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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
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☒
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934 |
For the quarterly period ended
September 30, 2020
OR
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☐
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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: 001-36296
Sesen Bio, Inc.
(Exact name of registrant as specified in its charter)
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Delaware
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26-2025616
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(State or other jurisdiction of
incorporation or organization) |
(I.R.S. Employer
Identification No.) |
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245 First Street, Suite 1800
Cambridge, MA
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02142
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(Address of principal executive offices) |
(Zip Code) |
(617) 444-8550
(Registrant’s telephone number, including area code)
Not applicable.
(Former name, former address and former fiscal year, if changed
since last report)
Securities registered pursuant to Section 12(b) of the
Act:
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Title of each class |
Trading Symbol(s) |
Name of each exchange on which registered |
Common Stock, $0.001 par value |
SESN |
The Nasdaq Stock 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 ☒ 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 during the
preceding 12 months (or for such shorter period that the registrant
was required to submit such files). Yes ☒ No ☐
Indicate by check mark whether the registrant is a large
accelerated filer, an accelerated filer, a non-accelerated filer,
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.
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Large accelerated filer |
☐ |
Smaller reporting company |
☒
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Accelerated Filer
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☒ |
Emerging growth company |
☐
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Non-accelerated filer |
☐ |
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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
☒
There were 129,339,617 shares of the registrant's common stock
outstanding as of November 2, 2020.
SESEN BIO, INC.
Quarterly Report on Form 10-Q for the Quarterly Period ended
September 30, 2020
Table of Contents
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Page |
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PART I - FINANCIAL INFORMATION |
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Item 1. |
Financial Statements. |
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Condensed Consolidated Balance Sheets as of September 30, 2020 and
December 31, 2019
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Condensed Consolidated Statements of Operations and Comprehensive
Loss for the Three and Nine Months ended September 30, 2020 and
2019 |
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Condensed Consolidated Statements of Changes in Stockholders'
Equity (Deficit) for the Three and Nine Months ended September 30,
2020 and 2019
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Condensed Consolidated Statements of Cash Flows for the Nine Months
ended
September 30, 2020 and 2019
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Notes to Condensed Consolidated Financial Statements
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Item 2. |
Management’s Discussion and Analysis of Financial Condition and
Results of Operations. |
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Item 3. |
Quantitative and Qualitative Disclosures About Market
Risk. |
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Item 4. |
Controls and Procedures. |
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PART II - OTHER INFORMATION |
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Item 1. |
Legal Proceedings. |
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Item 1A. |
Risk Factors. |
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Item 2. |
Unregistered Sales of Equity Securities and Use of
Proceeds. |
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Item 3. |
Defaults Upon Senior Securities. |
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Item 4. |
Mine Safety Disclosures. |
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Item 5. |
Other Information. |
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Item 6. |
Exhibits. |
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PART I - FINANCIAL INFORMATION
Item 1. Financial
Statements.
SESEN BIO, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited; In thousands, except share and per share
data)
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September 30,
2020 |
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December 31, 2019 |
Assets |
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Current assets: |
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Cash and cash equivalents |
$ |
41,969 |
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$ |
48,121 |
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Prepaid expenses and other current assets |
7,072 |
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6,326 |
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Total current assets |
49,041 |
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54,447 |
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Restricted cash |
20 |
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20 |
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Property and equipment, net of accumulated
depreciation
of $850 and $758, respectively
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154 |
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238 |
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Intangible assets |
46,400 |
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46,400 |
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Goodwill |
13,064 |
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13,064 |
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Other assets |
349 |
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196 |
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Total Assets |
$ |
109,028 |
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$ |
114,365 |
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Liabilities and Stockholders’ Deficit |
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Current liabilities: |
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Accounts payable |
$ |
1,524 |
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$ |
1,902 |
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Accrued expenses |
7,703 |
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6,169 |
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Other current liabilities |
481 |
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446 |
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Total current liabilities |
9,708 |
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8,517 |
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Contingent consideration |
103,200 |
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120,020 |
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Deferred tax liability |
12,528 |
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12,528 |
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Other liabilities |
145 |
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— |
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Total Liabilities |
$ |
125,581 |
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$ |
141,065 |
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Commitments and contingencies |
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Stockholders’ Deficit: |
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Preferred stock, $0.001 par value per share; 5,000,000 shares
authorized at September 30, 2020 and December 31, 2019;
no shares issued and outstanding at September 30, 2020 and
December 31, 2019
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— |
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— |
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Common stock, $0.001 par value per share; 200,000,000 shares
authorized at September 30, 2020 and December 31, 2019;
123,645,007 and 106,801,409 shares issued and outstanding at
September 30, 2020 and December 31, 2019,
respectively
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123 |
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107 |
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Additional paid-in capital |
284,236 |
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266,717 |
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Accumulated deficit |
(300,912) |
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(293,524) |
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Total Stockholders’ Deficit |
(16,553) |
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(26,700) |
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Total Liabilities and Stockholders’ Deficit |
$ |
109,028 |
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$ |
114,365 |
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The accompanying notes are an integral part of these condensed
consolidated financial statements.
SESEN BIO, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
AND COMPREHENSIVE LOSS
(Unaudited; In thousands, except per share data)
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Three Months ended
September 30, |
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Nine Months ended September 30, |
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2020 |
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2019 |
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2020 |
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2019 |
License revenue |
$ |
11,236 |
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$ |
— |
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$ |
11,236 |
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$ |
— |
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Operating expenses: |
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Research and development |
10,196 |
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6,613 |
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23,625 |
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19,243 |
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General and administrative |
4,115 |
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3,238 |
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10,882 |
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8,910 |
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Change in fair value of contingent consideration |
18,400 |
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3,600 |
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(16,820) |
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46,600 |
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Total operating expenses |
32,711 |
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13,451 |
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17,687 |
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74,753 |
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Loss from operations |
(21,475) |
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(13,451) |
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(6,451) |
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(74,753) |
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Other income (expense), net: |
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Other income (expense), net |
(1) |
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319 |
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195 |
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806 |
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Net Loss and Comprehensive Loss Before Taxes |
(21,476) |
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(13,132) |
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(6,256) |
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(73,947) |
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Provision for income taxes |
(1,132) |
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— |
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(1,132) |
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— |
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Net Loss and Comprehensive Loss After Taxes |
$ |
(22,608) |
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$ |
(13,132) |
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$ |
(7,388) |
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$ |
(73,947) |
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Deemed dividend on adjustment of exercise price on certain
warrants |
$ |
— |
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$ |
— |
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(147) |
|
|
$ |
— |
|
Net Loss and Comprehensive Loss Attributable to Common
Shareholders |
$ |
(22,608) |
|
|
$ |
(13,132) |
|
|
$ |
(7,535) |
|
|
$ |
(73,947) |
|
|
|
|
|
|
|
|
|
Net loss per common share - basic and diluted |
$ |
(0.19) |
|
|
$ |
(0.13) |
|
|
$ |
(0.07) |
|
|
$ |
(0.85) |
|
Weighted-average common shares outstanding - basic and
diluted |
117,886 |
|
|
101,266 |
|
|
113,437 |
|
|
86,575 |
|
The accompanying notes are an integral part of these condensed
consolidated financial statements.
SESEN BIO, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’
EQUITY (DEFICIT)
(Unaudited; In thousands, except share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common Stock |
|
Additional
Paid-in
Capital |
|
Accumulated
Deficit |
|
Stockholders’
Equity (Deficit) |
|
Shares |
|
Amount |
|
Balance at December 31, 2019 |
106,801,409 |
|
|
$ |
107 |
|
|
$ |
266,717 |
|
|
$ |
(293,524) |
|
|
$ |
(26,700) |
|
Net income (loss) |
— |
|
|
— |
|
|
— |
|
|
41,564 |
|
|
41,564 |
|
Share-based compensation |
— |
|
|
— |
|
|
407 |
|
|
— |
|
|
407 |
|
Sales of common stock under 2014 ESPP |
2,785 |
|
|
— |
|
|
1 |
|
|
— |
|
|
1 |
|
Issuance of common stock under ATM Offering, net of issuance costs
of $0.1 million
|
3,187,359 |
|
|
3 |
|
|
3,176 |
|
|
— |
|
|
3,179 |
|
Balance at March 31, 2020 |
109,991,553 |
|
|
$ |
110 |
|
|
$ |
270,301 |
|
|
$ |
(251,960) |
|
|
$ |
18,451 |
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) |
— |
|
|
— |
|
|
— |
|
|
(26,344) |
|
|
(26,344) |
|
Share-based compensation |
— |
|
|
— |
|
|
491 |
|
|
— |
|
|
491 |
|
Issuance of common stock under ATM Offering, net of issuance costs
of $0.1 million
|
6,636,100 |
|
|
6 |
|
|
4,768 |
|
|
— |
|
|
4,774 |
|
Balance at June 30, 2020 |
116,627,653 |
|
|
$ |
116 |
|
|
$ |
275,560 |
|
|
$ |
(278,304) |
|
|
$ |
(2,628) |
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) |
— |
|
|
— |
|
|
— |
|
|
(22,608) |
|
|
(22,608) |
|
Share-based compensation |
— |
|
|
— |
|
|
453 |
|
|
— |
|
|
453 |
|
Sales of common stock under 2014 ESPP |
25,401 |
|
|
— |
|
|
9 |
|
|
|
|
9 |
|
Issuance of common stock under ATM Offering, net of issuance costs
of $0.3 million
|
6,991,953 |
|
|
7 |
|
|
8,214 |
|
|
— |
|
|
8,221 |
|
Balance at September 30, 2020 |
123,645,007 |
|
|
$ |
123 |
|
|
$ |
284,236 |
|
|
$ |
(300,912) |
|
|
$ |
(16,553) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common Stock |
|
Additional
Paid-in
Capital |
|
Accumulated
Deficit |
|
Stockholders’
Equity |
|
Shares |
|
Amount |
|
Balance at December 31, 2018 |
77,456,180 |
|
|
$ |
77 |
|
|
$ |
230,154 |
|
|
$ |
(186,024) |
|
|
$ |
44,207 |
|
Net income (loss) |
— |
|
|
— |
|
|
— |
|
|
(6,480) |
|
|
(6,480) |
|
Share-based compensation |
— |
|
|
— |
|
|
326 |
|
|
— |
|
|
326 |
|
Sales of common stock under 2014 ESPP |
8,601 |
|
|
— |
|
|
7 |
|
|
— |
|
|
7 |
|
Balance at March 31, 2019 |
77,464,781 |
|
|
$ |
77 |
|
|
$ |
230,487 |
|
|
$ |
(192,504) |
|
|
$ |
38,060 |
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) |
— |
|
|
— |
|
|
— |
|
|
(54,335) |
|
|
(54,335) |
|
Share-based compensation |
— |
|
|
— |
|
|
356 |
|
|
— |
|
|
356 |
|
Exercise of stock options |
30,000 |
|
|
— |
|
|
45 |
|
|
— |
|
|
45 |
|
Exercise of common stock warrants |
3,361,115 |
|
|
4 |
|
|
3,430 |
|
|
— |
|
|
3,434 |
|
Issuance of common stock and common stock warrants, net of issuance
costs of $2.2 million
|
20,410,000 |
|
|
20 |
|
|
27,789 |
|
|
— |
|
|
27,809 |
|
Balance as of June 30, 2019 |
101,265,896 |
|
|
$ |
101 |
|
|
$ |
262,107 |
|
|
$ |
(246,839) |
|
|
$ |
15,369 |
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) |
— |
|
|
— |
|
|
— |
|
|
(13,132) |
|
|
(13,132) |
|
Share-based compensation |
— |
|
|
— |
|
|
229 |
|
|
— |
|
|
229 |
|
Sales of common stock under the 2014 ESPP |
1,682 |
|
|
— |
|
|
1 |
|
|
— |
|
|
1 |
|
Balance at September 30, 2019 |
101,267,578 |
|
|
$ |
101 |
|
|
$ |
262,337 |
|
|
$ |
(259,971) |
|
|
$ |
2,467 |
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these condensed
consolidated financial statements.
SESEN BIO, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited; In thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months ended September 30, |
|
2020 |
|
2019 |
Cash Flows from Operating Activities: |
|
|
|
Net loss |
$ |
(7,388) |
|
|
$ |
(73,947) |
|
Adjustments to reconcile net loss to net cash used in operating
activities: |
|
|
|
Depreciation |
92 |
|
|
164 |
|
Share-based compensation |
1,351 |
|
|
911 |
|
Change in fair value of contingent consideration |
(16,820) |
|
|
46,600 |
|
Changes in operating assets and liabilities: |
|
|
|
Prepaid expenses and other assets |
(899) |
|
|
(421) |
|
Accounts payable |
(378) |
|
|
1,216 |
|
Accrued expenses and other liabilities |
1,714 |
|
|
1,761 |
|
Net Cash Used in Operating Activities |
(22,328) |
|
|
(23,716) |
|
Cash Flows from Investing Activities: |
|
|
|
|
|
|
|
Net Cash Used in Investing Activities |
(8) |
|
|
(137) |
|
Cash Flows from Financing Activities: |
|
|
|
Proceeds from issuance of common stock under ATM Offering, net of
issuance costs |
16,174 |
|
|
— |
|
Proceeds from sales of common stock under 2014 ESPP |
10 |
|
|
8 |
|
Proceeds from exercises of stock options |
— |
|
|
45 |
Proceeds from the issuance of common stock and common stock
warrants, net of issuance costs |
— |
|
|
27,809 |
|
Proceeds from the exercise of common stock warrants |
— |
|
|
3,434 |
|
Net Cash Provided by Financing Activities |
16,184 |
|
|
31,296 |
|
Net Increase (Decrease) in Cash, Cash Equivalents and Restricted
Cash |
(6,152) |
|
|
7,443 |
|
Cash, Cash Equivalents and Restricted Cash - Beginning of
Period |
48,141 |
|
|
50,442 |
|
Cash, Cash Equivalents and Restricted Cash - End of
Period |
$ |
41,989 |
|
|
$ |
57,885 |
|
|
|
|
|
Supplemental disclosure of non-cash operating
activities: |
|
|
|
Right-of-use assets related to the adoption of ASC
842 |
$ |
— |
|
|
$ |
236 |
|
Right-of-use assets obtained in exchange for lease
obligations |
290 |
|
$ |
— |
|
Cash paid for amounts included in the measurement of lease
liabilities |
$ |
113 |
|
|
$ |
115 |
|
Supplemental disclosure of non-cash financing
activities: |
|
|
|
Deemed dividend on adjustment of exercise price on certain
warrants |
$ |
147 |
|
|
$ |
— |
|
The accompanying notes are an integral part of these condensed
consolidated financial statements.
SESEN BIO, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
1. DESCRIPTION OF BUSINESS
Sesen Bio, Inc. ("Sesen" or the “Company”), a Delaware corporation
formed in February 2008, is a late-stage clinical company
developing targeted fusion protein therapeutics ("TFPTs") for the
treatment of patients with cancer. The Company’s most advanced
product candidate, VicineumTM,
also known as VB4-845, is a locally-administered targeted fusion
protein composed of an anti-epithelial cell adhesion molecule
("EpCAM") antibody fragment tethered to a truncated form of
Pseudomonas exotoxin A.
The Company has an ongoing single-arm, multi-center, open-label
Phase 3 clinical trial of Vicineum as a monotherapy in patients
with high-risk, bacillus Calmette-Guérin ("BCG")-unresponsive
non-muscle invasive bladder cancer ("NMIBC") (the "VISTA Trial").
The VISTA Trial completed enrollment in April 2018 with a total of
133 patients, and in December 2019, the Company initiated
submission of the Biologics License Application ("BLA") for
Vicineum to the United States Food and Drug Administration ("FDA")
under Rolling Review, which enables individual modules to be
submitted and reviewed on an ongoing basis, rather than waiting for
all sections to be completed before submission. The Company
operates in one segment under the direction of its Chief Executive
Officer (chief operating decision maker).
Viventia Acquisition
In September 2016, the Company entered into a Share Purchase
Agreement with Viventia Bio, Inc., a corporation incorporated under
the laws of the Province of Ontario, Canada ("Viventia"), the
shareholders of Viventia named therein (the “Selling Shareholders”)
and, solely in its capacity as seller representative, Clairmark
Investments Ltd., a corporation incorporated under the laws of the
Province of Ontario, Canada (“Clairmark”) (the “Share Purchase
Agreement”), pursuant to which the Company agreed to and
simultaneously completed the acquisition of all of the outstanding
capital stock of Viventia from the Selling Shareholders (the
“Viventia Acquisition”). In connection with the closing of the
Viventia Acquisition, the Company issued 4.0 million shares of
its common stock to the Selling Shareholders, which at that time
represented approximately 19.9% of the voting power of the Company
as of immediately prior to the issuance of such shares. Clairmark
is an affiliate of Leslie L. Dan, a director of the Company until
his retirement in July 2019.
In addition, under the Share Purchase Agreement, the Company is
obligated to pay to the Selling Shareholders certain post-closing
contingent cash payments upon the achievement of specified
milestones and based upon net sales, in each case subject to the
terms and conditions set forth in the Share Purchase Agreement,
including: (i) a one-time milestone payment of $12.5 million
payable upon the first sale of Vicineum (the “Purchased Product”)
in the United States; (ii) a one-time milestone payment of
$7.0 million payable upon the first sale of the Purchased
Product in any one of certain specified European countries; (iii) a
one-time milestone payment of $3.0 million payable upon the
first sale of the Purchased Product in Japan; and (iv) quarterly
earn-out payments equal to 2% of net sales of the Purchased Product
during specified earn-out periods. Such earn-out payments are
payable with respect to net sales in a country beginning on the
date of the first sale in such country and ending on the earlier of
(i) December 31, 2033 and (ii) fifteen years after the date of such
sale, subject to early termination in certain circumstances if a
biosimilar product is on the market in the applicable country
(collectively, the "Contingent Consideration"). Under the Share
Purchase Agreement, the Company, its affiliates, licensees and
subcontractors are required to use commercially reasonable efforts
for the first seven years following the closing of the Viventia
Acquisition, to achieve marketing authorizations throughout the
world and, during the applicable earn-out period, to commercialize
the Purchased Product in the United States, France, Germany, Italy,
Spain, United Kingdom, Japan, China and Canada. Certain of these
payments are payable to individuals or affiliates of individuals
that were previously employees or members of the Company's board of
directors.
Liquidity and Going Concern
As of September 30, 2020, the Company had cash and cash
equivalents of $42 million, net working capital of $39.3 million
and an accumulated deficit of $300.9 million. The Company incurred
negative cash flows from operating activities of $37.5 million for
the year ended December 31, 2019 and $22.3 million for the
nine months ended September 30, 2020. Since its inception, the
Company has received no revenue from sales of its products, and
management anticipates that operating losses will continue for the
foreseeable future as the Company continues its ongoing Phase 3
VISTA Trial for Vicineum for the treatment of high-risk NMIBC and
seeks marketing approval from the FDA and the European Medicines
Agency. The Company has financed its operations to date primarily
through private placements of its common stock, preferred stock,
common stock warrants and convertible bridge notes, venture debt
borrowings, its initial public offering ("IPO"), follow-on public
offerings, sales effected in "at-the-market" ("ATM") offerings, a
License Agreement with F. Hoffmann-La Roche Ltd and Hoffman-La
Roche Inc. (collectively, "Roche") (the "License Agreement with
Roche"), a License Agreement with Qilu Pharmaceuticals Ltd.
(“Qilu”) (the "License Agreement with Qilu"), and, to a lesser
extent, from a collaboration. See “Note 9. Stockholders’ Equity”
below for information regarding the Company’s recently completed
equity financings.
Under Accounting Standards Codification ("ASC") Topic
205-40,
Presentation of Financial Statements - Going
Concern,
management is required at each reporting period to evaluate whether
there are conditions and events, considered in the aggregate, that
raise substantial doubt about an entity's ability to continue as a
going concern within one year after the date that the financial
statements are issued. This evaluation initially does not take into
consideration the potential mitigating effect of management's plans
that have not been fully implemented as of the date the financial
statements are issued. When substantial doubt exists, management
evaluates whether the mitigating effect of its plans sufficiently
alleviates the substantial doubt about the Company's ability to
continue as a going concern. The mitigating effect of management's
plans, however, is only considered if both (i) it is probable that
the plans will be effectively implemented within one year after the
date that the financial statements are issued and (ii) it is
probable that the plans, when implemented, will mitigate the
relevant conditions or events that raise substantial doubt about
the entity's ability to continue as a going concern within one year
after the date that the financial statements are issued. Generally,
to be considered probable of being effectively implemented, the
plans must have been approved by the Company's board of directors
before the date that the financial statements are
issued.
The Company's future success is dependent on its ability to develop
and commercialize Vicineum for the treatment of high-risk NMIBC,
and ultimately upon its ability to attain profitable operations. In
order to commercialize its product candidates, including Vicineum
for the treatment of high-risk NMIBC, the Company needs to complete
clinical development and comply with comprehensive regulatory
requirements. The Company is subject to a number of risks similar
to other late-stage clinical companies, including, but not limited
to, successful discovery and development of its product candidates,
raising additional capital, development and commercialization by
its competitors of new technological innovations, protection of
proprietary technology, market acceptance of its products and
dependence on third parties for the development and
commercialization of Vicineum in certain markets. The successful
discovery and development of product candidates, including Vicineum
for the treatment of high-risk NMIBC, requires substantial working
capital, and management expects to seek additional funds through
equity or debt financings or through additional collaboration or
licensing transactions or other sources. The Company may be unable
to obtain equity or debt financings or enter into additional
collaboration or licensing transactions on favorable terms, or at
all. To the extent that the Company raises additional capital
through the sale of equity or convertible debt securities, the
ownership interests of existing stockholders will be diluted, and
the terms of these securities may include liquidation or other
preferences that adversely affect the rights of existing
stockholders. Debt financing, if available, may involve agreements
that include liens or other restrictive covenants limiting the
Company's ability to take specific actions, such as incurring
additional debt, making capital expenditures or declaring
dividends. If the Company raises additional funds through
government or other third-party funding, strategic collaborations
and alliances or licensing arrangements, it may have to relinquish
valuable rights to its technologies, future revenue streams,
research programs or product candidates or grant licenses on terms
that may not be favorable. If the Company is unable to raise
additional funds when needed, it may be required to implement cost
reduction strategies and delay, limit, reduce or terminate its
product development, regulatory approval or future
commercialization efforts or grant rights to develop and market
products or product candidates that management would otherwise
prefer to develop and market.
The Company's management does not believe that its cash and cash
equivalents of $42.0 million as of September 30, 2020 are
sufficient to fund the Company's current operating plan for at
least twelve months after the issuance of these condensed
consolidated financial statements. Given the history of significant
losses, negative cash flows from operations, limited cash resources
currently on hand, the ongoing COVID-19 pandemic and dependence by
the Company on its ability - about which there can be no certainty
- to obtain additional financing to fund its operations after the
current cash resources are exhausted, substantial doubt exists
about the Company's ability to continue as a going concern. These
condensed consolidated financial statements were prepared under the
assumption that the Company will continue as a going concern and do
not include any adjustments relating to the recoverability and
classification of recorded asset amounts or the amounts and
classification of liabilities that might result from the outcome of
this uncertainty.
2. BASIS OF PRESENTATION
The accompanying financial statements have been prepared in
accordance with United States generally accepted accounting
principles (“GAAP”). Any reference in these notes to applicable
guidance is meant to refer to GAAP as found in the ASC and
Accounting Standards Updates (“ASUs”), promulgated by the Financial
Accounting Standards Board (“FASB”).
Interim Financial Statements
The accompanying unaudited interim condensed consolidated financial
statements have been prepared from the books and records of the
Company in accordance with GAAP for interim financial information
and Rule 10-01 of Regulation S-X promulgated by the United States
Securities and Exchange Commission (“SEC”), which permit reduced
disclosures for interim periods. All adjustments, consisting only
of normal recurring adjustments, necessary for a fair presentation
of the accompanying condensed consolidated balance sheets and
statements of operations and comprehensive loss, stockholders’
equity (deficit) and cash flows have been made. Although these
interim financial statements do not include all of the
information and footnotes required for complete annual financial
statements, management believes the disclosures are adequate to
make the information presented not misleading. These unaudited
interim results of operations and cash flows for the nine months
ended September 30, 2020 are not necessarily indicative of the
results that may be expected for the full year. These unaudited
interim condensed consolidated financial statements and footnotes
should be read in conjunction with the Company’s audited annual
consolidated financial statements and footnotes included in its
Annual Report on Form 10-K, as filed with the SEC on March 16,
2020, wherein a more complete discussion of significant accounting
policies and certain other information can be found.
Use of Estimates
The preparation of financial statements in accordance with GAAP and
the rules and regulations of the SEC requires the use of estimates
and assumptions, based on judgments considered reasonable, which
affect the reported amounts of assets and liabilities and
disclosure of contingent assets and liabilities at the date of the
financial statements and the reported amounts of revenues and
expenses during the reporting period. The Company bases its
estimates and assumptions on historical experience, known trends
and events and various other factors that management believes to be
reasonable under the circumstances, the results of which form the
basis for making judgments about the carrying value of assets and
liabilities that are not readily apparent from other sources.
Although management believes its estimates and assumptions are
reasonable when made, they are based upon information available at
the time they are made. Management evaluates the estimates and
assumptions on an ongoing basis and, if necessary, makes
adjustments. Due to the risks and uncertainties involved in the
Company’s business and evolving market conditions, and given the
subjective element of the estimates and assumptions made, actual
results may differ from estimated results. The most significant
estimates and judgments impact the fair value of intangible assets,
goodwill and contingent consideration; income taxes (including the
valuation allowance for deferred tax assets); research and
development expenses; revenue recognition and going concern
considerations.
Principles of Consolidation
The Company’s consolidated financial statements include the
accounts of the Company, its wholly owned subsidiary Viventia and
its indirect subsidiaries, Viventia Bio USA Inc. and Viventia
Biotech (EU) Limited. All intercompany transactions and balances
have been eliminated in consolidation.
Foreign Currency Translation
The functional currency of the Company and each of its subsidiaries
is the U.S. dollar.
3. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
The Company's complete summary of significant accounting policies
can be found in "Item 15. Exhibits and Financial Statement
Schedules - Note 3. Summary of Significant Accounting Policies" in
the audited annual consolidated financial statements included in
its Annual Report on Form 10-K for the year ended December 31,
2019.
4. RECENT ACCOUNTING PRONOUNCEMENTS
Adopted in 2020
In June 2016, the FASB issued ASU No. 2016-13,
Financial Instruments - Credit Losses (Topic 326): Measurement of
Credit Losses on Financial Instruments
("ASU 2016-13"). ASU 2016-13 requires measurement and recognition
of expected credit losses for financial assets held. The amendments
in ASU 2016-13 eliminate the probable threshold for initial
recognition of a credit loss in GAAP and reflect an entity’s
current estimate of all expected credit losses. ASU 2016-13 is
effective for annual and interim periods beginning January 1, 2020
and is to be applied using a modified retrospective transition
method. The Company adopted this guidance effective January 1,
2020, and it did not have a material impact on the Company’s
financial position, results of operations or cash
flows.
In August 2018, the FASB issued ASU No.
2018-13, Fair
Value Measurement (Topic 820): Disclosure Framework - Changes to
the Disclosure Requirements for Fair Value Measurements
("ASU 2018-13"). ASU 2018-13 modifies fair value measurement
disclosure requirements. ASU 2018-13 is effective for annual and
interim periods beginning after December 15, 2019. The Company
adopted this guidance effective January 1, 2020, and although it
resulted in some additional footnote disclosures, it did not have a
material impact on the Company’s disclosures. For the new
disclosures regarding our Level 3 instruments, please read Note 5,
Fair Value Measurements and Financial Instruments, to these
condensed consolidated financial statements.
In August 2018, the FASB issued ASU No. 2018-15,
Intangibles - Goodwill and Other - Internal-Use Software (Subtopic
350-40): Customer’s Accounting for Implementation Costs Incurred in
a Cloud Computing Arrangement That Is a Service
Contract
("ASU 2018-15").
ASU 2018-15 requires a customer in a cloud computing
arrangement that is a service contract to follow the internal-use
software guidance to determine which implementation costs to defer
and recognize as an asset. The effective date for ASU 2018-15 is
for annual and interim periods beginning after December 15, 2019.
The amendments in this ASU should be applied either retrospectively
or prospectively to all implementation costs incurred after the
date of adoption. The Company adopted this guidance effective
January 1, 2020, and it did not have a material impact on the
Company’s financial position, results of operations or cash
flows.
Pending Adoption
In December 2019, the FASB issued ASU No. 2019-12,
Income Taxes (Topic 740): Simplifying the Accounting for Income
Taxes
("ASU 2019-12"). ASU 2019-12 simplifies the accounting for income
taxes by removing certain exceptions to the general principles in
Topic 740. The amendments in ASU 2019-12 also improve consistent
application of and simplify GAAP for other areas of Topic 740 by
clarifying and amending existing guidance. ASU 2019-12 is effective
for fiscal years, and interim periods within those fiscal years,
beginning after December 15, 2020. Early adoption is permitted. The
method with which the amendments in this ASU are to be applied
varies depending on the nature of the tax item impacted by
amendment. Because the Company generates losses and pays no income
taxes, it does not expect the adoption of ASU 2019-12 to have a
material impact on the Company's financial position, results of
operations or cash flows.
5. FAIR VALUE MEASUREMENT AND FINANCIAL INSTRUMENTS
The carrying values of cash and cash equivalents, restricted cash,
prepaid expenses and other current assets, and accounts payable on
the Company’s condensed consolidated balance sheets approximated
their fair values as of September 30, 2020 and
December 31, 2019 due to their short-term nature.
Certain of the Company’s financial instruments are measured at fair
value using a three-level hierarchy that prioritizes the inputs
used to measure fair value. This fair value hierarchy prioritizes
the use of observable inputs and minimizes the use of unobservable
inputs. The three levels of inputs used to measure fair value are
as follows:
Level 1: Inputs
are quoted prices for identical instruments in active
markets.
Level 2: Inputs
are quoted prices for similar instruments in active markets; quoted
prices for identical or similar instruments in markets that are not
active; or model-derived valuations whose inputs are observable or
whose significant value drivers are observable.
Level 3: Inputs
are unobservable and reflect the Company’s own assumptions, based
on the best information available, including the Company’s own
data.
The following tables set forth the carrying amounts and fair values
of the Company's financial instruments measured at fair value on a
recurring basis as of September 30, 2020 and December 31,
2019 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30, 2020 |
|
|
|
|
|
Fair Value Measurement Based on |
|
Carrying Amount |
|
Fair Value |
|
Quoted Prices in Active
Markets
(Level 1) |
|
Significant other Observable
Inputs
(Level 2) |
|
Significant Unobservable
Inputs
(Level 3) |
Assets: |
|
|
|
|
|
|
|
|
|
Money market funds
(cash equivalents) |
$ |
16,370 |
|
|
$ |
16,370 |
|
|
$ |
16,370 |
|
|
$ |
— |
|
|
$ |
— |
|
Liabilities: |
|
|
|
|
|
|
|
|
|
Contingent consideration |
$ |
103,200 |
|
|
$ |
103,200 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
103,200 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2019 |
|
|
|
|
|
Fair Value Measurement Based on |
|
Carrying Amount |
|
Fair Value |
|
Quoted Prices in Active
Markets
(Level 1) |
|
Significant other Observable
Inputs
(Level 2) |
|
Significant Unobservable
Inputs
(Level 3) |
Assets: |
|
|
|
|
|
|
|
|
|
Money market funds
(cash equivalents) |
$ |
31,146 |
|
|
$ |
31,146 |
|
|
$ |
31,146 |
|
|
$ |
— |
|
|
$ |
— |
|
Liabilities: |
|
|
|
|
|
|
|
|
|
Contingent consideration |
$ |
120,020 |
|
|
$ |
120,020 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
120,020 |
|
The Company evaluates transfers between fair value levels at the
end of each reporting period. There were no transfers of assets or
liabilities between fair value levels during the nine months ended
September 30, 2020.
Contingent Consideration
On September 20, 2016, the Company acquired Viventia through the
issuance of shares of common stock plus contingent consideration,
pursuant to the terms of a Share Purchase Agreement. The Company
recorded the acquired assets and liabilities based on their
estimated fair values as of the acquisition date and finalized its
purchase accounting for the Viventia Acquisition during the third
quarter of 2017. The contingent consideration relates to amounts
potentially payable to the former shareholders of Viventia under
the Share Purchase Agreement. Contingent consideration is measured
at its estimated fair value at each reporting period, with
fluctuations in value resulting in a non-cash charge to earnings
(or loss) during the period. The estimated fair value measurement
is based on significant inputs, including internally developed
financial forecasts, probabilities of success, and the timing of
certain milestone events and achievements, which are not observable
in the market, representing a Level 3 measurement within the fair
value hierarchy. The valuation of contingent consideration requires
the use of significant assumptions and judgments, which management
believes are consistent with those that would be made by a market
participant. Management reviews its assumptions and judgments on an
ongoing basis as additional market and other data is obtained, and
any future changes in the assumptions and judgments utilized by
management may cause the estimated fair value of contingent
consideration to fluctuate materially, resulting in earnings
volatility.
The following table sets forth a summary of the change in the fair
value of the Company's contingent consideration liability, measured
on a recurring basis at each reporting period, for the nine months
ended September 30, 2020 (in thousands):
|
|
|
|
|
|
Balance at December 31, 2019 |
$ |
120,020 |
|
Change in fair value of contingent consideration |
(16,820) |
|
Balance at September 30, 2020 |
$ |
103,200 |
|
The fair value of the Company’s contingent consideration was
determined using probabilities of successful achievement of
regulatory milestones and commercial sales, the period in which
these milestones and sales are expected to be achieved ranging from
2021 to 2033, and the level of commercial sales of Vicineum
forecasted for the United States, Europe, Japan, China and other
potential markets. There have been no changes to the valuation
methods utilized during the nine months ended September 30, 2020.
Because of the ongoing business environment uncertainty created by
the ongoing COVID-19 pandemic, management carefully reviewed as of
September 30, 2020 all of the Company’s financial forecast
assumptions related to probability, timing and anticipated level of
commercial sales in both US and OUS markets which were used to
determine the estimated fair value of contingent consideration, and
updated its forecasts for commercial sales in the third quarter of
2020 as needed. However, given the evolving and uncertain nature of
the COVID-19 pandemic, management will continue to closely monitor
developments in order to timely determine if any financial forecast
changes may be required. As of September 30, 2020, no financial
forecast changes due to COVID-19 were currently required. Changes
to probabilities of success, timing of certain milestones and
achievements, and level of commercial sales could materially affect
the valuation of contingent consideration.
The estimated fair value of contingent consideration is also
determined by applying appropriate discount rates to future cash
outflows related to the contingent payment obligations, and these
discount rates have fluctuated significantly in 2020 as a result of
the extreme volatility of financial markets as global economies
shut down in order to contain the spread of COVID-19. The milestone
payments constitute debt-like obligations, and the high-yield debt
index rate applied to the milestones in order to determine the
estimated fair value moved from 11.8% as of December 31, 2019
to 17.9% as of March 31, 2020, 14.5% as of June 30, 2020 and back
to 11.8% as of September 30, 2020. The discount rate applied
to the 2% royalty due on forecasted Vicineum revenues is derived
from the Company’s estimated weighted-average cost of capital
(“WACC”), and this WACC-derived discount rate fluctuated from 5.6%
as of December 31, 2019 to 14.7% as of March 31, 2020, to
13.2% as of June 30,
2020 and to 9.4% as of September 30, 2020. These changes in
the applicable discount rates, plus refinement of timelines in
certain OUS markets and changes to the competitive landscape,
resulted in an overall $16.8 million decrease in the estimated
fair value of contingent consideration as of September 30, 2020.
Changes to the discount rates could materially affect the valuation
of the contingent consideration.
6. INTANGIBLE ASSETS AND GOODWILL
Intangible Assets
Intangible assets on the Company's condensed consolidated balance
sheet are the result of the Viventia Acquisition in September 2016.
The following table sets forth the composition of intangible assets
as of September 30, 2020 and December 31, 2019 (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30, 2020 |
|
December 31, 2019 |
IPR&D intangible assets: |
|
|
|
Vicineum United States rights
|
$ |
31,700 |
|
|
$ |
31,700 |
|
Vicineum European Union rights
|
14,700 |
|
|
14,700 |
|
Total Intangibles |
$ |
46,400 |
|
|
$ |
46,400 |
|
Goodwill
Goodwill on the Company's consolidated balance sheet is the result
of the Viventia Acquisition in September 2016. Goodwill had a
carrying value of $13.1 million as of September 30, 2020 and
December 31, 2019.
7. LEASES
On January 1, 2019, the Company adopted ASC Topic 842,
Leases
using the optional transition method. The Company’s lease portfolio
includes:
1.An
operating lease for its 31,100 square foot facility in Winnipeg,
Manitoba which consists of manufacturing, laboratory, warehouse and
office space. In September 2020, the Company entered into an
extension of this lease for an additional two years, through
September 2022, with a right to extend the lease for one subsequent
three-year term. The minimum monthly rent under this lease is
$13,500 per month. In addition to rent expense, the Company expects
to incur $12,300 per month in related operating expenses. Operating
lease cost under this lease, including the related operating costs,
was $75,000 and $223,000 for the three and nine months ended
September 30, 2020 and $76,000 and $222,000 for the three and nine
months ended September 30, 2019, respectively;
2.Short-term
property leases for modular office space for 1) its corporate
headquarters in Cambridge, MA and 2) office space in Philadelphia,
PA. The short-term leases renew every
four to nine months and currently extend through May 2021.
The minimum monthly rent for these office spaces is $21,400 per
month, which is subject to change if and as the Company adds or
deducts space to or from the leases. The Company recorded $64,000
and $195,000 in rent expense for the three and nine months ended
September 30, 2020, respectively, and $59,000 and $188,000 in rent
expense for the three and nine months ended September 30, 2019,
respectively, for these leases.
The asset component of the Company’s operating leases is recorded
as operating lease right-of-use assets and reported within other
assets on the Company's condensed consolidated balance sheets. The
short-term liability is recorded in other current liabilities on
the Company’s condensed consolidated balance sheet. Operating lease
cost is recognized on a straight-line basis over the term of the
lease.
8. ACCRUED EXPENSES
The following table sets forth the composition of accrued expenses
as of September 30, 2020 and December 31, 2019 (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30,
2020 |
|
December 31, 2019 |
Research and development |
$ |
5,145 |
|
|
$ |
3,688 |
|
Payroll-related expenses |
1,474 |
|
|
1,638 |
|
Severance to former Executives and other employees |
— |
|
|
378 |
|
Professional fees |
1,060 |
|
|
378 |
|
Other |
24 |
|
|
87 |
|
Total Accrued Expenses |
$ |
7,703 |
|
|
$ |
6,169 |
|
Management Changes
On August 26, 2019, Richard Fitzgerald departed as the Company's
Chief Financial Officer. In connection with his separation from the
Company, Mr. Fitzgerald and the Company entered into a Separation
Agreement and General Release dated as of September 9, 2019 (the
"Fitzgerald Separation Agreement), pursuant to which the Company
provided Mr. Fitzgerald with twelve months of separation payments
and benefits. The Company recorded $0.3 million of expense related
to this agreement in 2019. The separation payments were paid
through the normal payroll cycle through August 2020, when the
Company concluded its obligations under the Fitzgerald Separation
Agreement.
On August 2, 2019, Dennis Kim, M.D., MPH departed as the Company's
Chief Medical Officer. In connection with his separation from the
Company, Dr. Kim and the Company entered into a Separation
Agreement and General Release dated as of August 2, 2019 (the “Kim
Separation Agreement”), pursuant to which the Company provided Dr.
Kim with six months of separation payments in the amount of $0.2
million. In addition, Dr. Kim and the Company entered into a
Consulting Agreement dated as of August 3, 2019 (the "Kim
Consulting Agreement"), pursuant to which the Company agreed to pay
Dr. Kim $0.1 million in consulting fees and transition expenses
over the three months ended November 2, 2019. The Company recorded
$0.3 million of expenses related to these agreements in 2019. The
Kim Consulting Agreement payments were made in a lump sum when the
agreement concluded in November 2019. The separation payments were
paid through the normal payroll cycle through January 2020, when
the Company concluded its obligations under the Kim Separation
Agreement.
9. STOCKHOLDERS' EQUITY (DEFICIT)
Equity Financings
ATM Offering
In November 2019, the Company entered into an Open Market Sale
Agreement
SM
(the "Sale Agreement") with Jefferies LLC ("Jefferies"), under
which the Company may issue and sell shares of its common stock
from time to time for an aggregate sales price of up to
$35.0 million through Jefferies (the "ATM Offering"). Sales of
common stock under the Sale Agreement are made by any method that
is deemed to be an ATM offering as defined in
Rule 415(a)(4) of the Securities Act of 1933, as amended,
including but not limited to sales made directly on or through the
Nasdaq Global Market or any other existing trading market for the
common stock. The Company has no obligation to sell any of its
common stock and may at any time suspend offers under the Sale
Agreement or terminate the Sale Agreement. Subject to the terms and
conditions of the Sale Agreement, Jefferies will use its
commercially reasonable efforts to sell common stock from time to
time, as the sales agent, based upon the Company’s instructions,
which include a prohibition on sales below a minimum price set by
the Company from time to time. The Company has provided Jefferies
with customary indemnification rights, and Jefferies is entitled to
a commission at a fixed rate equal to 3.0% of the gross proceeds
for each sale of common stock under the Sale Agreement. The Company
incurred $0.2 million in legal, accounting and printing costs
related to the commencement of the ATM Offering. For the nine
months ended September 30, 2020, the Company raised
$16.2 million of net proceeds from the sale of 16.8 million
shares of common stock at a weighted-average price of $0.99 per
share under the ATM Offering, including $8.2 million of net
proceeds from the sale of 7.0 million shares of common stock
at a weighted-average price of $1.21 per share during the three
months ended September 30, 2020. Share issue costs, including sales
agent commissions, related to the ATM Offering totaled
$0.3 million and $0.5 million during the three and nine months
ended September 30, 2020, respectively.
June 2019 Financing
In June 2019, the Company raised $27.8 million of net proceeds from
the sale of 20.4 million shares of common stock and
accompanying warrants to purchase an additional 20.4 million
shares of common stock in an underwritten public offering (the
"June 2019 Financing"). The combined purchase price for each share
of common stock and accompanying warrant was $1.47. Subject to
certain ownership limitations, the warrants issued in the June 2019
Financing were exercisable immediately upon issuance at an exercise
price of $1.47 per share, subject to adjustments as provided under
the terms of such warrants, and had a
one-year term expiring on June 21, 2020. As of September 30, 2020,
all warrants issued in connection with the June 2019 financing have
expired.
Preferred Stock
Pursuant to its Amended and Restated Certificate of Incorporation
(the "Certificate of Incorporation"), the Company is authorized to
issue 5.0 million shares of "blank check" preferred stock, $0.001
par value per share, which enables its board of directors, from
time to time, to create one or more series of preferred stock. Each
series of preferred stock issued shall have the rights,
preferences, privileges and restrictions as designated by the board
of directors. The issuance of any series of preferred stock could
affect, among other things, the dividend, voting and liquidation
rights of the common stock. The Company had no preferred stock
issued and outstanding as of
September 30, 2020 and December 31, 2019.
Common Stock
Pursuant to its Certificate of Incorporation, the Company is
authorized to issue 200.0 million shares of common stock, $0.001
par value per share, of which 123.6 million and 106.8 million
shares were issued and outstanding as of
September 30, 2020 and December 31, 2019, respectively.
In addition, the Company had reserved for issuance the following
amounts of shares of its common stock for the purposes described
below as of September 30, 2020 and December 31, 2019 (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30, 2020 |
|
December 31, 2019 |
Shares of common stock issued |
123,645 |
|
|
106,801 |
|
Shares of common stock reserved for issuance for: |
|
|
|
Warrants |
2,485 |
|
|
22,895 |
|
Stock options |
10,227 |
|
|
6,236 |
|
Shares available for grant under 2014 Stock Incentive
Plan |
4,795 |
|
|
8,753 |
|
Shares available for sale under 2014 Employee Stock Purchase
Plan |
— |
|
|
28 |
|
Total shares of common stock issued and reserved for
issuance |
141,152 |
|
|
144,713 |
|
The voting, dividend and liquidation rights of holders of shares of
common stock are subject to and qualified by the rights, powers and
preferences of holders of shares of preferred stock. Each share of
common stock entitles the holder to one vote on all matters
submitted to a vote of the Company's stockholders; provided,
however, that, except as otherwise required by law, holders of
common stock shall not be entitled to vote on any amendment to the
Company’s Certificate of Incorporation that relates solely to the
terms of one or more outstanding series of preferred stock if the
holders of such affected series are entitled, either separately or
together as a class with the holders of one or more such series, to
vote thereon. There shall be no cumulative voting.
Dividends may be declared and paid on the common stock from funds
lawfully available thereof as and when determined by the board of
directors and subject to any preferential dividend or other rights
of any then-outstanding preferred stock. The Company has never
declared or paid, and for the foreseeable future does not expect to
declare or pay, dividends on its common stock.
Upon the dissolution or liquidation of the Company, whether
voluntary or involuntary, holders of common stock will be entitled
to receive all assets of the Company available for distribution to
its stockholders, subject to any preferential or other rights of
any then-outstanding preferred stock.
Warrants
All of the Company’s outstanding warrants are non-tradeable and
permanently classified as equity because they meet the derivative
scope exception under ASC Topic 815-40,
Derivatives and Hedging - Contracts in Entity’s Own Equity
("ASC 815-40").
The following table sets forth the Company's warrant activity for
the nine months ended September 30, 2020 (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year-to-Date Warrant Activity |
Issued |
|
Exercise
Price
(1)
|
|
Expiration |
|
December 31, 2019 |
|
Issued |
|
(Exercised) |
|
(Expired) |
|
September 30, 2020 |
Jun-2019 |
|
$1.47 |
|
Jun-2020 |
|
20,410 |
|
|
— |
|
|
— |
|
|
(20,410) |
|
— |
|
Mar-2018 |
|
$0.55* |
|
Mar-2023 |
|
1,943 |
|
|
— |
|
|
— |
|
|
— |
|
|
1,943 |
|
Nov-2017 |
|
$0.55* |
|
Nov-2022 |
|
487 |
|
|
— |
|
|
— |
|
|
— |
|
|
487 |
|
May-2015 |
|
$11.83 |
|
Nov-2024 |
|
28 |
|
|
— |
|
|
— |
|
|
— |
|
|
28 |
|
Nov-2014 |
|
$11.04 |
|
Nov-2024 |
|
27 |
|
|
— |
|
|
— |
|
|
— |
|
|
27 |
|
|
|
|
|
|
|
22,895 |
|
|
— |
|
|
— |
|
|
(20,410) |
|
|
2,485 |
|
(1)
As of September 30, 2020.
*
Exercise price shown subject to further adjustment based on down
round provision added by amendment.
In March 2018, the Company raised $9.0 million of net proceeds
from the sale of common stock in a registered direct public
offering and the sale of warrants to purchase shares of common
stock with an exercise price of $1.20 per share (the "2018
Warrants") in a concurrent private placement. On October 28, 2019,
the Company entered into transactions with certain holders of its
then outstanding 2018 Warrants to amend their warrants pursuant to
a Warrant Amendment Agreement (the "2018 Warrant Amendment
Agreements"). The 2018 Warrant Amendment Agreements reduced the
exercise price of the warrants from $1.20 to the lesser of (a)
$0.95 per share of common stock and (b) the exercise price as
determined from time to time, pursuant to the anti-dilution
provisions in the 2018 Warrant Amendment Agreements. During the
second quarter of 2020, the anti-dilution provision was triggered;
as such, the Company recognized a deemed dividend of approximately
$0.1 million which reduced the income available to common
stockholders. As the Company has an accumulated deficit balance,
there is no overall impact to additional paid-in capital, as the
deemed dividend is recorded as offsetting debit and credit entries
to additional paid-in capital. Therefore the amounts were not
presented on the Statement of Stockholders' Equity (Deficit). There
were no adjustments to the exercise price of any warrants for the
three month period ended September 30, 2020.
10. LOSS PER SHARE
A net loss cannot be diluted. Therefore, when the Company is in a
net loss position, basic and diluted loss per common share are the
same. If the Company achieves profitability, the denominator of a
diluted earnings per common share calculation includes both the
weighted-average number of shares outstanding and the number of
common stock equivalents, if the inclusion of such common stock
equivalents would be dilutive. Dilutive common stock equivalents
potentially include warrants, stock options and non-vested
restricted stock awards and units using the treasury stock method,
along with the effect, if any, from outstanding convertible
securities. The majority of the Company’s outstanding warrants to
purchase common stock have participation rights to any dividends
that may be declared in the future and are therefore considered to
be participating securities. Participating securities have the
effect of diluting both basic and diluted earnings per share during
periods of income. During periods of loss, no loss is allocated to
the participating securities since the holders have no contractual
obligation to share in the losses of the Company.
The following potentially dilutive securities outstanding as of
September 30, 2020 and 2019 have been excluded from the
denominator of the diluted loss per share of common stock
outstanding calculation as their effect is anti-dilutive (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
Nine Months Ended September 30, |
|
2020 |
|
2019 |
2020 |
|
2019 |
Warrants |
2,485 |
|
|
6,450 |
|
2,485 |
|
|
6,450 |
|
Stock options |
10,227 |
|
|
26,307 |
|
10,227 |
|
|
26,307 |
|
|
12,712 |
|
|
32,757 |
|
12,712 |
|
|
32,757 |
|
11. SHARE-BASED COMPENSATION
The following table sets forth the amount of share-based
compensation expense recognized by the Company by line item on its
consolidated statements of operations for the three and nine months
ended September 30, 2020 and 2019 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months ended
September 30, |
Nine Months ended
September 30, |
|
2020 |
|
2019 |
2020 |
|
2019 |
Research and development |
$ |
95 |
|
|
$ |
(20) |
|
$ |
266 |
|
|
$ |
119 |
|
General and administrative |
358 |
|
|
249 |
|
1,085 |
|
|
792 |
|
|
$ |
453 |
|
|
$ |
229 |
|
$ |
1,351 |
|
|
$ |
911 |
|
2014 Stock Incentive Plan
The Company's 2014 Stock Incentive Plan, as amended ("2014 Plan"),
was adopted by its board of directors in December 2013 and
subsequently approved by its stockholders in January 2014. The 2014
Plan became effective immediately prior to the closing of the
Company's IPO in February 2014 and provides for the grant of
incentive and non-qualified stock options, restricted stock awards
and units, stock appreciation rights and other stock-based awards,
with amounts and terms of grants determined by the Company's board
of directors at the time of grant, to the Company's employees,
officers, directors, consultants and advisors. Currently there are
only stock options outstanding under the 2014 Plan, which generally
vest over a four-year period at the rate of 25% of the grant
vesting on the first anniversary of the date of grant and 6.25% of
the grant vesting at the end of each successive three-month period
thereafter. Stock options granted under the 2014 Plan are
exercisable for a period of ten years from the date of grant. There
were 8.0 million stock options outstanding under the 2014 Plan
as of September 30, 2020. There were 4.8 million shares
of common stock available for issuance under the 2014 Plan as of
September 30, 2020.
2009 Stock Incentive Plan
The Company maintains a 2009 Stock Incentive Plan, as amended and
restated ("2009 Plan"), which provided for the grant of incentive
and non-qualified stock options and restricted stock awards and
units, with amounts and terms of grants determined by the Company's
board of directors at the time of grant, to its employees,
officers, directors, consultants and advisors. Upon the closing of
its IPO in February 2014, the Company ceased granting awards under
the 2009 Plan and all shares (i) available for issuance under the
2009 Plan at such time and (ii) subject to outstanding awards under
the 2009 Plan that expire, terminate or are otherwise surrendered,
canceled, forfeited or repurchased without having been fully
exercised or resulting in any common stock being issued were
carried over to the 2014 Plan. Stock options granted under the 2009
Plan are exercisable for a period of ten years from the date of
grant. There were 0.1 million fully vested stock options
outstanding under the 2009 Plan as of September 30,
2020.
Out-of-Plan Inducement Grants
From time to time, the Company has granted equity awards to its
newly hired executives in accordance with the Nasdaq Stock Market
LLC ("Nasdaq") employment inducement grant exemption (Nasdaq
Listing Rule 5635(c)(4)). Such grants are made outside of the 2014
Plan and act as an inducement material to the executive's
acceptance of employment with the Company. There
were 2.1 million stock options outstanding which were granted as
employment inducement awards outside of the 2014 Plan as of
September 30, 2020.
Stock Options
The following table sets forth a summary of the Company’s total
stock option activity, including awards granted under the 2014 Plan
and 2009 Plan and inducement grants made outside of stockholder
approved plans, for the nine months ended September 30,
2020:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of Shares under Option
(in thousands) |
|
Weighted-average Exercise Price per Option |
|
Weighted-average Remaining Contractual Life
(in years) |
|
Aggregate Intrinsic Value
(in thousands) |
Outstanding at December 31, 2019 |
6,236 |
|
|
$1.52 |
|
8.8 |
|
$ |
358 |
|
Granted |
4,044 |
|
|
$0.87 |
|
|
|
|
Exercised |
— |
|
|
$0.00 |
|
|
|
|
Canceled or forfeited |
(53) |
|
|
$0.84 |
|
|
|
|
Outstanding at September 30, 2020 |
10,227 |
|
|
$1.26 |
|
8.6 |
|
$ |
3,541 |
|
Exercisable at September 30, 2020 |
3,637 |
|
|
$1.73 |
|
8.0 |
|
$ |
786 |
|
The Company recognized share-based compensation expense related to
stock options of $0.5 million and $1.4 million for the three
and nine months ended September 30, 2020, respectively, and $0.2
million and $0.9 million for the three and nine months ended
September 30, 2019, respectively. As of September 30, 2020,
there was $4.1 million of total unrecognized compensation cost
related to non-vested stock options which the Company expects to
recognize over a weighted-average period of 2.6 years. The
weighted-average grant-date fair value of stock options granted
during the nine months ended September 30, 2020 was $0.56 per
option. The total intrinsic value of stock options exercised during
the nine months ended September 30, 2020 was de
minimus.
For the nine months ended September 30, 2020 and 2019, the
grant-date fair value of stock options was determined using the
following weighted-average inputs and assumptions in the
Black-Scholes option pricing model:
|
|
|
|
|
|
|
|
|
|
September 30, 2020 |
September 30, 2019 |
Fair value of common stock |
$0.56 |
$0.69 |
Exercise price |
$0.87 |
$1.02 |
Expected term (in years) |
6.10 |
5.98 |
Risk-free interest rate |
1.3 |
2.1 |
Expected volatility |
71.5 |
78.1 |
Dividend yield |
—% |
—% |
12. EMPLOYEE BENEFIT PLANS
2014 Employee Stock Purchase Plan
The Company's 2014 Employee Stock Purchase Plan ("2014 ESPP") was
adopted by its board of directors in December 2013 and subsequently
approved by its stockholders in January 2014. The 2014 ESPP became
effective immediately prior to the closing of the Company's IPO in
February 2014 and established an initial reserve of 0.2 million
shares of the Company's common stock for issuance to participating
employees. The purpose of the 2014 ESPP is to enhance employee
interest in the success and progress of the Company by encouraging
employee ownership of common stock of the Company. The 2014 ESPP
provides employees with the opportunity to purchase shares of
common stock at a 15% discount to the market price through payroll
deductions or lump sum cash investments. The Company estimates the
number of shares to be issued at the end of an offering period and
recognizes expense over the requisite service period. Shares of the
common stock issued and sold pursuant to the 2014 ESPP are shown on
the consolidated statements of changes in stockholders' equity
(deficit). The most recent offering of the 2014 ESPP, which closed
in September 2020, exhausted the remaining shares available for
sale under the 2014 ESPP. As such, as of September 30, 2020,
there were no further shares of common stock available for sale
under the 2014 ESPP.
Defined Contribution Plans
United States - 401(k) Plan
The Company maintains a 401(k) defined contribution retirement plan
which covers all of its U.S. employees. Employees are eligible to
participate immediately upon their date of hire. Under the 401(k)
plan, participating employees may defer up to 75% of their pre-tax
salary, subject to certain statutory limitations. Employee
contributions vest immediately. The plan allows for a
discretionary match per participating employee up to a maximum
$4,000 per year. The expenses incurred for the periods presented
were de minimis.
Canada - Defined Contribution Plan
The Company maintains a defined contribution plan for its Canadian
employees. Participants may contribute a percentage of their annual
compensation to this plan, subject to statutory limitations. The
Company contributes up to the first 4% of eligible compensation for
its Canadian-based employees to the retirement plan. The expenses
incurred for the periods presented were de minimis.
13. LICENSE AGREEMENTS
In-License Agreements
License Agreement with Zurich
The Company has a License Agreement with the University of Zurich
("Zurich") which grants the Company exclusive license rights, with
the right to sublicense, to make, have made, use and sell under
certain patents primarily directed to the Company's targeting
agent, including an EpCAM chimera and related immunoconjugates and
methods of use and manufacture of the same. These patents cover
some key aspects of Vicineum. The Company may be obligated to pay
$0.75 million in milestone payments for the first product
candidate that achieves applicable clinical development milestones.
Based on current status, the Company anticipates that these
milestones may be triggered by Vicineum's clinical development
pathway. As part of the consideration, the Company is also
obligated to pay up to a 4% royalty on the net product sales for
products covered by or manufactured using a method covered by a
valid claim in the Zurich patent rights. Royalties owed to Zurich
will be reduced if the total royalty rate owed by the Company to
Zurich and any other third party is 10% or greater, provided that
the royalty rate to Zurich may not be less than 2% of net sales.
The obligation to pay royalties in a particular country expires
upon the expiration or termination of the last of the Zurich patent
rights that covers the manufacture, use or sale of a product. There
is no obligation to pay royalties in a country if there is no valid
claim that covers the product or a method of manufacturing the
product.
License Agreement with Micromet
The Company has a License Agreement with Micromet AG ("Micromet"),
now part of Amgen, Inc., which grants it nonexclusive rights, with
certain sublicense rights, for know-how and patents allowing
exploitation of certain single chain antibody products. These
patents cover some key aspects of Vicineum. Under the terms of the
License Agreement with Micromet, the Company may be obligated to
pay up to €3.6 million in milestone payments for the first
product candidate that achieves applicable clinical development
milestones. The Company anticipates that certain of these
milestones may be triggered by Vicineum’s clinical development
pathway. The Company is also required to pay up to a 3.5% royalty
on the net sales for products covered by the agreement, which
includes Vicineum. The royalty rate owed to Micromet in a
particular country will be reduced to 1.5% if there are no valid
claims covering the product in that country. The obligation to pay
royalties in a particular country expires upon the later of the
expiration date of the last valid claim covering the product and
the tenth anniversary of the first commercial sale of the product
in such country. Finally, the Company is required to pay to
Micromet an annual license maintenance fee of €50,000, which can be
credited towards any royalty payment the Company owes to
Micromet.
License Agreement with XOMA
The Company has a License Agreement with XOMA Ireland Limited
("XOMA") which grants it non-exclusive rights to certain XOMA
patent rights and know-how related to certain expression
technology, including plasmids, expression strains, plasmid maps
and production systems. These patents and related know-how cover
some key aspects of Vicineum. Under the terms of the License
Agreement with XOMA, the Company is required to pay up to
$0.25 million in milestone payments for a product candidate
that incorporates know-how under the license and achieves
applicable clinical development milestones. Based on current
clinical status, the Company anticipates that these milestones may
be triggered by Vicineum’s clinical development pathway. The
Company is also required to pay a 2.5% royalty on the net sales for
products incorporating XOMA’s technology, which includes Vicineum.
The Company has the right to reduce the amount of royalties owed to
XOMA on a country-by-country basis by the amount of royalties paid
to other third parties, provided that the royalty rate to XOMA may
not be less than 1.75% of net sales. In addition, the foregoing
royalty rates are reduced by 50% with respect to products that are
not covered by a valid patent claim in the country of sale. The
obligation to pay royalties in a particular country expires upon
the later of the expiration date of the last valid claim covering
the product and the tenth anniversary of the first commercial sale
of the product in such country.
Out-License Agreements
License Agreement with Roche
In June 2016, the Company entered into the License Agreement with
Roche, pursuant to which the Company granted Roche an exclusive,
worldwide license, including the right to sublicense, to its patent
rights and know-how related to the Company’s monoclonal antibody
EBI-031 and all other IL-6 anti-IL-6 antagonist
monoclonal antibody technology owned by the Company
(collectively, the "Roche Licensed Intellectual Property"). Under
the License Agreement with Roche, Roche is required to continue
developing, at its cost, EBI-031 and any other product made from
the Licensed Intellectual Property that contains an IL-6 antagonist
anti-IL monoclonal antibody (“Roche Licensed Product”) and pursue
ongoing patent prosecution, at its cost.
Financial Terms
The Company received from Roche an upfront license fee of $7.5
million in August 2016 upon the effectiveness of the License
Agreement with Roche following approval by the Company's
stockholders, and Roche agreed to pay up to an additional
$262.5 million upon the achievement of specified regulatory,
development and commercialization milestones with respect to up to
two unrelated indications. Specifically, an aggregate amount of up
to $197.5 million is payable to the Company for the achievement of
specified milestones with respect to the first indication,
consisting of $72.5 million in development milestones, $50.0
million in regulatory milestones and $75.0 million in
commercialization milestones. In September 2016, Roche paid the
Company the first development milestone of $22.5 million as a
result of the Investigational New Drug application for EBI-031
becoming effective on or before September 15, 2016. Additional
amounts of up to $65.0 million are payable upon the achievement of
specified development and regulatory milestones in a second
indication.
In addition, the Company is entitled to receive royalty payments in
accordance with a tiered royalty rate scale, with rates ranging
from 7.5% to 15% of net sales of potential future products
containing EBI-031 and up to 50% of these rates for net sales of
potential future products containing other IL-6 compounds, with
each of the royalties subject to reduction under certain
circumstances and to the buy-out options of Roche.
Buy-Out Options
The License Agreement with Roche provides for two “option periods”
during which Roche may elect to make a one-time payment to the
Company and, in turn, terminate its diligence, milestone and
royalty payment obligations under the License Agreement with Roche.
Specifically, (i) Roche may exercise a buy-out option following the
first dosing (“Initiation”) in the first Phase 2 study for a
Licensed Product until the day before Initiation of the first Phase
3 study for a Licensed Product, in which case Roche is required to
pay the Company $135.0 million within 30 days after Roche's
exercise of such buy-out option and receipt of an invoice from the
Company, or (ii) Roche may exercise a buy-out option following the
day after Initiation of the first Phase 3 study for a Licensed
Product until the day before the acceptance for review by the FDA
or other regulatory authority of a BLA or similar application for
marketing approval for a Licensed Product in either the United
States or in the E.U., in which case Roche is required to pay the
Company, within 30 days after Roche’s exercise of such buy-out
option and receipt of an invoice from the Company,
$265.0 million, which amount would be reduced to
$220.0 million if none of the Company’s patent rights
containing a composition of matter claim covering any compound or
Roche Licensed Product has issued in the E.U.
Termination
Either the Company or Roche may each terminate the License
Agreement with Roche if the other party breaches any of its
material obligations under the agreement and does not cure such
breach within a specified cure period. Roche may terminate the
License Agreement with Roche following effectiveness by providing
advance written notice to the Company or by providing written
notice if the Company is debarred, disqualified, suspended,
excluded, or otherwise declared ineligible from certain federal or
state agencies or programs. The Company may terminate the License
Agreement with Roche if, prior to the first filing of a BLA for a
Roche Licensed Product, there is a period of 12 months where Roche
is not conducting sufficient development activities with respect to
the products made from the Roche Licensed Intellectual
Property.
License Agreement with Qilu
On July 30, 2020, the Company and its a wholly-owned subsidiary,
Viventia Bio, Inc., entered into the License Agreement with Qilu
pursuant to which the Company granted Qilu an exclusive,
sublicensable, royalty-bearing license, under certain intellectual
property owned or exclusively licensed by the Company,
to develop, manufacture and commercialize
Vicineum™ (the “Licensed Product”) for the treatment of NMIBC and
other types of cancer (the “Field”) in China, Hong Kong, Macau and
Taiwan (the “Territory”). The Company also granted Qilu a
non-exclusive, sublicensable, royalty-bearing sublicense, under
certain other intellectual property licensed by the Company to
develop, manufacture and commercialize the Licensed Product in the
Territory. The Company retains development, manufacturing and
commercialization rights with respect to Vicineum in the rest of
the world.
In consideration for the rights granted by the Company, Qilu agreed
to pay to the Company (i) a one-time upfront cash payment of
$12 million, subject to certain tax withholdings such as
income taxes and value added taxes ("VAT"), payable within 45
business days of the execution date, subject to delivery by the
Company of certain know-how and other documentation
related
to the Licensed Product to Qilu, and (ii) milestone payments
totaling up to $23 million upon the achievement of certain
technology transfer, development and regulatory milestones. All
payments are inclusive of VAT, which are withheld by Qilu upon
payment, and for which future recovery of such taxes may be
available. In September 2020, the Company received
$10.0 million in net proceeds associated with the
$12 million upfront payment due under the License Agreement
with Qilu.
Qilu also agreed to pay the Company a 12% royalty based upon annual
net sales of Licensed Products in the Territory. The royalties are
payable on a Licensed Product-by-Licensed Product and
region-by-region basis commencing on the first commercial sale of a
Licensed Product in a region and continuing until the latest of (i)
twelve years after the first commercial sale of such Licensed
Product in such region, (ii) the expiration of the last valid
patent claim covering or claiming the composition of matter, method
of treatment, or method of manufacture of such Licensed Product in
such region, and (iii) the expiration of regulatory or data
exclusivity for such Licensed Product in such region (collectively,
the “Royalty Term”).
The royalty rate is subject to reduction under certain
circumstances, including when there is no valid claim of a licensed
patent that covers a Licensed Product in a particular region or no
data or regulatory exclusivity of a Licensed Product in a
particular region.
Qilu is responsible for all costs related to developing, obtaining
regulatory approval of and commercializing the Licensed Products in
the Field in the Territory. Qilu is required to use commercially
reasonable efforts to develop, seek regulatory approval for, and
commercialize at least one Licensed Product in the Field in the
Territory. A joint development committee will be established
between the Company and Qilu to coordinate and review the
development, manufacturing and commercialization plans with respect
to the Licensed Products in the Territory. The Company and Qilu
also agreed to negotiate in good faith the terms and conditions of
a supply agreement and related quality agreement pursuant to which
the Company will manufacture or have manufactured and supply Qilu
with all quantities of the Licensed Product necessary for Qilu to
develop and commercialize the Licensed Product in the Field in the
Territory until the Company has completed manufacturing technology
transfer to Qilu and approval of a Qilu manufactured product by the
National Medical Products Administration in China for the Licensed
Product.
The License Agreement with Qilu will expire on a Licensed
Product-by-Licensed Product and region-by-region basis on the date
of the expiration of all applicable Royalty Terms. Either party may
terminate the License Agreement with Qilu for the other party’s
material breach following a cure period or upon certain insolvency
events. Qilu has the right to receive a refund of all amounts paid
to the Company in the event the License Agreement with Qilu is
terminated under certain circumstances. The License Agreement with
Qilu includes customary representations and warranties, covenants
and indemnification obligations for a transaction of this
nature.
The License Agreement with Qilu is subject to the provisions of
Accounting Standards Codification 606, Revenue from Contracts with
Customers ("ASC 606"), which was adopted effective January 1, 2018.
The initial transaction price was estimated to be
$11.2 million and was based on the up-front fixed
consideration of $12 million less amounts withheld for VAT. The
Company concluded that its promises under the License Agreement
with Qilu represented one bundled performance obligation that had
been achieved as of September 30, 2020. As such, $11.2 million
of the total $11.2 million transaction price was considered
earned and the Company recorded $11.2 million of revenue
during the three-month period ended September 30, 2020. The Company
is reasonably certain that no refund of the upfront payment will be
due to Qilu. As of September 30, 2020, $0.2 million of the
up-front fixed consideration remains payable to the Company.
Additional consideration to be paid to the Company upon the
achievement of certain milestones, as well as recoverability of
VAT, will be included if it is expected that the amounts will be
received and the amounts would not be subject to a constraint. As
of September 30, 2020, none of these amounts were reasonably
certain to be achieved due to the nature and timing of the
underlying activities.
For the three and nine months ended September 30, 2020, the Company
recorded $1.1 million of income tax expense pursuant to the
License Agreement with Qilu. The income tax expense relates to
withholding taxes paid in foreign jurisdictions and is reported as
provision for income taxes on the condensed consolidated statement
of operations and comprehensive loss for each period.
14. RELATED PARTY TRANSACTIONS
The Company leases its facility in Winnipeg, Manitoba from an
affiliate of Leslie L. Dan, a director of the Company until his
retirement in July 2019. The Company paid $0.1 million and
$0.2 million of rent for the three and nine months ended
September 30, 2020, respectively, and $0.1 million and
$0.2 million of rent for the three and nine months ended
September 30, 2019, respectively. All payments include related
operating expenses. In September 2020, the Company entered into an
extension of this lease for an additional two years, through
September 2022, with a right to extend the lease for one subsequent
three-year term.
The Company pays fees under an intellectual property license
agreement to Protoden Technologies Inc. (“Protoden”), a company
owned by Clairmark, an affiliate of Mr. Dan. Pursuant to the
agreement, the Company has an exclusive, perpetual, irrevocable and
non-royalty bearing license, with the right to sublicense, to
certain patents and technology to make, use and sell
products that utilize such patents and technology. The annual fee
is $0.1 million. Upon expiration of the term on December 31, 2024,
the licenses granted to the Company will require no further
payments to Protoden. For each of the nine months ended September
30, 2020 and 2019, the Company paid $0.1 million under this
agreement. The Company did not make payments under this agreement
during the three months ended September 30, 2020 and
2019.
Mr. Dan was not deemed a related party during the three and nine
months ended September 30, 2020; as such, only payments made
during the three and nine months ended September 30, 2019 are
considered payments to a related party.
15. SUBSEQUENT EVENTS
On October 30, 2020, the Company entered into an amendment to the
Sale Agreement pursuant to which it may issue and sell an
additional $50 million of shares of common stock through
Jefferies.
Item 2.
Management’s
Discussion and Analysis of Financial Condition and Results of
Operations.
The following discussion and analysis of our financial condition
and results of operations, as well as other sections in this
Quarterly Report on Form 10-Q, should be read in conjunction with
our unaudited interim condensed consolidated financial statements
and related notes thereto appearing elsewhere herein and our
audited annual consolidated financial statements and related notes
thereto and “Management's Discussion and Analysis of Financial
Condition and Results of Operations” for the year ended
December 31, 2019, included in our Annual Report on Form 10-K
filed with the United States Securities and Exchange Commission
(“SEC”) on March 16, 2020. In addition to historical financial
information, some of the information contained in the following
discussion and analysis contains forward-looking statements within
the meaning of Section 27A of the Securities Act of 1933, as
amended, and Section 21E of the Securities Exchange Act of 1934, as
amended ("Exchange Act"). All statements other than statements of
historical facts, including statements regarding our future results
of operations and financial position, the impact of the COVID-19
pandemic, business strategy, current and prospective products,
product approvals, research and development costs, current and
prospective collaborations, timing and likelihood of success, plans
and objectives of management for future operations and future
results of current and anticipated products, are forward-looking
statements. These statements involve known and unknown risks,
uncertainties, assumptions and other important 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.
In some cases, you can identify forward-looking statements by terms
such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,”
“could,” “intend,” “target,” “project,” “contemplates,” “believes,”
“estimates,” “predicts,” “potential” or “continue” or the negative
of these terms or other similar expressions. The forward-looking
statements in this Quarterly Report on Form 10-Q are only
predictions. We have based these forward-looking statements largely
on our current expectations and projections about future events and
financial trends that we believe may affect our business, financial
condition and results of operations. These forward-looking
statements speak only as of the date of this Quarterly Report on
Form 10-Q and are subject to a number of risks, uncertainties and
assumptions described in “Risk Factors” and “Management’s
Discussion and Analysis of Financial Condition and Results of
Operations” in our Annual Report on Form 10-K. The events and
circumstances reflected in our forward-looking statements may not
be achieved or occur and actual results could differ materially
from those projected in the forward-looking statements. Moreover,
we operate in an evolving environment. New risk factors and
uncertainties may emerge from time to time, and it is not possible
for us to predict all risk factors and uncertainties. Except as
required by applicable law, we do not plan to publicly update or
revise any forward-looking statements contained herein, whether as
a result of any new information, future events, changed
circumstances or otherwise.
Unless the context otherwise requires, all references in this
Quarterly Report on Form 10-Q to the “Company,” “Sesen,” “we,”
“us,” and “our” include Sesen Bio, Inc. and its
subsidiaries.
Overview
We are a late-stage clinical company advancing targeted fusion
protein therapeutics ("TFPTs") for the treatment of patients with
cancer. We genetically fuse the targeting antibody fragment and the
cytotoxic protein payload into a single molecule which is produced
through our proprietary one-step, microbial manufacturing process.
We target tumor cell surface antigens with limited expression on
normal cells. Binding of the target antigen by the TFPT allows for
rapid internalization into the targeted cancer cell. We have
designed our targeted proteins to overcome the fundamental efficacy
and safety challenges inherent in existing antibody-drug conjugates
("ADCs") where a payload is chemically attached to a targeting
antibody.
Our most advanced product candidate, Vicineum, also known as
VB4-845, is a locally-administered targeted fusion protein composed
of an anti-epithelial cell adhesion molecule ("EpCAM") antibody
fragment tethered to a truncated form of
Pseudomonas exotoxin A
for the treatment of high-risk non-muscle invasive bladder cancer
("NMIBC"). On December 6, 2019, we initiated our Biologics License
Application ("BLA") submission for Vicineum to the United States
Food and Drug Administration ("FDA") under Rolling Review. "Rolling
Review" of the BLA enables individual modules to be submitted and
reviewed on an ongoing basis, rather than waiting for all sections
to be completed before submission. The submission consisted of
Modules 1, 2, 4 and 5, with information amendments to be submitted
to these modules throughout 2020. We anticipate completing Module 3
(Chemistry, Manufacturing and Controls ("CMC")) to finalize the BLA
submission by the end of 2020. We may experience disruptions as a
result of the COVID-19 pandemic that may impact our expected
timeline to finalize the BLA submission, including manufacturing
activities of our contract manufacturers due to limitations on work
and travel imposed or recommended by federal or state governments,
employers and others.
In August 2019, we reported updated preliminary efficacy data from
our ongoing single-arm, multi-center, open-label Phase 3
clinical trial of Vicineum as a monotherapy in patients with
high-risk, bacillus Calmette-Guérin ("BCG")-unresponsive NMIBC (the
"VISTA Trial"). As of the May 29, 2019 data cutoff date, we
reported the preliminary complete response rates ("CRRs") in
evaluable carcinoma
in situ
("CIS") patients following three, six, nine and 12 months of
treatment in the clinical trial. The results were consistent with
the results observed in the previously completed Phase 1 and Phase
2 clinical trials of Vicineum for the treatment of high-risk NMIBC.
The VISTA Trial completed enrollment in April 2018 with a total of
133 patients across three cohorts based on histology and time to
disease recurrence after adequate BCG treatment (under 2018 FDA
guidance on treatment of NMIBC, adequate BCG is defined as at least
two courses of BCG with at least five doses in an initial induction
course of treatment, plus at least two doses in a second course of
treatment):
•Cohort
1 (n=86): Patients with CIS
with or without papillary disease that were determined to be
refractory or recurred within six months of their last course of
adequate BCG;
•Cohort
2 (n=7): Patients with CIS with or without papillary disease that
recurred after six months, but less than 11 months, after their
last course of adequate BCG; and
•Cohort
3 (n=40): Patients with high-risk (Ta or T1) papillary disease
without CIS that was determined to be refractory or recurred within
six months of their last course of adequate BCG.
As of the end of April 2020, all patients have completed treatment
in the VISTA Trial. The primary endpoints of the VISTA Trial are
CRR at 3 months in patients with CIS (with or without papillary
disease) whose disease is BCG-unresponsive and duration of response
("DoR") for BCG-unresponsive CIS patients who experience a complete
response ("CR").
As of the May 29, 2019 data cutoff date, preliminary primary and
secondary endpoint data for each of the trial cohorts were as
follows:
Cohort 1 (n=86) Evaluable Population (n=82) Complete Response Rate,
for CIS:
|
|
|
|
|
|
|
|
|
Time Point |
Evaluable Patients* |
Complete Response Rate
(95% Confidence Interval) |
3-months |
n=82 |
39% (28%-50%) |
6-months |
n=82 |
26% (17%-36%) |
9-months |
n=82 |
20% (12%-30%) |
12-months |
n=82 |
17% (10%-27%) |
* Response-evaluable population includes any modified
intention-to-treat ("mITT") subject who completed the induction
phase.
Cohort 2 (n=7) Evaluable Population (n=7) Complete Response Rate,
for CIS:
|
|
|
|
|
|
|
|
|
Time Point |
Evaluable Patients* |
Complete Response Rate
(95% Confidence Interval) |
3-months |
n=7 |
57% (18%-90%) |
6-months |
n=7 |
57% (18%-90%) |
9-months |
n=7 |
43% (10%-82%) |
12-months |
n=7 |
14% (0%-58%) |
* Response-evaluable population includes any mITT subject who
completed the induction phase.
Pooled Cohorts 1 and 2 Evaluable Population (n=89) Complete
Response Rate, for CIS:
|
|
|
|
|
|
|
|
|
Time Point |
Evaluable Patients* |
Complete Response Rate
(95% Confidence Interval)
|
3-months |
n=89 |
40% (30%-51%) |
6-months |
n=89 |
28% (19%-39%) |
9-months |
n=89 |
21% (13%-31%) |
12-months |
n=89 |
17% (10%-26%) |
* Response-evaluable population includes any mITT subject who
completed the induction phase.
Phase 3 Pooled Complete Response Rate vs. Phase 2 Pooled Complete
Response Rate:
|
|
|
|
|
|
|
|
|
Time Point |
Preliminary Phase 3 Pooled CRR
(95% Confidence Interval)
|
Phase 2 Pooled CRR
(95% Confidence Interval)
|
3-months |
40% (30%-51%) |
40% (26%-56%) |
6-months |
28% (19%-39%) |
27% (15%-42%) |
9-months |
21% (13%-31%) |
18% (8%-32%) |
12-months |
17% (10%-26%) |
16% (7%-30%) |
Cohort 3 (n=40) Evaluable Population (n=38) Recurrence-Free
Rate†:
|
|
|
|
|
|
|
|
|
Time Point |
Evaluable Patients* |
Recurrence-Free Rate
(95% Confidence Interval)
|
3-months |
n=38 |
71% (54%-85%) |
6-months |
n=38 |
58% (41%-74%) |
9-months |
n=38 |
45% (29%-62%) |
12-months |
n=38 |
42% (26%-59%) |
† Recurrence-free rate is defined as the percentage of patients
that are recurrence-free at the given assessment time
point.
* Response-evaluable population includes any mITT subject who
completed the induction phase.
Duration of Response:
The median DoR for patients in Cohort 1 and Cohort 2 combined
(n=93) is 287 days (lower 95% confidence interval ("CI") = 154
days, upper 95% confidence interval is not estimable ("NE") due to
the limited number of events occurring beyond the median), using
the Kaplan-Meier method. The Kaplan-Meier method is a
non-parametric statistical analysis used to estimate survival times
and times to event when incomplete observations in data
exist.
Additional
ad hoc
analysis of pooled data for all patients with CIS (Cohorts 1 and 2,
n=93) shows that among patients who achieved a complete response at
3 months, 52% remained disease-free for a total of 12 months or
longer after starting treatment, using the Kaplan-Meier method. DoR
is defined as the time from first occurrence of complete response
to documentation of treatment failure or death.
We have conducted additional analyses for secondary endpoints based
on the May 29, 2019 data cutoff date. These additional preliminary
data include the following:
•Time
to Cystectomy:
Across all 133 patients treated with Vicineum in the VISTA Trial,
greater than 75% of all patients are estimated to remain
cystectomy-free at 3 years, using the Kaplan-Meier method.
Additional
ad hoc
analysis shows that approximately 88% of responders are estimated
to remain cystectomy-free at 3 years. Time to cystectomy is defined
as the time from the date of first dose of study treatment to
surgical bladder removal. The first 2018 FDA guidance on treatment
of BCG-unresponsive NMIBC patients states that the goal of therapy
in such patients is to avoid cystectomy. Therefore, time to
cystectomy is a key secondary endpoint in the VISTA
Trial.
•Time
to Disease Recurrence:
High-grade papillary (Ta or T1) NMIBC is associated with higher
rates of progression and recurrence. The median time to disease
recurrence for patients in Cohort 3 (n=40) is 402 days (95% CI,
170-NE), using the Kaplan-Meier method. Time to disease recurrence
is defined as the time from the date of the first dose of study
treatment to the first occurrence of treatment failure or death on
or prior to treatment discontinuation.
•Progression-Free
Survival ("PFS"):
90% of all 133 patients treated with Vicineum in the VISTA Trial
are estimated to remain progression-free for 2 years or greater,
using the Kaplan-Meier method. PFS is defined as the time from the
date of first dose of study treatment to the first occurrence of
disease progression (e.g. T2 or more advanced disease) or death on
or prior to treatment discontinuation.
•Event-Free
Survival:
29% of all 133 patients treated with Vicineum in the VISTA Trial
are estimated to remain event-free at 12 months, using the
Kaplan-Meier method. Event-free survival is defined as the time
from the date of first dose of study treatment to the first
occurrence of disease recurrence, progression or death on or prior
to treatment discontinuation.
◦Overall
Survival ("OS"):
96% of all 133 patients treated with Vicineum in the VISTA Trial
are estimated to have an overall survival of 2 years or greater,
using the Kaplan-Meier method. OS is defined as the time from the
date of first dose of study treatment to death from any
cause.
Preliminary Safety Results
As of the May 29, 2019 data cutoff date, in patients across all
cohorts (n=133) of our Phase 3 VISTA Trial of Vicineum for the
treatment of high-risk NMIBC, 88% experienced at least one adverse
event, with 95% of adverse events being Grade 1 or 2. The most
commonly reported treatment-related adverse events were dysuria
(14%), hematuria (13%) and urinary tract infection (12%) - all of
which are consistent with the profile of bladder cancer patients
and the use of catheterization for treatment delivery. These
adverse events were determined by the clinical investigators to be
manageable and reversible, and only four patients (3%) discontinued
treatment due to an adverse event. Serious adverse events,
regardless of treatment attribution, were reported in 14% of
patients. There were four treatment-related serious adverse events
reported in three patients including acute kidney injury (Grade 3),
pyrexia (Grade 2), cholestatic hepatitis (Grade 4) and renal
failure (Grade 5). There were no age-related increases in adverse
events observed in the VISTA Trial.
Other Vicineum Activity
In August 2018, we received Fast Track designation from the FDA for
Vicineum for the treatment of high-risk NMIBC.
In May 2019, we met with the FDA for a Type C meeting for CMC and
reached agreement with the FDA on the analytical comparability plan
to be used to assess comparability between the drug supply used in
clinical trials and the potential commercial drug supply to be
produced by Fujifilm. We also confirmed with the FDA that, subject
to final comparability data to be provided in the BLA submission,
no additional clinical trials were deemed necessary to establish
comparability.
In June 2019, we met with the FDA for a Type B Pre-BLA meeting
regarding the approval pathway for Vicineum for the treatment of
patients with high-risk, BCG-unresponsive NMIBC. At the
meeting, we reached alignment with the FDA on an accelerated
approval pathway for Vicineum along with Rolling Review. The FDA
also indicated that the clinical data, nonclinical data, clinical
pharmacology data, and the safety database were sufficient to
support a BLA submission, and that no additional clinical trials
were necessary for a BLA submission. Per the official FDA minutes
received post-meeting, the FDA stated that the pre-licensing
inspection may be completed at the time of process performance
qualification manufacturing, which we believe will benefit the
overall review timeline for the BLA. In addition, the FDA
communicated that they expect that a meeting with the FDA’s
Oncologic Drugs Advisory Committee ("ODAC") will be required as
part of the accelerated approval pathway. If Vicineum receives
marketing approval for treatment of NMIBC, a post-marketing
confirmatory trial will also be required.
In November 2019, we met with the FDA for a Type C meeting to
discuss the details of a post-marketing confirmatory trial for
Vicineum for the treatment of high-risk NMIBC. At that meeting, we
reached agreement with the FDA that the post-marketing confirmatory
trial for Vicineum will enroll BCG-refractory patients who have
received less-than-adequate BCG, which is especially important in
light of the ongoing BCG shortage. This represents a broader
patient population than the BCG-intolerant population originally
proposed. We anticipate that, if Vicineum is approved by the FDA,
the initial indication will be for BCG-unresponsive patients who
have received adequate BCG. If the post-marketing confirmatory
trial is successful, it could result in an expanded label to
include this additional population of patients who have received
less-than-adequate BCG.
On December 4, 2019, we met with the FDA for a Type B pre-BLA
meeting for CMC. At that meeting, we reached agreement with the FDA
on the final content for Module 3 (CMC) of the BLA.
On December 6, 2019, we initiated our BLA submission for Vicineum
to the FDA under Rolling Review. The submission consisted of
Modules 1, 2, 4 and 5, with information amendments to be submitted
to these modules throughout 2020. We anticipate completing Module 3
(CMC) to finalize the BLA submission in December 2020.
On May 7, 2020, we received clinical Scientific Advice from the
Committee for Medicinal Products for Human Use ("CHMP") of the
European Medicines Agency ("EMA") stating that the Committee agreed
that our nonclinical, clinical pharmacology and safety database are
all sufficient to support a marketing authorization application
("MAA"). Furthermore, additional clinical trials were not requested
by the CHMP in support of the MAA submission for Vicineum for the
treatment of high-risk NMIBC. Based on the guidance received, we
expect to submit the MAA for Vicineum for the treatment of
high-risk NMIBC to the EMA in early 2021, with potential approval
anticipated in early 2022.
On May 29, 2020, we received CMC Scientific Advice from the CHMP of
the EMA, stating that the committee agreed that our comparability
plan provides a strong analytical package, and no additional
clinical trials to establish comparability are deemed necessary at
this time.
Furthermore, the CHMP agreed to accept the Good
Manufacturing Practice ("GMP") inspections conducted by the FDA and
will therefore not conduct an independent inspection of the
manufacturing facilities.
On June 17, 2020, we were informed that the FDA has conditionally
accepted the proprietary brand name VICINEUM™ for our product
candidate, oportuzumab monatox. The name VICINEUM was developed in
compliance with the FDA’s final Guidance for Industry, Contents of
a Complete Submission for the Evaluation of Proprietary Names and
the FDA’s draft Guidance for Industry, Best Practices in Developing
Proprietary Name for Drugs. We believe VICINEUM is a proprietary
name with strong marketing potential that is also consistent with
FDA’s goal of preventing medication errors and potential harm to
the public by ensuring that only appropriate proprietary names are
approved for use. Final approval of the VICINEUM brand name is
conditional on FDA approval of our product candidate, oportuzumab
monatox. Based upon FDA feedback, we withdrew our previously
submitted proposed brand name, VICINIUM®, from consideration due to
potential for confusion with ammonium derivatives products with the
“-ium” suffix as established by the United States Adopted Names
Council.
On July 28, 2020, we received notice from the EMA that it has
approved our request to review Vicineum under the EMA’s centralized
authorization procedure drug review process and on September 29,
2020, we received notice from the EMA that it has appointed the
Rapporteur and Co-Rapporteur for our planned MAA. The Rapporteur
and Co-Rapporteur are members of EMA’s CHMP and will jointly
coordinate CHMP’s evaluation of our planned MAA for
Vicineum.
On October 23, 2020, we completed a successful pre-submission
meeting with the EMA which addressed product-specific, legal,
regulatory and scientific topics related to Vicineum. The
information and insights gained from the meeting will help to
facilitate the validation of the MAA and support a smooth
evaluation. The agency also provided guidance on various
administrative topics which helps to clarify the regulatory path
forward. The success of this meeting, in addition to the receipt of
centralized procedure eligibility confirmation from the EMA, are
significant milestones toward our regulatory path forward in Europe
and reaffirms our intent to complete all necessary pre-submission
activities with the EMA by the end of 2020 and submit the MAA in
early 2021.
Manufacturing
In October 2018, we entered into a Master Bioprocessing Services
Agreement with Fujifilm (the "Fujifilm MSA") for the manufacturing
process and technology transfer of Vicineum drug substance
production. In April 2019, the first full, commercial-scale current
GMP ("cGMP") run was completed at Fujifilm and all quality
acceptance criteria were met. This supports Fujifilm’s ability to
produce the bulk drug substance form of Vicineum for commercial
purposes if we receive regulatory approval to market Vicineum for
the treatment of high-risk NMIBC. In February 2020, manufacturing
of the pre-process performance qualification ("pre-PPQ") cGMP batch
was completed at Fujifilm. Full quality release testing of the drug
substance has been completed and all quality acceptance criteria
were met. On August 4, 2020, we completed manufacturing of the drug
substance PPQ batches. In September, 2020, we successfully
completed the final of three drug product PPQ batches. All of the
completed drug substance PPQ batches and the first and second of
three drug product PPQ batches met all quality acceptance criteria.
We believe these results are a strong indicator for meeting the
quality testing acceptance criteria for the third drug product PPQ
batch. Testing of this batch is currently underway and is expected
to be completed in November 2020.
Joint Development
In June 2017, we entered into a Cooperative Research and
Development Agreement ("CRADA") with the National Cancer Institute
("NCI") for the development of Vicineum in combination with
AstraZeneca’s immune checkpoint inhibitor durvalumab for the
treatment of NMIBC. Under the terms of the CRADA, the NCI will
conduct a Phase 1 clinical trial in patients with high-risk NMIBC
to evaluate the safety, efficacy and biological correlates of
Vicineum in combination with durvalumab. This Phase 1 clinical
trial is open and is actively recruiting patients.
Vicineum has also been evaluated for the treatment of squamous cell
carcinoma of the head and neck ("SCCHN"). Vicineum for the
treatment of SCCHN had previously been designated as
ProxiniumTM
to indicate its different fill volume and vial size as well as its
different route for local administration via intratumoral
injection. In addition to our locally-administered TFPTs, our
pipeline also includes systemically-administered TFPTs that are
built around our proprietary de-immunized variant of the
plant-derived cytotoxin bouganin ("deBouganin"). One of these
product candidates, VB6-845d, is a TFPT consisting of an
EpCAM-targeting fragment antigen binding domain ("Fab") genetically
linked to deBouganin, a novel plant derived cytotoxic payload that
we have optimized for minimal immunogenic potential and is
administered by intravenous infusion. We have deferred further
development of Vicineum for the treatment of SCCHN and of VB6-845d
in order to focus our efforts and our
resources on our ongoing development of Vicineum for the treatment
of high-risk NMIBC. We are also exploring collaborations for
Vicineum for the treatment of SCCHN and for VB6-845d.
We maintain global development, marketing and commercialization
rights for all of our TFPT-based product candidates. We intend to
explore various commercialization strategies to market our approved
products. If we obtain regulatory approval for Vicineum for the
treatment of high-risk NMIBC, we intend to build a specialty
urology sales force to market the product in the United States.
Outside the United States, we will seek commercialization partners
with urology expertise. We also own or exclusively license
worldwide intellectual property rights for all of our TFPT-based
product candidates, covering our key patents with protection into
2036.
License Agreement with Roche
In June 2016, we entered into a License Agreement with F.
Hoffman-La Roche Ltd. and Hoffman-La Roche Inc. (collectively,
"Roche") (the "License Agreement with Roche"), pursuant to which we
granted Roche an exclusive, worldwide license, including the right
to sublicense, to our patent rights and know-how related to our
monoclonal antibody EBI-031 and all other IL-6 anti-IL antagonist
monoclonal antibody technology owned by us (collectively, the
"Licensed Intellectual Property"). Under the License Agreement with
Roche, Roche is required to continue developing, at its cost,
EBI-031 and any other product made from the Licensed Intellectual
Property that contains an IL-6 antagonist anti-IL monoclonal
antibody ("Licensed Product") and pursue ongoing patent
prosecution, at its cost. At the time of the License Agreement with
Roche, EBI-031, which was derived using our previous AMP-Rx
platform, was in pre-clinical development as an intravitreal
injection for diabetic macular edema and uveitis.
Through September 30, 2020, we have received a total of $30.0
million in payments pursuant to the License Agreement with Roche,
including a $7.5 million upfront payment in August 2016 and a $22.5
million milestone payment in September 2016 as a result of the
investigational new drug ("IND") application for EBI-031 becoming
effective. We are also entitled to receive up to an additional
$240.0 million upon the achievement of other specified regulatory,
development and commercial milestones, as well as royalty payments
in accordance with a tiered royalty rate scale, with rates ranging
from 7.5% to 15% of net sales of potential future products
containing EBI-031 and up to 50% of these rates for net sales of
potential future products containing other IL-6 compounds, with
each of the royalties subject to reduction under certain
circumstances and to the buy-out options of Roche.
License Agreement with Qilu
On July 30, 2020, we and our wholly-owned subsidiary, Viventia Bio,
Inc., entered into an exclusive license agreement with Qilu
Pharmaceuticals, Ltd. ("Qilu") ("License Agreement with Qilu")
pursuant to which we granted Qilu an exclusive, sublicensable,
royalty-bearing license, under certain intellectual property owned
or exclusively licensed by us,
to develop, manufacture and commercialize
Vicineum for the treatment of NMIBC and other types of cancer in
China, Hong Kong, Macau and Taiwan ("the Territory"). We also
granted Qilu a non-exclusive, sublicensable, royalty-bearing
sublicense, under certain other intellectual property licensed by
us to develop, manufacture and commercialize Vicineum™ in the
Territory. We retained development, manufacturing and
commercialization rights with respect to Vicineum in the rest of
the world.
Through September 30, 2020, we have received a total of $10
million in net proceeds associated with the $12 upfront payment due
pursuant to the License Agreement with Qilu. We are also entitled
to receive up to an additional $23 million upon the achievement of
certain technology transfer, development and regulatory milestones,
as well as a
12% royalty based upon annual net sales of Vicineum in the
Territory. The royalties are payable upon the first commercial sale
of Vicineum in a region and continuing until the latest of (i)
twelve years after the first commercial sale of Vicineum in such
region, (ii) the expiration of the last valid patent claim covering
or claiming the composition of matter, method of treatment, or
method of manufacture of such Vicineum in such region, and (iii)
the expiration of regulatory or data exclusivity for such Vicineum
in such region.
The royalty rate is subject to reduction under certain
circumstances, including when there is no valid claim of a licensed
patent that covers Vicineum in a particular region or no data or
regulatory exclusivity of Vicineum in a particular
region.
Liquidity and Going Concern
As of September 30, 2020, we had cash and cash equivalents of
$42.0 million, net working capital (current assets less current
liabilities) of $39.3 million and an accumulated deficit of $300.9
million. We incurred negative cash flows from operating activities
of $37.5 million for the year ended December 31, 2019 and
$22.3 million for the nine months ended September 30, 2020. Since
our inception, we have received no revenue from sales of our
products, and we anticipate that operating losses will continue for
the foreseeable future as we continue our ongoing Phase 3 VISTA
Trial of Vicineum for the treatment of high-risk NMIBC and seek
marketing approval from the FDA and EMA. We have financed our
operations to date primarily through private placements of our
common stock, preferred stock, common stock warrants and
convertible bridge notes, venture debt borrowings, our
initial public offering ("IPO"), follow-on public offerings, sales
effected in "at-the-market" ("ATM") offerings, our License
Agreement with Roche, our License Agreement with Qilu and, to a
lesser extent, from a collaboration.
Under Accounting Standards Codification Topic 205-40,
Presentation of Financial Statements - Going
Concern,
we are required at each reporting period to evaluate whether there
are conditions and events, considered in the aggregate, that raise
substantial doubt about our ability to continue as a going concern
within one year after the date that the financial statements are
issued. This evaluation initially does not take into consideration
the potential mitigating effect of our plans that have not been
fully implemented as of the date the financial statements are
issued. When substantial doubt exists, we evaluate whether the
mitigating effect of our plans sufficiently alleviates the
substantial doubt about our ability to continue as a going concern.
The mitigating effect of our plans, however, is only considered if
both (i) it is probable that our plans will be effectively
implemented within one year after the date that our financial
statements are issued and (ii) it is probable that our plans, when
implemented, will mitigate the relevant conditions or events that
raise substantial doubt about our ability to continue as a going
concern within one year after the date that our financial
statements are issued. Generally, to be considered probable of
being effectively implemented, our plans must have been approved by
our board of directors before the date that our financial
statements are issued.
Our future success is dependent on our ability to develop our
product candidates, including Vicineum for the treatment of
high-risk NMIBC, and ultimately upon our ability to attain
profitable operations. In order to commercialize our product
candidates, including Vicineum for the treatment of high-risk
NMIBC, we need to complete clinical development and comply with
comprehensive regulatory requirements. We are subject to a number
of risks similar to other late-stage clinical companies, including,
but not limited to, successful discovery and development of our
product candidates, raising additional capital, development and
commercialization by our competitors of new technological
innovations, protection of proprietary technology and market
acceptance of our products. The successful discovery and
development of product candidates, including Vicineum for the
treatment of high-risk NMIBC, requires substantial working capital,
and we expect to seek additional funds through equity or debt
financings or through additional collaboration, licensing
transactions or other sources. We may be unable to obtain equity or
debt financings or enter into additional collaboration or licensing
transactions at favorable terms, or at all. To the extent that we
raise additional capital through the sale of equity or convertible
debt securities, the ownership interests of existing stockholders
will be diluted, and the terms of these securities may include
liquidation or other preferences that adversely affect the rights
of existing stockholders. Debt financing, if available, may involve
agreements that include liens or other restrictive covenants
limiting our ability to take specific actions, such as incurring
additional debt, making capital expenditures or declaring
dividends. If we raise additional funds through government or other
third-party funding, strategic collaborations and alliances or
licensing arrangements, we may have to relinquish valuable rights
to our technologies, future revenue streams, research programs or
product candidates or grant licenses on terms that may not be
favorable. If we are unable to raise additional funds when needed,
we may be required to implement cost reduction strategies and
delay, limit, reduce or terminate our product development or future
commercialization efforts or grant rights to develop and market
products or product candidates that we would otherwise prefer to
develop and market.
We continue to monitor the effect of the outbreak of a novel strain
of coronavirus ("COVID-19"). This virus continues to spread
globally, has been declared a pandemic by the World Health
Organization and has spread to over 200 countries and territories,
including the United States disproportionately. The impact of this
pandemic has been and will likely continue to be extensive in many
aspects of society, which has resulted in and will likely continue
to result in significant disruptions to businesses and capital
markets around the world. We are proactively executing risk
mitigation strategies to attenuate the impact of COVID-19 on us,
and at this time, we have not yet experienced any business
disruptions as a result of the pandemic. We are continually
assessing the effect of the COVID-19 pandemic on our operations and
we are monitoring the spread of COVID-19 and the actions
implemented to combat the virus throughout the world.
We do not believe that our cash and cash equivalents of $42.0
million as of September 30, 2020 is sufficient to fund our
current operating plan for at least twelve months after the
issuance of our condensed consolidated financial statements. Based
on our current operating plan, we anticipate having sufficient cash
and cash equivalents to fund our operations into the second quarter
of 2021; however, we have based this estimate on assumptions that
may prove to be wrong, and our capital resources may be utilized
faster than we currently expect. Given our history of significant
losses, negative cash flows from operations, limited cash resources
currently on hand, the ongoing COVID-19 pandemic and dependence on
our ability - about which there can be no certainty - to obtain
additional financing to fund our operations after the current cash
resources are exhausted, substantial doubt exists about our ability
to continue as a going concern. The condensed consolidated
financial statements included elsewhere in this Quarterly Report on
Form 10-Q were prepared under the assumption that we will continue
as a going concern and
do not include any adjustments relating to the recoverability and
classification of recorded asset amounts or the amounts and
classification of liabilities that might result from the outcome of
this uncertainty.
Components of Our Results of Operations
License Revenue
License revenue consists of revenue recognized pursuant to our
License Agreement with Qilu and for which is assessed under ASC
606. In the future, we may generate revenue from a combination of
reimbursements, up-front payments, milestone payments and royalties
in connection with the License Agreement with Qilu.
Research and Development
Research and development expenses consist primarily of costs
incurred for the development of Vicineum for the treatment of
high-risk NMIBC, which include:
•employee-related
expenses, including salaries, benefits, travel and share-based
compensation expense;
•expenses
incurred under agreements with contract research organizations
("CROs") and investigative sites that conduct our clinical
trials;
•expenses
associated with developing manufacturing capabilities;
•expenses
associated with transferring manufacturing capabilities to contract
manufacturing organizations ("CMOs") for commercial-scale
production;
•facilities,
depreciation and other expenses, which include direct and allocated
expenses for rent and maintenance of facilities, insurance and
other supplies; and
•expenses
associated with regulatory activities.
We expense research and development costs as incurred. We recognize
external development costs based on an evaluation of the progress
to completion of specific tasks using information and data provided
to us by our vendors and our clinical sites.
The successful development and commercialization of Vicineum for
the treatment of high-risk NMIBC is highly uncertain. This is due
to the numerous risks and uncertainties associated with product
development and commercialization, including the uncertainty
of:
•the
scope, progress, outcome and costs of our clinical trials and other
research and development activities;
•the
efficacy and potential advantages of Vicineum for the treatment of
high-risk NMIBC compared to alternative treatments, including any
standard of care;
•the
market acceptance of Vicineum for the treatment of high-risk
NMIBC;
•the
cost and timing of the implementation of commercial-scale
manufacturing of Vicineum;
•obtaining,
maintaining, defending and enforcing patent claims and other
intellectual property rights;
•significant
and changing government regulation;
•the
impact of the COVID-19 pandemic; and
•the
timing, receipt and terms of any marketing approvals.
A change in the outcome of any of these variables with respect to
the development of Vicineum for the treatment of high-risk NMIBC
could mean a significant change in the costs and timing associated
with the development of Vicineum for the treatment of high-risk
NMIBC. For example, if the FDA, EMA or another regulatory authority
were to require us to conduct clinical trials or other testing
beyond those that we currently contemplate will be required for the
completion of clinical development of Vicineum for the treatment of
high-risk NMIBC, we could be required to expend significant
additional financial resources and time on the completion of
clinical development of Vicineum for the treatment of high-risk
NMIBC.
We allocate direct research and development expenses, consisting
principally of external costs, such as fees paid to investigators,
consultants, central laboratories and CROs in connection with our
clinical trials, and costs related to manufacturing or purchasing
clinical trial materials and technology transfer, to specific
product programs. We do not allocate employee and
contractor-related costs, costs associated with our platform and
facility expenses, including depreciation or other indirect costs,
to specific product programs because these costs may be deployed
across multiple product programs under research and development
and, as such, are separately classified. The table below provides
research and development expenses incurred for Vicineum for the
treatment of high-risk NMIBC and other expenses by category. We
have deferred further development of Vicineum for the treatment of
SCCHN and VB6-845d in order to focus our efforts and our resources
on our ongoing development of Vicineum for the treatment of
high-risk NMIBC.
We did not allocate research and development expenses to any other
specific product program during the periods presented (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months ended
September 30, |
Nine Months ended
September 30, |
|
2020 |
|
2019 |
2020 |
|
2019 |
Programs: |
|
|
|
|
|
|
Vicineum for the treatment of high-risk NMIBC
|
$ |
8,506 |
|
|
$ |
4,248 |
|
$ |
19,005 |
|
|
$ |
12,620 |
|
Total direct program expenses |
8,506 |
|
|
4,248 |
|
19,005 |
|
|
12,620 |
|
Personnel and other expenses: |
|
|
|
|
|
|
Employee and contractor-related expenses |
1,314 |
|
|
1,916 |
|
3,688 |
|
|
4,973 |
|
Platform-related lab expenses |
184 |
|
|
51 |
|
264 |
|
|
464 |
|
Facility expenses |
109 |
|
|
94 |
|
322 |
|
|
319 |
|
Other expenses |
83 |
|
|
304 |
|
346 |
|
|
867 |
|
Total personnel and other expenses |
1,690 |
|
|
2,365 |
|
4,620 |
|
|
6,623 |
|
Total Research and Development |
$ |
10,196 |
|
|
$ |
6,613 |
|
$ |
23,625 |
|
|
$ |
19,243 |
|
General and Administrative
General and administrative expenses consist primarily of salaries
and related costs for personnel, including share-based
compensation, in executive, operational, finance, business
development and human resource functions. Other general and
administrative expenses include facility-related costs,
professional fees for legal, insurance, patent, consulting and
accounting services, commercial market research and United States
pre-launch market readiness.
Change in Fair Value of Contingent Consideration
In connection with the acquisition of Viventia Bio, Inc.
("Viventia") in September 2016, we recorded contingent
consideration pertaining to the amounts potentially payable to the
former shareholders of Viventia pursuant to the terms of the Share
Purchase Agreement among us, Viventia and the other signatories
thereto (the "Share Purchase Agreement") and are based on
regulatory approval in certain markets and future revenue levels.
The fair value of contingent consideration is assessed at each
balance sheet date and changes, if any, to the fair value are
recognized in earnings (or loss) for the period.
Other Income (Expense), Net
Other income (expense), net consists primarily of interest income
earned on cash and cash equivalents and, to a lessor extent, any
gains or losses on foreign exchange.
Provision for Income Taxes
Provision for income taxes consists of income taxes paid to foreign
jurisdictions pursuant to our License Agreement with
Qilu.
Our Results of Operations
Comparison of the Three Months ended September 30, 2020 and
2019
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months ended
September 30, |
|
Increase/(Decrease) |
|
2020 |
|
2019 |
|
Dollars |
|
Percentage |
|
(in thousands, except percentages) |
License revenue |
$ |
11,236 |
|
|
$ |
— |
|
|
$ |
11,236 |
|
|
— |
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
$ |
10,196 |
|
|
$ |
6,613 |
|
|
$ |
3,583 |
|
|
54 |
% |
General and administrative |
4,115 |
|
|
3,238 |
|
|
877 |
|
|
27 |
% |
Change in fair value of contingent consideration
|
18,400 |
|
|
3,600 |
|
|
14,800 |
|
|
411 |
% |
Total operating expenses |
32,711 |
|
|
13,451 |
|
|
19,260 |
|
|
143 |
% |
Loss from operations |
(21,475) |
|
|
(13,451) |
|
|
(8,024) |
|
|
60 |
% |
Other income (expense), net: |
|
|
|
|
|
|
|
Other income (expense), net |
(1) |
|
|
319 |
|
|
(320) |
|
|
(100) |
% |
Net Loss and Comprehensive Loss Before Taxes |
$ |
(21,476) |
|
|
$ |
(13,132) |
|
|
$ |
(8,344) |
|
|
64 |
% |
Provision for income taxes |
$ |
(1,132) |
|
|
$ |
— |
|
|
$ |
(1,132) |
|
|
— |
|
Net Loss and Comprehensive Loss After Taxes |
$ |
(22,608) |
|
|
$ |
(13,132) |
|
|
$ |
(9,476) |
|
|
72 |
% |
Revenue
Revenue for the three months ended September 30, 2020 was $11.2
million, which was due to the recognition of revenue pursuant to
the License Agreement with Qilu. The Company did not record any
revenue for the three months ended September 30, 2019.
Research and Development
Research and development expenses were $10.2 million for the three
months ended September 30, 2020 compared to $6.6 million for
the three months ended September 30, 2019. The increase of
$3.6 million was due primarily to increased costs associated with
technology transfer and manufacturing scale-up for commercial
supply and timing of procurement of manufacturing consumables,
offset by lower clinical trial expenses as a result of our Phase 3
VISTA Trial winding down and lower regulatory consulting
fees.
General and Administrative
General and administrative expenses were $4.1 million for the three
months ended September 30, 2020 compared to $3.2 million for
the three months ended September 30, 2019. The increase of
$0.9 million was due primarily to increases in investment banking
and legal fees related to our License Agreement with
Qilu.
Change in Fair Value of Contingent Consideration
The non-cash change in fair value of contingent consideration was
an $18.4 million loss for the three months ended September 30,
2020 compared to a $3.6 million loss for the three months ended
September 30, 2019. The increase in the fair value of
contingent consideration of $18.4 million for the three months
ended September 30, 2020 was attributable primarily to lower
discount rates, based on prevailing market conditions as of
September 30, 2020, and to a lessor extent by refinement of
timelines in certain OUS markets. The estimated fair value of
contingent consideration is determined by applying appropriate
discount rates to future cash outflows related to the contingent
payment obligations, and these discount rates continue to remain
volatile as global economies shut down in order to contain the
spread of COVID-19. The milestone payments constitute debt-like
obligations, and the high-yield debt index rate applied to the
milestones in order to determine the estimated fair value
fluctuated from 11.8% as of December 31, 2019, to 17.9% of
March 31, 2020, to 14.5% as of June 30, 2020 and to 11.8% as of
September 30, 2020. The discount rate applied to the 2%
royalty due on forecasted Vicineum revenues is derived from our
estimated weighted-average cost of capital ("WACC"), and this
WACC-derived discount rate fluctuated from 5.6% as of
December 31, 2019, 14.7% as of March 31, 2020, 13.2% as of
June 30, 2020 and 9.4% as of September 30, 2020.
The change in the fair value of contingent consideration was a $3.6
million loss for the three months ended September 30, 2019 and
was primarily attributable to a slightly lower discount rate, based
on prevailing market conditions as of September 30,
2019, applicable to the earnout royalty payments potentially
payable to Viventia's shareholders under the Share Purchase
Agreement.
Changes in forecast assumptions, including the probability of
regulatory approvals and Vicineum pricing and sales volumes, as
well as changes in the discount rates utilized based on prevailing
market conditions, could result in materially different fair value
estimates.
Other Income (Expense), Net
Other income (expense), net was de minimus for the three months
ended September 30, 2020 compared to $0.3 million of income
for the three months ended September 30, 2019. The change of
$0.3 million was due primarily to lower interest income earned on
cash balances.
Provision for Income Taxes
Provision for income taxes was $1.1 million of expense for the
three months ended September 30, 2020 compared to no provision
for income taxes for the three months ended September 30,
2019. The increase of $1.1 million was due to income taxes paid to
a foreign jurisdiction pursuant to our License Agreement with
Qilu.
Comparison of the Nine Months ended September 30, 2020 and
2019
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months ended
September 30, |
|
Increase/(Decrease) |
|
2020 |
|
2019 |
|
Dollars |
|
Percentage |
|
(in thousands, except percentages) |
License revenue |
$ |
11,236 |
|
|
$ |
— |
|
|
$ |
11,236 |
|
|
— |
% |
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
$ |
23,625 |
|
|
$ |
19,243 |
|
|
$ |
4,382 |
|
|
23 |
% |
General and administrative |
10,882 |
|
|
8,910 |
|
|
1,972 |
|
|
22 |
% |
Change in fair value of contingent consideration |
(16,820) |
|
|
46,600 |
|
|
(63,420) |
|
|
(136) |
% |
Total operating expenses |
17,687 |
|
|
74,753 |
|
|
(57,066) |
|
|
(76) |
% |
Loss from operations |
(6,451) |
|
|
(74,753) |
|
|
68,302 |
|
|
(91) |
% |
Other income (expense), net: |
|
|
|
|
|
|
|
Other income (expense), net |
195 |
|
|
806 |
|
|
(611) |
|
|
(76) |
% |
Net Loss and Comprehensive Loss |
$ |
(6,256) |
|
|
$ |
(73,947) |
|
|
$ |
67,691 |
|
|
(92) |
% |
Provision for income taxes |
$ |
(1,132) |
|
|
$ |
— |
|
|
(1,132) |
|
|
— |
% |
Net Loss and Comprehensive Loss |
$ |
(7,388) |
|
|
$ |
(73,947) |
|
|
$ |
66,559 |
|
|
(90) |
% |
Revenue
Revenue for the nine months ended September 30, 2020 was $11.2
million, which was due to the recognition of revenue pursuant to
the License Agreement with Qilu. The Company did not record any
revenue for the nine months ended September 30, 2019.
Research and Development
Research and development expenses were $23.6 million for the nine
months ended September 30, 2020 compared to $19.2 million for
the nine months ended September 30, 2019. The increase of $4.4
million was due primarily to increased costs associated with
technology transfer and manufacturing scale-up for commercial
supply, timing of procurement of manufacturing consumables and
professional fees in support of regulatory activities, partially
offset by lower employee compensation and lower clinical trial
expenses as a result of our Phase 3 VISTA Trial winding
down.
General and Administrative
General and administrative expenses were $10.9 million for the nine
months ended September 30, 2020 compared to $8.9 million for
the nine months ended September 30, 2019. The increase of $2.0
million was due primarily to increases in employee compensation,
legal, insurance and investment banking fees, which were partially
offset by reduced market research.
Change in Fair Value of Contingent Consideration
The non-cash change in fair value of contingent consideration was
income of $16.8 million for the nine months ended
September 30, 2020 compared to a $46.6 million loss for the
nine months ended September 30, 2019. The decrease in the fair
value of contingent consideration of $16.8 million for the nine
months ended September 30, 2020 was attributable primarily to
significantly higher discount rates as a result of financial market
conditions as of September 30, 2020, offset by changes to the
current competitive landscape. The estimated fair value of
contingent consideration is determined by applying appropriate
discount rates to future cash outflows related to the contingent
payment obligations, and these discount rates have increased
significantly as a result of the extreme volatility of financial
markets as global economies shut down in order to contain the
spread of COVID-19. The milestone payments constitute debt-like
obligations, and the high-yield debt index rate applied to the
milestones in order to determine the estimated fair value remained
unchanged at 11.8% as of both December 31, 2019 and September 30,
2020. However, the discount rate applied to the 2% royalty due on
forecasted Vicineum revenues is derived from our estimated WACC,
and this WACC-derived discount rate increased from 5.6% as of
December 31, 2019 to 9.4% as of September 30,
2020.
The change in fair value of contingent consideration was $46.6
million for the nine months ended September 30, 2019. During the
quarter ended June 30, 2019, we reassessed the total addressable
global market for NMIBC and determined that both the global market
size and estimated potential Vicineum commercial net sales within
the global NMIBC market were likely higher than the Company’s
previous estimates. Specific drivers of the increased revenue
estimates include the expectation that Vicineum could achieve peak
market penetration earlier than previously estimated and the
expectation that Vicineum sales outside the United States could be
two to three times the expected sales volumes in the United States.
As contingent consideration incorporates a royalty rate of 2% on
all commercial net sales reported through December 2033, an
increase in expected future net sales correlates to an increase in
the fair value of our potential contingent consideration.
Accordingly, our contingent consideration at September 30, 2019 was
adjusted to reflect our updated view of the NMIBC market and the
potential sales volumes of Vicineum in that market. The change in
the nine months ended September 30, 2019 was therefore due to
changes in assumptions related to forecasted Vicineum pricing and
sales volumes in the U.S. and outside the U.S. ("OUS") compared to
prior assumptions utilized as of December 31, 2018.
Changes in forecast assumptions, including the probability of
regulatory approvals and Vicineum pricing and sales volumes, as
well as changes in the discount rates utilized based on prevailing
market conditions, could result in materially different fair value
estimates.
Other Income (Expense), Net
Other income (expense), net was $0.2 million of income for the nine
months ended September 30, 2020 compared to $0.8 million of
income for the nine months ended September 30, 2019. The
overall decrease of $0.6 million was due primarily to lower
interest income earned on cash balances.
Provision for Income Taxes
Provision for income taxes was $1.1 million of expense for the nine
months ended September 30, 2020 compared to no provision for
income taxes for the nine months ended September 30, 2019. The
increase of $1.1 million was due to income taxes paid to a foreign
jurisdiction pursuant to our License Agreement with
Qilu.
Liquidity and Capital Resources
Overview
As of September 30, 2020, we had cash and cash equivalents of
$42.0 million, net working capital of $39.3 million and an
accumulated deficit of $300.9 million. We incurred negative cash
flows from operating activities of $37.5 million for the year ended
December 31, 2019 and $22.3 million for the nine months ended
September 30, 2020. Since our inception, we have received no
revenue from sales of our products, and we anticipate that
operating losses will continue for the foreseeable future as we
continue our ongoing Phase 3 VISTA Trial of Vicineum for the
treatment of high-risk NMIBC and seek marketing approval from the
FDA and the EMA. We have financed our operations to date primarily
through private placements of our common stock, preferred stock,
common stock warrants and convertible bridge notes, venture debt
borrowings, our IPO, follow-on public offerings, sales effected in
ATM offerings, our License Agreement with Roche, our License
Agreement with Qilu and, to a lesser extent, from a
collaboration.
In November 2019, we entered into an Open Market Sale
Agreement
SM
(the "Sale Agreement") with Jefferies LLC ("Jefferies"), under
which we may issue and sell shares of our common stock from time to
time for an aggregate sales price of up to $35.0 million through
Jefferies (the "ATM Offering"). Sales of common stock under the
Sale Agreement are made by any method that is deemed to be an ATM
offering as defined in Rule 415(a)(4) of the Securities
Act of 1933, as amended, including but not limited to sales made
directly on or through the Nasdaq Global Market or any other
existing trading market for our
common stock. We have no obligation to sell any of our common stock
and may at any time suspend offers under the Sale Agreement or
terminate the Sale Agreement. Subject to the terms and conditions
of the Sale Agreement, Jefferies will use its commercially
reasonable efforts to sell common stock from time to time, as the
sales agent, based upon our instructions, which include a
prohibition on sales below a minimum price set by us from time to
time. We have provided Jefferies with customary indemnification
rights, and Jefferies is entitled to a commission at a fixed rate
equal to 3.0% of the gross proceeds for each sale of common stock
under the Sale Agreement. We incurred $0.2 million in legal,
accounting and printing costs related to the commencement of the
ATM Offering. For the nine months ended September 30, 2020, we
raised $16.2 million of net proceeds from the sale of
16.8 million shares of common stock at a weighted-average
price of $0.99 per share under the ATM Offering, including
$8.2 million of net proceeds from the sale of 7.0 million
shares of common stock at a weighted-average price of $1.21 per
share during the three months ended September 30, 2020. Share issue
costs, including sales agent commissions, related to the ATM
Offering totaled $0.3 million and $0.5 million during the
three and nine months ended September 30, 2020,
respectively.
On October 30, 2020, we entered into an amendment to the Sale
Agreement pursuant to which we may issue and sell an additional
$50.0 million of shares of our common stock through
Jefferies.
We continue to monitor the effect of the outbreak of COVID-19. This
virus continues to spread globally, has been declared a pandemic by
the World Health Organization and has spread to over 200 countries
and territories, including the United States disproportionately.
The impact of this pandemic has been and will likely continue to be
extensive in many aspects of society, which has resulted in and
will likely continue to result in significant disruptions to
businesses and capital markets around the world. We are proactively
executing risk mitigation strategies to attenuate the impact of
COVID-19 on us, and at this time, we have not yet experienced any
business disruptions as a result of the pandemic. We are
continually assessing the effect of the COVID-19 pandemic on our
operations and we are monitoring the spread of COVID-19 and the
actions implemented to combat the virus throughout the
world.
We do not believe that our cash and cash equivalents of $42.0
million as of September 30, 2020 is sufficient to fund our
current operating plan for at least twelve months after the
issuance of our condensed consolidated financial statements. Based
on our current operating plan, we anticipate having sufficient cash
and cash equivalents to fund our operations into the second quarter
of 2021; however, we have based this estimate on assumptions that
may prove to be wrong, and our capital resources may be utilized
faster than we currently expect. Given our history of significant
losses, negative cash flows from operations, limited cash resources
currently on hand, the impact of the ongoing COVID-19 pandemic on
the capital markets and dependence on our ability - about which
there can be no certainty - to obtain additional financing to fund
our operations after the current cash resources are exhausted,
substantial doubt exists about our ability to continue as a going
concern. The condensed consolidated financial statements included
elsewhere in this Quarterly Report on Form 10-Q were prepared under
the assumption that we will continue as a going concern and do not
include any adjustments relating to the recoverability and
classification of recorded asset amounts or the amounts and
classification of liabilities that might result from the outcome of
this uncertainty.
Nasdaq Notice
On March 2, 2020, we received written notice (the “Notice”) from
The Nasdaq Stock Market, LLC (“Nasdaq”) indicating that we are not
in compliance with the $1.00 minimum bid price requirement for
continued listing on The Nasdaq Global Market, as set forth in
Nasdaq Listing Rule 5450(a)(1).
In accordance with Nasdaq Listing Rule 5810(c)(3)(A), we had a
period of 180 calendar days, or until August 31, 2020, to regain
compliance with the minimum bid price requirement. To regain
compliance, the closing bid price of our common stock must meet or
exceed $1.00 per share for a minimum of ten consecutive business
days during this 180-day period.
On April 17, 2020, we received written notice from Nasdaq that the
180-day grace period to regain compliance with the $1.00 minimum
bid price requirement had been extended in response to the COVID-19
pandemic and related extraordinary market conditions.
On August 21, 2020, we received notice from Nasdaq confirming that
for the last 10 consecutive business days, the closing bid price of
our common stock has been equal to or in excess of the $1.00 per
share minimum bid price requirement for continued listing, as set
forth in Nasdaq Listing Rule 5450(a)(1). Accordingly, Nasdaq has
determined that we had regained compliance with Nasdaq Listing Rule
5450(a)(1) and indicated to us that this matter is now
closed.
Funding Requirements
Our future success is dependent on our ability to develop our
product candidates, including Vicineum for the treatment of
high-risk NMIBC, and ultimately upon our ability to attain
profitable operations. In order to commercialize our product
candidates, including Vicineum for the treatment of high-risk
NMIBC, we need to complete clinical development and comply
with
comprehensive regulatory requirements. We are subject to a number
of risks similar to other late-stage clinical companies, including,
but not limited to, successful discovery and development of our
product candidates, raising additional capital, development and
commercialization by our competitors of new technological
innovations, protection of proprietary technology and market
acceptance of our products. The successful discovery and
development of product candidates, including Vicineum for the
treatment of high-risk NMIBC, requires substantial working capital,
and we expect to seek additional funds through equity or debt
financings or through additional collaboration, licensing
transactions or other sources. We may be unable to obtain equity or
debt financings or enter into additional collaboration or licensing
transactions at favorable terms, or at all, and, if necessary, we
may be required to implement cost reduction
strategies.
We will incur substantial expenses if and as we:
•continue
our Phase 3 VISTA Trial for Vicineum for the treatment of high-risk
NMIBC;
•seek
marketing approvals for Vicineum for the treatment of high-risk
NMIBC;
•establish
sales, marketing and distribution capabilities and scale up and
validate external manufacturing capabilities (including completing
the manufacturing process and technology transfer to any
third-party manufacturers) to commercialize Vicineum for the
treatment of high-risk NMIBC, if approved;
•maintain,
expand and protect our intellectual property
portfolio;
•add
equipment and physical infrastructure to support our research and
development;
•hire
additional clinical, regulatory, quality control, scientific and
management personnel;
•expand
our operational, financial and management systems and
personnel;
•conduct
research and pre-clinical and clinical development of Vicineum for
the treatment of high-risk NMIBC and our other product
candidates;
•seek
to discover and develop additional product candidates;
and
•in-license
or acquire the rights to other products, product candidates or
technologies.
Our future capital requirements will depend on many factors,
including:
•the
scope, initiation, progress, timing, costs and results of
pre-clinical development and laboratory testing and clinical trials
for Vicineum for the treatment of high-risk NMIBC and our other
product candidates;
•the
cost and timing of any new clinical trials or studies of Vicineum
for the treatment of high-risk NMIBC;
•the
ongoing COVID-19 pandemic and its impact on our
business;
•our
ability to establish collaborations or licensing arrangements on
favorable terms, if at all, particularly manufacturing, marketing
and distribution arrangements for our product
candidates;
•the
costs and timing of the implementation of commercial-scale
manufacturing activities, including those associated with the
manufacturing process and technology transfer to third-party
manufacturers to facilitate such commercial-scale manufacturing of
Vicineum;
•the
costs and timing of establishing sales, marketing and distribution
capabilities for Vicineum for the treatment of high-risk NMIBC, if
approved;
•the
costs and timing of preparing, filing and prosecuting patent
applications, maintaining and enforcing our intellectual property
rights and defending any intellectual property-related
claims;
•our
obligation to make milestone, royalty and other payments to
third-party licensors under our licensing agreements;
•the
extent to which we in-license or acquire rights to other products,
product candidates or technologies;
•the
outcome, timing and cost of regulatory review by the FDA, EMA and
comparable foreign regulatory authorities for Vicineum for the
treatment of high-risk NMIBC, including the potential for the FDA,
EMA or comparable foreign regulatory authorities to require that we
perform more studies than those that we currently expect to
perform;
•our
ability to achieve certain future regulatory, development and
commercialization milestones under the License Agreement with Roche
and our License Agreement with Qilu;
•the
effect of competing technological and market developments;
and
•the
revenue, if any, received from commercial sales of Vicineum for the
treatment of high-risk NMIBC, if approved.
Until such time, if ever, as we can generate substantial product
revenues from commercial sales, we expect to finance our cash needs
through a combination of equity offerings, debt financings,
government or other third-party funding, strategic collaborations
and alliances, and licensing arrangements. We do not have any
committed external source of funds other than the amounts payable
under the License Agreement with Roche and the License Agreement
with Qilu. To the extent that we raise additional capital through
the sale of equity or convertible debt securities, the ownership
interests of existing stockholders will be diluted, and the terms
of these securities may include liquidation or other preferences
that adversely affect the rights of existing stockholders. Debt
financing, if available, may involve agreements that include liens
or other restrictive covenants limiting our ability to take
specific actions, such as incurring additional debt, making capital
expenditures or declaring dividends. If we raise additional funds
through government or other third-party funding, strategic
collaborations and alliances or licensing arrangements, we may have
to relinquish valuable rights to our technologies, future revenue
streams, research programs or product candidates or grant licenses
on terms that may not be favorable to us. If we are unable to raise
additional
funds when needed, we may be required to delay, limit, reduce or
terminate our product development or future commercialization
efforts or grant rights to develop and market products or product
candidates that we would otherwise prefer to develop and market
ourselves.
The COVID-19 pandemic has negatively impacted the global economy,
disrupted business operations and created significant volatility
and disruption to financial markets. Significant uncertainty
remains as to the potential impact of the COVID-19 pandemic on our
operations, and on the global economy as a whole. The extent and
duration of the pandemic could continue to disrupt global markets
and may affect our ability to raise additional capital in the
future.
Cash Flows
The following table sets forth a summary of our cash flows for the
nine months ended September 30, 2020 and 2019 (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months ended September 30, |
|
2020 |
|
2019 |
Net Cash Used in Operating Activities |
$ |
(22,328) |
|
|
$ |
(23,716) |
|
Net Cash Used in Investing Activities |
(8) |
|
|
(137) |
|
Net Cash Provided by Financing Activities |
16,184 |
|
|
31,296 |
|
Net Increase (Decrease) in Cash, Cash Equivalents and Restricted
Cash |
$ |
(6,152) |
|
|
$ |
7,443 |
|
Net Cash Used in Operating Activities
Net cash used in operating activities was $22.3 million for the
nine months ended September 30, 2020 and consisted primarily of a
net loss of $7.4 million, which includes $11.2 million of revenue
recognized pursuant to the License Agreement with Qilu, adjusted
for non-cash items, including share-based compensation of $1.4
million, a decrease in the fair value of contingent consideration
of $16.8 million and a net increase in operating assets and
liabilities of $0.4 million.
Net cash used in operating activities was $23.7 million for the
nine months ended September 30, 2019 and consisted primarily of a
net loss of $73.9 million, adjusted for non-cash items, including
share-based compensation of $0.9 million, an increase in the fair
value of contingent consideration of $46.6 million and a net
increase in operating assets and liabilities of $2.6
million.
Net Cash Used in Investing Activities
Net cash (used in) provided by investing activities consisted of
purchases of equipment during each of the nine months ended
September 30, 2020 and 2019.
Net Cash Provided by Financing Activities
Net cash provided by financing activities was $16.2 million for the
nine months ended September 30, 2020 and consisted of net proceeds
from the sale of common stock under the ATM Offering and sales of
common stock under our 2014 ESPP. Net cash provided by financing
activities for the nine months ended September 30, 2019 consisted
of (i) $27.8 million in net proceeds on the sale of 20.4 million
shares of common stock and accompanying warrants to purchase an
additional 20.4 million shares of common stock in an underwritten
public offering
in June 2019 and (ii) $3.4 million in proceeds from the exercise of
3.4 million of warrants to purchase our common stock.
Critical Accounting Policies and Use of Estimates
The preparation of our consolidated financial statements in
accordance with United States generally accepted accounting
principles and the rules and regulations of the SEC require the use
of estimates and assumptions, based on complex judgments considered
reasonable, and affect the reported amounts of assets and
liabilities and disclosure of contingent assets and liabilities at
the date of the consolidated financial statements and the reported
amounts of expenses during the reporting period. Our critical
accounting policies are those policies which require the most
significant judgments and estimates in the preparation of our
consolidated financial statements. Management has determined that
our most critical accounting policies are those relating to the
fair value of intangible assets, goodwill and contingent
consideration; income taxes (including the valuation allowance for
deferred tax assets); research and development costs; revenue
recognition and going concern considerations.
Indefinite-Lived Intangible Assets
Our intangible assets consist of indefinite-lived, acquired
in-process research and development ("IPR&D") worldwide product
rights to Vicineum as a result of the acquisition of Viventia in
2016. IPR&D assets acquired in a business combination
are
considered indefinite-lived until the completion or abandonment of
the associated research and development efforts. Amortization over
the estimated useful life will commence at the time of Vicineum's
launch in the respective markets, if approved. If regulatory
approval to market Vicineum for the treatment of high-risk NMIBC is
not obtained, we will immediately expense the related capitalized
cost.
Indefinite-lived intangible assets are quantitatively tested for
impairment at least annually during the fourth quarter of the
fiscal year, or more often if indicators of impairment are present.
Impairment testing of indefinite-lived intangible assets requires
management to estimate the future discounted cash flows of an asset
using assumptions believed to be reasonable, but which are
unpredictable and inherently uncertain. Actual future cash flows
may differ from the estimates used in impairment testing. We
recognize an impairment loss when and to the extent that the
estimated fair value of an intangible asset is less than its
carrying value. In addition, on a quarterly basis, we perform a
qualitative review of our business operations to determine whether
events or changes in circumstances have occurred which could
indicate that the carrying value of our intangible assets was not
recoverable. If an impairment indicator is identified, an interim
impairment assessment is performed. Based on the annual testing and
quarterly reviews performed, we concluded that the carrying value
of our intangible assets was not impaired as of September 30,
2020 and December 31, 2019.
Goodwill
Goodwill on our consolidated balance sheet is the result of our
acquisition of Viventia in September 2016 and represents the
difference between the purchase price and the fair value of the
identifiable tangible and intangible net assets acquired under the
acquisition method of accounting. Goodwill is not amortized; rather
than recording periodic amortization, goodwill is quantitatively
tested for impairment at least annually during the fourth quarter
of the fiscal year, or more often if indicators of impairment are
present. Impairment testing of goodwill requires management to
estimate the future discounted cash flows of a reporting unit using
assumptions believed to be reasonable, but which are unpredictable
and inherently uncertain. Actual future cash flows may differ from
the estimates used in impairment testing. If the fair value of the
equity of a reporting unit exceeds the reporting unit’s carrying
value, including goodwill, then goodwill is considered not to be
impaired. We recognize a goodwill impairment when and to the extent
that the fair value of the equity of a reporting unit is less than
the reporting unit's carrying value, including goodwill. We have
only one reporting unit. In addition, on a quarterly basis, we
perform a qualitative review of our business operations to
determine whether events or changes in circumstances have occurred
which could have a material adverse effect on the estimated fair
value of each reporting unit and thus indicate a potential
impairment of the goodwill carrying value. If an impairment
indicator is identified, an interim impairment assessment is
performed. Based on the annual testing and quarterly reviews
performed, we concluded that there was no goodwill impairment as of
September 30, 2020 and December 31, 2019.
Contingent Consideration
Contingent consideration on our consolidated balance sheet is the
result of our acquisition of Viventia in September 2016 and
represents the discounted present value of future launch milestones
and net sales royalties due to the former shareholders of Viventia
pursuant to the Share Purchase Agreement. For additional
information, see "Item 1. Financial Statements - Notes to Condensed
Consolidated Financial Statements - Note 1. Description of
Business" of this Quarterly Report on Form 10-Q. Contingent
consideration is measured at its estimated fair value on a
recurring basis at each reporting period, with fluctuations in
value resulting in a non-cash charge to earnings (or loss) during
the period. The estimated fair value measurement is based on
significant unobservable inputs (Level 3 within the fair value
hierarchy), including internally developed financial forecasts,
probabilities of success and timing of certain milestone events and
achievements, which are unpredictable and inherently uncertain.
Actual future cash flows may differ from the assumptions used to
estimate the fair value of contingent consideration. The valuation
of contingent consideration requires the use of significant
assumptions and judgments, which management believes are consistent
with those that would be made by a market participant. Management
reviews its assumptions and judgments on an ongoing basis as
additional market and other data is obtained, and any future
changes in the assumptions and judgments utilized by management may
cause the estimated fair value of contingent consideration to
fluctuate materially, resulting in earnings
volatility.
Income Taxes
Income taxes are accounted for under the asset and liability
method. Deferred tax assets and liabilities are recognized for the
future tax consequences attributable to differences between the
financial statement carrying amounts of existing assets and
liabilities and their respective tax bases and net operating loss
("NOL") and research and development credit ("R&D credit")
carryforwards. Deferred tax assets and liabilities are measured
using enacted tax rates expected to apply to taxable income in the
years in which those temporary differences are expected to be
recovered or settled. The effect on deferred tax assets and
liabilities of a change in tax rates is recognized in operations in
the period that includes the enactment date. A valuation allowance
is recorded to the extent it is more likely than not that some
portion or all of the deferred tax assets will not be
realized.
Unrecognized income tax benefits represent income tax positions
taken on income tax returns that have not been recognized in the
financial statements. We recognize the benefit of an income tax
position only if it is more likely than not (greater than 50%) that
the tax position will be sustained upon tax examination, based
solely on the technical merits of the tax position. Otherwise, no
benefit is recognized. The tax benefits recognized are measured
based on the largest benefit that has a greater than 50% likelihood
of being realized upon ultimate settlement. We recognize accrued
interest and penalties related to uncertain tax positions as income
tax expense in our consolidated statements of operations. As of
September 30, 2020 and December 31, 2019, we did not have
any uncertain tax positions.
Revenue
The Company records revenue from its License Agreement with Roche
and its License Agreement with Qilu. Under both agreements, the
Company granted the counterparty an exclusive license to develop
and commercialize the underlying licensed product. Both agreements
contain up-front license fees, development and regulatory milestone
payments, and sales-based royalty payments.
We determine whether our license agreements are in scope of ASC
606, which we adopted as of January 1, 2018. Under ASC 606, in
determining the appropriate amount of revenue to be recognized as
it fulfills its obligations under its license agreements, we
perform the following steps:
1) Identification of the contract;
2) Determination of whether the promised goods or services are
performance obligations including whether they are distinct in
the context of the contract;
3) Measurement of the transaction price, including the constraint
on variable consideration;
4) Allocation of the transaction price to the performance
obligations;
5) Recognition of revenue when or as the Company satisfies each
performance obligation.
Development and Regulatory Milestones and Other
Payments
At the inception of an arrangement that includes development
milestone payments, we evaluate whether the development milestones
are considered probable of being reached and estimate the amount to
be included in the transaction price using the most likely amount
method. If it is probable that a significant revenue reversal would
not occur, the associated development milestone value is included
in the transaction price. Development milestone payments that are
not within our control or the licensee's control, such as
regulatory approvals, are not considered probable of being achieved
until those approvals are received. The milestones are allocated
entirely to the license performance obligation, as (1) the terms of
milestone and royalty payments relate specifically to the license
and (2) allocating milestones and royalties to the license
performance obligation is consistent with the overall allocation
objective, because management’s estimate of milestones and
royalties approximates the standalone selling price of the license.
Other payments, such as amounts associated with withheld VAT, will
also be included in the transaction price using the most likely
method once recoverability is reasonably assured.
Research and Development Costs
Research and development activities are expensed in the period
incurred. Research and development expenses consist of both
internal and external costs associated with all basic research
activities, clinical development activities and technical efforts
required to develop a product candidate. Internal research and
development consist primarily of personnel costs, including
salaries, benefits and share-based compensation, facilities leases,
research-related overhead, pre-approval regulatory and clinical
trial costs, manufacturing and other contracted services, license
fees and other external costs.
In certain circumstances, we are required to make advance payments
to vendors for goods or services that will be received in the
future for use in research and development activities. In such
circumstances, the advance payments are recorded as prepaid assets
and expensed when the activity has been performed or when the goods
have been received.
Recently Issued Accounting Standards
Recently issued accounting standards are discussed in “Item 1.
Financial Statements - Notes to Condensed Consolidated Financial
Statements - Note 4. Recent Accounting Pronouncements” of this
Quarterly Report on Form 10-Q.
Off-Balance Sheet Arrangements
We did not have during the periods presented, and we do not
currently have, any off-balance sheet arrangements, as defined in
the rules and regulations of the SEC.
Item 3. Quantitative
and Qualitative Disclosures About Market Risk.
The information under this item is not required to be provided by
smaller reporting companies.
Item 4. Controls
and Procedures.
Evaluation of Disclosure Controls and Procedures
We maintain disclosure controls and procedures, as defined in
Exchange Act
Rules 13a-15(e) and 15d-15(e), that are designed to ensure
information required to be disclosed by us in reports we file or
submit under the Exchange Act is recorded, processed, summarized
and reported within the time periods specified in the SEC's rules
and forms and that such information is accumulated and communicated
to our management, including our principal executive officer and
principle financial officer, to allow timely decisions regarding
required disclosure.
Our management, with the participation of our Chief Executive
Officer and Chief Financial Officer, evaluated the effectiveness of
our disclosure controls and procedures as the end of the period
covered by this Quarterly Report on Form 10-Q. Based upon this
evaluation, our Chief Executive Officer and Chief Financial Officer
concluded that our disclosure controls and procedures were
effective at the reasonable assurance level as of
September 30, 2020.
Limitations on Effectiveness of Controls and
Procedures
A control system, no matter how well conceived and operated, can
provide only reasonable, not absolute, assurance that the
objectives of the control system are achieved. Further, the design
of a control system must be balanced against resource constraints,
and therefore, the benefits of controls must be considered relative
to their costs. Given the inherent limitations in all systems of
controls, no evaluation of controls can provide absolute assurance
all control issues and instances of fraud, if any, within a company
have been detected. These inherent limitations include the
realities that judgments in decision making can be faulty and that
breakdowns can occur because of a simple error or mistake.
Additionally, controls can be circumvented by the individual acts
of some persons, by collusion of two or more people or by
management override of controls. The design of any system of
controls is also based in part upon certain assumptions about the
likelihood of future events, and there can be no assurance that any
design will succeed in achieving its stated goals under all
potential future conditions; over time, controls may become
inadequate because of changes in conditions or the degree of
compliance with the policies and procedures may deteriorate.
Accordingly, given the inherent limitations in a cost-effective
system of controls, financial statement misstatements due to error
or fraud may occur and may not be detected. Our disclosure controls
and procedures are designed to provide reasonable, not absolute,
assurance of achieving their objectives. We conduct periodic
evaluations of our system of controls to enhance, where necessary,
our control policies and procedures.
Changes in Internal Control Over Financial Reporting
During the nine months ended September 30, 2020, there were no
changes in our internal control over financial reporting, as
defined in Exchange Act Rules 13a-15(f) and 15d-15(f), which
materially affected, or are reasonably likely to materially affect,
our internal control over financial reporting.
PART II - OTHER INFORMATION
Item 1. Legal
Proceedings.
We are not currently subject to any material legal
proceedings.
Item 1A. Risk Factors.
During the nine months ended September 30, 2020, other than as set
forth below, there were no material changes to the "Risk Factors"
included in our Annual Report on Form 10-K for the year ended
December 31, 2019. You should carefully consider the information
described therein and in this Quarterly Report on Form 10-Q, which
could materially affect our business condition, results of
operations and cash flows.
The COVID-19 coronavirus could adversely impact our
business.
We continue to monitor the effect of the outbreak of the novel
strain of coronavirus, COVID-19. The COVID-19 coronavirus has
spread to multiple countries, including the United States, and has
caused significant disruptions around the world. We may experience
disruptions as a result of the COVID-19 pandemic that could
severely impact our business, including:
•difficulties
in raising additional capital needed to commercialize Vicineum for
the treatment of high-risk NMIBC due to the slowing of our economy
and near term and/or long term negative effects of the pandemic on
the financial, banking and capital markets;
•delays
in necessary interactions with regulators and other important
agencies and contractors due to limitations in employee resources,
travel restrictions or forced furlough of government
employees;
•interruption
of key business activities due to illness and/or quarantine of key
individuals and delays associated with recruiting, hiring and
training new temporary or permanent replacements for such key
individuals, both internally and at our third party service
providers;
•changes
in local regulations as part of a response to the COVID-19
coronavirus outbreak that may require us to change the ways in
which operate, which may result in unexpected costs;
•interruption
of key commercialization, manufacturing, and related activities due
to limitations on work and travel imposed or recommended by federal
or state governments, employers and others; and
•delays
or difficulties related to any future clinical trials that may be
required, including delays in clinical trial sites receiving the
supplies and materials needed to conduct clinical trials,
difficulties in recruiting clinical site investigators and clinical
site staff and difficulties in enrolling patients or treating
patients in active trials.
The global outbreak of the COVID-19 coronavirus continues to
rapidly evolve. The extent to which the COVID-19 coronavirus may
impact our business will depend on future developments, which are
highly uncertain and cannot be predicted with confidence, such as
the ultimate geographic spread of the disease, the duration of the
outbreak, travel restrictions and social distancing in the United
States and other countries, business closures or business
disruptions and the effectiveness of actions taken in the United
States and other countries to contain and treat the virus. The full
impact of the COVID-19 pandemic on our operational and financial
performance, including our ability to execute our business
strategies and initiatives in the expected time frame, will depend
on future developments, including the duration and spread of the
pandemic and related restrictions on travel and transports, and
shelter-in-place, social distancing, and similar measures, all of
which are uncertain and difficult to predict. The broad-based
business and economic disruptions caused by the pandemic could
materially affect our business condition, results of operations and
cash flows, including our ability to raise additional
capital.
We will depend on Qilu for the development and commercialization of
Vicineum in the greater China region.
On July 30, 2020 we entered into the License Agreement with Qilu.
Under the terms of the License Agreement with Qilu, Qilu has an
exclusive license to manufacture, develop and commercialize
Vicineum in the greater China region, including mainland China,
Hong Kong, Macau and Taiwan. The timing and amount of any milestone
and royalty payments we may receive under the License Agreement
with Qilu will depend in part on Qilu’s efforts. We will also
depend on Qilu to comply with all applicable laws relative to the
manufacturing, development and commercialization of Vicineum in the
greater China region. We do not control the individual efforts of
Qilu, and any failure by Qilu to devote sufficient time and effort
to the manufacture, development and commercialization of Vicineum
could have a material adverse impact on our financial results and
operations, such as by a failure of Qilu to meet its obligations to
us, including for future milestone and royalty payments. In
addition, if Qilu were to violate, or was alleged to have violated,
any laws or regulations during the performance of its obligations
for us, it is possible that we could suffer financial and
reputational harm or other negative outcomes, including possible
legal consequences.
Any termination, breach or expiration of the License Agreement with
Qilu could have a material adverse effect on our financial position
by reducing or eliminating the potential for us to receive
milestones and royalties. In such an event, we may be required to
devote additional efforts and to incur additional costs associated
with pursuing the manufacture, development and commercialization of
Vicineum in greater China. If we breach our obligations under the
Qilu License Agreement and are unable to cure such breach, Qilu may
terminate the Qilu License Agreement and retain all rights to
manufacture, develop and commercialize Vicineum in the greater
China region with no obligation to make any additional milestone or
royalty payments. Qilu has the right to receive a refund of all
amounts paid to the Company in the event the Qilu License Agreement
is terminated under certain circumstances. In addition, the royalty
rate is subject to reduction under certain circumstances, including
when there is no valid claim of a licensed patent for Vicineum in a
particular region or no data or regulatory exclusivity for Viceneum
in a particular region.
Item 2. Unregistered
Sales of Equity Securities and Use of Proceeds.
We did not issue any unregistered equity securities during the nine
months ended September 30, 2020.
Item 3. Defaults
Upon Senior Securities.
Not applicable.
Item 4. Mine Safety
Disclosures.
Not applicable.
Item 5. Other
Information.
None.
Item
6. Exhibits.
Exhibit Index
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Exhibit
No.
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Description |
3.1 |
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3.2 |
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3.3 |
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3.4 |
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4.1 |
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4.2 |
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4.3 |
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4.4 |
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4.5 |
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10.1* # |
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31.1* |
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31.2* |
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32.1** |
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32.2** |
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101 |
Interactive Data File (Form 10-Q for the Quarterly Period ended
September 30, 2020 filed in XBRL). The financial information
contained in the XBRL-related documents is "unaudited" and
"unreviewed." The instance document does not appear in the
interactive file because its XBRL tags are embedded within the
Inline XBRL document. |
104 |
Cover Page Interactive File (embedded within the Inline XBRL
document and included in Exhibit 101). |
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* |
Filed herewith. |
** |
This certification is being furnished solely to accompany this
Quarterly Report on Form 10-Q pursuant to 18 U.S.C. Section 1350
and is not being filed for purposes of Section 18 of the Securities
Exchange Act of 1934, as amended, or otherwise subject to the
liability of that section, nor shall it be deemed incorporated by
reference into any filing of the registrant under the Securities
Act of 1933, as amended, or the Securities Exchange Act of 1934, as
amended, whether made before or after the date hereof, regardless
of any general incorporation language in such filing. |
# |
Portions of this exhibit have been omitted in compliance with Item
601 of Regulation S-K. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of
1934, the registrant has duly caused this report to be signed on
its behalf by the undersigned thereunto duly
authorized.
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SESEN BIO, INC. |
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(Registrant) |
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Date: |
November 9, 2020 |
By: |
/s/ Thomas R. Cannell, D.V.M. |
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Name: |
Thomas R. Cannell, D.V.M. |
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Title: |
President and Chief Executive Officer |
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(Principal Executive Officer and Duly Authorized
Officer) |
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