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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
þ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended June 30, 2022
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: 001-37507
_____________________________________
IMMUNITYBIO, INC.
(Exact name of registrant as specified in its charter)
_____________________________________
Delaware 43-1979754
(State or other jurisdiction of
incorporation or organization)
(I.R.S. Employer
Identification No.)
3530 John Hopkins Court
San Diego, California
92121
(Address of principal executive offices) (Zip Code)
Registrant’s telephone number, including area code: (858) 633-0300
_____________________________________
Securities registered pursuant to Section 12(b) of the Act:
Title of each class Trading Symbol(s) Name of each exchange on which registered
Common Stock, par value $0.0001 per share IBRX The Nasdaq Global Select Market
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 þ 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 þ 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 “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer
þ
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. ¨
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ¨ No þ
The number of shares of the Registrant’s common stock outstanding as of August 4, 2022 was 400,304,106 (excluding 163,800 shares held by a majority owned subsidiary of ours which are treated as treasury shares for accounting purposes).



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PART I—FINANCIAL INFORMATION
ITEM 1.     FINANCIAL STATEMENTS.
ImmunityBio, Inc. and Subsidiaries
Condensed Consolidated Balance Sheets
(in thousands, except share and per share amounts)
June 30,
2022
December 31,
2021
(Unaudited)  
ASSETS    
Current assets:    
Cash and cash equivalents $ 61,900  $ 181,101 
Marketable securities 21,038  136,015 
Due from related parties 1,451  1,333 
Prepaid expenses and other current assets (including amounts with related parties) 30,601  15,898 
Total current assets 114,990  334,347 
Marketable securities, noncurrent 914  822 
Property, plant and equipment, net 119,445  82,863 
Intangible assets, net 21,738  1,420 
Convertible note receivable 6,503  6,379 
Operating lease right-of-use assets, net (including amounts with related parties) 48,103  36,304 
Other assets (including amounts with related parties) 6,024  6,775 
Total assets $ 317,717  $ 468,910 
LIABILITIES AND STOCKHOLDERS’ DEFICIT    
Current liabilities:    
Accounts payable $ 18,053  $ 11,418 
Accrued expenses and other liabilities 52,351  51,387 
Related-party promissory notes, current portion 300,084  299,236 
Due to related parties 4,158  3,943 
Operating lease liabilities (including amounts with related parties) 1,404  3,011 
Total current liabilities 376,050  368,995 
Related-party promissory notes, less current portion 312,541  306,349 
Operating lease liabilities, less current portion (including amounts with related parties) 50,648  37,068 
Deferred income tax liability 162  162 
Other liabilities 290  249 
Total liabilities 739,691  712,823 
Commitments and contingencies (Note 7)
Stockholders’ deficit:    
Common stock, $0.0001 par value; 900,000,000 shares authorized; 398,069,766 and
   397,830,044 shares issued and outstanding as of June 30, 2022 and
   December 31, 2021, respectively; excluding treasury stock, 163,800 shares
   outstanding as of June 30, 2022 and December 31, 2021, respectively
40  40 
Additional paid-in capital 1,739,590  1,719,704 
Accumulated deficit (2,159,335) (1,961,921)
Accumulated other comprehensive (loss) income (110)
Total ImmunityBio stockholders’ deficit (419,815) (242,173)
Noncontrolling interests (2,159) (1,740)
Total stockholders’ deficit (421,974) (243,913)
Total liabilities and stockholders’ deficit $ 317,717  $ 468,910 
The accompanying notes are an integral part of these condensed consolidated financial statements.
1

ImmunityBio, Inc. and Subsidiaries
Condensed Consolidated Statements of Operations
(in thousands, except share and per share amounts)
(Unaudited)
Three Months Ended
June 30,
Six Months Ended
June 30,
2022 2021 2022 2021
Revenue $ 35  $ 339  $ 49  $ 478 
Operating expenses:
Research and development (including amounts
   with related parties)
63,082  53,800  118,460  94,928 
Selling, general and administrative (including amounts
   with related parties)
16,575  32,445  57,183  77,720 
Total operating expenses 79,657  86,245  175,643  172,648 
Loss from operations (79,622) (85,906) (175,594) (172,170)
Other (expense) income, net:      
Interest and investment (loss) income, net (1,800) (177) (134) 8,767 
Interest expense (including amounts with related parties) (9,698) (3,577) (18,189) (6,745)
Loss on equity method investment (3,900) —  (4,097) — 
Other income, net (including amounts
   with related parties)
185  277  181  290 
Total other (expense) income, net (15,213) (3,477) (22,239) 2,312 
Loss before income taxes and noncontrolling interests (94,835) (89,383) (197,833) (169,858)
Income tax expense —  (2) —  (8)
Net loss (94,835) (89,385) (197,833) (169,866)
Net loss attributable to noncontrolling interests, net of tax (247) (1,097) (419) (1,964)
Net loss attributable to ImmunityBio common stockholders $ (94,588) $ (88,288) $ (197,414) $ (167,902)
Net loss per ImmunityBio common share – basic and diluted $ (0.24) $ (0.23) $ (0.50) $ (0.44)
Weighted-average number of common shares used in computing
   net loss per share – basic and diluted
397,991,630  384,820,486  397,937,333  383,939,031 
The accompanying notes are an integral part of these condensed consolidated financial statements.
2

ImmunityBio, Inc. and Subsidiaries
Condensed Consolidated Statements of Comprehensive Loss
(in thousands)
(Unaudited)
Three Months Ended
June 30,
Six Months Ended
June 30,
2022 2021 2022 2021
Net loss $ (94,835) $ (89,385) $ (197,833) $ (169,866)
Other comprehensive income (loss), net of income taxes:
Net unrealized gains (losses) on available-for-sale securities 149  18  (161) 17 
Reclassification of net realized gains (losses) on
   available-for-sale securities included in net loss
119  (3) 119  — 
Foreign currency translation adjustments (11) 60  (72) (102)
Total other comprehensive income (loss) 257  75  (114) (85)
Comprehensive loss (94,578) (89,310) (197,947) (169,951)
Less: Comprehensive loss attributable to noncontrolling interests (247) (1,097) (419) (1,964)
Comprehensive loss attributable to ImmunityBio
   common stockholders
$ (94,331) $ (88,213) $ (197,528) $ (167,987)
The accompanying notes are an integral part of these condensed consolidated financial statements.
3

ImmunityBio, Inc. and Subsidiaries
Condensed Consolidated Statements of Stockholders’ Deficit
(in thousands, except share amounts)
(Unaudited)
Three Months Ended June 30, 2022
Common Stock
Additional
Paid-in
Capital
Accumulated
Deficit
Accumulated
Other
Comprehensive
Loss
Total
ImmunityBio
Stockholders’
Deficit
Noncontrolling
Interests
Total
Stockholders’
Deficit
Shares Amount
Balance as of March 31, 2022
397,956,762  $ 40  $ 1,729,430  $ (2,064,747) $ (367) $ (335,644) $ (1,912) $ (337,556)
Stock-based compensation expense
—  —  10,175  —  —  10,175  —  10,175 
Exercise of stock options —  —  —  —  —  —  —  — 
Vesting of restricted stock units (RSUs)
116,608  —  —  —  —  —  —  — 
Net share settlement for RSUs vesting
(3,604) —  (15) —  —  (15) —  (15)
Other comprehensive income, net of tax
—  —  —  —  257  257  —  257 
Net loss —  —  —  (94,588) —  (94,588) (247) (94,835)
Balance as of June 30, 2022
398,069,766  $ 40  $ 1,739,590  $ (2,159,335) $ (110) $ (419,815) $ (2,159) $ (421,974)
Six Months Ended June 30, 2022
Common Stock
Additional
Paid-in
Capital
Accumulated
Deficit
Accumulated
Other
Comprehensive
Income (Loss)
Total
ImmunityBio
Stockholders’
Deficit
Noncontrolling
Interests
Total
Stockholders’
Deficit
Shares Amount
Balance as of December 31, 2021
397,830,044  $ 40  $ 1,719,704  $ (1,961,921) $ $ (242,173) $ (1,740) $ (243,913)
Stock-based compensation expense
—  —  20,199  —  —  20,199  —  20,199 
Exercise of stock options 14,767  —  74  —  —  74  —  74 
Vesting of RSUs 294,391  —  —  —  —  —  —  — 
Net share settlement for RSUs vesting
(69,436) —  (387) —  —  (387) —  (387)
Other comprehensive loss, net of tax
—  —  —  —  (114) (114) —  (114)
Net loss —  —  —  (197,414) —  (197,414) (419) (197,833)
Balance as of June 30, 2022
398,069,766  $ 40  $ 1,739,590  $ (2,159,335) $ (110) $ (419,815) $ (2,159) $ (421,974)
The accompanying notes are an integral part of these condensed consolidated financial statements.
4

ImmunityBio, Inc. and Subsidiaries
Condensed Consolidated Statements of Stockholders’ Deficit
(in thousands, except share amounts)
(Unaudited)
Three Months Ended June 30, 2021
Common Stock
Additional
Paid-in
Capital
Accumulated
Deficit
Accumulated
Other
Comprehensive
(Loss) Income
Total
ImmunityBio
Stockholders’
Deficit
Noncontrolling
Interests
Total
Stockholders’
Deficit
Shares Amount
Balance as of March 31, 2021
383,067,321  $ 38  $ 1,508,958  $ (1,694,745) $ (38) $ (185,787) $ 451  $ (185,336)
Issuance of common stock under “at-the-market”
   offering, net of commissions and
   offering costs of $3,077
6,420,441  94,886  —  —  94,887  —  94,887 
Stock-based compensation expense
—  —  17,863  —  —  17,863  —  17,863 
Exercise of stock options 759,639  —  3,311  —  —  3,311  —  3,311 
Vesting of RSUs 100,359  —  —  —  —  —  —  — 
Net share settlement for RSUs vesting
(20) —  —  —  —  —  —  — 
Other comprehensive income, net of tax
—  —  —  —  75  75  —  75 
Net loss —  —  —  (88,288) —  (88,288) (1,097) (89,385)
Balance as of June 30, 2021
390,347,740  $ 39  $ 1,625,018  $ (1,783,033) $ 37  $ (157,939) $ (646) $ (158,585)
Six Months Ended June 30, 2021
Common Stock
Additional
Paid-in
Capital
Accumulated
Deficit
Accumulated
Other
Comprehensive
Income
Total
ImmunityBio
Stockholders’
Deficit
Noncontrolling
Interests
Total
Stockholders’
Deficit
Shares Amount
Balance as of December 31, 2020
382,243,142 $ 38  $ 1,495,163  $ (1,615,131) $ 122  $ (119,808) $ 1,318  $ (118,490)
Issuance of common stock under “at-the-market”
   offering, net of commissions and
   offering costs of $3,077
6,420,441 94,886  —  —  94,887  —  94,887 
Stock-based compensation expense
—  —  33,161  —  —  33,161  —  33,161 
Exercise of stock options 1,450,104 —  4,432  —  —  4,432  —  4,432 
Vesting of RSUs 336,084 —  —  —  —  —  —  — 
Net share settlement for RSUs vesting
(102,031) —  (2,624) —  —  (2,624) —  (2,624)
Other comprehensive loss, net of tax
—  —  —  —  (85) (85) —  (85)
Net loss —  —  —  (167,902) —  (167,902) (1,964) (169,866)
Balance as of June 30, 2021
390,347,740 $ 39  $ 1,625,018  $ (1,783,033) $ 37  $ (157,939) $ (646) $ (158,585)
The accompanying notes are an integral part of these condensed consolidated financial statements.
5

ImmunityBio, Inc. and Subsidiaries
Condensed Consolidated Statements of Cash Flows
(in thousands)
(Unaudited)
  Six Months Ended
June 30,
  2022 2021
Operating activities:  
Net loss $ (197,833) $ (169,866)
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation expense 20,199  33,161 
Depreciation and amortization 8,534  6,956 
Non-cash interest items, net (including amounts with related parties) 6,922  6,248 
Loss on equity method investment 4,097  — 
Non-cash lease expense related to operating lease right-of-use assets 2,805  2,269 
Amortization of net premiums and discounts on marketable debt securities 1,308  248 
Unrealized losses (gains) on equity securities 452  (8,391)
Other 25  (291)
Changes in operating assets and liabilities:
Prepaid expenses and other current assets (14,474) 5,420 
Other assets 699  (4,199)
Accounts payable 6,535  2,600 
Accrued expenses and other liabilities 602  (3,821)
Related parties (3,859) 2,579 
Operating lease liabilities (2,194) (2,977)
Net cash used in operating activities (166,182) (130,064)
Investing activities:
Purchases of property, plant and equipment (43,296) (15,128)
Purchase of intangible assets (21,229) — 
Purchases of marketable debt securities, available-for-sale (34,207) (266)
Maturities of marketable debt securities, available for sale 113,434  44,159 
Proceeds from sales of marketable debt and equity securities 33,657  13,569 
Investment in joint venture – an equity method investment (1,000) — 
Net cash provided by investing activities 47,359  42,334 
Financing activities:
Proceeds from equity offering, net of issuance costs paid —  95,026 
Proceeds from issuance of related-party promissory notes,
   net of issuance costs paid
—  40,000 
Proceeds from exercises of stock options 74  4,432 
Net share settlement for RSUs vesting (387) (2,624)
Net cash (used in) provided by financing activities (313) 136,834 
Effect of exchange rate changes on cash, cash equivalents, and restricted cash 80  (61)
Net change in cash, cash equivalents, and restricted cash (119,056) 49,043 
Cash, cash equivalents, and restricted cash, beginning of period 181,280  35,094 
Cash, cash equivalents, and restricted cash, end of period $ 62,224  $ 84,137 
The accompanying notes are an integral part of these condensed consolidated financial statements.
6

ImmunityBio, Inc. and Subsidiaries
Condensed Consolidated Statements of Cash Flows (Continued)
(in thousands)
(Unaudited)
  Six Months Ended
June 30,
  2022 2021
Reconciliation of cash, cash equivalents, and restricted cash, end of period:    
Cash and cash equivalents $ 61,900  $ 83,958 
Restricted cash 324  179 
Cash, cash equivalents, and restricted cash, end of period $ 62,224  $ 84,137 
Supplemental disclosure of cash flow information:    
Cash paid during the period for:    
Interest $ 11,149  $ 842 
Income taxes —  10 
Supplemental disclosure of non-cash activities:    
Right-of-use assets obtained in exchange for operating lease liabilities $ 13,986  $ 12,361 
Property and equipment purchases included in accounts payable,
   accrued expenses and due to related parties
13,454  8,347 
Unrealized (losses) gains on marketable debt securities, net (42) 17 
Unpaid offering costs included in accounts payable and accrued expenses —  140 
The accompanying notes are an integral part of these condensed consolidated financial statements.
7

ImmunityBio, Inc. and Subsidiaries
Notes to Unaudited Condensed Consolidated Financial Statements
1.    Description of Business
In these notes to unaudited condensed consolidated financial statements, the terms “ImmunityBio,” “the company,” “the combined company,” “we,” “us,” and “our” refer to ImmunityBio and subsidiaries.
Our Business
ImmunityBio, Inc. is a clinical-stage biotechnology company developing next-generation therapies and vaccines that complement, harness, and amplify the immune system to defeat cancers and infectious diseases. We strive to be a vertically-integrated immunotherapy company designing and manufacturing our products so they are more effective, accessible, more conveniently stored, and more easily administered to patients.
Our broad immunotherapy and cell therapy platforms are designed to attack cancer and infectious pathogens by activating both the innate immune system—natural killer (NK) cells, dendritic cells, and macrophages—and the adaptive immune system—B cells and T cells—in an orchestrated manner. The goal of this potentially best-in-class approach is to generate immunogenic cell death thereby eliminating rogue cells from the body whether they are cancerous or virally infected. Our ultimate goal is to employ this approach to establish an “immunological memory” that confers long-term benefit for the patient.
Although such designations may not lead to a faster development process or regulatory review and may not increase the likelihood that a product candidate will receive approval, N-803, our novel antibody cytokine fusion protein, has received Breakthrough Therapy and Fast Track designations in combination with bacillus Calmette-Guérin (BCG) from the United States (U.S.) Food and Drug Administration (FDA) for BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS). In May 2022, we announced the submission of a Biologics License Application (BLA) to the FDA for our product candidate, N-803 in combination with BCG for the treatment of patients with BCG-unresponsive NMIBC with CIS with or without Ta or T1 disease. In July 2022, we announced the FDA has accepted our BLA for review and set a Prescription Drug User Fee Act (PDUFA) target action date of May 23, 2023. It is unclear when the FDA will approve our BLA, if at all.
Our platforms include 9 first-in-human therapeutic agents that are currently being studied in 27 clinical trials—18 of which are in Phase 2 or 3 development—across 13 indications in liquid and solid tumors, including bladder, pancreatic and lung cancers. These are among the most frequent and lethal cancer types for which there are high failure rates for existing standards of care or, in some cases, no available effective treatment. In infectious disease, our pipeline currently targets such pathogens as the novel strain of the coronavirus (SARS-CoV-2) and human immunodeficiency virus (HIV).
We have established Good Manufacturing Practice (GMP) manufacturing capacity at scale with cutting-edge cell manufacturing expertise and ready-to-scale facilities, as well as extensive and seasoned research and development (R&D), clinical trial, and regulatory operations, and development teams.
The Merger
On December 21, 2020, NantKwest, Inc. (NantKwest) and NantCell, Inc. (formerly known as ImmunityBio, Inc., a private company) (NantCell) entered into an Agreement and Plan of Merger (the Merger Agreement), pursuant to which NantKwest and NantCell agreed to combine their businesses. The Merger Agreement provided that a wholly-owned subsidiary of the company would merge with and into NantCell (the Merger), with NantCell surviving the Merger as a wholly-owned subsidiary of the company.
8

On March 9, 2021, we completed the Merger pursuant to the terms of the Merger Agreement. Under the terms of the Merger Agreement, at the effective time of the Merger (the Effective Time), each share of NantCell common stock, par value $0.001 per share, issued and outstanding immediately prior to the Effective Time, subject to certain exceptions as set forth in the Merger Agreement, was converted automatically into a right to receive 0.8190 (the Exchange Ratio) newly issued shares of common stock, par value $0.0001 per share, of the company (Company Common Stock), with cash paid in lieu of any fractional shares. At the Effective Time, each share of the company’s common stock issued and outstanding immediately prior to the Effective Time, remained an issued and outstanding share of the combined company. At the Effective Time, each outstanding option, RSU or warrant to purchase NantCell common stock was converted using the Exchange Ratio into an option, RSU or warrant, respectively, on the same terms and conditions immediately prior to the Effective Time, to purchase shares of Company Common Stock.
Immediately following the Effective Time, the former stockholders of NantCell held approximately 71.5% of the outstanding shares of Company Common Stock and the stockholders of NantKwest as of immediately prior to the Merger held approximately 28.5% of the outstanding shares of Company Common Stock. As a result of the Merger and immediately following the Effective Time, Dr. Patrick Soon-Shiong, our Executive Chairman and Global Chief Scientific and Medical Officer, and his affiliates beneficially owned, in the aggregate, approximately 81.8% of the outstanding shares of Company Common Stock. Following the consummation of the Merger, the symbol for shares of the company’s common stock was changed to “IBRX.”
2.    Summary of Significant Accounting Policies
Basis of Presentation
The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (U.S. GAAP) and pursuant to the rules and regulations of the U.S. Securities and Exchange Commission (SEC). The unaudited condensed consolidated financial statements reflect all adjustments which are, in the opinion of management, necessary for a fair presentation of our financial position and results of operations. The unaudited condensed consolidated financial statements do not include all information and notes required by U.S. GAAP for annual reports and therefore should be read in conjunction with our consolidated financial statements and the notes thereto contained in our Annual Report on Form 10-K for the year ended December 31, 2021 filed with the SEC on March 1, 2022. These interim financials are not necessarily indicative of results expected for the full fiscal year.
Principles of Consolidation
The accompanying unaudited condensed consolidated financial statements include the accounts of the company, our wholly owned subsidiaries, and a variable interest entity (VIE) for which we are the primary beneficiary. Any material intercompany transactions and balances have been eliminated upon consolidation. For consolidated entities where we have less than 100% of ownership, we record net loss attributable to noncontrolling interest on the unaudited condensed consolidated statements of operations equal to the percentage of the ownership interest retained in such entities by the respective noncontrolling parties.
We assess whether we are the primary beneficiary of a VIE at the inception of the arrangement and at each reporting date. This assessment is based on our power to direct the activities of the VIE that most significantly impact the VIE’s economic performance and our obligation to absorb losses or the right to receive benefits from the VIE that could potentially be significant to the VIE.
9

Liquidity
As of June 30, 2022, the company had an accumulated deficit of $2.2 billion. We also had negative cash flows from operations of $166.2 million for the six months ended June 30, 2022. The company will likely need additional capital to further fund the development of, and to seek regulatory approvals for, our product candidates, and to begin to commercialize any approved products.
The condensed consolidated financial statements have been prepared assuming the company will continue as a going concern, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business, and do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or amounts and classification of liabilities that may result from the outcome of the uncertainty of our ability to continue as a going concern. As a result of continuing anticipated operating cash outflows, we believe that substantial doubt exists regarding our ability to continue as a going concern without additional funding or financial support. However, we believe our existing cash, cash equivalents, and investments in marketable securities, together with capital to be raised through equity offerings (including but not limited to the offering, issuance and sale by us of our common stock that may be issued and sold under an “at-the-market” sales agreement with Jefferies LLC (the ATM), of which we had $330.8 million available for future issuance as of June 30, 2022), and our potential ability to borrow from affiliated entities, will be sufficient to fund our operations through at least the next 12 months following the issuance date of the condensed consolidated financial statements based primarily upon our Executive Chairman and Global Chief Scientific and Medical Officer’s intent and ability to support our operations with additional funds, including loans from affiliated entities, as required, which we believe alleviates such doubt. We may also seek to sell additional equity, through one or more follow-on public offerings, or in separate financings, or obtain a credit facility. However, we may not be able to secure such external financing in a timely manner or on favorable terms. Without additional funds, we may choose to delay or reduce our operating or investment expenditures. Further, because of the risk and uncertainties associated with the potential commercialization of our product candidates in development, we may need additional funds to meet our needs sooner than planned.
Use of Estimates
The preparation of condensed consolidated financial statements in conformity with U.S. GAAP requires management to make certain estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements and the reported amounts of revenues and expenses during the reporting period. On an ongoing basis, we evaluate our estimates, including those related to the valuation of equity-based awards, deferred income taxes and related valuation allowances, preclinical and clinical trial accruals, impairment assessments, contingent value right measurement and assessments, the measurement of right-of-use assets and lease liabilities, useful lives of long-lived assets, loss contingencies, fair value measurements, asset acquisition, and the assessment of our ability to fund our operations for at least the next 12 months from the date of issuance of these condensed consolidated financial statements. We base our estimates on historical experience and on various other market-specific and relevant assumptions that we believe to be reasonable under the circumstances. Estimates are assessed each period and updated to reflect current information, such as the economic considerations related to the impact that the ongoing coronavirus pandemic could have on our significant accounting estimates. Actual results could differ from those estimates.
Significant Accounting Policies
There have been no material changes to our significant accounting policies from those described in Note 2, Summary of Significant Accounting Policies, of the “Notes to Consolidated Financial Statements” that appears in Part II, Item 8. “Financial Statements and Supplementary Data” of our Annual Report on Form 10-K filed with the SEC on March 1, 2022.
10

Acquisitions
We make certain judgments to determine whether transactions should be accounted for as acquisitions of assets or as business combinations. If it is determined that substantially all of the fair value of gross assets acquired in a transaction is concentrated in a single asset (or a group of similar assets), the transaction is treated as an acquisition of assets. We evaluate the inputs, processes, and outputs associated with the acquired set of activities and assets. If the assets in a transaction include an input and a substantive process that together significantly contribute to the ability to create outputs, the transaction is treated as an acquisition of a business.
We account for business combinations using the acquisition method of accounting, which requires that assets acquired and liabilities assumed generally be recorded at their fair values as of the acquisition date. Excess of consideration over the fair value of net assets acquired is recorded as goodwill. Estimating fair value requires us to make significant judgments and assumptions. We perform impairment testing of goodwill annually or more frequently if events or changes in circumstances indicate that it is more likely than not that the asset is impaired.
In transactions accounted for as asset acquisitions, the cost of an asset acquisition, including transaction costs, are allocated to identifiable assets acquired and liabilities assumed based on a relative fair value basis. Goodwill is not recognized in an asset acquisition. Any difference between the cost of an asset acquisition and the fair value of the net assets acquired is allocated to the non-monetary identifiable assets based on their relative fair values. In an asset acquisition, upfront payments allocated to in-process research and development projects at the acquisition date are expensed unless there is an alternative future use. In addition, product development milestones are expensed upon achievement. Any contingent consideration, such as payments upon achievement of various developmental, regulatory and commercial milestones, generally is not recognized at the acquisition date.
Basic and Diluted Net Loss per Share of Common Stock
Basic net loss per share is calculated by dividing the net loss attributable to ImmunityBio common stockholders by the weighted-average number of common shares outstanding for the period. Diluted loss per share is computed by dividing net loss attributable to ImmunityBio common stockholders by the weighted-average number of common shares, including the number of additional shares that would have been outstanding if the potential common shares had been issued and if the additional common shares were dilutive.
For all periods presented, potentially dilutive securities are excluded from the computation of fully diluted loss per share as their effect is anti-dilutive. The following table details those securities that have been excluded from the computation of potentially dilutive securities:
As of June 30,
2022 2021
(Unaudited)
Outstanding stock options 9,447,190  4,330,318 
Outstanding RSUs 6,867,512  7,443,504 
Outstanding related-party warrants 1,638,000  1,638,000 
Total 17,952,702  13,411,822 
Amounts in the table above reflect the common stock equivalents of the noted instruments, including awards issued under the NantKwest 2015 Equity Incentive Plan (the 2015 Plan) and the NantKwest 2014 Equity Incentive Plan. At the Effective Time, each outstanding option or RSU issued under the 2015 NantCell Stock Incentive Plan and warrants issued by NantCell to purchase or acquire NantCell common stock were converted using the Exchange Ratio into an option, RSU or warrant, respectively, on the same terms and conditions immediately prior to the Effective Time. See Note 11, Stock-Based Compensation, for further information.
11

Recent Accounting Pronouncements
Application of New or Revised Accounting Standards – Adopted
In May 2021, the FASB issued Accounting Standards Update (ASU) 2021-04, Earnings Per Share (Topic 260), Debt—Modifications and Extinguishments (Subtopic 470-50), Compensation—Stock Compensation (Topic 718), and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40). This update provides guidance to clarify and reduce diversity in an accounting for modifications or exchanges of freestanding equity-classified written call options (for example, warrants) that is not within the scope of another Topic. An entity should treat a modification of the terms or conditions or an exchange of a freestanding equity-classified written call option that remains equity classified after modification or exchange as an exchange of the original instrument for a new instrument. This update additionally provides further guidance on measuring the effect of a modification or an exchange of a freestanding equity-classified written call option that remains equity classified after modification or exchange on the basis of the substance of the transaction, in the same manner as if cash had been paid as consideration. This guidance is effective for the fiscal years beginning after December 15, 2021, including interim periods within those fiscal years. The company adopted this guidance on January 1, 2022 on a prospective basis. The adoption did not have a material impact on the company’s condensed consolidated financial statements.
In August 2020, the FASB issued ASU 2020-06, Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity, which simplifies and clarifies certain calculation and presentation matters related to convertible equity and debt instruments. Specifically, ASU 2020-06 removes requirements to separately account for conversion features as a derivative under ASC Topic 815 and removing the requirement to account for beneficial conversion features on such instruments. In addition, ASU 2020-06 eliminates the treasury stock method when calculating diluted earnings per share for convertible instruments that can be settled in whole or in part with equity and requires the use of the if-converted method. The guidance is effective for fiscal years beginning after December 15, 2021, including interim periods within those fiscal years. The company adopted this guidance on January 1, 2022 on a modified prospective basis. The adoption did not have a material impact on the company’s condensed consolidated financial statements.
Other recent authoritative guidance issued by the FASB (including technical corrections to the ASC), the American Institute of Certified Public Accountants, and the SEC during the six months ended June 30, 2022 did not, or are not expected to, have a material effect on our condensed consolidated financial statements.
12

3.    Financial Statement Details
Prepaid Expenses and Other Current Assets
Prepaid expenses and other current assets consist of the following (in thousands):
June 30,
2022
December 31,
2021
(Unaudited)
Prepaid services $ 16,958  $ 6,966 
Insurance claims receivable 5,005  — 
Prepaid supplies 2,160  — 
Prepaid software license fees 1,849  1,111 
Prepaid insurance 1,630  2,266 
Other 2,999  5,555 
Prepaid expenses and other current assets $ 30,601  $ 15,898 
Property, Plant and Equipment, Net
Property, plant and equipment, net, consist of the following (in thousands):
June 30,
2022
December 31,
2021
(Unaudited)
Leasehold improvements $ 68,406  $ 62,482 
Equipment 62,059  54,284 
Construction in progress 46,454  16,575 
Software 1,658  1,544 
Furniture & fixtures 1,533  1,052 
Gross property, plant and equipment 180,110  135,937 
Less: Accumulated depreciation and amortization 60,665  53,074 
Property, plant and equipment, net $ 119,445  $ 82,863 
Depreciation expense related to property, plant and equipment totaled $3.9 million and $4.0 million for the three months ended June 30, 2022 and 2021, respectively, and $7.7 million and $7.0 million for the six months ended June 30, 2022 and 2021, respectively.
13

Accrued Expenses and Other Liabilities
Accrued expenses and other liabilities consist of the following (in thousands):
June 30,
2022
December 31,
2021
(Unaudited)  
Accrued litigation payable (Note 7)
$ 15,656  $ 7,118 
Accrued construction costs 8,931  8,145 
Accrued preclinical and clinical trial costs 5,888  5,842 
Accrued bonus 5,754  8,316 
Accrued professional and service fees 5,744  6,909 
Accrued compensation 5,635  5,613 
Accrued research and development costs 2,521  2,107 
Accrued laboratory equipment, supplies and related services 577  2,144 
Other 1,645  5,193 
Accrued expenses and other liabilities $ 52,351  $ 51,387 
Interest and Investment (Loss) Income, Net
Interest and investment (loss) income, net consists of the following (in thousands):
Three Months Ended
June 30,
Six Months Ended
June 30,
2022 2021 2022 2021
(Unaudited) (Unaudited)
Unrealized (losses) gains from equity securities $ (1,871) $ (442) $ (452) $ 8,391 
Interest income 644  112  1,940  451 
Investment amortization expense, net (454) (23) (1,503) (248)
Net realized (losses) gains on investments (119) 176  (119) 173 
Interest and investment (loss) income , net $ (1,800) $ (177) $ (134) $ 8,767 
Interest income includes interest from marketable securities, convertible notes receivable, other assets, and interest from bank deposits.
14

4.    Financial Instruments
Investments in Marketable Debt Securities
As of June 30, 2022, the weighted-average remaining contractual life, amortized cost, gross unrealized gains, gross unrealized losses and fair value of marketable debt securities, which were considered as available-for-sale, by type of security were as follows (in thousands):
  June 30, 2022
  (Unaudited)
Weighted-
Average
Remaining
Contractual Life
(in years)
Amortized
Cost
Gross
Unrealized
Gains
Gross
Unrealized
Losses
Fair
Value
Current:
Corporate debt securities 0.1 $ 14,764  $ —  $ (9) $ 14,755 
Mutual funds 34  (6) 37 
Current portion 14,798  (15) 14,792 
Noncurrent:
Foreign bonds 4.8 969  (56) 914 
Noncurrent portion 969  (56) 914 
Total $ 15,767  $ 10  $ (71) $ 15,706 
As of December 31, 2021, the amortized cost, gross unrealized gains, gross unrealized losses and fair value of marketable debt securities, which were considered as available-for-sale, by type of security were as follows (in thousands):
December 31, 2021
Weighted-
Average
Remaining
Contractual Life
(in years)
Amortized
Cost
Gross
Unrealized
Gains
Gross
Unrealized
Losses
Fair 
Value
Current:
Corporate debt securities 0.5 $ 129,190  $ 10  $ (36) $ 129,164 
Foreign bonds 0.4 116  —  (1) 115 
Mutual funds 35  —  38 
Current portion 129,341  13  (37) 129,317 
Noncurrent:
Foreign bonds 5.0 719  103  —  822 
Noncurrent portion 719  103  —  822 
Total $ 130,060  $ 116  $ (37) $ 130,139 
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Accumulated unrealized losses on marketable debt securities that have been in a continuous loss position for less than 12 months and more than 12 months were as follows (in thousands):
June 30, 2022
(Unaudited)
Less than 12 months More than 12 months
Estimated
Fair
Value
Gross
Unrealized
Losses
Estimated
Fair
Value
Gross
Unrealized
Losses
Corporate debt securities $ 7,074  $ (9) $ —  $ — 
Mutual funds —  —  31  (6)
Foreign bonds 720  (41) 89  (15)
Total $ 7,794  $ (50) $ 120  $ (21)

December 31, 2021
Less than 12 months More than 12 months
Estimated
Fair
Value
Gross
Unrealized
Losses
Estimated
Fair
Value
Gross
Unrealized
Losses
Corporate debt securities $ 86,158  $ (36) $ —  $ — 
Mutual funds —  —  34  (2)
Foreign bonds 115  (1) 113  (1)
Total $ 86,273  $ (37) $ 147  $ (3)
Realized gains and losses on sales of available-for-sale marketable debt securities were not material for the three and six months ended June 30, 2022 and 2021.
Marketable Equity Securities
We held investments in marketable equity securities with readily determinable fair values of $6.2 million and $6.7 million as of June 30, 2022 and December 31, 2021, respectively. Unrealized losses recorded on these securities totaled $1.9 million and $0.4 million for the three months ended June 30, 2022 and 2021, respectively, and unrealized losses and gains totaled a $0.5 million loss and an $8.4 million gain for the six months ended June 30, 2022 and 2021, respectively, in interest and investment income loss (income), net, on the condensed consolidated statements of operations.
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5.    Fair Value Measurements
Fair value is defined as an exit price that would be received from the sale of an asset or paid to transfer a liability in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. We use a three-tier fair value hierarchy to classify and disclose all assets and liabilities measured at fair value on a recurring basis, as well as assets and liabilities measured at fair value on a non-recurring basis, in periods subsequent to their initial measurement. The hierarchy requires us to use observable inputs when available, and to minimize the use of unobservable inputs, when determining fair value.
The three tiers are defined as follows:
Level 1—Observable inputs that reflect quoted market prices (unadjusted) for identical assets or liabilities in active markets at the measurement date. Since valuations are based on quoted prices that are readily and regularly available in an active market, the valuation of these products does not entail a significant degree of judgment. Our Level 1 assets consist of bank deposits, money market funds, and marketable equity securities.
Level 2—Observable inputs other than quoted prices in active markets that are observable either directly or indirectly in the marketplace for identical or similar assets and liabilities. Our Level 2 assets consist of corporate debt securities including commercial paper, government-sponsored securities and corporate bonds, as well as foreign municipal securities.
Level 3—Valuations based on inputs that are unobservable and significant to the overall fair value measurement.
We utilize a third-party pricing service to assist in obtaining fair value pricing for our investments in marketable debt securities. Inputs are documented in accordance with the fair value disclosure hierarchy. The fair values of financial instruments other than marketable securities and cash and cash equivalents are determined through a combination of management estimates and third-party valuations.
Recurring Valuations
Financial assets and liabilities measured at fair value on a recurring basis are summarized below (in thousands):
Fair Value Measurements at June 30, 2022
(Unaudited)
Total Level 1 Level 2 Level 3
Assets:
Current:
Cash and cash equivalents $ 61,900  $ 61,900  $ —  $ — 
Equity securities 6,246  6,246  —  — 
Corporate debt securities 14,755  —  14,755  — 
Mutual funds 37  37  —  — 
Noncurrent:
Foreign bonds 914  —  914  — 
Total assets measured at fair value $ 83,852  $ 68,183  $ 15,669  $ — 
Liabilities:
Accrued litigation payable $ 10,656  (1) $ 10,656  $ —  $ — 
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Fair Value Measurements at December 31, 2021
Total Level 1 Level 2 Level 3
Assets:        
Current:        
Cash and cash equivalents $ 181,101  (2) $ 51,421  $ 129,680  $ — 
Equity securities 6,698  6,698  —  — 
Corporate debt securities 129,164  —  129,164  — 
Foreign bonds 115  115  —  — 
Mutual funds 38  38  —  — 
Noncurrent:
Foreign bonds 822  822  —  — 
Total assets measured at fair value $ 317,938  $ 59,094  $ 258,844  $ — 
_______________
(1)
The accrued litigation payable as of June 30, 2022 was measured at the fair value of the company’s common stock to be issued pursuant to the terms of the court-approved settlement agreement related to the Altor BioScience, LLC litigation. On July 9, 2022, the company issued 2,229,296 shares of its common stock with an aggregate market value of $10.7 million, based on the closing price of its common stock as of July 8, 2022. See Note 7, Commitments and Contingencies—Litigation, for further information.
(2)
Amounts shown as a Level 2 measurement as of December 31, 2021 include government-sponsored securities of $75.0 million, corporate debt securities of $54.2 million, and commercial paper of $0.5 million with original maturities of less than 90 days.
6.    Collaboration and License Agreements and Acquisition
Collaboration Agreement
Amyris Joint Venture
In December 2021, ImmunityBio and Amyris, Inc. (Amyris) entered into a 50:50 joint venture arrangement and formed a new limited liability company to conduct the business of the joint venture. The purpose of the joint venture is to accelerate commercialization of a next-generation COVID-19 vaccine utilizing an RNA vaccine platform. As part of the limited liability agreement, we agreed to contribute $1.0 million in cash and priority access to our manufacturing capacity for the joint venture product. Amyris agreed to contribute $1.0 million in cash and rights to its license agreement with the Access to Advanced Health Institute (AAHI) (formerly known as the Infectious Disease Research Institute, or IDRI) for an RNA platform for the field of COVID-19. Both parties agreed to enter into a separate manufacturing and supply agreement and a sublicense agreement following the execution of the joint venture agreement.
The joint venture agreement stipulates the initial terms for equal representation in the management of the newly-formed joint venture. The joint venture is managed by a board of directors consisting of four directors: two appointed by the company and two appointed by Amyris. Both parties agreed to make additional capital contributions in cash, in proportion to their respective interests, as determined by the board of directors of the joint venture.
We considered the joint venture entity as a VIE and determined that we are not the primary beneficiary of the VIE. In February 2022, we made a cash investment totaling $1.0 million in the joint venture’s common stock. We account for our investment in the joint venture using the equity method of accounting, and recorded our 50% share of the net loss from the joint venture totaling $3.9 million and $4.1 million, respectively, in other expense, net, on the condensed consolidated statement of operations for the three and six months ended June 30, 2022. Such losses include $3.9 million of expenses incurred by us on behalf of the joint venture during the six months ended June 30, 2022. We are not obligated to fund the joint venture’s potential future losses, and therefore will not record additional equity method losses that would result in our equity investment in the joint venture to fall below zero. As of June 30, 2022, the carrying amount of our equity investment in the joint venture was zero.
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License Agreements
3M Innovative Properties Company (3M IPC) and the Access to Advanced Health Institute (AAHI) License Agreement
We have licensed rights to 3M-052, a synthetic TLR7/8 agonist, 3M-052 formulations and related technology from 3M IPC and its affiliates and AAHI. In November 2021 we obtained nonexclusive rights in the field of SARS-CoV-2 and in June 2022 we modified those rights and expanded the scope of the license to include (1) SARS-CoV-2 and other infectious diseases including malaria, HIV, tuberculosis, hookworm and varicella zoster on an exclusive basis in countries other than low- and middle-income countries (LMIC), and (2) oncology applications, when used in combination with our proprietary technology and/or IL-15 agonists. In consideration for the license, we agreed to make certain periodic license payments, including $2.25 million each year through June 2025, with the June 2022 payment being partially offset by the $0.5 million previously paid under the initial November 2021 license agreement. We have also agreed to make payments upon the achievement of certain regulatory milestone events and tiered royalties ranging from the low to high single-digits as a percentage of net sales. Beginning in April 2026, the annual minimum licensing payment is $1.0 million, which can be credited against any royalty payments due under this agreement.
We made a payment of $1.75 million for the annual license maintenance fee and recorded $0.2 million in research and development expense, on the condensed consolidated statements of operations during the three and six months ended June 30, 2022.
AAHI License Agreements
In May 2021, we entered into two license agreements with AAHI pursuant to which we received a license to certain patents and know-how relating to AAHI’s (i) adjuvant formulations for the treatment, prevention and/or diagnosis of SARS-CoV-2 (the AAHI Adjuvant Formulation License Agreement) and (ii) RNA vaccine platform as further described below (the AAHI RNA License Agreement). Under both agreements, we were obligated to pay one-time, non-creditable, non-refundable upfront cash payments totaling $2.0 million. In addition, under the AAHI Adjuvant Formulation License Agreement we owe milestone payments to a total of up to $2.5 million based on the achievement of certain development and regulatory milestones for the first licensed product and royalties on annual net sales of licensed products on a country-by-country and product-by-product basis of a low-single digit percentage, subject to certain royalty-reduction provisions. No milestone fees were incurred for the six months ended June 30, 2022.
In September 2021, we amended and restated the AAHI RNA License Agreement, pursuant to which AAHI granted us an exclusive, worldwide, sublicensable license to AAHI’s rights to an RNA vaccine platform for the development and commercialization of certain therapeutic, diagnostic or prophylactic products for the prevention, treatment or diagnosis of any indication, other than those subject to pre-existing third-party license grants, including, without limitation, SARS-CoV-2. Pursuant to the terms of the amended and restated AAHI RNA License Agreement, we made an additional one-time, non-creditable, non-refundable, upfront payment to AAHI of $1.5 million. The company is also required to pay license maintenance fees to AAHI as follows: $3.0 million in 2022 and $5.5 million annually from 2023 through 2030. The company may terminate the restated agreement without cause by paying AAHI a $10.0 million one-time early termination fee. In addition, the milestone payments to AAHI based on the achievement of certain development and regulatory milestones for the first licensed product were amended to a total of up to $4.0 million. We are required to pay royalties on annual net sales of licensed products on a country-by-country and product-by-product basis of a low to mid-single digit percentage. We made a payment of $3.0 million for the annual license maintenance fee and recorded $0.3 million in research and development expense, on the condensed consolidated statements of operations during the three and six months ended June 30, 2022.
In connection with the license agreements, in May 2021 we also entered into a sponsored research agreement with the AAHI pursuant to which we will fund continued research of at least $2.0 million per year, payable in four equal quarterly installments each year until May 2024, or such year of earlier termination.
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EnGeneIC License Agreement
During the fourth quarter of 2021, we signed a binding term sheet with EnGeneIC for an exclusive, worldwide license to develop, manufacture and commercialize their patented endosomal delivery vector (EDV) nanocell technology as a single agent in certain cancer fields and with respect to the treatment and prevention of COVID-19 and in combination with our COVID-19 vaccine and anti-cancer drugs in a more broadly defined field of use. The companies have agreed to a 50:50 split of the net profit from worldwide sales of EDV-based products, and we have agreed to pay certain periodic license fees. The parties continue to work on definitive agreements for this transaction.
Acquisition
Dunkirk Facility Leasehold Interest
On February 14, 2022, we completed the acquisition of a leasehold interest in approximately 409,000 rentable square feet of current Good Manufacturing Practice (cGMP) ISO Class 5 pharmaceutical manufacturing space in western New York (the Dunkirk Facility) from Athenex, Inc. (the Seller), which we believe provides us with a state-of-the-art biotech production center that substantially expands and diversifies our manufacturing capacity in the U.S. and ability to scale production associated with certain of our product candidates. The company accounted for the transaction as an asset acquisition because the Dunkirk Facility’s integrated set of assets and activities does not meet the definition of a business.
The total consideration for the acquisition was approximately $40.5 million, including a cash payment of $40.0 million, and transaction costs of approximately $0.5 million. The following table summarizes the fair value of assets acquired as of the acquisition date (in thousands):
Construction in progress $ 10,043 
Leasehold improvements 6,253 
Definite-lived intangible assets (1)
21,229 
Other depreciable assets and prepaid expenses 2,983 
Total consideration $ 40,508 
_______________
(1)Definite-lived intangible assets consist of favorable leasehold rights totaling $20.4 million and organized workforce totaling $0.8 million as of the acquisition date. We recorded amortization expense of $0.6 million and $0.9 million, respectively, in research and development expense, on the condensed consolidated statement of operations for the three and six months ended June 30, 2022. As of June 30, 2022, the remaining weighted-average amortization period for our definite-lived intangible assets was approximately 9.4 years. Future amortization expense for the favorable leasehold rights is as follows: $1.0 million for the remainder of 2022; $2.0 million for each of the years from 2023 to 2026; and $10.5 million thereafter. Future amortization expense for the organized workforce is as follows: $0.1 million for the remainder of 2022 and $0.3 million for 2023 and 2024.
Upon the closing of the Dunkirk transaction, the company became the tenant of the Dunkirk Facility under the Fort Schuyler Management Corporation Lease, dated October 1, 2021 and as amended as of the February 14, 2022 closing date (as amended, the Dunkirk Lease), with Fort Schuyler Management Corporation, a not-for-profit corporation affiliated with the State of New York (FSMC) as landlord. The Dunkirk Facility, as well as certain equipment, is owned by FSMC and is leased to us under the Dunkirk Lease. Our annual lease payment will be $2.00 per year for an initial 10-year term, with an option to renew the lease under substantially the same terms and conditions for an additional 10-year term. As part of the transaction, we assumed certain of the Seller’s obligations under various third-party agreements (the Facility Agreements), subject to the terms and conditions of the purchase agreement by and between the company and Seller dated as of January 7, 2022, and committed to spend an aggregate of $1.52 billion on operational expenses during the initial term, and an additional $1.50 billion on operational expenses if we elect to renew the lease for the additional 10-year term. We also committed to hiring 450 employees at the Dunkirk Facility within the first 5 years of operations, with 300 such employees to be hired within the first 2.5 years of operation. We are eligible for certain sales-tax exemption savings during the development of the Dunkirk Facility, and certain property tax savings over the next 20 years, subject to certain terms and conditions, including performance of certain of the obligations described above. Failure to satisfy the obligations over the lease term may give rise to certain rights and remedies of governmental authorities including, for example, termination of the lease agreement and other Facility Agreements and potential recoupment of a percentage of the grant funding received by the Seller for construction of the facility and other benefits received, subject to the terms and conditions of the applicable agreements.
20

7.    Commitments and Contingencies
Contingent Consideration Related to Business Combinations
VivaBioCell, S.p.A.
In April 2015, NantWorks, LLC (NantWorks), a related party, acquired a 100% interest in VivaBioCell, S.p.A. (VivaBioCell) through its wholly-owned subsidiary, VBC Holdings, LLC, (VBC Holdings) for $0.7 million, less working capital adjustments. In June 2015, NantWorks contributed its equity interest in VBC Holdings to the company, in exchange for cash consideration equal to its cost basis in the investment. VivaBioCell develops bioreactors and products based on cell culture and tissue engineering in Italy.
In connection with our acquisition of VBC, we are obligated to pay the former owners contingent consideration upon the achievement of certain milestones related to the GMP-in-a-Box technology. A clinical milestone totaling $0.8 million was earned by the former owners of VivaBioCell, of which $0.4 million was paid during 2021. The remaining $0.4 million was accrued as of June 30, 2022 and is expected to be paid in 2022. If the regulatory milestone is achieved, we are obligated to pay approximately $2.1 million.
Altor BioScience Corporation
In connection with the 2017 acquisition of Altor BioScience Corporation (Altor), we issued contingent value rights (CVRs) under which we agreed to pay the prior stockholders of Altor approximately $304.0 million contingent upon successful approval of the BLA, or foreign equivalent, for N-803 by December 31, 2022 and approximately $304.0 million contingent upon calendar-year worldwide net sales of N-803 exceeding $1.0 billion prior to December 31, 2026 (with amounts payable in cash or shares of our common stock or a combination thereof). We have submitted the BLA, and in July 2022, we announced the FDA has accepted our BLA for review and set a PDUFA target action date of May 23, 2023. It is unclear when the FDA will approve our BLA, if at all. Dr. Soon-Shiong and his related party hold approximately $279.5 million in the aggregate of CVRs and they have both irrevocably agreed to receive shares of the company’s common stock in satisfaction of their CVRs. We may be required to pay the other prior Altor stockholders up to $164.2 million in settlement of the CVRs relating to the regulatory milestone and up to $164.2 million of the CVRs relating to the sales milestone should they choose to have the CVRs paid in cash instead of common stock. As the transaction was recorded as an asset acquisition, future CVR payments will be recorded when the corresponding events are probable of achievement or the consideration becomes payable.
Litigation
From time to time, we may be involved in various claims and legal proceedings relating to claims arising out of our operations. We are not currently a party to any legal proceedings that, in the opinion of our management, are likely to have a material adverse effect on our business. We are aware of complaints that have been filed regarding the Merger, but we have not been served with any of such complaints. If we are served with any such complaints, we will assess at that time any contingencies for which we may need to reserve. Regardless of the outcome, litigation can have an adverse impact on us because of defense and settlement costs, diversion of management resources and other factors.
Altor BioScience, LLC Litigation
In 2017, NantCell announced it had entered into a definitive merger agreement to acquire Altor BioScience Corporation. An action captioned Gray v. Soon-Shiong, et al. was filed in Delaware Chancery Court by plaintiffs Clayland Boyden Gray (Gray) and Adam R. Waldman. The plaintiffs, two minority stockholders, asserted claims against the company and other defendants for (1) breach of fiduciary duty and (2) aiding and abetting breach of fiduciary duty and filed a motion to enjoin the merger. The court denied the motion and permitted the merger to close.
Subsequent to the close of the merger, in 2017 the plaintiffs (joined by two additional minority stockholders, Barbara Sturm Waldman and Douglas E. Henderson (Henderson)) filed a second amended complaint, asserting claims for (1) appraisal; (2) quasi-appraisal; (3) breach of fiduciary duty; and (4) aiding and abetting breach of fiduciary duty. The defendants moved to dismiss the second amended complaint, raising grounds that included a “standstill” agreement under which defendants maintained that Gray and Adam R. Waldman and Barbara Strum Waldman (the Waldmans) agreed not to bring the lawsuit.
21

In a second action, Dyad Pharmaceutical Corporation (Dyad) filed a petition in Delaware Chancery Court for appraisal in connection with the merger. Respondent moved to dismiss the appraisal petition in 2018, arguing in part that the petition was barred by the same “standstill” agreement. In 2018, the court heard oral arguments on the motions to dismiss in both consolidated cases and converted the motions to dismiss into motions for summary judgment with regard to the “standstill” agreement argument (the Converted Motions).
The court issued an oral ruling in 2019 that dismissed certain claims and dismissed Altor BioScience from the action. The following claims remained: (a) the appraisal claims by all plaintiffs and Dyad (against Altor BioScience, LLC), and (b) Henderson’s claims for breach of fiduciary duty and aiding and abetting breach of fiduciary duty.
In 2019, the court issued a written order implementing its ruling on the Converted Motions (the Implementing Order). In the Implementing Order, the court confirmed that all fiduciary duty claims brought by Gray, both individually and as trustee of the Gordon Gray Trust f/b/o C. Boyden Gray, were dismissed. Gray and the Waldmans filed answers denying the counterclaims and asserting defenses. The plaintiffs then moved for leave to file a third amended complaint to add two former Altor stockholders as plaintiffs and a fiduciary duty claim on behalf of a purported class of former Altor stockholders, which the defendants opposed.
In 2020, the court granted the plaintiffs’ motion, and the plaintiffs filed the third amended complaint. In 2020, the defendants answered the third amended complaint and asserted counter claims against the plaintiffs. The defendants are seeking damages for attorneys’ fees and costs incurred as a result of the breaches of the “standstill” agreements discussed above and of stockholder releases. The plaintiffs filed an answer denying the counterclaims and asserting defenses. Trial was set to commence on August 8, 2022, but the parties received notice that the Vice Chancellor assigned to the case was retiring, and there may be a new trial date.
The shares of the former Altor stockholders seeking appraisal met the definition of dissenting shares under the merger agreement and were not entitled to receive any portion of the merger consideration at the closing date, given that those shares were the subject of the above-described appraisal claims.
In late March 2022, the company agreed to the terms of a settlement with the appraisal petitioners, without any admission of liability or fault. The settlement provides that in exchange for complete releases, the appraisal petitioners, who as a group held 3,167,565 dissenting Altor shares, collectively will receive an aggregate of 2,229,296 shares of the company’s common stock issued in a private placement, plus an aggregate of $21.13 in cash in lieu of fractional shares. The company’s Board of Directors approved the settlement and stock issuance in April 2022, and the court approved the settlement and dismissed the appraisal petitioners’ claims on July 9, 2022. On July 9, 2022, the company issued 2,229,296 shares of its common stock with an aggregate market value of $10.7 million, based on the closing price of its common stock as of July 8, 2022. As of June 30, 2022 and December 31, 2021, we had accrued $10.7 million and $7.1 million, respectively, related to the dissenting share obligation.
In late April 2022, the company also agreed to the terms of a settlement with the putative class plaintiffs without any admission of liability or fault. In exchange for class-wide releases, and assuming the settlement receives court approval, the company will make a settlement payment of $5.0 million in cash by December 31, 2022. The parties are in the process of documenting and obtaining court approval of the settlement. Prior to finalization and court approval, there can be no assurance as to when the settlement will be finalized and approved. As of June 30, 2022, we have included $5.0 million of accrued litigation expense related to this settlement on the condensed consolidated balance sheet.
Should the settlement with the class plaintiffs not be approved by the court, we cannot reasonably estimate a range of loss or likelihood of loss beyond the amounts recorded. The company intends to defend the case vigorously should that prove necessary.
22

Sorrento Therapeutics, Inc. Litigation
Sorrento Therapeutics, Inc. (Sorrento), derivatively on behalf of NANTibody, LLC (NANTibody) filed an action in the Superior Court of California, Los Angeles County (the Superior Court) against the company, Dr. Soon-Shiong and Charles Kim. The action alleged that the defendants improperly caused NANTibody to acquire IgDraSol, Inc. from our affiliate NantPharma, LLC (NantPharma) and sought to have the transaction undone and the purchase amount returned to NANTibody. In 2019, we filed a demurrer to several causes of action alleged in the Superior Court action, and Sorrento filed an amended complaint, eliminating Mr. Kim as a defendant and dropping the causes of action we had challenged in our demurrer.
Sorrento filed a related arbitration proceeding (the Cynviloq arbitration) against Dr. Soon-Shiong and NantPharma; the company is not named in the Cynviloq arbitration. In 2020, the Superior Court granted Dr. Soon-Shiong’s request for a preliminary injunction barring Sorrento from pursuing claims against him in the Cynviloq arbitration. Sorrento then filed the claims it had previously asserted in arbitration against Dr. Soon-Shiong in the Superior Court, and at Sorrento’s request, the arbitrator entered an order dismissing Sorrento’s claims against Dr. Soon-Shiong in the Cynviloq arbitration. The hearing in the Cynviloq arbitration commenced in June 2021, and continued with breaks until early October 2021. The parties completed post-hearing briefing in early May 2022, and summations will likely be scheduled for September 2022.
Also in 2019, the company and Dr. Soon-Shiong filed cross-claims in the Superior Court action against Sorrento and its Chief Executive Officer Henry Ji, asserting claims for fraud, breach of contract, breach of the covenant of good faith and fair dealing, tortious interference with contract, unjust enrichment, and declaratory relief. Our claims allege that Dr. Ji and Sorrento breached the terms of an exclusive license agreement between the company and Sorrento related to Sorrento’s antibody library and that Sorrento did not perform its obligations under the exclusive license agreement. The Superior Court ruled that the company’s claims should be pursued in arbitration and that Dr. Soon-Shiong’s claims could be pursued in Superior Court.
In 2019, the company, along with NANTibody, filed an arbitration against Sorrento and Dr. Ji asserting our claims relating to the exclusive license agreement. In 2020, Sorrento sent letters purporting to terminate the exclusive license agreement with the company, and an exclusive license agreement with NANTibody and demanding the return of its confidential information and transfer of all regulatory filings and related materials. As required pursuant to the exclusive license agreements, both parties must engage in good-faith negotiations before attempting to invoke any termination provision contained in the agreement. Notwithstanding such negotiations, Sorrento sent a letter purporting to terminate the exclusive license agreements, maintaining the negotiations did not reach a successful resolution. We believe we have cured any perceived breaches during the 90-day contractual cure period provided under the agreements. Sorrento filed counterclaims against the company and NANTibody in the arbitration and requested leave to file a dispositive motion. The hearings in the NANTibody arbitration commenced in April 2021 and concluded in early August 2021. After post-hearing briefing was concluded, the parties were notified on November 30, 2021 that the arbitrator in the NANTibody arbitration had passed away. A substitute arbitrator was appointed on February 25, 2022, and the parties have been working with the substitute arbitrator to conclude the proceedings. Additional hearing sessions were held in May and July 2022, and summations are scheduled for August 2022. We intend to prosecute our claims, and to defend the claims asserted against us, vigorously. An estimate of the possible loss or range of loss cannot be made at this time.
Shenzhen Beike Biotechnology Co. Ltd. Arbitration
In 2020, we received a Request for Arbitration before the International Chamber of Commerce, International Court of Arbitration. The arbitration relates to a license, development, and commercialization agreement that Altor entered into with Beike in 2014, which agreement was amended and restated in 2017, pursuant to which Altor granted to Beike an exclusive license to use, research, develop and commercialize products based on N-803 in China for human therapeutic uses. In the arbitration, Beike is asserting a claim for breach of contract under the license agreement. Among other things, Beike alleges that we failed to use commercially reasonable efforts to deliver to Beike materials and data related to N-803. Beike is seeking specific performance, or in the alternative, damages for the alleged breaches. On September 25, 2020, the parties entered into a standstill and tolling agreement under which, among other things, the parties affirmed they will perform certain of their obligations under the license agreement by specified dates and agreed that all deadlines in the arbitration are indefinitely extended. The standstill agreement may be terminated by any party on ten calendar days’ notice, and upon termination, the parties will have the right to pursue claims arising from the license agreement in any appropriate tribunal. The parties have been providing periodic updates to the International Chamber of Commerce confirming a stay of all proceedings during the standstill. Given that this action remains at the pleading stage and no discovery has occurred, it remains too early to evaluate the likely outcome of the case or to estimate any range of potential loss. We believe the claims lack merit and intend to defend the case vigorously and further believe that we may have counterclaims.
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Litigation Related to the Merger with ImmunityBio, Inc.
In connection with the Merger with NantCell, Inc. (formerly known as ImmunityBio, Inc., a private company), a Delaware corporation, via a wholly-owned subsidiary of NantKwest, several complaints were filed as individual actions in the United States District Courts, and subsequently were voluntarily dismissed. Two complaints were filed in the United States District Court for the Southern District of California and are captioned Weiss v. NantKwest, Inc., et al., 3:21‑cv‑00280 (filed February 16, 2021) (the Weiss Complaint) and Carlisle v. NantKwest, Inc., et al., 3:21‑cv‑00304 (filed February 19, 2021) (the Carlisle Complaint), (together, the Merger Actions). The Merger Actions generally allege that the Definitive Proxy Statement filed with the SEC on February 2, 2021 misrepresented and/or omitted certain purportedly material information relating to financial projections, analysis performed by the financial advisor to NantKwest’s Special Committee, alleged past engagements of the Special Committee’s financial advisor and industry consultant, and the terms of the engagement of such consultant. The Merger Actions asserted violations of Section 14(a) of the Securities Exchange Act of 1934, as amended (the Exchange Act), and Rule 14a-9 promulgated thereunder against all defendants and violations of Section 20(a) of the Exchange Act against NantKwest’s directors. The Merger Actions sought, among other things, an injunction enjoining the stockholder vote on the Merger and the consummation of the Merger unless and until certain additional information was disclosed to NantKwest’s stockholders, costs of the action, including plaintiffs’ attorneys’ fees and experts’ fees, and other relief the Court may deem just and proper. Neither the stockholder vote on the Merger nor the Merger were enjoined and both occurred on March 8 and March 9, 2021, respectively. The Merger Actions were voluntarily dismissed on March 25, 2022.
Commitments
We did not enter into any significant contracts during the six months ended June 30, 2022, other than those disclosed in these condensed consolidated financial statements.
In addition, we are also a party to various contracts with contract research organizations and contract manufacturers that generally provide for termination on notice, with the exact amounts in the event of termination to be based on the timing of the termination and the terms of the agreement. There have been no material changes in unconditional purchase commitments from those disclosed in Note 7, Commitments and Contingencies, of the “Notes to Consolidated Financial Statements” that appears in Part II, Item 8. “Financial Statements and Supplementary Data” of our Annual Report on Form 10-K filed with the SEC on March 1, 2022.
8.    Lease Arrangements
We lease property in multiple facilities across the U.S. (including the Dunkirk Facility in upstate New York) and Italy, including facilities located in El Segundo, CA, that are leased from related parties. Substantially all of our operating lease right-of-use assets and operating lease liabilities relate to facilities leases. See Note 9, Related-Party Agreements, for additional information about our related-party leases.
Our leases generally have initial terms ranging from two to ten years and often include one or more options to renew. These renewal terms can extend the lease term from one to ten years, and are included in the lease term when it is reasonably certain that we will exercise the option.
Information regarding our operating leases is as follows:
June 30,
2022
December 31,
2021
(Unaudited)
Weighted average remaining lease term 7.0 years 7.8 years
Weighted average discount rate 10.5  % 9.6  %
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The components of lease expense consist of the following (in thousands):
Three Months Ended
June 30,
Six Months Ended
June 30,
2022 2021 2022 2021
(Unaudited) (Unaudited)
Operating lease costs $ 2,942  $ 1,717  $ 5,250  $ 3,864 
Variable lease costs 934  517  2,116  1,183 
Total lease costs $ 3,876  $ 2,234  $ 7,366  $ 5,047 
Cash paid for amounts included in the measurement of lease liabilities is as follows (in thousands):
Six Months Ended
June 30,
2022 2021
(Unaudited)
Cash paid for operating leases (excluding variable lease costs) $ 5,091  $ 4,004 
Future minimum lease payments as of June 30, 2022, including $14.8 million related to options to extend lease terms that are reasonably certain of being exercised, are presented in the following table (in thousands). Common area maintenance costs and taxes are not included in these payments.
Years ending December 31:
Operating
Leases
2022 (excluding the six months ended June 30, 2022)
$ 5,000 
2023 9,625 
2024 12,182 
2025 12,154 
2026 10,289 
Thereafter 31,457 
Total future minimum lease payments 80,707 
Less: Interest 24,768 
Less: Tenant improvement allowance receivable 3,887 
Present value of operating lease liabilities $ 52,052 
3530 John Hopkins Court
In April 2022, we extended our existing lease for 44,681 rentable square feet at 3530 John Hopkins Court in San Diego, California from July 31, 2023 to July 31, 2030 (the Extended Lease Term). This facility is used primarily as a research laboratory and our corporate offices. The Extended Lease Term will commence on August 1, 2023, and includes an option to extend the lease for one five-year term through July 31, 2035. The base rent effective during the Extended Lease Term will be approximately $323,937 per month with an annual increase of 3% beginning on August 1, 2024. At the beginning of the option term, the initial monthly base rent will be adjusted to market rent (as defined in the lease agreement). We will receive a rent abatement for the first seven months of the Extended Lease Term beginning on August 1, 2023, and a tenant improvement allowance of $0.7 million from the landlord for costs and expenses associated with the construction of tenant improvements that can be used during the 12-month period ending on August 1, 2024.
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Other than the lease described above, the acquisition of a leasehold interest at the Dunkirk Facility discussed in Note 6, Collaboration and License Agreements and Acquisition, the entry into new related-party leases, and the termination of an existing related-party lease discussed in Note 9, Related-Party Agreements, there have been no other material changes related to our existing lease agreements from those disclosed in Note 8 of the Notes to Consolidated Financial Statements of our Annual Report on Form 10-K filed with the SEC on March 1, 2022.
9.    Related-Party Agreements
Our related-party promissory notes consist of the following (in thousands):
Total Notes and Interest Payable
Related-Party Promissory Notes Maturity
Year
Outstanding
Advances
Interest
Rate
June 30,
2022
December 31,
2021
(Unaudited)
Nant Capital, LLC (1)
2022 $ 300,000 
Term SOFR + 5.4%
$ 300,084  (1) $ 299,236  (1)
Nant Capital, LLC (2)
2025 55,226  5.0% 62,864  (3) 61,367  (3)
Nant Capital, LLC (2)
2025 50,000  6.0% 55,387  (4) 53,810  (4)
Nant Capital, LLC (5)
2025 40,000  6.0% 40,000  (5) 40,000  (5)
NantMobile, LLC (2)
2025 55,000  3.0% 59,227  (6) 58,359  (6)
NantWorks, LLC (2)
2025 43,418  5.0% 55,374  (7) 54,067  (7)
NantCancerStemCell, LLC (2)
2025 33,000  5.0% 39,689  (8) 38,746  (8)
Total related-party promissory notes $ 576,644  $ 612,625  $ 605,585 
_______________
(1)
The outstanding advance is due and payable on December 17, 2022. This loan bears interest at Term SOFR + 5.4%, which is compounded annually and payable quarterly commencing on March 17, 2022. As of June 30, 2022, the interest rate on this loan was 7.29%. We paid $9.9 million in interest on this loan during the six months ended June 30, 2022. Accrued and unpaid interest on this note totaled $0.8 million as of June 30, 2022. In the event of a default on the loan (as defined in the promissory note), including if we do not repay the loan at maturity, the company has the right, at its sole option, to convert the outstanding principal amount and accrued and unpaid interest due under this note into fully paid and non-assessable shares of the company’s common stock at a price per share equal to $5.67. Total amortization on the debt issuance cost of $1.5 million paid to the lender was $0.8 million as of June 30, 2022 and was recorded as a reduction of the principal amount of the note.
(2)
All outstanding advances and accrued and unpaid interest is due and payable on September 30, 2025. Interest on related-party promissory notes is compounded annually. We may prepay the outstanding principal at any time without premium, penalty or the prior consent of the issuer. All outstanding amounts under the notes become due and payable upon certain bankruptcy and insolvency-related events. There are no equity or equity-linked convertible rights related to these promissory notes.
(3)
Accrued and unpaid interest on this note totaled $7.6 million and $6.1 million as of June 30, 2022 and December 31, 2021, respectively.
(4)
Accrued and unpaid interest on this note totaled $5.4 million and $3.8 million as of June 30, 2022 and December 31, 2021, respectively.
(5)
The outstanding principal is due and payable on September 30, 2025. Interest on this related-party promissory note is compounded annually and payable quarterly commencing on June 30, 2021. We paid $1.2 million in interest on this loan during the six months ended June 30, 2022. All outstanding amounts under the note become due and payable upon certain bankruptcy and insolvency-related events. There are no equity or equity-linked convertible rights related to this promissory note.
(6)
Accrued and unpaid interest on this note totaled $4.2 million and $3.4 million as of June 30, 2022 and December 31, 2021, respectively.
(7)
Accrued and unpaid interest on this note totaled $12.0 million and $10.6 million as of June 30, 2022 and December 31, 2021, respectively.
(8)
Accrued and unpaid interest on this note totaled $6.7 million and $5.7 million as of June 30, 2022 and December 31, 2021, respectively.
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The following table summarizes our estimated future contractual obligations for related-party promissory notes as of June 30, 2022 (unaudited; in thousands):
Principal
Payments
Interest
Payments (1)
Total
2022 (excluding the six months ended June 30, 2022)
$ 300,000  $ 12,169  $ 312,169 
2023 —  2,400  2,400 
2024 —  2,407  2,407 
2025 276,644  85,823  362,467 
Total principal and estimated interest due on related-party
   promissory notes
$ 576,644  $ 102,799  $ 679,443 
_______________
(1)
Interest payments on our fixed-rate promissory notes are calculated based on contractual interest rates and scheduled maturity dates. Interest payments on our variable-rate promissory note are calculated based on schedule maturity dates and the Term SOFR rate plus the contractual spread per the loan agreement. The rate on our variable-rate promissory note as of June 30, 2022 was 7.29%.
We conduct business with several affiliates under written agreements and informal arrangements. Below is a summary of outstanding balances and a description of significant relationships (in thousands):
June 30,
2022
December 31,
2021
(Unaudited)
Due from related party–NantBio, Inc. $ 1,294  $ 1,294 
Due from related parties–Various 157  39 
Total due from related parties $ 1,451  $ 1,333 
   
Due to related party–Duley Road, LLC $ 1,807  $ 1,380 
Due to related party–NantWorks, LLC 1,179  1,113 
Due to related party–NantBio, Inc. 943  943 
Due to related party–Immuno-Oncology Clinic, Inc. —  507 
Due to related party–Various 229  — 
Total due to related parties $ 4,158  $ 3,943 
Our Executive Chairman, Global Chief Scientific and Medical Officer, and principal stockholder founded and has a controlling interest in NantWorks, which is a collection of companies in the healthcare and technology space. As described below, we have entered into arrangements with NantWorks, and certain affiliates of NantWorks, to facilitate the development of new immunotherapies for our product pipeline. Affiliates of NantWorks are also affiliates of the company due to the common control by and/or common ownership interest of our Executive Chairman and Global Chief Scientific and Medical Officer.
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NantWorks, LLC
Shared Services Agreement
Under the NantWorks shared services agreement executed in November 2015, but effective August 2015, NantWorks, a related party, provides corporate, general and administrative, certain research and development, and other support services. We are charged for the services at cost plus reasonable allocations of employee benefits, facilities and other direct or fairly allocated indirect costs that relate to the employees providing the services. For the six months ended June 30, 2022 and 2021, we recorded $2.3 million and $3.0 million, respectively, in selling, general and administrative expense, and $0.3 million and $0.4 million, respectively, of expense reimbursements under this arrangement in research and development expense, on the condensed consolidated statements of operations. These amounts exclude certain general and administrative expenses provided by third-party vendors directly for our benefit, which were reimbursed to NantWorks based on those vendors’ invoiced amounts without markup by NantWorks.
As of June 30, 2022 and December 31, 2021, we owed NantWorks a net amount of $1.2 million and $1.1 million, respectively, for all agreements between the two affiliates, which is included in due to related parties, on the condensed consolidated balance sheets. We also recorded $2.8 million and $2.2 million of prepaid expenses for services that have been passed through to the company from NantWorks as of June 30, 2022 and December 31, 2021, respectively, which are included in prepaid expenses and other current assets, on the condensed consolidated balance sheets.
Facility License Agreement
In 2015, we entered into a facility license agreement with NantWorks for approximately 9,500 square feet of office space in Culver City, California, which was converted to a research and development laboratory and a cGMP manufacturing facility. In 2020, we amended this agreement to extend the term of this license agreement through December 31, 2021. Commencing on January 1, 2022, the license fee increased by 3% to approximately $56,120 per month.
On May 6, 2022, we amended our facility license agreement with NantWorks to expand the licensed premises by 36,830 rentable square feet to an aggregate total of 46,330 rentable square feet. Effective May 1, 2022, the license fee is approximately $273,700 per month, which is subject to a 3% increase commencing on January 1 of each year. The space continues to be rented on a month-to-month basis, which can be terminated by either party with at least 30 days’ prior written notice to the other party. We recorded license fee expense for this facility totaling $0.8 million and $0.3 million for the six months ended June 30, 2022 and 2021, respectively, in research and development expense, on the condensed consolidated statements of operations.
Immuno-Oncology Clinic, Inc.
We entered into multiple agreements with Immuno-Oncology Clinic, Inc. (the Clinic) to conduct clinical trials related to certain of our product candidates. The Clinic is a related party as it is owned by an officer of the company and NantWorks manages the administrative operations of the Clinic. Pursuant to the terms of the Clinic agreement (as amended), we made payments totaling $5.6 million in consideration of future services to be performed by the Clinic.
In 2021, we completed a review of alternative structures that could support our more complex clinical trial requirements and made a decision to explore a potential transition of clinical trials at the Clinic to a new structure (including contracting with a new, non-affiliated professional corporation) to be determined and agreed upon by all parties. Based on this decision to explore a potential transition, we determined that it was more likely than not that the previously recorded prepaid asset would not result in the collection of fees for services performed by the Clinic as contemplated in the original agreements. As a result, we wrote down the remaining value of our prepaid asset and recorded approximately $4.4 million in research and development expense, on the condensed consolidated statement of operations for the year ended December 31, 2021.
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We recorded $1.3 million and $0.8 million for the six months ended June 30, 2022 and 2021, respectively, in research and development expense, on the condensed consolidated statements of operations related to clinical trial and transition services provided by the Clinic. As of June 30, 2022, we have no balances due from or to the Clinic.
NantBio, Inc.
In August 2018, we entered into a supply agreement with NantCancerStemCell, LLC (NCSC), a 60% owned subsidiary of NantBio (with the other 40% owned by Sorrento). Under this agreement, we agreed to supply VivaBioCell’s proprietary GMP-in-a-Box bioreactors and related consumables, made according to specifications mutually agreed to with both companies. The agreement has an initial term of five years and renews automatically for successive one-year terms unless terminated by either party in the event of material default upon prior written notice of such default and the failure of the defaulting party to remedy the default within 30 days of the delivery of such notice, or upon 90 days’ prior written notice by NCSC. We recognized no revenue for the six months ended June 30, 2022 and $0.3 million of revenue for the six months ended June 30, 2021. We recorded $0.1 million of deferred revenue for bioreactors that were delivered but not installed in accrued expenses and other liabilities, on the condensed consolidated balance sheets as of June 30, 2022 and December 31, 2021. As of June 30, 2022 and December 31, 2021, we recorded $0.9 million in due to related parties, on the condensed consolidated balance sheets related to this agreement.
In 2018, we entered into a shared service agreement pursuant to which we are charged for services at cost, without mark-up or profit by NantBio, but including reasonable allocations of employee benefits that relate to the employees providing the services. In April 2019, we agreed with NantBio to transfer certain NantBio employees and associated research and development projects, comprising the majority of NantBio’s business, to the company. As of June 30, 2022 and December 31, 2021, we recorded a net receivable from NantBio of $1.3 million for amounts we paid on behalf of NantBio during the year ended December 31, 2019.
605 Doug St, LLC
In September 2016, we entered into a lease agreement with 605 Doug St, LLC, an entity owned by our Executive Chairman and Global Chief Scientific and Medical Officer, for approximately 24,250 rentable square feet in El Segundo, California, which has been converted to a research and development laboratory and a cGMP manufacturing facility. The lease runs from July 2016 through July 2023. We have the option to extend the lease for one additional three-year term through July 2026. The base rent is approximately $72,385 per month, with annual increases of 3% that began in July 2017. We recorded lease expense for this facility of $0.4 million for the six months ended June 30, 2022 and 2021, respectively, in research and development expense, on the condensed consolidated statements of operations.
Duley Road, LLC
In February 2017, Altor BioScience Corporation (succeeded by our wholly-owned subsidiary Altor BioScience, LLC), through its wholly-owned subsidiary, entered into a lease agreement with Duley Road, a related party that is indirectly controlled by our Executive Chairman and Global Chief Scientific and Medical Officer, for approximately 12,000 rentable square feet of office and cGMP manufacturing facility space in El Segundo, California. The lease term is from February 2017 through October 2024. We have the option to extend the initial term for two consecutive five-year periods through October 2034. The base rent is approximately $40,700 per month, with annual increases of 3% that began in November 2018. As of June 30, 2022 and December 31, 2021, we recorded rent payable to Duley Road of $0.3 million and $0.2 million, respectively. We recorded rent expense for this lease of $0.2 million and $0.3 million for the six months ended June 30, 2022 and 2021, respectively, in research and development expense, on the condensed consolidated statements of operations.
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Effective in January 2019, we entered into two lease agreements with Duley Road for a second building located in El Segundo, California. The first lease is for the first floor of the building with approximately 5,650 rentable square feet. The lease has a seven-year term commencing in September 2019. The second lease is for the second floor of the building with approximately 6,488 rentable square feet. The lease has a seven-year term commencing in July 2019. Both floors of the building are used for research and development and office space. We have options to extend the initial terms of both leases for two consecutive five-year periods through 2036. The base rent for the two leases is approximately $35,800 per month that increases at a rate of 3% per year.
As of June 30, 2022 and December 31, 2021, we recorded $0.9 million and $0.9 million of leasehold improvement payables, respectively, and $0.6 million and $0.3 million of lease-related payables to Duley Road, which were included in due to related parties, on the condensed consolidated balance sheets. We recorded rent expense for this lease of $0.2 million for the six months ended June 30, 2022 and 2021, respectively, in research and development expense, on the condensed consolidated statements of operations.
605 Nash, LLC
In February 2021, but effective on January 1, 2021, we entered into a lease agreement with 605 Nash, a related party, whereby we leased approximately 6,883 square feet (the Initial Premises) in a two story mixed use building containing approximately 64,643 rentable square feet on 605-607 Nash Street in El Segundo, California. This facility is used primarily for pharmaceutical development and manufacturing purposes. The lease term commenced in January 2021 and expires in December 2027, and includes an option to extend the lease for one three-year term through December 2030. The base rent is approximately $20,300 per month with an annual increase of 3% on January 1 of each year during the initial term and, if applicable, during the option term. In addition, under the agreement, we are required to pay our share of estimated property taxes and operating expenses. We received a rent abatement for the first seven months, and a tenant improvement incentive of $0.3 million from the landlord for costs and expenses associated with the construction of tenant improvements for the Initial Premises. We recorded rent expense for this lease of $0.1 million for the six months ended June 30, 2022 and 2021, respectively, in research and development expense, on the condensed consolidated statements of operations.
In May 2021, but effective on April 1, 2021, we entered into an amendment to our Initial Premises lease with 605 Nash. The amendment expanded the leased square feet by approximately 57,760 rentable square feet (the Expansion Premises). The lease term of the Expansion Premises commenced in April 2021 and expires in March 2028, whereby the company has the option to extend the initial term for three years. Per the terms of the amendment, the term of the Initial Premises lease was extended for an additional three months and now expires on March 31, 2028. Base rent for the Expansion Premises is approximately $170,400 per month with annual increases of 3% on April 1 of each year. We are responsible for the build out of the facility space and associated costs. The amended lease provides for a rent abatement for the first seven months, and for a tenant improvement allowance of approximately $2.6 million for costs and expenses related to improvements made by us to the Expansion Premises. We recorded rent expense related to the Expansion Premises lease agreement of $1.0 million and $0.5 million for the six months ended June 30, 2022 and 2021, respectively, in research and development expense, on the condensed consolidated statements of operations
557 Doug St, LLC
Effective September 27, 2021, we entered into a lease agreement with Nant Capital under which we leased 557 South Douglas Street in El Segundo, California. Effective May 31, 2022, we executed a lease termination agreement with Nant Capital under which we will receive a full refund of the first month’s rent and security deposit totaling $0.2 million that we paid upon execution of the lease. We recorded rent expense related to this lease of $0.4 million for the six months ended June 30, 2022 in research and development expense, on the condensed consolidated statement of operations. We recognized a gain of $0.6 million on the disposal of this lease for the three months ended June 30, 2022 in other income, net, on the condensed consolidated statement of operations.
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420 Nash, LLC
On September 27, 2021, we entered into a lease agreement with 420 Nash, LLC, a related party, whereby we leased an approximately 19,125 rentable square foot property located at 420 Nash Street, El Segundo, California, to be used primarily for the warehousing and storage of drug manufacturing supplies, products and equipment and ancillary office space.
Under the terms of the lease agreement, the lease term began on October 1, 2021 and expires on September 30, 2026. The base rent is approximately $38,250 per month with an annual increase of 3% on October 1 of each year beginning in 2022 during the initial term. The company is responsible for the payment of real property taxes, repairs and maintenance, improvements, insurance and operating expenses during the term of the lease. We received a rent abatement for the first month of the lease, and a one-time improvement allowance of $15,000 from the landlord that was credited against base rent obligations for the second month of the lease.
The company has options to extend the lease term for two additional consecutive periods of five years each. At the beginning of each option term, the initial monthly base rent will be adjusted to market rent (as defined in the lease agreement) with an annual increase of 3% during the option term. We have included the first option to extend the lease term for five years as part of the initial term of the lease as it is reasonably certain that we will exercise the option, which implies lease expiration in September 2031. We recorded $0.3 million of rent expense related to this lease for the six months ended June 30, 2022 in research and development expense, on the condensed consolidated statement of operations.
23 Alaska, LLC
On May 6, 2022, we entered into a lease agreement with 23 Alaska, LLC, a related party, for a 47,265 rentable square foot facility located at 2335 Alaska Ave., El Segundo, California, to be used primarily for pharmaceutical development and manufacturing, research and development, and office space.
Under the terms of the agreement, the lease term begins on May 1, 2022 and expires on April 30, 2027. The base rent is approximately $139,400 per month with an annual increase of 3% on May 1 of each year beginning in 2023 during the initial term. We will receive a rent abatement for the second through sixth month of the lease. We are also required to pay $7,600 per month for parking during the initial term and extension term, if exercised. The company is responsible for the payment of real property taxes, repairs and maintenance, improvements, insurance, and operating expenses during the term of the lease.
The company is responsible for the costs associated with the build-out of the premises and will received a one-time tenant improvement allowance of $945,300 from the landlord.
The company has an option to extend the lease term for one additional consecutive five-year period. At the beginning of the option term, the initial monthly base rent will be adjusted to market rent (as defined in the lease agreement) with an annual increase of 3% during the option term. We recorded $0.3 million of rent expense for this lease for the six months ended June 30, 2022 in research and development expense, on the condensed consolidated statement of operations.
10.    Stockholders’ Deficit
Stock Authorized for Issuance
Effective February 1, 2022, ImmunityBio amended and restated its Amended and Restated Certificate of Incorporation to increase the number of shares of common stock that the company is authorized to issue from 500,000,000 shares, $0.0001 par value per share, to 900,000,000 shares, $0.0001 par value per share. The number of shares of preferred stock that the company is authorized to issue remains unchanged at 20,000,000 shares.
Stock Repurchases
No shares of our common stock were repurchased during the six months ended June 30, 2022 and 2021 under the company’s 2015 Share Repurchase Program. As of June 30, 2022, $18.3 million remained authorized for repurchase under the program.
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Open Market Sale Agreement
On April 30, 2021, we entered into an open market sale agreement (the Sale Agreement) with respect to an ATM offering program under which we may offer and sell, from time to time at our sole discretion, shares of our common stock, having an aggregate offering price of up to $500.0 million through our sales agent. We pay our sales agent a commission of up to 3.0% of the gross sales proceeds of any shares of our common stock sold through them under the Sale Agreement, and also have provided them with customary indemnification and contribution rights. We issued no shares under the ATM during the six months ended June 30, 2022. As of June 30, 2022, we had $330.8 million available for future stock issuances under the ATM.
We are not obligated to sell any shares and may at any time suspend solicitation and offers under the Sale Agreement. The Sale Agreement may be terminated by us at any time given written notice to the sales agent for any reason or by the sales agent at any time by giving written notice to us for any reason or immediately under certain circumstances, and shall automatically terminate upon the issuance and sale of all of the shares.
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11.    Stock-Based Compensation
2015 Equity Incentive Plan
At the company’s 2022 Annual Meeting of Stockholders held on June 14, 2022, stockholders approved an amendment to increase the number of shares of common stock authorized for issuance under the 2015 Plan by 19,900,000 shares. As of June 30, 2022, approximately 18.5 million shares were available for future grants under the 2015 Plan.
Stock-Based Compensation
The following table presents stock-based compensation included on the condensed consolidated statements of operations (in thousands):
Three Months Ended
June 30,
Six Months Ended
June 30,
2022 2021 2022 2021
(Unaudited) (Unaudited)
Stock-based compensation expense:      
Stock options $ 3,742  $ 1,610  $ 5,764  $ 7,965 
RSUs 6,433  16,253  14,435  25,196 
$ 10,175  $ 17,863  $ 20,199  $ 33,161 
Stock-based compensation expense in operating expenses:
Research and development $ 3,216  $ 8,545  $ 6,201  $ 11,433 
Selling, general and administrative 6,959  9,318  13,998  21,728 
$ 10,175  $ 17,863  $ 20,199  $ 33,161 
Stock Options
The following table summarizes stock option activity and related information for the six months ended June 30, 2022:
 
Number of
Options
Weighted-
Average
Exercise
Price
Aggregate
Intrinsic
Value
(in thousands)
Weighted-
Average
Remaining
Contractual
Life
(in years)
Outstanding at December 31, 2021
4,124,930  $ 15.62  $ 4,178  5.3
Granted 5,736,256  $ 5.33 
Exercised (14,767) $ 5.07 
Forfeited/expired (399,229) $ 6.02 
Outstanding at June 30, 2022
9,447,190  $ 9.79  $ 2,239  7.7
Vested and exercisable at June 30, 2022
3,464,277  $ 14.70  $ 1,483  4.3
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On March 23, 2022, the Compensation Committee of the Board of Directors granted option awards to purchase a total of 4,728,634 shares of our common stock pursuant to the 2015 Plan at an exercise price of $5.83 per share, the closing price reported on the Nasdaq on the date of grant.
Of the option awards granted, 3,903,634 shares subject to such option awards were awarded to employees of the company (of which 825,000 options were awarded to the company’s named executive officers (NEOs)). The shares subject to the option shall vest in equal annual installments of 1/3rd on each of the first, second and third anniversaries of March 23, 2022 (the “vesting commencement date”), such that all shares shall be fully vested on the third anniversary of the vesting commencement date, subject to the recipient continuing to be a “service provider” as defined in the 2015 Plan through each applicable vesting date.
The remaining 825,000 shares subject to such option awards were awarded to the company’s NEOs. Subject to the company’s attainment of a financial goal for the fiscal year ending December 31, 2022, 1/3rd of the shares subject to the option shall vest in equal annual installments on each of the first, second and third anniversaries of the vesting commencement date, such that all shares shall be fully vested on the third anniversary of the vesting commencement date, subject to the recipient continuing to be a “service provider” through each applicable vesting date.
As of June 30, 2022, the unrecognized compensation cost related to outstanding stock options was $28.6 million, which is expected to be recognized over a remaining weighted-average period of 2.2 years.
The total intrinsic value of stock options exercised during the six months ended June 30, 2022 was immaterial. Cash proceeds received from stock option exercises during the six months ended June 30, 2022 and 2021 totaled $0.1 million and $4.4 million, respectively.
As of December 31, 2021, a total of 3,038,322 vested and exercisable shares were outstanding.
The fair value of stock options issued was estimated at the date of grant using the Black-Scholes option pricing model with the following weighted-average assumptions:
Six Months Ended
June 30,
2022
(Unaudited)
Expected term 5.7 years
Risk-free interest rate 2.6  %
Expected volatility 101.8  %
Dividend yield 0.0  %
Weighted-average grant date fair value $ 4.20 
The expected term was estimated using the average of the contractual term and the weighted-average vesting term of the options. The risk-free interest rate was based on the U.S. Treasury’s rates for U.S. Treasury zero-coupon bonds with maturities similar to those of the expected term of the award being valued. The expected volatility was estimated based on the historical volatility of our common stock. The assumed dividend yield was based on our expectation of not paying dividends in the foreseeable future.
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Restricted Stock Units
The following table summarizes RSU activity during the six months ended June 30, 2022:
Number of
Units
Weighted-
Average
Grant Date
Fair Value
Nonvested balance at December 31, 2021
6,515,889  $ 21.88 
Granted 1,185,177  $ 3.21 
Vested (294,391) $ 11.70 
Forfeited/canceled (539,163) $ 20.90 
Nonvested balance at June 30, 2022
6,867,512  $ 19.17 
As of June 30, 2022, there was $89.9 million of unrecognized stock-based compensation expense related to RSUs that is expected to be recognized over a weighted-average period of 3.1 years. The total intrinsic value of RSUs vested during the six months ended June 30, 2022 was $1.1 million.
RSUs awarded to employees and consultants of affiliated companies are accounted for as stock-based compensation in accordance with ASU 2018-07, Compensation—Stock Compensation (Topic 718), as the compensation was in exchange for continued support or services expected to be provided to the company over the vesting periods under the NantWorks shared services agreement discussed in Note 9, Related-Party Agreements. We have evaluated the associated benefit of these awards to the affiliated companies under common control and determined that the benefit is limited to the retention of their employees. We estimated such benefit at the grant date fair value of $4.0 million and recorded $0.3 million and $0.5 million of deemed dividends for the six months ended June 30, 2022 and 2021 in additional paid-in capital, on the condensed consolidated balance sheets, with a corresponding credit to stock-based compensation expense.
Warrants
In connection with the Merger, warrants issued to NantWorks, a related party, in connection with NantCell’s acquisition of Altor were assumed by the company. After applying the Exchange Ratio at the Effective Time of the Merger, a total of 1,638,000 warrants with an exercise price of $3.24 per share were outstanding as of June 30, 2022. The fair value of $18.0 million assigned to the warrants will be recognized in equity upon achievement of a performance-based vesting condition pertaining to building manufacturing capacity to support supply requirements for one of our product candidates.
12.    Income Taxes
We are subject to U.S. federal income tax, as well as income tax in Italy, South Korea, California and other states. From inception through June 30, 2022, we have not been required to pay U.S. federal and state income taxes because of current and accumulated net operating losses (NOLs). The company computes its quarterly income tax provision by using a forecasted annual effective tax rate and adjusts for any discrete items arising during the quarter. No tax benefit was provided for losses incurred in the U.S., Italy, and South Korea because those losses are offset by a full valuation allowance.
The company is no longer subject to income tax examination by the U.S. federal, state or local tax authorities for years ended on or before December 31, 2016. Carryforward attributes that were generated in years where the statute of limitations is closed may still be adjusted upon examination by the Internal Revenue Service or other respective tax authorities. No income tax returns are currently under examination by taxing authorities.
On March 9, 2021, the company completed the Merger with NantCell. The Merger is accounted for as a transaction between entities under common control, and is considered a nontaxable transaction for U.S. income tax purposes, as it is intended to qualify as a “reorganization” within the meaning of Section 368(a) of the Internal Revenue Code of 1986, as amended (the Code).
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ITEM 2.     MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.
Forward-Looking Statements
The following discussion and analysis should be read together with our condensed consolidated financial statements and the notes to those statements included elsewhere in this Quarterly Report on Form 10-Q. This Quarterly Report on Form 10-Q contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (Securities Act) and Section 21E of the Exchange Act that are based on our management’s beliefs and assumptions and on information currently available to our management. The forward-looking statements are contained in this Management’s Discussion and Analysis of Financial Condition and Results of Operations. Forward-looking statements include, but are not limited to:
our ability to develop next-generation therapies and vaccines that complement, harness, and amplify the immune system to defeat cancers and infectious diseases;
our ability to implement and support our SARS-CoV-2 vaccine and therapeutic programs;
any impact of the coronavirus pandemic, or responses to the pandemic, on our business, clinical trials or personnel;
our expectations regarding the potential benefits of our strategy and technology;
our expectations regarding the operation of our product candidates and related benefits;
our ability to utilize multiple modes to induce cell death;
our beliefs regarding the benefits and perceived limitations of competing approaches, and the future of competing technologies and our industry;
details regarding our strategic vision and planned product candidate pipeline, including that we eventually plan to advance vaccines and therapies for virally-induced infectious diseases;
our beliefs regarding the success, cost and timing of our product candidate development activities and current and future clinical trials and studies, including study design and the enrollment of patients;
our expectations regarding our ability to utilize the Phase 1/2 aNK and haNK® clinical trials data to support the development of our product candidates, including our haNK, taNK, t‑haNK, MSC, and M-ceNK product candidates;
our expectations regarding the development, application, commercialization, marketing, prospects and use generally of our product candidates, including N-803, self-amplifying RNA (saRNA), hAd5 and yeast constructs, recombinant sub-unit proteins, EDV constructs, toll-like receptor-activating adjuvants, and aldoxorubicin;
the timing or likelihood of regulatory submissions or other actions and related regulatory authority responses and approvals, including any planned investigational new drug (IND), BLA or New Drug Application (NDA) submissions to the FDA, including, without limitation, the progress of our BLA submission for N-803 in combination with BCG for the treatment of patients with BCG-unresponsive NMIBC with CIS with or without Ta or T1 disease submitted to the FDA in May 2022 or the pursuit of accelerated regulatory approval pathways or orphan drug status and Breakthrough Therapy designations for applicable product candidates;
our ability to implement an integrated discovery ecosystem and the operation of that planned ecosystem, including being able to regularly add neoepitopes and subsequently formulate new product candidates;
the ability and willingness of strategic collaborators to share our vision and effectively work with us to achieve our goals;
the ability and willingness of various third parties to engage in research and development activities involving our product candidates, and our ability to leverage those activities;
our ability to attract additional third-party collaborators;
our expectations regarding the ease of administration associated with our product candidates;
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the ability to transition our clinical trials at the Clinic to a new structure on the anticipated timeline, if at all;
our ability to finalize and execute definitive agreements with third parties with whom we have entered into term sheets or reached agreements in principle on various potential transactions;
our expectations regarding patient compatibility associated with our product candidates;
our beliefs regarding the potential markets for our product candidates and our ability to serve those markets;
our expectations regarding the timing of enrollment and submission of our clinical trials, and protocols related to such trials;
our ability to produce an antibody cytokine fusion protein, a DNA, RNA, or recombinant protein vaccine, a toll-like receptor-activating adjuvant, an NK-cell therapy, or a damage-associated molecular patterns (DAMP) inducer therapy;
our beliefs regarding the potential manufacturing and distribution benefits associated with our product candidates, and our ability to scale up the production of our product candidates;
our plans regarding our manufacturing facilities and our belief that our manufacturing is capable of being conducted in‑house;
our belief in the potential of our antibody cytokine fusion proteins, DNA, RNA or recombinant protein vaccines, toll-like receptor-activating adjuvants, NK-cell therapy, or DAMP inducer platforms, and the fact that our business is based upon the success individually and collectively of these platforms;
our belief regarding the magnitude or duration for additional clinical testing of our antibody cytokine fusion proteins, DNA, RNA or recombinant protein vaccines, toll-like receptor-activating adjuvants, NK-cell therapy, or DAMP inducers along with other product candidate families;
even if we successfully develop and commercialize specific product candidates like our N-803 or PD-L1 t‑haNK, our ability to develop and commercialize our other product candidates either alone or in combination with other therapeutic agents;
the ability to obtain and maintain regulatory approval of any of our product candidates, and any related restrictions, limitations and/or warnings in the label of any approved product candidate;
our ability to commercialize any approved products;
the rate and degree of market acceptance of any approved products;
our ability to attract and retain key personnel;
the accuracy of our estimates regarding our future revenue, as well as our future operating expenses, capital requirements and needs for additional financing;
our ability to obtain funding for our operations, including funding necessary to complete further development and any commercialization of our product candidates;
our ability to obtain, maintain, protect and enforce intellectual property protection for our product candidates and technology and not infringe upon, misappropriate or otherwise violate the intellectual property of others;
the terms and conditions of licenses granted to us and our ability to license additional intellectual property relating to our product candidates and technology;
the impact on us, if any, if the CVRs held by former Altor stockholders become due and payable in accordance with their terms;
regulatory developments in the U.S. and foreign countries; and
the timing of the development and commercialization of our product candidates.
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Forward-looking statements include statements that are not historical facts and can be identified by terms such as “anticipates,” “believes,” “could,” “seeks,” “estimates,” “expects,” “intends,” “may,” “plans,” “potential,” “predicts,” “projects,” “should,” “will,” “would,” or similar expressions and the negatives of those terms. In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this Quarterly Report on Form 10-Q, and although we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted a thorough inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain, and investors are cautioned not to unduly rely upon these 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. We discuss these risks in greater detail in Part II, Item 1A. “Risk Factors” of this Quarterly Report on Form 10-Q. Given these uncertainties, you should not place undue reliance on these forward-looking statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame. Also, forward-looking statements represent our management’s beliefs and assumptions only as of the date of this Quarterly Report on Form 10-Q.
Except as required by law, we assume no obligation to update these forward-looking statements, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. You should read this Quarterly Report on Form 10-Q completely and with the understanding that our actual future results may be materially different from what we expect.
Anktiva, ceNK, Conkwest, GlobeImmune, GlobeImmune (logo), haNK, haNK (Chinese characters), ImmunityBio, NantKwest, NK-92, Outsmart your disease, taNK, Tarmogen, Vesanktiva, and VivaBioCell are trademarks or registered trademarks of ImmunityBio, Inc., its subsidiaries, or its affiliates.
This Quarterly Report on Form 10-Q contains references to our trademarks and trademarks belonging to other entities. Solely for convenience, trademarks and trade names referred to in this Quarterly Report on Form 10-Q, including logos, artwork and other visual displays, may appear without the ® or TM symbols, but such references are not intended to indicate, in any way, that we will not assert, to the fullest extent under applicable law, our rights or the rights of the applicable licensor to these trademarks and trade names. We do not intend our use or display of other companies’ trade names or trademarks to imply a relationship with, or endorsement or sponsorship of us, by any other companies.
In this Quarterly Report on Form 10-Q, “ImmunityBio,” “the company,” “the combined company,” “we,” “us,” and “our” refer to ImmunityBio, Inc. and its subsidiaries.
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Our Business
ImmunityBio, Inc. is a clinical-stage biotechnology company developing next-generation therapies and vaccines that complement, harness, and amplify the immune system to defeat cancers and infectious diseases. We strive to be a vertically-integrated immunotherapy company designing and manufacturing our products so they are more effective, accessible, more conveniently stored, and more easily administered to patients.
Our broad immunotherapy and cell therapy platforms are designed to attack cancer and infectious pathogens by activating both the innate immune system—NK cells, dendritic cells, and macrophages—and the adaptive immune system—B cells and T cells—in an orchestrated manner. The goal of this potentially best-in-class approach is to generate immunogenic cell death thereby eliminating rogue cells from the body whether they are cancerous or virally infected. Our ultimate goal is to employ this approach to establish an “immunological memory” that confers long-term benefit for the patient.
Our business is based on the foundation of multiple platforms that collectively act on the entire immune response with the goal of targeted, durable, coordinated, and safe immunity against disease. These platforms and their associated product candidates are designed to overcome the limitations of the current standards of care in oncology and infectious diseases, such as checkpoint inhibitors and antiretroviral therapies. We believe that we have established one of the most comprehensive portfolios of immunotherapy and vaccine platforms, which includes:
ibrx-20220630_g1.jpg
Our platforms include 9 first-in-human therapeutic agents that are currently being studied in 27 clinical trials—18 of which are in Phase 2 or 3 development—across 13 indications in liquid and solid tumors, including bladder, pancreatic and lung cancers. These are among the most frequent and lethal cancer types for which there are high failure rates for existing standards of care or, in some cases, no available effective treatment. In infectious disease, our pipeline currently targets such pathogens as SARS-CoV-2 and HIV. We believe SARS-CoV-2 currently lacks a vaccine that provides long-term protection against the virus, particularly its variants, while HIV affects tens of millions of people globally and currently has no known cure.
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We believe that our innovative approach to orchestrate and combine therapies for optimal immune system response will become a therapeutic foundation across multiple clinical indications. Additionally, we believe that data from multiple clinical trials indicates N-803 has broad potential to enhance the activity of therapeutic monoclonal antibodies (mAbs), including checkpoint inhibitors (e.g., Keytruda), across a wide range of tumor types. N-803 is currently being studied in 21 clinical trials (both ImmunityBio and investigator-sponsored) across 13 indications. Although such designations may not lead to a faster development process or regulatory review and may not increase the likelihood that a product candidate will receive approval, N-803, ImmunityBio’s novel antibody cytokine fusion protein, has received Breakthrough Therapy and Fast Track designations from the FDA in combination with BCG for the treatment of patients with BCG-unresponsive NMIBC with CIS with or without Ta or T1 disease. In May 2022, we announced the submission of a BLA to the FDA for our product candidate, N-803 in combination with BCG for the treatment of patients with BCG-unresponsive NMIBC with CIS with or without Ta or T1 disease. In July 2022, we announced the FDA has accepted our BLA for review and set a PDUFA target action date of May 23, 2023. It is unclear when the FDA will approve our BLA, if at all.
We have established GMP manufacturing capacity at scale with cutting-edge cell manufacturing expertise and ready-to-scale facilities, as well as extensive and seasoned R&D, clinical trial, and regulatory operations, and development teams.
The Merger
On December 21, 2020, NantKwest and NantCell entered into the Merger Agreement pursuant to which NantKwest and NantCell agreed to combine their businesses. The Merger Agreement provided that a wholly-owned subsidiary of the company would merge with and into NantCell, with NantCell surviving the Merger as a wholly-owned subsidiary of the company.
On March 9, 2021, we completed the Merger pursuant to the terms of the Merger Agreement. Under the terms of the Merger Agreement, at the Effective Time, each share of NantCell common stock, par value $0.001 per share, issued and outstanding immediately prior to the Effective Time, subject to certain exceptions as set forth in the Merger Agreement, was converted automatically into a right to receive 0.8190 newly issued shares of Company Common Stock, with cash paid in lieu of any fractional shares. At the Effective Time, each share of the company’s common stock issued and outstanding immediately prior to the Effective Time, remained an issued and outstanding share of the combined company. At the Effective Time, each outstanding option, RSU or warrant to purchase NantCell common stock was converted using the Exchange Ratio into an option, RSU or warrant, respectively, on the same terms and conditions immediately prior to the Effective Time, to purchase shares of Company Common Stock.
Immediately following the Effective Time, the former stockholders of NantCell held approximately 71.5% of the outstanding shares of Company Common Stock and the stockholders of NantKwest as of immediately prior to the Merger held approximately 28.5% of the outstanding shares of Company Common Stock. As a result of the Merger and immediately following the Effective Time, Dr. Patrick Soon-Shiong, our Executive Chairman and Global Chief Scientific and Medical Officer, and his affiliates beneficially owned, in the aggregate, approximately 81.8% of the outstanding shares of Company Common Stock. Following the consummation of the Merger, the symbol for shares of the company’s common stock was changed to “IBRX.”
Accounting Treatment of the Merger
The Merger represents a business combination pursuant to FASB ASC Topic 805-50, which is accounted for as a transaction between entities under common control as Dr. Soon‑Shiong and his affiliates were the controlling stockholders of both the company and NantCell for all of the periods presented in this report. As a result, all of the assets and liabilities of NantCell were combined with ours at their historical carrying amounts on the closing date of the Merger. We have recast our prior period financial statements to reflect the conveyance of NantCell’s common shares as if the Merger had occurred as of the earliest date of the condensed consolidated financial statements presented in Item 1. “Financial Statements” of this Quarterly Report on Form 10-Q. All material intercompany accounts and transactions have been eliminated in consolidation.
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COVID-19 Pandemic
The COVID-19 pandemic continues to present a substantial public health and economic challenge around the world. Through the date of this Quarterly Report on Form 10-Q, we have not seen a material adverse impact to our business from the pandemic. However, given the unprecedented and continuously evolving nature of the pandemic, we cannot at this time predict the specific extent, duration, or full impact that this pandemic may have on our financial condition and results of operations, including ongoing and planned clinical trials. More specifically, the pandemic may result in prolonged impacts that we cannot predict at this time and we expect that such uncertainties will continue to exist for the foreseeable future. The impact of the pandemic on our financial performance will depend on future developments, including the duration and spread of the outbreak, impact of potential variants and the related governmental advisories and restrictions. These developments and the impact of the ongoing pandemic on the financial markets and the overall economy are highly uncertain. If the financial markets and/or the overall economy are impacted for an extended period, our results may be adversely affected. In addition, we anticipate that enrollment of patients in certain studies will likely take longer than previously forecasted and that our clinical trials may require additional time to complete which would in turn impact the timeline of BLA submissions of our product candidates and subsequent revenue generation.
These factors have been accounted for in the company’s anticipated upcoming milestones. During any such delays in our clinical trials, we will continue to incur fixed costs such as selling, general and administrative expenses and operating expenses related to our laboratory, GMP manufacturing, and office facilities.
Many of our office-based employees have been working from home since mid-March 2020. Essential staffing levels for our research and development operations remain in place, including maintaining key personnel in our laboratory and GMP manufacturing facilities. It is likely that the pandemic and resulting mitigation efforts could have an impact in the future on our third-party suppliers who manufacture laboratory supplies required for our in-house manufacturing process, which in turn could have an impact on having sufficient clinical product supply available for our clinical trials. We have addressed this in part by ensuring that we have sufficient supplies on hand to weather interruptions in our supply chain.
We continue to monitor the impact of the COVID-19 pandemic on our business, including our clinical trials, manufacturing facilities and capabilities, and ability to access necessary resources. For a discussion of the risks presented by the COVID-19 pandemic to our results of operations and financial condition, see Part II, Item 1A. “Risk Factors.”
Operating Results
From inception through the date of this Quarterly Report on Form 10-Q, we have generated minimal revenue from non-exclusive license agreements related to our cell lines, the sale of our bioreactors and related consumables, and grant programs. We have no clinical products approved for commercial sale and have not generated any revenue from therapeutic and vaccine product candidates that are under development. We have incurred net losses in each year since our inception and, as of June 30, 2022, we had an accumulated deficit of $2.2 billion. Our net losses attributable to ImmunityBio common stockholders were $197.4 million and $167.9 million for the six months ended June 30, 2022 and 2021, respectively. Substantially all of our net losses resulted principally from costs incurred in connection with our ongoing clinical trials and operations, our research and development programs, and from selling, general and administrative costs associated with our operations, including stock-based compensation expense.
As of June 30, 2022, we had 740 employees. Personnel of related companies who provide corporate, general and administrative, manufacturing strategy, research and development, regulatory and clinical trial strategy and other support services under our shared services agreement with NantWorks are not included in this number. For additional information, see Note 9, Related-Party Agreements, of the “Notes to Unaudited Condensed Consolidated Financial Statements” that appears in Item 1. “Financial Statements” of this Quarterly Report on Form 10-Q. In anticipation of the commercialization of select drug candidates, we expect to continue to incur significant expenses and increasing operating losses for the foreseeable future, which may fluctuate significantly from quarter-to-quarter and year-to-year. See “—Future Funding Requirements” below for a discussion of our anticipated expenditures and sources of capital we expect to access to fund these expenditures.
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