Document and Entity Information
Document and Entity Information - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2020 | Mar. 15, 2021 | Jun. 30, 2020 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2020 | ||
Document Fiscal Year Focus | 2020 | ||
Document Fiscal Period Focus | FY | ||
Trading Symbol | AVEO | ||
Entity Registrant Name | AVEO PHARMACEUTICALS, INC. | ||
Entity Central Index Key | 0001325879 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Current Reporting Status | Yes | ||
Entity Voluntary Filers | No | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | false | ||
ICFR Auditor Attestation Flag | true | ||
Entity Shell Company | false | ||
Entity Common Stock, Shares Outstanding | 27,130,087 | ||
Entity Public Float | $ 105.7 | ||
Entity Interactive Data Current | Yes | ||
Title of 12(g) Security | Common Stock, $0.001 par value | ||
Security Exchange Name | NASDAQ | ||
Entity File Number | 001-34655 | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Tax Identification Number | 04-3581650 | ||
Entity Address, Address Line One | 30 Winter Street | ||
Entity Address, City or Town | Boston | ||
Entity Address, State or Province | MA | ||
Entity Address, Postal Zip Code | 02108 | ||
City Area Code | 857 | ||
Local Phone Number | 400-0101 | ||
Document Annual Report | true | ||
Document Transition Report | false | ||
Documents Incorporated by Reference | Portions of our definitive proxy statement for our 2021 annual meeting of stockholders are incorporated by reference into Part III of this Annual Report on Form 10-K. |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Current assets: | ||
Cash and cash equivalents | $ 61,761 | $ 29,785 |
Marketable securities | 17,960 | |
Accounts receivable | 1,197 | 1,631 |
Clinical trial retainers | 355 | 589 |
Other prepaid expenses and other current assets | 2,195 | 635 |
Total current assets | 65,508 | 50,600 |
Property and equipment, net | 343 | |
Operating lease right-of-use asset | 903 | |
Other assets | 158 | |
Total assets | 66,912 | 50,600 |
Current liabilities: | ||
Accounts payable | 3,380 | 1,466 |
Accrued clinical trial costs and contract research | 4,550 | 5,680 |
Other accrued liabilities | 4,463 | 2,336 |
Operating lease liability | 369 | |
Loans payable, net of discount | 1,056 | 9,569 |
Deferred revenue | 1,974 | 1,974 |
Deferred research and development reimbursements | 164 | 93 |
PIPE Warrant liability (Note 7) | 199 | |
Other liabilities (Note 6) | 790 | |
Total current liabilities | 16,945 | 21,118 |
Loans payable, net of current portion and discount | 12,716 | 6,197 |
Deferred revenue | 578 | 2,552 |
PIPE Warrant liability (Note 7) | 5,097 | |
Operating lease liability, non-current | 336 | |
Other liabilities (Note 6) | 1,043 | 790 |
Total liabilities | 31,618 | 35,754 |
Stockholders’ equity: | ||
Preferred stock, $.001 par value: 5,000 shares authorized at December 31, 2020 and December 31, 2019; no shares issued and outstanding at each of December 31, 2020 and December 31, 2019 | ||
Common stock, $.001 par value: 50,000 shares authorized at December 31, 2020 and December 31, 2019; 26,883 shares issued and outstanding at December 31, 2020 and 16,081 issued and outstanding at December 31, 2019 | 27 | 16 |
Additional paid-in capital | 656,472 | 600,451 |
Accumulated deficit | (621,205) | (585,621) |
Total stockholders’ equity | 35,294 | 14,846 |
Total liabilities and stockholders’ equity | $ 66,912 | $ 50,600 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Mar. 31, 2020 | Dec. 31, 2019 |
Statement Of Financial Position [Abstract] | ||
Preferred stock, par value | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 5,000,000 | 5,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 50,000,000 | 50,000,000 |
Common stock, shares issued | 26,883,000 | 16,081,000 |
Common stock, shares outstanding | 26,883,000 | 16,081,000 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) shares in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Revenues: | |||
Revenues | $ 6,019,000 | $ 28,795,000 | $ 5,409,000 |
Operating expenses: | |||
Research and development | 22,679,000 | 17,958,000 | 20,652,000 |
Selling, general and administrative | 22,217,000 | 11,211,000 | 10,781,000 |
Settlement costs | (667,000) | ||
Operating expenses, total | 44,896,000 | 29,169,000 | 30,766,000 |
Loss from operations | (38,877,000) | (374,000) | (25,357,000) |
Other income (expense), net: | |||
Interest expense, net | (1,605,000) | (1,815,000) | (2,191,000) |
Change in fair value of PIPE Warrant liability | 4,898,000 | 11,577,000 | 19,919,000 |
Other income | 2,300,000 | ||
Other income (expense), net | 3,293,000 | 9,762,000 | 20,028,000 |
Net income (loss) before provision for income taxes | (35,584,000) | 9,388,000 | (5,329,000) |
Provision for income taxes | 0 | 0 | |
Net income (loss) | $ (35,584,000) | $ 9,388,000 | $ (5,329,000) |
Basic net income (loss) per share: | |||
Net income (loss) per share | $ (1.66) | $ 0.61 | $ (0.44) |
Weighted average number of common shares outstanding | 21,402 | 15,331 | 12,059 |
Diluted net income (loss) per share: | |||
Net income (loss) per share | $ (1.66) | $ 0.61 | $ (1.93) |
Weighted average number of common shares outstanding and dilutive share equivalents outstanding | 21,402 | 15,376 | 13,073 |
Collaboration and Licensing Revenue | |||
Revenues: | |||
Revenues | $ 4,774,000 | $ 27,934,000 | $ 4,947,000 |
Partnership Royalties | |||
Revenues: | |||
Revenues | $ 1,245,000 | $ 861,000 | $ 462,000 |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive Income (Loss) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Statement Of Income And Comprehensive Income [Abstract] | |||
Net income (loss) | $ (35,584) | $ 9,388 | $ (5,329) |
Other comprehensive income (loss): | |||
Unrealized gain (loss) on available-for-sale securities | (1) | 5 | |
Comprehensive income (loss) | $ (35,584) | $ 9,387 | $ (5,324) |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Equity (Deficit) - USD ($) $ in Thousands | Total | SVB Leerink | Equity-classified awards | Common Shares | Common SharesSVB Leerink | Additional Paid-in Capital | Additional Paid-in CapitalSVB Leerink | Additional Paid-in CapitalEquity-classified awards | Accumulated Other Comprehensive Income (Loss) | Accumulated Deficit |
Beginning Balance at Dec. 31, 2017 | $ (40,763) | $ 12 | $ 546,198 | $ (4) | $ (586,969) | |||||
Beginning Balance (in shares) at Dec. 31, 2017 | 11,833,000 | |||||||||
Issuance of common stock under employee stock purchase plan | 17 | 17 | ||||||||
Issuance of common stock under employee stock purchase plan (in shares) | 1,000 | |||||||||
Adjustment related to adoption of new revenue recognition standard ASC 606 | ASC 606 | (2,711) | (2,711) | ||||||||
Issuance of common stock and warrants in a public offering, excluding to related parties | 597 | 597 | ||||||||
Issuance of common stock in a public offering, excluding to related parties, net (in shares) | 51,000 | |||||||||
Issuance of common stock to related parties | 4,500 | 4,500 | ||||||||
Issuance of common stock to related parties (in shares) | 199,000 | |||||||||
Issuance of common stock from the SVB Leerink sales agreement (net of issuance costs of $0.2 million) | $ 10,330 | $ 1 | $ 10,329 | |||||||
Issuance of common stock (in shares) | 470,000 | |||||||||
Issuance of Settlement Warrants in connection with a class action settlement (Note 13) | 1,406 | 1,406 | ||||||||
Stock-based compensation expense related to equity-classified awards | $ 2,546 | $ 2,546 | ||||||||
Issuance of common stock in connection with warrant exercises | 544 | 544 | ||||||||
Issuance of common stock in connection with warrant exercises (in shares) | 54,000 | |||||||||
Reduction in PIPE Warrant liability in connection with warrant exercises | 1,153 | 1,153 | ||||||||
Exercise of stock options | 478 | 478 | ||||||||
Exercise of stock options (in shares) | 40,000 | |||||||||
Change in unrealized gain (loss) on investments | 5 | 5 | ||||||||
Net income (loss) | (5,329) | (5,329) | ||||||||
Ending Balance at Dec. 31, 2018 | (27,227) | $ 13 | 567,768 | 1 | (595,009) | |||||
Ending Balance (in shares) at Dec. 31, 2018 | 12,648,000 | |||||||||
Issuance of common stock and warrants in a public offering, excluding to related parties | 17,767 | $ 2 | 17,765 | |||||||
Issuance of common stock in a public offering, excluding to related parties, net (in shares) | 1,739,000 | |||||||||
Issuance of common stock and warrants in public offering, to related parties | 5,000 | 5,000 | ||||||||
Issuance of common stock in public offering to related parties (in shares) | 435,000 | |||||||||
Issuance of common stock from the SVB Leerink sales agreement (net of issuance costs of $0.2 million) | 7,512 | $ 1 | 7,511 | |||||||
Issuance of common stock (in shares) | 1,251,000 | |||||||||
Stock-based compensation expense related to equity-classified awards | 2,358 | 2,358 | ||||||||
Exercise of stock options | 49 | 49 | ||||||||
Exercise of stock options (in shares) | 8,000 | |||||||||
Change in unrealized gain (loss) on investments | (1) | $ (1) | ||||||||
Net income (loss) | 9,388 | 9,388 | ||||||||
Ending Balance at Dec. 31, 2019 | 14,846 | $ 16 | 600,451 | (585,621) | ||||||
Ending Balance (in shares) at Dec. 31, 2019 | 16,081,000 | |||||||||
Issuance of common stock under employee stock purchase plan | 32 | 32 | ||||||||
Issuance of common stock under employee stock purchase plan (in shares) | 6,000 | |||||||||
Issuance of common stock and warrants in a public offering, excluding to related parties | 24,079 | $ 5 | 24,074 | |||||||
Issuance of common stock in a public offering, excluding to related parties, net (in shares) | 5,221,000 | |||||||||
Issuance of common stock and warrants in public offering, to related parties | 23,644 | $ 5 | 23,639 | |||||||
Issuance of common stock in public offering to related parties (in shares) | 4,504,000 | |||||||||
Issuance of common stock from the SVB Leerink sales agreement (net of issuance costs of $0.2 million) | $ 5,917 | $ 1 | $ 5,916 | |||||||
Issuance of common stock (in shares) | 1,070,000 | |||||||||
Stock-based compensation expense related to equity-classified awards | $ 2,355 | $ 2,355 | ||||||||
Exercise of stock options | $ 5 | 5 | ||||||||
Exercise of stock options (in shares) | 934 | 1,000 | ||||||||
Net income (loss) | $ (35,584) | (35,584) | ||||||||
Ending Balance at Dec. 31, 2020 | $ 35,294 | $ 27 | $ 656,472 | $ (621,205) | ||||||
Ending Balance (in shares) at Dec. 31, 2020 | 26,883,000 |
Consolidated Statements of St_2
Consolidated Statements of Stockholders' Equity (Deficit) (Parenthetical) - Additional Paid-in Capital - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
FBR & Co | |||
Issuance of common stock, issuance costs | $ 0.2 | ||
SVB Leerink | |||
Issuance of common stock, issuance costs | $ 0.2 | $ 0.2 | |
Public Offering | |||
Issuance of common stock, issuance costs | $ 3.4 | $ 2.2 | $ 0.6 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | |||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Operating activities | ||||
Net income (loss) | $ (35,584) | $ 9,388 | $ (5,329) | |
Adjustments to reconcile net income (loss) to net cash used in operating activities: | ||||
Depreciation and amortization | 21 | |||
Stock-based compensation | 2,355 | 2,358 | 2,546 | |
Non-cash interest expense | 469 | 567 | 556 | |
Non-cash change in fair value of PIPE Warrant liability | (4,898) | (11,577) | (19,919) | |
Non-cash charge for settlement costs (Note 13) | (667) | $ 2,100 | ||
Amortization of premium and discount on investments | (106) | (44) | 3 | |
Changes in operating assets and liabilities: | ||||
Accounts receivable | 433 | 1,395 | (2,624) | |
Insurance recovery (Note 13) | 15,000 | |||
Prepaid expenses and other current assets | (1,326) | (742) | 774 | |
Operating lease right-of-use asset | (1,060) | |||
Other noncurrent assets | 15 | |||
Accounts payable | 1,914 | (2,033) | 1,063 | |
Accrued contract research | (1,130) | (574) | (2,067) | |
Other accrued liabilities | 2,127 | (362) | 240 | |
Operating lease liability | 369 | |||
Settlement liability (Note 13) | (15,000) | |||
Deferred revenue | (1,974) | (934) | 1,052 | |
Deferred research and development reimbursements | 71 | (361) | (669) | |
Operating lease liability, non-current | 336 | |||
Net cash used in operating activities | (37,983) | (2,919) | (25,026) | |
Investing activities | ||||
Purchases of marketable securities | (36,133) | (17,917) | (6,733) | |
Proceeds from maturities and sales of marketable securities | 54,200 | 25,312 | ||
Purchases of property and equipment | (363) | |||
Net cash provided by (used in) investing activities | 17,704 | (17,917) | 18,579 | |
Financing activities | ||||
Proceeds from issuance of common stock and warrants, net of issuance costs | 29,996 | 25,279 | 11,471 | |
Proceeds from issuance of common stock and warrants to related parties | 23,644 | 5,000 | 4,500 | |
Proceeds from issuance of loan payable | 5,329 | |||
Proceeds from issuance of stock for stock-based compensation arrangements | 38 | 49 | 494 | |
Payment on principal of loan payable | (6,497) | (3,834) | ||
Payment of loan maturity fees | (300) | (540) | ||
Payments of debt issuance costs | (255) | 0 | ||
Net cash provided by financing activities | 52,255 | 26,194 | 15,925 | |
Net increase in cash and cash equivalents | 31,976 | 5,358 | 9,478 | |
Cash and cash equivalents at beginning of period | 29,785 | 24,427 | 14,949 | |
Cash and cash equivalents at end of period | 61,761 | 29,785 | 24,427 | $ 14,949 |
Supplemental cash flow information | ||||
Cash paid for interest | 1,337 | $ 1,971 | 1,986 | |
Right-of-use asset obtained in exchange for operating lease liability | $ 1,225 | |||
Non-cash financing activity | ||||
Fair value of warrants issued in connection with a class action settlement (Note 13) | 1,406 | |||
ASC 606 | ||||
Non-cash adjustment | ||||
Increase to deferred revenue due to adoption of ASC 606 - transition adjustment on January 1, 2018 | $ 2,711 |
Organization
Organization | 12 Months Ended |
Dec. 31, 2020 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Organization | (1) Organization AVEO Pharmaceuticals, Inc. (the “Company”) is an oncology-focused biopharmaceutical company committed to delivering medicines that provide a better life for cancer patients. The Company’s strategy is to focus its resources toward the development and commercialization of its product candidates in North America, while leveraging partnerships to support development and commercialization in other geographies. With the approval of its first commercial product, FOTIVDA ® (tivozanib), On March 10, 2021, the U.S. Food and Drug Administration (the “FDA”), approved FOTIVDA in the United States for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (“RCC”) following two or more prior systemic therapies. FOTIVDA is an oral, next-generation vascular endothelial growth factor receptor (“VEGFR”) tyrosine kinase inhibitor (“TKI”). The approval of FOTIVDA is based on the Company’s pivotal ® The approval is also supported by three additional trials in RCC and includes safety data from over 1,000 clinical trial subjects. The Company is actively preparing for the commercial launch of FOTIVDA in the United States. T he Company’s the Company expects to have full promotional capabilities and FOTIVDA available to patients . FOTIVDA is also approved and commercialized through the Company’s development partner EUSA Pharma (UK) Limited (“EUSA”) in the United Kingdom, Germany, Spain and certain other countries in their territory, for the treatment of adult patients with advanced RCC who are VEGFR pathway inhibitor-naïve and are either untreated or who have failed prior therapy with interferon-alpha (IFN-a) or interleukin-2 (IL-2). B ased on FOTIVDA’s demonstrated anti-tumor activity, tolerability profile and reduction of regulatory T-cell production, the Company is studying FOTIVDA in combination with immune checkpoint inhibitors for the treatment of RCC and hepatocellular carcinoma (“HCC”) in phase 2 clinical trials. The Company recently announced its entry into a collaboration with Bristol Myers Squibb (“BMS”) to conduct a phase 3 study of FOTIVDA ® The Company’s pipeline of product candidates includes ficlatuzumab, a potent humanized immunoglobulin G1, or IgG1, monoclonal antibody that targets hepatocyte growth factor (“HGF”). The Company has previously reported promising early clinical data on ficlatuzumab in squamous cell carcinoma of the head and neck (“HNSCC”), pancreatic cancer and acute myeloid leukemia (“AML”). The Company is currently conducting a randomized phase 2 confirmatory study of ficlatuzumab for the potential treatment of HNSCC. The Company’s pipeline of product candidates also includes worldwide rights to AV-380, a potent humanized IgG1 monoclonal antibody that targets growth differentiation factor 15 (“GDF15”). In December 2020, the FDA accepted the Company’s investigational new drug application (“IND”) for AV-380 for the potential treatment of cancer cachexia, and the Company has initiated a phase 1 clinical trial in healthy subjects. The Company’s earlier-stage pipeline includes AV-203 and AV-353, both as potential oncology treatments. AV-203 is a potent humanized IgG1 monoclonal antibody that targets ErbB3 (also known as HER3) to which the Company expects to regain worldwide rights in September 2021. AV-353 is the Company’s a The Company is subject to a number of risks, including the need for substantial additional capital to continue its development programs and to fulfill its planned operating goals. In particular, the Company’s currently planned operating and capital requirements include the need for substantial working capital to support the development and commercialization activities for its lead product, FOTIVDA. As used throughout these consolidated financial statements, the terms “AVEO,” and the “Company” refer to the business of AVEO Pharmaceuticals, Inc. and its three wholly-owned subsidiaries, AVEO Pharma Limited, AVEO Pharma (Ireland) Limited and AVEO Securities Corporation. Liquidity and Going Concern In accordance with Accounting Standards Update (“ASU”) No. 2014-15, Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern that the consolidated financial statements are issued. The Company’s financial statements have been prepared on the basis of continuity of operations, realization of assets and the satisfaction of liabilities in the ordinary course of business. Through December 31, 2020, the Company has financed its operations primarily through private placements and public offerings of its common stock and preferred stock, license fees, milestone payments and research and development funding from strategic partners, and loan proceeds. The Company has devoted substantially all of its resources to its drug development efforts, comprising research and development, manufacturing, conducting clinical trials for its product candidates, protecting its intellectual property and general and administrative functions relating to these operations. The future success of the Company is dependent on its ability to commercialize FOTIVDA in the United States and to develop its clinical stage assets and, ultimately, upon the Company’s ability to create shareholder value. On March 10, 2021, the FDA approved FOTIVDA The Company has incurred recurring losses and cash outflows from operations since its inception, including an accumulated deficit of $621.2 million as of December 31, 2020. The Company anticipates that it will continue to incur significant operating expenses for the foreseeable future as it commercializes FOTIVDA in the United States and continues its planned development activities for its clinical stage assets. The Company may require substantial additional funding to advance its pipeline of clinical stage assets, and the timing and nature of these activities will be conducted subject to the availability of sufficient financial resources. As of March 16, 2021, the date of issuance of these consolidated financial statements, the Company expects that its cash and cash equivalents of $61.8 million as of December 31, 2020, along with proceeds from the $20.0 million drawdown under the 2020 Loan Facility with Hercules Capital, Inc. and certain of its affiliates (collectively “Hercules”) in March 2021 and from warrant exercises to date, and product revenues upon the commercial launch of FOTIVDA in the Management’s expectations with respect to its ability to fund current planned operations is based on estimates that are subject to risks and uncertainties. If actual results are different from management’s estimates, the Company may need to seek additional strategic or financing opportunities sooner than would otherwise be expected. However, there is no guarantee that any of these strategic or financing opportunities would be executed or executed on favorable terms, and some could be dilutive to existing stockholders. If the Company is unable to obtain additional funding on a timely basis, it may be forced to significantly curtail, delay or discontinue one or more of its planned research or development programs or be unable to expand its operations or otherwise capitalize on its commercialization of its product and product candidates. |
Basis of Presentation
Basis of Presentation | 12 Months Ended |
Dec. 31, 2020 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Basis of Presentation | (2) Basis of Presentation These consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries, AVEO Pharma Limited, AVEO Pharma (Ireland) Limited and AVEO Securities Corporation. The Company has eliminated all significant intercompany accounts and transactions in consolidation. Effective as of 5:00 p.m. Eastern Time on February 19, 2020, the Company effected a 1-for-10 Refer to Note 7, “ Common Stock—Reverse Stock Split – February 2020” for further details. |
Significant Accounting Policies
Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2020 | |
Accounting Policies [Abstract] | |
Significant Accounting Policies | (3) Significant Accounting Policies Revenue Recognition As of December 31, 2020, the Company’s revenues have been generated primarily through collaborative research, development and commercialization agreements. The terms of these agreements generally contain multiple promised goods and services, which may include (i) licenses, or options to obtain licenses, to the Company’s technology, (ii) research and development activities to be performed on behalf of the collaborative partner, and (iii) in certain cases, services in connection with the manufacturing of preclinical and clinical material. Payments to the Company under these arrangements typically include one or more of the following: non-refundable, upfront license fees; option exercise fees; funding of research and/or development efforts; milestone payments; and royalties on future product sales. Collaboration Arrangements Within the Scope of ASC 808, Collaborative Arrangements The Company analyzes its collaboration arrangements to assess whether such arrangements involve joint operating activities performed by parties that are both active participants in the activities and exposed to significant risks and rewards dependent on the commercial success of such activities and are therefore within the scope of ASC Topic 808, Collaborative Arrangements Revenue from Contracts with Customers Arrangements Within the Scope of ASC 606, Revenue from Contracts with Customers Under ASC 606, the Company recognizes revenue when its customers obtain control of promised goods or services, in an amount that reflects the consideration which the Company determines it expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that the Company determines are within the scope of ASC 606, the Company performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligation(s) in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligation(s) in the contract; and (v) recognize revenue when (or as) the Company satisfies its performance obligation(s). As part of the accounting for these arrangements, the Company must make significant judgments, including identifying performance obligations in the contract, estimating the amount of variable consideration to include in the transaction price and allocating the transaction price to each performance obligation. Once a contract is determined to be within the scope of ASC 606, the Company assesses the goods or services promised within the contract and determines those that are performance obligations. Arrangements that include rights to additional goods or services that are exercisable at a customer’s discretion are generally considered options. The Company assesses if these options provide a material right to the customer and if so, they are considered performance obligations. The exercise of a material right is accounted for as a contract modification for accounting purposes. The Company assesses whether each promised good or service is distinct for the purpose of identifying the performance obligations in the contract. This assessment involves subjective determinations and requires management to make judgments about the individual promised goods or services and whether such are separable from the other aspects of the contractual relationship. Promised goods and services are considered distinct provided that: (i) the customer can benefit from the good or service either on its own or together with other resources that are readily available to the customer (that is, the good or service is capable of being distinct) and (ii) the entity’s promise to transfer the good or service to the customer is separately identifiable from other promises in the contract (that is, the promise to transfer the good or service is distinct within the context of the contract). In assessing whether a promised good or service is distinct, the Company considers factors such as the research, manufacturing and commercialization capabilities of the collaboration partner and the availability of the associated expertise in the general marketplace. The Company also considers the intended benefit of the contract in assessing whether a promised good or service is separately identifiable from other promises in the contract. If a promised good or service is not distinct, an entity is required to combine that good or service with other promised goods or services until it identifies a bundle of goods or services that is distinct. The transaction price is then determined and allocated to the identified performance obligations in proportion to their standalone selling prices (“SSP”) on a relative SSP basis. SSP is determined at contract inception and is not updated to reflect changes between contract inception and when the performance obligations are satisfied. Determining the SSP for performance obligations requires significant judgment. In developing the SSP for a performance obligation, the Company considers applicable market conditions and relevant entity-specific factors, including factors that were contemplated in negotiating the agreement with the customer and estimated costs. The Company validates the SSP for performance obligations by evaluating whether changes in the key assumptions used to determine the SSP will have a significant effect on the allocation of arrangement consideration between multiple performance obligations. If the consideration promised in a contract includes a variable amount, the Company estimates the amount of consideration to which it will be entitled in exchange for transferring the promised goods or services to a customer. The Company determines the amount of variable consideration by using the expected value method or the most likely amount method. The Company includes the unconstrained amount of estimated variable consideration in the transaction price. The amount included in the transaction price is constrained to the amount for which it is probable that a significant reversal of cumulative revenue recognized will not occur. At the end of each subsequent reporting period, the Company re-evaluates the estimated variable consideration included in the transaction price and any related constraint, and if necessary, adjusts its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis in the period of adjustment. In determining the transaction price, the Company adjusts consideration for the effects of the time value of money if the timing of payments provides the Company with a significant benefit of financing. The Company does not assess whether a contract has a significant financing component if the expectation at contract inception is such that the period between payment by the licensees and the transfer of the promised goods or services to the licensees will be one year or less. The Company assessed each of its revenue generating arrangements in order to determine whether a significant financing component exists and concluded that a significant financing component does not exist in any of its arrangements. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) each performance obligation is satisfied at a point in time or over time, and if over time based on the use of an output or input method. Licenses of Intellectual Property: The terms of the Company’s license agreements include the license of functional intellectual property, given the functionality of the intellectual property is not expected to change substantially as a result of the Company’s ongoing activities. If the license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenues from the portion of the transaction price allocated to the license when the license is transferred to the licensee and the licensee is able to use and benefit from the license. For licenses that are bundled with other promises (that is, for licenses that are not distinct from other promised goods and services in an arrangement), the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition. Research and Development Funding: Arrangements that include payment for research and development services are generally considered to have variable consideration. If and when the Company assesses the payment for these services is no longer subject to the constraint on variable consideration, the related revenue is included in the transaction price. Milestone payments: At the inception of each arrangement that includes non-refundable payments for contingent milestones, including preclinical research and development, clinical development and regulatory, the Company evaluates whether the milestones are considered probable of being achieved and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within the control of the Company or the licensee, such as regulatory approvals, are not considered probable of being achieved until those approvals are received. At the end of each reporting period, the Company re-evaluates the probability of the achievement of contingent milestones and the likelihood of a significant reversal of such milestone revenue, and if necessary, adjusts its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect collaboration and licensing revenue in the period of adjustment. This quarterly assessment may result in the recognition of revenue related to a contingent milestone payment before the milestone event has been achieved. Royalties: For arrangements that include sales-based royalties, including milestone payments based on the level of sales, and the license is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). The following table summarizes the total revenues earned in the years ended December 31, 2020, 2019 and 2018, respectively, by partner (in thousands). Refer to Note 4, “Collaborations and License Agreements” regarding specific details. Years Ended December 31, 2020 2019 2018 Strategic Partner: ($ in thousands) KKC $ 2,800 $ 25,000 $ — EUSA 3,219 3,795 3,409 CANbridge — — 2,000 Total revenues $ 6,019 $ 28,795 $ 5,409 Leases The Company adopted ASU 2016-02, Leases (Topic 842) Leases As of the date of initial application of ASU 2016-02, the Company’s lease arrangement for its former corporate headquarters at One Broadway, Cambridge, Massachusetts was cancellable within 30 days’ notice to its landlord and excluded any extension incentives or disincentives to renew for an extended period of time. In addition, the Company has drug storage arrangements with multiple storage providers that are cancellable at any time without penalty to the Company. The Company recognized short-term operating lease expense in its Consolidated Statements of Operations of approximately $0.5 million, $1.0 million and $0.7 million in the years ended December 31, 2020, 2019 and 2018, respectively. Application of ASC 842 policy elections to leases post adoption The Company has made certain accounting policy elections to apply to its leases executed post adoption of ASU 2016-02 , or subsequent to January 1, 2019, as further described below. In accordance with ASC 842, components of a lease should be split into three categories: lease components, non-lease components, and non-components. The fixed and in-substance fixed contract consideration (including any consideration related to non-components) must be allocated based on the respective relative fair values to the lease components and non-lease components. The Company made an accounting policy election to combine lease and non-lease components as a single lease component At the inception of an arrangement, the Company determines whether the arrangement is or contains a lease based on the unique facts and circumstances present in the arrangement. Leases with a term greater than one year are recognized on the balance sheet as right-of-use assets and short-term and long-term lease liabilities, as applicable. Operating lease liabilities and their corresponding right-of-use assets are initially recorded based on the present value of lease payments over the expected remaining lease term. Certain adjustments to the right-of-use asset may be required for items such as incentives received. The interest rate implicit in lease contracts is typically not readily determinable. As a result, the Company utilizes its incremental borrowing rate to discount lease payments, which reflects the fixed rate at which the Company could borrow on a collateralized basis the amount of the lease payments in the same currency, for a similar term, in a similar economic environment. To estimate its incremental borrowing rate, a credit rating applicable to the Company is estimated using a synthetic credit rating analysis since the Company does not currently have a rating agency-based credit rating. ASC 842 allows for the use of judgment in determining whether the assumed lease term is for a major part of the remaining economic life of the underlying asset and whether the present value of lease payments represents substantially all of the fair value of the underlying asset. The Company applies the bright line thresholds referenced in ASC 842-10-55-2 to assist in evaluating leases for appropriate classification. 30 Winter Street Lease On March 5, 2020, the Company entered into a sublease agreement for office space located at 30 Winter Street in Boston, Massachusetts (the “Winter Street Sublease”) to relocate the Company’s corporate headquarters previously located at One Broadway in Cambridge, Massachusetts. Under the terms of the Winter Street Sublease, the Company leases 10,158 square feet of office space for $47.00 per square foot, or approximately $0.5 million per year in base rent subject to certain operating expenses, taxes and annual base rent increases of approximately 3%. The Winter Street Sublease commenced when the space became available for use by the Company on March 24, 2020 and will continue until its expiration on November 30, 2022. Upon commencement of the Winter Street Sublease, the Company paid a security deposit, in the amount of $0.3 million, which is subject to certain reductions to be applied to future base rent payments provided that no event of default has occurred in the preceding twelve months. The Company is accounting for the Winter Street Sublease under ASC 842 using its initial 2.7-year term through November 30, 2022. In applying ASC 842, the Company classified the Winter Street Sublease as an operating lease and recorded a right-of-use asset of approximately $1.2 million and a lease liability of approximately $1.0 million upon the effective lease commencement date. In calculating the lease liability, the Company used the present value of all future lease payments using an incremental borrowing rate of 7.58%. The Company is recognizing rent expense on a straight-line basis throughout the remaining term of the lease. In the year ended December 31, 2020, the Company recognized $0.4 million in rent expense. In connection with the execution of the Winter Street Sublease, the Company also entered into a Purchase Agreement for furniture (the “Furniture Purchase Agreement”) located on the premises upon the lease commencement. Upon execution of the Furniture Purchase Agreement, the Company paid the $0.1 million purchase price and recorded the furniture acquisition as property and equipment, net. The Company is recognizing depreciation using the straight-line method over the estimated useful life of 7 years. As of December 31, 2020, future minimum lease payments under the Company’s Winter Street Sublease are as follows (amounts in thousands): Year Ending December 31: 2021 385 2022 328 Total lease payments 713 Less imputed interest (8 ) Total operating lease liabilities $ 705 Short-term arrangements As of the date of initial application of ASU 2016-02, the Company’s lease arrangement for its former corporate headquarters at One Broadway, Cambridge, Massachusetts was cancellable within 30 days’ notice to its landlord and excluded any extension incentives or disincentives to renew for an extended period of time. In addition, the Company has drug storage arrangements with multiple storage providers that are cancellable at any time without penalty to the Company. The Company recognized short-term operating lease expense in its Consolidated Statements of Operations of approximately $0.5 million, $1.0 million and $0.7 million in the years ended December 31, 2020, 2019 and 2018, respectively. Research and Development Expenses Research and development expenses are charged to expense as incurred. Research and development expenses consist of costs incurred in performing research and development activities, including (i) clinical trials, drug manufacturing and distribution, preclinical studies, upfront license payments, milestones and sublicense fees related to in-licensed products and technology , consultants and other contracted services . Warrants Issued in Connection with Private Placement In May 2016, the Company issued warrants to purchase an aggregate of 1,764,242 shares of common stock in connection with a private placement financing and recorded the warrants as a liability (the “PIPE Warrants”). The Company accounts for warrant instruments that either conditionally or unconditionally obligate the issuer to transfer assets as liabilities regardless of the timing of the redemption feature or price, even though the underlying shares may be classified as permanent or temporary equity. As of December 31, 2020, PIPE Warrants exercisable for 80,309 shares of common stock had been exercised, for approximately $0.8 million in cash proceeds, and PIPE Warrants exercisable for 1,683,933 shares of common stock were outstanding. Refer to Note 7, “ Common Stock—Private Placement – May 2016” The PIPE Warrants contain a provision giving the warrant holder the option to receive cash, equal to the fair value of the remaining unexercised portion of the warrant, as cash settlement in the event that there is a fundamental transaction (contractually defined to include various merger, acquisition or stock transfer activities). Due to this provision, ASC 480, Distinguishing Liabilities from Equity The Company recorded a non-cash gain of approximately $4.9 million The following table rolls forward the fair value of the Company’s PIPE Warrant liability, the fair value of which is determined by Level 3 inputs for the years ended December 31, 2020, 2019 and 2018, respectively (in thousands): Fair value at December 31, 2017 $ 37,746 Decrease in fair value (19,919 ) Reduction in warrant liability for PIPE Warrant exercises (1,153 ) Fair value at December 31, 2018 $ 16,674 Decrease in fair value (11,577 ) Fair value at December 31, 2019 $ 5,097 Decrease in fair value (4,898 ) Fair value at December 31, 2020 $ 199 The key assumptions used to value the PIPE Warrants were as follows: Original Issuance December 31, 2017 December 31, 2018 December 31, 2019 December 31, 2020 Expected price volatility 76.25 % 84.86 % 82.64 % 133.07 % 56.79 % Expected term (in years) 5.00 3.50 2.50 1.50 0.50 Risk-free interest rates 1.22 % 2.09 % 2.47 % 1.59 % 0.09 % Stock price $ 8.90 $ 27.90 $ 16.00 $ 6.20 $ 5.77 Dividend yield — — — — — Prior Class Action Settlement and Settlement Warrants In December 2017, the Company entered into a binding memorandum of understanding (the “MOU”) with class representatives Bob Levine and William Windham (the “Plaintiffs”), regarding the settlement of a securities class action lawsuit (the “2013 Class Action”) that had been filed in 2013 and was pending in the United States District Court for the District of Massachusetts (the “District Court”) against the Company and certain of the Company’s former officers (Tuan Ha-Ngoc, David Johnston, and William Slichenmyer, together, the “Individual Defendants”), In re AVEO Pharmaceuticals, Inc. Securities Litigation et al. In December 2017, upon entering into the MOU, the Company’s liability related to this settlement became estimable and probable. Accordingly, the Company recorded an estimated $17.1 million contingent liability, including $15.0 million for the cash portion of the settlement with a corresponding insurance recovery for the 100% portion to be paid directly by certain of the Company’s insurance carriers, and an approximate $2.1 million estimate for the fair value on December 31, 2017 of 200,000 warrants to purchase shares of its common stock that the Company agreed to issue the Class (the “Settlement Warrants”), with a corresponding non-cash charge to the Statement of Operations as a component of operating expense. The Settlement Warrants were exercisable for a one-year In February 2018, the District Court preliminarily approved a definitive stipulation of settlement agreement (the “Stipulation”), following which the insurance carriers funded the settlement escrow account related to the $15.0 million cash portion of the settlement. On May 30, 2018, the District Court approved the Stipulation in its order of final approval and final judgment (the “Final Judgment”), which became effective on June 29, 2018 (the “Effective Date”). Pursuant to the Final Judgment, all claims against the Company were released upon the Effective Date. In addition, pursuant to the Stipulation, the Company had no interest in the settlement escrow account subsequent to the Effective Date. Accordingly, the $15 million contingent liability associated with the cash portion of the settlement and the corresponding insurance recovery was eliminated on the Effective Date. On July 16, 2018, the Company issued and delivered the Settlement Warrants in accordance with the Stipulation and filed a corresponding shelf registration statement, File No. (333-226190) to register the shares of common stock underlying the Settlement Warrants which was declared effective by the SEC on July 25, 2018. All 200,000 Settlement Warrants expired on July 15, 2019 as none of the warrants had been exercised during the one-year exercise period. Refer to Note 13, “ Legal Proceedings The estimated fair value of the Settlement Warrants was determined using the Black-Scholes pricing model. The estimated fair value of the Settlement Warrants was subject to revaluation at each balance sheet date and any changes in fair value were recorded as a non-cash gain or (loss) in the Statement of Operations as a component of operating expenses until the Settlement Warrants were issued. The fair value of the Settlement Warrants on June 30, 2018 was determined based on the estimated fair value of the Settlement Warrants at the time of issuance. The Company recorded a non-cash gain of approximately $0.7 million in the year ended December 31, 2018 in its Statement of Operations attributable to the decrease in the fair value of the Settlement Warrants that principally resulted from a lower volatility rate relative to prior periods. In July 2018, upon the issuance of the Settlement Warrants, the Company reclassified the approximate $1.4 million value of the Settlement Warrants from a liability to stockholders equity as a component of additional paid-in-capital based upon the terms of the warrant agreement and, accordingly, the approximate $1.4 million contingent liability on the Company’s balance sheet associated with the warrant portion of the settlement was eliminated. The key assumptions used to estimate the fair value the Settlement Warrants were as follows: December 31, 2017 June 30, 2018 Expected price volatility 101.52 % 62.74 % Expected term (in years) 1.00 1.00 Risk-free interest rates 1.76 % 2.37 % Stock price $ 27.90 $ 29.00 Dividend yield — — Cash, Cash Equivalents and Marketable Securities The Company considers all highly liquid investments with original maturities of three months or less at the date of purchase and an investment in a U.S. government money market fund to be cash equivalents. Changes in the balance of cash and cash equivalents may be affected by changes in investment portfolio maturities, as well as actual cash disbursements to fund operations. The Company’s cash is deposited in highly-rated financial institutions in the United States. The Company invests in United States government money market funds, high-grade, short-term commercial paper, corporate bonds and other United States government agency securities, which management believes are subject to minimal credit and market risk. The carrying values of the Company’s cash and cash equivalents approximate fair value due to their short-term maturities. The Company does not have any restricted cash balances. Marketable Securities Marketable securities consist primarily of investments which have expected average maturity dates in excess of three months. The Company invests in high-grade corporate obligations, including commercial paper, and U.S. government and government agency obligations that are classified as available-for-sale. Since these securities are available to fund current operations they are classified as current assets on the consolidated balance sheets. Marketable securities are stated at fair value, including accrued interest, with their unrealized gains and losses included as a component of accumulated other comprehensive income or loss, which is a separate component of stockholders’ equity. The fair value of these securities is based on quoted prices and observable inputs on a recurring basis. The cost of marketable securities is adjusted for amortization of premiums and accretion of discounts, with such amortization and accretion recorded as a component of interest expense, net. Realized gains and losses are determined on the specific identification method. Unrealized gains and losses are included in other comprehensive loss until realized, at which point they would be recorded as a component of interest expense, net. Below is a summary of cash, cash equivalents and marketable securities at December 31, 2020 and December 31, 2019: Amortized Cost Unrealized Gains Unrealized Losses Fair Value December 31, 2020 Cash and cash equivalents: Cash and money market funds $ 61,761 $ — $ — $ 61,761 Total cash, cash equivalents and marketable securities $ 61,761 $ — $ — $ 61,761 December 31, 2019 Cash and cash equivalents: Cash and money market funds $ 25,278 $ — $ — $ 25,278 Corporate debt securities 4,507 — — 4,507 Total cash and cash equivalents 29,785 — — 29,785 Marketable securities: Corporate debt securities due within 1 year $ 17,960 $ — $ — $ 17,960 Total marketable securities 17,960 — — 17,960 Total cash, cash equivalents and marketable securities $ 47,745 $ — $ — $ 47,745 Concentrations of Credit Risk Financial instruments that potentially subject the Company to credit risk primarily consist of cash and cash equivalents, marketable securities and accounts receivable. The Company maintains deposits in highly-rated, federally-insured financial institutions in excess of federally insured limits. The Company’s investment strategy is focused on capital preservation. The Company invests in instruments that meet the high credit quality standards outlined in the Company’s investment policy. This policy also limits the amount of credit exposure to any one issue or type of instrument. The Company’s accounts receivable primarily consists of amounts due to the Company from licensees and collaborators. The Company has not experienced any material losses related to accounts receivable from individual licensees or collaborators. Fair Value Measurements The fair value of the Company’s financial assets and liabilities reflects the Company’s estimate of amounts that it would have received in connection with the sale of the assets or paid in connection with the transfer of the liabilities in an orderly transaction between market participants at the measurement date. In connection with measuring the fair value of its assets and liabilities, the Company seeks to maximize the use of observable inputs (market data obtained from sources independent from the Company) and to minimize the use of unobservable inputs (the Company’s assumptions about how market participants would price assets and liabilities). The following fair value hierarchy is used to classify assets and liabilities based on the observable inputs and unobservable inputs used in order to value the assets and liabilities: Level 1: Quoted prices in active markets for identical assets or liabilities. An active market for an asset or liability is a market in which transactions for the asset or liability occur with sufficient frequency and volume to provide pricing information on an ongoing basis. Level 2: Observable inputs other than Level 1 inputs. Examples of Level 2 inputs include quoted prices in active markets for similar assets or liabilities and quoted prices for identical assets or liabilities in markets that are not active. Level 3: Unobservable inputs based on the Company’s assessment of the assumptions that market participants would use in pricing the asset or liability. Financial assets and liabilities are classified in their entirety within the fair value hierarchy based on the lowest level of input that is significant to the fair value measurement. The Company measures the fair value of its marketable securities by taking into consideration valuations obtained from third-party pricing sources. The pricing services utilize industry standard valuation models, including both income and market-based approaches, for which all significant inputs are observable, either directly or indirectly, to estimate fair value. These inputs include reported trades of and broker-dealer quotes on the same or similar securities, issuer credit spreads, benchmark securities and other observable inputs. As of December 31, 2020, the Company had financial assets valued based on Level 1 inputs consisting of cash and cash equivalents in a United States government money market fund. During the year ended December 31, 2020, the Company did not have any transfers of financial assets between Levels 1 and 2. As of December 31, 2020, the Company’s financial liability that was recorded at fair value consisted of the PIPE Warrant liability. The fair value of the Company’s loans payable at December 31, 2020 and December 31, 2019 approximates its carrying value, computed pursuant to a discounted cash flow technique using a market interest rate and is considered a Level 3 fair value measurement. The effective interest rate, which reflects the current market rate, considers the loan issuance costs and the deferred financing charge. The following table summarizes the assets and liabilities measured at fair value on a recurring basis at December 31, 2020 and December 31, 2019: Fair Value Measurements as of December 31, 2020 Level 1 Level 2 Level 3 Total (in thousands) Financial assets carried at fair value: Cash and money market funds $ 61,761 $ — $ — $ 61,761 Total cash, cash equivalents and marketable securities $ 61,761 $ — $ — $ 61,761 Financial liabilities carried at fair value: Total PIPE Warrant liability $ — $ — $ 199 $ 199 Fair Value Measurements as of December 31, 2019 Level 1 Level 2 Level 3 Total (in thousands) Financial assets carried at fair value: Cash and money market funds $ 25,278 $ — $ — $ 25,278 Corporate debt securities — 4,507 — 4,507 Total cash and cash equivalents $ 25,278 $ 4,507 $ — $ 29,785 Marketable securities: Corporate debt securities due within 1 year $ — $ 17,960 $ — $ 17,960 Total marketable securities $ — $ 17,960 $ — $ 17,960 Total cash, cash equivalents and marketable securities $ 25,278 $ 22,467 $ — $ 47,745 Financial liabil |
Collaborations and License Agre
Collaborations and License Agreements | 12 Months Ended |
Dec. 31, 2020 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Collaborations and License Agreements | (4) Collaborations and License Agreements Collaboration Agreement AstraZeneca In December 2018, the Company entered into a clinical supply agreement (the “AstraZeneca Agreement”) with a wholly-owned subsidiary of AstraZeneca PLC (“AstraZeneca”) to evaluate the safety and efficacy of AstraZeneca’s IMFINZI (durvalumab), a human monoclonal antibody directed against programmed death-ligand 1 (PD-L1), in combination with tivozanib as a first-line treatment for patients with advanced, unresectable HCC in an open-label, multi-center, randomized phase 1b/2 clinical trial (the “DEDUCTIVE trial”). The Company serves as the study sponsor; each party contributes the clinical supply of its study drug; key decisions are made by both parties by consensus; and external study costs are otherwise shared equally. The Company is accounting for the joint development activities under the AstraZeneca Agreement as a joint risk-sharing collaboration in accordance with ASC 808 Payments from AstraZeneca with respect to its share of the external costs for the DEDUCTIVE trial incurred by the Company pursuant to a joint development plan are recorded as a reduction in research and development expenses due to the joint risk-sharing nature of the activities that is not representative of a vendor-customer relationship. The Company records reimbursements from AstraZeneca for external study costs as a reduction in research and development expense during the period that reimbursable expenses are incurred. As a result of the cost sharing provisions in the AstraZeneca Agreement, the Company’s research and development expenses were reduced by approximately $1.1 million, $0.5 million and $0 in the years ended December 31, 2020, 2019 and 2018, respectively. The amount due to the Company from AstraZeneca pursuant to the cost-sharing provision was approximately $0.4 million as of December 31, 2020. Out-License Agreements CANbridge In March 2016 Pursuant to the CANbridge Agreement, CANbridge made an upfront payment to the Company of $1.0 million in April 2016, net of $0.1 million of foreign withholding taxes. CANbridge also reimbursed the Company for $1.0 million of certain AV-203 manufacturing costs incurred by the Company prior to entering into the CANbridge Agreement. CANbridge paid this manufacturing reimbursement in two installments of $0.5 million each, one in March 2017 and one in September 2017, net of foreign withholding taxes, following CANbridge’s validation of the manufacturing process for AV-203 drug substance. In December 2017, CANbridge filed an investigative new drug (“IND”) application with the National Medical Products Administration (formerly, the China Food and Drug Administration) (the “NMPA”) for a clinical study of AV-203, which CANbridge refers to as CAN017, in esophageal squamous cell carcinoma (“ESCC”). In August 2018, CANbridge obtained regulatory approval of this IND application from the NMPA and, accordingly, the Company earned a $2.0 million development and regulatory milestone payment that was received from CANbridge in August 2018. No milestones had been achieved by CANbridge in the years ended December 31, 2020 and 2019, respectively. A percentage of any milestone and royalty payments received by the Company pursuant to the CANbridge Agreement, excluding upfront and reimbursement payments, or under future partnership agreements related to the AV-203 program, are due to Biogen Idec International GmbH (“Biogen”) as a sublicensing fee under the option and license agreement between the Company and Biogen dated March 18, 2009, as amended. The $2.0 million development and regulatory milestone the Company earned in August 2018 for regulatory approval from the NMPA of an IND application for a clinical study of AV-203 in ESCC was subject to this sublicense fee, or $0.7 million, which was paid to Biogen in October 2018. In March 2021, CANbridge exercised its right to terminate for convenience the CANbridge Agreement. Under the terms of the CANbridge Agreement, the Company expects the transfer of the AV-203 program to be complete in September 2021 and, at that time, the Company will regain worldwide rights to the AV-203 program. Accounting Analysis Under ASC 606 The Company evaluated the CANbridge Agreement under ASC 606 and determined the CANbridge Agreement contained a single performance obligation related to the exclusive license to develop and commercialize AV-203 that was satisfied at the inception of the arrangement. The Company determined that the $1.0 million in upfront consideration received upon the execution of the CANbridge Agreement in March 2016 and the $1.0 million reimbursement received in the year ended December 31, 2017 for certain manufacturing costs incurred by the Company prior to the effective date constituted the amount of the consideration to be included in the transaction price upon the adoption of ASC 606 on January 1, 2018 and attributed these amounts to the Company’s single performance obligation Because the Company satisfied the single performance obligation at the inception of the contract and had no remaining performance obligations, each of these amounts were recognized upon receipt. Upon adoption of ASC 606 on January 1, 2018, none of the development and regulatory milestones were included in the transaction price, as these milestone amounts were fully constrained. As part of its evaluation of the constraint, the Company considered multiple factors: (i) regulatory approvals are outside of the control of CANbridge, (ii) certain development and regulatory milestones are contingent upon the success of future clinical trials, if any, which is out of the control of CANbridge, and (iii) efforts by CANbridge. Under the CANbridge Agreement, the Company had been eligible to receive milestone payments and royalties tied to the commencement of clinical trials, to regulatory approvals and to sales of such products upon commercialization. In the third quarter of 2018, the Company increased the transaction price to $4.0 million to include the $2.0 million development and regulatory milestone that was earned in August 2018 for regulatory approval from the NMPA of an IND application for a clinical study of AV-203 in ESCC. Accordingly, the Company recognized the full $2.0 million amount as collaboration and licensing revenue in the year ended December 31, 2018, as the Company did not have any ongoing performance obligations under the CANbridge Agreement. EUSA In December 2015, the Company entered into the EUSA Agreement, under which the Company granted to EUSA the exclusive, sublicensable right to develop, manufacture and commercialize tivozanib in the territories of Europe (excluding Russia, Ukraine and the Commonwealth of Independent States), Latin America (excluding Mexico), Africa and Australasia (collectively, the “EUSA Licensed Territories”) for all diseases and conditions in humans, excluding non-oncologic diseases or conditions of the eye. EUSA made research and development reimbursement payments to the Company of $2.5 million upon the execution of the EUSA Agreement during the year ended December 31, 2015 and $4.0 million in September 2017 upon its receipt of marketing approval from the European Commission in August 2017 for FOTIVDA (tivozanib) for the treatment of RCC. In September 2017, EUSA elected to opt-in to co-develop the phase 2 clinical trial of tivozanib in combination with OPDIVO (nivolumab), a PD-1 inhibitor, in the first-line and the second-line treatment of RCC (the “TiNivo trial”). As a result of exercising its opt-in right, EUSA made an additional research and development reimbursement payment to the Company of $2.0 million. This $2.0 million payment was received in October 2017, in advance of the completion of the TiNivo trial, and represents EUSA’s approximate 50% share of the total estimated costs of the TiNivo trial. The Company is also eligible to receive an additional research and development reimbursement payment from EUSA of 50% of the total costs for the Company’s phase 3 randomized, controlled, multi-center, open-label clinical trial comparing tivozanib to an approved therapy, sorafenib (Nexavar ® The Company is entitled to receive milestone payments of $2.0 million per country upon reimbursement approval for RCC, if any, in each of France, Germany, Italy, Spain and the United Kingdom (collectively, the “EU5”). The Company is also entitled to receive an additional $2.0 million for the grant of marketing approval for RCC, if any, in three of the licensed countries outside of the EU, as mutually agreed by the parties, of which approvals have been obtained in New Zealand in July 2019 and in South Africa in September 2020. In February 2018, November 2018 and February 2019, EUSA obtained reimbursement approval from the National Institute for Health and Care Excellence (“NICE”) in the United Kingdom, the German Federal Association of the Statutory Health Insurances (“GKV-SV”) in Germany and the Ministry of Health, Consumer Affairs and Social Welfare (“MSCBS”) in Spain, respectively, for the first-line treatment of RCC. Accordingly, the Company earned a $2.0 million milestone payment with respect to reimbursement approval in the United Kingdom that was received in March 2018, a $2.0 million milestone payment with respect to reimbursement approval in Germany that was received in December 2018 and a $2.0 million milestone payment with respect to reimbursement approval in Spain that was received in May 2019. The Company is also eligible to receive a payment of $2.0 million per indication in connection with a filing by EUSA with the EMA for marketing approval, if any, for tivozanib for the treatment of each of up to three additional indications and $5.0 million per indication in connection with the EMA’s grant of marketing approval for each of up to three additional indications, as well as potentially up to $335.0 million upon EUSA’s achievement of certain sales thresholds. The Company is also eligible to receive tiered double digit royalties on net sales, if any, of licensed products in the EUSA Licensed Territories ranging from a low double digit up to mid-twenty percent depending on the level of annual net sales. No milestone payments nor research and development reimbursement payments were earned in the year ended December 31, 2020. The research and development reimbursement payments under the EUSA Agreement are not subject to the 30% sublicensing payment payable to KKC, subject to certain limitations. The Company, however, would owe KKC 30% of other, non-research and development payments it may receive from EUSA pursuant to the EUSA Agreement, including reimbursement approvals for RCC in the EU5, marketing approvals for RCC in three specified non-EU licensed territories, EU marketing approval filings and corresponding marketing approvals by the EMA for up to three additional indications beyond RCC, and sales-based milestones and royalties, as set forth above. The $2.0 million milestone payments the Company earned in each of February 2018, November 2018 and February 2019 upon EUSA’s reimbursement approval for FOTIVDA from the NICE in the United Kingdom, the GKV-SV in Germany and the MSCBS in Spain, respectively, for the first-line treatment of RCC were subject to the 30% KKC sublicense fee, or $0.6 million, each. The sublicense fees for EUSA’s reimbursement approvals in the United Kingdom, Germany and Spain were paid in April 2018, January 2019 and June 2019, respectively. EUSA is obligated to use commercially reasonable efforts to seek regulatory approval for and commercialize tivozanib throughout the EUSA Licensed Territories in RCC. EUSA has responsibility for all activities and costs associated with the further development, manufacture, regulatory filings and commercialization of tivozanib in the EUSA Licensed Territories. Accounting Analysis Under ASC 606 Pursuant to ASC 606, the Company identified the following promised goods and services at the inception of the EUSA Agreement: (i) the Company’s grant of an exclusive license to develop and commercialize tivozanib in the EUSA Licensed Territories, including the Company’s obligation to transfer all technical knowledge and data useful in the development and manufacture of tivozanib; (ii) the Company’s obligation to cooperate with EUSA and support its efforts to file for marketing approval in the EUSA Licensed Territories and in its commercialization efforts; (iii) the Company’s obligation to provide access to certain regulatory information resulting from the Company’s ongoing development activities outside of the EUSA Licensed Territories; and (iv) the Company’s participation in a joint steering committee. The Company determined that the license to develop and commercialize tivozanib in the EUSA Licensed Territories was not distinct from the other promised goods and services and has accordingly accounted for these items as a single performance obligation. In reaching this conclusion, the Company concluded the remaining promises were essential to EUSA’s use of the license. The Company concluded at contract inception that EUSA’s opt-in rights with respect to the TiNivo trial and the TIVO-3 trial did not represent material rights because at contract inception the Company had not yet initiated either trial and the option price (representing approximately 50% of the costs of the respective trial) was proportional to the value attributed to the EUSA Licensed Territories relative to the territorial rights retained by the Company. Accordingly, the Company accounts for each opt-in as a separate arrangement when such opt-ins occur. The Company evaluated the promised goods and services at the inception of the EUSA Agreement under ASC 606. Based on this evaluation, the Company determined that $6.5 million in research and development payments by EUSA, including the $2.5 million upfront consideration received upon the execution of the EUSA Agreement in December 2015 and the $4.0 million payment upon the receipt of marketing approval from the EMA for FOTIVDA (tivozanib) Under ASC 606, the upfront consideration and regulatory milestones included in the transaction price are being recognized as collaboration and licensing revenue over the Company’s performance period from contract execution in December 2015 through the remaining patent life of tivozanib in April 2022. Under ASC 606, upon the achievement of a regulatory milestone, the amount that represents the cumulative catch-up for the period from contract execution in December 2015 through the date of the milestone achievement is recognized as collaboration and licensing revenue, with the balance classified as deferred revenue and recognized as collaboration and licensing revenue over the remainder of the performance period, currently estimated through April 2022 . In November 2017, the Company began earning sales royalties upon EUSA’s commencement of the first commercial launch of FOTIVDA (tivozanib) . In the first quarter of 2018, the Company increased the transaction price to $8.5 million to include the $2.0 million milestone for reimbursement approval from the NICE in the United Kingdom in first-line RCC that was achieved in February 2018. Accordingly, the Company recognized approximately $0.7 million in collaboration and licensing revenue for the cumulative catch-up for the period from contract execution in December 2015 through the milestone achievement in February 2018, with the approximate $1.3 million balance classified as deferred revenue that is being recognized as collaboration and licensing revenue over the remainder of the performance period through April 2022. In the fourth quarter of 2018, the Company increased the transaction price to $10.5 million to include the $2.0 million milestone for reimbursement approval from the GKV-SV in Germany in first-line RCC that was achieved in November 2018. Accordingly, the Company recognized approximately $0.9 million in collaboration and licensing revenue for the cumulative catch-up for the period from contract execution in December 2015 through the milestone achievement in November 2018, with the approximate $1.1 million balance classified as deferred revenue that is being recognized as collaboration and licensing revenue over the remainder of the performance period through April 2022. In the first quarter of 2019, the Company increased the transaction price to $12.5 million to include the $2.0 million milestone for reimbursement approval from the MSCBS in Spain in first-line RCC that was achieved in February 2019. Accordingly, the Company recognized approximately $1.0 million in collaboration and licensing revenue for the cumulative catch-up for the period from contract execution in December 2015 through the milestone achievement in February 2019, with the approximate $1.0 million balance classified as deferred revenue that is being recognized as collaboration and licensing revenue over the remainder of the performance period through April 2022. The Company recognized total revenues under the EUSA Agreement of approximately $3.2 million, $3.8 million and $3.4 million in the years ended December 31, 2020, 2019 and 2018, respectively. As of December 31, 2020, there was approximately $2.6 million in total deferred revenue that is expected to continue to be recognized as collaboration and licensing revenue, in the approximate amount of $0.5 million per quarter, over the duration of the Company’s performance period through April 2022. The following table summarizes the revenues earned in connection with the EUSA Agreement under ASC 606 for the year ended December 31, 2020, 2019 and 2018 (in thousands): Year Ended December 31, Year Ended December 31, Year Ended December 31, Revenue Type Date Achieved 2020 2019 2018 Collaboration and Licensing Revenue: Amounts in contract liabilities at the beginning of the period: Upfront payment December 2015 $ 395 $ 395 $ 395 R&D payment - EMA approval in RCC August 2017 631 631 632 Milestone - UK reimbursement approval February 2018 316 316 960 Milestone - German reimbursement approval November 2018 316 316 960 Milestone - Spanish reimbursement approval February 2019 316 1,276 — $ 1,974 $ 2,934 $ 2,947 Partnership Royalties 1,245 861 462 Total $ 3,219 $ 3,795 $ 3,409 The following table summarizes changes in the Company ’ Contract Assets Beginning Balance January 1, 2020 Additions Deductions Ending Balance December 31, 2020 Accounts Receivable $ 270 $ 1,245 $ (1,123 ) $ 392 Deferred Revenue Contract Liabilities Transaction Price Date Achieved Date Paid Beginning Balance January 1, 2020 Additions Deductions Ending Balance December 31, 2020 Amounts in contract liabilities at the beginning of the period: Upfront payment $ 2,500 December 2015 December 2015 $ 907 $ — $ (395 ) $ 512 R&D payment - EMA approval in RCC 4,000 August 2017 September 2017 1,448 — (631 ) 817 Milestone - UK reimbursement approval 2,000 February 2018 March 2018 724 — (316 ) 408 Milestone - German reimbursement approval 2,000 November 2018 December 2018 723 — (316 ) 407 Milestone - Spanish reimbursement approval 2,000 February 2019 May 2019 724 — (316 ) 408 Total $ 12,500 $ 4,526 $ — $ (1,974 ) $ 2,552 Opt-In to the TiNivo Trial In September 2017, EUSA elected to opt-in to co-develop the TiNivo trial. As previously described, the Company accounts for each opt-in as a separate arrangement. As a result of EUSA’s exercise of its opt-in right, it became an active participant in the ongoing conduct of the TiNivo trial and is able to utilize the resulting data from the TiNivo trial for regulatory and commercial purposes in the EUSA Licensed Territories. Upon the exercise of its opt-in right, EUSA became responsible for funding 50% of the total estimated costs of the TiNivo trial, up to $2.0 million. The Company is accounting for the joint development activities relative to the TiNivo trial as a joint risk-sharing collaboration in accordance with ASC 808 The Company recognized reductions in research and development expenses of approximately $0.1 million, $0.4 million and $0.5 million in the years ended December 31, 2020, 2019 and 2018, respectively. As of December 31, 2020, the Company had recognized $2.0 million in cumulative total reductions in research and development expenses related to EUSA’s approximate 50% share of the cumulative study-to-date costs. EUSA paid the $2.0 million maximum amount of cost sharing per the EUSA Agreement in advance of the completion of the trial. Novartis In August 2015, the Company entered into a license agreement (the “Novartis Agreement”) with Novartis International Pharmaceutical, Ltd. (“Novartis”), under which the Company granted Novartis the exclusive right to develop and commercialize AV-380 and the Company’s related antibodies worldwide. On June 29, 2018, Novartis notified the Company that it would be terminating the Novartis Agreement without cause, following a change in strategic direction at Novartis. Effective August 28, 2018 the Company regained the rights to AV-380, and on December 19, 2018, the Company entered into a new agreement with Novartis (the “AV-380 Transfer Agreement”) to further establish and clarify the terms on which Novartis would return the AV-380 program to the Company and to support the Company’s continuing development of the AV-380 program. Pursuant to the AV-380 Transfer Agreement, Novartis made a one-time payment to the Company of $2.3 million in January 2019, which the Company used to cover the $2.3 million time-based milestone obligation due to St. Vincent’s Hospital Sydney Limited (“St. Vincent’s”) in January 2019 under its license agreement as further described below under the heading “—In-License Agreements – St. Vincent’s.” In connection with the AV-380 Transfer Agreement, the $2.3 million payment due from Novartis was not considered a revenue transaction due to the effective termination of the Novartis Agreement on August 28, 2018 and was instead considered other income. The Company evaluated the return of the AV-380 drug supply and determined that the inventory was not capitalizable as future economic benefit was not probable due to the AV-380 product candidate being in the pre-clinical development stage. Biodesix In April 2014, the Company entered into a worldwide co-development and collaboration agreement (the “Biodesix Agreement”) with Biodesix, Inc. (“Biodesix”) to develop and commercialize ficlatuzumab, the Company’s potent humanized IgG1 monoclonal antibody that targets HGF. In September 2020, the Company regained full global rights to ficlatuzumab, effective December 2, 2020, when Biodesix exercised its “Opt-Out” rights (as defined below) under the Biodesix Agreement. Under the Biodesix Agreement, the Company granted Biodesix perpetual, non-exclusive rights to certain intellectual property, including all clinical and biomarker data related to ficlatuzumab, to develop and commercialize VeriStrat ® ® Under the Biodesix Agreement, prior to the first commercial sale of ficlatuzumab, each party had the right to elect to discontinue its funding obligation for further development or commercialization efforts with respect to ficlatuzumab in exchange for reduced economics in the program, which is referred to as an “Opt-Out.” Pursuant to the terms of the Biodesix Agreement, as a result of Biodesix’s election to Opt-Out, Biodesix will (i) continue to be responsible for reimbursement of development costs with respect to the ongoing open label Phase 2 investigator-sponsored clinical trial of ficlatuzumab in combination with ERBITUX® (cetuximab) in HNSCC (the “Phase 2 HNSCC Trial”), (ii) cease to be entitled to 50% sharing of profits resulting from commercialization of ficlatuzumab, (iii) be entitled to a low double digit royalty on future product sales and 25% of future licensing revenue (excluding contributions to research and development expenses) less approximately $2.5 million that Biodesix would be required to pay to the Company pursuant to the October 2016 amendment to the Biodesix Agreement and (iv) remain responsible for development obligations under the Biodesix Agreement with respect to VeriStrat. Biodesix and the Company also remain obligated to negotiate a commercialization agreement to delineate their rights and obligations in the event of any commercialization of VeriStrat with ficlatuzumab. As a result of Biodesix’s decision to Opt-Out, the Company now has worldwide licensing rights and sole decision-making authority with respect to further development and commercialization of ficlatuzumab. The payment obligations between the parties under the Biodesix Agreement are in effect until completion of the Phase 2 HNSCC Trial. The Company is accounting for the joint development activities under the Biodesix Agreement as a joint risk-sharing collaboration in accordance with ASC 808 The Company records reimbursements from Biodesix for expenses related to these trials and drug manufacturing as a reduction in research and development expense during the period that reimbursable expenses are incurred. As a result of the cost sharing provisions in the Biodesix Agreement, the Company reduced research and development expenses by approximately $0.8 million, $0.9 million and $0.3 million in the years ended December 31, 2020, 2019 and 2018, respectively. The amount due to the Company from Biodesix pursuant to the cost-sharing provision was approximately $0.1 million as of December 31, 2020. Biogen Idec International GmbH In March 2009, the Company entered into an exclusive option and license agreement with Biogen regarding the development and commercialization of the Company’s discovery-stage ErbB3-targeted antibodies, including AV-203, for the potential treatment and diagnosis of cancer and other diseases outside of North America (the “Biogen Agreement”). Under the Biogen Agreement, the Company was responsible for developing ErbB3 antibodies through completion of the first phase 2 clinical trial designed in a manner that, if successful, would generate data sufficient to support advancement to a phase 3 clinical trial. In March 2014, the Company and Biogen amended the Biogen Agreement (the “Biogen Amendment”). Pursuant to the Biogen Amendment, Biogen agreed to the termination of its rights and obligations under the Biogen Agreement, including Biogen’s option to (i) obtain a co-exclusive (with the Company) worldwide license to develop and manufacture ErbB3 targeted antibodies and (ii) obtain exclusive commercialization rights to ErbB3 products in countries in the world other than North America. As a result, the Company has worldwide rights to AV-203. Pursuant to the Biogen Amendment, the Company was obligated to use reasonable efforts to seek a collaboration partner for the purpose of funding further development and commercialization of ErbB3 targeted antibodies. The Company is also obligated to pay Biogen a percentage of milestone payments received by the Company from future partnerships after March 28, 2016 and single digit royalty payments on net sales related to the sale of ErbB3 products, if any, up to a cumulative maximum amount of $50.0 million. In March 2016, the Company entered into a collaboration and license agreement for AV-203 with CANbridge, which satisfied its obligation to seek a collaboration partner for the purpose of funding further development and commercialization of ErbB3 targeted antibodies. The $2.0 million development and regulatory milestone the Company earned in August 2018 in connection with CANbridge’s regulatory approval from the NMPA of an IND application for a clinical study of AV-203 in ESCC was subject to this sublicense fee, or $0.7 million, which was paid to Biogen in October 2018. See “— CANbridge In-License Agreements St. Vincent’s In July 2012, the Company entered into a license agreement with St. Vincent’s, under which the Company obtained an exclusive, worldwide sublicensable right to research, develop, manufacture and commercialize products for human therapeutic, preventative and palliative applications that benefit from inhibition or decreased expression or activity of GDF15, which is also referred to as MIC-1 (the “St. Vincent’s Agreement”). Under the St. Vincent’s Agreement, St. Vincent’s also granted the Company non-exclusive rights for certain related diagnostic products and research tools. In order to sublicense certain necessary intellectual property rights to Novartis in August 2015, the Company amended and restated the St. Vincent’s Agreement and made an additional upfront payment to St. Vincent’s of $1.5 million. As of December 31, 2020, the Company is required to make future milestone payments, up to an aggregate total of $14.4 million, upon the earlier of the achievement of specified development and regulatory milestones or a specified date for the first indication, and upon the achievement of specified development and regulatory milestones for the second and third indications, for licensed therapeutic products, some of which payments may be increased by a mid to high double digit percentage rate for milestone payments made after the Company grants any sublicense, depending on the sublicensed territory. In February 2017, Novartis agreed to pay $1.8 million out of its then future payment obligations to the Company under the Novartis Agreement. These funds were used to satisfy a $1.8 million time-based milestone obligation that the Company owed to St. Vincent’s in March 2017. The Company used the $2.3 million payment received from Novartis in January 2019, pursuant to the AV-380 Transfer Agreement, to cover a $2.3 million time-based milestone obligation that became due to St. Vincent’s in January 2019. The Company will also be required to pay St. Vincent’s tiered royalty payments equal to a low-single-digit percentage of any net sales it or its sublicensees make from licensed therapeutic products. The royalty rate escalates within the low-single-digit range during each calendar year based on increasing licensed therapeutic product sales during such calendar year. Kyowa Kirin Co. (KKC) In December 2006, the Company entered into the KKC Agreement with KKC, under which it obtained an exclusive, sublicensable license to develop, manufacture and commercialize tivozanib in all territories in the world except for Asia and the Middle East, where KKC retained the rights to tivozanib. Under the KKC Agreement, the Company obtained exclusive rights to tivozanib in its territory under certain KKC patents, patent applications and know-how for the diagnosis, prevention and treatment of all human diseases and conditions (the “Field”). On August 1, 2019, the Company entered into an amendment to the KKC Agreement pursuant to which KKC repurchased the non-oncology rights to tivozanib in the Company’s territory, excluding the rights the Company has sublicensed to EUSA under the EUSA Agreement. The Company has upfront, milestone and royalty payment obligations to KKC under the KKC Agreement related to the amended Field for oncology development by the Company, and following the amendment, KKC also has upfront, milestone and royalty payment obligations to the Company related to non-oncology development by KKC in the Company’s territory. Pursuant to the amendment to the KKC Agreement, KKC was required to make a non-refundable upfront payment to the Company in the amount of $25.0 million that was received in September 2019 and KKC waived a one-time milestone payment of KKC Agreement Upon entering into the KKC Agreement, the Company made an upfront payment in the amount of $5.0 million. In March 2010, the Company made a milestone payment to KKC in the amount of $10.0 million in connection with the dosing of the first patient in the Company’s TIVO-1 trial. In December 2012, the Company made a $12.0 million milestone payment to KKC in connection with the acceptance by the FDA of the Company’s 2012 NDA filing for tivozanib. Each milestone under the KKC Agreement is a one-time only payment obligation, accordingly, the Company did not owe KKC another milestone payment in connection with the dosing of the first patient in the Company’s TIVO-3 trial, and would not owe a milestone payment to KKC when the Company filed its then anticipated NDA with the FDA, which was subsequently filed on March 31, 2020. The Company has no remaining development and commercialization milestone payments due to KKC under the KKC Agreement. If the Company sublicenses any of its rights to tivozanib to a third-party, as it has done with EUSA, the sublicense defines the payment obligations of the sublicensee, which may vary from the milestone and royalty payment obligations under the KKC Agreement relating to rights th |
Other Accrued Liabilities
Other Accrued Liabilities | 12 Months Ended |
Dec. 31, 2020 | |
Payables And Accruals [Abstract] | |
Other Accrued Liabilities | (5) Other Accrued Liabilities Other accrued expenses consisted of the following: December 31, 2020 December 31, 2019 (in thousands) Professional fees $ 1,061 $ 806 Compensation and benefits 3,082 1,284 Other 320 246 Total $ 4,463 $ 2,336 |
Hercules Loan Facility
Hercules Loan Facility | 12 Months Ended |
Dec. 31, 2020 | |
Debt Disclosure [Abstract] | |
Hercules Loan Facility | (6) Hercules Loan Facility On May 28, 2010, the Company entered into a loan and security agreement with Hercules Capital Inc. and certain of its affiliates (the “First Loan Agreement”). The First Loan Agreement was subsequently amended in March 2012, September 2014 and May 2016 (the “2016 Amendment”). Amounts borrowed under the amendment in 2012 were repaid in full in 2015. In December 2017, the Company entered into an amended and restated loan and security agreement (the “2017 Loan Agreement”) to refinance the Company’s prior loan facility with Hercules and to retire the $20.0 million in secured debt then-outstanding under the First Loan Agreement. Per the terms of the 2017 Loan Agreement, the $20.0 million loan facility had a 42-month maturity from closing, no financial covenants, a lower interest rate and an interest-only period of no less than 12 months, which could be extended up to a maximum of 24 months, assuming the achievement of specified milestones relating to the development of tivozanib. Per the 2017 Loan Agreement, the loan maturity date was revised from December 2019 to July 2021. The Company was not required to make principal payments until February 1, 2019, at which time the Company would have been required to make 29 equal monthly payments of principal and interest, in the approximate amount of $0.8 million, through July 2021. An additional end-of-term payment of approximately $0.8 million is due on July 1, 2021. The financial covenant per the 2016 Amendment to maintain an unrestricted cash position greater than or equal to $10.0 million through the date of completion of the Company’s TIVO-3 trial with results that are satisfactory to Hercules was removed. Per the 2017 Loan Agreement, the interest rate decreased from 11.9% to 9.45%. The Company incurred approximately $0.1 million in loan issuance costs paid directly to Hercules, which was accounted for as a loan discount. The 2017 Loan Agreement was accounted for as a loan modification in accordance with ASC 470-50, Modifications and extinguishments The Company must make interest payments on the principal balance of the loan each month it remains outstanding. Per annum interest was payable on the loan balance at the greater of 9.45% and an amount equal to 9.45% plus the prime rate minus 4.75%, as determined daily, provided however, that the per annum interest rate shall not exceed 15.0%. In 2018, the interest rate increased to 9.70%, 9.95% and 10.20% in June 2018, September 2018 and December 2018, respectively, due to corresponding increases in the prime rate. In 2019, the interest rate decreased to 9.95%, 9.70% and 9.45% in August 2019, September 2019 and October 2019, respectively, due to corresponding decreases in the prime rate. The interest rate as of August 1, 2020 was 9.45%. The interest-only period could be extended by two 6-month deferrals of principal payments upon the achievement of specified milestones relating to the development of tivozanib, subject to confirmation by Hercules at its reasonable discretion. In November 2018, Hercules granted the first 6-month extension of the interest-only period. Accordingly, this resulted in the deferment of principal payments until August 1, 2019, at which time the Company resumed making 24 equal monthly payments of principal and interest, in the approximate amount of $0.9 million through July 2021. The outstanding principal balance as of August 1, 2020 was approximately $9.7 million. On August 7, 2020, the Company entered into a first amendment to the 2017 Loan Agreement (the “2020 Loan Amendment”) to provide the Company , The Company received the initial $15.0 million of the 2020 Loan Facility upon the closing of the 2020 Loan Amendment, of which approximately $9.7 million was used to retire the then outstanding balance under the 2017 Loan Agreement and of which approximately $5.3 million was new loan funding which was used for general working capital purposes. The remainder of the loan amount will be available to the Company, at its option, subject to certain terms and conditions, including upon the achievement of the following milestones: (i) the second tranche of $10.0 million (“Tranche Two”) would be available through June 30, 2021 upon achieving FDA approval of FOTIVDA (“Performance Milestone I”), (ii) the third tranche of $5.0 million (“Tranche Three”) would be available from July 1, 2021 through January 31, 2022 assuming the Company achieves $20.0 million in net product revenues from sales of FOTIVDA, by no later than December 31, 2021 (“Performance Milestone II”), and (iii) the fourth tranche of $5.0 million would be available through June 30, 2022 contingent upon the achievement of both Performance Milestone I and Performance Milestone II, and subject to the consent of Hercules. The 2020 Loan Amendment also amends the 2017 Loan Agreement by: (i) extending maturity until September 1, 2023, which is extendable to September 1, 2024 at the Company’s option assuming the Tranche Three funding has occurred, (ii) providing for an interest-only period beginning on the closing date of 2020 Loan Amendment and ending on September 30, 2021, which period may be extended through September 30, 2022 provided the Company achieved Performance Milestone I and further extendable through March 31, 2023 after the Tranche Three funding has occurred, if at all, and (iii) revising the per annum interest rate to the greater of (x) 9.65% and (y) an amount equal to 9.65% plus the prime rate as reported in the Wall Street Journal minus 3.25% as determined daily, provided however, that the per annum interest rate shall not exceed 15%. Principal payments are scheduled to commence on October 1, 2021, at the earliest, as described above. The interest rate as of December 31, 2020 was 9.65%. Per the terms of the 2020 Loan Facility, principal will be repaid in equal monthly installments following the conclusion of the interest-only period. The Company may prepay all of the outstanding principal and accrued interest under the 2020 Loan Facility, subject to a prepayment charge up to 3.0% in the first year following the closing of the 2020 Loan Amendment, decreasing to 2.0% in year two and 1.0% in year three. The Company is obligated to make an end-of-term payment of 6.95% of the aggregate amount of loan funding received under the 2020 Loan Facility on the earlier of the maturity of the loan or the date on which the Company prepays any outstanding loan balance. The approximate $0.8 million end-of-term payment under the 2017 Loan Agreement continues to be due on July 1, 2021. In connection with the 2020 Loan Amendment, the Company incurred approximately $0.3 million in loan issuance costs paid directly to Hercules, which are accounted for as a loan discount. The 2020 Loan Amendment was accounted for as a loan modification in accordance with ASC 470-50. The unamortized discount to be recognized over the remainder of the loan period was approximately $1.2 million and $0.4 million as of December 31, 2020 and December 31, 2019, respectively. The 2020 Loan Facility includes various financial and operating covenants, including that the Company maintain an unrestricted cash position of at least $10.0 million through the date the Third Tranche funding is received and at least $5.0 million thereafter through the maturity of the loan. The Company is also required to achieve greater than or equal to 75% of its forecasted net product revenues from its sales of tivozanib over a 6-month trailing period, as defined and measured on a monthly basis, effective upon the Third Tranche funding and continuing through the maturity of the loan. The net product revenue covenant will not apply at any time the Third Tranche funding has not been provided nor such advance has been prepaid in full. On February 1, 2021, the Company entered into the second amendment to the 2017 Loan Agreement (the “2021 Loan Amendment”), which increases the 2020 Loan Facility from up to $35.0 million to up to $45.0 million following FDA approval of FOTIVDA. The 2021 Loan Amendment makes certain changes to the 2020 Loan Amendment, including, among other things, (i) increasing Tranche Two funding upon achieving Performance Milestone I from $10.0 million to $20.0 million, thereby increasing the total amount of unfunded term loan commitments under the 2020 Loan Facility from $20.0 million to $30.0 million, (ii) increasing the amount of net product revenues from sales of FOTIVDA required to achieve Performance Milestone II from $20.0 million to $35.0 million and changing the deadline for achieving Performance Milestone II from December 31, 2021 to April 1, 2022 and (iii) increasing the amount of the financial covenant for the maintenance of an unrestricted cash position from at least $10.0 million to at least $15.0 million from the date the Tranche Two funding is received until the date the Tranche Three funding is received and at least $10.0 million thereafter through the maturity of the Loan Agreement. On March 11, 2021, the Company completed the $20.0 million drawdown of Tranche Two funding under the 2021 Loan Amendment that was made available in connection with the achievement of Performance Milestone I upon FDA approval of FOTIVDA on March 10, 2021. The achievement of Performance Milestone I extended the interest-only period by twelve months from September 30, 2021 to September 30, 2022 and increased the amount of unrestricted cash required for the Company to satisfy the minimum financial covenant during the period between receiving Tranche Two funding and Tranche Three funding from $10.0 million to $15.0 million. The 2020 Loan Facility is secured by substantially all of the Company’s assets, excluding intellectual property. The 2020 Loan Facility provides that certain events shall constitute a default by the Company, including failure by the Company to pay amounts under the 2020 Loan Amendment when due; breach or default in the performance of any covenant under the 2020 Loan Amendment by the Company, subject to certain cure periods; insolvency of the Company and certain other bankruptcy proceedings involving the Company; default by the Company of obligations involving indebtedness in excess of $500,000; and the occurrence of an event or circumstance that would have a material adverse effect upon the business of the Company. As of December 31, 2020, the Company was in compliance with all loan covenants, Hercules has not asserted any events of default and the Company does not believe that there has been a material adverse effect as defined in the 2020 Loan Amendment. The Company has determined that the risk of subjective acceleration under the material adverse events clause is remote and therefore has classified the outstanding principal as a long-term liability based on the timing of scheduled principal payments. Future minimum payments under the loans payable outstanding as of December 31, 2020 are as follows (amounts in thousands): Year Ending December 31: 2021 3,961 2022 8,277 2023 7,272 19,510 Less amount representing interest (2,678 ) Less unamortized discount (1,228 ) Less deferred charges (1,832 ) Less loans payable current, net of discount (1,056 ) Loans payable, net of current portion and discount $ 12,716 |
Common Stock
Common Stock | 12 Months Ended |
Dec. 31, 2020 | |
Equity [Abstract] | |
Common Stock | (7) Common Stock As of December 31, 2020, the Company had 50,000,000 authorized shares of common stock, $0.001 par value, of which 26,882,696 shares were issued and outstanding. Reverse Stock Split – February 2020 On February 13, 2020, the holders of a majority of the Company’s outstanding shares of common stock approved the reverse stock split and gave the Company’s board of directors discretionary authority to select a ratio for the split ranging from 1-for-5 to 1-for-15. The Company’s board of directors approved the reverse stock split at a ratio of 1-for-10 on February 13, 2020. On February 19, 2020, the Company effected a reverse stock split of its outstanding shares of common stock at a ratio of one-for-ten pursuant to a Certificate of Amendment to its Certificate of Incorporation filed with the Secretary of State of the State of Delaware. The reverse stock split was reflected on Nasdaq beginning with the opening of trading on February 20, 2020. The primary purpose of the reverse stock split was to enable the Company to regain compliance with the $1.00 minimum bid price requirement for continued listing on Nasdaq. The reverse stock split affected all issued and outstanding shares of the Company’s common stock, as well as the number of authorized shares of the Company’s common stock and the number of shares of common stock available for issuance under the Company’s equity incentive plans. The reverse stock split reduced the number of shares of the Company’s issued and outstanding common stock from approximately 160.8 million to approximately 16.1 million. In addition, the reverse stock split effected a reduction in the number of shares of the Company’s common stock issuable upon the exercise of stock options and warrants outstanding immediately prior to the reverse stock split, with a proportional increase in the respective exercise prices. The reverse stock split proportionately reduced the number of authorized shares of the Company’s common stock from 500.0 million shares to 50.0 million shares. The reverse stock split did not change the par value of the Company’s common stock or the authorized number of shares of the Company’s preferred stock. All share and per share amounts give effect to the reverse stock split on a retroactive basis. Public Offering – June 2020 On June 19, 2020, the Company completed an underwritten public offering of 9,725,000 shares of its common stock, including the partial exercise by the underwriters of their option to purchase an additional 1,225,000 shares, at the public offering price of $5.25 per share for gross proceeds of approximately $51.1 million. Three stockholders beneficially holding more than 5% of the Company’s voting securities, including an entity affiliated with New Enterprise Associates and two other stockholders, purchased an aggregate of 4,503,571 shares in this offering at the same public offering price per share as the other investors. At such time, entities affiliated with New Enterprise Associates (collectively) beneficially held more than 5% of the Company’s voting securities. Universal Shelf Registration Statement On November 9, 2020, the Company filed a shelf registration statement on Form S-3 with the U.S. Securities and Exchange Commission, which covers the offering, issuance and sale of up to $300.0 million of its common stock, preferred stock, debt securities, warrants and/or units (the “2020 Shelf”). The 2020 Shelf (File No. 333-249982) was declared effective by the SEC on November 18, 2020 and was filed to replace the Company’s then existing shelf registration statement, which was terminated. As of December 31, 2020, there was approximately $268.2 million available for future issuance of common stock, preferred stock, debt securities, warrants and/or units. Public Offering – April 2019 $ 22.8 million after deducting underwriting discounts and commissions and estimated offering expenses payable by the Company. As of December 31 , 2020, Offering Warrants to purchase 2,500,000 shares of the Company’s common stock were outstanding. The Company determined the shares of common stock and the Offering Warrants represented freestanding financial instruments. In addition, the Company conducted an assessment of the classification of the Offering Warrants and, based on their terms, concluded the Offering Warrants are equity-classified. Accordingly, the net offering proceeds of $22.8 million have been recorded within stockholders’ equity (deficit ) . In March 2021, Offering Warrants exercisable for 247,391 shares of common stock had been exercised, for approximately $3.1 million in cash proceeds, and Offering Warrants exercisable for 2,252,609 shares of common stock were outstanding. Sales Agreement with SVB Leerink In February 2018, the Company entered into a sales agreement with SVB Leerink (the “SVB Leerink Sales Agreement”) pursuant to which the Company may issue and sell shares of its common stock from time to time up to an aggregate amount of $50.0 million, at its option, through SVB Leerink as its sales agent, with any sales of common stock through SVB Leerink being made by any method that is deemed an “at-the-market offering” as defined in Rule 415 promulgated under the Securities Act of 1933, as amended (the “Securities Act”), or in other transactions pursuant to an effective shelf registration statement on Form S-3. The Company agreed to pay SVB Leerink a commission of up to 3% of the gross proceeds of any sales of common stock pursuant to the SVB Leerink Sales Agreement. In the fourth quarter of 2018, the Company sold 470,777 shares pursuant to the SVB Leerink Sales Agreement, resulting in approximately $10.3 million in proceeds, net of commissions. In February 2019, the Company sold 1,251,555 shares pursuant to the SVB Leerink Sales Agreement, resulting in proceeds of approximately $7.5 million, net of commissions. In November 2020, the Company sold 1,070,175 shares pursuant to the SVB Leerink Sales Agreement, resulting in proceeds of approximately $5.9 million, As of December 31, 2020, approximately $25.7 million was available for issuance in connection with future stock sales pursuant to the SVB Leerink Sales Agreement. Public Offering – August 2018 On August 21, 2018, the Company completed an underwritten public offering of 250,000 shares of its common stock at the public offering price of $22.60 per share for gross proceeds of approximately $5.7 million. Two greater than 5% stockholders, including an entity affiliated with New Enterprise Associates and another stockholder purchased approximately 200,000 shares in this offering at the same public offering price per share as the other investors. The net offering proceeds to the Company were approximately $5.1 million after deducting underwriting discounts and estimated offering expenses payable by the Company. Settlement Warrants On July 16, 2018, the Company issued and delivered 200,000 warrants to purchase shares of its common stock that the Company agreed to issue in connection with the settlement of the former 2013 class action lawsuit (the “Settlement Warrants”). The Settlement Warrants were exercisable for a one-year period after the date of issuance at an exercise price equal to $30.00 per share. All 200,000 Settlement Warrants expired on July 15, 2019 as none of the warrants had been exercised during the one-year Private Placement – May 2016 In May 2016, the Company entered into a securities purchase agreement with a select group of qualified institutional buyers, institutional accredited investors and accredited investors pursuant to which the Company sold 1,764,242 units, at a price of $9.65 per unit, for gross proceeds of approximately $17.0 million. Each unit consisted of one share of the Company’s common stock and a warrant to purchase one share of the Company’s common stock (the “PIPE Warrants”). The PIPE Warrants have an exercise price of $10.00 per share and are exercisable for a period of five years from the date of issuance until their scheduled expiration on May 16, 2021. Certain of the Company’s directors and executive officers purchased an aggregate of 54,402 units in this offering at the same price as the other investors. The net offering proceeds to the Company were approximately $15.4 million after deducting placement agent fees and other offering expenses payable by the Company. As of December 31, 2020, PIPE Warrants exercisable for 80,309 shares of common stock had been exercised, for approximately $0.8 million in cash proceeds, and PIPE Warrants exercisable for 1,683,933 shares of common stock were outstanding. |
Stock-based Compensation
Stock-based Compensation | 12 Months Ended |
Dec. 31, 2020 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Stock-based Compensation | (8) Stock-based Compensation Stock Incentive Plan The Company previously maintained the 2010 Stock Incentive Plan (the “2010 Plan”) for employees, consultants, advisors, and directors, as amended in March 2013, June 2014 and June 2017. In April 2019, the Company’s b oard of d irectors adopted the 2019 Equity Incentive Plan (the “2019 Plan”) and on June 12, 2019 the stockholders approved the 2019 Plan at the Annual Meeting of Stockholders. The 2019 Plan provides similar terms as the 2010 Plan, including: (i) a provision for the grant of equity awards such as stock options and restricted stock, (ii) that the exercise price of incentive stock options cannot be less than 100 % of the fair market value of the common stock on the date of the grant for participants who own less than 10% of the total combined voting power of stock of the Company and not less than 110 % for participants who own more than 10% of the total combined voting power of the stock of the Company, (iii) that options and restricted stock granted under the 2019 Plan vest over periods as determined by the b oard of d irectors, which generally are equal to four years , and (iv) that options granted under the 2019 Plan expire over periods as determined by the b oard of d irectors, which generally are ten years from the date of grant. In April 2020, the b oard of d irectors adopted an amendment to the 2019 Plan to increase the total number of shares reserved under the Plan by 1,300,000 shares, among other things. The amendment was approved by stockholders at the Annual Meeting of Stockholders held on June 10, 2020. Awards may be made under the 2019 Plan for up to the sum of (i) 2,300,000 shares of common stock and (ii) such additional number of shares of common stock (up to 1,068,901 shares) as is equal to (x) the number of shares of common stock reserved for issuance under the 2010 Plan that were available for grant under the 2010 Plan immediately prior to the date the 2019 Plan was approved by the Company’s stockholders and (y) the number of shares of common stock subject to awards outstanding under the 2010 Plan, which awards expire, terminate or are otherwise surrendered, cancelled, forfeited or repurchased by the Company pursuant to a contractual repurchase right. As of December 31, 2020, there were 1,563,282 shares of common stock available for future issuance under the 2019 Plan and no shares of common stock available for future issuance under the 2010 Plan. The following table summarizes stock option activity during the year ended December 31, 2020: Options Weighted- Average Exercise Price Weighted- Average Remaining Contractual Term Aggregate Intrinsic Value Outstanding at January 1, 2020 1,168,222 $ 16.77 Granted 740,522 $ 5.83 Exercised (934 ) $ 5.60 Forfeited (111,120 ) $ 36.45 Outstanding at December 31, 2020 1,796,690 $ 11.05 7.53 $ 170,000 Exercisable at December 31, 2020 909,963 $ 14.56 6.14 $ 12,000 The aggregate intrinsic value is based upon the Company’s closing stock price of $5.77 on December 31, 2020. The fair value of stock options subject only to service or performance conditions that are granted to employees is estimated on the date of grant using the Black-Scholes option-pricing model using the assumptions noted in the following table: Years Ended December 31, 2020 2019 2018 Volatility factor 94.37% - 102.48% 88.27% - 98.81% 80.18% - 83.61% Expected term (in years) 5.50 - 6.25 5.50 - 6.25 5.50 - 6.25 Risk-free interest rates 0.31% - 1.67% 1.43% - 2.55% 2.64% - 3.10% Dividend yield — — — The risk-free interest rate is determined based upon the United States Treasury’s rates for U.S. Treasury zero-coupon bonds with maturities similar to those of the expected term of the options being valued. The Company does not expect to pay dividends in the foreseeable future. Based upon these assumptions, the weighted-average grant date fair value of stock options granted was $4.54, $5.70 and $21.40 during the years ended December 31, 2020, 2019 and 2018, respectively. As of December 31, 2020, there was $4.9 million of total unrecognized stock-based compensation expense related to stock options granted to employees under the Plan. The expense is expected to be recognized over a weighted-average period of 2.8 years. The intrinsic value of options exercised was $1,000, $7,000 and $0.4 million in the years ended December 31, 2020, 2019 and 2018, respectively. Employee Stock Purchase Plan In February 2010, the board of directors adopted the 2010 Employee Stock Purchase Plan (the “ESPP”) pursuant to which the Company may sell up to an aggregate of 25,000 shares of Common Stock, as amended in March 2013. The ESPP allows eligible employees to purchase common stock at a price per share equal to 85% of the lower of the fair market value of the common stock at the beginning or end of each six-month Pursuant to the ESPP, the Company sold a total of 5,971 shares of common stock during the year ended December 31, 2020 at purchases prices of $6.46 and $4.57, which represents 85% of the closing price of the Company’s common stock on December 1, 2019 and November 30, 2020, respectively. Pursuant to the ESPP, the Company sold a total of 897 shares of common stock during the year ended December 31, 2018 at purchases prices of $18.80 and $17.60, which represents 85% of the closing price of the Company’s common stock on May 31, 2018 and November 30, 2018, respectively. The Company did not sell any shares of common stock during the year ended December 31, 2019. The total stock-based compensation expense recorded as a result of the ESPP was approximately $25,000, $2,000 and $8,000 during the years ended December 31, 2020, 2019 and 2018, respectively. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2019 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | ( 9) Commitments and Contingencies Operating Leases On March 5, 2020, the Company entered into the Winter Street Sublease to relocate the Company’s corporate headquarters previously located at One Broadway in Cambridge, Massachusetts. Under the terms of the Winter Street Sublease, the Company leases 10,158 square feet of office space for $47.00 per square foot, or approximately $0.5 million per year in base rent subject to certain operating expenses, taxes and annual base rent increases of approximately 3%. Previously, the Company leased office space under a month-to-month lease. Rent expense under the operating leases amounted to $0.6 million, $0.8 million and $0.7 million for the years ended December 31, 2020, 2019 and 2018, respectively. Manufacturing Commitments The Company has entered into a contract with a clinical manufacturing organization for the manufacture of clinical drug supply for tivozanib and commercial drug supply for FOTIVDA in the United States, which includes minimum annual purchase requirements, in the approximate amount of $1.4 million for the next few years. In addition, the Company has entered into contracts with another clinical manufacturing organization for the manufacture of clinical drug supply for ficlatuzumab and AV-380, for which we have manufacturing commitments in 2021, in the aggregate amount of approximately $10.3 million. Employment Agreements Certain key executives are covered by severance and change in control agreements. Under these agreements, if the executive’s employment is terminated without cause or if the executive terminates his employment for good reason, such executive will be entitled to receive severance equal to his base salary, benefits and prorated bonuses for a period of time equal to either 12 months or 18 months, depending on the terms of such executive’s individual agreement. In addition, in December 2007, the Company approved a key employee change in control severance benefits plan, which was amended in November 2009, and which provides for severance and other benefits under certain qualifying termination events upon a change in control for a period of time ranging from 6 months to 18 months, depending upon the position of the key employee. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2020 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | ( 10) Income Taxes The Company accounts for income taxes under the provisions of ASC 740. The Company recorded no tax provision for each of the years ended December 31, 2020 and 2019. For the year ended December 31, 2020, the Company did not have any federal, state, or foreign income tax expense as it generated taxable losses in all filing jurisdictions. A reconciliation of the expected income tax benefit computed using the federal statutory income tax rate to the Company’s effective income tax rate is as follows for the years ended December 31, 2020, 2019 and 2018: Years Ended December 31, 2020 2019 2018 Income tax computed at federal statutory tax rate 21.0 % 21.0 % 21.0 % State taxes, net of federal benefit 6.7 % 1.3 % 27.2 % Research and development credits 1.5 % (4.2 )% 5.2 % PIPE Warrants 2.9 % (25.9 )% 78.5 % Other permanent differences (0.5 )% 1.8 % (3.5 )% Other (1.1 )% 5.7 % (2.0 )% Change in valuation allowance (30.5 )% 0.3 % (126.4 )% Total — — — With limited exceptions, the Company has incurred net operating losses from inception. At December 31, 2020, the Company had domestic federal, state, and United Kingdom (UK) net operating loss carryforwards of approximately $565.8 million, $420.9 million, and $6.0 million respectively, available to reduce future taxable income. The federal net operating loss carryforwards expire beginning in 2022 and continue through 2037 and the state loss carryforwards begin to expire in 2030 and continue through 2040. The Company’s federal net operating losses include $63.2 million, which do not expire. The foreign net operating loss carryforwards in the UK do not expire. The Company also had federal and state research and development tax credit carryforwards of approximately $11.8 million and $4.3 million, respectively, available to reduce future tax liabilities and which expire at various dates. The federal credits expire beginning in 2023 through 2040 and the state credits expire beginning in 2021 through 2035. The net operating loss and research and development carryforwards are subject to review and possible adjustment by the Internal Revenue Service and may be limited in the event of certain changes in the ownership interest of significant stockholders. The Company’s net deferred tax assets as of December 31, 2020 and 2019 are as follows (in thousands): December 31, 2020 2019 (in thousands) Deferred tax assets: NOL carryforwards $ 148,689 $ 138,105 Research and development credits 15,271 14,666 Deferred revenue and R&D reimbursements 742 1,262 Other temporary differences 5,001 4,820 Total deferred tax assets: 169,703 158,853 Valuation allowance (169,703 ) (158,853 ) Total $ — $ — A full valuation allowance has been recorded in the accompanying consolidated financial statements to offset these deferred tax assets because the future realizability of such assets is uncertain. This determination is based primarily on the Company’s historical and expected future losses. The valuation allowance increased by $10.9 million and $27 thousand during the years ended December 31, 2020 and 2019, respectively, which was primarily due to the generation of net operating losses and tax credits. The Company applies the provisions of ASC 740, Income Taxes Utilization of the net operating loss carryforwards and research and development tax credit carryforwards may be subject to an annual limitation under Section 382 of the Internal Revenue Code of 1986, as amended (the “Internal Revenue Code”), and corresponding provisions of state law, due to ownership changes that have occurred previously or that could occur in the future. These ownership changes may limit the amount of carryforwards that can be utilized annually to offset future taxable income. In general, an ownership change, as defined by Section 382, results from transactions increasing the ownership of certain shareholders or public groups in the stock of a corporation by more than 50% over a three-year period. The Company has not recently conducted a study to assess whether a change of control has occurred or whether there have been multiple changes of control since the last study was completed due to the significant complexity and cost associated with such a study. If the Company has experienced a change of control, as defined by Section 382, at any time since the last study was completed, utilization of the net operating loss carryforwards or research and development tax credit carryforwards would be subject to an annual limitation under Section 382, which is determined by first multiplying the value of the Company’s stock at the time of the ownership change by the applicable long-term tax-exempt rate, and then could be subject to additional adjustments, as required. Any limitation may result in expiration of a portion of the net operating loss carryforwards or research and development tax credit carryforwards before utilization. The Company may from time to time be assessed interest or penalties by major tax jurisdictions. The Company recognizes interest and penalties related to uncertain tax positions in income tax expense. No interest and penalties have been recognized by the Company to date. The Company anticipates that the amount of unrecognized tax benefits recorded will not change in the next twelve months. The following is a reconciliation of the Company’s gross uncertain tax positions at December 31, 2020, 2019 and 2018: Years Ended December 31, 2020 2019 2018 (in thousands) Amount established upon adoption $ 1,200 $ 1,200 $ 1,200 Additions for current year tax provisions — — — Additions for prior year tax provisions — — — Reductions of prior year tax provisions (122 ) — — Balance as of end of year $ 1,078 $ 1,200 $ 1,200 |
Employee Benefit Plan
Employee Benefit Plan | 12 Months Ended |
Dec. 31, 2020 | |
Compensation And Retirement Disclosure [Abstract] | |
Employee Benefit Plan | ( 11) Employee Benefit Plan In 2002, the Company established the AVEO Pharmaceuticals, Inc. 401(k) Plan (the “401(k) Plan”) for its employees, which is designed to be qualified under Section 401(k) of the Code. Eligible employees are permitted to contribute to the 401(k) Plan within statutory and 401(k) Plan limits. The Company makes matching contributions of 50% of the first 5% of employee contributions. The Company made matching contributions of $0.1 million for each of the years ended December 31, 2020, 2019 and 2018. |
Quarterly Results (Unaudited)
Quarterly Results (Unaudited) | 12 Months Ended |
Dec. 31, 2020 | |
Quarterly Financial Information Disclosure [Abstract] | |
Quarterly Results (Unaudited) | ( 12) Quarterly Results (Unaudited) Three Month Ended March 31, 2020 June 30, 2020 September 30, 2020 December 31, 2020 (in thousands, expect per share data) (unaudited) Revenues $ 784 $ 749 $ 3,600 $ 886 Operating expenses 11,498 8,156 11,660 13,582 Loss from operations (10,714 ) (7,407 ) (8,060 ) (12,696 ) Change in fair value of PIPE Warrant liability 2,648 450 86 1,714 Other income (expense), net (315 ) (349 ) (419 ) (522 ) Net income (loss) $ (8,381 ) $ (7,306 ) $ (8,393 ) $ (11,504 ) Basic net income (loss) per share Net income (loss) per share $ (0.52 ) $ (0.42 ) $ (0.33 ) $ (0.44 ) Weighted average number of common shares outstanding 16,081 17,364 25,808 26,252 Diluted net income (loss) per share Net income (loss) per share $ (0.52 ) $ (0.42 ) $ (0.33 ) $ (0.44 ) Weighted average number of common shares and dilutive common share equivalents outstanding 16,081 17,364 25,808 26,252 Three Month Ended March 31, 2019 June 30, 2019 September 30, 2019 December 31, 2019 (in thousands, expect per share data) (unaudited) Revenues $ 1,611 $ 703 $ 25,717 $ 764 Operating expenses 9,307 5,597 6,867 7,398 Loss from operations (7,696 ) (4,894 ) 18,850 (6,634 ) Change in fair value of PIPE Warrant liability 8,815 2,210 (1,954 ) 2,506 Other income (expense), net (564 ) (451 ) (467 ) (333 ) Net income (loss) $ 555 $ (3,135 ) $ 16,429 $ (4,461 ) Basic net income (loss) per share Net income (loss) per share $ 0.04 $ (0.20 ) $ 1.02 $ (0.28 ) Weighted average number of common shares outstanding 13,230 15,902 16,074 16,077 Diluted net income (loss) per share Net income (loss) per share $ (0.62 ) $ (0.20 ) $ 1.02 $ (0.28 ) Weighted average number of common shares and dilutive common share equivalents outstanding 13,283 15,902 16,083 16,077 |
Legal Proceedings
Legal Proceedings | 12 Months Ended |
Dec. 31, 2019 | |
Commitments And Contingencies Disclosure [Abstract] | |
Legal Proceedings | (13) Legal Proceedings As of the date of filing this Annual Report on Form 10-K, there are no outstanding legal proceedings against the Company or its current officers or directors. On July 24, 2020, the District Court for the District of Massachusetts dismissed a purported class action filed against the Company in 2019. This purported class action lawsuit (the “2019 Class Action”) was filed against the Company and certain of its present and former officers, Michael Bailey, Matthew Dallas, and Keith Ehrlich, in the Southern District of New York for the District of New York, captioned David Hackel v. AVEO Pharmaceuticals, Inc., et al In connection with the filing of the 2019 Class Action, two derivative lawsuits were filed on July 8, 2019 and July 10, 2019 against the Company, certain of its present and former officers and its directors in the Suffolk Superior Court, Commonwealth of Massachusetts, captioned Stephen Favre v. Michael P. Bailey, et al Jianbin Yu v. Michael P. Bailey, et al. On December 8, 2021, the court entered an order dismissing the derivative action. In June 2018, the Company settled a consolidated class action lawsuit (the “2013 Class Action”), In re AVEO Pharmaceuticals, Inc. Securities Litigation et al., No. 1:13-cv-11157-DJC , that had been filed in 2013 against the Company and certain of its former officers (Tuan Ha-Ngoc, David N. Johnston, William Slichenmyer, and Ronald DePinho) in the United States District Court for the District of Massachusetts (the “District Court”). The 2013 Class Action had been dismissed without prejudice in March 2015, and the lead plaintiffs then filed a second amended complaint bringing similar allegations, but which no longer named Mr. DePinho as a defendant. The Company moved to dismiss again, and the District Court ruled in the Company’s favor and dismissed the second amended complaint with prejudice in November 2015. The lead plaintiffs appealed the District Court’s decision and also filed a motion to vacate and reconsider the District Court’s judgment. In January 2017, the District Court granted the plaintiffs’ motion to vacate the dismissal and judgment. In February 2017, the plaintiffs filed a third amended complaint, on behalf of stockholders who purchased common stock between May 16, 2012 and May 1, 2013 (the “2013 Class”) alleging claims similar to those alleged in the prior complaints, namely that the Company and certain of the Company’s former officers and directors violated Sections 10(b) and/or 20(a) of the Exchange Act and Rule 10b-5 promulgated thereunder by making allegedly false and/or misleading statements concerning the phase 3 trial design and results for the Company’s TIVO-1 clinical trial in an effort to lead investors to believe that the drug would receive approval from the FDA. In July 2017, the District Court entered an order referring the case to alternative dispute resolution. The parties mediated during the fall of 2017. On December 26, 2017, the parties entered into a binding memorandum of understanding (the “MOU”) to settle the 2013 Class Action. Under the terms of the MOU, the Company agreed to cause certain of the Company’s and the individual defendants’ insurance carriers to provide the 2013 Class with a cash payment of $15.0 million, which included the cash amount of any attorneys’ fees or litigation expenses that the District Court may award. Additionally, the Company agreed to issue to the 2013 Class the Settlement Warrants, for the purchase of 0.2 million shares of the Company’s common stock, which, subject to certain conditions, are exercisable from the date of issue until the expiration of a one-year The Company evaluates developments in legal proceedings on a quarterly basis. The Company records an accrual for loss contingencies to the extent that the Company concludes that it is probable that a liability has been incurred and the amount of the related loss can be reasonably estimated. In December 2017, upon entering into the MOU, the Company’s liability related to this settlement became estimable and probable. Accordingly, the Company recorded an estimated $17.1 million contingent liability, including $15.0 million for the cash portion of the settlement with a corresponding insurance recovery for the 100% portion to be paid directly by certain of the Company’s insurance carriers, and an approximate $2.1 million estimate for the warrant portion of the settlement with a corresponding non-cash charge to the Statement of Operations as a component of operating expenses. Pursuant to the Final Judgment, all claims against the Company were released upon the Effective Date. In addition, pursuant to the Stipulation, the Company has no interest in the settlement escrow account subsequent to the Effective Date. Accordingly, the Company reversed the $15.0 million cash portion of the settlement from both the contingent liability and the corresponding insurance recovery as of the Effective Date. |
Significant Accounting Polici_2
Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2020 | |
Accounting Policies [Abstract] | |
Revenue Recognition | Revenue Recognition As of December 31, 2020, the Company’s revenues have been generated primarily through collaborative research, development and commercialization agreements. The terms of these agreements generally contain multiple promised goods and services, which may include (i) licenses, or options to obtain licenses, to the Company’s technology, (ii) research and development activities to be performed on behalf of the collaborative partner, and (iii) in certain cases, services in connection with the manufacturing of preclinical and clinical material. Payments to the Company under these arrangements typically include one or more of the following: non-refundable, upfront license fees; option exercise fees; funding of research and/or development efforts; milestone payments; and royalties on future product sales. Collaboration Arrangements Within the Scope of ASC 808, Collaborative Arrangements The Company analyzes its collaboration arrangements to assess whether such arrangements involve joint operating activities performed by parties that are both active participants in the activities and exposed to significant risks and rewards dependent on the commercial success of such activities and are therefore within the scope of ASC Topic 808, Collaborative Arrangements Revenue from Contracts with Customers Arrangements Within the Scope of ASC 606, Revenue from Contracts with Customers Under ASC 606, the Company recognizes revenue when its customers obtain control of promised goods or services, in an amount that reflects the consideration which the Company determines it expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that the Company determines are within the scope of ASC 606, the Company performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligation(s) in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligation(s) in the contract; and (v) recognize revenue when (or as) the Company satisfies its performance obligation(s). As part of the accounting for these arrangements, the Company must make significant judgments, including identifying performance obligations in the contract, estimating the amount of variable consideration to include in the transaction price and allocating the transaction price to each performance obligation. Once a contract is determined to be within the scope of ASC 606, the Company assesses the goods or services promised within the contract and determines those that are performance obligations. Arrangements that include rights to additional goods or services that are exercisable at a customer’s discretion are generally considered options. The Company assesses if these options provide a material right to the customer and if so, they are considered performance obligations. The exercise of a material right is accounted for as a contract modification for accounting purposes. The Company assesses whether each promised good or service is distinct for the purpose of identifying the performance obligations in the contract. This assessment involves subjective determinations and requires management to make judgments about the individual promised goods or services and whether such are separable from the other aspects of the contractual relationship. Promised goods and services are considered distinct provided that: (i) the customer can benefit from the good or service either on its own or together with other resources that are readily available to the customer (that is, the good or service is capable of being distinct) and (ii) the entity’s promise to transfer the good or service to the customer is separately identifiable from other promises in the contract (that is, the promise to transfer the good or service is distinct within the context of the contract). In assessing whether a promised good or service is distinct, the Company considers factors such as the research, manufacturing and commercialization capabilities of the collaboration partner and the availability of the associated expertise in the general marketplace. The Company also considers the intended benefit of the contract in assessing whether a promised good or service is separately identifiable from other promises in the contract. If a promised good or service is not distinct, an entity is required to combine that good or service with other promised goods or services until it identifies a bundle of goods or services that is distinct. The transaction price is then determined and allocated to the identified performance obligations in proportion to their standalone selling prices (“SSP”) on a relative SSP basis. SSP is determined at contract inception and is not updated to reflect changes between contract inception and when the performance obligations are satisfied. Determining the SSP for performance obligations requires significant judgment. In developing the SSP for a performance obligation, the Company considers applicable market conditions and relevant entity-specific factors, including factors that were contemplated in negotiating the agreement with the customer and estimated costs. The Company validates the SSP for performance obligations by evaluating whether changes in the key assumptions used to determine the SSP will have a significant effect on the allocation of arrangement consideration between multiple performance obligations. If the consideration promised in a contract includes a variable amount, the Company estimates the amount of consideration to which it will be entitled in exchange for transferring the promised goods or services to a customer. The Company determines the amount of variable consideration by using the expected value method or the most likely amount method. The Company includes the unconstrained amount of estimated variable consideration in the transaction price. The amount included in the transaction price is constrained to the amount for which it is probable that a significant reversal of cumulative revenue recognized will not occur. At the end of each subsequent reporting period, the Company re-evaluates the estimated variable consideration included in the transaction price and any related constraint, and if necessary, adjusts its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis in the period of adjustment. In determining the transaction price, the Company adjusts consideration for the effects of the time value of money if the timing of payments provides the Company with a significant benefit of financing. The Company does not assess whether a contract has a significant financing component if the expectation at contract inception is such that the period between payment by the licensees and the transfer of the promised goods or services to the licensees will be one year or less. The Company assessed each of its revenue generating arrangements in order to determine whether a significant financing component exists and concluded that a significant financing component does not exist in any of its arrangements. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) each performance obligation is satisfied at a point in time or over time, and if over time based on the use of an output or input method. Licenses of Intellectual Property: The terms of the Company’s license agreements include the license of functional intellectual property, given the functionality of the intellectual property is not expected to change substantially as a result of the Company’s ongoing activities. If the license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenues from the portion of the transaction price allocated to the license when the license is transferred to the licensee and the licensee is able to use and benefit from the license. For licenses that are bundled with other promises (that is, for licenses that are not distinct from other promised goods and services in an arrangement), the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition. Research and Development Funding: Arrangements that include payment for research and development services are generally considered to have variable consideration. If and when the Company assesses the payment for these services is no longer subject to the constraint on variable consideration, the related revenue is included in the transaction price. Milestone payments: At the inception of each arrangement that includes non-refundable payments for contingent milestones, including preclinical research and development, clinical development and regulatory, the Company evaluates whether the milestones are considered probable of being achieved and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within the control of the Company or the licensee, such as regulatory approvals, are not considered probable of being achieved until those approvals are received. At the end of each reporting period, the Company re-evaluates the probability of the achievement of contingent milestones and the likelihood of a significant reversal of such milestone revenue, and if necessary, adjusts its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect collaboration and licensing revenue in the period of adjustment. This quarterly assessment may result in the recognition of revenue related to a contingent milestone payment before the milestone event has been achieved. Royalties: For arrangements that include sales-based royalties, including milestone payments based on the level of sales, and the license is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). The following table summarizes the total revenues earned in the years ended December 31, 2020, 2019 and 2018, respectively, by partner (in thousands). Refer to Note 4, “Collaborations and License Agreements” regarding specific details. Years Ended December 31, 2020 2019 2018 Strategic Partner: ($ in thousands) KKC $ 2,800 $ 25,000 $ — EUSA 3,219 3,795 3,409 CANbridge — — 2,000 Total revenues $ 6,019 $ 28,795 $ 5,409 |
Leases | Leases The Company adopted ASU 2016-02, Leases (Topic 842) Leases As of the date of initial application of ASU 2016-02, the Company’s lease arrangement for its former corporate headquarters at One Broadway, Cambridge, Massachusetts was cancellable within 30 days’ notice to its landlord and excluded any extension incentives or disincentives to renew for an extended period of time. In addition, the Company has drug storage arrangements with multiple storage providers that are cancellable at any time without penalty to the Company. The Company recognized short-term operating lease expense in its Consolidated Statements of Operations of approximately $0.5 million, $1.0 million and $0.7 million in the years ended December 31, 2020, 2019 and 2018, respectively. Application of ASC 842 policy elections to leases post adoption The Company has made certain accounting policy elections to apply to its leases executed post adoption of ASU 2016-02 , or subsequent to January 1, 2019, as further described below. In accordance with ASC 842, components of a lease should be split into three categories: lease components, non-lease components, and non-components. The fixed and in-substance fixed contract consideration (including any consideration related to non-components) must be allocated based on the respective relative fair values to the lease components and non-lease components. The Company made an accounting policy election to combine lease and non-lease components as a single lease component At the inception of an arrangement, the Company determines whether the arrangement is or contains a lease based on the unique facts and circumstances present in the arrangement. Leases with a term greater than one year are recognized on the balance sheet as right-of-use assets and short-term and long-term lease liabilities, as applicable. Operating lease liabilities and their corresponding right-of-use assets are initially recorded based on the present value of lease payments over the expected remaining lease term. Certain adjustments to the right-of-use asset may be required for items such as incentives received. The interest rate implicit in lease contracts is typically not readily determinable. As a result, the Company utilizes its incremental borrowing rate to discount lease payments, which reflects the fixed rate at which the Company could borrow on a collateralized basis the amount of the lease payments in the same currency, for a similar term, in a similar economic environment. To estimate its incremental borrowing rate, a credit rating applicable to the Company is estimated using a synthetic credit rating analysis since the Company does not currently have a rating agency-based credit rating. ASC 842 allows for the use of judgment in determining whether the assumed lease term is for a major part of the remaining economic life of the underlying asset and whether the present value of lease payments represents substantially all of the fair value of the underlying asset. The Company applies the bright line thresholds referenced in ASC 842-10-55-2 to assist in evaluating leases for appropriate classification. 30 Winter Street Lease On March 5, 2020, the Company entered into a sublease agreement for office space located at 30 Winter Street in Boston, Massachusetts (the “Winter Street Sublease”) to relocate the Company’s corporate headquarters previously located at One Broadway in Cambridge, Massachusetts. Under the terms of the Winter Street Sublease, the Company leases 10,158 square feet of office space for $47.00 per square foot, or approximately $0.5 million per year in base rent subject to certain operating expenses, taxes and annual base rent increases of approximately 3%. The Winter Street Sublease commenced when the space became available for use by the Company on March 24, 2020 and will continue until its expiration on November 30, 2022. Upon commencement of the Winter Street Sublease, the Company paid a security deposit, in the amount of $0.3 million, which is subject to certain reductions to be applied to future base rent payments provided that no event of default has occurred in the preceding twelve months. The Company is accounting for the Winter Street Sublease under ASC 842 using its initial 2.7-year term through November 30, 2022. In applying ASC 842, the Company classified the Winter Street Sublease as an operating lease and recorded a right-of-use asset of approximately $1.2 million and a lease liability of approximately $1.0 million upon the effective lease commencement date. In calculating the lease liability, the Company used the present value of all future lease payments using an incremental borrowing rate of 7.58%. The Company is recognizing rent expense on a straight-line basis throughout the remaining term of the lease. In the year ended December 31, 2020, the Company recognized $0.4 million in rent expense. In connection with the execution of the Winter Street Sublease, the Company also entered into a Purchase Agreement for furniture (the “Furniture Purchase Agreement”) located on the premises upon the lease commencement. Upon execution of the Furniture Purchase Agreement, the Company paid the $0.1 million purchase price and recorded the furniture acquisition as property and equipment, net. The Company is recognizing depreciation using the straight-line method over the estimated useful life of 7 years. As of December 31, 2020, future minimum lease payments under the Company’s Winter Street Sublease are as follows (amounts in thousands): Year Ending December 31: 2021 385 2022 328 Total lease payments 713 Less imputed interest (8 ) Total operating lease liabilities $ 705 Short-term arrangements As of the date of initial application of ASU 2016-02, the Company’s lease arrangement for its former corporate headquarters at One Broadway, Cambridge, Massachusetts was cancellable within 30 days’ notice to its landlord and excluded any extension incentives or disincentives to renew for an extended period of time. In addition, the Company has drug storage arrangements with multiple storage providers that are cancellable at any time without penalty to the Company. The Company recognized short-term operating lease expense in its Consolidated Statements of Operations of approximately $0.5 million, $1.0 million and $0.7 million in the years ended December 31, 2020, 2019 and 2018, respectively. |
Research and Development Expenses | Research and Development Expenses (i) clinical trials, drug manufacturing and distribution, preclinical studies, upfront license payments, milestones and sublicense fees related to in-licensed products and technology , consultants and other contracted services . |
Warrants Issued in Connection with Private Placement | Warrants Issued in Connection with Private Placement In May 2016, the Company issued warrants to purchase an aggregate of 1,764,242 shares of common stock in connection with a private placement financing and recorded the warrants as a liability (the “PIPE Warrants”). The Company accounts for warrant instruments that either conditionally or unconditionally obligate the issuer to transfer assets as liabilities regardless of the timing of the redemption feature or price, even though the underlying shares may be classified as permanent or temporary equity. As of December 31, 2020, PIPE Warrants exercisable for 80,309 shares of common stock had been exercised, for approximately $0.8 million in cash proceeds, and PIPE Warrants exercisable for 1,683,933 shares of common stock were outstanding. Refer to Note 7, “ Common Stock—Private Placement – May 2016” The PIPE Warrants contain a provision giving the warrant holder the option to receive cash, equal to the fair value of the remaining unexercised portion of the warrant, as cash settlement in the event that there is a fundamental transaction (contractually defined to include various merger, acquisition or stock transfer activities). Due to this provision, ASC 480, Distinguishing Liabilities from Equity The Company recorded a non-cash gain of approximately $4.9 million The following table rolls forward the fair value of the Company’s PIPE Warrant liability, the fair value of which is determined by Level 3 inputs for the years ended December 31, 2020, 2019 and 2018, respectively (in thousands): Fair value at December 31, 2017 $ 37,746 Decrease in fair value (19,919 ) Reduction in warrant liability for PIPE Warrant exercises (1,153 ) Fair value at December 31, 2018 $ 16,674 Decrease in fair value (11,577 ) Fair value at December 31, 2019 $ 5,097 Decrease in fair value (4,898 ) Fair value at December 31, 2020 $ 199 The key assumptions used to value the PIPE Warrants were as follows: Original Issuance December 31, 2017 December 31, 2018 December 31, 2019 December 31, 2020 Expected price volatility 76.25 % 84.86 % 82.64 % 133.07 % 56.79 % Expected term (in years) 5.00 3.50 2.50 1.50 0.50 Risk-free interest rates 1.22 % 2.09 % 2.47 % 1.59 % 0.09 % Stock price $ 8.90 $ 27.90 $ 16.00 $ 6.20 $ 5.77 Dividend yield — — — — — |
Prior Class Action Settlement and Settlement Warrants | Prior Class Action Settlement and Settlement Warrants In December 2017, the Company entered into a binding memorandum of understanding (the “MOU”) with class representatives Bob Levine and William Windham (the “Plaintiffs”), regarding the settlement of a securities class action lawsuit (the “2013 Class Action”) that had been filed in 2013 and was pending in the United States District Court for the District of Massachusetts (the “District Court”) against the Company and certain of the Company’s former officers (Tuan Ha-Ngoc, David Johnston, and William Slichenmyer, together, the “Individual Defendants”), In re AVEO Pharmaceuticals, Inc. Securities Litigation et al. In December 2017, upon entering into the MOU, the Company’s liability related to this settlement became estimable and probable. Accordingly, the Company recorded an estimated $17.1 million contingent liability, including $15.0 million for the cash portion of the settlement with a corresponding insurance recovery for the 100% portion to be paid directly by certain of the Company’s insurance carriers, and an approximate $2.1 million estimate for the fair value on December 31, 2017 of 200,000 warrants to purchase shares of its common stock that the Company agreed to issue the Class (the “Settlement Warrants”), with a corresponding non-cash charge to the Statement of Operations as a component of operating expense. The Settlement Warrants were exercisable for a one-year In February 2018, the District Court preliminarily approved a definitive stipulation of settlement agreement (the “Stipulation”), following which the insurance carriers funded the settlement escrow account related to the $15.0 million cash portion of the settlement. On May 30, 2018, the District Court approved the Stipulation in its order of final approval and final judgment (the “Final Judgment”), which became effective on June 29, 2018 (the “Effective Date”). Pursuant to the Final Judgment, all claims against the Company were released upon the Effective Date. In addition, pursuant to the Stipulation, the Company had no interest in the settlement escrow account subsequent to the Effective Date. Accordingly, the $15 million contingent liability associated with the cash portion of the settlement and the corresponding insurance recovery was eliminated on the Effective Date. On July 16, 2018, the Company issued and delivered the Settlement Warrants in accordance with the Stipulation and filed a corresponding shelf registration statement, File No. (333-226190) to register the shares of common stock underlying the Settlement Warrants which was declared effective by the SEC on July 25, 2018. All 200,000 Settlement Warrants expired on July 15, 2019 as none of the warrants had been exercised during the one-year exercise period. Refer to Note 13, “ Legal Proceedings The estimated fair value of the Settlement Warrants was determined using the Black-Scholes pricing model. The estimated fair value of the Settlement Warrants was subject to revaluation at each balance sheet date and any changes in fair value were recorded as a non-cash gain or (loss) in the Statement of Operations as a component of operating expenses until the Settlement Warrants were issued. The fair value of the Settlement Warrants on June 30, 2018 was determined based on the estimated fair value of the Settlement Warrants at the time of issuance. The Company recorded a non-cash gain of approximately $0.7 million in the year ended December 31, 2018 in its Statement of Operations attributable to the decrease in the fair value of the Settlement Warrants that principally resulted from a lower volatility rate relative to prior periods. In July 2018, upon the issuance of the Settlement Warrants, the Company reclassified the approximate $1.4 million value of the Settlement Warrants from a liability to stockholders equity as a component of additional paid-in-capital based upon the terms of the warrant agreement and, accordingly, the approximate $1.4 million contingent liability on the Company’s balance sheet associated with the warrant portion of the settlement was eliminated. The key assumptions used to estimate the fair value the Settlement Warrants were as follows: December 31, 2017 June 30, 2018 Expected price volatility 101.52 % 62.74 % Expected term (in years) 1.00 1.00 Risk-free interest rates 1.76 % 2.37 % Stock price $ 27.90 $ 29.00 Dividend yield — — |
Cash, Cash Equivalents and Marketable Securities | Cash, Cash Equivalents and Marketable Securities The Company considers all highly liquid investments with original maturities of three months or less at the date of purchase and an investment in a U.S. government money market fund to be cash equivalents. Changes in the balance of cash and cash equivalents may be affected by changes in investment portfolio maturities, as well as actual cash disbursements to fund operations. The Company’s cash is deposited in highly-rated financial institutions in the United States. The Company invests in United States government money market funds, high-grade, short-term commercial paper, corporate bonds and other United States government agency securities, which management believes are subject to minimal credit and market risk. The carrying values of the Company’s cash and cash equivalents approximate fair value due to their short-term maturities. The Company does not have any restricted cash balances. |
Marketable Securities | Marketable Securities Marketable securities consist primarily of investments which have expected average maturity dates in excess of three months. The Company invests in high-grade corporate obligations, including commercial paper, and U.S. government and government agency obligations that are classified as available-for-sale. Since these securities are available to fund current operations they are classified as current assets on the consolidated balance sheets. Marketable securities are stated at fair value, including accrued interest, with their unrealized gains and losses included as a component of accumulated other comprehensive income or loss, which is a separate component of stockholders’ equity. The fair value of these securities is based on quoted prices and observable inputs on a recurring basis. The cost of marketable securities is adjusted for amortization of premiums and accretion of discounts, with such amortization and accretion recorded as a component of interest expense, net. Realized gains and losses are determined on the specific identification method. Unrealized gains and losses are included in other comprehensive loss until realized, at which point they would be recorded as a component of interest expense, net. Below is a summary of cash, cash equivalents and marketable securities at December 31, 2020 and December 31, 2019: Amortized Cost Unrealized Gains Unrealized Losses Fair Value December 31, 2020 Cash and cash equivalents: Cash and money market funds $ 61,761 $ — $ — $ 61,761 Total cash, cash equivalents and marketable securities $ 61,761 $ — $ — $ 61,761 December 31, 2019 Cash and cash equivalents: Cash and money market funds $ 25,278 $ — $ — $ 25,278 Corporate debt securities 4,507 — — 4,507 Total cash and cash equivalents 29,785 — — 29,785 Marketable securities: Corporate debt securities due within 1 year $ 17,960 $ — $ — $ 17,960 Total marketable securities 17,960 — — 17,960 Total cash, cash equivalents and marketable securities $ 47,745 $ — $ — $ 47,745 |
Concentrations of Credit Risk | Concentrations of Credit Risk Financial instruments that potentially subject the Company to credit risk primarily consist of cash and cash equivalents, marketable securities and accounts receivable. The Company maintains deposits in highly-rated, federally-insured financial institutions in excess of federally insured limits. The Company’s investment strategy is focused on capital preservation. The Company invests in instruments that meet the high credit quality standards outlined in the Company’s investment policy. This policy also limits the amount of credit exposure to any one issue or type of instrument. The Company’s accounts receivable primarily consists of amounts due to the Company from licensees and collaborators. The Company has not experienced any material losses related to accounts receivable from individual licensees or collaborators. |
Fair Value Measurements | Fair Value Measurements The fair value of the Company’s financial assets and liabilities reflects the Company’s estimate of amounts that it would have received in connection with the sale of the assets or paid in connection with the transfer of the liabilities in an orderly transaction between market participants at the measurement date. In connection with measuring the fair value of its assets and liabilities, the Company seeks to maximize the use of observable inputs (market data obtained from sources independent from the Company) and to minimize the use of unobservable inputs (the Company’s assumptions about how market participants would price assets and liabilities). The following fair value hierarchy is used to classify assets and liabilities based on the observable inputs and unobservable inputs used in order to value the assets and liabilities: Level 1: Quoted prices in active markets for identical assets or liabilities. An active market for an asset or liability is a market in which transactions for the asset or liability occur with sufficient frequency and volume to provide pricing information on an ongoing basis. Level 2: Observable inputs other than Level 1 inputs. Examples of Level 2 inputs include quoted prices in active markets for similar assets or liabilities and quoted prices for identical assets or liabilities in markets that are not active. Level 3: Unobservable inputs based on the Company’s assessment of the assumptions that market participants would use in pricing the asset or liability. Financial assets and liabilities are classified in their entirety within the fair value hierarchy based on the lowest level of input that is significant to the fair value measurement. The Company measures the fair value of its marketable securities by taking into consideration valuations obtained from third-party pricing sources. The pricing services utilize industry standard valuation models, including both income and market-based approaches, for which all significant inputs are observable, either directly or indirectly, to estimate fair value. These inputs include reported trades of and broker-dealer quotes on the same or similar securities, issuer credit spreads, benchmark securities and other observable inputs. As of December 31, 2020, the Company had financial assets valued based on Level 1 inputs consisting of cash and cash equivalents in a United States government money market fund. During the year ended December 31, 2020, the Company did not have any transfers of financial assets between Levels 1 and 2. As of December 31, 2020, the Company’s financial liability that was recorded at fair value consisted of the PIPE Warrant liability. The fair value of the Company’s loans payable at December 31, 2020 and December 31, 2019 approximates its carrying value, computed pursuant to a discounted cash flow technique using a market interest rate and is considered a Level 3 fair value measurement. The effective interest rate, which reflects the current market rate, considers the loan issuance costs and the deferred financing charge. The following table summarizes the assets and liabilities measured at fair value on a recurring basis at December 31, 2020 and December 31, 2019: Fair Value Measurements as of December 31, 2020 Level 1 Level 2 Level 3 Total (in thousands) Financial assets carried at fair value: Cash and money market funds $ 61,761 $ — $ — $ 61,761 Total cash, cash equivalents and marketable securities $ 61,761 $ — $ — $ 61,761 Financial liabilities carried at fair value: Total PIPE Warrant liability $ — $ — $ 199 $ 199 Fair Value Measurements as of December 31, 2019 Level 1 Level 2 Level 3 Total (in thousands) Financial assets carried at fair value: Cash and money market funds $ 25,278 $ — $ — $ 25,278 Corporate debt securities — 4,507 — 4,507 Total cash and cash equivalents $ 25,278 $ 4,507 $ — $ 29,785 Marketable securities: Corporate debt securities due within 1 year $ — $ 17,960 $ — $ 17,960 Total marketable securities $ — $ 17,960 $ — $ 17,960 Total cash, cash equivalents and marketable securities $ 25,278 $ 22,467 $ — $ 47,745 Financial liabilities carried at fair value: Total PIPE Warrant liability $ — $ — $ 5,097 $ 5,097 |
Basic and Diluted Net Loss per Common Share | Basic and Diluted Net Loss per Common Share Basic net income (loss) per share attributable to the Company’s common stockholders is based on the weighted-average number of common shares outstanding during the period. Diluted net income (loss) per share attributable to the Company’s common stockholders is based on the weighted-average number of common shares outstanding during the period plus additional weighted-average common equivalent shares outstanding during the period when the effect is dilutive. For the year ended December 31, 2020, diluted net loss per share is the same as basic net loss per share as the inclusion of common stock issuable upon the exercise of warrants and stock options would be anti-dilutive under the treasury stock method. In the year ended December 31, 2020, the average market prices of the Company’s common stock were below the exercise prices of $10.00 and $12.50 per share for the PIPE Warrants and Offering Warrants. Refer to Note 7, “ Common Stock—Private Placement – May 2016, - Public Offering – April 2019 and - Settlement Warrants” For the year ended December 31, 2019, diluted net income per share (i) includes common equivalent shares issuable upon the exercise of in-the-money stock options, as determined using the treasury stock method, as the average market prices of the Company’s common stock during the respective period exceeded the exercise prices of certain stock options, and (ii) excludes the incremental common shares issuable upon the exercise of the PIPE Warrants, Offering Warrants and out-of-the money stock options as their effect would be anti-dilutive. In the year ended December 31, 2019, the average market prices of the Company’s common stock were below the exercise prices of $10.00 and $12.50 per share for the PIPE Warrants and Offering Warrants, respectively. For the year ended December 31, 2018, diluted net income per share (i) includes common equivalent shares issuable upon the exercise of the PIPE Warrants, as determined using the treasury stock method, as the average market prices of the Company’s common stock during the respective period exceeded the exercise price of $10.00 per share for the PIPE Warrants, and (ii) excludes the incremental common shares issuable upon the exercise of the Settlement Warrants (as defined in Note 7, “– Common Stock – Settlement Warrants” below) and stock options as their effect would be anti-dilutive. In the year ended December 31, 2018, the average market prices of the Company’s common stock were below the exercise price of $30.00 per share for Settlement Warrants. The following tables summarizes the computation of basic and diluted net loss per share for the years ended December 31, 2020, 2019 and 2018, respectively (in thousands except per share amounts): Year Ended December 31, 2020 2019 2018 Basic net income (loss) attributable to Aveo common stockholders $ (35,584 ) $ 9,388 $ (5,329 ) Less: non-cash gains attributable to the change in fair value of the PIPE Warrant liability — — (19,919 ) Diluted net income (loss) attributable to Aveo common stockholders $ (35,584 ) $ 9,388 $ (25,248 ) Weighted-average shares of common stock outstanding 21,402 15,331 12,059 Dilutive securities: Incremental common shares issuable upon the exercise of the PIPE Warrants — — 1,014 Incremental common shares issuable upon the exercise of dilutive stock options — 45 — Weighted-average number of common shares outstanding and dilutive share equivalents outstanding 21,402 15,376 13,073 Basic net income (loss) per share $ (1.66 ) $ 0.61 $ (0.44 ) Diluted net income (loss) per share $ (1.66 ) $ 0.61 $ (1.93 ) The following table summarizes outstanding securities not included in the computation of diluted net loss per common share as their inclusion would be anti-dilutive for the years ended December 31, 2020, 2019 and 2018, respectively: Years Ended December 31, 2020 2019 2018 Stock options outstanding 1,796,690 1,168,250 958,334 Offering Warrants Outstanding 2,500,000 2,500,000 — PIPE Warrants outstanding 1,683,933 1,683,933 — Settlement Warrants outstanding — — 200,000 Total 5,980,623 5,352,183 1,158,334 |
Stock-Based Compensation | Stock-Based Compensation Under the Company’s stock-based compensation programs, the Company periodically grants stock options and restricted stock to employees, directors and nonemployee consultants. The Company also issues shares under an employee stock purchase plan. The fair value of each award is recognized in the Company’s statements of operations over the requisite service period for such award. Awards that vest as the recipient provides service are expensed on a straight-line basis over the requisite service period. The Company uses the Black-Scholes option pricing model to value its stock option awards without market conditions, which requires the Company to make certain assumptions regarding the expected volatility of its common stock price, the expected term of the option grants, the risk-free interest rate and the dividend yield with respect to its common stock. The Company calculates volatility using its historical stock price data. Due to the lack of the Company’s own historical data, the Company elected to use the “simplified” method for “plain vanilla” options to estimate the expected term of the Company’s stock option grants. Under this approach, the weighted-average expected life is presumed to be the average of the vesting term and the contractual term of the option. The risk-free interest rate used for each grant is based on the United States Treasury yield curve in effect at the time of grant for instruments with a similar expected life. The Company utilizes a dividend yield of zero based on the fact that the Company has never paid cash dividends and has no present intention to pay cash dividends. The fair value of equity-classified awards to employees and directors are measured at fair value on the date the awards are granted. During the year s ended December 31, 20 20 , 201 9 and 201 8 , the Company recorded the following stock-based compensation expense (in thousands): Years Ended December 31, 2020 2019 2018 (in thousands) Research and development $ 499 $ 662 $ 774 Selling, general and administrative 1,856 1,696 1,772 Total stock-based compensation expense $ 2,355 $ 2,358 $ 2,546 Stock-based compensation expense is allocated to research and development and selling, general and administrative expense based upon the department of the employee to whom each award was granted. No related tax benefits of the stock-based compensation expense have been recognized. |
Income Taxes | Income Taxes The Company provides for income taxes using the asset-liability method. Under this method, deferred tax assets and liabilities are recognized based on differences between financial reporting and tax bases of assets and liabilities, and are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. The Company calculates its provision for income taxes on ordinary income based on its projected annual tax rate for the year. Uncertain tax positions are recognized if the position is more-likely-than-not to be sustained upon examination by a tax authority. Unrecognized tax benefits represent tax positions for which reserves have been established. The Company maintains a full valuation allowance on all deferred tax assets. |
Segment and Geographic Information | Segment and Geographic Information Operating segments are defined as components of an enterprise engaging in business activities for which discrete financial information is available and regularly reviewed by the chief operating decision maker in deciding how to allocate resources and in assessing performance. The Company views its operations and manages its business in one operating segment principally in the United States. As of December 31, 2020, 2019 and 2018, the Company has no net assets located outside of the United States. |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect certain reported amounts of assets and liabilities, disclosure of contingent assets and liabilities at the date of the financial statements, the assessment of the Company’s ability to continue as a going concern, and the reported amounts of revenues and expenses during the reporting periods. Significant items subject to such estimates and assumptions include revenue recognition, clinical trial costs and contract research accruals, measurement of the PIPE Warrant liability, measurement of stock-based compensation, measurement of right-of-use assets and lease liabilities, and estimates of the Company’s capital requirements over the next twelve months from the date of issuance of the consolidated financial statements. The Company bases its estimates on historical experience and various other assumptions that management believes to be reasonable under the circumstances. Material changes in these estimates could occur in the future. Changes in estimates are recorded or reflected in the Company’s disclosures in the period in which they become known. Actual results could differ from those estimates if past experience or other assumptions do not turn out to be substantially accurate. |
Accrued Clinical Trial Costs and Contract Research Liabilities | Accrued Clinical Trial Costs and Contract Research Liabilities During the years ended December 31, 2020, 2019 and 2018, the Company had arrangements with multiple CROs whereby these organizations commit to performing services for the Company over multiple reporting periods. The Company recognizes the expenses associated with these arrangements based on its expectation of the timing of the performance of components under these arrangements by these organizations. Generally, these components consist of the costs of setting up the trial, monitoring the trial, closing the trial and preparing the resulting data. Costs related to patient enrollment in clinical trials are accrued as patients are enrolled in the trial. In addition to fees earned by the clinical research organizations to manage the Company’s clinical trials, the clinical research organizations are also responsible for managing payments to the clinical trial sites on the Company’s behalf. There can be significant lag time in clinical trial sites invoicing the clinical research organizations. The date on which services are performed, the level of services performed and the cost of such services are often determined based on subjective judgments. The Company makes these judgments based upon the facts and circumstances known to it, such as the terms of the contract and its knowledge of activity that has been incurred, including the number of active clinical sites, the number of patients enrolled, the activities to be performed for each patient, including patient treatment and any imaging, if applicable, the activities to be performed for each patient, and the duration for which the patients will be enrolled in the trial. In the event that the Company does not identify some costs which have begun to be incurred, or the Company under or overestimates the level of services performed or the costs of such services in a given period, its reported expenses for such period would be understated or overstated. The Company currently reflects the effects of any changes in estimates based on changes in facts and circumstances directly in its operations in the period such change becomes known. With respect to financial reporting periods presented in this Annual Report on Form 10-K, the timing of the Company’s actual costs incurred have not differed materially from its estimated timing of such costs. |
Recently Adopted Accounting Pronouncements | Recently Adopted Accounting Pronouncements In June 2016, the Financial Accounting Standards Board (“FASB”) issued Measurement of Credit Losses on Financial Instruments, In August 2018, the FASB issued ASU 2018-13, Fair Value Measurement (Topic 820): Disclosure Framework-Changes to the Disclosure Requirements for Fair Value Measurement |
Recently Issued Accounting Pronouncements | Recently Issued Accounting Pronouncements In December 2019, the FASB issued ASU 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes . |
Significant Accounting Polici_3
Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Summary of Total Revenues Earned by Partner | The following table summarizes the total revenues earned in the years ended December 31, 2020, 2019 and 2018, respectively, by partner (in thousands). Refer to Note 4, “Collaborations and License Agreements” regarding specific details. Years Ended December 31, 2020 2019 2018 Strategic Partner: ($ in thousands) KKC $ 2,800 $ 25,000 $ — EUSA 3,219 3,795 3,409 CANbridge — — 2,000 Total revenues $ 6,019 $ 28,795 $ 5,409 |
Summary of Future Minimum Lease Payment | As of December 31, 2020, future minimum lease payments under the Company’s Winter Street Sublease are as follows (amounts in thousands): Year Ending December 31: 2021 385 2022 328 Total lease payments 713 Less imputed interest (8 ) Total operating lease liabilities $ 705 |
Summary of Cash, Cash Equivalents and Marketable Securities | Below is a summary of cash, cash equivalents and marketable securities at December 31, 2020 and December 31, 2019: Amortized Cost Unrealized Gains Unrealized Losses Fair Value December 31, 2020 Cash and cash equivalents: Cash and money market funds $ 61,761 $ — $ — $ 61,761 Total cash, cash equivalents and marketable securities $ 61,761 $ — $ — $ 61,761 December 31, 2019 Cash and cash equivalents: Cash and money market funds $ 25,278 $ — $ — $ 25,278 Corporate debt securities 4,507 — — 4,507 Total cash and cash equivalents 29,785 — — 29,785 Marketable securities: Corporate debt securities due within 1 year $ 17,960 $ — $ — $ 17,960 Total marketable securities 17,960 — — 17,960 Total cash, cash equivalents and marketable securities $ 47,745 $ — $ — $ 47,745 |
Summary of Assets and Liabilities Measured at Fair Value on Recurring Basis | The following table summarizes the assets and liabilities measured at fair value on a recurring basis at December 31, 2020 and December 31, 2019: Fair Value Measurements as of December 31, 2020 Level 1 Level 2 Level 3 Total (in thousands) Financial assets carried at fair value: Cash and money market funds $ 61,761 $ — $ — $ 61,761 Total cash, cash equivalents and marketable securities $ 61,761 $ — $ — $ 61,761 Financial liabilities carried at fair value: Total PIPE Warrant liability $ — $ — $ 199 $ 199 Fair Value Measurements as of December 31, 2019 Level 1 Level 2 Level 3 Total (in thousands) Financial assets carried at fair value: Cash and money market funds $ 25,278 $ — $ — $ 25,278 Corporate debt securities — 4,507 — 4,507 Total cash and cash equivalents $ 25,278 $ 4,507 $ — $ 29,785 Marketable securities: Corporate debt securities due within 1 year $ — $ 17,960 $ — $ 17,960 Total marketable securities $ — $ 17,960 $ — $ 17,960 Total cash, cash equivalents and marketable securities $ 25,278 $ 22,467 $ — $ 47,745 Financial liabilities carried at fair value: Total PIPE Warrant liability $ — $ — $ 5,097 $ 5,097 |
Summary of Computation of Basic and Diluted Net Loss per Share | The following tables summarizes the computation of basic and diluted net loss per share for the years ended December 31, 2020, 2019 and 2018, respectively (in thousands except per share amounts): Year Ended December 31, 2020 2019 2018 Basic net income (loss) attributable to Aveo common stockholders $ (35,584 ) $ 9,388 $ (5,329 ) Less: non-cash gains attributable to the change in fair value of the PIPE Warrant liability — — (19,919 ) Diluted net income (loss) attributable to Aveo common stockholders $ (35,584 ) $ 9,388 $ (25,248 ) Weighted-average shares of common stock outstanding 21,402 15,331 12,059 Dilutive securities: Incremental common shares issuable upon the exercise of the PIPE Warrants — — 1,014 Incremental common shares issuable upon the exercise of dilutive stock options — 45 — Weighted-average number of common shares outstanding and dilutive share equivalents outstanding 21,402 15,376 13,073 Basic net income (loss) per share $ (1.66 ) $ 0.61 $ (0.44 ) Diluted net income (loss) per share $ (1.66 ) $ 0.61 $ (1.93 ) |
Summary of Outstanding Securities not Included in Computation of Diluted Net Loss Per Common Share | The following table summarizes outstanding securities not included in the computation of diluted net loss per common share as their inclusion would be anti-dilutive for the years ended December 31, 2020, 2019 and 2018, respectively: Years Ended December 31, 2020 2019 2018 Stock options outstanding 1,796,690 1,168,250 958,334 Offering Warrants Outstanding 2,500,000 2,500,000 — PIPE Warrants outstanding 1,683,933 1,683,933 — Settlement Warrants outstanding — — 200,000 Total 5,980,623 5,352,183 1,158,334 |
Stock-Based Compensation Expense | During the year s ended December 31, 20 20 , 201 9 and 201 8 , the Company recorded the following stock-based compensation expense (in thousands): Years Ended December 31, 2020 2019 2018 (in thousands) Research and development $ 499 $ 662 $ 774 Selling, general and administrative 1,856 1,696 1,772 Total stock-based compensation expense $ 2,355 $ 2,358 $ 2,546 |
Settlement Warrants | |
Key Assumptions Used to Value the Warrants | The key assumptions used to estimate the fair value the Settlement Warrants were as follows: December 31, 2017 June 30, 2018 Expected price volatility 101.52 % 62.74 % Expected term (in years) 1.00 1.00 Risk-free interest rates 1.76 % 2.37 % Stock price $ 27.90 $ 29.00 Dividend yield — — |
PIPE Warrants | |
Summary of Fair Value of Company's Warrant Liability | The following table rolls forward the fair value of the Company’s PIPE Warrant liability, the fair value of which is determined by Level 3 inputs for the years ended December 31, 2020, 2019 and 2018, respectively (in thousands): Fair value at December 31, 2017 $ 37,746 Decrease in fair value (19,919 ) Reduction in warrant liability for PIPE Warrant exercises (1,153 ) Fair value at December 31, 2018 $ 16,674 Decrease in fair value (11,577 ) Fair value at December 31, 2019 $ 5,097 Decrease in fair value (4,898 ) Fair value at December 31, 2020 $ 199 |
Key Assumptions Used to Value the Warrants | The key assumptions used to value the PIPE Warrants were as follows: Original Issuance December 31, 2017 December 31, 2018 December 31, 2019 December 31, 2020 Expected price volatility 76.25 % 84.86 % 82.64 % 133.07 % 56.79 % Expected term (in years) 5.00 3.50 2.50 1.50 0.50 Risk-free interest rates 1.22 % 2.09 % 2.47 % 1.59 % 0.09 % Stock price $ 8.90 $ 27.90 $ 16.00 $ 6.20 $ 5.77 Dividend yield — — — — — |
Collaborations and License Ag_2
Collaborations and License Agreements (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Summary of Revenues Earned in Connection with EUSA Agreement under ASC 606 | The following table summarizes the revenues earned in connection with the EUSA Agreement under ASC 606 for the year ended December 31, 2020, 2019 and 2018 (in thousands): Year Ended December 31, Year Ended December 31, Year Ended December 31, Revenue Type Date Achieved 2020 2019 2018 Collaboration and Licensing Revenue: Amounts in contract liabilities at the beginning of the period: Upfront payment December 2015 $ 395 $ 395 $ 395 R&D payment - EMA approval in RCC August 2017 631 631 632 Milestone - UK reimbursement approval February 2018 316 316 960 Milestone - German reimbursement approval November 2018 316 316 960 Milestone - Spanish reimbursement approval February 2019 316 1,276 — $ 1,974 $ 2,934 $ 2,947 Partnership Royalties 1,245 861 462 Total $ 3,219 $ 3,795 $ 3,409 |
Summary of Changes in Accounts Receivable and Contract Liabilities (Deferred Revenue) | The following table summarizes changes in the Company ’ Contract Assets Beginning Balance January 1, 2020 Additions Deductions Ending Balance December 31, 2020 Accounts Receivable $ 270 $ 1,245 $ (1,123 ) $ 392 Deferred Revenue Contract Liabilities Transaction Price Date Achieved Date Paid Beginning Balance January 1, 2020 Additions Deductions Ending Balance December 31, 2020 Amounts in contract liabilities at the beginning of the period: Upfront payment $ 2,500 December 2015 December 2015 $ 907 $ — $ (395 ) $ 512 R&D payment - EMA approval in RCC 4,000 August 2017 September 2017 1,448 — (631 ) 817 Milestone - UK reimbursement approval 2,000 February 2018 March 2018 724 — (316 ) 408 Milestone - German reimbursement approval 2,000 November 2018 December 2018 723 — (316 ) 407 Milestone - Spanish reimbursement approval 2,000 February 2019 May 2019 724 — (316 ) 408 Total $ 12,500 $ 4,526 $ — $ (1,974 ) $ 2,552 |
Other Accrued Liabilities (Tabl
Other Accrued Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Payables And Accruals [Abstract] | |
Other Accrued Liabilities | Other accrued expenses consisted of the following: December 31, 2020 December 31, 2019 (in thousands) Professional fees $ 1,061 $ 806 Compensation and benefits 3,082 1,284 Other 320 246 Total $ 4,463 $ 2,336 |
Hercules Loan Facility (Tables)
Hercules Loan Facility (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Debt Disclosure [Abstract] | |
Future Minimum Payments Under Loans Payable | Future minimum payments under the loans payable outstanding as of December 31, 2020 are as follows (amounts in thousands): Year Ending December 31: 2021 3,961 2022 8,277 2023 7,272 19,510 Less amount representing interest (2,678 ) Less unamortized discount (1,228 ) Less deferred charges (1,832 ) Less loans payable current, net of discount (1,056 ) Loans payable, net of current portion and discount $ 12,716 |
Stock-based Compensation (Table
Stock-based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Stock Option Activity | The following table summarizes stock option activity during the year ended December 31, 2020: Options Weighted- Average Exercise Price Weighted- Average Remaining Contractual Term Aggregate Intrinsic Value Outstanding at January 1, 2020 1,168,222 $ 16.77 Granted 740,522 $ 5.83 Exercised (934 ) $ 5.60 Forfeited (111,120 ) $ 36.45 Outstanding at December 31, 2020 1,796,690 $ 11.05 7.53 $ 170,000 Exercisable at December 31, 2020 909,963 $ 14.56 6.14 $ 12,000 |
Assumptions used in Black-Scholes Pricing Model for New Grants | The fair value of stock options subject only to service or performance conditions that are granted to employees is estimated on the date of grant using the Black-Scholes option-pricing model using the assumptions noted in the following table: Years Ended December 31, 2020 2019 2018 Volatility factor 94.37% - 102.48% 88.27% - 98.81% 80.18% - 83.61% Expected term (in years) 5.50 - 6.25 5.50 - 6.25 5.50 - 6.25 Risk-free interest rates 0.31% - 1.67% 1.43% - 2.55% 2.64% - 3.10% Dividend yield — — — |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Income Tax Disclosure [Abstract] | |
Reconciliation of Expected Income Tax Benefit | A reconciliation of the expected income tax benefit computed using the federal statutory income tax rate to the Company’s effective income tax rate is as follows for the years ended December 31, 2020, 2019 and 2018: Years Ended December 31, 2020 2019 2018 Income tax computed at federal statutory tax rate 21.0 % 21.0 % 21.0 % State taxes, net of federal benefit 6.7 % 1.3 % 27.2 % Research and development credits 1.5 % (4.2 )% 5.2 % PIPE Warrants 2.9 % (25.9 )% 78.5 % Other permanent differences (0.5 )% 1.8 % (3.5 )% Other (1.1 )% 5.7 % (2.0 )% Change in valuation allowance (30.5 )% 0.3 % (126.4 )% Total — — — |
Company Net Deferred Tax Assets | The Company’s net deferred tax assets as of December 31, 2020 and 2019 are as follows (in thousands): December 31, 2020 2019 (in thousands) Deferred tax assets: NOL carryforwards $ 148,689 $ 138,105 Research and development credits 15,271 14,666 Deferred revenue and R&D reimbursements 742 1,262 Other temporary differences 5,001 4,820 Total deferred tax assets: 169,703 158,853 Valuation allowance (169,703 ) (158,853 ) Total $ — $ — |
Reconciliation of Gross Uncertain Tax Positions | The following is a reconciliation of the Company’s gross uncertain tax positions at December 31, 2020, 2019 and 2018: Years Ended December 31, 2020 2019 2018 (in thousands) Amount established upon adoption $ 1,200 $ 1,200 $ 1,200 Additions for current year tax provisions — — — Additions for prior year tax provisions — — — Reductions of prior year tax provisions (122 ) — — Balance as of end of year $ 1,078 $ 1,200 $ 1,200 |
Quarterly Results (Unaudited) (
Quarterly Results (Unaudited) (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Quarterly Financial Information Disclosure [Abstract] | |
Summary of Quarterly Results | Three Month Ended March 31, 2020 June 30, 2020 September 30, 2020 December 31, 2020 (in thousands, expect per share data) (unaudited) Revenues $ 784 $ 749 $ 3,600 $ 886 Operating expenses 11,498 8,156 11,660 13,582 Loss from operations (10,714 ) (7,407 ) (8,060 ) (12,696 ) Change in fair value of PIPE Warrant liability 2,648 450 86 1,714 Other income (expense), net (315 ) (349 ) (419 ) (522 ) Net income (loss) $ (8,381 ) $ (7,306 ) $ (8,393 ) $ (11,504 ) Basic net income (loss) per share Net income (loss) per share $ (0.52 ) $ (0.42 ) $ (0.33 ) $ (0.44 ) Weighted average number of common shares outstanding 16,081 17,364 25,808 26,252 Diluted net income (loss) per share Net income (loss) per share $ (0.52 ) $ (0.42 ) $ (0.33 ) $ (0.44 ) Weighted average number of common shares and dilutive common share equivalents outstanding 16,081 17,364 25,808 26,252 Three Month Ended March 31, 2019 June 30, 2019 September 30, 2019 December 31, 2019 (in thousands, expect per share data) (unaudited) Revenues $ 1,611 $ 703 $ 25,717 $ 764 Operating expenses 9,307 5,597 6,867 7,398 Loss from operations (7,696 ) (4,894 ) 18,850 (6,634 ) Change in fair value of PIPE Warrant liability 8,815 2,210 (1,954 ) 2,506 Other income (expense), net (564 ) (451 ) (467 ) (333 ) Net income (loss) $ 555 $ (3,135 ) $ 16,429 $ (4,461 ) Basic net income (loss) per share Net income (loss) per share $ 0.04 $ (0.20 ) $ 1.02 $ (0.28 ) Weighted average number of common shares outstanding 13,230 15,902 16,074 16,077 Diluted net income (loss) per share Net income (loss) per share $ (0.62 ) $ (0.20 ) $ 1.02 $ (0.28 ) Weighted average number of common shares and dilutive common share equivalents outstanding 13,283 15,902 16,083 16,077 |
Organization - Additional Infor
Organization - Additional Information (Detail) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020USD ($)Subsidiary | Dec. 31, 2019USD ($) | |
Organization [Line Items] | ||
Number of subsidiaries | Subsidiary | 3 | |
Cash, cash equivalents and marketable securities | $ 61,761 | $ 47,745 |
Accumulated deficit | 621,205 | $ 585,621 |
2020 Loan Facility with Hercules | ||
Organization [Line Items] | ||
Proceeds from additional borrowing capacity | $ 20,000 |
Basis of Presentation - Additio
Basis of Presentation - Additional Information (Detail) | Feb. 19, 2020 | Feb. 29, 2020 |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | ||
Reverse stock split, conversion ratio | 0.10 | |
Reverse stock split, description | one-for-ten | 1-for-10 |
Significant Accounting Polici_4
Significant Accounting Policies - Additional Information (Detail) | Mar. 05, 2020USD ($)ft²$ / ft² | Jul. 16, 2018$ / sharesshares | Dec. 26, 2017$ / shares | Jul. 31, 2018USD ($) | Feb. 28, 2018USD ($) | Dec. 31, 2017USD ($)$ / sharesshares | Dec. 31, 2020USD ($)Segment$ / sharesshares | Dec. 31, 2019USD ($)$ / sharesshares | Jul. 15, 2019shares | Dec. 31, 2018USD ($)$ / shares | Mar. 31, 2020shares | May 31, 2016shares |
Significant Accounting Policies [Line Items] | ||||||||||||
License payment term for product goods and service | 1 year | |||||||||||
Payment by licensees and transfer of promised goods or services to licensees will be one year or less | true | |||||||||||
Short-term operating lease expense | $ 500,000 | $ 1,000,000 | $ 700,000 | |||||||||
Sub lease area | ft² | 10,158 | |||||||||||
Sublease income, per square foot | $ / ft² | 47 | |||||||||||
Sublease income, per year in base rent | $ 500,000 | |||||||||||
Increase in annual rent, percentage | 3.00% | |||||||||||
Subleases security deposit | $ 300,000 | |||||||||||
Subleases expiration date | Nov. 30, 2022 | |||||||||||
Sublease term | 2 years 8 months 12 days | |||||||||||
Operating lease right-of-use asset | $ 1,200,000 | 903,000 | ||||||||||
Operating lease liability | $ 1,000,000 | 705,000 | ||||||||||
Lease incremental borrowing rate | 7.58% | |||||||||||
Operating leases, rent expense, net | $ 600,000 | $ 800,000 | 700,000 | |||||||||
Payments to acquire furniture | $ 100,000 | |||||||||||
Estimated Useful Life | 7 years | |||||||||||
Common stock, shares issued | shares | 26,882,696 | 16,081,000 | 26,883,000 | |||||||||
Non-cash change in fair value of PIPE Warrant liability | $ (4,898,000) | $ (11,577,000) | (19,919,000) | |||||||||
Reserve for settlement of fines | $ 17,100,000 | |||||||||||
Estimated insurance recoveries | 15,000,000 | |||||||||||
Restricted cash balances | 0 | |||||||||||
Transfers of financial assets from Level 1 to Level 2 | 0 | |||||||||||
Transfers of financial assets from Level 2 to Level 1 | 0 | |||||||||||
Tax benefits of the stock based compensation expenses recognized | $ 0 | 0 | 0 | |||||||||
United States | ||||||||||||
Significant Accounting Policies [Line Items] | ||||||||||||
Number of operating segments | Segment | 1 | |||||||||||
Non-US | ||||||||||||
Significant Accounting Policies [Line Items] | ||||||||||||
Net assets located outside of the United States | $ 0 | $ 0 | $ 0 | |||||||||
PIPE Warrants | ||||||||||||
Significant Accounting Policies [Line Items] | ||||||||||||
Warrants exercise price | $ / shares | $ 10 | $ 10 | $ 10 | |||||||||
Minimum | ||||||||||||
Significant Accounting Policies [Line Items] | ||||||||||||
Marketable securities maturity term | 3 months | |||||||||||
PIPE Warrants | ||||||||||||
Significant Accounting Policies [Line Items] | ||||||||||||
Warrant liability | $ 9,300,000 | |||||||||||
Non-cash change in fair value of PIPE Warrant liability | 4,900,000 | $ 11,600,000 | $ 19,900,000 | |||||||||
Reduction in warrant liability in connection with warrant exercises | $ 0 | $ 0 | 1,200,000 | |||||||||
PIPE Warrants | Private Placement | ||||||||||||
Significant Accounting Policies [Line Items] | ||||||||||||
Common stock, shares issued | shares | 1,764,242 | |||||||||||
Warrants exercisable shares of common stock exercised | shares | 80,309 | |||||||||||
Cash proceeds | $ 800,000 | |||||||||||
Warrants exercisable shares of common stock outstanding | shares | 1,683,933 | |||||||||||
Settlement Warrants | ||||||||||||
Significant Accounting Policies [Line Items] | ||||||||||||
Non-cash change in fair value of PIPE Warrant liability | $ (700,000) | |||||||||||
Reserve for settlement of fines | 17,100,000 | |||||||||||
Estimated insurance recoveries | 15,000,000 | $ 15,000,000 | ||||||||||
Estimated fair value of warrants | $ 1,400,000 | $ 2,100,000 | ||||||||||
Warrants to purchase of common stock shares | shares | 200,000 | 200,000 | ||||||||||
Warrants exercisable expiration period | 1 year | 1 year | 1 year | |||||||||
Warrants exercise price | $ / shares | $ 30 | $ 3 | $ 30 | $ 30 | ||||||||
Cash settlement from insurance carriers | $ 15,000,000 | |||||||||||
Warrant expired | shares | 200,000 | |||||||||||
Warrant Expiration Date | Jul. 15, 2019 | |||||||||||
Warrants exercised during period | shares | 0 | 0 | ||||||||||
Reclassified of settlement warrants from a liability to stockholders equity | $ 1,400,000 | |||||||||||
Offering Warrants | ||||||||||||
Significant Accounting Policies [Line Items] | ||||||||||||
Warrants exercise price | $ / shares | $ 12.50 | $ 12.50 | ||||||||||
Straight Line Basis | ||||||||||||
Significant Accounting Policies [Line Items] | ||||||||||||
Operating leases, rent expense, net | $ 400,000 |
Summary of Total Revenues Earne
Summary of Total Revenues Earned by Partner (Detail) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2020 | Sep. 30, 2020 | Jun. 30, 2020 | Mar. 31, 2020 | Dec. 31, 2019 | Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Disaggregation Of Revenue [Line Items] | |||||||||||
Total revenues | $ 886 | $ 3,600 | $ 749 | $ 784 | $ 764 | $ 25,717 | $ 703 | $ 1,611 | $ 6,019 | $ 28,795 | $ 5,409 |
KKC | |||||||||||
Disaggregation Of Revenue [Line Items] | |||||||||||
Total revenues | 2,800 | 25,000 | |||||||||
EUSA | |||||||||||
Disaggregation Of Revenue [Line Items] | |||||||||||
Total revenues | $ 3,219 | $ 3,795 | 3,409 | ||||||||
CANbridge | |||||||||||
Disaggregation Of Revenue [Line Items] | |||||||||||
Total revenues | $ 2,000 |
Summary of Future Minimum Lease
Summary of Future Minimum Lease Payment (Detail) - USD ($) $ in Thousands | Dec. 31, 2020 | Mar. 05, 2020 |
Operating Lease Liabilities Payments Due [Abstract] | ||
2021 | $ 385 | |
2022 | 328 | |
Total lease payments | 713 | |
Less imputed interest | (8) | |
Total operating lease liabilities | $ 705 | $ 1,000 |
Summary of Fair Value of Compan
Summary of Fair Value of Company's Warrant Liability (Detail) - PIPE Warrants - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | |||
Fair value, beginning of period | $ 5,097 | $ 16,674 | $ 37,746 |
Decrease in fair value | (4,898) | (11,577) | (19,919) |
Reduction in warrant liability for PIPE Warrant exercises | (1,153) | ||
Fair value, end of period | $ 199 | $ 5,097 | $ 16,674 |
Key Assumptions Used to Value t
Key Assumptions Used to Value the Warrants (Detail) | Dec. 31, 2020$ / shares | Dec. 31, 2019$ / shares | Dec. 31, 2018$ / shares | Jun. 30, 2018$ / shares | Dec. 31, 2017$ / shares | May 31, 2016$ / shares |
Fair Value Measurements, Recurring and Nonrecurring, Valuation Techniques [Line Items] | ||||||
Stock price | $ 5.77 | |||||
Settlement Warrants | ||||||
Fair Value Measurements, Recurring and Nonrecurring, Valuation Techniques [Line Items] | ||||||
Stock price | $ 29 | $ 27.90 | ||||
Measurement Input, Price Volatility | Settlement Warrants | ||||||
Fair Value Measurements, Recurring and Nonrecurring, Valuation Techniques [Line Items] | ||||||
Expected price volatility | 62.74 | 101.52 | ||||
Measurement Input, Expected Term | Settlement Warrants | ||||||
Fair Value Measurements, Recurring and Nonrecurring, Valuation Techniques [Line Items] | ||||||
Expected term (in years) | 1 year | 1 year | ||||
Measurement Input, Risk Free Interest Rate | Settlement Warrants | ||||||
Fair Value Measurements, Recurring and Nonrecurring, Valuation Techniques [Line Items] | ||||||
Expected price volatility | 2.37 | 1.76 | ||||
Measurement Input, Expected Dividend Rate | Settlement Warrants | ||||||
Fair Value Measurements, Recurring and Nonrecurring, Valuation Techniques [Line Items] | ||||||
Expected price volatility | 0 | 0 | ||||
PIPE Warrants | ||||||
Fair Value Measurements, Recurring and Nonrecurring, Valuation Techniques [Line Items] | ||||||
Stock price | $ 5.77 | $ 6.20 | $ 16 | $ 27.90 | $ 8.90 | |
PIPE Warrants | Measurement Input, Price Volatility | ||||||
Fair Value Measurements, Recurring and Nonrecurring, Valuation Techniques [Line Items] | ||||||
Expected price volatility | 56.79 | 133.07 | 82.64 | 84.86 | 76.25 | |
PIPE Warrants | Measurement Input, Expected Term | ||||||
Fair Value Measurements, Recurring and Nonrecurring, Valuation Techniques [Line Items] | ||||||
Expected term (in years) | 6 months | 1 year 6 months | 2 years 6 months | 3 years 6 months | 5 years | |
PIPE Warrants | Measurement Input, Risk Free Interest Rate | ||||||
Fair Value Measurements, Recurring and Nonrecurring, Valuation Techniques [Line Items] | ||||||
Expected price volatility | 0.09 | 1.59 | 2.47 | 2.09 | 1.22 | |
PIPE Warrants | Measurement Input, Expected Dividend Rate | ||||||
Fair Value Measurements, Recurring and Nonrecurring, Valuation Techniques [Line Items] | ||||||
Expected price volatility | 0 | 0 | 0 | 0 | 0 |
Summary of Cash, Cash Equivalen
Summary of Cash, Cash Equivalents and Marketable Securities (Detail) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Amortized Cost | $ 61,761 | $ 47,745 |
Fair Value | 61,761 | 47,745 |
Amortized Cost | 29,785 | |
Fair Value | 29,785 | |
Amortized Cost | 17,960 | |
Fair Value | 17,960 | |
Cash and money market funds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Amortized Cost | 61,761 | 25,278 |
Fair Value | $ 61,761 | 25,278 |
Corporate debt securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Amortized Cost | 4,507 | |
Fair Value | 4,507 | |
Amortized Cost | 17,960 | |
Fair Value | $ 17,960 |
Summary of Assets And Liabiliti
Summary of Assets And Liabilities Measured at Fair Value on Recurring Basis (Detail) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents | $ 29,785 | |
Total cash, cash equivalents and marketable securities | $ 61,761 | 47,745 |
Cash and money market funds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents | 61,761 | 25,278 |
Fair Value Measurements Recurring | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents | 29,785 | |
Total cash, cash equivalents and marketable securities | 61,761 | 47,745 |
Marketable securities | 17,960 | |
Fair Value Measurements Recurring | Corporate debt securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents | 4,507 | |
Marketable securities | 17,960 | |
Fair Value Measurements Recurring | PIPE Warrants | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Warrant liability | 199 | 5,097 |
Fair Value Measurements Recurring | Level 1 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents | 25,278 | |
Total cash, cash equivalents and marketable securities | 61,761 | 25,278 |
Fair Value Measurements Recurring | Level 2 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents | 4,507 | |
Total cash, cash equivalents and marketable securities | 22,467 | |
Marketable securities | 17,960 | |
Fair Value Measurements Recurring | Level 2 | Corporate debt securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents | 4,507 | |
Marketable securities | 17,960 | |
Fair Value Measurements Recurring | Level 3 | PIPE Warrants | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Warrant liability | 199 | 5,097 |
Fair Value Measurements Recurring | Cash and money market funds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents | 61,761 | 25,278 |
Fair Value Measurements Recurring | Cash and money market funds | Level 1 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents | $ 61,761 | $ 25,278 |
Summary of Computation of Basic
Summary of Computation of Basic and Diluted Net Loss per Share (Detail) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2020 | Sep. 30, 2020 | Jun. 30, 2020 | Mar. 31, 2020 | Dec. 31, 2019 | Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Earnings Per Share [Abstract] | |||||||||||
Basic net income (loss) attributable to Aveo common stockholders | $ (11,504) | $ (8,393) | $ (7,306) | $ (8,381) | $ (4,461) | $ 16,429 | $ (3,135) | $ 555 | $ (35,584) | $ 9,388 | $ (5,329) |
Less: non-cash gains attributable to the change in fair value of the PIPE Warrant liability | (19,919) | ||||||||||
Diluted net income (loss) attributable to Aveo common stockholders | $ (35,584) | $ 9,388 | $ (25,248) | ||||||||
Weighted-average shares of common stock outstanding | 26,252 | 25,808 | 17,364 | 16,081 | 16,077 | 16,074 | 15,902 | 13,230 | 21,402 | 15,331 | 12,059 |
Dilutive securities: | |||||||||||
Incremental common shares issuable upon the exercise of the PIPE Warrants | 1,014 | ||||||||||
Incremental common shares issuable upon the exercise of dilutive stock options | 45 | ||||||||||
Weighted-average number of common shares outstanding and dilutive share equivalents outstanding | 21,402 | 15,376 | 13,073 | ||||||||
Net income (loss) per share - basic | $ (0.44) | $ (0.33) | $ (0.42) | $ (0.52) | $ (0.28) | $ 1.02 | $ (0.20) | $ 0.04 | $ (1.66) | $ 0.61 | $ (0.44) |
Net income (loss) per share - diluted | $ (0.44) | $ (0.33) | $ (0.42) | $ (0.52) | $ (0.28) | $ 1.02 | $ (0.20) | $ (0.62) | $ (1.66) | $ 0.61 | $ (1.93) |
Summary of Outstanding Securiti
Summary of Outstanding Securities not Included in Computation of Diluted Net Loss Per Common Share (Detail) - 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] | |||
Antidilutive securities excluded from computation of earnings per share amount, outstanding | 5,980,623 | 5,352,183 | 1,158,334 |
Stock Options | |||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | |||
Antidilutive securities excluded from computation of earnings per share amount, outstanding | 1,796,690 | 1,168,250 | 958,334 |
PIPE Warrants | |||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | |||
Antidilutive securities excluded from computation of earnings per share amount, outstanding | 1,683,933 | 1,683,933 | |
Offering Warrants | |||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | |||
Antidilutive securities excluded from computation of earnings per share amount, outstanding | 2,500,000 | 2,500,000 | |
Settlement Warrants | |||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | |||
Antidilutive securities excluded from computation of earnings per share amount, outstanding | 200,000 |
Stock Based Compensation Expens
Stock Based Compensation Expense for Equity-Classified Awards (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Total stock-based compensation expense | $ 2,355 | $ 2,358 | $ 2,546 |
Research and development | |||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Total stock-based compensation expense | 499 | 662 | 774 |
Selling, general and administrative | |||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Total stock-based compensation expense | $ 1,856 | $ 1,696 | $ 1,772 |
Collaborations and License Ag_3
Collaborations and License Agreements - Additional Information (Detail) | Aug. 02, 2020USD ($) | Jan. 31, 2019USD ($) | Sep. 30, 2019USD ($) | Jun. 30, 2019USD ($) | May 31, 2019USD ($) | Feb. 28, 2019USD ($) | Dec. 31, 2018USD ($) | Nov. 30, 2018USD ($) | Oct. 31, 2018USD ($) | Aug. 31, 2018USD ($) | Apr. 30, 2018USD ($) | Mar. 31, 2018USD ($) | Feb. 28, 2018USD ($) | Oct. 31, 2017USD ($) | Sep. 30, 2017USD ($) | Mar. 31, 2017USD ($) | Oct. 31, 2016USD ($) | Apr. 30, 2016USD ($) | Mar. 31, 2016USD ($) | Dec. 31, 2015USD ($) | Dec. 31, 2012USD ($) | Mar. 31, 2010USD ($) | Dec. 31, 2006USD ($) | Dec. 31, 2020USD ($) | Sep. 30, 2020USD ($) | Jun. 30, 2020USD ($) | Mar. 31, 2020USD ($) | Dec. 31, 2019USD ($) | Sep. 30, 2019USD ($) | Jun. 30, 2019USD ($) | Mar. 31, 2019USD ($) | Dec. 31, 2018USD ($) | Sep. 30, 2018USD ($) | Mar. 31, 2018USD ($) | Dec. 31, 2020USD ($)InstallmentIndication | Dec. 31, 2019USD ($) | Dec. 31, 2018USD ($) | Dec. 31, 2017USD ($) | Dec. 31, 2015USD ($) | Feb. 28, 2018USD ($) | Nov. 30, 2018USD ($) | Feb. 28, 2019USD ($) | Aug. 31, 2019USD ($) | Feb. 28, 2017USD ($) | Apr. 30, 2014 |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||||||||||||||||||||||||||
License agreement month and date | 2018-12 | ||||||||||||||||||||||||||||||||||||||||||||
Amounts due from pursuant to the cost-sharing provisions | $ 1,197,000 | $ 1,631,000 | $ 1,197,000 | $ 1,631,000 | |||||||||||||||||||||||||||||||||||||||||
Transaction price | $ 12,500,000 | ||||||||||||||||||||||||||||||||||||||||||||
Revenues | 886,000 | $ 3,600,000 | $ 749,000 | $ 784,000 | 764,000 | $ 25,717,000 | $ 703,000 | 1,611,000 | 6,019,000 | 28,795,000 | $ 5,409,000 | ||||||||||||||||||||||||||||||||||
Revenue recognized as collaboration and licensing revenue related to the cumulative catch-up | $ 1,000,000 | ||||||||||||||||||||||||||||||||||||||||||||
Deferred revenue, current portion | 1,974,000 | $ 1,974,000 | $ 1,000,000 | 1,974,000 | 1,974,000 | ||||||||||||||||||||||||||||||||||||||||
Collaboration and Licensing Revenue | |||||||||||||||||||||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||||||||||||||||||||||||||
Revenues | 4,774,000 | 27,934,000 | 4,947,000 | ||||||||||||||||||||||||||||||||||||||||||
Partnership Royalties | |||||||||||||||||||||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||||||||||||||||||||||||||
Revenues | 1,245,000 | 861,000 | 462,000 | ||||||||||||||||||||||||||||||||||||||||||
Astra Zeneca Inc. | Astra Zeneca Agreement | |||||||||||||||||||||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||||||||||||||||||||||||||
Amounts due from pursuant to the cost-sharing provisions | $ 400,000 | $ 400,000 | |||||||||||||||||||||||||||||||||||||||||||
CANbridge | |||||||||||||||||||||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||||||||||||||||||||||||||
Licence agreement date | Mar. 31, 2016 | ||||||||||||||||||||||||||||||||||||||||||||
Allocation of upfront payment | $ 700,000 | ||||||||||||||||||||||||||||||||||||||||||||
Revenues | 2,000,000 | ||||||||||||||||||||||||||||||||||||||||||||
CANbridge | Licensing Agreements | |||||||||||||||||||||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||||||||||||||||||||||||||
Upfront payment received | $ 1,000,000 | ||||||||||||||||||||||||||||||||||||||||||||
Upfront payment, withholding taxes | $ 100,000 | ||||||||||||||||||||||||||||||||||||||||||||
Number of installments paid | Installment | 2 | ||||||||||||||||||||||||||||||||||||||||||||
Revenue recognized from reimbursement of manufacturing development activities | $ 500,000 | $ 500,000 | $ 500,000 | $ 1,000,000 | |||||||||||||||||||||||||||||||||||||||||
Upfront consideration received upon execution | $ 1,000,000 | ||||||||||||||||||||||||||||||||||||||||||||
Transaction price | $ 4,000,000 | ||||||||||||||||||||||||||||||||||||||||||||
Performance obligation | 0 | ||||||||||||||||||||||||||||||||||||||||||||
CANbridge | Licensing Agreements | Collaboration and Licensing Revenue | |||||||||||||||||||||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||||||||||||||||||||||||||
Revenues | 2,000,000 | ||||||||||||||||||||||||||||||||||||||||||||
CANbridge | Licensing Agreements | Development and Regulatory Milestone Events | |||||||||||||||||||||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||||||||||||||||||||||||||
Collaboration and licensing revenue | 2,000,000 | ||||||||||||||||||||||||||||||||||||||||||||
Collaborations and license agreements, expected milestone receivable | 2,000,000 | ||||||||||||||||||||||||||||||||||||||||||||
CANbridge | Licensing Agreements | Development and Regulatory Milestone Events | |||||||||||||||||||||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||||||||||||||||||||||||||
Collaboration and licensing revenue | 2,000,000 | ||||||||||||||||||||||||||||||||||||||||||||
EUSA | |||||||||||||||||||||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||||||||||||||||||||||||||
Transaction price | $ 10,500,000 | $ 8,500,000 | |||||||||||||||||||||||||||||||||||||||||||
Revenues | 3,219,000 | 3,795,000 | 3,409,000 | ||||||||||||||||||||||||||||||||||||||||||
Research and development reimbursement received | 4,000,000 | $ 6,500,000 | $ 2,500,000 | ||||||||||||||||||||||||||||||||||||||||||
Percentage of EUSA cost-sharing for TIVO-3 trial | 50.00% | ||||||||||||||||||||||||||||||||||||||||||||
Collaborations and license agreements, expected milestone receivable | $ 2,000,000 | $ 2,000,000 | $ 2,000,000 | 4,000,000 | $ 2,500,000 | ||||||||||||||||||||||||||||||||||||||||
Eligible number of indications | Indication | 3 | ||||||||||||||||||||||||||||||||||||||||||||
Payments received in connection with additional indications | $ 5,000,000 | ||||||||||||||||||||||||||||||||||||||||||||
Potential payments received in connection with additional indications | $ 335,000,000 | ||||||||||||||||||||||||||||||||||||||||||||
Description of royalty percentage receivable on net sales | The Company is also eligible to receive tiered double digit royalties on net sales, if any, of licensed products in the EUSA Licensed Territories ranging from a low double digit up to mid-twenty percent depending on the level of annual net sales | ||||||||||||||||||||||||||||||||||||||||||||
Collaborations and license agreements, potential future payment as percentage of certain amounts the Company receives under sublicense agreements | 30.00% | 30.00% | |||||||||||||||||||||||||||||||||||||||||||
Revenue, Information Used to Allocate Transaction Price | The Company evaluated the promised goods and services at the inception of the EUSA Agreement under ASC 606. Based on this evaluation, the Company determined that $6.5 million in research and development payments by EUSA, including the $2.5 million upfront consideration received upon the execution of the EUSA Agreement in December 2015 and the $4.0 million payment upon the receipt of marketing approval from the EMA for FOTIVDA (tivozanib) for the treatment of RCC in August 2017, constituted the amount of the consideration that was included in the transaction price upon the adoption of ASC 606 on January 1, 2018 and attributed this amount to the Company’s single performance obligation | ||||||||||||||||||||||||||||||||||||||||||||
Remaining performance obligation revenue expected to be recognized over month and year | 2022-04 | ||||||||||||||||||||||||||||||||||||||||||||
Revenue recognized as collaboration and licensing revenue related to the cumulative catch-up | $ 700,000 | $ 900,000 | |||||||||||||||||||||||||||||||||||||||||||
Deferred revenue, current portion | $ 1,300,000 | $ 1,100,000 | $ 1,300,000 | ||||||||||||||||||||||||||||||||||||||||||
Total revenue recognized | $ 3,200,000 | 3,800,000 | 3,400,000 | ||||||||||||||||||||||||||||||||||||||||||
Deferred revenue recognized as collaboration and licensing revenue | $ 2,600,000 | 2,600,000 | 2,600,000 | ||||||||||||||||||||||||||||||||||||||||||
Deferred revenue continue to be recognized as collaboration and licensing revenue per quarter | 500,000 | $ 500,000 | 500,000 | ||||||||||||||||||||||||||||||||||||||||||
Reductions in research and development expenses | 2,000,000 | ||||||||||||||||||||||||||||||||||||||||||||
EUSA | Milestone - UK Reimbursement Approval | |||||||||||||||||||||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||||||||||||||||||||||||||
Allocation of upfront payment | $ 600,000 | ||||||||||||||||||||||||||||||||||||||||||||
Collaborations and license agreements, expected milestone receivable | $ 2,000,000 | ||||||||||||||||||||||||||||||||||||||||||||
EUSA | Milestone - German Reimbursement Approval | |||||||||||||||||||||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||||||||||||||||||||||||||
Allocation of upfront payment | $ 600,000 | ||||||||||||||||||||||||||||||||||||||||||||
Collaborations and license agreements, expected milestone receivable | $ 2,000,000 | ||||||||||||||||||||||||||||||||||||||||||||
EUSA | Milestone Spain Reimbursement Approval | |||||||||||||||||||||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||||||||||||||||||||||||||
Allocation of upfront payment | $ 600,000 | ||||||||||||||||||||||||||||||||||||||||||||
Collaborations and license agreements, expected milestone receivable | $ 2,000,000 | ||||||||||||||||||||||||||||||||||||||||||||
EUSA | Opt In To Planned Phase Three Study | |||||||||||||||||||||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||||||||||||||||||||||||||
Milestone payment to be received | $ 20,000,000 | 20,000,000 | |||||||||||||||||||||||||||||||||||||||||||
EUSA | Marketing Approval in France, Germany, Italy, Spain and the United Kingdom | |||||||||||||||||||||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||||||||||||||||||||||||||
Milestone payment to be received | 2,000,000 | 2,000,000 | |||||||||||||||||||||||||||||||||||||||||||
EUSA | Marketing Approval in Australia, Brazil, New Zealand, South Africa and Switzerland | |||||||||||||||||||||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||||||||||||||||||||||||||
Milestone payment to be received | 2,000,000 | 2,000,000 | |||||||||||||||||||||||||||||||||||||||||||
EUSA | Opt-in to Co-develop TiNivo Trial | |||||||||||||||||||||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||||||||||||||||||||||||||
Collaborations and license agreements, expected milestone receivable | $ 2,000,000 | ||||||||||||||||||||||||||||||||||||||||||||
EUSA | Partnership Royalties | |||||||||||||||||||||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||||||||||||||||||||||||||
Sales royalties revenue recognized | 1,200,000 | 900,000 | 500,000 | ||||||||||||||||||||||||||||||||||||||||||
EUSA | TiNivo trial | |||||||||||||||||||||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||||||||||||||||||||||||||
Research and development reimbursement received | $ 2,000,000 | ||||||||||||||||||||||||||||||||||||||||||||
Novartis | Collaboration and Licensing Revenue | |||||||||||||||||||||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||||||||||||||||||||||||||
Collaboration and licensing revenue | 2,300,000 | ||||||||||||||||||||||||||||||||||||||||||||
Collaboration and licensing revenue | 2,300,000 | ||||||||||||||||||||||||||||||||||||||||||||
Biodesix | |||||||||||||||||||||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||||||||||||||||||||||||||
Amounts due from pursuant to the cost-sharing provisions | 100,000 | 100,000 | |||||||||||||||||||||||||||||||||||||||||||
Biodesix | FOCAL study | |||||||||||||||||||||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||||||||||||||||||||||||||
Revenue recognized as collaboration and licensing revenue related to the cumulative catch-up | $ 2,500,000 | ||||||||||||||||||||||||||||||||||||||||||||
Collaborations and license agreements, royalties payment on revenue | 25.00% | ||||||||||||||||||||||||||||||||||||||||||||
Biodesix | FOCAL study | Minimum | |||||||||||||||||||||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||||||||||||||||||||||||||
Contribution percentage of clinical, regulatory, manufacturing and other costs | 50.00% | ||||||||||||||||||||||||||||||||||||||||||||
Biodesix | F O C A L Trial | |||||||||||||||||||||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||||||||||||||||||||||||||
Reductions in research and development expenses | 800,000 | 900,000 | 300,000 | ||||||||||||||||||||||||||||||||||||||||||
Biogen Idec International GmbH | |||||||||||||||||||||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||||||||||||||||||||||||||
Allocation of upfront payment | $ 700,000 | ||||||||||||||||||||||||||||||||||||||||||||
Biogen Idec International GmbH | Maximum | |||||||||||||||||||||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||||||||||||||||||||||||||
Royalty payments | $ 50,000,000 | ||||||||||||||||||||||||||||||||||||||||||||
Biogen Idec International GmbH | Licensing Agreements | Development and Regulatory Milestone Events | |||||||||||||||||||||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||||||||||||||||||||||||||
Collaboration and licensing revenue | $ 2,000,000 | ||||||||||||||||||||||||||||||||||||||||||||
St Vincent's Hospital Sydney Limited | |||||||||||||||||||||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||||||||||||||||||||||||||
Collaboration and licensing revenue | 2,300,000 | ||||||||||||||||||||||||||||||||||||||||||||
Amendment agreement date | 2015-08 | ||||||||||||||||||||||||||||||||||||||||||||
Future payment obligations | $ 1,800,000 | ||||||||||||||||||||||||||||||||||||||||||||
Time-based milestone obligation payment | $ 1,800,000 | ||||||||||||||||||||||||||||||||||||||||||||
Additional time-based milestone obligation payable | $ 2,300,000 | ||||||||||||||||||||||||||||||||||||||||||||
St Vincent's Hospital Sydney Limited | Development and Regulatory Milestone Events | Maximum | |||||||||||||||||||||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||||||||||||||||||||||||||
Revenue recognition milestone method milestone payables | 14,400,000 | $ 14,400,000 | |||||||||||||||||||||||||||||||||||||||||||
St Vincent's Hospital Sydney Limited | Licensing Agreements | |||||||||||||||||||||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||||||||||||||||||||||||||
Upfront payment received | 1,500,000 | ||||||||||||||||||||||||||||||||||||||||||||
Kyowa Kirin | |||||||||||||||||||||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||||||||||||||||||||||||||
Milestone Payment | $ 0 | 0 | |||||||||||||||||||||||||||||||||||||||||||
Kyowa Kirin | Licensing Agreements | |||||||||||||||||||||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||||||||||||||||||||||||||
Upfront payment received | 5,000,000 | ||||||||||||||||||||||||||||||||||||||||||||
Upfront payment receivable | $ 25,000,000 | ||||||||||||||||||||||||||||||||||||||||||||
Collaborations and license agreements, one time milestone payment waived | $ 18,000,000 | ||||||||||||||||||||||||||||||||||||||||||||
Collaborations and license agreements, milestone payment | $ 10,000,000 | ||||||||||||||||||||||||||||||||||||||||||||
Kyowa Kirin | |||||||||||||||||||||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||||||||||||||||||||||||||
Collaboration and licensing revenue | 2,800 | ||||||||||||||||||||||||||||||||||||||||||||
Transaction price | 27,800 | ||||||||||||||||||||||||||||||||||||||||||||
Revenues | $ 2,800,000 | $ 25,000,000 | |||||||||||||||||||||||||||||||||||||||||||
Non refundable upfront payment | $ 25,000,000 | ||||||||||||||||||||||||||||||||||||||||||||
Kyowa Kirin | Opt In To Planned Phase Three Study | Maximum | |||||||||||||||||||||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||||||||||||||||||||||||||
Research and development reimbursement potential opt-in payment | $ 20,000,000 | ||||||||||||||||||||||||||||||||||||||||||||
Kyowa Kirin | Licensing Agreements | |||||||||||||||||||||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||||||||||||||||||||||||||
Collaborations and license agreements, expected milestone receivable | $ 390,700,000 | ||||||||||||||||||||||||||||||||||||||||||||
Collaborations and license agreements, potential future payment as percentage of certain amounts the Company receives under sublicense agreements | 30.00% | 30.00% | |||||||||||||||||||||||||||||||||||||||||||
Term of royalty payment obligations | 12 years | 10 years | |||||||||||||||||||||||||||||||||||||||||||
Non refundable upfront payment | $ 25,000,000 | ||||||||||||||||||||||||||||||||||||||||||||
Kyowa Kirin | Licensing Agreements | FDA Marketing Approval | |||||||||||||||||||||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||||||||||||||||||||||||||
Collaborations and license agreements, milestone payment | $ 12,000,000 | ||||||||||||||||||||||||||||||||||||||||||||
Kyowa Kirin | Licensing Agreements | IND Marketing Approval | |||||||||||||||||||||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||||||||||||||||||||||||||
Collaboration and licensing revenue | $ 2,800,000 | ||||||||||||||||||||||||||||||||||||||||||||
Research and development | Astra Zeneca Inc. | Astra Zeneca Agreement | |||||||||||||||||||||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||||||||||||||||||||||||||
Payments received and recorded as an increased (decreased) to expense pursuant to cost-sharing provisions | 1,100,000 | 500,000 | 0 | ||||||||||||||||||||||||||||||||||||||||||
Research and development | EUSA | TiNivo trial | |||||||||||||||||||||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||||||||||||||||||||||||||
Payments received and recorded as an increased (decreased) to expense pursuant to cost-sharing provisions | $ 100,000 | $ 400,000 | $ 500,000 |
Summary of Revenues Earned in C
Summary of Revenues Earned in Connection with EUSA Agreement under ASC 606 (Detail) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2020 | Sep. 30, 2020 | Jun. 30, 2020 | Mar. 31, 2020 | Dec. 31, 2019 | Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||
Revenues | $ 886 | $ 3,600 | $ 749 | $ 784 | $ 764 | $ 25,717 | $ 703 | $ 1,611 | $ 6,019 | $ 28,795 | $ 5,409 |
Partnership Royalties | |||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||
Revenues | 1,245 | 861 | 462 | ||||||||
EUSA | |||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||
Revenues | 3,219 | 3,795 | 3,409 | ||||||||
ASC 606 | EUSA | |||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||
Revenues | 3,219 | 3,795 | 3,409 | ||||||||
ASC 606 | EUSA | Collaboration and Licensing Revenue | |||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||
Revenues | 1,974 | 2,934 | 2,947 | ||||||||
ASC 606 | EUSA | Partnership Royalties | |||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||
Revenues | $ 1,245 | 861 | 462 | ||||||||
Upfront Payment | ASC 606 | EUSA | |||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||
Date Achieved | 2015-12 | ||||||||||
Collaboration and Licensing Revenue | $ 395 | 395 | 395 | ||||||||
R&D Payment - EMA Approval in RCC | ASC 606 | EUSA | |||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||
Date Achieved | 2017-08 | ||||||||||
Collaboration and Licensing Revenue | $ 631 | 631 | 632 | ||||||||
Milestone - UK Reimbursement Approval | ASC 606 | EUSA | |||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||
Date Achieved | 2018-02 | ||||||||||
Collaboration and Licensing Revenue | $ 316 | 316 | 960 | ||||||||
Milestone - German Reimbursement Approval | ASC 606 | EUSA | |||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||
Date Achieved | 2018-11 | ||||||||||
Collaboration and Licensing Revenue | $ 316 | 316 | $ 960 | ||||||||
Milestone Spanish Reimbursement Approval | ASC 606 | EUSA | |||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||
Date Achieved | 2019-02 | ||||||||||
Collaboration and Licensing Revenue | $ 316 | $ 1,276 |
Summary of Changes in Accounts
Summary of Changes in Accounts Receivable and Contract Liabilities (Deferred Revenue) (Detail) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | ||
Mar. 31, 2019 | Dec. 31, 2018 | Mar. 31, 2018 | Dec. 31, 2020 | |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||
Contract Liabilities, Transaction Price | $ 12,500 | |||
EUSA | ||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||
Contract Liabilities, Transaction Price | $ 10,500 | $ 8,500 | ||
Beginning Balance January 1, 2020 | $ 2,600 | |||
Ending Balance December 31, 2020 | $ 2,600 | |||
Accounting Standards Update 2014-09 | EUSA | ||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||
Contract Liabilities, Transaction Price | $ 12,500 | |||
Beginning Balance January 1, 2020 | 4,526 | |||
Deductions | (1,974) | |||
Ending Balance December 31, 2020 | 2,552 | |||
Accounting Standards Update 2014-09 | EUSA | Upfront Payment | ||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||
Contract Liabilities, Transaction Price | $ 2,500 | |||
Contract Liabilities, Date Achieved | 2015-12 | |||
Contract Liabilities Date Paid | 2015-12 | |||
Beginning Balance January 1, 2020 | $ 907 | |||
Deductions | (395) | |||
Ending Balance December 31, 2020 | 512 | |||
Accounting Standards Update 2014-09 | EUSA | R&D Payment - EMA Approval in RCC | ||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||
Contract Liabilities, Transaction Price | $ 4,000 | |||
Contract Liabilities, Date Achieved | 2017-08 | |||
Contract Liabilities Date Paid | 2017-09 | |||
Beginning Balance January 1, 2020 | $ 1,448 | |||
Deductions | (631) | |||
Ending Balance December 31, 2020 | 817 | |||
Accounting Standards Update 2014-09 | EUSA | Milestone - UK Reimbursement Approval | ||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||
Contract Liabilities, Transaction Price | $ 2,000 | |||
Contract Liabilities, Date Achieved | 2018-02 | |||
Contract Liabilities Date Paid | 2018-03 | |||
Beginning Balance January 1, 2020 | $ 724 | |||
Deductions | (316) | |||
Ending Balance December 31, 2020 | 408 | |||
Accounting Standards Update 2014-09 | EUSA | Milestone - German Reimbursement Approval | ||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||
Contract Liabilities, Transaction Price | $ 2,000 | |||
Contract Liabilities, Date Achieved | 2018-11 | |||
Contract Liabilities Date Paid | 2018-12 | |||
Beginning Balance January 1, 2020 | $ 723 | |||
Deductions | (316) | |||
Ending Balance December 31, 2020 | 407 | |||
Accounting Standards Update 2014-09 | EUSA | Milestone Spanish Reimbursement Approval | ||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||
Contract Liabilities, Transaction Price | $ 2,000 | |||
Contract Liabilities, Date Achieved | 2019-02 | |||
Contract Liabilities Date Paid | 2019-05 | |||
Beginning Balance January 1, 2020 | $ 724 | |||
Deductions | (316) | |||
Ending Balance December 31, 2020 | 408 | |||
Accounting Standards Update 2014-09 | EUSA | Accounts Receivable | ||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||
Beginning Balance January 1, 2020 | 270 | |||
Additions | 1,245 | |||
Deductions | (1,123) | |||
Ending Balance December 31, 2020 | $ 392 |
Other Accrued Liabilities (Deta
Other Accrued Liabilities (Detail) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Payables And Accruals [Abstract] | ||
Professional fees | $ 1,061 | $ 806 |
Compensation and benefits | 3,082 | 1,284 |
Other | 320 | 246 |
Total | $ 4,463 | $ 2,336 |
Hercules Loan Facility - Additi
Hercules Loan Facility - Additional Information (Detail) | Mar. 11, 2021USD ($) | Feb. 01, 2021USD ($) | Aug. 31, 2020USD ($) | Nov. 30, 2018USD ($)Installment | Dec. 31, 2017USD ($)Installment | Dec. 31, 2020USD ($) | Jun. 30, 2022USD ($) | Jul. 02, 2021USD ($) | Jun. 30, 2021USD ($) | Aug. 01, 2020 | Dec. 31, 2019USD ($) | Oct. 31, 2019 | Sep. 30, 2019 | Aug. 31, 2019 | Dec. 31, 2018 | Sep. 30, 2018 | Jun. 30, 2018 |
Debt Instrument [Line Items] | |||||||||||||||||
Loan payable, interest rate | 9.45% | 9.70% | 9.95% | 9.95% | 9.70% | ||||||||||||
Approximate payment of principle and interest | $ 7,272,000 | ||||||||||||||||
Revenues | $ 20,000,000 | ||||||||||||||||
Loan description | Per the terms of the 2020 Loan Facility, principal will be repaid in equal monthly installments following the conclusion of the interest-only period. The Company may prepay all of the outstanding principal and accrued interest under the 2020 Loan Facility, subject to a prepayment charge up to 3.0% in the first year following the closing of the 2020 Loan Amendment, decreasing to 2.0% in year two and 1.0% in year three. | ||||||||||||||||
Unamortized discount recognized | $ 1,228,000 | $ 400,000 | |||||||||||||||
2020 Loan Agreement | |||||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||||
Loan facility | $ 35,000,000 | ||||||||||||||||
Secured Debt | 9,700,000 | ||||||||||||||||
New Loan Funding Received | $ 5,300,000 | ||||||||||||||||
Interest rate | 9.65% | ||||||||||||||||
Prime interest rate | 3.25% | ||||||||||||||||
Principle payment commencement date | Oct. 1, 2021 | ||||||||||||||||
Unrestricted Cash | $ 5,000,000 | ||||||||||||||||
2020 Loan Agreement | Tranche one | |||||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||||
Loan facility received | $ 15,000,000 | ||||||||||||||||
Scenario Forecast | Tranche Two | |||||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||||
Loan facility received | $ 10,000,000 | ||||||||||||||||
Scenario Forecast | Tranche Three | |||||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||||
Loan facility received | $ 5,000,000 | ||||||||||||||||
Scenario Forecast | Tranche Four | |||||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||||
Loan facility received | $ 5,000,000 | ||||||||||||||||
Minimum | 2020 Loan Agreement | |||||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||||
Interest rate | 9.65% | ||||||||||||||||
Unrestricted Cash | $ 10,000,000 | ||||||||||||||||
Percentage of forecast revenue | 75.00% | ||||||||||||||||
Maximum | 2020 Loan Agreement | |||||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||||
Interest rate | 15.00% | ||||||||||||||||
Undiscounted Excess Amount | $ 500,000 | ||||||||||||||||
Hercules Amended Loan Agreement | |||||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||||
Refinancing amount | $ 20,000,000 | ||||||||||||||||
Proceeds from additional borrowing capacity | $ 20,000,000 | ||||||||||||||||
Loan facility maturity period | 42 months | ||||||||||||||||
Loan facility extension period | 24 months | ||||||||||||||||
Loan payable, interest rate | 11.90% | 9.45% | |||||||||||||||
Hercules Amended Loan Agreement | Tranche Two | Subsequent Event | |||||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||||
Proceeds from additional borrowing capacity | $ 20,000,000 | ||||||||||||||||
Hercules Amended Loan Agreement | Minimum | Subsequent Event | |||||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||||
Unrestricted and unencumbered cash and cash equivalents | $ 10,000,000 | ||||||||||||||||
Loan facility | 35,000,000 | ||||||||||||||||
Unrestricted Cash | $ 15,000,000 | 10,000,000 | |||||||||||||||
Unfunded term Loan | 20,000,000 | ||||||||||||||||
Hercules Amended Loan Agreement | Minimum | Tranche Two | Subsequent Event | |||||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||||
Loan facility received | 10,000,000 | ||||||||||||||||
Hercules Amended Loan Agreement | Minimum | Tranche Three | Subsequent Event | |||||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||||
Loan facility received | 20,000,000 | ||||||||||||||||
Hercules Amended Loan Agreement | Maximum | Subsequent Event | |||||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||||
Unrestricted and unencumbered cash and cash equivalents | 15,000,000 | ||||||||||||||||
Loan facility | 45,000,000 | ||||||||||||||||
Unfunded term Loan | 30,000,000 | ||||||||||||||||
Hercules Amended Loan Agreement | Maximum | Tranche Two | Subsequent Event | |||||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||||
Loan facility received | 20,000,000 | ||||||||||||||||
Hercules Amended Loan Agreement | Maximum | Tranche Three | Subsequent Event | |||||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||||
Loan facility received | $ 35,000,000 | ||||||||||||||||
2017 Loan Agreement with Hercules | |||||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||||
Loan payable, due date | Jul. 1, 2021 | ||||||||||||||||
Loan payable, number of installments of principal and interest | Installment | 24 | 29 | |||||||||||||||
Loan issuance costs paid | $ 100,000 | ||||||||||||||||
Loan payable, Commencement date deferred by six months | Aug. 1, 2019 | Feb. 1, 2019 | |||||||||||||||
Additional, end-of-term payment | $ 800,000 | ||||||||||||||||
Loan payable, frequency of installments of principal and interest | monthly payments of principal and interest | monthly payments of principal and interest | |||||||||||||||
Loan outstanding principal amount | $ 9,700,000 | ||||||||||||||||
2017 Loan Agreement with Hercules | Loans Payable | |||||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||||
Loan payable, interest rate | 15.00% | 9.45% | 10.20% | ||||||||||||||
Loan payable, interest rate, base rate | 9.45% | ||||||||||||||||
Loan payable, interest rate, additional rate deducted from base rate | 4.75% | ||||||||||||||||
Loan payable, description of interest rate terms | Per annum interest was payable on the loan balance at the greater of 9.45% and an amount equal to 9.45% plus the prime rate minus 4.75%, as determined daily, provided however, that the per annum interest rate shall not exceed 15.0%. In 2018, the interest rate increased to 9.70%, 9.95% and 10.20% in June 2018, September 2018 and December 2018, respectively, due to corresponding increases in the prime rate. In 2019, the interest rate decreased to 9.95%, 9.70% and 9.45% in August 2019, September 2019 and October 2019, respectively, due to corresponding decreases in the prime rate | ||||||||||||||||
2017 Loan Agreement with Hercules | July 2021 | |||||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||||
Approximate payment of principle and interest | $ 900,000 | $ 800,000 | |||||||||||||||
2017 Loan Agreement with Hercules | Minimum | Loans Payable | |||||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||||
Loan payable, interest rate | 9.45% | ||||||||||||||||
2017 Loan Agreement with Hercules | Minimum | Financial covenant | |||||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||||
Unrestricted and unencumbered cash and cash equivalents | $ 10,000,000 |
Future Minimum Payments Under L
Future Minimum Payments Under Loans Payable (Detail) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Debt Disclosure [Abstract] | ||
2021 | $ 3,961 | |
2022 | 8,277 | |
2023 | 7,272 | |
Long-term Debt, Gross, Total | 19,510 | |
Less amount representing interest | (2,678) | |
Less unamortized discount | (1,228) | $ (400) |
Less deferred charges | (1,832) | |
Less loans payable current, net of discount | (1,056) | (9,569) |
Loans payable, net of current portion and discount | $ 12,716 | $ 6,197 |
Common Stock - Additional Infor
Common Stock - Additional Information (Detail) | Feb. 19, 2020$ / shares | Feb. 13, 2020shares | Jul. 16, 2018$ / sharesshares | Dec. 26, 2017$ / shares | Mar. 31, 2021USD ($)shares | Nov. 30, 2020USD ($)shares | Jun. 19, 2020USD ($)Affiliate$ / sharesshares | Feb. 29, 2020 | Apr. 30, 2019USD ($)$ / sharesshares | Feb. 28, 2019USD ($)shares | Aug. 21, 2018USD ($)Affiliate$ / sharesshares | Dec. 31, 2017$ / sharesshares | May 31, 2016USD ($)$ / sharesshares | Dec. 31, 2020USD ($)$ / sharesshares | Dec. 31, 2019USD ($)$ / sharesshares | Jul. 15, 2019shares | Dec. 31, 2018USD ($)$ / sharesshares | Nov. 09, 2020USD ($) | Mar. 31, 2020$ / sharesshares | Feb. 28, 2018USD ($) |
Class Of Stock [Line Items] | ||||||||||||||||||||
Common stock, shares authorized | 50,000,000 | 50,000,000 | 50,000,000 | |||||||||||||||||
Common stock, shares issued | 26,882,696 | 16,081,000 | 26,883,000 | |||||||||||||||||
Common stock, shares outstanding | 26,882,696 | 16,081,000 | 26,883,000 | |||||||||||||||||
Common stock, par value | $ / shares | $ 0.001 | $ 0.001 | $ 0.001 | |||||||||||||||||
Reverse stock split, description | one-for-ten | 1-for-10 | ||||||||||||||||||
Reverse stock split, conversion ratio | 0.10 | |||||||||||||||||||
Reduction in the number of shares of common stock | 16,100,000 | 160,800,000 | ||||||||||||||||||
Gross proceeds from common stock and warrant issed | $ | $ 268,200 | |||||||||||||||||||
Proceeds from issuance of preferred stock | $ | 268,200 | |||||||||||||||||||
Proceeds from issuance of debt securities | $ | 268,200 | |||||||||||||||||||
Proceeds from issuance of warrants | $ | 268,200 | |||||||||||||||||||
Common stock sales agreement, aggregate offering amount | $ | 27,000 | $ 16,000 | ||||||||||||||||||
Gross proceeds from public offering | $ | $ 268,200 | |||||||||||||||||||
Offering Warrants | ||||||||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||||||||
Warrants exercise price | $ / shares | $ 12.50 | $ 12.50 | ||||||||||||||||||
Settlement Warrants | ||||||||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||||||||
Warrants to purchase of common stock shares | 200,000 | 200,000 | ||||||||||||||||||
Warrants exercise price | $ / shares | $ 30 | $ 3 | $ 30 | $ 30 | ||||||||||||||||
Warrants exercisable period | 1 year | 1 year | 1 year | |||||||||||||||||
Warrant Expiration Date | Jul. 15, 2019 | |||||||||||||||||||
Warrants exercised during period | 0 | 0 | ||||||||||||||||||
SVB Leerink | ||||||||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||||||||
Stock issued during period, shares | 470,777 | |||||||||||||||||||
Net proceeds from issuance of common stock | $ | $ 10,300,000 | |||||||||||||||||||
Common stock value available for issuance in connection with future stock sales | $ | $ 25,700,000 | |||||||||||||||||||
Underwritten Public Offering | ||||||||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||||||||
Common stock, shares issued | 247,391 | 9,725,000 | 2,173,913 | 250,000 | ||||||||||||||||
Gross proceeds from common stock and warrant issed | $ | $ 51,100,000 | $ 5,700,000 | ||||||||||||||||||
Number Of Affiliates Stockholders | Affiliate | 3 | 2 | ||||||||||||||||||
Number of other stockholders | Affiliate | 2 | |||||||||||||||||||
Percentage Of affiliates stockholders | 5.00% | 5.00% | ||||||||||||||||||
Net proceeds from public offering | $ | $ 47,700,000 | $ 22,800,000 | $ 5,100,000 | |||||||||||||||||
Gross proceeds from common stock and warrant issued | $ | $ 3,100,000 | $ 25,000,000 | ||||||||||||||||||
Percentage of beneficial ownership of voting securities | 5.00% | |||||||||||||||||||
Gross proceeds from public offering | $ | $ 51,100,000 | $ 5,700,000 | ||||||||||||||||||
Underwritten Public Offering | Offering Warrants | ||||||||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||||||||
Warrants to purchase of common stock shares | 2,500,000 | |||||||||||||||||||
Warrants exercise price | $ / shares | $ 12.50 | |||||||||||||||||||
Warrants exercisable period | 2 years | |||||||||||||||||||
Class of warrant or right, outstanding | 2,252,609 | 2,500,000 | ||||||||||||||||||
Underwritten Public Offering | New Enterprise Associates and Another Stockholder | ||||||||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||||||||
Common stock, shares issued | 4,503,571 | 200,000 | ||||||||||||||||||
Underwritten Public Offering | Other Investors | ||||||||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||||||||
Common stock, shares issued | 434,782 | |||||||||||||||||||
Underwritten Public Offering | Other Investors | Offering Warrants | ||||||||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||||||||
Warrants to purchase of common stock shares | 434,782 | |||||||||||||||||||
Over Allotment Option | ||||||||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||||||||
Warrants to purchase of common stock shares | 1,225,000 | |||||||||||||||||||
Over Allotment Option | Offering Warrants | ||||||||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||||||||
Warrants to purchase of common stock shares | 326,086 | |||||||||||||||||||
Common Stock | ||||||||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||||||||
Reduction in the number of shares of common stock | 50,000,000 | 500,000,000 | ||||||||||||||||||
Common Stock | SVB Leerink | ||||||||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||||||||
Stock issued during period, shares | 1,070,175 | 1,251,555 | ||||||||||||||||||
Net proceeds from issuance of common stock | $ | $ 5,900,000 | $ 7,500,000 | ||||||||||||||||||
PIPE Warrants | Private Placement | ||||||||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||||||||
Common stock, shares issued | 1,764,242,000 | |||||||||||||||||||
Shares issued, price per share | $ / shares | $ 9.65 | |||||||||||||||||||
Warrants exercise price | $ / shares | $ 10 | |||||||||||||||||||
Warrants exercisable period | 5 years | |||||||||||||||||||
Gross proceeds from issuance of private placement | $ | $ 17,000,000 | |||||||||||||||||||
Exchange of unit to share | 1 | |||||||||||||||||||
Warrants exercisable shares of common stock exercised | 80,309 | |||||||||||||||||||
Cash proceeds in connection with warrants exercised | $ | $ 800,000 | |||||||||||||||||||
Warrants exercisable shares of common stock outstanding | 1,683,933 | |||||||||||||||||||
Board of Directors | ||||||||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||||||||
Reverse stock split, description | split ranging from 1-for-5 to 1-for-15. | |||||||||||||||||||
Director and Executive Officer | PIPE Warrants | Private Placement | ||||||||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||||||||
Common stock, shares issued | 54,402 | |||||||||||||||||||
Net offering proceeds to the company | $ | $ 15,400,000 | |||||||||||||||||||
Minimum | ||||||||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||||||||
Bid price per share | $ / shares | $ 1 | |||||||||||||||||||
Shares issued, price per share | $ / shares | $ 5.25 | |||||||||||||||||||
Minimum | Underwritten Public Offering | ||||||||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||||||||
Shares issued, price per share | $ / shares | $ 11.40 | $ 22.60 | ||||||||||||||||||
Minimum | Underwritten Public Offering | Offering Warrants | ||||||||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||||||||
Shares issued, price per share | $ / shares | $ 0.10 | |||||||||||||||||||
Minimum | Board of Directors | ||||||||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||||||||
Reverse stock split, conversion ratio | 0.066 | |||||||||||||||||||
Maximum | ||||||||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||||||||
Offering, issuance and sale of stocks and securities, shelf registration | $ | $ 300,000,000 | |||||||||||||||||||
Maximum | SVB Leerink | ||||||||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||||||||
Common stock sales agreement, aggregate offering amount | $ | $ 50,000,000 | |||||||||||||||||||
Common stock sales agreement commission, percentage | 3.00% | |||||||||||||||||||
Maximum | Board of Directors | ||||||||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||||||||
Reverse stock split, conversion ratio | 0.2 |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional Information (Detail) - USD ($) | 1 Months Ended | 5 Months Ended | 11 Months Ended | 12 Months Ended | ||||||
Nov. 30, 2020 | Mar. 31, 2013 | Feb. 28, 2010 | May 31, 2018 | Dec. 01, 2019 | Nov. 30, 2018 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||||
Increase total number of shares reserved | 1,300,000 | |||||||||
Stock price | $ 5.77 | |||||||||
Total unrecognized stock-based compensation expense related to stock options granted | $ 4,900,000 | |||||||||
Stock-based compensation expense | $ 2,355,000 | $ 2,358,000 | $ 2,546,000 | |||||||
2019 Equity Incentive Plan | ||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||||
Description of share based payment award | Awards may be made under the 2019 Plan for up to the sum of (i) 2,300,000 shares of common stock and (ii) such additional number of shares of common stock (up to 1,068,901 shares) as is equal to (x) the number of shares of common stock reserved for issuance under the 2010 Plan that were available for grant under the 2010 Plan immediately prior to the date the 2019 Plan was approved by the Company’s stockholders and (y) the number of shares of common stock subject to awards outstanding under the 2010 Plan, which awards expire, terminate or are otherwise surrendered, cancelled, forfeited or repurchased by the Company pursuant to a contractual repurchase right | |||||||||
Shares of common stock available for future issuance | 1,563,282 | |||||||||
2010 Stock Incentive Plan | ||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||||
Shares of common stock available for future issuance | 0 | |||||||||
Employee Stock Purchase Plan, 2010 | ||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||||
Shares of common stock available for future issuance | 23,859 | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Authorized | 25,000 | |||||||||
Common stock price per share percentage as of lower of fair market value of the common stock | 85.00% | 85.00% | 85.00% | 85.00% | 85.00% | |||||
Employee stock purchase plan, each offering period | 6 months | |||||||||
Common stock reserved for issuance | 76,400 | |||||||||
Employee stock purchase plan, number of share sold | 5,971 | 0 | 897 | |||||||
Price per share of shares sold to employees | $ 6.46 | $ 4.57 | $ 18.80 | $ 17.60 | ||||||
Stock-based compensation expense | $ 25,000,000 | $ 2,000,000 | $ 8,000,000 | |||||||
Stock Options | ||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||||
Awards, vesting period | 4 years | |||||||||
Awards, Expiration period | 10 years | |||||||||
Weighted-average grant date fair value of stock options granted | $ 4.54 | $ 5.70 | $ 21.40 | |||||||
Total unrecognized stock-based compensation expense, weighted-average period Recognition | 2 years 9 months 18 days | |||||||||
Intrinsic value of options exercised | $ 1,000 | $ 7,000 | $ 400,000 | |||||||
Minimum | Stock Options | Participants Who Own Less Than Ten Percent Of Combined Voting Power | ||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||||
Exercise price of incentive stock options as percentage of fair market value of common stock on the date of the award | 100.00% | |||||||||
Maximum | 2019 Equity Incentive Plan | ||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Authorized | 2,300,000 | |||||||||
Common stock reserved for issuance | 1,068,901 | |||||||||
Maximum | Stock Options | Participants Who Own More than 10% of Total Combined Voting Power | ||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||||
Exercise price of incentive stock options as percentage of fair market value of common stock on the date of the award | 110.00% |
Stock Option Activity (Detail)
Stock Option Activity (Detail) | 12 Months Ended |
Dec. 31, 2020USD ($)$ / sharesshares | |
Options | |
Outstanding at beginning of period | shares | 1,168,222 |
Granted | shares | 740,522 |
Exercised | shares | (934) |
Forfeited | shares | (111,120) |
Outstanding at end of period | shares | 1,796,690 |
Exercisable at December 31, 2020 | shares | 909,963 |
Weighted-Average Exercise Price | |
Outstanding at beginning of period | $ / shares | $ 16.77 |
Granted | $ / shares | 5.83 |
Exercised | $ / shares | 5.60 |
Forfeited | $ / shares | 36.45 |
Outstanding at end of period | $ / shares | 11.05 |
Exercisable at December 31, 2020 | $ / shares | $ 14.56 |
Weighted-Average Remaining Contractual Term | |
Outstanding at December 31, 2020 | 7 years 6 months 10 days |
Exercisable at December 31, 2020 | 6 years 1 month 20 days |
Aggregate Intrinsic Value | |
Outstanding at end of year | $ | $ 170,000 |
Exercisable at end of year | $ | $ 12,000 |
Assumptions Used in Black Schol
Assumptions Used in Black Scholes Pricing Model for New Grants (Detail) | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Volatility factor, minimum | 94.37% | 88.27% | 80.18% |
Volatility factor, maximum | 102.48% | 98.81% | 83.61% |
Risk-free interest rates, minimum | 0.31% | 1.43% | 2.64% |
Risk-free interest rates, maximum | 1.67% | 2.55% | 3.10% |
Dividend yield | 0.00% | 0.00% | 0.00% |
Minimum | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Expected term (in years) | 5 years 6 months | 5 years 6 months | 5 years 6 months |
Maximum | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Expected term (in years) | 6 years 3 months | 6 years 3 months | 6 years 3 months |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) | 12 Months Ended | ||
Dec. 31, 2020USD ($)ft² | Dec. 31, 2019USD ($) | Dec. 31, 2018USD ($) | |
Commitment And Contingencies [Line Items] | |||
Rented office space, square feet | ft² | 10,158 | ||
Office space per square foot | 47 | ||
Percentage increase in base rent | 3.00% | ||
Annual base rent of lease | $ 500,000 | ||
Operating leases, rent expense, net | 600,000 | $ 800,000 | $ 700,000 |
Minimum annual purchase requirements | 1,400,000 | ||
Manufacturing purchase commitment | $ 10,300,000 | ||
Maximum | |||
Commitment And Contingencies [Line Items] | |||
Severance and bonus payment period | 18 months | ||
Severance and bonus payment period | 18 months | ||
Minimum | |||
Commitment And Contingencies [Line Items] | |||
Severance and bonus payment period | 12 months | ||
Severance and bonus payment period | 6 months |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Detail) - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Income Taxes [Line Items] | ||
Tax provision | $ 0 | $ 0 |
Increase in valuation allowance | $ 10,900,000 | $ 27,000 |
Equity method investment description | In general, an ownership change, as defined by Section 382, results from transactions increasing the ownership of certain shareholders or public groups in the stock of a corporation by more than 50% over a three-year period. | |
Minimum | Shareholders or Public Groups | ||
Income Taxes [Line Items] | ||
Equity method investment ownership percentage | 50.00% | |
State and Local Jurisdiction | ||
Income Taxes [Line Items] | ||
Operating loss carryforwards, net | $ 420,900,000 | |
Research and development tax credit carryforwards | $ 4,300,000 | |
State and Local Jurisdiction | Minimum | ||
Income Taxes [Line Items] | ||
Operating loss carryforwards, expiration year | 2030 | |
Research and development tax credit, expiration year | 2021 | |
State and Local Jurisdiction | Maximum [Member] | ||
Income Taxes [Line Items] | ||
Operating loss carryforwards, expiration year | 2040 | |
Research and development tax credit, expiration year | 2035 | |
Domestic Federal | ||
Income Taxes [Line Items] | ||
Operating loss carryforwards, net | $ 63,200,000 | |
Internal Revenue Service (IRS) | ||
Income Taxes [Line Items] | ||
Operating loss carryforwards, net | 565,800,000 | |
Research and development tax credit carryforwards | $ 11,800,000 | |
Internal Revenue Service (IRS) | Minimum | ||
Income Taxes [Line Items] | ||
Operating loss carryforwards, expiration year | 2022 | |
Research and development tax credit, expiration year | 2023 | |
Internal Revenue Service (IRS) | Maximum [Member] | ||
Income Taxes [Line Items] | ||
Operating loss carryforwards, expiration year | 2037 | |
Research and development tax credit, expiration year | 2040 | |
United Kingdom | ||
Income Taxes [Line Items] | ||
Operating loss carryforwards, net | $ 6,000,000 |
Reconciliation of Expected Inco
Reconciliation of Expected Income Tax Benefit (Detail) | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | |||
Income tax computed at federal statutory tax rate | 21.00% | 21.00% | 21.00% |
State taxes, net of federal benefit | 6.70% | 1.30% | 27.20% |
Research and development credits | 1.50% | (4.20%) | 5.20% |
PIPE Warrants | 2.90% | (25.90%) | 78.50% |
Other permanent differences | (0.50%) | 1.80% | (3.50%) |
Other | (1.10%) | 5.70% | (2.00%) |
Change in valuation allowance | (30.50%) | 0.30% | (126.40%) |
Total | 0.00% | 0.00% | 0.00% |
Company Net Deferred Tax Assets
Company Net Deferred Tax Assets (Detail) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Deferred tax assets: | ||
NOL carryforwards | $ 148,689 | $ 138,105 |
Research and development credits | 15,271 | 14,666 |
Deferred revenue and R&D reimbursements | 742 | 1,262 |
Other temporary differences | 5,001 | 4,820 |
Total deferred tax assets: | 169,703 | 158,853 |
Valuation allowance | (169,703) | (158,853) |
Total | $ 0 | $ 0 |
Reconciliation of Gross Uncerta
Reconciliation of Gross Uncertain Tax Positions (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | |||
Amount established upon adoption | $ 1,200 | $ 1,200 | $ 1,200 |
Additions for current year tax provisions | 0 | 0 | |
Additions for prior year tax provisions | 0 | 0 | |
Reductions of prior year tax provisions | (122) | 0 | 0 |
Balance as of end of year | $ 1,078 | $ 1,200 | $ 1,200 |
Employee Benefit Plan - Additio
Employee Benefit Plan - Additional Information (Detail) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Compensation And Retirement Disclosure [Abstract] | |||
401(k) Plan, matching employer contribution percentage | 50.00% | ||
401(k) Plan, employee contributions percentage | 5.00% | ||
Contributions made under the plan | $ 0.1 | $ 0.1 | $ 0.1 |
Summary of Quarterly Results (D
Summary of Quarterly Results (Detail) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2020 | Sep. 30, 2020 | Jun. 30, 2020 | Mar. 31, 2020 | Dec. 31, 2019 | Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Quarterly Financial Information Disclosure [Abstract] | |||||||||||
Revenues | $ 886 | $ 3,600 | $ 749 | $ 784 | $ 764 | $ 25,717 | $ 703 | $ 1,611 | $ 6,019 | $ 28,795 | $ 5,409 |
Operating expenses | 13,582 | 11,660 | 8,156 | 11,498 | 7,398 | 6,867 | 5,597 | 9,307 | 44,896 | 29,169 | 30,766 |
Loss from operations | (12,696) | (8,060) | (7,407) | (10,714) | (6,634) | 18,850 | (4,894) | (7,696) | (38,877) | (374) | (25,357) |
Change in fair value of PIPE Warrant liability | 1,714 | 86 | 450 | 2,648 | 2,506 | (1,954) | 2,210 | 8,815 | 4,898 | 11,577 | 19,919 |
Other income (expense), net | (522) | (419) | (349) | (315) | (333) | (467) | (451) | (564) | |||
Net income (loss) | $ (11,504) | $ (8,393) | $ (7,306) | $ (8,381) | $ (4,461) | $ 16,429 | $ (3,135) | $ 555 | $ (35,584) | $ 9,388 | $ (5,329) |
Basic net income (loss) per share | |||||||||||
Net income (loss) per share - basic | $ (0.44) | $ (0.33) | $ (0.42) | $ (0.52) | $ (0.28) | $ 1.02 | $ (0.20) | $ 0.04 | $ (1.66) | $ 0.61 | $ (0.44) |
Weighted average number of common shares outstanding | 26,252 | 25,808 | 17,364 | 16,081 | 16,077 | 16,074 | 15,902 | 13,230 | 21,402 | 15,331 | 12,059 |
Diluted net income (loss) per share | |||||||||||
Net income (loss) per share - diluted | $ (0.44) | $ (0.33) | $ (0.42) | $ (0.52) | $ (0.28) | $ 1.02 | $ (0.20) | $ (0.62) | $ (1.66) | $ 0.61 | $ (1.93) |
Weighted average number of common shares and dilutive common share equivalents outstanding | 26,252 | 25,808 | 17,364 | 16,081 | 16,077 | 16,083 | 15,902 | 13,283 | 21,402 | 15,376 | 13,073 |
Legal Proceedings -Additional I
Legal Proceedings -Additional Information (Detail) $ / shares in Units, $ in Thousands | Jul. 16, 2018$ / shares | Dec. 26, 2017USD ($)$ / sharesshares | Feb. 28, 2018USD ($) | Dec. 31, 2017USD ($)$ / shares | Dec. 31, 2020USD ($)LegalMatter | Dec. 31, 2019shares | Jul. 15, 2019shares | Dec. 31, 2018USD ($)$ / shares | Dec. 31, 2017USD ($)$ / shares | Jun. 29, 2018USD ($) |
Loss Contingencies [Line Items] | ||||||||||
Attorney fees cost and expenses | $ 15,000 | |||||||||
Reserve for settlement of fines | $ 17,100 | $ 17,100 | ||||||||
Estimated insurance recoveries | $ 15,000 | 15,000 | ||||||||
Non-cash charge for Settlement warrants | $ (667) | $ 2,100 | ||||||||
Reversal of cash settlement from contingent liability | $ 15,000 | |||||||||
Settlement Warrants | ||||||||||
Loss Contingencies [Line Items] | ||||||||||
Warrants to purchase of common stock shares | shares | 200,000 | |||||||||
Warrants exercisable period | 1 year | 1 year | 1 year | |||||||
Warrants exercise price | $ / shares | $ 30 | $ 3 | $ 30 | $ 30 | $ 30 | |||||
Cash settlement from insurance carriers | $ 15,000 | |||||||||
Warrant expired | shares | 200,000 | |||||||||
Warrant Expiration Date | Jul. 15, 2019 | |||||||||
Warrants exercised during period | shares | 0 | 0 | ||||||||
Reserve for settlement of fines | $ 17,100 | $ 17,100 | ||||||||
Estimated insurance recoveries | $ 15,000 | $ 15,000 | $ 15,000 | |||||||
Derivative Lawsuits | ||||||||||
Loss Contingencies [Line Items] | ||||||||||
Loss contingency claims filed against company | LegalMatter | 2 |