric development plans with these regulatory agencies, or if we are unable to perform the activities described in an agreed plan, we could experience significant delays or an inability to successfully commercialize our product candidates, which would materially harm our business.
Biopharmaceutical development is a long, expensive and uncertain process, and delay or failure can occur at any stage of any of our clinical trials. Failure to obtain regulatory approval for our product candidates will prevent us from commercializing and marketing our product candidates.
The success in the development of our programmed T cell product candidates will depend on many factors, including:
•completing preclinical studies and receiving regulatory approvals or clearance for conducting clinical trials for our preclinical-stage programs;
•obtaining positive results in our clinical trials demonstrating efficacy, safety, and durability of effect of our product candidates;
•establishing pediatric development plans with respect to product candidates for which we seek regulatory approval;
•receiving approvals for commercialization of our product candidates from regulatory authorities;
•manufacturing our product candidates at an acceptable cost; and
•maintaining and growing an organization of scientists, medical professionals and business people who can develop and commercialize our products and technology.
Many of these factors are beyond our control, including the time needed to adequately complete clinical testing and the regulatory submission process. It is possible that none of our other product candidates will ever obtain regulatory approval, even if we expend substantial time and resources seeking such approval. If we do not achieve one or more of these factors in a timely manner or at all, or any other factors impacting the successful development of biopharmaceutical products, we could experience significant delays or an inability to successfully develop our product candidates, which would materially harm our business.
Our proprietary, next-generation T cell programming technologies, our modular approach for engineering T cells and our manufacturing platform for our programmed T cell product candidates, represent emerging therapeutic approaches that face significant challenges and hurdles.
We have concentrated our research and development efforts on our T cell technology platform using our expertise in disease biology and cell programming, and our future success is highly dependent on the successful development and manufacture of our programmed T cell product candidates. Some of our product candidates employ a dual-targeting mechanism. By targeting two separate antigens on the cancer cell surface, we believe these product candidates have the potential to improve durability of treatment response and reduce the frequency of cancer relapse as compared to other currently available single-targeting T cell therapies. AUTO4, our product candidate for the treatment of T cell lymphoma, employs a novel approach to killing malignant T cells that aims to preserve approximately half of the normal, healthy T cells. Some of our product candidates include a “safety switch” that is designed to allow for the elimination of the engineered T cells if a patient experiences severe adverse side effects from the treatment. However, this “safety switch” technology has not been activated to date in our clinical studies, and we do not know whether it would have the intended effect if used. Additionally, as with other targeted therapies, off-tumor or off-target activity could delay development or require us to re-engineer or abandon a particular product candidate. Because programmed T cell therapies represent a relatively new field of cellular immunotherapy and cancer treatment and autoimmune diseases generally, developing and commercializing our product candidates subjects us to a number of risks and challenges, including:
•obtaining regulatory approval for our product candidates, as the FDA, the European Commission and other regulatory authorities have limited experience with programmed T cell therapies for cancer;
•sourcing clinical and, if approved, commercial supplies of the materials used to manufacture our product candidates;
•developing programming modules with the desired properties, while avoiding adverse reactions;
•creating viral vectors capable of delivering multiple programming modules;
•developing a reliable and consistent vector and cell manufacturing process;
•establishing manufacturing capacity suitable for the manufacture of our product candidates in line with expanding enrollment in our clinical studies and our projected commercial requirements;
•achieving cost efficiencies in the scale-up of our manufacturing capacity;
•developing protocols for the safe administration of our product candidates;
•educating medical personnel regarding our programmed T cell therapies and the potential side effect profile of each of our product candidates, such as potential adverse side effects related to CRS;
•establishing integrated solutions in collaboration with specialty treatment centers in order to reduce the burdens and complex logistics commonly associated with the administration of T cell therapies;
•establishing sales and marketing capabilities to successfully launch and commercialize our product candidates if and when we obtain any required regulatory approvals, and risks associated with gaining market acceptance of a novel therapy if we receive approval; and
•obtaining coverage and adequate reimbursement from third-party payors for our novel and personalized therapies in connection with commercialization of any approved product candidates.
We may not be able to successfully develop our programmed T cell product candidates or our T cell programming technologies in a manner that will yield products that are safe and effective, scalable or profitable.
Additionally, because our technology involves the genetic modification of patient cells ex vivo, we are subject to additional regulatory challenges and risks, including regulatory requirements governing genetically modified organisms that have changed frequently and will likely continue to change in the future, and that may limit or delay our ability to import our product candidates into certain countries for use in clinical trials or for commercial sale even if we receive applicable marketing approvals.
Moreover, public perception and awareness of T cell therapy safety issues may adversely influence the willingness of subjects to participate in clinical trials of our product candidates, or if approved, of physicians to prescribe our products. Physicians, hospitals and third-party payors often are slow to adopt new products, technologies and treatment practices that require additional upfront costs and training. Treatment centers may not be willing or able to devote the personnel and establish other infrastructure required for the administration of programmed T cell therapies. Physicians may not be willing to undergo training to adopt this novel and personalized therapy, may decide the therapy is too complex to adopt without appropriate training and may choose not to administer the therapy. Based on these and other factors, hospitals and payors may decide that the benefits of this new therapy do not or will not outweigh its costs.
Our future success is highly dependent on the regulatory approval of our other clinical-stage programmed T cell product candidates and our preclinical programs. Our product candidates will require significant clinical or preclinical testing before we can seek regulatory approval for and launch a product commercially.
Although we have received FDA approval for AUCATZYL in r/r adult B-ALL, our business remains substantially dependent on our ability to successfully obtain regulatory approval for, and, if approved, to successfully commercialize our other programmed T cell product candidates. We cannot commercialize product candidates in the United States without first obtaining regulatory approval for the product from the FDA; similarly, we cannot commercialize product candidates in countries outside of the United States without obtaining regulatory approval from comparable regulatory authorities in relevant jurisdictions, such as the European Commission in the EU (granted on the basis of a positive opinion from the CHMP of the EMA). Additionally, to file for licensure in any jurisdiction outside of the UK we must first receive GMP certification from the MHRA. Before obtaining regulatory approvals for the commercial sale of any product candidate for a particular indication, if approved, we must demonstrate with substantial evidence gathered in preclinical and clinical studies, that the product candidate is safe and effective for that indication and that the manufacturing facilities, processes and controls are adequate with respect to such product candidate. The obe-cel Regenerative Medicine Advanced Therapy (“RMAT”) designation was submitted to FDA in February 2022 and was granted in April 2022. Similarly, in the UK, Autolus utilized the MHRA Innovative Licensing and Access Pathway (“ILAP”) and applied for ‘Innovative Passport’ designation (“Innovation Passport”) which aims to accelerate the timeline to regulatory approval. The UK ILAP designation in r/r adult B-ALL was granted in June 2021 and we submitted an MAA to the MHRA at the end of July 2024. Additionally, EMA PRIME designation in r/r B-ALL was obtained in March 2021 and we submitted an MAA to the EMA, which was accepted in April 2024. Moreover, Orphan Designation in B-ALL was granted by the FDA in November 2019 and by the European Commission in March 2022. Prior to seeking approval for any of our other product candidates, we will need to confer with the FDA, MHRA, the EMA and other regulatory authorities regarding the design of our clinical trials and the type and amount of clinical data necessary to seek and gain approval for our product candidates.
The time required to obtain approval by the FDA, MHRA, the European Commission and other regulatory authorities is unpredictable but typically takes many years following the commencement of preclinical studies and clinical trials and depends upon numerous factors, including the substantial discretion of the regulatory authorities. In addition, approval policies, regulations, or the type and amount of clinical data necessary to gain approval may change during the course of a product candidate’s clinical development and may vary among jurisdictions. It is possible that none of our other existing product candidates or any future product candidates will ever obtain regulatory approval.
Our product candidates could fail to receive regulatory approval from the FDA, MHRA, the European Commission or other regulatory authorities and, consequently, fail to achieve suitable commercial success for many reasons, including:
•disagreement with the design, protocol or conduct of our clinical trials;
•failure to demonstrate that a product candidate is safe and effective for its proposed indication;
•failure of clinical trials to meet the level of statistical significance required for approval;
•failure to demonstrate that a product candidate’s clinical and other benefits outweigh its safety risks;
•disagreement with our interpretation of data from preclinical studies or clinical trials;
•insufficiency of data collected from clinical trials of our product candidates to support the submission and filing of a BLA or other submission or to obtain regulatory approval;
•failure to obtain approval of the manufacturing processes or our facilities;
•failure to receive timely handover of our planned commercial launch facility to enable on-time completion of all operational qualification activities;
•failure to achieve timely acceptance of Technical Transfer and Performance Qualification of our commercial manufacturing facility;
•augmentation of the requirements to satisfy facility qualification or licensure submission by the regulating authorities, thus delaying time to submission and licensure of;
•failure to achieve a competitive value proposition in terms of product release specifications and our vein-to-vein delivery time;
•failure to achieve approval of state of the art in-process and release assays critical to optimizing intent to treat and achieving a competitive vein to vein time;
•failure to have adequate funding to sustain the full complement of staff required to facilitate targeted product launch volumes;
•changes in the approval policies or regulations that render our preclinical and clinical data insufficient for approval; or
•lack of adequate funding to complete a clinical trial in a manner that is satisfactory to the applicable regulatory authority.
The FDA, the EMA or the European Commission, or a comparable regulatory authority may require more information, including additional preclinical or clinical data to support approval, including data that would require us to perform additional clinical trials or modify our manufacturing processes, which may delay or prevent approval and our commercialization plans, or we may decide to abandon the development program. If we change our manufacturing processes or manufacturing facilities, we may be required to conduct additional clinical trials or other studies, which also could delay or prevent approval of our product candidates. If we were to obtain approval, regulatory authorities may approve any of our product candidates for fewer indications than we request (including failing to approve the most commercially promising indications) or for different indications from those obtained in other territories, may limit indications, may grant approval contingent on the performance of costly post-marketing clinical trials or other post-marketing commitments, or may approve a product candidate with a label that does not include the labeling claims necessary or desirable for the successful commercialization of that product candidate. Furthermore, the indication granted by health authorities may vary from region to region, which may impair our commercialization plans. Finally, even with licensures in the relevant regions we initially do not have production redundancy. Due to this, we are at higher risk of supply disruptions to regional factors that could impair our supply chains.
Even though we have received FDA approval for AUCATZYL in r/r adult B-ALL, and even if any of our other product candidates were to successfully obtain approval from the FDA, the European Commission or other comparable regulatory authorities in other jurisdictions, any approval might contain significant limitations related to use restrictions for specified age groups, warnings, precautions or contraindications, or may be subject to burdensome post-approval study or risk management requirements. If we are unable to obtain regulatory approval for one of our product candidates in one or more jurisdictions, or any approval contains significant limitations, we may not be able to obtain sufficient funding to continue the development of that product or generate revenues attributable to that product candidate. Also, the regulatory approval of AUCATZYL, or of any of our other current or future product candidates, once obtained, may be withdrawn. See the risk factor titled “—Even if we complete the necessary preclinical studies and clinical trials, the regulatory approval process is expensive, time-consuming and uncertain and may prevent us from obtaining approvals for the commercialization of some or all of our product candidates. As a result, we cannot predict when or if, and in which territories, we will obtain marketing approval to commercialize a product candidate.”
We may not be successful in our efforts to build a pipeline of product candidates.
A key element of our strategy is to use our expertise in tumor biology and cell programming and our proprietary and modular T cell programming technologies to develop what we believe are safer and more effective T cell therapies. Our initial focus is on the development of a pipeline of product candidates for the treatment of hematological cancers and the progression of these product candidates through clinical development. We also intend to develop follow-on, or next-generation, product candidates with additional elements of programming built into the programmed T cell product candidate to offer enhanced characteristics as compared to the earlier product generation, such as pharmacological control or insensitivity to checkpoint inhibition. However, we may not be able to develop product candidates that are safe and effective, or which compare favorably with our existing product candidates.
Even if we are successful in continuing to build our pipeline and developing next-generation product candidates or expanding into solid tumor indications or autoimmune diseases, the potential product candidates that we identify may not be suitable for clinical development, including as a result of lack of safety, lack of tolerability, lack of anti-tumor activity, or other characteristics that indicate that they are unlikely to be products that will receive marketing approval, achieve market acceptance or obtain reimbursements from third-party payors. If we do not successfully develop and commercialize product candidates or collaborate with others to do so, we will not be able to obtain product revenue in future periods, which could significantly harm our financial position and adversely affect the trading price of our ADSs.
Our preclinical programs may experience delays or may never advance to clinical trials, which would adversely affect our ability to obtain regulatory approvals or to commercialize these programs on a timely basis or at all, which would have an adverse effect on our business.
Many of our product candidates are in the preclinical development stage. The risk of failure of preclinical programs is high. Before we can commence clinical trials for a product candidate, we must complete extensive preclinical testing and studies to obtain regulatory clearance to initiate human clinical trials, including based on IND applications in effect in the United States and clinical trial applications (“CTAs”) in the EU and other European countries. We cannot be certain of the timely completion or outcome of our preclinical testing and studies and cannot predict if the FDA, the competent authorities of EU Member States or other regulatory authorities will accept our proposed clinical programs or if the outcome of our preclinical testing and studies will ultimately support the further development of our programs. As a result, we cannot be sure that we will be able to submit INDs or similar applications for our preclinical programs on the timelines we expect, if at all, and we cannot be sure that submission of INDs or similar applications will result in the FDA, the competent authorities of EU Member States or other regulatory authorities allowing clinical trials to begin.
Clinical trials are difficult to design and implement, involve uncertain outcomes and may not be successful.
Human clinical trials are difficult to design and implement, in part because they are subject to rigorous regulatory requirements. The design of a clinical trial can determine whether its results will support approval of a product, and flaws in the design of a clinical trial may not become apparent until the clinical trial is well advanced. As an organization, we have limited experience designing clinical trials and may be unable to design and execute a clinical trial to support regulatory approval. There is a high failure rate for biologic products proceeding through clinical trials, which may be higher for our product candidates because they are based on new technology and engineered on a patient-by-patient basis. Many companies in the pharmaceutical and biotechnology industries have suffered significant setbacks in late-stage clinical trials even after achieving promising results in preclinical testing and earlier-stage clinical trials. Data obtained from preclinical and clinical activities are subject to varying interpretations, which may delay, limit or prevent regulatory approval. In addition, we may experience regulatory delays or rejections as a result of many factors, including changes in regulatory policy during the period of our product candidate development. Any such delays could negatively impact our business, financial condition, results of operations and prospects.
Success in preclinical studies or clinical trials may not be indicative of results in future clinical trials.
Results from preclinical studies are not necessarily predictive of future clinical trial results, and interim results of a clinical trial are not necessarily indicative of final results. For example, we have treated only a small number of patients in some of our ongoing clinical trials. For that reason, we do not know whether these candidates will be effective for the intended indications or safe in humans. Our product candidates may fail to show the desired safety and efficacy in clinical development despite positive results in preclinical studies or having successfully advanced through initial clinical trials. This failure to establish sufficient efficacy and safety could cause us to abandon clinical development of our product candidates.
We depend on enrollment of patients in our clinical trials for our product candidates. If we encounter difficulties enrolling patients in our clinical trials, our clinical development activities could be delayed or otherwise adversely affected.
Identifying and qualifying patients to participate in clinical trials of our product candidates is critical to our success. We may experience difficulties in patient enrollment in our clinical trials for a variety of reasons. The timely completion of clinical trials in accordance with their protocols depends, among other things, on our ability to enroll a sufficient number of patients who remain in the trial until its conclusion. The enrollment of patients depends on many factors, including:
•the patient eligibility criteria defined in the protocol;
•the number of patients with the disease or condition being studied;
•the perceived risks and benefits of the product candidate in the trial;
•clinicians’ and patients’ perceptions as to the potential advantages of the product candidate being studied in relation to other available therapies, including any new drugs that may be approved for the indications we are investigating or drugs that may be used off-label for these indications;
•the size and nature of the patient population required for analysis of the trial’s primary and secondary endpoints;
•the proximity of patients to trial sites;
•the design of the clinical trial;
•our ability to recruit clinical trial investigators with the appropriate competencies and experience;
•competing clinical trials for similar therapies or other new therapeutics not involving T cell-based immunotherapy;
•our ability to obtain and maintain patient consents;
•disruptions to healthcare systems caused by global disease pandemics;
•the risk that patients enrolled in clinical trials will drop out of the clinical trials before completion of their treatment; and
•other public health factors.
In particular, some of our clinical trials will look to enroll patients with characteristics which are found in a very small population. For example, our clinical trial for AUTO4 seeks to enroll patients with peripheral T cell lymphoma, a rare and heterogeneous form of non-Hodgkin lymphoma (“NHL”). Other companies are conducting clinical trials with their redirected T cell therapies in multiple myeloma, pediatric or adult r/r B-ALL, or pediatric or adult ALL, and r/r DLBCL, r/r MCL and seek to enroll patients in their studies that may otherwise be eligible for our clinical trials, which could lead to slow recruitment and delays in our clinical programs. In addition, since the number of qualified clinical investigators is limited, we expect to conduct some of our clinical trials at the same clinical trial sites that some of our competitors use, which could further reduce the number of patients who are available for our clinical trials in these clinical trial sites.
Moreover, because our product candidates represent a departure from more commonly used methods for cancer treatment and autoimmune diseases, potential trial participants and their doctors may be inclined to use conventional therapies, such as chemotherapy and antibody therapy, rather than participate in our clinical trials.
Delays in patient enrollment may result in increased costs or may affect the timing or outcome of the planned clinical trials, which could prevent completion of these clinical trials and adversely affect our ability to advance the development of our product candidates. In addition, many of the factors that may lead to a delay in the commencement or completion of clinical trials may also ultimately lead to the denial of regulatory approval of our product candidates.
The market opportunities for our product candidates may be limited to those patients who are ineligible for or have failed prior treatments and may be small, and our projections regarding the size of the addressable market may be incorrect.
Cancer therapies are sometimes characterized as first line, second line or later lines, and the FDA often approves new therapies initially only for later line use. When blood cancers are detected, they are treated with the first line of therapy with the intention of curing the cancer. This generally consists of chemotherapy, radiation, antibody drugs, tumor-targeted small molecules, or a combination of these. In addition, sometimes a bone marrow transplantation can be added to the first line therapy after the combination chemotherapy is given. If the patient’s cancer relapses, e.g. a B-cell malignancy, then they are given salvage therapies which can consist of more chemotherapy, radiation, CAR T cell products, antibody drug conjugates, tumor-targeted small molecules, or a combination of these, or a bone marrow transplant. Generally, the higher the line of therapy, the lower the chance of a cure. With third or higher line, the goal of the therapy in the treatment of lymphoma and myeloma is to control the growth of the tumor and extend the life of the patient, as a cure is unlikely to happen. Patients are generally referred to clinical trials in these situations.
Our product candidate AUTO4 is currently being developed as a treatment option for r/r TRBC1-positive T cell lymphoma patients. If AUTO4 is eventually approved as a second line therapy, we may seek to initiate a trial to position it as a consolidation therapy after first line chemotherapy in T cell lymphoma. There is no guarantee that any of our product candidates, even if approved in later lines, would be approved for an earlier line of therapy. In addition, we may have to conduct additional large randomized clinical trials prior to gaining approval for the earlier line of therapy.
Our projections of both the number of people who have the cancers we are targeting, as well as the size of the patient population subset of people with these cancers in a position to receive first, second, third and fourth line therapy and who have the potential to benefit from treatment with our product candidates, are based on our beliefs and estimates. These estimates have been derived from a variety of sources, including scientific literature, surveys of clinics, patient foundations, or market research and may prove to be incorrect. Further, new studies may change the estimated incidence or prevalence of these cancers.
The number of patients may turn out to be fewer than expected. Additionally, the potentially addressable patient population for our product candidates may be limited or may not be amenable to treatment with our product candidates. For instance, in our clinical trial for AUTO4, we are initially targeting a small patient population that suffers from peripheral T cell lymphoma, a rare and heterogeneous form of NHL. Even if we obtain significant market share for our product candidates, because the potential target populations are small, we may never achieve significant revenues without obtaining regulatory approval for additional indications or as part of earlier lines of therapy.
Adverse side effects or other safety risks associated with our product candidates could delay or preclude approval, cause us to suspend or discontinue clinical trials, cause us to abandon product candidates, limit the commercial profile of an approved label, or result in significant negative consequences following any potential marketing approval.
In clinical trials conducted by other companies involving CAR T cells, the most prominent acute toxicities included symptoms thought to be associated with CRS, such as fever, low blood pressure and kidney dysfunction. Some patients also experienced toxicity of the central nervous system, or neurotoxicity, such as confusion, tremor, cranial nerve dysfunction, seizures and speech impairment. CAR T cell associated neurotoxicity is also known as ICANS. Adverse events with the worst grades and attributed to CAR T cells were severe and life threatening in some patients. The life-threatening events were related to cardiac dysfunction, kidney dysfunction and neurotoxicity. Severe and life-threatening toxicities occurred mostly in the first two weeks after cell infusion and generally resolved within three - four weeks, but several patients died in clinical trials involving CAR T cells developed by other companies and academic institutions. For example, the FDA-approved label for AUCATZYL carries a boxed warning for, among other adverse side effects, the risk of developing secondary T-cell malignancies.
There can be no assurance that patients in ongoing or future trials of obe-cel in additional indications, AUTO4 or any of our other product candidates will not experience more severe CRS, unacceptable levels of neurotoxicity or other serious adverse events.
Our clinical trials include cancer patients who are very sick and whose health is deteriorating, and we expect that additional clinical trials of our other product candidates will include similar patients with deteriorating health. It is possible that some of these patients may experience similar adverse side effects as were observed in clinical trials conducted by other companies and academic institutions involving CAR T cells, and that additional patients may die during our clinical trials for various reasons, including as a result of receiving our product candidates, because the patient’s disease is too advanced, or because the patient experiences medical problems that may not be related to our product candidate. Even if the deaths are not related to our product candidate, the deaths could affect perceptions regarding the safety of our product candidate.
Patient deaths and severe side effects caused by our product candidates, or by products or product candidates of other companies that are thought to have similarities with our therapeutic candidates, could result in the delay, suspension, clinical hold or termination of clinical trials by us, the FDA, the competent authorities of EU Member States or other regulatory authorities for a number of reasons. If we elect or are required to delay, suspend or terminate any clinical trial of any product candidates that we develop, the commercial prospects of such product candidates will be harmed and our ability to generate product revenues from any of these product candidates would be delayed or eliminated. Serious adverse events observed in clinical trials could hinder or prevent market acceptance of the product candidate at issue. Any of these occurrences may harm our business, prospects, financial condition and results of operations significantly.
If the clinical trials of any of our product candidates fail to demonstrate safety and efficacy to the satisfaction of the FDA, the EMA and the European Commission or other comparable regulatory authorities, or do not otherwise produce favorable results, we may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of our product candidates.
We may not commercialize, market, promote or sell any product candidate without obtaining marketing approval from the FDA, the European Commission or other comparable regulatory authority, and we may never receive such approvals. Although we have received FDA approval for AUCATZYL in r/r adult B-ALL, it is impossible to predict accurately when or if any of our other product candidates will prove effective or safe in humans and will receive regulatory approval. Before obtaining marketing approval from regulatory authorities for the commercial sale of any of our product candidates, we must demonstrate through lengthy, complex and expensive preclinical testing and clinical trials that our product candidates are both safe and effective for use in each target indication. The potential label for the same product may differ in different territories based on the approval by different health authorities. Clinical testing is expensive, difficult to design and implement, can take many years to complete and is uncertain as to outcome. A failure of one or more clinical trials can occur at any stage of testing.
We may experience numerous unforeseen events prior to, during, or as a result of, clinical trials that could delay or prevent our ability to receive marketing approval or commercialize any of our product candidates, including:
•the FDA, the EMA, the European Commission or other comparable regulatory authority may disagree as to the number, design or implementation of our clinical trials, or may not interpret the results from clinical trials as we do;
•regulators or IRBs may not authorize us or our investigators to commence a clinical trial or conduct a clinical trial at a prospective trial site;
•we may not reach agreement on acceptable terms with prospective clinical trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different clinical trial sites;
•clinical trials of our product candidates may produce negative or inconclusive results;
•we may decide, or regulators may require us, to conduct additional clinical trials or abandon product development programs;
•the number of patients required for clinical trials of our product candidates may be larger than we anticipate, enrollment in these clinical trials may be slower than we anticipate, participants may drop out of these clinical trials at a higher rate than we anticipate or we may fail to recruit suitable patients to participate in a trial;
•our third-party contractors may fail to comply with regulatory requirements or meet their contractual obligations to us in a timely manner, or at all;
•regulators may issue a clinical hold, or regulators or IRBs may require that we or our investigators suspend or terminate clinical research for various reasons, including noncompliance with regulatory requirements or a finding that the participants are being exposed to unacceptable health risks;
•the cost of clinical development of our product candidates may be greater than we anticipate;
•the FDA, the competent authorities of EU Member States or other comparable regulatory authorities may fail to approve our manufacturing processes or facilities;
•the supply or quality of our product candidates or other materials necessary to conduct clinical trials of our product candidates may be insufficient or inadequate;
•our product candidates may have undesirable side effects or other unexpected characteristics, particularly given their novel, first-in-human application, such as cytokine-induced toxicity and T cell aplasia, causing us or our investigators, regulators or IRBs to suspend or terminate the clinical trials; and
•the approval policies and related requirements of the FDA, the EMA of the European Commission, or other comparable regulatory authorities may significantly change in a manner rendering our clinical data insufficient for approval.
To the extent that the results of the trials are not satisfactory for the FDA, the EMA, the European Commission, or regulatory authorities in other countries or jurisdiction to approve our BLA, MAA, or other comparable application, the commercialization of our product candidates may be significantly delayed, or we may be required to expend significant additional resources, which may not be available to us, to conduct additional trials in support of potential approval of our product candidates.
We may not be able to successfully create our own manufacturing infrastructure for supply of our, or our current or future collaborators', requirements of programmed T cell product candidates for use in clinical trials and for commercial sale.
Our manufacturing and commercialization strategy is based on establishing a fully integrated vein-to-vein product delivery cycle. We have constructed and use a new facility (which we call “The Nucleus”) in Stevenage, UK which we believe will support our commercial manufacturing needs for AUCATZYL and any future products. Although we have received approval and licensure from health authorities to enter into operations at this facility, we may not be able to maintain ongoing licensure requirements. At present, we currently also use facilities and equipment at the Cell and Gene Therapy Catapult, as well as third party vendors, for vector and cell manufacturing. Over time we can add additional manufacturing sites in the United States and in Europe as needed.
The implementation of this plan is subject to many risks. For example, the establishment of a cell-therapy manufacturing facility is a complex endeavor requiring knowledgeable individuals. Creating an internal manufacturing infrastructure will rely upon finding personnel with an appropriate background and training to staff and operate the facility. Should we be unable to find these individuals, we may need to rely on external contractors or train additional personnel to fill the needed roles. There are a small number of individuals with experience in cell therapy and the competition for these individuals is high.
We have limited experience as a company in designing and operating a commercial cell therapy or vector manufacturing facility and may not be successful in sustaining our own manufacturing capability. We may establish additional manufacturing sites as we expand our commercial footprint to multiple geographies, which may lead to regulatory delays or prove costly. Our manufacturing operations could be affected by cost-overruns, unexpected delays, equipment failures, labor shortages, natural disasters, power failures and numerous other factors, or we may not be successful in establishing sufficient capacity to produce our product candidates in sufficient quantities to meet the requirements for the potential launch or to meet potential future demand, all of which could prevent us from realizing the intended benefits of our manufacturing strategy and have a material adverse effect on our business.
We may not be successful in achieving cost of goods at commercial scale that provide for an attractive margin.
We believe that our current, enclosed manufacturing processes are fit for commercial scale and we anticipate they will enable commercial supply at an economical cost. However, we have not yet sustained manufacturing capacity at commercial scale and may underestimate the cost and time required to do so, and may overestimate cost reductions from economies of scale that can be realized with our manufacturing processes. We may ultimately be unable to manage the cost of goods for our product candidates to levels that will allow for a margin in line with our expectations and return on investment if and when those product candidates are commercialized.
Our products and product candidates are biologics and the manufacture of such biologics is complex and we may encounter difficulties in production, particularly with respect to process development or scaling-out of our manufacturing capabilities. If we encounter such difficulties, our ability to provide supply of our product candidates for clinical trials or our products for patients could be delayed or stopped.
We have developed a process for manufacturing programmed T cells in a fully enclosed system designed to minimize the risk of contamination, and we have improved the viral transduction process to help eliminate processing inconsistencies. We believe that our current processes are suitable for commercialization. While we have established a process which we believe is scalable for commercial production, each manufacturing process must be validated through the performance of process validation runs to guarantee that the facility, personnel, equipment, and process work as designed. We have not yet manufactured or processed our product candidates on a commercial scale and may not be able to do so for any of our products or product candidates.
We, like other manufacturers of biologic products, may encounter difficulties in production, particularly in scaling up or out, validating the production process, and assuring high reliability of the manufacturing process. These problems include delays or break-downs in logistics and shipping, difficulties with production costs and yields, quality control, and product testing, operator error, lack of availability of qualified personnel, as well as failure to comply with strictly enforced federal, state and foreign regulations, which are updated regularly.
Furthermore, if microbial, viral or other contaminants are discovered in our supply of products or product candidates, or in the manufacturing facilities, such manufacturing facilities may need to be closed for an extended period of time to investigate and remedy the contamination. We cannot assure you that any of these or other issues relating to the manufacture of our products or product candidates will not occur in the future. Any delay or interruption in the supply of clinical trial supplies could delay the completion of clinical trials, increase the costs associated with maintaining clinical trial programs and, depending upon the period of delay, require us to begin new clinical trials at additional expense or terminate clinical trials completely.
The manufacture and delivery of programmed T cell therapies to patients involves complex, integrated processes, including harvesting T cells from patients, programming the T cells ex vivo, multiplying the T cells to obtain the desired dose, and ultimately infusing the T cells back into a patient’s body. As a result of the complexities, the cost to manufacture biologics in general, and our programmed T cell products and product candidates in particular, is higher than traditional small molecule chemical compounds, and the manufacturing process is less reliable and is more difficult and costly to reproduce. In addition, our manufacturing process will be susceptible to product loss or failure due to logistical issues associated with the collection of white blood cells from the patient, shipping such patient material to the manufacturing site, storing and processing such patient material, shipping the patient material with the programmed T cells back to the patient, and infusing the patient with the final product. Other manufacturing issues include the differences in patient starting materials, inconsistency in cell growth, variability in product characteristics, interruptions in the manufacturing process, equipment or reagent failure, improper installation or operation of equipment, and vendor or operator error. Even minor deviations from normal manufacturing processes could result in reduced production yields, product defects, and other supply disruptions. For example, in the FELIX clinical trial of obe-cel reported at the ASH Annual Meeting in December 2023, 7 patients out of the 153 patients enrolled on to the clinical trial did not receive an infusion of obe-cel due to manufacturing related reasons. If we lose, destroy or otherwise impair the patient materials at any point in the vein-to-vein supply chain, the manufacturing process for that patient will need to be restarted and the resulting delay may adversely affect that patient’s outcome due to the risk of disease progression.
In addition, because our products and product candidates are manufactured for each particular patient, we will be required to maintain a chain of identity with respect to materials as they move from the patient to the manufacturing facility, through the manufacturing process, and back to the patient. Maintaining such a chain of identity is difficult and complex, and failure to do so could result in adverse patient outcomes, loss of product, or regulatory action including withdrawal of our products from the market. Further, as product candidates are developed through preclinical to late-stage clinical trials towards approval and commercialization, changes may be considered in an effort to optimize processes or clinical approach. Any changes to a process or clinical approach must serve the needs of the patient and delivery must be economically viable. Such changes carry the risk that they will not achieve these intended objectives, and any of these changes could cause our product candidates to perform differently and affect the results of planned clinical trials or other future clinical trials.
Our manufacturing facilities also require commissioning and validation activities to demonstrate that they operate as designed, and are subject to government inspections by the FDA, the MHRA, the competent authorities of EU Member States and other comparable regulatory authorities. If we are unable to reliably produce products to specifications acceptable to the regulatory authorities, we may not obtain or maintain the approvals we need to manufacture our products. Further, our facilities may fail to pass government inspections prior to or after the commercial launch of our product candidates, which would cause significant delays and additional costs required to remediate any deficiencies identified by the regulatory authorities. Any of these challenges could delay completion of clinical trials, require bridging clinical trials or the repetition of one or more clinical trials, increase clinical trial costs, delay approval of our product candidates, impair commercialization efforts of our products, increase our cost of goods, and have an adverse effect on our business, financial condition, results of operations and growth prospects.
Prior treatments can alter the patient's disease and negatively impact chances for achieving clinical activity with our programmed T cells.
Patients with hematological cancers receive highly toxic lympho-depleting chemotherapy as their initial treatments. These therapies can impact the viability of the T cells collected from the patient and can contribute to highly variable responses to programmed T cell therapies. Patients could also have received prior therapies that target the same target antigen on the cancer cells as our intended programmed T cell product candidate and thereby lead to a selection of cancer cells with low or no expression of the target. As a result, our programmed T cell product candidates may not recognize the cancer cell and may fail to achieve clinical activity. For example, patients with autoimmune diseases receive multiple types of treatment including toxic lympho-depleting chemotherapies, which may have an impact on the viability of T cells collected from a patient and may also contribute to highly variable responses to programmed T cell therapies. If any of our product candidates do not achieve a sufficient level of clinical activity, we may discontinue the development of that product candidate, which could have an adverse effect on the value of our ADSs.
We may expend our resources to pursue a particular product candidate or indication and fail to capitalize on product candidates or indications that may be more profitable or have a greater likelihood of success.
Because we have limited financial and management resources, we focus on research programs and product candidates that we identify for specific indications. As a result, we may forego or delay pursuit of opportunities with other product candidates or for other indications that later prove to have greater commercial potential. Our resource allocation decisions may cause us to fail to capitalize on viable commercial products or profitable market opportunities. Our spending on current and future research and development programs and product candidates for specific indications may not yield any commercially viable products. If we do not accurately evaluate the commercial potential or target market for a particular product candidate, we may relinquish valuable rights to that product candidate through collaboration, licensing or other royalty arrangements in cases in which it would have been more advantageous for us to retain sole development and commercialization rights to such product candidate.
We plan to seek, but may fail to obtain breakthrough therapy designation or RMAT designation from the FDA and PRIME designation from the EMA, and may pursue accelerated approval for some or all of our programmed T cell product candidates, which may prolong the regulatory approval process for our product candidates.
In 2012, the FDA established a breakthrough therapy designation which is intended to expedite the development and review of product candidates that treat serious or life-threatening diseases when “preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development.” The designation of a product candidate as a breakthrough therapy provides potential benefits that include more frequent meetings with FDA to discuss the development plan for the product candidate and ensure collection of appropriate data needed to support approval; more frequent written correspondence from the FDA about such things as the design of the proposed clinical trials and use of biomarkers; guidance on an efficient drug development program, beginning as early as Phase 1; organizational commitment involving senior managers; and eligibility for rolling review and priority review. The frequency of communication from the FDA is intended to allow for questions and issues to be resolved quickly, which often leads to earlier drug approval and access by patients.
RMAT was introduced as a new designation under the 21st Century Cures Act for the development and review of certain regenerative medicine therapies. To receive RMAT designation, a regenerative medicine product candidate must be intended to treat, modify, reverse, or cure a serious or life-threatening disease or condition with preliminary clinical evidence indicating that the drug has the potential to address unmet medical need. RMAT designation does not require evidence to indicate that the drug may offer a substantial improvement over available therapies, as breakthrough designation requires. In February 2019, the FDA released guidance that clarified that gene therapies, including genetically modified cells, that lead to a durable modification of cells or tissues, may meet the definition of a regenerative medicine therapy for RMAT designation.
Similar to breakthrough designation, an RMAT product candidate receives: intensive guidance on an efficient drug development program; intensive involvement of senior managers and experienced staff on a proactive, collaborative and cross-disciplinary review; and a rolling review. Regenerative medicine therapies that qualify for RMAT designation may also qualify for other FDA expedited programs, if they meet the criteria for such programs.
Similarly, the EMA has established the PRIME scheme to expedite the development and review of product candidates that show a potential to address to a significant extent an unmet medical need, based on early clinical data. Likewise, the MHRA has established the ILAP scheme to expedite the development and review of product candidates that show a potential to address to a significant extent an unmet medical need, based on early clinical data.
We intend to seek breakthrough therapy designation, RMAT designation, ILAP or PRIME designation for some or all of our programmed T cell product candidates that may qualify. There is no assurance that we will obtain breakthrough therapy designation or RMAT designation, or that we will obtain access to PRIME or ILAP for any of our product candidates.
Breakthrough therapy designation, RMAT designation ILAP and PRIME eligibility do not change the standards for product approval, and there is no assurance that such designation or eligibility will result in expedited review or approval. Additionally, breakthrough therapy designation, RMAT designation and access to PRIME or ILAP can each be revoked if the criteria for eligibility cease to be met as clinical data emerges.
We may also seek accelerated approval for certain of our product candidates. Under the FDA’s fast track and accelerated approval programs, the FDA may approve a drug or biologic for a serious or life-threatening illness that provides meaningful therapeutic benefit to patients over existing treatments based upon a surrogate endpoint that is reasonably likely to predict clinical benefit, or on a clinical endpoint that can be measured earlier than irreversible morbidity or mortality, that is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit, taking into account the severity, rarity, or prevalence of the condition and the availability or lack of alternative treatments. For drugs granted accelerated approval, post-marketing confirmatory trials have been required to describe the anticipated effect on irreversible morbidity or mortality or other clinical benefit. These confirmatory trials must be completed with due diligence.
Moreover, the FDA may withdraw approval of our indication approved under the accelerated approval pathway if, for example:
•the trial or trials required to verify the predicted clinical benefit of our product candidates fail to verify such benefit or do not demonstrate sufficient clinical benefit to justify the risks associated with the drug;
•other evidence demonstrates that our product candidates are not shown to be safe or effective under the conditions of use;
•we fail to conduct any required post-approval trial of our product candidates with due diligence; or
•we disseminate false or misleading promotional materials relating to the relevant product candidate.
Risks Related to Our Business Operations
As a company based outside of the United States, our business is subject to economic, political, regulatory and other risks associated with international operations.
Our business is subject to risks associated with conducting business outside of the United States, as our company is based in the UK and conducts operations internationally. Many of our suppliers and clinical trial relationships are located outside the United States. Accordingly, our future results could be harmed by a variety of factors, including:
•economic weakness, including inflation, or political instability in particular non-U.S. economies and markets;
•differing and changing regulatory requirements for product approvals;
•differing jurisdictions could present different issues for securing, maintaining or obtaining freedom to operate in such jurisdictions;
•potentially reduced protection for intellectual property rights;
•difficulties in compliance with different, complex and changing laws, regulations and court systems of multiple jurisdictions and compliance with a wide variety of foreign laws, treaties and regulations;
•changes in non-U.S. regulations and customs, tariffs and trade barriers;
•changes in non-U.S. currency exchange rates of the pound sterling, U.S. dollar, euro and currency controls;
•changes in a specific country’s or region’s political or economic environment, including the implications of the UK's withdrawal from the EU;
•trade protection measures, import or export licensing requirements or other restrictive actions by governments;
•differing reimbursement regimes and price controls in certain non-U.S. markets;
•negative consequences from changes in tax laws;
•compliance with tax, employment, immigration and labor laws for employees living or traveling abroad, including, for example, the variable tax treatment in different jurisdictions of options granted under our share option schemes or equity incentive plans;
•workforce uncertainty in countries where labor unrest is more common than in the United States;
•litigation or administrative actions resulting from claims against us by current or former employees or consultants individually or as part of class actions, including claims of wrongful terminations, discrimination, misclassification or other violations of labor law or other alleged conduct;
•difficulties associated with staffing and managing international operations, including differing labor relations;
•production shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad; and
•business interruptions resulting from geopolitical actions, including war and terrorism, natural disasters, including earthquakes, typhoons, floods and fires, or health epidemics, such as the coronavirus pandemic.
The United Kingdom’s withdrawal from the EU may have a negative effect on global economic conditions, financial markets and our business, which could reduce the price of our ordinary shares.
Following Brexit, the UK and the EU signed an EU-UK Trade and Cooperation Agreement (“TCA”), which became provisionally applicable on January 1, 2021 and entered into force on May 1, 2021. This agreement provides details on how some aspects of the UK and EU’s relationship will operate going forwards however there are still uncertainties. The TCA primarily focuses on ensuring free trade between the EU and the UK in relation to goods, including medicinal products. Among the changes that have occurred are that Great Britain (England, Scotland and Wales) is treated as a “third country,” a country that is not a member of the EU and whose citizens do not enjoy the EU right to free movement. Northern Ireland continues to follow many aspects of the EU regulatory rules, particularly in relation to trade in goods. As part of the TCA, the EU and the UK recognize GMP inspections carried out by the other party and the acceptance of official GMP documents issued by the other party. The TCA also encourages, although it does not oblige, the parties to consult one another on proposals to introduce significant changes to technical regulations or inspection procedures. Among the areas of absence of mutual recognition are batch testing and batch release. The UK has unilaterally agreed to accept EU batch testing and batch release.
However, the EU continues to apply EU laws that require batch testing and batch release to take place in the EU territory. This means that medicinal products that are tested and released in the UK must be retested and re-released when entering the EU market for commercial use.
As it relates to marketing authorizations, Great Britain has a separate regulatory submission process, approval process and a separate national marketing authorization. Northern Ireland continues, however, to be covered by the marketing authorizations granted by the European Commission. For example, the scope of a marketing authorization for a medicinal product granted by the European Commission or by the competent authorities of EU Member States no longer encompasses Great Britain (England, Scotland and Wales). In these circumstances, a separate marketing authorization granted by the UK competent authorities is required to place medicinal products on the market in Great Britain. Northern Ireland continues, however, to be covered by the marketing authorizations granted by the European Commission.
On February 27, 2023, the UK Government and the European Commission reached a political agreement on the so-called “Windsor Framework”. The Framework is intended to revise the Northern Ireland Protocol to address some of the perceived shortcomings in its operation. The agreement was adopted at the Withdrawal Agreement Joint Committee on March 24, 2023. If the changes are adopted in the form proposed, medicinal products to be placed on the market in the UK will be authorized solely in accordance with UK laws. Northern Ireland would be reintegrated back into a UK-only regulatory environment under the authority of the MHRA with respect to all medicinal products. The implementation of the Windsor Framework would occur in stages, with new arrangements relating to the supply of medicinal products into Northern Ireland anticipated to take effect in 2025.
A significant proportion of the regulatory framework in the UK applicable to medicinal products is currently derived from EU Directives and Regulations. The potential for UK legislation to diverge from EU legislation following Brexit could materially impact the regulatory regime with respect to the development, manufacture, import, approval, and commercialization of our product candidates in the UK or the EU. If we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies governing clinical trials, our development plans may be impacted.
All of these changes could increase our costs and otherwise adversely affect our business. Any delay in obtaining, or an inability to obtain, any regulatory approvals, as a result of Brexit or otherwise, would prevent us from commercializing our product candidates in the UK or the EU and restrict our ability to generate revenue and achieve and sustain profitability. In addition, we may be required to pay taxes or duties or be subjected to other hurdles in connection with the importation of our product candidates into the EU. If any of these outcomes occur, we may be forced to restrict or delay efforts to seek regulatory approval in the UK or the EU for our product candidates, or incur significant additional expenses to operate our business, which could significantly and materially harm or delay our ability to generate revenues or achieve profitability of our business. Any further changes in international trade, tariff and import/export regulations as a result of Brexit or otherwise may impose unexpected duty costs or other non-tariff barriers on us. These developments, or the perception that any of them could occur, may significantly reduce global trade and, in particular, trade between the impacted nations and the UK. It is also possible that Brexit may negatively affect our ability to attract and retain employees, particularly those from the EU.
Exchange rate fluctuations may materially affect our results of operations and financial condition.
Our functional currency and that of our subsidiaries is the pound sterling, the U.S. dollar, the euro and Swiss franc and our reporting currency is the U.S. dollar. Given that our functional currency and that of our subsidiaries differ from our reporting currency, fluctuations in currency exchange rates between the U.S. dollar and the functional currencies of our subsidiaries could materially and adversely affect our business. There may be instances in which costs and revenue will not be matched with respect to currency denomination. Currently, we do not have any exchange rate hedging arrangements in place.
Additionally, although we are based in the UK, we source research and development, manufacturing, consulting and other services from the United States and other countries. Further, potential future revenue may be derived from the United States, countries within the euro zone, and various other countries around the world. As a result, our business and the price of our ADSs may be affected by fluctuations in foreign exchange rates not only between the pound sterling and the U.S. dollar, but also the euro, swiss franc, and other currencies, which may have a significant impact on our results of operations and cash flows from period to period. As a result, to the extent we continue our expansion on a global basis, we expect that increasing portions of our revenue, cost of revenue, assets and liabilities will be subject to fluctuations in currency valuations. We may experience economic loss and a negative impact on earnings or net assets solely as a result of currency exchange rate fluctuations.
We expect to continue to expand our development, commercial and regulatory capabilities and have recently developed sales, marketing and distribution capabilities, and as a result, we may encounter difficulties in managing our growth, which could disrupt our operations.
As of September 30, 2023, we had 610 employees, 607 of whom are full-time. We expect to experience significant growth in the number of our employees and the scope of our operations, particularly as our development and commercialization plans and strategies develop, and as we further develop as a public company, we may need additional managerial, operational, financial and other personnel, including personnel to support our product development and commercialization efforts. Future growth will impose significant added responsibilities on members of management, including:
•identifying, recruiting, integrating, maintaining and motivating additional employees;
•managing our internal development efforts effectively, including the clinical, FDA and EMA review processes for our product candidates; and
•improving our operational, financial and management controls, reporting systems and procedures.
There are a small number of individuals with experience in cell therapy and the competition for these individuals is high. Our future financial performance and our ability to commercialize our product candidates will depend, in part, on our ability to effectively manage any future growth, and our management may also have to divert a disproportionate amount of its attention away from day-to-day activities in order to devote a substantial amount of time to managing these growth activities.
If we are not able to effectively manage the size of our organization, we may not be able to successfully implement the tasks necessary to further develop and commercialize our product candidates and, accordingly, may not achieve our research, development and commercialization goals.
In addition to expanding our organization, we are building out our development and manufacturing capabilities, which requires significant capital expenditures. If these capital expenditures are higher than expected, it may adversely affect our financial condition and capital resources. In addition, if the availability of manufacturing capacity is delayed, it may limit our ability to rapidly expand the size of our organization in order to meet our corporate goals.
Our future success depends on our ability to retain key members of senior management and to attract, retain and motivate qualified personnel.
Our ability to compete in the highly competitive biopharmaceutical industry depends upon our ability to attract and retain highly qualified management, research and development, clinical, financial and business development personnel. We are highly dependent on our management, scientific and medical personnel. Each member of our senior management may terminate their employment with us at any time. We do not maintain ‘‘key person’’ insurance for any of our employees.
Recruiting and retaining qualified scientific and clinical personnel and, if we progress the development of any of our product candidates, commercialization, manufacturing and sales and marketing personnel, will be critical to our success. The loss of the services of members of our senior management or other key employees could impede the achievement of our research, development and commercialization objectives and seriously harm our ability to successfully implement our business strategy. Furthermore, replacing members of our senior management and key employees may be difficult and may take an extended period of time because of the limited number of individuals in our industry with the breadth of skills and experience required to successfully develop, gain regulatory approval of and commercialize our product candidates. Our success also depends on our ability to continue to attract, retain and motivate highly skilled junior, mid-level and senior managers, as well as junior, mid-level and senior scientific and medical personnel. Competition to hire from this limited candidate pool is intense, and we may be unable to hire, train, retain or motivate these key personnel on acceptable terms given the competition among numerous pharmaceutical and biotechnology companies for similar personnel.
We also experience competition for the hiring of scientific and clinical personnel from universities and research institutions. In addition, we rely on consultants and advisors, including scientific and clinical advisors, to assist us in formulating our research and development and commercialization strategy. Our consultants and advisors may have commitments under consulting or advisory contracts with other entities that may limit their availability to us. If we are unable to continue to attract and retain high-quality personnel, our ability to pursue our growth strategy will be limited.
If we engage in future acquisitions or strategic collaborations, this may increase our capital requirements, dilute our shareholders, cause us to incur debt or assume contingent liabilities and subject us to other risks.
From time to time, we may also evaluate various acquisitions and strategic collaborations, including collaborating with respect to our product candidates, or licensing or acquiring complementary products, intellectual property rights, technologies or businesses, as we may deem appropriate to carry out our business plan. Any potential acquisition or strategic collaboration, such as the Blackstone Collaboration Agreement and the BioNTech License Agreement, may entail numerous risks, including:
•increased operating expenses and cash requirements;
•the assumption of additional indebtedness or contingent liabilities;
•negative covenants that may affect our ability to develop and commercialize our product candidates;
•assimilation of operations, intellectual property and products of an acquired company, including difficulties associated with integrating new personnel;
•the diversion of our management’s attention from our existing programs and initiatives in pursuing such a strategic partnership, merger or acquisition;
•retention of key employees, the loss of key personnel and uncertainties in our ability to maintain key business relationships;
•risks and uncertainties associated with the other party to such a transaction, including the prospects of that party and their existing products or product candidates and regulatory approvals; and
•our inability to generate revenue from acquired technology sufficient to meet our objectives in undertaking the acquisition or even to offset the associated acquisition and maintenance costs.
Additionally, if we undertake acquisitions, we may issue dilutive securities, assume or incur debt obligations, incur large one-time expenses and acquire intangible assets that could result in significant future amortization expenses. Moreover, we may not be able to locate suitable acquisition opportunities and this inability could impair our ability to grow or obtain access to technology or products that may be important to the development of our business.
If our information technology systems or data, or those of third parties upon which we rely, are or were compromised, we could experience adverse consequences resulting from such compromise, including but not limited to regulatory investigations or actions; litigation; fines and penalties; disruptions of our business operations; reputational harm; loss of revenue or profits; and other adverse consequences.
In the ordinary course of our business, we and the third parties upon which we rely, collect, receive, store, process, generate, use, transfer, disclose, make accessible, protect, secure, dispose of, transmit, and share (collectively, process) personal data and other sensitive information, including proprietary and confidential business data, trade secrets, intellectual property, data we collect about trial participants in connection with clinical trials and sensitive third-party data (collectively, sensitive data). As a result, we and the third parties upon which we rely face a variety of evolving threats, including but not limited to ransomware attacks, which could cause security incidents.
Cyber-attacks, malicious internet-based activity, online and offline fraud, and other similar activities threaten the confidentiality, integrity, and availability of our sensitive data and information technology systems, and those of the third parties upon which we rely. Such threats are prevalent and continue to rise, are increasingly difficult to detect, and come from a variety of sources, including traditional computer “hackers,” threat actors, “hacktivists,” organized criminal threat actors, personnel (such as through theft or misuse), sophisticated nation states, and nation-state-supported actors.
Some actors now engage and are expected to continue to engage in cyber-attacks, including without limitation nation-state actors for geopolitical reasons and in conjunction with military conflicts and defense activities. During times of war and other major conflicts, we, and the third parties upon which we rely, may be vulnerable to a heightened risk of these attacks, including retaliatory cyber-attacks, that could materially disrupt our systems and operations, supply chain, and ability to produce, sell and distribute our products and services.
We and the third parties upon which we rely are subject to a variety of evolving threats, including but not limited to social-engineering attacks (including through deep fakes, which may be increasingly more difficult to identify as fake, and phishing attacks), malicious code (such as viruses and worms), malware (including as a result of advanced persistent threat intrusions), denial-of-service attacks, credential stuffing, credential harvesting, personnel misconduct or error, ransomware attacks, supply-chain attacks, software bugs, server malfunctions, software or hardware failures, loss of data or other information technology assets, adware, attacks enhanced or facilitated by artificial intelligence (“AI”), telecommunications failures, earthquakes, fires, floods, and other similar threats.
In particular, severe ransomware attacks are becoming increasingly prevalent and can lead to significant interruptions in our operations (including our clinical trial activities), ability to provide our products or services, loss of sensitive data and income, reputational harm, and diversion of funds. Extortion payments may alleviate the negative impact of a ransomware attack, but we may be unwilling or unable to make such payments due to, for example, applicable laws or regulations prohibiting such payments.
Remote work has become more common and has increased risks to our information technology systems and data, as more of our employees utilize network connections, computers, and devices outside our premises or network, including working at home, while in transit and in public locations. Additionally, future or past business transactions (such as acquisitions or integrations) could expose us to additional cybersecurity risks and vulnerabilities, as our systems could be negatively affected by vulnerabilities present in acquired or integrated entities’ systems and technologies. Furthermore, we may discover security issues that were not found during due diligence of such acquired or integrated entities, and it may be difficult to integrate companies into our information technology environment and security program.
We rely on third-party service providers and technologies to operate critical business systems to process sensitive data in a variety of contexts, including, without limitation, cloud-based infrastructure, data center facilities, encryption and authentication technology, employee email, content delivery to customers, and other functions. We also rely on third-party research collaborators, CROs, contract manufacturers, and suppliers for many aspects of our business, including research and development in connection with our clinical trial activities. Our reliance on such third-party service providers, technologies and collaborators could introduce new cybersecurity risks and vulnerabilities, including supply-chain attacks, and other threats to our business operations. Our ability to monitor these third parties’ information security practices is limited, and these third parties may not have adequate information security measures in place. If our third-party service providers experience a security incident or other interruption, we could experience adverse consequences. While we may be entitled to damages if our third-party service providers fail to satisfy their privacy or security-related obligations to us, any award may be insufficient to cover our damages, or we may be unable to recover such award. In addition, supply-chain attacks have increased in frequency and severity, and we cannot guarantee that third parties’ infrastructure in our supply chain or our third-party partners’ supply chains have not been compromised.
While we have implemented security measures designed to protect against security incidents, there can be no assurance that these measures will be effective. We take steps designed to detect, mitigate, and remediate vulnerabilities in our information systems (such as our hardware and/or software, including that of third parties upon which we rely). We may not, however, be able to detect and remediate all such vulnerabilities, including on a timely basis. Further, we may experience delays in developing and deploying remedial measures and patches designed to address any such identified vulnerabilities. Vulnerabilities could be exploited and result in a security incident.
Any of the previously identified or similar threats could cause a security incident or other interruption that could result in unauthorized, unlawful, or accidental acquisition, modification, destruction, loss, alteration, encryption, disclosure of, or access to our sensitive data or our information technology systems, or those of the third parties upon which we rely. A security incident or other interruption could disrupt our ability (and that of third parties upon which we rely) to provide our products and services.
We may expend significant resources or modify our business activities (including our clinical trial activities) to try to protect against security incidents. Additionally, certain data privacy and security obligations may require us to implement and maintain specific security measures or industry-standard or reasonable security measures to protect our information technology systems and sensitive data. Applicable data privacy and security obligations may require us to notify relevant stakeholders, including affected individuals, customers, regulators, and investors, of security incidents or to implement other requirements, such as providing credit monitoring. Such disclosures and compliance with such requirements are costly, and the disclosure or the failure to comply with such requirements could lead to adverse consequences.
If we (or a third party upon which we rely) experience a security incident or are perceived to have experienced a security incident, we may experience adverse consequences, such as government enforcement actions (for example, investigations, fines, penalties, audits, and inspections); additional reporting requirements and/or oversight; restrictions on processing sensitive data (including personal data); litigation (including class claims); indemnification obligations; negative publicity; reputational harm; monetary fund diversions; diversion of management attention; interruptions in our operations (including in connection with our clinical trial activities); financial loss; and other similar harms. Security incidents and attendant consequences may prevent or cause customers to stop using our products and services, deter new customers from using our products and services, and negatively impact our ability to grow and operate our business.
Our contracts may not contain limitations of liability, and even where they do, there can be no assurance that limitations of liability in our contracts are sufficient to protect us from liabilities, damages, or claims related to our data privacy and security obligations. We maintain cybersecurity insurance coverage for claims related to cyber crime (up to £250,000 per occurrence) and other cybersecurity incidents (up to £6,000,000 per occurrence). However, we cannot be sure that our insurance coverage will be adequate or sufficient to protect us from or to mitigate liabilities arising out of our privacy and security practices, that such coverage will continue to be available on commercially reasonable terms or at all, or that such coverage will pay future claims.
In addition to experiencing a security incident, third parties may gather, collect, or infer sensitive data about us from public sources, data brokers, or other means that reveals competitively sensitive details about our organization and could be used to undermine our competitive advantage or market position. Additionally, sensitive data of ours could be leaked, disclosed, or revealed as a result of or in connection with our employees’, personnel’s, or vendors’ use of generative AI technologies.
We are subject to stringent and evolving U.S. and foreign laws, regulations and rules, contractual obligations, industry standards, policies and other obligations related to data privacy and security. Our actual or perceived failure to comply with such obligations could lead to regulatory investigations or actions; litigation (including class claims) and mass arbitration demands; fines and penalties; disruptions of our business operations; reputational harm; loss of revenue or profits; loss of customers or sales; and other adverse business consequences.
In the ordinary course of business, we process personal data and other sensitive information, including proprietary and confidential business data, trade secrets, intellectual property, and data we collect about trial participants in connection with clinical trials. Our data processing activities may subject us to numerous data privacy and security obligations, such as various laws, regulations, guidance, industry standards, external and internal privacy and security policies, contractual requirements, and other obligations relating to data privacy and security.
An increasing number of laws, regulations, and industry standards may govern data privacy and security. For example, the EU GDPR and the UK GDPR impose strict requirements for processing personal data. Under the EU GDPR, companies may face temporary or definitive bans on data processing and other corrective actions; fines of up to 20 million Euros under the EU GDPR, 17.5 million pounds sterling under the UK GDPR or, in each case, 4% of annual global revenue, whichever is greater; or private litigation related to processing of personal data brought by classes of data subjects or consumer protection organizations authorized at law to represent their interests.
In addition, the processing of “special category personal data”, such as health information, may also impose heightened compliance burdens under the EU GDPR and the UK GDPR and is a topic of active interest among relevant regulators.
The EU GDPR provides that European Economic Area (“EEA”) Member States may make their own further laws and regulations to introduce specific requirements related to the processing of “special categories of personal data”, including personal data related to health.
This fact may lead to greater divergence on the law that applies to the processing of such data types across the EEA and/or UK, compliance with which, as and where applicable, may increase our costs and could increase our overall compliance risk. Such country-specific regulations could also limit our ability to collect, use and share data in the context of our EEA and/or UK operations, and/or could cause our compliance costs to increase, ultimately having an adverse impact on our business, and harming our business and financial condition.
In the ordinary course of business, we transfer personal data from Europe and other jurisdictions to the United States. Europe and other jurisdictions have enacted laws requiring data to be localized or limiting the transfer of personal data to other countries. In particular, the EEA, the UK, and Switzerland have significantly restricted the transfer of personal data to the United States and other countries whose privacy laws it believes are inadequate. Other jurisdictions may adopt similarly stringent interpretations of their data localization and cross-border data transfer laws. Although there are currently various mechanisms that may be used to transfer personal data from the EEA, the UK, and Switzerland to the United States in compliance with law, such as the EEA standard contractual clauses, the UK’s International Data Transfer Agreement/Addendum, the Swiss-U.S. Data Privacy Framework (once officially recognized as a valid data transfer mechanism by the Swiss government), and the EU-U.S. Data Privacy Framework and the UK Extension thereto (which allows for transfers to relevant U.S.-based organizations who self-certify compliance and participate in the Framework), these mechanisms are subject to legal challenges, and there is no assurance that we can satisfy or rely on these measures to lawfully transfer personal data to the United States. If there is no lawful manner for us to transfer personal data from the EEA, the UK, Switzerland, or other jurisdictions to the United States, or if the requirements for a legally-compliant transfer are too onerous, we could face significant adverse consequences, including the interruption or degradation of our operations, the need to relocate part of or all of our business or data processing activities to other jurisdictions at significant expense, increased exposure to regulatory actions, substantial fines and penalties, the inability to transfer data and work with partners, vendors and other third parties, and injunctions against our processing or transferring of personal data necessary to operate our business. Additionally, companies that transfer personal data out of the EEA and UK to other jurisdictions, particularly to the United States, are subject to increased scrutiny from regulators, individual litigants, and activist groups. Some European regulators have ordered certain companies to suspend or permanently cease certain transfers out of Europe for allegedly violating the EU GDPR’s cross-border data transfer limitations.
In the United States, federal, state and local governments have enacted numerous data privacy and security laws, including data breach notification laws, data privacy laws, consumer protection laws (e.g., Section 5 of the Federal Trade Commission Act), and other similar laws (e.g., wiretapping laws). For example, HIPAA, as amended by the HITECH, imposes specific requirements relating to the privacy, security and transmission of protected health information. Additionally, in the past few years, numerous U.S. states—including California, Virginia, Colorado, Connecticut, and Utah—have enacted comprehensive privacy laws that impose certain obligations on covered businesses, including providing specific disclosures in privacy notices and affording residents with certain rights concerning their personal data. As applicable, such rights may include the right to access, correct, or delete certain personal data, and to opt-out of certain data processing activities, such as targeted advertising, profiling, and automated decision-making. The exercise of these rights may impact our business and ability to provide our products and services. Certain states also impose stricter requirements for processing certain personal data, including sensitive data, such as conducting data privacy impact assessments. These state laws allow for statutory fines for noncompliance. For example the CCPA provides fines of up to $7,500 per intentional violation and allows private litigants affected by certain data breaches to recover significant statutory damages.
Although the CCPA exempts some data processed in the context of clinical trials, the CCPA increases compliance costs and potential liability with respect to other personal data we maintain about California residents. Similar laws are being considered in several other states, as well as at the federal and local levels, and we expect more states to pass similar laws in the future. While these state laws, like the CCPA, also exempt some data processed in the context of clinical trials, these developments may further complicate compliance efforts, and increase legal risk and compliance costs for us and the third parties upon whom we rely.
In addition to data privacy and security laws, we are subject to industry standards adopted by industry groups and may become subject to such obligations in the future. We are also bound by other contractual obligations related to data privacy and security, and our efforts to comply with such obligations may not be successful.
We publish privacy policies, marketing materials, and other statements regarding data privacy and security. If these policies, materials or statements are found to be deficient, lacking in transparency, deceptive, unfair, or misrepresentative of our practices, we may be subject to investigation, enforcement actions by regulators, or other adverse consequences.
Obligations related to data privacy and security (and consumers' data privacy expectations) are quickly changing, becoming increasingly stringent, and creating uncertainty. Additionally, these obligations may be subject to differing applications and interpretations, which may be inconsistent or conflict among jurisdictions. Preparing for and complying with these obligations requires us to devote significant resources, which may necessitate changes to our services, information technologies, systems, and practices and to those of any third parties that process personal data on our behalf.
We may at times fail (or be perceived to have failed) in our efforts to comply with our data privacy and security obligations. Moreover, despite our efforts, our personnel or third parties upon whom we rely may fail to comply with such obligations, which could negatively impact our business operations. If we or the third parties upon whom we rely fail, or are perceived to have failed, to address or comply with applicable data privacy and security obligations, we could face significant consequences, including but not limited to: government enforcement actions (e.g., investigations, fines, penalties, audits, inspections, and similar); litigation (including class-action claims) and mass arbitration demands; additional reporting requirements and/or oversight; bans on processing personal data; orders to destroy or not use personal data; and imprisonment of company officials. Any of these events could have a material adverse effect on our reputation, business, or financial condition, including but not limited to: loss of customers; interruptions or stoppages in our business operations (including, as relevant, clinical trials); inability to process personal data or to operate in certain jurisdictions; limited ability to develop or commercialize our products; expenditure of time and resources to defend any claim or inquiry; adverse publicity; or substantial changes to our business model or operations. In particular, plaintiffs have become increasingly more active in bringing privacy-related claims against companies, including class claims and mass arbitration demands. Some of these claims allow for the recovery of statutory damages on a per violation basis, and, if viable, carry the potential for monumental statutory damages, depending on the volume of data and the number of violations.
Business disruptions, including those caused by the ongoing geopolitical conflicts, could seriously harm our future revenue and financial condition and increase our costs and expenses.
Our operations, and those of our vendors and suppliers, could be subject to earthquakes, power shortages, telecommunications failures, water shortages, floods, hurricanes, typhoons, fires, extreme weather conditions, medical epidemics and other natural or man-made disasters, geopolitical conflict or business interruptions, for which we are predominantly self-insured. The occurrence of any of these business disruptions could seriously harm our operations and financial condition and increase our costs and expenses. We currently rely on third-party suppliers to produce and process our product candidates on a patient-by-patient basis. Our ability to obtain clinical supplies of our product candidates could be disrupted if the operations of these suppliers are affected by a man-made or natural disaster or other business interruption.
The global economy has experienced volatility and disruptions from the impacts of the international conflicts, terrorism and other geopolitical events, including the ongoing war in Ukraine and the current Israel-Hamas conflict in Gaza. Although the length and impact of the ongoing military conflict is highly unpredictable, the war in Ukraine has led to market disruptions, including significant volatility in commodity prices, credit and capital markets, as well as supply chain interruptions, which contributed to record inflation globally. In addition, global markets may experience additional disruptions as a result of the current Israel-Hamas conflict, with Israel having declared war on Hamas, a U.S. designated Foreign Terrorist Organization, due to recent attacks. Although, to date, our business has not been materially impacted by the events described above, it is impossible to predict the extent to which our operations will be impacted in the short and long term, or the ways in which such matters may impact our business. The extent and duration of the conflicts in Ukraine and Gaza, geopolitical tensions, record inflation and resulting market disruptions are impossible to predict but could be substantial. Any such disruptions may also magnify the impact of other risks we face.
As a public company with operations in the EU, we may be subject to the sustainability disclosure requirements set out in the EU Corporate Sustainability Reporting Directive.
A growing number of investors, regulators, self-regulatory organizations and other stakeholders have expressed an interest in Environmental, Social and Corporate Governance (“ESG”) matters, and are requiring more robust ESG disclosures. The related legislative landscape in the EU has been evolving accordingly. For example, EU Directive No 2464/2022 on Corporate Sustainability Reporting (“CSRD”) was adopted and entered into force on January 5, 2023, amending the current EU Accounting Directive No 2013/34. The CSRD introduces new mandatory reporting obligations that will require the publication of audited sustainability information. The CSRD is supplemented by EU Delegated Regulation No 2023/2772 which establishes the first set of European Sustainability Reporting Standards (“ESRS”), which are applicable to in-scope EU entities. Further reporting standards are due to be adopted by June 2026, including for in-scope non-EU entities.
The CSRD and ESRS require certain mandatory disclosures, as well as disclosures of certain “material” sustainability matters in the company’s own operations, those of their subsidiaries and those of their value chain. The identification of material sustainability matters requires a “double materiality” assessment. This means that in-scope entities will have to assess both financial materiality, which are sustainability matters which generate risks or opportunities that affect, or could reasonably be expected to affect, the company’s financial position, financial performance, cash flows, access to finance or cost of capital over the short-, medium- or long-term, and impact materiality, which are the company’s material actual or potential, positive or negative impacts on people or the environment over the short-, medium- and long-term.). Sustainability matters are material if they satisfy one or both of these materiality tests.
The CSRD applies to entities with securities admitted to trading on an EU regulated market, as well as large EU companies, EU parents of a “large group”, and to listed EU small or medium-sized enterprises, amongst others. It will also apply to non-EU companies that have a certain threshold of EU-generated turnover and an in-scope EU subsidiary or EU branch meeting the turnover thresholds. Companies subject to the CSRD are required to fulfil their reporting obligations in accordance with a staggered timeline depending on the category of company. The first reports are expected in 2025 for the 2024 financial year, predominantly for entities with securities admitted to trading on an EU regulated market, and in 2026 for the 2025 financial year for many other EU companies (including EU subsidiaries of non-EU parents) that are not listed on an EU regulated market but meet the relevant size thresholds.
In response to new ESG initiatives and regulations we may voluntarily elect, or be required, to adopt strategies, policies, or procedures related to ESG matters and report on these. Reporting on ESG goals and objectives may cause us to expend significant capital and human resources, and could divert management’s attention from central operational matters. Reports could also lead to the disclosure of information that which may have a negative impact on our operations and reputation which may lead to additional exposure. Failure to accurately comply with any ESG reporting obligations may result in enforcement actions, sanctions, reputational harm or private litigation.
Risks Related to Our Dependence on Third Parties
We are dependent on intellectual property obtained or licensed from third parties, and if we were to fail to comply with our obligations under our existing and any future intellectual property licenses with third parties, we could lose intellectual property rights that are important to our business and we may not be able to continue developing or commercializing our product candidates, if approved.
We are party to an exclusive intellectual property license agreement with UCLB, the technology-transfer company of UCL, which is important to our business and under which we have acquired or licensed patent rights related to 17 patent families and other intellectual property related to our business. We expect to enter into additional license agreements in the future. Our existing license agreement with UCLB imposes, and we expect that future license agreements will impose, various due diligence, milestone payment, royalty, insurance and other obligations on us. Any uncured, material breach under the UCLB license agreement could result in our loss of rights to practice the patent rights (including those that have been assigned to us from UCLB) and other intellectual property licensed to us, and could compromise our development and commercialization efforts for our products and product candidates.
Licensing of intellectual property is of critical importance to our business and involves complex legal, business and scientific issues. For example, under our license agreement with UCLB, our exclusive rights under certain of the patents is subject to specified exclusions. Our right to enforce any patents that may issue from such patent rights similarly excludes enforcing them in such excluded fields, and obligates us to coordinate our enforcement efforts with a third-party licensee, if any, with rights in that excluded field. If a third party-licensee has the right to enforce those patents in their field, it could put a patent that may issue from this family at risk of being invalidated or construed narrowly, in which case we would no longer have the benefit of the patents for our own exclusivity.
Disputes may arise between us and our licensors regarding intellectual property subject to a license agreement, including disputes regarding:
•the scope of rights granted under the license agreement and other interpretation-related issues;
•whether and the extent to which our technology and processes infringe on intellectual property of the licensor that is not subject to the licensing agreement;
•our obligations to third parties;
•our diligence obligations with respect to the use of the licensed technology in relation to our development and commercialization of our product candidates, and what activities satisfy those diligence obligations;
•the ownership of inventions and know-how resulting from the joint creation or use of intellectual property by our licensors and us;
•our right to transfer or assign the license; and
•the effects of termination.
If disputes over intellectual property that we have licensed prevent or impair our ability to maintain our current licensing arrangement on acceptable terms, we may be unable to successfully develop and commercialize the affected product candidates.
We rely, and expect to continue to rely, on third parties to conduct the preclinical and clinical trials for our product candidates, and those third parties may not perform satisfactorily, including failing to meet deadlines for the completion of such trials or failing to comply with applicable regulatory requirements.
We depend and will continue to depend upon independent investigators and collaborators, such as universities, medical institutions, and strategic partners to conduct our preclinical and clinical trials. Agreements with such third parties might terminate for a variety of reasons, including a failure to perform by the third parties. If we need to enter into alternative arrangements, our product development activities would be delayed.
Our reliance on these third parties for research and development activities will reduce our control over these activities but will not relieve us of our responsibilities. For example, we will remain responsible for ensuring that each of our clinical trials is conducted in accordance with the general investigational plan and protocols for the trial. Moreover, the FDA requires us to comply with regulatory standards, commonly referred to as GLP and GCP, for conducting, recording and reporting the results of preclinical and clinical trials to assure that data and reported results are credible and accurate and that the rights, integrity and confidentiality of trial participants are protected. Similar regulatory requirements apply outside the United States, including the International Council for Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (the “ICH”).
Furthermore, these third parties may also have relationships with other entities, some of which may be our competitors. If these third parties do not successfully carry out their contractual duties, meet expected deadlines or conduct our clinical trials in accordance with regulatory requirements or our stated protocols, we will not be able to obtain, or may be delayed in obtaining, marketing approvals for our product candidates and will not be able to, or may be delayed in our efforts to, successfully commercialize our product candidates.
In addition, principal investigators for our clinical trials may serve as scientific advisors or consultants to us from time to time and may receive cash or equity compensation in connection with such services. If these relationships and any related compensation result in perceived or actual conflicts of interest, or the FDA or comparable foreign regulatory authorities concludes that the financial relationship may have affected the interpretation of the trial, the integrity of the data generated at the applicable clinical trial site may be questioned and the utility of the clinical trial itself may be jeopardized, which could result in the delay or rejection by the FDA or comparable foreign regulatory authorities. Any such delay or rejection could prevent us from commercializing our clinical-stage product candidates or any future product candidates.
We are also required to register certain ongoing clinical trials and post the results of certain completed clinical trials on a government-sponsored databases, such as ClinicalTrials.gov and foreign equivalents, within specified timeframes. Failure to do so by us or third parties can result in FDA or comparable foreign regulatory authority refusal to approve applications based on the clinical data, enforcement actions, adverse publicity and civil and criminal sanctions.
Cell-based therapies rely on the availability of reagents, specialized equipment, and other specialty materials, which may not be available to us on acceptable terms or at all. For some of these reagents, equipment, and materials, we rely or may rely on sole source vendors or a limited number of vendors, which could impair our ability to manufacture and supply our products.
Manufacturing our product and product candidates will require many reagents, which are substances used in our manufacturing processes to bring about chemical or biological reactions, and other specialty materials and equipment, some of which are manufactured or supplied by small companies with limited resources and experience to support commercial biologics production. We currently depend on a limited number of vendors for access to facilities and supply of certain materials and equipment used in the manufacture of our product and product candidates. For example, we currently use facilities and equipment at the Cell and Gene Therapy Catapult, as well as third party vendors, for vector and clinical cell manufacturing. In addition, we purchase equipment and reagents critical for the manufacture of our product and product candidates from Miltenyi and other suppliers on a purchase order basis. Some of our suppliers may not have the capacity to support commercial products manufactured under cGMP by biopharmaceutical firms or may otherwise be ill-equipped to support our needs.
We also do not have supply contracts with many of these suppliers, and may not be able to obtain supply contracts with them on acceptable terms or at all. Accordingly, we may not be able to obtain key materials and equipment to support clinical or commercial manufacturing.
For some of these reagents, equipment, and materials, we rely and may in the future rely on sole source vendors or a limited number of vendors. An inability to continue to source product from any of these suppliers, which could be due to regulatory actions or requirements affecting the supplier, adverse financial or other strategic developments experienced by a supplier, labor disputes or shortages, unexpected demands, or quality issues, could adversely affect our ability to satisfy demand for our product candidates, which could adversely and materially affect our product sales and operating results or our ability to conduct clinical trials, either of which could significantly harm our business.
As we continue to develop and scale our manufacturing process, we may need to obtain rights to and supplies of certain materials and equipment to be used as part of that process. We may not be able to obtain rights to such materials on commercially reasonable terms, or at all, and if we are unable to alter our process in a commercially viable manner to avoid the use of such materials or find a suitable substitute, it would have a material adverse effect on our business.
We operate a manufacturing facility to manufacture materials for AUCATZYL and our product candidates, which requires significant resources. A failure to successfully operate our manufacturing facility could lead to substantial delays and adversely affect our research and development efforts, including clinical trials, and commercial success of AUCATZYL and our product candidates, if approved. We are also obligated to share some of the capabilities of the manufacturing facility with BioNTech under the BioNTech License Agreement.
Our clinical and commercial manufacturing facility, The Nucleus, must be periodically inspected and licensed by the appropriate authorities. While we will continue to source raw materials from external CMOs, we plan to make the transition from external CMOs to our manufacturing facility and we expect our manufacturing facility to be the sole source supplier of clinical materials for our clinical trials and for commercial products, once approved. This sole source reliance increases the risk that we will not have sufficient quantities of our CAR T product candidates at an acceptable cost or quality, which could delay, prevent or impair our development or commercialization efforts, if approved.
In addition, under the terms of the BioNTech License Agreement, we granted BioNTech the option to negotiate a joint Manufacturing and Commercial Agreement pursuant to which the parties may access and leverage each other’s manufacturing and commercial capabilities, in addition to Autolus’ commercial site network and infrastructure, with respect to certain of each parties’ CAR T products, including BioNTech’s product candidate BNT211 (the “Manufacturing and Commercial Agreement”). The Manufacturing and Commercial Agreement, if entered into, would also grant BioNTech access to our commercial site network and infrastructure. If required under the Manufacturing and Commercial Agreement, we may need to subordinate production of our CAR T products in order to BioNTech’s products. Sharing The Nucleus facility with BioNTech increases the risk that we will not have sufficient quantities of our CAR T product candidates at an acceptable cost or quality, which could delay, prevent or impair our development or commercialization efforts, if approved.
In either case, if we are unable to manufacture sufficient clinical or commercial materials at our manufacturing facility, we may be forced to contract with external CMOs, which we may not be able to do on commercially reasonable terms, if at all. Even if commercially reasonable terms are available, any transition of manufacturing from our manufacturing facility to an external CMO could be time-consuming and require significant effort and expertise because there may be a limited number of qualified replacements. In some cases, the technical skills or technology required to manufacture our CAR T product candidates may be unique or proprietary and we may have difficulty transferring such skills or technology to another CMO and a feasible alternative may not exist. If we fail to manufacture at our manufacturing facility, or obtain from a CMO, a sufficient supply of clinical materials for our clinical trials, or commercial materials for our commercial product in accordance with applicable specifications on a timely basis, our research and development efforts, including clinical trials, and the commercial success of our CAR T product, and product candidates, if approved, and our business, financial condition, results of operations and growth prospects could be materially adversely affected.
We, and the third parties on whom we rely in part for sales, marketing and distribution capabilities, may not be able to effectively market, sell and distribute AUCATZYL or our other product candidates, if approved.
We have invested, and expect to continue to invest, significant financial and management resources to develop internal our sales, distribution and marketing capabilities, particularly in anticipation of the commercial launch of AUCATZYL. With respect to jurisdictions outside the US, we will need to commit resources to buildings these capabilities prior to any confirmation that obe-cel or our other product candidates will be approved in a territory.
We utilize a hybrid model that includes in-house and contracted resources in the United States and Europe, and we have engaged third parties and may engage additional third parties to provide these services. We may enter into agreements with third parties to develop our commercial infrastructure for the commercial launch and continued sale of AUCATZYL and any product candidates that receive approval, including to potentially retain, train and deploy a direct sales force, but we have limited experience operating or managing a third-party sales force as a company. There can be no assurance that the capabilities of the third parties will be more effective than an internally developed sales organization. If third parties fail to hire, train, and retain qualified sales personnel, market our product successfully or on a cost-effective basis or otherwise terminates our relationship, our ability to generate revenue will be limited and we will need to identify and retain an alternative organization or develop our own sales and marketing capability. This could involve significant delays and costs, including the diversion of our management’s attention from other activities. We may also need to retain additional consultants or external service providers to assist us in sales, marketing and distribution functions, and may be unsuccessful in retaining such services on acceptable financial terms or at all.
There are risks involved with both establishing our own sales and marketing capabilities and entering into arrangements with third parties to perform these services. For example, recruiting and training a commercial organization is expensive and time consuming and could delay any product launch. If the commercial launch of a product candidate for which we recruit a sales force and establish marketing capabilities is delayed or does not occur for any reason, we would have prematurely or unnecessarily incurred these commercialization expenses. This may be costly and our investment would be lost if we cannot retain or reposition our sales and marketing personnel.
Factors that may inhibit our efforts to commercialize our product candidates on our own include:
•the inability to recruit, train and retain adequate numbers of effective sales and marketing personnel;
•the inability of sales personnel to obtain access to physicians or educate adequate numbers of physicians on the benefits of prescribing any future product that we may develop;
•the lack of complementary treatments to be offered by sales personnel, which may put us at a competitive disadvantage relative to companies with more extensive product lines; and
•unforeseen costs and expenses associated with creating an independent sales and marketing organization.
If we enter into arrangements with third parties to perform sales, marketing and distribution services, our product revenue or the profitability to us from these revenue streams is likely to be lower than if we were to market and sell any product candidates that we develop ourselves. In addition, we may not be successful in entering into arrangements with third parties to sell and market our product candidates or may be unable to do so on terms that are favorable to us. We likely will have little control over such third parties and any of them may fail to devote the necessary resources and attention to sell and market our product candidates effectively. If we do not establish sales and marketing capabilities successfully, either on our own or in collaboration with third parties, we may not be successful in commercializing our product candidates.
We collaborate with third parties in the research, development and commercialization of certain of our product and product candidates. If our collaborators do not perform as expected or if we are unable to maintain existing or establish additional collaborations, our ability to develop and commercialize our product candidates may be adversely affected.
We have collaboration and license agreements with, for example, BioNTech SE, Cabaletta Bio Inc., Moderna Inc., Bristol-Myers Squibb Company, and an investee of Syncona Portfolio Limited. These agreements provide us with important funding for our programs. If our therapeutic programs and related collaborations do not result in the successful development and commercialization of products or if one of our collaborators or licensees terminates its agreement with us, we may not receive any future research funding or milestone or royalty payments associated with such collaboration or license arrangement. In addition, any termination of an agreement by the relevant collaborators could affect our ability to develop further such product candidates or adversely affect how we are perceived in scientific and financial communities. All of the risks we face relating to product development, regulatory approval and commercialization also apply to the activities of our program collaborators.
In our collaboration arrangements, we depend on the performance of our collaborators. Our licensees have the right to make decisions regarding the development and commercialization of product candidates under the collaborations without consulting us and may make decisions with which we do not agree. Our collaborators may fail to perform their obligations under the collaboration agreements or may not perform their obligations in a timely manner. If conflicts arise between our collaborators and us, the other party may act in a manner adverse to us and could limit our ability to implement our strategies. Furthermore, our collaborators may not properly obtain, maintain, enforce or defend our intellectual property or proprietary rights or may use our proprietary information in such a way as to invite litigation that could jeopardize or invalidate our proprietary information or expose us to potential litigation.
In addition, we cannot control the amount and timing of resources our collaborators may devote to our product candidates. They may separately pursue competing products, therapeutic approaches or technologies to develop treatments for the diseases targeted by us. Competing products, either developed by the collaborators or to which the collaborators have rights, may result in the withdrawal of support for our product candidates. Even if our collaborators continue their contributions to the strategic collaborations, they may nevertheless determine not to actively pursue the development or commercialization of any resulting products.
Additionally, if our collaborators pursue different clinical or regulatory strategies with their product candidates based on similar technology as used in our product candidates, adverse events with their product candidates could negatively affect our product candidates. Any of these developments could harm our product development efforts.
If our collaborators terminate or breach our agreements with them, or otherwise fail to complete their obligations in a timely manner, it may have a detrimental effect on our financial position by reducing or eliminating the potential for us to receive technology access and license fees, milestones and royalties, reimbursement of development costs, as well as possibly requiring us to devote additional efforts and incur costs associated with pursuing internal development of product candidates. Furthermore, if our collaborators do not prioritize and commit sufficient resources to our product or product candidates, we or our partners may be unable to develop or commercialize these products or product candidates, which would limit our ability to generate revenue and become profitable.
We do not and will not have access to all information regarding the product candidates we license to our collaborators. Consequently, our ability to inform our shareholders about the status of such product candidates, and to make informed operational and investment decisions about the product candidates to which we have retained development and commercialization rights, may be limited.
We do not and will not have access to all information regarding the product candidates being developed and potentially commercialized by BioNTech, including potentially material information about clinical trial design and execution, regulatory affairs, process development, manufacturing, marketing and other areas known by BioNTech. In addition, we have confidentiality obligations under our agreement with BioNTech. Thus, our ability to keep our shareholders informed about the status of product candidates under our collaboration will be limited by the degree to which BioNTech keeps us informed and allows us to disclose such information to the public.
We may form or seek strategic alliances or enter into additional licensing arrangements in the future, and we may not realize the benefits of such alliances or licensing arrangements.
We may form or seek strategic alliances, create joint ventures or collaborations or enter into additional licensing arrangements with third parties that we believe will complement or augment our development and commercialization efforts with respect to our product candidates and any future product candidates that we may develop. Additionally, although we intend to develop product candidates through our own internal research, we may need to obtain additional licenses from others to advance our research or allow commercialization of our product candidates and it is possible that we may be unable to obtain additional licenses at a reasonable cost or on reasonable terms, if at all. Any of these relationships may require us to incur non-recurring and other charges, increase our near and long-term expenditures, issue securities that dilute our existing shareholders or disrupt our management and business.
We face significant competition in seeking appropriate collaborative partners. Our ability to reach a definitive agreement for a collaboration will depend, among other things, upon an assessment of the collaborator's resources and expertise, the terms and conditions of the proposed partnership and the proposed collaborator's evaluation of a number of factors. These factors may include the design or results of clinical trials, the likelihood of regulatory approval, the potential market for the subject product candidate, the costs and complexities of manufacturing and delivering such product candidate to patients, the potential of competing products, the existence of uncertainty with respect to our ownership of technology, which can exist if there is a challenge to such ownership regardless of the merits of the challenge and industry and market conditions generally. The collaborator may also consider alternative product candidates or technologies for similar indications that may be available to collaborate on and whether such a partnership could be more attractive than the one with us.
We may not be able to negotiate collaborations on a timely basis, on acceptable terms, or at all. If we are unable to do so, we may have to curtail the development of the product candidate for which we are seeking to collaborate, reduce or delay its development program or one or more of our other development programs, delay its potential commercialization or reduce the scope of any sales or marketing activities or increase our expenditures and undertake development or commercialization activities at our own expense. If we elect to increase our expenditures to fund development or commercialization activities on our own, we may need to obtain additional capital, which may not be available to us on acceptable terms or at all. If we do not have sufficient funds, we may not be able to further develop product candidates or bring them to market and generate product revenue.
Risks Related to Regulatory Approval of Our Product Candidates and Other Legal Compliance Matters
Even if we complete the necessary preclinical studies and clinical trials, the regulatory approval process is expensive, time-consuming and uncertain and may prevent us from obtaining approvals for the commercialization of our product candidates. As a result, we cannot predict when or if, and in which territories, we will obtain marketing approval to commercialize a product candidate.
Our product candidates and the activities associated with their development and commercialization, including their design, research, testing, manufacture, safety, efficacy, quality control, recordkeeping, labeling, packaging, storage, approval, advertising, promotion, sale, distribution, import, export, and reporting of safety and other post-market information, are subject to comprehensive regulation by the FDA, the EU and other comparable regulatory authorities in other jurisdictions. Failure to obtain marketing approval for a product candidate will prevent us from commercializing the product candidate. We have not received approval to market any of our product candidates from regulatory authorities in any jurisdiction.
We have only limited experience in filing and supporting the applications necessary to gain marketing approvals and may rely on third-party CROs, to assist us in this process. Securing marketing approval requires the submission of extensive preclinical and clinical data and supporting information to regulatory authorities for each therapeutic indication to establish the product candidate’s safety and efficacy. Securing marketing approval also requires the submission of information about the product manufacturing process to, and inspection of manufacturing facilities by, the regulatory authorities. Our product candidates may not be effective, may be only moderately effective or may prove to have undesirable or unintended side effects, toxicities or other characteristics that may preclude our obtaining marketing approval or prevent or limit commercial use. If any of our product candidates receives marketing approval, the accompanying label may limit its approved use, which could limit sales of the product.
The process of obtaining marketing approvals, both in the United States and abroad, is expensive and may take many years, if approval is obtained at all, and can vary substantially based upon a variety of factors, including the type, complexity and novelty of the product candidates involved. Securing marketing approval requires the submission of extensive preclinical and clinical data and supporting information to regulatory authorities for each therapeutic indication to establish the product candidate’s safety and efficacy.
Securing marketing approval also requires the submission of information about the product manufacturing process demonstrating the products quality to, and inspection of manufacturing facilities by, the regulatory authorities. The FDA, the EMA or the European Commission or other regulatory authorities may determine that our product candidates are not safe and effective, only moderately effective or have undesirable or unintended side effects, toxicities or other characteristics that preclude our obtaining marketing approval or prevent or limit commercial use.
In addition, changes in marketing approval policies during the development period, changes in or the enactment of additional statutes or regulations, or changes in regulatory review for each submitted product application, may cause delays in the approval or rejection of an application. Regulatory authorities have discretion in the approval process and may refuse to accept any application or may decide that our data is insufficient for approval and require additional preclinical, clinical or other studies including further manufacturing process or quality control data. In addition, varying interpretations of the data obtained from manufacturing procedures, quality control, preclinical and clinical testing could delay, limit or prevent marketing approval of a product candidate. Any marketing approval we ultimately obtain may be limited or subject to restrictions or post-approval commitments that render the approved product not commercially viable.
If we experience delays in obtaining approval or if we fail to obtain approval of our product candidates, the commercial prospects for our product candidates may be harmed and our ability to generate revenues will be impaired.
In order to market and sell our products in the EU and any other jurisdictions, we must obtain separate marketing approvals and comply with numerous and varying regulatory requirements. The approval procedure varies among countries and can involve additional testing. The time required to obtain approval may differ substantially from that required to obtain approval from the FDA. The regulatory approval process outside the United States generally includes all of the risks associated with obtaining approval from the FDA. In addition, in many countries outside the United States, it is required that the product be approved for reimbursement before the product can be approved for sale in that country. We may not obtain approvals from regulatory authorities outside the United States on a timely basis, if at all.
Approval by the FDA does not ensure approval by regulatory authorities in other countries or jurisdictions, and approval by one regulatory authority outside the United States does not ensure approval by regulatory authorities in other countries or jurisdictions or by the FDA. However, failure to obtain approval in one jurisdiction may impact our ability to obtain approval elsewhere. We may not be able to file for marketing approvals and may not receive necessary approvals to commercialize our products in any market.
Obtaining and maintaining regulatory approval of AUCATZYL or our other product candidates in one jurisdiction does not mean that we will be successful in obtaining regulatory approval of our product candidates in other jurisdictions.
Obtaining and maintaining regulatory approval of our product candidates in one jurisdiction does not guarantee that we will be able to obtain or maintain regulatory approval in any other jurisdiction, but a failure or delay in obtaining regulatory approval in one jurisdiction may have a negative effect on the regulatory approval process in others. For example, even though the FDA granted marketing approval for AUCATZYL in the US for the treatment of r/r adult B-ALL, comparable regulatory authorities in other jurisdictions must also approve the manufacturing, marketing and promotion of AUCATZYL/obe-cel in those countries. Approval procedures vary among jurisdictions and can involve requirements and administrative review periods different from those in the United States, including additional manufacturing quality controls, or additional preclinical studies or clinical trials, as clinical studies conducted in one jurisdiction may not be accepted by regulatory authorities in other jurisdictions. In many jurisdictions outside the United States, a product candidate must be approved for reimbursement before it can be approved for sale in that jurisdiction. In some cases, the price that we intend to charge for our products is also subject to approval.
Obtaining foreign regulatory approvals and compliance with foreign regulatory requirements could result in significant delays, difficulties and costs for us and could delay or prevent the introduction of our products in certain countries. If we fail to comply with the regulatory requirements in international markets and/or to receive applicable marketing approvals, our target market will be reduced and our ability to realize the full market potential of our product or product candidates will be harmed.
Even though we have obtained marketing approval by the FDA for AUCATZYL, the terms of approvals and ongoing regulation of AUCATZYL may limit how we manufacture and market AUCATZYL and compliance with such requirements may involve substantial resources, which could materially impair our ability to generate revenue.
Even though we have been granted marketing approval by the FDA for AUCATZYL, an approved product and its manufacturer and marketer are subject to ongoing review and extensive regulatory requirements for manufacturing processes, labeling, packaging, distribution, adverse event reporting, pharmacovigilance oversight, storage, advertising, promotion, sampling, and recordkeeping, including the potential requirements to implement a REMS program in the United States or comparable foreign strategies, or similar schemes in other countries, or to conduct costly post-marketing studies or clinical trials and surveillance to monitor the safety or efficacy of the product. We must also comply with requirements concerning advertising and promotion for AUCATZYL/obe-cel and for any of our other product candidates for which we obtain marketing approval. Promotional communications with respect to prescription drugs are subject to a variety of legal and regulatory restrictions and must be consistent with the information in the product’s approved labeling. Thus, we will not be able to promote any products we develop for indications or uses for which they are not approved. In addition, manufacturers of approved products and those manufacturers’ facilities are required to comply with extensive regulatory requirements of the FDA, the EU and national competent authorities of EU Member States and other regulatory authorities, including ensuring that quality control and manufacturing procedures conform to cGMP and other comparable regulations and standards, which include requirements relating to quality control and quality assurance as well as the corresponding maintenance of records and documentation and reporting requirements. We or our suppliers could be subject to periodic unannounced inspections by the FDA, the competent authorities of EU Member States, or other regulatory authorities to monitor and ensure compliance with cGMP. Failure to comply with applicable regulations could result in sanctions being imposed on us, including shutdown of the third-party vendor or invalidation of drug product lots or processes, fines, injunctions, civil penalties, delays, suspension, variation or withdrawal of approvals, license revocation, seizures or recalls of product candidates or drugs, operating restrictions and criminal prosecutions, any of which could significantly and adversely affect supplies of our products, and product candidates, if approved, and significantly harm our business, financial condition, results of operations and prospects.
Accordingly, we and suppliers will continue to expend time, money and effort in all areas of regulatory compliance, including manufacturing, production, product surveillance and quality control. If we are not able to comply with post-approval regulatory requirements, we could have the marketing approvals for our products withdrawn by regulatory authorities and our ability to market any future products could be limited, which could adversely affect our ability to achieve or sustain profitability. Thus, the cost of compliance with post-approval regulations may have a negative effect on our operating results and financial condition.
AUCATZYL, and any other product candidate for which we obtain marketing approval, could be subject to post-marketing restrictions or recall or withdrawal from the market, and we may be subject to penalties if we fail to comply with regulatory requirements or if we experience unanticipated problems with our product candidates, when and if any of them are approved.
The FDA and other federal and state agencies, including the U.S. Department of Justice (“DOJ”), closely regulate compliance with all requirements governing prescription drug products, including requirements pertaining to marketing and promotion of products in accordance with the provisions of the approved labeling and manufacturing of products in accordance with cGMP requirements. Similar legislation or provisions may also apply in other jurisdictions. The FDA and DOJ impose stringent restrictions on manufacturers’ communications regarding off-label use and if we do not market our products for their approved indications, or if other of our marketing claims are deemed false or misleading, we may be subject to enforcement action. Physicians, on the other hand, may prescribe products for off-label uses. The FDA and other regulatory authorities do not regulate a physician’s choice of drug treatment made in the physician’s independent medical judgment. However, companies may only share truthful and not misleading information that is otherwise consistent with a product’s FDA approved labeling.
Violations of such requirements may lead to investigations alleging violations of the FDCA and other statutes, including the U.S. federal False Claims Act and other federal and state healthcare fraud and abuse laws as well as state consumer protection laws. Similar legislation or provisions may also apply in other jurisdictions. In the EU, the advertising and promotion of medicinal products are subject to both EU and EU Member States’ laws governing promotion of medicinal products, interactions with physicians and other healthcare professionals, misleading and comparative advertising and unfair commercial practices. General requirements for advertising and promotion of medicinal products, such as direct-to-consumer advertising of prescription medicinal products are established in EU law. However, the details are governed by regulations in individual EU Member States and can differ from one country to another. For example, applicable laws require that promotional materials and advertising in relation to medicinal products comply with the product’s Summary of Product Characteristics, or SmPC, which may require approval by the competent national authorities in connection with an MA. The SmPC is the document that provides information to physicians concerning the safe and effective use of the product. Promotional activity that does not comply with the SmPC is considered off-label and is prohibited in the EU.
Our failure to comply with all regulatory requirements, and later discovery of previously unknown adverse events or other problems with our products, manufacturers or manufacturing processes, may yield various results, including:
•litigation involving patients taking our products;
•restrictions on such products, manufacturers or manufacturing processes;
•restrictions on the labeling or marketing of a product;
•restrictions on product distribution or use;
•requirements to conduct post-marketing studies or clinical trials;
•warning or untitled letters;
•withdrawal of the products from the market;
•refusal to approve pending applications or supplements to approved applications that we submit;
•recall of products;
•fines, restitution or disgorgement of profits or revenues;
•suspension, variation or withdrawal of marketing approvals;
•suspension of any ongoing clinical trials;
•damage to relationships with any potential collaborators;
•unfavorable press coverage and damage to our reputation;
•refusal to permit the import or export of our products;
•product seizure; or
•injunctions or the imposition of civil or criminal penalties.
Non-compliance by us or any future collaborator with regulatory requirements regarding safety monitoring or pharmacovigilance, and with requirements related to the development of products for the pediatric population, can also result in significant financial penalties and reputational damage. Similarly, failure to comply with regulatory requirements regarding the protection of personal data can also lead to significant penalties and sanctions.
Failure to comply with EU and EU Member State laws that apply to the conduct of clinical trials, manufacturing approval, marketing authorization of medicinal products and marketing of such products, both before and after grant of the marketing authorization, or with other applicable regulatory requirements may result in administrative, civil or criminal penalties. These penalties could include delays or refusal to authorize the conduct of clinical trials, or to grant marketing authorization, product withdrawals and recalls, product seizures, suspension, withdrawal or variation of the marketing authorization, total or partial suspension of production, distribution, manufacturing or clinical trials, operating restrictions, injunctions, suspension of licenses, fines and criminal penalties.
Non-compliance with EU requirements regarding safety monitoring or pharmacovigilance, and with requirements related to the development of products for the pediatric population, also can result in significant financial penalties. Similarly, failure to comply with the EU’s requirements regarding the protection of personal data can also lead to significant penalties and sanctions.
If any of these events occurs, our ability to sell such product may be impaired, and we may incur substantial additional expense to comply with regulatory requirements, which could adversely affect our business, financial condition and results of operations.
Our employees, independent contractors, principal investigators, consultants, commercial partners and vendors may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements.
We are exposed to the risk of employee fraud or other misconduct or failure to comply with applicable regulatory requirements. Misconduct by employees and independent contractors, such as principal investigators, consultants, commercial partners, and vendors, could include failures to comply with regulations of the FDA, the EU, EU Member States and other comparable regulatory authorities, to provide accurate information to such regulators, to comply with manufacturing standards we have established, to comply with healthcare fraud and abuse laws, to report financial information or data accurately or to disclose unauthorized activities to us. In particular, sales, marketing and other business arrangements in the healthcare industry are subject to extensive laws and regulations intended to prevent fraud, misconduct, kickbacks, self-dealing and other abusive practices. These laws and regulations may restrict or prohibit a wide range of business activities, including, but not limited to, research, manufacturing, distribution, pricing, discounting, marketing and promotion, sales commission, customer incentive programs and other business arrangements.
Employee and independent contractor misconduct could also involve the improper use of individually identifiable information, including, without limitation, information obtained in the course of clinical trials, which could result in regulatory sanctions and serious harm to our reputation. In addition, federal procurement laws impose substantial penalties for misconduct in connection with government contracts and require certain contractors to maintain a code of business ethics and conduct.
It is not always possible to identify and deter employee and independent contractor misconduct, and any precautions we take to detect and prevent improper activities may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to be in compliance with such laws. If any such actions are instituted against us, those actions could have a significant impact on our business, including the imposition of civil, criminal and administrative penalties, damages, monetary fines, disgorgement of profits, possible exclusion from participation in Medicare, Medicaid and other federal healthcare programs, National Health Service in the UK, or other government supported healthcare in other jurisdictions, contractual damages, reputational harm, diminished profits and future earnings, additional reporting or oversight obligations if we become subject to a corporate integrity agreement or other agreement to resolve allegations of non-compliance with the law and curtailment or restructuring of our operations, any of which could adversely affect our ability to operate.
Our business operations and current and future relationships with healthcare professionals, principal investigators, consultants, customers and third-party payors in the United States and elsewhere may be subject, directly or indirectly, to applicable anti-kickback, fraud and abuse, false claims, physician payment transparency, health information privacy and security and other healthcare laws and regulations, which could expose us to substantial penalties.
Healthcare providers, physicians and third-party payors in the United States and elsewhere will play a primary role in the recommendation and prescription of any products or product candidates for which we obtain marketing approval. Our current and future arrangements with healthcare professionals, principal investigators, consultants, customers and third-party payors may expose us to broadly applicable fraud and abuse and other healthcare laws, including, without limitation, the U.S. federal Anti-Kickback Statute and the U.S. federal False Claims Act, that may constrain the business or financial arrangements and relationships through which we sell, market and distribute any products or product candidates for which we obtain marketing approval, and foreign equivalents. In addition, we will be subject to physician payment transparency laws and patient privacy and security regulation by the U.S. federal government and by the states and foreign jurisdictions in which we conduct our business.
The applicable federal, state and foreign healthcare laws that may affect our ability to operate include the following:
•the U.S. federal Anti-Kickback Statute, which prohibits, among other things, persons or entities from knowingly and willfully soliciting, offering, receiving or providing remuneration, directly or indirectly, in cash or in kind, to induce or reward, or in return for, either the referral of an individual for, or the purchase, lease, order or recommendation of, any good, facility, item or service, for which payment may be made, in whole or in part, under federal and state healthcare programs such as Medicare and Medicaid. The term ‘‘remuneration’’ has been broadly interpreted to include anything of value. This statute has been interpreted to apply to arrangements between pharmaceutical manufacturers on the one hand and prescribers, purchasers and formulary managers on the other hand. Although there are a number of statutory exceptions and regulatory safe harbors protecting certain common activities from prosecution or other regulatory sanctions, the exceptions and safe harbors are drawn narrowly, and practices that involve remuneration that are alleged to be intended to induce prescribing, purchases or recommendations may be subject to scrutiny if they do not qualify for an exception or safe harbor. Failure to meet all of the requirements of a particular applicable statutory exception or regulatory safe harbor does not make the conduct per se illegal under the U.S. federal Anti-Kickback Statute. Instead, the legality of the arrangement will be evaluated on a case-by-case basis based on a cumulative review of all its facts and circumstances. Several courts have interpreted the statute’s intent requirement to mean that if any one purpose of an arrangement involving remuneration is to induce referrals of federal healthcare covered business, the U.S. federal Anti-Kickback Statute has been violated;
•U.S. federal civil and criminal false claims laws, including the U.S. federal False Claims Act, which can be enforced though civil whistleblower or qui tam actions, and civil monetary penalty laws, which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, to the federal government, including the Medicare and Medicaid programs, claims for payment that are false or fraudulent or making a false statement to avoid, decrease or conceal an obligation to pay money to the federal government. Pharmaceutical and other healthcare companies have been prosecuted under these laws for, among other things, allegedly inflating drug prices they report to pricing services, which in turn were used by the government to set Medicare and Medicaid reimbursement rates, and for allegedly providing free product to customers with the expectation that the customers would bill federal programs for the product. In addition, certain marketing practices, including off-label promotion, may also violate false claims laws. Further, pharmaceutical manufacturers can be held liable under the U.S. federal False Claims Act even when they do not submit claims directly to government payors if they are deemed to “cause” the submission of false or fraudulent claims;
•HIPAA, which created new federal criminal statutes that prohibit knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program or obtain, by means of false or fraudulent pretenses, representations or promises, any of the money or property owned by, or under the custody or control of, any healthcare benefit program, regardless of whether the payor is public or private, knowingly and willfully embezzling or stealing from a healthcare benefit program, willfully obstructing a criminal investigation of a healthcare offense and knowingly and willfully falsifying, concealing or covering up by any trick or device a material fact or making any materially false statements in connection with the delivery of, or payment for, healthcare benefits, items or services relating to healthcare matters;
•HIPAA, as amended by HITECH, and their respective implementing regulations, which impose obligations on “covered entities,” including certain healthcare providers, health plans, and healthcare clearinghouses, as well as their respective “business associates” that create, receive, maintain or transmit individually identifiable health information for or on behalf of a covered entity, and their covered subcontractors, with respect to safeguarding the privacy, security and transmission of individually identifiable health information. Additionally, HITECH also created four new tiers of civil monetary penalties, amended HIPAA to make civil and criminal penalties directly applicable to business associates, and gave state attorneys general new authority to file civil actions for damages or injunctions in U.S. federal courts to enforce HIPAA and seek attorneys’ fees and costs associated with pursuing federal civil actions;
•the FDCA, which prohibits, among other things, the adulteration or misbranding of drugs, biologics and medical devices;
•the U.S. federal Physician Payments Sunshine Act, created under Section 6002 of Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act (collectively, the “ACA”), and its implementing regulations, created annual reporting requirements for certain manufacturers of drugs, devices, biologicals and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program (with certain exceptions), to annually report to the CMS, information related to certain payments and “transfers of value” provided to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors), certain other health care professionals (such as physicians assistants and nurse practitioners) and teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family members;
•analogous state laws and regulations and foreign laws, such as state anti-kickback and false claims laws, which may apply to sales or marketing arrangements and claims involving healthcare items or services reimbursed by non-governmental third-party payors, including private insurers; state and foreign laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government or to adopt compliance programs as prescribed by state laws and regulations, or that otherwise restrict payments that may be made to healthcare providers; state and foreign laws that require drug manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures; state and local laws that require the registration of pharmaceutical sales representatives; and state and foreign laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts; and
•similar healthcare laws and regulations in the EU and other jurisdictions, including reporting requirements detailing interactions with and payments to healthcare providers and laws governing the data privacy and security of certain protected information, such as the EU GDPR and UK GDPR, which imposes obligations and restrictions on the collection and use of personal data relating to individuals located in the EU and UK (including health data).
Outside the United States, interactions between pharmaceutical companies and health care professionals are also governed by strict laws, such as national anti-bribery laws of European countries, national sunshine rules, regulations, industry self-regulation codes of conduct and physicians’ codes of professional conduct. Failure to comply with these requirements could result in reputational risk, public reprimands, administrative penalties, fines or imprisonment.
Further, the ACA, among other things, amended the intent requirement of the U.S. federal Anti-Kickback Statute and certain criminal statutes governing healthcare fraud. A person or entity no longer needs to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation. In addition, the ACA provided that the government may assert that a claim including items or services resulting from a violation of the U.S. federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the U.S. federal False Claims Act.
Because of the breadth of these laws and the narrowness of their exceptions and safe harbors, it is possible that our business activities can be subject to challenge under one or more of such laws. The scope and enforcement of each of these laws is uncertain and subject to rapid change in the current environment of healthcare reform. Federal and state enforcement bodies have continued their scrutiny of interactions between healthcare companies and healthcare providers, which has led to a number of significant investigations, prosecutions, convictions and settlements in the healthcare industry.
Efforts to ensure that our internal operations and future business arrangements with third parties will comply with applicable healthcare laws and regulations will involve substantial costs. If our operations are found to be in violation of any of these laws or any other governmental regulations that may apply to us, we may be subject to significant civil, criminal and administrative penalties, including, without limitation, damages, monetary fines, imprisonment, disgorgement of profits, possible exclusion from participation in Medicare, Medicaid and other federal healthcare programs, contractual damages, reputational harm, diminished profits and future earnings, additional reporting or oversight obligations if we become subject to a corporate integrity agreement or other agreement to resolve allegations of non-compliance with the law and curtailment or restructuring of our operations, any of which could adversely affect our ability to operate our business and pursue our strategy. If any of the physicians or other healthcare providers or entities with whom we expect to do business, including future collaborators, are found not to be in compliance with applicable laws, they may be subject to criminal, civil or administrative sanctions, including exclusions from participation in government healthcare programs, which could also affect our business.
Our products and product candidates are subject to government price controls in certain jurisdictions that may affect our revenue.
There has been heightened governmental scrutiny in the UK, United States, EU and other jurisdictions of pharmaceutical pricing practices in light of the rising cost of prescription drugs and biologics. In the United States, such scrutiny has resulted in several recent Congressional inquiries and proposed and enacted federal and state legislation designed to, among other things, bring more transparency to product pricing, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for products. For example, in the United States, at the federal level in July 2021, the Biden administration released an executive order, “Promoting Competition in the American Economy,” with multiple provisions aimed at prescription drugs. In response to Biden’s executive order, on September 9, 2021, the HHS, released a Comprehensive Plan for Addressing High Drug Prices that outlines principles for drug pricing reform and sets out a variety of potential legislative policies that Congress could pursue to advance these principles. Further, on August 16, 2022, the Inflation Reduction Act was signed into law, which among other things (i) directed HHS to negotiate the price of certain high-expenditure, single-source drugs and biologics covered under Medicare and (ii) imposed rebates under Medicare Part B and Medicare Part D to penalize price increases that outpace inflation. These provisions took effect progressively starting in fiscal year 2023. On August 15, 2024, HHS announced the agreed-upon reimbursement prices of the first ten drugs that were subject to price negotiations, although the Medicare drug price negotiation program is currently subject to legal challenges. HHS will select up to fifteen additional drugs covered under Part D for price negotiation in 2025.
In response to the Biden administration’s October 2022 executive order, on February 14, 2023, HHS released a report outlining three new models for testing by the CMS Innovation Center which will be evaluated on their ability to lower the cost of drugs, promote accessibility, and improve quality of care. It is unclear whether the models will be utilized in any health reform measures in the future. Further, on December 7, 2023, the Biden administration announced an initiative to control the price of prescription drugs through the use of march-in rights under the Bayh-Dole Act. On December 8, 2023, the National Institute of Standards and Technology published for comment a Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights which for the first time includes the price of a product as one factor an agency can use when deciding to exercise march-in rights. While march-in rights have not previously been exercised, it is uncertain if that will continue under the new framework.
At the state level, legislatures have increasingly enacted legislation and implemented regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing.
We cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrative or executive action, either in the United States or abroad, particularly in light of the upcoming U.S. presidential and Congressional elections. We expect that additional state and federal health care reform measures will be adopted in the future, any of which could limit the amounts that federal and state governments will pay for health care products and services, which could result in reduced demand for our development candidates or additional pricing pressures, or otherwise adversely impact our operations.
Outside of the United States, particularly in the UK and EU, the pricing of prescription pharmaceuticals is subject to governmental control by individual EU Member States. In these countries, pricing negotiations with governmental authorities can take considerable time after the receipt of marketing approval for a product. In the EU, EU Member States may restrict the range of medicinal products for which their national health insurance systems provide reimbursement and to control the prices of medicinal products for human use. An EU Member State may approve a specific price for the medicinal product, it may refuse to reimburse a product at the price set by the manufacturer or it may instead adopt a system of direct or indirect controls on the profitability of the company placing the medicinal product on the market. Many EU Member States also periodically review their reimbursement procedures for medicinal products, which could have an adverse impact on reimbursement status. Moreover, in order to obtain reimbursement for our products in some European countries, including some EU Member States, we may be required to compile additional data comparing the cost-effectiveness of our products to other available therapies. This Health Technology Assessment (“HTA”) of medicinal products is becoming an increasingly common part of the pricing and reimbursement procedures in some EU Member States, including those representing the larger markets. The HTA process is the procedure to assess therapeutic, economic and societal impact of a given medicinal product in the national healthcare systems of the individual country.
The outcome of an HTA will often influence the pricing and reimbursement status granted to these medicinal products by the competent authorities of individual EU Member States. The extent to which pricing and reimbursement decisions are influenced by the HTA of the specific medicinal product currently varies between EU Member States. To obtain coverage and reimbursement or pricing approval in some countries, we may be required to conduct a clinical trial that compares the cost-effectiveness of our product candidate to other available therapies. If reimbursement of our products is unavailable or limited in scope or amount, or if pricing is set at unsatisfactory levels, our business could be harmed.
Current and future legislation in the United States and other countries may affect the prices we may obtain for our products and future candidates and increase the difficulty and cost for us to commercialize our product candidates.
In the United States and many other countries, rising healthcare costs have been a concern for governments, patients and the health insurance sector, which has resulted in a number of changes to laws and regulations, and may result in further legislative and regulatory action regarding the healthcare and health insurance systems that could affect our ability to profitably sell any product candidates for which we obtain marketing approval.
For example, the ACA was enacted in the United States in March 2010 with the stated goals of containing healthcare costs, improving quality and expanding access to healthcare, and includes measures to change healthcare delivery, increase the number of individuals with insurance, ensure access to certain basic healthcare services, and contain the rising cost of care. There have been executive, judicial and Congressional challenges to certain aspects of the ACA. While Congress has not passed repeal legislation, several bills affecting the implementation of certain taxes under the ACA have been signed into law. Further, the Bipartisan Budget Act of 2018, among other things, amended the ACA, effective January 1, 2019, to increase from 50% to 70% the point-of-sale discount that is owed by pharmaceutical manufacturers who participate in Medicare Part D and to close the coverage gap in most Medicare drug plans, commonly referred to as the “donut hole”. On June 17, 2021, the U.S. Supreme Court dismissed a challenge on procedural grounds that argued the ACA is unconstitutional in its entirety because the “individual mandate” was repealed by Congress. Further, the IRA, among other things, extends enhanced subsidies for individuals purchasing health insurance coverage in ACA marketplaces through plan year 2025. The IRA also eliminates the “donut hole” under the Medicare Part D program beginning in 2025 by significantly lowering the beneficiary maximum out-of-pocket cost and creating a new manufacturer discount program.
In addition, other federal health reform measures have been proposed and adopted in the United States. For example, as a result of the Budget Control Act of 2011, providers are subject to Medicare payment reductions of 2% per fiscal year until 2032 unless additional Congressional action is taken. Further, the American Taxpayer Relief Act of 2012 reduced Medicare payments to several providers and increased the statute of limitations period for the government to recover overpayments from providers from three to five years. The Medicare Access and CHIP Reauthorization Act of 2015 also introduced a quality payment program (“Quality Payment Program”), under which certain individual Medicare providers will be subject to certain incentives or penalties based on new program quality standards. The Quality Payment Program provides clinicians with two ways to participate, including through the Advanced Alternative Payment Models (“APMs”), and the Merit-based Incentive Payment System (“MIPS”). Under both APMs and MIPS, performance data collected each performance year will affect Medicare payments in later years, including potentially reducing payments. Any reduction in reimbursement from Medicare or other government programs may result in a similar reduction in payments from private payors.
In December 2021, Regulation No 2021/2282 on HTA amending Directive 2011/24/EU, was adopted in the EU. This Regulation, which entered into force in January 2022 and will apply as of January 2025, is intended to boost cooperation among EU Member States in assessing health technologies, including new medicinal products, and providing the basis for cooperation at EU level for joint clinical assessments in these areas. The Regulation foresees a three-year transitional period and will permit EU Member States to use common HTA tools, methodologies, and procedures across the EU, working together in four main areas, including joint clinical assessment of the innovative health technologies with the most potential impact for patients, joint scientific consultations whereby developers can seek advice from HTA authorities, identification of emerging health technologies to identify promising technologies early, and continuing voluntary cooperation in other areas.
Individual EU Member States will continue to be responsible for assessing non-clinical (e.g., economic, social, ethical) aspects of health technologies, and making decisions on pricing and reimbursement. If we are unable to maintain favorable pricing and reimbursement status in EU Member States for product candidates that we may successfully develop and for which we may obtain regulatory approval, any anticipated revenue from and growth prospects for those products in the EU could be negatively affected.
The combination of healthcare cost containment measures, increased health insurance costs, reduction of the number of people with health insurance coverage, as well as future legislation and regulations focused on reducing healthcare costs by reducing the cost of or reimbursement and access to pharmaceutical products, may limit or delay our ability to generate revenue, attain profitability, or commercialize our products.
We cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrative action, either in the United States or abroad. As an example, the regulatory landscape related to clinical trials in the EU has evolved. The EU Clinical Trials Regulation, or CTR, which was adopted in April 2014 and repeals the EU Clinical Trials Directive, became applicable on January 31, 2022. The CTR permits trial sponsors to make a single submission to both the competent authority and an ethics committee in each EU Member State, leading to a single decision for each EU Member State. The assessment procedure for the authorization of clinical trials has been harmonized as well, including a joint assessment of some elements of the application by all EU Member States in which the trial is to be conducted, and a separate assessment by each EU Member State with respect to specific requirements related to its own territory, including ethics rules. Each EU Member State’s decision is communicated to the sponsor through a centralized EU portal, the Clinical Trial Information System, or CTIS. The CTR provides a three-year transition period. The extent to which ongoing clinical trials will be governed by the CTR varies. For clinical trials in relation to which an application for approval was made on the basis of the Clinical Trials Directive before January 31, 2023, the CTD will continue to apply on a transitional basis until January 31, 2025. By that date, all ongoing trials will become subject to the provisions of the CTR. The CTR will apply to clinical trials from an earlier date if the related clinical trial application was made on the basis of the CTR or if the clinical trial has already transitioned to the CTR framework before January 31, 2025.
In addition, on April 26, 2023, the European Commission adopted a proposal for a new Directive and Regulation to revise the existing pharmaceutical legislation. If adopted in the form proposed, the recent European Commission proposals to revise the existing EU laws governing authorization of medicinal products may result in a decrease in data and market exclusivity opportunities for our product candidates in the EU and make them open to generic or biosimilar competition earlier than is currently the case with a related reduction in reimbursement status.
We are subject to the U.K. Bribery Act, the FCPA, and other anti-corruption laws, as well as export control laws, import and customs laws, trade and economic sanctions laws and other laws governing our operations.
Our operations are subject to anti-corruption laws, including the UK Bribery Act, the FCPA, the U.S. domestic bribery statute contained in 18 U.S.C. §201, the U.S. Travel Act, and other anti-corruption laws that apply in countries where we do business. The UK Bribery Act, the FCPA and these other laws generally prohibit us and our employees and intermediaries from authorizing, promising, offering, or providing, directly or indirectly, improper or prohibited payments, or anything else of value, to government officials or other persons to obtain or retain business or gain some other business advantage. The FCPA also obligates companies whose securities are listed in the United States to comply with accounting provisions requiring us to maintain books and records that accurately and fairly reflect all transactions of the corporation, including international subsidiaries, and to devise and maintain an adequate system of internal accounting controls.
Under the UK Bribery Act, we may also be liable for failing to prevent a person associated with us from committing a bribery offense. We and those acting on our behalf operate in a number of jurisdictions that pose a high risk of potential UK Bribery Act or FCPA violations, and we participate in collaborations and relationships with third parties whose corrupt or illegal activities could potentially subject us to liability under the UK Bribery Act, FCPA or local anticorruption laws, even if we do not explicitly authorize or have actual knowledge of such activities. In addition, we cannot predict the nature, scope or effect of future regulatory requirements to which our international operations might be subject or the manner in which existing laws might be administered or interpreted.
Compliance with the UK Bribery Act, the FCPA and these other laws is expensive and difficult, particularly in countries in which corruption is a recognized problem. In addition, anti-corruption laws present particular challenges in the pharmaceutical industry, because, in many countries, hospitals are operated by the government, and doctors and other hospital employees are considered foreign officials.
We are also subject to other laws and regulations governing our international operations, including regulations administered by the governments of the United States and the UK, and authorities in the EU, including applicable export control regulations, economic sanctions and embargoes on certain countries and persons, anti-money laundering laws, import and customs requirements and currency exchange regulations, collectively referred to as the Trade Control laws.
There is no assurance that we will be completely effective in ensuring our compliance with all applicable anti-corruption laws, including the UK Bribery Act, the FCPA or other legal requirements, including Trade Control laws. If we are not in compliance with the UK Bribery Act, the FCPA and other anti-corruption laws or Trade Control laws, we may be subject to criminal and civil penalties, disgorgement and other sanctions and remedial measures, and legal expenses, which could have an adverse impact on our business, financial condition, results of operations and liquidity. Likewise, any investigation of any potential violations of the UK Bribery Act, the FCPA, other anti-corruption laws or Trade Control laws by United States, UK or other authorities could also have an adverse impact on our reputation, our business, results of operations and financial condition. Further, the failure to comply with laws governing international business practices may result in substantial civil and criminal penalties and suspension or debarment from government contracting.
If we fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could harm our business.
We are subject to numerous environmental, health and safety laws and regulations, including those governing laboratory procedures and the handling, use, storage, treatment and disposal of hazardous materials and wastes. Our operations involve the use of hazardous materials, including chemicals and biological materials. Our operations also produce hazardous waste products. We generally contract with third parties for the disposal of these materials and wastes. We cannot eliminate the risk of contamination or injury from these materials. In the event of contamination or injury resulting from our use of hazardous materials, we could be held liable for any resulting damages, and any liability could exceed our resources. We also could incur significant costs associated with civil or criminal fines and penalties for failure to comply with such laws and regulations.
Although we maintain insurance to cover us for costs and expenses we may incur due to injuries to our employees resulting from the use of hazardous materials, this insurance may not provide adequate coverage against potential liabilities. We do not maintain insurance for environmental liability or toxic tort claims that may be asserted against us in connection with our storage or disposal of biological or hazardous materials.
In addition, we may incur substantial costs in order to comply with current or future environmental, health and safety laws and regulations. These current or future laws and regulations may impair our research, development or production efforts. Our failure to comply with these laws and regulations also may result in substantial fines, penalties or other sanctions.
We have identified material weaknesses in our internal control over financial reporting, which could continue to adversely affect our ability to report our results of operations and financial condition accurately and in a timely manner.
As a public company, we are subject to the reporting requirements of the Exchange Act, as well as the requirements of the Sarbanes-Oxley Act of 2002, as amended (the “Sarbanes-Oxley Act”), and the listing standards of the Nasdaq Stock Market.
The Sarbanes-Oxley Act requires, among other things, that we maintain effective disclosure controls and procedures and internal control over financial reporting. It also requires management to perform an annual assessment of the effectiveness of our internal control over financial reporting and disclosure of any material weaknesses in such controls. In connection with the audit of our financial statements for the year ended December 31, 2023, we identified a material weakness in our internal control over financial reporting in connection with the historic misinterpretation and application of ASC 740, resulting in our UK SME tax credits being incorrectly presented in income tax benefit (expense). Refer to Note 3, Restatement of Previously Issued Consolidated Financial Statements, in the Consolidated Financial Statements in Part II, Item 8 of our Annual Report for additional information. We have taken steps to remediate the material weakness by (i) enhancing the training provided to the individuals operating the income taxation controls and related financial reporting controls and (ii) improving the design of our controls related to the use of taxation subject matter experts in the determination of our U.K. SME tax credits balances. We believe this material weakness was remediated at June 30, 2024, but there can be no assurance that we will not identify further control deficiencies in this area.
In addition, in connection with our review procedures for the three months ended March 31, 2024, we identified an additional material weakness due to an insufficiency of controls over complex accounting transactions. The lack of controls did not allow us to identify, understand and evaluate the impact of certain key judgments that arose during the three months ended March 31, 2024 related to the BioNTech Agreements. Our process, as designed, was inadequate to deal with the complexity of the accounting for the transaction and did not allow for an effective and timely evaluation of these matters and their impact on our financial statements.
Any failure to remediate the identified material weakness, or to develop or maintain effective controls, or any difficulties encountered in the implementation or improvement of such controls, could harm our operating results or cause us to fail to meet our reporting obligations and may result in a restatement of our financial statements for prior periods, such as the restatement of our previously issued consolidated financial statements described in more detail in our most Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on March 21, 2024.
Any failure to remediate the identified material weakness, or to implement and maintain effective internal control over financial reporting also could adversely affect the results of management evaluations and, to the extent they are required in the future, attestations of our independent registered public accounting firm with respect to our internal control over financial reporting. We can provide no assurance that the measures we are taking and plan to take in the future will remediate the material weaknesses described above, or that any additional material weaknesses or restatements of financial results will not arise in the future due to a failure to implement and maintain adequate internal control over financial reporting or circumvention of these controls. In addition, even if we are successful in strengthening our controls and procedures, in the future those controls and procedures may not be adequate to prevent or identify irregularities or errors or to facilitate the fair presentation of our financial statements. We continue to evaluate steps to remediate the material weakness identified. Any failure to maintain effective internal control over financial reporting could adversely impact our ability to report our financial position and results from operations on a timely and accurate basis. If our financial statements are not accurate, investors may not have a complete understanding of our operations.
Likewise, if our financial statements are not filed on a timely basis, we could be subject to sanctions or investigations by the Nasdaq, the SEC or other regulatory authorities, or other potential claims or litigation. Ineffective internal control over financial reporting could also cause investors to lose confidence in our reported financial information, which could have a negative effect on the trading price of our ADSs.
Ineffective disclosure controls and procedures and internal control over financial reporting could also cause investors to lose confidence in our reported financial and other information, which may have a negative effect on the trading price of our ADSs. In addition, if we are unable to continue to meet these requirements, we may not be able to remain listed on the Nasdaq Global Select Market.
Risks Related to Our Intellectual Property
If we are unable to obtain and maintain patent protection for our T cell programming technologies and product candidates, or if the scope of the patent protection obtained is not sufficiently broad, our competitors could develop and commercialize technology and biologics similar or identical to ours, and our ability to successfully commercialize our technology and product candidates may be impaired.
Our success depends, in large part, on our ability to obtain and maintain patent protection in the United States, the EU, the UK and other countries with respect to our product candidates. We seek to protect our proprietary position by filing patent applications related to our technology and product candidates in the major pharmaceutical markets, including the United States, major countries in Europe and Japan. If we do not adequately protect our intellectual property, competitors may be able to use our technologies and erode or negate any competitive advantage that we may have, which could harm our business and ability to achieve profitability.
To protect our proprietary positions, we file patent applications in the United States and other countries related to our novel technologies and product candidates that are important to our business. The patent application and prosecution process is expensive and time-consuming. We may not be able to file and prosecute all necessary or desirable patent applications at a reasonable cost or in a timely manner. We may also fail to identify patentable aspects of our research and development before it is too late to obtain patent protection. It is possible that defects of form in the preparation or filing of our patents or patent applications may exist, or may arise in the future, such as with respect to proper priority claims, inventorship, claim scope or patent term adjustments. If any current or future licensors or licensees are not fully cooperative or disagree with us as to the prosecution, maintenance or enforcement of any patent rights, such patent rights could be compromised and we might not be able to prevent third parties from making, using and selling competing products. If there are material defects in the form or preparation of our patents or patent applications, such patents or applications may be invalid and unenforceable. Moreover, our competitors may independently develop equivalent knowledge, methods and know-how. Any of these outcomes could impair our ability to prevent competition from third parties.
Prosecution of our owned and in-licensed patent portfolio is at an early stage for some of our patent families. We currently have 39 patents that have been issued from our pending applications in the United States, and 16 patents that have been issued from our pending applications in Europe. Some of our patent portfolio consists of pending priority applications that are not examined and pending applications under the Patent Cooperation Treaty (“PCT”).
Neither priority applications nor PCT applications can themselves give rise to issued patents. Rather, protection for the inventions disclosed in these applications must be further pursued by applicable deadlines via applications that are subject to examination. As applicable deadlines for the priority and PCT applications become due, we will need to decide whether and in which countries or jurisdictions to pursue patent protection for the various inventions claimed in these applications, and we will only have the opportunity to pursue and obtain patents in those jurisdictions where we pursue protection.
It is also possible that we will fail to identify patentable aspects of our research and development output before it is too late to obtain patent protection. The patent applications that we own or in-license may fail to result in issued patents with claims that cover our current and future product candidates in the United States or in other foreign countries. Our patent applications cannot be enforced against third parties practicing the technology claimed in such applications unless, and until, a patent issues from such applications, and then only to the extent the issued claims cover the technology.
If the patent applications we hold or have in-licensed with respect to our development programs and product candidates fail to issue, if their breadth or strength of protection is threatened, or if they fail to provide meaningful exclusivity for our current and future product candidates, it could threaten our ability to commercialize our product candidates. Any such outcome could have a negative effect on our business.
The patent position of biotechnology and pharmaceutical companies generally is highly uncertain. Changes in either the patent laws or interpretation of the patent laws in the United States and other countries may diminish the value of our patents or narrow the scope of our patent protection. In addition, the protections offered by laws of different countries vary. No consistent policy regarding the breadth of claims allowed in biotechnology and pharmaceutical patents has emerged to date in the United States or in many foreign jurisdictions. In addition, the determination of patent rights with respect to pharmaceutical compounds and technologies commonly involves complex legal and factual questions, which has in recent years been the subject of much litigation.
As a result, the issuance, scope, validity, enforceability and commercial value of our patent rights, whether owned or in-licensed, are highly uncertain. Furthermore, recent changes in patent laws in the United States, may affect the scope, strength and enforceability of our patent rights or the nature of proceedings that may be brought by or against us related to our patent rights. Additionally, the U.S. Supreme Court has ruled on several patent cases in recent years either narrowing the scope of patent protection available in certain circumstances or weakening the rights of patent owners in certain situations. In addition to increasing uncertainty with regard to our ability to obtain patents in the future, this combination of events has created uncertainty with respect to the value of patents, once obtained. Depending on decisions by the U.S. Congress, the U.S. federal courts, and the USPTO, the laws and regulations governing patents could change in unpredictable ways that could weaken our ability to obtain patents or to enforce any patents that we might obtain in the future.
We may not be aware of all third-party intellectual property rights potentially relating to our current and future our product candidates. Publications of discoveries in the scientific literature often lag behind the actual discoveries, and patent applications in the United States and other jurisdictions are typically not published until 18 months after filing, or in some cases not at all. Therefore, we cannot be certain that we or our licensors were the first to make the inventions claimed in our patents or pending patent applications, or that we or our licensors were the first to file for patent protection of such inventions. Similarly, should we own or in-license any patents or patent applications in the future, we may not be certain that we or the applicable licensor were the first to file for patent protection for the inventions claimed in such patents or patent applications. As a result, the issuance, scope, validity and commercial value of our patent rights cannot be predicted with any certainty. Moreover, we may be subject to a third-party pre-issuance submission of prior art to the USPTO, or become involved in opposition, derivation, reexamination, inter partes review or interference proceedings, in the United States or elsewhere, challenging our patent rights or the patent rights of others. An adverse determination in any such submission, proceeding or litigation could reduce the scope of, or invalidate, our patent rights, allow third parties to commercialize our technology or product candidates and compete directly with us, without payment to us, or result in our inability to manufacture or commercialize products without infringing third-party patent rights, which could significantly harm our business and results of operations.
Our pending and future patent applications, whether owned or in-licensed, may not result in patents being issued that protect our technology or product candidates, in whole or in part, or which effectively prevent others from commercializing competitive technologies and products. Even if our patent applications issue as patents, they may not issue in a form that will provide us with any meaningful protection against competing products or processes sufficient to achieve our business objectives, prevent competitors from competing with us or otherwise provide us with any competitive advantage. Our competitors may be able to circumvent our owned or licensed patents, should they issue, by developing similar or alternative technologies or products in a non-infringing manner. Our competitors may seek approval to market their own products similar to or otherwise competitive with our products. In these circumstances, we may need to defend and/or assert our patents, including by filing lawsuits alleging patent infringement. In any of these types of proceedings, a court or other agency with jurisdiction may find our patents invalid and/or unenforceable.
The issuance of a patent is not conclusive as to its inventorship, scope, validity or enforceability, and our owned and licensed patents may be challenged in the courts or patent offices in the United States and abroad. Such challenges may result in loss of exclusivity or freedom to operate or in patent claims being narrowed, invalidated or held unenforceable, in whole or in part, which could limit our ability to stop others from using or commercializing similar or identical technology and products, or limit the duration of the patent protection of our technology and products. In addition, given the amount of time required for the development, testing and regulatory review of new product candidates, patents protecting such candidates might expire before or shortly after such candidates are commercialized.
Third parties may initiate legal proceedings alleging that we are infringing their intellectual property rights, the outcome of which would be uncertain and could significantly harm our business.
Our commercial success depends, in part, on our ability to develop, manufacture, market and sell our product candidates and use our proprietary and modular T cell programming technology without infringing the intellectual property and other proprietary rights of third parties. Numerous third-party U.S. and non-U.S. issued patents exist in the area of biotechnology, including in the area of programmed T cell therapies and including patents held by our competitors. If any third-party patents cover our product candidates or technologies, we may not be free to manufacture or commercialize our product candidates as planned.
There is a substantial amount of intellectual property litigation in the biotechnology and pharmaceutical industries, and we may become party to, or threatened with, litigation or other adversarial proceedings regarding intellectual property rights with respect to our technology or product candidates, including interference proceedings before the USPTO. Intellectual property disputes arise in a number of areas including with respect to patents, use of other proprietary rights and the contractual terms of license arrangements. Third parties may assert claims against us based on existing or future intellectual property rights and claims may also come from competitors against whom our own patent portfolio may have no deterrent effect. The outcome of intellectual property litigation is subject to uncertainties that cannot be adequately quantified in advance. Other parties may allege that our product candidates or the use of our technologies infringes patent claims or other intellectual property rights held by them or that we are employing their proprietary technology without authorization.
As we continue to develop and, if approved, commercialize our current and future product candidates, competitors may claim that our technology infringes their intellectual property rights as part of business strategies designed to impede our successful commercialization. There are and may in the future be additional third-party patents or patent applications with claims to, for example, materials, compositions, formulations, methods of manufacture or methods for treatment related to the use or manufacture of any one or more of our product candidates. For example, we are aware of third-party U.S. patents that may claim technology related to obe-cel. patents that claim technology potentially related to obe-cel. These U.S. patents will expire between 2025 and 2038. There are no counterpart patents in Europe or the rest of the world that extend beyond the earliest expected regulatory approval date of obe-cel in those jurisdictions. Unless we are able to obtain a license or licenses to the third-party U.S. patent or patents on commercially reasonable terms or any applicable patent or patents are invalidated, held to be unenforceable, or deemed uninfringed by our activities. As a result, the future commercial opportunity of AUCATZYL in the United States could be adversely impacted.
Moreover, we may fail to identify relevant third party patents or patent applications, or we may incorrectly conclude that the claims of an issued patent are invalid or are not infringed by our activities. Because patent applications can take many years to issue, third parties may have currently pending patent applications which may later result in issued patents that any of our product candidates may infringe, or which such third parties claim are infringed by our technologies.
If we are found to infringe a third party’s intellectual property rights, we could be forced, including by court order, to cease developing, manufacturing or commercializing the infringing product candidate or product. Alternatively, we may be required or may choose to obtain a license from such third party in order to use the infringing technology and continue developing, manufacturing or marketing the infringing product candidate. However, we may not be able to obtain any required license on commercially reasonable terms or at all. Even if we were able to obtain a license, it could be non-exclusive, thereby giving our competitors access to the same technologies licensed to us. In addition, we could be found liable for monetary damages, including treble damages and attorneys’ fees if we are found to have willfully infringed a patent. A finding of infringement could prevent us from commercializing our product candidates or force us to cease some of our business operations. Claims that we have misappropriated the confidential information or trade secrets of third parties could have a similar negative effect on our business. Even if successful, the defense of any claim of infringement or misappropriation is time-consuming, expensive and diverts the attention of our management from our ongoing business operations.
We may need to license intellectual property from third parties, and such licenses may not be available or may not be available on commercially reasonable terms.
A third party may hold intellectual property rights, including patent rights, that are important or necessary to the development or manufacture of our product candidates. It may be necessary for us to use the patented or proprietary technology of third parties to commercialize our product candidates, in which case we would be required to obtain a license from these third parties. Such a license may not be available on commercially reasonable terms, or at all, and we could be forced to accept unfavorable contractual terms. If we are unable to obtain such licenses on commercially reasonable terms, our business could be harmed.
We may become involved in lawsuits to protect or enforce our intellectual property, which could be expensive, time-consuming and unsuccessful.
Competitors may infringe our patents, trademarks, copyrights or other intellectual property. To counter infringement or unauthorized use, we may be required to file infringement claims, which can be expensive and time-consuming and divert the time and attention of our management and scientific personnel. Any claims we assert against perceived infringers could provoke these parties to assert counterclaims against us alleging that we infringe their patents, trademarks, copyrights or other intellectual property. In addition, in a patent infringement proceeding, there is a risk that a court will decide that a patent of ours is invalid or unenforceable, in whole or in part, and that we do not have the right to stop the other party from using the invention at issue. There is also a risk that, even if the validity of such patents is upheld, the court will construe the patent’s claims narrowly or decide that we do not have the right to stop the other party from using the invention at issue on the grounds that our patents do not cover the invention. An adverse outcome in a litigation or proceeding involving our patents could limit our ability to assert our patents against those parties or other competitors and may curtail or preclude our ability to exclude third parties from making and selling similar or competitive products.
Similarly, if we assert trademark infringement claims, a court may determine that the marks we have asserted are invalid or unenforceable, or that the party against whom we have asserted trademark infringement has superior rights to the marks in question. In this case, we could ultimately be forced to cease use of such trademarks.
In any infringement litigation, any award of monetary damages we receive may not be commercially valuable. Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of our confidential information could be compromised by disclosure during litigation. In addition, there could be public announcements of the results of hearings, motions or other interim proceedings or developments and if securities analysts or investors perceive these results to be negative, it could have a substantial adverse effect on the price of our ADSs.
Moreover, there can be no assurance that we will have sufficient financial or other resources to file and pursue such infringement claims, which typically last for years before they are concluded. Some of our competitors may be able to sustain the costs of such litigation or proceedings more effectively than we can because of their greater financial resources and more mature and developed intellectual property portfolios. Even if we ultimately prevail in such claims, the monetary cost of such litigation and the diversion of the attention of our management and scientific personnel could outweigh any benefit we receive as a result of the proceedings. Accordingly, despite our efforts, we may not be able to prevent third parties from infringing, misappropriating or successfully challenging our intellectual property rights. Uncertainties resulting from the initiation and continuation of patent litigation or other proceedings could have a negative impact on our ability to compete in the marketplace.
We may be subject to claims by third parties asserting that we or our employees have misappropriated their intellectual property, or claiming ownership of what we regard as our own intellectual property.
Many of our employees were previously employed at universities or other biotechnology or pharmaceutical companies, and our founder and Chief Scientific Officer, Dr. Martin Pulé, is currently employed both by us and UCL. Although we try to ensure that our employees do not use the proprietary information or know-how of third parties in their work for us, we may be subject to claims that these employees or we have inadvertently or otherwise used intellectual property, including trade secrets or other proprietary information, of any such employee’s former employer. We may also in the future be subject to claims that we have caused an employee to breach the terms of his or her non-competition or non-solicitation agreement. Litigation may be necessary to defend against these potential claims.
In addition, while it is our policy to require our employees and contractors who may be involved in the development of intellectual property to execute agreements assigning such intellectual property to us, such employees and contractors may breach the agreement and claim the developed intellectual property as their own.
As of September 30, 2024, our patent portfolio was comprised of 77 patent families, of which 17 patent families originated from UCLB, the technology-transfer company of UCL, 3 patent families are in-licensed from Noile-Immune Biotech, Inc., and 57 patent families we own and have originated from our own research. Of the 17 live patent families that were originally in-licensed from UCL, 16 have been assigned to us. Because we have acquired or licensed certain of our patents from UCLB and licensed certain other patents from third parties, we must rely on their prior practices with regard to the assignment of such intellectual property. Our and their assignment agreements may not be self-executing or may be breached, and we may be forced to bring claims against third parties or defend claims they may bring against us, to determine the ownership of what we regard as our intellectual property.
If we fail in prosecuting or defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights or personnel. A court could prohibit us from using technologies or features that are essential to our products if such technologies or features are found to incorporate or be derived from the trade secrets or other proprietary information of the former employers. Even if we are successful in prosecuting or defending against such claims, litigation could result in substantial costs and could be a distraction to management. In addition, any litigation or threat thereof may adversely affect our ability to hire employees or contract with independent service providers. Moreover, a loss of key personnel or their work product could hamper or prevent our ability to commercialize our products.
We may be subject to claims challenging the inventorship or ownership of our owned or in-licensed patent rights and other intellectual property.
We generally enter into confidentiality and intellectual property assignment agreements with our employees, consultants, outside scientific collaborators, sponsored researchers and other advisors. However, these agreements may not be honored and may not effectively assign intellectual property rights to us. For example, disputes may arise from conflicting obligations of consultants or others who are involved in developing our technology and product candidates. Litigation may be necessary to defend against these and other claims challenging inventorship or ownership. The owners of intellectual property in-licensed to us could also face such claims. If we or our licensors fail in defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights, such as exclusive ownership of, or right to use, valuable intellectual property.
Such an outcome could have a material adverse effect on our business. Even if we or our licensors are successful in defending against such claims, litigation could result in substantial costs and be a distraction to management and other employees.
Our existing trademarks and any trademarks we may obtain may be infringed or successfully challenged, resulting in harm to our business.
We expect to rely on trademarks as one means to distinguish AUCATZYL from the products of competitors, and also expect to rely in the future trademarks to protect any of our other product candidates that are approved for marketing. We have a U.S. trademark for AUCATZYL but we have not yet selected trademarks for our other product candidates, including obe-cel for r/r adult B-ALL in other jurisdictions. For each selected trademark, we will need to apply to register them and our trademark applications may not be approved. Third parties may oppose our trademark applications, or otherwise challenge our use of the trademarks. In the event that our trademarks are successfully challenged, we could be forced to rebrand our products, which could result in loss of brand recognition and could require us to devote resources to advertising and marketing new brands. Our competitors may infringe our trademarks and we may not have adequate resources to enforce our trademarks.
In addition, any proprietary name we propose to use with our clinical-stage product candidates or any other product candidate in the United States must be approved by the FDA, regardless of whether we have registered it, or applied to register it, as a trademark. The FDA typically conducts a review of proposed product names, including an evaluation of the potential for confusion with other product names. If the FDA objects to any of our proposed proprietary product names, we may be required to expend significant additional resources in an effort to identify a suitable proprietary product name that would qualify under applicable trademark laws, not infringe the existing rights of third parties and be acceptable to the FDA.
If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.
In addition to seeking patent and trademark protection for our product candidates, we also rely on trade secrets, including unpatented know-how, technology and other proprietary information, to maintain our competitive position. We seek to protect our trade secrets, in part, by entering into non-disclosure and confidentiality agreements with parties who have access to them, such as our employees, consultants, advisors and other third parties. We also enter into confidentiality and invention or patent assignment agreements with our employees and consultants. Despite these efforts, any of these parties may breach the agreements and disclose our proprietary information, including our trade secrets. Monitoring unauthorized uses and disclosures of our intellectual property is difficult, and we do not know whether the steps we have taken to protect our intellectual property will be effective. In addition, we may not be able to obtain adequate remedies for any such breaches. Enforcing a claim that a party illegally disclosed or misappropriated a trade secret is difficult, expensive and time-consuming, and the outcome is unpredictable. In addition, some courts inside and outside the United States are less willing or unwilling to protect trade secrets.
Moreover, our competitors may independently develop knowledge, methods and know-how equivalent to our trade secrets. Competitors could purchase our products and replicate some or all of the competitive advantages we derive from our development efforts for technologies on which we do not have patent protection. If any of our trade secrets were to be lawfully obtained or independently developed by a competitor, we would have no right to prevent them, or those to whom they communicate it, from using that technology or information to compete with us. If any of our trade secrets were to be disclosed to or independently developed by a competitor, our competitive position would be harmed.
We may not be able to protect our intellectual property rights throughout the world.
Filing, prosecuting and defending patents on product candidates in all countries throughout the world would be prohibitively expensive, and our intellectual property rights in some countries outside the United States could be less extensive than those in the United States. In some cases, we may not be able to obtain patent protection for certain technology outside the United States. In addition, the laws of some foreign countries do not protect intellectual property rights to the same extent as federal and state laws in the United States, even in jurisdictions where we do pursue patent protection. Consequently, we may not be able to prevent third parties from practicing our inventions in all countries outside the United States, even in jurisdictions where we do pursue patent protection or from selling or importing products made using our inventions in and into the United States or other jurisdictions.
Competitors may use our technologies in jurisdictions where we have not pursued and obtained patent protection to develop their own products and, further, may export otherwise infringing products to territories where we have patent protection, but enforcement is not as strong as that in the United States. These products may compete with our product candidates and preclinical programs and our patents or other intellectual property rights may not be effective or sufficient to prevent them from competing.
Many companies have encountered significant problems in protecting and defending intellectual property rights in foreign jurisdictions. The legal systems of certain countries, particularly certain developing countries, do not favor the enforcement of patents, trade secrets and other intellectual property protection, particularly those relating to biotechnology products, which could make it difficult for us to stop the infringement of our patents, if pursued and obtained, or marketing of competing products in violation of our proprietary rights generally. Proceedings to enforce our patent rights in foreign jurisdictions could result in substantial costs and divert our efforts and attention from other aspects of our business, could put our patents at risk of being invalidated or interpreted narrowly and our patent applications at risk of not issuing and could provoke third parties to assert claims against us. We may not prevail in any lawsuits that we initiate, and the damages or other remedies awarded, if any, may not be commercially meaningful. Accordingly, our efforts to enforce our intellectual property rights around the world may be inadequate to obtain a significant commercial advantage from the intellectual property that we develop or license.
Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
Periodic maintenance and annuity fees on any issued patent are due to be paid to the USPTO and patent agencies outside the United States in several stages over the lifetime of the patent. The USPTO and various foreign governmental patent agencies require compliance with a number of procedural, documentary, fee payment and other similar provisions during the patent application process. While an inadvertent lapse can in many cases be cured by payment of a late fee or by other means in accordance with the applicable rules, there are situations in which noncompliance can result in abandonment or lapse of the patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction.
Non-compliance events that could result in abandonment or lapse of a patent or patent application include failure to respond to official actions within prescribed time limits, non-payment of fees and failure to properly legalize and submit formal documents.
If we or our licensors fail to maintain the patents and patent applications covering our products or product candidates, our competitors might be able to enter the market, which would harm our business. In addition, to the extent that we have responsibility for taking any action related to the prosecution or maintenance of patents or patent application in-licensed from a third party, any failure on our part to maintain the in-licensed rights could jeopardize our rights under the relevant license and may expose us to liability.
Risks Related to Ownership of Our Securities and Our Status as a Public Company
The trading price of our ADSs has been and may continue to be highly volatile and may fluctuate due to factors beyond our control.
The trading price of our ADSs has been volatile. The stock market in general, and the market for biopharmaceutical and pharmaceutical companies in particular, has experienced extreme price and volume fluctuations that have often been unrelated or disproportionate to the operating performance of these companies. Broad market and industry factors, including economic conditions and other adverse effects or developments relating to geopolitical instability, may negatively affect the market price of our ADSs, regardless of our actual operating performance.
As a result of this volatility, you may not be able to sell your ADSs at or above the price paid for the ADSs. In addition to the factors discussed in this “Risk Factors” section and elsewhere in this report, the trading price for our ADSs may be influenced by the following:
•our failure to successfully execute our commercialization strategy with respect to AUCATZYL;
•actions or announcements by third-party or government payers with respect to coverage and reimbursement of AUCATZYL;
•the commencement, enrollment or results of our planned or future clinical trials our product candidates;
•the clinical or commercial success of competitive drugs, therapies or technologies;
•positive or negative results from, or delays in, testing and clinical trials by us, collaborators or competitors;
•the loss of any of our key scientific or management personnel;
•regulatory or legal developments in the US, UK and other countries;
•adverse actions taken by regulatory agencies with respect to our clinical trials or manufacturers;
•changes or developments in laws or regulations applicable to our product candidates and preclinical programs;
•changes to our relationships with collaborators, manufacturers or suppliers;
•concerns regarding the safety of AUCATZYL or our product candidates or programmed T cells in general;
•announcements concerning our competitors or the pharmaceutical industry in general;
•actual or anticipated fluctuations in our operating results;
•changes in financial estimates or recommendations by securities analysts;
•potential acquisitions, financing, collaborations or other corporate transactions;
•the results of our efforts to discover, develop, acquire or in-license additional product candidates;
•the trading volume of our ADSs on Nasdaq;
•sales of our ADSs or ordinary shares by us, members of our senior management and directors or our shareholders or the anticipation that such sales may occur in the future;
•general economic, political, and market conditions and overall fluctuations in the financial markets in the United States or the UK;
•price and volume fluctuations of the listed securities of comparable companies and, in particular, those that operate in the biopharmaceutical industry;
•investors’ general perception of us and our business; and
•other events and factors, many of which are beyond our control.
These and other market and industry factors may cause the market price and demand for our ADSs to fluctuate substantially, regardless of our actual operating performance, which may limit or prevent investors from selling their ADSs and may otherwise negatively affect the liquidity of our ADSs. In addition, the stock market in general, and biopharmaceutical companies in particular, have experienced extreme price and volume fluctuations that have often been unrelated or disproportionate to the operating performance of these companies.
Some companies that have experienced volatility in the trading price of their securities have been the subject of securities class action litigation. Any lawsuit to which we are a party, with or without merit, may result in an unfavorable judgment. We also may decide to settle lawsuits on unfavorable terms. Any such negative outcome could result in payments of substantial damages or fines, damage to our reputation or adverse changes to our business practices. Defending against litigation is costly and time-consuming, and could divert our management’s attention and our resources. Furthermore, during the course of litigation, there could be negative public announcements of the results of hearings, motions or other interim proceedings or developments, which could have a negative effect on the market price of our ADSs.
Our ADSs are thinly traded and our shareholders may be unable to sell their ADSs quickly or at market price.
Although we have had periods of high volume daily trading in our ADSs, generally our ADSs are thinly traded. As a consequence of this lack of liquidity, the trading of relatively small quantities of ADSs by our shareholders may disproportionately influence the price of those ADSs in either direction. The price for our ADSs could, for example, decline significantly in the event that a large number of ADSs are sold on the market without commensurate demand, as compared to a seasoned issuer that could better absorb those sales without adverse impact on the price of the security.
Future sales of our ADSs in the public market could cause our share price to decline, even if our business is doing well.
Sales of a substantial number of shares of our ADSs in the public market, or the perception that these sales might occur, could depress the market price of our ADSs and could impair our ability to raise capital through the sale of additional equity securities.
We have filed registration statements on Form S-8 under the Securities Act to register ordinary shares (including in the form of ADSs) subject to options or other equity awards issued or reserved for future issuance under our equity incentive plans, and we have also filed an automatic shelf registration statement on Form S-3 under the Securities Act to register an unspecified number of securities. In addition, in the future, we may issue ordinary shares, ADS or other securities if we need to raise additional capital. The number of new ordinary shares or ADSs, or securities convertible into our ordinary shares or ADSs, issued in connection with raising additional capital could represent a material portion of our then-outstanding ordinary shares. For example, in February 2024, we sold ADSs representing 58.3 million ordinary shares in an underwritten offering resulting in gross proceeds of $350.0 million, and we also sold ADSs representing 33.3 million ordinary shares to BioNTech in a private placement, resulting in gross proceeds of $200.0 million.
We filed a resale registration statement on Form S-3 to register the ADSs we sold to BioNTech in February 2024. Additionally, in 2022, we filed two “resale” registration statements on Form F-3 under the Securities Act to register a total of approximately 33.4 million of our ordinary shares, or securities convertible into our ordinary shares, held by certain of our investors, allowing these shares or ADSs to be sold in the public market. If these shares or ADSs are sold, or if it is perceived that they will be sold, in the public market, the trading price of our ADSs could decline.
Our senior management, directors and principal shareholders, if they choose to act together, have the ability to control or significantly influence all matters submitted to our shareholders for approval.
Members of our senior management, directors and current beneficial owners of 5% or more of our ordinary shares and their respective affiliates beneficially own, in the aggregate, a majority of our outstanding ordinary shares (including ordinary shares in the form of ADSs). As a result, if these shareholders were to choose to act together, they would be able to control or significantly influence all matters submitted to our shareholders for approval, as well as our management and affairs. For example, these persons, if they choose to act together, would control or significantly influence the election of directors and approval of any merger, consolidation or sale of all or substantially all of our assets.
This concentration of ownership control may harm the market price of our ADSs by:
•delaying, deferring, or preventing a change in control;
•entrenching our management and/or the board of directors;
•impeding a merger, scheme of arrangement, consolidation, takeover, or other business combination involving us; or
•discouraging a potential acquirer from making a tender offer or otherwise attempting to obtain control of us.
In addition, some of these persons or entities may have interests different than yours. For example, because many of these shareholders purchased their shares at prices substantially lower than our current trading price and have held their shares for a longer period, they may be more interested in selling our company to an acquirer than other investors, or they may want us to pursue strategies that deviate from the interests of other shareholders.
The rights of our shareholders may differ from the rights typically offered to shareholders of a U.S. corporation.
We are incorporated under English law. The rights of holders of ordinary shares and, therefore, certain of the rights of holders of our ADSs, are governed by English law, including the provisions of the U.K. Companies Act 2006 (the “Companies Act”), and by our Articles of Association. These rights differ in certain respects from the rights of shareholders in typical U.S. corporations.
Holders of our ADSs may not have the same voting rights as the holders of our ordinary shares and may not receive voting materials in time to be able to exercise their right to vote.
Holders of the ADSs do not have the same rights as our shareholders and in accordance with the provisions of the deposit agreement, will not be able to exercise voting rights attaching to the ordinary shares evidenced by the ADSs on an individual basis. The Depositary or its nominee will act as the representative for the holders of the ADSs and will exercise the voting rights attached to the ordinary shares represented by the ADSs. Holders of our ADSs may not receive voting materials in time to instruct the Depositary to vote, and it is possible that they, or persons who hold their ADSs through brokers, dealers or other third parties, will not have the opportunity to exercise a right to vote. Furthermore, the Depositary will not be liable for any failure to carry out any instructions to vote, for the manner in which any vote is cast or for the effect of any such vote. As a result, holders of our ADSs may not be able to exercise voting rights and may lack recourse if their ADSs are not voted as requested. In addition, holders of our ADSs will not be able to call a shareholders’ meeting.
Holders of our ADSs may not receive distributions on our ordinary shares represented by the ADSs or any value for them if it is illegal or impractical to make them available to holders of ADSs.
Although we do not have any present plans to declare or pay any dividends, in the event we declare and pay any dividend, the Depositary for the ADSs has agreed to pay to holders of our ADSs the cash dividends or other distributions it or the custodian receives on our ordinary shares or other deposited securities after deducting its fees and expenses. Holders of our ADSs will receive these distributions in proportion to the number of our ordinary shares their ADSs represent. However, in accordance with the limitations set forth in the deposit agreement, it may be unlawful or impractical to make a distribution available to holders of the ADSs. We have no obligation to take any other action to permit distribution on the ADSs, ordinary shares, rights or anything else to holders of the ADSs. This means that holders of our ADSs may not receive the distributions we make on our ordinary shares or any value from them if it is unlawful or impractical to make them available to you. These restrictions may have an adverse effect on the value of the ADSs.
Because we do not anticipate paying any cash dividends on our ADSs in the foreseeable future, capital appreciation, if any, will be our ADS holders’ and shareholders’ sole source of gains and they may never receive a return on their investment.
Under current English law, a company’s accumulated realized profits must exceed its accumulated realized losses (on a non-consolidated basis) before dividends can be paid. Therefore, we must have distributable profits before issuing a dividend. We have never declared or paid a dividend on our ordinary shares in the past, and we currently intend to retain our future earnings, if any, to fund the development and growth of our business. As a result, capital appreciation, if any, on our ADSs will be our ADS holders’ sole source of gains for the foreseeable future, and they will suffer a loss on their investment if they are unable to sell their ADSs at or above the price at which they purchased the ADSs.
If we are a PFIC, there could be adverse U.S. federal income tax consequences to U.S. Holders.
Under the Internal Revenue Code of 1986, as amended, (the “Code”), we will be a PFIC, for any taxable year in which (1) 75% or more of our gross income consists of passive income or (2) 50% or more of the average quarterly value of our assets consists of assets that produce, or are held for the production of, passive income, including cash (other than certain cash held in non-interest bearing accounts for short-term working capital needs). For purposes of these tests, passive income includes dividends, interest, gains from the sale or exchange of investment property and certain rents and royalties. In addition, for purposes of the above calculations, a non-U.S. corporation that directly or indirectly owns at least 25% by value of the shares of another corporation is treated as if it held its proportionate share of the assets and received directly its proportionate share of the income of such other corporation.
If we are a PFIC for any taxable year during which a U.S. holder holds our ADSs, the U.S. holder may be subject to adverse tax consequences regardless of whether we continue to qualify as a PFIC, including ineligibility for any preferred tax rates on capital gains or on actual or deemed dividends, interest charges on certain taxes treated as deferred, and additional reporting requirements.
Based on our analysis of our income, assets, activities and market capitalization, we believe we were not a PFIC for our taxable year ended December 31, 2023. However, the determination of whether we are a PFIC is a fact-intensive determination made on an annual basis and the applicable law is subject to varying interpretation. In particular, the characterization of our assets as active or passive may depend in part on our current and intended future business plans, which are subject to change. In addition, for our current and future taxable years, the total value of our assets for PFIC testing purposes may be determined in part by reference to the market price of our ordinary shares or ADSs from time to time, which may fluctuate considerably. Under the income test, our status as a PFIC depends on the composition of our income which will depend on the transactions we enter into in the future and our corporate structure. The composition of our income and assets is also affected by how, and how quickly, we spend the cash we raise in any offering. Even if we determine that we are not a PFIC for a taxable year, there can be no assurance that the Internal Revenue Service (“IRS”), will agree with our conclusion and that the IRS would not successfully challenge our position. Accordingly, our U.S. counsel expresses no opinion with respect to our PFIC status for our taxable year ended December 31, 2023, or any future taxable year.
If a United States person is treated as owning at least 10% of our ordinary shares, including ordinary shares represented by ADSs, such holder may be subject to adverse U.S. federal income tax consequences.
If a U.S. Holder is treated as owning (directly, indirectly or constructively through the application of attribution rules) at least 10% of the value or voting power of our ordinary shares, including ordinary shares represented by ADSs, such U.S. Holder may be treated as a “United States shareholder” with respect to each “controlled foreign corporation” in our group (if any). Because our group includes at least one U.S. subsidiary (Autolus Inc.), certain of our non-U.S. subsidiaries may be treated as controlled foreign corporations (regardless of whether Autolus Therapeutics plc is treated as a controlled foreign corporation). A United States shareholder of a controlled foreign corporation may be required to annually report and include in its U.S. taxable income its pro rata share of “Subpart F income,” “global intangible low-taxed income” and investments in U.S. property by controlled foreign corporations, regardless of whether we make any distributions. An individual that is a United States shareholder with respect to a controlled foreign corporation generally would not be allowed certain tax deductions or foreign tax credits that would be allowed to a United States shareholder that is a U.S. corporation. We cannot provide any assurances that we will assist investors in determining whether any of our non-U.S. subsidiaries, if any, are treated as a controlled foreign corporation or whether such investor is treated as a United States shareholder with respect to any of such controlled foreign corporations.
Further, we cannot provide any assurances that we will furnish to any U.S. shareholder information that may be necessary to comply with the reporting and tax paying obligations discussed above. Failure to comply with these reporting obligations may subject you to significant monetary penalties and may prevent the statute of limitations with respect to your U.S. federal income tax return for the year for which reporting was due from starting. U.S. Holders should consult their tax advisors regarding the potential application of these rules to their investment in our ADSs.
Future changes to tax laws could materially adversely affect our company and reduce net returns to our shareholders.
Our business and our ADSs and ordinary shares are subject to changes in tax laws, regulations and treaties, or the interpretation thereof, and tax policy initiatives and reforms under consideration or being implemented by tax authorities in the jurisdictions in which we operate, including in connection with the Base Erosion and Profit Shifting, or BEPS, Project of the Organization for Economic Co-Operation and Development, or OECD, and initiatives of the European Commission.
Such changes may include (but are not limited to) the taxation of operating income, investment income, dividends received or (in the specific context of withholding tax) dividends paid, or the stamp duty or stamp duty reserve tax treatment of our ADSs or ordinary shares. We are unable to predict what tax reform may be proposed or enacted in the future or what effect such changes would have on our business, but such changes, to the extent they are brought into tax legislation, regulations, policies or practices, could affect our financial position and overall or effective tax rates in the future in countries where we have operations, reduce post-tax returns to our shareholders, and increase the complexity, burden and cost of tax compliance.
The IRA enacted in the United States introduced, among other changes, a 15% corporate minimum tax on certain United States corporations and a 1% excise tax on certain stock redemptions by United States corporations (which the U.S. Treasury indicated may also apply to certain stock redemptions by a foreign corporation funded (or deemed funded) by certain United States affiliates. In addition, effective in 2022, the Tax Cuts and Jobs Act of 2017 eliminates the option to deduct research and development expenditures in the current period and requires taxpayers to capitalize and amortize them over five or fifteen years pursuant to Internal Revenue Code Section 174.
Tax authorities may disagree with our positions and conclusions regarding certain tax positions, or may apply existing rules in an unforeseen manner, resulting in unanticipated costs, taxes or non-realization of expected benefits.
A tax authority may disagree with tax positions that we have taken, which could result in increased tax liabilities. For example, His Majesty’s Revenue & Customs (“HMRC”), the U.S. IRS or another tax authority could challenge our allocation of income by tax jurisdiction and the amounts paid between our affiliated companies pursuant to our intercompany arrangements and transfer pricing policies, including amounts paid with respect to our intellectual property development. Similarly, a tax authority could assert that we are subject to tax in a jurisdiction where we believe we have not established a taxable connection, often referred to as a ‘‘permanent establishment’’ under international tax treaties, and such an assertion, if successful, could increase our expected tax liability in one or more jurisdictions. A tax authority may take the position that material income tax liabilities, interest and penalties are payable by us, in which case, we expect that we might contest such assessment. Contesting such an assessment may be lengthy and costly and if we were unsuccessful in disputing the assessment, the implications could increase our anticipated effective tax rate, where applicable.
We may be unable to use net operating loss and tax credit carryforwards and certain built-in losses to reduce future tax payments or benefits from favorable UK tax legislation.
As a UK resident trading entity, we are subject to UK corporate taxation. Due to the nature of our business, we have generated losses since inception. As of December 31, 2023, we had cumulative carryforward tax losses of $418.1 million. Subject to any relevant utilization criteria and restrictions (including those that limit the percentage of profits that can be reduced by carried forward losses and those that can restrict the use of carried forward losses where there is a change of ownership of more than half the ordinary shares of the company and a major change in the nature, conduct or scale of the trade), we expect these to be eligible for carry forward and utilization against future operating profits.
Research and development, or R&D, expenditure is presented net of reimbursements from reimbursable tax and expenditure credits from the UK government. As a company that carries out extensive R&D activities, we benefit from the UK R&D tax credit regime.
In respect of accounting periods in which we qualify as a Small and Medium-sized Enterprise, or SME, we may surrender trading losses that arise from our R&D activities for a cash rebate of up to 18.6% of qualifying R&D expenditure. If our qualifying R&D expenditure represents 40% or more of the total (meaning we also qualify as “R&D intensive”) during such accounting period, the cash rebate would increase to 27% of qualifying R&D expenditure. A large proportion of costs in relation to our pipeline research, clinical trials management and manufacturing development activities, all of which are being carried out by our subsidiary Autolus Limited, are currently eligible for inclusion within these tax credit cash rebate claims. However, if we do not qualify as R&D intensive, or as an SME, during that or future accounting periods (noting that the threshold for qualifying as “R&D intensive” will decrease from 40% qualifying R&D expenditure to 30% for accounting periods commencing after April 1, 2024), we will either not be able to claim cash rebates in respect of our R&D activities, or will only be able to receive cash payments or other tax relief at a significantly lower rate than at present. Further, the regime’s rules are complex, and if a tax authority were to challenge or seek to disallow our claims (in whole or in part), for example by asserting that we do not (or the relevant expenditure does not) meet the technical conditions to be granted tax credits (or cash rebates), then such challenge or disallowance, if successful, could have a material impact on our cash-flow and financial performance. In addition, future changes by HMRC to the UK R&D tax credit regime may mean that we no longer qualify or have a material impact on the extent to which we can make claims (or benefit from them).We may also benefit in the future from the UK’s “Patent Box” regime, which allows certain profits attributable to revenues from patented products (and other qualifying income) to be taxed at an effective rate of 10% by giving an additional tax deduction.
We are the exclusive licensee or owner of one patent and several patent applications which, if issued, would cover our product candidates, and accordingly, future upfront fees, milestone fees, product revenues and royalties could be eligible for this deduction. When taken in combination with the enhanced relief available on R&D expenditures, we expect a long-term rate of corporation tax lower than statutory to apply to us. If, however, there are unexpected adverse changes to the UK R&D tax credit regime or the “patent box” regime, or for any reason we are unable to qualify for such advantageous tax legislation, or we are unable to use net operating loss and tax credit carryforwards and certain built-in losses to reduce future tax payments then our business, results of operations and financial condition may be adversely affected. This may impact our ongoing requirement for investment and the timeframes within which additional investment is required.
We have been advised by HMRC that the sale of our obe-cel CAR T therapy to UK customers in the future will be considered an Exempt supply from a UK VAT perspective. Consequently, Autolus Limited will be reassessing and restricting the amount of U.K. VAT it has reclaimed and will continue to do so in the future. The restriction will be based on the estimated UK market turnover as a percentage of global turnover. We currently expect revenue from UK customers to only represent a small proportion of our overall activity. If the proportion of revenue from UK customers increases this would further restrict the amount of UK input VAT recovered.
We have incurred, and will continue to incur, significant costs and demands upon management as a result of being a public company, and our management have devoted, and will continue to devote, substantial time to existing and new compliance initiatives.
As a public company listed in the United States, we incur significant legal, accounting and other expenses. These expenses will likely become even more significant now that we no longer qualify as an emerging growth company under SEC rules. The Sarbanes-Oxley Act, the Dodd-Frank Wall Street Reform and Consumer Protection Act, the listing requirements of Nasdaq and other applicable securities rules and regulations impose various requirements on public companies in the United States, including the establishment and maintenance of effective disclosure and financial controls and corporate governance practices. Our senior management and other personnel will need to devote a substantial amount of time to these compliance initiatives. Moreover, these rules and regulations increase our legal and financial compliance costs and will make some activities more time-consuming and costly. For example, we expect that these rules and regulations may make it more difficult and more expensive for us to maintain director and officer liability insurance, which in turn could make it more difficult for us to attract and retain qualified senior management personnel or members for our board of directors.
As a foreign private issuer, we are permitted to and follow certain home country practices in relation to corporate governance matters that differ significantly from Nasdaq corporate governance listing standards applicable to public companies organized in the United States. These practices may afford less protection to shareholders than they would enjoy if we complied fully with Nasdaq corporate governance listing standards.
We are entitled to rely on a provision in Nasdaq’s corporate governance rules that allows us to follow English corporate law with regard to certain aspects of corporate governance. This allows us to follow certain corporate governance practices that differ in significant respects from the corporate governance requirements applicable to domestic issuers listed on Nasdaq.
We are not subject to Nasdaq Listing Rule 5605(b)(2) because English law does not require that independent directors regularly have scheduled meetings at which only independent directors are present. Similarly, we have adopted a compensation committee, but English law does not require that we adopt a compensation committee or that such committee be fully independent. As a result, our practice varies from the requirements of Nasdaq Listing Rule 5605(d), which sets forth certain requirements as to the responsibilities, composition and independence of compensation committees. English law requires that we disclose information regarding compensation of our directors for services as a director of an undertaking that is our subsidiary undertaking and as a director of any other undertaking of which a director is appointed by virtue of our nomination (directly or indirectly) but not other third-party compensation of our directors or director nominees. As a result, our practice varies from the third-party compensation disclosure requirements of Nasdaq Listing Rule 5250(b)(3). In addition, while we have a compensation committee, English law does not require that we adopt a compensation committee or that such committee be fully independent. Additionally, we are not subject to Nasdaq Listing Rule 5605(e) because, under English law, director nominees are not required to be selected or recommended for selection by either a majority of the independent directors or a nominations committee comprised solely of independent directors.
Furthermore, English law does not have a regulatory regime for the solicitation of proxies applicable to us, thus our practice varies from the requirement of Nasdaq Listing Rule 5620(b), which sets forth certain requirements regarding the solicitation of proxies. In addition, we have opted out of shareholder approval requirements for the issuance of securities in connection with certain events such as the acquisition of stock or assets of another company, the establishment of or amendments to equity-based compensation plans for employees, a change of control of us and certain private placements.
To this extent, our practice will vary from the requirements of Nasdaq Listing Rule 5635, which generally requires an issuer to obtain shareholder approval for the issuance of securities in connection with such events. In addition, while we have adopted a code of business conduct and ethics, English law does not require us to publicly disclose waivers from this code that have been approved by our board within four business days. We expect to report any such waivers on our website in lieu of any SEC filing. Moreover, we are not required to comply with Regulation FD, which restricts the selective disclosure of material information, although we have voluntarily adopted a corporate disclosure policy substantially similar to Regulation FD. These exemptions and leniencies will reduce the frequency and scope of information and protections to which you may otherwise have been eligible in relation to a U.S. domestic issuer.
As a result, our practice varies from the requirements for domestic issuers pursuant to Nasdaq Listing Rule 5610.
In accordance with our Nasdaq listing, our audit committee is required to comply with the provisions of Section 301 of the Sarbanes-Oxley Act and Rule 10A-3 of the Exchange Act, both of which are also applicable to Nasdaq listed U.S. companies. Because we are a foreign private issuer, however, our audit committee is not subject to additional requirements applicable to Nasdaq listed U.S. companies, including an affirmative determination that all members of the audit committee are “independent,” using more stringent criteria than those applicable to us as a foreign private issuer, subject to certain phase-in requirements permitted by Rule 10A-3 of the Exchange Act.
We may lose our foreign private issuer status in the future, which could result in significant additional costs and expenses.
As discussed above, we are a foreign private issuer, and therefore, we are not required to comply with all of the periodic disclosure and current reporting requirements of the Exchange Act. The determination of foreign private issuer status is made annually on the last business day of an issuer’s most recently completed second fiscal quarter, and, accordingly, the next determination will be made with respect to us on June 30, 2025. We would lose our foreign private issuer status if, for example, more than 50% of our ordinary shares are directly or indirectly held by residents of the United States and we fail to meet additional requirements necessary to maintain our foreign private issuer status.
If we lose our foreign private issuer status on this determination date, we would have to comply with U.S. federal proxy requirements, and our officers, directors and principal shareholders would become subject to the short-swing profit disclosure and recovery provisions of Section 16 of the Exchange Act. In addition, we would lose our ability to rely upon exemptions from certain corporate governance requirements under the Nasdaq listing rules. As a U.S. listed public company that is not a foreign private issuer, we would incur significant additional legal, accounting and other expenses that we do not currently incur as a foreign private issuer, as well as increased accounting, reporting and other expenses in order to maintain a listing on a U.S. securities exchange. If we lose our foreign private issuer status and are unable to devote adequate funding and the resources needed to maintain compliance with U.S. securities laws, while continuing our operations, we could be forced to deregister with the SEC. A deregistration would substantially reduce or effectively terminate the trading of our securities in the United States. We also expect that if we were required to comply with the rules and regulations applicable to U.S. domestic issuers, it would make it more difficult and expensive for us to obtain director and officer liability insurance, and we may be required to accept reduced coverage or incur substantially higher costs to obtain coverage. These rules and regulations could also make it more difficult for us to attract and retain qualified members of our board of directors.
Provisions in the U.K. City Code on Takeovers and Mergers that may have anti-takeover effects do not currently apply to us.
The U.K. City Code on Takeovers and Mergers (the “Takeover Code”), applies to an offer for, among other things, a public company whose registered office is in the UK if the company is considered by the Panel on Takeovers and Mergers (the “Takeover Panel”), to have its place of central management and control in the UK (or the Channel Islands or the Isle of Man). This is known as the “residency test.” The test for central management and control under the Takeover Code is different from that used by the UK tax authorities.
Under the Takeover Code, the Takeover Panel will determine whether we have our place of central management and control in the UK by looking at various factors, primarily where the directors are resident.
In June 2019, the Takeover Panel Executive confirmed that, based on our current circumstances, we are not subject to the Takeover Code. As a result, our shareholders are not entitled to the benefit of certain takeover offer protections provided under the Takeover Code. We believe that this position is unlikely to change at any time in the near future but, in accordance with good practice, we will review the situation on a regular basis and consult with the Takeover Panel if there is any change in our circumstances which may have a bearing on whether the Takeover Panel would determine our place of central management and control to be in the UK.
You may face difficulties in protecting your interests, and your ability to protect your rights through the U.S. federal courts may be limited, because we are incorporated under the laws of England and Wales, conduct most of our operations outside the United States and most of our directors and senior management reside outside the United States.
We are incorporated and have our registered office in, and are currently existing under the laws of, England and Wales. In addition, most of our tangible assets are located, and most of our senior management and directors reside, outside of the United States. As a result, it may not be possible to serve process within the United States on certain directors or us or to enforce judgments obtained in U.S. courts against such directors or us based on civil liability provisions of the securities laws of the United States. As a result, it may not be possible for investors to effect service of process within the United States upon such persons or to enforce judgments obtained in U.S. courts against them or us, including judgments predicated upon the civil liability provisions of the U.S. federal securities laws.
The United States and the UK do not currently have a treaty providing for recognition and enforcement of judgments (other than arbitration awards) in civil and commercial matters. Consequently, a final judgment for payment given by a court in the United States, whether or not predicated solely upon U.S. securities laws, would not automatically be recognized or enforceable in the UK. In addition, uncertainty exists as to whether English courts would entertain original actions brought in the UK against us or our directors or senior management predicated upon the securities laws of the United States or any state in the United States. Any final and conclusive monetary judgment for a definite sum obtained against us in U.S. courts would be treated by English courts as a cause of action in itself and sued upon as a debt at common law so that no retrial of the issues would be necessary, provided that certain requirements are met.
Whether these requirements are met in respect of a judgment based upon the civil liability provisions of the U.S. securities laws, including whether the award of monetary damages under such laws would constitute a penalty, is subject to determination by the court making such decision. If an English court gives judgment for the sum payable under a U.S. judgment, the English judgment will be enforceable by methods generally available for this purpose. These methods generally permit the English court discretion to prescribe the manner of enforcement.
As a result, U.S. investors may not be able to enforce against us or certain of our directors any judgments obtained in U.S. courts in civil and commercial matters, including judgments under the U.S. federal securities laws.
As an English public limited company, certain capital structure decisions will require shareholder approval, which may limit our flexibility to manage our capital structure.
On June 18, 2018, we altered the legal status of our company under English law from a private limited company by re-registering as a public limited company and changing our name from Autolus Therapeutics Limited to Autolus Therapeutics plc. English law provides that a board of directors may only allot shares (or rights to subscribe for or convertible into shares) with the prior authorization of shareholders, such authorization stating the aggregate nominal amount of shares that it covers and valid for a maximum period of five years, each as specified in the articles of association or relevant shareholder resolution.
We obtained authority from our shareholders at our Annual General Meeting held on June 28, 2024 to allot additional shares (or to grant rights to subscribe for or to convert any security into our shares) for a period of five years from June 28, 2024, up to a maximum nominal amount of $8,400, which authorization will need to be renewed upon expiration (i.e., at least every five years) but may be sought more frequently for additional five-year terms (or any shorter period).
English law also generally provides shareholders with preemptive rights when new shares are issued for cash. However, it is possible for the articles of association, or for shareholders to pass a special resolution at a general meeting, being a resolution passed by at least 75% of the votes cast, to disapply preemptive rights. Such a disapplication of preemptive rights may be for a maximum period of up to five years from the date of adoption of the articles of association, if the disapplication is contained in the articles of association, or from the date of the shareholder special resolution, if the disapplication is by shareholder special resolution. In either case, this disapplication would need to be renewed by our shareholders upon its expiration (i.e., at least every five years). We obtained authority from our shareholders at our Annual General Meeting held on June 28, 2024 to disapply preemptive rights for a period of five years from June 28, 2024 up to a maximum nominal amount of $8,400, which disapplication will need to be renewed upon expiration (i.e., at least every five years) to remain effective, but may be sought more frequently for additional five-year terms (or any shorter period).
English law also generally prohibits a public company from repurchasing its own shares without the prior approval of shareholders by ordinary resolution, being a resolution passed by a simple majority of votes cast, and other formalities. Such approval may be for a maximum period of up to five years.
Our articles of association provide that the courts of England and Wales are the exclusive forum for the resolution of all shareholder complaints other than complaints asserting a cause of action arising under the Securities Act and the Exchange Act, and that the U.S. District Court for the Southern District of New York will be the exclusive forum for the resolution of any shareholder complaint asserting a cause of action arising under the Securities Act or the Exchange Act.
Our articles of association provide that the courts of England and Wales are to be the exclusive forum for resolving all shareholder complaints (i.e., any derivative action or proceeding brought on behalf of us, any action or proceeding asserting a claim of breach of fiduciary duty owed by any of our directors, officers or other employees, any action or proceeding asserting a claim arising out of any provision of the Companies Act or our articles of association or any action or proceeding asserting a claim or otherwise related to the affairs of our company) other than shareholder complaints asserting a cause of action arising under the Securities Act or the Exchange Act, and that the U.S. District Court for the Southern District of New York will be the exclusive forum for resolving any shareholder complaint asserting a cause of action arising under the Securities Act or the Exchange Act. In addition, our articles of association provide that any person or entity purchasing or otherwise acquiring any interest in our shares is deemed to have notice of and consented to these provisions.
This choice of forum provision may limit a shareholder’s ability to bring a claim in a judicial forum that it finds favorable for disputes with us or our directors, officers or other employees, which may discourage such lawsuits. The enforceability of similar exclusive forum provisions (including exclusive federal forum provisions for actions, suits or proceedings asserting a cause of action arising under the Securities Act) in other companies’ organizational documents has been challenged in legal proceedings, and there is uncertainty as to whether courts would enforce the exclusive forum provisions in our articles of association. Additionally, our shareholders cannot waive compliance with the federal securities laws and the rules and regulations thereunder. If a court were to find either choice of forum provision contained in our articles of association to be inapplicable or unenforceable in an action, we may incur additional costs associated with resolving such action in other jurisdictions, which could adversely affect our results of operations and financial condition.
If equity research analysts do not publish research or reports, or publish unfavorable research or reports, about us, our business or our market, the price and trading volume of our ADSs could decline.
The trading market for our ADSs is influenced by the research and reports that equity research analysts publish about us and our business. We currently have research coverage by several equity research, industry or financial analysts. The price of our ADSs could decline if one or more analysts covering our business downgrade our ADSs or issue other unfavorable commentary or research about us. If one or more equity research analysts ceases coverage of us or fails to publish reports on us regularly, demand for our ADSs could decrease, which in turn could cause the trading price or trading volume of our ADSs to decline.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.
None.
Item 3. Defaults Upon Senior Securities.
None.
Item 4. Mine Safety Disclosures.
Not applicable.
Item 5. Other Information.
Insider Trading Arrangements
During the three months ended September 30, 2024, none of our directors or officers (as defined in Rule 16a-1(f) under the Exchange Act) adopted or terminated a “Rule 10b5-1 trading arrangement” or “non-Rule 10b5-1 trading arrangement,” as each term is defined in Item 408(a) of Regulation S-K.
Item 6. Exhibits.
The following exhibits are either provided with this Quarterly Report on Form 10-Q or are incorporated herein by reference:
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| 101.INS* | | Inline XBRL Instance Document |
| 101.SCH* | | Inline XBRL Taxonomy Extension Schema With Embedded Linkbase Documents |
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104 | | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
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| + | Indicates management contract or compensatory plan. |
| † | Certain portions of the exhibit (indicated by asterisks) have been omitted pursuant to Item 601(b)(10)(iv) of Regulation S-K. The registrant hereby undertakes to furnish supplementally a copy of any omitted exhibit or schedule upon request by the SEC. |
| # | Certain exhibits and schedules have been omitted pursuant to Item 601(a)(5) of Regulation S-K. The registrant hereby undertakes to furnish supplementally a copy of any omitted exhibit or schedule upon request by the SEC. |
* | Filed herewith |
** | This certification is being furnished solely to accompany this Quarterly Report on Form 10-Q pursuant to 18 U.S.C. Section 1350, and is not being filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liability of that section, nor shall it be deemed incorporated by reference into any filing of the registrant under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, whether made before or after the date hereof, regardless of any general incorporation language in such filing. |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
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| | | Autolus Therapeutics plc |
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| Date: | November 12, 2024 | By: | /s/ Christian Itin, Ph.D. |
| | | | Name | Christian Itin, Ph.D. |
| | | | Title: | Chief Executive Officer |
| | | | (On Behalf of the Registrant) |
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| Date: | November 12, 2024 | By: | /s/ Robert Dolski |
| | | Name | Robert Dolski |
| | | Title: | Chief Financial Officer |
| | | | (Principal Financial Officer) |
Email: [***] 4171312.18 Dated 2024 FORGE LIFE SCIENCES NOMINEE I LTD AND FORGE LIFE SCIENCES NOMINEE 2 LTD and AUTOLUS LIMITED and AUTOLUS THERAPEUTICS PLC Capital Contribution Deed relating to premises known as The Nucleus Marshgate, Stevenage SG1 1FR formerly known as part of The Marshgate Car Park, Stevenage EX-10.1
4171312.18 1 THIS DEED is dated the day of 2024 PARTIES (1) Forge Life Sciences Nominee 1 Ltd (company number 13523380) and Forge Life Sciences Nominee 2 Ltd (company number 13523683) in their capacity as nominees for and on behalf of Forge Life Sciences GP Limited (company number 13520188) all of whose registered offices are at 4th Floor 52-54 Gracechurch Street, London, England, EC3V 0EH acting in the capacity of general partner of Forge Life Sciences L.P. (a limited partnership registered under the Limited Partnerships Act 1907) of the same address as the general partner (the Landlord); and (2) Autolus Limited registered in England and Wales with company registration number 09115837 whose registered office is at The Mediaworks, 191 Wood Lane, London W12 7FP (the Tenant); and (3) Autolus Therapeutics PLC registered in England and Wales with company registration number 11185179 whose registered office is at The Mediaworks, 191 Wood Lane, London W12 7FP. (the Guarantor). RECITALS (A) The Landlord and the Tenant entered into the Lease. (B) The Tenant wishes to carry out the Works. (C) The Landlord and the Tenant have agreed that, subject to the terms of this deed, if the Tenant chooses to undertake the works, the Landlord shall make payments to the Tenant in respect of the costs of the Works. (D) This deed is supplemental and collateral to the Lease. IT IS AGREED AS FOLLOWS: 1. DEFINITIONS The following definitions apply in this deed: Building Contract means as defined in the Licence for Alterations; CAA means the Capital Allowances Act 2001; Construction Industry Scheme means the provisions of Part 3 Ch 3 Finance Act 2004 and the Income Tax (Construction Industry Scheme) Regulations 2005 (2005/2045); Construction Car Park means the car park adjoining the Premises which is the subject of the Construction Car Park Licence; Construction Car Park Licence means the licence of the Construction Car Park between (1) SBC and (2) the Tenant in the form attached at Appendix 1; Employer's Agent has the meaning specified in the Licence for Alterations; Landlord includes successors in title;
4171312.18 2 Lease means a lease of the Premises dated 19 September 2023 and made between (1) the Landlord (2) the Tenant and (3) the Guarantor (as varied by a deed of variation date the same date as this deed); Lender means such reputable commercial lender as the Landlord may from time to time notify in writing to the Tenant; Licence for Alterations means the Licence for Alterations relating to the Premises dated the same date as this deed and made between (1) the Landlord (2) the Tenant and (3) the Guarantor; Monitoring Surveyor means [***] at Savills plc or such other properly qualified surveyor as the Landlord may specify from time to time; Phase 1 Works means as defined in the Licence for Alterations; Phase 2 Works means as defined in the Licence for Alterations; Premises means premises known as The Nucleus Marshgate Stevenage SG1 1FR formerly known as part of the Marshgate car park at Stevenage Town Centre as more particularly described in the Lease; Project Condition has the meaning given to it in clause 3 and Project Conditions shall mean all of them; Project Condition Satisfaction Date means the date on which (i) the Project Conditions are satisfied (or waived by the Landlord) in respect of the Phase 1 Works and (ii) the Project Conditions are satisfied (or waived by the Landlord) in respect of the Phase 2 Works, or each of them, if applicable; VAT means value added tax and/or any similar tax from time to time replacing it or performing a similar fiscal function; Works Payment means the amount payable by the Landlord pursuant to clause 4; Works Payment Cap means £18,500,000 exclusive of VAT less the amount paid or due to be paid by the Landlord and/or the Lender to any person employed (or formerly employed) by the Tenant in connection with the Works following exercising the rights in clause 7 (remedying breaches) of the Licence for Alterations (other than costs repaid by the Tenant where they are entitled to repay those costs pursuant to the Licence for Alterations); and Works means the Phase 1 Works and/or the Phase 2 Works, as relevant which the Tenant elects to carry out or procures the carrying out of as approved by the Landlord pursuant to the Licence for Alterations. 2. INTERPRETATION 2.1 Unless otherwise expressly stated, the rules of interpretation set out in this clause 2 apply in this deed. 2.2 The headings and sub-headings in this deed are for ease of reference only and do not affect the meaning of this deed. 2.3 Words in the singular include the plural and vice versa.
4171312.18 3 2.4 References to one gender include all genders. 2.5 A reference to a clause, paragraph or schedule is to a clause or paragraph of or schedule to this deed and a reference to this deed includes its schedules. 2.6 A reference to particular legislation is a reference to that legislation as amended, modified, consolidated, re-enacted or replaced from time to time and to all subordinate legislation made under it from time to time. 2.7 A reference to a person includes an individual, firm, partnership, company, association, organisation or trust (in each case whether or not having a separate legal personality). 2.8 A reference to a company includes any company, corporation or any other body corporate (wherever incorporated). 2.9 A reference to a party is to a party to this deed. 2.10 Any words following the terms "include" and "including" or any similar expression shall be interpreted as illustrative and shall not limit the sense of the words preceding those terms. 2.11 General words do not have a restrictive meaning because they are preceded or followed by specific words indicating a particular type, class or category. 3. PROJECT CONDITIONS 3.1 The Landlord and the Tenant are diligently and expeditiously to comply with their respective obligations in this deed so far as necessary to procure that the Project Condition is satisfied on the terms of this deed. 3.2 As from the Project Condition Satisfaction Date, the Landlord and the Tenant are diligently and expeditiously to comply with their other respective obligations in this deed in relation to as relevant, the Phase 1 Works and the Phase 2 Works. 3.3 The Project Conditions in respect of each of the Phase 1 Works and the Phase 2 Works are: 3.3.1 completion of the Construction Car Park Licence; and 3.3.2 satisfaction by the Tenant of all of the Development Obligations as defined in and pursuant to the Licence for Alterations; and the project condition in clause 3.3.1 and each of the Development Obligations as defined in and pursuant to the Licence for Alterations being a Project Condition. 3.4 On satisfaction of each Project Condition, the Tenant or Landlord (as the case may be) shall give to the other such written evidence as that other party reasonably requires, to demonstrate that the Project Condition has been satisfied on the terms of this deed. 3.5 Where the Landlord in writing unconditionally and irrevocably waives compliance, or procuring compliance, with a Project Condition then for the purposes only of determining whether the Project Condition Satisfaction Date has occurred (but not for any other purpose), the relevant Project Condition shall be deemed to have been satisfied.
4171312.18 4 3.6 Within 5 working days of the date on which all of the Project Conditions have either been satisfied or been waived by the Landlord, the Tenant shall give written notice to the Landlord that the Project Condition Satisfaction Date has occurred. 3.7 If the Project Condition Satisfaction Date for one of the Phase 1 Works or the Phase 2 Works has not occurred by 31 November 2025, then: 3.7.1 either party may terminate this deed by giving written notice to the other party (but not once the Project Condition Satisfaction Date for one of the Phase 1 Works or the Phase 2 has occurred); and 3.7.2 this deed shall then immediately cease to have effect without prejudice to any rights or remedies each party has against the other for any outstanding breaches of this deed. 4. WORKS PAYMENT 4.1 If the Tenant elects to undertake the Works the Landlord shall pay to the Tenant an amount equal to the actual cost (net of any VAT charged to the Tenant on such costs) incurred by the Tenant in carrying out the Works (which may include any costs incurred by the Tenant pursuant to the Licence for Alterations) up to a maximum sum equal to the Works Payment Cap, in aggregate for all payments. 4.2 The Landlord and the Tenant agree the Tenant or the Employer's Agent may issue a request for payment (but only once in any month) for any part of the Works and such request must include: 4.2.1 a certificate from the Employer's Agent to the Landlord and the Monitoring Surveyors confirming the following: (a) the information included with the request is true and accurate and not misleading; (b) that the invoices raised are due and payable; (c) the amount to be paid; 4.2.2 confirmation and sufficient evidence reasonably required to support that confirmation from the Tenant that: (a) the Development Obligations have and remain satisfied; (b) (for the first draw down only in relation to the Phase 1 Works) the Tenant is permitted to have commenced the relevant Works; (c) (for the first draw down only in relation to the Phase 2 Works) the Tenant is permitted to have commenced the relevant Works 4.2.3 a copy of each invoice addressed to the Tenant in respect of the Works included in the certificate; 4.2.4 where the costs relate to construction materials, evidence that such materials have been delivered to the Premises free from any retention, lien encumbrance or charge prior to the date of the Tenant's request for payment;
4171312.18 5 4.2.5 where possible, a breakdown of the Works that have been carried out by the contractors pursuant to the invoices; and 4.2.6 evidence (save in respect of the first payment) that the previous payment made pursuant to clause 4.1, was made to the contractor or member of the professional team. 4.3 Within 10 working days of any request for payment, the Monitoring Surveyor may: 4.3.1 inspect the Premises to confirm that the Works referred to in the certificate issued on or before the relevant date have been undertaken. The Tenant is to have due regard to any matters that are raised by the Monitoring Surveyor but will not be bound by them; and 4.3.2 request such further evidence as is reasonably necessary in respect of the confirmations at clause 4.2.2 to enable the Monitoring Surveyor (acting reasonably) to validate such confirmations. 4.4 4.5 4.6 4.7 4.8 If the Tenant provides all of the documentation required by clause 4.2 and the Monitoring Surveyor (acting reasonably) has validated the confirmations at clause 4.2.2 then this shall be sufficient confirmation that the Works referred to in the relevant certificate have been undertaken. The Monitoring Surveyor shall have 15 working days to review the request and (subject to the Monitoring Surveyor being given sufficient evidence to be able to validate the confirmations at clause 4.2.2) after that period the Tenant shall issue a valid invoice to the Landlord (which shall be a valid VAT invoice if VAT is applicable) for the requested amount of the Works to be paid and (subject to the Tenant's request for payment including all of the required information and details listed in clause 4.2) within five working days of receipt of such invoice, the Landlord shall pay to the Tenant the amount shown on the invoice (subject to receipt of bank details of the Tenant pursuant to clause 4.8). The Landlord or its Monitoring Surveyor may request such other information as the Landlord may reasonably require in relation to the Works but this request will not affect the obligation to make payment pursuant to clause 4.5. The Landlord shall procure that the Monitoring Surveyor acts reasonably when validating the confirmations at clause 4.2.2 pursuant to clause 4.3.2. The Tenant has confirmed that the relevant bank details of the bank account of the Tenant (being a clearing bank in the United Kingdom) are: Account name: Autolus Limited Bank name: [***] Bank address: [***] Sort code: [***] Account number: [***] (the Bank Account).
4171312.18 6 4.9 The sums paid by the Landlord as a Works Payment (exclusive of VAT) under clause 4.1 shall not (in aggregate) in any circumstances exceed the Works Payment Cap. 4.10 Payment pursuant to clause 4.5 is without prejudice to clause 4.13. 4.11 Any sum to be paid by the Landlord to the Tenant under this deed shall be paid to the Tenant by means of a direct credit to the Bank Account. 4.12 The Landlord may, at any time, before the deadline below arises, at its absolute discretion, pay to the Tenant: 4.12.1 any retention under the Building Contract; and 4.12.2 any other amounts agreed between the Landlord and Tenant acting reasonably which are due to be incurred to complete the Works. 4.13 This clause 4 shall remain in force from the Project Condition Satisfaction Date until and including the Works Completion Longstop Date (as defined in the Licence for Alterations) after which the Landlord shall be released from its obligation in respect of Works Payment(s) other than those relating to valid certificates that have been submitted pursuant to clause 4.2 but not yet paid unless the Landlord, in its absolute discretion, has extended this deadline, which the Landlord may do on more than one occasion, in which case the relevant date shall be the revised deadline as confirmed by the Landlord, to the Tenant from time to time. 5. CONSTRUCTION CAR PARK LICENCE 5.1 This clause 5 shall apply from the date of completion of the Construction Car Park Licence. 5.2 The Tenant covenants to use all reasonable but commercially prudent endeavours to remedy any breach of which it is given notice pursuant to the Construction Car Park Licence with a view to ensuring that Stevenage Borough Council are not able to terminate the Construction Car Park Licence due to a breach of the obligations on the Tenant in the Construction Car Park Licence. 5.3 The Tenant covenants: 5.3.1 to, as soon as possible and in any event within 5 working days of receipt of a notice described in clause 5.3.1(a),: (a) notify the Landlord if Stevenage Borough Council serve any notice of breach(es) of or notice to terminate the Construction Car Park Licence; and (b) in regards to a notice of breach only, provide an explanation of how the Tenant intends to remedy the breach (including anticipated timing for remedying the breach); and 5.3.2 not to vary the terms of or terminate the Construction Car Park Licence without the Landlord's approval (such approval not to be unreasonably withheld or delayed). 5.4 The Tenant confirms that the Landlord (and its lender) may: 5.4.1 enter the land licenced to the Tenant pursuant to the Construction Car Park Licence (as are required from time to time in relation to or connected with the Works);
4171312.18 7 5.4.2 enter the land licenced to the Tenant pursuant to the Construction Car Park Licence to remedy any breaches if the Landlord is not satisfied (acting reasonably) that the Tenant will remedy the breaches in sufficient time to prevent the licence from being terminated; and 5.4.3 (following exercising its rights under Clause 7 (Remedying Breaches) of the Licence for Alterations) to exercise all of the Tenant's rights under the Construction Car Park Licence. 6. DETERMINATION OF DISPUTES 6.1 Any dispute which may arise between the Landlord and the Tenant or the Tenant concerning whether any of the Works have been undertaken under clause 4 shall, except to the extent such matters relate to the legal effect or construction of this deed, shall be determined by an independent chartered surveyor appointed in accordance with this clause 6. 6.2 The following provisions shall apply to the appointment of the surveyor: 6.2.1 if the parties fail to agree the appointment within 14 days of either party serving details of a suggested surveyor on the other, the surveyor shall be nominated on the application of either party by or on behalf of the President of the RICS; 6.2.2 the surveyor shall act as an expert and not as an arbitrator; 6.2.3 the surveyor's decision shall be final and binding on the parties in the absence of manifest error; 6.2.4 the surveyor shall decide the procedure to be followed in the determination and shall be requested to make his decision within 20 working days of his appointment; 6.2.5 the surveyor shall be instructed by the parties to consider any written representations which they may submit to him within such time limits as the surveyor may fix in his discretion; 6.2.6 the surveyor's fees and costs shall be borne between the parties in such proportions as the surveyor may in his discretion determine; 6.2.7 the parties mutually undertake to use their respective reasonable endeavours to enable the surveyor to reach his determination as quickly as reasonably possible; and 6.2.8 if the surveyor becomes unable or unwilling to act, then the procedure for his appointment shall be repeated as often as may be necessary. 6.3 If either party fails to pay its proportion of the surveyor's fees and costs, then the other party may pay them on its behalf and then recover such amount from the defaulting party as a debt on demand, or set it off against any other sum payable to the defaulting party pursuant to this deed or pursuant to the Lease. 6.4 If the surveyor finds that a sum is payable by the Landlord to the Tenant or the Tenant, the date on which the surveyor gives notice to the parties of such decision shall be treated as the date on which the certificate is deemed approved for the purposes of clause 4.5.
4171312.18 8 7. CAPITAL ALLOWANCES 7.1 The Landlord shall be entitled to claim capital allowances under the CAA in accordance with this clause 7 in respect of qualifying expenditure on the Premises, to the extent that such expenditure relates to the Works up to an amount equal to the total which are treated as financed by the Works Payment. 7.2 The Landlord and the Tenant agree that, for the purposes of Chapter 11 of the CAA, expenditure (excluding input VAT incurred by the Tenant) incurred on the Works which is eligible for capital allowances under the CAA shall, so far as possible, be treated as having been funded by the Works Payment, and shall be attributed to the maximum extent possible in the following order: 7.2.1 first, to that expenditure relating to the Works eligible for plant and machinery allowances at the highest rate; 7.2.2 second, to that expenditure relating to the Works eligible for plant and machinery allowances at the next highest rate and so on until the Works Payment has been exhaustively attributed to expenditure qualifying for plant and machinery allowances; 7.2.3 third, to that expenditure relating to the Works eligible for structures and buildings allowances; and 7.2.4 fourth, to that expenditure relating to the Works that do not qualify for capital allowances. 7.3 The Tenant undertakes not to claim capital allowances in respect of such qualifying expenditure treated as funded by the Works Payment pursuant to this clause 7 and to provide all information in relation to the Works and all assistance reasonably required by the Landlord within 14 days of request to allow the Landlord to obtain the maximum allowances which may be available provided that any assistance provided by the Tenant pursuant to this clause shall be at the reasonable cost of the Landlord. This should include, but not be limited to, providing the main contractor's construction cost information, details of directly procured works, specification documents and floor plans. 7.4 The Tenant shall sign any notice of election which the Landlord may properly require in order to give effect to the terms of this clause 7. 8. VAT 8.1 Subject to the specific provisions of this clause 8, all sums payable pursuant to this Deed are expressed exclusive of VAT and if one party (the Supplier) makes a supply to another party (the Recipient) for VAT purposes pursuant to this Deed, on receipt of a valid VAT invoice the Recipient shall pay to the Supplier (in addition to any other consideration for that supply) a sum equal to the amount of VAT which is or becomes chargeable on that supply. 8.2 The Works Payment is exclusive of VAT, and in this clause 8: VAT Payment means the sum which is equal to the VAT payable on the relevant Works Payment; VAT Payment Date means the later of:
4171312.18 9 (a) the date on which the Landlord pays the relevant Works Payment in accordance with clause 4.1; and (b) the date which is 10 working days after the Tenant has delivered a valid VAT invoice in respect of the relevant Works Payment to the Landlord (which invoice must be issued in the Tenant's name (or the name of the representative member of any VAT group of which the Tenant is a member) and be addressed to the Landlord). 8.3 The Landlord shall pay the VAT Payment to the Tenant on the VAT Payment Date (by direct credit to the Bank Account). 8.4 The VAT Payment shall not be taken into account when calculating whether the total sums payable pursuant to clause 4 has either exceeded the Works Payment Cap, save to the extent it is irrecoverable as a result of the Tenant's act or default. 8.5 In relation to any supplies by the Tenant to the Landlord pursuant or in connection with this deed which meets the conditions for the VAT reverse charge pursuant to section 55A Value Added Tax Act 1994 and the Value Added Tax (Section 55A) (Specified Services and Excepted Supplies) Order 2019 (the "Specified Services Order")) to apply, the Landlord confirms to the Tenant that it is an end user within the meaning of Article 2 of the Specified Services Order and accordingly the Landlord and the Tenant each agree and acknowledge that any such supplies would, if not otherwise excepted, be excepted supplies for the purposes of the Specified Services Order and that the VAT reverse charge (as provided for in section 55A Value Added Tax Act 1994) does not apply to any such supplies. 9. CONSTRUCTION INDUSTRY SCHEME 9.1 The Parties shall comply with the provisions of the Construction Industry Scheme. 9.2 The Parties acknowledge and agree that each Works Payment (or part of them) is a "contract payment" in respect of which the Tenant is a "sub-contractor" pursuant to the provisions of the Construction Industry Scheme as at the date of this deed. 9.3 Without prejudice to clause 9.4, the Landlord agrees to work collaboratively with the Tenant (the reasonable costs incurred by the Landlord will be payable by the Tenant) to consider, acting reasonably, whether any part of a Works Payment is not a "contract payment" pursuant to the provisions of the Construction Industry Scheme such that the Landlord is not required to make deductions pursuant to the Construction Industry Scheme, and the Tenant shall provide any reasonably necessary information and assurance to the Landlord to the extent that it considers that Regulation 20A of SI 2005/2045 can apply to the whole or part of a Works Payment. 9.4 The Landlord may make such deductions from a Works Payment as are required by the Construction Industry Scheme or by any other law. Any sums so deducted shall be deemed to have been received by the Tenant in satisfaction of the Landlord's payment obligations. 9.5 The Tenant confirms its Unique Tax Reference Number is 9243914802. The Tenant intends to apply for sub-contractor registration status for the purposes of the Construction Industry Scheme as soon as reasonably possible and will confirm to the Landlord when it is so registered (and if applicable, that it is registered for gross payment) and shall provide all other information requested by the Landlord for the purposes of verifying the Tenant's sub- contractor registration status for the purposes of the Construction Industry Scheme.
4171312.18 10 9.6 The Landlord shall not make any deductions within the meaning of clause 9.3 to the extent that the Landlord verifies under the Construction Industry Scheme that the Tenant is registered for gross payment under s. 63(2) of the Finance Act 2004. 9.7 If at any time the Tenant is registered for gross-payment under s.63(2) of the Finance Act 2004, the Tenant shall: 9.7.1 maintain its registration for gross payment under s.63(2) of the Finance Act 2004 until all Works Payments have been paid; 9.7.2 comply with the Tenant's filing obligations under the Construction Industry Scheme; and 9.7.3 immediately notify the Landlord in writing if it ceases to be registered for gross payment or becomes aware of any circumstances which may adversely affect its registration or which may lead to payment of the Works Payment being subject to deduction under the Construction Industry Scheme. 9.8 The Tenant shall indemnify the Landlord against any liability under the Construction Industry Scheme by reason of the Tenant's failure to comply or procure compliance with any obligation under this clause 9. 10. OBLIGATIONS UNDER THIS DEED 10.1 The burden of the tenant covenants and the benefit of the landlord covenants (in each case within the meaning of the Landlord and Tenant (Covenants) Act 1995) are personal to the person named as the Tenant in this deed. 10.2 To the extent that the obligations on the Landlord contained or implied in this deed relate to any time after a person has parted with the whole of its interest in the reversion immediately expectant on the termination of the term granted by the Lease or after a person has granted an overriding lease, they will not be binding on or enforceable against that person after that person has parted with the whole of that interest or granted an overriding lease. 10.3 The obligations on the Landlord contained or implied in this deed are binding on the Landlord under the Lease. 11. GUARANTORS' CONSENT The Guarantor consents to the Tenant entering into this deed and agrees with the Landlord that its covenants in the Lease remain fully effective and shall apply to the Lease as varied by this deed. 12. COSTS Each party shall be responsible for its own costs in connection with the preparation and completion of this deed. 13. CONTRACTS (RIGHTS OF THIRD PARTIES) ACT 1999 The parties to this deed do not intend any of its terms to be enforceable by a third party (as defined in section 1 of the Contracts (Rights of Third Parties) Act 1999) other than the Landlord's successors in title and the Lender as if it were the Landlord if Clause 7 and/or paragraph 11 of Schedule 2 of the Licence for Alterations applies.
4171312.18 11 14. GOVERNING LAW AND JURISDICTION 14.1 This deed and any dispute or claim arising out of or in connection with it or its subject matter or formation (including non-contractual disputes or claims) are governed by the law of England and Wales. 14.2 The parties irrevocably agree that the courts of England and Wales have exclusive jurisdiction to determine any dispute or claim that arises out of or in connection with this deed or its subject matter or formation (including non-contractual disputes or claims). This document has been executed as a deed, is delivered and takes effect on the date stated at the beginning of it.
4171312.18 12 APPENDIX 1 CONSTRUCTION CAR PARK LICENCE
4171312.18 13 EXECUTED as a deed by FORGE LIFE SCIENCES NOMINEE 1 LTD acting by a director, in the presence of: Signature Director Print name Witness signature Name (in BLOCK CAPITALS) Address EXECUTED as a deed by FORGE LIFE SCIENCES NOMINEE 2 LTD acting by a director, in the presence of: Signature Director Print name Witness signature Name (in BLOCK CAPITALS) Address /s/ /s/ /s/ /s/
4171312.18 14 Signature Director Print name Signature Director Print name EXECUTED as a deed by AUTOLUS THERAPEUTICS PLC acting by a director EXECUTED as a deed by AUTOLUS LIMITED acting by two directors /s/ /s/ /s/ /s/
Email: [***] 4174912.2 Dated FORGE LIFE SCIENCES NOMINEE 1 LTD AND FORGE LIFE SCIENCES NOMINEE 2 LTD - and - AUTOLUS LIMITED and AUTOLUS THERAPEUTICS PLC Deed of Variation relating to premises known as The Nucleus Marshgate Stevenage SG1 1FR formerly known as part of The Marshgate Car Park, Stevenage EX-10.2
4174912.2 i TABLE OF CONTENTS No. Heading Page 1. DEFINITIONS AND INTERPRETATION 1 2. BACKGROUND 2 3. VARIATION 2 4. CONTINUATION OF LEASE 6 5. GUARANTOR'S AGREEMENT 6 6. REGISTRATION AT LAND REGISTRY 6 SCHEDULE 1 - WORKED EXAMPLES 7 SCHEDULE 2 - OCCUPIER ESG REQUIREMENTS 8
4174912.2 1 THIS DEED OF VARIATION dated 2024 is made between (1) the Landlord and (2) the Tenant and (3) the Guarantor 1. DEFINITIONS AND INTERPRETATION 1.1 In this deed the following definitions apply: Landlord means Forge Life Sciences Nominee 1 Ltd (company number 13523380) and Forge Life Sciences Nominee 2 Ltd (company number 13523683) in their capacity as nominees for and on behalf of Forge Life Sciences GP Limited (company number 13520188) all of whose registered offices are at 4th Floor 52-54 Gracechurch Street, London, England, EC3V 0EH acting in the capacity of general partner of Forge Life Sciences L.P. (a limited partnership registered under the Limited Partnerships Act 1907) of the same address as the general partner; Tenant means Autolus Limited registered in England and Wales with company registration number 09115837 whose registered office is at The Mediaworks, 191 Wood Lane, London W12 7FP; Guarantor means Autolus Therapeutics PLC registered in England and Wales with company registration number 11185179 whose registered office is at The Mediaworks, 191 Wood Lane, London W12 7FP; Lease means the lease of the Property dated 19 September 2023 and made between (1) the Landlord (2) the Tenant and (3) the Guarantor for a term of 20 years from and including 19 September 2023; Property means the property demised by the Lease briefly known as The Nucleus Marshgate Stevenage SG1 1FR formerly known as part of the Marshgate car park at Stevenage Town Centre. 1.2 The expression the Landlord includes the person or persons for the time being entitled to the reversion immediately expectant upon the term of the Lease. 1.3 The expression the Tenant means the person (however described in the lease) in whom the Lease is vested from time to time. 1.4 The singular includes the plural and vice versa, person includes corporation, the neuter includes the masculine and the feminine, and a covenant by a party which comprise two or more persons shall be joint and several. 1.5 Words and expressions defined in the Lease have the same meanings in this deed except to the extent they are expressly varied by this deed. 1.6 The provisions of the Lease relating to its interpretation apply to this deed except to the extent they are expressly varied by this deed. 1.7 Clause headings do not affect the interpretation of this deed. 1.8 The parties to this deed do not intend any of its terms to be enforceable by a third party (as defined in section 1 of the Contracts (Rights of Third Parties) Act 1999).
4174912.2 2 2. BACKGROUND 2.1 This deed is supplemental to the Lease which is vested in the Tenant. 2.2 The Landlord is entitled to the reversion immediately expectant on the unexpired residue of the term of the Lease the reversion being registered under title number HD608165 at the Land Registry. 2.3 The parties to this deed wish to vary the terms of the Lease in the following manner. 3. VARIATION 3.1 The Lease is varied with immediate effect as follows: 3.1.1 The definition of Principal Rent is deleted from the Lease and replaced by the following definition: "Principal Rent": means £3,050,000 per year (exclusive of VAT) subject to increase in accordance with clauses 3.4 and 3.1.4. Non-binding worked examples of how the Principal Rent will be increased pursuant to clauses 3.4 and 3.1.4 are included at Schedule 2 3.1.2 Clause 2.2.2 is deleted from the Lease and replaced by the following: the right to such shelter and support from the property registered under title number HD153773 as the Property enjoys at the date of this lease 3.1.3 Clause 3.4.6 will be varied so that the words "or in relation to the calculation or payment of the Principal Rent on the Additional Review Date and on the Reconciliation Date" after the words "….construction of this clause". 3.1.4 The following new definitions will be added to the Lease: (a) Additional Review Date means the earliest of: (i) the date the PC Certificate is issued pursuant to the Licence for Alterations ("PC Date"); (ii) the date that the payments made by the Landlord pursuant to the Capital Contribution Deed reaches the Works Payment Cap; and (iii) 1 December 2025. (b) Capital Contribution Deed means the capital contribution deed entered into on 2024 between (1) the Landlord (2) the Tenant and (3) the Guarantor. (c) Interim Principal Rent means a figure equal to the aggregate of (1) the Principal Rent payable (but for any suspension) under this Lease immediately before the Additional Review Date and (2) the higher of: (i) 11.85% of £15,500,000 (exclusive of VAT); and
4174912.2 3 (ii) 11.85% of the aggregate of payments (1) made by the Landlord pursuant to Clause 4.1 of the Capital Contribution Deed and (2) due to be made pursuant to any outstanding certificates issued pursuant to Clause 4.2 of the Capital Contribution Deed and (3) any other payments made by the Landlord or the Lender to any person employed (or formally employed) by the Tenant in connection with the Works following exercising rights in Clause 7 of the Licence for Alterations (exclusive of VAT) calculated on the day before the Additional Review Date; (d) Project Conditions has the meaning given to it in the Capital Contribution Deed. (e) Project Condition Satisfaction Date has the meaning given to it in the Capital Contribution Deed. (f) Lender has the meaning given to it in the Capital Contribution Deed. (g) Licence for Alterations means the licence for alterations entered into on 2024 between (1) the Landlord (2) the Tenant and (3) the Guarantor. (h) Occupier ESG Requirements means the occupier ESG requirements set out in the document annexed to this lease at Schedule 3 or such replacement of it issued from time to time. (i) PC Certificate has the meaning given to it in the Licence for Alterations. (j) Regulatory Approvals means all certificates and licences which are either necessary or reasonably required for the operation of the facility on the Property. (k) Reviewed Principal Rent means the higher of: (i) an amount equal to the Principal Rent payable (but for any suspension) under this Lease immediately before the later of (1) the Additional Review Date and (2) the Reconciliation Date; and (ii) an amount equal to the Principal Rent that would have been payable (but for any suspension) under this Lease immediately before the later of the (1) Additional Review Date and (2) the Reconciliation Date had all rent reviews pursuant to clause 3.4 under this Lease been concluded (if not actually concluded) before the later of the (1) Additional Review Date and (2) the Reconciliation Date. (l) Reconciliation Date means the earliest of: (i) the date that the payments made by the Landlord pursuant to the Capital Contribution Deed reaches the Works Payment Cap; and (ii) Works Completion Longstop Date or such revised date, if applicable, pursuant to Clause 4.11 of the Capital Contribution Deed.
4174912.2 4 (m) Works has the meaning given to it in the Licence for Alterations. (n) Works Payment Cap has the meaning given to it in the Capital Contribution Deed. (o) Works Completion Longstop Date has the meaning given to it in the Licence for Alterations. 3.1.5 The following clauses will be added to the Lease: 3.1.3 Subject to the Project Condition Satisfaction Date occurring in relation to the Phase 1 Works or the Phase 2 Works pursuant to the Capital Contribution Deed and without prejudice to clauses 3.1.4 and 3.4, the Tenant shall pay the Principal Rent proportionately from and including the Additional Review Date to the next Rent Day and then by equal payments in advance on the Rent Days subject to clauses 3.1.5, 3.1.6, 4.1.3 and 4.1.4 (if applicable). 3.1.4 Subject to the Project Condition Satisfaction Date occurring in relation to the Phase 1 Works or the Phase 2 Works pursuant to the Capital Contribution Deed, the Principal Rent will (in addition to the review on each Rent Review Date) be increased on each of the Additional Review Date and the Reconciliation Date (or once if the Additional Review Date and the Reconciliation Date are on the same date) to a figure equal to the aggregate of (1) the Reviewed Principal Rent and (2) the higher of: (i) 11.85% of £15,500,000 (exclusive of VAT); and (ii) 11.85% of the aggregate of payments (1) made by the Landlord pursuant to clause 4.1 of the Capital Contribution Deed and (2) due to be made pursuant to any outstanding certificates issued pursuant to clause 4.2 of the Capital Contribution Deed and (3) any other payments made (or due to be made) by the Landlord or the Lender to any person employed (or formally employed) by the Tenant in connection with the Works following exercising rights in clause 7 of the Licence for Alterations (exclusive of VAT) calculated as at both the Additional Review Date and the Reconciliation Date; and on each date that the Principal Rent increases, the increased amount will be payable from and including the Additional Review Date. 3.1.5 If any of the relevant Rent Review Date, Additional Review Date and Reconciliation Date occur on the same date or any of the reviews to be undertaken on those dates have not been completed before another review date arises or any of the relevant dates are close in time then each relevant review will be applied sequentially and separately in the order in which the relevant review dates occur as set out in this Lease or where they occur on the same date they will occur in the following order (1) relevant Rent Review Date but subject to clause 3.1.6 (2) Additional Review Date (3) Reconciliation Date and then (if relevant and subject to clause 3.1.6) (4) any Late Reviews.
4174912.2 5 3.1.6 If the Principal Rent is due to be reviewed on one or more Rent Review Dates (as applicable) which occur pursuant to clause 3.4 of the Lease after the Additional Review Date but on or before the Reconciliation Date ("Late Reviews") then the Late Reviews will be delayed until (i) such Reconciliation Date has occurred and (ii) the Principal Rent has been calculated pursuant to clause 3.1.4 with the increased amount payable from and including the Additional Review Date (but such Late Reviews will be carried out with effect from the actual Rent Review Dates specified in the Lease). 4.1.3 if the Tenant may draw down additional payments or the Landlord is obliged to make or makes additional payments pursuant to the Capital Contribution Deed after the Additional Review Date, pay the Landlord the Interim Principal Rent on account of the Principal Rent from and including the Additional Review Date; and 4.1.4 if clause 4.1.3 applies, on the Rent Day immediately following the Reconciliation Date, pay to the Landlord (as rent in arrear) the amount by which the Principal Rent for the period beginning on the Additional Review Date and ending on the next Rent Day after the Reconciliation Date exceeds the payments actually made for that period together with (i) interest at Base Rate in respect of the Principal Rent payable from the relevant Rent Review Date pursuant to clause 3.4 of the Lease and (ii) interest at the Base Rate in respect of the Principal Rent payable from the Additional Review Date in each case such interest to be calculated instalment by instalment. 4.18.3 The Tenant will comply with all requirements and recommendations contained within the Occupier ESG Requirements from time to time Provided That where there is a conflict between the Occupier ESG Requirements and the remaining terms of this Lease, then those remaining terms will prevail. 6.6 Good Faith The parties shall act in good faith in all respects and not take any action or do any other thing, with the intention of avoiding or circumventing any of their respective obligations for the purpose of clauses 3.1.4, 3.1.5, 4.1.3 and 4.1.4 of this Lease. 3.1.6 Clause 4.6.1(a) shall be replaced with the following clause 4.6.1(a): "comply with and obtain all existing and future Regulatory Approvals and comply with all existing and future Legislation and any planning permissions and other statutory consents (in the case of any planning permissions, which are granted after the date of this Lease, only those obtained by or on behalf of or with the consent of the Tenant) applicable to the Property and its use" 3.1.7 Clause 4.11.1 shall be amended so that the following words will be added at the end of the clause: "Provided that from and including the date the Project Condition Satisfaction Date has occurred in relation to the Phase 1 Works or the Phase 2 Works pursuant to the Capital Contribution Deed to and including the latest of:
4174912.2 6 (a) the Reconciliation Date; and (b) the date the revised Principal Rent has been calculated pursuant to clause 4.1.4 the Tenant will not be permitted to assign or underlet the whole or any part of the Property." 3.1.8 Schedule 1 to this deed shall be added as a new Schedule 2 to the Lease. 3.1.9 Schedule 2 to this deed shall be the Occupier ESG Requirements annexed to the Lease as a new Schedule 3. 4. CONTINUATION OF LEASE 4.1 The Lease continues fully effective subject to the variations in this deed. 4.2 The parties agree for the avoidance of doubt that this deed does not effect a surrender and regrant of the Lease. 5. GUARANTOR'S AGREEMENT The Guarantor consents to the Tenant entering into this deed and agrees with the Landlord that its covenants in the Lease remain fully effective and shall apply to the Lease as varied by this deed. 6. REGISTRATION AT LAND REGISTRY The Tenant will: 6.1.1 take all steps necessary to procure that this deed is noted at the Land Registry against the Tenant's title and against the Landlord's registered reversionary title as soon as reasonably possible; and 6.1.2 deliver to the Landlord within 10 days of completion of such application, official copy entries of the Tenant's title. The parties have executed and delivered this document as a deed on the date stated at the beginning of it.
4174912.2 7 SCHEDULE 1 - WORKED EXAMPLES
4174912.2 8 SCHEDULE 2 - OCCUPIER ESG REQUIREMENTS
4174912.2 9 EXECUTED as a deed by FORGE LIFE SCIENCES NOMINEE 1 LTD acting by a director, in the presence of: Signature Director Print name Witness signature Name (in BLOCK CAPITALS) Address EXECUTED as a deed by FORGE LIFE SCIENCES NOMINEE 2 LTD acting by a director, in the presence of: Signature Director Print name Witness signature Name (in BLOCK CAPITALS) Address /s/ /s/ /s/ /s/
4174912.2 10 EXECUTED as a deed by AUTOLUS LIMITED acting by : Signature Director Print name Signature Director Print name /s/ EXECUTED as a deed by AUTOLUS THERAPEUTICS PLC acting by a director two directors /s/ /s/ /s/
Email: [***] 4171693.3 Dated 2024 FORGE LIFE SCIENCES NOMINEE 1 LTD AND FORGE LIFE SCIENCES NOMINEE 2 LTD and AUTOLUS LIMITED and AUTOLUS THERAPEUTICS PLC Licence for Alterations relating to The Nucleus Marshgate Stevenage SG1 1FR formerly known as part of The Marshgate Car Park, Stevenage EX-10.3
79025116.1 i TABLE OF CONTENTS No. Heading Page 1. INTERPRETATION AND GENERAL PROVISIONS 1 2. GRANT OF LICENCE 7 3. TENANT'S COVENANTS 7 4. INSURANCE 13 5. REINSTATEMENT 14 6. INSOLVENCY 14 7. DETERMINATION OF DISPUTES 15 8. AGREEMENTS AND DECLARATIONS 16 9. NOTICES 17 10. GUARANTOR'S CONSENT AND OBLIGATIONS 17 11. FEES AND EXPENSES 17 SCHEDULE 1 - THE LEASE 19 SCHEDULE 2 – APPOINTMENTS OF BUILDING CONTRACTOR AND PROFESSIONAL TEAM 20 SCHEDULE 3 - PRE-DEVELOPMENT OBLIGATIONS 26 SCHEDULE 4 - THE WORKS 28 SCHEDULE 5 -PROFESSIONAL TEAM 29 APPENDIX 1 APPOINTMENTS 30 APPENDIX 2 MAIN WARRANTIES 31 APPENDIX 3 SCHEDULE OF AMENDMENTS TO JCT CONTRACT 32
4171693.3 1 THIS LICENCE dated 2024 is made between (1) the Landlord, (2) the Tenant and (3) the Guarantor. 1. INTERPRETATION AND GENERAL PROVISIONS 1.1 The following definitions apply: Adverse Matters means any part of the Works to be approved pursuant to clause 3.1; Appointments means each of the deeds of appointment of the Professional Team to be entered into in accordance with Schedule 2 as amended by the amendments (if any) agreed by the Landlord pursuant to paragraph 2.3 of Schedule 2; Base Build Warranties means: (a) Collateral Warranty from Acquisition Systems Limited dated 12 July 2023; (b) Collateral Warranty from Roger Bullivant Limited dated 12 July 2023; (c) Collateral Warranty from FP McCann Limited dated 12 July 2023; (d) Collateral Warranty from Pureplan Building Services Limited dated 12 July 2023; (e) Collateral Warranty from APS Façade Engineering Limited dated 12 July 2023; (f) Collateral Warranty from Norder Design Associates Limited dated 12 July 2023; (g) Collateral Warranty from Harrison Lightning Protection and Earthing Limited dated 12 July 2023; (h) Collateral Warranty from BD Structures Limited dated 12 July 2023; (i) Collateral Warranty from Kone PLC dated 12 July 2023; (j) Collateral Warranty from Marlowe Fire & Security Limited dated 12 July 2023; (k) Collateral Warranty from Northern Switchgear & Controls Limited dated 12 July 2023; (l) Third party rights granted in appointment of Cube Management Services Limited dated 27 October 2021; (m) Third party rights granted in appointment of Fullard Rosier dated 28 October 2021; (n) Third party rights granted in appointment of Price & Myers LLP dated 27 October 2021; (o) Third party rights granted in appointment of KJ Tait Engineers Limited dated 27 October 2021; (p) Third party rights granted in appointment of Merit Health Limited dated 27 October 2021.
4171693.3 2 Building Contract means the building contract to be entered into by the Tenant with the Building Contractor for the carrying out the Works in accordance with paragraphs 2.2 and 2.3 of Schedule 2 in the form of the JCT Design and Build Contract 2016 as amended by: (a) a schedule of amendments in the form attached to this agreement at Appendix 3; and (b) the amendments (if any) by the Landlord pursuant to paragraph 2.3 of Schedule 2; Building Contractor means MA24 Limited or (if the Building Contract is terminated) such other replacement contractor to be employed by the Tenant for the Works under Schedule 2 with the Landlord's prior approval, such approval not to be unreasonably withheld. Capital Contribution Deed means the capital contribution deed relating to the Premises made between (1) the Landlord (2) the Tenant and (3) the Guarantor dated the same date as this deed; CDM Regulations means the Construction (Design and Management) Regulations 2015; Certificate of Practical Completion means the certificate or statement to be issued in accordance with the Building Contract certifying that Practical Completion has taken place; Construction Phase Plan means the construction phase plan to be prepared in respect of the Works under the CDM Regulations; Date of Practical Completion means the date certified in the Certificate of Practical Completion as the date of Practical Completion; Deed of Variation means the deed of variation relating to the Premises and to be made between (1) the Landlord (2) the Tenant and (3) the Guarantor dated the same date as this deed; Design Documents means all or any of the following which relate to the Works: (a) designs, drawings, models, plans, specifications, design details, photographs, brochures, reports, notes of meetings, CAD materials and other materials provided or to be provided under this licence and any additions or alterations made to them; (b) the Detailed Design; and (c) works, designs, calculations and inventions incorporated into any of the items listed in paragraphs (a) and (b) of this definition; Detailed Design means the detailed plans, drawings, specifications (including the Plans and Specification), drawings and calculations and other design and building details for the Works; Determination means the procedure for resolving a dispute between the parties set out in clause 7; Development Obligations has the meaning set out in clause 3.3.3; Employer's Agent means the relevant person listed in Schedule 5 or such other reputable and properly qualified person as the Tenant appoints as the employer's agent for the purposes of the Building Contract in accordance with Schedule 2;
4171693.3 3 Event of Default means the occurrence of one or more of the following events: (a) the Tenant commits a material breach of this licence which cannot be remedied; (b) the Tenant commits a material breach of this licence (other than as mentioned in (a) to (d) of this definition) which is capable of being remedied, and: (i) does not begin diligently to remedy that breach within 20 working days of written notice from the Landlord (or immediately in case of emergency); or (ii) does not remedy the breach within a reasonable period of time, to be specified in the notice, to the reasonable satisfaction of the Landlord; (c) the Tenant fails to complete the Works on or before the Works Completion Longstop Date; or (d) the Insolvency of the Tenant or the Guarantor; Existing Structures has the meaning given to it in the Building Contract; Guarantor means Autolus Therapeutics PLC registered in England and Wales with company registration number 11185179 whose registered office is at The Mediaworks, 191 Wood Lane, London, England, W12 7FP; Insolvency has the meaning given to it in clause 6; Landlord means Forge Life Sciences Nominee 1 Limited (company number 13523380) and Forge Life Sciences Nominee 2 Limited (company number 13523683) in their capacity as nominees for and on behalf of Forge Life Sciences GP Limited (company number 13520188) all of whose registered offices are at 4th Floor 52-54 Gracechurch Street, London, England, EC3V 0EH acting in the capacity of general partner of Forge Life Sciences L.P. (a limited partnership registered under the Limited Partnerships Act 1907) of the same address as the general partner; Lease means the lease described in Schedule 1 together with any deeds and documents supplemental to it; Lender means such reputable commercial lender as the Landlord may from time to time notify in writing to the Tenant; Letter of Reliance means the letter of reliance in respect of the condition survey referred to in the fit out contract in a form to be agreed by the Landlord and the Tenant acting reasonably: Main Warranties means collateral warranties to be given by the Main Warrantors in accordance with paragraph 4.1 of Schedule 2; Main Warrantors means the Building Contractor, each member of the Professional Team and Jubb Consulting Engineers Limited; Monitoring Surveyor is as defined in the Capital Contribution Deed;
4171693.3 4 Parent Company Guarantee means the parent company guarantee (in the form prescribed by the Building Contract) to be delivered by the Tenant in accordance with Schedule 2. Phase 1 Works means such parts of the Works which are not the Phase 2 Works; Phase 2 Works means such parts of the Works which are detailed within the planning application with reference 24/00550/FP (or any other planning application made from time to time in accordance with this licence for the Planning Permission) and any other works which are consequential to or required by the planning permission granted by such application; Planning Application means any application or applications for the Planning Permission or for any approval required as part of the Planning Permission, and includes any s.73 Application; Planning Authority means Stevenage Borough Council or such other person or body from time to time empowered to act as the local planning authority in respect of the Phase 2 Works; Planning Permission means full planning permission for the Phase 2 Works; Plans and Specifications means the plans, drawings, and specifications listed in Schedule 4; Practical Completion means the Works have been completed in accordance with the Building Contract; Premises means the property known as The Nucleus Marshgate Stevenage SG1 1FR formerly known as part of the Marshgate car park at Stevenage Town Centre as demised by the Lease; Principal Designer has the meaning given to it in Schedule 5 or such other reputable and suitably qualified person appointed by the Tenant to provide various services in connection with the Works, including as the principal designer for the Works in accordance with regulation 5 of the CDM Regulations; Professional Team means each of the consultants listed in Schedule 5; Project Conditions Satisfaction Date has the meaning set out in the Capital Contribution Deed; Satisfactory Planning Permission means a Planning Permission which, in the Landlord's reasonable opinion, does not impose conditions or restrictions which are more onerous than the existing planning permission(s) pursuant to which the Premises were constructed with reference number 21/00627/FPM, as amended by non-material amendment 22/00812/NMA dated 29 September 2022); Specified Clean Rooms means any clean rooms at the Premises forming part of the Works; Specified Perils has the meaning given to it in the Building Contract; Statutory Consents means any statutory approvals, consents, licences or permissions required from any local or other competent authority to enable the Tenant lawfully to carry out and complete the Works or to reinstate them following their damage or destruction;
4171693.3 5 Sub-Contractors means the sub-contractors or suppliers with design responsibility appointed or to be appointed by the Building Contractor including sub-contractors responsible for the carrying out of the following elements of the Works: (a) Mechanical & Electrical (b) AHU's (c) Heat Pumps (d) Cleanrooms (e) BMS (f) EMS (g) Structural Steel (h) Structural and Civil engineering works (i) Medical Gases (j) Fire Detection (k) Access Control (l) Cold Store and Freezer Store (m) VHP/Pass Throughs (n) Structural frame (o) Cladding (p) Roofing (q) Façade Alterations (r) Data Cabling (to the extent this element of the Works is not carried out by the Contractor) (s) Lightning Protection (t) Architectural services (u) Interlocking (v) Specialist Steelwork Connections / Secondary Steelwork. (including any replacement sub-contractor); Sub-Contractor Warranties means collateral warranties to be given by each Sub- Contractor in accordance with Schedule 2;
4171693.3 6 Sub-Contracts means the sub-contracts between the Building Contractor and the Sub- Contractors to be entered into in accordance with Schedule 2; s.73 Application means any application pursuant to section 73 of the Planning Act in respect of any condition attached to a planning permission which means it is not a Satisfactory Planning Permission; Tenant means Autolus Limited registered in England and Wales with company registration number 09115837 whose registered office is at The Mediaworks, 191 Wood Lane, London, England, W12 7FP; Third Party Rights means third party rights in favour of beneficiaries as detailed in the relevant Appointment, contract or subcontract; TPR Notices means notices that the Landlord and, separately, the Lender has the benefit of third party rights, to be given to the relevant contractor or to any member of the Professional Team or sub-contractor whose Appointment, contract or subcontract makes provision for third party rights in favour of beneficiaries which include the Landlord and, separately, the Lender, in the form required by the relevant Appointment, contract or subcontract; Warranties means the Main Warranties and the Sub-Contractor Warranties; Works means the works described in the Plans and Specifications forming the Phase 1 Works and the Phase 2 Works or any part of them; Works Completion Longstop Date means 30 June 2026 as extended in line with any extensions of time: (a) allowed by the Employer's Agent under the terms of the Building Contract; and/or (b) certified by the Employer's Agent as being fair and reasonable, having regard to the delay in question, where completion of the Works is delayed due to an event or cause that is beyond the Tenant's reasonable control but which shall be no later than 31 December 2026. 1.2 Landlord includes the person or persons for the time being entitled to the reversion immediately expectant upon the Term and Tenant includes the Tenant's successors in title and underlessees. 1.3 Insurers means the insurers with whom the Landlord insures the Building. 1.4 Term means the term of years granted by the Lease and any extension or continuation of it by statute, agreement or otherwise. References to the end of the Term are to the end of the Term however it ends. 1.5 Any words introduced by the term including or similar expression are illustrative and shall not limit the meaning of other words in the relevant clause. 1.6 A covenant to indemnify the Landlord means to indemnify against all actions, claims, demands and proceedings made against the Landlord and all costs, expenses, damages, liabilities and losses incurred directly or indirectly by the Landlord.
4171693.3 7 1.7 The singular includes the plural and vice versa, person includes corporation, the neuter includes the masculine and the feminine and vice versa, and covenants by a party which comprises two or more persons shall be joint and several. 1.8 Any obligation on a party not to do something includes an obligation not to allow it to be done. 1.9 Reference to a statute, statutory provision or subordinate legislation includes any consolidation, re-enactment, modification or replacement of it and any subordinate legislation in force from time to time. 1.10 Clause, schedule and paragraph headings in this licence shall not affect its construction. 2. GRANT OF LICENCE In consideration of the covenants by the Tenant and the Guarantor, the Landlord consents to the Tenant carrying out the Works on the terms of this licence. 3. TENANT'S COVENANTS The Tenant covenants with the Landlord as follows: 3.1 Approval of the Tenant's plans The Landlord has approved the Detailed Design, details of which are attached to this licence and form part of the Plans and Specifications. 3.2 Planning 3.2.1 To the extent it has not done so already, the Tenant shall submit a planning application for the Phase 2 Works as soon as reasonably practicable following the date of this licence. 3.2.2 Having submitted the planning application in accordance with clause 3.2.1, the Tenant shall use all reasonable but commercially prudent endeavours to obtain a Satisfactory Planning Permission as soon as reasonably practicable. 3.2.3 The Landlord shall at the Tenant's cost give all such assistance to, and make such representations in relation to, any Planning Application as the Tenant may reasonably require. 3.2.4 Subject to the provisions of this licence, neither party shall do anything which may prevent or delay the issue of the Satisfactory Planning Permission. 3.2.5 The Tenant may, if at any time it appears necessary or desirable in order to obtain a Satisfactory Planning Permission and subject always to obtaining the Landlord's prior written consent (such consent not to be unreasonably withheld or delayed): (a) amend any planning application; (b) withdraw any planning application and submit a further planning application; and/or (c) submit a s.73 Application
4171693.3 8 and if it does so it shall notify the Landlord of the same and provided to the Landlord copies of all relevant documents forthwith. 3.2.6 The Tenant shall keep the Landlord reasonably informed as to the material progress of any Planning Application and as to all material discussions with the Planning Authority and shall provide to the Landlord copies of all relevant documents, correspondence and minutes of all meetings held with the Planning Authority. 3.2.7 The Tenant shall procure that within five working days of it or its agent receiving a Planning Permission a copy is delivered to the Landlord. The Landlord shall then have 10 working days from the date of delivery (time being of the essence) to notify the Tenant in writing whether or not it considers the Planning Permission to be a Satisfactory Planning Permission and if it does not, to give its reasons. 3.2.8 If the Landlord fails to make an objection within the time limit specified in clause 3.2.7 or notifies the Tenant that it considers the Planning Permission to be a Satisfactory Planning Permission, then the Landlord shall be deemed to have accepted irrevocably that the Planning Permission is a Satisfactory Planning Permission. 3.2.9 The Landlord may waive an objection to any condition of the Planning Permission which would render it not to be a Satisfactory Planning Permission by giving written notice to that effect to the Tenant. The provisions of clause 3.2.8 shall then apply to the Landlord in respect of that condition from the date of receipt of such notice by the Tenant. 3.3 Before starting the Works 3.3.1 Before starting the Works, the Tenant shall diligently and expeditiously comply with its obligations in this licence (including in the schedules to this licence) so far as necessary to procure that all of the Development Obligations are satisfied on the terms of this licence. 3.3.2 As from the Project Conditions Satisfaction Date, the Landlord and the Tenant are diligently and expeditiously to comply with their other respective obligations in this licence (including in the schedules to this licence). 3.3.3 The Development Obligations are: (a) the Tenant obtaining (in compliance with Schedule 3) the grant of all Statutory Consents; (b) in relation to the Phase 2 Works only, the Tenant obtaining a Satisfactory Planning Permission; (c) the Tenant satisfying all conditions of the Planning Permission that are in each case required before beginning the Works; (d) the Tenant and the relevant counter party(ies) entering into the: (i) Building Contract; (ii) Parent Company Guarantee;
4171693.3 9 (iii) Appointments; (e) the Building Contractor and Jubb Consulting Engineers Limited entering into the relevant subcontract; (f) the Tenant delivering to the Landlord originals or certified copies properly signed by the relevant party of the Main Warranties or TPR Notices vesting Third Party Rights in favour of the Landlord and, separately, the Lender in accordance with Schedule 3; and (g) delivery to the Landlord of documentary evidence in the form of a broker's letter or verification note that the professional indemnity insurance in accordance with the levels set out at paragraphs 5.1.1 and 5.1.2 of Schedule 2 are in full force and effect and comply with the requirements of Schedule 2. with each being a Development Obligation. 3.3.4 If any variations to the Plans and Specifications are required to obtain any of the Statutory Consents, the Tenant shall obtain the Landlord's written approval of those variations. Such approval is not to be unreasonably withheld or delayed, to the extent that such a variation involves an alteration to the Premises for which the Landlord's consent could not be unreasonably withheld or delayed under the terms of the Lease. 3.4 Carrying out the Works 3.4.1 Prior to the Project Conditions Satisfaction Date, the Tenant may not carry out the Works. 3.4.2 As from the relevant Project Conditions Satisfaction Date, the Tenant may but shall not be obliged to carry out the relevant Works and if it commences the relevant Works, it must carry out and complete the relevant Works: (a) in accordance with: (i) the Lease including the obligation not to alter or add to the Property in a way which would invalidate the Base Build Warranties or (to the extent disclosed to the Tenant by the Landlord or the building contractor) Product Guarantees (as defined in the Lease) in respect of the Property; (i) the Plans and Specifications; (ii) the terms of the Building Contract; (iii) the Planning Permission; (iv) the Statutory Consents; (v) all Statutory Requirements including the CDM Regulations; (vi) the requirements, if any, of the insurers of the Premises; and
4171693.3 10 (vii) all relevant British standards and codes of practice. (b) at its own cost subject to the Capital Contribution Deed; (c) in a good and workmanlike manner, with good and suitable materials; (d) to the satisfaction of the Building Control Officer and any other relevant body or authority; (e) to the reasonable satisfaction of the Landlord and in accordance with any reasonable directions given by it or by its professional advisers; and (f) with all due diligence and, in any event, by 1 December 2025. 3.4.3 The Tenant shall: (a) not cause any damage or legal nuisance to the Landlord or owners or occupiers of any neighbouring property; (b) keep all equipment, materials and debris stored securely in the Premises or within any area which the Tenant has use of pursuant to a licence to occupy to be made between Stevenage Borough Council (1) and the Tenant (2) in relation to the area known as Marshgate Car Park; 3.4.4 The Tenant shall allow the Landlord and those authorised by it to enter the Premises at reasonable times and (except in an emergency) on reasonable notice to inspect the progress of the Works and the materials used in them and to ensure they are being carried out in accordance with the terms of this licence. 3.4.5 The Tenant shall: (a) ensure that all utilities that are installed are connected to the relevant mains services in or under the public highway; (b) negotiate and complete (subject to the Landlord's prior written approval (such approval not to be unreasonably withheld or delayed)) such agreements with utility providers and others as may be required to secure all utilities required for the Works. 3.5 Practical completion of the Works 3.5.1 Not less than five working days before the anticipated date of completion of the Works: (a) the Tenant shall notify the Landlord and the Monitoring Surveyor in writing of such date; and (a) the Tenant shall permit the Monitoring Surveyor to attend the inspection of the Works by the Tenant and their Employer's Agent for the purpose of considering whether to issue the Certificate of Practical Completion. 3.5.2 The Monitoring Surveyor shall be entitled to attend such inspection and to make reasonable representations to the Employer's Agent on whether the Certificate of Practical Completion should be issued. The Tenant shall instruct the Employer's
4171693.3 11 Agent to have proper regard to any such representations (but without prejudice to the Employer's Agent's independent discretion in deciding whether to issue the Certificate of Practical Completion). 3.5.3 If following inspection, the Certificate of Practical Completion is not issued, the Tenant shall carry out such further works as the Employer's Agent shall specify. The procedure set out in paragraphs 3.5.1 and 3.5.2 shall then be repeated as many times as necessary until the issue of the Certificate of Practical Completion. 3.5.4 Any dispute regarding paragraphs 3.5.2 or 3.5.3 may be referred by either party for Determination. 3.5.5 The Tenant shall use all reasonable endeavours to procure that the Date of Practical Completion occurs by the Works Completion Longstop Date. 3.6 Following Practical Completion 3.6.1 As soon as reasonably practicable and in any event no later than 20 working days after the Date of Practical Completion, the Tenant shall: (a) ensure the Premises are cleared of all unused building materials, plant and equipment used in the carrying out of the Works and temporary structures; and (b) prepare the following documents: (i) the health and safety file maintained under the CDM Regulations; (ii) evidence of compliance with all conditions and obligations in the Planning Permission; (iii) one set of as-built plans stored as CAD files in electronic format; (iv) the commissioning reports, test certificates and operating manuals for all plant and equipment, utilities and other services installed as part of the Works; (c) provide the Landlord with copies of the following documents: (i) one set of as-built plans stored as CAD files in electronic format; (ii) product guarantees relating to the following elements of the Works: (A) roofing; (B) cladding replacement panels; (C) controls and switch gear; (D) EMS; (E) cleanroom partitions; (F) vinyl flooring;
4171693.3 12 (G) AHU's; (H) heat pumps; (I) lighting; and (J) pass through hatches/mal; (iii) a copy of the Certificate of Practical Completion; (iv) evidence of compliance with all conditions and obligations in the Planning Permission; (v) any energy performance certificates (as defined in regulation 2(1) of the Energy Performance of Buildings (England and Wales) Regulations 2012 (SI 2012/3118)) relating to the Premises as altered by the Works. 3.6.2 As soon as reasonably practicable and in any event no later than 20 working days following Practical Completion, the Tenant shall obtain any Statutory Consents that are required on the completion of the Works and can only be obtained after completion of the Works and provide copies of them to the Landlord; 3.6.3 As soon as reasonably practicable following Practical Completion but in any event before the expiry of any defects period under the Building Contract, the Tenant shall procure that the Building Contractor carries out any further works that are required to make good (1) any snagging items identified in the snagging list annexed to the Certificate of Practical Completion and (2) any defects that arise in the Works which are the responsibility of the Building Contractor in accordance with the Building Contract. 3.6.4 The Tenant must use all reasonable endeavours to deliver to the Landlord as soon as reasonably practicable but: (a) in any event before the Date of Practical Completion originals or certified copies properly signed by the relevant party of the following in accordance with Schedule 2: (i) Sub-Contractor Warranties in favour of the Landlord and, separately, the Lender; and (ii) (if Tenant is able to obtain reliance for the Landlord and any Lender on the condition survey having used all reasonable but commercially prudent endeavours to obtain such reliance) the Letter of Reliance in favour of the Landlord and, separately, the Lender; and (b) on or before the date on which the conditions set out at clauses 3.3.3(a) to 3.3.3(g) (inclusive) have all been satisfied, the Sub-Contractor Warranty from Jubb Consulting Engineers Limited. 3.7 General covenants The Tenant shall:
4171693.3 13 3.7.1 forthwith repair and make good to the Landlord's satisfaction any damage or injury to any person or property caused by the carrying out of the Works; 3.7.2 pay all additional fees, rates, taxes, levies, outgoings and assessments resulting from the Works (including charges for electricity and water); 3.7.3 indemnify the Landlord against any liability arising out of: (a) the Works including, but not limited to, any expense, liability, loss, claim or proceedings in respect of any death, personal injury or loss or damage whatsoever to any property, real or personal (which includes loss, injury or damage to the Existing Structures and their contents due to a Specified Peril), in so far as such death, personal injury or loss or damage arises out of or in the course of the carrying out any of the Works; (b) any breach of the Tenant's covenants in this licence; (c) the removal of the Works and the reinstatement of the Premises as referred to in clause 5. 4. INSURANCE 4.1 The Landlord shall only be obliged to insure the Works once they form part of the Premises, and only: 4.1.1 after they have been completed in accordance with this licence; 4.1.2 for the amount for which the Tenant has notified the Landlord that they should be insured; and 4.1.3 otherwise in accordance with the terms of the Lease. 4.2 Until the Landlord is obliged to insure the Works, the Tenant shall (or shall procure the occurrence of): 4.2.1 keep the Works and any plant, equipment and materials used in carrying them out insured against the insured risks defined in the Lease in their full reinstatement value with reputable insurers; 4.2.2 apply all insurance moneys payable under such insurance in reinstating the Works; 4.2.3 procure that the Building Contractor takes out third party and public liability insurance in respect of the Works in the sum of £20,000,000 for any occurrence; and 4.2.4 provide the Landlord with reasonable evidence of the policies of insurance referred to in this clause and evidence that they are in force. 4.3 The Tenant shall pay during the Term, as additional rent on demand, any increase in the insurance premium payable for the Building or any neighbouring property because of the Works, including buildings insurance and third party/public liability insurance. 4.4 On or prior to the commencement of the Works, the Landlord shall use reasonable endeavours to procure from the Insurers a waiver by such insurers of any right or subrogation
4171693.3 14 which they may have against the Building Contractor or any of the Building Contractor's personnel in respect of the cost of reinstating any loss or damage to the Existing Structures and the contents thereof caused by the occurrence of Specified Perils in excess of £20,000,000 for any occurrence. 5. REINSTATEMENT 5.1 Except to the extent requested not to do so by the Landlord no later than nine months before the end of the Term, the Tenant shall at its own cost during the six months immediately preceding the end of the Term: 5.1.1 remove the Works other than the Specified Clean Rooms; and 5.1.2 reinstate and make good the Premises to the same state and condition they were in immediately before the Works were carried out. 5.2 Such reinstatement and making good must be carried out in accordance with drawings and specifications approved in writing by the Landlord (such approval not to be unreasonably withheld or delayed). 5.3 In carrying out the removal and reinstatement works referred to in clause 5.1, the Tenant shall comply with the provisions of clause 3.4 as if references in that clause to the Works were to the works required by clause 5.1. 6. INSOLVENCY 6.1 Insolvency occurs if: 6.1.1 a person is a company and: (a) it enters into a voluntary arrangement under Part I of the 1986 Act or it enters into a scheme of arrangement with its creditors in satisfaction or composition of its debt; (b) an administrator is appointed under Part II of the 1986 Act; (c) a receiver or manager, including an administrative receiver, is appointed whether under Part III of the 1986 Act or otherwise; (d) a resolution to wind-up is passed or a provisional liquidator is appointed or a winding-up order is made under Part IV of the 1986 Act unless for the purpose of a solvent amalgamation or reconstruction of the company; (e) a scheme of arrangement is made under Part 26 of the Companies Act 2006; (f) a restructuring plan is entered into under Part 26A of the Companies Act 2006; or (g) it is struck off the register of companies or otherwise ceases to exist;
4171693.3 15 6.1.2 a person is an individual and: (a) an interim order or voluntary arrangement is made under Part VIII of the 1986 Act; (b) a trustee in bankruptcy is appointed or the individual otherwise becomes bankrupt; (c) the individual enters into a deed of arrangement or composition with his or her creditors; (d) a deputy is appointed under the Mental Capacity Act 2005 or the individual becomes incapable of managing his or her affairs; or (e) the individual dies; 6.1.3 two or more people are in partnership and: (a) they enter into a voluntary arrangement under Part II of the 1994 Order; (b) an administration order is made under Part III of the 1994 Order; or (c) a winding up order is made under Parts IV or V of the 1994 Order; or 6.1.4 a person is incorporated or resident in a jurisdiction outside England and Wales and any event or circumstance occurs which under the laws of that jurisdiction has an analogous or equivalent effect to any of the events in this clause 6. 7. REMEDYING BREACHES 6.2 If there is an Event of Default, the Landlord may enter the Premises and carry out of the Works required itself (or procure another carries them out). 6.3 The Tenant must repay, as a debt on demand, all the proper costs the Landlord properly incurs in so doing to the extent these costs are not paid or due to be paid to any person employed (or formally employed) by the Tenant in connection with the Works. 6.4 The Landlord's rights under the Lease will be unaffected. 7. DETERMINATION OF DISPUTES 7.1 Any dispute which may arise between the Landlord and the Tenant concerning: 7.1.1 whether a Planning Permission is a Satisfactory Planning Permission; 7.1.2 the Works; or 7.1.3 any other matter where this licence expressly provides for such matter to be referred for Determination; shall, except to the extent such matters relate to the legal effect or construction of this licence, be determined by an independent chartered surveyor appointed in accordance with this clause 7.
4171693.3 16 7.2 The following provisions shall apply to the appointment of the surveyor: 7.2.1 if the parties fail to agree the appointment within 14 days of either party serving details of a suggested surveyor on the other, the surveyor shall be nominated on the application of either party by or on behalf of the President of the RICS; 7.2.2 the surveyor shall act as an expert and not as an arbitrator; 7.2.3 the surveyor's decision shall be final and binding on the parties in the absence of manifest error; 7.2.4 the surveyor shall decide the procedure to be followed in the determination and shall be requested to make their decision within 20 working days of their appointment; 7.2.5 the surveyor shall be instructed by the parties to consider any written representations which they may submit to the surveyor within such time limits as may be fixed in the surveyor's discretion; 7.2.6 the surveyor's fees and costs, and the fees and costs of the persons mentioned in clause 7.2.7, shall be borne between the parties in such proportions as the surveyor may in their discretion determine; 7.2.7 the surveyor may engage the assistance of such advisers of other professions whose expertise is necessary or desirable to resolve issues arising from the dispute, and the parties shall be bound by the advice of such persons; 7.2.8 the parties mutually undertake to use their respective reasonable endeavours to enable the surveyor to reach their determination as quickly as reasonably possible; and 7.2.9 if the surveyor becomes unable or unwilling to act, then the procedure for their appointment shall be repeated as often as may be necessary. 7.3 If either party fails to pay its proportion of the fees and costs referred to in clause 7.2.6, then the other party may pay them on its behalf and then recover such amount from the defaulting party as a debt on demand, or set it off against any other sum payable to the defaulting party pursuant to this licence. 7.4 All information, data or documentation disclosed or delivered by either party to the surveyor in consequence of or in connection with their appointment under this clause must be treated as confidential. All such information, data or documentation shall remain the property of the party disclosing or delivering it and all copies shall be returned to that party on completion of the surveyor's work. 8. AGREEMENTS AND DECLARATIONS 8.1 The consent given by this licence relates only to the Works, and does not obviate the need for the consent of any person other than the Landlord that may be required. This licence does not permit entry on any premises other than the Premises without the further consent of the Landlord and of any persons entitled to possession of such other premises.
4171693.3 17 8.2 The Tenant must satisfy itself as to: 8.2.1 the suitability of the Premises and the Building for the execution of the Works; 8.2.2 the suitability of any materials to be used in the Works; 8.2.3 the compatibility of the Works with any services used in common by the Premises and the remainder of the Building; and 8.2.4 whether the Works or any removal or reinstatement of them may be lawfully carried out. 8.3 The Landlord's approval of the Works shall not be taken as an express or implied representation or warranty as to any of the matters referred to in clause 8.2. Neither the Landlord nor its agents shall have any liability in respect of such matters. 8.4 Nothing in this licence releases or reduces the liability of any person to the Landlord under the covenants or conditions in the Lease, amounts to a waiver of any breach of the Lease, or is to be taken as a representation that there are no subsisting breaches of the Lease. 8.5 The Tenant's covenants in the Lease shall extend to the Works and apply to the Premises as altered by the Works. The right of re-entry in the Lease shall extend to and be exercisable by the Landlord on any breach of the Tenant's obligations in this licence. 8.6 The parties to this licence do not intend any of its terms to be enforceable by a third party (as defined in section 1 of the Contracts (Rights of Third Parties) Act 1999) other than the Landlord's and the Tenant's respective successors in title and in relation clause 7 and/or paragraph 11 of Schedule 2 of this licence only the Lender as if it were the Landlord. 9. NOTICES Section 196 of the Law of Property Act 1925 as amended by the Recorded Delivery Service Act 1962 applies to notices served under this licence. 10. GUARANTOR'S CONSENT AND OBLIGATIONS In consideration of the Landlord's consent in clause 2 of this licence (granted at the Guarantor's request), the Guarantor consents to the Tenant entering into this licence and agrees that: 10.1.1 its liability to the Landlord for the Tenant's obligations in the Lease remains fully effective and extends to the Tenant's obligations in this licence; and 10.1.2 to the extent any provision of this licence varies the Lease, its guarantee applies to the Lease as varied. 11. FEES AND EXPENSES 11.1 The Tenant shall on demand pay and indemnify the Landlord against the proper fees and expenses (plus Value Added Tax) of the Landlord's solicitors, surveyors, architects, managing agents and other professional advisers and the Insurers in relation to: 11.1.1 considering and approving all plans, drawings and specifications of the Works and any Consents;
4171693.3 18 11.1.2 inspecting and supervising the Works; 11.1.3 approving, inspecting and supervising the removal and reinstatement works referred to in clause 5; and 11.1.4 the negotiation, preparation and grant of this Licence, the Capital Contribution Deed and the Deed of Variation and due diligence relating to the technical aspects of the Works; 11.1.5 in the case of the fees and expenses referred to in clause 11.1.4, these shall be limited to £100,000 plus any irrecoverable Value Added Tax in the case of legal fees and £46,000 plus any irrecoverable Value Added Tax in the case of surveyors and other technical advisors' fees The parties have executed and delivered this document as a deed on the date stated at the beginning of it.
4171693.3 19 SCHEDULE 1 - THE LEASE Date Parties Term 19 September 2023 (1) Forge Life Sciences Nominee 1 Limited and Forge Life Sciences Nominee 2 Limited (2) Autolus Limited (3) Autolus Therapeutics Plc 20 years from and including 19 September 2023 to but excluding 19 September 2043
4171693.3 20 SCHEDULE 2 – APPOINTMENTS OF BUILDING CONTRACTOR AND PROFESSIONAL TEAM 1. Basis of appointments 1.1 Subject to the Landlord approving any matters pursuant to paragraph 2, if it has not already done so, the Tenant shall: 1.1.1 appoint the Building Contractor; 1.1.2 appoint each member of the Professional Team; and 1.1.3 use all reasonable but commercially prudent endeavours to procure that each Sub- Contractor is appointed by the Building Contractor; as soon as reasonably practicable and in any event before the Project Conditions Satisfaction Date. 1.2 Each appointment under paragraph 1.1 shall comply with the procedure set out in this Schedule 2. 1.3 Each member of the Professional Team shall be: 1.3.1 the relevant person listed in Schedule 5; or 1.3.2 (if their appointment is terminated) such other reputable and suitably qualified and experienced consultant as the Tenant appoints for the relevant function in connection with the Works with the Landlord's prior approval (such approval not to be unreasonably withheld); 1.4 If appointing a new consultant pursuant to paragraph 1.3.2, the Tenant shall have due regard inter alia to any concerns that the Landlord may have about: 1.4.1 the financial standing or experience of the alternative consultant; or 1.4.2 its ability to perform the relevant scope of services. 2. Terms of appointments 2.1 The appointment of each member of the Professional Team shall be executed as a deed and substantially in the form attached to this licence at Appendix 1 provided that the Tenant shall obtain the Landlord's approval (not to be unreasonably withheld or delayed) to the form of appointment provided that the Landlord: 2.1.1 acknowledges the Appointment annexed to this licence at the date of this Licence is agreed; and 2.1.2 shall not be obliged to approve any further amendments that materially or adversely affect the rights of the Landlord (or any Lender) against the Professional Team 2.2 The Building Contract shall be executed as a deed. 2.3 The Tenant shall obtain the Landlord's approval (not to be unreasonably withheld or delayed) to the form of Building Contract provided that the Landlord:
4171693.3 21 2.3.1 acknowledges the Schedule of amendments annexed to this licence at the date of this Licence are agreed; and 2.3.2 shall not be obliged to approve any further amendments that materially or adversely affect the rights of the Landlord (or any Lender) against the Building Contractor, the Sub-Contractors or the Professional Team. 2.4 The Tenant shall provide the Landlord with two certified copies of the Building Contract (and the Contract Documents as defined therein) and the Appointment under this schedule within 15 working days of each document being entered into. 3. Additional provisions relating to the Building Contract 3.1 If the Building Contractor is to be responsible for appointing any members of the Professional Team under the terms of the Building Contract, the Tenant is to procure that those appointments are made in compliance with this Schedule 2. 3.2 The Tenant shall procure that: 3.2.1 the Parent Company Guarantee is executed as a deed and delivered on or before the date of the Building Contract; 3.2.2 the Building Contract contains a rectification period of not less than 12 months from the Date of Practical Completion; 3.2.3 the Building Contractor is registered under the Construction Industry Scheme with gross payment status; 3.2.4 the Building Contractor operates the Construction Industry Scheme in respect of payments made to sub-contractors (within the meaning of the Construction Industry Scheme); and 3.2.5 the Building Contract provides for a retention percentage of at least 10% (such percentage reducing to 2.5% following Practical Completion) on of the contract sum specified in the Building Contract. 4. Warranties 4.1 As soon as reasonably practicable (and in any event within 15 working days of the Building Contract or Appointment (as the case may be) being entered into), the Tenant shall procure that the duly executed and completed Main Warranties or TPR Notices are unconditionally delivered by or served (as the case may be) pursuant to the Building Contract or the Appointments of or the subcontract relating to the Main Warrantors in favour of: 4.1.1 the Landlord and (where the Lender's identity is notified to the Tenant in advance) separately to the Lender (each as beneficiaries of a Main Warranty); and 4.1.2 (where the Lender's identity is not notified to the Tenant in advance) to the Lender within 10 working days of such notification; 4.2 Not Used. 4.3 The Tenant shall procure that each Sub-Contractor unconditionally delivers duly executed and completed Sub-Contractor Warranties (together with a copy of the relevant Sub-
4171693.3 22 Contract) to each of the Landlord and the Lender as soon as reasonably practicable after entering into a Sub-Contract with the Building Contractor and in any event before the issue of the Certificate of Practical Completion. 4.4 The Main Warranties shall be in the form at Appendix 2 and the Sub-Contractor Warranties shall be in the form appended to the Building Contract, with such further amendments as shall be required by the Tenant and agreed by the respective counterparty (both acting reasonably) and to which the Landlord shall first approve (such approval not to be unreasonably withheld, except under paragraph 4.5). 4.5 The Landlord shall not be obliged to approve any amendments to the terms of the Warranties or the Third Party Rights that adversely affect the rights of the Landlord under its Warranties or Third Party Rights or lessen the liability of the Building Contractor, the relevant Sub- Contractor or the member of the Professional Team (as applicable). 4.6 In particular, without prejudice to the generality of paragraph 4.5 above, the Landlord shall not be obliged to approve any amendments to the terms of the Warranties or the Third Party Rights which: 4.6.1 exclude work carried out pre-appointment; 4.6.2 include a net contribution clause; 4.6.3 restrict assignments without consent to less than twice; 4.6.4 (in relation to the Main Warrantors) restrict unlimited assignments without consent: (a) intragroup; or (b) by way of security to any lender (including any reassignment on redemption of such security); and any such assignment shall not count towards the assignments permitted by paragraph 4.6.3; 4.6.5 restrict any further assignments (but it shall be acceptable for such assignment to be permitted with consent, such consent not to be unreasonably withheld); and/or 4.6.6 exclude a full copyright licence. 5. Insurance 5.1 The Tenant shall require that professional indemnity insurance is maintained throughout the period of the Works and for 12 years after the Date of Practical Completion with reputable insurers approved by the Landlord, such approval not to be unreasonably withheld: 5.1.1 by each member of the Professional Team with a limit of indemnity of not less than the sum stated in Schedule 5 or such other limit as shall be agreed with such member of the Professional Team and to which the Landlord shall first approve (such approval not to be unreasonably withheld); 5.1.2 the Building Contractor for £10,000,000 in the aggregate or upon such basis as shall be agreed with the Building Contractor and to which the Landlord shall first approve (such approval not to be unreasonably withheld); and
4171693.3 23 5.1.3 by each Sub-Contractor for a level appropriate to the services being provided in respect of each claim that may be made or upon such other basis as shall be agreed with such Sub-Contractor and to which the Landlord shall first approve (such approval not to be unreasonably withheld) for so long as professional indemnity insurance is generally available in the insurance market to those persons at a reasonable cost and on reasonable terms. 5.2 Payment of any increased or additional premiums required by insurers by reason of those persons' own claim records or other acts or omissions or things peculiar to those persons shall be disregarded in determining whether such insurance is available at a reasonable cost or, as the case may be, on reasonable terms. 6. Copyright 6.1 The Tenant shall procure that the Building Contractor, each Sub-Contractor and each member of the Professional Team: 6.1.1 grants to the Landlord an irrevocable, royalty-free licence to use and reproduce the Design Documents prepared by them or on their behalf or in which they have copyright, such licence carrying the right to grant sub-licences and to be transferable without the consent of the licensor; and 6.1.2 waives all moral rights to the Design Documents under the Copyright, Design and Patents Act 1988. 7. Tenant's obligations 7.1 The Tenant shall: 7.1.1 use all reasonable but commercially prudent endeavours to ensure that: (a) each member of the Professional Team complies with the terms of its appointment; (b) the Building Contractor complies with the terms of the Building Contract; and (c) the Building Contractor and each Sub-Contractor comply with the terms of their Sub-Contracts. 7.2 The Tenant shall not without the prior written consent of the Landlord, such consent not to be unreasonably withheld or delayed: 7.2.1 dismiss any member of the Professional Team, or the Building Contractor, or permit a Sub-Contractor to be dismissed; 7.2.2 make or agree any variations or amendments to the terms of any appointment, Building Contract or Sub-Contract; 7.2.3 permit any member of the Professional Team to sub-contract any part of its responsibilities under its appointment;
4171693.3 24 7.2.4 consent to any member of the Professional Team removing or replacing any key personnel identified in the relevant appointments; or 7.2.5 permit any assignment or novation of the appointments, the Building Contract or the Sub-Contracts (save as expressly permitted by this licence). 7.3 The Tenant shall not: 7.3.1 waive, release, nor stop itself from enforcing or seeking redress for, any breach of the appointments, the Building Contract or the Sub-Contracts; 7.3.2 do or omit to do any other act or thing which would prejudice the rights or claims of the Landlord under the Warranties or Third Party Rights as the case may be; 7.3.3 do or omit to do any act or thing which would entitle: (a) any member of the Professional Team to treat its appointment as terminated; (b) the Building Contractor to treat the Building Contract as terminated; (c) a Sub-Contractor to treat a Sub-Contract as terminated; nor 7.3.4 receive any commissions, inducements, or pecuniary or other advantages at any time arising from the appointment of the members of the Professional Team, the Building Contractor or any Sub-Contractor. 7.4 If the Building Contractor or a member of the Professional Team is affected by Insolvency, the Tenant shall, at the written direction of the Landlord, exercise its right to terminate the relevant Building Contract or appointment (and the provisions of paragraph 8 shall then apply). 8. Termination of the Building Contract or an appointment 8.1 If there is a termination (brought into effect by any party to the relevant instrument and including a rescission or disclaimer) of the Building Contract or any appointment, the Tenant is promptly to notify the Landlord in writing of that termination and (unless carried out at the direction of the Landlord) the reasons for it. 8.2 Following such a termination: 8.2.1 where the Building Contract is terminated, the Tenant shall appoint another Building Contractor whose identity and terms of Building Contract shall comply with the provisions of this licence in substitution for the person whose Building Contract was terminated; and 8.2.2 where an Appointment is terminated and the Tenant was responsible for the original appointment, the Tenant shall appoint another person whose identity and terms of Appointment shall comply with the provisions of this licence in substitution for the person whose appointment was terminated, in each case, such substitute Building Contract and/or Appointment to be approved by the Landlord (such approval not to be unreasonably withheld or delayed)
4171693.3 25 8.3 The Landlord shall not be obliged to approve the terms of a substitute Building Contract or Appointment under paragraph 8.2 if the terms of the Appointment or Building Contract impose less onerous obligations on the person to be appointed than those contained in the Building Contractor or Appointment (as applicable) that was terminated. 9. Ownership of goods, materials and insurance proceeds 9.1 Where the Building Contract provides for the ownership of unfixed materials and goods to become the property of the employer under the Building Contract under certain circumstances then, as between the Tenant and the Landlord, the Tenant is to hold them on trust for the Landlord absolutely. 9.2 Any interest which the Tenant may have in any insurance proceeds received or receivable under the Building Contract are to be held on trust by the Tenant for the Landlord absolutely and are to be paid as the Landlord directs. 10. Proceedings 10.1 If the Building Contractor, any Sub-Contractor or any member of the Professional Team are in breach of their obligations in relation to the Works, the Tenant shall, subject to the terms of this paragraph 10.1, enforce its rights and remedies in respect of that breach but: 10.1.1 shall first seek the approval of the Landlord as to the action to be taken, which approval shall not be unreasonably withheld or delayed (having regard to any limitations of time within which the Tenant may be required to act); and 10.1.2 shall take such action, at the Landlord's cost, as the Landlord may reasonably require. 11. Assignment of rights 11.1 Following an Event of Default, the Landlord may, but without being under an obligation to do so, serve written notice on the Tenant and any Building Contractor to elect that the Landlord is to act and to be treated as the employer under the Building Contract. 11.2 If the Landlord serves notice under paragraph 11.1: 11.2.1 the Landlord may (but shall not be obliged to) exercise its step-in rights under any Warranties; 11.2.2 the Tenant shall remain liable for any act or default of the Building Contractor as if no notice had been served; and 11.2.3 the rights and duties of the Tenant under this licence shall remain in full force except to the extent that they are inconsistent with the Landlord becoming the employer under the Building Contract. 11.3 The Landlord may, at any time, cancel an election made under paragraph 11.1 and require the Tenant to resume the role of employer in relation to the Building Contract. 11.4 The provisions of this paragraph 11 apply equally to the appointments of the Professional Team.
4171693.3 26 SCHEDULE 3 - PRE-DEVELOPMENT OBLIGATIONS 1. Statutory Consents 1.1 As soon as reasonably practicable (to the extent not already obtained) the Tenant shall make applications for, and use all reasonable endeavours to obtain, the Statutory Consents or obtain lawful relaxations or waivers of them. 1.2 The Tenant shall keep the Landlord properly informed as to the progress of each application for the Statutory Consents and of all negotiations relating to those applications and shall provide to the Landlord copies of all applications, correspondence and notes of meetings relating to those applications and negotiations. 1.3 If any Statutory Consent is refused, the Tenant may but shall not be obliged to appeal against the refusal. 1.4 The Tenant shall provide a copy of each Statutory Consent obtained to the Landlord and shall not start the relevant Works until the Landlord has given its written approval to the Statutory Consent (such approval not to be unreasonably withheld or delayed). 1.5 The Tenant shall procure that all Statutory Consents remain valid and unrevoked and, if it carries out the Works, use all reasonable endeavours to renew any that become invalid or revoked. 2. CDM Regulations 2.1 By entering into this licence, the Tenant elects, for the purposes of the CDM Regulations, to be treated as the only client in respect of the Works. 2.2 The Landlord agrees to the Tenant's election to be treated as the only client. 2.3 The Tenant shall appoint the Principal Designer as the principal designer and the Building Contractor as the principal contractor for the Works for the purposes of the CDM Regulations and make all other appointments required under the CDM Regulations. 2.4 The Tenant shall, in carrying out and completing the Works in accordance with the Building Contract: 2.4.1 comply with its obligations as the client under the CDM Regulations; 2.4.2 discharge its obligations thereunder with the object that the persons appointed under paragraph 2.3 comply with their obligations under the CDM Regulations; 2.4.3 discharge its obligations thereunder with the object that designers and contractors for the purposes of the CDM Regulations comply with their obligations under the CDM Regulations; 2.4.4 in conjunction with the Principal Designer, discharge its obligations thereunder with the object that: (a) notice of the Works is given to the Health and Safety Executive; and (b) a Construction Phase Plan is prepared in accordance with the CDM Regulations; and
4171693.3 27 2.4.5 not start the Works until the provisions of this paragraph 2 (as are required or capable of being satisfied prior to commencing the Works) have been complied with.
4171693.3 28 SCHEDULE 4 - THE WORKS The works set out in the attached plans and specifications.
4171693.3 29 SCHEDULE 5 -PROFESSIONAL TEAM Professional Team Member Type of Insurance Minimum Limit of Indemnity and Basis of Cover Gleeds Cost Management Limited (Company No. 06472932) the registered office of which is at 95 New Cavendish Street, London, W1W 6XF (the "Employer's Agent") to be appointed by the Tenant Professional indemnity insurance £5,000,000 each and every claim but limited to an aggregate basis in respect of pollution/contamination and/or asbestos and/or fire safety Gleeds Cost Management Limited (Company No. 06472932) the registered office of which is at 95 New Cavendish Street, London, W1W 6XF (the "Quantity Surveyor") to be appointed by the Tenant Professional indemnity insurance £5,000,000 each and every claim but limited to an aggregate basis in respect of pollution/contamination and/or asbestos and/or fire safety MA24 Limited (Company No. 07159714) the registered office of which is at 14 High Cross, Truro, England, TR1 2AJ (the "Principal Designer"), such role as the Principal Designer to be performed pursuant to the Building Contract Professional indemnity insurance £10,000,000 in the aggregate (as set out in the Building Contract)
4171693.3 30 APPENDIX 1 APPOINTMENTS
4171693.3 31 APPENDIX 2 MAIN WARRANTIES
4171693.3 32 APPENDIX 3 SCHEDULE OF AMENDMENTS TO JCT CONTRACT
4171693.3 33 EXECUTED as a deed by FORGE LIFE SCIENCES NOMINEE 1 LTD acting by a director, in the presence of: Signature Director Print name Witness signature Name (in BLOCK CAPITALS) Address EXECUTED as a deed by FORGE LIFE SCIENCES NOMINEE 2 LTD acting by a director, in the presence of: Signature Director Print name Witness signature Name (in BLOCK CAPITALS) Address /s/ /s/ /s/ /s/
4171693.3 34 Signature Director Print name Signature Director Print name EXECUTED as a deed by AUTOLUS LIMITED acting by two directors EXECUTED as a deed by AUTOLUS THERAPEUTICS PLC acting by a director, /s/ /s/ /s/ /s/
EX-10.4 Management Incentive Compensation Plan (October 2024) 1. Purpose of the Plan The Management Incentive Compensation Plan (the “Plan”) of Autolus Therapeutics plc and its group companies (collectively, “Autolus”) is designed to offer incentive compensation to officers and managers of Autolus (the “Associates”) by rewarding the achievement of corporate goals and specifically measured personal goals that are consistent with and support the achievement of the corporate goals. The Plan will create an environment that will focus Associates on the achievement of objectives. Since cooperation between departments and Associates is required to achieve the corporate goals and because such corporate goals represent a significant portion of the incentive compensation paid under the Plan, the Plan fosters teamwork and a cohesive management team. The Plan is designed to: • Provide an incentive program to achieve overall corporate objectives and to enhance shareholder value • Reward those individuals who significantly impact corporate results • Encourage increased teamwork among all disciplines within Autolus • Incorporate an incentive program in the overall compensation program of Autolus to help attract and retain key Associates 2. Plan Governance The Chief Executive Officer of Autolus (the “CEO”) will be responsible for the administration of the Plan for Associates of Autolus, except that the Compensation Committee (the “Committee”) of the Board of Directors of Autolus (the “Board”) will be responsible for approving any incentive awards to the CEO and the executive officers of Autolus (each of whom is hereafter referred to as an “Executive Officer”). 3. Plan Year The period for the measurement of performance is the fiscal year of the Company, which is currently Jan 1 to Dec 31 (the “Plan Year”), unless otherwise determined by the Committee. 4. Eligibility 4.1. The Executive Officers are eligible to participate in the Plan. Any other Associates who may be eligible to participate in the Plan will be selected at the sole discretion of Autolus. Each Executive Officer and each Associate selected to participate in the Plan is hereafter referred to as a “Plan Participant”. 4.2. In order to be eligible to receive any incentive award under this Plan, an Associate (a) must have been employed by Autolus for at least three (3) consecutive months during the Plan Year, and (b) must reach a personal goal rating of at least 75%.
5. Form of Incentive Award Payments Incentive award payments may be made in cash, or, at the discretion of the Committee and subject to the approval of the Board, through the issuance of vested stock or stock options, or by a combination of cash, stock and/or stock options. In the event that the Committee and the Board elect to pay incentive awards in stock or stock options, the Committee, in its sole discretion, will make a determination of the number of shares of stock or stock options to be issued to each Plan Participant based, in part, upon the Plan Participant’s achievement of corporate and personal goals as described below. Stock options will be subject to the terms and conditions of Autolus’ then-current equity incentive plan. 6. Target Award Multiplier The target incentive award of each Plan Participant is determined by applying a “target award multiplier” to the base salary of the Plan Participant. The target award multiplier is dependent on the management level of the Plan Participant. The following target award multipliers will apply to determine the target incentive award of the Plan Participants for the Plan Year, provided that the Committee, based on individual circumstances and in its discretion, may approve a target award multiplier for a Plan Participant that is different from that listed below: Position Target Award Multipli er CEO 50% Executive Officer (C-level) 40% Senior Vice President 35% Vice President 30% Executive/Senior Director 25% Director 20% Associate Director 15% Manager and Group Leader 10% Team Leader and General Staff 5%
7. Corporate and Personal Goals 7.1. Prior to the beginning of the Plan Year, the CEO will present to the Committee a list of the overall corporate goals for the Plan Year, which are subject to approval of the Committee and the Board. The Committee assigns a percentage to each corporate goal based on the relative importance of the goal compared to the other corporate goals, with the sum of all percentages amounting to 100%. In addition to the Corporate Goals all Plan Participants except for the CEO develop a list of personal goals, which must be approved by the immediate supervisor and the EM Member responsible for the applicable department, or by the CEO for personal goals of the other EM Members. The supervisor assigns a percentage to each personal goal based on the relative importance of the goal compared to the other personal goals, with the sum of all percentages amounting to 100%. 7.2. The Plan calls for incentive awards based on the achievement of annual corporate and personal goals that have been approved as described in Section 7.1 above. The relative weight between corporate goals and personal goals varies based on the Plan Participant’s level within the organization. The weighting of the corporate goals relative to the personal goals for the Plan Year is as follows: Position Weighti ng of Corpor ate Goals Weight ing of Person al Goals CEO 100% 0% Executive Officer (C-level) 75% 25% Senior Vice President 75% 25% Vice President 75% 25% Executive/Senior Director 50% 50% Director 50% 50% Associate Director 25% 75% Manager and Group Leader 25% 75% Team Leader and General Staff 0% 100% 8. Performance Assessment 8.1. Achievement of Corporate Goals Within 30 days after the end of the Plan Year, the Chief Executive Officer will present to the Committee his assessment of the achievement of the corporate goals for that Plan Year. The Committee will review and discuss the assessment with the Chief Executive Officer, and will determine the percentage of the achievement of the corporate goals during a meeting of the Committee in a closed session. The payment multiplier for the corporate goals determined by the Committee will be used for all Plan Participants in any given year. The Committee may, in its discretion, include achievements that have not been established as corporate goals at
the beginning of the Plan Year or determine that the level of achievement of a particular corporate goal exceeds 100%. 8.2. Achievement of Personal Goals Within 30 days after the end of the Plan Year, the Chief Executive Officer will present to the Committee his assessment of the achievement of the personal goals of each other Executive Officer for that Plan Year. The Committee will review and discuss the assessment with the Chief Executive Officer, and will determine the percentage of the achievement of the personal goals during a meeting of the Committee in consultation with the Chief Executive Officer. Each supervisor will determine the achievement of the personal goals of the Associates reporting to him, subject to the approval of the Executive Officer responsible for the applicable department. The final determination of the achievement of the personal goals will be made by the executive management team taking into account the variances in goal setting and assessment practices across the departments of Autolus. The Committee and the supervisors may, in their discretion, include achievements that have not been established as personal goals at the beginning of the Plan Year or determine that the level of achievement of a particular personal goal exceeds 100%. 9. Calculation of Cash Incentive Award 9.1. The target award of a Plan Participant is calculated by multiplying the Plan Participant’s base salary as of the last day of the Plan Year by the target award multiplier. This amount is then divided between its corporate component and its individual component based on the weighting assigned for the specific management level. After the end of the Plan Year, the achievement of the corporate and personal goals (each expressed as a percentage) will be established as described in Section 8 above. The corporate award multiplier, which is based on overall corporate performance, is used to calculate corporate goal component of the incentive award by multiplying the target award for the corporate goal component by the percentage of the corporate goal achievement determined by the Committee. The percentage determined by the Compensation Committee or the responsible supervisor for the achievement of the personal goals of a Plan Participant is used in the same way to calculate the personal goal component of the incentive award. Example: Position: Vice President Base Salary: GBP 150,000 Target Award Multiplier: 30% Target Award: GBP 45,000 (GBP150,000 x 30%) Weighting of corporate goal component: 75% Weighting of personal 25%
goal component: Target Award Calculation: Target Award based on corporate goals: GBP 33,750 (GBP 45,000 x 75%) Target Award based on personal goals: GBP 11,250 (GBP 45,000 x 25%) Actual achievement of corporate goals: 90% Actual achievement of personal goals: 95% Actual Incentive Award: Corporate goals component: GBP 30,375 (GBP 33,750 x 90%) Personal goals component: GBP 10,688 (GBP 11,250 x 95%) Total Incentive Award: GBP 41,063 9.2. Any incentive award payable to a Plan Participant who has a part-time work schedule will be based on the actual base salary paid to such Plan Participant during the Plan Year. 9.3. Any incentive award payable to a Plan Participant who has been eligible for an incentive award payment under the Plan for less than a full Plan Year will be pro-rated based on the number of days in which such Plan Participant was in an eligible position. 9.4. If a Plan Participant is promoted during the Plan Year from one target award multiplier level to another, such Plan Participant’s incentive award will be calculated based on their base salary on the last day of the Plan Year, but based on the amount of time during the Plan Year served at each target award multiplier level.
10. Payment of the Incentive Award Annual performance reviews for Plan Participants will be completed before March 31 of the year following the Plan Year. Payment of incentive awards will be made as soon as practicable thereafter. Incentive award payments to the CEO and to the Executive Officers must be approved by the Committee. 11. Termination If a Plan Participant has given or received a notice of termination or if a Plan Participant’s employment is terminated prior to the payment of the incentive award under this Plan, Autolus will have sole and absolute discretion as to whether or not to pay an incentive award. If Autolus decides to pay an incentive award to such Plan Participant, Autolus will have sole and absolute discretion as to whether to pay the full amount or a portion of the amount of the incentive award that may be payable to the Plan Participant in accordance with the provisions of this Plan. 12. Absolute Right to Alter or Abolish the Plan Autolus reserves the right in its absolute discretion to abolish the Plan at any time or to alter the terms and conditions under which incentive compensation will be paid. Such discretion may be exercised any time before, during, and after the Plan Year is completed. 13. No Right to Incentive Award Payments No Plan Participant will have any vested right to receive any compensation under the Plan until actual delivery of such compensation. If an eligible Associate has been on probation for performance or other issues at any time during the Plan Year or during the period from the end of the Plan Year until the time at which incentive award determinations are made, any award to such individual will be subject to the discretion of Autolus. The Associate will not have any right to receive any such incentive award payment and any payments made cannot be taken as a precedent for future or further incentive award payments. 14. Employment Relationship This Plan does not, and Autolus’s policies and practices in administering this Plan do not, constitute a contract or other agreement concerning the duration of any Plan Participant’s employment with Autolus. The employment relationship of each Plan Participant of Autolus is governed by the employment agreement of the Plan Participant and applicable law, and may be terminated by Autolus or by the Plan Participant in accordance with the terms of such agreement and applicable law. To the extent that an employment agreement contains provisions regarding incentive or bonus awards or payments that are inconsistent with any provisions of the Plan, the provisions that are more favorable to the Associate will apply.
Certification by the Principal Executive Officer pursuant to
Securities Exchange Act Rules 13a-14(a) and 15d-14(a)
as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
I, Christian Itin, certify that:
| | | | | | | | |
| | |
| 1. | I have reviewed this Quarterly Report on Form 10-Q of Autolus Therapeutics plc; |
| | |
| 2. | Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; |
| | |
| 3. | Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; |
| | |
| 4. | The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: |
| | |
| (a) | Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; |
| | |
| (b) | Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; |
| | |
| (c) | Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and |
| | |
| (d) | Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
| | |
| 5. | | The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions): |
| | |
| (a) | All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and |
| | |
| (b) | Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting. |
| | | | | |
| Date: November 12, 2024 | /s/ Christian Itin, Ph.D. |
| Name: Christian Itin, Ph.D. |
| Title: Chief Executive Officer |
| (Principal Executive Officer) |
Certification by the Principal Financial Officer pursuant to
Securities Exchange Act Rules 13a-14(a) and 15d-14(a)
as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
I, Robert Dolski, certify that:
| | | | | | | | |
| | |
| 1. | I have reviewed this Quarterly Report on Form 10-Q of Autolus Therapeutics plc; |
| | |
| 2. | Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; |
| | |
| 3. | Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; |
| | |
| 4. | The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: |
| | |
| (a) | Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; |
| | |
| (b) | Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; |
| | |
| (c) | Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and |
| | |
| (d) | Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
| | |
| 5. | | The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions): |
| | |
| (a) | All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and |
| | |
| (b) | Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting. |
| | | | | |
| Date: November 12, 2024 | /s/ Robert Dolski |
| Name: Robert Dolski |
| Title: Chief Financial Officer |
| (Principal Financial Officer) |
Certification pursuant to
18 U.S.C. Section 1350, as adopted pursuant to
Section 906 of the Sarbanes-Oxley Act of 2002
Pursuant to the requirement set forth in Rule 13a-14(b) of the Securities Exchange Act of 1934, as amended, (the “Exchange Act”) and Section 1350 of Chapter 63 of Title 18 of the United States Code (18 U.S.C. §1350), Christian Itin, Chief Executive Officer of Autolus Therapeutics plc (the “Company”), and Robert Dolski, Chief Financial Officer of the Company, each hereby certifies that, to the best of his or her knowledge:
| | | | | |
| |
| (1) | The Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2024, to which this Certification is attached as Exhibit 32.1 (the “Periodic Report”) fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and |
| | | | | |
| |
| (2) | The information contained in the Quarterly Report fairly presents, in all material respects, the financial condition and results of operations of the Company. |
| | | | | | | | |
/s/ Christian Itin, Ph.D. | | /s/ Robert Dolski. |
| Name: Christian Itin, Ph.D. | | Name: Robert Dolski |
| Title: Chief Executive Officer | | Title: Chief Financial Officer |
| (Principal Executive Officer) | | (Principal Financial Officer) |
This certification accompanies the Form 10-Q to which it relates, is not deemed filed with the Securities and Exchange Commission and is not to be incorporated by reference into any filing of Autolus Therapeutics plc under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended (whether made before or after the date of the Form 10-Q), irrespective of any general incorporation language contained in such filing.
v3.24.3
Cover - shares
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9 Months Ended |
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Sep. 30, 2024 |
Nov. 08, 2024 |
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AUTOLUS THERAPEUTICS PLC
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X0
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The Mediaworks
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191 Wood Lane
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London
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GB
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NASDAQ
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v3.24.3
Unaudited Condensed Consolidated Balance Sheets - USD ($)
$ in Thousands |
Sep. 30, 2024 |
Dec. 31, 2023 |
| Current assets: |
|
|
| Cash and cash equivalents |
$ 657,067
|
$ 239,566
|
| Restricted cash |
1,470
|
769
|
| Prepaid expenses and other current assets |
59,577
|
34,967
|
| Total current assets |
718,114
|
275,302
|
| Non-current assets: |
|
|
| Property and equipment, net |
44,258
|
34,862
|
| Prepaid expenses and other non-current assets |
193
|
380
|
| Long-term deposits |
1,033
|
983
|
| Operating lease right-of-use assets, net |
60,503
|
60,791
|
| Deferred tax asset |
3,389
|
3,063
|
| Total assets |
827,490
|
375,381
|
| Current liabilities: |
|
|
| Accounts payable |
1,418
|
103
|
| Accrued expenses and other liabilities |
47,488
|
39,581
|
| Operating lease liabilities, current |
3,568
|
5,053
|
| Total current liabilities |
52,474
|
44,737
|
| Non-current liabilities: |
|
|
| Operating lease liabilities, non-current |
48,661
|
47,914
|
| Liabilities related to future royalties and milestones, net |
248,943
|
170,899
|
| Other long-term payables |
447
|
357
|
| Total liabilities |
350,525
|
263,907
|
| Commitments and contingencies |
|
|
| Shareholders’ equity: |
|
|
| Additional paid-in capital |
1,549,351
|
1,018,902
|
| Accumulated other comprehensive loss |
(898)
|
(28,992)
|
| Accumulated deficit |
(1,071,618)
|
(878,562)
|
| Total shareholders’ equity |
476,965
|
111,474
|
| Total liabilities and shareholders’ equity |
827,490
|
375,381
|
| Ordinary shares |
|
|
| Shareholders’ equity: |
|
|
| Share value |
12
|
8
|
| Deferred shares |
|
|
| Shareholders’ equity: |
|
|
| Share value |
0
|
0
|
| Deferred B Shares |
|
|
| Shareholders’ equity: |
|
|
| Share value |
118
|
118
|
| Deferred C Shares |
|
|
| Shareholders’ equity: |
|
|
| Share value |
$ 0
|
$ 0
|
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v3.24.3
Unaudited Condensed Consolidated Balance Sheets (Parentheticals)
|
Sep. 30, 2024
$ / shares
shares
|
Sep. 30, 2024
£ / shares
shares
|
Dec. 31, 2023
$ / shares
shares
|
Dec. 31, 2023
£ / shares
shares
|
| Ordinary shares |
|
|
|
|
| Shareholders’ equity: |
|
|
|
|
| Stock par value (in usd/gbp per share) | $ / shares |
$ 0.000042
|
|
$ 0.000042
|
|
| Shares authorized (in shares) |
490,909,783
|
490,909,783
|
290,909,783
|
290,909,783
|
| Shares issued (in shares) |
266,117,277
|
266,117,277
|
174,101,361
|
174,101,361
|
| Shares outstanding, including RSUs vested but not yet released (in shares) |
266,119,252
|
266,119,252
|
174,158,985
|
174,158,985
|
| Deferred shares |
|
|
|
|
| Shareholders’ equity: |
|
|
|
|
| Stock par value (in usd/gbp per share) | £ / shares |
|
£ 0.00001
|
|
£ 0.00001
|
| Shares authorized (in shares) |
34,425
|
34,425
|
34,425
|
34,425
|
| Shares issued (in shares) |
34,425
|
34,425
|
34,425
|
34,425
|
| Shares outstanding (in shares) |
34,425
|
34,425
|
34,425
|
34,425
|
| Deferred B Shares |
|
|
|
|
| Shareholders’ equity: |
|
|
|
|
| Stock par value (in usd/gbp per share) | £ / shares |
|
£ 0.00099
|
|
£ 0.00099
|
| Shares authorized (in shares) |
88,893,548
|
88,893,548
|
88,893,548
|
88,893,548
|
| Shares issued (in shares) |
88,893,548
|
88,893,548
|
88,893,548
|
88,893,548
|
| Shares outstanding (in shares) |
88,893,548
|
88,893,548
|
88,893,548
|
88,893,548
|
| Deferred C Shares |
|
|
|
|
| Shareholders’ equity: |
|
|
|
|
| Stock par value (in usd/gbp per share) | £ / shares |
|
£ 0.000008
|
|
£ 0.000008
|
| Shares authorized (in shares) |
1
|
1
|
1
|
1
|
| Shares issued (in shares) |
1
|
1
|
1
|
1
|
| Shares outstanding (in shares) |
1
|
1
|
1
|
1
|
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v3.24.3
Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss - USD ($)
$ in Thousands |
3 Months Ended |
9 Months Ended |
Sep. 30, 2024 |
Sep. 30, 2023 |
Sep. 30, 2024 |
Sep. 30, 2023 |
| Operating expenses: |
|
|
|
|
| Research and development |
$ (40,323)
|
$ (32,318)
|
$ (107,606)
|
$ (92,938)
|
| General and administrative |
(27,330)
|
(10,611)
|
(67,410)
|
(31,017)
|
| Loss on disposal of property and equipment |
(223)
|
0
|
(223)
|
(3,791)
|
| Impairment of operating lease right-of-use assets and related property and equipment |
0
|
(382)
|
(414)
|
(382)
|
| Total operating expenses, net |
(67,876)
|
(42,905)
|
(165,562)
|
(126,430)
|
| Other income (expense): |
|
|
|
|
| Other income, net |
54
|
136
|
161
|
109
|
| Foreign exchange losses |
(11,884)
|
(1,733)
|
(12,368)
|
(442)
|
| Interest income |
8,320
|
3,646
|
24,908
|
10,495
|
| Interest expense |
(10,686)
|
(5,014)
|
(40,129)
|
(14,939)
|
| Total other expenses, net |
(14,196)
|
(2,965)
|
(27,428)
|
(4,777)
|
| Net loss before income tax |
(82,072)
|
(45,870)
|
(192,990)
|
(131,207)
|
| Income tax (expense) benefit |
(22)
|
21
|
(66)
|
(5)
|
| Net loss |
(82,094)
|
(45,849)
|
(193,056)
|
(131,212)
|
| Other comprehensive income (loss): |
|
|
|
|
| Foreign currency exchange translation adjustment |
27,010
|
(5,837)
|
28,094
|
5,104
|
| Total comprehensive loss |
$ (55,084)
|
$ (51,686)
|
$ (164,962)
|
$ (126,108)
|
| Basic net loss per ordinary share (in usd per share) |
$ (0.31)
|
$ (0.26)
|
$ (0.77)
|
$ (0.75)
|
| Diluted net loss per ordinary share (in usd per share) |
$ (0.31)
|
$ (0.26)
|
$ (0.77)
|
$ (0.75)
|
| Weighted-average basic ordinary shares (in shares) |
266,084,589
|
173,984,101
|
251,480,521
|
173,890,666
|
| Weighted-average diluted ordinary shares (in shares) |
266,084,589
|
173,984,101
|
251,480,521
|
173,890,666
|
| License revenue |
|
|
|
|
| License revenue |
$ 0
|
$ 406
|
$ 10,091
|
$ 1,698
|
| X |
- DefinitionAmount after tax of increase (decrease) in equity from transactions and other events and circumstances from net income and other comprehensive income, attributable to parent entity. Excludes changes in equity resulting from investments by owners and distributions to owners. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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-Topic 280
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Reference 2: http://www.xbrl.org/2003/role/disclosureRef
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-Subparagraph (a)
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Reference 3: http://www.xbrl.org/2003/role/disclosureRef
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Reference 4: http://www.xbrl.org/2003/role/disclosureRef
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-Subparagraph (a)
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Reference 7: http://www.xbrl.org/2003/role/disclosureRef
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-Section S99
-Paragraph 1
-Subparagraph (SX 210.4-08(g)(1)(ii))
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Reference 8: http://www.xbrl.org/2003/role/disclosureRef
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-Subparagraph (c)
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Reference 9: http://www.xbrl.org/2003/role/disclosureRef
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-Subparagraph (f)
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Reference 10: http://www.xbrl.org/2003/role/disclosureRef
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-Section S99
-Paragraph 1A
-Subparagraph (SX 210.13-01(a)(4)(i))
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Reference 11: http://www.xbrl.org/2009/role/commonPracticeRef
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-Section S99
-Paragraph 1A
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Reference 12: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
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-Section S99
-Paragraph 1A
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Reference 13: http://www.xbrl.org/2003/role/disclosureRef
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-Section S99
-Paragraph 1A
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Reference 14: http://www.xbrl.org/2003/role/disclosureRef
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-Section S99
-Paragraph 1A
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Reference 15: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
-SubTopic 10
-Name Accounting Standards Codification
-Section S99
-Paragraph 1B
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Reference 16: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
-SubTopic 10
-Name Accounting Standards Codification
-Section S99
-Paragraph 1B
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Reference 17: http://www.xbrl.org/2003/role/disclosureRef
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-Section S99
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Reference 18: http://www.xbrl.org/2003/role/disclosureRef
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Reference 19: http://www.xbrl.org/2003/role/disclosureRef
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Reference 20: http://www.xbrl.org/2003/role/disclosureRef
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-Section 50
-Paragraph 30
-Subparagraph (a)
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Reference 21: http://www.xbrl.org/2003/role/disclosureRef
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-Section 50
-Paragraph 42
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Reference 22: http://www.xbrl.org/2003/role/disclosureRef
-Topic 280
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 22
-Subparagraph (b)
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Reference 23: http://www.xbrl.org/2003/role/disclosureRef
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-Section 50
-Paragraph 40
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Reference 24: http://www.xbrl.org/2003/role/disclosureRef
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-Section 50
-Paragraph 22
-Subparagraph (a)
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Reference 25: http://www.xbrl.org/2003/role/disclosureRef
-Topic 942
-SubTopic 235
-Name Accounting Standards Codification
-Section S99
-Paragraph 1
-Subparagraph (SX 210.9-05(b)(2))
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147477314/942-235-S99-1
Reference 26: http://www.xbrl.org/2003/role/disclosureRef
-Topic 220
-SubTopic 10
-Name Accounting Standards Codification
-Section S99
-Paragraph 2
-Subparagraph (SX 210.5-03(1))
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147483621/220-10-S99-2
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v3.24.3
Unaudited Condensed Consolidated Statements of Shareholders’ Equity - USD ($)
$ in Thousands |
Total |
Deferred Shares |
Deferred B Shares |
Deferred C Shares |
Common shares
Ordinary Shares
|
Common shares
Deferred Shares
|
Common shares
Deferred B Shares
|
Common shares
Deferred C Shares
|
Additional Paid in Capital |
Accumulated other comprehensive loss |
Accumulated deficit |
| Beginning balance (in shares) at Dec. 31, 2022 |
|
|
|
|
173,074,510
|
34,425
|
88,893,548
|
1
|
|
|
|
| Beginning balance at Dec. 31, 2022 |
$ 298,674
|
|
|
|
$ 8
|
$ 0
|
$ 118
|
$ 0
|
$ 1,007,625
|
$ (38,898)
|
$ (670,179)
|
| Stockholders' Equity |
|
|
|
|
|
|
|
|
|
|
|
| Share-based compensation expense |
7,948
|
|
|
|
|
|
|
|
7,948
|
|
|
| Vesting of restricted stock unit awards net of shares withheld to cover tax withholding (in shares) |
|
|
|
|
860,213
|
|
|
|
|
|
|
| Vesting of restricted stock unit awards net of shares withheld to cover tax withholding |
0
|
|
|
|
|
|
|
|
|
|
|
| Exercise of share options (in shares) |
|
|
|
|
2,071
|
|
|
|
|
|
|
| Exercise of share options |
4
|
|
|
|
|
|
|
|
4
|
|
|
| Unrealized gain (loss) on foreign currency translation |
5,104
|
|
|
|
|
|
|
|
|
5,104
|
|
| Net loss |
(131,212)
|
|
|
|
|
|
|
|
|
|
(131,212)
|
| Ending balance (in shares) at Sep. 30, 2023 |
|
|
|
|
173,936,794
|
34,425
|
88,893,548
|
1
|
|
|
|
| Ending balance at Sep. 30, 2023 |
180,518
|
|
|
|
$ 8
|
$ 0
|
$ 118
|
$ 0
|
1,015,577
|
(33,794)
|
(801,391)
|
| Beginning balance (in shares) at Jun. 30, 2023 |
|
|
|
|
173,680,872
|
34,425
|
88,893,548
|
1
|
|
|
|
| Beginning balance at Jun. 30, 2023 |
229,336
|
|
|
|
$ 8
|
$ 0
|
$ 118
|
$ 0
|
1,012,709
|
(27,957)
|
(755,542)
|
| Stockholders' Equity |
|
|
|
|
|
|
|
|
|
|
|
| Share-based compensation expense |
2,864
|
|
|
|
|
|
|
|
2,864
|
|
|
| Vesting of restricted stock unit awards net of shares withheld to cover tax withholding (in shares) |
|
|
|
|
253,851
|
|
|
|
|
|
|
| Vesting of restricted stock unit awards net of shares withheld to cover tax withholding |
0
|
|
|
|
|
|
|
|
|
|
|
| Exercise of share options (in shares) |
|
|
|
|
2,071
|
|
|
|
|
|
|
| Exercise of share options |
4
|
|
|
|
|
|
|
|
4
|
|
|
| Unrealized gain (loss) on foreign currency translation |
(5,837)
|
|
|
|
|
|
|
|
|
(5,837)
|
|
| Net loss |
(45,849)
|
|
|
|
|
|
|
|
|
|
(45,849)
|
| Ending balance (in shares) at Sep. 30, 2023 |
|
|
|
|
173,936,794
|
34,425
|
88,893,548
|
1
|
|
|
|
| Ending balance at Sep. 30, 2023 |
180,518
|
|
|
|
$ 8
|
$ 0
|
$ 118
|
$ 0
|
1,015,577
|
(33,794)
|
(801,391)
|
| Beginning balance (in shares) at Dec. 31, 2023 |
|
34,425
|
88,893,548
|
1
|
174,101,361
|
34,425
|
88,893,548
|
1
|
|
|
|
| Beginning balance at Dec. 31, 2023 |
111,474
|
|
|
|
$ 8
|
$ 0
|
$ 118
|
$ 0
|
1,018,902
|
(28,992)
|
(878,562)
|
| Stockholders' Equity |
|
|
|
|
|
|
|
|
|
|
|
| Issuance of ordinary shares, net of issuance costs (in shares) |
|
|
|
|
91,666,669
|
|
|
|
|
|
|
| Issuance of ordinary shares, net of issuance costs |
520,617
|
|
|
|
$ 4
|
|
|
|
520,613
|
|
|
| Share-based compensation expense |
9,241
|
|
|
|
|
|
|
|
9,241
|
|
|
| Vesting of restricted stock unit awards net of shares withheld to cover tax withholding (in shares) |
|
|
|
|
134,849
|
|
|
|
|
|
|
| Vesting of restricted stock unit awards net of shares withheld to cover tax withholding |
$ 0
|
|
|
|
|
|
|
|
|
|
|
| Exercise of share options (in shares) |
214,398
|
|
|
|
214,398
|
|
|
|
|
|
|
| Exercise of share options |
$ 595
|
|
|
|
|
|
|
|
595
|
|
|
| Unrealized gain (loss) on foreign currency translation |
28,094
|
|
|
|
|
|
|
|
|
28,094
|
|
| Net loss |
(193,056)
|
|
|
|
|
|
|
|
|
|
(193,056)
|
| Ending balance (in shares) at Sep. 30, 2024 |
|
34,425
|
88,893,548
|
1
|
266,117,277
|
34,425
|
88,893,548
|
1
|
|
|
|
| Ending balance at Sep. 30, 2024 |
476,965
|
|
|
|
$ 12
|
$ 0
|
$ 118
|
$ 0
|
1,549,351
|
(898)
|
(1,071,618)
|
| Beginning balance (in shares) at Jun. 30, 2024 |
|
|
|
|
266,045,468
|
34,425
|
88,893,548
|
1
|
|
|
|
| Beginning balance at Jun. 30, 2024 |
527,844
|
|
|
|
$ 12
|
$ 0
|
$ 118
|
$ 0
|
1,545,146
|
(27,908)
|
(989,524)
|
| Stockholders' Equity |
|
|
|
|
|
|
|
|
|
|
|
| Share-based compensation expense |
4,020
|
|
|
|
|
|
|
|
4,020
|
|
|
| Vesting of restricted stock unit awards net of shares withheld to cover tax withholding (in shares) |
|
|
|
|
3,721
|
|
|
|
|
|
|
| Vesting of restricted stock unit awards net of shares withheld to cover tax withholding |
0
|
|
|
|
|
|
|
|
|
|
|
| Exercise of share options (in shares) |
|
|
|
|
68,088
|
|
|
|
|
|
|
| Exercise of share options |
185
|
|
|
|
|
|
|
|
185
|
|
|
| Unrealized gain (loss) on foreign currency translation |
27,010
|
|
|
|
|
|
|
|
|
27,010
|
|
| Net loss |
(82,094)
|
|
|
|
|
|
|
|
|
|
(82,094)
|
| Ending balance (in shares) at Sep. 30, 2024 |
|
34,425
|
88,893,548
|
1
|
266,117,277
|
34,425
|
88,893,548
|
1
|
|
|
|
| Ending balance at Sep. 30, 2024 |
$ 476,965
|
|
|
|
$ 12
|
$ 0
|
$ 118
|
$ 0
|
$ 1,549,351
|
$ (898)
|
$ (1,071,618)
|
| X |
- DefinitionStock Vested During Period, Shares, Restricted Stock
| Name: |
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| Namespace Prefix: |
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| Data Type: |
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| Balance Type: |
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| Period Type: |
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|
| X |
- DefinitionStock Vested During Period, Value, Restricted Stock
| Name: |
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| Namespace Prefix: |
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| Data Type: |
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| Balance Type: |
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| Period Type: |
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|
| X |
- DefinitionAmount of increase to additional paid-in capital (APIC) for recognition of cost for award under share-based payment arrangement. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Topic 718
-SubTopic 10
-Name Accounting Standards Codification
-Section 35
-Paragraph 2
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480483/718-10-35-2
Reference 2: http://fasb.org/us-gaap/role/ref/legacyRef
-Name Accounting Standards Codification
-Topic 718
-SubTopic 20
-Section 55
-Paragraph 13
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481089/718-20-55-13
Reference 3: http://fasb.org/us-gaap/role/ref/legacyRef
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-Topic 718
-SubTopic 20
-Section 55
-Paragraph 12
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481089/718-20-55-12
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v3.24.3
Unaudited Condensed Consolidated Statements of Cash Flows - USD ($)
$ in Thousands |
9 Months Ended |
Sep. 30, 2024 |
Sep. 30, 2023 |
| Cash flows from operating activities: |
|
|
| Net loss |
$ (193,056)
|
$ (131,212)
|
| Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
| Depreciation and amortization |
5,639
|
4,790
|
| Share-based compensation net of amounts capitalized |
9,239
|
7,929
|
| Interest expense on liabilities related to future royalties and milestones, net |
39,709
|
14,878
|
| Foreign exchange differences |
(13,166)
|
(366)
|
| Non-cash operating lease expense |
3,480
|
2,963
|
| Loss on termination of operating lease |
176
|
95
|
| Loss on disposal of property and equipment |
223
|
3,812
|
| Impairment of operating lease right-of-use assets and related property and equipment |
414
|
382
|
| Deferred income tax |
(326)
|
(520)
|
| Changes in operating assets and liabilities: |
|
|
| Increase in prepaid expenses and other current assets |
(21,851)
|
(7,655)
|
| Decrease in prepaid expenses and other non-current assets |
288
|
1,932
|
| Decrease in long-term deposits |
0
|
937
|
| Increase in accounts payable |
1,259
|
69
|
| Increase (decrease) in accrued expenses and other liabilities |
3,713
|
(6,823)
|
| Decrease in operating lease liability |
(4,078)
|
(11,965)
|
| Net cash used in operating activities |
(168,337)
|
(120,754)
|
| Cash flows from investing activities: |
|
|
| Purchases of property and equipment |
(10,963)
|
(9,509)
|
| Net cash used in investing activities |
(10,963)
|
(9,509)
|
| Cash flows from financing activities: |
|
|
| Proceeds of issuance of ordinary shares |
549,977
|
0
|
| Payments of equity issuance costs |
(29,360)
|
(910)
|
| Proceeds from the exercise of share options |
595
|
4
|
| Proceeds from liabilities related to future royalties and milestones, net |
40,000
|
0
|
| Payments of issuance costs related to the liabilities related to the sale of future royalties and milestones, net |
(1,665)
|
0
|
| Net cash provided by (used in) financing activities |
559,547
|
(906)
|
| Effect of exchange rate changes on cash, cash equivalents and restricted cash |
37,955
|
5,257
|
| Net increase (decrease) in cash, cash equivalents and restricted cash |
418,202
|
(125,912)
|
| Cash, cash equivalents and restricted cash, beginning of period |
240,335
|
382,761
|
| Cash, cash equivalents and restricted cash, end of period |
658,537
|
256,849
|
| Unaudited supplemental cash flow information |
|
|
| Cash paid for income taxes |
1,263
|
0
|
| Unaudited supplemental non-cash flow information |
|
|
| Property and equipment purchases included in accounts payable or accrued expenses |
2,889
|
1,389
|
| Leased assets terminated and obtained in exchange for operating lease liabilities, net |
(975)
|
(1,110)
|
| Leased assets obtained in exchange for operating lease liabilities |
1,640
|
41,211
|
| Capitalized share-based compensation, net of forfeitures |
2
|
19
|
| Capitalized implementation costs included in accrued expenses |
204
|
74
|
| Reconciliation of cash, cash equivalents and restricted cash reported within the unaudited condensed consolidated balance sheets: |
|
|
| Cash and cash equivalents |
657,067
|
256,415
|
| Restricted cash |
1,470
|
434
|
| Total cash, cash equivalents and restricted cash |
$ 658,537
|
$ 256,849
|
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- DefinitionAmount of increase in right-of-use asset obtained in exchange for operating lease liability. Reference 1: http://www.xbrl.org/2003/role/exampleRef
-Topic 842
-SubTopic 20
-Name Accounting Standards Codification
-Section 55
-Paragraph 53
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147479589/842-20-55-53
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-Topic 842
-SubTopic 20
-Name Accounting Standards Codification
-Section 50
-Paragraph 4
-Subparagraph (g)(2)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147478964/842-20-50-4
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v3.24.3
Nature of the Business
|
9 Months Ended |
Sep. 30, 2024 |
|---|
| Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
| Nature of the Business |
Nature of the Business Autolus Therapeutics plc (with its subsidiaries, collectively, “Autolus” or the “Company”) is an early commercial-stage biopharmaceutical company developing next-generation programmed T cell therapies for the treatment of cancer and autoimmune diseases. Using its broad suite of proprietary and modular T cell programming technologies, the Company is engineering precisely targeted, controlled and highly active T cell therapies that are designed to better recognize target cells, break down their defense mechanisms and attack and kill these cells. The Company believes its programmed T cell therapies have the potential to be best-in-class and to offer patients substantial benefits over the existing standard of care, including the potential for cure in some patients. On November 8, 2024 the Company was notified by the U.S. Food and Drug Administration (“FDA”) that the Company’s biologics license application (“BLA”) was approved, allowing for the marketing of AUCATZYL (obecabtagene autoleucel, also known as obe-cel) in the US for the treatment of adult patients (18 years and older) with r/r B-ALL. Obe-cel is under regulatory review in both the European Union (“EU”) and the United Kingdom (“U.K.”) for the treatment of r/r adult B-ALL, with marketing authorization submissions accepted by the European Medicines Agency (“EMA”) in April 2024, and the UK Medicines and Healthcare products Regulatory Agency (“MHRA”) in August 2024. Autolus Therapeutics plc is registered in England and Wales. Its registered office is The MediaWorks, 191 Wood Lane, London, W12 7FP, United Kingdom. The Company is subject to risks and uncertainties common to companies in the biotechnology industry, including, but not limited to, development by competitors of new technological innovations, dependence on key personnel, protection of proprietary technology, compliance with government regulations and the ability to secure additional capital to fund operations. The Company’s product candidates currently under development will require significant additional research and development efforts, including preclinical and clinical testing and regulatory approval, prior to commercialization. Although AUCATZYL has been granted marketing approval in the US by the FDA, the Company will continue to incur significant additional costs to commercialize it. These efforts will require significant amounts of capital, as well as additional personnel, infrastructure, and compliance capabilities. Even if the Company’s product development efforts for obe-cel and its other product candidates are successful, it is uncertain when, if ever, the Company will realize revenue from its product sales. BioNTech Agreements On February 6, 2024 (the “Execution Date”), the Company concurrently entered into a (i) Securities Purchase Agreement (the “BioNTech Securities Purchase Agreement”), (ii) a Registration Rights Agreement (the “BioNTech Registration Rights Agreement”), (iii) a Letter Agreement (the “BioNTech Letter Agreement”) and (iv) a License and Option Agreement (the “BioNTech License and Option Agreement”), collectively called the “BioNTech Agreements”, with BioNTech. The BioNTech Agreements were entered into and in contemplation of one another and, accordingly, the Company assessed the accounting for these agreements in the aggregate. The following descriptions of the BioNTech Agreements do not purport to be complete and are qualified in their entirety by reference to the full text of such agreements. (i) BioNTech Securities Purchase Agreement Pursuant to the BioNTech Securities Purchase Agreement the Company sold to BioNTech ADSs, each representing one ordinary share with a nominal value of $0.000042 per share, of the Company (the “Ordinary Shares”) in a private placement transaction (the “Private Placement”). On February 13, 2024, the Company completed the Private Placement of 33,333,333 ADSs (the “Initial ADSs”), representing 33,333,333 Ordinary Shares at an offering price of $6.00 per Initial ADS. Aggregate net proceeds to the Company, after underwriting discounts and offering expenses, were $193.8 million. In the event that BioNTech and the Company enter into a Manufacturing and Commercial Services Agreement (as defined below) within 18 months of the initial closing of the Private Placement, BioNTech will purchase additional ADSs (the “Subsequent ADSs” and, together with the Initial ADSs, the “Private Placement ADSs”), not to exceed 15,000,000 ADSs, for an aggregate purchase price of up to $20.0 million. The total number of Subsequent ADSs that may be issued is subject to additional limitations and restrictions. The BioNTech Securities Purchase Agreement contains customary representations, warranties, and covenants of each of the Company and BioNTech. (ii) BioNTech Registration Rights Agreement Pursuant to the BioNTech Registration Rights Agreement the Company agreed to file a registration statement with the SEC to register the resale of the Private Placement ADSs. (iii) BioNTech Letter Agreement The BioNTech Letter Agreement provides BioNTech with certain additional rights and subjects BioNTech’s investment in the Company to certain restrictions. BioNTech received the right to nominate a director to the Company’s board of directors. If BioNTech acquires beneficial ownership of at least 30% of the issued and outstanding Ordinary Shares of the Company (including in the form of ADSs) within five years of the Execution Date, BioNTech will have the right to designate an additional director who shall be independent. BioNTech’s director nomination rights shall automatically terminate upon BioNTech’s ownership of Ordinary Shares dropping below certain specified percentages. Additionally, BioNTech has the right to purchase equity securities sold by the Company in bona fide financing transactions in amounts that are based on BioNTech maintaining specified ownership thresholds following such financing transactions. Subject to specified exceptions, BioNTech may not sell the Private Placement ADSs without the Company’s approval for a period of six months following the applicable closing date for such ADSs. The BioNTech Letter Agreement terminates upon the earlier of (a) the later of (i) February 6, 2027 and (ii) such time as no securities of the Company are held by BioNTech or its affiliates and (b) the consummation of a change of control transaction involving the Company. (iv) BioNTech License and Option Agreement License and Options The Company, through its wholly owned subsidiaries, Autolus Limited and Autolus Holdings (U.K.) Limited, entered into the BioNTech License and Option Agreement with BioNTech pursuant to which the Company granted to BioNTech: •an exclusive, worldwide, sublicensable license (the “Binder License”) to certain binders and to exploit products that express in vivo such binders (collectively, the “Binder Licensed Products”), and •several time-limited options (the “Options”) to acquire additional rights to specified clinical-stage product candidates, binders and technologies of the Company, described in more detail below: ◦an option to obtain exclusive rights to co-fund development costs of the Company’s development-stage programs AUTO1/22 and AUTO6NG (“Product Options”), in return for agreed upon economic terms, including an option exercise fee, milestone payments and a profit-sharing arrangement for each such product candidate, with additional options to co-promote or co-commercialize each such product candidate; ◦an option to obtain an exclusive worldwide license to exploit products that express certain additional binders in vivo or, with respect to certain binders, in an antibody drug conjugate (the “Binder Option”); ◦an option to obtain a co-exclusive worldwide license to exploit products that express in vivo the Company’s modules for activity enhancement, with a non-exclusive right, in certain agreed instances, to exploit products that include Company’s modules for activity enhancement but do not express in vivo such modules (the “Activity Enhancement Option”); and ◦an option to obtain a non-exclusive worldwide license to exploit products that contain the Company’s safety switches (the “Safety Switch Option” and, together with the Binder Option and the Activity Enhancement Option, the “Technology Options”). In consideration for the Binder License and the Technology Options, BioNTech made an initial payment to the Company of $10.0 million. In the event that all Options are fully exercised, the Company would be eligible to receive maximum aggregate payments of up to $582.0 million pursuant to the License Agreement. This maximum amount includes the potential milestone payments for the Binder Licensed Products described below, all option exercise fees and potential milestone payments for licenses to optioned products and technologies, and additional payments that BioNTech may pay to the Company for an increased revenue interest with respect to the Company’s product candidate obe-cel as described below. The option exercise fee for each Technology Option is a low seven-digit amount. Each of the Activity Enhancement Option and the Safety Switch Option must be exercised with respect to a given biological target or combination of targets. There is a cap on the total option exercise fee if multiple options are exercised with respect to a given target. There is also a cap on milestone payments across all agreements entered into as the result of BioNTech exercising one or more of the Technology Options and a cap on the royalty rate payable on any given product for which multiple Options are exercised. Obe-cel Product Revenue Interest BioNTech has also agreed to financially support the expansion of the clinical development program for, and planned commercialization of obe-cel. In exchange for the grant of rights to future revenues from the sales of obe-cel products, BioNTech made an upfront payment to the Company of $40.0 million. The Company will pay BioNTech a low single-digit percentage of annual net sales of obe-cel products, which may be increased up to a mid-single digit percentage in exchange for milestone payments of up to $100.0 million in the aggregate on achievement of certain regulatory events for specific new indications upon BioNTech’s election. Manufacturing and Commercial Services Agreement Under the terms of the BioNTech License and Option Agreement, the Company has agreed to grant BioNTech the option to negotiate a joint manufacturing and commercial services agreement pursuant to which the parties may access and leverage each other’s manufacturing and commercial capabilities, in addition to Autolus’ commercial site network and infrastructure, with respect to certain of each parties’ CAR T products, including BioNTech’s product candidate BNT211 (the “Manufacturing and Commercial Services Agreement” or “MCSA”). The MCSA, if entered into, would also grant BioNTech access to the Company’s commercial site network and infrastructure. The Company concluded there were four freestanding financial instruments arising from the execution of the BioNTech Agreements, comprising: 1.the Initial ADSs representing ordinary shares purchased pursuant to the BioNTech Securities Purchase Agreement; 2.the potential Subsequent ADSs representing ordinary shares that may be purchased pursuant to the BioNTech Securities Purchase Agreement; 3.the BioNTech License and Option Agreement, and 4.the MCSA. The Subsequent ADSs are classified as a forward instrument contingent on the MCSA being executed. As of September 30, 2024, the MCSA had not been entered into. The forward instrument has an inconsequential market value as the exercise price approximates the Company’s stock price on the last trading day prior to the signing date of the MCSA. Consequently, the initial proceeds arising from the purchase of Initial ADSs pursuant to the BioNTech Securities Purchase Agreement will not be separately allocated to this freestanding financial instrument at inception of the BioNTech Agreements. Furthermore, as the MCSA has yet to be entered into no consideration will be allocated to this freestanding financial instrument at inception of the BioNTech Agreements. Within the BioNTech License and Option Agreement, there are a number of embedded features which have each been assessed for freestanding financial instrument accounting in accordance with Accounting Standards Codification (“ASC”) 480 – Distinguishing Liabilities from Equity. Although these embedded features are separately exercisable, they lack legal detachability and, therefore, the BioNTech License and Option Agreement is accounted for as one freestanding financial instrument. However, each embedded feature is assessed for derivative accounting in accordance to ASC 815 – Derivative and Hedging (“ASC 815”). The Company analyzed how it should account for the host contract (i.e., the BioNTech License and Option Agreement) as the Binder License represents an agreement with customer for goods and services and therefore should be accounted for under ASC 606 – Revenue from Contracts with Customers (“ASC 606”). However, as the other embedded features of the BioNTech License and Option Agreement fall under the scope of other topics that specify how to initially measure the contract (i.e., ASC 470 – Debt (“ASC 470”)), the Company determined that the host contract should not be accounted for and initially measured pursuant to ASC 606. Furthermore, the Company determined the host contract (the BioNTech License and Option Agreement) met the scope exception of ASC 815-10-15-59(d) and therefore should not be accounted for as a derivative under ASC 815 but instead be accounted for as a debt financial instrument in accordance with ASC 470. The four units of accounting were recorded at fair value upon initial recognition and will not be subsequently measured at fair value. The Company allocated the total gross proceeds arising from the BioNTech Securities Purchase Agreement (i.e. the Initial ADSs representing ordinary shares), and the BioNTech License and Option Agreement among the four units of accounting on a relative fair value basis at the time of the transaction as follows:
| | | | | | | | | | | | | | | | | | | | | | | | | | | | Units of Accounting | | Gross proceeds (in millions) | | Initial fair value (in millions) | | Allocated consideration based on relative fair value (in millions) | | Net allocated consideration based on relative fair value after transaction costs* (in millions) | Initial ADSs, representing ordinary shares | | $ | 200.0 | | | $ | 200.0 | | | $ | 200.0 | | | $ | 193.8 | | Subsequent ADSs, representing ordinary shares | | $ | — | | | $ | — | | | $ | — | | | $ | — | | BioNTech License and Option Agreement | | $ | 50.0 | | | $ | 50.0 | | | $ | 50.0 | | | $ | 47.9 | | Liabilities related to future royalties and milestones, net (Obe-cel Product Revenue Interest) | | $ | 40.0 | | | $ | 40.0 | | | $ | 40.0 | | | $ | 38.3 | | License Revenue (Binder License) | | $ | 10.0 | | | $ | 10.0 | | | $ | 10.0 | | | $ | 9.6 | | MCSA | | $ | — | | | $ | — | | | $ | — | | | $ | — | | | Total | | $ | 250.0 | | | $ | 250.0 | | | $ | 250.0 | | | $ | 241.7 | | * In addition, the total shared transaction costs of $8.3 million, relating to the BioNTech Agreements have been allocated to the four units of accounting on a relative fair value basis. |
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| X |
- DefinitionThe entire disclosure for the nature of an entity's business, major products or services, principal markets including location, and the relative importance of its operations in each business and the basis for the determination, including but not limited to, assets, revenues, or earnings. For an entity that has not commenced principal operations, disclosures about the risks and uncertainties related to the activities in which the entity is currently engaged and an understanding of what those activities are being directed toward. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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v3.24.3
Summary of Significant Accounting Policies
|
9 Months Ended |
Sep. 30, 2024 |
|---|
| Accounting Policies [Abstract] |
|
| Summary of Significant Accounting Policies |
Summary of Significant Accounting Policies Basis of Presentation The accompanying unaudited condensed consolidated financial statements of the Company have been prepared in accordance with generally accepted accounting principles in the US (“US GAAP”) and are presented in US dollars. All intercompany accounts and transactions between the Company and its subsidiaries have been eliminated upon consolidation. The significant accounting policies used in the preparation of these unaudited condensed consolidated financial statements are consistent with those discussed in Note 2, “Summary of Significant Accounting Policies” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023 as filed with the Securities and Exchange Commission on March 21, 2024 (the “Annual Report”). Certain information and footnote disclosures have been condensed or omitted as permitted under US GAAP. The information included in these unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and the related notes thereto as of and for the year ended December 31, 2023, included in the Annual Report. However, these interim financial statements include all adjustments, consisting only of normal recurring adjustments, which are, in the opinion of management, necessary to fairly state the results of the interim period. The interim results are not necessarily indicative of results to be expected for the full year ending December 31, 2024, any other interim periods, or any future year or period. Going Concern The Company has incurred recurring losses since its inception, including net losses of $82.1 million and $45.8 million for the three months ended September 30, 2024 and 2023, respectively and $193.1 million and $131.2 million for the nine months ended September 30, 2024 and 2023, respectively. The Company had an accumulated deficit of $1,071.6 million and $878.6 million as of September 30, 2024 and December 31, 2023, respectively. The Company expects to continue to generate operating losses in the foreseeable future. The Company’s inability to raise additional capital as and when needed could have a negative impact on its financial condition and ability to pursue its business strategies. There can be no assurances, however, that the current operating plan will be achieved or that additional funding will be available on terms acceptable to the Company, or at all. The Company expects that its cash and cash equivalents at September 30, 2024 of $657.1 million will be sufficient to fund the Company’s operations for at least twelve months from the issuance date of these unaudited condensed consolidated financial statements and accordingly they have been prepared on a going concern basis. As the Company continues to incur losses, the transition to profitability is dependent upon the successful development, approval and commercialization of its product candidates and achieving a level of revenues adequate to support its cost structure. Even if the Company’s planned regulatory submissions for its products are approved, and the Company is successful in its commercialization efforts, additional funding will be needed before the Company is expected to reach cash breakeven. Foreign Currency Translation The reporting currency of the Company is US dollars. The Company has determined that its functional currency of the ultimate parent company, Autolus Therapeutics plc, is British Pound Sterling. The functional currency of each subsidiary’s operations is the applicable local currency. Monetary assets and liabilities denominated in currencies other than the Company’s functional currency are translated into the functional currency at rates of exchange prevailing at the balance sheet dates. Non-monetary assets and liabilities denominated in foreign currencies are translated into the functional currency at the exchange rates prevailing at the date of the transaction. The Company recorded foreign exchange losses of $11.9 million and $1.7 million for the three months ended September 30, 2024 and 2023, respectively, and foreign exchange losses of $12.4 million and $0.4 million for the nine months ended September 30, 2024 and 2023, respectively, which are included in foreign exchange losses in the unaudited condensed Consolidated Statements of Operations and Comprehensive Loss. For financial reporting purposes, the financial statements of the Company have been translated into US dollars. Assets and liabilities have been translated at the exchange rates at the balance sheet dates, while revenue and expenses are translated at the average exchange rates over the reporting period and shareholders’ equity amounts are translated based on historical exchange rates as of the date of each transaction. Translation adjustments are not included in determining net income (loss) but are included in foreign currency translation to other comprehensive loss, a component of shareholders’ equity. Segment Information The Company’s chief operating decision maker (the “CODM”), its Chief Executive Officer, manages the Company’s operations on an integrated basis for the purpose of appropriately allocating resources. When evaluating the Company’s financial performance, the CODM reviews total revenue, total expenses and expenses by function and makes decisions using this information on a global basis. The Company and the CODM view the Company’s operations and manage its business as a single operating segment, which is the business of developing and commercializing CAR T therapies. Use of Estimates The preparation of consolidated financial statements in conformity with US GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of income and expenses during the reporting periods. Significant estimates and assumptions reflected in these consolidated financial statements include, but are not limited to, the accrual for research and development expenses, share-based compensation including assessing the probability of meeting performance conditions, income taxes, initial fair value of warrants, and interest expense on liabilities related to future royalties and milestones, net and related cumulative catch-up adjustment, lease term of the Company’s new manufacturing facility (“The Nucleus”), incremental borrowing rates related to the Company’s leased properties and allocation of transaction price using the relative standalone selling price. Estimates are periodically reviewed in light of changes in circumstances, facts and experience. Actual results could differ from those estimates. Allocation of transaction price using the relative standalone selling price Upfront payments are allocated between performance obligations using the Company’s best estimate of the relative standalone selling price of the performance obligation. The relative standalone selling price is estimated by determining the market values of development and license obligations. As these inputs are not directly observable, the estimate is determined considering all reasonably available information including internal pricing objectives used in negotiating the contract, taking into account the different stage of development of each development program and consideration of adjusted-market data from comparable arrangements. Where performance obligations have been identified relating to material rights, the determination of the relative standalone selling price of these performance obligations also includes an assessment of the likelihood that the options will be exercised and any payments by the customer that are triggered upon exercising the right. This assessment involves significant judgment and could have a significant impact on the amount and timing of revenue recognition. An assessment of the allocation of transaction price using the relative standalone selling price was required for the three and nine months ended September 30, 2024 and 2023 for the BioNTech License and Option Agreement and the Option and License Agreement with Cabaletta Bio Inc. (“Cabaletta”), respectively. See Note 3 for additional information on the allocation of the transaction price for those agreements. Liabilities related to future royalties and milestones, net and cumulative catch-up adjustments The Company accounted for each of the Blackstone Collaboration Agreement (See Note 12) (“Blackstone Collaboration Agreement Liability”) and the BioNTech Obe-cel Product Revenue Interest (“BioNTech Liability”) as liabilities measured at amortized cost based on an effective interest rate determined at the outset of the Blackstone Collaboration Agreement Liability related to future royalties and milestones, net is measured based on the Company’s current estimates of the timing and amount of expected future royalties, milestone payments to be paid and the milestones receivable upon the achievement of certain specified clinical, manufacturing and regulatory milestones (each such payment, a “Blackstone Development Payment” and collectively, the “Blackstone Development Payments”) expected to be received over the estimated term of the agreement. Similarly, the BioNTech Liability related to future royalties is measured based on the Company’s current estimates of the timing and amount of expected future royalty expected to be paid over the estimated term of the agreement. Milestone payments pursuant to the BioNTech License and Option Agreement (“BioNTech Milestone Payments”) are payable upon BioNTech’s election, and therefore have not been included in the determination of the effective interest rate or in the measurement of the liability. The liabilities are amortized using the effective interest rate, resulting in recognition of interest expense over the estimated term of the agreement. Each reporting period the Company assesses the estimated probability, timing and amount of the future expected royalty, milestone payments, the Blackstone Development Payment over the estimated term. If there are changes to the estimates, the Company recognizes the impact to the liability’s amortization schedule and the related interest expense using the cumulative catch-up method. The Company’s estimate of the probability, timing and amount of expected future royalties and milestones to be paid by the Company and the expected Blackstone Development Payment to be paid to the Company, considers significant unobservable inputs. These inputs include regulatory approval, the estimated patient population, estimated selling price, estimated sales, estimated peak sales and sales ramp, timing of the expected launch and its impact on the royalties as well as the overall probability of a success. Additionally, the transaction costs associated with the liability will be amortized to interest expense over the estimated term of the agreements. The carrying amount of the Blackstone Collaboration Agreement Liability and BioNTech Liability is based on the Company’s estimate of the future royalties, milestones to be paid to Blackstone by the Company and the expected Blackstone Development Payment to be received over the life of the arrangement as discounted using the initial effective interest rate. The excess estimated present value of future royalties, milestone payments and the future Blackstone Development Payment received over the carrying amount is recognized as a cumulative catch-up adjustment within interest expense using the effective interest rate. Recent Accounting Pronouncements Not Yet Adopted In November 2023, the Financial Accounting Standards Board, (“FASB”), issued Accounting Standards Update, or (“ASU”), 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures, or (“ASU 2023-07”), which expanded the disclosures for reportable segments made by public entities. These amendments within ASU 2023-07 retained the existing disclosure requirements in ASC 280 - Segment Reporting (“ASC 280”) and expanded upon them to require public entities to disclose significant expenses for reportable segments in both interim and annual reporting periods, as well as items that were previously disclosed only annually on an interim basis, including disclosures related to a reportable segment’s profit or loss and assets. In addition, entities with a single reportable segment must provide all segment disclosures required in ASC 280, including the new disclosures for reportable segments under the amendments in ASU 2023-07. The amendments did not change the existing guidance on how a public entity identified and determined its reportable segments. A public entity should apply the amendments in ASU 2023-07 retrospectively to all prior periods presented in the financial statements. Upon transition, the segment expense categories and amounts disclosed in the prior periods should be based on the significant segment expense categories identified and disclosed in the period of adoption. The amendments in ASU 2023-07 are effective for annual periods for all public entities in fiscal years beginning after December 15, 2023, and in interim periods within fiscal years beginning after December 15, 2024. The Company will comply with any new applicable disclosures in its Annual Report on Form 10-K for the year ending December 31, 2024. The Company does not expect the adoption to have a material effect on its financial statements and related disclosures. In December 2023, the FASB issued ASU 2023-09, Improvements to Income Tax Disclosures. This ASU improves the transparency of income tax disclosure by requiring consistent categories and greater disaggregation of information in the rate reconciliation, and income taxes paid disaggregated by jurisdiction. This guidance is effective for the Company for the year beginning January 1, 2025, with early adoption permitted. The amendments should be applied on a prospective basis, with retrospective application permitted. The Company intends to adopt the guidance in the fiscal year beginning January 1, 2025. The Company does not expect the adoption of ASU 2023-09 to have a material effect on its financial statements and related disclosures in this Quarterly Report on Form 10-Q or in its Annual Report on Form 10-K for the full year ending December 31, 2024. Unless otherwise discussed, the impact of recently issued standards that are not yet effective are not expected to have a material impact on the Company’s consolidated financial statements and disclosures.
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v3.24.3
License Revenue
|
9 Months Ended |
Sep. 30, 2024 |
|---|
| Revenue from Contract with Customer [Abstract] |
|
| License Revenue |
License Revenue License revenue for the three and nine months ended September 30, 2024, and 2023, is presented in the table below by geographical location (in thousands): | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Three Months Ended September 30, | | Nine Months Ended September 30, | | | 2024 | | 2023 | | 2024 | | 2023 | | License revenue | | | | | | | | | | United Kingdom | | $ | — | | | $ | 346 | | | $ | — | | | $ | 346 | | | United States | | — | | | 60 | | | — | | | 1,352 | | Germany | | — | | | — | | | 10,091 | | | — | | | Total license revenue | | $ | — | | | $ | 406 | | | $ | 10,091 | | | $ | 1,698 | |
Major customers During the nine months ended September 30, 2024, 100% of the Company’s license revenues were generated from BioNTech. For the nine months ended September 30, 2023, 80% and 20% of the Company's license revenues were primarily generated from Cabaletta and an investee of Syncona Portfolio Limited, respectively. License and Option Agreement with BioNTech See Note 1 for a description of the BioNTech License and Option Agreement, under which the Company recognized revenue during the nine months ended September 30, 2024. For further details on the terms and accounting treatment considerations for the BioNTech Agreement, refer to following notes to these interim condensed consolidated financial statements: •Note 1, “Nature of the business” •Note 2, “Summary of significant accounting policies” •Note 10, “Shareholders’ equity” •Note 12, “Liabilities related to future royalties and milestones, net” •Note 14, “Commitments and contingencies” As the BioNTech License and Option Agreement has been accounted for as one freestanding financial instrument with various embedded features, including the Binder License and related transfer of know-how, Technology Options, and Product Options, the Company is required to consider if the embedded features are required to be bifurcated from the host contract and therefore accounted for as a separate derivative. The Company concluded the Binder License and related transfer of know-how, Technology Options, and Product Options meet the scope exception set out in ASC 815-10-15-59(d) and therefore not accounted for as derivatives under ASC 815. Binder License The Company applied ASC 606 to account for the Binder License and related know-how as functional intellectual property. The Binder License and related transfer of know-how were not distinct from one another and must be combined as a performance obligation, as BioNTech requires the know-how to derive benefit from the license. Based on these determinations, the Company identified one combined distinct performance obligation at the inception of the BioNTech License and Option Agreement. The Company further determined the consideration received included in the transaction price at contract inception, is to be allocated to the one combined performance obligation. The Company determined that the performance obligation was recognized at a point-in-time, upon the delivery of the transfer of know-how and Binder License to BioNTech. The Company recognized total license revenue of $10.1 million (net of foreign exchange differences), related to the BioNTech License and Option Agreement during the three months ended March 31, 2024. No license revenue was recognized during the three months ended September 30, 2024. The Company is eligible to receive milestone payments of up to $32.0 million in the aggregate upon the achievement of specified clinical development and regulatory milestones for each Binder Licensed Product that achieves such milestones. The Company is also eligible to receive a low single-digit royalty on net sales of Binder Licensed Products, subject to customary reductions, which are subject to specified limits. The royalty will be increased if BioNTech, its affiliates or sublicensees commercialize a Binder Licensed Product in an indication and country in which the Company or its affiliates or licensees also commercializes a product containing the same binders. Under the BioNTech License and Option Agreement, BioNTech is solely responsible for, and has sole decision-making authority with respect to, at its own expense, the exploitation of Binder Licensed Products. Milestone payments and royalty payments are regarded as variable consideration and will be evaluated under the most likely amount method. Milestone payments and royalty payments were not included in the transaction price, as these amounts were fully constrained as of September 30, 2024. Technology Options As the Technology Options are outside the scope of ASC 815, the Company considered other relevant accounting guidance to apply to this component of the BioNTech License and Option Agreement. The Company therefore applied ASC 606, considering particularly the accounting guidance related to any options granted to customers to purchase additional goods or services at a future date as this could provide a material right to the customer. A material right is a promise embedded in a current contract that should be accounted for as a separate performance obligation. The Company determined the Technology Options were not offered at a significant and incremental discount. Accordingly, the Technology Options granted to BioNTech do not represent a material right and, therefore, were not a performance obligation at the outset of the arrangement. The Technology Option exercise fee equates to the standalone selling price of the technologies underlying each option and consequently, the transaction price of $10.0 million was not allocated to the Technology Options’ performance obligation. No Technology Options were exercised during the three and nine months ended September 30, 2024. Product Options As the Product Options are precluded from being accounted for under ASC 815 due to the scope exception, management considered the terms of the Product Options and concluded that they should be accounted for as a gain contingency under the scope of ASC 450 - Contingencies (“ASC 450”). The Product Options, unlike the Technology Options, are 1) still subject to negotiation as to the specific activities to be performed by each party, which will be determined and agreed before the Product Options can be exercised, and 2) have not been exercised upon signature of the BioNTech License and Option Agreement. As a result, Product Options are not accounted for under to ASC 606, and no recognition is required under ASC 450, until the Product Options are exercised. No Product Options were exercised during the three and nine months ended September 30, 2024. Option and License Agreement with Cabaletta On January 9, 2023, the Company entered into an Option and License Agreement (the “Cabaletta Agreement”) with Cabaletta, pursuant to which the Company granted to Cabaletta a non-exclusive license to research, develop, manufacture, have manufactured, use, and commercialize products incorporating the Company’s safety switch technology (the “RQR8 technology”). Upon the execution of the Cabaletta Agreement, the Company made available the RQR8 licensed know-how to Cabaletta for a non-refundable license fee of $1.2 million. The Company has no further material performance obligations related to the Cabaletta Agreement. The Company further granted to Cabaletta the option to expand the rights and licenses granted under the Cabaletta Agreement to include the research, development, manufacture, use, or commercialization of licensed products up to a predetermined number of target options upon payment of an option exercise fee. The Company identified the following material promises relating to the granting of a non-exclusive license for research, development, manufacturing and commercialization activities as well as the initial transfer of know-how and information to Cabaletta. The Company determined the option exercise fee is not offered at a significant and incremental discount. Accordingly, the option granted to Cabaletta does not represent a material right and, therefore, is not a performance obligation at the outset of the arrangement. The Company determined that the granting of the research license and the initial transfer of know-how were not distinct from one another and must be combined as a performance obligation, as Cabaletta requires the know-how to derive benefit from the license. Based on these determinations, the Company identified one distinct performance obligation at the inception of the contract. The Company further determined that the license fee payable constituted the entirety of the consideration included in the transaction price at contract inception, which was allocated to the one performance obligation. The amount of the transaction price allocated to the performance obligation is recognized as or when the Company satisfies the performance obligation. The Company determined that the performance obligation was recognized at a point-in-time, upon the delivery of the transfer of know-how and research license to Cabaletta. The Company recognized total license revenue of $1.2 million related to the Cabaletta Agreement for the nine months ended September 30, 2023. No license revenue was recognized related to the Cabaletta Agreement for the three and nine months ended September 30, 2024. Upon execution of the Cabaletta Agreement, the transaction price included only the $1.2 million non-refundable license fee payable to the Company. The Company may receive further payments upon the exercise of the options for licensed targets, the achievement of certain development and sales milestones, as well as royalty payments based on net sales of each product covered by the licensed intellectual property. Research, Option and License Agreement with an Investee of Syncona Portfolio Limited The Company entered into a license agreement with an investee of Syncona Portfolio Limited on September 2, 2020. The terms of the agreement include a non-refundable license fee, payments based upon achievement of clinical development and regulatory objectives, and royalties on product sales. During the three and nine months ended September 30, 2023, Company received variable consideration arising from the achievement of a development milestone amounting to $0.4 million. Consequently, the Company recognized license revenue of $0.4 million (net of foreign exchange differences) for the three and nine months ended September 30, 2023. The future milestones, which represent variable consideration, will be evaluated under the most likely amount method, and were not included in the transaction price, as these amounts were fully constrained as of September 30, 2024. For the three and nine months ended September 30, 2024 and 2023, the Company has not recognized any variable consideration with regards to the development milestones and sales-based milestones with its customers as they are deemed not probable.
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v3.24.3
Interest expense
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9 Months Ended |
Sep. 30, 2024 |
|---|
| Banking and Thrift, Interest [Abstract] |
|
| Interest expense |
Interest expense Interest expense consisted of the following (in thousands): | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Three Months Ended September 30, | | Nine Months Ended September 30, | | | 2024 | | 2023 | | 2024 | | 2023 | Interest expense on liabilities related to future royalties and milestones, net (refer to Note 12) | | $ | 10,280 | | | $ | 5,014 | | | $ | 28,839 | | | $ | 14,878 | | Cumulative catch-up adjustment arising from the liabilities related to future royalties and milestones, net (refer to Note 12) | | — | | | — | | | 10,870 | | | — | | Other interest expense | | 406 | | | — | | | 420 | | | 61 | | Total interest expense | | $ | 10,686 | | | $ | 5,014 | | | $ | 40,129 | | | $ | 14,939 | |
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v3.24.3
Net loss per ordinary share
|
9 Months Ended |
Sep. 30, 2024 |
|---|
| Earnings Per Share [Abstract] |
|
| Net loss per ordinary share |
Net loss per ordinary share Basic and diluted net loss per ordinary share was calculated as follows (in thousands, except share and per share amounts): | | | | | | | | | | | | | | | | | | | | | | | | | Three Months Ended September 30, | | Nine Months Ended September 30, | | 2024 | | 2023 | | 2024 | | 2023 | | Numerator | | | | | | | | | Net loss | $ | (82,094) | | | $ | (45,849) | | | $ | (193,056) | | | $ | (131,212) | | | Net loss - basic and diluted | $ | (82,094) | | | $ | (45,849) | | | $ | (193,056) | | | $ | (131,212) | | | | | | | | | | | Denominator | | | | | | | | | Weighted-average number of ordinary shares used in net loss per share - basic and diluted | 266,084,589 | | | 173,984,101 | | | 251,480,521 | | | 173,890,666 | | | Basic and diluted net loss per ordinary share | $ | (0.31) | | | $ | (0.26) | | | $ | (0.77) | | | $ | (0.75) | |
For all periods presented, outstanding but unvested restricted stock units, share options and warrants have been excluded from the calculation, because their effects would be anti-dilutive. Therefore, the weighted average number of ordinary shares used to calculate both basic and diluted loss per share is the same for all periods presented. The following potentially dilutive securities have been excluded from the calculation of diluted net loss per share due to their anti-dilutive effect: | | | | | | | | | | | | | Three and Nine Months Ended September 30, | | 2024 | | 2023 | Unvested restricted stock units | 36,186 | | | 264,326 | | Share options | 20,382,429 | | | 14,074,842 | | | Warrants | 3,265,306 | | | 3,265,306 | | Total potentially dilutive securities | 23,683,921 | | | 17,604,474 | |
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v3.24.3
Fair value measurements
|
9 Months Ended |
Sep. 30, 2024 |
|---|
| Fair Value Disclosures [Abstract] |
|
| Fair value measurements |
Fair value measurements The Company uses valuation approaches that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible. The Company determines the fair value based on assumptions that market participants would use in pricing an asset or liability in the principal or most advantageous market. When considering market participant assumptions in fair value measurements, the following fair value hierarchy distinguishes between observable and unobservable inputs, which are categorized in of the following levels: • Level 1 — Quoted prices in active markets for identical assets or liabilities. • Level 2 — Inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly. • Level 3 — Unobservable inputs that reflect the Company’s own assumptions about the assumptions market participants would use in pricing the asset or liability. The carrying amounts reported in the balance sheet for cash and cash equivalents, restricted cash, prepaid expenses and other assets, accounts payable and accrued expenses and other liabilities approximate their fair value because of the short-term nature of these instruments. The following tables present information about the Company’s financial assets measured at fair value on a recurring basis and indicate the level of the fair value hierarchy utilized to determine such fair values (in thousands): | | | | | | | | | | | | | | | | | | | | | | | | | | | | | September 30, 2024 | | | | Total | | Quoted Prices in Active Markets for Identical Assets (Level 1) | | Significant Other Observable Inputs (Level 2) | | Significant Unobservable Inputs (Level 3) | | | | | | Financial assets | | | | | | | | | | | | Cash and cash equivalents: | | | | | | | | | | | | Money market funds | $ | 596,387 | | | $ | 596,387 | | | $ | — | | | $ | — | | | | | | | Total | $ | 596,387 | | | $ | 596,387 | | | $ | — | | | $ | — | | | | | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | December 31, 2023 | | | | Total | | Quoted Prices in Active Markets for Identical Assets (Level 1) | | Significant Other Observable Inputs (Level 2) | | Significant Unobservable Inputs (Level 3) | | | | | | Financial assets | | | | | | | | | | | | Cash and cash equivalents: | | | | | | | | | | | | Money market funds | $ | 184,635 | | | $ | 184,635 | | | $ | — | | | $ | — | | | | | | Total | $ | 184,635 | | | $ | 184,635 | | | $ | — | | | $ | — | | | | | |
During the three and nine months ended September 30, 2024 and the year ended December 31, 2023, there were no transfers between fair value levels.
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v3.24.3
Prepaid Expenses and Other Current Assets
|
9 Months Ended |
Sep. 30, 2024 |
|---|
| Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] |
|
| Prepaid Expenses and Other Current Assets |
Prepaid Expenses and Other Current Assets Prepaid expenses and other current assets consisted of the following (in thousands): | | | | | | | | | | | | | September 30, | | December 31, | | 2024 | | 2023 | | Research and development claims receivable | $ | 34,766 | | | $ | 19,209 | | Prepayments | 14,057 | | | 8,638 | | | VAT receivable | 3,140 | | | 2,771 | | | Deferred cost | 2,237 | | | 1,787 | | Other taxes receivable | 1,678 | | | — | | Accrued interest income | 1,409 | | | 999 | | Lease deposit receivable | 993 | | | 938 | | Corporate tax receivable | 699 | | | — | | Other receivables | 598 | | | 516 | | | Accounts receivable | — | | | 109 | | | Total prepaid expenses and other current assets | $ | 59,577 | | | $ | 34,967 | |
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v3.24.3
Property and Equipment, Net
|
9 Months Ended |
Sep. 30, 2024 |
|---|
| Property, Plant and Equipment [Abstract] |
|
| Property and Equipment, Net |
Property and Equipment, Net Property and equipment, net consisted of the following (in thousands): | | | | | | | | | | | | | September 30, | | December 31, | | 2024 | | 2023 | Lab equipment | $ | 42,857 | | | $ | 32,232 | | Office equipment | 5,571 | | | 3,777 | | Furniture and fixtures | 2,519 | | | 2,360 | | Leasehold improvements | 15,055 | | | 12,728 | | Assets under construction | 13,513 | | | 12,539 | | Less: accumulated depreciation | (35,257) | | | (28,774) | | Total property and equipment, net | $ | 44,258 | | | $ | 34,862 | |
Depreciation expense for the three months ended September 30, 2024 and 2023 was $1.9 million and $1.4 million, respectively, and for the nine months ended September 30, 2024 and 2023 was $5.6 million and $4.8 million, respectively.
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v3.24.3
Accrued Expenses and Other Liabilities
|
9 Months Ended |
Sep. 30, 2024 |
|---|
| Payables and Accruals [Abstract] |
|
| Accrued Expenses and Other Liabilities |
Accrued Expenses and Other Liabilities Accrued expenses and other liabilities consisted of the following (in thousands): | | | | | | | | | | | | | September 30, | | December 31, | | 2024 | | 2023 | Research and development costs | $ | 20,093 | | | $ | 19,825 | | Compensation and benefits | 15,444 | | | 14,757 | | Professional fees | 7,584 | | | 4,466 | | VAT accrual | 3,964 | | | — | | | | | | Other accrued liabilities | 403 | | | 533 | | Total accrued expenses and other liabilities | $ | 47,488 | | | $ | 39,581 | |
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v3.24.3
Shareholders’ Equity
|
9 Months Ended |
Sep. 30, 2024 |
|---|
| Equity [Abstract] |
|
| Shareholders’ Equity |
Shareholders’ Equity Ordinary Shares Each holder of ordinary shares is entitled to one vote per ordinary share and to receive dividends when and if such dividends are recommended by the Company’s board of directors and declared by the shareholders. As of September 30, 2024, the Company has not declared any dividends. Restricted Stock Units At September 30, 2024, restricted stock unit awards for 1,975 ordinary shares had vested but the underlying shares had not been issued. However, these vested restricted stock unit awards have been included in the calculation of the Company’s outstanding shares at September 30, 2024 as they are considered issuable for little or no cash consideration. Subsequent to September 30, 2024, all of the underlying ordinary shares were issued. February 2024 Underwritten Offering On February 12, 2024, the Company completed an underwritten offering of 58,333,336 ADSs representing 58,333,336 ordinary shares at an offering price of $6.00 per ADS. Aggregate net proceeds to the Company, after underwriting discounts and offering expenses, were $326.8 million. BioNTech Securities Purchase Agreement Concurrently with the execution of the BioNTech License and Option Agreement (see Note 1 and Note 3), the Company and BioNTech entered into the BioNTech Securities Purchase Agreement pursuant to which the Company sold ADSs, each representing one ordinary share, to BioNTech in a Private Placement transaction. On February 13, 2024, the Company completed the Private Placement of 33,333,333 ADSs representing 33,333,333 ordinary shares at an offering price of $6.00 per ADS. Aggregate net proceeds to the Company, after underwriting discounts and offering expenses, were $193.8 million. In the event that BioNTech and the Company enter into the MCSA within 18 months of the initial closing of the Private Placement, BioNTech will purchase up to 15,000,000 ADSs for an aggregate purchase price of up to $20.0 million, subject to additional limitations and restrictions.
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-Subparagraph (b)
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v3.24.3
Share-based Compensation
|
9 Months Ended |
Sep. 30, 2024 |
|---|
| Share-Based Payment Arrangement [Abstract] |
|
| Share-based Compensation |
Share-based Compensation The following table summarizes the total share-based compensation expense included in the unaudited condensed consolidated statements of operations and comprehensive loss (in thousands): | | | | | | | | | | | | | | | | | | | | | | | | | Three Months Ended September 30, | | Nine Months Ended September 30, | | 2024 | | 2023 | | 2024 | | 2023 | | Research and development | $ | 1,218 | | | $ | 1,525 | | | $ | 2,716 | | | $ | 4,982 | | | General and administrative | 2,802 | | | 1,335 | | | 6,525 | | | 2,947 | | | Capitalized | — | | | 4 | | | (2) | | | 19 | | Total share-based compensation expense | $ | 4,020 | | | $ | 2,864 | | | $ | 9,239 | | | $ | 7,948 | |
Share Options The table below summarizes Company’s share option activity during the nine months ended September 30, 2024: | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Number of
Options | | Weighted-
Average
Exercise
Price per share | | Weighted-
Average
Remaining
Contractual
Term
(Years) | | Aggregate Intrinsic Value (1) (in thousands) | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Outstanding as of December 31, 2023 | | 17,956,385 | | | $ | 5.64 | | | 8.35 | | $ | 48,968 | | | Granted | | 3,797,650 | | | 4.19 | | | | | 268 | | | Exercised | | (214,398) | | | 2.77 | | | | | 480 | | | Forfeited | | (902,906) | | | 3.30 | | | | | 857 | | | Expired | | (254,302) | | | 9.41 | | | | | 5 | | | Outstanding as of September 30, 2024 | | 20,382,429 | | | $ | 5.45 | | | 7.98 | | $ | 13,411 | | | Exercisable as of September 30, 2024 | | 8,879,183 | | | $ | 8.13 | | | 6.88 | | $ | 4,561 | | | Vested and expected to vest as of September 30, 2024 | | 20,382,429 | | | $ | 5.45 | | | 7.98 | | $ | 13,411 | | | | | | | | | | | (1) Aggregate intrinsic value is calculated as the difference between the exercise price of the underlying options and the fair value of ordinary shares for those options in the money as of September 30, 2024 |
During the nine months ended September 30, 2024, the Company modified the exercise period of 571,352 share options resulting in the recognition of incremental share-based compensation expense of $0.4 million. The total intrinsic value of options exercised was $0.5 million for the nine months ended September 30, 2024. The weighted average grant-date fair value of share options granted was $3.02 per share option for the nine months ended September 30, 2024. As of September 30, 2024, the total unrecognized compensation expense related to unvested share options without performance conditions was $13.5 million, which the Company expects to recognize over a weighted average vesting period of 3.04 years. As of September 30, 2024, the total unrecognized share-based compensation expense related to unvested share options with performance conditions was $2.9 million, which the Company expects to recognize when the performance condition becomes probable. Restricted Stock Units The table below summarizes Company’s restricted stock unit (“RSU”) awards activity during the nine months ended September 30, 2024: | | | | | | | | | | | | | | | | | Number of
restricted
units | | Weighted average
grant date
fair value | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Unvested and outstanding at December 31, 2023 | | 116,436 | | | $ | 3.43 | | | | | | | | Vested | | (79,200) | | | 2.94 | | | Forfeited | | (1,050) | | | 6.20 | | Unvested and outstanding at September 30, 2024 | | 36,186 | | | $ | 4.43 | |
As of September 30, 2024, there was less than $0.1 million of unrecognized share-based compensation expense related to unvested RSUs without performance conditions, which is expected to be recognized over a weighted average period of 1.44 years.
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v3.24.3
Liabilities related to future royalties and milestones, net
|
9 Months Ended |
Sep. 30, 2024 |
|---|
| Investments, Debt and Equity Securities [Abstract] |
|
| Liabilities related to future royalties and milestones, net |
Liabilities related to future royalties and milestones, net | | | | | | | | | | | | | | | Amount in thousands | Balance at 1 January, 2023 | | | $ | 125,900 | | Interest expense on liability related to future royalties and milestones, net | | 4,905 | | Balance at March 31, 2023 | | | $ | 130,805 | | Interest expense on liability related to future royalties and milestones, net | | 4,959 | | Balance at June 30, 2023 | | | $ | 135,764 | | Interest expense on liability related to future royalties and milestones, net | | 5,014 | | Balance at September 30, 2023 | | | $ | 140,778 | | Interest expense on liability related to future royalties and milestones, net | | 5,014 | | Cumulative catch-up adjustment | | 25,107 | | Balance at December 31, 2023 | | | $ | 170,899 | | | Initial recognition of BioNTech liability | | 38,335 | | Interest expense on liability related to future royalties and milestones, net | | 8,390 | | Cumulative catch-up adjustment | | 10,870 | | Balance at March 31, 2024 | | | $ | 228,494 | | Interest expense on liability related to future royalties and milestones, net | | 10,169 | | Balance at June 30, 2024 | | | $ | 238,663 | | Interest expense on liability related to future royalties and milestones, net | | 10,280 | | | | | Balance at September 30, 2024 | | | $ | 248,943 | |
During the three months ended September 30, 2024 and 2023, interest expense on liabilities related to future royalties and milestones, net amounted to $10.3 million and $5.0 million, respectively. During the nine months ended September 30, 2024 and 2023, interest expense on liabilities related to future royalties and milestones, net amounted to $28.8 million and $14.9 million, respectively. During the three months ended September 30, 2024 and 2023 and nine months ended September 30, 2023, there was no cumulative catch-up adjustment (included in interest expense). During the nine months ended September 30, 2024, the cumulative catch-up adjustment amounted to $10.9 million. Blackstone Collaboration Agreement On November 6, 2021, the Company concurrently entered into the following agreements with BXLS V - Autobahn L.P, (“Blackstone”): (i) Strategic Collaboration Agreement (the “Blackstone Collaboration Agreement”), (ii) Securities Purchase Agreement (the “Blackstone Securities Purchase Agreement”), (iii) Warrant Agreement (the “Blackstone Warrant”) and (iv) a Registration Rights Agreement (the “Blackstone Registration Rights Agreement”). The Blackstone Collaboration Agreement, the Blackstone Securities Purchase Agreement, the Blackstone Warrant and the Blackstone Registration Rights Agreement are collectively referred to as the “Blackstone Agreements”. The Blackstone Agreements were entered into and in contemplation of one another and, accordingly, the Company assessed the accounting for the Blackstone Agreements in the aggregate. For further details on the terms and accounting treatment considerations for these contracts, please refer to following notes to the Company’s consolidated financial statements contained in the Company’s Annual Report: •Note 2, “Summary of significant accounting policies” •Note 11, “Liability related to future royalties and milestones, net” •Note 12, “Warrants” •Note 13, “Shareholders’ equity” In November 2021, the upfront payment of $50.0 million was paid by Blackstone upon execution of the Blackstone Collaboration Agreement. In December 2022, two Blackstone Development Payments were paid by Blackstone of $35.0 million each as a result of (i) the joint steering committee’s review of the Company’s interim analysis of pivotal FELIX Phase 2 clinical trial of obe-cel in r/r B-ALL and (ii) achievement of a pre-agreed manufacturing milestone as a result of completion of planned activities demonstrating the performance and qualification of the Company’s obe-cel’s manufacturing process. On November 8, 2024, the Company was notified by the FDA that the Company has been granted marketing approval for AUCATZYL for the treatment of adult patients (18 years and older) with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (r/r B-ALL). The remaining $30.0 million of Blackstone Development Payments are now payable to the Company as a result of such approval. BioNTech Agreements On February 6, 2024, the Company concurrently entered into the BioNTech Agreements. For further details on the terms and accounting treatment considerations for these contracts, refer to following notes to these interim condensed consolidated financial statements: •Note 1, “Nature of the business” •Note 2, “Summary of significant accounting policies” •Note 3, “License Revenue” •Note 10, “Shareholders’ equity” •Note 14, “Commitment and contingencies” Obe-cel Product Revenue Interest Under the BioNTech License and Option Agreement, BioNTech has agreed to financially support the expansion of the clinical development program for, and planned commercialization of obe-cel. In exchange for the grant of rights to future revenues from the sales of obe-cel products, BioNTech made an upfront payment to the Company of $40.0 million. The Company will pay BioNTech a low single-digit percentage of annual net sales of obe-cel products, which may be increased up to a mid-single digit percentage in exchange for milestone payments of up to $100.0 million in the aggregate on achievement of certain regulatory events for specific new indications upon BioNTech's election. As the BioNTech License and Option Agreement has been accounted for as one freestanding financial instrument with various embedded features, (e.g. the Obe-cel Product Revenue Interest, milestone payments and royalties), the Company is required to consider if these embedded features are required to bifurcated from the host contract and therefore accounted for as a separate derivative. The Company determined the host contract to be debt-like and therefore the embedded features were analyzed pursuant to a debt host contract. The Company concluded the BioNTech License and Option Agreement (the host contract) should not be accounted as a derivative in accordance with ASC 815-10-15-59(d) but rather as a debt instrument under ASC 470. The Company has accounted for the Obe-cel Product Revenue Interest as a liability primarily due to the Company’s significant continuing involvement in generating the royalty stream. The Company initially recognized the BioNTech Liability at $38.3 million being the face value less debt issuance costs. Once the Company commences commercial sales of AUCATZYL that generate royalties, the Company will recognize the portion of royalties paid to BioNTech as a decrease to the liability with a corresponding reduction in cash. The carrying amount of the BioNTech Liability is based on the Company’s estimate of the future royalties to be paid to BioNTech to be received over the life of the arrangement as discounted using an effective interest rate. The excess or deficit of estimated present value of future royalties over the initial carrying amount, is recognized using the cumulative catch-up method within interest expense using the initial effective interest rate. The imputed rate of interest on the unamortized portion of the BioNTech Liability was approximately 28.70% as of February 6, 2024, the execution date of the BioNTech Agreements and September 30, 2024. On a quarterly basis, the Company assesses the amount and timing of expected royalty using a combination of internal projections and forecasts from external sources. To the extent the present value of such payments is greater or less than its initial estimates or the timing of such payments is materially different than its original estimates, the Company will adjust the amortization of the BioNTech Liability using the cumulative catch-up method.
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v3.24.3
Leases
|
9 Months Ended |
Sep. 30, 2024 |
|---|
| Leases [Abstract] |
|
| Leases |
Leases Operating leases - Lessee The Company leases certain office space, laboratory space, and equipment. At the inception of an arrangement, the Company determines whether the arrangement is or contains a lease based on the unique facts and circumstances present. Since September 2017, the Company has had an arrangement with Cell Therapy Catapult Limited to lease manufacturing suites at the Cell and Gene Therapy Catapult manufacturing center in Stevenage, United Kingdom. In August 2024, one of the leased manufacturing suites ended and the Company exited the suite. In September 2024, the Company extended the lease term from August 2024 to March 2025 for the remaining manufacturing suite. On September 19, 2023, the Company entered into a 20-year lease agreement with the landlord of The Nucleus. The Company made fit-out costs in other areas of the building which may be required to be removed at the end of the lease term. On September 10, 2024, the Company completed a variation of the lease for the manufacturing facility, related to additional works at the site. The landlord will provide funding for certain specified improvements to the facility (the “Works”), which the Company commits to undertake on a mutually agreed schedule. Funding received for the Works done are deemed lease incentives in accordance to ASC 842. Once the Works are complete, the rental payments under the lease will be increased according to a specified formula for the remainder of the lease term. The deed of variation does not affect the lease term, which continues to run for 20 years from September 19, 2023. The Company’s costs as a lessee for the three and nine months ended September 30, 2024 and 2023 were as follows (in thousands): | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Three Months Ended September 30, | | Nine Months Ended September 30, | | | 2024 | | 2023 | | 2024 | | 2023 | | Operating lease costs | | $ | 2,155 | | | $ | 2,061 | | | $ | 6,340 | | | $ | 5,235 | | | Variable costs | | 157 | | | 573 | | | 1,186 | | | 657 | | | Short term lease costs | | 72 | | | 227 | | | 276 | | | 451 | | | Total lease costs | | $ | 2,384 | | | $ | 2,861 | | | $ | 7,802 | | | $ | 6,343 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Supplemental cash flow information for the nine months ended September 30, 2024 and 2023 were as follows (in thousands): | | | | | | | | | | | | | | | | | | | | | | | | | Nine Months Ended September 30, | | Other information | | | | 2024 | | 2023 | | Cash paid for amounts included in the measurement of lease liabilities: | | | | | Operating cash outflows from operating leases | | $ | 7,067 | | $ | 7,817 | | | | | |
The weighted average remaining lease term and weighted average discount rate of operating leases at September 30, 2024 and 2023 were as follows: | | | | | | | | | | | | | | | | | | | | | | | | | Nine Months Ended September 30, | | | | | 2024 | | 2023 | | | | | | | | | | | | | | | | | | | | | | | Weighted-average remaining lease term - operating leases | | 15.6 years | | 15.9 years | | Weighted-average discount rate - operating leases | | 8.14 | % | | 7.44 | % |
The maturities of operating lease liabilities as of September 30, 2024 were as follows (in thousands): | | | | | | | | | | | | | | | Remainder of 2024(1) | | | | $ | (1,941) | | 2025(1) | | | | (2,952) | | 2026(1) | | | | 8,514 | | 2027 | | | | 8,912 | | | 2028 | | | | 8,156 | | | Thereafter | | | | 88,819 | | | Total lease payments | | | | 109,508 | | | Less: imputed interest | | | | (57,279) | | | Present value of lease liabilities | | | | $ | 52,229 | | (1) Includes lease incentives from the Nucleus lease variation amounting to $4.5 million, $11.3 million and $0.9 million, for the year ended December 31, 2024, 2025 and 2026, respectively. |
Operating leases - Lessor (sublease agreements) The Company subleases two manufacturing spaces in Enfield, U.K. to third parties. The annual lease payments to be received for each of the subleased units are £97,000 and £109,000, over lease terms from October 2021 to February 2029 and October 2021 to October 2026, respectively. The following table shows the sublease rental income for the three and nine months ended September 30, 2024 and 2023 (in thousands): | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Three Months Ended September 30, | | Nine Months Ended September 30, | | Sublease rental income | | 2024 | | 2023 | | 2024 | | 2023 | Sublease rental income (included in other income (expense), net) | | $ | 63 | | | $ | 61 | | | $ | 186 | | | $ | 181 | | | Total sublease rental income | | $ | 63 | | | $ | 61 | | | $ | 186 | | | $ | 181 | |
Future fixed receipts for non-cancellable operating subleases in effect as of September 30, 2024 are receivable as follows (in thousands): | | | | | | | | | Remainder of 2024 | | $ | 69 | 2025 | | $ | 276 | 2026 | | $ | 215 | 2027 | | $ | 130 | | 2028 | | $ | 112 | | | | | Total lease payments receivable | | $ | 802 |
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v3.24.3
Commitments and Contingencies
|
9 Months Ended |
Sep. 30, 2024 |
|---|
| Commitments and Contingencies Disclosure [Abstract] |
|
| Commitments and Contingencies |
Commitments and Contingencies License Agreements The Company has entered into an exclusive license agreement, as amended (the “UCLB License Agreement”), with UCL Business Ltd (“UCLB”). In connection with the UCLB License Agreement, the Company is required to make annual license payments and may be required to make payments to UCLB upon the achievement of specified milestones, including upon regulatory approval for obe-cel. During the three and nine months ended September 30, 2024, less than $0.1 million was paid or payable to UCLB by the Company, relating to the income allocable to the value of the sublicensed intellectual property rights. The BLA approval for AUCATZYL in the fourth quarter of 2024, resulted in the Company now being obligated to make a £10.0 million ($13.4 million translated at the balance sheet date spot rate) regulatory milestone payment in accordance with the UCLB license agreement, which the Company expects to pay in the first quarter of 2025. In September 2023, the Company entered into a non-exclusive sublicense agreement with Miltenyi Biotech B.V. & Co. KG (“Miltenyi”) under which the Company received a sublicense related to the use of certain Miltenyi products in the Company’s development, manufacture and sale of its products. Under the agreement, the Company is obligated to make specified payments to Miltenyi upon the achievement of certain regulatory and clinical milestones. The Company recognized $0.4 million of expense in aggregate relating to an upfront license payment and milestone payments that were deemed probable during the year ended December 31, 2023. The Company recognized milestone payments of less than $0.1 million during the three and nine months ended September 30, 2024. Contractual obligations In July 2022, the Company renegotiated a master services agreement (the “Adaptive Master Services Agreement”) with Adaptive Biotechnologies Corporation (“Adaptive”), under which Adaptive's assay is used to analyze patient samples from r/r B-ALL patients. Under the agreement, the Company is obligated to make specified payments to Adaptive upon the achievement and receipt of certain regulatory approvals and achievement of commercial milestones in connection with the Company’s use of the Adaptive assay. During the year ended December 31, 2023, the Company recognized all contractual milestones relating to this contract, and as a result no contractual milestones were recognized during the three and nine months ended September 30, 2024. In previous periods, the Company has entered into agreements with certain advisory firms. The Company is obligated to make specified payments upon the achievement of certain strategic transactions involving the Company. During the three and nine months ended September 30, 2024, the Company paid a fee under these agreements. The Company has estimated the probability of the Company achieving each potential milestone in relation to the agreements with UCLB, Miltenyi and its agreements with certain advisory firms in accordance with ASC 450. The Company considers the regulatory approval, commercial milestones and execution of collaboration agreements probable when actually achieved. Furthermore, the Company recognizes expenses for clinical milestones when their achievement is deemed probable. The Company concluded that, as of September 30, 2024, there were no other milestones for which the likelihood of achievement was currently probable. Capital Commitments As of September 30, 2024, the Company’s unconditional purchase obligations for capital expenditures totaled $27.1 million and included signed orders for capital equipment and capital expenditures for construction and related expenditures relating to its properties in the United Kingdom and the United States. The Company expects to incur the full amount of these obligations within one year. Master Supply Commitments As of September 30, 2024, the Company’s unconditional purchase obligations with Miltenyi Biotec GmbH for reagents and consumables totaled $0.6 million, which the Company expects to incur within one year. Distribution Commitments The Company entered into an Exclusive Distribution Agreement, effective as of April 25, 2024 (the “Effective Date”), with Cardinal Health 105, LLC (“Cardinal Health”). Pursuant to, and subject to the terms and conditions of, the Exclusive Distribution Agreement, the Company engaged Cardinal Health as its exclusive third-party logistics distribution agent for sales of AUCATZYL in the US. The Exclusive Distribution Agreement runs for an initial term of three years following commercial launch and automatically renews for additional terms of one year each, unless either party elects not to renew. Under the terms of the Exclusive Distribution Agreement, the Company must pay to Cardinal Health a one-time start-up fee, and if the Company proceeds with commercialization of obe-cel, upon its launch, a monthly account management fee, and other fees for various services, including post-launch program implementation, information systems, warehouse operations and financial services. Blackstone and BioNTech Agreements Refer to Note 12, “Liabilities related to future royalties and milestones, net” for further details about the BioNTech Agreements and Blackstone Agreements. BioNTech License and Option Agreement - Product Options gain contingency As the Product Options within the BioNTech License and Option Agreement were an embedded feature within a freestanding financial instrument, the Company assessed if the Product Options should be accounted for as a derivative under ASC 815. However, the Company determined the Product Options met the scope exception for derivative accounting under ASC 815 and therefore should be accounted for a gain contingency under the scope of ASC 450. As of September 30, 2024, Product Options were not exercised and therefore no amounts were recognized. Legal Proceedings From time to time, the Company may be a party to litigation or subject to claims incident to the ordinary course of business. Regardless of the outcome, litigation can have an adverse impact on the Company because of defense and settlement costs, diversion of management resources and other factors. The Company was not a party to any litigation and did not have contingency reserves established for any liabilities as of September 30, 2024 and December 31, 2023. Indemnification Agreements In the normal course of business, the Company enters into contracts and agreements that contain a variety of representations and warranties and provide for general indemnification. The Company’s exposure under these agreements is unknown because they involve claims that may be made against the Company in the future. To date, the Company has not paid any claims or been required to defend any action related to its indemnification obligations. However, the Company may record charges in the future as a result of these indemnification obligations. In accordance with the indemnification agreements entered into with relevant individuals in accordance with the Company’s Articles of Association, the Company has indemnification obligations to its directors, officers and members of senior management for certain events or occurrences, subject to certain limits, while they are serving at the Company’s request in such capacity. There have been no claims to date under these indemnification agreements, and the Company has director and officer insurance that may enable it to recover a portion of any amounts paid for future potential claims.
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v3.24.3
Related party transactions
|
9 Months Ended |
Sep. 30, 2024 |
|---|
| Related Party Transactions [Abstract] |
|
| Related party transactions |
Related party transactions Blackstone Agreements In November 2021, the Company concurrently entered into the Blackstone Agreements. As of the execution of the Blackstone Agreements, Blackstone became a related party of the Company, as Blackstone became the owner of more than 10% of the Company’s outstanding voting securities. In addition, Blackstone received and exercised its right to nominate one director to the board of directors of the Company and is therefore considered to be one of the principal owners of the Company. As of September 30, 2024, the carrying amount of the Blackstone Collaboration Agreement Liability was $203.4 million which included aggregated cumulative non-cash interest expense and cumulative catch-up adjustment of $32.5 million. As of December 31, 2023, the carrying amount of the Blackstone Collaboration Agreement Liability was $170.9 million which included aggregated cumulative non-cash interest expense (including cumulative catch-up adjustments), of $45.0 million. Refer to Note 12, “Liabilities related to future royalties and milestones, net” for further details. BioNTech Agreements In February 2024, the Company concurrently entered into the BioNTech Agreements. Upon the execution of the BioNTech Agreements, BioNTech became a related party of the Company. BioNTech owns more than 10% of the Company’s outstanding voting securities and is therefore one of the principal owners of the Company. In addition, BioNTech has the right to nominate one director to the board of directors of the Company which BioNTech has not yet exercised. As of September 30, 2024, the carrying amount of the BioNTech Liability was $45.5 million which included aggregated cumulative interest expense and cumulative catch-up adjustment of $5.5 million. Refer to Note 12, “Liabilities related to future royalties and milestones, net” for further details.
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-Subparagraph (c)
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-Subparagraph (e)
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-Section S99
-Paragraph 1
-Subparagraph (SX 210.6-07(2)(e))
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-URI https://asc.fasb.org/850/tableOfContent
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v3.24.3
Subsequent Events
|
9 Months Ended |
Sep. 30, 2024 |
|---|
| Subsequent Events [Abstract] |
|
| Subsequent Events |
Subsequent EventsThe Company evaluated subsequent events through November 12, 2024, the date on which these unaudited condensed consolidated financial statements were issued.
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v3.24.3
Pay vs Performance Disclosure - USD ($)
$ in Thousands |
3 Months Ended |
9 Months Ended |
Sep. 30, 2024 |
Sep. 30, 2023 |
Sep. 30, 2024 |
Sep. 30, 2023 |
| Pay vs Performance Disclosure |
|
|
|
|
| Net loss |
$ (82,094)
|
$ (45,849)
|
$ (193,056)
|
$ (131,212)
|
| X |
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-Publisher SEC
-Name Regulation S-K
-Number 229
-Section 402
-Subsection v
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-Topic 250
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-Section 50
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-Section 65
-Paragraph 1
-Subparagraph (g)
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-SubTopic 323
-Name Accounting Standards Codification
-Section 65
-Paragraph 2
-Subparagraph (g)(3)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147478666/740-323-65-2
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-Name Accounting Standards Codification
-Section S99
-Paragraph 2
-Subparagraph (SX 210.5-03(20))
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147483621/220-10-S99-2
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-Name Accounting Standards Codification
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-Paragraph 1
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-URI https://asc.fasb.org/1943274/2147480678/235-10-S99-1
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-Paragraph 3
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-URI https://asc.fasb.org/1943274/2147481687/323-10-50-3
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-Subparagraph (f)
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v3.24.3
Summary of Significant Accounting Policies (Policies)
|
9 Months Ended |
Sep. 30, 2024 |
|---|
| Accounting Policies [Abstract] |
|
| Basis of Presentation |
Basis of Presentation The accompanying unaudited condensed consolidated financial statements of the Company have been prepared in accordance with generally accepted accounting principles in the US (“US GAAP”) and are presented in US dollars. All intercompany accounts and transactions between the Company and its subsidiaries have been eliminated upon consolidation. The significant accounting policies used in the preparation of these unaudited condensed consolidated financial statements are consistent with those discussed in Note 2, “Summary of Significant Accounting Policies” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023 as filed with the Securities and Exchange Commission on March 21, 2024 (the “Annual Report”). Certain information and footnote disclosures have been condensed or omitted as permitted under US GAAP. The information included in these unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and the related notes thereto as of and for the year ended December 31, 2023, included in the Annual Report. However, these interim financial statements include all adjustments, consisting only of normal recurring adjustments, which are, in the opinion of management, necessary to fairly state the results of the interim period. The interim results are not necessarily indicative of results to be expected for the full year ending December 31, 2024, any other interim periods, or any future year or period.
|
| Going Concern |
Going Concern The Company has incurred recurring losses since its inception, including net losses of $82.1 million and $45.8 million for the three months ended September 30, 2024 and 2023, respectively and $193.1 million and $131.2 million for the nine months ended September 30, 2024 and 2023, respectively. The Company had an accumulated deficit of $1,071.6 million and $878.6 million as of September 30, 2024 and December 31, 2023, respectively. The Company expects to continue to generate operating losses in the foreseeable future. The Company’s inability to raise additional capital as and when needed could have a negative impact on its financial condition and ability to pursue its business strategies. There can be no assurances, however, that the current operating plan will be achieved or that additional funding will be available on terms acceptable to the Company, or at all. The Company expects that its cash and cash equivalents at September 30, 2024 of $657.1 million will be sufficient to fund the Company’s operations for at least twelve months from the issuance date of these unaudited condensed consolidated financial statements and accordingly they have been prepared on a going concern basis. As the Company continues to incur losses, the transition to profitability is dependent upon the successful development, approval and commercialization of its product candidates and achieving a level of revenues adequate to support its cost structure. Even if the Company’s planned regulatory submissions for its products are approved, and the Company is successful in its commercialization efforts, additional funding will be needed before the Company is expected to reach cash breakeven.
|
| Foreign Currency Translation |
Foreign Currency Translation The reporting currency of the Company is US dollars. The Company has determined that its functional currency of the ultimate parent company, Autolus Therapeutics plc, is British Pound Sterling. The functional currency of each subsidiary’s operations is the applicable local currency. Monetary assets and liabilities denominated in currencies other than the Company’s functional currency are translated into the functional currency at rates of exchange prevailing at the balance sheet dates. Non-monetary assets and liabilities denominated in foreign currencies are translated into the functional currency at the exchange rates prevailing at the date of the transaction. The Company recorded foreign exchange losses of $11.9 million and $1.7 million for the three months ended September 30, 2024 and 2023, respectively, and foreign exchange losses of $12.4 million and $0.4 million for the nine months ended September 30, 2024 and 2023, respectively, which are included in foreign exchange losses in the unaudited condensed Consolidated Statements of Operations and Comprehensive Loss. For financial reporting purposes, the financial statements of the Company have been translated into US dollars. Assets and liabilities have been translated at the exchange rates at the balance sheet dates, while revenue and expenses are translated at the average exchange rates over the reporting period and shareholders’ equity amounts are translated based on historical exchange rates as of the date of each transaction. Translation adjustments are not included in determining net income (loss) but are included in foreign currency translation to other comprehensive loss, a component of shareholders’ equity.
|
| Segment Information |
Segment Information The Company’s chief operating decision maker (the “CODM”), its Chief Executive Officer, manages the Company’s operations on an integrated basis for the purpose of appropriately allocating resources. When evaluating the Company’s financial performance, the CODM reviews total revenue, total expenses and expenses by function and makes decisions using this information on a global basis. The Company and the CODM view the Company’s operations and manage its business as a single operating segment, which is the business of developing and commercializing CAR T therapies.
|
| Use of Estimates |
Use of Estimates The preparation of consolidated financial statements in conformity with US GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of income and expenses during the reporting periods. Significant estimates and assumptions reflected in these consolidated financial statements include, but are not limited to, the accrual for research and development expenses, share-based compensation including assessing the probability of meeting performance conditions, income taxes, initial fair value of warrants, and interest expense on liabilities related to future royalties and milestones, net and related cumulative catch-up adjustment, lease term of the Company’s new manufacturing facility (“The Nucleus”), incremental borrowing rates related to the Company’s leased properties and allocation of transaction price using the relative standalone selling price. Estimates are periodically reviewed in light of changes in circumstances, facts and experience. Actual results could differ from those estimates. Allocation of transaction price using the relative standalone selling price Upfront payments are allocated between performance obligations using the Company’s best estimate of the relative standalone selling price of the performance obligation. The relative standalone selling price is estimated by determining the market values of development and license obligations. As these inputs are not directly observable, the estimate is determined considering all reasonably available information including internal pricing objectives used in negotiating the contract, taking into account the different stage of development of each development program and consideration of adjusted-market data from comparable arrangements. Where performance obligations have been identified relating to material rights, the determination of the relative standalone selling price of these performance obligations also includes an assessment of the likelihood that the options will be exercised and any payments by the customer that are triggered upon exercising the right. This assessment involves significant judgment and could have a significant impact on the amount and timing of revenue recognition. An assessment of the allocation of transaction price using the relative standalone selling price was required for the three and nine months ended September 30, 2024 and 2023 for the BioNTech License and Option Agreement and the Option and License Agreement with Cabaletta Bio Inc. (“Cabaletta”), respectively. See Note 3 for additional information on the allocation of the transaction price for those agreements. Liabilities related to future royalties and milestones, net and cumulative catch-up adjustments The Company accounted for each of the Blackstone Collaboration Agreement (See Note 12) (“Blackstone Collaboration Agreement Liability”) and the BioNTech Obe-cel Product Revenue Interest (“BioNTech Liability”) as liabilities measured at amortized cost based on an effective interest rate determined at the outset of the Blackstone Collaboration Agreement Liability related to future royalties and milestones, net is measured based on the Company’s current estimates of the timing and amount of expected future royalties, milestone payments to be paid and the milestones receivable upon the achievement of certain specified clinical, manufacturing and regulatory milestones (each such payment, a “Blackstone Development Payment” and collectively, the “Blackstone Development Payments”) expected to be received over the estimated term of the agreement. Similarly, the BioNTech Liability related to future royalties is measured based on the Company’s current estimates of the timing and amount of expected future royalty expected to be paid over the estimated term of the agreement. Milestone payments pursuant to the BioNTech License and Option Agreement (“BioNTech Milestone Payments”) are payable upon BioNTech’s election, and therefore have not been included in the determination of the effective interest rate or in the measurement of the liability. The liabilities are amortized using the effective interest rate, resulting in recognition of interest expense over the estimated term of the agreement. Each reporting period the Company assesses the estimated probability, timing and amount of the future expected royalty, milestone payments, the Blackstone Development Payment over the estimated term. If there are changes to the estimates, the Company recognizes the impact to the liability’s amortization schedule and the related interest expense using the cumulative catch-up method. The Company’s estimate of the probability, timing and amount of expected future royalties and milestones to be paid by the Company and the expected Blackstone Development Payment to be paid to the Company, considers significant unobservable inputs. These inputs include regulatory approval, the estimated patient population, estimated selling price, estimated sales, estimated peak sales and sales ramp, timing of the expected launch and its impact on the royalties as well as the overall probability of a success. Additionally, the transaction costs associated with the liability will be amortized to interest expense over the estimated term of the agreements. The carrying amount of the Blackstone Collaboration Agreement Liability and BioNTech Liability is based on the Company’s estimate of the future royalties, milestones to be paid to Blackstone by the Company and the expected Blackstone Development Payment to be received over the life of the arrangement as discounted using the initial effective interest rate. The excess estimated present value of future royalties, milestone payments and the future Blackstone Development Payment received over the carrying amount is recognized as a cumulative catch-up adjustment within interest expense using the effective interest rate.
|
| Recent Accounting Pronouncements Not Yet Adopted |
Recent Accounting Pronouncements Not Yet Adopted In November 2023, the Financial Accounting Standards Board, (“FASB”), issued Accounting Standards Update, or (“ASU”), 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures, or (“ASU 2023-07”), which expanded the disclosures for reportable segments made by public entities. These amendments within ASU 2023-07 retained the existing disclosure requirements in ASC 280 - Segment Reporting (“ASC 280”) and expanded upon them to require public entities to disclose significant expenses for reportable segments in both interim and annual reporting periods, as well as items that were previously disclosed only annually on an interim basis, including disclosures related to a reportable segment’s profit or loss and assets. In addition, entities with a single reportable segment must provide all segment disclosures required in ASC 280, including the new disclosures for reportable segments under the amendments in ASU 2023-07. The amendments did not change the existing guidance on how a public entity identified and determined its reportable segments. A public entity should apply the amendments in ASU 2023-07 retrospectively to all prior periods presented in the financial statements. Upon transition, the segment expense categories and amounts disclosed in the prior periods should be based on the significant segment expense categories identified and disclosed in the period of adoption. The amendments in ASU 2023-07 are effective for annual periods for all public entities in fiscal years beginning after December 15, 2023, and in interim periods within fiscal years beginning after December 15, 2024. The Company will comply with any new applicable disclosures in its Annual Report on Form 10-K for the year ending December 31, 2024. The Company does not expect the adoption to have a material effect on its financial statements and related disclosures. In December 2023, the FASB issued ASU 2023-09, Improvements to Income Tax Disclosures. This ASU improves the transparency of income tax disclosure by requiring consistent categories and greater disaggregation of information in the rate reconciliation, and income taxes paid disaggregated by jurisdiction. This guidance is effective for the Company for the year beginning January 1, 2025, with early adoption permitted. The amendments should be applied on a prospective basis, with retrospective application permitted. The Company intends to adopt the guidance in the fiscal year beginning January 1, 2025. The Company does not expect the adoption of ASU 2023-09 to have a material effect on its financial statements and related disclosures in this Quarterly Report on Form 10-Q or in its Annual Report on Form 10-K for the full year ending December 31, 2024. Unless otherwise discussed, the impact of recently issued standards that are not yet effective are not expected to have a material impact on the Company’s consolidated financial statements and disclosures.
|
| Fair value measurements |
The Company uses valuation approaches that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible. The Company determines the fair value based on assumptions that market participants would use in pricing an asset or liability in the principal or most advantageous market. When considering market participant assumptions in fair value measurements, the following fair value hierarchy distinguishes between observable and unobservable inputs, which are categorized in of the following levels: • Level 1 — Quoted prices in active markets for identical assets or liabilities. • Level 2 — Inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly. • Level 3 — Unobservable inputs that reflect the Company’s own assumptions about the assumptions market participants would use in pricing the asset or liability. The carrying amounts reported in the balance sheet for cash and cash equivalents, restricted cash, prepaid expenses and other assets, accounts payable and accrued expenses and other liabilities approximate their fair value because of the short-term nature of these instruments.
|
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-Section 50
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v3.24.3
Nature of the Business (Tables)
|
9 Months Ended |
Sep. 30, 2024 |
|---|
| Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
| Schedule of Units of Accounting from Financing Agreement |
The four units of accounting were recorded at fair value upon initial recognition and will not be subsequently measured at fair value. The Company allocated the total gross proceeds arising from the BioNTech Securities Purchase Agreement (i.e. the Initial ADSs representing ordinary shares), and the BioNTech License and Option Agreement among the four units of accounting on a relative fair value basis at the time of the transaction as follows:
| | | | | | | | | | | | | | | | | | | | | | | | | | | | Units of Accounting | | Gross proceeds (in millions) | | Initial fair value (in millions) | | Allocated consideration based on relative fair value (in millions) | | Net allocated consideration based on relative fair value after transaction costs* (in millions) | Initial ADSs, representing ordinary shares | | $ | 200.0 | | | $ | 200.0 | | | $ | 200.0 | | | $ | 193.8 | | Subsequent ADSs, representing ordinary shares | | $ | — | | | $ | — | | | $ | — | | | $ | — | | BioNTech License and Option Agreement | | $ | 50.0 | | | $ | 50.0 | | | $ | 50.0 | | | $ | 47.9 | | Liabilities related to future royalties and milestones, net (Obe-cel Product Revenue Interest) | | $ | 40.0 | | | $ | 40.0 | | | $ | 40.0 | | | $ | 38.3 | | License Revenue (Binder License) | | $ | 10.0 | | | $ | 10.0 | | | $ | 10.0 | | | $ | 9.6 | | MCSA | | $ | — | | | $ | — | | | $ | — | | | $ | — | | | Total | | $ | 250.0 | | | $ | 250.0 | | | $ | 250.0 | | | $ | 241.7 | | * In addition, the total shared transaction costs of $8.3 million, relating to the BioNTech Agreements have been allocated to the four units of accounting on a relative fair value basis. |
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v3.24.3
License Revenue (Tables)
|
9 Months Ended |
Sep. 30, 2024 |
|---|
| Revenue from Contract with Customer [Abstract] |
|
| Schedule of Revenue by Geographical Location |
License revenue for the three and nine months ended September 30, 2024, and 2023, is presented in the table below by geographical location (in thousands): | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Three Months Ended September 30, | | Nine Months Ended September 30, | | | 2024 | | 2023 | | 2024 | | 2023 | | License revenue | | | | | | | | | | United Kingdom | | $ | — | | | $ | 346 | | | $ | — | | | $ | 346 | | | United States | | — | | | 60 | | | — | | | 1,352 | | Germany | | — | | | — | | | 10,091 | | | — | | | Total license revenue | | $ | — | | | $ | 406 | | | $ | 10,091 | | | $ | 1,698 | |
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v3.24.3
Interest expense (Tables)
|
9 Months Ended |
Sep. 30, 2024 |
|---|
| Banking and Thrift, Interest [Abstract] |
|
| Schedule of Interest Income and Interest Expense Disclosure |
Interest expense consisted of the following (in thousands): | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Three Months Ended September 30, | | Nine Months Ended September 30, | | | 2024 | | 2023 | | 2024 | | 2023 | Interest expense on liabilities related to future royalties and milestones, net (refer to Note 12) | | $ | 10,280 | | | $ | 5,014 | | | $ | 28,839 | | | $ | 14,878 | | Cumulative catch-up adjustment arising from the liabilities related to future royalties and milestones, net (refer to Note 12) | | — | | | — | | | 10,870 | | | — | | Other interest expense | | 406 | | | — | | | 420 | | | 61 | | Total interest expense | | $ | 10,686 | | | $ | 5,014 | | | $ | 40,129 | | | $ | 14,939 | |
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v3.24.3
Net loss per ordinary share (Tables)
|
9 Months Ended |
Sep. 30, 2024 |
|---|
| Earnings Per Share [Abstract] |
|
| Schedule of Loss Per Share, Basic and Diluted |
Basic and diluted net loss per ordinary share was calculated as follows (in thousands, except share and per share amounts): | | | | | | | | | | | | | | | | | | | | | | | | | Three Months Ended September 30, | | Nine Months Ended September 30, | | 2024 | | 2023 | | 2024 | | 2023 | | Numerator | | | | | | | | | Net loss | $ | (82,094) | | | $ | (45,849) | | | $ | (193,056) | | | $ | (131,212) | | | Net loss - basic and diluted | $ | (82,094) | | | $ | (45,849) | | | $ | (193,056) | | | $ | (131,212) | | | | | | | | | | | Denominator | | | | | | | | | Weighted-average number of ordinary shares used in net loss per share - basic and diluted | 266,084,589 | | | 173,984,101 | | | 251,480,521 | | | 173,890,666 | | | Basic and diluted net loss per ordinary share | $ | (0.31) | | | $ | (0.26) | | | $ | (0.77) | | | $ | (0.75) | |
|
| Schedule of Anti-dilutive Securities |
The following potentially dilutive securities have been excluded from the calculation of diluted net loss per share due to their anti-dilutive effect: | | | | | | | | | | | | | Three and Nine Months Ended September 30, | | 2024 | | 2023 | Unvested restricted stock units | 36,186 | | | 264,326 | | Share options | 20,382,429 | | | 14,074,842 | | | Warrants | 3,265,306 | | | 3,265,306 | | Total potentially dilutive securities | 23,683,921 | | | 17,604,474 | |
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v3.24.3
Fair value measurements (Tables)
|
9 Months Ended |
Sep. 30, 2024 |
|---|
| Fair Value Disclosures [Abstract] |
|
| Schedule of Fair Value Measurements, Recurring and Nonrecurring |
The following tables present information about the Company’s financial assets measured at fair value on a recurring basis and indicate the level of the fair value hierarchy utilized to determine such fair values (in thousands): | | | | | | | | | | | | | | | | | | | | | | | | | | | | | September 30, 2024 | | | | Total | | Quoted Prices in Active Markets for Identical Assets (Level 1) | | Significant Other Observable Inputs (Level 2) | | Significant Unobservable Inputs (Level 3) | | | | | | Financial assets | | | | | | | | | | | | Cash and cash equivalents: | | | | | | | | | | | | Money market funds | $ | 596,387 | | | $ | 596,387 | | | $ | — | | | $ | — | | | | | | | Total | $ | 596,387 | | | $ | 596,387 | | | $ | — | | | $ | — | | | | | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | December 31, 2023 | | | | Total | | Quoted Prices in Active Markets for Identical Assets (Level 1) | | Significant Other Observable Inputs (Level 2) | | Significant Unobservable Inputs (Level 3) | | | | | | Financial assets | | | | | | | | | | | | Cash and cash equivalents: | | | | | | | | | | | | Money market funds | $ | 184,635 | | | $ | 184,635 | | | $ | — | | | $ | — | | | | | | Total | $ | 184,635 | | | $ | 184,635 | | | $ | — | | | $ | — | | | | | |
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v3.24.3
Prepaid Expenses and Other Current Assets (Tables)
|
9 Months Ended |
Sep. 30, 2024 |
|---|
| Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] |
|
| Schedule of Prepaid Expenses and Other Current Assets |
Prepaid expenses and other current assets consisted of the following (in thousands): | | | | | | | | | | | | | September 30, | | December 31, | | 2024 | | 2023 | | Research and development claims receivable | $ | 34,766 | | | $ | 19,209 | | Prepayments | 14,057 | | | 8,638 | | | VAT receivable | 3,140 | | | 2,771 | | | Deferred cost | 2,237 | | | 1,787 | | Other taxes receivable | 1,678 | | | — | | Accrued interest income | 1,409 | | | 999 | | Lease deposit receivable | 993 | | | 938 | | Corporate tax receivable | 699 | | | — | | Other receivables | 598 | | | 516 | | | Accounts receivable | — | | | 109 | | | Total prepaid expenses and other current assets | $ | 59,577 | | | $ | 34,967 | |
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v3.24.3
Property and Equipment, Net (Tables)
|
9 Months Ended |
Sep. 30, 2024 |
|---|
| Property, Plant and Equipment [Abstract] |
|
| Schedule of Property and Equipment, Net |
Property and equipment, net consisted of the following (in thousands): | | | | | | | | | | | | | September 30, | | December 31, | | 2024 | | 2023 | Lab equipment | $ | 42,857 | | | $ | 32,232 | | Office equipment | 5,571 | | | 3,777 | | Furniture and fixtures | 2,519 | | | 2,360 | | Leasehold improvements | 15,055 | | | 12,728 | | Assets under construction | 13,513 | | | 12,539 | | Less: accumulated depreciation | (35,257) | | | (28,774) | | Total property and equipment, net | $ | 44,258 | | | $ | 34,862 | |
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v3.24.3
Accrued Expenses and Other Liabilities (Tables)
|
9 Months Ended |
Sep. 30, 2024 |
|---|
| Payables and Accruals [Abstract] |
|
| Schedule of Accrued Expenses and Other Liabilities |
Accrued expenses and other liabilities consisted of the following (in thousands): | | | | | | | | | | | | | September 30, | | December 31, | | 2024 | | 2023 | Research and development costs | $ | 20,093 | | | $ | 19,825 | | Compensation and benefits | 15,444 | | | 14,757 | | Professional fees | 7,584 | | | 4,466 | | VAT accrual | 3,964 | | | — | | | | | | Other accrued liabilities | 403 | | | 533 | | Total accrued expenses and other liabilities | $ | 47,488 | | | $ | 39,581 | |
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v3.24.3
Share-based Compensation (Tables)
|
9 Months Ended |
Sep. 30, 2024 |
|---|
| Share-Based Payment Arrangement [Abstract] |
|
| Schedule of Share-based Compensation Expense |
The following table summarizes the total share-based compensation expense included in the unaudited condensed consolidated statements of operations and comprehensive loss (in thousands): | | | | | | | | | | | | | | | | | | | | | | | | | Three Months Ended September 30, | | Nine Months Ended September 30, | | 2024 | | 2023 | | 2024 | | 2023 | | Research and development | $ | 1,218 | | | $ | 1,525 | | | $ | 2,716 | | | $ | 4,982 | | | General and administrative | 2,802 | | | 1,335 | | | 6,525 | | | 2,947 | | | Capitalized | — | | | 4 | | | (2) | | | 19 | | Total share-based compensation expense | $ | 4,020 | | | $ | 2,864 | | | $ | 9,239 | | | $ | 7,948 | |
|
| Schedule of Stock Options |
The table below summarizes Company’s share option activity during the nine months ended September 30, 2024: | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Number of
Options | | Weighted-
Average
Exercise
Price per share | | Weighted-
Average
Remaining
Contractual
Term
(Years) | | Aggregate Intrinsic Value (1) (in thousands) | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Outstanding as of December 31, 2023 | | 17,956,385 | | | $ | 5.64 | | | 8.35 | | $ | 48,968 | | | Granted | | 3,797,650 | | | 4.19 | | | | | 268 | | | Exercised | | (214,398) | | | 2.77 | | | | | 480 | | | Forfeited | | (902,906) | | | 3.30 | | | | | 857 | | | Expired | | (254,302) | | | 9.41 | | | | | 5 | | | Outstanding as of September 30, 2024 | | 20,382,429 | | | $ | 5.45 | | | 7.98 | | $ | 13,411 | | | Exercisable as of September 30, 2024 | | 8,879,183 | | | $ | 8.13 | | | 6.88 | | $ | 4,561 | | | Vested and expected to vest as of September 30, 2024 | | 20,382,429 | | | $ | 5.45 | | | 7.98 | | $ | 13,411 | | | | | | | | | | | (1) Aggregate intrinsic value is calculated as the difference between the exercise price of the underlying options and the fair value of ordinary shares for those options in the money as of September 30, 2024 |
|
| Schedule of Restricted Stock Units |
The table below summarizes Company’s restricted stock unit (“RSU”) awards activity during the nine months ended September 30, 2024: | | | | | | | | | | | | | | | | | Number of
restricted
units | | Weighted average
grant date
fair value | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Unvested and outstanding at December 31, 2023 | | 116,436 | | | $ | 3.43 | | | | | | | | Vested | | (79,200) | | | 2.94 | | | Forfeited | | (1,050) | | | 6.20 | | Unvested and outstanding at September 30, 2024 | | 36,186 | | | $ | 4.43 | |
|
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-Name Accounting Standards Codification
-Topic 718
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-Paragraph 2
-Subparagraph (h)(1)
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v3.24.3
Liabilities related to future royalties and milestones, net (Tables)
|
9 Months Ended |
Sep. 30, 2024 |
|---|
| Investments, Debt and Equity Securities [Abstract] |
|
| Schedule of Liability Related Debt Arising Financial Agreement |
| | | | | | | | | | | | | | | Amount in thousands | Balance at 1 January, 2023 | | | $ | 125,900 | | Interest expense on liability related to future royalties and milestones, net | | 4,905 | | Balance at March 31, 2023 | | | $ | 130,805 | | Interest expense on liability related to future royalties and milestones, net | | 4,959 | | Balance at June 30, 2023 | | | $ | 135,764 | | Interest expense on liability related to future royalties and milestones, net | | 5,014 | | Balance at September 30, 2023 | | | $ | 140,778 | | Interest expense on liability related to future royalties and milestones, net | | 5,014 | | Cumulative catch-up adjustment | | 25,107 | | Balance at December 31, 2023 | | | $ | 170,899 | | | Initial recognition of BioNTech liability | | 38,335 | | Interest expense on liability related to future royalties and milestones, net | | 8,390 | | Cumulative catch-up adjustment | | 10,870 | | Balance at March 31, 2024 | | | $ | 228,494 | | Interest expense on liability related to future royalties and milestones, net | | 10,169 | | Balance at June 30, 2024 | | | $ | 238,663 | | Interest expense on liability related to future royalties and milestones, net | | 10,280 | | | | | Balance at September 30, 2024 | | | $ | 248,943 | |
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v3.24.3
Leases (Tables)
|
9 Months Ended |
Sep. 30, 2024 |
|---|
| Leases [Abstract] |
|
| Schedule of Lease Cost |
The Company’s costs as a lessee for the three and nine months ended September 30, 2024 and 2023 were as follows (in thousands): | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Three Months Ended September 30, | | Nine Months Ended September 30, | | | 2024 | | 2023 | | 2024 | | 2023 | | Operating lease costs | | $ | 2,155 | | | $ | 2,061 | | | $ | 6,340 | | | $ | 5,235 | | | Variable costs | | 157 | | | 573 | | | 1,186 | | | 657 | | | Short term lease costs | | 72 | | | 227 | | | 276 | | | 451 | | | Total lease costs | | $ | 2,384 | | | $ | 2,861 | | | $ | 7,802 | | | $ | 6,343 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Supplemental cash flow information for the nine months ended September 30, 2024 and 2023 were as follows (in thousands): | | | | | | | | | | | | | | | | | | | | | | | | | Nine Months Ended September 30, | | Other information | | | | 2024 | | 2023 | | Cash paid for amounts included in the measurement of lease liabilities: | | | | | Operating cash outflows from operating leases | | $ | 7,067 | | $ | 7,817 | | | | | |
The weighted average remaining lease term and weighted average discount rate of operating leases at September 30, 2024 and 2023 were as follows: | | | | | | | | | | | | | | | | | | | | | | | | | Nine Months Ended September 30, | | | | | 2024 | | 2023 | | | | | | | | | | | | | | | | | | | | | | | Weighted-average remaining lease term - operating leases | | 15.6 years | | 15.9 years | | Weighted-average discount rate - operating leases | | 8.14 | % | | 7.44 | % |
|
| Schedule of Lease Maturity |
The maturities of operating lease liabilities as of September 30, 2024 were as follows (in thousands): | | | | | | | | | | | | | | | Remainder of 2024(1) | | | | $ | (1,941) | | 2025(1) | | | | (2,952) | | 2026(1) | | | | 8,514 | | 2027 | | | | 8,912 | | | 2028 | | | | 8,156 | | | Thereafter | | | | 88,819 | | | Total lease payments | | | | 109,508 | | | Less: imputed interest | | | | (57,279) | | | Present value of lease liabilities | | | | $ | 52,229 | | (1) Includes lease incentives from the Nucleus lease variation amounting to $4.5 million, $11.3 million and $0.9 million, for the year ended December 31, 2024, 2025 and 2026, respectively. |
|
| Schedule of Sublease Classification |
The following table shows the sublease rental income for the three and nine months ended September 30, 2024 and 2023 (in thousands): | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Three Months Ended September 30, | | Nine Months Ended September 30, | | Sublease rental income | | 2024 | | 2023 | | 2024 | | 2023 | Sublease rental income (included in other income (expense), net) | | $ | 63 | | | $ | 61 | | | $ | 186 | | | $ | 181 | | | Total sublease rental income | | $ | 63 | | | $ | 61 | | | $ | 186 | | | $ | 181 | |
|
| Schedule of Lease Receivable Maturity |
Future fixed receipts for non-cancellable operating subleases in effect as of September 30, 2024 are receivable as follows (in thousands): | | | | | | | | | Remainder of 2024 | | $ | 69 | 2025 | | $ | 276 | 2026 | | $ | 215 | 2027 | | $ | 130 | | 2028 | | $ | 112 | | | | | Total lease payments receivable | | $ | 802 |
|
| X |
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-Topic 842
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-Name Accounting Standards Codification
-Section 50
-Paragraph 4
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-Topic 842
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-Paragraph 6
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-Paragraph 12
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v3.24.3
Nature of the Business - Narrative (Details)
$ / shares in Units, $ in Millions |
|
|
1 Months Ended |
|
|
|
|
|
Feb. 13, 2024
USD ($)
$ / shares
shares
|
Feb. 06, 2024
USD ($)
$ / shares
shares
|
Nov. 30, 2021
USD ($)
|
Sep. 30, 2024
USD ($)
unit
financialInstrument
$ / shares
|
Dec. 31, 2023
$ / shares
|
Dec. 31, 2022
USD ($)
|
Nov. 06, 2021
USD ($)
|
| Product Information [Line Items] |
|
|
|
|
|
|
|
| Contract with customer, liability |
|
|
|
$ 203.4
|
|
|
|
| Number of freestanding financial instruments | financialInstrument |
|
|
|
1
|
|
|
|
| Units of accounting | unit |
|
|
|
4
|
|
|
|
| BioNTech |
|
|
|
|
|
|
|
| Product Information [Line Items] |
|
|
|
|
|
|
|
| Collaborative agreement, period to acquire beneficial ownership from execution date (in years) |
|
5 years
|
|
|
|
|
|
| Ordinary Shares |
|
|
|
|
|
|
|
| Product Information [Line Items] |
|
|
|
|
|
|
|
| Stock par value (in usd per share) | $ / shares |
|
|
|
$ 0.000042
|
$ 0.000042
|
|
|
| Number of shares issued in transaction (in shares) | shares |
33,333,333
|
|
|
|
|
|
|
| Per share price of issuance (in usd per share) | $ / shares |
$ 6.00
|
|
|
|
|
|
|
| Proceeds of issuance of ordinary shares, net of issuance costs |
$ 193.8
|
|
|
|
|
|
|
| Ordinary Shares | BioNTech |
|
|
|
|
|
|
|
| Product Information [Line Items] |
|
|
|
|
|
|
|
| Collaborative arrangement, rights and obligations, maximum share purchase requirement, shares (in shares) | shares |
15,000,000
|
|
|
|
|
|
|
| Collaborative arrangement, rights and obligations, maximum share purchase requirement, value |
$ 20.0
|
|
|
|
|
|
|
| Collaborative agreement, beneficial ownership percentage, threshold (in percent) |
|
0.30
|
|
|
|
|
|
| Blackstone Collaboration Agreement |
|
|
|
|
|
|
|
| Product Information [Line Items] |
|
|
|
|
|
|
|
| Number of freestanding financial instruments | financialInstrument |
|
|
|
4
|
|
|
|
| BioNTech License and Option Agreement |
|
|
|
|
|
|
|
| Product Information [Line Items] |
|
|
|
|
|
|
|
| Number of freestanding financial instruments | financialInstrument |
|
|
|
1
|
|
|
|
| BioNTech |
|
|
|
|
|
|
|
| Product Information [Line Items] |
|
|
|
|
|
|
|
| Collaborative arrangement, period to enter agreement from initial closing date (in months) |
18 months
|
|
|
|
|
|
|
| Collaborative agreement, sale of stock prohibited without registrant's approval, period (in months) |
|
6 months
|
|
|
|
|
|
| BioNTech | License And Options |
|
|
|
|
|
|
|
| Product Information [Line Items] |
|
|
|
|
|
|
|
| Contract with customer, liability |
|
$ 10.0
|
|
|
|
|
|
| Revenue, remaining performance obligation, maximum consideration, amount |
|
582.0
|
|
|
|
|
|
| Remaining performance obligation, variable consideration amount |
|
$ 32.0
|
|
|
|
|
|
| BioNTech | Ordinary Shares |
|
|
|
|
|
|
|
| Product Information [Line Items] |
|
|
|
|
|
|
|
| Stockholders' equity, common stock, conversion ratio (in shares) | shares |
|
1
|
|
|
|
|
|
| Stock par value (in usd per share) | $ / shares |
|
$ 0.000042
|
|
|
|
|
|
| Blackstone | Affiliated Entity | Obe-cel Product |
|
|
|
|
|
|
|
| Product Information [Line Items] |
|
|
|
|
|
|
|
| Contract with customer, liability gross |
|
|
$ 40.0
|
|
|
|
|
| Remaining performance obligation, variable consideration amount |
|
|
|
|
|
|
$ 100.0
|
| Blackstone | Blackstone Collaboration Agreement |
|
|
|
|
|
|
|
| Product Information [Line Items] |
|
|
|
|
|
|
|
| Contract with customer, liability |
|
|
|
|
|
$ 35.0
|
|
| Contract with customer, liability gross |
|
|
$ 50.0
|
|
|
|
|
| Remaining performance obligation, variable consideration amount |
|
|
|
|
|
$ 30.0
|
|
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-Topic 210
-SubTopic 10
-Name Accounting Standards Codification
-Section S99
-Paragraph 1
-Subparagraph (SX 210.5-02(29))
-Publisher FASB
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-Topic 606
-SubTopic 10
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-Section 45
-Paragraph 1
-Publisher FASB
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Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Topic 606
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 8
-Subparagraph (a)
-Publisher FASB
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Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Topic 606
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-Section 45
-Paragraph 2
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v3.24.3
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Reference 4: http://www.xbrl.org/2009/role/commonPracticeRef
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Reference 5: http://www.xbrl.org/2003/role/disclosureRef
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v3.24.3
Summary of Significant Accounting Policies - Narrative (Details) - USD ($)
$ in Thousands |
3 Months Ended |
9 Months Ended |
|
Sep. 30, 2024 |
Sep. 30, 2023 |
Sep. 30, 2024 |
Sep. 30, 2023 |
Dec. 31, 2023 |
| Accounting Policies [Abstract] |
|
|
|
|
|
| Net loss |
$ (82,094)
|
$ (45,849)
|
$ (193,056)
|
$ (131,212)
|
|
| Accumulated deficit |
(1,071,618)
|
|
(1,071,618)
|
|
$ (878,562)
|
| Cash and cash equivalents |
657,067
|
256,415
|
657,067
|
256,415
|
$ 239,566
|
| Foreign currency gain (loss) |
$ (11,884)
|
$ (1,733)
|
$ (12,368)
|
$ (442)
|
|
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Reference 17: http://www.xbrl.org/2003/role/exampleRef
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Reference 19: http://www.xbrl.org/2003/role/disclosureRef
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v3.24.3
License revenue - Narrative (Details)
|
|
3 Months Ended |
9 Months Ended |
|
|
Jan. 09, 2023
USD ($)
|
Sep. 30, 2024
USD ($)
performanceObligation
financialInstrument
|
Mar. 31, 2024
USD ($)
|
Sep. 30, 2023
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|
Sep. 30, 2024
USD ($)
performanceObligation
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|
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|
|
|
|
|
|
|
| Number of freestanding financial instruments | financialInstrument |
|
1
|
|
|
1
|
|
|
| Number of combined performance obligations | performanceObligation |
|
1
|
|
|
1
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|
|
| Distinct performance obligation | performanceObligation |
|
1
|
|
|
1
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|
|
| BioNTech | Revenue Benchmark | Customer Concentration Risk |
|
|
|
|
|
|
|
| Disaggregation of Revenue [Line Items] |
|
|
|
|
|
|
|
| Concentration risk (in percent) |
|
|
|
|
100.00%
|
|
|
| BioNTech And Cabaletta | Revenue Benchmark | Customer Concentration Risk |
|
|
|
|
|
|
|
| Disaggregation of Revenue [Line Items] |
|
|
|
|
|
|
|
| Concentration risk (in percent) |
|
|
|
|
|
80.00%
|
|
| Investee of Syncona | Revenue Benchmark | Customer Concentration Risk |
|
|
|
|
|
|
|
| Disaggregation of Revenue [Line Items] |
|
|
|
|
|
|
|
| Concentration risk (in percent) |
|
|
|
|
|
20.00%
|
|
| License revenue |
|
|
|
|
|
|
|
| Disaggregation of Revenue [Line Items] |
|
|
|
|
|
|
|
| Revenue from contract with customer |
|
$ 0
|
|
$ 406,000
|
$ 10,091,000
|
$ 1,698,000
|
|
| License revenue | BioNTech |
|
|
|
|
|
|
|
| Disaggregation of Revenue [Line Items] |
|
|
|
|
|
|
|
| Revenue from contract with customer |
|
0
|
$ 10,100,000
|
|
|
|
|
| License revenue | Investee of Syncona |
|
|
|
|
|
|
|
| Disaggregation of Revenue [Line Items] |
|
|
|
|
|
|
|
| Remaining performance obligation, variable consideration amount |
|
|
|
$ 400,000
|
|
400,000
|
|
| License revenue | Cabaletta Bio Inc. (“Cabaletta”) |
|
|
|
|
|
|
|
| Disaggregation of Revenue [Line Items] |
|
|
|
|
|
|
|
| Revenue from contract with customer |
$ 1,200,000
|
$ 0
|
|
|
0
|
$ 1,200,000
|
|
| License And Options | BioNTech |
|
|
|
|
|
|
|
| Disaggregation of Revenue [Line Items] |
|
|
|
|
|
|
|
| Remaining performance obligation, variable consideration amount |
|
|
|
|
|
|
$ 32,000,000
|
| Technology Options | BioNTech |
|
|
|
|
|
|
|
| Disaggregation of Revenue [Line Items] |
|
|
|
|
|
|
|
| Revenue from contract with customer |
|
|
|
|
$ 10,000,000
|
|
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v3.24.3
Interest expense (Details) - USD ($)
|
3 Months Ended |
9 Months Ended |
Sep. 30, 2024 |
Jun. 30, 2024 |
Mar. 31, 2024 |
Dec. 31, 2023 |
Sep. 30, 2023 |
Jun. 30, 2023 |
Mar. 31, 2023 |
Sep. 30, 2024 |
Sep. 30, 2023 |
| Banking and Thrift, Interest [Abstract] |
|
|
|
|
|
|
|
|
|
| Interest expense on liabilities related to future royalties and milestones, net (refer to Note 12) |
$ 10,280,000
|
$ 10,169,000
|
$ 8,390,000
|
$ 5,014,000
|
$ 5,014,000
|
$ 4,959,000
|
$ 4,905,000
|
$ 28,839,000
|
$ 14,878,000
|
| Cumulative catch-up adjustment arising from the liabilities related to future royalties and milestones, net (refer to Note 12) |
0
|
|
$ 10,870,000
|
$ 25,107,000
|
0
|
|
|
10,870,000
|
0
|
| Other interest expense |
406,000
|
|
|
|
0
|
|
|
420,000
|
61,000
|
| Total interest expense |
$ 10,686,000
|
|
|
|
$ 5,014,000
|
|
|
$ 40,129,000
|
$ 14,939,000
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v3.24.3
Net loss per ordinary share - Schedule of Net Loss Per Share (Details) - USD ($)
$ / shares in Units, $ in Thousands |
3 Months Ended |
9 Months Ended |
Sep. 30, 2024 |
Sep. 30, 2023 |
Sep. 30, 2024 |
Sep. 30, 2023 |
| Numerator |
|
|
|
|
| Net loss |
$ (82,094)
|
$ (45,849)
|
$ (193,056)
|
$ (131,212)
|
| Net loss - basic |
(82,094)
|
(45,849)
|
(193,056)
|
(131,212)
|
| Net loss - diluted |
$ (82,094)
|
$ (45,849)
|
$ (193,056)
|
$ (131,212)
|
| Denominator |
|
|
|
|
| Weighted-average number of ordinary shares used in net loss per share - basic (in shares) |
266,084,589
|
173,984,101
|
251,480,521
|
173,890,666
|
| Weighted-average number of ordinary shares used in net loss per share - diluted (in shares) |
266,084,589
|
173,984,101
|
251,480,521
|
173,890,666
|
| Earnings Per Share |
|
|
|
|
| Net loss per share - basic (in usd per share) |
$ (0.31)
|
$ (0.26)
|
$ (0.77)
|
$ (0.75)
|
| Net loss per share - diluted (in usd per share) |
$ (0.31)
|
$ (0.26)
|
$ (0.77)
|
$ (0.75)
|
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v3.24.3
Net loss per ordinary share - Schedule of Anti-dilutive Securities (Details) - shares
|
3 Months Ended |
9 Months Ended |
Sep. 30, 2024 |
Sep. 30, 2023 |
Sep. 30, 2024 |
Sep. 30, 2023 |
| Antidilutive Securities |
|
|
|
|
| Total potentially dilutive securities (in shares) |
23,683,921
|
17,604,474
|
23,683,921
|
17,604,474
|
| Unvested restricted stock units |
|
|
|
|
| Antidilutive Securities |
|
|
|
|
| Total potentially dilutive securities (in shares) |
36,186
|
264,326
|
36,186
|
264,326
|
| Share options |
|
|
|
|
| Antidilutive Securities |
|
|
|
|
| Total potentially dilutive securities (in shares) |
20,382,429
|
14,074,842
|
20,382,429
|
14,074,842
|
| Warrants |
|
|
|
|
| Antidilutive Securities |
|
|
|
|
| Total potentially dilutive securities (in shares) |
3,265,306
|
3,265,306
|
3,265,306
|
3,265,306
|
| X |
- DefinitionSecurities (including those issuable pursuant to contingent stock agreements) that could potentially dilute basic earnings per share (EPS) or earnings per unit (EPU) in the future that were not included in the computation of diluted EPS or EPU because to do so would increase EPS or EPU amounts or decrease loss per share or unit amounts for the period presented. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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v3.24.3
Fair value measurements (Details) - USD ($)
$ in Thousands |
Sep. 30, 2024 |
Dec. 31, 2023 |
| Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
| Cash and cash equivalents: |
$ 596,387
|
$ 184,635
|
| Money market funds |
|
|
| Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
| Cash and cash equivalents: |
596,387
|
184,635
|
| Quoted Prices in Active Markets for Identical Assets (Level 1) |
|
|
| Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
| Cash and cash equivalents: |
596,387
|
184,635
|
| Quoted Prices in Active Markets for Identical Assets (Level 1) | Money market funds |
|
|
| Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
| Cash and cash equivalents: |
596,387
|
184,635
|
| Significant Other Observable Inputs (Level 2) |
|
|
| Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
| Cash and cash equivalents: |
0
|
0
|
| Significant Other Observable Inputs (Level 2) | Money market funds |
|
|
| Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
| Cash and cash equivalents: |
0
|
0
|
| Significant Unobservable Inputs (Level 3) |
|
|
| Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
| Cash and cash equivalents: |
0
|
0
|
| Significant Unobservable Inputs (Level 3) | Money market funds |
|
|
| Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
| Cash and cash equivalents: |
$ 0
|
$ 0
|
| X |
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v3.24.3
Prepaid Expenses and Other Current Assets (Details) - USD ($)
$ in Thousands |
Sep. 30, 2024 |
Dec. 31, 2023 |
| Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] |
|
|
| Research and development claims receivable |
$ 34,766
|
$ 19,209
|
| Prepayments |
14,057
|
8,638
|
| VAT receivable |
3,140
|
2,771
|
| Deferred cost |
2,237
|
1,787
|
| Other taxes receivable |
1,678
|
0
|
| Accrued interest income |
1,409
|
999
|
| Lease deposit receivable |
993
|
938
|
| Corporate tax receivable |
699
|
0
|
| Other receivables |
598
|
516
|
| Accounts receivable |
0
|
109
|
| Prepaid expenses and other current assets |
$ 59,577
|
$ 34,967
|
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v3.24.3
Property and Equipment, Net - Schedule of Property and Equipment, Net (Details) - USD ($)
$ in Thousands |
Sep. 30, 2024 |
Dec. 31, 2023 |
| Property, Plant and Equipment |
|
|
| Less: accumulated depreciation |
$ (35,257)
|
$ (28,774)
|
| Total property and equipment, net |
44,258
|
34,862
|
| Lab equipment |
|
|
| Property, Plant and Equipment |
|
|
| Property and equipment, gross |
42,857
|
32,232
|
| Office equipment |
|
|
| Property, Plant and Equipment |
|
|
| Property and equipment, gross |
5,571
|
3,777
|
| Furniture and fixtures |
|
|
| Property, Plant and Equipment |
|
|
| Property and equipment, gross |
2,519
|
2,360
|
| Leasehold improvements |
|
|
| Property, Plant and Equipment |
|
|
| Property and equipment, gross |
15,055
|
12,728
|
| Assets under construction |
|
|
| Property, Plant and Equipment |
|
|
| Property and equipment, gross |
$ 13,513
|
$ 12,539
|
| X |
- DefinitionAmount of accumulated depreciation, depletion and amortization for physical assets used in the normal conduct of business to produce goods and services. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Topic 944
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v3.24.3
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v3.24.3
Accrued Expenses and Other Liabilities (Details) - USD ($)
$ in Thousands |
Sep. 30, 2024 |
Dec. 31, 2023 |
| Payables and Accruals [Abstract] |
|
|
| Research and development costs |
$ 20,093
|
$ 19,825
|
| Compensation and benefits |
15,444
|
14,757
|
| Professional fees |
7,584
|
4,466
|
| VAT accrual |
3,964
|
0
|
| Other accrued liabilities |
403
|
533
|
| Total accrued expenses and other liabilities |
$ 47,488
|
$ 39,581
|
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v3.24.3
Shareholders’ Equity - Narrative (Details)
$ / shares in Units, $ in Millions |
Feb. 13, 2024
USD ($)
$ / shares
shares
|
Feb. 12, 2024
USD ($)
$ / shares
shares
|
Sep. 30, 2024
vote
shares
|
Feb. 06, 2024
shares
|
| Class of Stock |
|
|
|
|
| Voting rights, votes per share | vote |
|
|
1
|
|
| Restricted stock units |
|
|
|
|
| Class of Stock |
|
|
|
|
| Vested not issued (in shares) |
|
|
1,975
|
|
| BioNTech |
|
|
|
|
| Class of Stock |
|
|
|
|
| Collaborative arrangement, period to enter agreement from initial closing date (in months) |
18 months
|
|
|
|
| Ordinary Shares |
|
|
|
|
| Class of Stock |
|
|
|
|
| Number of shares issued in transaction (in shares) |
33,333,333
|
|
|
|
| Per share price of issuance (in usd per share) | $ / shares |
$ 6.00
|
|
|
|
| Proceeds of issuance of ordinary shares, net of issuance costs | $ |
$ 193.8
|
|
|
|
| Ordinary Shares | BioNTech |
|
|
|
|
| Class of Stock |
|
|
|
|
| Collaborative arrangement, rights and obligations, maximum share purchase requirement, shares (in shares) |
15,000,000
|
|
|
|
| Collaborative arrangement, rights and obligations, maximum share purchase requirement, value | $ |
$ 20.0
|
|
|
|
| Ordinary Shares | BioNTech |
|
|
|
|
| Class of Stock |
|
|
|
|
| Stockholders' equity, common stock, conversion ratio (in shares) |
|
|
|
1
|
| Ordinary Shares | Underwriters public offering |
|
|
|
|
| Class of Stock |
|
|
|
|
| Number of shares issued in transaction (in shares) |
|
58,333,336
|
|
|
| Per share price of issuance (in usd per share) | $ / shares |
|
$ 6.00
|
|
|
| Proceeds of issuance of ordinary shares, net of issuance costs | $ |
|
$ 326.8
|
|
|
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v3.24.3
Share-based Compensation - Share-based Compensation Allocation (Details) - USD ($)
$ in Thousands |
3 Months Ended |
9 Months Ended |
Sep. 30, 2024 |
Sep. 30, 2023 |
Sep. 30, 2024 |
Sep. 30, 2023 |
| Share-based Compensation Arrangement by Share-based Payment Award |
|
|
|
|
| Total share-based compensation expense |
$ 4,020
|
$ 2,864
|
$ 9,239
|
$ 7,948
|
| Research and development |
|
|
|
|
| Share-based Compensation Arrangement by Share-based Payment Award |
|
|
|
|
| Total share-based compensation expense |
1,218
|
1,525
|
2,716
|
4,982
|
| General and administrative |
|
|
|
|
| Share-based Compensation Arrangement by Share-based Payment Award |
|
|
|
|
| Total share-based compensation expense |
2,802
|
1,335
|
6,525
|
2,947
|
| Capitalized |
|
|
|
|
| Share-based Compensation Arrangement by Share-based Payment Award |
|
|
|
|
| Total share-based compensation expense |
$ 0
|
$ 4
|
$ (2)
|
$ 19
|
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v3.24.3
Share-based Compensation - Share Options Rollforward (Details)
$ / shares in Units, $ in Thousands |
9 Months Ended |
12 Months Ended |
|
Sep. 30, 2024
USD ($)
$ / shares
shares
|
Dec. 31, 2023
USD ($)
$ / shares
shares
|
| Number of Options |
|
|
| Beginning balance (in shares) | shares |
17,956,385
|
|
| Granted (in shares) | shares |
3,797,650
|
|
| Exercised (in shares) | shares |
(214,398)
|
|
| Forfeited (in shares) | shares |
(902,906)
|
|
| Expired (in shares) | shares |
(254,302)
|
|
| Ending balance (in shares) | shares |
20,382,429
|
17,956,385
|
| Exercisable (in shares) | shares |
8,879,183
|
|
| Vested and expected to vest (in shares) | shares |
20,382,429
|
|
| Weighted- Average Exercise Price per share |
|
|
| Beginning balance (in usd per share) | $ / shares |
$ 5.64
|
|
| Granted (in usd per share) | $ / shares |
4.19
|
|
| Exercised (in usd per share) | $ / shares |
2.77
|
|
| Forfeited (in usd per share) | $ / shares |
3.30
|
|
| Expired (in usd per share) | $ / shares |
9.41
|
|
| Ending balance (in usd per share) | $ / shares |
5.45
|
$ 5.64
|
| Exercisable (in usd per share) | $ / shares |
8.13
|
|
| Vested and expected to vest (in usd per share) | $ / shares |
$ 5.45
|
|
| Weighted- Average Remaining Contractual Term (Years) |
|
|
| Weighted average contractual term outstanding |
7 years 11 months 23 days
|
8 years 4 months 6 days
|
| Weighted average contractual term exercisable |
6 years 10 months 17 days
|
|
| Weighted average contractual term vested and expected to vest |
7 years 11 months 23 days
|
|
| Aggregate Intrinsic Value |
|
|
| Options outstanding, Aggregate Intrinsic Value | $ |
$ 13,411
|
$ 48,968
|
| Options granted, Aggregate Intrinsic Value | $ |
268
|
|
| Options exercised, Aggregate Intrinsic Value | $ |
480
|
|
| Options forfeited, Aggregate Intrinsic Value | $ |
857
|
|
| Options expired, Aggregate Intrinsic Value | $ |
5
|
|
| Options exercisable | $ |
4,561
|
|
| Options vested and expected to vest | $ |
$ 13,411
|
|
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-Paragraph 2
-Subparagraph (a)(1)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480429/718-10-50-2
Reference 4: http://www.xbrl.org/2003/role/disclosureRef
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-Section 50
-Paragraph 2
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-URI https://asc.fasb.org/1943274/2147480429/718-10-50-2
Reference 5: http://www.xbrl.org/2003/role/disclosureRef
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-URI https://asc.fasb.org/1943274/2147480429/718-10-50-2
Reference 6: http://www.xbrl.org/2003/role/disclosureRef
-Topic 718
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-URI https://asc.fasb.org/1943274/2147480429/718-10-50-2
Reference 7: http://www.xbrl.org/2003/role/disclosureRef
-Topic 718
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Reference 8: http://www.xbrl.org/2003/role/disclosureRef
-Topic 718
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Reference 9: http://www.xbrl.org/2003/role/disclosureRef
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Reference 10: http://www.xbrl.org/2003/role/disclosureRef
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Reference 11: http://www.xbrl.org/2003/role/disclosureRef
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Reference 12: http://www.xbrl.org/2003/role/disclosureRef
-Topic 718
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Reference 13: http://www.xbrl.org/2003/role/disclosureRef
-Topic 718
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-URI https://asc.fasb.org/1943274/2147480429/718-10-50-2
Reference 14: http://www.xbrl.org/2003/role/disclosureRef
-Topic 718
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-URI https://asc.fasb.org/1943274/2147480429/718-10-50-2
Reference 15: http://www.xbrl.org/2003/role/disclosureRef
-Topic 718
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Reference 16: http://www.xbrl.org/2003/role/disclosureRef
-Topic 718
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Reference 17: http://www.xbrl.org/2003/role/disclosureRef
-Topic 718
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-URI https://asc.fasb.org/1943274/2147480429/718-10-50-2
Reference 18: http://www.xbrl.org/2003/role/disclosureRef
-Topic 718
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-Section 50
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-URI https://asc.fasb.org/1943274/2147480429/718-10-50-2
Reference 19: http://www.xbrl.org/2003/role/disclosureRef
-Topic 718
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-Section 50
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Reference 20: http://www.xbrl.org/2003/role/disclosureRef
-Topic 718
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-Section 50
-Paragraph 2
-Subparagraph (d)(1)
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-URI https://asc.fasb.org/1943274/2147480429/718-10-50-2
Reference 21: http://www.xbrl.org/2003/role/disclosureRef
-Topic 718
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-Section 50
-Paragraph 2
-Subparagraph (d)(2)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480429/718-10-50-2
Reference 22: http://www.xbrl.org/2003/role/disclosureRef
-Topic 718
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 2
-Subparagraph (e)(1)
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-URI https://asc.fasb.org/1943274/2147480429/718-10-50-2
Reference 23: http://www.xbrl.org/2003/role/disclosureRef
-Topic 718
-SubTopic 10
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-Section 50
-Paragraph 2
-Subparagraph (e)(2)
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-URI https://asc.fasb.org/1943274/2147480429/718-10-50-2
Reference 24: http://www.xbrl.org/2003/role/disclosureRef
-Topic 718
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 2
-Subparagraph (f)(2)(i)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480429/718-10-50-2
Reference 25: http://www.xbrl.org/2003/role/disclosureRef
-Topic 718
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 2
-Subparagraph (f)(2)(ii)
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-URI https://asc.fasb.org/1943274/2147480429/718-10-50-2
Reference 26: http://www.xbrl.org/2003/role/disclosureRef
-Topic 718
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-URI https://asc.fasb.org/1943274/2147480429/718-10-50-2
Reference 27: http://www.xbrl.org/2003/role/disclosureRef
-Topic 718
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-Paragraph 2
-Subparagraph (f)(2)(iv)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480429/718-10-50-2
Reference 28: http://www.xbrl.org/2003/role/disclosureRef
-Topic 718
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-Section 50
-Paragraph 2
-Subparagraph (f)(2)(v)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480429/718-10-50-2
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| X |
- DefinitionAmount of accumulated difference between fair value of underlying shares on dates of exercise and exercise price on options exercised (or share units converted) into shares. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Topic 718
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-URI https://asc.fasb.org/1943274/2147480429/718-10-50-2
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| X |
- DefinitionThe weighted average grant-date fair value of options granted during the reporting period as calculated by applying the disclosed option pricing methodology. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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-URI https://asc.fasb.org/1943274/2147480429/718-10-50-2
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| X |
- DefinitionAn excess of the fair value of the modified award over the fair value of the award immediately before the modification. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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-SubTopic 10
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-Section 50
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-URI https://asc.fasb.org/1943274/2147480429/718-10-50-2
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| X |
- Details
| Name: |
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| Namespace Prefix: |
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| Namespace Prefix: |
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v3.24.3
| X |
- DefinitionThe number of equity-based payment instruments, excluding stock (or unit) options, that were forfeited during the reporting period. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Topic 718
-SubTopic 10
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-URI https://asc.fasb.org/1943274/2147480429/718-10-50-2
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| Data Type: |
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| Balance Type: |
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| X |
- DefinitionWeighted average fair value as of the grant date of equity-based award plans other than stock (unit) option plans that were not exercised or put into effect as a result of the occurrence of a terminating event. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Topic 718
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| X |
- DefinitionThe number of non-vested equity-based payment instruments, excluding stock (or unit) options, that validly exist and are outstanding as of the balance sheet date. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Topic 718
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-URI https://asc.fasb.org/1943274/2147480429/718-10-50-2
Reference 2: http://www.xbrl.org/2003/role/disclosureRef
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-URI https://asc.fasb.org/1943274/2147480429/718-10-50-2
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| X |
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| X |
- DefinitionPer share or unit weighted-average fair value of nonvested award under share-based payment arrangement. Excludes share and unit options. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Topic 718
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Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Topic 718
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-URI https://asc.fasb.org/1943274/2147480429/718-10-50-2
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| X |
- References
+ Details
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| Namespace Prefix: |
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| Balance Type: |
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| X |
- DefinitionThe number of equity-based payment instruments, excluding stock (or unit) options, that vested during the reporting period. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Topic 718
-SubTopic 10
-Name Accounting Standards Codification
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-URI https://asc.fasb.org/1943274/2147480429/718-10-50-2
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| X |
- DefinitionThe weighted average fair value as of grant date pertaining to an equity-based award plan other than a stock (or unit) option plan for which the grantee gained the right during the reporting period, by satisfying service and performance requirements, to receive or retain shares or units, other instruments, or cash in accordance with the terms of the arrangement. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Topic 718
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-URI https://asc.fasb.org/1943274/2147480429/718-10-50-2
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| Namespace Prefix: |
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| Balance Type: |
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| Period Type: |
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|
v3.24.3
Liabilities related to future royalties and milestones, net - Schedule of Liability Related to Revenue (Details) - USD ($)
|
3 Months Ended |
9 Months Ended |
Sep. 30, 2024 |
Jun. 30, 2024 |
Mar. 31, 2024 |
Dec. 31, 2023 |
Sep. 30, 2023 |
Jun. 30, 2023 |
Mar. 31, 2023 |
Sep. 30, 2024 |
Sep. 30, 2023 |
| Collaborative Agreements, Debt Liability |
|
|
|
|
|
|
|
|
|
| Beginning Balance |
$ 238,663,000
|
$ 228,494,000
|
$ 170,899,000
|
$ 140,778,000
|
$ 135,764,000
|
$ 130,805,000
|
$ 125,900,000
|
$ 170,899,000
|
$ 125,900,000
|
| Initial recognition of BioNTech liability |
|
|
38,335,000
|
|
|
|
|
|
|
| Interest expense on liability related to future royalties and milestones, net |
10,280,000
|
10,169,000
|
8,390,000
|
5,014,000
|
5,014,000
|
4,959,000
|
4,905,000
|
28,839,000
|
14,878,000
|
| Cumulative catch-up adjustment |
0
|
|
10,870,000
|
25,107,000
|
0
|
|
|
10,870,000
|
0
|
| Ending Balance |
$ 248,943,000
|
$ 238,663,000
|
$ 228,494,000
|
$ 170,899,000
|
$ 140,778,000
|
$ 135,764,000
|
$ 130,805,000
|
$ 248,943,000
|
$ 140,778,000
|
| X |
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|
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|
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| Balance Type: |
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| Period Type: |
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|
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|
v3.24.3
Liabilities related to future royalties and milestones, net - Narrative (Details)
|
1 Months Ended |
3 Months Ended |
9 Months Ended |
|
|
|
Dec. 31, 2022
USD ($)
payment
|
Nov. 30, 2021
USD ($)
|
Sep. 30, 2024
USD ($)
financialInstrument
|
Jun. 30, 2024
USD ($)
|
Mar. 31, 2024
USD ($)
|
Dec. 31, 2023
USD ($)
|
Sep. 30, 2023
USD ($)
|
Jun. 30, 2023
USD ($)
|
Mar. 31, 2023
USD ($)
|
Sep. 30, 2024
USD ($)
financialInstrument
|
Sep. 30, 2023
USD ($)
|
Feb. 06, 2024 |
Nov. 06, 2021
USD ($)
|
| Class of Warrant or Right [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
| Interest expense on liability related to future royalties and milestones, net |
|
|
$ 10,280,000
|
$ 10,169,000
|
$ 8,390,000
|
$ 5,014,000
|
$ 5,014,000
|
$ 4,959,000
|
$ 4,905,000
|
$ 28,839,000
|
$ 14,878,000
|
|
|
| Cumulative catch-up adjustment |
|
|
0
|
|
$ 10,870,000
|
25,107,000
|
$ 0
|
|
|
10,870,000
|
$ 0
|
|
|
| Number of development payments | payment |
2
|
|
|
|
|
|
|
|
|
|
|
|
|
| Contract with customer, liability |
|
|
$ 203,400,000
|
|
|
|
|
|
|
$ 203,400,000
|
|
|
|
| Number of freestanding financial instruments | financialInstrument |
|
|
1
|
|
|
|
|
|
|
1
|
|
|
|
| Contract with customer, liability, noncurrent |
|
|
$ 248,943,000
|
|
|
$ 170,899,000
|
|
|
|
$ 248,943,000
|
|
|
|
| BioNTech Liability |
|
|
|
|
|
|
|
|
|
|
|
|
|
| Class of Warrant or Right [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
| Interest rate (in percent) |
|
|
28.70%
|
|
|
|
|
|
|
28.70%
|
|
28.70%
|
|
| Blackstone Collaboration Agreement |
|
|
|
|
|
|
|
|
|
|
|
|
|
| Class of Warrant or Right [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
| Number of freestanding financial instruments | financialInstrument |
|
|
4
|
|
|
|
|
|
|
4
|
|
|
|
| Blackstone | Blackstone Collaboration Agreement |
|
|
|
|
|
|
|
|
|
|
|
|
|
| Class of Warrant or Right [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
| Contract with customer, liability gross |
|
$ 50,000,000.0
|
|
|
|
|
|
|
|
|
|
|
|
| Contract with customer, liability |
$ 35,000,000.0
|
|
|
|
|
|
|
|
|
|
|
|
|
| Remaining performance obligation, variable consideration amount |
$ 30,000,000
|
|
|
|
|
|
|
|
|
|
|
|
|
| Blackstone | Affiliated Entity | Obe-cel Product |
|
|
|
|
|
|
|
|
|
|
|
|
|
| Class of Warrant or Right [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
| Contract with customer, liability gross |
|
$ 40,000,000
|
|
|
|
|
|
|
|
|
|
|
|
| Remaining performance obligation, variable consideration amount |
|
|
|
|
|
|
|
|
|
|
|
|
$ 100,000,000
|
| BioNTech |
|
|
|
|
|
|
|
|
|
|
|
|
|
| Class of Warrant or Right [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
| Contract with customer, liability, noncurrent |
|
|
$ 38,300,000
|
|
|
|
|
|
|
$ 38,300,000
|
|
|
|
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Reference 2: http://www.xbrl.org/2003/role/disclosureRef
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-Paragraph 8
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-Topic 835
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Reference 5: http://www.xbrl.org/2003/role/disclosureRef
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| X |
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| X |
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| X |
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|
v3.24.3
Leases - Narrative (Details)
$ in Thousands |
9 Months Ended |
|
|
|
Sep. 30, 2024
USD ($)
contract
|
Sep. 19, 2023 |
Oct. 31, 2021
USD ($)
|
| Lessor, Lease, Description [Line Items] |
|
|
|
| Number of manufacturing properties | contract |
2
|
|
|
| Lessor, operating lease, payment to be received |
$ 802
|
|
|
| Manufacturing Suite in Stevenage, United Kingdom |
|
|
|
| Lessor, Lease, Description [Line Items] |
|
|
|
| Operating lease contract term (in years) |
|
20 years
|
|
| Sublease, Lease Term 1 |
|
|
|
| Lessor, Lease, Description [Line Items] |
|
|
|
| Lessor, operating lease, payment to be received |
|
|
$ 97
|
| Sublease, Lease Term 2 |
|
|
|
| Lessor, Lease, Description [Line Items] |
|
|
|
| Lessor, operating lease, payment to be received |
|
|
$ 109
|
| X |
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|
v3.24.3
Leases - Lease Cost (Details) - USD ($)
$ in Thousands |
3 Months Ended |
9 Months Ended |
Sep. 30, 2024 |
Sep. 30, 2023 |
Sep. 30, 2024 |
Sep. 30, 2023 |
| Leases [Abstract] |
|
|
|
|
| Operating lease costs |
$ 2,155
|
$ 2,061
|
$ 6,340
|
$ 5,235
|
| Variable costs |
157
|
573
|
1,186
|
657
|
| Short term lease costs |
72
|
227
|
276
|
451
|
| Total lease costs |
$ 2,384
|
$ 2,861
|
7,802
|
6,343
|
| Operating cash outflows from operating leases |
|
|
$ 7,067
|
$ 7,817
|
| Weighted-average remaining lease term - operating leases |
15 years 7 months 6 days
|
15 years 10 months 24 days
|
15 years 7 months 6 days
|
15 years 10 months 24 days
|
| Weighted-average discount rate - operating leases |
8.14%
|
7.44%
|
8.14%
|
7.44%
|
| X |
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Reference 2: http://www.xbrl.org/2003/role/disclosureRef
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Reference 2: http://www.xbrl.org/2003/role/disclosureRef
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-Topic 842
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-Publisher FASB
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Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Topic 842
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-Section 50
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-Topic 842
-SubTopic 20
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-Section 55
-Paragraph 53
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147479589/842-20-55-53
Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Topic 842
-SubTopic 20
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-Section 50
-Paragraph 4
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-Topic 842
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-Section 55
-Paragraph 53
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147479589/842-20-55-53
Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Topic 842
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-Section 50
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v3.24.3
Leases - Schedule of Maturity Payments (Details) - USD ($)
$ in Thousands |
Dec. 31, 2026 |
Dec. 31, 2025 |
Dec. 31, 2024 |
Sep. 30, 2024 |
| Lessor, Lease, Description [Line Items] |
|
|
|
|
| Remainder of 2024 |
|
|
|
$ (1,941)
|
| 2025 |
|
|
|
(2,952)
|
| 2026 |
|
|
|
8,514
|
| 2027 |
|
|
|
8,912
|
| 2028 |
|
|
|
8,156
|
| Thereafter |
|
|
|
88,819
|
| Total lease payments |
|
|
|
109,508
|
| Less: imputed interest |
|
|
|
(57,279)
|
| Present value of lease liabilities |
|
|
|
$ 52,229
|
| Forecast |
|
|
|
|
| Lessor, Lease, Description [Line Items] |
|
|
|
|
| Incentive to Lessee |
$ 900
|
$ 11,300
|
$ 4,500
|
|
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-Topic 840
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-Section 30
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-Topic 842
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-Paragraph 6
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-Topic 842
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-Paragraph 3
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-Topic 842
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-Section 45
-Paragraph 1
-Subparagraph (b)
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v3.24.3
| X |
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Reference 2: http://www.xbrl.org/2003/role/disclosureRef
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| X |
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-Paragraph 12
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-Topic 842
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-Paragraph 12
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-Topic 842
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-Section 50
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v3.24.3
Commitments and Contingencies - Narrative (Details) - USD ($)
|
|
3 Months Ended |
9 Months Ended |
12 Months Ended |
Apr. 25, 2024 |
Sep. 30, 2024 |
Sep. 30, 2024 |
Dec. 31, 2023 |
| Long-term Purchase Commitment [Line Items] |
|
|
|
|
| Payments for license fees (less than) |
|
$ 100,000
|
$ 100,000
|
|
| Loss contingency accrual |
|
0
|
0
|
$ 0
|
| Miltenyi Biotech B.V. & Co. KG ("Miltenyi") |
|
|
|
|
| Long-term Purchase Commitment [Line Items] |
|
|
|
|
| Annual license fee |
|
100,000
|
100,000
|
$ 400,000
|
| Cardinal Health 105, LLC (“Cardinal Health”) |
|
|
|
|
| Long-term Purchase Commitment [Line Items] |
|
|
|
|
| Agreement term (in years) |
3 years
|
|
|
|
| Additional agreement term (in years) |
1 year
|
|
|
|
| Capital Addition Purchase Commitments |
|
|
|
|
| Long-term Purchase Commitment [Line Items] |
|
|
|
|
| Unconditional purchase obligations for capital expenditures |
|
27,100,000
|
27,100,000
|
|
| Master Supply Commitments |
|
|
|
|
| Long-term Purchase Commitment [Line Items] |
|
|
|
|
| Unconditional purchase obligations for capital expenditures |
|
$ 600,000
|
$ 600,000
|
|
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-Topic 450
-SubTopic 20
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-Section 50
-Paragraph 1
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147483076/450-20-50-1
Reference 2: http://www.xbrl.org/2003/role/recommendedDisclosureRef
-Topic 450
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-Section 50
-Paragraph 10
-Publisher FASB
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-Topic 440
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 4
-Subparagraph (b)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482648/440-10-50-4
Reference 2: http://www.xbrl.org/2009/role/commonPracticeRef
-Topic 842
-SubTopic 20
-Name Accounting Standards Codification
-Section 50
-Paragraph 3
-Subparagraph (b)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147478964/842-20-50-3
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|
| X |
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| X |
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v3.24.3
Related party transactions - Narrative (Details)
$ in Thousands |
9 Months Ended |
12 Months Ended |
|
|
|
|
|
|
|
|
|
Sep. 30, 2024
USD ($)
|
Dec. 31, 2023
USD ($)
|
Jun. 30, 2024
USD ($)
|
Mar. 31, 2024
USD ($)
|
Feb. 28, 2024
director
|
Sep. 30, 2023
USD ($)
|
Jun. 30, 2023
USD ($)
|
Mar. 31, 2023
USD ($)
|
Dec. 31, 2022
USD ($)
|
Nov. 30, 2021
director
|
| Related Party Transaction |
|
|
|
|
|
|
|
|
|
|
| Number of directors | director |
|
|
|
|
1
|
|
|
|
|
1
|
| Contract with customer, liability |
$ 203,400
|
|
|
|
|
|
|
|
|
|
| Accrued interest |
32,500
|
|
|
|
|
|
|
|
|
|
| Carrying amount of liability |
248,943
|
$ 170,899
|
$ 238,663
|
$ 228,494
|
|
$ 140,778
|
$ 135,764
|
$ 130,805
|
$ 125,900
|
|
| Blackstone Collaboration Agreement |
|
|
|
|
|
|
|
|
|
|
| Related Party Transaction |
|
|
|
|
|
|
|
|
|
|
| Carrying amount of liability |
|
170,900
|
|
|
|
|
|
|
|
|
| Non-cash interest expense, catch-up |
|
$ 45,000
|
|
|
|
|
|
|
|
|
| BioNTech Liability |
|
|
|
|
|
|
|
|
|
|
| Related Party Transaction |
|
|
|
|
|
|
|
|
|
|
| Carrying amount of liability |
45,500
|
|
|
|
|
|
|
|
|
|
| Non-cash interest expense, catch-up |
$ 5,500
|
|
|
|
|
|
|
|
|
|
| Blackstone | Autolus |
|
|
|
|
|
|
|
|
|
|
| Related Party Transaction |
|
|
|
|
|
|
|
|
|
|
| Ownership percentage by noncontrolling owners (in percent) |
10.00%
|
|
|
|
|
|
|
|
|
|
| X |
- DefinitionCollaboration Agreement, Non-Cash Interest Expense, Including Cumulative Catch-Up Adjustment
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| Namespace Prefix: |
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| Data Type: |
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| Balance Type: |
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| Period Type: |
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|
| X |
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| Namespace Prefix: |
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| Data Type: |
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| Balance Type: |
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| Period Type: |
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|
| X |
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| Namespace Prefix: |
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| Data Type: |
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| Balance Type: |
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| Period Type: |
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|
| X |
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-Topic 606
-SubTopic 10
-Name Accounting Standards Codification
-Section 45
-Paragraph 1
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147479837/606-10-45-1
Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Topic 606
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 8
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147479806/606-10-50-8
Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Topic 606
-SubTopic 10
-Name Accounting Standards Codification
-Section 45
-Paragraph 2
-Publisher FASB
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