Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2020 | Aug. 07, 2020 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Jun. 30, 2020 | |
Document Fiscal Year Focus | 2020 | |
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 | 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 | 25,808,315 | |
Title of 12(b) Security | Common Stock, $0.001 par value | |
Security Exchange Name | NASDAQ | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Entity Incorporation, State or Country Code | DE | |
Entity Interactive Data Current | Yes |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets (Unaudited) - USD ($) $ in Thousands | Jun. 30, 2020 | Dec. 31, 2019 |
Current assets: | ||
Cash and cash equivalents | $ 45,670 | $ 29,785 |
Marketable securities | 25,779 | 17,960 |
Accounts receivable | 1,208 | 1,631 |
Clinical trial retainers | 524 | 589 |
Other prepaid expenses and other current assets | 1,047 | 635 |
Total current assets | 74,228 | 50,600 |
Property and equipment, net | 96 | |
Operating lease right-of-use asset | 1,120 | |
Other assets | 158 | |
Total assets | 75,602 | 50,600 |
Current liabilities: | ||
Accounts payable | 1,785 | 1,466 |
Accrued clinical trial costs and contract research | 5,000 | 5,680 |
Other accrued liabilities | 2,121 | 2,336 |
Operating lease liability | 451 | |
Loans payable, net of discount | 10,193 | 9,569 |
Deferred revenue | 1,974 | 1,974 |
Deferred research and development reimbursements | 259 | 93 |
Total current liabilities | 21,783 | 21,118 |
Loans payable, net of current portion and discount | 940 | 6,197 |
Deferred revenue | 1,565 | 2,552 |
PIPE Warrant liability (Note 7) | 1,999 | 5,097 |
Operating lease liability, non-current | 473 | |
Other liabilities (Note 6) | 790 | 790 |
Total liabilities | 27,550 | 35,754 |
Stockholders’ equity: | ||
Preferred stock, $.001 par value: 5,000 shares authorized at June 30, 2020 and December 31, 2019; no shares issued and outstanding at each of June 30, 2020 and December 31, 2019 | ||
Common stock, $.001 par value: 50,000 shares authorized at June 30, 2020 and December 31, 2019; 25,808 shares issued and outstanding at June 30, 2020 and 16,081 issued and outstanding at December 31, 2019 | 26 | 16 |
Additional paid-in capital | 649,335 | 600,451 |
Accumulated other comprehensive loss | (1) | |
Accumulated deficit | (601,308) | (585,621) |
Total stockholders’ equity | 48,052 | 14,846 |
Total liabilities and stockholders’ equity | $ 75,602 | $ 50,600 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Unaudited) (Parenthetical) - $ / shares | Jun. 30, 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 | 25,808,315 | 16,081,000 |
Common stock, shares outstanding | 25,808,315 | 16,081,000 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations (Unaudited) - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | |
Revenues: | ||||
Revenues | $ 749 | $ 703 | $ 1,533 | $ 2,314 |
Operating expenses: | ||||
Research and development | 4,419 | 2,611 | 12,245 | 9,463 |
General and administrative | 3,737 | 2,986 | 7,409 | 5,441 |
Operating expenses, total | 8,156 | 5,597 | 19,654 | 14,904 |
Loss from operations | (7,407) | (4,894) | (18,121) | (12,590) |
Other income (expense), net: | ||||
Interest expense, net | (349) | (451) | (664) | (1,015) |
Change in fair value of PIPE Warrant liability | 450 | 2,210 | 3,098 | 11,025 |
Other income (expense), net | 101 | 1,759 | 2,434 | 10,010 |
Net loss | $ (7,306) | $ (3,135) | $ (15,687) | $ (2,580) |
Net loss per share - basic and diluted | $ (0.42) | $ (0.20) | $ (0.94) | $ (0.18) |
Weighted average number of common shares outstanding | 17,364 | 15,902 | 16,722 | 14,574 |
Collaboration and Licensing Revenue | ||||
Revenues: | ||||
Revenues | $ 494 | $ 493 | $ 987 | $ 1,947 |
Partnership Royalties | ||||
Revenues: | ||||
Revenues | $ 255 | $ 210 | $ 546 | $ 367 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Comprehensive Loss (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | |
Statement Of Income And Comprehensive Income [Abstract] | ||||
Net loss | $ (7,306) | $ (3,135) | $ (15,687) | $ (2,580) |
Other comprehensive income (loss): | ||||
Unrealized gain (loss) on available-for-sale securities | (1) | (1) | ||
Comprehensive loss | $ (7,307) | $ (3,135) | $ (15,688) | $ (2,580) |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Stockholders' Equity (Deficit) (Unaudited) - USD ($) shares in Thousands, $ in Thousands | Total | S V B Leerink | Equity-classified awards | Common Shares | Common SharesS V B Leerink | Additional Paid-in Capital | Additional Paid-in CapitalS V B Leerink | Additional Paid-in CapitalEquity-classified awards | Accumulated Other Comprehensive Income (Loss) | Accumulated Deficit |
Beginning Balance at Dec. 31, 2018 | $ (27,227) | $ 13 | $ 567,768 | $ 1 | $ (595,009) | |||||
Beginning Balance (in shares) at Dec. 31, 2018 | 12,648 | |||||||||
Issuance of common stock from the SVB Leerinksales agreement (net of issuance costs of $0.2million) | $ 7,512 | $ 1 | $ 7,511 | |||||||
Issuance of common stock from the SVB Leerink sales agreement (net of issuance costs of $0.2 million) (in shares) | 1,252 | |||||||||
Stock-based compensation expense related to equity- classified awards | $ 584 | $ 584 | ||||||||
Net loss | 555 | 555 | ||||||||
Ending Balance at Mar. 31, 2019 | (18,576) | $ 14 | 575,863 | 1 | (594,454) | |||||
Ending Balance (in shares) at Mar. 31, 2019 | 13,900 | |||||||||
Beginning Balance at Dec. 31, 2018 | (27,227) | $ 13 | 567,768 | 1 | (595,009) | |||||
Beginning Balance (in shares) at Dec. 31, 2018 | 12,648 | |||||||||
Net loss | (2,580) | |||||||||
Ending Balance at Jun. 30, 2019 | 1,643 | $ 16 | 599,215 | 1 | (597,589) | |||||
Ending Balance (in shares) at Jun. 30, 2019 | 16,074 | |||||||||
Beginning Balance at Mar. 31, 2019 | (18,576) | $ 14 | 575,863 | 1 | (594,454) | |||||
Beginning Balance (in shares) at Mar. 31, 2019 | 13,900 | |||||||||
Issuance of common stock in a public offering, excluding to related parties, net | 17,767 | $ 2 | 17,765 | |||||||
Issuance of common stock in a public offering, excluding to related parties, net (in shares) | 1,739 | |||||||||
Issuance of common stock in a public offering, to related parties | 5,000 | 5,000 | ||||||||
Issuance of common stock and warrants in public offering, to related parties (in shares) | 435 | |||||||||
Stock-based compensation expense related to equity- classified awards | 584 | 584 | ||||||||
Exercise of stock options | 3 | 3 | ||||||||
Net loss | (3,135) | (3,135) | ||||||||
Ending Balance at Jun. 30, 2019 | 1,643 | $ 16 | 599,215 | 1 | (597,589) | |||||
Ending Balance (in shares) at Jun. 30, 2019 | 16,074 | |||||||||
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 | |||||||||
Change in unrealized gain (loss) oninvestments | (1) | |||||||||
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 | |||||||||
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, 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 in a public offering, to related parties | 23,644 | $ 5 | 23,639 | |||||||
Issuance of common stock and warrants in public offering, to related parties (in shares) | 4,504 | |||||||||
Stock-based compensation expense related to equity- classified awards | $ 578 | $ 578 | ||||||||
Issuance of common stock under employee stock purchase plan | 18 | 18 | ||||||||
ssuance of common stock under employee stock purchase plan (in shares) | 2 | |||||||||
Change in unrealized gain (loss) oninvestments | (1) | (1) | ||||||||
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 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Stockholders' Equity (Deficit) (Unaudited) (Parenthetical) - USD ($) $ in Millions | 3 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Mar. 31, 2019 | |
Public Offering | |||
Issuance of common stock, issuance costs | $ 3.3 | $ 2.3 | |
S V B Leerink | |||
Issuance of common stock, issuance costs | $ 0.2 |
Condensed Consolidated Statem_5
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2020 | Jun. 30, 2019 | |
Operating activities | ||
Net loss | $ (15,687) | $ (2,580) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and Amortization | 4 | |
Stock-based compensation | 1,121 | 1,168 |
Non-cash interest expense | 200 | 311 |
Non-cash change in fair value of PIPE Warrant liability | (3,098) | (11,025) |
Amortization of premium and discount on investments | (81) | |
Changes in operating assets and liabilities: | ||
Accounts receivable | 423 | 2,415 |
Prepaid expenses and other current assets | (347) | |
Operating lease right-of-use asset | (1,278) | (337) |
Accounts payable | 319 | (1,536) |
Accrued contract research | (680) | (1,546) |
Other accrued liabilities | (215) | (1,143) |
Other current liabilities | 451 | |
Deferred revenue | (987) | 53 |
Deferred research and development reimbursements | 166 | (247) |
Other non-current liabilities | 473 | |
Net cash used in operating activities | (19,216) | (14,467) |
Investing activities | ||
Purchases of property and equipment | (100) | |
Purchases of marketable securities | (28,139) | |
Proceeds from maturities and sales of marketable securities | 20,400 | |
Net cash used in investing activities | (7,839) | |
Financing activities | ||
Proceeds from issuance of common stock and warrants, net of issuance costs | 24,111 | 25,269 |
Proceeds from issuance of common stock and warrants to related parties | 23,644 | 5,000 |
Proceeds from issuance of common stock for stock-based compensation arrangements | 18 | 3 |
Payment of principal of loan payable (Note 6) | (4,833) | |
Net cash provided by financing activities | 42,940 | 30,272 |
Net increase in cash and cash equivalents | 15,885 | 15,805 |
Cash and cash equivalents at beginning of period | 29,785 | 24,427 |
Cash and cash equivalents at end of period | 45,670 | 40,232 |
Supplemental cash flow information | ||
Cash paid for interest | 681 | $ 1,029 |
Right-of-use asset obtained in exchange for operating lease liabilities | $ 1,225 |
Organization
Organization | 6 Months Ended |
Jun. 30, 2020 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Organization | (1) Organization AVEO Pharmaceuticals, Inc. (the “Company”) is a biopharmaceutical company developing and seeking to commercialize its pipeline of product candidates designed to provide a better life for patients with cancer. The Company’s strategy is to focus its efforts and resources toward development and commercialization of its product candidates in North America while leveraging partnerships to support development and commercialization in other geographies. Its lead candidate is tivozanib (FOTIVDA ® 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 candidate, tivozanib. 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, 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 develop its product candidates and ultimately upon its ability to attain profitable operations. The Company has incurred recurring losses and cash outflows from operations since its inception, including net losses of $15.7 million and $2.6 million for the six months ended June, 2020 and 2019, respectively. In addition, the Company had an accumulated deficit of $601.3 million as of June 30, 2020. The Company expects to continue to generate operating losses for the foreseeable future. As of August 10, 2020, the date of issuance of these unaudited condensed consolidated financial statements, the Company expects that its cash, cash equivalents and marketable securities of $71.4 million as of June 30, 2020, together with (i) the $2.8 million development milestone payment earned from Kyowa Kirin Co. on August 2, 2020 (“KKC”) (see Note 4) and (ii) approximately $5.3 million in new loan funding from the amendment to its loan agreement with Hercules Funding III, LLC and Hercules Capital, Inc. (collectively “Hercules”) received on August 7, 2020 (see Note 10), will not be sufficient to fund its current operations for more than twelve months from the date of filing this Quarterly Report on Form 10-Q. This condition raises substantial doubt about the Company’s ability to continue as a going concern. The Company’s plans to address this condition include pursuing one or more of the following options to secure additional funding, none of which can be guaranteed or are entirely within the Company’s control: • Earn royalty payments pursuant to the Company’s license agreement (the “EUSA Agreement”) with EUSA Pharma (UK) Limited (“EUSA”) for EUSA’s sales of tivozanib in its territory. • Earn milestone payments pursuant to the collaboration and license agreements described in Note 4 or restructure / monetize existing potential milestone and/or royalty payments under those collaboration and license agreements. • Raise funding through the possible additional sale of the Company’s common stock, including public or private equity financings and / or sales of the Company’s common stock under the Leerink Sales Agreement, as defined and discussed in Note 7. • Drawdown potential future borrowings pursuant to the loan agreement with Hercules, subject to the satisfaction of the conditions to future borrowing. • Partner a portion or all rights to the Company’s portfolio candidates to secure potential additional non-dilutive funds. Pursuant to the EUSA Agreement, the Company is entitled to receive up to an additional $4.0 million in milestone payments of $2.0 million per country upon reimbursement approval for RCC, if any, in each of France and Italy, and an additional $2.0 million milestone payment for the grant of marketing approval, if any, in three of the licensed countries outside of the European Union (the “EU”), as mutually agreed by the parties. These milestone payments are subject to the 30% sublicense fee payable to KKC pursuant to the Company’s license agreement with KKC (the “KKC Agreement”). The Company is also eligible to receive additional research and development reimbursement payments from EUSA if EUSA elects to opt-in to the TIVO-3 study.Refer to Note 4 “ Collaborations and License Agreements - InLicense Agreements – Kyowa Kirin Co. (KKC) ” f The Company is also eligible, at its option, to borrow up to an additional $20.0 million under the amendment to the loan agreement with Hercules, subject to certain terms and conditions including FDA approval of FOTIVDA and, if approved, the Company’s net product revenues from sales of FOTIVDA reaching $20.0 million within a specified time frame. There can be no assurance, however, that the FDA will approve FOTIVDA or that the other conditions to the funding of such loan amounts will be satisfied. Refer to Note 10 “Subsequent Event – Hercules Loan Restructuring” for further details. Furthermore, there can be no assurance that the Company will receive cash proceeds from any of these potential resources or to the extent cash proceeds are received such proceeds would be sufficient to support the Company’s current operating plan for more than twelve months from the date of filing this Quarterly Report on Form 10-Q. Pursuant to the requirements of Accounting Standards Codification (ASC) 205-40, Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern Under ASC 205-40, the future receipt of potential funding from the Company’s collaborators and funding that is contingent on FDA approval of FOTIVDA, such as the potential future borrowings pursuant to the loan agreement with Hercules and product revenues from the sales of FOTIVDA, cannot be considered probable at this time because none of the Company’s current plans have been finalized at the time of filing this Quarterly Report on Form 10-Q and the implementation of any such plan is not probable of being effectively implemented as none of the plans are entirely within the Company’s control. Accordingly, substantial doubt is deemed to exist about the Company’s ability to continue as a going concern within one year after the date these financial statements are issued. If the Company is unable to obtain sufficient capital to continue to advance its programs, the Company would be forced to delay, reduce or eliminate its research and development programs and any future commercialization efforts. The accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the ordinary course of business. The financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result from the outcome of the uncertainties described above. |
Basis of Presentation
Basis of Presentation | 6 Months Ended |
Jun. 30, 2020 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Basis of Presentation | (2) Basis of Presentation These condensed 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 U.S. 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, 2020 are not necessarily indicative of the results that may be expected for the fiscal year ending December 31, 2020 or any other future period. The information presented in the condensed consolidated financial statements and related footnotes at June 30, 2020, and for the three months and six months ended June 30, 2020 and 2019, is unaudited, and the condensed consolidated balance sheet amounts and related footnotes as of December 31, 2019 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, 2019, which was filed with the U.S. Securities and Exchange Commission (“SEC”) on March 16, 2020. Effective as of 5:00 p.m. Eastern Time on February 19, 2020, the Company effected a 1-for-10 reverse stock split of its common stock. All references to shares of common stock outstanding and per share amounts in these condensed consolidated financial statements and the notes to the condensed consolidated financial statements have been restated to reflect the reverse stock split on a retroactive basis. Refer to Note 7, “ Common Stock – Reverse Stock Split – February 2020 |
Significant Accounting Policies
Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2020 | |
Accounting Policies [Abstract] | |
Significant Accounting Policies | (3) Significant Accounting Policies Revenue Recognition The Company’s revenues are 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 Effective January 1, 2018, the Company adopted ASC 606 using the modified retrospective transition method. Under this method, the Company has recognized the cumulative effect of the adoption as an adjustment to the opening balance of accumulated deficit in the prior year condensed consolidated balance sheet. Financial results for the year ended December 31, 2018 and thereafter are presented under ASC 606. The provisions of ASC 606 apply to all contracts with customers, except for contracts that are within the scope of other standards, such as collaboration arrangements and leases. 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 three months and six months ended June 30, 2020 and 2019, 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, 2020 2019 2020 2019 EUSA $ 749 $ 703 $ 1,533 $ 2,314 Total $ 749 $ 703 $ 1,533 $ 2,314 Leases The Company adopted Accounting Standards Update (“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 approximately $0.2 million and $0.4 million in short-term operating lease expense in its Consolidated Statements of Operations in each of the three and six months ended June 30, 2020 and 2019, 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 six months ended June 30, 2020, the Company recognized $0.1 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 June 30, 2020, future minimum lease payments under the Company’s Winter Street Sublease are as follows (amounts in thousands): Year Ending December 31: 2020 (remaining 6 months) 239 2021 385 2022 328 Total lease payments 952 Less imputed interest (28 ) Total operating lease liabilities $ 924 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, manufacturing costs for pre-launch inventory that did not qualify for capitalization, Warrants Issued in Connection with Private Placement In 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 non-cash gains of approximately $ 0.5 million and $ 3.1 million in the three months 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 approach their expiration in May 2021. The Company recorded non-cash gains of approximately $2.2 million and $11.0 million in the three months and six months ended June 30, 2019, respectively, in its Statement of Operations attributable to the decreases in the fair value of the warrant liability that principally resulted from lower stock prices as of June 30, 2019 relative to prior periods. 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 months ended June 30, 2020 (in thousands): Fair value at January 1, 2020 $ 5,097 Decrease in fair value (2,648 ) Fair value at March 31, 2020 $ 2,449 Decrease in fair value (450 ) Fair value at June 30, 2020 $ 1,999 The key assumptions used to value the PIPE Warrants were as follows: Issuance December 31, 2019 March 31, 2020 June 30, 2020 Expected price volatility 76.25 % 133.07 % 153.57 % 108.20 % Expected term (in years) 5.00 1.50 1.25 1.00 Risk-free interest rates 1.22 % 1.59 % 0.17 % 0.16 % Stock price $ 8.90 $ 6.20 $ 3.62 $ 5.15 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 U.S. government money market funds, high-grade, short-term commercial paper, corporate bonds and other U.S. 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 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 condensed 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, 2020 and December 31, 2019 (in thousands): Amortized Cost Unrealized Gains Unrealized Losses Fair Value June 30, 2020 Cash and cash equivalents: Cash and money market funds $ 45,670 $ — $ — $ 45,670 Total cash and cash equivalents 45,670 — — 45,670 Marketable securities: Corporate debt securities due within 1 year $ 6,791 $ — $ — $ 6,791 U.S. government agency securities due within 1 year 18,989 — (1 ) 18,988 Total marketable securities 25,780 — (1 ) 25,779 Total cash, cash equivalents and marketable securities $ 71,450 $ — $ (1 ) $ 71,449 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 June 30, 2020, the Company had financial assets valued based on Level 1 inputs consisting of cash and cash equivalents in U.S. government money market funds, and had financial assets based on Level 2 inputs consisting of high-grade debt securities, including commercial paper. During the three months and six months ended June 30, 2020, the Company did not have any transfers of financial assets between Levels 1 and 2. As of June 30, 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 June 30, 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 fair value of the warrants issued in connection with the loan, 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, 2020 and December 31, 2019 (in thousands): Fair Value Measurements as of June 30, 2020 Level 1 Level 2 Level 3 Total (in thousands) Financial assets carried at fair value: Cash and money market funds $ 45,670 $ — $ — $ 45,670 Total cash and cash equivalents $ 45,670 $ — $ — $ 45,670 Marketable securities: Corporate debt securities due within 1 year $ — $ 6,791 $ — $ 6,791 U.S. government agency securities due within 1 year — 18,988 — 18,988 Total marketable securities $ — $ 25,779 $ — $ 25,779 Total cash, cash equivalents and marketable securities $ 45,670 $ 25,779 $ — $ 71,449 Financial liabilities carried at fair value: Total PIPE Warrant liability $ — $ — $ 1,999 $ 1,999 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 Income (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 each of the three months and six months ended June 30, 2020 and 2019, 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 would be anti-dilutive. In each of the three months and six months ended June 30, 2020 and 2019, the average market prices of the Company’s common stock were below the exercise prices of $10.00 and $12.50 In each of and six months June 30 All 200,000 Settlement Warrants expired on July 15, 2019 as none of these warrants had been exercised. Refer to Note 7, “ Common Stock—Private Placement – May 2016, Public Offering – April 2019 and Settlement Warrants” for further discussion of these warrants. 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 months and six months ended June 30, 2020 and 2019, respectively (in thousands): Outstanding at June 30, 2020 2019 Options outstanding 1,610 1,295 Offering Warrants outstanding 2,500 2,500 PIPE Warrants outstanding 1,684 1,684 Settlement Warrants outstanding — 200 Total 5,794 5,679 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 U.S. 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 award is granted. During the three and six months ended June 30, 2020 and 2019, the Company recorded the following stock-based compensation expense (in thousands): Three Months Ended June 30, Six Months Ended June 30, 2020 2019 2020 2019 Research and development $ 125 $ 168 $ 240 $ 338 General and administrative 453 416 881 830 Total $ 578 $ 584 $ 1,1 |
Collaborations and License Agre
Collaborations and License Agreements | 6 Months Ended |
Jun. 30, 2020 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Collaborations and License Agreements | (4) Collaborations and License Agreements Out-License and Collaboration Agreements 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 $0.2 million and $0.1 million in the three months ended June 30, 2020 and 2019, respectively, and by approximately $0.6 million and $0.1 million in the six months ended June 30, 2020 and 2019, respectively. The amount due to the Company from AstraZeneca pursuant to the cost-sharing provision was approximately $0.6 million as of June 30, 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. In December 2017, CANbridge filed an investigative new drug (“IND”) application with the National Medical Products Administration (formerly, the China Food and Drug Administration) (“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 three months and six months ended June 30, 2020 and 2019, respectively. The Company is also eligible to receive up to $40.0 million in potential additional development and regulatory milestone payments and up to $90.0 million in potential commercial milestone payments based on annual net sales of licensed products. Upon commercialization, the Company is eligible to receive a tiered royalty, with a percentage range in the low double-digits, on net sales of approved licensed products. CANbridge’s obligation to pay royalties for each licensed product expires on a country-by-country basis on the later of the expiration of patent rights covering such licensed product in such country, the expiration of regulatory data exclusivity in such country and ten years after the first commercial sale of such licensed product in such country. CANbridge is obligated to use commercially reasonable efforts to develop and commercialize AV-203 in each of China, Japan, the United Kingdom, France, Italy, Spain, and Germany. CANbridge has responsibility for all activities and costs associated with the further development, manufacture and commercialization of AV-203 in the CANbridge Licensed Territory, including the clinical development of AV-203 through phase 2 proof-of-concept in ESCC or another agreed upon indication, after which the Company may elect to contribute to certain worldwide development efforts . A percentage of any milestone and royalty payments received by the Company pursuant to the CANbridge Agreement, excluding upfront and reimbursement payments, 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. 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. Any consideration related to development and regulatory milestones will be recognized when the corresponding milestones are no longer constrained as the Company does not have any ongoing performance obligations. 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 CANbridge and therefore are recognized at the later of when the performance obligation is 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 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 tivozanib (FOTIVDA) 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 ® 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 ® ), in 350 subjects as a third- and fourth-line treatment for RCC, including subjects with prior checkpoint inhibitor therapy (the“TIVO-3 trial”), up to $ 20.0 million, 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, the first of which was obtained in New Zealand in July 2019. 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 three months and six months ended June 30, 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 tivozanib (FOTIVDA) 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. Upon adoption of ASC 606 on January 1, 2018, none of the remaining regulatory-related 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) 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. 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 tivozanib (FOTIVDA) 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 and $0.2 million in the three months ended June 30, 2020 and 2019, respectively, and approximately $0.5 million and $0.4 million in the six months ended June 30, 2020 and 2019, respectively . 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 $0.7 million in each of the three months ended June 30, 2020 and 2019, respectively, and approximately $1.5 million and $2.3 million in the six months ended June 30, 2020 and 2019, respectively. As of June 30, 2020, there was approximately $3.5 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 three months ended June 30, 2020 and 2019 (in thousands): Three Months Ended June 30, Three Months Ended June 30, Revenue Type Date Achieved 2020 2019 Collaboration and Licensing Revenue: Amounts in contract liabilities at the beginning of the period: Upfront payment December 2015 $ 99 $ 98 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 $ 493 Partnership Royalties 255 210 Total $ 749 $ 703 The following table summarizes the revenues earned in connection with the EUSA Agreement under ASC 606 for the six months ended June 30, 2020 and 2019 (in thousands): Six Months Ended June 30, Six Months Ended June 30, Revenue Type Date Achieved 2020 2019 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 1,118 $ 987 $ 1,947 Partnership Royalties 546 367 Total $ 1,533 $ 2,314 The following table summarizes changes in the Company ’ Contract Assets Beginning Balance January 1, 2020 Additions Deductions Ending Balance June 30, 2020 Accounts Receivable $ 270 $ 546 $ (561 ) $ 255 Deferred Revenue Contract Liabilities Transaction Price Date Achieved Date Paid Beginning Balance January 1, 2020 Additions Deductions Ending Balance June 30, 2020 Amounts in contract liabilities at the beginning of the period: Upfront payment $ 2,500 December 2015 December 2015 $ 907 $ — $ (197 ) $ 710 R&D payment - EMA approval in RCC 4,000 August 2017 September 2017 1,448 — (316 ) 1,132 Milestone - UK reimbursement approval 2,000 February 2018 March 2018 724 — (158 ) 566 Milestone - German reimbursement approval 2,000 November 2018 December 2018 723 — (158 ) 565 Milestone - Spanish reimbursement approval 2,000 February 2019 May 2019 724 — (158 ) 566 Total $ 12,500 $ 4,526 $ - $ (987 ) $ 3,539 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 and $0.1 million in the three months ended June 30, 2020 and 2019, respectively, and approximately $0.1 million and $0.2 million in the six months ended June 30, 2020 and 2019, respectively. As of June 30, 2020, the Company had recognized approximately $1.9 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. The remaining $0.1 million in prepaid cost sharing was classified as deferred research and development reimbursements as of June 30, 2020 and will continue to be recognized as a reduction in research and development expenses as the related TiNivo trial costs are incurred over the duration 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 drug candidate being in the pre-clinical development stage. Biodesix In April 2014, the Company entered into a worldwide co-development and collaboration agreement with Biodesix (the “Biodesix Agreement”) to develop and commercialize ficlatuzumab, the Company’s HGF inhibitory antibody. 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 ® ® The Biodesix Agreement generally provides for each party to contribute 50% of all clinical, regulatory, manufacturing and other costs to develop ficlatuzumab and to share equally in any future revenue from development or commercialization, subject to opt-out rights and certain other exceptions . Prior to the first commercial sale of ficlatuzumab, each party has the right to elect to discontinue participating in further development or commercialization efforts with respect to ficlatuzumab, which is referred to as an “Opt-Out”. If either the Company or Biodesix elects to Opt-Out, with such party referred to as the “Opting-Out Party”, then the Opting-Out Party shall not be responsible for any future uncommitted costs associated with developing and commercializing ficlatuzumab other than any ongoing clinical trials. The non-opting out party shall have sole decision-making authority with respect to further development and commercialization of ficlatuzumab. Additionally, the Opting-Out Party shall generally be entitled to receive a royalty equal to 10% of any future net sales of ficlatuzumab throughout the world, and 25% of any future revenue from collaborations. The Biodesix Agreement remains in effect until the expiration of all payment obligations between the parties related to development and commercialization of ficlatuzumab, unless earlier terminated. Prior to any Opt-Out, the parties shall share equally in any payments received from a third-party licensee; provided, however, after any Opt-Out, the Opting-Out Party shall be entitled to receive only a reduced portion of such third-party payments. The agreement will remain in effect until the expiration of all payment obligations between the parties related to development and commercialization of ficlatuzumab, unless earlier terminated. 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 $0.1 million in each of the three months ended June 30, 2020 and 2019 and by approximately $0.7 million and $0.2 million in the six months ended June 30, 2020 and 2019, respectively. The amount due to the Company from Biodesix pursuant to the cost-sharing provision was approximately $0.1 million as of June 30, 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, will 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. Refer to “— CANbridge In-License Agreements St. Vincent’s In July 2012, the Company entered into |
Other Accrued Liabilities
Other Accrued Liabilities | 6 Months Ended |
Jun. 30, 2020 | |
Payables And Accruals [Abstract] | |
Other Accrued Liabilities | (5) Other Accrued Liabilities Other accrued expenses consisted of the following (in thousands): June 30, 2020 December 31, 2019 Professional fees $ 656 $ 806 Compensation and benefits 1,248 1,284 Other 217 246 Total $ 2,121 $ 2,336 |
Loans Payable
Loans Payable | 6 Months Ended |
Jun. 30, 2020 | |
Debt Disclosure [Abstract] | |
Loans Payable | (6) Loans Payable 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 (the “2012 Amendment”), September 2014 (the “2014 Amendment”) and May 2016 (the “2016 Amendment”). Amounts borrowed under the 2012 Amendment 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”) with Hercules Funding III, LLC and Hercules Capital, Inc. (collectively “Hercules”). On August 7, 2020, the Company and Hercules further amended the 2017 Loan Agrement. The loan amendment further amends certain of the terms described in this Note 6. Refer to Note 10 “Subsequent Event – Hercules Loan Restructuring” for further details. Pursuant to the 2014 Amendment, the Company received additional loan proceeds from Hercules in the amount of $10.0 million and paid an end-of-term payment, in the approximate amount of $0.5 million, on January 2, 2018 as scheduled. The Company incurred approximately $0.2 million in loan issuance costs paid directly to Hercules, which were offset against the loan proceeds and are accounted for as a loan discount. Pursuant to the 2016 Amendment, the Company received additional loan proceeds from Hercules, in an aggregate amount of $10.0 million, in installments of $5.0 million in each of May 2016 and June 2017, which increased the aggregate outstanding principal balance under the First Loan Agreement to $20.0 million. The Company paid an end-of-term payment, in the amount of $0.3 million, on December 1, 2019 as scheduled. The Company incurred approximately $0.1 million in loan issuance costs paid directly to Hercules, which were offset against the loan proceeds and are accounted for as a loan discount. The 2016 Amendment included a financial covenant that required the Company to maintain an unrestricted cash position (defined as cash and liquid cash, including marketable securities) greater than or equal to $10.0 million through the date of completion of the Company’s TIVO-3 trial, with results that were satisfactory to Hercules. Principal payments were scheduled to commence on January 1, 2018 and the loan was scheduled to mature on December 1, 2019. In connection with the 2016 Amendment, Hercules also received an option, subject to the Company’s written consent, not to be unreasonably withheld, to purchase, either with cash or through conversion of outstanding principal under the loan, up to $2.0 million of equity of the Company sold in any sale by the Company to third parties of equity securities resulting in at least $10.0 million in net cash proceeds to the Company, subject to certain exceptions. In December 2017, the Company entered into the 2017 Loan Agreement to refinance the Company’s existing 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 new $20.0 million loan facility has 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, Hercules did not receive any warrants to purchase shares of the Company’s common stock and no longer has the option, subject to the Company’s written consent, to participate in its future equity financings up to $2.0 million through the purchase of the Company’s common stock either with cash or through the conversion of outstanding principal under the loan. 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 has been 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 are accounted for as a loan discount. The 2017 Loan Agreement was accounted for as a loan modification in accordance with ASC 470-50. The Company must make interest payments on the principal balance of the loan each month it remains outstanding. Per annum interest is 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 June 30, 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 June 30, 2020 was approximately $11.3 million. The unamortized discount to be recognized over the remainder of the loan period was approximately $0.2 million and $0.4 million as of June 30, 2020 and December 31, 2019, respectively. The loans are secured by a lien on all the Company’s personal property (other than intellectual property), whether owned or acquired after the date of the First Loan Agreement. The 2017 Loan Agreement defines events of default, including the occurrence of an event that results in a material adverse effect upon the Company’s business operations, properties, assets or condition (financial or otherwise), its ability to perform its obligations or upon the ability of the lenders to enforce any of their rights or remedies with respect to such obligations, or upon the collateral under the 2017 Loan Agreement, the related liens or the priority thereof. As of June 30, 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 change as defined in the 2017 Loan Agreement. 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 in current and long-term liabilities based on the timing of scheduled principal payments. Future minimum payments under the loans payable outstanding as of June 30, 2020 are as follows (amounts in thousands): Year Ending December 31: 2020 (remaining 6 months) 5,514 2021 7,254 12,768 Less amount representing interest (646 ) Less unamortized discount (199 ) Less deferred charges (790 ) Less loans payable current, net of discount (10,193 ) Loans payable, net of current portion and discount $ 940 |
Common Stock
Common Stock | 6 Months Ended |
Jun. 30, 2020 | |
Equity [Abstract] | |
Common Stock | (7) Common Stock As of June 30, 2020, the Company had 50,000,000 authorized shares of common stock, $0.001 par value, of which 25,808,315 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. Public Offering – April 2019 In April 2019, the Company completed an underwritten public offering of 2,173,913 shares of its common stock and warrants to purchase an aggregate of 2,500,000 shares of its common stock (“the Offering Warrants”), including warrants to purchase an aggregate of 326,086 shares of its common stock sold pursuant to the underwriter’s partial exercise of its overallotment option, at the public offering price of $11.40 per share and $0.10 per warrant for gross proceeds of approximately $25.0 million. The Offering Warrants were immediately exercisable upon issuance at an exercise price of $12.50 per share, subject to adjustment in certain circumstances, and will expire two years from the date of issuance upon their scheduled expiration on April 8, 2021. Any Offering Warrants that have not been exercised for cash prior to their expiration shall be automatically exercised via cashless exercise on the expiration date. The shares and warrants were issued separately and are separately transferable. An entity affiliated with New Enterprise Associates purchased 434,782 shares and warrants to purchase an aggregate of 434,782 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. The net offering proceeds to the Company were approximately $22.8 million after deducting underwriting discounts and commissions and estimated offering expenses payable by the Company. As of June 30, 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). Sales Agreement with SVB Leerink In February 2018, the Company entered into the 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 Leerink Sales Agreement. In the fourth quarter of 2018, the Company sold 470,777 shares pursuant to the 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 Leerink Sales Agreement, resulting in proceeds of approximately $7.5 million, net of commissions. As of June 30, 2020, approximately $32 million was available for issuance in connection with future stock sales pursuant to the Leerink Sales Agreement. 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 Universal Shelf Registration Statement On November 30, 2017, the Company filed a shelf registration statement on Form S-3 with the SEC, which covers the offering, issuance and sale of up to $200.0 million of its common stock, preferred stock, debt securities, warrants and/or units (the “2017 Shelf”). The 2017 Shelf (File No. 333-221873) was declared effective by the SEC on December 15, 2017 and was filed to replace the Company’s then existing shelf registration statement, which was terminated. As of June 30, 2020, approximately $37 million was available for issuance in connection with future stock sales under the 2017 Shelf. 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 June 30, 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 | 6 Months Ended |
Jun. 30, 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 Board of Directors 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 Board of Directors, which generally are equal to four years, and (iv) that options granted under the 2019 Plan expire over periods as determined by the Board of Directors, which generally are ten years from the date of grant. In April 2020, the Board of Directors 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 June 30, 2020, there were 1,750,500 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 six months ended June 30, 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 485,802 $ 6.07 Exercised — $ — Forfeited (43,618 ) $ 26.27 Outstanding at June 30, 2020 1,610,406 $ 13.29 7.64 $ — Exercisable at June 30, 2020 795,266 $ 18.15 6.16 $ — The aggregate intrinsic value is based upon the Company’s closing stock price of $5.15 on June 30, 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 table below. Three Months Ended June 30, 2020 2019 Volatility factor 100.62% - 104.77% 95.72% - 96.23% Expected term (in years) 5.50 - 6.25 5.50 - 6.25 Risk-free interest rates 0.44% - 0.57% 1.94% Dividend yield — — Six Months Ended June 30, 2020 2019 Volatility factor 94.37% - 104.77% 88.27% - 96.23% Expected term (in years) 5.50 - 6.25 5.50 - 6.25 Risk-free interest rates 0.44% - 1.67% 1.94% - 2.55% 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 during the six months ended June 30, 2020 and 2019 was $4.71 and $5.80, respectively. As of June 30, 2020, there was $5.3 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. |
Legal Proceedings
Legal Proceedings | 6 Months Ended |
Jun. 30, 2020 | |
Commitments And Contingencies Disclosure [Abstract] | |
Legal Proceedings | (9) Legal Proceedings On July 24, 2020, the District Court for the District of Massachusetts dismissed a purported class action filed against the Company in 2019. Although the time for appeal has not yet expired, plaintiffs have indicated that they do not intend to appeal the dismissal. 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 Following 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. 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. In 2013, the SEC also served a subpoena on the Company for documents and information concerning tivozanib, including related communications with the FDA, investors and others. In September 2015, the SEC invited the Company to discuss the settlement of potential claims asserting that the Company violated federal securities laws by omitting to disclose to investors the recommendation by the staff of the FDA on May 11, 2012, that the Company conduct an additional clinical trial with respect to tivozanib. On March 29, 2016, the SEC filed a complaint against the Company and three of its former officers in the District Court alleging that the Company misled investors about its efforts to obtain FDA approval for tivozanib. Without admitting or denying the allegations in the SEC’s complaint, the Company consented to the entry of a final judgment pursuant to which the Company paid the SEC a $4.0 million civil penalty to settle the SEC’s claims against it. As this settlement was probable and estimable as of December 31, 2015, the Company recorded an estimated settlement liability of $4.0 million and recorded a corresponding loss in the Statement of Operations as a component of operating expenses. On March 31, 2016, the District Court entered a final judgment which (i) approved the settlement; (ii) permanently enjoined the Company from violating Section 17(a) of the Securities Act of 1933, as amended, Sections 10(b) and 13(a) of the Exchange Act and rules 10b-5, 12b-20, 13a-1, 13a-11 and 13a-13 promulgated thereunder; and (iii) ordered the Company to pay the agreed-to civil penalty. In September 2017 and October 2017, respectively, two of the Company’s former officers consented to entry of final judgment to settle the SEC’s claims against them. In November 2018, the District Court jury ruled against the remaining former officer. In April 2019, that individual moved for judgment as a matter of law or in the alternative for a new trial. In October 2019, the District Court denied the motion. In December 2019, the individual appealed this decision to the U.S. Court of Appeals for the First Circuit (No. 19-2264). The Company is not a party to the litigation between the SEC and the remaining former officer, and the Company can make no assurance regarding the outcome of that action or the SEC’s claims against that individual. |
Subsequent Events - Hercules Lo
Subsequent Events - Hercules Loan Restructuring | 6 Months Ended |
Jun. 30, 2020 | |
Subsequent Events [Abstract] | |
Subsequent Events - Hercules Loan Restructuring | (10) Subsequent Event – Hercules Loan Restructuring On August 7, 2020, the Company entered into a first amendment to the 2017 Loan Agreement (the “2020 Loan Amendment”) to provide the Company with an additional term loan in an aggregate principal amount of up to $35.0 million (the “2020 Loan Facility”) in four tranches to be used to refinance outstanding loans under the 2017 Loan Agreement, and for general working capital purposes through the potential commercial launch of FOTIVDA, if approved by the FDA, subject to certain terms and conditions. The Company received the initial $15.0 million of the 2020 Loan Facility upon the closing of the 2020 Loan Amendment, including approximately $9.7 million of which was used to retire the outstanding balance under the 2017 Loan Agreement and approximately $5.3 million of which is new loan funding. The remainder of the loan amount will be available to the Company, at its options, subject to certain terms and conditions, including upon the achievement of the following milestones: (i) the second tranche of $10.0 million available through June 30, 2021 upon FDA approval of FOTIVDA (“Performance Milestone I”), (ii) the third tranche of $5.0 million (“Tranche Three”) available from July 1, 2021 through January 31, 2022 upon the Company achieving $20.0 million in net product revenues from sales of FOTIVDA, if approved by the FDA, by no later than December 31, 2021 (“Performance Milestone II”), and (iii) the fourth tranche of $5.0 million available through June 30, 2022 contingent upon the achievement of Performance Milestone I and Performance Milestone II, and subject to the consent of Hercules. The 2020 Loan Facility also amends the 2017 Loan Agreement by: (i) extending maturity until September 1, 2023, which is extendable to September 1, 2024 upon the Company’s option after the Tranche Three funding has occurred, (ii) providing for an interest-only period through September 30, 2021, which is extendable through September 30, 2022 upon the achievement of Performance Milestone I and further extendable through March 31, 2023 after the Tranche Three funding has occurred, 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% . 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. 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 FOTIVDA 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. 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. |
Significant Accounting Polici_2
Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2020 | |
Accounting Policies [Abstract] | |
Revenue Recognition | Revenue Recognition The Company’s revenues are 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 Effective January 1, 2018, the Company adopted ASC 606 using the modified retrospective transition method. Under this method, the Company has recognized the cumulative effect of the adoption as an adjustment to the opening balance of accumulated deficit in the prior year condensed consolidated balance sheet. Financial results for the year ended December 31, 2018 and thereafter are presented under ASC 606. The provisions of ASC 606 apply to all contracts with customers, except for contracts that are within the scope of other standards, such as collaboration arrangements and leases. 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 three months and six months ended June 30, 2020 and 2019, 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, 2020 2019 2020 2019 EUSA $ 749 $ 703 $ 1,533 $ 2,314 Total $ 749 $ 703 $ 1,533 $ 2,314 |
Leases | Leases The Company adopted Accounting Standards Update (“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 approximately $0.2 million and $0.4 million in short-term operating lease expense in its Consolidated Statements of Operations in each of the three and six months ended June 30, 2020 and 2019, 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 six months ended June 30, 2020, the Company recognized $0.1 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 June 30, 2020, future minimum lease payments under the Company’s Winter Street Sublease are as follows (amounts in thousands): Year Ending December 31: 2020 (remaining 6 months) 239 2021 385 2022 328 Total lease payments 952 Less imputed interest (28 ) Total operating lease liabilities $ 924 |
Research and Development Expenses | 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, manufacturing costs for pre-launch inventory that did not qualify for capitalization, |
Warrants Issued in Connection with Private Placement | Warrants Issued in Connection with Private Placement In 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 non-cash gains of approximately $ 0.5 million and $ 3.1 million in the three months 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 approach their expiration in May 2021. The Company recorded non-cash gains of approximately $2.2 million and $11.0 million in the three months and six months ended June 30, 2019, respectively, in its Statement of Operations attributable to the decreases in the fair value of the warrant liability that principally resulted from lower stock prices as of June 30, 2019 relative to prior periods. 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 months ended June 30, 2020 (in thousands): Fair value at January 1, 2020 $ 5,097 Decrease in fair value (2,648 ) Fair value at March 31, 2020 $ 2,449 Decrease in fair value (450 ) Fair value at June 30, 2020 $ 1,999 The key assumptions used to value the PIPE Warrants were as follows: Issuance December 31, 2019 March 31, 2020 June 30, 2020 Expected price volatility 76.25 % 133.07 % 153.57 % 108.20 % Expected term (in years) 5.00 1.50 1.25 1.00 Risk-free interest rates 1.22 % 1.59 % 0.17 % 0.16 % Stock price $ 8.90 $ 6.20 $ 3.62 $ 5.15 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 U.S. government money market funds, high-grade, short-term commercial paper, corporate bonds and other U.S. 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 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 condensed 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, 2020 and December 31, 2019 (in thousands): Amortized Cost Unrealized Gains Unrealized Losses Fair Value June 30, 2020 Cash and cash equivalents: Cash and money market funds $ 45,670 $ — $ — $ 45,670 Total cash and cash equivalents 45,670 — — 45,670 Marketable securities: Corporate debt securities due within 1 year $ 6,791 $ — $ — $ 6,791 U.S. government agency securities due within 1 year 18,989 — (1 ) 18,988 Total marketable securities 25,780 — (1 ) 25,779 Total cash, cash equivalents and marketable securities $ 71,450 $ — $ (1 ) $ 71,449 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 June 30, 2020, the Company had financial assets valued based on Level 1 inputs consisting of cash and cash equivalents in U.S. government money market funds, and had financial assets based on Level 2 inputs consisting of high-grade debt securities, including commercial paper. During the three months and six months ended June 30, 2020, the Company did not have any transfers of financial assets between Levels 1 and 2. As of June 30, 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 June 30, 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 fair value of the warrants issued in connection with the loan, 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, 2020 and December 31, 2019 (in thousands): Fair Value Measurements as of June 30, 2020 Level 1 Level 2 Level 3 Total (in thousands) Financial assets carried at fair value: Cash and money market funds $ 45,670 $ — $ — $ 45,670 Total cash and cash equivalents $ 45,670 $ — $ — $ 45,670 Marketable securities: Corporate debt securities due within 1 year $ — $ 6,791 $ — $ 6,791 U.S. government agency securities due within 1 year — 18,988 — 18,988 Total marketable securities $ — $ 25,779 $ — $ 25,779 Total cash, cash equivalents and marketable securities $ 45,670 $ 25,779 $ — $ 71,449 Financial liabilities carried at fair value: Total PIPE Warrant liability $ — $ — $ 1,999 $ 1,999 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 Income (Loss) per Common Share | Basic and Diluted Net Income (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 each of the three months and six months ended June 30, 2020 and 2019, 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 would be anti-dilutive. In each of the three months and six months ended June 30, 2020 and 2019, the average market prices of the Company’s common stock were below the exercise prices of $10.00 and $12.50 In each of and six months June 30 All 200,000 Settlement Warrants expired on July 15, 2019 as none of these warrants had been exercised. Refer to Note 7, “ Common Stock—Private Placement – May 2016, Public Offering – April 2019 and Settlement Warrants” for further discussion of these warrants. 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 months and six months ended June 30, 2020 and 2019, respectively (in thousands): Outstanding at June 30, 2020 2019 Options outstanding 1,610 1,295 Offering Warrants outstanding 2,500 2,500 PIPE Warrants outstanding 1,684 1,684 Settlement Warrants outstanding — 200 Total 5,794 5,679 |
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 U.S. 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 award is granted. During the three and six months ended June 30, 2020 and 2019, the Company recorded the following stock-based compensation expense (in thousands): Three Months Ended June 30, Six Months Ended June 30, 2020 2019 2020 2019 Research and development $ 125 $ 168 $ 240 $ 338 General and administrative 453 416 881 830 Total $ 578 $ 584 $ 1,121 $ 1,168 Stock-based compensation expense is allocated to research and development and 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. As of June 30, 2020, the Company is forecasting an effective tax rate of 0% for the year ending December 31, 2020. 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 June 30, 2020, the Company had 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 condensed 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. |
Recently Adopted Accounting Pronouncements | Recently Adopted In June 2016, the FASB issued ASU 2016-13, 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) | 6 Months Ended |
Jun. 30, 2020 | |
Summary of Total Revenues Earned by Partner | The following table summarizes the total revenues earned in the three months and six months ended June 30, 2020 and 2019, 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, 2020 2019 2020 2019 EUSA $ 749 $ 703 $ 1,533 $ 2,314 Total $ 749 $ 703 $ 1,533 $ 2,314 |
Summary of Future Minimum Lease Payment | As of June 30, 2020, future minimum lease payments under the Company’s Winter Street Sublease are as follows (amounts in thousands): Year Ending December 31: 2020 (remaining 6 months) 239 2021 385 2022 328 Total lease payments 952 Less imputed interest (28 ) Total operating lease liabilities $ 924 |
Summary of Cash, Cash Equivalents and Marketable Securities | Below is a summary of cash, cash equivalents and marketable securities at June 30, 2020 and December 31, 2019 (in thousands): Amortized Cost Unrealized Gains Unrealized Losses Fair Value June 30, 2020 Cash and cash equivalents: Cash and money market funds $ 45,670 $ — $ — $ 45,670 Total cash and cash equivalents 45,670 — — 45,670 Marketable securities: Corporate debt securities due within 1 year $ 6,791 $ — $ — $ 6,791 U.S. government agency securities due within 1 year 18,989 — (1 ) 18,988 Total marketable securities 25,780 — (1 ) 25,779 Total cash, cash equivalents and marketable securities $ 71,450 $ — $ (1 ) $ 71,449 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 financial assets and liabilities measured at fair value on a recurring basis at June 30, 2020 and December 31, 2019 (in thousands): Fair Value Measurements as of June 30, 2020 Level 1 Level 2 Level 3 Total (in thousands) Financial assets carried at fair value: Cash and money market funds $ 45,670 $ — $ — $ 45,670 Total cash and cash equivalents $ 45,670 $ — $ — $ 45,670 Marketable securities: Corporate debt securities due within 1 year $ — $ 6,791 $ — $ 6,791 U.S. government agency securities due within 1 year — 18,988 — 18,988 Total marketable securities $ — $ 25,779 $ — $ 25,779 Total cash, cash equivalents and marketable securities $ 45,670 $ 25,779 $ — $ 71,449 Financial liabilities carried at fair value: Total PIPE Warrant liability $ — $ — $ 1,999 $ 1,999 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 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 the effect would have been anti-dilutive for the three months and six months ended June 30, 2020 and 2019, respectively (in thousands): Outstanding at June 30, 2020 2019 Options outstanding 1,610 1,295 Offering Warrants outstanding 2,500 2,500 PIPE Warrants outstanding 1,684 1,684 Settlement Warrants outstanding — 200 Total 5,794 5,679 |
Stock-Based Compensation Expense | During the three and six months ended June 30, 2020 and 2019, the Company recorded the following stock-based compensation expense (in thousands): Three Months Ended June 30, Six Months Ended June 30, 2020 2019 2020 2019 Research and development $ 125 $ 168 $ 240 $ 338 General and administrative 453 416 881 830 Total $ 578 $ 584 $ 1,121 $ 1,168 |
PIPE Warrants | |
Summary of Fair Value of Company's Warrant Liability | The Company recorded non-cash gains of approximately $2.2 million and $11.0 million in the three months and six months ended June 30, 2019, respectively, in its Statement of Operations attributable to the decreases in the fair value of the warrant liability that principally resulted from lower stock prices as of June 30, 2019 relative to prior periods. 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 months ended June 30, 2020 (in thousands): Fair value at January 1, 2020 $ 5,097 Decrease in fair value (2,648 ) Fair value at March 31, 2020 $ 2,449 Decrease in fair value (450 ) Fair value at June 30, 2020 $ 1,999 |
Key Assumptions Used to Value the Warrants | The key assumptions used to value the PIPE Warrants were as follows: Issuance December 31, 2019 March 31, 2020 June 30, 2020 Expected price volatility 76.25 % 133.07 % 153.57 % 108.20 % Expected term (in years) 5.00 1.50 1.25 1.00 Risk-free interest rates 1.22 % 1.59 % 0.17 % 0.16 % Stock price $ 8.90 $ 6.20 $ 3.62 $ 5.15 Dividend yield — — — — |
Collaborations and License Ag_2
Collaborations and License Agreements (Tables) | 6 Months Ended |
Jun. 30, 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 three months ended June 30, 2020 and 2019 (in thousands): Three Months Ended June 30, Three Months Ended June 30, Revenue Type Date Achieved 2020 2019 Collaboration and Licensing Revenue: Amounts in contract liabilities at the beginning of the period: Upfront payment December 2015 $ 99 $ 98 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 $ 493 Partnership Royalties 255 210 Total $ 749 $ 703 The following table summarizes the revenues earned in connection with the EUSA Agreement under ASC 606 for the six months ended June 30, 2020 and 2019 (in thousands): Six Months Ended June 30, Six Months Ended June 30, Revenue Type Date Achieved 2020 2019 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 1,118 $ 987 $ 1,947 Partnership Royalties 546 367 Total $ 1,533 $ 2,314 |
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 June 30, 2020 Accounts Receivable $ 270 $ 546 $ (561 ) $ 255 Deferred Revenue Contract Liabilities Transaction Price Date Achieved Date Paid Beginning Balance January 1, 2020 Additions Deductions Ending Balance June 30, 2020 Amounts in contract liabilities at the beginning of the period: Upfront payment $ 2,500 December 2015 December 2015 $ 907 $ — $ (197 ) $ 710 R&D payment - EMA approval in RCC 4,000 August 2017 September 2017 1,448 — (316 ) 1,132 Milestone - UK reimbursement approval 2,000 February 2018 March 2018 724 — (158 ) 566 Milestone - German reimbursement approval 2,000 November 2018 December 2018 723 — (158 ) 565 Milestone - Spanish reimbursement approval 2,000 February 2019 May 2019 724 — (158 ) 566 Total $ 12,500 $ 4,526 $ - $ (987 ) $ 3,539 |
Other Accrued Liabilities (Tabl
Other Accrued Liabilities (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
Payables And Accruals [Abstract] | |
Other Accrued Liabilities | Other accrued expenses consisted of the following (in thousands): June 30, 2020 December 31, 2019 Professional fees $ 656 $ 806 Compensation and benefits 1,248 1,284 Other 217 246 Total $ 2,121 $ 2,336 |
Loans Payable (Tables)
Loans Payable (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
Debt Disclosure [Abstract] | |
Future Minimum Payments Under Loans Payable | Future minimum payments under the loans payable outstanding as of June 30, 2020 are as follows (amounts in thousands): Year Ending December 31: 2020 (remaining 6 months) 5,514 2021 7,254 12,768 Less amount representing interest (646 ) Less unamortized discount (199 ) Less deferred charges (790 ) Less loans payable current, net of discount (10,193 ) Loans payable, net of current portion and discount $ 940 |
Stock-based Compensation (Table
Stock-based Compensation (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Stock Option Activity | The following table summarizes stock option activity during the six months ended June 30, 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 485,802 $ 6.07 Exercised — $ — Forfeited (43,618 ) $ 26.27 Outstanding at June 30, 2020 1,610,406 $ 13.29 7.64 $ — Exercisable at June 30, 2020 795,266 $ 18.15 6.16 $ — |
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 table below. Three Months Ended June 30, 2020 2019 Volatility factor 100.62% - 104.77% 95.72% - 96.23% Expected term (in years) 5.50 - 6.25 5.50 - 6.25 Risk-free interest rates 0.44% - 0.57% 1.94% Dividend yield — — Six Months Ended June 30, 2020 2019 Volatility factor 94.37% - 104.77% 88.27% - 96.23% Expected term (in years) 5.50 - 6.25 5.50 - 6.25 Risk-free interest rates 0.44% - 1.67% 1.94% - 2.55% Dividend yield — — |
Organization - Additional Infor
Organization - Additional Information (Detail) $ in Thousands | Aug. 07, 2020USD ($) | Aug. 02, 2020USD ($) | Jun. 30, 2020USD ($)Subsidiary | Jun. 30, 2019USD ($) | Dec. 31, 2019USD ($) |
Organization [Line Items] | |||||
Number of subsidiaries | Subsidiary | 3 | ||||
Recurring net losses of assets and liabilities | $ 15,700 | $ 2,600 | |||
Accumulated deficit | 601,308 | $ 585,621 | |||
Cash, cash equivalents and marketable securities | 71,449 | $ 47,745 | |||
Subsequent Event | Amended And Restated Loan And Security Agreement | Food And Drug Administration Marketing Approval | |||||
Organization [Line Items] | |||||
New loan funding received | $ 5,300 | ||||
Additional loan funding received | 20,000 | ||||
Product revenue, net | $ 20,000 | ||||
Kyowa Kirin | Subsequent Event | |||||
Organization [Line Items] | |||||
Milestone payment received | $ 2,800 | ||||
EUSA | Maximum | |||||
Organization [Line Items] | |||||
Potential additional reimbursement milestones | 4,000 | ||||
EUSA | Marketing Approval in France, Italy, Spain and the United Kingdom | |||||
Organization [Line Items] | |||||
Milestone payment to be received | 2,000 | ||||
EUSA | Marketing Approval in Australia, Brazil, New Zealand, South Africa and Switzerland | |||||
Organization [Line Items] | |||||
Milestone payment to be received | $ 2,000 | ||||
Kyowa Hakko Kirin | |||||
Organization [Line Items] | |||||
Percentage of sublicense fee payable | 30.00% |
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 | Jun. 30, 2020USD ($)$ / sharesshares | Jun. 30, 2019USD ($)$ / sharesshares | Jun. 30, 2020USD ($)Segment$ / sharesshares | Jun. 30, 2019USD ($)$ / sharesshares | Dec. 31, 2019shares | Jul. 16, 2018$ / shares | Dec. 26, 2017$ / shares | 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 | $ 200,000 | $ 200,000 | $ 400,000 | $ 400,000 | |||||
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 | 1,120,000 | 1,120,000 | ||||||
Operating lease liability | $ 1,000,000 | $ 924,000 | 924,000 | ||||||
Lease incremental borrowing rate | 7.58% | ||||||||
Operating Leases, Rent Expense, Net | $ 100,000 | ||||||||
Payments to acquire furniture | $ 100,000 | ||||||||
Estimated Useful Life | 7 years | ||||||||
Common stock, shares issued | shares | 25,808,315 | 25,808,315 | 16,081,000 | ||||||
Non-cash change in fair value of PIPE Warrant liability | $ (3,098,000) | (11,025,000) | |||||||
Restricted cash balances | $ 0 | 0 | |||||||
Transfers of financial assets from Level 1 to Level 2 | 0 | 0 | |||||||
Transfers of financial assets from Level 2 to Level 1 | 0 | 0 | |||||||
Tax benefits of the stock based compensation expenses recognized | $ 0 | $ 0 | |||||||
Effective tax rate | 0.00% | ||||||||
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 | |||||||
PIPE Warrants | |||||||||
Significant Accounting Policies [Line Items] | |||||||||
Warrants exercise price | $ / shares | $ 10 | $ 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 | $ 9,300,000 | |||||||
Non-cash change in fair value of PIPE Warrant liability | $ 500,000 | $ 2,200,000 | $ 3,100,000 | $ 11,000,000 | |||||
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 | 80,309 | |||||||
Cash proceeds | $ 800,000 | ||||||||
Warrants exercisable shares of common stock outstanding | shares | 1,683,933 | 1,683,933 | |||||||
Offering Warrants | |||||||||
Significant Accounting Policies [Line Items] | |||||||||
Warrants exercise price | $ / shares | $ 12.50 | $ 12.50 | $ 12.50 | $ 12.50 | |||||
Settlement Warrants | |||||||||
Significant Accounting Policies [Line Items] | |||||||||
Warrants exercise price | $ / shares | $ 30 | $ 30 | $ 30 | $ 3 | |||||
Class of Warrant or Right, Outstanding | shares | 200,000,000 | 200,000,000 | |||||||
Class of Warrant or Right, Unissued | shares | 0 | 0 |
Summary of Total Revenues Earne
Summary of Total Revenues Earned by Partner (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | |
Disaggregation Of Revenue [Line Items] | ||||
Total revenues | $ 749 | $ 703 | $ 1,533 | $ 2,314 |
EUSA | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total revenues | $ 749 | $ 703 | $ 1,533 | $ 2,314 |
Summary of Future Minimum Lease
Summary of Future Minimum Lease Payment (Detail) - USD ($) $ in Thousands | Jun. 30, 2020 | Mar. 05, 2020 |
Operating Lease Liabilities Payments Due [Abstract] | ||
2020 (remaining 6 months) | $ 239 | |
2021 | 385 | |
2022 | 328 | |
Total lease payments | 952 | |
Less imputed interest | (28) | |
Total operating lease liabilities | $ 924 | $ 1,000 |
Summary of Fair Value of Compan
Summary of Fair Value of Company's Warrant Liability (Detail) - PIPE Warrants - USD ($) $ in Thousands | 3 Months Ended | |
Jun. 30, 2020 | Mar. 31, 2020 | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | ||
Fair value, beginning of period | $ 2,449 | $ 5,097 |
Decrease in fair value | (450) | (2,648) |
Fair value, end of period | $ 1,999 | $ 2,449 |
Key Assumptions Used to Value t
Key Assumptions Used to Value the Warrants (Detail) | Jun. 30, 2020$ / shares | Mar. 31, 2020$ / shares | Dec. 31, 2019$ / shares | May 31, 2016$ / shares |
Fair Value Measurements, Recurring and Nonrecurring, Valuation Techniques [Line Items] | ||||
Stock price | $ 5.15 | |||
PIPE Warrants | ||||
Fair Value Measurements, Recurring and Nonrecurring, Valuation Techniques [Line Items] | ||||
Stock price | $ 5.15 | $ 3.62 | $ 6.20 | $ 8.90 |
PIPE Warrants | Measurement Input, Price Volatility | ||||
Fair Value Measurements, Recurring and Nonrecurring, Valuation Techniques [Line Items] | ||||
Expected price volatility | 108.20 | 153.57 | 133.07 | 76.25 |
PIPE Warrants | Measurement Input, Expected Term | ||||
Fair Value Measurements, Recurring and Nonrecurring, Valuation Techniques [Line Items] | ||||
Expected term (in years) | 1 year | 1 year 3 months | 1 year 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 | 0.16 | 0.17 | 1.59 | 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 |
Summary of Cash, Cash Equivalen
Summary of Cash, Cash Equivalents and Marketable Securities (Detail) - USD ($) $ in Thousands | Jun. 30, 2020 | Dec. 31, 2019 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Amortized Cost | $ 71,450 | $ 47,745 |
Unrealized Losses | (1) | |
Fair Value | 71,449 | 47,745 |
Amortized Cost | 45,670 | 29,785 |
Fair Value | 45,670 | 29,785 |
Amortized Cost | 25,780 | 17,960 |
Unrealized Losses | (1) | |
Fair Value | 25,779 | 17,960 |
Cash and money market funds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Amortized Cost | 45,670 | 25,278 |
Fair Value | 45,670 | 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 | 6,791 | 17,960 |
Fair Value | 6,791 | $ 17,960 |
U.S. government agency securitie | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Amortized Cost | 18,989 | |
Unrealized Losses | (1) | |
Fair Value | $ 18,988 |
Summary of Assets and Liabiliti
Summary of Assets and Liabilities Measured at Fair Value on Recurring Basis (Detail) - USD ($) $ in Thousands | Jun. 30, 2020 | Dec. 31, 2019 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents | $ 45,670 | $ 29,785 |
Total cash, cash equivalents and marketable securities | 71,449 | 47,745 |
Cash and money market funds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents | 45,670 | 25,278 |
Fair Value Measurements Recurring | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents | 45,670 | 29,785 |
Marketable securities | 25,779 | 17,960 |
Total cash, cash equivalents and marketable securities | 71,449 | 47,745 |
Fair Value Measurements Recurring | PIPE Warrants | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Warrant liability | 1,999 | 5,097 |
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 | 6,791 | 17,960 |
Fair Value Measurements Recurring | U.S. government agency securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable securities | 18,988 | |
Fair Value Measurements Recurring | Level 1 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents | 45,670 | 25,278 |
Total cash, cash equivalents and marketable securities | 45,670 | 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 | |
Marketable securities | 25,779 | 17,960 |
Total cash, cash equivalents and marketable securities | 25,779 | 22,467 |
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 | 6,791 | 17,960 |
Fair Value Measurements Recurring | Level 2 | U.S. government agency securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable securities | 18,988 | |
Fair Value Measurements Recurring | Level 3 | PIPE Warrants | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Warrant liability | 1,999 | 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 | 45,670 | 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 | $ 45,670 | $ 25,278 |
Summary of Outstanding Securiti
Summary of Outstanding Securities not Included in Computation of Diluted Net Loss Per Common Share (Detail) - shares shares in Thousands | 6 Months Ended | |
Jun. 30, 2020 | Jun. 30, 2019 | |
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share amount, outstanding | 5,794 | 5,679 |
Stock Options | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share amount, outstanding | 1,610 | 1,295 |
PIPE Warrants | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share amount, outstanding | 1,684 | 1,684 |
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 | 2,500 |
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 |
Stock Based Compensation Expens
Stock Based Compensation Expense for Equity-Classified Awards (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Total stock-based compensation expense | $ 578 | $ 584 | $ 1,121 | $ 1,168 |
Research and development | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Total stock-based compensation expense | 125 | 168 | 240 | 338 |
General and administrative | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Total stock-based compensation expense | $ 453 | $ 416 | $ 881 | $ 830 |
Collaborations and License Ag_3
Collaborations and License Agreements - Additional Information (Detail) | Aug. 02, 2020USD ($) | Aug. 28, 2018USD ($) | Sep. 30, 2019USD ($) | Jun. 30, 2019USD ($) | May 31, 2019USD ($) | Feb. 28, 2019USD ($) | Jan. 31, 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 ($) | Apr. 30, 2016USD ($) | Mar. 31, 2016USD ($) | Dec. 31, 2015USD ($) | Dec. 31, 2012USD ($) | Mar. 31, 2010USD ($) | Dec. 31, 2006USD ($) | Jun. 30, 2020USD ($) | Sep. 30, 2019USD ($) | Jun. 30, 2019USD ($) | Mar. 31, 2019USD ($) | Dec. 31, 2018USD ($) | Sep. 30, 2018USD ($) | Mar. 31, 2018USD ($) | Jun. 30, 2020USD ($)InstallmentIndication | Jun. 30, 2019USD ($) | Dec. 31, 2017USD ($) | Dec. 31, 2015USD ($) | Feb. 28, 2018USD ($) | Nov. 30, 2018USD ($) | Feb. 28, 2019USD ($) | Dec. 31, 2019USD ($) | Aug. 31, 2019USD ($) | Feb. 28, 2017USD ($) | Apr. 30, 2014 |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||||||||||||||||||||||
License agreement date month and year | 2018-12 | ||||||||||||||||||||||||||||||||||||||||
Amounts due from pursuant to the cost-sharing provisions | $ 1,208,000 | $ 1,208,000 | $ 1,631,000 | ||||||||||||||||||||||||||||||||||||||
Revenues | 749,000 | $ 703,000 | 1,533,000 | $ 2,314,000 | |||||||||||||||||||||||||||||||||||||
Deferred revenue, current portion | 1,974,000 | 1,974,000 | $ 1,974,000 | ||||||||||||||||||||||||||||||||||||||
Deferred revenue | 3,500,000 | 3,500,000 | |||||||||||||||||||||||||||||||||||||||
Collaboration and Licensing Revenue | |||||||||||||||||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||||||||||||||||||||||
Revenues | 494,000 | 493,000 | 987,000 | 1,947,000 | |||||||||||||||||||||||||||||||||||||
Partnership Royalties | |||||||||||||||||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||||||||||||||||||||||
Revenues | 255,000 | 210,000 | 546,000 | 367,000 | |||||||||||||||||||||||||||||||||||||
Astra Zeneca Inc. | Astra Zeneca Agreement | |||||||||||||||||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||||||||||||||||||||||
Amounts due from pursuant to the cost-sharing provisions | 600,000 | $ 600,000 | |||||||||||||||||||||||||||||||||||||||
CANbridge | |||||||||||||||||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||||||||||||||||||||||
License agreement date | Mar. 31, 2016 | ||||||||||||||||||||||||||||||||||||||||
Allocation of upfront payment | $ 700,000 | ||||||||||||||||||||||||||||||||||||||||
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 | $ 1,000,000 | $ 1,000,000 | |||||||||||||||||||||||||||||||||||||
Collaborations and license agreements, time period from first commercial sale of certain product upon which the agreement expires | 10 years | ||||||||||||||||||||||||||||||||||||||||
Description of royalty percentage receivable on net sales | Upon commercialization, the Company is eligible to receive a tiered royalty, with a percentage range in the low double-digits, on net sales of approved licensed products. | ||||||||||||||||||||||||||||||||||||||||
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 | Commercial Milestone Payments | |||||||||||||||||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||||||||||||||||||||||
Collaborations and license agreements, expected milestone receivable | $ 90,000,000 | ||||||||||||||||||||||||||||||||||||||||
CANbridge | Licensing Agreements | Additional Development and Regulatory Milestone Events | |||||||||||||||||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||||||||||||||||||||||
Collaborations and license agreements, expected milestone receivable | $ 40,000,000 | ||||||||||||||||||||||||||||||||||||||||
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] | |||||||||||||||||||||||||||||||||||||||||
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. | ||||||||||||||||||||||||||||||||||||||||
Transaction price | $ 12,500,000 | $ 10,500,000 | $ 8,500,000 | ||||||||||||||||||||||||||||||||||||||
Revenues | $ 749,000 | 703,000 | $ 1,533,000 | 2,314,000 | |||||||||||||||||||||||||||||||||||||
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 | ||||||||||||||||||||||||||||||||||||
Payments received in connection with reimbursement milestones | $ 2,000,000 | ||||||||||||||||||||||||||||||||||||||||
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 | ||||||||||||||||||||||||||||||||||||||||
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 tivozanib (FOTIVDA) 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 | ||||||||||||||||||||||||||||||||||||||||
Revenue recognized as collaboration and licensing revenue related to the cumulative catch-up | $ 700,000 | $ 900,000 | $ 1,000,000 | ||||||||||||||||||||||||||||||||||||||
Deferred revenue, current portion | $ 1,000,000 | $ 1,100,000 | $ 1,300,000 | $ 1,300,000 | $ 1,100,000 | $ 1,000,000 | |||||||||||||||||||||||||||||||||||
Remaining performance obligation revenue expected to be recognized over month and year | 2022-04 | ||||||||||||||||||||||||||||||||||||||||
Research and development payment recognized | $ 700,000 | 700,000 | $ 1,500,000 | 2,300,000 | |||||||||||||||||||||||||||||||||||||
Deferred revenue continue to be recognized as collaboration and licensing revenue per quarter | 500,000 | 500,000 | |||||||||||||||||||||||||||||||||||||||
Reductions in research and development expenses | 1,900,000 | ||||||||||||||||||||||||||||||||||||||||
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 | Partnership Royalties | |||||||||||||||||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||||||||||||||||||||||
Sales royalties revenue recognized | 300,000 | 200,000 | 500,000 | 400,000 | |||||||||||||||||||||||||||||||||||||
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, 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 | TiNivo trial | |||||||||||||||||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||||||||||||||||||||||
Research and development reimbursement received | $ 2,000,000 | ||||||||||||||||||||||||||||||||||||||||
Collaborations and license agreements, deferred research and development reimbursements | 100,000 | 100,000 | |||||||||||||||||||||||||||||||||||||||
Novartis | Collaboration and Licensing Revenue | |||||||||||||||||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||||||||||||||||||||||
Collaboration and licensing revenue | 2,300,000 | ||||||||||||||||||||||||||||||||||||||||
Other income | $ 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] | |||||||||||||||||||||||||||||||||||||||||
Contribution percentage of clinical, regulatory, manufacturing and other costs | 50.00% | ||||||||||||||||||||||||||||||||||||||||
Biodesix | FOCAL trial | |||||||||||||||||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||||||||||||||||||||||
Reductions in research and development expenses | 100,000 | 100,000 | 700,000 | 200,000 | |||||||||||||||||||||||||||||||||||||
Collaborations and license agreements, royalties payment on net sales | 10.00% | ||||||||||||||||||||||||||||||||||||||||
Collaborations and license agreements, royalties payment on revenue | 25.00% | ||||||||||||||||||||||||||||||||||||||||
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] | |||||||||||||||||||||||||||||||||||||||||
Revenues | $ 25,000,000 | ||||||||||||||||||||||||||||||||||||||||
Non refundable upfront payment | $ 25,000,000 | ||||||||||||||||||||||||||||||||||||||||
Kyowa Kirin | Subsequent Event | |||||||||||||||||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||||||||||||||||||||||
Collaboration and licensing revenue | $ 2,800,000 | ||||||||||||||||||||||||||||||||||||||||
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 | Food And Drug Administration 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 | Subsequent Event | |||||||||||||||||||||||||||||||||||||||||
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 | $ 200,000 | 100,000 | 600,000 | 100,000 | |||||||||||||||||||||||||||||||||||||
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 | $ 0 | $ 100,000 | $ 100,000 | $ 200,000 |
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 | 6 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||
Revenues | $ 749 | $ 703 | $ 1,533 | $ 2,314 |
Partnership Royalties | ||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||
Revenues | 255 | 210 | 546 | 367 |
EUSA | ||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||
Collaboration and Licensing Revenue | 700 | 700 | 1,500 | 2,300 |
Revenues | 749 | 703 | 1,533 | 2,314 |
ASC 606 | EUSA | ||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||
Revenues | 749 | 703 | 1,533 | 2,314 |
ASC 606 | EUSA | Collaboration and Licensing Revenue | ||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||
Revenues | 494 | 493 | 987 | 1,947 |
ASC 606 | EUSA | Partnership Royalties | ||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||
Revenues | 255 | 210 | $ 546 | 367 |
Upfront Payment | ASC 606 | EUSA | ||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||
Date Achieved | 2015-12 | |||
Collaboration and Licensing Revenue | 99 | 98 | $ 197 | 197 |
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 | 158 | 158 | $ 316 | 316 |
Milestone - UK Reimbursement Approval | ASC 606 | EUSA | ||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||
Date Achieved | 2018-02 | |||
Collaboration and Licensing Revenue | 79 | 79 | $ 158 | 158 |
Milestone - German Reimbursement Approval | ASC 606 | EUSA | ||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||
Date Achieved | 2018-11 | |||
Collaboration and Licensing Revenue | 79 | 79 | $ 158 | 158 |
Milestone - Spanish Reimbursement Approval | ASC 606 | EUSA | ||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||
Date Achieved | 2019-02 | |||
Collaboration and Licensing Revenue | $ 79 | $ 79 | $ 158 | $ 1,118 |
Summary of Changes in Accounts
Summary of Changes in Accounts Receivable and Contract Liabilities (Deferred Revenue) (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2020 | Mar. 31, 2019 | Dec. 31, 2018 | Mar. 31, 2018 | Jun. 30, 2020 | |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||
Ending Balance June 30, 2020 | $ 3,500 | $ 3,500 | |||
EUSA | |||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||
Contract Liabilities, Transaction Price | $ 12,500 | $ 10,500 | $ 8,500 | ||
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 | (987) | ||||
Ending Balance June 30, 2020 | 3,539 | 3,539 | |||
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 | (197) | ||||
Ending Balance June 30, 2020 | $ 710 | 710 | |||
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 | (316) | ||||
Ending Balance June 30, 2020 | $ 1,132 | 1,132 | |||
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 | (158) | ||||
Ending Balance June 30, 2020 | $ 566 | 566 | |||
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 | (158) | ||||
Ending Balance June 30, 2020 | $ 565 | 565 | |||
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 | (158) | ||||
Ending Balance June 30, 2020 | $ 566 | 566 | |||
Accounting Standards Update 2014-09 | EUSA | Accounts Receivable | |||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||
Beginning Balance January 1, 2020 | 270 | ||||
Additions | 546 | ||||
Deductions | (561) | ||||
Ending Balance June 30, 2020 | $ 255 | $ 255 |
Other Accrued Liabilities (Deta
Other Accrued Liabilities (Detail) - USD ($) $ in Thousands | Jun. 30, 2020 | Dec. 31, 2019 |
Payables And Accruals [Abstract] | ||
Professional fees | $ 656 | $ 806 |
Compensation and benefits | 1,248 | 1,284 |
Other | 217 | 246 |
Total | $ 2,121 | $ 2,336 |
Loans Payable - Additional Info
Loans Payable - Additional Information (Detail) | 1 Months Ended | 6 Months Ended | |||||||||||
Nov. 30, 2018USD ($)Installment | Dec. 31, 2017USD ($)Installmentshares | Jun. 30, 2017USD ($) | May 31, 2016USD ($) | Sep. 30, 2014USD ($) | Jun. 30, 2020USD ($) | 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, end-of-term payment due | $ 790,000 | ||||||||||||
Maximum amount of debt conversion | 2,000,000 | ||||||||||||
Loan payable, interest rate | 9.45% | 9.70% | 9.95% | 9.95% | 9.70% | ||||||||
Unamortized discount recognized | 199,000 | $ 400,000 | |||||||||||
Loans Payable | Minimum | |||||||||||||
Debt Instrument [Line Items] | |||||||||||||
Option to purchase equity, net cash proceeds of equity securities | $ 10,000,000 | ||||||||||||
Hercules Amended Loan Agreement | Loans Payable | |||||||||||||
Debt Instrument [Line Items] | |||||||||||||
Proceeds from additional borrowing capacity | $ 10,000,000 | ||||||||||||
Loan payable, due date | Jan. 2, 2018 | ||||||||||||
Loan payable, end-of-term payment due | $ 500,000 | ||||||||||||
Loan issuance costs paid | $ 200,000 | ||||||||||||
Loan payable, interest rate | 11.90% | 9.45% | |||||||||||
Hercules May 2016 Loan Agreement | Loans Payable | |||||||||||||
Debt Instrument [Line Items] | |||||||||||||
Proceeds from additional borrowing capacity | $ 10,000,000 | ||||||||||||
Loan payable, due date | Dec. 1, 2019 | ||||||||||||
Loan payable, end-of-term payment due | $ 300,000 | ||||||||||||
Loan issuance costs paid | 100,000 | ||||||||||||
Loan outstanding principal amount | $ 20,000,000 | ||||||||||||
Loan payable, Commencement date | Jan. 1, 2018 | ||||||||||||
Hercules May 2016 Loan Agreement | Loans Payable | Tranche One | |||||||||||||
Debt Instrument [Line Items] | |||||||||||||
Proceeds from additional borrowing capacity | $ 5,000,000 | ||||||||||||
Hercules May 2016 Loan Agreement | Loans Payable | Tranche Two | |||||||||||||
Debt Instrument [Line Items] | |||||||||||||
Proceeds from additional borrowing capacity | $ 5,000,000 | ||||||||||||
Hercules May 2016 Loan Agreement | Loans Payable | Minimum | Financial covenant | |||||||||||||
Debt Instrument [Line Items] | |||||||||||||
Unrestricted and unencumbered cash and cash equivalents | $ 10,000,000 | ||||||||||||
2017 Loan Agreement with Hercules | |||||||||||||
Debt Instrument [Line Items] | |||||||||||||
Proceeds from additional borrowing capacity | $ 20,000,000 | ||||||||||||
Loan outstanding principal amount | $ 11,300,000 | ||||||||||||
Maximum amount of debt conversion | 2,000,000 | ||||||||||||
Refinancing amount | $ 20,000,000 | ||||||||||||
Loan facility maturity period | 42 months | ||||||||||||
Loan facility extension period | 24 months | ||||||||||||
Warrants issued to lenders as part of new loan agreement, shares of common stock to purchase | shares | 0 | ||||||||||||
Loan payable, number of installments of principal and interest | Installment | 24 | ||||||||||||
Loan payable, Commencement date deferred by six months | Aug. 1, 2019 | ||||||||||||
Loan payable, frequency of installments of principal and interest | monthly payments of principal and interest | ||||||||||||
2017 Loan Agreement with Hercules | July 2021 | |||||||||||||
Debt Instrument [Line Items] | |||||||||||||
Approximate payment of principle and interest | $ 900,000 | ||||||||||||
2017 Loan Agreement with Hercules | Loans Payable | |||||||||||||
Debt Instrument [Line Items] | |||||||||||||
Loan payable, due date | Jul. 1, 2021 | ||||||||||||
Loan issuance costs paid | $ 100,000 | ||||||||||||
Loan payable, number of installments of principal and interest | Installment | 29 | ||||||||||||
Loan payable, interest rate | 9.45% | 10.20% | |||||||||||
Loan payable, Commencement date deferred by six months | 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 | ||||||||||||
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 is 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 | Loans Payable | July 2021 | |||||||||||||
Debt Instrument [Line Items] | |||||||||||||
Approximate payment of principle and interest | $ 800,000 | ||||||||||||
2017 Loan Agreement with Hercules | Loans Payable | Minimum | |||||||||||||
Debt Instrument [Line Items] | |||||||||||||
Loan payable, interest rate | 9.45% | ||||||||||||
2017 Loan Agreement with Hercules | Loans Payable | Minimum | Financial covenant | |||||||||||||
Debt Instrument [Line Items] | |||||||||||||
Unrestricted and unencumbered cash and cash equivalents | $ 10,000,000 | ||||||||||||
2017 Loan Agreement with Hercules | Loans Payable | Maximum | |||||||||||||
Debt Instrument [Line Items] | |||||||||||||
Loan payable, interest rate | 15.00% |
Future Minimum Payments Under L
Future Minimum Payments Under Loans Payable (Detail) - USD ($) $ in Thousands | Jun. 30, 2020 | Dec. 31, 2019 |
Debt Disclosure [Abstract] | ||
2020 (remaining 6 months) | $ 5,514 | |
2021 | 7,254 | |
Long-term Debt, Gross, Total | 12,768 | |
Less amount representing interest | (646) | |
Less unamortized discount | (199) | $ (400) |
Less deferred charges | (790) | |
Less loans payable current, net of discount | (10,193) | (9,569) |
Loans payable, net of current portion and discount | $ 940 | $ 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 | Jun. 19, 2020USD ($)Affiliate$ / sharesshares | Feb. 29, 2020 | Apr. 30, 2019USD ($)$ / sharesshares | Feb. 28, 2019USD ($)shares | May 31, 2016USD ($)$ / sharesshares | Dec. 31, 2018USD ($)shares | Jun. 30, 2020USD ($)$ / sharesshares | Jul. 15, 2019shares | Dec. 31, 2019USD ($)$ / sharesshares | Jun. 30, 2019$ / sharesshares | Feb. 28, 2018USD ($) | Nov. 30, 2017USD ($) |
Class of Stock [Line Items] | ||||||||||||||||
Common stock, shares authorized | 50,000,000 | 50,000,000 | ||||||||||||||
Common stock, shares issued | 25,808,315 | 16,081,000 | ||||||||||||||
Common stock, shares outstanding | 25,808,315 | 16,081,000 | ||||||||||||||
Common stock, par value | $ / shares | $ 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 | $ | $ 37,000 | |||||||||||||||
Common stock sales agreement, aggregate offering amount | $ | $ 26,000 | $ 16,000 | ||||||||||||||
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 | |||||||||||||||
Warrants exercise price | $ / shares | $ 30 | $ 3 | $ 30 | |||||||||||||
Warrants exercisable period | 1 year | 1 year | ||||||||||||||
Class of Warrant or Right, Outstanding | 200,000,000 | |||||||||||||||
Warrant expiration date | Jul. 15, 2019 | |||||||||||||||
Warrants exercised during period | 0 | |||||||||||||||
S V B 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 | $ | $ 32,000,000 | |||||||||||||||
Underwritten Public Offering | ||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||
Common stock, shares issued | 9,725,000 | 2,173,913 | ||||||||||||||
Gross proceeds from common stock and warrant issed | $ | $ 51,100,000 | |||||||||||||||
Number Of Affiliates Stockholders | Affiliate | 3 | |||||||||||||||
Number of other stockholders | Affiliate | 2 | |||||||||||||||
Percentage Of affiliates stockholders | 5.00% | |||||||||||||||
Net proceeds from public offering | $ | $ 47,800,000 | $ 22,800,000 | ||||||||||||||
Gross proceeds from common stock and warrant issed | $ | $ 25,000,000 | |||||||||||||||
Percentage of beneficial ownership of voting securities | 5.00% | |||||||||||||||
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 | |||||||||||||||
Warrant expiration period | 2021-04 | |||||||||||||||
Class of Warrant or Right, Outstanding | 2,500,000 | |||||||||||||||
Underwritten Public Offering | New Enterprise Associates and Another Stockholder | ||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||
Common stock, shares issued | 4,503,571 | |||||||||||||||
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 | S V B Leerink | ||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||
Stock issued during period, shares | 1,251,555 | |||||||||||||||
Net proceeds from issuance of common stock | $ | $ 7,500,000 | |||||||||||||||
PIPE Warrants | Private Placement | ||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||
Common stock, shares issued | 1,764,242 | |||||||||||||||
Shares issued, price per share | $ / shares | $ 9.65 | |||||||||||||||
Warrants exercise price | $ / shares | $ 10 | |||||||||||||||
Warrants exercisable period | 5 years | |||||||||||||||
Warrant expiration period | 2021-05 | |||||||||||||||
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 | $ | $ 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 | |||||||||||||||
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 | $ | $ 200,000,000 | |||||||||||||||
Maximum | S V B 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 ($) $ / shares in Units, $ in Millions | 6 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Mar. 31, 2020 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Additional Shares Authorized | 1,300,000 | ||
Increase total number of shares reserved | 1,300,000 | ||
Stock price | $ 5.15 | ||
Total unrecognized stock-based compensation expense related to stock options granted | $ 5.3 | ||
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 | 1,750,500 | ||
Employee Stock Purchase Plan, 2010 | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Shares of common stock available for future issuance | 0 | ||
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 | $ 4.71 | $ 5.80 | |
Total unrecognized stock-based compensation expense, weighted-average period Recognition | 2 years 9 months 18 days | ||
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) | 6 Months Ended |
Jun. 30, 2020$ / sharesshares | |
Options | |
Outstanding at beginning of period | shares | 1,168,222 |
Granted | shares | 485,802 |
Forfeited | shares | (43,618) |
Outstanding at end of period | shares | 1,610,406 |
Exercisable at June 30, 2020 | shares | 795,266 |
Weighted-Average Exercise Price | |
Outstanding at beginning of period | $ / shares | $ 16.77 |
Granted | $ / shares | 6.07 |
Forfeited | $ / shares | 26.27 |
Outstanding at end of period | $ / shares | 13.29 |
Exercisable at June 30, 2020 | $ / shares | $ 18.15 |
Weighted-Average Remaining Contractual Term | |
Outstanding at June 30, 2020 | 7 years 9 months 14 days |
Exercisable at June 30, 2020 | 6 years 2 months 4 days |
Assumptions Used in Black Schol
Assumptions Used in Black Scholes Pricing Model for New Grants (Detail) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Volatility factor, minimum | 100.62% | 95.72% | 94.37% | 88.27% |
Volatility factor, maximum | 104.77% | 96.23% | 104.77% | 96.23% |
Risk-free interest rates, minimum | 0.44% | 0.44% | 1.94% | |
Risk-free interest rates, maximum | 0.57% | 1.94% | 1.67% | 2.55% |
Dividend yield | 0.00% | 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 | 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 | 6 years 3 months |
Legal Proceedings - Additional
Legal Proceedings - Additional Information (Detail) $ / shares in Units, $ in Millions | Jul. 16, 2018$ / shares | Dec. 26, 2017USD ($)$ / sharesshares | Mar. 29, 2016USD ($) | Feb. 28, 2018USD ($) | Jun. 30, 2020LegalMatter | Jul. 15, 2019shares | Dec. 31, 2017USD ($) | Dec. 31, 2015USD ($) | Jun. 30, 2019$ / shares | Jun. 29, 2018USD ($) |
Loss Contingencies [Line Items] | ||||||||||
Attorney fees cost and expenses | $ 15 | |||||||||
Reserve for settlement of fines | $ 17.1 | |||||||||
Estimated insurance recoveries | 15 | |||||||||
Non-cash charge for Settlement warrants | 2.1 | $ 4 | ||||||||
Reversal of cash settlement from contingent liability | $ 15 | |||||||||
Litigation settlement amount paid by company | $ 4 | |||||||||
Settlement fees | $ 2.1 | $ 4 | ||||||||
Settlement Warrants | ||||||||||
Loss Contingencies [Line Items] | ||||||||||
Warrants to purchase of common stock shares | shares | 200,000 | |||||||||
Warrants exercisable period | 1 year | 1 year | ||||||||
Warrants exercise price | $ / shares | $ 30 | $ 3 | $ 30 | |||||||
Cash settlement from insurance carriers | $ 15 | |||||||||
Warrant expired | shares | 200,000 | |||||||||
Warrant expiration date | Jul. 15, 2019 | |||||||||
Warrants exercised during period | shares | 0 | |||||||||
Derivative Lawsuits | ||||||||||
Loss Contingencies [Line Items] | ||||||||||
Loss contingency claims filed against company | LegalMatter | 2 |
Subsequent Events - Hercules _2
Subsequent Events - Hercules Loan Restructuring - Additional Information (Detail) | Jul. 01, 2021USD ($) | Aug. 31, 2020USD ($) | Jun. 30, 2022USD ($) | Jul. 02, 2021USD ($) | Jun. 30, 2021USD ($) |
Subsequent Event [Line Items] | |||||
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. | ||||
Subsequent Event | |||||
Subsequent Event [Line Items] | |||||
Revenues | $ 20,000,000 | ||||
Tranche Two | Scenario Forecast | |||||
Subsequent Event [Line Items] | |||||
Loan facility received | $ 10,000,000 | ||||
Tranche Three | Scenario Forecast | |||||
Subsequent Event [Line Items] | |||||
Loan facility received | $ 5,000,000 | ||||
Tranche four | Scenario Forecast | |||||
Subsequent Event [Line Items] | |||||
Loan facility received | $ 5,000,000 | ||||
2020 Loan Agreement | Subsequent Event | |||||
Subsequent Event [Line Items] | |||||
Loan facility | 35,000,000 | ||||
Secured Debt | 9,700,000 | ||||
New loan funding received | $ 5,300,000 | ||||
Prime interest rate | 3.25% | ||||
Interest rate | 0.030 | ||||
Percentage of loan aggregate amount | 6.95% | ||||
Loan issuance costs paid | $ 300,000 | ||||
Unrestricted cash | $ 5,000,000 | ||||
2020 Loan Agreement | Subsequent Event | Minimum | |||||
Subsequent Event [Line Items] | |||||
Interest rate | 9.65% | ||||
Unrestricted cash | $ 10,000,000 | ||||
Percentage of forecast revenue | 75.00% | ||||
2020 Loan Agreement | Subsequent Event | Maximum | |||||
Subsequent Event [Line Items] | |||||
Interest rate | 15.00% | ||||
Undiscounted Excess Amount | $ 500,000 | ||||
2020 Loan Agreement | Tranche one | Subsequent Event | |||||
Subsequent Event [Line Items] | |||||
Loan facility received | $ 15,000,000 | ||||
2017 Loan Agreement | Scenario Forecast | |||||
Subsequent Event [Line Items] | |||||
Amount of term payment | $ 800,000 |