0001564590-21-041703 | 10-Q | XBRL Viewer

Document and Entity Information - shares	6 Months Ended
Document and Entity Information - shares	Jun. 30, 2021	Jul. 30, 2021
Cover [Abstract]
Document Type	10-Q
Amendment Flag	false
Document Period End Date	Jun. 30, 2021
Document Fiscal Year Focus	2021
Document Fiscal Period Focus	Q2
Trading Symbol	AVEO
Entity Registrant Name	AVEO PHARMACEUTICALS, INC.
Entity Central Index Key	0001325879
Current Fiscal Year End Date	--12-31
Entity Filer Category	Non-accelerated Filer
Entity Small Business	true
Entity Emerging Growth Company	false
Entity Current Reporting Status	Yes
Entity Shell Company	false
Entity File Number	001-34655
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
Entity Common Stock, Shares Outstanding		34,373,995
Title of 12(b) Security	Common Stock, $0.001 par value
Security Exchange Name	NASDAQ
Document Quarterly Report	true
Document Transition Report	false
Entity Incorporation, State or Country Code	DE
Entity Interactive Data Current	Yes

Condensed Consolidated Balance Sheets (Unaudited) - USD ($) $ in Thousands	Jun. 30, 2021	Dec. 31, 2020
Current assets:
Cash and cash equivalents	$ 74,735	$ 61,761
Marketable securities	28,185
Trade receivables, net	4,220
Partnership receivables	1,365	1,197
Clinical trial retainers	482	355
Other prepaid expenses and other current assets	2,753	2,195
Total current assets	111,740	65,508
Property and equipment, net	310	343
Operating lease right-of-use asset	676	903
Other assets	258	158
Total assets	112,984	66,912
Current liabilities:
Accounts payable	3,162	3,380
Accrued clinical trial costs and contract research	4,819	4,550
Other accrued liabilities	6,779	4,463
Operating lease liability	324	369
Loans payable, net of discount		1,056
Deferred revenue	1,565	1,974
Deferred research and development reimbursements	36	164
PIPE Warrant liability (Note 7)		199
Other liabilities (Note 6)	790	790
Total current liabilities	17,475	16,945
Loans payable, net of current portion and discount	32,725	12,716
Deferred revenue, non-current		578
Operating lease liability, non-current	149	336
Other liabilities, non-current (Note 6)	2,432	1,043
Total liabilities	52,781	31,618
Stockholders’ equity:
Preferred stock, $.001 par value: 5,000 shares authorized at June 30, 2021 and December 31, 2020; no shares issued and outstanding at each of June 30, 2021 and December 31, 2020
Common stock, $.001 par value: 50,000 shares authorized at June 30, 2021 and December 31, 2020; 34,374 shares issued and outstanding at June 30, 2021 and 26,883 issued and outstanding at December 31, 2020	34	27
Additional paid-in capital	717,093	656,472
Accumulated deficit	(656,924)	(621,205)
Total stockholders’ equity	60,203	35,294
Total liabilities and stockholders’ equity	$ 112,984	$ 66,912

Condensed Consolidated Balance Sheets (Unaudited) (Parenthetical) - $ / shares	Jun. 30, 2021	Dec. 31, 2020
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	34,373,995	26,883,000
Common stock, shares outstanding	34,373,995	26,883,000

Condensed Consolidated Statements of Operations (Unaudited) - USD ($) shares in Thousands, $ in Thousands	3 Months Ended		6 Months Ended
	Jun. 30, 2021	Jun. 30, 2020	Jun. 30, 2021	Jun. 30, 2020
Revenues:
Revenues	$ 7,556	$ 749	$ 9,476	$ 1,533
Operating expenses:
Research and development	6,878	4,419	12,675	12,245
Selling, general and administrative	14,920	3,737	30,020	7,409
Operating expenses, total	22,620	8,156	43,655	19,654
Loss from operations	(15,064)	(7,407)	(34,179)	(18,121)
Other income (expense), net:
Interest expense, net	(1,128)	(349)	(1,739)	(664)
Change in fair value of PIPE Warrant liability	2,595	450	199	3,098
Other income (expense), net	1,467	101	(1,540)	2,434
Net loss	$ (13,597)	$ (7,306)	$ (35,719)	$ (15,687)
Net loss per share - basic and diluted	$ (0.40)	$ (0.42)	$ (1.16)	$ (0.94)
Weighted average number of common shares outstanding	34,362	17,364	30,915	16,722
Product Revenue
Revenues:
Revenues	$ 6,735		$ 7,801
Partnership Royalties
Revenues:
Revenues	821	$ 749	1,675	$ 1,533
Product
Operating expenses:
Cost of products sold	$ 822		$ 960

Condensed Consolidated Statements of Comprehensive Income (Loss ) (Unaudited) - USD ($) $ in Thousands	3 Months Ended		6 Months Ended
	Jun. 30, 2021	Jun. 30, 2020	Jun. 30, 2021	Jun. 30, 2020
Statement Of Income And Comprehensive Income [Abstract]
Net loss	$ (13,597)	$ (7,306)	$ (35,719)	$ (15,687)
Other comprehensive income (loss):
Unrealized gain (loss) on available-for-sale securities		(1)		(1)
Comprehensive loss	$ (13,597)	$ (7,307)	$ (35,719)	$ (15,688)

- Definition

The portion of profit or loss for the period, net of income taxes, which is attributable to the parent.

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+ Details

Condensed Consolidated Statements of Stockholders' Equity (Unaudited) - USD ($) shares in Thousands, $ in Thousands	Total	Equity Classified Awards	Common Shares	Additional Paid-in Capital	Additional Paid-in Capital Equity Classified Awards	Accumulated Other Comprehensive Income (Loss)	Accumulated Deficit
Beginning Balance at Dec. 31, 2019	$ 14,846		$ 16	$ 600,451			$ (585,621)
Beginning Balance (in shares) at Dec. 31, 2019			16,081
Stock-based compensation expense related to equity- classified awards		$ 543			$ 543
Net loss	(8,381)						(8,381)
Ending Balance at Mar. 31, 2020	7,008		$ 16	600,994			(594,002)
Ending Balance (in shares) at Mar. 31, 2020			16,081
Beginning Balance at Dec. 31, 2019	14,846		$ 16	600,451			(585,621)
Beginning Balance (in shares) at Dec. 31, 2019			16,081
Net loss	(15,687)
Ending Balance at Jun. 30, 2020	48,052		$ 26	649,335		$ (1)	(601,308)
Ending Balance (in shares) at Jun. 30, 2020			25,808
Unrealized gain (loss) on available-for-sale securities	(1)
Beginning Balance at Mar. 31, 2020	7,008		$ 16	600,994			(594,002)
Beginning Balance (in shares) at Mar. 31, 2020			16,081
Issuance of common stock in a public offering (net of issuance costs of $3.5 million)	23,644		$ 5	23,639
Issuance of common stock in a public offering, excluding to related parties, net (in shares)			5,221
Issuance of common stock under employee stock purchase plan	18			18
Issuance of common stock under employee stock purchase plan (in shares)			2
Stock-based compensation expense related to equity- classified awards		578			578
Net loss	(7,306)						(7,306)
Ending Balance at Jun. 30, 2020	48,052		$ 26	649,335		(1)	(601,308)
Ending Balance (in shares) at Jun. 30, 2020			25,808
Unrealized gain (loss) on available-for-sale securities	(1)					$ (1)
Issuance of common stock in a public offering, excluding to related parties, net	24,111		$ 5	24,106
Issuance of common stock in a public offering, excluding to related parties, net (in shares)			5,221
Issuance of common stock and warrants in public offering, to related parties (in shares)			4,504
Beginning Balance at Dec. 31, 2020	35,294		$ 27	656,472			(621,205)
Beginning Balance (in shares) at Dec. 31, 2020			26,883
Issuance of common stock in a public offering (net of issuance costs of $3.5 million)	51,718		$ 7	51,711
Issuance of common stock in a public offering, excluding to related parties, net (in shares)			6,900
Issuance of common stock from the SVB Leerink sales agreement (net of issuance costs of $0.1 million)	3,377			3,377
Issuance of common stock from the SVB Leerink sales agreement (in shares)			331
Issuance of common stock in connection with warrant exercises	3,092			3,092
Issuance of common stock in connection with warrant exercises (in shares)			247
Stock-based compensation expense related to equity- classified awards		1,204			1,204
Net loss	(22,122)						(22,122)
Ending Balance at Mar. 31, 2021	72,563		$ 34	715,856			(643,327)
Ending Balance (in shares) at Mar. 31, 2021			34,361
Issuance of common stock in a public offering, excluding to related parties, net (in shares)			6,900
Beginning Balance at Dec. 31, 2020	35,294		$ 27	656,472			(621,205)
Beginning Balance (in shares) at Dec. 31, 2020			26,883
Net loss	(35,719)
Ending Balance at Jun. 30, 2021	60,203		$ 34	717,093			(656,924)
Ending Balance (in shares) at Jun. 30, 2021			34,374
Beginning Balance at Mar. 31, 2021	72,563		$ 34	715,856			(643,327)
Beginning Balance (in shares) at Mar. 31, 2021			34,361
Issuance of common stock under employee stock purchase plan	68			68
Issuance of common stock under employee stock purchase plan (in shares)			13
Stock-based compensation expense related to equity- classified awards		$ 1,169			$ 1,169
Net loss	(13,597)						(13,597)
Ending Balance at Jun. 30, 2021	$ 60,203		$ 34	$ 717,093			$ (656,924)
Ending Balance (in shares) at Jun. 30, 2021			34,374

Condensed Consolidated Statements of Stockholders' Equity (Unaudited) (Parenthetical) - USD ($) $ in Millions	3 Months Ended
	Mar. 31, 2021	Jun. 30, 2020
Public Offering
Issuance of common stock, issuance costs	$ 0.1
Public Offering \| Additional Paid-in Capital
Issuance of common stock, issuance costs		$ 3.3
Leerink Capital Partners LLC
Issuance of common stock, issuance costs	$ 3.5

Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands	6 Months Ended
	Jun. 30, 2021	Jun. 30, 2020
Operating activities
Net loss	$ (35,719)	$ (15,687)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization	33	4
Stock-based compensation	2,373	1,121
Non-cash interest expense	428	200
Non-cash change in fair value of PIPE Warrant liability	(199)	(3,098)
Amortization of premium and discount on investments	10	(81)
Changes in operating assets and liabilities:
Trade receivables, net	(4,220)
Partnership receivables	(168)	423
Prepaid expenses and other current assets	(685)	(347)
Operating lease right-of-use asset	227	(1,278)
Other non-current assets	(100)
Accounts payable	(219)	319
Accrued contract research	269	(680)
Other accrued liabilities	2,316	(215)
Operating lease liability	(45)	451
Deferred revenue	(987)	(987)
Deferred research and development reimbursements	(128)	166
Operating lease liability, non-current	(187)	473
Net cash used in operating activities	(37,001)	(19,216)
Investing activities
Purchases of marketable securities	(28,195)	(28,139)
Proceeds from maturities and sales of marketable securities		20,400
Purchases of property and equipment		(100)
Net cash used by investing activities	(28,195)	(7,839)
Financing activities
Proceeds from issuance of common stock, net of issuance costs	55,095	24,111
Proceeds from issuance of common stock and warrants to related parties		23,644
Proceeds from warrant exercises	3,092
Proceeds from issuance of stock for stock-based compensation arrangements	68	18
Proceeds from issuance of loan payable	20,000
Payment on principal of loan payable (Note 6)		(4,833)
Payment of debt issuance costs	(85)
Net cash provided by financing activities	78,170	42,940
Net increase in cash and cash equivalents	12,974	15,885
Cash and cash equivalents at beginning of period	61,761	29,785
Cash and cash equivalents at end of period	74,735	45,670
Supplemental cash flow information
Cash paid for interest	$ 1,171	681
Right-of-use asset obtained in exchange for operating lease liabilities		$ 1,225

Organization

6 Months Ended

Jun. 30, 2021

Organization Consolidation And Presentation Of Financial Statements [Abstract]

Organization

(1) Organization

AVEO Pharmaceuticals, Inc. (the “Company”) is a commercial stage, oncology-focused biopharmaceutical company committed to delivering medicines that provide a better life for patients with cancer. The Company currently markets FOTIVDA^® (tivozanib) in the U.S. for the treatment of adult patients with relapsed or refractory renal cell carcinoma (“RCC”) following two or more prior systemic therapies. The Company continues to develop FOTIVDA in immuno-oncology combinations in RCC and other indications, and has several other investigational programs in clinical development.

FOTIVDAis the Company’s lead product and was approved by the U.S. Food and Drug Administration (“FDA”), for marketing and sale in the United States on March 10, 2021. FOTIVDA is approved in the United States for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma following two or more prior systemic therapies. FOTIVDA is an oral, next-generation vascular endothelial growth factor receptor (“VEGFR”) tyrosine kinase inhibitor (“TKI”). The FDA approval of FOTIVDA is based on the Company’s pivotal phase 3 randomized, controlled, multi-center, open-label clinical trial comparing tivozanib to an approved therapy, Nexavar® (sorafenib), in renal cell carcinoma (“RCC”) patients whose disease had relapsed or become refractory to two or three prior systemic therapies, which the Company refers to as the TIVO-3 trial. The approval is also supported by three additional trials in RCC and includes safety data from over 1,000 clinical trial subjects. FOTIVDA became commercially available in the United States on March 22, 2021. The Company is currently commercializing FOTIVDA in the United States through the support of approximately 65 field-based employees, which includes approximately 50 oncology sales professionals calling on practicing oncologists. FOTIVDA is available to patients through a network of specialty pharmacies and distributors.

Based on FOTIVDA’s demonstrated anti-tumor activity, tolerability profile and reduction of regulatory T-cell production, the Company is seeking to advance FOTIVDA in additional cancer indications with significant unmet medical needs. The Company is studying FOTIVDA in combination with immune checkpoint inhibitors for the treatment of RCC and hepatocellular carcinoma (“HCC”).

The Company plans to initiate enrollment during the third quarter of 2021 in a phase 3 clinical trial (the “TiNivo-2 Trial”) in collaboration with Bristol-Myers Squibb Company (“BMS”). The TiNivo-2 Trial is a randomized, open-label, controlled phase 3 clinical trial of FOTIVDA in combination with OPDIVO^®, in patients with advanced relapsed or refractory RCC following prior immunotherapy exposure. The Company is the sponsor of the study and BMS is supplying OPDIVO^® (nivolumab), BMS’s antibody directed against programmed death ligand-1 (“PD-1”) therapy, for the trial. The TiNivo-2 Trial will seek to further understand the activity and tolerability of this combination following prior immunotherapy.

The Company is conducting the DEDUCTIVE trial through a drug supply and cost sharing collaboration with AstraZeneca PLC (“AstraZeneca”). The DEDUCTIVE trial is an open-label, multi-center, randomized phase 1b/2 clinical trial of tivozanib in combination with IMFINZI (durvalumab), AstraZeneca’s monoclonal PD-1 therapy. The DEDUCTIVE trial was recently amended to include patients with advanced, unresectable HCC who have progressed after front line bevacizumab and atezolizumab treatment as well as first-line treatment of patients with advanced, unresectable HCC who have not received prior systemic therapy. Enrollment for the DEDUCTIVE trial continues and is expected to be completed in the first half of 2022, which is a delay from the Company’s previous expectation for enrollment to be completed by the end of 2021.

FOTIVDA, through the Company’s partner EUSA Pharma (UK) Limited (“EUSA”), is also approved in the European Union (“EU”), New Zealand and South Africa and is reimbursed in the United Kingdom, Germany, Spain and certain other countries in EUSA’s territory. FOTIVDA is approved in the EU for the first line treatment of adult patients with advanced RCC and for adult patients who are VEGFR and mTOR pathway inhibitor-naïve following disease progression after one prior treatment with cytokine therapy for advanced RCC. FOTIVDA has been commercially available in the EU since 2017. EUSA has not commercially launched FOTIVDA in France or Italy, among other countries in their territory. EUSA is working to secure reimbursement approval in and commercially launch FOTIVDA in additional EU countries. However, there is significant competition in the front-line RCC setting in the EU due to the approval of several immunotherapy combinations which have become a standard of care and impacted the market opportunity for monotherapy treatments. EUSA has reported to us that to date, it has not experienced a decrease in sales trends or interruptions in supply or distribution of FOTIVDA during the COVID-19 pandemic; however, the future impact of the COVID-19 pandemic on FOTIVDA sales is difficult to predict.

The Company is also seeking to advance its pipeline of three wholly owned humanized immunoglobulin G1 (“IgG1”) monoclonal antibody product candidates: ficlatuzumab, AV-380 and AV-203 (AV-203 will be wholly owned as of September 2021).

Ficlatuzumab is a potent humanized 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”). In June 2021, the Company announced results from the randomized phase 2 confirmatory study of ficlatuzumab (the “Phase 2 HNSCC Trial”), for the potential treatment of HNSCC in a poster session at the 2021 American Society of Clinical Oncology, or ASCO, Annual Meeting.

The Company continues to evaluate opportunities for the further clinical development of ficlatuzumab, including a potential registrational study of ficlatuzumab in the human papillomavirus negative HNSCC patient population. In 2020, the Company contracted with a contract manufacturing organization (“CMO”) to manufacture the clinical supply for this potential registrational trial of ficlatuzumab. However, the delivery of the clinical supply of ficlatuzumab originally expected in the first half of 2022 has been delayed significantly due to the shortage of key raw materials and manufacturing supplies also used in COVID-19 vaccine manufacturing, and will require the Company to delay the start date of this potential registrational trial until 2023.

AV-380 is a potent humanized IgG1 monoclonal antibody that targets growth differentiation factor 15 (“GDF15”). In December 2020, the FDA approved the Company’s investigational new drug application (“IND”) for AV-380 for the potential treatment of cancer cachexia, and, in the first quarter of 2021, the Company initiated a phase 1 clinical trial in healthy volunteers.

AV-203 is a potent humanized IgG1 monoclonal antibody that targets ErbB3 (also known as HER3) to which the Company will regain worldwide rights in September 2021. It is exploring AV-203 as a potential oncology treatment.

AV-353 is an IgG1 monoclonal antibody that targets the Notch 3 pathway.

As used throughout these condensed 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 (Subtopic 205-40), the Company has evaluated whether there are conditions and events, considered in the aggregate, that raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date 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 June 30, 2021, 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 FOTIVDAin the United States for the treatment of adult patients with relapsed or refractory advanced RCC following two or more prior systemic therapies. The Company’s future product revenues will depend upon the size of markets in which FOTIVDA, and any future products, have received approval, and its ability to achieve sufficient market acceptance, reimbursement from third-party payers and adequate market share for FOTIVDA and any future products in those markets. The likelihood of the Company’s long-term success must be considered in light of the expenses, difficulties and potential delays that may be encountered in the development and commercialization of new pharmaceutical products, competitive factors in the marketplace and the complex regulatory environment in which the Company operates. Absent the realization of sufficient revenues from product sales to support the Company’s cost structure, the Company may never attain or sustain profitability.

The Company has incurred recurring losses and cash outflows from operations since its inception, including an accumulated deficit of $656.9 million as of June 30, 2021. 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 August 5, 2021, the date of issuance of these consolidated financial statements, the Company expects that its cash, cash equivalents and marketable securities of $102.9 million as of June 30, 2021, along with net product revenues from the commercial launch of FOTIVDA in the United States, will be sufficient to fund its current operations for more than twelve months from the date of filing this Quarterly Report on Form 10-Q.

Management’s expectations with respect to its ability to fund current planned operations is based on estimates that are subject to risks and uncertainties, including, without limitation, risks related to its ability to generate product revenue from sales of FOTIVDA in the United States, which became commercially available in the United States on March 22, 2021. 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

6 Months Ended

Jun. 30, 2021

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.

The accompanying condensed consolidated financial statements have been prepared in accordance with United States generally accepted accounting principles (“GAAP”) for interim financial information and with the instructions to Form 10-Q and Article 8 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements. In the opinion of management, all adjustments, consisting of normal recurring accruals and revisions of estimates, considered necessary for a fair presentation of the condensed consolidated financial statements have been included. Interim results for the three and six months ended June 30, 2021 are not necessarily indicative of the results that may be expected for the fiscal year ending December 31, 2021 or any other future period.

The information presented in the condensed consolidated financial statements and related footnotes at June 30, 2021, and for the three and six months ended June 30, 2021 and 2020, is unaudited, and the condensed consolidated balance sheet amounts and related footnotes as of December 31, 2020 have been derived from the Company’s audited financial statements. For further information, refer to the consolidated financial statements and accompanying footnotes included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2020, which was filed with the U.S. Securities and Exchange Commission (“SEC”) on March 16, 2021.

Significant Accounting Policies

6 Months Ended

Jun. 30, 2021

Accounting Policies [Abstract]

Significant Accounting Policies

(3) Significant Accounting Policies

Revenue Recognition

Under Accounting Standards Codification (“ASC”) 606, Revenue from Contracts with Customers, 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.

Net Product Revenue

On March 10, 2021, the FDA approved FOTIVDAin the United States for the treatment of adult patients with relapsed or refractory advanced RCC after two prior systemic therapies. FOTIVDA became commercially available on March 22, 2021. FOTIVDA is the Company’s first commercial product. The Company sells its products principally through a limited distribution network comprised of two specialty pharmacies, Biologics and Onco360, and the following specialty distributors: Amerisource Specialty Distribution, Oncology Supply, McKesson Plasma and Biologics, McKesson Specialty and Cardinal Specialty, or collectively, the Company’s Customers. These Customers subsequently resell the Company’s products to health care providers and patients. In addition to distribution agreements with Customers, the Company enters into arrangements with health care providers and payors that provide for government-mandated and/or privately-negotiated rebates, chargebacks and discounts with respect to the

purchase of the Company’s products. Revenues from product sales are recognized when the Customer obtains control of the Company’s product, which occurs at a point in time, typically upon delivery to the Customer.

Product Sales Discounts and Allowances

The Company records revenues from product sales at the net sales price (transaction price), which includes estimates of variable consideration for which reserves are established primarily from discounts, chargebacks, rebates, co-pay assistance, returns and other allowances that are offered within contracts between the Company and its Customers, health care providers, payors and other indirect customers relating to the sales of its products. These reserves are based on the amounts earned or to be claimed on the related sales and are classified as reductions of accounts receivable (if the amount is deductible by the Customer from payments to the Company) or a current liability (if the amount is payable by the Company to a third party or Customer). Where appropriate, these estimates take into consideration a range of possible outcomes that are probability-weighted for relevant factors such as current contractual and statutory requirements, specific known market events and trends, industry data, forecasted Customer buying and payment patterns, and the Company’s historical experience that will develop overtime as FOTIVDA is the Company’s first commercial product. Overall, these reserves reflect the Company’s best estimates of the amount of consideration to which it is entitled based on the terms of its contracts. The amount of variable consideration that is included in the transaction price may be constrained, and is included in the net sales price only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period. Actual amounts of consideration ultimately received may differ from the Company’s estimates. If actual results in the future vary from the Company’s estimates, the Company will adjust these estimates, which would affect net product revenues and earnings in the period such variances become known.

Chargebacks: Chargebacks are discounts that occur when contracted customers purchase directly from a specialty distributor. Contracted customers, which currently consist primarily of Public Health Service institutions, Federal government entities purchasing via the Federal Supply Schedule, Group Purchasing Organizations, and health maintenance organizations, generally purchase the product at a discounted price. The specialty distributor, in turn, charges back to the Company the difference between the price initially paid by the specialty distributor and the discounted price paid to the specialty distributor by its contracted customer. The allowance for chargebacks is based on actual chargebacks received and an estimate of sales by the specialty distributor to its contracted customers.

Discounts for Prompt Payment: The Company’s Customers receive a discount of 2% for prompt payment. The Company expects its Customers will earn 100% of their prompt payment discounts and, therefore, the Company deducts the full amount of these discounts from total product sales when revenues are recognized.

Rebates: Allowances for rebates include mandated discounts under the Medicaid Drug Rebate Program Medicare Part D Coverage GAP Discounts Program, other government programs and commercial contracts. Rebate amounts owed after the final dispensing of the product to a benefit plan participant are based upon contractual agreements or legal requirements with public sector benefit providers, such as Medicaid. In addition, in the United States during 2020, the Medicare Part D prescription drug benefit mandated participating manufacturers to fund 70% of the Medicare Part D insurance coverage gap for prescription drugs sold to eligible patients. The allowance for rebates is based on statutory or contractual discount rates and expected utilization. The Company’s estimates for the expected utilization of rebates are based on Customer and payer data received from the specialty pharmacies and distributors and historical utilization rates that will develop overtime as FOTIVDA is the Company’s first commercial product. Rebates are generally invoiced by the payer and paid in arrears, such that the accrual balance consists of an estimate of the amount expected to be incurred for the current quarter’s shipments to the Company’s Customers, plus an accrual balance for known prior quarters’ unpaid rebates. If actual future rebates vary from estimates, the Company may need to adjust its accruals, which would affect net product revenues in the period of adjustment.

Co-payment Assistance: Patients who have commercial insurance and meet certain eligibility requirements may receive co-payment assistance. The Company accrues a liability for co-payment assistance based on actual program participation and estimates of program redemption using Customer data provided by the third party that administers the copay program.

Other Customer Credits: The Company pays fees to its Customers for account management, data management and other administrative services. To the extent the services received are distinct from the sale of products to its Customers, the Company classifies these payments in selling, general and administrative expenses in its Consolidated Statements of Income.

The following table summarizes net product revenues for FOTIVDA in the United States earned in the three and six months ended June 30, 2021 and 2020, respectively (in thousands).

	Three Months Ended June 30,					Six Months Ended June 30,
	2021			2020		2021			2020
Product revenues:
Gross product revenues	$	7,993		$	—	$	9,249		$	—
Discounts and allowances		(1,258	)		—		(1,448	)		—
Net product revenues	$	6,735		$	—	$	7,801		$	—

The following table summarizes the percentage of total product revenues for FOTIVDA in the United States by customer who individually accounted for 10% or more of total product revenues earned in the three and six months ended June 30, 2021 and 2020, respectively:

	Three Months Ended June 30,					Six Months Ended June 30,
	2021			2020		2021			2020
OncoMed Specialty, LLC (Onco360)		24	%		—		25	%		—
Affiliates of McKesson Corporation		41	%		—		40	%		—
Affiliates of AmerisourceBergen Corporation		25	%		—		24	%		—
Affiliates of Cardinal Health Specialty		10	%		—		11	%		—
		100	%		—		100	%		—

Product Sales Discounts and Allowances

The activities and ending allowance balances for each significant category of discounts and allowances for FOTIVDA (which constitute variable consideration) for the six months ended June 30, 2021 were as follows (in thousands):

	Chargebacks, Discounts for Prompt Pay and Other Allowances			Rebates, Customer Fees / Credits and Co-Pay Assistance			Totals
Balance at December 31, 2020		—			—			—
Provision related to sales made in:
Current period	$	841		$	607		$	1,448
Prior periods		—			—			—
Payments and customer credits issued	$	(388	)	$	(137	)		(525	)
Balance at June 30, 2021	$	453		$	470		$	923

The allowances for chargebacks, discounts for prompt payment and other allowances are recorded as a reduction of trade receivables, net, and the remaining reserves are recorded as rebates and fees due to customers in the accompanying Consolidated Balance Sheets.

Collaboration Revenues

The Company’s historical 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 (“ASC 808”). This assessment is performed throughout the life of the arrangement based on changes in the responsibilities of all parties in the arrangement. For collaboration arrangements that are deemed to be within the scope of ASC 808, the Company first determines which elements of the collaboration are deemed to be within the scope of ASC 808 and those that are more reflective of a vendor-customer relationship and therefore within the scope of ASC 606. The Company’s policy is generally to recognize amounts received from collaborators in connection with joint operating activities that are within the scope of ASC 808 as a reduction in research and development expense.

Arrangements Within the Scope of ASC 606, Revenue from Contracts with Customers

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 collaboration revenues earned in the three and six months ended June 30, 2021 and 2020, respectively, by partner (in thousands). Refer to Note 4, “Collaborations and License Agreements” regarding specific details.

	Three Months Ended June 30,				Six Months Ended June 30,
	2021		2020		2021		2020
EUSA	$	821	$	749	$	1,675	$	1,533
Total	$	821	$	749	$	1,675	$	1,533

Trade Receivables

Trade receivables, net, includes amounts billed to the Company’s customers for product sales of FOTIVDA. The Company records trade receivables net of chargebacks, cash discounts for prompt payment and any allowances for credit losses. The Company may apply an aging method to estimate credit losses and consider its own historical loss, if any, adjusted to account for current conditions, and reasonable and supportable forecasts of future economic conditions affecting its customers. The Company’s Customers are specialty pharmacies and specialty distributors, and accordingly, the Company considers the risk of potential credit losses to be low.

Cost of Products Sold

Cost of products sold is related to our product revenues for FOTIVDA and consists primarily of tiered royalty payments the Company is required to pay to Kyowa Kirin Co. (“KKC”) on all net sales of tivozanib in the Company’s North American territory, which range from the low to mid-teens as a percentage of net sales. Refer to Note 4, “Collaborations and License Agreements” regarding specific details. Cost of products sold also consists of shipping and other third-party logistics and distribution costs for the Company’s products. The Company considers regulatory approval of product candidates to be uncertain and product manufactured prior to regulatory approval may not be sold unless regulatory approval is obtained. As such, the manufacturing costs for FOTIVDA incurred prior to regulatory approval were not capitalized as inventory, but were expensed as research and development costs.

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) internal costs for salaries, bonuses, benefits, stock-based compensation, research-related overhead, and allocated expenses for facilities and information technology, and (ii) external costs for 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.

Expired Warrants Issued in Connection with Private Placement – Expiration Date of May 16, 2021

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 remaining 1,683,933 PIPE Warrants expired on May 16, 2021, as scheduled five years from the date of issuance. 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. Refer to Note 7, “Common Stock—Private Placement – May 2016” for further discussion of the private placement financing.

The PIPE Warrants contained 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 had been a fundamental transaction (contractually defined to include various merger, acquisition or stock transfer activities). Due to this provision, ASC 480, Distinguishing Liabilities from Equity required that these warrants be classified as a liability and not as equity. Accordingly, the Company recorded a warrant liability in the amount of approximately $9.3 million upon issuance of the PIPE Warrants. The fair value of these warrants had been determined using the Black-Scholes pricing model. These warrants were 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 other income (expense), net until the expiration of the warrants.

The Company recorded a non-cash gain of approximately $2.6 million in the three months ended June 30, 2021 in its Statement of Operations attributable to the decrease in fair value of the warrant liability that resulted from the expiration of the PIPE Warrants on May 16, 2021, including reversals of the $2.4 million non-cash loss recognized in the first quarter of 2021 and the $0.2 million fair value of the PIPE Warrant liability as of December 31, 2020.

The Company recorded non-cash gains of approximately $0.5 million and $3.1 million in the three and six months ended June 30, 2020, respectively, in its Statement of Operations attributable to the decreases in the fair value of the warrant liability that resulted from changes in the Company’s stock price as of June 30, 2020 relative to prior periods, decreases in the Company’s stock volatility rate and a shorter remaining term as the PIPE Warrants approached their expiration in May 2021. No PIPE Warrants were exercised during the three and six months ended June 30, 2021 and 2020.

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 three and six months ended June 30, 2021 (in thousands):

Fair value at January 1, 2021	$	199
Increase in fair value		2,396
Fair value at March 31, 2021	$	2,595
Decrease in fair value		(2,595	)
Fair value at June 30, 2021	$	—

The key assumptions used to value the PIPE Warrants were as follows:

	Issuance			December 31, 2020			March 31, 2021
Expected price volatility		76.25	%		56.79	%		159.96	%
Expected term (in years)		5.00			0.50			0.25
Risk-free interest rates		1.22	%		0.09	%		0.03	%
Stock price	$	8.90		$	5.77		$	7.32
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 United States 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 United States 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 June 30, 2021 and December 31, 2020 (in thousands):

	Amortized Cost		Unrealized Gains		Unrealized Losses		Fair Value
June 30, 2021
Cash and cash equivalents:
Cash and money market funds	$	74,735	$	—	$	—	$	74,735
Total cash and cash equivalents		74,735		—		—		74,735

Marketable securities:
Corporate debt securities due within 1 year	$	28,185	$	—	$	—	$	28,185
Total marketable securities		28,185		—		—		28,185
Total cash, cash equivalents and marketable securities	$	102,920	$	—	$	—	$	102,920

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

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 trade receivables, net, includes amounts billed to the Company’s customers for product sales of FOTIVDA, which is the Company’s first commercial product that was approved by the FDA in the United States for the treatment of adult patients with relapsed or refractory advanced RCC after two prior systemic therapies. The Company’s Customers are a limited group of specialty pharmacies and specialty distributors, and accordingly, the Company considers the risk of potential credit losses to be low.

The Company’s partnership receivables include amounts due to the Company from licensees and collaborators. The Company has not experienced any material losses related to partnership receivables 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 June 30, 2021, 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 and had financial assets based on Level 2 inputs consisting of high-grade debt securities, including commercial paper. During the three and six months ended June 30, 2021, the Company did not have any transfers of financial assets between Levels 1 and 2.

As of June 30, 2021, the Company did not have any financial liability recorded at fair value as the remaining 1,683,933 PIPE Warrants expired on May 16, 2021, as scheduled.

The fair value of the Company’s loans payable at June 30, 2021 and December 31, 2020 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 financial assets and liabilities measured at fair value on a recurring basis at June 30, 2021 and December 31, 2020 (in thousands):

	Fair Value Measurements as of June 30, 2021
	Level 1		Level 2		Level 3		Total
Financial assets carried at fair value:
Cash and money market funds	$	74,735	$	—	$	—	$	74,735
Total cash and cash equivalents	$	74,735	$	—	$	—	$	74,735
Marketable securities:
Corporate debt securities due within 1 year	$	—	$	28,185	$	—	$	28,185
Total marketable securities	$	—	$	28,185	$	—	$	28,185
Total cash, cash equivalents and marketable securities	$	74,735	$	28,185	$	—	$	102,920

	Fair Value Measurements as of December 31, 2020
	Level 1		Level 2		Level 3		Total
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

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 three and six months ended June 30, 2021 and 2020, diluted net loss per share is the same as basic net loss per share as the inclusion of weighted-average shares of common stock issuable upon the exercise of outstanding stock options and warrants until the scheduled expirations of the Offering Warrants on April 8, 2021 and the PIPE Warrants on May 16, 2021 would be anti-dilutive.

The following table summarizes outstanding securities not included in the computation of diluted net loss per common share as the effect would have been anti-dilutive for the three and six months ended June 30, 2021 and 2020, respectively (in thousands):

	Outstanding at June 30,
	2021		2020
Stock options outstanding		3,242		1,610
Offering Warrants outstanding (warrants expired April 8, 2021)		—		2,500
PIPE Warrants outstanding (warrants expired May 16, 2021)		—		1,684
Total		3,242		5,794

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 is measured at fair value on the date the awards are granted. During the three and six months ended June 30, 2021 and 2020, the Company recorded the following stock-based compensation expense (in thousands):

	Three Months Ended June 30,				Six Months Ended June 30,
	2021		2020		2021		2020
Research and development	$	289	$	125	$	644	$	240
Selling, general and administrative		880		453		1,729		881
Total	$	1,169	$	578	$	2,373	$	1,121

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. As of June 30, 2021, the Company is forecasting an effective tax rate of 0% for the year ending December 31, 2021. The Company maintains a full valuation allowance on all deferred tax assets.

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 June 30, 2021, the Company has no net assets located outside of the United States.

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 trade receivables net, measurement of stock-based compensation 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

During each of the three and six months ended June 30, 2021 and 2020, the Company had arrangements with multiple contract research organizations (“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 CROs to manage the Company’s clinical trials, the CROs 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 CROs. 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 Quarterly Report on Form 10-Q, the timing of the Company’s actual costs incurred have not differed materially from its estimated timing of such costs.

Recently Adopted Accounting Pronouncements

In December 2019, the FASB issued ASU 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes (“ASU 2019-12”), which is intended to simplify the accounting for income taxes. ASU 2019-12 removes certain exceptions to the general principles in Topic 740 and also clarifies and amends existing guidance to improve consistent application. The Company adopted ASU 2019-02 effective January 1, 2021. The adoption of this standard did not have a material impact on the Company’s consolidated financial statements.

Collaborations and License Agreements

6 Months Ended

Jun. 30, 2021

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 to evaluate the safety and efficacy of AstraZeneca’s IMFINZI (durvalumab), a human monoclonal antibody directed against programmed death-ligand 1, in combination with tivozanib as a first-line treatment or following bevacizumab and atezolizumab 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 because both the Company and AstraZeneca are active participants in the oversight of the DEDUCTIVE trial via their participation on a joint steering committee and are exposed to significant risk and rewards in connection with the activity based on their obligation to share in the costs. AstraZeneca does not meet the definition of a customer, thus the joint development activities under the AstraZeneca Agreement are not accounted for under ASC 606.

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 $0.3 million and $0.2 million in the three months ended June 30, 2021 and 2020, respectively, and by approximately $0.5 million and $0.6 million in the six months ended June 30, 2021 and 2020, respectively. The amount due to the Company from AstraZeneca pursuant to the cost-sharing provision was approximately $0.3 million as of June 30, 2021.

Out-License Agreements

CANbridge

In March 2016, the Company entered into a collaboration and license agreement (the “CANbridge Agreement”) with CANbridge Life Sciences, Ltd. (“CANbridge”). Under the terms of the CANbridge Agreement, the Company granted CANbridge the exclusive right to develop, manufacture and commercialize AV-203, the Company’s potent humanized IgG1 monoclonal antibody that targets ErbB3 (also known as HER3), for the diagnosis, treatment and prevention of disease in all countries outside of North America.

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.

EUSA

In December 2015, the Company entered into an agreement (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 represented EUSA’s approximate 50% share of the total costs of the TiNivo trial. The Company is also eligible to receive an additional research and development reimbursement payment from EUSA, in the amount of $20.0 million, for the Company’s phase 3 randomized, controlled, multi-center, open-label clinical trial comparing tivozanib to an approved therapy, sorafenib (Nexavar^®), in 350 subjects in RCC patients whose disease had relapsed or become refractory to two or three prior systemic therapies, including subjects with prior checkpoint inhibitor therapy (the “TIVO-3 trial”) , if EUSA elects to opt-in to that study.

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 European Medicines Agency (“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 three and six months ended June 30, 2021 and 2020.

Pursant to the KKC Agreement, the Company is required to pay KKC a 30% sublicense fee related to earned milestone payments and royalties from EUSA. However, research and development reimbursement payments by EUSA are excluded from the 30% sublicense fee due to KKC, subject to certain limitations. If EUSA elects to opt-in to the TIVO-3 trial, only approximately $8.7 million of the final $20.0 million research and development payment by EUSA would be subject to the 30% sublicense fee due to KKC. 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 Under ASC 606

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 substantive performance period from contract execution in December 2015 through 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.

None of the remaining regulatory-related milestones are 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) the remaining reimbursement and marketing approvals in RCC are outside of the control of EUSA and vary on a country-by-country basis, (ii) milestones related to the submission filings for EMA approval of tivozanib in up to three additional indications are contingent upon the success of future clinical trials in additional indications, if any, and are outside of the control of EUSA, (iii) milestones related to the marketing

approval by the EMA for tivozanib in up to three additional indications are contingent upon the success of the corresponding future clinical trials, if any, and are outside of the control of EUSA, and (iv) efforts by EUSA.

Any consideration related to sales-based milestones (including royalties) will be recognized when the related sales occur as these amounts have been determined to relate predominantly to the license granted to EUSA and therefore are recognized at the later of when the performance obligation is satisfied (or partially satisfied) or the related sales occur. The Company will re-evaluate the transaction price, including its estimated variable consideration for milestones included in the transaction price and all constrained amounts, in each reporting period and as uncertain events are resolved or other changes in circumstances occur.

In November 2017, the Company began earning sales royalties upon EUSA’s commencement of the first commercial launch of FOTIVDA (tivozanib) with the initiation of product sales in Germany. EUSA has received reimbursement approval for and commercially launched FOTIVDA in Germany, the United Kingdom, and Spain as well as in some additional non-EU5 countries. EUSA is working to secure reimbursement approval in Italy and France and commercially launch FOTIVDA in additional European countries. The Company recognized royalty revenue of approximately $0.3 million in each of the three months ended June 30, 2021 and 2020, respectively, and approximately $0.7 million and $0.5 million in the six months ended June 30, 2021 and 2020, respectively.

The Company recognized total revenues under the EUSA Agreement of approximately $0.8 million and $0.7 million in the three months ended June 30, 2021 and 2020, respectively, and approximately $1.7 million and $1.5 million in the six months ended June 30, 2021 and 2020, respectively. As of June 30, 2021, there was approximately $1.6 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, currently estimated through April 2022.

The following table summarizes the revenues earned in connection with the EUSA Agreement under ASC 606 for the three and six months ended June 30, 2021 and 2020 (in thousands):

		Three Months Ended June 30,
Revenue Type	Date Achieved	2021		2020
Collaboration and Licensing Revenue:
Amounts in contract liabilities at the beginning of the period:
Upfront payment	December 2015	$	99	$	99
R&D payment - EMA approval in RCC	August 2017		158		158
Milestone - UK reimbursement approval	February 2018		79		79
Milestone - German reimbursement approval	November 2018		79		79
Milestone - Spanish reimbursement approval	February 2019		79		79
		$	494	$	494
Partnership Royalties			327		255
Total		$	821	$	749

		Six Months Ended June 30,
Revenue Type	Date Achieved	2021		2020
Collaboration and Licensing Revenue:
Amounts in contract liabilities at the beginning of the period:
Upfront payment	December 2015	$	197	$	197
R&D payment - EMA approval in RCC	August 2017		316		316
Milestone - UK reimbursement approval	February 2018		158		158
Milestone - German reimbursement approval	November 2018		158		158
Milestone - Spanish reimbursement approval	February 2019		158		158
		$	987	$	987
Partnership Royalties			688		546
Total