Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2019 | May 03, 2019 | |
Document And Entity Information [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Mar. 31, 2019 | |
Document Fiscal Year Focus | 2019 | |
Document Fiscal Period Focus | Q1 | |
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 Common Stock, Shares Outstanding | 160,739,471 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets (Unaudited) - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
Current assets: | ||
Cash and cash equivalents | $ 23,483 | $ 24,427 |
Accounts receivable | 2,571 | 3,026 |
Clinical trial retainers | 42 | 126 |
Other prepaid expenses and other current assets | 199 | 356 |
Total current assets | 26,295 | 27,935 |
Other assets | 212 | |
Total assets | 26,507 | 27,935 |
Current liabilities: | ||
Accounts payable | 2,109 | 3,499 |
Accrued clinical trial costs and contract research | 6,352 | 6,254 |
Other accrued liabilities | 2,132 | 2,698 |
Loans payable, net of discount | 5,688 | 3,254 |
Deferred revenue | 1,974 | 1,658 |
Deferred research and development reimbursements | 336 | 454 |
Other liabilities (Note 6) | 300 | 300 |
Total current liabilities | 18,891 | 18,117 |
Loans payable, net of current portion and discount | 13,511 | 15,779 |
Deferred revenue | 4,032 | 3,802 |
PIPE Warrant liability (Note 7) | 7,859 | 16,674 |
Other liabilities (Note 6) | 790 | 790 |
Total liabilities | 45,083 | 55,162 |
Stockholders’ deficit: | ||
Preferred stock, $.001 par value: 5,000 shares authorized at March 31, 2019 and December 31, 2018; no shares issued and outstanding at each of March 31, 2019 and December 31, 2018 | ||
Common stock, $.001 par value: 250,000 shares authorized at March 31, 2019 and December 31, 2018; 139,000 and 126,485 shares issued and outstanding as of March 31, 2019 and December 31, 2018, respectively | 139 | 126 |
Additional paid-in capital | 575,738 | 567,655 |
Accumulated other comprehensive income | 1 | 1 |
Accumulated deficit | (594,454) | (595,009) |
Total stockholders’ deficit | (18,576) | (27,227) |
Total liabilities and stockholders’ deficit | $ 26,507 | $ 27,935 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Mar. 31, 2019 | Dec. 31, 2018 |
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 | 250,000,000 | 250,000,000 |
Common stock, shares issued | 139,000,000 | 126,485,000 |
Common stock, shares outstanding | 139,000,000 | 126,485,000 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations (Unaudited) - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Revenues: | ||
Revenues | $ 1,611 | $ 1,026 |
Operating expenses: | ||
Research and development | 6,852 | 5,404 |
General and administrative | 2,455 | 2,610 |
Settlement costs (Note 9) | 42 | |
Operating expenses, total | 9,307 | 8,056 |
Loss from operations | (7,696) | (7,030) |
Other income (expense), net: | ||
Interest expense, net | (564) | (493) |
Change in fair value of PIPE Warrant liability | 8,815 | (1,465) |
Other income (expense), net | 8,251 | (1,958) |
Net income (loss) | $ 555 | $ (8,988) |
Basic net income (loss) per share | ||
Net income (loss) per share | $ 0.01 | $ (0.08) |
Weighted average number of common shares outstanding | 132,304 | 118,840 |
Diluted net income (loss) per share | ||
Net income (loss) per share | $ (0.06) | $ (0.08) |
Weighted average number of common shares and dilutive common share equivalents outstanding | 132,831 | 118,840 |
Collaboration and Licensing Revenue | ||
Revenues: | ||
Revenues | $ 1,454 | $ 980 |
Partnership Royalties | ||
Revenues: | ||
Revenues | $ 157 | $ 46 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Comprehensive Income (Loss) (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Statement Of Income And Comprehensive Income [Abstract] | ||
Net income (loss) | $ 555 | $ (8,988) |
Other comprehensive income (loss): | ||
Comprehensive income (loss) | $ 555 | $ (8,988) |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Stockholders' Deficit (Unaudited) - USD ($) shares in Thousands, $ in Thousands | Total | SVB Leerink | Common Shares | Common SharesSVB Leerink | Additional Paid-in Capital | Additional Paid-in CapitalSVB Leerink | Accumulated Other Comprehensive Income (Loss) | Accumulated Deficit |
Beginning Balance at Dec. 31, 2017 | $ (40,763) | $ 118 | $ 546,092 | $ (4) | $ (586,969) | |||
Beginning Balance (in shares) at Dec. 31, 2017 | 118,325 | |||||||
Adjustment related to adoption of new revenue recognition standard ASC 606 | ASC 606 | (2,711) | (2,711) | ||||||
Stock-based compensation expense related to equity-classified awards | Equity-classified awards | 583 | 583 | ||||||
Issuance of common stock in connection with warrant exercises | 518 | $ 1 | 517 | |||||
Issuance of common stock in connection with warrant exercises (in shares) | 518 | |||||||
Reduction in PIPE Warrant liability in connection with warrant exercises | 1,101 | 1,101 | ||||||
Exercise of stock options | 15 | 15 | ||||||
Exercise of stock options (in shares) | 24 | |||||||
Net income (loss) | (8,988) | (8,988) | ||||||
Ending Balance at Mar. 31, 2018 | (50,245) | $ 119 | 548,308 | (4) | (598,668) | |||
Ending Balance (in shares) at Mar. 31, 2018 | 118,867 | |||||||
Beginning Balance at Dec. 31, 2018 | (27,227) | $ 126 | 567,655 | 1 | (595,009) | |||
Beginning Balance (in shares) at Dec. 31, 2018 | 126,485 | |||||||
Issuance of common stock from the SVB Leerink sales agreement (net of issuance costs of $0.2 million) | $ 7,512 | $ 13 | $ 7,499 | |||||
Issuance of common stock from the SVB Leerink sales agreement (net of issuance costs of $0.2 million) (in shares) | 12,515 | |||||||
Stock-based compensation expense related to equity-classified awards | Equity-classified awards | 584 | 584 | ||||||
Net income (loss) | 555 | 555 | ||||||
Ending Balance at Mar. 31, 2019 | $ (18,576) | $ 139 | $ 575,738 | $ 1 | $ (594,454) | |||
Ending Balance (in shares) at Mar. 31, 2019 | 139,000 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Stockholders' Deficit (Unaudited) (Parenthetical) $ in Millions | 3 Months Ended |
Mar. 31, 2019USD ($) | |
Additional Paid-in Capital | SVB Leerink | |
Issuance of common stock, issuance costs | $ 0.2 |
Condensed Consolidated Statem_5
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Operating activities | ||
Net income (loss) | $ 555 | $ (8,988) |
Adjustments to reconcile net income (loss) to net cash used in operating activities: | ||
Stock-based compensation | 584 | 583 |
Non-cash interest expense | 166 | 111 |
Non-cash change in fair value of PIPE Warrant liability | (8,815) | 1,465 |
Non-cash charge for Settlement Warrants (Note 9) | 42 | |
Amortization of premium and discount on investments | 5 | |
Changes in operating assets and liabilities: | ||
Accounts receivable | 455 | (198) |
Prepaid expenses and other current assets | 241 | 249 |
Other noncurrent assets | 4 | |
Accounts payable | (1,390) | 944 |
Accrued contract research | 98 | (984) |
Other accrued liabilities | (778) | (496) |
Deferred revenue | 546 | 1,019 |
Deferred research and development reimbursements | (118) | (274) |
Net cash used in operating activities | (8,456) | (6,518) |
Investing activities | ||
Purchases of marketable securities | (6,801) | |
Proceeds from maturities and sales of marketable securities | 14,537 | |
Net cash provided by investing activities | 7,736 | |
Financing activities | ||
Proceeds from issuance of common stock, net of issuance costs | 7,512 | 518 |
Proceeds from issuance of stock for stock-based compensation arrangements | 15 | |
Payment of end-of-term loan costs (Note 6) | (540) | |
Net cash provided by (used in) financing activities | 7,512 | (7) |
Net (decrease) increase in cash and cash equivalents | (944) | 1,211 |
Cash and cash equivalents at beginning of period | 24,427 | 14,949 |
Cash and cash equivalents at end of period | 23,483 | 16,160 |
Supplemental cash flow information | ||
Cash paid for interest | 507 | 509 |
Non-cash operating activity | ||
Increase to deferred revenue due to adoption of ASC Topic 606 - transition adjustment on January 1, 2018 | $ 2,711 | |
Deferred offering costs accrued at period end | $ 212 |
Organization
Organization | 3 Months Ended |
Mar. 31, 2019 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Organization | (1) Organization AVEO Pharmaceuticals, Inc. (the “Company”) is a biopharmaceutical company seeking to advance targeted medicines for oncology and other unmet medical needs. The Company is working to develop and commercialize its lead candidate tivozanib in North America as a treatment for advanced or metastatic renal cell carcinoma (“RCC”). In November 2018, the Company announced that its phase 3 randomized, controlled, multi-center, open-label trial comparing tivozanib to an approved therapy, sorafenib (Nexavar ® The Company is leveraging several collaborations in the development of tivozanib. The Company has sublicensed tivozanib, marketed under the brand name FOTIVDA ® ® ® As part of the Company’s strategy, the Company has also entered into partnerships to help fund the development and commercialization of its other product candidates. Ficlatuzumab, a hepatocyte growth factor (“HGF”) inhibitory antibody, is currently being tested in several investigator sponsored studies jointly funded by the Company and its development partner for the potential treatment of squamous cell carcinoma of the head and neck, acute myeloid leukemia, and pancreatic cancer. The Company’s partner for AV-203, an anti-ErbB3 monoclonal antibody, is planning to initiate clinical studies in China in 2019 in esophageal squamous cell carcinoma (“ESCC”), and has committed to funding the development of AV-203 through proof-of-concept. The Company recently regained the rights to AV-380, a humanized IgG1 inhibitory monoclonal antibody targeting growth differentiation factor 15 (“GDF15”), a divergent member of the TGF-ß family, for the potential treatment of cancer cachexia, and is working to initiate preclinical toxicology studies in 2019 to support the potential filing of an investigational new drug application (“IND”) with the FDA. The Company is evaluating options for the development of its preclinical AV-353 program which targets the Notch 3 pathway. As used throughout these condensed consolidated financial statements, the terms “AVEO,” and the “Company” refer to the business of AVEO Pharmaceuticals, Inc. and its three wholly-owned subsidiaries, AVEO Pharma Limited, AVEO Pharma (Ireland) Limited and AVEO Securities Corporation. Liquidity The Company has financed its operations to date 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. As of March 31, 2019, the Company had cash, cash equivalents and marketable securities totaling approximately $23.5 million, working capital of $7.4 million and an accumulated deficit of $594.5 million. The Company is subject to a number of risks, including the need for substantial additional capital for clinical research and product development. As of March 31, 2019, the Company had approximately $23.5 million in cash, cash equivalents and marketable securities. In April 2019, the Company completed an underwritten public offering of 21,739,131 shares of its common stock and warrants to purchase an aggregate of 25,000,000 shares of its common stock (“the Offering Warrants”), including warrants to purchase an aggregate of 3,260,869 shares of its common stock sold pursuant to the underwriter’s partial exercise of its overallotment option, Common Stock – Public Offering – April 2019 Collaborations and License Agreements Based on its available cash resources, the Company believes it has sufficient cash on hand to support current operations for at least the next twelve months from the date of filing this Quarterly Report on Form 10-Q. This estimate excludes possible additional clinical trials the Company may sponsor and remaining costs to prepare and filing fees Common Stock.” The Company will need additional funding to support its planned operating activities. Accordingly, the timing and nature of activities contemplated for 2019 and thereafter will be conducted subject to the availability of sufficient financial resources. If the Company is unable to raise capital when needed or on attractive terms, it would be forced to delay, reduce or eliminate its research and development programs and any future commercialization efforts. |
Basis of Presentation
Basis of Presentation | 3 Months Ended |
Mar. 31, 2019 | |
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 10 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 months ended March 31, 2019 are not necessarily indicative of the results that may be expected for the fiscal year ending December 31, 2019 or any other future period. The information presented in the condensed consolidated financial statements and related footnotes at March 31, 2019, and for the three months ended March 31, 2019 and 2018, is unaudited, and the condensed consolidated balance sheet amounts and related footnotes as of December 31, 2018 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, 2018, which was filed with the U.S. Securities and Exchange Commission (“SEC”) on March 14, 2019. |
Significant Accounting Policies
Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2019 | |
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 Accounting Standards Codification (“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 ended March 31, 2019 and 2018, respectively, by partner (in thousands). Refer to Note 4, “Collaborations and License Agreements” regarding specific details. Three Months Ended March 31, 2019 2018 EUSA $ 1,611 $ 1,026 Total $ 1,611 $ 1,026 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 internal costs for salaries, bonuses, benefits, stock-based compensation, facilities, and research-related overhead, and external costs for clinical trials, drug manufacturing and distribution, license fees, consultants and other contracted services. Warrants Issued in Connection with Private Placement In May 2016, the Company issued warrants to purchase an aggregate of 17,642,482 shares of common stock in connection with a private placement financing and recorded the warrants as a liability (the “PIPE Warrants”). The Company accounts for warrant instruments that either conditionally or unconditionally obligate the issuer to transfer assets as liabilities regardless of the timing of the redemption feature or price, even though the underlying shares may be classified as permanent or temporary equity. As of March 31, 2019, PIPE Warrants exercisable for 803,108 shares of common stock had been exercised, for approximately $0.8 million in cash proceeds, and PIPE Warrants exercisable for 16,839,375 shares of common stock were outstanding. Refer to Note 7, “ Common Stock—Private Placement / PIPE Warrants” The PIPE Warrants contain a provision giving the warrant holder the option to receive cash, equal to the fair value of the remaining unexercised portion of the warrant, as cash settlement in the event that there is a fundamental transaction (contractually defined to include various merger, acquisition or stock transfer activities). Due to this provision, ASC 480, Distinguishing Liabilities from Equity The Company recorded a non-cash gain of approximately $8.8 million and a non-cash loss of approximately $1.5 million in the three months ended March 31, 2019 and 2018, respectively, in its Statement of Operations attributable to the decrease and increase, respectively, in the fair value of the PIPE Warrant liability that resulted from a lower stock price as of March 31, 2019 and a higher stock price as of March 31, 2018, respectively, relative to prior periods. In the three months ended March 31, 2018, the Company recorded a reduction in the PIPE Warrant liability, with a corresponding increase to additional paid-in capital, of approximately $1.1 million attributable to PIPE Warrant exercises in the first quarter of 2018. 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 March 31, 2019 (in thousands): Fair value at January 1, 2019 $ 16,674 Decrease in fair value (8,815 ) Fair value at March 31, 2019 $ 7,859 The key assumptions used to value the PIPE Warrants were as follows: Issuance December 31, 2018 March 31, 2019 Expected price volatility 76.25 % 82.64 % 111.99 % Expected term (in years) 5.00 2.50 2.25 Risk-free interest rates 1.22 % 2.47 % 2.27 % Stock price $ 0.89 $ 1.60 $ 0.82 Dividend yield — — — Prior Class Action Settlement and Settlement Warrants In December 2017, the Company entered into a binding memorandum of understanding (the “MOU”) with class representatives Bob Levine and William Windham (the “Plaintiffs”), regarding the settlement of a securities class action lawsuit (the “2013 Class Action”) that had been filed in 2013 and was pending in the United States District Court for the District of Massachusetts (the “District Court”) against the Company and certain of the Company’s former officers (Tuan Ha-Ngoc, David Johnston, and William Slichenmyer, together, the “Individual Defendants”), In re AVEO Pharmaceuticals, Inc. Securities Litigation et al. In December 2017, upon entering into the MOU, the Company’s liability related to this settlement became estimable and probable. Accordingly, the Company recorded an estimated $17.1 million contingent liability, including $15.0 million for the cash portion of the settlement with a corresponding insurance recovery for the 100% portion to be paid directly by certain of the Company’s insurance carriers, and an approximate $2.1 million estimate for the fair value on December 31, 2017 of 2.0 million warrants to purchase shares of its common stock that the Company agreed to issue the Class (the “Settlement Warrants”), with a corresponding non-cash charge to the Statement of Operations as a component of operating expense. The Settlement Warrants are exercisable for a one-year period from their date of issue at an exercise price equal to the closing price on December 22, 2017, the trading day prior to the execution of the MOU, which was $3.00 per share. In January 2018, the Company entered into a definitive stipulation of settlement agreement (the “Stipulation”). In February 2018, the District Court preliminarily approved the Stipulation, following which the insurance carriers funded the settlement escrow account related to the $15.0 million cash portion of the settlement. On May 30, 2018, the District Court approved the Stipulation in its order of final approval and final judgment (the “Final Judgment”). Upon the conclusion of a 30-day appeal period, the Effective Date was deemed to be June 29, 2018. Pursuant to the Final Judgment, all claims against the Company were released upon the Effective Date. In addition, pursuant to the Stipulation, the Company had no interest in the settlement escrow account subsequent to the Effective Date. Accordingly, the $15 million contingent liability associated with the cash portion of the settlement and the corresponding insurance recovery was eliminated on the Effective Date. The Company had agreed to use its best efforts to issue and deliver the Settlement Warrants within ten business days following the Effective Date. On July 16, 2018, the Company issued and delivered the Settlement Warrants in accordance with the Stipulation and filed a corresponding shelf registration statement, File No. (333-226190) to register the shares of common stock underlying the Settlement Warrants which was declared effective by the SEC on July 25, 2018. Refer to Note 9, “ Legal Proceedings The estimated fair value of the Settlement Warrants was determined using the Black-Scholes pricing model. The estimated fair value of the Settlement Warrants was subject to revaluation at each balance sheet date and any changes in fair value were recorded as a non-cash gain or (loss) in the Statement of Operations as a component of operating expenses until the Settlement Warrants were issued. The Company recorded a non-cash loss of approximately $42,000 in the three months ended March 31, 2018 in its Statement of Operations attributable to the increase in the fair value of the Settlement Warrants that principally resulted from a higher stock price as of March 31, 2018, relative to prior periods. In addition, the fair value of the Settlement Warrants on June 30, 2018 was determined based on the estimated fair value of the Settlement Warrants at the time of issuance. The Company recorded non-cash gains of approximately $0.7 million in each of the three months and six months ended June 30, 2018, respectively, in its Statement of Operations attributable to the decrease in the fair value of the Settlement Warrants that principally resulted from a lower volatility rate relative to prior periods. In July 2018, upon the issuance of the Settlement Warrants, the Company reclassified the approximate $1.4 million value of the Settlement Warrants from a liability to stockholders equity as a component of additional paid-in-capital based upon the terms of the warrant agreement and, accordingly, the approximate $1.4 million contingent liability on the Company’s balance sheet associated with the warrant portion of the settlement was eliminated. The key assumptions used to estimate the fair value the Settlement Warrants were as follows: December 31, 2017 March 31, 2018 June 30, 2018 Expected price volatility 101.52 % 96.01 % 62.74 % Expected term (in years) 1.00 1.00 1.00 Risk-free interest rates 1.76 % 2.09 % 2.37 % Stock price $ 2.79 $ 2.90 $ 2.90 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, but not longer than 24 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. The Company did not have any marketable securities as of March 31, 2019 or December 31, 2018, other than those classified as cash equivalents. Marketable securities, including those classified as cash equivalents, 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’ deficit. The fair value of these securities is based on quoted prices and observable inputs on a recurring basis. The cost of marketable securities, including those classified as cash equivalents, is adjusted for amortization of premiums and accretion of discounts to maturity, 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 March 31, 2019 and December 31, 2018 (in thousands): Amortized Cost Unrealized Gains Unrealized Losses Fair Value March 31, 2019 Cash and cash equivalents: Cash and money market funds $ 14,806 $ — $ — $ 14,806 Corporate debt securities 8,677 — — 8,677 Total cash, cash equivalents and marketable securities $ 23,483 $ — $ — $ 23,483 December 31, 2018: Cash and cash equivalents: Cash and money market funds $ 16,211 $ — $ — $ 16,211 Corporate debt securities 8,215 1 — 8,216 Total cash, cash equivalents and marketable securities $ 24,426 $ 1 $ — $ 24,427 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 March 31, 2019, the Company’s financial assets valued based on Level 1 inputs consisted of cash and cash equivalents in a U.S. government money market fund and its financial assets valued based on Level 2 inputs consisted of high-grade corporate debt securities, including commercial paper. During the three months ended March 31, 2019, the Company did not have any transfers of financial assets between Levels 1 and 2. As of March 31, 2019, 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 March 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 assets and liabilities measured at fair value on a recurring basis at March 31, 2019 and December 31, 2018 (in thousands): Fair Value Measurements as of March 31, 2019 Level 1 Level 2 Level 3 Total Financial assets carried at fair value: Cash and money market funds $ 14,806 $ — $ — $ 14,806 Corporate debt securities — 8,677 — 8,677 Total cash, cash equivalents and marketable securities $ 14,806 $ 8,677 $ — $ 23,483 Financial liabilities carried at fair value: Total PIPE Warrant liability $ — $ — $ 7,859 $ 7,859 Fair Value Measurements as of December 31, 2018 Level 1 Level 2 Level 3 Total Financial assets carried at fair value: Cash and money market funds $ 16,211 $ — $ — $ 16,211 Corporate debt securities — 8,216 — 8,216 Total cash, cash equivalents and marketable securities $ 16,211 $ 8,216 $ — $ 24,427 Financial liabilities carried at fair value: Total PIPE Warrant liability $ — $ — $ 16,674 $ 16,674 Basic and Diluted Net Income (Loss) per Common Share Basic net income (loss) per share attributable to AVEO common stockholders is based on the weighted-average number of common shares outstanding during the period. Diluted net income (loss) per share attributable to AVEO common stockholders is based on the weighted-average number of common shares outstanding during the period plus additional weighted-average common equivalent shares outstanding during the period when the effect is dilutive. For the three months ended March 31, 2019, common equivalent shares include the incremental common shares issuable upon the exercise of the PIPE Warrants, as determined using the treasury stock method, and exclude the incremental common shares issuable upon the exercise of stock options and the Settlement Warrants as their effect would be anti-dilutive. For the three months ended March 31, 2018, 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 stock options and warrants would be anti-dilutive. The following table summarizes the computation of basic and diluted net income (loss) per share for the three months ended March 31, 2019 and 2018, respectively (in thousands except per share amounts): Three Months Ended March 31, 2019 2018 Basic net income (loss) attributable to AVEO common stockholders $ 555 $ (8,988 ) Less: non-cash gains attributable to the change in fair value of the PIPE Warrant liability (8,815 ) — Diluted net income (loss) attributable to AVEO common stockholders $ (8,260 ) $ (8,988 ) Weighted-average shares of common stock outstanding 132,304 118,840 Dilutive securities: Incremental common shares issuable upon the exercise of the PIPE Warrants 527 — Weighted-average number of common shares outstanding and dilutive share equivalents outstanding 132,831 118,840 Basic net income (loss) per share $ 0.01 $ (0.08 ) Diluted net income (loss) per share $ (0.06 ) $ (0.08 ) 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 ended March 31, 2019 and 2018, respectively (in thousands): Outstanding at March 31, 2019 2018 Options outstanding 10,190 10,029 PIPE Warrants outstanding — 16,865 Settlement Warrants outstanding 2,000 — Total 12,190 26,894 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 all awards is recognized in the Company’s statements of operations over the requisite service period for each award. Awards that vest as the recipient provides service are expensed on a straight-line basis over the requisite service period. Other awards, such as performance-based awards that vest upon the achievement of specified goals, are expensed using the accelerated attribution method if achievement of the specified goals is considered probable. The Company has also granted awards that vest upon the achievement of market conditions. Per ASC 718, Share-Based Payments, The Company uses the Black-Scholes option pricing model to value its stock option awards without market conditions, which require 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 are measured at fair value on the date the awards are granted. During the three months ended March 31, 2019 and 2018, the Company recorded the following stock-based compensation expense (in thousands): Three Months Ended March 31, 2019 2018 Research and development $ 170 $ 183 General and administrative 414 400 Total $ 584 $ 583 Stock-based compensation expense is allocated |
Collaborations and License Agre
Collaborations and License Agreements | 3 Months Ended |
Mar. 31, 2019 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Collaborations and License Agreements | (4) Collaborations and License 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 in first-line HCC in a phase 1/2 study. The Company will serve as the study sponsor; each party will contribute the clinical supply of its study drug; and study costs will be otherwise shared equally. The phase 1 portion of the study is expected to commence in 2019. The Company did not incur any external costs under the AstraZeneca Agreement as of March 31, 2019. Out-License Agreements CANbridge In March 2016, the Company entered a collaboration and license agreement with CANbridge (the “CANbridge Agreement”). Under the terms of the CANbridge Agreement, the Company granted CANbridge the exclusive right to develop, manufacture and commercialize AV-203, the Company’s proprietary ErbB3 (HER3) inhibitory antibody, for the diagnosis, treatment and prevention of disease in all countries outside of North America (the “CANbridge Licensed Territory”). In addition, CANbridge has the right of first refusal if the Company determines to out-license any North American rights. The parties have both agreed not to develop or commercialize any ErbB3 inhibitory antibody other than AV-203 during the term of the CANbridge Agreement. 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 initial new drug (“IND”) application with the China National Drug Administration (“CNDA”) for a clinical study of AV-203, which CANbridge refers to as CAN017, in ESCC 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. 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, 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 CNDA 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 commercialized AV-203 that was satisfied at the inception of the arrangement The Company determined that 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 CNDA 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 ongoing TiNivo trial. As a result of exercising its opt-in right, EUSA made an additional research and development reimbursement payment to the Company of $2.0 million. This $2.0 million payment was received in October 2017, in advance of the completion of the TiNivo trial, and represents EUSA’s approximate 50% share of the total estimated costs of the TiNivo trial. The Company is also eligible to receive an additional research and development reimbursement payment from EUSA of 50% of the total costs for the Company’s 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”), and 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. 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 is expected to be received in the second quarter of 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. The research and development reimbursement payments under the EUSA Agreement are not subject to the 30% sublicensing payment payable to KHK, subject to certain limitations. The Company, however, would owe KHK 30% of other, non-research and development payments it may receive from EUSA pursuant to the EUSA Agreement, including reimbursement approvals for RCC in up to five specified EU countries (“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% KHK sublicense fee, or $0.6 million, each. The sublicense fees for EUSA’s reimbursement approvals in the United Kingdom and Germany were paid in April 2018 and in January 2019, respectively, and is expected to be paid in the second quarter of 2019 for Spain. 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 Topic 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 AVEO. 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 commercially launched and received reimbursement approval for FOTIVDA in Germany, the United Kingdom, and Spain as well as some additional non-EU5 countries EUSA is working to secure reimbursement approval in Italy and France and commercially launch FOTIVDA in additional European countries. . 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 approximately $1.6 million and $1.0 million in total revenues under the EUSA Agreement in the three months ended March 31, 2019 and 2018, respectively. As of March 31, 2019, there was approximately $6.0 million in total deferred revenue that will 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 March 31, 2019 and 2018 (in thousands): Three Months Ended March 31, Three Months Ended March 31, Revenue Type Date Achieved 2019 2018 Collaboration and Licensing Revenue: Amounts in contract liabilities at the beginning of the period: Upfront payment December 2015 $ 99 $ 99 R&D payment - EMA approval in RCC August 2017 158 158 Milestone - UK reimbursement approval February 2018 79 723 Milestone - German reimbursement approval November 2018 79 — New amounts in contract liabilities during the current period: Milestone - Spanish reimbursement approval February 2019 1,039 — $ 1,454 $ 980 Partnership Royalties 157 46 Total $ 1,611 $ 1,026 The following table summarizes changes in the Company ’ Contract Assets Beginning Balance January 1, 2019 Additions Deductions Ending Balance March 31, 2019 Accounts Receivable $ 187 $ 2,157 $ (187 ) 2,157 Deferred Revenue Contract Liabilities Transaction Price Date Achieved Date Paid Beginning Balance January 1, 2019 Additions Deductions Ending Balance March 31, 2019 Amounts in contract liabilities at the beginning of the period: Upfront payment $ 2,500 December 2015 December 2015 $ 1,302 $ — $ (99 ) $ 1,203 R&D payment - EMA approval in RCC 4,000 August 2017 September 2017 2,079 — (158 ) 1,921 Milestone - UK reimbursement approval 2,000 February 2018 March 2018 1,040 — (79 ) 961 Milestone - German reimbursement approval 2,000 November 2018 December 2018 1,039 — (79 ) 960 New amounts in contract liabilities during the current period: Milestone - Spanish reimbursement approval 2,000 February 2019 — — 1,000 (39 ) 961 Total $ 12,500 $ 5,460 $ 1,000 $ (454 ) $ 6,006 Opt-In to the TiNivo Trial In September 2017, EUSA elected to opt-in to co-develop the TiNivo trial. As previously described, the Company accounts for each opt-in as a separate arrangement. As a result of EUSA’s exercise of its opt-in right, it became an active participant in the ongoing conduct of the TiNivo trial and is able to utilize the resulting data from the TiNivo trial for regulatory and commercial purposes in the EUSA Licensed Territories. Upon the exercise of its opt-in right, EUSA became responsible for funding 50% of the total estimated costs of the TiNivo trial, up to $2.0 million. The Company is accounting for the joint development activities relative to the TiNivo trial as a joint risk-sharing collaboration in accordance with ASC 808 The Company recognized reductions in research and development expenses of approximately $0.1 million and $0.3 million in the three months ended March 31, 2019 and 2018, respectively. As of March 31, 2019, the Company had recognized approximately $1.7 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 $0.3 million in prepaid cost sharing was classified as deferred research and development reimbursements as of March 31, 2019 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 with Novartis (the “Novartis Agreement”), under which the Company granted Novartis the exclusive right to develop and commercialize AV-380 and the Company’s related antibodies worldwide. Novartis was responsible under the Novartis Agreement for the development, manufacture and commercialization of the Company’s antibodies and any resulting approved therapeutic products. On June 29, 2018, Novartis notified the Company that it would be terminating its collaboration without cause. Effective August 28, 2018 the Company regained the rights to AV-380. Novartis’ termination without cause triggered the termination of all licenses and other rights granted by the Company to Novartis with regard to the AV-380 program, and the grant by Novartis to the Company of an irrevocable, exclusive, fully paid-up license, with a right to sublicense, to any patent rights or know-how controlled by Novartis as of the termination date related to the AV-380 program. Following termination, Novartis has initiated the process of transferring the AV-380 program back to the Company. In connection with entry into the Novartis Agreement, Novartis made a non-refundable upfront payment to the Company of $15.0 million in September 2015. In December 2015, Novartis exercised an option to acquire the Company’s inventory of clinical quality, AV-380 biological drug substance and reimbursed the Company approximately $3.5 million for such existing inventory. In February 2017, Novartis agreed to pay the Company $1.8 million out of its then future payment obligations, if any, to the Company under the Novartis Agreement. The funds were used to satisfy a $1.8 million time-based milestone obligation that the Company owed to St. Vincent’s Hospital Sydney Limited (“St. Vincent’s”) in March 2017. Under the Novartis Agreement, the Company had been eligible to receive milestone payments and royalties tied to the commencement of clinical trials, to regulatory approvals and to sales of such products upon commercialization. None of the milestones set forth in the Novartis Agreement had been achieved prior to the termination of the Novartis Agreement. In December 2018, the Company entered into an agreement with Novartis (the “AV-380 Transfer Agreement”) to further establish and clarify the terms on which the AV-380 program will be returned to the Company and to support the Company’s continuing development of the AV-380 program. The AV-380 Transfer Agreement provides for the continued transfer to the Company of the AV-380 program as well as cooperation regarding the Company’s future regulatory filings relating to AV-380. Novartis is also required to provide the AV-380 drug supply to the Company at no charge. 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 in January 2019 under its license agreement as further described below under the heading “—St. Vincent’s Hospital.” The AV-380 Transfer Agreement contains mutual releases by both parties of all claims arising out of the Novartis Agreement, other than indemnification obligations. Novartis has also agreed that it will not develop, manufacture or commercialize any anti-GDF15 antagonist antibody for three years following the date of the AV-380 Transfer Agreement. 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 including costs related to a phase 2 proof-of-concept clinical study of ficlatuzumab for the treatment of non-small cell lung cancer in poor prognosis patients in which VeriStrat ® In addition, the Company and Biodesix are funding investigator-sponsored clinical trials, including ficlatuzumab in combination with ERBITUX ® Pending marketing approval or the sublicense of ficlatuzumab, and subject to the negotiation of a commercialization agreement, each party would share equally in commercialization profits and losses, subject to the Company’s right to be the lead commercialization party. 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 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 March 31, 2019 and 2018, respectively. The amount due to the Company from Biodesix pursuant to the cost-sharing provision was approximately $0.3 million as of March 31, 2019. 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, 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 exclusive option and license 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 AVEO) 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, AVEO 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 AVEO 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 CNDA 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 a license agreement with St. Vincent’s, under which the Company obtained an exclusive, worldwide sublicensable right to research, develop, manufacture and commercialize products for human therapeutic, preventative and palliative applications that benefit from inhibition or decreased expression or activity of GDF15, which is also referred to as MIC-1 (the “St. Vincent’s Agreement”). Under the St. Vincent’s Agreement, St. Vincent’s also granted the Company non-exclusive rights for certain related diagnostic products and research tools. In order to sublicense certain necessary intellectual property rights to Novartis in August 2015, the Company amended and restated the St. Vincent’s Agreement and made an additional upfront payment to St. Vincent’s of $1.5 million. The Company is required to make future milestone payments |
Other Accrued Liabilities
Other Accrued Liabilities | 3 Months Ended |
Mar. 31, 2019 | |
Payables And Accruals [Abstract] | |
Other Accrued Liabilities | (5) Other Accrued Liabilities Other accrued expenses consisted of the following (in thousands): March 31, 2019 December 31, 2018 Professional fees $ 674 $ 798 Compensation and benefits 557 1,046 Other 901 854 Total $ 2,132 $ 2,698 |
Loans Payable
Loans Payable | 3 Months Ended |
Mar. 31, 2019 | |
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 an amended and restated loan and security agreement (the “2017 Loan Agreement”) with Hercules Funding III, LLC and Hercules Capital, Inc. (collectively “Hercules”). Pursuant to the 2014 Amendment, the Company received additional loan proceeds from Hercules in the amount of $10.0 million and was required to make an end-of-term payment of approximately $0.5 million on January 1, 2018. This payment was made on the first business day of 2018. 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 is required to make an end-of-term payment totaling $0.3 million on December 1, 2019. 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, which increased the total end-of-term payments under the 2014 Amendment, 2016 Amendment and 2017 Loan Agreement to approximately $1.6 million. The end-of-term payments under the 2014 Amendment, in the approximate amount of $0.5 million, and the 2016 Amendment, in the amount of $0.3 million, continued to be due on their original due dates of January 1, 2018 and December 1, 2019, respectively. 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. The interest rate as of March 31, 2019 remained at 10.20%. 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 will be required to make 24 equal monthly payments of principal and interest, in the approximate amount of $0.9 million through July 2021. The end-of-term payments under the 2016 Amendment, in the amount of $0.3 million, and the 2017 Amendment, in the approximate amount of $0.8 million, continue to be due on their original due dates of December 1, 2019 and July 1, 2021, respectively. The unamortized discount to be recognized over the remainder of the loan period was approximately $0.8 million and $1.0 million as of March 31, 2019 and December 31, 2018, 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 March 31, 2019, 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 March 31, 2019 are as follows (amounts in thousands): Year Ending December 31: 2019 (remaining 9 months) $ 5,615 2020 11,097 2021 7,308 24,020 Less amount representing interest (2,930 ) Less unamortized discount (801 ) Less deferred charges (1,090 ) Less loans payable current, net of discount (5,688 ) Loans payable, net of current portion and discount $ 13,511 |
Common Stock
Common Stock | 3 Months Ended |
Mar. 31, 2019 | |
Equity [Abstract] | |
Common Stock | (7) Common Stock Public Offering – April 2019 In April 2019, the Company completed an underwritten public offering of 21,739,131 shares of its common stock and warrants to purchase an aggregate of 25,000,000 shares of its common stock (“the Offering Warrants”), including warrants to purchase an aggregate of 3,260,869 shares of its common stock sold pursuant to the underwriter’s partial exercise of its overallotment option, At such time, entities affiliated with New Enterprise Associates (collectively) beneficially held more than 5% of the Company’s voting securities. 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 4,707,770 shares pursuant to the Leerink Sales Agreement, resulting in approximately $10.3 million in proceeds, net of commissions. In February 2019, the Company sold 12,515,559 shares pursuant to the Leerink Sales Agreement, resulting in proceeds of approximately $7.5 million, net of commissions. As of March 31, 2019, approximately $32 million was available for issuance in connection with future stock sales pursuant to the Leerink Sales Agreement. Public Offering – August 2018 On August 21, 2018, the Company completed an underwritten public offering of 2,500,000 shares of its common stock at the public offering price of $2.26 per share for gross proceeds of approximately $5.7 million. Two greater than 5% stockholders, including an entity affiliated with New Enterprise Associates and another stockholder purchased approximately 2,000,000 shares in this offering at the same public offering price per share as the other investors. The net offering proceeds to the Company were approximately $5.1 million after deducting underwriting discounts and estimated offering expenses payable by the Company. Settlement Warrants On July 16, 2018, the Company issued and delivered 2.0 million Settlement Warrants to purchase shares of its common stock for a one-year period after the date of issuance at an exercise price equal to $3.00 per share. Refer to Note 3, “ Significant Accounting Policies – Prior Class Action Settlement and Settlement Warrants 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. 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 17,642,482 units, at a price of $0.965 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 $1.00 per share and are exercisable for a period of five years from the date of issuance. Certain of the Company’s directors and executive officers purchased an aggregate of 544,039 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 March 31, 2019, PIPE Warrants exercisable for 803,108 shares of common stock had been exercised, for approximately $0.8 million in cash proceeds, and PIPE Warrants exercisable for 16,839,375 shares of common stock were outstanding. |
Stock-based Compensation
Stock-based Compensation | 3 Months Ended |
Mar. 31, 2019 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Stock-based Compensation | (8) Stock-based Compensation Stock Incentive Plan The Company maintains the 2010 Stock Incentive Plan (the “Plan”) for employees, consultants, advisors, and directors, as amended in March 2013, June 2014 and June 2017. The Plan provides for the grant of equity awards such as stock options and restricted stock. The Plan provides 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 award 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. Options and restricted stock granted under the Plan vest over periods as determined by the Board of Directors, which generally are equal to four years. Options generally expire ten years from the date of grant. A total of 12,000,000 shares has been reserved under the Plan and as of March 31, 2019, there were 499,196 shares of common stock available for future issuance. The following table summarizes stock option activity during the three months ended March 31, 2019: Options Weighted- Average Exercise Price Weighted- Average Remaining Contractual Term Aggregate Intrinsic Value Outstanding at January 1, 2019 9,583,349 $ 2.28 Granted 712,500 $ 0.60 Exercised — $ — Forfeited (106,030 ) $ 2.28 Outstanding at March 31, 2019 10,189,819 $ 2.17 7.37 $ 524,000 Exercisable at March 31, 2019 5,926,360 $ 2.21 6.54 $ 228,000 Stock options to purchase 487,759 shares of common stock contain performance-based vesting conditions, which were not deemed probable of vesting at March 31, 2019. The aggregate intrinsic value is based upon the Company’s closing stock price of $0.82 on March 29, 2019, the last trading day of the quarter. In February 2019, as part of the Company’s annual individual performance evaluations of its executive officers, the Board of Directors, upon the recommendation of the Compensation Committee, granted to the Company’s executive officers options to purchase an aggregate of 3,303,600 shares of the Company’s common stock, contingent on the approval of the 2019 Equity Incentive Plan by the Company’s stockholders as the Company did not have enough shares under the Plan to make these stock option grants (“Contingent Option Awards”). The Contingent Option Awards Contingent Option Awards 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 the following table: Three Months Ended March 31, 2019 2018 Volatility factor 88.27% - 90.49% 80.18% - 83.40% Expected term (in years) 5.50 - 6.25 5.50 - 6.25 Risk-free interest rates 2.24% - 2.55% 2.64% Dividend yield — — Based upon these assumptions, the weighted-average grant date fair value of stock options granted during the three months ended March 31, 2019 and 2018 was $0.46 and $2.18, respectively. On January 1, 2017, the Company adopted ASU No. 2016-09, Compensation–Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting As of March 31, 2019, there was $5.4 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 2.6 years. |
Legal Proceedings
Legal Proceedings | 3 Months Ended |
Mar. 31, 2019 | |
Commitments And Contingencies Disclosure [Abstract] | |
Legal Proceedings | (9) Legal Proceedings On February 25, 2019, a class action lawsuit was filed against the Company and certain of its present officers and a former officer, Michael Bailey, Matthew Dallas, and Keith Ehrlich, in the Southern District of New York for the District of New York, captioned David Hackel v. AVEO Pharmaceuticals, Inc., et al In 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 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 2.0 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 period after the date of issue at an exercise price of $3.00 per share, equal to the closing price on December 22, 2017, the trading day prior to the execution of the MOU. On January 29, 2018, the parties entered into a definitive Stipulation of Settlement (the “Stipulation”), which was filed with the District Court on February 2, 2018. On February 8, 2018, the District Court issued an order preliminarily approving the terms of the Stipulation. In February 2018, the insurance carriers funded the settlement escrow account for the $15.0 million cash settlement. On May 30, 2018, the District Court held the Final Approval Hearing and approved the settlement and the plaintiffs’ request for attorneys’ fees and expenses, subject to the Final Judgment. Upon the conclusion of a standard 30-day appeal period, the Effective Date was deemed to be June 29, 2018. On July 16, 2018, the Company issued and delivered the Settlement Warrants in accordance with the Stipulation and filed a corresponding shelf registration statement to register the shares of common stock underlying the Settlement Warrants which was declared effective by the SEC on July 25, 2018. 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. Refer to Note 3, “ Significant Accounting Policies – Prior Class Action Settlement and Settlement Warrants 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. 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. |
Significant Accounting Polici_2
Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2019 | |
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 Accounting Standards Codification (“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 ended March 31, 2019 and 2018, respectively, by partner (in thousands). Refer to Note 4, “Collaborations and License Agreements” regarding specific details. Three Months Ended March 31, 2019 2018 EUSA $ 1,611 $ 1,026 Total $ 1,611 $ 1,026 |
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 internal costs for salaries, bonuses, benefits, stock-based compensation, facilities, and research-related overhead, and external costs for clinical trials, drug manufacturing and distribution, license fees, consultants and other contracted services. |
Warrants Issued in Connection with Private Placement | Warrants Issued in Connection with Private Placement In May 2016, the Company issued warrants to purchase an aggregate of 17,642,482 shares of common stock in connection with a private placement financing and recorded the warrants as a liability (the “PIPE Warrants”). The Company accounts for warrant instruments that either conditionally or unconditionally obligate the issuer to transfer assets as liabilities regardless of the timing of the redemption feature or price, even though the underlying shares may be classified as permanent or temporary equity. As of March 31, 2019, PIPE Warrants exercisable for 803,108 shares of common stock had been exercised, for approximately $0.8 million in cash proceeds, and PIPE Warrants exercisable for 16,839,375 shares of common stock were outstanding. Refer to Note 7, “ Common Stock—Private Placement / PIPE Warrants” The PIPE Warrants contain a provision giving the warrant holder the option to receive cash, equal to the fair value of the remaining unexercised portion of the warrant, as cash settlement in the event that there is a fundamental transaction (contractually defined to include various merger, acquisition or stock transfer activities). Due to this provision, ASC 480, Distinguishing Liabilities from Equity The Company recorded a non-cash gain of approximately $8.8 million and a non-cash loss of approximately $1.5 million in the three months ended March 31, 2019 and 2018, respectively, in its Statement of Operations attributable to the decrease and increase, respectively, in the fair value of the PIPE Warrant liability that resulted from a lower stock price as of March 31, 2019 and a higher stock price as of March 31, 2018, respectively, relative to prior periods. In the three months ended March 31, 2018, the Company recorded a reduction in the PIPE Warrant liability, with a corresponding increase to additional paid-in capital, of approximately $1.1 million attributable to PIPE Warrant exercises in the first quarter of 2018. 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 March 31, 2019 (in thousands): Fair value at January 1, 2019 $ 16,674 Decrease in fair value (8,815 ) Fair value at March 31, 2019 $ 7,859 The key assumptions used to value the PIPE Warrants were as follows: Issuance December 31, 2018 March 31, 2019 Expected price volatility 76.25 % 82.64 % 111.99 % Expected term (in years) 5.00 2.50 2.25 Risk-free interest rates 1.22 % 2.47 % 2.27 % Stock price $ 0.89 $ 1.60 $ 0.82 Dividend yield — — — |
Prior Class Action Settlement and Settlement Warrants | Prior Class Action Settlement and Settlement Warrants In December 2017, the Company entered into a binding memorandum of understanding (the “MOU”) with class representatives Bob Levine and William Windham (the “Plaintiffs”), regarding the settlement of a securities class action lawsuit (the “2013 Class Action”) that had been filed in 2013 and was pending in the United States District Court for the District of Massachusetts (the “District Court”) against the Company and certain of the Company’s former officers (Tuan Ha-Ngoc, David Johnston, and William Slichenmyer, together, the “Individual Defendants”), In re AVEO Pharmaceuticals, Inc. Securities Litigation et al. In December 2017, upon entering into the MOU, the Company’s liability related to this settlement became estimable and probable. Accordingly, the Company recorded an estimated $17.1 million contingent liability, including $15.0 million for the cash portion of the settlement with a corresponding insurance recovery for the 100% portion to be paid directly by certain of the Company’s insurance carriers, and an approximate $2.1 million estimate for the fair value on December 31, 2017 of 2.0 million warrants to purchase shares of its common stock that the Company agreed to issue the Class (the “Settlement Warrants”), with a corresponding non-cash charge to the Statement of Operations as a component of operating expense. The Settlement Warrants are exercisable for a one-year period from their date of issue at an exercise price equal to the closing price on December 22, 2017, the trading day prior to the execution of the MOU, which was $3.00 per share. In January 2018, the Company entered into a definitive stipulation of settlement agreement (the “Stipulation”). In February 2018, the District Court preliminarily approved the Stipulation, following which the insurance carriers funded the settlement escrow account related to the $15.0 million cash portion of the settlement. On May 30, 2018, the District Court approved the Stipulation in its order of final approval and final judgment (the “Final Judgment”). Upon the conclusion of a 30-day appeal period, the Effective Date was deemed to be June 29, 2018. Pursuant to the Final Judgment, all claims against the Company were released upon the Effective Date. In addition, pursuant to the Stipulation, the Company had no interest in the settlement escrow account subsequent to the Effective Date. Accordingly, the $15 million contingent liability associated with the cash portion of the settlement and the corresponding insurance recovery was eliminated on the Effective Date. The Company had agreed to use its best efforts to issue and deliver the Settlement Warrants within ten business days following the Effective Date. On July 16, 2018, the Company issued and delivered the Settlement Warrants in accordance with the Stipulation and filed a corresponding shelf registration statement, File No. (333-226190) to register the shares of common stock underlying the Settlement Warrants which was declared effective by the SEC on July 25, 2018. Refer to Note 9, “ Legal Proceedings The estimated fair value of the Settlement Warrants was determined using the Black-Scholes pricing model. The estimated fair value of the Settlement Warrants was subject to revaluation at each balance sheet date and any changes in fair value were recorded as a non-cash gain or (loss) in the Statement of Operations as a component of operating expenses until the Settlement Warrants were issued. The Company recorded a non-cash loss of approximately $42,000 in the three months ended March 31, 2018 in its Statement of Operations attributable to the increase in the fair value of the Settlement Warrants that principally resulted from a higher stock price as of March 31, 2018, relative to prior periods. In addition, the fair value of the Settlement Warrants on June 30, 2018 was determined based on the estimated fair value of the Settlement Warrants at the time of issuance. The Company recorded non-cash gains of approximately $0.7 million in each of the three months and six months ended June 30, 2018, respectively, in its Statement of Operations attributable to the decrease in the fair value of the Settlement Warrants that principally resulted from a lower volatility rate relative to prior periods. In July 2018, upon the issuance of the Settlement Warrants, the Company reclassified the approximate $1.4 million value of the Settlement Warrants from a liability to stockholders equity as a component of additional paid-in-capital based upon the terms of the warrant agreement and, accordingly, the approximate $1.4 million contingent liability on the Company’s balance sheet associated with the warrant portion of the settlement was eliminated. The key assumptions used to estimate the fair value the Settlement Warrants were as follows: December 31, 2017 March 31, 2018 June 30, 2018 Expected price volatility 101.52 % 96.01 % 62.74 % Expected term (in years) 1.00 1.00 1.00 Risk-free interest rates 1.76 % 2.09 % 2.37 % Stock price $ 2.79 $ 2.90 $ 2.90 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, but not longer than 24 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. The Company did not have any marketable securities as of March 31, 2019 or December 31, 2018, other than those classified as cash equivalents. Marketable securities, including those classified as cash equivalents, 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’ deficit. The fair value of these securities is based on quoted prices and observable inputs on a recurring basis. The cost of marketable securities, including those classified as cash equivalents, is adjusted for amortization of premiums and accretion of discounts to maturity, 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 March 31, 2019 and December 31, 2018 (in thousands): Amortized Cost Unrealized Gains Unrealized Losses Fair Value March 31, 2019 Cash and cash equivalents: Cash and money market funds $ 14,806 $ — $ — $ 14,806 Corporate debt securities 8,677 — — 8,677 Total cash, cash equivalents and marketable securities $ 23,483 $ — $ — $ 23,483 December 31, 2018: Cash and cash equivalents: Cash and money market funds $ 16,211 $ — $ — $ 16,211 Corporate debt securities 8,215 1 — 8,216 Total cash, cash equivalents and marketable securities $ 24,426 $ 1 $ — $ 24,427 |
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 March 31, 2019, the Company’s financial assets valued based on Level 1 inputs consisted of cash and cash equivalents in a U.S. government money market fund and its financial assets valued based on Level 2 inputs consisted of high-grade corporate debt securities, including commercial paper. During the three months ended March 31, 2019, the Company did not have any transfers of financial assets between Levels 1 and 2. As of March 31, 2019, 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 March 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 assets and liabilities measured at fair value on a recurring basis at March 31, 2019 and December 31, 2018 (in thousands): Fair Value Measurements as of March 31, 2019 Level 1 Level 2 Level 3 Total Financial assets carried at fair value: Cash and money market funds $ 14,806 $ — $ — $ 14,806 Corporate debt securities — 8,677 — 8,677 Total cash, cash equivalents and marketable securities $ 14,806 $ 8,677 $ — $ 23,483 Financial liabilities carried at fair value: Total PIPE Warrant liability $ — $ — $ 7,859 $ 7,859 Fair Value Measurements as of December 31, 2018 Level 1 Level 2 Level 3 Total Financial assets carried at fair value: Cash and money market funds $ 16,211 $ — $ — $ 16,211 Corporate debt securities — 8,216 — 8,216 Total cash, cash equivalents and marketable securities $ 16,211 $ 8,216 $ — $ 24,427 Financial liabilities carried at fair value: Total PIPE Warrant liability $ — $ — $ 16,674 $ 16,674 |
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 AVEO common stockholders is based on the weighted-average number of common shares outstanding during the period. Diluted net income (loss) per share attributable to AVEO common stockholders is based on the weighted-average number of common shares outstanding during the period plus additional weighted-average common equivalent shares outstanding during the period when the effect is dilutive. For the three months ended March 31, 2019, common equivalent shares include the incremental common shares issuable upon the exercise of the PIPE Warrants, as determined using the treasury stock method, and exclude the incremental common shares issuable upon the exercise of stock options and the Settlement Warrants as their effect would be anti-dilutive. For the three months ended March 31, 2018, 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 stock options and warrants would be anti-dilutive. The following table summarizes the computation of basic and diluted net income (loss) per share for the three months ended March 31, 2019 and 2018, respectively (in thousands except per share amounts): Three Months Ended March 31, 2019 2018 Basic net income (loss) attributable to AVEO common stockholders $ 555 $ (8,988 ) Less: non-cash gains attributable to the change in fair value of the PIPE Warrant liability (8,815 ) — Diluted net income (loss) attributable to AVEO common stockholders $ (8,260 ) $ (8,988 ) Weighted-average shares of common stock outstanding 132,304 118,840 Dilutive securities: Incremental common shares issuable upon the exercise of the PIPE Warrants 527 — Weighted-average number of common shares outstanding and dilutive share equivalents outstanding 132,831 118,840 Basic net income (loss) per share $ 0.01 $ (0.08 ) Diluted net income (loss) per share $ (0.06 ) $ (0.08 ) 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 ended March 31, 2019 and 2018, respectively (in thousands): Outstanding at March 31, 2019 2018 Options outstanding 10,190 10,029 PIPE Warrants outstanding — 16,865 Settlement Warrants outstanding 2,000 — Total 12,190 26,894 |
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 all awards is recognized in the Company’s statements of operations over the requisite service period for each award. Awards that vest as the recipient provides service are expensed on a straight-line basis over the requisite service period. Other awards, such as performance-based awards that vest upon the achievement of specified goals, are expensed using the accelerated attribution method if achievement of the specified goals is considered probable. The Company has also granted awards that vest upon the achievement of market conditions. Per ASC 718, Share-Based Payments, The Company uses the Black-Scholes option pricing model to value its stock option awards without market conditions, which require 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 are measured at fair value on the date the awards are granted. During the three months ended March 31, 2019 and 2018, the Company recorded the following stock-based compensation expense (in thousands): Three Months Ended March 31, 2019 2018 Research and development $ 170 $ 183 General and administrative 414 400 Total $ 584 $ 583 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 March 31, 2019, the Company is forecasting a net loss for the year ended December 31, 2019 and an effective tax rate of 0%. 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 March 31, 2019, the Company has no net assets located outside of the United States. |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect certain reported amounts of assets and liabilities, disclosure of contingent assets and liabilities at the date of the financial statements, the assessment of the Company’s ability to continue as a going concern, and the reported amounts of revenues and expenses during the reporting periods. Significant items subject to such estimates and assumptions include revenue recognition, contract research accruals, measurement of the PIPE Warrant liability, estimated settlement liabilities, measurement of stock-based compensation, and estimates of the Company’s capital requirements over the next twelve months from the date of issuance of the interim 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 February 2016, the FASB issued ASU 2016-02, Leases (Topic 842) Codification Improvement to Topic 842, Leases Leases (Topic 842), Targeted Improvements . The Company adopted ASU 2016-02 effective January 1, 2019 using the As a result, prior periods are presented in accordance with the previous guidance in ASC 840, Leases (“ASC 840”). permitted under the transition guidance within the new standard, which does not require the reassessment of the following: i) whether existing or expired arrangements are or contain a lease, ii) the lease classification of existing or expired leases, and iii) whether previous initial direct costs would qualify for capitalization under the new lease standard. The Company made an accounting policy election not to recognize ROU assets or related lease liabilities with a lease term of twelve months or less in its Consolidated Balance Sheet. Such short-term lease payments are recorded in its in the period in which the obligation for those payments was incurred As of the date of initial application of ASU 2016-02 and as of March 31, 2019, all of the Company’s lease obligations have lease terms that are less than twelve months. The Company’s lease arrangement for its office facility is cancellable within 30 days’ notice to its landlord and excludes 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. In the three months ended March 31, 2019, the Company recognized approximately $0.2 million in short-term lease expense in its Statement of Operations. In June 2018, the FASB issued ASU 2018-07, Improvements to Nonemployee Share-Based Payment Accounting, which simplifies the accounting for share-based payments to nonemployees by aligning it with the accounting for share-based payments to employees, with certain exceptions. The new standard is effective for annual reporting periods beginning after December 15, 2018 with early adoption permitted. |
Recently Issued Accounting Pronouncements | Recently Issued Accounting Pronouncements 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 |
Significant Accounting Polici_3
Significant Accounting Policies (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Summary of Total Revenues Earned by Partner | The following table summarizes the total revenues earned in the three months ended March 31, 2019 and 2018, respectively, by partner (in thousands). Refer to Note 4, “Collaborations and License Agreements” regarding specific details. Three Months Ended March 31, 2019 2018 EUSA $ 1,611 $ 1,026 Total $ 1,611 $ 1,026 |
Summary of Cash, Cash Equivalents and Marketable Securities | Below is a summary of cash, cash equivalents and marketable securities at March 31, 2019 and December 31, 2018 (in thousands): Amortized Cost Unrealized Gains Unrealized Losses Fair Value March 31, 2019 Cash and cash equivalents: Cash and money market funds $ 14,806 $ — $ — $ 14,806 Corporate debt securities 8,677 — — 8,677 Total cash, cash equivalents and marketable securities $ 23,483 $ — $ — $ 23,483 December 31, 2018: Cash and cash equivalents: Cash and money market funds $ 16,211 $ — $ — $ 16,211 Corporate debt securities 8,215 1 — 8,216 Total cash, cash equivalents and marketable securities $ 24,426 $ 1 $ — $ 24,427 |
Summary of Assets And Liabilities Measured at Fair Value on Recurring Basis | The following table summarizes the assets and liabilities measured at fair value on a recurring basis at March 31, 2019 and December 31, 2018 (in thousands): Fair Value Measurements as of March 31, 2019 Level 1 Level 2 Level 3 Total Financial assets carried at fair value: Cash and money market funds $ 14,806 $ — $ — $ 14,806 Corporate debt securities — 8,677 — 8,677 Total cash, cash equivalents and marketable securities $ 14,806 $ 8,677 $ — $ 23,483 Financial liabilities carried at fair value: Total PIPE Warrant liability $ — $ — $ 7,859 $ 7,859 Fair Value Measurements as of December 31, 2018 Level 1 Level 2 Level 3 Total Financial assets carried at fair value: Cash and money market funds $ 16,211 $ — $ — $ 16,211 Corporate debt securities — 8,216 — 8,216 Total cash, cash equivalents and marketable securities $ 16,211 $ 8,216 $ — $ 24,427 Financial liabilities carried at fair value: Total PIPE Warrant liability $ — $ — $ 16,674 $ 16,674 |
Summary of Computation of Basic and Diluted Net Income (Loss) per Share | The following table summarizes the computation of basic and diluted net income (loss) per share for the three months ended March 31, 2019 and 2018, respectively (in thousands except per share amounts): Three Months Ended March 31, 2019 2018 Basic net income (loss) attributable to AVEO common stockholders $ 555 $ (8,988 ) Less: non-cash gains attributable to the change in fair value of the PIPE Warrant liability (8,815 ) — Diluted net income (loss) attributable to AVEO common stockholders $ (8,260 ) $ (8,988 ) Weighted-average shares of common stock outstanding 132,304 118,840 Dilutive securities: Incremental common shares issuable upon the exercise of the PIPE Warrants 527 — Weighted-average number of common shares outstanding and dilutive share equivalents outstanding 132,831 118,840 Basic net income (loss) per share $ 0.01 $ (0.08 ) Diluted net income (loss) per share $ (0.06 ) $ (0.08 ) |
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 ended March 31, 2019 and 2018, respectively (in thousands): Outstanding at March 31, 2019 2018 Options outstanding 10,190 10,029 PIPE Warrants outstanding — 16,865 Settlement Warrants outstanding 2,000 — Total 12,190 26,894 |
Stock-Based Compensation Expense | During the three months ended March 31, 2019 and 2018, the Company recorded the following stock-based compensation expense (in thousands): Three Months Ended March 31, 2019 2018 Research and development $ 170 $ 183 General and administrative 414 400 Total $ 584 $ 583 |
Settlement Warrants | |
Key Assumptions Used to Value the Warrants | The key assumptions used to estimate the fair value the Settlement Warrants were as follows: December 31, 2017 March 31, 2018 June 30, 2018 Expected price volatility 101.52 % 96.01 % 62.74 % Expected term (in years) 1.00 1.00 1.00 Risk-free interest rates 1.76 % 2.09 % 2.37 % Stock price $ 2.79 $ 2.90 $ 2.90 Dividend yield — — — |
PIPE Warrants | |
Summary of Fair Value of Company's Warrant Liability | The following table rolls forward the fair value of the Company’s PIPE Warrant liability, the fair value of which is determined by Level 3 inputs for the three months ended March 31, 2019 (in thousands): Fair value at January 1, 2019 $ 16,674 Decrease in fair value (8,815 ) Fair value at March 31, 2019 $ 7,859 |
Key Assumptions Used to Value the Warrants | The key assumptions used to value the PIPE Warrants were as follows: Issuance December 31, 2018 March 31, 2019 Expected price volatility 76.25 % 82.64 % 111.99 % Expected term (in years) 5.00 2.50 2.25 Risk-free interest rates 1.22 % 2.47 % 2.27 % Stock price $ 0.89 $ 1.60 $ 0.82 Dividend yield — — — |
Collaborations and License Ag_2
Collaborations and License Agreements (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
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 March 31, 2019 and 2018 (in thousands): Three Months Ended March 31, Three Months Ended March 31, Revenue Type Date Achieved 2019 2018 Collaboration and Licensing Revenue: Amounts in contract liabilities at the beginning of the period: Upfront payment December 2015 $ 99 $ 99 R&D payment - EMA approval in RCC August 2017 158 158 Milestone - UK reimbursement approval February 2018 79 723 Milestone - German reimbursement approval November 2018 79 — New amounts in contract liabilities during the current period: Milestone - Spanish reimbursement approval February 2019 1,039 — $ 1,454 $ 980 Partnership Royalties 157 46 Total $ 1,611 $ 1,026 |
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, 2019 Additions Deductions Ending Balance March 31, 2019 Accounts Receivable $ 187 $ 2,157 $ (187 ) 2,157 Deferred Revenue Contract Liabilities Transaction Price Date Achieved Date Paid Beginning Balance January 1, 2019 Additions Deductions Ending Balance March 31, 2019 Amounts in contract liabilities at the beginning of the period: Upfront payment $ 2,500 December 2015 December 2015 $ 1,302 $ — $ (99 ) $ 1,203 R&D payment - EMA approval in RCC 4,000 August 2017 September 2017 2,079 — (158 ) 1,921 Milestone - UK reimbursement approval 2,000 February 2018 March 2018 1,040 — (79 ) 961 Milestone - German reimbursement approval 2,000 November 2018 December 2018 1,039 — (79 ) 960 New amounts in contract liabilities during the current period: Milestone - Spanish reimbursement approval 2,000 February 2019 — — 1,000 (39 ) 961 Total $ 12,500 $ 5,460 $ 1,000 $ (454 ) $ 6,006 |
Other Accrued Liabilities (Tabl
Other Accrued Liabilities (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Payables And Accruals [Abstract] | |
Other Accrued Liabilities | Other accrued expenses consisted of the following (in thousands): March 31, 2019 December 31, 2018 Professional fees $ 674 $ 798 Compensation and benefits 557 1,046 Other 901 854 Total $ 2,132 $ 2,698 |
Loans Payable (Tables)
Loans Payable (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Debt Disclosure [Abstract] | |
Future Minimum Payments Under Loans Payable | Future minimum payments under the loans payable outstanding as of March 31, 2019 are as follows (amounts in thousands): Year Ending December 31: 2019 (remaining 9 months) $ 5,615 2020 11,097 2021 7,308 24,020 Less amount representing interest (2,930 ) Less unamortized discount (801 ) Less deferred charges (1,090 ) Less loans payable current, net of discount (5,688 ) Loans payable, net of current portion and discount $ 13,511 |
Stock-based Compensation (Table
Stock-based Compensation (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Stock Option Activity | The following table summarizes stock option activity during the three months ended March 31, 2019: Options Weighted- Average Exercise Price Weighted- Average Remaining Contractual Term Aggregate Intrinsic Value Outstanding at January 1, 2019 9,583,349 $ 2.28 Granted 712,500 $ 0.60 Exercised — $ — Forfeited (106,030 ) $ 2.28 Outstanding at March 31, 2019 10,189,819 $ 2.17 7.37 $ 524,000 Exercisable at March 31, 2019 5,926,360 $ 2.21 6.54 $ 228,000 |
Assumptions used in Black-Scholes Pricing Model for New Grants | The fair value of stock options subject only to service or performance conditions that are granted to employees is estimated on the date of grant using the Black-Scholes option-pricing model using the assumptions noted the following table: Three Months Ended March 31, 2019 2018 Volatility factor 88.27% - 90.49% 80.18% - 83.40% Expected term (in years) 5.50 - 6.25 5.50 - 6.25 Risk-free interest rates 2.24% - 2.55% 2.64% Dividend yield — — |
Organization - Additional Infor
Organization - Additional Information (Detail) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | |||||
Apr. 30, 2019USD ($)$ / sharesshares | Feb. 28, 2019USD ($) | Aug. 21, 2018USD ($)shares | Jun. 30, 2019 | Mar. 31, 2019USD ($)Subsidiaryshares | Mar. 31, 2018shares | Dec. 31, 2018USD ($)shares | |
Organization [Line Items] | |||||||
Number of subsidiaries | Subsidiary | 3 | ||||||
Cash, cash equivalents and marketable securities | $ 23,483 | $ 24,427 | |||||
Working capital | 7,400 | ||||||
Accumulated deficit | $ 594,454 | $ 595,009 | |||||
Common stock, shares issued | shares | 139,000,000 | 126,485,000 | |||||
Underwritten Public Offering | |||||||
Organization [Line Items] | |||||||
Common stock, shares issued | shares | 2,500,000 | ||||||
Net proceeds from issuance of common stock | $ 5,100 | ||||||
Underwritten Public Offering | Subsequent Event | |||||||
Organization [Line Items] | |||||||
Common stock, shares issued | shares | 21,739,131 | ||||||
Net proceeds from issuance of common stock | $ 22,800 | ||||||
EUSA | Marketing Approval in Spain and Unite Kingdom | |||||||
Organization [Line Items] | |||||||
Milestone payment received | $ 2,000 | ||||||
Kyowa Hakko Kirin | Scenario Forecast | |||||||
Organization [Line Items] | |||||||
Percentage of sublicense fee payable | 30.00% | ||||||
Common Stock | |||||||
Organization [Line Items] | |||||||
Cash, cash equivalents and marketable securities | $ 23,500 | ||||||
Warrants to purchase of common stock | shares | 24,000 | ||||||
Common Stock | Underwritten Public Offering | Subsequent Event | |||||||
Organization [Line Items] | |||||||
Warrants to purchase of common stock | shares | 3,260,869 | ||||||
Shares issued, price per share | $ / shares | $ 1.14 | ||||||
Warrant issued, price per warrants | $ / shares | $ 0.01 | ||||||
Proceeds from issuance of warrants | $ 25,000 | ||||||
Net proceeds from issuance of common stock | $ 22,800 | ||||||
Offering Warrants | Underwritten Public Offering | Subsequent Event | |||||||
Organization [Line Items] | |||||||
Common stock, shares issued | shares | 25,000,000 |
Significant Accounting Polici_4
Significant Accounting Policies - Additional Information (Detail) | Jul. 16, 2018$ / sharesshares | Dec. 26, 2017$ / shares | Jul. 31, 2018USD ($) | Feb. 28, 2018USD ($) | Dec. 31, 2017USD ($)$ / sharesshares | Mar. 31, 2019USD ($)Segmentshares | Jun. 30, 2018USD ($) | Mar. 31, 2018USD ($) | Jun. 30, 2018USD ($) | Dec. 31, 2019 | Jan. 01, 2019 | Dec. 31, 2018shares | May 31, 2016shares | Dec. 31, 2015USD ($) |
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 | |||||||||||||
Common stock, shares issued | shares | 139,000,000 | 126,485,000 | ||||||||||||
Increase (decrease) in the fair value of warrant liability | $ (8,815,000) | $ 1,465,000 | ||||||||||||
Reserve for settlement of fines | $ 17,100,000 | $ 4,000,000 | ||||||||||||
Estimated insurance recoveries | 15,000,000 | |||||||||||||
Restricted cash balances | 0 | |||||||||||||
Transfers of financial assets from Level 1 to Level 2 | 0 | |||||||||||||
Transfers of financial assets from Level 2 to Level 1 | 0 | |||||||||||||
Tax benefits of the stock based compensation expenses recognized | 0 | 0 | ||||||||||||
Short-term operating lease obligations recognized | $ 200,000 | |||||||||||||
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 | |||||||||||||
Scenario Forecast | ||||||||||||||
Significant Accounting Policies [Line Items] | ||||||||||||||
Effective tax rate | 0.00% | |||||||||||||
Minimum | ||||||||||||||
Significant Accounting Policies [Line Items] | ||||||||||||||
Marketable securities maturity term | 3 months | |||||||||||||
Maximum | ||||||||||||||
Significant Accounting Policies [Line Items] | ||||||||||||||
Marketable securities maturity term | 24 months | |||||||||||||
Term of lease obligations | 12 months | |||||||||||||
PIPE Warrants | ||||||||||||||
Significant Accounting Policies [Line Items] | ||||||||||||||
Warrant liability | $ 9,300,000 | |||||||||||||
Increase (decrease) in the fair value of warrant liability | $ (8,800,000) | 1,500,000 | ||||||||||||
Reduction in warrant liability in connection with warrant exercises | 1,100,000 | |||||||||||||
PIPE Warrants | Private Placement | ||||||||||||||
Significant Accounting Policies [Line Items] | ||||||||||||||
Common stock, shares issued | shares | 17,642,482 | |||||||||||||
Warrants exercisable shares of common stock exercised | shares | 803,108 | |||||||||||||
Cash proceeds | $ 800,000 | |||||||||||||
Warrants exercisable shares of common stock outstanding | shares | 16,839,375 | |||||||||||||
Settlement Warrants | ||||||||||||||
Significant Accounting Policies [Line Items] | ||||||||||||||
Increase (decrease) in the fair value of warrant liability | $ (700,000) | $ 42,000 | $ (700,000) | |||||||||||
Reserve for settlement of fines | 17,100,000 | |||||||||||||
Estimated insurance recoveries | 15,000,000 | $ 15,000,000 | ||||||||||||
Estimated fair value of warrants | $ 1,400,000 | $ 2,100,000 | ||||||||||||
Warrants to purchase of common stock shares | shares | 2,000,000 | 2,000,000 | ||||||||||||
Warrants exercisable expiration period | 1 year | 1 year | 1 year | |||||||||||
Warrants exercise price | $ / shares | $ 3 | $ 3 | $ 3 | |||||||||||
Cash settlement from insurance carriers | $ 15,000,000 | |||||||||||||
Reclassified of settlement warrants from a liability to stockholders equity | $ 1,400,000 |
Summary of Total Revenues Earne
Summary of Total Revenues Earned by Partner (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Disaggregation Of Revenue [Line Items] | ||
Total revenues | $ 1,611 | $ 1,026 |
EUSA | ||
Disaggregation Of Revenue [Line Items] | ||
Total revenues | $ 1,611 | $ 1,026 |
Summary of Fair Value of Compan
Summary of Fair Value of Company's Warrant Liability (Detail) - PIPE Warrants $ in Thousands | 3 Months Ended |
Mar. 31, 2019USD ($) | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | |
Fair value, beginning of period | $ 16,674 |
Decrease in fair value | (8,815) |
Fair value, end of period | $ 7,859 |
Key Assumptions Used to Value t
Key Assumptions Used to Value the Warrants (Detail) | Mar. 31, 2019$ / shares | Mar. 29, 2019$ / shares | Dec. 31, 2018$ / shares | Jun. 30, 2018$ / shares | Mar. 31, 2018$ / shares | Dec. 31, 2017$ / shares | May 31, 2016$ / shares |
Fair Value Measurements, Recurring and Nonrecurring, Valuation Techniques [Line Items] | |||||||
Stock price | $ 0.82 | ||||||
Settlement Warrants | |||||||
Fair Value Measurements, Recurring and Nonrecurring, Valuation Techniques [Line Items] | |||||||
Stock price | $ 2.90 | $ 2.90 | $ 2.79 | ||||
Measurement Input, Price Volatility | Settlement Warrants | |||||||
Fair Value Measurements, Recurring and Nonrecurring, Valuation Techniques [Line Items] | |||||||
Expected price volatility | 62.74 | 96.01 | 101.52 | ||||
Measurement Input, Expected Term | Settlement Warrants | |||||||
Fair Value Measurements, Recurring and Nonrecurring, Valuation Techniques [Line Items] | |||||||
Expected term (in years) | 1 year | 1 year | 1 year | ||||
Measurement Input, Risk Free Interest Rate | Settlement Warrants | |||||||
Fair Value Measurements, Recurring and Nonrecurring, Valuation Techniques [Line Items] | |||||||
Expected price volatility | 2.37 | 2.09 | 1.76 | ||||
Measurement Input, Expected Dividend Rate | Settlement Warrants | |||||||
Fair Value Measurements, Recurring and Nonrecurring, Valuation Techniques [Line Items] | |||||||
Expected price volatility | 0 | 0 | 0 | ||||
PIPE Warrants | |||||||
Fair Value Measurements, Recurring and Nonrecurring, Valuation Techniques [Line Items] | |||||||
Stock price | $ 0.82 | $ 1.60 | $ 0.89 | ||||
PIPE Warrants | Measurement Input, Price Volatility | |||||||
Fair Value Measurements, Recurring and Nonrecurring, Valuation Techniques [Line Items] | |||||||
Expected price volatility | 111.99 | 82.64 | 76.25 | ||||
PIPE Warrants | Measurement Input, Expected Term | |||||||
Fair Value Measurements, Recurring and Nonrecurring, Valuation Techniques [Line Items] | |||||||
Expected term (in years) | 2 years 3 months | 2 years 6 months | 5 years | ||||
PIPE Warrants | Measurement Input, Risk Free Interest Rate | |||||||
Fair Value Measurements, Recurring and Nonrecurring, Valuation Techniques [Line Items] | |||||||
Expected price volatility | 2.27 | 2.47 | 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 |
Summary of Cash, Cash Equivalen
Summary of Cash, Cash Equivalents and Marketable Securities (Detail) - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Amortized Cost | $ 23,483 | $ 24,426 |
Unrealized Gains | 1 | |
Fair Value | 23,483 | 24,427 |
Cash and money market funds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Amortized Cost | 14,806 | 16,211 |
Fair Value | 14,806 | 16,211 |
Corporate debt securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Unrealized Gains | 1 | |
Amortized Cost | 8,677 | 8,215 |
Fair Value | $ 8,677 | $ 8,216 |
Summary of Assets And Liabiliti
Summary of Assets And Liabilities Measured at Fair Value on Recurring Basis (Detail) - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total cash, cash equivalents and marketable securities | $ 23,483 | $ 24,427 |
Cash and money market funds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents | 14,806 | 16,211 |
Fair Value Measurements Recurring | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total cash, cash equivalents and marketable securities | 23,483 | 24,427 |
Fair Value Measurements Recurring | PIPE Warrants | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total PIPE Warrant liability | 7,859 | 16,674 |
Fair Value Measurements Recurring | Corporate debt securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents | 8,677 | 8,216 |
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 | 14,806 | 16,211 |
Fair Value Measurements Recurring | Level 1 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total cash, cash equivalents and marketable securities | 14,806 | 16,211 |
Fair Value Measurements Recurring | Level 1 | Cash and money market funds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents | 14,806 | 16,211 |
Fair Value Measurements Recurring | Level 2 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total cash, cash equivalents and marketable securities | 8,677 | 8,216 |
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 | 8,677 | 8,216 |
Fair Value Measurements Recurring | Level 3 | PIPE Warrants | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total PIPE Warrant liability | $ 7,859 | $ 16,674 |
Summary of Computation of Basic
Summary of Computation of Basic and Diluted Net Income (Loss) per Share (Detail) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Earnings Per Share [Abstract] | ||
Basic net income (loss) attributable to AVEO common stockholders | $ 555 | $ (8,988) |
Less: non-cash gains attributable to the change in fair value of the PIPE Warrant liability | (8,815) | |
Diluted net income (loss) attributable to AVEO common stockholders | $ (8,260) | $ (8,988) |
Weighted-average shares of common stock outstanding | 132,304 | 118,840 |
Dilutive securities: | ||
Incremental common shares issuable upon the exercise of the PIPE Warrants | 527 | |
Weighted-average number of common shares outstanding and dilutive share equivalents outstanding | 132,831 | 118,840 |
Basic net income (loss) per share | $ 0.01 | $ (0.08) |
Diluted net income (loss) per share | $ (0.06) | $ (0.08) |
Summary of Outstanding Securiti
Summary of Outstanding Securities Not Included in Computation of Diluted Net Loss Per Common Share (Detail) - shares shares in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share amount, outstanding | 12,190 | 26,894 |
Stock Options | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share amount, outstanding | 10,190 | 10,029 |
PIPE Warrants | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share amount, outstanding | 16,865 | |
Settlement Warrants | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share amount, outstanding | 2,000 |
Stock Based Compensation Expens
Stock Based Compensation Expense for Equity-Classified Awards (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Total stock-based compensation expense | $ 584 | $ 583 |
Research and development | ||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Total stock-based compensation expense | 170 | 183 |
General and administrative | ||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Total stock-based compensation expense | $ 414 | $ 400 |
Collaborations and License Ag_3
Collaborations and License Agreements - Additional Information (Detail) | 1 Months Ended | 3 Months Ended | 12 Months Ended | 27 Months Ended | 36 Months Ended | 39 Months Ended | ||||||||||||||||||||||||||
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 ($) | Sep. 30, 2015USD ($) | Dec. 31, 2012USD ($) | Mar. 31, 2010USD ($) | Dec. 31, 2006USD ($) | Jun. 30, 2019USD ($) | Mar. 31, 2019USD ($)InstallmentIndication | Dec. 31, 2018USD ($) | Sep. 30, 2018USD ($) | Mar. 31, 2018USD ($) | Dec. 31, 2017USD ($) | Dec. 31, 2015USD ($) | Feb. 28, 2018USD ($) | Nov. 30, 2018USD ($) | Feb. 28, 2019USD ($) | Feb. 28, 2017USD ($) | Oct. 14, 2016 | Apr. 30, 2014USD ($) | |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||||||||||||||
License agreement date month and year | 2018-12 | |||||||||||||||||||||||||||||||
Revenues | $ 1,611,000 | $ 1,026,000 | ||||||||||||||||||||||||||||||
Deferred revenue, current portion | $ 1,658,000 | 1,974,000 | $ 1,658,000 | |||||||||||||||||||||||||||||
Amounts due from pursuant to the cost-sharing provisions | 3,026,000 | 2,571,000 | 3,026,000 | |||||||||||||||||||||||||||||
Collaboration and Licensing Revenue | ||||||||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||||||||||||||
Revenues | 1,454,000 | 980,000 | ||||||||||||||||||||||||||||||
Partnership Royalties | ||||||||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||||||||||||||
Revenues | $ 157,000 | 46,000 | ||||||||||||||||||||||||||||||
Development and Regulatory Milestone Events | ||||||||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||||||||||||||
Milestone payment due | $ 2,300,000 | |||||||||||||||||||||||||||||||
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 | 1,611,000 | 1,026,000 | ||||||||||||||||||||||||||||||
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% | |||||||||||||||||||||||||||||||
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 | $ 1,300,000 | $ 1,000,000 | $ 1,100,000 | $ 1,300,000 | ||||||||||||||||||||||||||||
Remaining performance obligation revenue expected to be recognized over month and year | 2022-04 | |||||||||||||||||||||||||||||||
Research and development payment recognized | $ 1,600,000 | 1,000,000 | ||||||||||||||||||||||||||||||
Deferred revenue | 6,000,000 | |||||||||||||||||||||||||||||||
Deferred revenue continue to be recognized as collaboration and licensing revenue per quarter | 500,000 | |||||||||||||||||||||||||||||||
Reductions in research and development expenses | 1,700,000 | |||||||||||||||||||||||||||||||
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 | Scenario Forecast | ||||||||||||||||||||||||||||||||
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 | 200,000 | 46,000 | ||||||||||||||||||||||||||||||
EUSA | Opt In To Planned Phase Three Study | ||||||||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||||||||||||||
Milestone payment to be received | 20,000,000 | |||||||||||||||||||||||||||||||
EUSA | Marketing Approval in France, Germany, Italy, Spain and the United Kingdom | ||||||||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||||||||||||||
Milestone payment to be received | 2,000,000 | |||||||||||||||||||||||||||||||
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 | |||||||||||||||||||||||||||||||
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 | 300,000 | |||||||||||||||||||||||||||||||
EUSA | TiNivo trial | Research and development | ||||||||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||||||||||||||
Payments received and recorded as an increased (decreased) to expense pursuant to cost-sharing provisions | 100,000 | 300,000 | ||||||||||||||||||||||||||||||
Novartis | ||||||||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||||||||||||||
Collaborations and license agreements, expected milestone receivable | 0 | |||||||||||||||||||||||||||||||
Non refundable upfront payment | $ 15,000,000 | |||||||||||||||||||||||||||||||
Reimbursable inventory | $ 3,500,000 | |||||||||||||||||||||||||||||||
Novartis | Collaboration and Licensing Revenue | ||||||||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||||||||||||||
Collaboration and licensing revenue | 2,300,000 | |||||||||||||||||||||||||||||||
Collaboration revenue | $ 1,800,000 | |||||||||||||||||||||||||||||||
Biodesix | ||||||||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||||||||||||||
Amounts due from pursuant to the cost-sharing provisions | 300,000 | |||||||||||||||||||||||||||||||
Biodesix | FOCAL study | ||||||||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||||||||||||||
Contribution percentage of clinical, regulatory, manufacturing and other costs | 50.00% | |||||||||||||||||||||||||||||||
Percentage of closeout project cost | 50.00% | |||||||||||||||||||||||||||||||
Biodesix | FOCAL study | Maximum | ||||||||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||||||||||||||
Funding | $ 15,000,000 | |||||||||||||||||||||||||||||||
Biodesix | FOCAL trial | ||||||||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||||||||||||||
Reductions in research and development expenses | 100,000 | $ 100,000 | ||||||||||||||||||||||||||||||
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] | ||||||||||||||||||||||||||||||||
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 | |||||||||||||||||||||||||||||||
St Vincent's Hospital Sydney Limited | Licensing Agreements | ||||||||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||||||||||||||
Upfront payment received | 1,500,000 | |||||||||||||||||||||||||||||||
Kyowa Hakko 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 Hakko Kirin | Licensing Agreements | ||||||||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||||||||||||||
Upfront payment received | $ 5,000,000 | |||||||||||||||||||||||||||||||
Collaborations and license agreements, potential future payment as percentage of certain amounts the Company receives under sublicense agreements | 30.00% | |||||||||||||||||||||||||||||||
Collaborations and license agreements, milestone payment | $ 10,000,000 | |||||||||||||||||||||||||||||||
Collaborations and license agreements, potential future milestone payments, maximum amount | $ 18,000,000 | |||||||||||||||||||||||||||||||
Term of royalty payment obligations | 12 years | |||||||||||||||||||||||||||||||
Kyowa Hakko Kirin | Licensing Agreements | FDA Marketing Approval | ||||||||||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||||||||||||||||||||
Collaborations and license agreements, milestone payment | $ 12,000,000 |
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 | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||
Revenues | $ 1,611 | $ 1,026 |
Partnership Royalties | ||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||
Revenues | 157 | 46 |
EUSA | ||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||
Collaboration and Licensing Revenue | 1,600 | 1,000 |
Revenues | 1,611 | 1,026 |
ASC 606 | EUSA | ||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||
Revenues | 1,611 | 1,026 |
ASC 606 | EUSA | Collaboration and Licensing Revenue | ||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||
Revenues | 1,454 | 980 |
ASC 606 | EUSA | Partnership Royalties | ||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||
Revenues | $ 157 | 46 |
Upfront Payment | ASC 606 | EUSA | ||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||
Date Achieved | 2015-12 | |
Collaboration and Licensing Revenue | $ 99 | 99 |
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 |
Milestone - UK Reimbursement Approval | ASC 606 | EUSA | ||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||
Date Achieved | 2018-02 | |
Collaboration and Licensing Revenue | $ 79 | $ 723 |
Milestone - German Reimbursement Approval | ASC 606 | EUSA | ||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||
Date Achieved | 2018-11 | |
Collaboration and Licensing Revenue | $ 79 | |
Milestone - Spanish Reimbursement Approval | ASC 606 | EUSA | ||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||
Date Achieved | 2019-02 | |
Collaboration and Licensing Revenue | $ 1,039 |
Summary of Changes in Accounts
Summary of Changes in Accounts Receivable and Contract Liabilities (Deferred Revenue) (Detail) - EUSA - USD ($) $ in Thousands | 3 Months Ended | ||
Mar. 31, 2019 | Dec. 31, 2018 | Mar. 31, 2018 | |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||
Contract Liabilities, Transaction Price | $ 12,500 | $ 10,500 | $ 8,500 |
Ending Balance March 31, 2019 | 6,000 | ||
Accounting Standards Update 2014-09 | |||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||
Contract Liabilities, Transaction Price | 12,500 | ||
Beginning Balance January 1, 2019 | 5,460 | ||
Additions | 1,000 | ||
Deductions | (454) | ||
Ending Balance March 31, 2019 | 6,006 | 5,460 | |
Accounting Standards Update 2014-09 | 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, 2019 | $ 1,302 | ||
Deductions | (99) | ||
Ending Balance March 31, 2019 | 1,203 | 1,302 | |
Accounting Standards Update 2014-09 | 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, 2019 | $ 2,079 | ||
Deductions | (158) | ||
Ending Balance March 31, 2019 | 1,921 | 2,079 | |
Accounting Standards Update 2014-09 | 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, 2019 | $ 1,040 | ||
Deductions | (79) | ||
Ending Balance March 31, 2019 | 961 | 1,040 | |
Accounting Standards Update 2014-09 | 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, 2019 | $ 1,039 | ||
Deductions | (79) | ||
Ending Balance March 31, 2019 | 960 | 1,039 | |
Accounting Standards Update 2014-09 | Milestone - Spanish Reimbursement Approval | |||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||
Contract Liabilities, Transaction Price | $ 2,000 | ||
Contract Liabilities, Date Achieved | 2019-02 | ||
Additions | $ 1,000 | ||
Deductions | (39) | ||
Ending Balance March 31, 2019 | 961 | ||
Accounting Standards Update 2014-09 | Accounts Receivable | |||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||
Beginning Balance January 1, 2019 | 187 | ||
Additions | 2,157 | ||
Deductions | (187) | ||
Ending Balance March 31, 2019 | $ 2,157 | $ 187 |
Other Accrued Liabilities (Deta
Other Accrued Liabilities (Detail) - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
Payables And Accruals [Abstract] | ||
Professional fees | $ 674 | $ 798 |
Compensation and benefits | 557 | 1,046 |
Other | 901 | 854 |
Total | $ 2,132 | $ 2,698 |
Loans Payable - Additional Info
Loans Payable - Additional Information (Detail) | 1 Months Ended | 3 Months Ended | |||||||
Nov. 30, 2018USD ($)Installment | Dec. 31, 2017USD ($)Installmentshares | Jun. 30, 2017USD ($) | May 31, 2016USD ($) | Sep. 30, 2014USD ($) | Mar. 31, 2019USD ($) | Dec. 31, 2018USD ($) | Sep. 30, 2018 | Jun. 30, 2018 | |
Debt Instrument [Line Items] | |||||||||
Loan payable, end-of-term payment due | $ 1,090,000 | ||||||||
Maximum amount of debt conversion | 2,000,000 | ||||||||
Loan payable, interest rate | 9.95% | 9.70% | |||||||
Approximate payment of principle and interest | 7,308,000 | ||||||||
Unamortized discount recognized | 801,000 | $ 1,000,000 | |||||||
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. 1, 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 | ||||||||
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 payable, end-of-term payment due | $ 1,600,000 | ||||||||
Loan issuance costs paid | $ 100,000 | ||||||||
Loan payable, number of installments of principal and interest | Installment | 29 | ||||||||
Loan payable, interest rate | 10.20% | 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 | ||||||||
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% | ||||||||
Hercules 2016 Loan Agreement Amendment | |||||||||
Debt Instrument [Line Items] | |||||||||
Loan payable, end-of-term payment due | 300,000 | ||||||||
Hercules 2017 Loan Agreement Amendment | |||||||||
Debt Instrument [Line Items] | |||||||||
Loan payable, end-of-term payment due | $ 800,000 |
Future Minimum Payments Under L
Future Minimum Payments Under Loans Payable (Detail) - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
Debt Disclosure [Abstract] | ||
2019 (remaining 9 months) | $ 5,615 | |
2020 | 11,097 | |
2021 | 7,308 | |
Long-term Debt, Gross, Total | 24,020 | |
Less amount representing interest | (2,930) | |
Less unamortized discount | (801) | $ (1,000) |
Less deferred charges | (1,090) | |
Less loans payable current, net of discount | (5,688) | (3,254) |
Loans payable, net of current portion and discount | $ 13,511 | $ 15,779 |
Common Stock - Additional Infor
Common Stock - Additional Information (Detail) | Jul. 16, 2018$ / sharesshares | Dec. 26, 2017$ / shares | Apr. 30, 2019USD ($)$ / sharesshares | Feb. 28, 2019USD ($)shares | Aug. 21, 2018USD ($)Affiliate$ / sharesshares | Dec. 31, 2017$ / sharesshares | May 31, 2016USD ($)$ / sharesshares | Mar. 31, 2019USD ($)shares | Dec. 31, 2018USD ($)shares | Mar. 31, 2018USD ($) | Feb. 28, 2018USD ($) | Nov. 30, 2017USD ($) |
Class of Stock [Line Items] | ||||||||||||
Common stock, shares issued | 139,000,000 | 126,485,000 | ||||||||||
Common stock sales agreement, aggregate offering amount | $ | $ 139,000 | $ 126,000 | ||||||||||
Gross proceeds from public offering | $ | $ 7,512,000 | $ 518,000 | ||||||||||
Settlement Warrants | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Warrants to purchase of common stock shares | 2,000,000 | 2,000,000 | ||||||||||
Warrants exercise price | $ / shares | $ 3 | $ 3 | $ 3 | |||||||||
Warrants exercisable period | 1 year | 1 year | 1 year | |||||||||
Underwritten Public Offering | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Common stock, shares issued | 2,500,000 | |||||||||||
Net proceeds from public offering | $ | $ 5,100,000 | |||||||||||
Gross proceeds from public offering | $ | $ 5,700,000 | |||||||||||
Number Of Affiliates Stock Holders | Affiliate | 2 | |||||||||||
Percentage of affiliates stock holders | 5.00% | |||||||||||
Private Placement | PIPE Warrants | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Common stock, shares issued | 17,642,482 | |||||||||||
Shares issued, price per share | $ / shares | $ 0.965 | |||||||||||
Warrants exercise price | $ / shares | $ 1 | |||||||||||
Warrants exercisable period | 5 years | |||||||||||
Gross proceeds from issuance of private placement | $ | $ 17,000,000 | |||||||||||
Exchange of unit to share | 1 | |||||||||||
Warrants exercisable shares of common stock exercised | 803,108 | |||||||||||
Cash proceeds | $ | $ 800,000 | |||||||||||
Warrants exercisable shares of common stock outstanding | 16,839,375 | |||||||||||
Private Placement | PIPE Warrants | Director and Executive Officer | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Common stock, shares issued | 544,039 | |||||||||||
Net offering proceeds to the company | $ | $ 15,400,000 | |||||||||||
SVB Leerink | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Stock issued during period, shares | 4,707,770 | |||||||||||
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 | |||||||||||
SVB Leerink | Common Stock | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Stock issued during period, shares | 12,515,559 | |||||||||||
Net proceeds from issuance of common stock | $ | $ 7,500,000 | |||||||||||
New Enterprise Associates and Another Stockholder | Underwritten Public Offering | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Common stock, shares issued | 2,000,000 | |||||||||||
Subsequent Event | Underwritten Public Offering | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Common stock, shares issued | 21,739,131 | |||||||||||
Gross proceeds from common stock and warrant issed | $ | $ 25,000,000 | |||||||||||
Percentage of beneficial ownership of voting securities | 5.00% | |||||||||||
Net proceeds from public offering | $ | $ 22,800,000 | |||||||||||
Subsequent Event | Underwritten Public Offering | Common Stock | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Shares issued, price per share | $ / shares | $ 1.14 | |||||||||||
Net proceeds from public offering | $ | $ 22,800,000 | |||||||||||
Subsequent Event | Underwritten Public Offering | Offering Warrants | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Warrants to purchase of common stock shares | 25,000,000 | |||||||||||
Warrants exercise price | $ / shares | $ 1.25 | |||||||||||
Warrants exercisable period | 2 years | |||||||||||
Subsequent Event | Over Allotment Option | Offering Warrants | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Warrants to purchase of common stock shares | 3,260,869 | |||||||||||
Subsequent Event | New Enterprise Associates | Underwritten Public Offering | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Common stock, shares issued | 4,347,827 | |||||||||||
Subsequent Event | New Enterprise Associates | Underwritten Public Offering | Offering Warrants | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Warrants to purchase of common stock shares | 4,347,827 | |||||||||||
Minimum | Underwritten Public Offering | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Shares issued, price per share | $ / shares | $ 2.26 | |||||||||||
Minimum | Subsequent Event | Underwritten Public Offering | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Shares issued, price per share | $ / shares | $ 1.14 | |||||||||||
Minimum | Subsequent Event | Underwritten Public Offering | Offering Warrants | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Shares issued, price per share | $ / shares | $ 0.01 | |||||||||||
Maximum | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Offering, issuance and sale of stocks and securities, shelf registration | $ | $ 200,000,000 | |||||||||||
Maximum | SVB Leerink | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Common stock sales agreement, aggregate offering amount | $ | $ 50,000,000 | |||||||||||
Common stock sales agreement commission, percentage | 3.00% |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional Information (Detail) - USD ($) | 1 Months Ended | 3 Months Ended | |||
Feb. 28, 2019 | Mar. 31, 2019 | Mar. 31, 2018 | Mar. 29, 2019 | Dec. 31, 2018 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Common stock reserved for issuance | 12,000,000 | ||||
Shares of common stock available for future issuance | 499,196 | ||||
Stock options issued to purchase common stock | 10,189,819 | 9,583,349 | |||
Stock price | $ 0.82 | ||||
Options granted to purchase common stock | 712,500 | ||||
Contractual term granted | 7 years 4 months 13 days | ||||
Exercise price per share on date of grant | $ 0.60 | ||||
Compensation expense recognized | $ 584,000 | $ 583,000 | |||
Total unrecognized stock-based compensation expense related to stock options granted | $ 5,400,000 | ||||
Stock Options | |||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Awards, vesting period | 4 years | ||||
Awards, Expiration period | 10 years | ||||
Weighted-average grant date fair value of stock options granted | $ 0.46 | $ 2.18 | |||
Total unrecognized stock-based compensation expense, weighted-average period Recognition | 2 years 7 months 6 days | ||||
Awards With Performance-Based Vesting Conditions | |||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Stock options issued to purchase common stock | 487,759 | ||||
Contingent Option Awards | 2019 Equity Incentive Plan | Executive Officer | |||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Awards, vesting period | 4 years | ||||
Options granted to purchase common stock | 3,303,600 | ||||
Contractual term granted | 10 years | ||||
Exercise price per share on date of grant | $ 0.62 | ||||
Description of share based payment award | The Contingent Option Awards vest in equal monthly installments over four years, subject to the officer’s continued employment with the Company; provided, that the Contingent Option Awards will automatically terminate and be forfeited if the Company’s stockholders do not approve the 2019 Equity Incentive Plan within 12 months of the grant date of the options, and further provided that the options will not be exercisable, and no common stock will be issuable thereunder, before the approval of the 2019 Equity Incentive Plan by the Company’s stockholders. | ||||
Compensation expense recognized | $ 0 | ||||
Minimum | Stock Options | Participants Who Own Less 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 | 100.00% | ||||
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) | 3 Months Ended |
Mar. 31, 2019USD ($)$ / sharesshares | |
Options | |
Outstanding at beginning of period | shares | 9,583,349 |
Granted | shares | 712,500 |
Forfeited | shares | (106,030) |
Outstanding at end of period | shares | 10,189,819 |
Exercisable at March 31, 2019 | shares | 5,926,360 |
Weighted-Average Exercise Price | |
Outstanding at beginning of period | $ / shares | $ 2.28 |
Granted | $ / shares | 0.60 |
Forfeited | $ / shares | 2.28 |
Outstanding at end of period | $ / shares | 2.17 |
Exercisable at March 31, 2019 | $ / shares | $ 2.21 |
Weighted-Average Remaining Contractual Term | |
Outstanding at March 31, 2019 | 7 years 4 months 13 days |
Exercisable at March 31, 2019 | 6 years 6 months 14 days |
Aggregate Intrinsic Value | |
Outstanding at end of year | $ | $ 524,000 |
Exercisable at end of year | $ | $ 228,000 |
Assumptions Used in Black Schol
Assumptions Used in Black Scholes Pricing Model for New Grants (Detail) | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Volatility factor, minimum | 88.27% | 80.18% |
Volatility factor, maximum | 90.49% | 83.40% |
Risk-free interest rates | 2.64% | |
Risk-free interest rates, minimum | 2.24% | |
Risk-free interest rates, maximum | 2.55% | |
Dividend yield | 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 |
Maximum | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Expected term (in years) | 6 years 3 months | 6 years 3 months |
Legal Proceedings -Additional I
Legal Proceedings -Additional Information (Detail) - USD ($) $ / shares in Units, $ in Thousands, shares in Millions | Jul. 16, 2018 | Dec. 26, 2017 | Mar. 29, 2016 | Feb. 28, 2018 | Dec. 31, 2017 | Mar. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2015 | Mar. 31, 2019 | Jun. 29, 2018 |
Loss Contingencies [Line Items] | ||||||||||
Attorney fees cost and expenses | $ 15,000 | |||||||||
Reserve for settlement of fines | $ 17,100 | $ 17,100 | $ 4,000 | |||||||
Estimated insurance recoveries | $ 15,000 | 15,000 | ||||||||
Non-cash charge for Settlement warrants | $ 42 | 2,100 | 4,000 | |||||||
Reversal of cash settlement from contingent liability | $ 15,000 | |||||||||
Litigation settlement amount paid by company | $ 4,000 | |||||||||
Settlement fees | $ 42 | $ 2,100 | $ 4,000 | |||||||
Settlement Warrants | ||||||||||
Loss Contingencies [Line Items] | ||||||||||
Warrants to purchase of common stock shares | 2 | |||||||||
Warrants exercisable period | 1 year | 1 year | 1 year | |||||||
Warrants exercise price | $ 3 | $ 3 | $ 3 | $ 3 | ||||||
Cash settlement from insurance carriers | $ 15,000 | |||||||||
Reserve for settlement of fines | $ 17,100 | $ 17,100 | ||||||||
Estimated insurance recoveries | $ 15,000 | $ 15,000 | $ 15,000 |