Cover
Cover - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Mar. 08, 2021 | Jun. 30, 2020 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Period End Date | Dec. 31, 2020 | ||
Current Fiscal Year End Date | --12-31 | ||
Document Transition Report | false | ||
Entity File Number | 001-36296 | ||
Entity Registrant Name | Sesen Bio, Inc. | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Tax Identification Number | 26-2025616 | ||
Entity Address, Address Line One | 245 First Street | ||
Entity Address, Address Line Two | Suite 1800 | ||
Entity Address, City or Town | Cambridge | ||
Entity Address, State or Province | MA | ||
Entity Address, Postal Zip Code | 02142 | ||
City Area Code | 617 | ||
Local Phone Number | 444-8550 | ||
Title of 12(b) Security | Common Stock, $0.001 par value | ||
Trading Symbol | SESN | ||
Security Exchange Name | NASDAQ | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | false | ||
Entity Shell Company | false | ||
ICFR Auditor Attestation Flag | false | ||
Entity Public Float | $ 84,000 | ||
Entity Common Stock, Shares Outstanding | 167,578,637 | ||
Entity Central Index Key | 0001485003 | ||
Document Fiscal Year Focus | 2020 | ||
Document Fiscal Period Focus | FY | ||
Amendment Flag | false | ||
Entity Filer Category | Non-accelerated Filer |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Current assets: | ||
Cash and cash equivalents | $ 52,389 | $ 48,121 |
Prepaid expenses and other current assets | 7,478 | 6,326 |
Restricted Cash | 3,000 | 0 |
Total current assets | 62,867 | 54,447 |
Restricted cash | 20 | 20 |
Property and equipment, net | 123 | 238 |
Intangibles | 46,400 | 46,400 |
Goodwill | 13,064 | 13,064 |
Other assets | 349 | 196 |
Total Assets | 122,823 | 114,365 |
Current liabilities: | ||
Accounts payable | 3,102 | 1,902 |
Accrued expenses | 3,973 | 6,169 |
Deferred revenue | 1,500 | 0 |
Other current liabilities | 489 | 446 |
Total current liabilities | 18,049 | 8,517 |
Contingent consideration, net of current portion | 99,855 | 120,020 |
Deferred revenue, net of current portion | 1,500 | 0 |
Deferred tax liability | 12,528 | 12,528 |
Other liabilities | 118 | 0 |
Total Liabilities | 132,050 | 141,065 |
Commitments and contingencies | ||
Stockholders’ Deficit: | ||
Preferred stock, $0.001 par value per share; 5,000,000 shares authorized at December 31, 2020 and 2019; no shares issued and outstanding at December 31, 2020 and 2019 | 0 | 0 |
Common stock, $0.001 par value per share; 200,000,000 shares authorized at December 31, 2020 and 2019; 140,449,647 and 106,801,409 shares issued and outstanding at December 31, 2020 and 2019, respectively | 140 | 107 |
Additional paid-in capital | 306,554 | 266,717 |
Accumulated deficit | (315,921) | (293,524) |
Total Stockholders’ Deficit | (9,227) | (26,700) |
Total Liabilities and Stockholders’ Deficit | $ 122,823 | $ 114,365 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Dec. 31, 2020 | Dec. 31, 2019 |
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 |
Preferred stock, shares outstanding (in shares) | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized (in shares) | 200,000,000 | 200,000,000 |
Common stock, shares issued (in shares) | 140,449,647 | 106,801,409 |
Common stock, shares outstanding (in shares) | 140,449,647 | 106,801,409 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) shares in Thousands, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Revenue: | |||
Total revenue | $ 11,236 | $ 0 | $ 0 |
Operating expenses: | |||
Research and development | 29,191 | 24,663 | 14,077 |
General and administrative | 14,302 | 12,208 | 11,623 |
Change in fair value of contingent consideration | (11,180) | 71,620 | 8,800 |
Total operating expenses | 32,313 | 108,491 | 34,500 |
Loss from Operations | (21,077) | (108,491) | (34,500) |
Other income (expense): | |||
Other income, net | 125 | 991 | 807 |
Net loss and comprehensive loss, before taxes | (20,952) | (107,500) | (33,693) |
Provision for Income Taxes | (1,445) | 0 | 0 |
Net Income (Loss) Attributable to Parent, Total | (22,397) | (107,500) | (33,693) |
Deemed dividend on adjustment of exercise price on certain warrants | (147) | 0 | 0 |
Net loss and comprehensive loss attributable to common shareholders | $ (22,544) | $ (107,500) | $ (33,693) |
Net loss per common share - basic and diluted (in dollars per share) | $ (0.19) | $ (1.18) | $ (0.55) |
Weighted-average common shares outstanding - basic and diluted (in shares) | 118,221 | 90,929 | 61,774 |
License revenue | |||
Revenue: | |||
Total revenue | $ 11,236 | $ 0 | $ 0 |
CONSOLIDATED STATEMENTS OF CHAN
CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ (DEFICIT) EQUITY - USD ($) $ in Thousands | Total | ATM Facility | Common Stock | Common StockATM Facility | Additional Paid-in Capital | Additional Paid-in CapitalATM Facility | Accumulated Deficit |
Beginning balance (in shares) at Dec. 31, 2017 | 34,702,565 | ||||||
Beginning balance at Dec. 31, 2017 | $ 18,034 | $ 35 | $ 170,330 | $ (152,331) | |||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||
Net loss | (33,693) | ||||||
Share-based compensation | $ 1,283 | 1,283 | |||||
Exercise of stock awards and vesting of restricted stock awards (in shares) | 439,000 | 443,443 | |||||
Exercises of stock options and vesting of restricted stock awards | $ 277 | 277 | |||||
Sales of common stock under 2014 ESPP (in shares) | 20,992 | ||||||
Sales of common stock under 2014 ESPP | 20 | 20 | |||||
Issuance of common stock and common stock warrants, net of issuance costs (in shares) | 33,523,684 | ||||||
Issuance of common stock and common stock warrants, net of issuance costs | 50,971 | $ 33 | 50,938 | ||||
Exercise of common stock warrants (in shares) | 8,765,496 | ||||||
Exercise of common stock warrants | 7,315 | $ 9 | 7,306 | ||||
Ending balance (in shares) at Dec. 31, 2018 | 77,456,180 | ||||||
Ending balance at Dec. 31, 2018 | 44,207 | $ 77 | 230,154 | (186,024) | |||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||
Issuance costs | 5,029 | ||||||
Net loss | (107,500) | ||||||
Share-based compensation | $ 1,237 | 1,237 | |||||
Exercise of stock awards and vesting of restricted stock awards (in shares) | 90,000 | 89,812 | |||||
Exercises of stock options and vesting of restricted stock awards | $ 98 | 98 | |||||
Sales of common stock under 2014 ESPP (in shares) | 10,283 | ||||||
Sales of common stock under 2014 ESPP | 8 | 8 | |||||
Issuance of common stock and common stock warrants, net of issuance costs (in shares) | 20,410,000 | 2,062,206 | |||||
Issuance of common stock and common stock warrants, net of issuance costs | 27,833 | $ 1,936 | $ 21 | $ 2 | 27,812 | $ 1,934 | |
Exercise of common stock warrants (in shares) | 6,772,928 | ||||||
Exercise of common stock warrants | $ 5,481 | $ 7 | 5,474 | ||||
Ending balance (in shares) at Dec. 31, 2019 | 106,800,000 | 106,801,409 | |||||
Ending balance at Dec. 31, 2019 | $ (26,700) | $ 107 | 266,717 | (293,524) | |||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||
Issuance costs | 2,171 | 212 | |||||
Net loss | (22,397) | ||||||
Share-based compensation | $ 1,757 | 1,757 | |||||
Exercise of stock awards and vesting of restricted stock awards (in shares) | 12,000 | 12,000 | |||||
Exercises of stock options and vesting of restricted stock awards | $ 13 | 13 | |||||
Sales of common stock under 2014 ESPP (in shares) | 28,186 | ||||||
Sales of common stock under 2014 ESPP | $ 11 | 11 | |||||
Issuance of common stock and common stock warrants, net of issuance costs (in shares) | 33,369,942 | ||||||
Issuance of common stock and common stock warrants, net of issuance costs | 37,958 | $ 33 | $ 37,925 | ||||
Exercise of common stock warrants (in shares) | 238,000 | 238,110 | |||||
Exercise of common stock warrants | $ 131 | $ 0 | 131 | ||||
Ending balance (in shares) at Dec. 31, 2020 | 140,400,000 | 140,449,647 | |||||
Ending balance at Dec. 31, 2020 | $ (9,227) | $ 140 | $ 306,554 | $ (315,921) | |||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||
Issuance costs | $ 1,174 |
CONSOLIDATED STATEMENTS OF CH_2
CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ (DEFICIT) EQUITY (Parenthetical) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Issuance costs | $ 2,171 | $ 5,029 | |
ATM Facility | |||
Issuance costs | $ 1,174 | $ 212 |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Cash Flows from Operating Activities: | |||
Net loss | $ (22,397) | $ (107,500) | $ (33,693) |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Depreciation | 122 | 219 | 208 |
Share-based compensation | 1,757 | 1,237 | 1,283 |
Change in fair value of contingent consideration | (11,180) | 71,620 | 8,800 |
Gain on sale of equipment | 0 | 0 | (5) |
Changes in operating assets and liabilities: | |||
Prepaid expenses and other assets | (1,304) | (5,188) | (913) |
Accounts payable | 1,200 | 535 | 460 |
Accrued expenses and other liabilities | (2,035) | 1,556 | 1,031 |
Deferred revenue | 3,000 | 0 | 0 |
Net Cash Used in Operating Activities | (30,837) | (37,521) | (22,829) |
Cash Flows from Investing Activities: | |||
Purchases of property and equipment | (8) | (136) | (2) |
Net Cash Used in Investing Activities | (8) | (136) | (2) |
Cash Flows from Financing Activities: | |||
Proceeds from issuance of common stock and common stock warrants, net of issuance costs | 0 | 27,833 | 50,971 |
Proceeds from exercises of common stock warrants | 131 | 5,481 | 7,315 |
Proceeds from issuance of common stock under ATM Offering, net of issuance costs | 37,958 | 1,936 | 0 |
Proceeds from exercises of stock options | 13 | 98 | 277 |
Proceeds from sales of common stock under 2014 ESPP | 11 | 8 | 20 |
Net Cash Provided by Financing Activities | 38,113 | 35,356 | 58,583 |
Net (Decrease) Increase in Cash, Cash Equivalents and Restricted Cash | 7,268 | (2,301) | 35,752 |
Cash, Cash Equivalents and Restricted Cash - Beginning of Period | 48,141 | 50,442 | 14,690 |
Cash, Cash Equivalents and Restricted Cash - End of Period | 55,409 | 48,141 | 50,442 |
Cash and cash equivalents | 52,389 | 48,121 | 50,422 |
Short term restricted cash | 3,000 | 0 | 0 |
Long term restricted cash | 20 | 20 | 20 |
Supplemental cash flow disclosure: | |||
Cash paid for amounts included in the measurement of lease liabilities | 154 | 153 | 0 |
Right-of-use assets related to the adoption of ASC 842 | 0 | 236 | 0 |
Right-of-use assets obtained in exchange for lease obligations | 290 | 0 | 0 |
Supplemental disclosure of non-cash financing activities: | |||
Deemed dividend on adjustment of exercise price on certain warrants | $ 147 | $ 0 | $ 0 |
DESCRIPTION OF BUSINESS
DESCRIPTION OF BUSINESS | 12 Months Ended |
Dec. 31, 2020 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
DESCRIPTION OF BUSINESS | DESCRIPTION OF BUSINESS Sesen Bio, Inc. ("Sesen" or the “Company”), a Delaware corporation formed in February 2008, is a late-stage clinical company developing targeted fusion protein therapeutics ("TFPTs") for the treatment of patients with cancer. The Company’s most advanced product candidate, Vicineum TM , also known as VB4-845, is a locally-administered targeted fusion protein composed of an anti-epithelial cell adhesion molecule ("EpCAM") antibody fragment tethered to a truncated form of Pseudomonas exotoxin A . The Company has an ongoing single-arm, multi-center, open-label Phase 3 clinical trial of Vicineum as a monotherapy in patients with bacillus Calmette-Guérin ("BCG")-unresponsive non-muscle invasive bladder cancer ("NMIBC") (the "VISTA Trial"). The VISTA Trial completed enrollment in April 2018 with a total of 133 patients, and in December 2019, the Company initiated submission of the Biologics License Application ("BLA") for Vicineum to the United States Food and Drug Administration ("FDA") under Rolling Review, which enables individual modules to be submitted and reviewed on an ongoing basis, rather than waiting for all sections to be completed before submission. On December 18, 2020, the Company submitted its completed BLA for Vicineum for the treatment of BCG-unresponsive NMIBC to the FDA.The Company operates in one segment under the direction of its Chief Executive Officer (chief operating decision maker). The Company was formerly known as Eleven Biotherapeutics, Inc. until its name changed in May 2018. Viventia Acquisition In September 2016, the Company entered into a Share Purchase Agreement with Viventia Bio, Inc., a corporation incorporated under the laws of the Province of Ontario, Canada ("Viventia"), the shareholders of Viventia named therein (the “Selling Shareholders”) and, solely in its capacity as seller representative, Clairmark Investments Ltd., a corporation incorporated under the laws of the Province of Ontario, Canada (“Clairmark”) (the “Share Purchase Agreement”), pursuant to which the Company agreed to and simultaneously completed the acquisition of all of the outstanding capital stock of Viventia from the Selling Shareholders (the “Viventia Acquisition”). In connection with the closing of the Viventia Acquisition, the Company issued 4.0 million shares of its common stock to the Selling Shareholders, which at that time represented approximately 19.9% of the voting power of the Company as of immediately prior to the issuance of such shares. Clairmark is an affiliate of Leslie L. Dan, a director of the Company until his retirement in July 2019. In addition, under the Share Purchase Agreement, the Company is obligated to pay to the Selling Shareholders certain post-closing contingent cash payments upon the achievement of specified milestones and based upon net sales, in each case subject to the terms and conditions set forth in the Share Purchase Agreement, including: (i) a one-time milestone payment of $12.5 million payable upon the first sale of Vicineum (the “Purchased Product”), in the United States; (ii) a one-time milestone payment of $7.0 million payable upon the first sale of the Purchased Product in any one of certain specified European countries; (iii) a one-time milestone payment of $3.0 million payable upon the first sale of the Purchased Product in Japan; and (iv) quarterly earn-out payments equal to 2% of net sales of the Purchased Product during specified earn-out periods. Such earn-out payments are payable with respect to net sales in a country beginning on the date of the first sale in such country and ending on the earlier of (i) December 31, 2033 and (ii) fifteen years after the date of such sale, subject to early termination in certain circumstances if a biosimilar product is on the market in the applicable country (collectively, the "Contingent Consideration"). Under the Share Purchase Agreement, the Company, its affiliates, licensees and subcontractors are required to use commercially reasonable efforts, for the first seven years following the closing of the Viventia Acquisition, to achieve marketing authorizations throughout the world and, during the applicable earn-out period, to commercialize the Purchased Product in the United States, France, Germany, Italy, Spain, United Kingdom, Japan, China and Canada. Certain of these payments are payable to individuals or affiliates of individuals that became employees or members of the Company's board of directors, however as of December 31, 2020, none of these individuals are active employees or members of the Company's board of directors. Liquidity and Going Concern As of December 31, 2020, the Company had cash and cash equivalents of $52.4 million and an accumulated deficit of $315.9 million. The Company incurred negative cash flows from operating activities of $30.8 million, $37.5 million and $22.8 million for the years ended December 31, 2020, 2019 and 2018, respectively. Since its inception, the Company has received no revenue from sales of its products, and management anticipates that operating losses will continue for the foreseeable future as the Company continues into the follow-up stage of its Phase 3 VISTA Trial of Vicineum for the treatment of BCG-unresponsive NMIBC, seeks marketing approval from the FDA and, if approved, commercialize Vicineum for the treatment of BCG-unresponsive NMIBC. The Company has financed its operations to date primarily through private placements of its common stock, preferred stock, common stock warrants and convertible bridge notes, venture debt borrowings, its initial public offering ("IPO"), follow-on public offerings, sales effected in "at-the-market" ("ATM") offerings, commercialization partnership and out-license agreements. See “Note 10. Stockholders’ Equity” below for information regarding the Company’s recently completed equity financings. Under Accounting Standards Codification ("ASC") Topic 205-40, Presentation of Financial Statements - Going Concern , management is required at each reporting period to evaluate whether there are conditions and events, considered in the aggregate, that raise substantial doubt about an entity's ability to continue as a going concern within one year after the date that the financial statements are issued. This evaluation initially does not take into consideration the potential mitigating effect of management's plans that have not been fully implemented as of the date the financial statements are issued. When substantial doubt exists, management evaluates whether the mitigating effect of its plans sufficiently alleviates the substantial doubt about the Company's ability to continue as a going concern. The mitigating effect of management's plans, however, is only considered if both (i) it is probable that the plans will be effectively implemented within one year after the date that the financial statements are issued and (ii) it is probable that the plans, when implemented, will mitigate the relevant conditions or events that raise substantial doubt about the entity's ability to continue as a going concern within one year after the date that the financial statements are issued. Generally, to be considered probable of being effectively implemented, the plans must have been approved by the Company's board of directors before the date that the financial statements are issued. The Company's future success is dependent on its ability to develop, obtain marketing approval for and, if approved, commercialize its product candidates, including Vicineum for the treatment of BCG-unresponsive NMIBC, and ultimately upon its ability to attain profitable operations. In order to commercialize its product candidates, including Vicineum for the treatment of BCG-unresponsive NMIBC, the Company needs to complete clinical development and comply with comprehensive regulatory requirements. The Company is subject to a number of risks similar to other late-stage clinical companies, including, but not limited to, successful discovery and development, marketing approval and, if approved, commercialization of its product candidates, raising additional capital, development and commercialization by its competitors of new technological innovations, protection of proprietary technology and market acceptance of its products. The successful discovery, development of product candidates, including Vicineum for the treatment of BCG-unresponsive NMIBC, requires substantial working capital, and management expects to seek additional funds through equity or debt financings or through additional commercialization partnerships , licensing transactions or other sources. The Company may be unable to obtain equity or debt financings or enter into additional commercialization partnerships or licensing transactions at favorable terms, or at all. To the extent that the Company raises additional capital through the sale of equity or convertible debt securities, the ownership interests of existing stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of existing stockholders. Debt financing, if available, may involve agreements that include liens or other restrictive covenants limiting the Company's ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If the Company raises additional funds through government or other third-party funding, strategic commercialization partnerships and alliances or licensing arrangements, it may have to relinquish valuable rights to its technologies, future revenue streams, research programs or product candidates or grant licenses on terms that may not be favorable. If the Company is unable to raise additional funds when needed, it may be required to implement cost reduction strategies and delay, limit, reduce or terminate its product development or future commercialization efforts or grant rights to develop and market products or product candidates that management would otherwise prefer to develop and market. The Company's management does not believe that its cash and cash equivalents of $52.4 million as of December 31, 2020 is sufficient to fund the Company's current operating plan for at least twelve months after the issuance of these consolidated financial statements. Given the history of significant losses, negative cash flows from operations, limited cash resources currently on hand and dependence by the Company on its ability - about which there can be no certainty - to obtain additional financing to fund its operations after the current cash resources are exhausted, substantial doubt exists about the Company's ability to continue as a going concern. These consolidated financial statements were prepared under the assumption that the Company will continue as a going concern and do not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result from the outcome of this uncertainty. |
BASIS OF PRESENTATION
BASIS OF PRESENTATION | 12 Months Ended |
Dec. 31, 2020 | |
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 ASC and Accounting Standards Updates ("ASUs"), promulgated by the Financial Accounting Standards Board ("FASB"). Use of Estimates The preparation of financial statements in accordance with GAAP and the rules and regulations of the United States Securities and Exchange Commission ("SEC") requires the use of estimates and assumptions, based on judgments considered reasonable, which affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. The Company bases its estimates and assumptions on historical experience, known trends and events and various other factors that management believes to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Although management believes its estimates and assumptions are reasonable when made, they are based upon information available at the time they are made. Management evaluates the estimates and assumptions on an ongoing basis and, if necessary, makes adjustments. Due to the risks and uncertainties involved in the Company’s business and evolving market conditions, and given the subjective element of the estimates and assumptions made, actual results may differ from estimated results. The most significant estimates and judgments impact the fair value of intangible assets, goodwill and contingent consideration; income taxes (including the valuation allowance for deferred tax assets); research and development expenses; and going concern considerations. Principles of Consolidation The Company’s consolidated financial statements include the accounts of the Company, its wholly owned subsidiary Viventia and its indirect subsidiaries, Viventia Bio USA Inc. and Viventia Biotech (EU) Limited. All intercompany transactions and balances have been eliminated in consolidation. Foreign Currency Translation The functional currency of the Company and each of its subsidiaries is the U.S. dollar. |
SUMMARY OF SIGNIFICANT ACCOUNTI
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 12 Months Ended |
Dec. 31, 2020 | |
Accounting Policies [Abstract] | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Cash, Cash Equivalents, Restricted Cash and Concentration of Credit Risk The Company's cash is held on deposit in demand accounts at a large financial institution in amounts in excess of the Federal Deposit Insurance Corporation ("FDIC") insurance coverage limit of $250,000 per depositor, per FDIC-insured bank, per ownership category. Restricted cash represents cash held by the Company's primary commercial bank to collateralize a letter of credit issued related to a license agreement and the credit limit on the Company's corporate credit card, and are classified as short term and long term, respectively. The Company considers all highly liquid investments purchased with an original maturity of three months or less to be cash equivalents. Financial instruments that potentially subject the Company to credit risk principally consists of cash equivalents. As of December 31, 2020 and 2019, the Company limited its credit risk associated with cash equivalents by placing investments in highly-rated money market funds. Property and Equipment Property and equipment are recorded at cost. Maintenance and repairs are charged to expense as incurred, and costs of improvements and renewals are capitalized. Depreciation is recognized using the straight-line method over the estimated useful lives of the relative assets. The Company uses an estimated useful life of five years for lab equipment, four years for furniture and fixtures, three years for computer equipment and software and the lesser of five years or the remaining lease term for leasehold improvements. Impairment of Long-Lived Assets Long-lived assets, such as property and equipment, are tested for impairment when events or changes in circumstances indicate that the carrying value of the asset may not be recoverable. Impairment testing of long-lived assets requires management to estimate the future net undiscounted cash flows of an asset using assumptions believed to be reasonable. Actual cash flows may differ from the estimates used in the impairment testing. If such assets are considered to be impaired, the Company recognizes an impairment loss when and to the extent that the estimated fair value of an asset is less than its carrying value. The Company did not recognize any impairment charges during the years ended December 31, 2020, 2019 and 2018. Indefinite-Lived Intangible Assets The Company's intangible assets consist of indefinite-lived, acquired in-process research and development ("IPR&D") worldwide product rights to Vicineum as a result of the Viventia Acquisition in 2016. IPR&D assets acquired in a business combination are considered indefinite-lived until the completion or abandonment of the associated research and development efforts. Amortization over the estimated useful life will commence at the time of the launch of Vicineum in the respective markets, if approved. If regulatory approval to market Vicineum for the treatment of BCG-unresponsive NMIBC is not obtained, the Company will immediately expense the related capitalized cost. Indefinite-lived intangible assets are quantitatively tested for impairment at least annually during the fourth quarter of the fiscal year, or more often if indicators of impairment are present. Impairment testing of indefinite-lived intangible assets requires management to estimate the future discounted cash flows of an asset using assumptions believed to be reasonable, but which are inherently uncertain. Actual future cash flows may differ from the estimates used in impairment testing. The Company recognizes an impairment loss when and to the extent that the estimated fair value of an intangible asset is less than its carrying value. In addition, on a quarterly basis, the Company performs a qualitative review of its business operations to determine whether events or changes in circumstances have occurred which could indicate that the carrying value of its intangible assets was not recoverable. Based on the annual testing and quarterly reviews performed, the Company concluded that the carrying value of its intangible assets was not impaired as of December 31, 2020 and 2019. Goodwill Goodwill on the Company's consolidated balance sheet is the result of the Viventia Acquisition in September 2016 and represents the difference between the purchase price and the fair value of the identifiable tangible and intangible net assets acquired under the acquisition method of accounting. Goodwill is not amortized; rather than recording periodic amortization, goodwill is quantitatively tested for impairment at least annually during the fourth quarter of the fiscal year, or more often if indicators of impairment are present. Impairment testing of goodwill requires management to estimate the future discounted cash flows of a reporting unit using assumptions believed to be reasonable, but which are inherently uncertain. Actual future cash flows may differ from the estimates used in impairment testing. If the fair value of the equity of a reporting unit exceeds the reporting unit’s carrying value, including goodwill, then goodwill is considered not to be impaired. The Company recognizes a goodwill impairment when and to the extent that the fair value of the equity of a reporting unit is less than the reporting unit's carrying value, including goodwill. The Company has only one reporting unit. In addition, on a quarterly basis, the Company performs a qualitative review of its business operations to determine whether events or changes in circumstances have occurred which could have a material adverse effect on the estimated fair value of each reporting unit and thus indicate a potential impairment of the goodwill carrying value. Based on the annual testing and quarterly reviews performed, the Company concluded that there was no goodwill impairment during the years ended December 31, 2020, 2019 and 2018. Contingent Consideration The Company uses a discounted cash flow model to estimate the fair value of the contingent consideration liability each reporting period, which represents the present value of projected future cash flows associated with regulatory approval milestones and royalties on net sales due to the selling shareholders of Viventia Bio Inc. as a result of the Viventia Acquisition in September 2016. See "Note 1. Description of Business" for additional information. Contingent consideration is measured at its estimated fair value on a recurring basis at each reporting period, with fluctuations in value resulting in a non-cash charge to earnings (or loss) during the period. The estimated fair value measurement is based on significant unobservable inputs (Level 3 within the fair value hierarchy), including internally developed financial forecasts, probabilities of success and timing of certain milestone events and achievements, which are inherently uncertain. Actual future cash flows may differ from the assumptions used to estimate the fair value of contingent consideration. The valuation of contingent consideration requires the use of significant assumptions and judgments, which management believes are consistent with those that would be made by a market participant. Management reviews its assumptions and judgments on an ongoing basis as additional market and other data is obtained, and any future changes in the assumptions and judgments utilized by management may cause the estimated fair value of contingent consideration to fluctuate materially, resulting in earnings volatility. Leases Effective January 1, 2019, the Company adopted ASC Topic 842, Leases (“ASC 842”) using the optional transition method outlined in ASU No. 2018-11, Leases (Topic 842), Targeted Improvements . The adoption of ASC 842 represents a change in accounting principle that aims to increase transparency and comparability among organizations by requiring the recognition of right-of-use assets and lease liabilities on the balance sheet for both operating and finance leases. In addition, the standard requires enhanced disclosures that meet the objective of enabling financial statement users to assess the amount, timing and uncertainty of cash flows arising from leases. The reported results for the year ended December 31, 2020 and 2019 reflect the application of ASC 842 guidance, while the reported results for priors were prepared in accordance with the previous ASC Topic 840, Leases ("ASC 840") guidance. The adoption of ASC 842 resulted in the recognition of operating lease right-of-use assets and corresponding lease liabilities of $0.2 million on the Company’s consolidated balance sheet as of January 1, 2019. The adoption of this guidance did not have a material impact on the Company’s financial condition, results of operations or cash flows; however, the adoption did result in significant changes to the Company’s financial statement disclosures. As part of the adoption of ASC 842, the Company utilized certain practical expedients outlined in the guidance. These practical expedients include: • Accounting policy election to use the short-term lease exception by asset class; • Election of the practical expedient package during transition, which includes: - An entity need not reassess whether any expired or existing contracts are or contain leases; - An entity need not reassess the classification for any expired or existing leases. As a result, all leases that were classified as operating leases in accordance with ASC 840 are classified as operating leases under ASC 842, and all leases that were classified as capital leases in accordance with ASC 840 are classified as finance leases under ASC 842; and - An entity need not reassess initial direct costs for any existing leases. The Company’s lease portfolio as of the adoption date and as of December 31, 2020 includes: a property lease for manufacturing, laboratory, warehouse and office space in Winnipeg, Manitoba, a property lease for its headquarters in Cambridge, MA, and a property lease for office space in Philadelphia, PA. The Company determines if an arrangement is a lease at the inception of the contract and has made a policy election to not separate out non-lease components from lease components, for all classes of underlying assets. The asset components of the Company’s operating leases are recorded as operating lease right-of-use assets and reported within other assets on the Company's consolidated balance sheet. The short-term and long-term liability components are recorded in other current liabilities and other liabilities, respectively, on the Company’s consolidated balance sheet. As of December 31, 2020, the Company did not have any finance leases. Right-of-use assets and operating lease liabilities are recognized based on the present value of lease payments over the lease term at the commencement date. Existing leases in the Company’s lease portfolio as of the adoption date were valued as of January 1, 2019. The Company uses an incremental borrowing rate based on the information available at commencement date in determining the present value of lease payments, if an implicit rate of return is not provided with the lease contract. Operating lease right-of-use assets are adjusted for incentives received. Operating lease costs are recognized on a straight-line basis over the lease term, in accordance with ASC 842, and also include variable operating costs incurred during the period. Lease costs also include amounts related to short-term leases. Research and Development Costs Research and development activities are expensed in the period incurred. Research and development expenses consist of both internal and external costs associated with all basic research activities, clinical development activities and technical efforts required to develop a product candidate. Internal research and development consist primarily of personnel costs, including salaries, benefits and share-based compensation, facilities leases, research-related overhead, pre-approval regulatory and clinical trial costs, manufacturing and other contracted services, license fees and other external costs. In certain circumstances, the Company is required to make advance payments to vendors for goods or services that will be received in the future for use in research and development activities. In such circumstances, the advance payments are recorded as prepaid assets and expensed when the activity has been performed or when the goods have been received. Share-Based Compensation The Company recognizes the grant-date fair value of share-based awards granted as compensation as expense on a straight-line basis over the requisite service period, which is generally the vesting period of the award. To date, the Company has not issued awards where vesting is subject to market conditions. From time to time, the Company has granted to its executives stock option awards which contain both performance-based and service-based vesting criteria. Performance milestone events were specific to the Company’s corporate goals, including certain clinical development objectives related to the VISTA Trial, regulatory and financial objectives. Share-based compensation expense associated with performance-based vesting criteria is recognized using the accelerated attribution method if the performance condition is considered probable of achievement in management’s judgment. The fair value of stock options is estimated at the time of grant using the Black-Scholes option pricing model, which requires the use of inputs and assumptions such as the fair value of the underlying stock, exercise price of the option, expected term, risk-free interest rate, expected volatility and dividend yield. The fair value of each grant of options during the years ended December 31, 2020, 2019 and 2018 was determined using the following methods and assumptions: • Expected Term. Due to the lack of historical exercise data and given the plain vanilla nature of the options granted by the Company, the expected term is determined using the “simplified" method, as prescribed in SEC Staff Accounting Bulletin ("SAB") No. 107 ("SAB 107"), whereby the expected life equals the arithmetic average of the vesting term (generally four years) and the original contractual term (ten years) of the option, taking into consideration multiple vesting tranches. • Risk-Free Interest Rate. The risk-free rate is based on the interest rate payable on United States Treasury securities in effect at the time of grant for a period that is commensurate with the assumed expected term. • Expected Volatility. The expected volatility is based on historical volatilities of a representative group of publicly traded biopharmaceutical companies, including the Company's own volatility, which were commensurate with the assumed expected term, as prescribed in SAB 107. • Dividend Yield. The dividend yield is 0% because the Company has never declared or paid, and for the foreseeable future does not expect to declare or pay, a dividend on its common stock. Income Taxes Income taxes are accounted for under the asset and liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases and net operating loss ("NOL") and research and development credit ("R&D credit") carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in operations in the period that includes the enactment date. A valuation allowance is recorded to the extent it is more likely than not that some portion or all of the deferred tax assets will not be realized. Unrecognized income tax benefits represent income tax positions taken on income tax returns that have not been recognized in the financial statements. The Company recognizes the benefit of an income tax position only if it is more likely than not (greater than 50%) that the tax position will be sustained upon tax examination, based solely on the technical merits of the tax position. Otherwise, no benefit is recognized. The tax benefits recognized are measured based on the largest benefit that has a greater than 50% likelihood of being realized upon ultimate settlement. The Company recognizes accrued interest and penalties related to uncertain tax positions as income tax expense in its consolidated statements of operations. As of December 31, 2020 and 2019, the Company did not have any uncertain tax positions. Revenue Recognition The Company has never received revenue from sales of its products. The Company has entered into several license agreements, as discussed in "Note 15. License Agreements," pursuant to which the Company received revenue from its commercialization partnership agreements , including the Qilu License Agreement. The Company may receive under each of its commercialization partnership agreements future additional development and regulatory milestone payments, sales-based milestones, and sales-based royalties. The Company recognizes revenue resulting from out-license and commercialization partnership agreements in accordance with ASC Topic 606, Revenue ("ASC 606"), which was effective for public companies on January 1, 2018. The Company adopted ASC 606 using the modified retrospective approach, and there was no resulting cumulative effect adjustment to opening accumulated deficit. Under ASC 606, an entity recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration which the entity expects to receive in exchange for those goods or services. To determine the appropriate amount of revenue to be recognized for arrangements determined to be within the scope of ASC 606, the Company performs the following five steps: (i) identification of the promised goods or services in the contract; (ii) determination of whether the promised goods or services are performance obligations, including whether they are distinct in the context of the contract; (iii) measurement of the transaction price, including the constraint on variable consideration; (iv) allocation of the transaction price to the performance obligations; and (v) recognition of revenue when each performance obligation is satisfied. The Company only recognizes revenue under the five-step model when collectability of payment is reasonably assured. |
RECENT ACCOUNTING PRONOUNCEMENT
RECENT ACCOUNTING PRONOUNCEMENTS | 12 Months Ended |
Dec. 31, 2020 | |
Accounting Standards Update and Change in Accounting Principle [Abstract] | |
RECENT ACCOUNTING PRONOUNCEMENTS | RECENT ACCOUNTING PRONOUNCEMENTS Adopted in 2020 In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments ("ASU 2016-13"). ASU 2016-13 requires measurement and recognition of expected credit losses for financial assets held. The amendments in ASU 2016-13 eliminate the probable threshold for initial recognition of a credit loss in GAAP and reflect an entity’s current estimate of all expected credit losses. ASU 2016-13 is effective for annual and interim periods beginning January 1, 2020 and is to be applied using a modified retrospective transition method. The Company adopted this guidance effective January 1, 2020, and it did not have a material impact on the Company’s financial position, results of operations or cash flows. In August 2018, the FASB issued ASU No. 2018-13, Fair Value Measurement (Topic 820): Disclosure Framework - Changes to the Disclosure Requirements for Fair Value Measurements ("ASU 2018-13"). ASU 2018-13 modifies fair value measurement disclosure requirements. ASU 2018-13 is effective for annual and interim periods beginning after December 15, 2019. The Company adopted this guidance effective January 1, 2020, and although it resulted in some additional footnote disclosures, it did not have a material impact on the Company’s disclosures. For the new disclosures regarding our Level 3 instruments, please read Note 5, Fair Value Measurements and Financial Instruments, to these consolidated financial statements. In August 2018, the FASB issued ASU No. 2018-15, Intangibles - Goodwill and Other - Internal-Use Software (Subtopic 350-40): Customer’s Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That Is a Service Contract ("ASU 2018-15") . ASU 2018-15 requires a customer in a cloud computing arrangement that is a service contract to follow the internal-use software guidance to determine which implementation costs to defer and recognize as an asset. The effective date for ASU 2018-15 is for annual and interim periods beginning after December 15, 2019. The amendments in this ASU should be applied either retrospectively or prospectively to all implementation costs incurred after the date of adoption. The Company adopted this guidance effective January 1, 2020, and it did not have a material impact on the Company’s financial position, results of operations or cash flows. Pending Adoption In December 2019, the FASB issued ASU No. 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes ("ASU 2019-12"). ASU 2019-12 simplifies the accounting for income taxes by removing certain exceptions to the general principles in Topic 740. The amendments in ASU 2019-12 also improve consistent application of and simplify GAAP for other areas of Topic 740 by clarifying and amending existing guidance. ASU 2019-12 is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2020. Early adoption is permitted. The method with which the amendments in this ASU are to be applied varies depending on the nature of the tax item impacted by amendment. The Company does not expect the adoption of ASU 2019-12 to have a material impact on the Company's financial position, results of operations or cash flows. |
FAIR VALUE MEASUREMENT AND FINA
FAIR VALUE MEASUREMENT AND FINANCIAL INSTRUMENTS | 12 Months Ended |
Dec. 31, 2020 | |
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 consolidated balance sheets approximated their fair values as of December 31, 2020 and 2019 due to their short-term nature. Certain of the Company’s financial instruments are measured at fair value using a three-level hierarchy that prioritizes the inputs used to measure fair value. This fair value hierarchy prioritizes the use of observable inputs and minimizes the use of unobservable inputs. The three levels of inputs used to measure fair value are as follows: Level 1 : Inputs are quoted prices for identical instruments in active markets, Level 2 : Inputs are quoted prices for similar instruments in active markets; quoted prices for identical or similar instruments in markets that are not active; or model-derived valuations whose inputs are observable or whose significant value drivers are observable. Level 3 : Inputs are unobservable and reflect the Company’s own assumptions, based on the best information available, including the Company’s own data. The following tables set forth the carrying amounts and fair values of the Company's financial instruments measured at fair value on a recurring basis as of December 31, 2020 and 2019 (in thousands): December 31, 2020 Fair Value Measurement Based on Carrying Amount Fair Value Quoted Prices in Active Significant other Observable Significant Unobservable Assets: Money market funds (cash equivalents) $ 16,374 $ 16,374 $ 16,374 $ — $ — Liabilities: Contingent consideration, current portion 8,985 $ 8,985 $ — $ — $ 8,985 Contingent consideration, net of current portion $ 99,855 $ 99,855 $ — $ — $ 99,855 December 31, 2019 Fair Value Measurement Based on Carrying Amount Fair Value Quoted Prices in Active Significant other Observable Significant Unobservable Assets: Money market funds (cash equivalents) $ 31,146 $ 31,146 $ 31,146 $ — $ — Liabilities: Contingent consideration, current portion — $ — $ — $ — $ — Contingent consideration, net of current portion $ 120,020 $ 120,020 $ — $ — $ 120,020 The Company evaluates transfers between fair value levels at the end of each reporting period. There were no transfers of assets or liabilities between fair value levels during the year ended December 31, 2020. Contingent Consideration 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 ranging from 2021 to 2033, the level of commercial sales of Vicineum forecasted for the United States, Europe, Japan, China and other potential markets and discount rates ranging from 8.4% to 8.8% as of December 31, 2020 and 5.6% to 11.8% as of December 31, 2019. There have been no changes to the valuation methods utilized during the year ended December 31, 2020. The following table sets forth a summary by quarter of the change in the fair value of the Company's contingent consideration liability, measured on a recurring basis at each reporting period, for the year ended December 31, 2020 (in thousands): Balance at December 31, 2019 $ 120,020 Change in fair value included in loss (53,700) Balance at March 31, 2020 66,320 Change in fair value included in loss 18,480 Balance at June 30, 2020 84,800 Change in fair value included in loss 18,400 Balance at September 30, 2020 103,200 Change in fair value included in loss 5,640 Balance at December 31, 2020 108,840 Balance at December 31, 2020, current portion 8,985 Balance at December 31, 2020, net of current portion 99,855 |
PROPERTY AND EQUIPMENT
PROPERTY AND EQUIPMENT | 12 Months Ended |
Dec. 31, 2020 | |
Property, Plant and Equipment [Abstract] | |
PROPERTY AND EQUIPMENT | PROPERTY AND EQUIPMENT The following table sets forth the composition of property and equipment, net as of December 31, 2020 and 2019 (in thousands): December 31, 2020 2019 Lab equipment $ 570 $ 572 Furniture and fixtures 16 16 Computer equipment 97 87 Software 28 28 Leasehold improvements 293 293 Property and equipment, gross 1,004 996 Less: accumulated depreciation (881) (758) Total Property and Equipment, Net $ 123 $ 238 |
INTANGIBLES AND GOODWILL
INTANGIBLES AND GOODWILL | 12 Months Ended |
Dec. 31, 2020 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
INTANGIBLES AND GOODWILL | INTANGIBLES AND GOODWILLIntangibles Intangible assets on the Company's consolidated balance sheet are the result of the Viventia Acquisition in September 2016. The following table sets forth the composition of intangible assets as of December 31, 2020 and 2019 (in thousands): December 31, 2020 2019 IPR&D intangible assets: Vicineum United States rights $ 31,700 $ 31,700 Vicineum European Union rights 14,700 14,700 Total Intangibles $ 46,400 $ 46,400 Goodwill |
ACCRUED EXPENSES
ACCRUED EXPENSES | 12 Months Ended |
Dec. 31, 2020 | |
Payables and Accruals [Abstract] | |
ACCRUED EXPENSES | ACCRUED EXPENSES The following table sets forth the composition of accrued expenses as of December 31, 2020 and 2019 (in thousands): December 31, 2020 2019 Research and development $ 1,372 $ 3,688 Payroll-related expenses 1,892 1,638 Severance to former Executives and other employees — 378 Professional fees 684 378 Other 25 87 Total Accrued Expenses $ 3,973 $ 6,169 Management Changes On August 26, 2019, the Company announced that Richard Fitzgerald departed as its Chief Financial Officer, effective immediately. In connection with his separation from the Company, Mr. Fitzgerald and the Company entered into a Separation Agreement and General Release dated as of September 9, 2019 (the “Fitzgerald Separation Agreement”), pursuant to which the Company provided Mr. Fitzgerald with twelve months of separation payments and benefits. The Company recorded $0.3 million of expense, which were paid through the normal payroll cycle through August 2020, when the Company completed its obligations related to the Fitzgerald Separation Agreement. On August 2, 2019, Dennis Kim, M.D., MPH departed as the Company's Chief Medical Officer, effective immediately. In connection with his separation from the Company, Dr. Kim and the Company entered into a Separation Agreement and General Release dated as of August 2, 2019 (the “Kim Separation Agreement”), pursuant to which the Company provided Dr. Kim with six months of separation payments in the amount of $0.2 million. In addition, Dr. Kim and the Company entered into a Consulting Agreement dated as of August 3, 2019 (the "Kim Consulting Agreement"), pursuant to which the Company agreed to pay Dr. Kim $0.1 million in consulting fees and transition expenses over the following three months ending November 2, 2019. The Company recorded $0.3 million of expenses related to these agreements. The Kim Consulting Agreement payments were made in a lump sum when the agreement concluded in November 2019. The separation payments were paid through the normal payroll cycle through January 2020, when the Company completed its obligations related to the Kim Separation Agreement. There was no remaining accrued severance as of December 31, 2020. |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 12 Months Ended |
Dec. 31, 2020 | |
Commitments and Contingencies Disclosure [Abstract] | |
COMMITMENTS AND CONTINGENCIES | COMMITMENTS AND CONTINGENCIES Executive Employment Agreements The Company has entered into employment agreements and offer letters with certain of its key executives, providing for separation payments and benefits in certain circumstances, as defined in the agreements. Legal Contingencies The Company is not currently subject to any material legal proceedings and has recorded no legal contingencies. Leases On January 1, 2019, the Company adopted ASC 842 using the optional transition method. The Company's lease portfolio includes: 1. An operating lease for its 31,100 square foot facility in Winnipeg, Manitoba which consists of manufacturing, laboratory, warehouse and office space, under a two-year renewable lease through September 2022 with a right to renew the lease for one subsequent three-year term. The minimum monthly rent under this lease is $12,600 per month. In addition to rent expense, the Company expects to incur $12,300 per month in related operating expenses. Operating lease cost under this lease, including the related operating costs, was $0.3 million for each of the years ended December 31, 2020 and 2019, respectively. Rent expense (under ASC 840), including the related operating costs, was $0.3 million for the year ended December 31, 2018; 2. A short-term property lease for modular office space for its current corporate headquarters in Cambridge, MA under a lease that renews every four months and currently extends through August 2021. The minimum monthly rent for this office space is currently $7,900 per month, which is subject to change if and as the Company adds or deducts space to or from the lease. The Company recorded $0.1 million in rent expense for each of the years ended December 31, 2020, 2019 and 2018 respectively, for this lease; and 3. A short-term property lease for modular office space in Philadelphia, PA under a lease that renews every six months and currently extends through October 2021. The minimum monthly rent for this office space is currently $13,500 per month, which is subject to change if and as the Company adds or deducts space to or from the lease. The Company recorded $0.2 million in rent expense for each of the years ended December 31, 2020 and 2019 and $0.1 million in rent expense for the year ended December 31,2018 for this lease. The asset component of the Company’s operating leases is recorded as operating lease right-of-use assets and reported within other assets on the Company's consolidated balance sheets. The short-term lease liability is recorded in other current liabilities and the long-term lease liability is recorded in other liabilities on the Company’s consolidated balance sheets. Operating lease cost is recognized on a straight-line basis over the lease term. The components of lease cost for the year ended December 31, 2020 is as follows (in thousands): Year Ended December 31, 2020 Year Ended December 31, 2019 Lease Cost: Operating lease (including related operating costs) 301 298 Short term property leases 261 263 Total lease costs 562 561 Supplemental Information: Year Ended December 31, 2020 Year Ended December 31, 2019 Weighted-average remaining lease term (years) 1.75 0.75 Weighted-average discount rate - operating leases 12 % 12 % The following table sets forth the Company's future minimum lease payments under non-cancelable leases as of December 31, 2020 (in thousands): Minimum Lease Payments: Year Ended December 31, 2020 2020 — 2021 162 2022 122 Total future minimum lease payments 284 Less: Amounts representing present value adjustment (13) Operating lease liabilities as of December 31, 2020 $ 271 |
STOCKHOLDERS' (DEFICIT) EQUITY
STOCKHOLDERS' (DEFICIT) EQUITY | 12 Months Ended |
Dec. 31, 2020 | |
Equity [Abstract] | |
STOCKHOLDERS' (DEFICIT) EQUITY | STOCKHOLDERS' (DEFICIT) EQUITY Equity Financings November 2019 ATM Offering In November 2019, the Company entered into an Open Market Sale Agreement SM (the "Sales Agreement") with Jefferies LLC ("Jefferies"), under which the Company may issue and sell shares of its common stock from time to time for an aggregate sales price of up to $35.0 million through Jefferies (the "ATM Offering"). Sales of common stock under the Sales Agreement are made by any method that is deemed to be an ATM offering as defined in Rule 415(a)(4) of the Securities Act of 1933, as amended, including but not limited to sales made directly on or through the Nasdaq Global Market or any other existing trading market for the common stock. The Company has no obligation to sell any of its common stock and may at any time suspend offers under the Sales Agreement or terminate the Sales Agreement. Subject to the terms and conditions of the Sales 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 floor price. 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. The Company incurred $0.2 million and $0.2 million in legal, accounting and printing costs in 2019 and 2020, respectively, in connection with the ATM Offering. From January 1, 2020 to December 31, 2020, the Company raised $38.0 million of net proceeds from the sale of 33.4 million shares of common stock at a weighted-average price of $1.17 per share under the ATM Offering, including $21.8 million of net proceeds from the sale of 16.6 million shares of common stock at a weighted-average price of $1.36 per share during the three months ended December 31, 2020. Share issue costs, including sales agent commissions, related to the ATM Offering totaled $0.7 million and $1.2 million during the three and twelve months ended December 31, 2020, respectively. On October 30, 2020, the Company entered into an amendment to the Sale Agreement pursuant to which it may issue and sell an additional $50 million of shares of common stock through Jefferies. June 2019 Financing In June 2019, the Company raised $27.8 million of net proceeds from the sale of 20.4 million shares of common stock and accompanying warrants to purchase an additional 20.4 million shares of common stock in an underwritten public offering (the "June 2019 Financing"). The combined purchase price for each share of common stock and accompanying warrant was $1.47. Subject to certain ownership limitations, the warrants issued in the June 2019 Financing were exercisable immediately upon issuance at an exercise price of $1.47 per share, subject to adjustments as provided under the terms of such warrants, and had a one-year term that expired on June 21, 2020. June 2018 Financing In June 2018, the Company raised $41.9 million of net proceeds from the sale of 25.6 million shares of common stock at a price of $1.80 per share in an underwritten public offering. March 2018 Financing In March 2018, the Company raised $9.0 million of net proceeds from the sale of (i) 8.0 million shares of common stock at a price of $1.13 per share in a registered direct public offering and (ii) 8.0 million warrants to purchase shares of common stock (the "2018 Warrants") at a price of $0.125 per 2018 Warrant in a concurrent private placement (collectively, the “March 2018 Financing”). Subject to certain ownership limitations, the 2018 Warrants issued in the March 2018 Financing were exercisable immediately upon issuance at an original exercise price of $1.20 per share, subject to adjustments as provided under the terms of such warrants, and have a five-year term expiring on March 23, 2023. See "Warrant Modifications" below for additional information. 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 December 31, 2020 and 2019. Common Stock Pursuant to its Certificate of Incorporation, the Company is authorized to issue 200.0 million shares of common stock, $0.001 par value per share, of which 140.4 million and 106.8 million shares were issued and outstanding as of December 31, 2020 and 2019, respectively. In addition, the Company had reserved for issuance the following amounts of shares of its common stock for the purposes described below as of December 31, 2020 and 2019 (in thousands): December 31, 2020 2019 Shares of common stock issued 140,450 106,801 Shares of common stock reserved for issuance for: Warrants 2,247 22,895 Stock options 10,147 6,236 Shares available for grant under 2014 Stock Incentive Plan 4,863 8,753 Shares available for sale under 2014 Employee Stock Purchase Plan — 28 Total shares of common stock issued and reserved for issuance 157,707 144,713 The voting, dividend and liquidation rights of holders of shares of common stock are subject to and qualified by the rights, powers and preferences of holders of shares of preferred stock. Each share of common stock entitles the holder to one vote on all matters submitted to a vote of the Company's stockholders; provided, however, that, except as otherwise required by law, holders of common stock shall not be entitled to vote on any amendment to the Company’s Certificate of Incorporation that relates solely to the terms of one or more outstanding series of preferred stock if the holders of such affected series are entitled, either separately or together as a class with the holders of one or more such series, to vote thereon. There shall be no cumulative voting. Dividends may be declared and paid on the common stock from funds lawfully available thereof as and when determined by the board of directors and subject to any preferential dividend or other rights of any then-outstanding preferred stock. The Company has never declared or paid, and for the foreseeable future does not expect to declare or pay, dividends on its common stock. Upon the dissolution or liquidation of the Company, whether voluntary or involuntary, holders of common stock will be entitled to receive all assets of the Company available for distribution to its stockholders, subject to any preferential or other rights of any then-outstanding preferred stock. Warrants All of the Company’s outstanding warrants are non-tradeable and equity-classified because they meet the derivative scope exception under ASC Topic 815-40, Derivatives and Hedging - Contracts in Entity’s Own Equity ("ASC 815-40") . The following table sets forth the Company's warrant activity for the year ended December 31, 2020 (in thousands): Issued Exercise Expiration December 31, 2019 Issued (Exercised) (Cancelled) December 31, 2020 Jun-2019 $1.47 Jun-2020 20,410 — — (20,410) — Mar-2018 $0.55* Mar-2023 1,943 — (238) — 1,705 Nov-2017 $0.55* Nov-2022 487 — — — 487 May-2015 $11.83 Nov-2024 28 — — — 28 Nov-2014 $11.04 Nov-2024 27 — — — 27 22,895 — (238) (20,410) 2,247 * Exercise price shown (i) reflects modification described below and (ii) subject to further adjustment based on down round provision added by amendment described below. During the year ended December 31, 2020, the Company received proceeds of $0.1 million from the exercises of 0.2 million 2018 Warrants. Warrant Modifications In October 2019, the Company entered into transactions with holders of its outstanding 2018 Warrants and 2017 Warrants to purchase the Company's common stock. At the time of the modification in October 2019, the 2018 Warrants and 2017 Warrants utilized the same form of warrant, which contained in a prohibition on variable rate transactions (as defined therein). Warrant holders agreed to waive such prohibition in exchange for certain concessions from the Company. Management evaluated the warrants after modifications and determined that they continued to be equity-classified under the derivative scope exception of ASC 815-40. The warrants were revalued immediately before and immediately after the modifications to calculate the $1.1 million incremental value of the modified warrants. The Company considers this incremental value to be akin to an offering cost since the modifications were directly related to enabling the ATM Offering and would not have otherwise been incurred. Therefore, in the fourth quarter of 2019, management initially capitalized the $1.1 million to deferred financing cost asset, with an offsetting credit to additional paid-in capital, and then reclassified the deferred financing cost asset to reduce the ATM Offering proceeds within equity as proceeds were received from sales of common stock under the ATM Offering. 2018 Warrants On October 28, 2019, the Company entered into transactions with the holders of its outstanding 2018 Warrants pursuant to which such holders either (i) exercised their warrants pursuant to a Warrant Exercise Agreement (the "2018 Warrant Exercise Agreements") or (ii) amended their warrants pursuant to a Warrant Amendment Agreement (the "2018 Warrant Amendment Agreements"). As consideration for those holders executing the 2018 Warrant Exercise Agreements, the Company reduced the exercise price of the warrants from $1.20 to $0.60 per share of the Company's common stock, resulting in proceeds of $2.0 million from the exercise of 3.4 million warrants. Pursuant to the 2018 Warrant Amendment Agreements, the prohibition on certain variable rate transactions included in the 2018 Warrants was amended to exclude ATM offerings and the exercise price of the warrants was reduced from $1.20 to the lesser of (a) $0.95 per share of common stock and (b) the exercise price as determined from time to time pursuant to the anti-dilution provisions in the 2018 Warrant Amendment Agreements. During the second quarter of 2020, the anti-dilution provision was triggered; as such, the Company recognized a deemed dividend of approximately $0.1 million which reduced the income available to common stockholders. As the Company has an accumulated deficit balance, there is no overall impact to additional paid-in capital, as the deemed dividend is recorded as offsetting debit and credit entries to additional paid-in capital. Therefore, the amounts were not presented on the Statement of Stockholders' (Deficit) Equity. In connection with the 2018 Warrant Exercise Agreements and 2018 Warrant Amendment Agreements, the Company entered into an amendment to the Securities Purchase Agreement dated March 21, 2018 related to the March 2018 Financing, by and among the Company and each purchaser identified on the signature pages thereto, with certain holders representing greater than 50.1% of the securities issued based on initial subscription amounts, pursuant to which the prohibition on variable rate transactions, including ATM offerings, was deleted in its entirety. 2017 Warrants On October 28, 2019, the Company entered into transactions with the holders of its outstanding 2017 Warrants pursuant to which such holders either (i) exercised their warrants pursuant to a Warrant Exercise Agreement (the "2017 Warrant Exercise Agreements") or (ii) amended their warrants pursuant to a Warrant Amendment Agreement (the "2017 Warrant Amendment Agreements"). As consideration for those holders executing the 2017 Warrant Exercise Agreements, the Company reduced the |
LOSS PER SHARE
LOSS PER SHARE | 12 Months Ended |
Dec. 31, 2020 | |
Earnings Per Share [Abstract] | |
LOSS PER SHARE | LOSS PER SHARE A net loss cannot be diluted. Therefore, when the Company is in a net loss position, basic and diluted loss per common share are the same. If the Company achieves profitability, the denominator of a diluted earnings per common share calculation includes both the weighted-average number of shares outstanding and the number of common stock equivalents, if the inclusion of such common stock equivalents would be dilutive. Dilutive common stock equivalents potentially include warrants, stock options and non-vested restricted stock awards and units using the treasury stock method, along with the effect, if any, from outstanding convertible securities. The majority of the Company’s outstanding warrants to purchase common stock have participation rights to any dividends that may be declared in the future and are therefore considered to be participating securities. Participating securities have the effect of diluting both basic and diluted earnings per share during periods of income. During periods of loss, no loss is allocated to the participating securities since the holders have no contractual obligation to share in the losses of the Company. 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. The two-class method was not applied for the twelve months ended December 31, 2020, 2019 and 2018 as the Company’s participating securities do not have any obligation to absorb net losses. The following potentially dilutive securities outstanding as of December 31, 2020, 2019 and 2018 have been excluded from the denominator of the diluted loss per share of common stock outstanding calculation (in thousands): December 31, 2020 2019 2018 Warrants 2,247 22,895 9,258 Stock options 10,147 6,236 3,942 12,394 29,131 13,200 |
SHARE-BASED COMPENSATION
SHARE-BASED COMPENSATION | 12 Months Ended |
Dec. 31, 2020 | |
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 consolidated statements of operations for the years ended December 31, 2020, 2019 and 2018 (in thousands): Year ended December 31, 2020 2019 2018 Research and development $ 350 $ 188 $ 505 General and administrative 1,407 1,049 778 Total Share-based Compensation $ 1,757 $ 1,237 $ 1,283 2014 Stock Incentive Plan The Company's 2014 Stock Incentive Plan, as amended ("2014 Plan"), was adopted by its board of directors in December 2013 and subsequently approved by its stockholders in January 2014. The 2014 Plan became effective immediately prior to the closing of the Company's IPO in February 2014 and provides for the grant of incentive and non-qualified stock options, restricted stock awards and units, stock appreciation rights and other stock-based awards, with amounts and terms of grants determined by the Company's board of directors at the time of grant, to the Company's employees, officers, directors, consultants and advisors. Currently there are only stock options outstanding under the 2014 Plan, which generally vest over a four-year period at the rate of 25% of the grant vesting on the first anniversary of the date of grant and 6.25% of the grant vesting at the end of each successive three-month period thereafter. Stock options granted under the 2014 Plan are exercisable for a period of ten years from the date of grant. There were 7.9 million stock options outstanding under the 2014 Plan as of December 31, 2020. At the Annual Meeting of 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. There were 4.9 million shares of common stock available for issuance under the 2014 Plan as of December 31, 2020. 2009 Stock Incentive Plan The Company maintains a 2009 Stock Incentive Plan, as amended and restated ("2009 Plan"), which provided for the grant of incentive and non-qualified stock options and restricted stock awards and units, with amounts and terms of grants determined by the Company's board of directors at the time of grant, to its employees, officers, directors, consultants and advisors. Upon the closing of its IPO in February 2014, the Company ceased granting awards under the 2009 Plan and all shares (i) available for issuance under the 2009 Plan at such time and (ii) subject to outstanding awards under the 2009 Plan that expire, terminate or are otherwise surrendered, canceled, forfeited or repurchased without having been fully exercised or resulting in any common stock being issued were carried over to the 2014 Plan. Stock options granted under the 2009 Plan are exercisable for a period of ten years from the date of grant. There were remaining 0.1 million fully vested stock options outstanding under the 2009 Plan as of December 31, 2020. Out-of-Plan Inducement Grants From time to time, the Company has granted equity awards to its newly hired employees in accordance with the Nasdaq Stock Market LLC ("Nasdaq") employment inducement grant exemption (Nasdaq Listing Rule 5635(c)(4)). Such grants are made outside of the 2014 Plan and act as an inducement material to the employee's acceptance of employment with the Company. As of December 31, 2020, there were 2.1 million stock options outstanding which were granted as employment inducement awards outside of the 2014 Plan. Stock Options The following table sets forth a summary of the Company’s total stock option activity, including awards granted under the 2014 Plan and 2009 Plan and inducement grants made outside of stockholder approved plans, for the years ended December 31, 2020, 2019 and 2018: Number of Shares under Option Weighted-Average Weighted-Average Remaining Aggregate Outstanding at December 31, 2017 2,696 $3.16 8.55 $ 146 Granted 3,546 $1.71 Exercised (439) $0.62 Canceled or forfeited (1,861) $3.21 Outstanding at December 31, 2018 3,942 $2.12 9.14 $ 57 Granted 3,986 $1.02 Exercised (90) $1.10 Canceled or forfeited (1,602) $1.78 Outstanding at December 31, 2019 6,236 $1.52 8.83 $ 358 Granted 4,044 $0.87 Exercised (12) $1.13 Canceled or forfeited (121) $1.04 Outstanding at December 31, 2020 10,147 $1.26 8.50 $ 3,160 Exercisable at December 31, 2020 4,228 $1.63 7.85 $ 931 The Company recognized share-based compensation expense related to stock options of $1.8 million, $1.2 million and $1.3 million for the years ended December 31, 2020, 2019 and 2018, respectively. As of December 31, 2020, there was $3.6 million of total unrecognized compensation cost related to non-vested stock options which the Company expects to recognize over a weighted-average period of 2.4 years. The weighted-average grant-date fair value of stock options granted during the years ended December 31, 2020, 2019 and 2018 were $0.87, $0.69 and $1.14, respectively. The total intrinsic value of stock options exercised for the years ended December 31, 2020, 2019 and 2018 was de minimis, de minimis and $0.5 million, respectively. For the years ended December 31, 2020, 2019 and 2018, 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: Year ended December 31, 2020 2019 2018 Fair value of common stock $0.56 $1.02 $1.71 Exercise price of the option $0.87 $1.02 $1.71 Expected term (in years) 6.1 6.0 6.0 Risk-free interest rate 1.3% 2.1% 2.8% Expected volatility 71.5% 78.1% 74.2% Dividend yield —% —% —% Performance-Based Grants |
EMPLOYEE BENEFIT PLANS
EMPLOYEE BENEFIT PLANS | 12 Months Ended |
Dec. 31, 2020 | |
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. 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 the Company’s 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 Company's common stock issued and sold pursuant to the 2014 ESPP are shown on the consolidated statements of changes in stockholders' (deficit) equity. As of December 31, 2020, there were no shares of the Company's common stock available for sale under the 2014 ESPP. The Company sold a de minimis number of shares under the ESPP for each of the three years ended December 31, 2020, 2019 and 2018, respectively. Defined Contribution Plans United States - 401(k) Plan The Company maintains a 401(k) defined contribution retirement plan which covers all of its U.S. employees. Employees are eligible to participate 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 Company contributed a de minimis amount for each of the three years ended December 31, 2020, 2019 and 2018, respectively. Canada - Defined Contribution Plan |
INCOME TAXES
INCOME TAXES | 12 Months Ended |
Dec. 31, 2020 | |
Income Tax Disclosure [Abstract] | |
INCOME TAXES | INCOME TAXES The following table sets forth the components of the Company's loss before income taxes by country (in thousands): Year ended December 31, 2020 2019 2018 Country: United States $ (35,529) $ (27,468) $ (15,977) Canada 14,577 (80,032) (17,716) Total Loss before Income Taxes $ (20,952) $ (107,500) $ (33,693) The Company's tax provision is comprised of the following components (in thousands): Year ended December 31, 2020 2019 2018 Current Tax Provision: Federal $ — $ — $ — State — — — Foreign 1,445 — — Total Current Provision $ 1,445 $ — $ — Deferred Tax Provision: Federal $ — $ — $ — State — — — Foreign — — — Total Deferred Provision $ — $ — $ — Total Tax Provision $ 1,445 $ — $ — The Company did not record current or deferred income tax or benefit for the years ended December 31, 2019 and 2018. The following table sets forth a reconciliation of the statutory United States federal income tax rate to the Company’s effective income tax rate: Year ended December 31, 2020 2019 2018 United States federal statutory income tax rate 21.0 % 21.0 % 21.0 % Impact of foreign rate differential (4.2) 4.4 1.6 State taxes, net of federal benefit 2.0 0.6 1.3 Stock option cancellations (0.2) — (1.2) Contingent consideration 14.4 (18.0) (5.5) General business credits and other credits 6.6 0.4 0.7 Permanent differences 0.2 — (0.3) Other (2.1) (0.5) 0.5 Foreign taxes (6.9) — — Change in valuation allowance (37.7) (7.9) (18.1) Effective Income Tax Rate (6.9) % — % — % The following table sets forth the tax effects of temporary differences that gave rise to significant portions of the Company's deferred tax assets and liabilities (in thousands): December 31, 2020 2019 Deferred tax assets: NOL carryforwards $ 57,935 $ 50,727 R&D credit carryforwards 3,787 4,385 Accruals and other 3,811 2,464 Capitalized start-up costs 70 91 Other 28 57 Gross deferred tax assets 65,631 57,724 Deferred tax liabilities: IPR&D (12,528) (12,528) Property and equipment — — Gross deferred tax liabilities (12,528) (12,528) Valuation allowance (65,631) (57,724) Net Deferred Tax Liability $ (12,528) $ (12,528) In assessing the realizability of the Company's deferred tax assets, management considers all relevant positive and negative evidence in determining whether it is more likely than not that some portion or all of the deferred tax assets will not be realized. The realization of deferred tax assets is dependent on several factors, including the generation of sufficient taxable income prior to the expiration of the NOL and R&D credit carryforwards . The Company has generated NOLs since its inception, and management believes that it is more likely than not that the Company's deferred tax assets will not be realized. As a result, valuation allowances of $65.6 million and $57.7 million have been established as of December 31, 2020 and 2019, respectively. The $7.9 million increase in the valuation allowance was attributable to the NOL for the year ended December 31, 2020. The net deferred tax liability of $12.5 million primarily relates to the potential future impairments or amortization associated with IPR&D intangible assets, which is not deductible for tax purposes and cannot be considered as a source of income to realize deferred tax assets. As a result, the Company recorded the deferred tax liability with an offset to goodwill. The following table summarizes the Company's NOL and R&D and other credit carryforwards in the United States and Canada as of December 31, 2020 (in millions): Amount Expiration Beginning in Through United States: Federal NOL carryforwards - indefinite $ 75.2 None None Federal NOL carryforwards $ 118.9 2030 2038 State NOL carryforwards $ 134.4 2030 2040 Federal R&D credit carryforwards $ 2.3 2027 2040 State R&D credit carryforwards $ 0.9 2027 2040 Canada: Federal non-capital loss carryforwards $ 32.2 2035 2040 Federal scientific research and experimental development expense carryforwards $ 7.0 2032 2040 Federal and provincial investment tax credit carryforwards $ 0.8 2032 2040 Under the Tax Reform Act of 1986 (the "Act'), NOL and R&D credit carryforwards are subject to review and possible adjustment by the Internal Revenue Service, and there are similar provisions in certain state and foreign tax laws. NOL and R&D credit carryforwards may become subject to an annual limitation in the event of certain cumulative changes in the ownership interests of significant shareholders over a three-year period in excess of 50 percent, as defined in Sections 382 and 383 of the Internal Revenue Code, respectively. This could limit the amount of tax attributes that can be utilized to offset future taxable income or tax liabilities. The amount of the annual limitation is determined based on the value of the Company immediately prior to the ownership change. Subsequent ownership changes may further affect the limitation in future years. Management completed a Section 382 study through March 31, 2016 and determined that it is more likely than not that the Company's NOL carryforwards are subject to a material limitation. Accordingly, the Company reduced its NOL carryforward by $0.8 million. The Company has continued to raise additional equity capital since March 2016 but has not done any additional analysis to determine whether or not ownership changes, as defined in the Act, have occurred, which would result in additional limitations. There could be additional ownership changes in the future that could further limit the amount of NOL carryforwards that the Company can utilize. The Company has not yet conducted a study of its R&D credit carryforwards. Such a study may result in an adjustment to the Company’s R&D credit carryforwards; however, until a study is completed and any adjustment is known, no amount is being presented as an uncertain tax position. A full valuation allowance has been provided against the Company’s R&D credit carryforwards, and, if an adjustment is required, it would be offset by an adjustment to the valuation allowance. As of December 31, 2020, the Company had no accrued interest or penalties related to uncertain tax positions and no amounts have been recognized in the Company's consolidated statements of operations. Due to NOL and R&D credit carryforwards that remain unutilized, income tax returns filed in the United States, certain states within the United States and Canadian tax jurisdictions from the Company's inception through 2019 remain subject to examination by the taxing jurisdictions. There are currently no audits in process in any of the Company's tax filing jurisdictions. |
LICENSE AGREEMENTS
LICENSE AGREEMENTS | 12 Months Ended |
Dec. 31, 2020 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
LICENSE AGREEMENTS | LICENSE AGREEMENTS Vicineum In-License Agreements Zurich License Agreement The Company has a license agreement with the University of Zurich ("Zurich") (the "Zurich License Agreement") which grants the Company exclusive license rights, with the right to sublicense, to make, have made, use and sell under certain patents primarily directed to the Company's targeting agent, including an EpCAM chimera and related immunoconjugates and methods of use and manufacture of the same. These patents cover some key aspects of Vicineum. The Company may be obligated to pay $0.5 million in milestone payments for the first product candidate that achieves applicable regulatory development milestones. Based on current status, the Company anticipates that these milestones may be triggered by regulatory development pathway of Vicineum. As part of the consideration, the Company is also obligated to pay up to a 4% royalty on the net product sales for products covered by or manufactured using a method covered by a valid claim in the Zurich patent rights. Royalties owed to Zurich will be reduced if the total royalty rate owed by the Company to Zurich and any other third party is 10% or greater, provided that the royalty rate to Zurich may not be less than 2% of net sales. The obligation to pay royalties in a particular country expires upon the expiration or termination of the last of the Zurich patent rights that covers the manufacture, use or sale of a product. There is no obligation to pay royalties in a country if there is no valid claim that covers the product or a method of manufacturing the product. The Company recorded an expense of $0.3 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 application with the FDA in December 2020. Micromet License Agreement The Company has a license agreement with Micromet AG ("Micromet"), now part of Amgen, Inc., (the "Micromet License Agreement") which grants it non-exclusive rights, with certain sublicense rights, for know-how and patents allowing exploitation of certain single chain antibody products. These patents cover some key aspects of Vicineum. Under the terms of the Micromet License Agreement, the Company may be obligated to pay up to €2.9 million in milestone payments for the first product candidate that achieves applicable regulatory and sales-based development milestones. Based on current development status, the Company anticipates that certain of these milestones may be triggered by the development pathway of Vicineum. The Company is also required to pay up to a 3.5% royalty on the net sales for products covered by the agreement, which includes Vicineum. The royalty rate owed to Micromet in a particular country will be reduced to 1.5% if there are no valid claims covering the product in that country. The obligation to pay royalties in a particular country expires upon the later of the expiration date of the last valid claim covering the product and the tenth anniversary of the first commercial sale of the product in such country. Finally, the Company is required to pay to Micromet an annual license maintenance fee of €50,000, which can be credited towards any royalty payment the Company owes to Micromet. The Company recorded an expense of €0.7 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 application with the FDA in December 2020. XOMA License Agreement The Company has a license agreement with XOMA Ireland Limited ("XOMA") (the "XOMA License Agreement") which grants it non-exclusive rights, with certain sublicense rights, to certain XOMA patent rights and know-how related to certain expression technology, including plasmids, expression strains, plasmid maps and production systems. These patents and related know-how cover some key aspects of Vicineum. Under the terms of the 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. Based on current clinical status, the Company anticipates that these milestones may be triggered by the clinical development pathway of Vicineum. 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 Agreement Roche License Agreement In June 2016, the Company entered into 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 anti-IL-6 antagonist monoclonal antibody technology owned by the Company (collectively, the “Licensed Intellectual Property”). Under the License Agreement, Roche is required to continue developing, at its cost, EBI-031 and any other product made from the Licensed Intellectual Property that contains an IL-6 antagonist anti-IL monoclonal antibody (“Licensed Product”) and pursue ongoing patent prosecution, at its cost. Financial Terms The Company received from Roche an upfront license fee of $7.5 million in August 2016 upon the effectiveness of the Roche License Agreement following approval by the Company's stockholders, and Roche agreed to pay up to an additional $262.5 million upon the achievement of specified regulatory, development and commercialization milestones with respect to up to two unrelated indications. Specifically, an aggregate amount of up to $197.5 million is payable to the Company for the achievement of specified milestones with respect to the first indication, consisting of (i) $72.5 million in development milestones, the first of which is $20.0 million for initiation of the first Phase II study, (ii), $50.0 million in regulatory milestones and (iii) $75.0 million in commercialization milestones. In September 2016, Roche paid the Company the first development milestone of $22.5 million as a result of the Investigational New Drug application for EBI-031 becoming effective on or before September 15, 2016. Additional amounts of up to $65.0 million are payable upon the achievement of specified development and regulatory milestones in a second indication. In addition, the Company is entitled to receive royalty payments in accordance with a tiered royalty rate scale, with rates ranging from 7.5% to 15% of net sales of potential future products containing EBI-031 and up to 50% of these rates for net sales of potential future products containing other IL-6 compounds, with each of the royalties subject to reduction under certain circumstances and to the buy-out options of Roche. Buy-Out Options The Roche License Agreement provides for two “option periods” during which Roche may elect to make a one-time payment to the Company and, in turn, terminate its diligence, milestone and royalty payment obligations under the License Agreement. Specifically, (i) Roche may exercise a buy-out option following the first dosing (“Initiation”) in the first Phase 2 study for a Licensed Product until the day before Initiation of the first Phase 3 study for a Licensed Product, in which case Roche is required to pay the Company $135.0 million within 30 days after Roche's exercise of such buy-out option and receipt of an invoice from the Company, or (ii) Roche may exercise a buy-out option following the day after Initiation of the first Phase 3 study for a Licensed Product until the day before the acceptance for review by the FDA or other regulatory authority of a BLA or similar application for marketing approval for a Licensed Product in either the United States or in the E.U., in which case Roche is required to pay the Company, within 30 days after Roche’s exercise of such buy-out option and receipt of an invoice from the Company, $265.0 million, which amount would be reduced to $220.0 million if none of the Company’s patent rights containing a composition of matter claim covering any compound or Licensed Product has issued in the E.U. Termination Either the Company or Roche may each terminate the Roche License Agreement if the other party breaches any of its material obligations under the Roche License Agreement and does not cure such breach within a specified cure period. Roche may terminate the Roche License Agreement following effectiveness by providing advance written notice to the Company or by providing written notice if the Company is debarred, disqualified, suspended, excluded, or otherwise declared ineligible from certain federal or state agencies or programs. The Company may terminate the Roche License Agreement if, prior to the first filing of a BLA for a Licensed Product, there is a period of 12 months where Roche is not conducting sufficient development activities with respect to the products made from the Licensed Intellectual Property. C ommercialization 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 “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 Licensed Product in Greater China. The Company retains (i) development and commercialization rights in the rest of the world excluding Greater China and MENA 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 (i) a one-time upfront cash payment of $12 million, subject to certain tax withholdings such as income taxes and value added taxes ("VAT"), payable within 45 business days of the execution date, subject to delivery by the Company of certain know-how and other documentation related to the Licensed Product to Qilu, and (ii) milestone payments totaling up to $23 million upon the achievement of certain technology transfer, development and regulatory milestones. All payments are inclusive of VAT, which are withheld by Qilu upon payment, and for which future recovery of such taxes may be available. In September 2020, the Company received $10.0 million in net proceeds due under the Qilu License Agreement. Qilu also agreed to pay the Company a 12% royalty based upon annual net sales of Licensed Products in Greater China. The royalties are payable on a Licensed Product-by-Licensed Product and region-by-region basis commencing on the first commercial sale of a Licensed Product in a region and continuing until the latest of (i) twelve years after the first commercial sale of such Licensed Product in such region, (ii) the expiration of the last valid patent claim covering or claiming the composition of matter, method of treatment, or method of manufacture of such Licensed Product in such region, and (iii) the expiration of regulatory or data exclusivity for such Licensed Product in such region (collectively, the “Royalty Term”). The royalty rate is subject to reduction under certain circumstances, including when there is no valid claim of a licensed patent that covers a Licensed Product in a particular region or no data or regulatory exclusivity of a Licensed Product in a particular region. Qilu is responsible for all costs related to developing, obtaining regulatory approval of and commercializing the Licensed Products in the Field in Greater China. Qilu is required to use commercially reasonable efforts to develop, seek regulatory approval for, and commercialize at least one Licensed Product in the Field in 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 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 Licensed Product necessary for Qilu to develop and commercialize the 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 for the Licensed Product has been obtained. The Qilu License Agreement will expire on a Licensed Product-by-Licensed Product and region-by-region basis on the date of the expiration of all applicable Royalty Terms. Either party may terminate the 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 Accounting Standards Codification 606, Revenue from Contracts with Customers ("ASC 606"), which was adopted effective January 1, 2018. The initial transaction price was estimated to be $11.2 million and was based on the up-front fixed consideration of $12 million less amounts withheld for VAT. The Company concluded that its promises under the 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 Company is reasonably certain that no refund of the upfront payment will be due to Qilu. Additional consideration to be paid to the Company upon the achievement of certain milestones, as well as recoverability of VAT, will be included if it is expected that the amounts will be received and the amounts would not be subject to a constraint. As of December 31, 2020, none of these amounts were reasonably certain to be achieved due to the nature and timing of the underlying activities. For the three and twelve months ended December 31, 2020, the Company recorded $1.1 million of income tax expense pursuant to the Qilu License Agreement. The income tax expense relates to withholding taxes paid in foreign jurisdictions and is reported as provision for income taxes on the consolidated statement of operations and comprehensive loss for each period. Other Commercialization Partnership Agreements On November 30, 2020, the Company entered into an additional license agreement 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") region, ("the MENA License Agreement"). The Company retains development and commercialization rights in the rest of the world excluding Greater China and MENA. In consideration for the rights granted by the Company, the counterparty 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 milestone payments upon the achievement of certain sales-based milestones as well as a royalty based upon annual net sales in the MENA region. During the three months ended December 31, 2020, the Company received $2.7 million under the MENA License Agreement. The MENA License Agreement is also subject to the provisions of ASC 606. The initial transaction price was estimated by management as $1.5 million as of December 31, 2020 and was based on 50% of the upfront payment, or the amount not subject to a refund if certain regulatory approvals in MENA are not obtained. The Company also concluded that its promises under the MENA License Agreement represented two distinct performance obligations, the first of which is a bundled performance obligation related to the delivery of the license, associated know-how and certain documentation. The second performance obligation relates to the delivery of manufactured product. Both performance obligations were not achieved as of December 31, 2020; as such, no revenue has been recognized under this agreement during 2020. Additional variable consideration, determined to be allocated entirely to the bundled license performance obligation, to be paid to the Company based upon future sales levels will be recognized as revenue when the underlying sales of the licensed product occurs. In addition, variable |
RELATED-PARTY TRANSACTIONS
RELATED-PARTY TRANSACTIONS | 12 Months Ended |
Dec. 31, 2020 | |
Related Party Transactions [Abstract] | |
RELATED-PARTY TRANSACTIONS | RELATED-PARTY TRANSACTIONS The Company leases its facility in Winnipeg, Manitoba from an affiliate of Leslie L. Dan, a director of the Company until his retirement in July 2019. For each of the years ended December 31, 2020, 2019 and 2018, the Company paid $0.3 million of rent, which includes the related operating expenses. The Company pays fees under an intellectual property license agreement to Protoden Technologies Inc. ("Protoden"), a company owned by Clairmark, an affiliate of Mr. Dan. Pursuant to the agreement, the Company has an exclusive, perpetual, irrevocable and non-royalty bearing license, with the right to sublicense, to certain patents and technology to make, use and sell products that utilize such patents and technology. The annual fee is $0.1 million. Upon expiration of the term on December 31, 2024, the licenses granted to the Company will require no further payments to Protoden. For each of the years ended December 31, 2020, 2019 and 2018, the Company paid $0.1 million under this license agreement. The Company previously leased office space in Toronto, Ontario from Mr. Dan. The lease was terminated by the Company in December 2018. For the year ended December 31, 2018, the Company paid $18,000 of rent. |
SUBSEQUENT EVENTS
SUBSEQUENT EVENTS | 12 Months Ended |
Dec. 31, 2020 | |
Subsequent Events [Abstract] | |
SUBSEQUENT EVENTS | SUBSEQUENT EVENTS On January 13, 2021, the Company issued a press release announcing that the Investigational New Drug application for Vicineum submitted by the Company’s licensee in China, Qilu Pharmaceutical Co., Ltd., was accepted for review by the China National Medical Products Administration. On February 16, 2021, the Company announced that the FDA has accepted for filing the Company’s BLA for Vicineum, for the treatment of BCG-unresponsive NMIBC, and granted the application Priority Review. With Priority Review, the anticipated target Prescription Drug User Fee Act (“PDUFA”) date for a decision on the BLA is August 18, 2021. In addition, the FDA stated that it is not currently planning to hold an advisory committee meeting to discuss the BLA for Vicineum. On February 17, 2021, the Company entered into Amendment No. 2 (the “Second Amendment”) to the Sale Agreement with Jefferies, dated November 29, 2019, as amended by Amendment No. 1 to the Sale Agreement. The Second Amendment allows for the Company to issue and sell through Jefferies up to an additional $34.5 million of shares of its common stock, par value $0.001 per share, under the Sale Agreement. As of the effective date of the Second Amendment, the Company had approximately $35.5 million in total remaining capacity under the Sale Agreement. On March 8, 2021, the Company issued a press release announcing the March 5, 2021 submission of the Marketing Authorization Application to the EMA for Vicineum for the treatment of BCG-unresponsive NMIBC under the EMA’s centralized procedure. The Company raised $60.3 million of net proceeds from the sale of 26.3 million shares of common stock under the ATM Offering from January 1, 2021 through March 8, 2021. Stock Options Granted In February 2021, the Company's board of directors granted 4.1 million stock options with an exercise price of $3.17 to employees and officers under the Company's 2014 Plan. These stock options had a grant-date fair value of $2.06 and vest at the rate of 6.25% of the grant every three months over a period of four years, subject to the recipient's continued service with the Company through the applicable vesting dates. |
SUMMARY OF SIGNIFICANT ACCOUN_2
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 12 Months Ended |
Dec. 31, 2020 | |
Accounting Policies [Abstract] | |
Use of Estimates | Use of EstimatesThe preparation of financial statements in accordance with GAAP and the rules and regulations of the United States Securities and Exchange Commission ("SEC") requires the use of estimates and assumptions, based on judgments considered reasonable, which affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. The Company bases its estimates and assumptions on historical experience, known trends and events and various other factors that management believes to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Although management believes its estimates and assumptions are reasonable when made, they are based upon information available at the time they are made. Management evaluates the estimates and assumptions on an ongoing basis and, if necessary, makes adjustments. Due to the risks and uncertainties involved in the Company’s business and evolving market conditions, and given the subjective element of the estimates and assumptions made, actual results may differ from estimated results. The most significant estimates and judgments impact the fair value of intangible assets, goodwill and contingent consideration; income taxes (including the valuation allowance for deferred tax assets); research and development expenses; and going concern considerations. |
Principles of Consolidation | Principles of Consolidation The Company’s consolidated financial statements include the accounts of the Company, its wholly owned subsidiary Viventia and its indirect subsidiaries, Viventia Bio USA Inc. and Viventia Biotech (EU) Limited. All intercompany transactions and balances have been eliminated in consolidation. |
Foreign Currency Translation | Foreign Currency Translation The functional currency of the Company and each of its subsidiaries is the U.S. dollar. |
Cash, Cash Equivalents, Restricted Cash and Concentration of Credit Risk | Cash, Cash Equivalents, Restricted Cash and Concentration of Credit RiskThe Company's cash is held on deposit in demand accounts at a large financial institution in amounts in excess of the Federal Deposit Insurance Corporation ("FDIC") insurance coverage limit of $250,000 per depositor, per FDIC-insured bank, per ownership category. Restricted cash represents cash held by the Company's primary commercial bank to collateralize a letter of credit issued related to a license agreement and the credit limit on the Company's corporate credit card, and are classified as short term and long term, respectively. The Company considers all highly liquid investments purchased with an original maturity of three months or less to be cash equivalents. Financial instruments that potentially subject the Company to credit risk principally consists of cash equivalents. As of December 31, 2020 and 2019, the Company limited its credit risk associated with cash equivalents by placing investments in highly-rated money market funds. |
Property and Equipment | Property and Equipment Property and equipment are recorded at cost. Maintenance and repairs are charged to expense as incurred, and costs of improvements and renewals are capitalized. Depreciation is recognized using the straight-line method over the estimated useful lives of the relative assets. The Company uses an estimated useful life of five years for lab equipment, four years for furniture and fixtures, three years for computer equipment and software and the lesser of five years or the remaining lease term for leasehold improvements. |
Impairment of Long-Lived Assets | Impairment of Long-Lived AssetsLong-lived assets, such as property and equipment, are tested for impairment when events or changes in circumstances indicate that the carrying value of the asset may not be recoverable. Impairment testing of long-lived assets requires management to estimate the future net undiscounted cash flows of an asset using assumptions believed to be reasonable. Actual cash flows may differ from the estimates used in the impairment testing. If such assets are considered to be impaired, the Company recognizes an impairment loss when and to the extent that the estimated fair value of an asset is less than its carrying value. The Company did not recognize any impairment charges during the years ended December 31, 2020, 2019 and 2018. |
Indefinite-Lived Intangible Assets | Indefinite-Lived Intangible Assets The Company's intangible assets consist of indefinite-lived, acquired in-process research and development ("IPR&D") worldwide product rights to Vicineum as a result of the Viventia Acquisition in 2016. IPR&D assets acquired in a business combination are considered indefinite-lived until the completion or abandonment of the associated research and development efforts. Amortization over the estimated useful life will commence at the time of the launch of Vicineum in the respective markets, if approved. If regulatory approval to market Vicineum for the treatment of BCG-unresponsive NMIBC is not obtained, the Company will immediately expense the related capitalized cost. Indefinite-lived intangible assets are quantitatively tested for impairment at least annually during the fourth quarter of the fiscal year, or more often if indicators of impairment are present. Impairment testing of indefinite-lived intangible assets requires management to estimate the future discounted cash flows of an asset using assumptions believed to be reasonable, but which are inherently uncertain. Actual future cash flows may differ from the estimates used in impairment testing. The Company recognizes an impairment loss when and to the extent that the estimated fair value of an intangible asset is less than its carrying value. In addition, on a quarterly basis, the Company performs a qualitative review of its business operations to determine whether events or changes in circumstances have occurred which could indicate that the carrying value of its intangible assets was not recoverable. Based on the annual testing and quarterly reviews performed, the Company concluded that the carrying value of its intangible assets was not impaired as of December 31, 2020 and 2019. |
Goodwill | Goodwill Goodwill on the Company's consolidated balance sheet is the result of the Viventia Acquisition in September 2016 and represents the difference between the purchase price and the fair value of the identifiable tangible and intangible net assets acquired under the acquisition method of accounting. Goodwill is not amortized; rather than recording periodic amortization, goodwill is quantitatively tested for impairment at least annually during the fourth quarter of the fiscal year, or more often if indicators of impairment are present. Impairment testing of goodwill requires management to estimate the future discounted cash flows of a reporting unit using assumptions believed to be reasonable, but which are inherently uncertain. Actual future cash flows may differ from the estimates used in impairment testing. If the fair value of the equity of a reporting unit exceeds the reporting unit’s carrying value, including goodwill, then goodwill is considered not to be impaired. The Company recognizes a goodwill impairment when and to the extent that the fair value of the equity of a reporting unit is less than the reporting unit's carrying value, including goodwill. The Company has only one reporting unit. In addition, on a quarterly basis, the Company performs a qualitative review of its business operations to determine whether events or changes in circumstances have occurred which could have a material adverse effect on the estimated fair value of each reporting unit and thus indicate a potential impairment of the goodwill carrying value. Based on the annual testing and quarterly reviews performed, the Company concluded that there was no goodwill impairment during the years ended December 31, 2020, 2019 and 2018. |
Contingent Consideration | Contingent ConsiderationThe Company uses a discounted cash flow model to estimate the fair value of the contingent consideration liability each reporting period, which represents the present value of projected future cash flows associated with regulatory approval milestones and royalties on net sales due to the selling shareholders of Viventia Bio Inc. as a result of the Viventia Acquisition in September 2016. See "Note 1. Description of Business" for additional information. Contingent consideration is measured at its estimated fair value on a recurring basis at each reporting period, with fluctuations in value resulting in a non-cash charge to earnings (or loss) during the period. The estimated fair value measurement is based on significant unobservable inputs (Level 3 within the fair value hierarchy), including internally developed financial forecasts, probabilities of success and timing of certain milestone events and achievements, which are inherently uncertain. Actual future cash flows may differ from the assumptions used to estimate the fair value of contingent consideration. The valuation of contingent consideration requires the use of significant assumptions and judgments, which management believes are consistent with those that would be made by a market participant. Management reviews its assumptions and judgments on an ongoing basis as additional market and other data is obtained, and any future changes in the assumptions and judgments utilized by management may cause the estimated fair value of contingent consideration to fluctuate materially, resulting in earnings volatility. |
Leases | Leases Effective January 1, 2019, the Company adopted ASC Topic 842, Leases (“ASC 842”) using the optional transition method outlined in ASU No. 2018-11, Leases (Topic 842), Targeted Improvements . The adoption of ASC 842 represents a change in accounting principle that aims to increase transparency and comparability among organizations by requiring the recognition of right-of-use assets and lease liabilities on the balance sheet for both operating and finance leases. In addition, the standard requires enhanced disclosures that meet the objective of enabling financial statement users to assess the amount, timing and uncertainty of cash flows arising from leases. The reported results for the year ended December 31, 2020 and 2019 reflect the application of ASC 842 guidance, while the reported results for priors were prepared in accordance with the previous ASC Topic 840, Leases ("ASC 840") guidance. The adoption of ASC 842 resulted in the recognition of operating lease right-of-use assets and corresponding lease liabilities of $0.2 million on the Company’s consolidated balance sheet as of January 1, 2019. The adoption of this guidance did not have a material impact on the Company’s financial condition, results of operations or cash flows; however, the adoption did result in significant changes to the Company’s financial statement disclosures. As part of the adoption of ASC 842, the Company utilized certain practical expedients outlined in the guidance. These practical expedients include: • Accounting policy election to use the short-term lease exception by asset class; • Election of the practical expedient package during transition, which includes: - An entity need not reassess whether any expired or existing contracts are or contain leases; - An entity need not reassess the classification for any expired or existing leases. As a result, all leases that were classified as operating leases in accordance with ASC 840 are classified as operating leases under ASC 842, and all leases that were classified as capital leases in accordance with ASC 840 are classified as finance leases under ASC 842; and - An entity need not reassess initial direct costs for any existing leases. The Company’s lease portfolio as of the adoption date and as of December 31, 2020 includes: a property lease for manufacturing, laboratory, warehouse and office space in Winnipeg, Manitoba, a property lease for its headquarters in Cambridge, MA, and a property lease for office space in Philadelphia, PA. The Company determines if an arrangement is a lease at the inception of the contract and has made a policy election to not separate out non-lease components from lease components, for all classes of underlying assets. The asset components of the Company’s operating leases are recorded as operating lease right-of-use assets and reported within other assets on the Company's consolidated balance sheet. The short-term and long-term liability components are recorded in other current liabilities and other liabilities, respectively, on the Company’s consolidated balance sheet. As of December 31, 2020, the Company did not have any finance leases. Right-of-use assets and operating lease liabilities are recognized based on the present value of lease payments over the lease term at the commencement date. Existing leases in the Company’s lease portfolio as of the adoption date were valued as of January 1, 2019. The Company uses an incremental borrowing rate based on the information available at commencement date in determining the present value of lease payments, if an implicit rate of return is not provided with the lease contract. Operating lease right-of-use assets are adjusted for incentives received. Operating lease costs are recognized on a straight-line basis over the lease term, in accordance with ASC 842, and also include variable operating costs incurred during the period. Lease costs also include amounts related to short-term leases. |
Research and Development Costs | Research and Development Costs Research and development activities are expensed in the period incurred. Research and development expenses consist of both internal and external costs associated with all basic research activities, clinical development activities and technical efforts required to develop a product candidate. Internal research and development consist primarily of personnel costs, including salaries, benefits and share-based compensation, facilities leases, research-related overhead, pre-approval regulatory and clinical trial costs, manufacturing and other contracted services, license fees and other external costs. In certain circumstances, the Company is required to make advance payments to vendors for goods or services that will be received in the future for use in research and development activities. In such circumstances, the advance payments are recorded as prepaid assets and expensed when the activity has been performed or when the goods have been received. |
Stock-Based Compensation | Share-Based Compensation The Company recognizes the grant-date fair value of share-based awards granted as compensation as expense on a straight-line basis over the requisite service period, which is generally the vesting period of the award. To date, the Company has not issued awards where vesting is subject to market conditions. From time to time, the Company has granted to its executives stock option awards which contain both performance-based and service-based vesting criteria. Performance milestone events were specific to the Company’s corporate goals, including certain clinical development objectives related to the VISTA Trial, regulatory and financial objectives. Share-based compensation expense associated with performance-based vesting criteria is recognized using the accelerated attribution method if the performance condition is considered probable of achievement in management’s judgment. The fair value of stock options is estimated at the time of grant using the Black-Scholes option pricing model, which requires the use of inputs and assumptions such as the fair value of the underlying stock, exercise price of the option, expected term, risk-free interest rate, expected volatility and dividend yield. The fair value of each grant of options during the years ended December 31, 2020, 2019 and 2018 was determined using the following methods and assumptions: • Expected Term. Due to the lack of historical exercise data and given the plain vanilla nature of the options granted by the Company, the expected term is determined using the “simplified" method, as prescribed in SEC Staff Accounting Bulletin ("SAB") No. 107 ("SAB 107"), whereby the expected life equals the arithmetic average of the vesting term (generally four years) and the original contractual term (ten years) of the option, taking into consideration multiple vesting tranches. • Risk-Free Interest Rate. The risk-free rate is based on the interest rate payable on United States Treasury securities in effect at the time of grant for a period that is commensurate with the assumed expected term. • Expected Volatility. The expected volatility is based on historical volatilities of a representative group of publicly traded biopharmaceutical companies, including the Company's own volatility, which were commensurate with the assumed expected term, as prescribed in SAB 107. • Dividend Yield. The dividend yield is 0% because the Company has never declared or paid, and for the foreseeable future does not expect to declare or pay, a dividend on its common stock. |
Income Taxes | Income Taxes Income taxes are accounted for under the asset and liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases and net operating loss ("NOL") and research and development credit ("R&D credit") carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in operations in the period that includes the enactment date. A valuation allowance is recorded to the extent it is more likely than not that some portion or all of the deferred tax assets will not be realized. Unrecognized income tax benefits represent income tax positions taken on income tax returns that have not been recognized in the financial statements. The Company recognizes the benefit of an income tax position only if it is more likely than not (greater than 50%) that the tax position will be sustained upon tax examination, based solely on the technical merits of the tax position. Otherwise, no benefit is recognized. The tax benefits recognized are measured based on the largest benefit that has a greater than 50% likelihood of being realized upon ultimate settlement. The Company recognizes accrued interest and penalties related to uncertain tax positions as income tax expense in its consolidated statements of operations. As of December 31, 2020 and 2019, the Company did not have any uncertain tax positions. |
Revenue Recognition | Revenue Recognition The Company has never received revenue from sales of its products. The Company has entered into several license agreements, as discussed in "Note 15. License Agreements," pursuant to which the Company received revenue from its commercialization partnership agreements , including the Qilu License Agreement. The Company may receive under each of its commercialization partnership agreements future additional development and regulatory milestone payments, sales-based milestones, and sales-based royalties. The Company recognizes revenue resulting from out-license and commercialization partnership agreements in accordance with ASC Topic 606, Revenue ("ASC 606"), which was effective for public companies on January 1, 2018. The Company adopted ASC 606 using the modified retrospective approach, and there was no resulting cumulative effect adjustment to opening accumulated deficit. Under ASC 606, an entity recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration which the entity expects to receive in exchange for those goods or services. To determine the appropriate amount of revenue to be recognized for arrangements determined to be within the scope of ASC 606, the Company performs the following five steps: (i) identification of the promised goods or services in the contract; (ii) determination of whether the promised goods or services are performance obligations, including whether they are distinct in the context of the contract; (iii) measurement of the transaction price, including the constraint on variable consideration; (iv) allocation of the transaction price to the performance obligations; and (v) recognition of revenue when each performance obligation is satisfied. The Company only recognizes revenue under the five-step model when collectability of payment is reasonably assured. |
Recent Accounting Pronouncements | Adopted in 2020 In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments ("ASU 2016-13"). ASU 2016-13 requires measurement and recognition of expected credit losses for financial assets held. The amendments in ASU 2016-13 eliminate the probable threshold for initial recognition of a credit loss in GAAP and reflect an entity’s current estimate of all expected credit losses. ASU 2016-13 is effective for annual and interim periods beginning January 1, 2020 and is to be applied using a modified retrospective transition method. The Company adopted this guidance effective January 1, 2020, and it did not have a material impact on the Company’s financial position, results of operations or cash flows. In August 2018, the FASB issued ASU No. 2018-13, Fair Value Measurement (Topic 820): Disclosure Framework - Changes to the Disclosure Requirements for Fair Value Measurements ("ASU 2018-13"). ASU 2018-13 modifies fair value measurement disclosure requirements. ASU 2018-13 is effective for annual and interim periods beginning after December 15, 2019. The Company adopted this guidance effective January 1, 2020, and although it resulted in some additional footnote disclosures, it did not have a material impact on the Company’s disclosures. For the new disclosures regarding our Level 3 instruments, please read Note 5, Fair Value Measurements and Financial Instruments, to these consolidated financial statements. In August 2018, the FASB issued ASU No. 2018-15, Intangibles - Goodwill and Other - Internal-Use Software (Subtopic 350-40): Customer’s Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That Is a Service Contract ("ASU 2018-15") . ASU 2018-15 requires a customer in a cloud computing arrangement that is a service contract to follow the internal-use software guidance to determine which implementation costs to defer and recognize as an asset. The effective date for ASU 2018-15 is for annual and interim periods beginning after December 15, 2019. The amendments in this ASU should be applied either retrospectively or prospectively to all implementation costs incurred after the date of adoption. The Company adopted this guidance effective January 1, 2020, and it did not have a material impact on the Company’s financial position, results of operations or cash flows. Pending Adoption In December 2019, the FASB issued ASU No. 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes ("ASU 2019-12"). ASU 2019-12 simplifies the accounting for income taxes by removing certain exceptions to the general principles in Topic 740. The amendments in ASU 2019-12 also improve consistent application of and simplify GAAP for other areas of Topic 740 by clarifying and amending existing guidance. ASU 2019-12 is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2020. Early adoption is permitted. The method with which the amendments in this ASU are to be applied varies depending on the nature of the tax item impacted by amendment. The Company does not expect the adoption of ASU 2019-12 to have a material impact on the Company's financial position, results of operations or cash flows. |
FAIR VALUE MEASUREMENT AND FI_2
FAIR VALUE MEASUREMENT AND FINANCIAL INSTRUMENTS (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Fair Value Disclosures [Abstract] | |
Summary of assets and liabilities measured at fair value on a recurring basis | 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 December 31, 2020 and 2019 (in thousands): December 31, 2020 Fair Value Measurement Based on Carrying Amount Fair Value Quoted Prices in Active Significant other Observable Significant Unobservable Assets: Money market funds (cash equivalents) $ 16,374 $ 16,374 $ 16,374 $ — $ — Liabilities: Contingent consideration, current portion 8,985 $ 8,985 $ — $ — $ 8,985 Contingent consideration, net of current portion $ 99,855 $ 99,855 $ — $ — $ 99,855 December 31, 2019 Fair Value Measurement Based on Carrying Amount Fair Value Quoted Prices in Active Significant other Observable Significant Unobservable Assets: Money market funds (cash equivalents) $ 31,146 $ 31,146 $ 31,146 $ — $ — Liabilities: Contingent consideration, current portion — $ — $ — $ — $ — Contingent consideration, net of current portion $ 120,020 $ 120,020 $ — $ — $ 120,020 |
Summary of Contingent Consideration Liability | The following table sets forth a summary by quarter of the change in the fair value of the Company's contingent consideration liability, measured on a recurring basis at each reporting period, for the year ended December 31, 2020 (in thousands): Balance at December 31, 2019 $ 120,020 Change in fair value included in loss (53,700) Balance at March 31, 2020 66,320 Change in fair value included in loss 18,480 Balance at June 30, 2020 84,800 Change in fair value included in loss 18,400 Balance at September 30, 2020 103,200 Change in fair value included in loss 5,640 Balance at December 31, 2020 108,840 Balance at December 31, 2020, current portion 8,985 Balance at December 31, 2020, net of current portion 99,855 |
PROPERTY AND EQUIPMENT (Tables)
PROPERTY AND EQUIPMENT (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Property, Plant and Equipment [Abstract] | |
Schedule of Composition of Property and Equipment | The following table sets forth the composition of property and equipment, net as of December 31, 2020 and 2019 (in thousands): December 31, 2020 2019 Lab equipment $ 570 $ 572 Furniture and fixtures 16 16 Computer equipment 97 87 Software 28 28 Leasehold improvements 293 293 Property and equipment, gross 1,004 996 Less: accumulated depreciation (881) (758) Total Property and Equipment, Net $ 123 $ 238 |
INTANGIBLES AND GOODWILL (Table
INTANGIBLES AND GOODWILL (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Schedule of Composition of Intangible Assets | The following table sets forth the composition of intangible assets as of December 31, 2020 and 2019 (in thousands): December 31, 2020 2019 IPR&D intangible assets: Vicineum United States rights $ 31,700 $ 31,700 Vicineum European Union rights 14,700 14,700 Total Intangibles $ 46,400 $ 46,400 |
ACCRUED EXPENSES (Tables)
ACCRUED EXPENSES (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Payables and Accruals [Abstract] | |
Components of accrued expenses | The following table sets forth the composition of accrued expenses as of December 31, 2020 and 2019 (in thousands): December 31, 2020 2019 Research and development $ 1,372 $ 3,688 Payroll-related expenses 1,892 1,638 Severance to former Executives and other employees — 378 Professional fees 684 378 Other 25 87 Total Accrued Expenses $ 3,973 $ 6,169 |
COMMITMENTS AND CONTINGENCIES (
COMMITMENTS AND CONTINGENCIES (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of Lease Cost | The components of lease cost for the year ended December 31, 2020 is as follows (in thousands): Year Ended December 31, 2020 Year Ended December 31, 2019 Lease Cost: Operating lease (including related operating costs) 301 298 Short term property leases 261 263 Total lease costs 562 561 Supplemental Information: Year Ended December 31, 2020 Year Ended December 31, 2019 Weighted-average remaining lease term (years) 1.75 0.75 Weighted-average discount rate - operating leases 12 % 12 % |
Schedule of Future Minimum Lease Payments Under Non-Cancelable Operating Leases | The following table sets forth the Company's future minimum lease payments under non-cancelable leases as of December 31, 2020 (in thousands): Minimum Lease Payments: Year Ended December 31, 2020 2020 — 2021 162 2022 122 Total future minimum lease payments 284 Less: Amounts representing present value adjustment (13) Operating lease liabilities as of December 31, 2020 $ 271 |
STOCKHOLDERS' (DEFICIT) EQUITY
STOCKHOLDERS' (DEFICIT) EQUITY (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Equity [Abstract] | |
Summary 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 December 31, 2020 and 2019 (in thousands): December 31, 2020 2019 Shares of common stock issued 140,450 106,801 Shares of common stock reserved for issuance for: Warrants 2,247 22,895 Stock options 10,147 6,236 Shares available for grant under 2014 Stock Incentive Plan 4,863 8,753 Shares available for sale under 2014 Employee Stock Purchase Plan — 28 Total shares of common stock issued and reserved for issuance 157,707 144,713 |
Summary of Warrants Outstanding and Warrant Activity | The following table sets forth the Company's warrant activity for the year ended December 31, 2020 (in thousands): Issued Exercise Expiration December 31, 2019 Issued (Exercised) (Cancelled) December 31, 2020 Jun-2019 $1.47 Jun-2020 20,410 — — (20,410) — Mar-2018 $0.55* Mar-2023 1,943 — (238) — 1,705 Nov-2017 $0.55* Nov-2022 487 — — — 487 May-2015 $11.83 Nov-2024 28 — — — 28 Nov-2014 $11.04 Nov-2024 27 — — — 27 22,895 — (238) (20,410) 2,247 * Exercise price shown (i) reflects modification described below and (ii) subject to further adjustment based on down round provision added by amendment described below. |
LOSS PER SHARE (Tables)
LOSS PER SHARE (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Earnings Per Share [Abstract] | |
Schedule of Potentially Dilutive Securities | The following potentially dilutive securities outstanding as of December 31, 2020, 2019 and 2018 have been excluded from the denominator of the diluted loss per share of common stock outstanding calculation (in thousands): December 31, 2020 2019 2018 Warrants 2,247 22,895 9,258 Stock options 10,147 6,236 3,942 12,394 29,131 13,200 |
SHARE-BASED COMPENSATION (Table
SHARE-BASED COMPENSATION (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
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 consolidated statements of operations for the years ended December 31, 2020, 2019 and 2018 (in thousands): Year ended December 31, 2020 2019 2018 Research and development $ 350 $ 188 $ 505 General and administrative 1,407 1,049 778 Total Share-based Compensation $ 1,757 $ 1,237 $ 1,283 |
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 2009 Plan and inducement grants made outside of stockholder approved plans, for the years ended December 31, 2020, 2019 and 2018: Number of Shares under Option Weighted-Average Weighted-Average Remaining Aggregate Outstanding at December 31, 2017 2,696 $3.16 8.55 $ 146 Granted 3,546 $1.71 Exercised (439) $0.62 Canceled or forfeited (1,861) $3.21 Outstanding at December 31, 2018 3,942 $2.12 9.14 $ 57 Granted 3,986 $1.02 Exercised (90) $1.10 Canceled or forfeited (1,602) $1.78 Outstanding at December 31, 2019 6,236 $1.52 8.83 $ 358 Granted 4,044 $0.87 Exercised (12) $1.13 Canceled or forfeited (121) $1.04 Outstanding at December 31, 2020 10,147 $1.26 8.50 $ 3,160 Exercisable at December 31, 2020 4,228 $1.63 7.85 $ 931 |
Schedule of Weighted-Average Inputs and Assumptions in Black-Scholes Option | For the years ended December 31, 2020, 2019 and 2018, 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: Year ended December 31, 2020 2019 2018 Fair value of common stock $0.56 $1.02 $1.71 Exercise price of the option $0.87 $1.02 $1.71 Expected term (in years) 6.1 6.0 6.0 Risk-free interest rate 1.3% 2.1% 2.8% Expected volatility 71.5% 78.1% 74.2% Dividend yield —% —% —% |
INCOME TAXES (Tables)
INCOME TAXES (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Income Tax Disclosure [Abstract] | |
Components of Pre-tax Income (Loss) | The following table sets forth the components of the Company's loss before income taxes by country (in thousands): Year ended December 31, 2020 2019 2018 Country: United States $ (35,529) $ (27,468) $ (15,977) Canada 14,577 (80,032) (17,716) Total Loss before Income Taxes $ (20,952) $ (107,500) $ (33,693) |
Components of Income Tax Provisions | The Company's tax provision is comprised of the following components (in thousands): Year ended December 31, 2020 2019 2018 Current Tax Provision: Federal $ — $ — $ — State — — — Foreign 1,445 — — Total Current Provision $ 1,445 $ — $ — Deferred Tax Provision: Federal $ — $ — $ — State — — — Foreign — — — Total Deferred Provision $ — $ — $ — Total Tax Provision $ 1,445 $ — $ — |
Reconciliation of Expected Income Tax Expense | The following table sets forth a reconciliation of the statutory United States federal income tax rate to the Company’s effective income tax rate: Year ended December 31, 2020 2019 2018 United States federal statutory income tax rate 21.0 % 21.0 % 21.0 % Impact of foreign rate differential (4.2) 4.4 1.6 State taxes, net of federal benefit 2.0 0.6 1.3 Stock option cancellations (0.2) — (1.2) Contingent consideration 14.4 (18.0) (5.5) General business credits and other credits 6.6 0.4 0.7 Permanent differences 0.2 — (0.3) Other (2.1) (0.5) 0.5 Foreign taxes (6.9) — — Change in valuation allowance (37.7) (7.9) (18.1) Effective Income Tax Rate (6.9) % — % — % |
Components of Deferred Tax Assets and Liabilities | The following table sets forth the tax effects of temporary differences that gave rise to significant portions of the Company's deferred tax assets and liabilities (in thousands): December 31, 2020 2019 Deferred tax assets: NOL carryforwards $ 57,935 $ 50,727 R&D credit carryforwards 3,787 4,385 Accruals and other 3,811 2,464 Capitalized start-up costs 70 91 Other 28 57 Gross deferred tax assets 65,631 57,724 Deferred tax liabilities: IPR&D (12,528) (12,528) Property and equipment — — Gross deferred tax liabilities (12,528) (12,528) Valuation allowance (65,631) (57,724) Net Deferred Tax Liability $ (12,528) $ (12,528) |
Schedule of Credit Carryforwards | The following table summarizes the Company's NOL and R&D and other credit carryforwards in the United States and Canada as of December 31, 2020 (in millions): Amount Expiration Beginning in Through United States: Federal NOL carryforwards - indefinite $ 75.2 None None Federal NOL carryforwards $ 118.9 2030 2038 State NOL carryforwards $ 134.4 2030 2040 Federal R&D credit carryforwards $ 2.3 2027 2040 State R&D credit carryforwards $ 0.9 2027 2040 Canada: Federal non-capital loss carryforwards $ 32.2 2035 2040 Federal scientific research and experimental development expense carryforwards $ 7.0 2032 2040 Federal and provincial investment tax credit carryforwards $ 0.8 2032 2040 |
DESCRIPTION OF BUSINESS (Detail
DESCRIPTION OF BUSINESS (Details) $ in Thousands, shares in Millions | 1 Months Ended | 12 Months Ended | |||
Sep. 30, 2016USD ($)shares | Dec. 31, 2020USD ($)segment | Dec. 31, 2019USD ($) | Dec. 31, 2018USD ($) | Sep. 30, 2017 | |
Variable Interest Entity [Line Items] | |||||
Number of operating segments | segment | 1 | ||||
Cash and cash equivalents | $ 52,389 | $ 48,121 | $ 50,422 | ||
Accumulated deficit | 315,921 | 293,524 | |||
Negative cash flows from operating activities incurred | $ 30,837 | $ 37,521 | $ 22,829 | ||
Viventia Bio Inc. | |||||
Variable Interest Entity [Line Items] | |||||
Shares of common stock issued to the selling shareholders (in shares) | shares | 4 | ||||
Percentage of voting interests acquired | 19.90% | ||||
Period during which quarterly earn-outs are payable after date of net sales | 15 years | ||||
Period in which acquiree is to use commercially reasonable efforts to achieve marketing authorizations | 7 years | ||||
Viventia Bio Inc. | Vicinium | Collaborative Arrangement, Revenue based on Specified Milestone | |||||
Variable Interest Entity [Line Items] | |||||
Percentage of net sales of quarterly earn-out payments during earn-out periods | 2.00% | ||||
Viventia Bio Inc. | Vicinium | Collaborative Arrangement, Revenue based on Specified Milestone | United States | |||||
Variable Interest Entity [Line Items] | |||||
One-time milestone payment upon first sale of product | $ 12,500 | ||||
Viventia Bio Inc. | Vicinium | Collaborative Arrangement, Revenue based on Specified Milestone | Europe | |||||
Variable Interest Entity [Line Items] | |||||
One-time milestone payment upon first sale of product | 7,000 | ||||
Viventia Bio Inc. | Vicinium | Collaborative Arrangement, Revenue based on Specified Milestone | Japan | |||||
Variable Interest Entity [Line Items] | |||||
One-time milestone payment upon first sale of product | $ 3,000 |
SUMMARY OF SIGNIFICANT ACCOUN_3
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Narrative (Details) | 12 Months Ended | |||
Dec. 31, 2020USD ($)reporting_unit | Dec. 31, 2019USD ($) | Dec. 31, 2018USD ($) | Jan. 01, 2019USD ($) | |
Property, Plant and Equipment [Line Items] | ||||
Insurance coverage limit | $ 250,000 | |||
Impairment of long-lived assets | 0 | $ 0 | $ 0 | |
Impairment of intangible assets | $ 0 | 0 | ||
Number of reporting units | reporting_unit | 1 | |||
Goodwill impairment | $ 0 | $ 0 | $ 0 | |
Right-of-use asset | $ 200,000 | |||
Lease liability | $ 271,000 | $ 200,000 | ||
Expected term | 6 years 1 month 6 days | 6 years | 6 years | |
Dividend yield | 0.00% | 0.00% | 0.00% | |
Operating Lease, Liability, Statement of Financial Position [Extensible List] | us-gaap:OtherLiabilities | us-gaap:OtherLiabilitiesNoncurrent | ||
Lab equipment | ||||
Property, Plant and Equipment [Line Items] | ||||
Estimated useful life (in years) | 5 years | |||
Furniture and fixtures | ||||
Property, Plant and Equipment [Line Items] | ||||
Estimated useful life (in years) | 4 years | |||
Computer equipment | ||||
Property, Plant and Equipment [Line Items] | ||||
Estimated useful life (in years) | 3 years | |||
Leasehold improvements | ||||
Property, Plant and Equipment [Line Items] | ||||
Estimated useful life (in years) | 5 years | |||
Performance-Based Awards | ||||
Property, Plant and Equipment [Line Items] | ||||
Award vesting period | 4 years | |||
Expected term | 10 years |
FAIR VALUE MEASUREMENT AND FI_3
FAIR VALUE MEASUREMENT AND FINANCIAL INSTRUMENTS - Summary of Assets and Liabilities Measured at Fair Value on Recurring Basis (Detail) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Liabilities: | ||
Contingent consideration, net of current portion | $ 99,855 | $ 120,020 |
Carrying Amount | ||
Assets: | ||
Money market funds (cash equivalents) | 16,374 | 31,146 |
Liabilities: | ||
Contingent consideration | 8,985 | 0 |
Fair Value | Recurring | ||
Assets: | ||
Money market funds (cash equivalents) | 16,374 | 31,146 |
Liabilities: | ||
Contingent consideration, net of current portion | 99,855 | 120,020 |
Contingent consideration | 8,985 | 0 |
Fair Value | Recurring | Quoted Prices in Active Markets (Level 1) | ||
Assets: | ||
Money market funds (cash equivalents) | 16,374 | 31,146 |
Liabilities: | ||
Contingent consideration, net of current portion | 0 | 0 |
Contingent consideration | 0 | 0 |
Fair Value | Recurring | Significant other Observable Inputs (Level 2) | ||
Assets: | ||
Money market funds (cash equivalents) | 0 | 0 |
Liabilities: | ||
Contingent consideration, net of current portion | 0 | 0 |
Contingent consideration | 0 | 0 |
Fair Value | Recurring | Significant Unobservable Inputs (Level 3) | ||
Assets: | ||
Money market funds (cash equivalents) | 0 | 0 |
Liabilities: | ||
Contingent consideration, net of current portion | 99,855 | 120,020 |
Contingent consideration | $ 8,985 | $ 0 |
FAIR VALUE MEASUREMENT AND FI_4
FAIR VALUE MEASUREMENT AND FINANCIAL INSTRUMENTS - Narrative (Details) $ in Thousands | 3 Months Ended | 12 Months Ended | ||||
Dec. 31, 2020USD ($) | Sep. 30, 2020USD ($) | Jun. 30, 2020USD ($) | Mar. 31, 2020USD ($) | Dec. 31, 2020USD ($) | Dec. 31, 2019 | |
Fair Value, Option, Quantitative Disclosures [Line Items] | ||||||
Contingent consideration liability, measurement input | 0.084 | 0.118 | 0.145 | 0.179 | 0.084 | 0.118 |
License agreement, royalty rate | 2.00% | 2.00% | ||||
Decrease in estimated fair value of contingent consideration | $ (5,640) | $ (18,400) | $ (18,480) | $ 53,700 | $ 11,800 | |
Discount Rate | ||||||
Fair Value, Option, Quantitative Disclosures [Line Items] | ||||||
Weighted-average cost of capital | 8.80% | 9.40% | 13.20% | 14.70% | 8.80% | 5.60% |
Discount Rate | Minimum | ||||||
Fair Value, Option, Quantitative Disclosures [Line Items] | ||||||
Contingent consideration liability, measurement input | 0.084 | 0.084 | 0.056 | |||
Discount Rate | Maximum | ||||||
Fair Value, Option, Quantitative Disclosures [Line Items] | ||||||
Contingent consideration liability, measurement input | 0.088 | 0.088 | 0.118 |
FAIR VALUE MEASUREMENT AND FI_5
FAIR VALUE MEASUREMENT AND FINANCIAL INSTRUMENTS - Summary of Changes in Fair Value of Contingent Consideration (Details) $ in Thousands | 3 Months Ended | 12 Months Ended | ||||
Dec. 31, 2020USD ($) | Sep. 30, 2020USD ($) | Jun. 30, 2020USD ($) | Mar. 31, 2020USD ($) | Dec. 31, 2020USD ($) | Dec. 31, 2019 | |
Fair Value, Net Derivative Asset (Liability) Measured on Recurring Basis, Unobservable Input Reconciliation [Roll Forward] | ||||||
Beginning balance | $ 103,200 | $ 84,800 | $ 66,320 | |||
Change in fair value included in loss | 5,640 | 18,400 | 18,480 | $ (53,700) | $ (11,800) | |
Ending balance | $ 108,840 | $ 103,200 | $ 84,800 | $ 66,320 | $ 108,840 | |
Contingent consideration liability, measurement input | 0.084 | 0.118 | 0.145 | 0.179 | 0.084 | 0.118 |
Discount Rate | Minimum | ||||||
Fair Value, Net Derivative Asset (Liability) Measured on Recurring Basis, Unobservable Input Reconciliation [Roll Forward] | ||||||
Contingent consideration liability, measurement input | 0.084 | 0.084 | 0.056 | |||
Discount Rate | Maximum | ||||||
Fair Value, Net Derivative Asset (Liability) Measured on Recurring Basis, Unobservable Input Reconciliation [Roll Forward] | ||||||
Contingent consideration liability, measurement input | 0.088 | 0.088 | 0.118 |
PROPERTY AND EQUIPMENT - Proper
PROPERTY AND EQUIPMENT - Property and Equipment and Related Accumulated Depreciation (Detail) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 1,004 | $ 996 |
Less: accumulated depreciation | (881) | (758) |
Total Property and Equipment, Net | 123 | 238 |
Lab equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 570 | 572 |
Furniture and fixtures | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 16 | 16 |
Computer equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 97 | 87 |
Software | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 28 | 28 |
Leasehold improvements | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 293 | $ 293 |
PROPERTY AND EQUIPMENT - Additi
PROPERTY AND EQUIPMENT - Additional Information (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Property, Plant and Equipment [Abstract] | |||
Depreciation expense | $ 122 | $ 219 | $ 208 |
INTANGIBLES AND GOODWILL - Comp
INTANGIBLES AND GOODWILL - Composition of Intangible Assets (Details) - IPR&D intangible assets - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Finite-Lived Intangible Assets [Line Items] | ||
Total Intangibles | $ 46,400 | $ 46,400 |
United States | Vicinium | ||
Finite-Lived Intangible Assets [Line Items] | ||
Total Intangibles | 31,700 | 31,700 |
Europe | Vicinium | ||
Finite-Lived Intangible Assets [Line Items] | ||
Total Intangibles | $ 14,700 | $ 14,700 |
INTANGIBLES AND GOODWILL - Addi
INTANGIBLES AND GOODWILL - Additional Information (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Goodwill and Intangible Assets Disclosure [Abstract] | ||
Goodwill | $ 13,064 | $ 13,064 |
ACCRUED EXPENSES - Components o
ACCRUED EXPENSES - Components of Accrued Expenses (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Payables and Accruals [Abstract] | ||
Research and development | $ 1,372 | $ 3,688 |
Payroll-related expenses | 1,892 | 1,638 |
Severance to former Executives and other employees | 0 | 378 |
Professional fees | 684 | 378 |
Other | 25 | 87 |
Total Accrued Expenses | $ 3,973 | $ 6,169 |
ACCRUED EXPENSES - Additional I
ACCRUED EXPENSES - Additional Information (Details) - USD ($) $ in Thousands | Sep. 09, 2019 | Aug. 02, 2019 | Dec. 31, 2020 | Dec. 31, 2019 | Aug. 03, 2019 |
Deferred Compensation Arrangement with Individual, Postretirement Benefits [Line Items] | |||||
Expense recorded related to management changes | $ 0 | $ 378 | |||
Former Chief Financial Officer | |||||
Deferred Compensation Arrangement with Individual, Postretirement Benefits [Line Items] | |||||
Separation Agreement, period of separation payments and benefits agreed to | 12 months | ||||
Expense recorded related to management changes | $ 300 | ||||
Former Chief Medical Officer | |||||
Deferred Compensation Arrangement with Individual, Postretirement Benefits [Line Items] | |||||
Separation Agreement, period of separation payments and benefits agreed to | 6 months | ||||
Expense recorded related to management changes | $ 300 | ||||
Separation payments | $ 200 | ||||
Consulting fees and transition expenses | $ 100 |
COMMITMENTS AND CONTINGENCIES -
COMMITMENTS AND CONTINGENCIES - Additional Information (Details) | 12 Months Ended | ||
Dec. 31, 2020USD ($)ft²option | Dec. 31, 2019USD ($) | Dec. 31, 2018USD ($) | |
Commitments And Contingencies [Line Items] | |||
Operating lease (including related operating costs) | $ 301,000 | $ 298,000 | |
Canada | |||
Commitments And Contingencies [Line Items] | |||
Office space, square foot | ft² | 31,100 | ||
Lease term | 2 years | ||
Renewal option | option | 1 | ||
Renewal term | 3 years | ||
Monthly rent | $ 12,600 | ||
Related operating expenses | 12,300 | ||
Operating lease (including related operating costs) | $ 300,000 | ||
Rent expense under ASC 842 | 300,000 | ||
Rent expense under ASC 840 | $ 300,000 | ||
Massachusetts | |||
Commitments And Contingencies [Line Items] | |||
Lease term | 4 months | ||
Monthly rent | $ 7,900 | ||
Rent expense under ASC 842 | 100,000 | ||
Pennsylvania | |||
Commitments And Contingencies [Line Items] | |||
Monthly rent | 13,500 | ||
Rent expense under ASC 842 | $ 200,000 | $ 100,000 |
COMMITMENTS AND CONTINGENCIES_2
COMMITMENTS AND CONTINGENCIES - Lease Costs (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Lease, Cost [Abstract] | ||
Operating lease (including related operating costs) | $ 301 | $ 298 |
Short term property leases | 261 | 263 |
Total lease costs | $ 562 | $ 561 |
Supplemental Lease Information [Abstract] | ||
Weighted-average remaining lease term (years) | 1 year 9 months | 9 months |
Weighted-average discount rate - operating leases | 12.00% | 12.00% |
COMMITMENTS AND CONTINGENCIES_3
COMMITMENTS AND CONTINGENCIES - Minimum Aggregate Future Lease Commitment (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Jan. 01, 2019 |
Year Ended December 31, 2020 | ||
2021 | $ 162 | |
2022 | 122 | |
Total future minimum lease payments | 284 | |
Less: Amounts representing present value adjustment | (13) | |
Operating lease liabilities as of December 31, 2020 | $ 271 | $ 200 |
Operating Lease, Liability, Statement of Financial Position [Extensible List] | us-gaap:OtherLiabilities | us-gaap:OtherLiabilitiesNoncurrent |
STOCKHOLDERS' (DEFICIT) EQUIT_2
STOCKHOLDERS' (DEFICIT) EQUITY - Equity Financing (Details) - USD ($) | Oct. 30, 2020 | Nov. 30, 2019 | Jun. 30, 2019 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2020 | Dec. 31, 2020 | Dec. 31, 2019 | Jun. 30, 2020 |
Common Stock Capital Shares Reserved For Future Issuance [Line Items] | |||||||||
Stock price per share (in dollars per share) | $ 1.80 | $ 1.13 | |||||||
Commission fixed rate | 3.00% | ||||||||
Legal, accounting and printing costs | $ 200,000 | $ 200,000 | |||||||
Proceeds from sale of stock | $ 27,800,000 | $ 41,900,000 | $ 9,000,000 | ||||||
Sale of stock, shares issued (in shares) | 20,400,000 | 25,600,000 | 8,000,000 | ||||||
Issuance of common stock, issuance cost | $ 700,000 | 1,200,000 | |||||||
Number of warrants (in shares) | 8,000,000 | 20,400,000 | |||||||
Stock and warrants price per share (in dollars per share) | $ 1.47 | ||||||||
Exercise price per warrant (in dollars per share) | $ 1.20 | $ 1.47 | |||||||
Warrant price per unit (in dollars per share) | $ 0.125 | ||||||||
Warrants exercise period | 5 years | 1 year | |||||||
ATM Facility | |||||||||
Common Stock Capital Shares Reserved For Future Issuance [Line Items] | |||||||||
Aggregate sales price | $ 35,000,000 | ||||||||
Proceeds from sale of stock | $ 21,800,000 | $ 38,000,000 | |||||||
Sale of stock, shares issued (in shares) | 16,600,000 | 33,400,000 | |||||||
Weighted-average stock price per share (in dollars per share) | $ 1.36 | $ 1.17 | |||||||
Additional shares issued (in shares) | 50,000,000 |
STOCKHOLDERS' (DEFICIT) EQUIT_3
STOCKHOLDERS' (DEFICIT) EQUITY - Preferred Stock (Details) - $ / shares | Dec. 31, 2020 | Dec. 31, 2019 |
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 |
Preferred stock, shares outstanding (in shares) | 0 | 0 |
STOCKHOLDERS' (DEFICIT) EQUIT_4
STOCKHOLDERS' (DEFICIT) EQUITY - Common Stock (Details) | 12 Months Ended | |||
Dec. 31, 2020vote$ / sharesshares | Dec. 31, 2019$ / sharesshares | Dec. 31, 2018shares | Dec. 31, 2017shares | |
Class of Stock [Line Items] | ||||
Common stock, shares authorized (in shares) | 200,000,000 | 200,000,000 | ||
Common stock, par value (in dollars per share) | $ / shares | $ 0.001 | $ 0.001 | ||
Common stock, shares issued (in shares) | 140,449,647 | 106,801,409 | ||
Common stock, shares outstanding (in shares) | 140,400,000 | 106,800,000 | ||
Common Stock | ||||
Class of Stock [Line Items] | ||||
Common stock, shares outstanding (in shares) | 140,449,647 | 106,801,409 | 77,456,180 | 34,702,565 |
Number of votes | vote | 1 |
STOCKHOLDERS' (DEFICIT) EQUIT_5
STOCKHOLDERS' (DEFICIT) EQUITY - Summary of Common Stock Issued and Reserved for Issuance (Details) - shares | Dec. 31, 2020 | Dec. 31, 2019 |
Class of Warrant or Right [Line Items] | ||
Common stock, shares issued (in shares) | 140,449,647 | 106,801,409 |
Shares of common stock reserved for issuance for: | ||
Shares of common stock reserved for issuance (in shares) | 10,147,000 | 6,236,000 |
Total shares of common stock issued and reserved for issuance (in shares) | 157,707,000 | 144,713,000 |
Common stock, shares outstanding (in shares) | 140,449,647 | 106,801,409 |
Warrants | ||
Shares of common stock reserved for issuance for: | ||
Shares of common stock reserved for issuance (in shares) | 2,247,000 | 22,895,000 |
Shares available for grant under 2014 Stock Incentive Plan | ||
Shares of common stock reserved for issuance for: | ||
Shares of common stock reserved for issuance (in shares) | 4,863,000 | 8,753,000 |
Shares available for sale under 2014 Employee Stock Purchase Plan | ||
Shares of common stock reserved for issuance for: | ||
Shares of common stock reserved for issuance (in shares) | 0 | 28,000 |
STOCKHOLDERS' (DEFICIT) EQUIT_6
STOCKHOLDERS' (DEFICIT) EQUITY - Warrants (Details) - $ / shares shares in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Jun. 30, 2020 | Mar. 31, 2018 | |
Class of Warrant or Right [Line Items] | |||
Exercise price per warrant (in dollars per share) | $ 1.47 | $ 1.20 | |
Warrant Or Right Outstanding [Roll Forward] | |||
Warrants outstanding, beginning balance (in shares) | 22,895 | ||
Warrants Issued (in shares) | 0 | ||
Warrants Exercised (in shares) | (238) | ||
Warrants Cancelled (in shares) | (20,410) | ||
Warrants outstanding, ending balance (in shares) | 2,247 | ||
Warrants, Expiring June 2020 | |||
Class of Warrant or Right [Line Items] | |||
Exercise price per warrant (in dollars per share) | $ 1.47 | ||
Warrant Or Right Outstanding [Roll Forward] | |||
Warrants outstanding, beginning balance (in shares) | 20,410 | ||
Warrants Issued (in shares) | 0 | ||
Warrants Exercised (in shares) | 0 | ||
Warrants Cancelled (in shares) | (20,410) | ||
Warrants outstanding, ending balance (in shares) | 0 | ||
Warrants, Expiring March 2023 | |||
Class of Warrant or Right [Line Items] | |||
Exercise price per warrant (in dollars per share) | $ 0.55 | ||
Warrant Or Right Outstanding [Roll Forward] | |||
Warrants outstanding, beginning balance (in shares) | 1,943 | ||
Warrants Issued (in shares) | 0 | ||
Warrants Exercised (in shares) | (238) | ||
Warrants Cancelled (in shares) | 0 | ||
Warrants outstanding, ending balance (in shares) | 1,705 | ||
Warrants, Expiring November 2022 | |||
Class of Warrant or Right [Line Items] | |||
Exercise price per warrant (in dollars per share) | $ 0.55 | ||
Warrant Or Right Outstanding [Roll Forward] | |||
Warrants outstanding, beginning balance (in shares) | 487 | ||
Warrants Issued (in shares) | 0 | ||
Warrants Exercised (in shares) | 0 | ||
Warrants Cancelled (in shares) | 0 | ||
Warrants outstanding, ending balance (in shares) | 487 | ||
Warrants, Expiring November 2024, Issued May 2015 | |||
Class of Warrant or Right [Line Items] | |||
Exercise price per warrant (in dollars per share) | $ 11.83 | ||
Warrant Or Right Outstanding [Roll Forward] | |||
Warrants outstanding, beginning balance (in shares) | 28 | ||
Warrants Issued (in shares) | 0 | ||
Warrants Exercised (in shares) | 0 | ||
Warrants Cancelled (in shares) | 0 | ||
Warrants outstanding, ending balance (in shares) | 28 | ||
Warrants, Expiring November 2024, Issued November 2014 | |||
Class of Warrant or Right [Line Items] | |||
Exercise price per warrant (in dollars per share) | $ 11.04 | ||
Warrant Or Right Outstanding [Roll Forward] | |||
Warrants outstanding, beginning balance (in shares) | 27 | ||
Warrants Issued (in shares) | 0 | ||
Warrants Exercised (in shares) | 0 | ||
Warrants Cancelled (in shares) | 0 | ||
Warrants outstanding, ending balance (in shares) | 27 |
STOCKHOLDERS' (DEFICIT) EQUIT_7
STOCKHOLDERS' (DEFICIT) EQUITY - Warrants Narrative (Details) - USD ($) $ / shares in Units, $ in Thousands | Oct. 28, 2019 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | Jun. 30, 2020 | Oct. 31, 2019 | Oct. 27, 2019 | Mar. 31, 2018 |
Class of Warrant or Right [Line Items] | ||||||||
Proceeds from exercises of common stock warrants | $ 131 | $ 5,481 | $ 7,315 | |||||
Exercises of common stock warrants (in shares) | 238,000 | |||||||
Exercise price per warrant (in dollars per share) | $ 1.47 | $ 1.20 | ||||||
Increase in warrant value | $ 1,100 | |||||||
Common Stock | ||||||||
Class of Warrant or Right [Line Items] | ||||||||
Exercises of common stock warrants (in shares) | 238,110 | 6,772,928 | 8,765,496 | |||||
2018 Warrants | Common Stock | ||||||||
Class of Warrant or Right [Line Items] | ||||||||
Exercises of common stock warrants (in shares) | 200,000 | |||||||
Warrants, Expiring March 2023 | ||||||||
Class of Warrant or Right [Line Items] | ||||||||
Exercises of common stock warrants (in shares) | 238,000 | |||||||
Exercise price per warrant (in dollars per share) | $ 0.55 | |||||||
Warrants, Expiring March 2023 | Common Stock | ||||||||
Class of Warrant or Right [Line Items] | ||||||||
Proceeds from exercises of common stock warrants | $ 2,000 | |||||||
Exercises of common stock warrants (in shares) | 3,400,000 | |||||||
Exercise price per warrant (in dollars per share) | $ 0.60 | $ 0.95 | $ 1.20 | |||||
2018 Warrant Amendment, Amendment to Securities Purchase Agreement | ||||||||
Class of Warrant or Right [Line Items] | ||||||||
Minimum percentage of securities issued | 50.10% | |||||||
Warrants, Expiring November 2022 | ||||||||
Class of Warrant or Right [Line Items] | ||||||||
Exercises of common stock warrants (in shares) | 0 | |||||||
Exercise price per warrant (in dollars per share) | $ 0.55 | |||||||
Warrants, Expiring November 2022 | Common Stock | ||||||||
Class of Warrant or Right [Line Items] | ||||||||
Exercise price per warrant (in dollars per share) | $ 0.55 | $ 0.55 | $ 0.80 |
LOSS PER SHARE (Details)
LOSS PER SHARE (Details) - shares shares in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Common stock equivalents excluded from calculation of diluted net (loss) income per share (in shares) | 12,394 | 29,131 | 13,200 |
Warrants | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Common stock equivalents excluded from calculation of diluted net (loss) income per share (in shares) | 2,247 | 22,895 | 9,258 |
Stock options | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Common stock equivalents excluded from calculation of diluted net (loss) income per share (in shares) | 10,147 | 6,236 | 3,942 |
SHARE-BASED COMPENSATION - Shar
SHARE-BASED COMPENSATION - Share-Based Compensation Expense (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Share-based compensation expense | $ 1,757 | $ 1,237 | $ 1,283 |
Total intrinsic value of options exercised | 0 | 0 | 500 |
Research and development | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Share-based compensation expense | 350 | 188 | 505 |
General and administrative | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Share-based compensation expense | $ 1,407 | $ 1,049 | $ 778 |
SHARE-BASED COMPENSATION - Addi
SHARE-BASED COMPENSATION - Additional Information (Details) - USD ($) | 1 Months Ended | 12 Months Ended | |||
Jun. 30, 2019 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Options outstanding (in shares) | 10,147,000 | 6,236,000 | 3,942,000 | 2,696,000 | |
Share-based compensation expense | $ 1,757,000 | $ 1,237,000 | $ 1,283,000 | ||
Unrecognized compensation expense | $ 3,600,000 | ||||
Option granted, weighted average grant date fair value (in dollars per share) | $ 0.87 | $ 0.69 | $ 1.14 | ||
Total intrinsic value of options exercised | $ 0 | $ 0 | $ 500,000 | ||
Stock options granted (in shares) | 4,044,000 | 3,986,000 | 3,546,000 | ||
Inducement Equity Award | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Options outstanding (in shares) | 2,100,000 | ||||
Performance-Based Awards | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Award vesting period | 4 years | ||||
Share-based compensation expense | $ 200,000 | ||||
Unrecognized compensation expense | $ 0 | ||||
Stock options | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Share-based compensation expense | $ 1,800,000 | $ 1,200,000 | $ 1,300,000 | ||
Weighted average period unvested stock to be recognized | 2 years 4 months 24 days | ||||
2014 Stock Incentive Plan | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Options outstanding (in shares) | 7,900,000 | ||||
Number of shares reserved for issuance (in shares) | 7,900,000 | ||||
Stock incentive plan, shares remained available for future issuance (in shares) | 4,900,000 | ||||
2014 Stock Incentive Plan | Stock options | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Award vesting period | 4 years | ||||
Expected term | 10 years | ||||
2009 Stock Incentive Plan | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Vested stock options outstanding (in shares) | 100,000 | ||||
Vesting on the First Anniversary of Date of Grant | 2014 Stock Incentive Plan | Stock options | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Percentage of original number of shares subject to the option vesting | 25.00% | ||||
Vesting at End of Each Successive Three-Month Period Thereafter | 2014 Stock Incentive Plan | Stock options | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Percentage of original number of shares subject to the option vesting | 6.25% |
SHARE-BASED COMPENSATION - Stoc
SHARE-BASED COMPENSATION - Stock Options (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Number of Shares | ||||
Outstanding at beginning of period (in shares) | 6,236,000 | 3,942,000 | 2,696,000 | |
Granted (in shares) | 4,044,000 | 3,986,000 | 3,546,000 | |
Exercised (in shares) | (12,000) | (90,000) | (439,000) | |
Cancelled or forfeited (in shares) | (121,000) | (1,602,000) | (1,861,000) | |
Outstanding at end of period (in shares) | 10,147,000 | 6,236,000 | 3,942,000 | 2,696,000 |
Exercisable at end of period (in shares) | 4,228,000 | |||
Weighted-Average Exercise Price | ||||
Outstanding at beginning of period (in dollars per share) | $ 1.52 | $ 2.12 | $ 3.16 | |
Granted (in dollars per share) | 0.87 | 1.02 | 1.71 | |
Exercised (in dollars per share) | 1.13 | 1.10 | 0.62 | |
Cancelled or forfeited (in dollars per share) | 1.04 | 1.78 | 3.21 | |
Outstanding at end of period (in dollars per share) | 1.26 | $ 1.52 | $ 2.12 | $ 3.16 |
Exercisable at end of period (in dollars per share) | $ 1.63 | |||
Weighted-Average Remaining Contractual Life (in years) | ||||
Remaining contractual life of stock options outstanding | 8 years 6 months | 8 years 9 months 29 days | 9 years 1 month 20 days | 8 years 6 months 18 days |
Exercisable at end of period | 7 years 10 months 6 days | |||
Outstanding intrinsic value beginning of period | $ 3,160 | $ 358 | $ 57 | $ 146 |
Aggregate intrinsic value exercisable | $ 931 |
SHARE-BASED COMPENSATION - Weig
SHARE-BASED COMPENSATION - Weighted-Average Inputs and Assumptions (Details) - $ / shares | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Share-based Payment Arrangement [Abstract] | |||
Fair value of common stock (in dollars per share) | $ 0.56 | $ 1.02 | $ 1.71 |
Exercise price of the option (in dollars per share) | $ 0.87 | $ 1.02 | $ 1.71 |
Expected term (in years) | 6 years 1 month 6 days | 6 years | 6 years |
Risk-free interest rate | 1.30% | 2.10% | 2.80% |
Expected volatility | 71.50% | 78.10% | 74.20% |
Dividend yield | 0.00% | 0.00% | 0.00% |
EMPLOYEE BENEFIT PLANS (Details
EMPLOYEE BENEFIT PLANS (Details) - USD ($) shares in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Feb. 28, 2014 | |
Defined Benefit Plan Disclosure [Line Items] | |||
Shares of common stock reserved for issuance (in shares) | 10,147 | 6,236 | |
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) | 200 | ||
Common stock purchase price, discount rate | 15.00% |
INCOME TAXES - Components of Pr
INCOME TAXES - Components of Pre-tax Income (Loss) (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Income Taxes [Line Items] | |||
Total pre-tax income (loss) | $ (20,952) | $ (107,500) | $ (33,693) |
United States | |||
Income Taxes [Line Items] | |||
Pre-tax income (loss) U.S. | (35,529) | (27,468) | (15,977) |
Canada | |||
Income Taxes [Line Items] | |||
Pre-tax income (loss) Canada | $ 14,577 | $ (80,032) | $ (17,716) |
INCOME TAXES - Components of In
INCOME TAXES - Components of Income Tax Provisions (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Current Tax Provision: | |||
Federal | $ 0 | $ 0 | $ 0 |
State | 0 | 0 | 0 |
Foreign | 1,445 | 0 | 0 |
Total Current Provision | 1,445 | 0 | 0 |
Deferred Tax Provision: | |||
Federal | 0 | 0 | 0 |
State | 0 | 0 | 0 |
Foreign | 0 | 0 | 0 |
Total Deferred Provision | 0 | 0 | 0 |
Provision for Income Taxes | $ 1,445 | $ 0 | $ 0 |
INCOME TAXES - Reconciliation o
INCOME TAXES - Reconciliation of Expected Income Tax Expense (Details) | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Effective Income Tax Rate Reconciliation: | |||
United States federal statutory income tax rate | 21.00% | 21.00% | 21.00% |
Impact of foreign rate differential | (4.20%) | 4.40% | 1.60% |
State taxes, net of federal benefit | 2.00% | 0.60% | 1.30% |
Stock option cancellations | (0.20%) | 0.00% | (1.20%) |
Contingent consideration | 14.40% | (18.00%) | (5.50%) |
General business credits and other credits | 6.60% | 0.40% | 0.70% |
Permanent differences | 0.20% | 0.00% | (0.30%) |
Other | (2.10%) | (0.50%) | 0.50% |
Foreign taxes | (6.90%) | 0.00% | 0.00% |
Change in valuation allowance | (37.70%) | (7.90%) | (18.10%) |
Effective Income Tax Rate | (6.90%) | 0.00% | 0.00% |
INCOME TAXES - Additional Infor
INCOME TAXES - Additional Information (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | |||
Valuation allowance | $ 65,631 | $ 57,724 | |
Valuation allowance change | 7,900 | ||
Deferred income tax liabilities, net | 12,528 | 12,528 | |
NOL carryforward reduced amount | 800 | ||
Provision for Income Taxes | $ 1,445 | $ 0 | $ 0 |
INCOME TAXES - Components of De
INCOME TAXES - Components of Deferred Tax Assets and Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Deferred tax assets: | ||
NOL carryforwards | $ 57,935 | $ 50,727 |
R&D credit carryforwards | 3,787 | 4,385 |
Accruals and other | 3,811 | 2,464 |
Capitalized start-up costs | 70 | 91 |
Other | 28 | 57 |
Gross deferred tax assets | 65,631 | 57,724 |
Deferred tax liabilities: | ||
IPR&D | (12,528) | (12,528) |
Property and equipment | 0 | 0 |
Gross deferred tax liabilities | (12,528) | (12,528) |
Valuation allowance | (65,631) | (57,724) |
Net Deferred Tax Liability | $ (12,528) | $ (12,528) |
INCOME TAXES - Schedule of Cred
INCOME TAXES - Schedule of Credit Carryforwards (Details) $ in Millions | Dec. 31, 2020USD ($) |
United States | Federal | |
Income Taxes [Line Items] | |
NOL carryforwards | $ 118.9 |
United States | State | |
Income Taxes [Line Items] | |
NOL carryforwards | 134.4 |
Indefinite | United States | Federal | |
Income Taxes [Line Items] | |
NOL carryforwards | 75.2 |
R&D credit carryforwards | United States | Federal | |
Income Taxes [Line Items] | |
Tax credit carryforwards | 2.3 |
R&D credit carryforwards | United States | State | |
Income Taxes [Line Items] | |
Tax credit carryforwards | 0.9 |
R&D credit carryforwards | Canada | |
Income Taxes [Line Items] | |
Tax credit carryforwards | 7 |
Non-capital loss carryforwards | Canada | |
Income Taxes [Line Items] | |
Tax credit carryforwards | 32.2 |
Investment tax credit carryforwards | Canada | |
Income Taxes [Line Items] | |
Tax credit carryforwards | $ 0.8 |
LICENSE AGREEMENTS (Details)
LICENSE AGREEMENTS (Details) $ in Thousands | Jul. 30, 2020USD ($) | Jun. 10, 2016USD ($)indicationoption | Sep. 30, 2020USD ($) | Aug. 31, 2016USD ($) | Sep. 15, 2016USD ($) | Dec. 31, 2020USD ($) | Dec. 31, 2020EUR (€) | Sep. 30, 2020USD ($) | Dec. 31, 2020USD ($) | Dec. 31, 2020EUR (€) | Dec. 31, 2019USD ($) | Dec. 31, 2018USD ($) |
Organization And Basis Of Presentation [Line Items] | ||||||||||||
License agreement, royalty rate | 2.00% | 2.00% | ||||||||||
Provision for Income Taxes | $ 1,445 | $ 0 | $ 0 | |||||||||
Total revenue | 11,236 | 0 | $ 0 | |||||||||
Deferred revenue, current | $ 1,500 | 1,500 | $ 0 | |||||||||
Qilu Pharmaceutical Co., Ltd. | ||||||||||||
Organization And Basis Of Presentation [Line Items] | ||||||||||||
Net proceeds | $ 10,000 | |||||||||||
Qilu Pharmaceutical Co., Ltd. | Licensing Agreements | ||||||||||||
Organization And Basis Of Presentation [Line Items] | ||||||||||||
Upfront payment | $ 12,000 | 12,000 | ||||||||||
Total milestone payments | $ 23,000 | |||||||||||
Royalty payment, percentage | 12.00% | |||||||||||
Transaction price | $ 11,200 | $ 11,200 | ||||||||||
Provision for Income Taxes | $ 1,100 | |||||||||||
Total revenue | $ 11,200 | |||||||||||
Micromet AG | ||||||||||||
Organization And Basis Of Presentation [Line Items] | ||||||||||||
Royalty payment obligation, percent | 3.50% | 3.50% | ||||||||||
Expenses related to achievement of development milestone | € | € 700,000 | |||||||||||
Potential milestone payments | € | € 2,900,000 | |||||||||||
License agreement, royalty payment, reduction, conditions not met | 1.50% | 1.50% | ||||||||||
License maintenance fees | € | € 50,000 | |||||||||||
XOMA Ireland Limited | ||||||||||||
Organization And Basis Of Presentation [Line Items] | ||||||||||||
License agreement, amount payable upon achievement of specified milestone | $ 250 | |||||||||||
Royalty payment obligation, percent | 2.50% | 2.50% | ||||||||||
Third party maximum ownership, percent | 50.00% | 50.00% | ||||||||||
Third party minimum ownership, percent | 1.75% | 1.75% | ||||||||||
Roche | ||||||||||||
Organization And Basis Of Presentation [Line Items] | ||||||||||||
License agreement, up-front fee | $ 7,500 | |||||||||||
License agreement, additional up-front fee | 262,500 | |||||||||||
License agreement, number of unrelated Indications | indication | 2 | |||||||||||
License agreement, option periods | option | 2 | |||||||||||
License agreement, buyout amount under first option period | $ 135,000 | |||||||||||
License agreement, period to pay buyout option once exercised | 30 days | |||||||||||
License agreement, buyout amount under second option period | $ 265,000 | |||||||||||
License agreement, buyout amount under second option period, upon non-issuance of patent rights or licensed product | $ 220,000 | |||||||||||
License agreement, period for termination where sufficient development activities are not performed | 12 months | |||||||||||
Roche | EBI-031 | Minimum | ||||||||||||
Organization And Basis Of Presentation [Line Items] | ||||||||||||
License agreement, royalty rate | 7.50% | |||||||||||
Roche | EBI-031 | Maximum | ||||||||||||
Organization And Basis Of Presentation [Line Items] | ||||||||||||
License agreement, royalty rate | 15.00% | |||||||||||
Roche | IL-6 | ||||||||||||
Organization And Basis Of Presentation [Line Items] | ||||||||||||
License agreement, royalty rate | 50.00% | |||||||||||
MENA License Agreement | ||||||||||||
Organization And Basis Of Presentation [Line Items] | ||||||||||||
Net proceeds | $ 2,700 | |||||||||||
Deferred revenue | 3,000 | 3,000 | ||||||||||
Deferred revenue, current | 1,500 | 1,500 | ||||||||||
MENA License Agreement | Licensing Agreements | ||||||||||||
Organization And Basis Of Presentation [Line Items] | ||||||||||||
Upfront payment | 3,000 | |||||||||||
Transaction price | 1,500 | 1,500 | ||||||||||
Provision for Income Taxes | $ 300 | |||||||||||
University of Zurich | ||||||||||||
Organization And Basis Of Presentation [Line Items] | ||||||||||||
Royalty payment obligation, percent | 4.00% | 4.00% | ||||||||||
Third party maximum ownership, percent | 10.00% | 10.00% | ||||||||||
Third party minimum ownership, percent | 2.00% | 2.00% | ||||||||||
Expenses related to achievement of development milestone | $ 300 | |||||||||||
First Indication | Roche | ||||||||||||
Organization And Basis Of Presentation [Line Items] | ||||||||||||
License agreement, amount payable upon achievement of specified milestone | 197,500 | |||||||||||
Collaborative arrangement, revenue based on development milestone | Roche | ||||||||||||
Organization And Basis Of Presentation [Line Items] | ||||||||||||
License agreement, amount payable upon achievement of specified milestone | $ 72,500 | |||||||||||
Collaborative arrangement, revenue based on development milestone | Roche | EBI-031 | ||||||||||||
Organization And Basis Of Presentation [Line Items] | ||||||||||||
License agreement, amount payable upon achievement of specified milestone | $ 22,500 | |||||||||||
Phase II Study | Roche | ||||||||||||
Organization And Basis Of Presentation [Line Items] | ||||||||||||
License agreement, amount payable upon achievement of specified milestone | 20,000 | |||||||||||
Collaborative arrangement, revenue based on regulatory milestone | Roche | ||||||||||||
Organization And Basis Of Presentation [Line Items] | ||||||||||||
License agreement, amount payable upon achievement of specified milestone | 50,000 | |||||||||||
Collaborative arrangement, revenue based on commercialization milestone | Roche | ||||||||||||
Organization And Basis Of Presentation [Line Items] | ||||||||||||
License agreement, amount payable upon achievement of specified milestone | $ 75,000 | |||||||||||
Second Indication | Roche | ||||||||||||
Organization And Basis Of Presentation [Line Items] | ||||||||||||
License agreement, amount payable upon achievement of specified milestone | $ 65,000 | |||||||||||
Collaborative Arrangement, Revenue Based on Clinical Development Milestone | University of Zurich | ||||||||||||
Organization And Basis Of Presentation [Line Items] | ||||||||||||
License agreement, amount payable upon achievement of specified milestone | $ 500 |
RELATED-PARTY TRANSACTIONS (Det
RELATED-PARTY TRANSACTIONS (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Majority Shareholder | Facility in Winnipeg, Manitola | |||
Related Party Transaction [Line Items] | |||
Rent expense in related party transaction | $ 300 | $ 300 | $ 300 |
Majority Shareholder | Facility in Toronto, Ontario | |||
Related Party Transaction [Line Items] | |||
Rent expense in related party transaction | 18 | 18 | |
Protoden | Intellectual Property | |||
Related Party Transaction [Line Items] | |||
Rent expense in related party transaction | 100 | $ 100 | $ 100 |
Annual fee for remaining term of lease | $ 100 |
SUBSEQUENT EVENTS (Details)
SUBSEQUENT EVENTS (Details) - USD ($) | Feb. 17, 2021 | Feb. 28, 2021 | Nov. 30, 2019 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 |
Subsequent Event [Line Items] | ||||||
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 | ||||
Stock options granted (in shares) | 4,044,000 | 3,986,000 | 3,546,000 | |||
Granted exercise price (in dollars per share) | $ 0.87 | $ 1.02 | $ 1.71 | |||
Stock options | 2014 Stock Incentive Plan | ||||||
Subsequent Event [Line Items] | ||||||
Award vesting period | 4 years | |||||
Award expiration period | 10 years | |||||
ATM Facility | ||||||
Subsequent Event [Line Items] | ||||||
Aggregate sales price | $ 35,000,000 | |||||
Subsequent Event | Stock options | Share-based Payment Arrangement, Nonemployee | 2014 Stock Incentive Plan | ||||||
Subsequent Event [Line Items] | ||||||
Stock options granted (in shares) | 4,100,000 | |||||
Granted exercise price (in dollars per share) | $ 3.17 | |||||
Stock options grant-date fair value (in dollars per share) | $ 2.06 | |||||
Vesting rights rate | 6.25% | |||||
Award vesting period | 3 months | |||||
Award expiration period | 4 years | |||||
Subsequent Event | ATM Facility | ||||||
Subsequent Event [Line Items] | ||||||
Common stock, par value (in dollars per share) | $ 0.001 | |||||
Additional shares to be issued | $ 34,500,000 | |||||
Aggregate sales price | $ 35,500,000 |