QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
(State or other jurisdiction of incorporation or organization) | (I.R.S. Employer Identification No.) |
(Address of principal executive offices) | (Zip Code) |
Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||||||
☒ | Smaller reporting company | ||||||||||
Accelerated filer | ☐ | Emerging growth company | |||||||||
Non-accelerated filer | ☐ |
Page | ||||||||
PART I - FINANCIAL INFORMATION | ||||||||
Item 1. | Financial Statements. | |||||||
Condensed Consolidated Balance Sheets as of September 30, 2022 and December 31, 2021 | ||||||||
Condensed Consolidated Statements of Income (Operations) for the Three and Nine Months Ended September 30, 2022 and 2021 | ||||||||
Condensed Consolidated Statements of Comprehensive Income (Loss) for the Three and Nine Months Ended September 30, 2022 and 2021 | ||||||||
Condensed Consolidated Statements of Changes in Stockholders' Equity for the Three and Nine Months Ended September 30, 2022 and 2021 | ||||||||
Condensed Consolidated Statements of Cash Flows for the Three and Nine Months Ended September 30, 2022 and 2021 | ||||||||
Notes to Condensed Consolidated Financial Statements | ||||||||
Item 2. | Management’s Discussion and Analysis of Financial Condition and Results of Operations. | |||||||
Item 3. | Quantitative and Qualitative Disclosures About Market Risk. | |||||||
Item 4. | Controls and Procedures. | |||||||
PART II - OTHER INFORMATION | ||||||||
Item 1. | Legal Proceedings. | |||||||
Item 1A. | Risk Factors. | |||||||
Item 2. | Unregistered Sales of Equity Securities and Use of Proceeds. | |||||||
Item 3. | Defaults Upon Senior Securities. | |||||||
Item 4. | Mine Safety Disclosures. | |||||||
Item 5. | Other Information. | |||||||
Item 6. | Exhibits. | |||||||
September 30, 2022 | December 31, 2021 | ||||||||||
Assets | |||||||||||
Current assets: | |||||||||||
Cash and cash equivalents | $ | $ | |||||||||
Short term marketable securities | |||||||||||
Accounts receivables | |||||||||||
Other receivables | |||||||||||
Prepaid expenses and other current assets | |||||||||||
Total current assets | |||||||||||
Non-current assets: | |||||||||||
Restricted cash | |||||||||||
Marketable securities | |||||||||||
Property and equipment, net | |||||||||||
Intangible assets | |||||||||||
Goodwill | |||||||||||
Long term prepaid expenses | |||||||||||
Other assets | |||||||||||
Total non-current assets | |||||||||||
Total Assets | $ | $ | |||||||||
Liabilities and Stockholders’ Equity | |||||||||||
Current liabilities: | |||||||||||
Accounts payable | $ | $ | |||||||||
Accrued expenses | |||||||||||
Other current liabilities | |||||||||||
Total current liabilities | |||||||||||
Non-current liabilities: | |||||||||||
Contingent consideration | |||||||||||
Deferred tax liability | |||||||||||
Deferred revenue | |||||||||||
Total non-current liabilities | |||||||||||
Total Liabilities | |||||||||||
Stockholders’ Equity: | |||||||||||
Preferred stock, $ | |||||||||||
Common stock, $ | |||||||||||
Additional paid-in capital | |||||||||||
Other comprehensive loss | ( | ||||||||||
Accumulated deficit | ( | ( | |||||||||
Total Stockholders’ Equity | |||||||||||
Total Liabilities and Stockholders’ Equity | $ | $ |
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||
2022 | 2021 | 2022 | 2021 | ||||||||||||||||||||
Revenue: | |||||||||||||||||||||||
$ | $ | $ | $ | ||||||||||||||||||||
Total revenue | |||||||||||||||||||||||
Operating expenses: | |||||||||||||||||||||||
Research and development | |||||||||||||||||||||||
General and administrative | |||||||||||||||||||||||
Restructuring charge | |||||||||||||||||||||||
Intangibles impairment charge | |||||||||||||||||||||||
Change in fair value of contingent consideration | ( | ( | ( | ( | |||||||||||||||||||
Total operating expenses | ( | ||||||||||||||||||||||
Income (Loss) from Operations | $ | $ | $ | ( | $ | ( | |||||||||||||||||
Other income (expense), net | ( | ||||||||||||||||||||||
Income (Loss) Before Taxes | $ | $ | $ | ( | $ | ( | |||||||||||||||||
Benefit from income taxes | |||||||||||||||||||||||
Net Income (Loss) After Taxes | $ | $ | $ | ( | $ | ( | |||||||||||||||||
Net income (loss) attributable to common stockholders - basic | $ | $ | $ | ( | $ | ( | |||||||||||||||||
Net income (loss) attributable to common stockholders - diluted | $ | $ | $ | ( | $ | ( | |||||||||||||||||
Net income (loss) per common share - basic | $ | $ | $ | ( | $ | ( | |||||||||||||||||
Weighted-average common shares outstanding - basic | |||||||||||||||||||||||
Net income (loss) per common share - diluted | $ | $ | $ | ( | $ | ( | |||||||||||||||||
Weighted-average common shares outstanding - diluted |
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||
2022 | 2021 | 2022 | 2021 | ||||||||||||||||||||
Net income (loss) | $ | $ | $ | ( | $ | ( | |||||||||||||||||
Unrealized (gain) loss on marketable securities | ( | ||||||||||||||||||||||
Total comprehensive income (loss) | $ | $ | $ | ( | $ | ( |
Common Stock | Additional Paid-in Capital | Accumulated Other Comprehensive Loss Investments | Accumulated Deficit | Stockholders' Equity | |||||||||||||||||||||||||||||||
Shares | Amount | ||||||||||||||||||||||||||||||||||
Balance at December 31, 2021 | $ | $ | $ | $ | ( | $ | |||||||||||||||||||||||||||||
Net loss | — | — | — | — | ( | ( | |||||||||||||||||||||||||||||
Share-based compensation | — | — | — | — | |||||||||||||||||||||||||||||||
Balance at March 31, 2022 | $ | $ | $ | $ | ( | $ | |||||||||||||||||||||||||||||
Net loss | — | — | — | — | ( | ( | |||||||||||||||||||||||||||||
Share-based compensation | — | — | — | — | |||||||||||||||||||||||||||||||
Unrealized loss of investments | — | — | — | ( | — | ( | |||||||||||||||||||||||||||||
Balance at June 30, 2022 | $ | $ | $ | ( | $ | ( | $ | ||||||||||||||||||||||||||||
Net income | — | — | — | — | |||||||||||||||||||||||||||||||
Share-based compensation | — | — | |||||||||||||||||||||||||||||||||
Unrealized gain of investments | — | — | — | — | |||||||||||||||||||||||||||||||
Balance at September 30, 2022 | $ | $ | $ | ( | $ | ( | $ | ||||||||||||||||||||||||||||
Common Stock | Additional Paid-in Capital | Accumulated Deficit | Stockholders’ Equity | ||||||||||||||||||||||||||
Shares | Amount | ||||||||||||||||||||||||||||
Balance at December 31, 2020 | $ | $ | $ | ( | $ | ( | |||||||||||||||||||||||
Net loss | — | — | — | ( | ( | ||||||||||||||||||||||||
Share-based compensation | — | — | — | ||||||||||||||||||||||||||
Exercises of stock options | — | — | |||||||||||||||||||||||||||
Exercises of common stock warrants | — | ||||||||||||||||||||||||||||
Issuance of common stock under ATM Offering, net of issuance costs of $ | — | ||||||||||||||||||||||||||||
Balance at March 31, 2021 | $ | $ | $ | ( | $ | ||||||||||||||||||||||||
Net loss | — | — | — | ( | ( | ||||||||||||||||||||||||
Share-based compensation | — | — | — | ||||||||||||||||||||||||||
Issuance of common stock under ATM Offering, net of issuance costs of $ | — | ||||||||||||||||||||||||||||
Balance at June 30, 2021 | $ | $ | $ | ( | $ | ||||||||||||||||||||||||
Net income | — | — | — | ||||||||||||||||||||||||||
Share-based compensation | — | — | — | ||||||||||||||||||||||||||
Exercises of stock options | — | — | |||||||||||||||||||||||||||
Exercises of common stock warrants | — | ||||||||||||||||||||||||||||
Issuance of common stock under ATM Offering, net of issuance costs of $ | — | ||||||||||||||||||||||||||||
Balance at September 30, 2021 | $ | $ | $ | ( | $ |
Nine Months Ended September 30, | |||||||||||
2022 | 2021 | ||||||||||
Cash Flows from Operating Activities: | |||||||||||
Net loss | $ | ( | $ | ( | |||||||
Adjustments to reconcile net loss to net cash used in operating activities: | |||||||||||
Depreciation | |||||||||||
Share-based compensation | |||||||||||
Change in fair value of contingent consideration | ( | ( | |||||||||
Intangibles impairment charge | |||||||||||
Changes in operating assets and liabilities: | |||||||||||
Accounts receivable (net) | ( | ||||||||||
Other receivables | ( | ||||||||||
Prepaid expenses and other current assets | ( | ||||||||||
Long term prepaid expenses | |||||||||||
Unrealized loss on marketable securities | ( | ||||||||||
Other assets | |||||||||||
Accounts payable | ( | ||||||||||
Accrued expenses and other liabilities | ( | ||||||||||
Deferred revenue | ( | ( | |||||||||
Net cash provided by (used in) operating activities | ( | ||||||||||
Cash Flows from Investing Activities: | |||||||||||
Purchase of marketable securities | ( | ||||||||||
Disposal (purchase) of equipment | ( | ||||||||||
Net cash used in investing activities | ( | ( | |||||||||
Cash Flows from Financing Activities: | |||||||||||
Proceeds from issuance of common stock under ATM Offering, net of issuance costs | |||||||||||
Proceeds from exercises of stock options | |||||||||||
Proceeds from exercises of common stock warrants | |||||||||||
Net cash provided by financing activities | |||||||||||
Net (decrease) increase in cash, cash equivalents and restricted cash | ( | ||||||||||
Cash, cash equivalents and restricted cash - beginning of period | |||||||||||
Cash, cash equivalents and restricted cash - end of period | $ | $ | |||||||||
Supplemental cash flow disclosure: | |||||||||||
Cash paid for amounts included in the measurement of lease liabilities | $ | $ | |||||||||
September 30, 2022 | |||||||||||||||||||||||||||||
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: | |||||||||||||||||||||||||||||
Marketable securities: | |||||||||||||||||||||||||||||
Money market funds (cash equivalents) | $ | $ | $ | $ | $ | ||||||||||||||||||||||||
Marketable securities | $ | $ | $ | $ | $ | ||||||||||||||||||||||||
Liabilities: | |||||||||||||||||||||||||||||
Contingent consideration | $ | $ | $ | $ | $ |
December 31, 2021 | |||||||||||||||||||||||||||||
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) | $ | $ | $ | $ | $ | ||||||||||||||||||||||||
Liabilities: | |||||||||||||||||||||||||||||
Contingent consideration | $ | $ | $ | $ | $ |
Balance at December 31, 2021 | $ | ||||
Change in fair value of contingent consideration | ( | ||||
Balance at September 30, 2022 | $ |
September 30, 2022 | December 31, 2021 | ||||||||||
IPR&D intangible assets: | |||||||||||
Vicineum European Union rights | $ | $ | |||||||||
Total Intangibles | $ | $ |
Balance at December 31, 2021 | $ | ||||
Impairment loss | ( | ||||
Balance at September 30, 2022 | $ |
September 30, 2022 | December 31, 2021 | ||||||||||
Research and development | $ | $ | |||||||||
Payroll-related expenses | |||||||||||
Restructuring charge related | |||||||||||
Professional fees | |||||||||||
Legal expenses, including preliminary litigation settlement | |||||||||||
Other | |||||||||||
Total Accrued Expenses | $ | $ |
September 30, 2022 | December 31, 2021 | ||||||||||
Shares of common stock issued | |||||||||||
Shares of common stock reserved for issuance for: | |||||||||||
Warrants | |||||||||||
Stock options | |||||||||||
Restricted stock units | |||||||||||
Shares available for grant under 2014 Stock Incentive Plan | |||||||||||
Shares available for sale under 2014 Employee Stock Purchase Plan | |||||||||||
Total shares of common stock issued and reserved for issuance |
Issued | Exercise Price | Expiration | December 31, 2021 | Issued | (Exercised) | (Cancelled) | September 30, 2022 | |||||||||||||||||||||||||||||||||||||
Mar-2018 | $ | Mar-2023 | ||||||||||||||||||||||||||||||||||||||||||
Nov-2017 | $ | Nov-2022 | ||||||||||||||||||||||||||||||||||||||||||
May-2015 | $ | Nov-2024 | ||||||||||||||||||||||||||||||||||||||||||
Nov-2014 | $ | Nov-2024 | ||||||||||||||||||||||||||||||||||||||||||
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||
2022 | 2021 | 2022 | 2021 | ||||||||||||||||||||
(in thousands, except per share amounts) | |||||||||||||||||||||||
Basic Earnings (Loss) Per Share: | |||||||||||||||||||||||
Numerator: | |||||||||||||||||||||||
Net income (loss) | $ | $ | $ | ( | $ | ( | |||||||||||||||||
Less: Income attributable to participating securities - basic | ( | ( | |||||||||||||||||||||
Net income (loss) attributable to common stockholders - basic | $ | $ | $ | ( | $ | ( | |||||||||||||||||
Denominator: | |||||||||||||||||||||||
Weighted average common shares outstanding - basic | |||||||||||||||||||||||
Net income (loss) per share applicable to common stockholders - basic | $ | $ | $ | ( | $ | ( | |||||||||||||||||
Dilutive Earnings (Loss) Per Share: | |||||||||||||||||||||||
Numerator: | |||||||||||||||||||||||
Net income (loss) | $ | $ | $ | ( | $ | ( | |||||||||||||||||
Less: Income attributable to participating securities - diluted | ( | ( | |||||||||||||||||||||
Net income (loss) attributable to common stockholders - diluted | $ | $ | $ | ( | $ | ( | |||||||||||||||||
Denominator: | |||||||||||||||||||||||
Weighted average shares outstanding | |||||||||||||||||||||||
Dilutive impact from: | |||||||||||||||||||||||
Stock options and employee stock purchase plan | |||||||||||||||||||||||
Restricted stock units & performance based stock units | |||||||||||||||||||||||
Weighted average common shares outstanding - diluted | |||||||||||||||||||||||
Net income (loss) per share applicable to common stockholders - diluted | $ | $ | $ | ( | $ | ( |
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||
2022 | 2021 | 2022 | 2021 | ||||||||||||||||||||
Warrants | |||||||||||||||||||||||
Stock options | |||||||||||||||||||||||
RSUs and PSUs | |||||||||||||||||||||||
Total |
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||
2022 | 2021 | 2022 | 2021 | ||||||||||||||||||||
Research and development | $ | $ | $ | $ | |||||||||||||||||||
General and administrative | |||||||||||||||||||||||
Total Share Based Compensation | $ | $ | $ | $ |
Number of Shares under Option (in thousands) | Weighted-Average Exercise Price | Weighted-Average Remaining Contractual Life (in years) | Aggregate Intrinsic Value (in thousands) | ||||||||||||||||||||
Outstanding at December 31, 2021 | $ | $ | |||||||||||||||||||||
Granted | $ | ||||||||||||||||||||||
Exercised | |||||||||||||||||||||||
Canceled or forfeited | ( | ||||||||||||||||||||||
Outstanding at September 30, 2022 | $ | DM | |||||||||||||||||||||
Exercisable at September 30, 2022 | $ | DM |
September 30, 2022 | September 30, 2021 | ||||||||||
Fair market value | $ | $ | |||||||||
Grant exercise price | $ | $ | |||||||||
Expected term (in years) | |||||||||||
Risk-free interest rate | |||||||||||
Expected volatility | |||||||||||
Dividend yield |
Restricted Stock Units (in thousands) | Weighted Average Grant Date Fair Value | ||||||||||
Unvested at December 31, 2021 | $ | ||||||||||
Granted RSU | $ | ||||||||||
Cancelled RSU | ( | $ | |||||||||
Released RSU | ( | $ | |||||||||
Granted PSU | $ | ||||||||||
Unvested at September 30, 2022 | $ |
Nine Months Ended September 30, | |||||||||||
2022 | 2021 | ||||||||||
Country: | |||||||||||
United States | $ | ( | $ | ( | |||||||
Canada | |||||||||||
Total loss before income taxes | $ | ( | $ | ( |
Nine Months Ended September 30, | |||||||||||
2022 | 2021 | ||||||||||
Current tax benefit (provision) | |||||||||||
Federal | $ | $ | |||||||||
State | |||||||||||
Foreign | ( | ||||||||||
Total current benefit | $ | $ |
September 30, 2022 | December 31, 2021 | ||||||||||
Deferred tax liabilities | |||||||||||
IPR&D | $ | $ | ( | ||||||||
Total deferred tax liabilities | $ | $ | ( |
2022 Restructuring Plan | |||||
Severance and benefits costs | $ | ||||
Contract termination and other associated costs | |||||
Total restructurings costs | |||||
Cash payments | ( | ||||
Balance at September 30, 2022 | $ | ||||
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%) |
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%) |
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%) |
Time Point | 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%) |
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%) |
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||
2022 | 2021 | 2022 | 2021 | ||||||||||||||||||||
Programs: | |||||||||||||||||||||||
Vicineum for the treatment of NMIBC | $ | 813 | $ | 2,989 | $ | 29,705 | $ | 10,888 | |||||||||||||||
Total direct program expenses | 813 | 2,989 | 29,705 | 10,888 | |||||||||||||||||||
Personnel and other expenses: | |||||||||||||||||||||||
Employee and contractor-related expenses | 1,840 | 1,732 | 6,920 | 6,392 | |||||||||||||||||||
Platform-related lab expenses | 5 | 19 | 100 | 133 | |||||||||||||||||||
Facility expenses | 150 | 124 | 428 | 392 | |||||||||||||||||||
Other expenses | 123 | 103 | 483 | 468 | |||||||||||||||||||
Total personnel and other expenses | 2,118 | 1,978 | 7,931 | 7,385 | |||||||||||||||||||
Total Research and Development | $ | 2,931 | $ | 4,967 | $ | 37,636 | $ | 18,273 |
Three Months Ended September 30, | Increase/(Decrease) | ||||||||||||||||||||||
2022 | 2021 | Dollars | Percentage | ||||||||||||||||||||
(in thousands, except percentages) | |||||||||||||||||||||||
Revenue: | |||||||||||||||||||||||
License and related revenue | $ | 40,000 | $ | — | $ | 40,000 | — | ||||||||||||||||
Total revenue | 40,000 | — | 40,000 | — | |||||||||||||||||||
Operating expenses: | |||||||||||||||||||||||
Research and development | $ | 2,931 | $ | 4,967 | $ | (2,036) | (41) | % | |||||||||||||||
General and administrative | 8,141 | 8,699 | (558) | (6) | % | ||||||||||||||||||
Restructuring charge | 10,947 | 5,522 | 5,425 | 98 | % | ||||||||||||||||||
Intangibles impairment charge | — | 31,700 | (31,700) | (100) | % | ||||||||||||||||||
Change in fair value of contingent consideration | (1,800) | (114,000) | 112,200 | (98) | % | ||||||||||||||||||
Total operating expenses | 20,219 | (63,112) | 83,331 | (132) | % | ||||||||||||||||||
Income from Operations | 19,781 | 63,112 | (43,331) | (69) | % | ||||||||||||||||||
Other income: | |||||||||||||||||||||||
Other income, net | 676 | 1 | 675 | 67,500 | % | ||||||||||||||||||
Income Before Taxes | $ | 20,457 | $ | 63,113 | $ | (42,656) | (68) | % | |||||||||||||||
Benefit from income taxes | — | 8,561 | (8,561) | (100) | % | ||||||||||||||||||
Net Income After Taxes | $ | 20,457 | $ | 71,674 | $ | (51,217) | (71) | % |
Nine Months Ended September 30, | Increase/(Decrease) | ||||||||||||||||||||||
2022 | 2021 | Dollars | Percentage | ||||||||||||||||||||
(in thousands, except percentages) | |||||||||||||||||||||||
Revenue: | |||||||||||||||||||||||
License and related revenue | $ | 40,000 | $ | 6,544 | $ | 33,456 | 511 | % | |||||||||||||||
Total revenue | 40,000 | 6,544 | 33,456 | 511 | % | ||||||||||||||||||
Operating expenses: | |||||||||||||||||||||||
Research and development | $ | 37,636 | $ | 18,273 | $ | 19,363 | 106 | % | |||||||||||||||
General and administrative | 32,705 | 20,797 | 11,908 | 57 | % | ||||||||||||||||||
Restructuring charge | 10,947 | 5,522 | 5,425 | 98 | % | ||||||||||||||||||
Intangibles impairment charge | 27,764 | 31,700 | (3,936) | (12) | % | ||||||||||||||||||
Change in fair value of contingent consideration | (52,000) | (52,240) | 240 | — | % | ||||||||||||||||||
Total operating expenses | 57,052 | 24,052 | 33,000 | 137 | % | ||||||||||||||||||
Loss from Operations | (17,052) | (17,508) | 456 | (3) | % | ||||||||||||||||||
Other income (expense), net | 867 | (45) | 912 | (2,027) | % | ||||||||||||||||||
Loss Before Taxes | $ | (16,185) | $ | (17,553) | $ | 1,368 | (8) | % | |||||||||||||||
Benefit from income taxes | 3,875 | 8,273 | (4,398) | (53) | % | ||||||||||||||||||
Net Loss After Taxes | $ | (12,310) | $ | (9,280) | $ | (3,030) | 33 | % |
Nine Months Ended September 30, | |||||||||||
2022 | 2021 | ||||||||||
Net Cash Provided by (Used in) Operating Activities | $ | 22,214 | $ | (56,278) | |||||||
Net Cash Used in Investing Activities | (113,733) | (4) | |||||||||
Net Cash Provided by Financing Activities | — | 176,129 | |||||||||
Net (Decrease) Increase in Cash, Cash Equivalents and Restricted Cash | $ | (91,519) | $ | 119,847 |
Exhibit No. | Description | ||||
2.1+ | |||||
3.1 | |||||
3.2 | |||||
3.3 | |||||
3.4 | |||||
4.1 | |||||
4.2 | |||||
4.3 | |||||
4.4 | |||||
4.5 | |||||
4.6 |
10.1† | |||||
10.2 | |||||
10.3 | |||||
10.4 | |||||
10.5 | |||||
31.1* | |||||
31.2* | |||||
32.1** | |||||
32.2** | |||||
101* | Interactive Data File (Form 10-Q for the Quarterly Period ended September 30, 2022 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 Data File (formatted as Inline XBRL and contained in Exhibit 101). |
* | 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. | ||||
† | In accordance with Item 601(b)(10)(iv) of Regulation S-K, certain provisions of the Asset Purchase Agreement have been redacted. We will provide an unredacted copy of the exhibit on a supplemental basis to the SEC or its staff upon request. | ||||
+ | Exhibits and/or schedules have been omitted pursuant to Item 601(a)(5) of Regulation S-K. The Company hereby undertakes to furnish supplementally copies of any of the omitted exhibits and schedules upon request by the SEC; provided, however, that we may request confidential treatment pursuant to Rule 24b-2 under the Exchange Act, for any exhibits or schedules so furnished. |
SESEN BIO, INC. | |||||||||||
(Registrant) | |||||||||||
Date: | November 7, 2022 | By: | /s/ Thomas R. Cannell, D.V.M. | ||||||||
Name: | Thomas R. Cannell, D.V.M. | ||||||||||
Title: | President and Chief Executive Officer | ||||||||||
(Principal Executive Officer and Duly Authorized Officer) |
Date: | November 7, 2022 | By: | /s/ Monica Forbes | ||||||||
Name: | Monica Forbes | ||||||||||
Title: | Chief Financial Officer | ||||||||||
(Principal Financial Officer) |
Date: | November 7, 2022 | By: | /s/ Thomas R. Cannell, D.V.M. | ||||||||
Name: | Thomas R. Cannell, D.V.M. | ||||||||||
Title: | President and Chief Executive Officer | ||||||||||
(Principal Executive Officer) |
Date: | November 7, 2022 | By: | /s/ Monica Forbes | ||||||||
Name: | Monica Forbes | ||||||||||
Title: | Chief Financial Officer | ||||||||||
(Principal Financial Officer) |
Date: | November 7, 2022 | By: | /s/ Thomas R. Cannell, D.V.M. | ||||||||
Name: | Thomas R. Cannell, D.V.M. | ||||||||||
Title: | President and Chief Executive Officer | ||||||||||
(Principal Executive Officer) |
Date: | November 7, 2022 | By: | /s/ Monica Forbes | ||||||||
Name: | Monica Forbes | ||||||||||
Title: | Chief Financial Officer | ||||||||||
(Principal Financial Officer) |
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares |
Sep. 30, 2022 |
Dec. 31, 2021 |
Sep. 30, 2021 |
May 03, 2021 |
May 02, 2021 |
---|---|---|---|---|---|
Statement of Financial Position [Abstract] | |||||
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 | |||
Preferred stock, shares authorized (in shares) | 5,000,000 | 5,000,000 | |||
Preferred stock, shares issued (in shares) | 0 | 0 | 0 | ||
Preferred stock, shares outstanding (in shares) | 0 | 0 | 0 | ||
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 | |||
Common stock, shares authorized (in shares) | 400,000,000 | 400,000,000 | 400,000,000 | 200,000,000 | |
Common stock, shares issued (in shares) | 202,757,012 | 199,463,645 | |||
Common stock, shares outstanding (in shares) | 202,757,012 | 199,463,645 |
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS) - USD ($) $ in Thousands |
3 Months Ended | 9 Months Ended | ||
---|---|---|---|---|
Sep. 30, 2022 |
Sep. 30, 2021 |
Sep. 30, 2022 |
Sep. 30, 2021 |
|
Statement of Comprehensive Income [Abstract] | ||||
Net Income (Loss) Attributable to Parent | $ 20,457 | $ 71,674 | $ (12,310) | $ (9,280) |
Unrealized (gain) loss on marketable securities | (46) | 0 | 235 | 0 |
Total comprehensive income (loss) | $ 20,503 | $ 71,674 | $ (12,545) | $ (9,280) |
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY (Parenthetical) - USD ($) $ in Millions |
3 Months Ended | ||
---|---|---|---|
Sep. 30, 2021 |
Jun. 30, 2021 |
Mar. 31, 2021 |
|
Statement of Stockholders' Equity [Abstract] | |||
Issuance costs | $ 1.2 | $ 2.0 | $ 2.2 |
DESCRIPTION OF BUSINESS |
9 Months Ended |
---|---|
Sep. 30, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
DESCRIPTION OF BUSINESS | DESCRIPTION OF BUSINESS Sesen Bio, Inc. ("Sesen Bio" or the “Company”), a Delaware corporation formed in February 2008, is a late-stage clinical company focused on advancing targeted fusion protein therapeutics 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 for the treatment of non-muscle invasive bladder cancer (“NMIBC”). On July 15, 2022, the Company made the strategic decision to voluntarily pause further development of Vicineum in the United States. The decision was based on a thorough reassessment of Vicineum following recent discussions with the United States Food and Drug Administration ("FDA"), which had implications on the size, timeline and costs of an additional Phase 3 clinical trial, which the FDA previously confirmed would be required for a potential resubmission of a biologics license application ("BLA") for Vicineum for the treatment of NMIBC. The Company continues to believe that Vicineum has benefits for patients and healthcare providers that can be maximized through a company with a larger infrastructure, and as such, intends to seek a partner that can execute further development to realize the full potential of Vicineum. As a result of this decision, the Company has turned its primary focus to the careful assessment of potential strategic alternatives with the goal of maximizing shareholder value. Anticipated Merger with CARISMA Therapeutics Inc. Following an extensive process of evaluating strategic alternatives, including identifying and reviewing potential candidates for a strategic transaction, on September 20, 2022, Sesen Bio, Seahawk Merger Sub, Inc., a Delaware corporation and wholly-owned subsidiary of Sesen Bio (“Merger Sub”), and CARISMA Therapeutics Inc., a Delaware corporation (“Carisma”), entered into an Agreement and Plan of Merger and Reorganization (the “Merger Agreement”), pursuant to which, among other things, and subject to the satisfaction or waiver of certain conditions set forth in the Merger Agreement, Merger Sub will merge with and into Carisma, with Carisma continuing as a wholly-owned subsidiary of Sesen Bio and the surviving corporation of the merger (the “Merger”). Sesen Bio's board of directors unanimously approved the Merger Agreement and resolved to recommend that Sesen Bio’s stockholders approve the proposals described in the Merger Agreement. If the Merger is completed, the business of Carisma will continue as the business of the combined company. Sesen Bio’s future operations are highly dependent on the success of the Merger and there can be no assurances that the Merger will be successfully consummated. In the event that Sesen Bio does not complete the Merger with Carisma, Sesen Bio may continue to review and evaluate a strategic alternatives, including, without limitation, another strategic transaction and/or pursue a liquidation and dissolution of Sesen Bio. 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 (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. 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. 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 became employees or members of the Company's board of directors. However, as of September 30, 2022, none of these individuals are active employees of the Company or members of the Company's board of directors.
|
BASIS OF PRESENTATION |
9 Months Ended |
---|---|
Sep. 30, 2022 | |
Accounting Policies [Abstract] | |
BASIS OF PRESENTATION | 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 Accounting Standards Codification (“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, which are, in the opinion of management, necessary for a fair presentation of the accompanying condensed consolidated balance sheets and statements of operations and comprehensive (loss) income, 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, 2022 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 February 28, 2022, 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); and research and development expenses. Principles of Consolidation The Company’s condensed consolidated financial statements include the accounts of the Company, its wholly owned subsidiaries Viventia and Seahawk Merger Sub, Inc. and its indirect subsidiary, Viventia Bio USA Inc. 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 US dollar.
|
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES |
9 Months Ended |
---|---|
Sep. 30, 2022 | |
Accounting Policies [Abstract] | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | SUMMARY OF SIGNIFICANT ACCOUNTING POLICIESThe 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, 2021. |
RECENT ACCOUNTING PRONOUNCEMENTS |
9 Months Ended |
---|---|
Sep. 30, 2022 | |
Accounting Standards Update and Change in Accounting Principle [Abstract] | |
RECENT ACCOUNTING PRONOUNCEMENTS | RECENT ACCOUNTING PRONOUNCEMENTS Adopted in 2022 In August 2020, the FASB issued ASU No. 2020-06, Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity ("ASU 2020-06"). ASU 2020-06 simplifies the complexity associated with applying US GAAP for certain financial instruments with characteristics of both liability and equity. More specifically, the amendments focus on the guidance for convertible instruments and derivative scope exception for contracts in an entity’s own equity. The ASU also amends the diluted earnings per share ("EPS") guidance, including the requirement to use the if-converted method for all convertible instruments. ASU 2020-06 is effective for public companies for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2021, and should be applied on a full or modified retrospective basis. The Company adopted this guidance on a modified retrospective basis effective January 1, 2022 and it did not have an impact on the Company's financial position, results of operations including per-share amounts, or cash flows. In May 2021, the FASB issued ASU No. 2021-04, Earnings Per Share (Topic 260), Debt—Modifications and Extinguishments (Subtopic 470-50), Compensation—Stock Compensation (Topic 718), and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Issuer’s Accounting for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options ("ASU 2021-04"). ASU 2021-04 clarifies and reduces diversity in an issuer’s accounting for modifications or exchanges of freestanding equity-classified written call options (for example, warrants) that remain equity classified after modification or exchange. ASU 2021-04 is effective for public companies for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2021, and should be applied on a prospective basis. The Company adopted this guidance effective January 1, 2022 and it did not have an impact on the Company's financial position, results of operations including per-share amounts, or cash flows. Other recent accounting pronouncements issued, but not yet effective, are not expected to be applicable to the Company or have a material effect on the consolidated financial statements upon future adoption.
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FAIR VALUE MEASUREMENT AND FINANCIAL INSTRUMENTS |
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Fair Value Disclosures [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
FAIR VALUE MEASUREMENT AND FINANCIAL INSTRUMENTS | 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, 2022 and December 31, 2021 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, 2022 and December 31, 2021 (in thousands):
The Company evaluates transfers between fair value levels at the end of each reporting period. There were no asset or liability transfers between fair value levels during the nine months ended September 30, 2022 and the year ended December 31, 2021. 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. On July 15, 2022, the Company made the strategic decision to voluntarily pause further development of Vicineum in the United States. The decision was based on a thorough reassessment of Vicineum following recent discussions with the FDA, which had implications on the size, timeline and costs of an additional Phase 3 clinical trial for the treatment of NMIBC. The Company continues to believe that Vicineum has benefits for patients and healthcare providers that can be maximized through a company with a larger infrastructure, and as such intends to seek a partner for the further development of Vicineum. Additionally, during the second quarter of 2022, the Company observed an evolution of the current market treatment paradigm in NMIBC, with substantial uptake of intravesical chemotherapy (monotherapy and combination therapy) during the bacillus Calmette-Guérin (“BCG”) shortage. Accordingly, during the second quarter of 2022, the Company concluded that it no longer expected to pay related milestone and earnout payments to the former shareholders of Viventia, with the exception of the potential 2% earnout payment related to the Greater China region since those territory rights had been out-licensed pursuant to the exclusive license agreement with Qilu Pharmaceutical Co., Ltd. ("Qilu") (the "Qilu License Agreement") (as further described in Note 17. “License Agreements” below). As of June 30, 2022, Qilu held the exclusive license to develop Vicineum in the Greater China region, and accordingly, the $1.8 million estimated earnout payment in the Greater China region remained as long-term contingent consideration as of June 30, 2022. The Company and Qilu are in the process of negotiating a termination of the Qilu License Agreement. Upon the termination of the Qilu License Agreement, the Company will regain the rights to develop, manufacture and commercialize Vicineum in Greater China. However, the Company does not plan to develop or commercialize Vicineum in that region or any other, as it is pursuing the Merger with Carisma. The Company is also seeking to sell or out-license Vicineum and all the related obligations related to Vicineum. The Company expects that any partner who acquires or licenses Vicineum from the Company will be obligated to make any payments, including those related to sales in the Greater China region (if any), that become payable to the former shareholders of Viventia under the Share Purchase Agreement. If a sale or license of Vicineum has not occurred at the time the Merger is completed, Carisma has indicated it may continue to seek a sale or license of Vicineum and has no plans to develop Vicineum. Accordingly, as of September 30, 2022, the Company concluded that it no longer expects to owe any future earnout payments related to the Greater China region and reduced its remaining $1.8 million of contingent consideration liabilities to zero as of September 30, 2022. The contingent consideration balance as of December 31, 2021 was $52.0 million which was based upon projected world-wide net sales. The estimated 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 through 2033, the level of commercial sales of Vicineum forecasted for the US, Europe, Japan, China and other potential markets and discount rates ranging from 8.0% to 9.3% as of December 31, 2021. 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 (in thousands).
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RECEIVABLES |
9 Months Ended |
---|---|
Sep. 30, 2022 | |
Receivables [Abstract] | |
RECEIVABLES | RECEIVABLES The accounts receivable balance as of December 31, 2021 was $21.0 million, comprised primarily of a $20 million milestone achieved in December 2021 due to F. Hoffmann-La Roche Ltd and Hoffmann-La Roche Inc. (collectively, “Roche”) initiating a Phase II clinical trial in the fourth quarter of 2021. In January 2022 the payment of $20 million was received. Additionally, in June 2021, the Qilu License Agreement was recognized by Shandong Province, Bureau of Science and Technology as a "Technology Transfer". As such, the Company recorded $0.9 million of revenue and accounts receivable for the additional purchase price resulting from Qilu's obligation to pay the Company an amount equal to its recovery of value-added tax ("VAT"). The accounts receivable balance as of September 30, 2022 was zero. The other receivables balance as of September 30, 2022 was $14.3 million compared to $3.5 million as of December 31, 2021. The increase of $10.8 million was primarily driven by expected insurance recovery of $13.4 million related to the preliminary settlements of the Securities Litigation and Derivative Litigation (as defined in Note 10. “Commitments and Contingencies” below). This amount was partially offset by the receipt of $2.4 million for German VAT recovery in the first half of 2022, related to drug substance sent to Baxter in 2020 and 2019 and other individually immaterial changes of $0.2 million.
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PREPAID EXPENSES |
9 Months Ended |
---|---|
Sep. 30, 2022 | |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | |
PREPAID EXPENSES | PREPAID EXPENSES The prepaid expenses balance as of September 30, 2022 was $0.5 million compared to $25.7 million as of December 31, 2021. In light of the Company's decision to voluntarily pause further development of Vicineum in the United States, the Company evaluated prepaid balances and determined that the prepayments for the manufacturing of Vicineum, including consumables, had no future economic benefit or value. Pursuant to ASC Topic 730, Certain Nonrefundable Advance Payment, the Company expensed $25.2 million of prepayments during the second quarter of 2022. |
INTANGIBLE ASSETS AND GOODWIL |
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Sep. 30, 2022 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Goodwill and Intangible Assets Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
INTANGIBLE ASSETS AND GOODWIL | INTANGIBLE ASSETS AND GOODWILL Intangibles Intangible assets on the Company's condensed consolidated balance sheets are the result of the Viventia Acquisition in September 2016. The following table sets forth the composition of intangible assets as of September 30, 2022 and December 31, 2021 (in thousands):
The fair value of the acquired intangible assets for the European Union ("EU") rights of Vicineum is determined using a risk-adjusted discounted cash flow approach, which includes probability adjustments for projected revenues and operating expenses based on the success rates assigned to each stage of development for each geographical region; as well as discount rates applied to the projected cash flows. During the second quarter of 2022, the Company observed an evolution of the current market treatment paradigm in NMIBC, with substantial uptake of intravesical chemotherapy (monotherapy and combination therapy) during the ongoing BCG shortage. On July 15, 2022, the Company made the strategic decision to voluntarily pause further development of Vicineum in the United States. The decision was based on a thorough reassessment of Vicineum following recent discussions with the FDA, which had implications on the size, timeline and costs of an additional Phase 3 clinical trial for the treatment of NMIBC. Management updated the discounted cash flow model using the market participant approach and considered preliminary terms of a potential partnering deal to conclude the fair value of the Company’s intangible asset of Vicineum EU rights. The Company concluded that the carrying value of the Company’s intangible asset of Vicineum EU rights of $14.7 million was fully impaired and was reduced to zero in the second quarter of 2022. Goodwill Goodwill on the Company's condensed consolidated balance sheets is the result of the Viventia Acquisition in September 2016. During the second quarter of 2022, the Company observed continued trends in the Company’s market capitalization as compared to the carrying value of its single reporting unit as well as changes in certain assumptions in the fair value of the business including market share, size, length and cost of a clinical trial, and time to potential market launch. The Company identified these changes as potential impairment indicators and performed a quantitative impairment analysis, in advance of the Company's typical annual assessment date of October 1 and concluded that the carrying value of its goodwill of $13.1 million was fully impaired and was reduced to zero in the second quarter of 2022. The following table sets forth a summary of the change in goodwill as of September 30, 2022 and December 31, 2021 (in thousands).
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ACCRUED EXPENSES |
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Payables and Accruals [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
ACCRUED EXPENSES | ACCRUED EXPENSES The following table sets forth the composition of accrued expenses as of September 30, 2022 and December 31, 2021 (in thousands):
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COMMITMENTS AND CONTINGENCIES |
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Sep. 30, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
COMMITMENTS AND CONTINGENCIES | COMMITMENTS AND CONTINGENCIES Legal Proceedings From time to time, the Company may become subject to legal proceedings, claims, and litigation arising in the ordinary course of business. When the Company becomes aware of a claim or potential claim, it assesses the likelihood of any loss or exposure. In accordance with authoritative guidance, the Company records loss contingencies in its financial statements only for matters in which losses are probable and can be reasonably estimated. Where a range of loss can be reasonably estimated with no best estimate in the range, the Company records the minimum estimated liability. If the loss is not probable or the amount of the loss cannot be reasonably estimated, the Company discloses the nature of the specific claim if the likelihood of a potential loss is reasonably possible, and the amount involved is material. The Company continuously assesses the potential liability related to the Company’s pending litigation and revises its estimates when additional information becomes available. The Company is not currently a party to any material legal proceedings, other than as described below. On August 19, 2021, August 31, 2021, and October 7, 2021, three substantially identical securities class action lawsuits captioned Bibb v. Sesen Bio, Inc., et. al., Case No. 1:21-cv-07025, Cizek v. Sesen Bio, Inc., et. al., Case No. 1:21-cv-07309, and Markman v. Sesen Bio, Inc. et al., Case No. 1:21-cv-08308 were filed against the Company and certain of its officers in the US District Court for the Southern District of New York. The three complaints alleged violations of Sections 10(b) and 20(a) of the Exchange Act and Rule 10b-5 promulgated thereunder based on statements made by the Company concerning its BLA for Vicineum for the treatment of BCG-unresponsive NMIBC. The three complaints sought compensatory damages and costs and expenses, including attorneys’ fees. On October 29, 2021, the court consolidated the three cases under the caption In re Sesen Bio, Inc. Securities Litigation, Master File No. 1:21-cv-07025-AKH (the “Securities Litigation”), and appointed Ryan Bibb, Rodney Samaan, Lionel Dreshaj and Benjamin Dreshaj (collectively, the “Lead Plaintiffs”) collectively as the lead plaintiffs under the Private Securities Litigation Reform Act. On November 1, 2021, two stockholders filed motions to reconsider asking the court to appoint a different lead plaintiff. On November 24, 2021, defendants filed a motion to transfer venue to the US District Court for the District of Massachusetts. That motion was fully briefed as of December 13, 2021, but the court has not ruled on that motion. On December 6, 2021, the Lead Plaintiffs filed an amended class action complaint (the “Amended Complaint”). The Amended Complaint alleges the same violations of Sections 10(b) and 20(a) of the Exchange Act and Rule 10b-5 promulgated thereunder on the same theory as the prior complaints. The defendants moved to dismiss the Amended Complaint on March 7, 2022, and that motion was fully briefed on May 6, 2022. On June 3, 2022, before the court ruled on the motion to dismiss, the parties requested that the court hold any decision on the motion to dismiss in abeyance to provide the parties with an opportunity to engage in mediation. On June 30, 2022 and July 6, 2022, the Company and the plaintiffs engaged in mediation sessions in an attempt to resolve the Securities Litigation and continued to discuss a potential settlement over the following weeks. On July 19, 2022, the parties reached an agreement in principle to settle the Securities Litigation. Pursuant to that agreement, the Company and the individual defendants will pay or cause to be paid to members of the class who submit timely and valid proofs of claims. In exchange, the Lead Plaintiffs will dismiss the action and all class members who do not timely and validly opt-out of the settlement will provide broad customary releases to the Company and the individual defendants. On August 3, 2022, the parties entered into a Stipulation and Agreement of Settlement to settle the Securities Litigation, which was filed with the court on August 17, 2022. The Stipulation and Agreement of Settlement related to the Securities Litigation provides for a settlement payment of $21.0 million to the class and the dismissal of all claims against the Company and the other defendants. The settlement payment is being funded by the Company and its insurance carriers. On September 1, 2022, the US District Court for the Southern District of New York issued an order denying the motions to appoint a different lead plaintiff. On September 28, 2022, the court issued an order granting preliminary approval of the proposed settlement of the Securities Litigation. The court has set a final settlement approval hearing for January 23, 2023 at 10:00 a.m. local time. On September 20, 2021 and September 24, 2021, two substantially similar derivative lawsuits captioned Myers v. Sesen Bio, Inc., et. al., Case No. 1:21-cv-11538 and D’Arcy v. Sesen Bio, Inc., et. al., Case No. 1:21-cv-11577 were filed against the Company’s board of directors and certain of its officers in the US District Court for the District of Massachusetts, with the Company named as nominal defendant. On January 12, 2022, a third derivative complaint captioned Tang v. Sesen Bio, Inc., et al., was filed in Superior Court in Massachusetts against the Company’s board of directors and certain of its officers (the “State Derivative Litigation”). The three derivative complaints allege breach of fiduciary duties, waste of corporate assets, and violations of federal securities laws based on statements made by the Company concerning its BLA for Vicineum for the treatment of BCG-unresponsive NMIBC. The D’Arcy complaint further alleges unjust enrichment, abuse of control, gross mismanagement and aiding and abetting thereof. The three derivative complaints seek unspecified damages, restitution and disgorgement of profits, benefits and compensation obtained by the defendants and costs and expenses, including attorneys’ fees. On October 18, 2021, the court consolidated the two federal court cases under the caption In re Sesen Bio, Inc. Derivative Litigation, Lead Case No. 1:21-cv-11538 (the “Federal Derivative Litigation”). On December 22, 2021, the court entered a joint stipulation among the parties to stay the Federal Derivative Litigation until after a ruling on any motion to dismiss filed by defendants in the Securities Litigation. On May 1, 2022, the plaintiffs filed a verified consolidated shareholder derivative complaint in the Federal Derivative Litigation. On May 18, 2022, the court entered a joint stipulation among the parties to stay the State Derivative Litigation until after a ruling on any motion to dismiss filed by defendants in the Securities Litigation. On July 6, 2022, the Company and the plaintiffs to the Federal Derivative Litigation and the State Derivative Litigation engaged in mediation in an attempt to resolve the litigation, with settlement discussions continuing over the following days. On July 19, 2002, the parties reached an agreement in principle to settle the Federal Derivative Litigation, the State Derivative Litigation and other potential related derivative claims (collectively, the “Derivative Litigation”). Pursuant to that agreement, the individual defendants will cause the Company to adopt certain enhancements to its corporate governance policies and procedures. In exchange, plaintiffs will dismiss the Derivative Litigation and, on behalf of the Company, provide broad customary releases to the individual defendants. On August 22, 2002, the parties entered into a Stipulation of Settlement to settle the Derivative Litigation, which was filed with the court on August 30, 2022. The Stipulation of Settlement related to the Derivative Litigation confirms that the Company previously adopted certain corporate governance enhancements in response to, among other things, the filing of the Derivative Litigation, and that, subject to final court approval, the Company will adopt additional corporate governance enhancements. The Stipulation of Settlement also provides for a $0.6 million payment for plaintiffs’ attorneys fees due to the benefits the corporate governance enhancements are intended to provide to the Company. The payment of plaintiffs’ attorneys fees is being funded by the Company. On September 2, 2022, the court issued an order granting preliminary approval of the Stipulation of Settlement related to the Derivative Litigation. The court has set a final settlement approval hearing for November 8, 2022 at 2:00 p.m. local time. During the second quarter of 2022, the Company deemed the settlements of the Securities Litigation and the Derivative Litigation probable and amounts reasonably estimable and recorded $21.6 million to litigation related liability. During the third quarter of 2022, the Company paid $0.6 million to be held in escrow for the plaintiffs' attorneys fees and $21.0 million remains as a litigation related liability as of September 30, 2022. The Company, its board of directors and the individual defendants continue to deny all allegations of any wrongdoing but are seeking to settle the Securities Litigation and the Derivative Litigation to avoid the uncertainty, risk, expense and distraction of protracted litigation. Subsequent to September 30, 2022, on October 21, 2022, the Company received two separate letters and on November 4, 2022, the Company received one letter from purported stockholders demanding that the Company amend the Registration Statement filed with the SEC on October 14, 2022 (the “Registration Statement”) to provide additional disclosures that such stockholders allege were improperly omitted from the Registration Statement, including information regarding the financial projections for Carisma, the financial analyses performed by the Company’s financial advisor in support of its fairness opinion, and the background and process leading to the execution of the Merger Agreement. The Company believes that these demands are without merit and intends to vigorously defend against them. See discussion in Note 19. “Subsequent Events.” Executive Employment Agreements The Company has entered into employment agreements or offer letters with certain of its key executives, providing for separation payments and benefits in certain circumstances, as defined in the agreements. Termination Fees associated with the Anticipated Merger with Carisma The Merger Agreement contains certain termination rights of each of the Company and Carisma. Upon termination of the Merger Agreement under specified circumstances, the Company may be required to pay Carisma a termination fee of $7.6 million and/or reimburse Carisma’s expenses up to a maximum of $1.75 million, and Carisma may be required to pay the Company a termination fee of $5.49 million and/or reimburse the Company expenses up to a maximum of $1.75 million. At this time, no assessment can be made as to the likely outcome or whether the outcome will be material to the Company
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LEASES |
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Sep. 30, 2022 | |
Leases [Abstract] | |
LEASES | LEASES During the third quarter of 2022, the Company entered into a Lease Termination Agreement (the “Lease Termination Agreement”) pursuant to which the Company terminated its operating lease agreement for its 31,000 square foot facility in Winnipeg, Manitoba which consists of manufacturing, laboratory, warehouse, and office space and agreed to end the lease by September 30, 2022. As part of the execution of the Lease Termination Agreement, the Company paid the landlord the all-inclusive sum of CAD $1.2 million (USD $0.9 million). Operating lease costs under this lease, including the related operating costs, were $81,000 and $245,000 for the three and nine months ended September 30, 2022, respectively, and $79,000 and $245,000 for the three and nine months ended September 30, 2021, respectively. The right of use asset total was zero as of September 30, 2022 and $123,300 as of December 31, 2021. As of December 31, 2021, the asset component of the Company’s operating leases was recorded as operating lease right-of-use assets and reported within on the Company's condensed consolidated balance sheets. The short-term lease liability was zero as of September 30, 2022 and $123,300 as of December 31, 2021. As of December 31, 2021, the short-term lease liability was recorded in on the Company’s condensed consolidated balance sheets. There was no long-term operating lease liability as of September 30, 2022 or December 31, 2021. Operating lease cost is recognized on a straight-line basis over the term of the lease. In addition, the Company has short-term property leases for modular office space for 1) its corporate headquarters in Cambridge, MA and 2) office space in Philadelphia, PA. The Company intends to terminate both leases in connection with the closing of the anticipated Merger with Carisma. The short-term lease in Philadelphia is renewed on a month-to-month basis. The short-term lease in Cambridge ends in June 2023. The minimum monthly rent for these office spaces is $2,500 and $17,200, respectively, which is subject to change if and as the Company adds space to or deducts space from the leases.
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STOCKHOLDERS' EQUITY |
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STOCKHOLDERS' EQUITY | STOCKHOLDERS' EQUITY Equity Financings ATM Offering The Company has entered into an Open Market Sale Agreement SM with Jefferies LLC ("Jefferies"), dated November 29, 2019, as amended by Amendment No. 1 dated October 30, 2020, Amendment No. 2 dated February 17, 2021 and Amendment No. 3, dated June 1, 2021 (as amended, the "Sale Agreement"), under which the Company may issue and sell shares of its common stock, par value $0.001 per share, from time to time through Jefferies (the “ATM Offering”). In June and July 2021, the Company filed prospectus supplements with the SEC in connection with the offer and sale of up to an aggregate of $200 million of common stock pursuant to the Sale Agreement of which $97.8 million of common stock remain available for future issuance as of September 30, 2022. 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 Stock Market or any other existing trading market for the Company's common stock. The Company may sell shares of its common stock efficiently from time to time but 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 did not sell any shares of common stock pursuant to the Sale Agreement during the nine months ended September 30, 2022. The Company raised $175.0 million of net proceeds from the sale of 56.9 million shares of common stock at a weighted-average price of $3.17 per share during the nine months ended September 30, 2021. The Company raised $38.2 million of net proceeds from the sale of 9.8 million shares of common stock at a weighted-average price of $4.01 per share during the three months ended September 30, 2021. Share issuance costs, including sales agent commissions, related to the ATM Offering totaled $1.2 million and $5.4 million during the three and nine months ended September 30, 2021, respectively. 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 Company's common stock. The Company had no preferred stock issued and outstanding as of September 30, 2022 and 2021. Common Stock Following approval by the Company’s stockholders on May 3, 2021, an amendment became effective to the Certificate of Incorporation that increased the number of authorized shares of common stock from 200 million to 400 million, of which approximately 203 million and 199 million shares were issued and outstanding as of September 30, 2022 and December 31, 2021, 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, 2022 and December 31, 2021 (in thousands):
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, other than the CVR (as further described in Note 17. “License Agreements” below) and any special cash dividend that the Company may pay to its stockholders in connection with the consummation of the Merger. 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 equity-classified because they meet the derivative scope exception under ASC Topic 815-40, Derivatives and Hedging - Contracts in Entity’s Own Equity. The following table sets forth the Company's warrant activity for the three months ended September 30, 2022 (in thousands):
*Exercise price shown (i) reflects modification and (ii) is subject to further adjustment based on down round provision added by amendment described in “Item 15. Exhibits and Financial Statement Schedules - Note 12. Stockholders’ Equity (Deficit)” in the audited annual consolidated financial statements included in the Company's Annual Report on Form 10-K for the year ended December 31, 2021.
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Earnings Per Share [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
EARNINGS (LOSS) PER SHARE | EARNINGS (LOSS) PER SHAREA 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 unvested 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. Additionally, an entity that presents earnings per share shall recognize the value of the effect of an anti-dilution provision in an equity-classified freestanding financial instrument in the period the anti-dilution provision is triggered. That effect shall be treated as a deemed dividend and as a reduction of income available to common stockholders in basic earnings per share. The deemed dividend is added back to income available to common stockholders when applying the treasury stock method for diluted earnings per share. For periods with net income, diluted net earnings per share is calculated by either (i) adjusting the weighted-average shares outstanding for the dilutive effect of common stock equivalents outstanding for the period as determined using the treasury stock method or (ii) the two-class method considering common stock equivalents, whichever is more dilutive. The two-class method is an earnings allocation formula that treats a participating security as having rights to earnings that otherwise would have been available to common stockholders. Accordingly, the Company applied the two-class method to calculate basic and diluted net earnings per share of common stock for the three months ended September 30, 2022 and September 30, 2021. For purposes of the diluted net loss per share calculation, common stock equivalents are excluded from the calculation if their effect would be anti-dilutive. The following table illustrates the determination of earnings (loss) per share for each period presented:
The following potentially dilutive securities outstanding as of September 30, 2022 and 2021 have been excluded from the denominator of the diluted loss per share of common stock outstanding calculation (in thousands):
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SHARE-BASED COMPENSATION |
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Share-Based Payment Arrangement [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
SHARE-BASED COMPENSATION | SHARE-BASED COMPENSATION The following table sets forth the amount of share-based compensation expense recognized by the Company by line item on its Condensed Consolidated Statements of Operations for the three and nine months ended September 30, 2022 and 2021 (in thousands):
2014 Stock Incentive Plan The Company's 2014 Stock Incentive Plan, as amended (the "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, restricted stock units ("RSU"), 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. At the Annual Meeting of the Company's stockholders in June 2019, the Company's stockholders approved an amendment to the 2014 Plan that (i) increased by 7.9 million the number of shares of common stock reserved for issuance under the 2014 Plan and (ii) eliminated the “evergreen” or automatic replenishment provision of the 2014 Plan, pursuant to which the number of shares of common stock authorized for issuance under the 2014 Plan was automatically increased on an annual basis. At the Annual Meeting of the Company’s stockholders in May 2021, the Company’s stockholders approved an amendment to the 2014 Plan that increased by 12 million the number of shares of common stock reserved for issuance under the 2014 Plan. There were approximately 3.7 million shares of common stock available for issuance under the 2014 Plan as of September 30, 2022. Stock options outstanding under the 2014 Plan 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 approximately 13.0 million stock options outstanding under the 2014 Plan as of September 30, 2022. On September 9, 2021, the Company’s board of directors and the compensation committee of the board of directors (the “Compensation Committee”) approved a retention program for all then-current employees, except for the Chief Executive Officer, pursuant to which the Company will provide certain incentives designed to retain such employees (the “2021 Retention Program”). Pursuant to the 2021 Retention Program and effective as of October 1, 2021, the Company’s non-executive employees received a combination of a cash bonus award and a one-time RSU award which vested in full on September 30, 2022, subject to continued employment through September 30, 2022. Each RSU represents a contingent right to receive one share of the Company’s common stock. Also pursuant to the 2021 Retention Program and effective as of October 1, 2021, the Company’s executive officers, except for the Chief Executive Officer, were granted a one-time performance-based restricted stock unit (“PSU”) award equal to the value of approximately fifty percent of then-current base salary. The fair value of PSUs at the grant date was $0.4 million. Each PSU represents a contingent right to receive one share of the Company’s common stock upon the satisfaction of pre-determined performance criteria. Subject to continued employment, such awards vest on September 30, 2023 upon the determination by the Compensation Committee of the level of achievement of certain key milestones consisting of a clinical trial milestone, an employee retention milestone and cash management milestones. As of September 30, 2022, achievement was deemed probable for only the cash management milestone, representing $87,000, 20% of the PSU awards. Therefore, $11,000 and $44,000 have been expensed during the three and nine months ended September 30, 2022, respectively and $43,000 remains measured but unrecognized. 2009 Stock Incentive Plan The Company maintains a 2009 Stock Incentive Plan, as amended and restated (the "2009 Plan"), which provided for the grant of incentive and non-qualified stock options and restricted stock awards and restricted stock 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 approximately 0.1 million fully vested stock options outstanding under the 2009 Plan as of September 30, 2022. Out-of-Plan Inducement Grants From time to time, the Company has granted equity awards to its newly hired employees, including executives, in accordance with 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 employee's acceptance of employment with the Company. There were approximately 3.1 million stock options outstanding which were granted as employment inducement awards outside of the 2014 Plan as of September 30, 2022. 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 the 2009 Plan and inducement grants made outside of stockholder approved plans, for the nine months ended September 30, 2022:
The Company recognized share-based compensation expense, related to stock options, of $1.0 million and $3.5 million for the three and nine months ended September 30, 2022, respectively and $1.2 million and $3.4 million for the three and nine months ended September 30, 2021, respectively. As of September 30, 2022, there was $6.4 million of total unrecognized compensation cost related to unvested stock options which the Company expects to recognize over a weighted-average period of 2.09 years. The weighted-average grant-date fair value of stock options granted during the nine months ended September 30, 2022 and 2021 were $0.46 and $2.20, respectively. No stock options were exercised during the nine months ended September 30, 2022. For the nine months ended September 30, 2022 and 2021, 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:
Restricted Stock Units and Performance Stock Units The following table sets forth a summary of the Company's RSU and PSU activity for the nine months ended September 30, 2022:
The Company did not grant any RSUs or PSUs during the nine months ended September 30, 2021. The share-based compensation expense related to RSUs and PSUs for the three and nine months ended September 30, 2022 was $1.2 million and $2.4 million, respectively. There was no shared-based compensation expense related to RSUs and PSUs for the three and nine months ended September 30, 2021. As of September 30, 2022, there was $1.8 million of total unrecognized compensation cost related to unvested RSUs and PSUs.
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EMPLOYEE BENEFIT PLANS |
9 Months Ended |
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Sep. 30, 2022 | |
Retirement Benefits [Abstract] | |
EMPLOYEE BENEFIT PLANS | 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. At the Annual Meeting of the Company's stockholders in May 2021, the Company's stockholders approved an amendment to the 2014 ESPP that increased by 2.3 million the number of shares of common stock reserved for issuance under the 2014 ESPP. 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 condensed consolidated statements of changes in stockholders' equity (deficit). As of September 30, 2022, there were 2.3 million shares of common stock available for sale under the 2014 ESPP. The Company did not sell any shares under the ESPP during the nine months ended September 30, 2022 and 2021. Defined Contribution Plans United States - 401(k) Plan The Company maintains a 401(k) defined contribution retirement plan which covers all of its US employees. Employees are eligible to participate on the first of the month following their date of hire. Under the 401(k) plan, participating employees may defer up to 100% 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 of $4,000 per year. The expenses incurred for the periods presented were de minimis amount for each of the nine months ended September 30, 2022 and 2021, respectively. 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 amount for each of the nine months ended September 30, 2022 and 2021, respectively.
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INCOME TAXES |
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INCOME TAXES | INCOME TAXES The following table sets forth the components of the Company's loss before income taxes by country (in thousands):
The Company's tax benefit (provision) is comprised of the following components (in thousands):
The Company's deferred tax liability is comprised of the following:
For the nine months ended September 30, 2022, the Company recorded a benefit from income taxes of $3.9 million. In the second quarter of 2022, the Company determined that the fair value of the Vicineum EU rights was zero, which resulted in an impairment charge of $14.7 million. In connection with this impairment charge, the Company reversed the associated deferred tax liability by $4.0 million as an income tax benefit, partially offset by $0.1 million income tax paid to foreign jurisdictions pursuant to the Qilu License Agreement. During the nine months ended September 30, 2021, the Company recorded a benefit from income taxes of $8.3 million. In the third quarter of 2021, the Company determined that the fair value of the Vicineum US rights was zero, which resulted in an impairment charge of $31.7 million. In connection with this impairment charge, in the third quarter of 2021, the Company wrote-down the associated deferred tax liability by $8.6 million as a benefit.
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LICENSE AGREEMENTS |
9 Months Ended |
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Sep. 30, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
LICENSE AGREEMENTS | 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 (the “Zurich License Agreement”). These patents cover some key aspects of Vicineum. The Company's receipt of the Complete Response Letter ("CRL") regarding the BLA for Vicineum for the treatment of BCG-unresponsive NMIBC triggered a $0.5 million milestone payment to Zurich. Under the Zurich License Agreement, as of September 30, 2022, 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, which includes Vicineum. 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. The Company recorded an expense of $0.3 million and $0.5 million related to meeting a development milestone, the submission of the Company’s BLA with the FDA in December 2020, in the fourth quarter of 2020, and a regulatory milestone, the Company’s receipt of the CRL from the FDA in August 2021, in the third quarter of 2021, respectively. 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 (the “Micromet License Agreement”). These patents cover some key aspects of Vicineum. Under the terms of the Micromet License Agreement, as of September 30, 2022, the Company may be obligated to pay up to €2.4 million in milestone payments for the first product candidate that achieves applicable regulatory and sales-based development milestones (approximately $2.4 million at exchange rates in effect on September 30, 2022). 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 (approximately $48,987 at exchange rates in effect as of September 30, 2022), that can be credited towards any royalty payment the Company owes to Micromet. The Company recorded an expense of €0.7 million ($0.9 million) related to achievement of a development milestone in the three months ended December 31, 2020, due to the submission of the Company's BLA for Vicineum with the FDA in December 2020. The Company recorded an expense of €0.5 million ($0.6 million) related to the submission of marketing authorization application (the “MAA”) to the European Medicines Agency (the “EMA”) for Vysyneum™ in the first quarter of 2021. Vysyneum is the proprietary brand name that was conditionally approved by the EMA for oportuzumab monatox in the EU. 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 (the “XOMA License Agreement”). These patents and related know-how cover some key aspects of Vicineum. Under the terms of the XOMA License Agreement, 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. 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 Roche License Agreement In June 2016, the Company entered into the license agreement with Roche (the “Roche License Agreement”), 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 antagonist monoclonal antibody technology owned by the Company (collectively, the "Roche Licensed Intellectual Property"). Under the Roche License Agreement, Roche was required to continue developing, at its cost, EBI-031 and any other product made from the Roche Licensed Intellectual Property that contains an IL-6 antagonist monoclonal antibody and pursue ongoing patent prosecution, at its cost. For additional information regarding the Roche License Agreement, see Note 17. “License Agreements” in the Notes to Condensed Consolidated Financial Statements in the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2022. On July 15, 2022, the Company entered into an asset purchase agreement with Roche (the “Roche Asset Purchase Agreement”) pursuant to which Roche purchased all patent rights and know-how related to the monoclonal antibody EBI-031 and all other IL-6 antagonist monoclonal antibody technology owned by the Company for up to $70 million. As a result of the Roche Asset Purchase Agreement, the Roche License Agreement was terminated resulting in no further diligence, milestone or royalty payment obligations under the Roche License Agreement. Pursuant to the Roche Asset Purchase Agreement, Roche made a $40 million payment to the Company upon execution of the Roche Asset Purchase Agreement, which was recorded as license revenue in the third quarter of 2022. The Roche Asset Purchase Agreement also provides that Roche will make an additional $30 million payment to the Company upon Roche’s initiation of a Phase 3 clinical trial with EBI-031 for a defined indication if initiated prior to December 31, 2026. Pursuant to ASC 606, the variable consideration of $30 million is constrained. Therefore, the amount was not recorded as revenue during the third quarter of 2022. Additionally, at or prior to the effective time of the Merger, the Company will enter into a Contingent Value Rights Agreement (the “CVR Agreement”) with a rights agent (“Rights Agent”) pursuant to which the Company intends to declare a dividend payable to the Company’s stockholders of record as of a date agreed to by the Company and Carisma prior to the effective time of the Merger with respect to the receipt of one contingent value right (each, a “CVR”) for each outstanding share of the Company’s common stock held by such stockholders on such date. Each CVR will represent the contractual right to receive contingent cash payments upon the receipt by the Company of certain proceeds payable by Roche, if any, pursuant to the Roche Asset Purchase Agreement, upon the achievement by Roche of a specified milestone set forth in the Roche Asset Purchase Agreement, subject to certain customary deductions, including for expenses and taxes. The contingent payments under the CVR Agreement, if they become due, will be payable to the Rights Agent for subsequent distribution to the holders of the CVRs. In the event that no such proceeds are received, holders of the CVRs will not receive any payment pursuant to the CVR Agreement. There can be no assurance that any cash payment will be made or that any holders of CVRs will receive any amounts with respect thereto. OUS Business Development Partnership Agreements Qilu License Agreement On July 30, 2020, the Company and its wholly-owned subsidiary, Viventia Bio, Inc., entered into the Qilu License Agreement 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 “Qilu Licensed Product”) for the treatment of NMIBC and other types of cancer (the “Field”) in China, Hong Kong, Macau and Taiwan ("Greater China”). 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 Qilu Licensed Product in Greater China. The Company retains (i) development, and commercialization rights in the rest of the world, excluding Greater China and (ii) manufacturing rights with respect to Vicineum in the rest of the world, excluding China. In consideration for the rights granted by the Company, Qilu agreed to pay to the Company a one-time upfront cash payment of $12 million, and milestone payments totaling up to $23 million upon the achievement of certain technology transfer, development and regulatory milestones. All payments were to be inclusive of VAT, which can be withheld by Qilu upon payment, and for which future recovery of such taxes may be available. Qilu also agreed to pay the Company a 12% royalty based upon annual net sales of Qilu Licensed Products in Greater China. The royalties are payable on a Qilu Licensed Product-by-Licensed Product and region-by-region basis commencing on the first commercial sale of a Qilu Licensed Product in a region and continuing until the latest of (i) twelve years after the first commercial sale of such Qilu 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 Qilu Licensed Product in such region, and (iii) the expiration of regulatory or data exclusivity for such Qilu Licensed Product in such region (collectively, the “Royalty Terms”). The royalty rate is subject to reduction under certain circumstances, including when there is no valid claim of a licensed patent that covers a Qilu Licensed Product in a particular region or no data or regulatory exclusivity of a Qilu Licensed Product in a particular region. Qilu is responsible for all costs related to developing, obtaining regulatory approval of and commercializing the Qilu Licensed Products in the Field in Greater China. Qilu is required to use commercially reasonable efforts to develop, seek regulatory approval for, and commercialize at least one Qilu Licensed Product in the Field in Greater China. A joint development committee was established between the Company and Qilu to coordinate and review the development, manufacturing and commercialization plans with respect to the Qilu Licensed Products in Greater China. The Company and Qilu also executed 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 Qilu Licensed Product necessary for Qilu to develop and commercialize the Qilu Licensed Product in the Field in Greater China 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 ("NMPA") for the Qilu Licensed Product has been obtained. The Qilu License Agreement will expire on a Qilu 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 Qilu License Agreement 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 Qilu License Agreement is terminated under certain circumstances. The Qilu License Agreement includes customary representations and warranties, covenants and indemnification obligations for a transaction of this nature. The Qilu License Agreement is subject to the provisions of ASC Topic 606, Revenue. In 2020, 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 agreements under the Qilu License Agreement 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 Investigational New Drug application for Vicineum submitted by Qilu to the Center for Drug Evaluation of the NMPA was accepted for review in January 2021 and approved in March 2021, resulting in a $3 million milestone payment from Qilu, the first milestone payment out of the $23 million in potential milestone payments. The Company recorded $2.8 million (net of VAT) as license revenue during the three-month period ended March 31, 2021. The Company received the payment in 2021. In June 2021, the Qilu License Agreement was recognized by Shandong Province, Bureau of Science and Technology as a "Technology Transfer". An agreement that is designated as a Technology Transfer shall be entitled to a tax incentive of VAT recovery. As such, the Company recorded $0.9 million of revenue during the three months ended June 30, 2021 for additional purchase price resulting from Qilu's obligation to pay Sesen Bio an amount equal to its recovery of VAT. MENA License Agreement On November 30, 2020, the Company entered into a license agreement with a third party pursuant to which the Company granted an exclusive, sublicensable, royalty-bearing license, under certain intellectual property owned or exclusively licensed by the Company, to commercialize Vicineum in the Middle East and North Africa region (“MENA”) (the "MENA License Agreement"). In consideration for the rights granted by the Company, the counterparty to the MENA License Agreement agreed to pay to the Company an upfront payment of $3 million, which would be subject to certain tax withholdings. In addition, the counterparty agreed to pay to the Company milestone payments upon the achievement of certain sales-based milestones as well as a royalty based upon annual net sales in the MENA region for the term of the MENA License Agreement. On July 20, 2022, the Company provided notice of termination of the MENA License Agreement as a result of the Company’s strategic decision to voluntarily pause further development of Vicineum in the US. EIP License Agreement On August 5, 2021, the Company entered into an exclusive license agreement with EİP Eczacıbaşı İlaç Pazarlama A.Ş., (“EIP”) pursuant to which it granted EIP an exclusive license to register and commercialize Vicineum for the treatment of BCG-unresponsive NMIBC in Turkey and Northern Cyprus (the “EIP License Agreement"). Under the terms of the EIP License Agreement, the Company was entitled to receive an upfront payment of $1.5 million. The Company and EIP have amended the license agreement to defer EIP's payment of the upfront payment to coincide with the potential FDA approval of Vicineum. The Company would be eligible to receive additional regulatory and commercial milestone payments of $2.0 million and also to receive a 30% royalty on net sales in Turkey and Northern Cyprus. On July 20, 2022, the Company provided notice of termination of the EIP License Agreement as a result of the Company’s strategic decision to voluntarily pause further development of Vicineum in the US. The EIP License Agreement was terminated on October 20, 2022.
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RESTRUCTURING AND RELATED ACTIVITIES |
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Restructuring and Related Activities [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||
RESTRUCTURING AND RELATED ACTIVITIES | RESTRUCTURING AND RELATED ACTIVITIES On July 15, 2022, the Company approved a restructuring plan to reduce operating expenses and better align its workforce with the needs of its business following the decision to voluntarily pause further development of Vicineum in the US (the “2022 Restructuring Plan”). Execution of the 2022 Restructuring Plan is expected to be substantially completed in connection with the closing of the Merger with Carisma, which is expected to occur approximately two to three months from the date of this form 10-Q filing, November 7, 2022. The 2022 Restructuring Plan includes an incremental reduction in the Company’s workforce as well as additional cost-saving initiatives intended to preserve capital during the pendency of the Merger with Carisma and while the Company seeks a potential partner for the further development of Vicineum. The Company also incurred one-time cash costs associated with the termination of certain contracts and all other activities under the 2022 Restructuring Plan. The following is a summary of accrued restructuring costs related to the 2022 Restructuring Plan, (in thousands):
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SUBSEQUENT EVENTS |
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Subsequent Events [Abstract] | |
SUBSEQUENT EVENTS | SUBSEQUENT EVENTSOn October 21, 2022, the Company received two separate letters and on November 4, 2022, the Company received one letter from purported stockholders demanding that the Company amend the Registration Statement filed with the SEC on October 14, 2022 to provide additional disclosures that such stockholders allege were improperly omitted from the Registration Statement, including information regarding the financial projections for Carisma, the financial analyses performed by the Company’s financial advisor in support of its fairness opinion, and the background and process leading to the execution of the Merger Agreement. The Company believes that these demands are without merit and intends to vigorously defend against them. At this time, no assessment can be made as to the likely outcome or whether the outcome will be material to the Company. |
BASIS OF PRESENTATION (Policies) |
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Sep. 30, 2022 | |
Accounting Policies [Abstract] | |
Use of Estimates | 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); and research and development expenses.
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Principles of Consolidation | Principles of Consolidation The Company’s condensed consolidated financial statements include the accounts of the Company, its wholly owned subsidiaries Viventia and Seahawk Merger Sub, Inc. and its indirect subsidiary, Viventia Bio USA Inc. All intercompany transactions and balances have been eliminated in consolidation.
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Foreign Currency Translation | Foreign Currency Translation The functional currency of the Company and each of its subsidiaries is the US dollar.
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Recent Accounting Pronouncements | Adopted in 2022 In August 2020, the FASB issued ASU No. 2020-06, Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity ("ASU 2020-06"). ASU 2020-06 simplifies the complexity associated with applying US GAAP for certain financial instruments with characteristics of both liability and equity. More specifically, the amendments focus on the guidance for convertible instruments and derivative scope exception for contracts in an entity’s own equity. The ASU also amends the diluted earnings per share ("EPS") guidance, including the requirement to use the if-converted method for all convertible instruments. ASU 2020-06 is effective for public companies for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2021, and should be applied on a full or modified retrospective basis. The Company adopted this guidance on a modified retrospective basis effective January 1, 2022 and it did not have an impact on the Company's financial position, results of operations including per-share amounts, or cash flows. In May 2021, the FASB issued ASU No. 2021-04, Earnings Per Share (Topic 260), Debt—Modifications and Extinguishments (Subtopic 470-50), Compensation—Stock Compensation (Topic 718), and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Issuer’s Accounting for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options ("ASU 2021-04"). ASU 2021-04 clarifies and reduces diversity in an issuer’s accounting for modifications or exchanges of freestanding equity-classified written call options (for example, warrants) that remain equity classified after modification or exchange. ASU 2021-04 is effective for public companies for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2021, and should be applied on a prospective basis. The Company adopted this guidance effective January 1, 2022 and it did not have an impact on the Company's financial position, results of operations including per-share amounts, or cash flows. Other recent accounting pronouncements issued, but not yet effective, are not expected to be applicable to the Company or have a material effect on the consolidated financial statements upon future adoption.
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Fair Value Measurement | 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, 2022 and December 31, 2021 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.
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FAIR VALUE MEASUREMENT AND FINANCIAL INSTRUMENTS (Tables) |
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Fair Value Disclosures [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Carrying Amounts and Fair Values of Financial Instruments Measured | 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, 2022 and December 31, 2021 (in thousands):
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Schedule of Contingent Consideration Liability | 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 (in thousands).
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INTANGIBLE ASSETS AND GOODWIL (Tables) |
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Goodwill and Intangible Assets Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Composition of Intangible Assets | The following table sets forth the composition of intangible assets as of September 30, 2022 and December 31, 2021 (in thousands):
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Schedule of Goodwill | The following table sets forth a summary of the change in goodwill as of September 30, 2022 and December 31, 2021 (in thousands).
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ACCRUED EXPENSES (Tables) |
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Schedule of Components of Accrued Expenses | The following table sets forth the composition of accrued expenses as of September 30, 2022 and December 31, 2021 (in thousands):
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STOCKHOLDERS' EQUITY (Tables) |
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Schedule of Common Stock | 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, 2022 and December 31, 2021 (in thousands):
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Schedule of Warrants Outstanding and Warrant Activity | The following table sets forth the Company's warrant activity for the three months ended September 30, 2022 (in thousands):
*Exercise price shown (i) reflects modification and (ii) is subject to further adjustment based on down round provision added by amendment described in “Item 15. Exhibits and Financial Statement Schedules - Note 12. Stockholders’ Equity (Deficit)” in the audited annual consolidated financial statements included in the Company's Annual Report on Form 10-K for the year ended December 31, 2021.
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EARNINGS (LOSS) PER SHARE (Tables) |
9 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Sep. 30, 2022 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Earnings Per Share [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Earnings (Loss) Per Share | The following table illustrates the determination of earnings (loss) per share for each period presented:
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Schedule of Potentially Dilutive Securities Excluded from Diluted Loss Calculation | The following potentially dilutive securities outstanding as of September 30, 2022 and 2021 have been excluded from the denominator of the diluted loss per share of common stock outstanding calculation (in thousands):
|
SHARE-BASED COMPENSATION (Tables) |
9 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Sep. 30, 2022 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Share-Based Payment Arrangement [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Share-Based Compensation Expense | The following table sets forth the amount of share-based compensation expense recognized by the Company by line item on its Condensed Consolidated Statements of Operations for the three and nine months ended September 30, 2022 and 2021 (in thousands):
|
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Schedule of Stock Option Activity | The following table sets forth a summary of the Company’s total stock option activity, including awards granted under the 2014 Plan and the 2009 Plan and inducement grants made outside of stockholder approved plans, for the nine months ended September 30, 2022:
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Weighted-Average Inputs and Assumptions in Black-Scholes Option | For the nine months ended September 30, 2022 and 2021, 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:
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of the Status of Restricted Stock Units | The following table sets forth a summary of the Company's RSU and PSU activity for the nine months ended September 30, 2022:
|
INCOME TAXES (Tables) |
9 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sep. 30, 2022 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Income Tax Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Components of Pre-tax Loss | The following table sets forth the components of the Company's loss before income taxes by country (in thousands):
|
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Schedule of Components of Income Tax Benefit (Provision) | The Company's tax benefit (provision) is comprised of the following components (in thousands):
|
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Schedule Components of Deferred Tax Liabilities | The Company's deferred tax liability is comprised of the following:
|
RESTRUCTURING AND RELATED ACTIVITIES (Tables) |
9 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sep. 30, 2022 | |||||||||||||||||||||||||||||||||||||||||||||||||
Restructuring and Related Activities [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Restructuring Reserve by Type of Cost | The following is a summary of accrued restructuring costs related to the 2022 Restructuring Plan, (in thousands):
|
FAIR VALUE MEASUREMENT AND FINANCIAL INSTRUMENTS - Narrative (Details) $ in Thousands |
3 Months Ended | 9 Months Ended | ||||
---|---|---|---|---|---|---|
Sep. 30, 2022
USD ($)
|
Sep. 30, 2021
USD ($)
|
Sep. 30, 2022
USD ($)
|
Sep. 30, 2021
USD ($)
|
Jun. 30, 2022
USD ($)
|
Dec. 31, 2021 |
|
Fair Value, Option, Quantitative Disclosures [Line Items] | ||||||
Business combination, contingent consideration, liability | $ 0 | $ 0 | $ 1,800 | |||
Contingent consideration liability, measurement input | 0.080 | |||||
License agreement, royalty rate | 2.00% | 2.00% | ||||
Decrease in the fair value of contingent consideration | $ (1,800) | $ (114,000) | $ (52,000) | $ (52,240) | ||
Discount Rate | ||||||
Fair Value, Option, Quantitative Disclosures [Line Items] | ||||||
Weighted-average cost of capital | 9.30% | |||||
Discount Rate | Minimum | ||||||
Fair Value, Option, Quantitative Disclosures [Line Items] | ||||||
Contingent consideration liability, measurement input | 0.080 | |||||
Discount Rate | Maximum | ||||||
Fair Value, Option, Quantitative Disclosures [Line Items] | ||||||
Contingent consideration liability, measurement input | 0.093 |
FAIR VALUE MEASUREMENT AND FINANCIAL INSTRUMENTS - Summary of Changes in Fair Value of Company's Total Contingent Consideration (Details) $ in Thousands |
9 Months Ended |
---|---|
Sep. 30, 2022
USD ($)
| |
Fair Value, Net Derivative Asset (Liability) Measured on Recurring Basis, Unobservable Input Reconciliation [Roll Forward] | |
Ending balance | $ 0 |
Significant Unobservable Inputs (Level 3) | |
Fair Value, Net Derivative Asset (Liability) Measured on Recurring Basis, Unobservable Input Reconciliation [Roll Forward] | |
Beginning balance | 52,000 |
Change in fair value of contingent consideration | (52,000) |
Ending balance | $ 0 |
PREPAID EXPENSES (Details) - USD ($) $ in Millions |
3 Months Ended | ||
---|---|---|---|
Jun. 30, 2022 |
Sep. 30, 2022 |
Dec. 31, 2021 |
|
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | |||
Prepaid expenses | $ 0.5 | $ 25.7 | |
Expenses previously classified as prepaid | $ 25.2 |
INTANGIBLE ASSETS AND GOODWIL - Composition of Intangible Assets (Details) - IPR&D intangible assets: - USD ($) $ in Thousands |
Sep. 30, 2022 |
Jun. 30, 2022 |
Dec. 31, 2021 |
Sep. 30, 2021 |
---|---|---|---|---|
Finite-Lived Intangible Assets [Line Items] | ||||
Total Intangibles | $ 0 | $ 14,700 | ||
European Union | Vicinium | ||||
Finite-Lived Intangible Assets [Line Items] | ||||
Total Intangibles | $ 0 | $ 0 | $ 14,700 | $ 0 |
INTANGIBLE ASSETS AND GOODWIL - Narrative (Details) - USD ($) $ in Thousands |
3 Months Ended | 9 Months Ended | ||||
---|---|---|---|---|---|---|
Sep. 30, 2022 |
Jun. 30, 2022 |
Sep. 30, 2021 |
Sep. 30, 2022 |
Sep. 30, 2021 |
Dec. 31, 2021 |
|
Finite-Lived Intangible Assets [Line Items] | ||||||
Intangibles impairment charge | $ 0 | $ 31,700 | $ 27,764 | $ 31,700 | ||
Goodwill | 0 | $ 0 | 0 | $ 13,064 | ||
IPR&D intangible assets: | ||||||
Finite-Lived Intangible Assets [Line Items] | ||||||
Total Intangibles | 0 | 0 | 14,700 | |||
Vicinium | Europe | IPR&D intangible assets: | ||||||
Finite-Lived Intangible Assets [Line Items] | ||||||
Intangibles impairment charge | 14,700 | |||||
Total Intangibles | $ 0 | $ 0 | $ 0 | $ 0 | $ 0 | $ 14,700 |
INTANGIBLE ASSETS AND GOODWIL - Schedule of Goodwill (Details) $ in Thousands |
9 Months Ended |
---|---|
Sep. 30, 2022
USD ($)
| |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Goodwill, Beginning Balance | $ 13,064 |
Impairment loss | (13,064) |
Goodwill, Ending Balance | $ 0 |
ACCRUED EXPENSES - Components of Accrued Expenses (Details) - USD ($) $ in Thousands |
Sep. 30, 2022 |
Dec. 31, 2021 |
---|---|---|
Payables and Accruals [Abstract] | ||
Research and development | $ 1,242 | $ 1,841 |
Payroll-related expenses | 2,043 | 2,967 |
Restructuring charge related | 6,365 | 1,497 |
Professional fees | 381 | 597 |
Legal expenses, including preliminary litigation settlement | 23,720 | 1,344 |
Other | 49 | 9 |
Total Accrued Expenses | $ 33,800 | $ 8,255 |
COMMITMENTS AND CONTINGENCIES (Details) $ in Thousands |
3 Months Ended | 9 Months Ended | |||
---|---|---|---|---|---|
Sep. 30, 2022
USD ($)
lawsuit
|
Sep. 30, 2022
USD ($)
lawsuit
|
Nov. 04, 2022
letter
|
Oct. 21, 2022
letter
|
Jun. 30, 2022
USD ($)
|
|
Gain Contingencies [Line Items] | |||||
Number of lawsuits | lawsuit | 3 | 3 | |||
Estimated litigation liability | $ 21,000 | $ 21,000 | $ 21,600 | ||
Payment of litigation fees | 600 | ||||
Subsequent Event | |||||
Gain Contingencies [Line Items] | |||||
Number of letters from stockholders | letter | 1 | 2 | |||
Carisma | |||||
Gain Contingencies [Line Items] | |||||
Contingent termination fee, payments to third party | 7,600 | 7,600 | |||
Contingent termination fee, proceeds | $ 5,490 | 5,490 | |||
Contingent reimbursement payments to third party | 1,750 | ||||
Contingent reimbursement proceeds | $ 1,750 |
STOCKHOLDERS' EQUITY - Equity Financing (Details) - USD ($) $ / shares in Units, shares in Millions, $ in Millions |
2 Months Ended | 3 Months Ended | 9 Months Ended | ||||
---|---|---|---|---|---|---|---|
Nov. 29, 2021 |
Jul. 31, 2021 |
Sep. 30, 2021 |
Sep. 30, 2021 |
Sep. 30, 2022 |
Dec. 31, 2021 |
Nov. 29, 2019 |
|
Class of Stock [Line Items] | |||||||
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 | |||||
ATM Facility | |||||||
Class of Stock [Line Items] | |||||||
Common stock, par value (in dollars per share) | $ 0.001 | ||||||
Aggregate sales price | $ 200.0 | ||||||
Shares reserved for future issuance amount | $ 97.8 | ||||||
Commission fixed rate | 3.00% | ||||||
Proceeds from sale of stock | $ 38.2 | $ 175.0 | |||||
Sale of stock, number of units issued (in shares) | 9.8 | 56.9 | |||||
Weighted-average stock price per share (in dollars per share) | $ 4.01 | $ 3.17 | |||||
Issuance of common stock, issuance cost | $ 1.2 | $ 5.4 |
STOCKHOLDERS' EQUITY - Preferred Stock (Details) - $ / shares |
Sep. 30, 2022 |
Dec. 31, 2021 |
Sep. 30, 2021 |
---|---|---|---|
Equity [Abstract] | |||
Preferred stock, shares authorized (in shares) | 5,000,000 | 5,000,000 | |
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 | |
Preferred stock, shares issued (in shares) | 0 | 0 | 0 |
Preferred stock, shares outstanding (in shares) | 0 | 0 | 0 |
STOCKHOLDERS' EQUITY - Common Stock (Details) |
9 Months Ended | |||
---|---|---|---|---|
Sep. 30, 2022
vote
shares
|
Dec. 31, 2021
shares
|
May 03, 2021
shares
|
May 02, 2021
shares
|
|
Class of Stock [Line Items] | ||||
Common stock, shares authorized (in shares) | 400,000,000 | 400,000,000 | 400,000,000 | 200,000,000 |
Common stock, shares issued (in shares) | 202,757,012 | 199,463,645 | ||
Common stock, shares outstanding (in shares) | 202,757,012 | 199,463,645 | ||
Common Stock | ||||
Class of Stock [Line Items] | ||||
Number of votes | vote | 1 |
SHARE-BASED COMPENSATION - Share-Based Compensation Expense (Details) - USD ($) $ in Thousands |
3 Months Ended | 9 Months Ended | ||
---|---|---|---|---|
Sep. 30, 2022 |
Sep. 30, 2021 |
Sep. 30, 2022 |
Sep. 30, 2021 |
|
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Total Share Based Compensation | $ 2,168 | $ 1,168 | $ 5,864 | $ 3,385 |
Research and development | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Total Share Based Compensation | 863 | 152 | 1,838 | 536 |
General and administrative | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Total Share Based Compensation | $ 1,305 | $ 1,016 | $ 4,026 | $ 2,849 |
SHARE-BASED COMPENSATION - Weighted-Average Inputs and Assumptions (Details) - Stock options - $ / shares |
9 Months Ended | |
---|---|---|
Sep. 30, 2022 |
Sep. 30, 2021 |
|
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Fair market value (in dollars per share) | $ 0.72 | $ 3.40 |
Grant exercise price (in dollars per share) | $ 0.72 | $ 3.40 |
Expected term (in years) | 6 years | 6 years 10 days |
Risk-free interest rate | 2.10% | 0.90% |
Expected volatility | 71.80% | 74.60% |
Dividend yield | 0.00% | 0.00% |
SHARE-BASED COMPENSATION - Summary of Status and Changes of Unvested Restricted Stock (Details) - $ / shares |
9 Months Ended | |
---|---|---|
Sep. 30, 2022 |
Sep. 30, 2021 |
|
Number of Shares | ||
Unvested, beginning balance (in shares) | 3,041,000 | |
Unvested, ending balance (in shares) | 4,695,000 | |
Weighted-Average Grant Date Fair Value | ||
Unvested beginning balance (in dollars per share) | $ 0.80 | |
Unvested ending balance (in dollars per share) | $ 0.68 | |
RSU | ||
Number of Shares | ||
Granted (in shares) | 4,160,000 | 0 |
Cancelled RSU (in shares) | (217,000) | |
Released RSU (in shares) | (3,293,000) | |
Weighted-Average Grant Date Fair Value | ||
Granted (in dollars per share) | $ 0.68 | |
Cancelled RSU (in dollars per share) | 0.75 | |
Released RSU (in dollars per share) | $ 0.76 | |
PSUs | ||
Number of Shares | ||
Granted (in shares) | 1,004,000 | 0 |
Weighted-Average Grant Date Fair Value | ||
Granted (in dollars per share) | $ 0.67 |
EMPLOYEE BENEFIT PLANS (Details) - USD ($) shares in Millions |
1 Months Ended | 9 Months Ended | |
---|---|---|---|
May 31, 2021 |
Sep. 30, 2022 |
Feb. 28, 2014 |
|
United States | |||
Defined Benefit Plan Disclosure [Line Items] | |||
Defined contribution retirement plan, maximum employee contribution deferred | 100.00% | ||
Discretionary match per participating employee, maximum | $ 4,000 | ||
Canada | |||
Defined Benefit Plan Disclosure [Line Items] | |||
Employer matching contribution, percent of employees' eligible compensation | 4.00% | ||
2014 Employee Stock Purchase Plan | |||
Defined Benefit Plan Disclosure [Line Items] | |||
Shares of common stock reserved for issuance (in shares) | 0.2 | ||
Number of additional shares authorized (in shares) | 2.3 | ||
Common stock purchase price, discount rate | 15.00% | ||
Common stock available for sale (in shares) | 2.3 |
INCOME TAXES - Components of Pre-tax Income (Loss) (Details) - USD ($) $ in Thousands |
9 Months Ended | |
---|---|---|
Sep. 30, 2022 |
Sep. 30, 2021 |
|
Income Taxes [Line Items] | ||
Pre-tax income (loss) U.S. | $ (32,083) | $ (38,864) |
Pre-tax income (loss) Canada | 15,898 | 21,311 |
Total loss before income taxes | $ (16,185) | $ (17,553) |
INCOME TAXES - Components of Income Tax Provisions (Details) - USD ($) $ in Thousands |
9 Months Ended | |
---|---|---|
Sep. 30, 2022 |
Sep. 30, 2021 |
|
Current tax benefit (provision) | ||
Federal | $ 0 | $ 8,559 |
State | 0 | 0 |
Foreign | 3,875 | (286) |
Total current benefit | $ 3,875 | $ 8,273 |
INCOME TAXES - Components of Deferred Tax Liabilities (Details) - USD ($) $ in Thousands |
Sep. 30, 2022 |
Dec. 31, 2021 |
---|---|---|
Deferred Tax Liabilities, Gross [Abstract] | ||
IPR&D | $ 0 | $ (3,969) |
Total deferred tax liabilities | $ 0 | $ (3,969) |
INCOME TAXES - Narrative (Details) - USD ($) $ in Thousands |
3 Months Ended | 9 Months Ended | ||||
---|---|---|---|---|---|---|
Sep. 30, 2022 |
Jun. 30, 2022 |
Sep. 30, 2021 |
Sep. 30, 2022 |
Sep. 30, 2021 |
Dec. 31, 2021 |
|
Income Taxes [Line Items] | ||||||
Benefit from income taxes | $ 0 | $ 8,561 | $ 3,875 | $ 8,273 | ||
Increase (decrease) in deferred tax liability | (4,000) | (8,600) | (4,000) | (8,600) | ||
Income Taxes Paid | 100 | |||||
IPR&D intangible assets: | ||||||
Income Taxes [Line Items] | ||||||
Intangible assets | 0 | 0 | $ 14,700 | |||
Vicinium | Europe | IPR&D intangible assets: | ||||||
Income Taxes [Line Items] | ||||||
Intangible assets | $ 0 | $ 0 | 0 | $ 0 | $ 0 | $ 14,700 |
Impairment of intangible assets | $ 14,700 | $ 31,700 |
RESTRUCTURING AND RELATED ACTIVITIES - Schedule of Restructuring Reserve by Type of Cost (Details) - USD ($) $ in Thousands |
3 Months Ended | 9 Months Ended | ||
---|---|---|---|---|
Sep. 30, 2022 |
Sep. 30, 2021 |
Sep. 30, 2022 |
Sep. 30, 2021 |
|
Restructuring Cost and Reserve [Line Items] | ||||
Restructuring charge | $ 10,947 | $ 5,522 | $ 10,947 | $ 5,522 |
Cash payments | (4,582) | |||
Restructuring Reserve | $ 6,365 | 6,365 | ||
Severance and benefits costs | ||||
Restructuring Cost and Reserve [Line Items] | ||||
Restructuring charge | 6,944 | |||
Contract termination and other associated costs | ||||
Restructuring Cost and Reserve [Line Items] | ||||
Restructuring charge | $ 4,003 |
SUBSEQUENT EVENTS (Details) - letter |
Nov. 04, 2022 |
Oct. 21, 2022 |
---|---|---|
Subsequent Event | ||
Subsequent Event [Line Items] | ||
Number of letters from stockholders | 1 | 2 |
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