Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2016 | Oct. 28, 2016 | |
Document And Entity Information [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Sep. 30, 2016 | |
Document Fiscal Year Focus | 2,016 | |
Document Fiscal Period Focus | Q3 | |
Trading Symbol | AVEO | |
Entity Registrant Name | AVEO PHARMACEUTICALS INC | |
Entity Central Index Key | 1,325,879 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Accelerated Filer | |
Entity Common Stock, Shares Outstanding | 75,862,946 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets (Unaudited) - USD ($) $ in Thousands | Sep. 30, 2016 | Dec. 31, 2015 |
Current assets: | ||
Cash and cash equivalents | $ 12,370 | $ 26,634 |
Marketable securities | 18,461 | 7,501 |
Accounts receivable | 990 | 4,641 |
Other prepaid expenses and other current assets | 2,203 | 1,600 |
Total current assets | 34,024 | 40,376 |
Property and equipment, net | 23 | 23 |
Other assets | 1,071 | 143 |
Total assets | 35,118 | 40,542 |
Current liabilities: | ||
Accounts payable | 1,179 | 1,425 |
Accrued contract research | 2,824 | 1,966 |
Other accrued liabilities | 1,525 | 2,140 |
Loans payable, net of discount | 766 | 2,053 |
Deferred revenue | 510 | 814 |
Settlement liability (Note 11) | 4,000 | 4,000 |
Total current liabilities | 6,804 | 12,398 |
Loans payable, net of current portion and discount | 13,103 | 7,418 |
Deferred revenue | 1,824 | 2,881 |
Warrant liability (Note 7) | 9,162 | |
Other liabilities | 690 | 618 |
Total liabilities | 31,583 | 23,315 |
Stockholders’ equity: | ||
Preferred stock, $.001 par value: 5,000 shares authorized; no shares issued and outstanding | ||
Common stock, $.001 par value: 200,000 shares authorized; 75,863 and 58,182 shares issued and outstanding at September 30, 2016 and December 31, 2015, respectively | 76 | 58 |
Additional paid-in capital | 519,742 | 512,201 |
Accumulated other comprehensive income (loss) | 28 | (3) |
Accumulated deficit | (516,311) | (495,029) |
Total stockholders’ equity | 3,535 | 17,227 |
Total liabilities and stockholders’ equity | $ 35,118 | $ 40,542 |
Condensed Consolidated Balance3
Condensed Consolidated Balance Sheets (Unaudited) (Parenthetical) - $ / shares | Sep. 30, 2016 | Dec. 31, 2015 |
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 | 200,000,000 | 200,000,000 |
Common stock, shares issued | 75,863,000 | 58,182,000 |
Common stock, shares outstanding | 75,863,000 | 58,182,000 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations (Unaudited) - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2016 | Sep. 30, 2015 | Sep. 30, 2016 | Sep. 30, 2015 | |
Income Statement [Abstract] | ||||
Collaboration and licensing revenue | $ 992 | $ 15,158 | $ 2,388 | $ 15,426 |
Operating expenses: | ||||
Research and development | 4,444 | 4,466 | 16,020 | 9,002 |
General and administrative | 2,141 | 2,225 | 6,344 | 8,367 |
Restructuring and lease exit | 4,358 | |||
Operating Expenses, Total | 6,585 | 6,691 | 22,364 | 21,727 |
(Loss) income from operations | (5,593) | 8,467 | (19,976) | (6,301) |
Other income (expense), net: | ||||
Interest expense, net | (551) | (531) | (1,388) | (1,866) |
Change in fair value of warrant liability | 1,178 | 182 | ||
Other expense | (22) | (245) | ||
Other income (expense), net | 627 | (553) | (1,206) | (2,111) |
(Loss) income before provision for income taxes | (4,966) | 7,914 | (21,182) | (8,412) |
Provision for income taxes | (100) | |||
Net (loss) income | $ (4,966) | $ 7,914 | $ (21,282) | $ (8,412) |
Basic net (loss) income per share | ||||
Net (loss) income per share | $ (0.07) | $ 0.14 | $ (0.32) | $ (0.15) |
Weighted average number of common shares outstanding | 75,861 | 56,794 | 67,046 | 54,880 |
Diluted net (loss) income per share | ||||
Net (loss) income per share | $ (0.07) | $ 0.14 | $ (0.32) | $ (0.15) |
Weighted average number of common shares and dilutive common share equivalents outstanding | 75,861 | 57,016 | 67,046 | 54,880 |
Condensed Consolidated Stateme5
Condensed Consolidated Statements of Comprehensive Loss (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2016 | Sep. 30, 2015 | Sep. 30, 2016 | Sep. 30, 2015 | |
Statement Of Income And Comprehensive Income [Abstract] | ||||
Net (loss) income | $ (4,966) | $ 7,914 | $ (21,282) | $ (8,412) |
Other comprehensive income (loss): | ||||
Unrealized gain (loss) on available-for-sale securities | 18 | 1 | 31 | 1 |
Comprehensive (loss) income | $ (4,948) | $ 7,915 | $ (21,251) | $ (8,411) |
Condensed Consolidated Stateme6
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2016 | Sep. 30, 2015 | |
Operating activities | ||
Net loss | $ (21,282) | $ (8,412) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Impairment of property and equipment | 232 | |
Depreciation and amortization | 7 | 9,561 |
Accretion | 224 | |
Loss on disposal of fixed assets | 230 | |
Stock-based compensation | 829 | 1,180 |
Non-cash interest expense | 331 | 344 |
Non-cash change in fair value of warrant liability | (182) | |
Amortization of premium and discount on investments | 6 | 33 |
Changes in operating assets and liabilities: | ||
Restricted cash | 135 | |
Accounts receivable | 3,651 | 7 |
Prepaid expenses and other current assets | (603) | 120 |
Other noncurrent assets | (928) | 75 |
Accounts payable | (246) | (2,958) |
Accrued contract research | 858 | (3,184) |
Other accrued liabilities | (615) | (664) |
Settlement liability | (4,000) | |
Deferred revenue | (1,361) | 573 |
Lease exit obligation | (5,205) | |
Deferred rent | (10,569) | |
Other liabilities | (78) | 37 |
Net cash used in operating activities | (23,613) | (18,241) |
Investing activities | ||
Purchases of marketable securities | (28,671) | (11,581) |
Proceeds from maturities and sales of marketable securities | 17,736 | 9,050 |
Purchases of property and equipment | (7) | (14) |
Proceeds from sale of property and equipment | 1,241 | |
Net cash used in investing activities | (10,942) | (1,304) |
Financing activities | ||
Proceeds from issuance of common stock and warrants, net of issuance costs | 14,846 | 10,217 |
Proceeds from issuance of common stock and warrants to related parties | 525 | |
Proceeds from issuance of loan payable and warrants | 5,000 | |
Proceeds from exercise of stock options and issuance of common and restricted stock | 35 | 278 |
Debt issuance costs | (115) | |
Principal payments on loans payable | (8,517) | |
Net cash provided by financing activities | 20,291 | 1,978 |
Net decrease in cash and cash equivalents | (14,264) | (17,567) |
Cash and cash equivalents at beginning of period | 26,634 | 52,306 |
Cash and cash equivalents at end of period | 12,370 | 34,739 |
Supplemental cash flow information | ||
Cash paid for interest | 1,088 | $ 1,619 |
Non-cash financing activity | ||
Fair value of warrants issued in connection with long term debt | 667 | |
Fair value of warrants issued in connection with private placement | $ 9,344 |
Organization
Organization | 9 Months Ended |
Sep. 30, 2016 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Organization | (1) Organization AVEO Pharmaceuticals, Inc. (the “Company”) is a biopharmaceutical company dedicated to advancing a broad portfolio of targeted therapeutics for oncology and other areas of unmet medical need. The Company’s proprietary platform has delivered unique insights into cancer and related diseases. The Company’s strategy is to leverage these biomarker insights and partner resources to advance the development of its clinical pipeline. The Company’s pipeline of product candidates includes tivozanib, a potent, selective, long half-life vascular endothelial growth factor tyrosine kinase inhibitor of all three vascular endothelial growth factors. In June 2013, the U.S. Food and Drug Administration issued a complete response letter denying the Company’s application for approval of the use of tivozanib in first-line treatment of advanced renal cell carcinoma (“RCC”), citing concerns regarding the negative trend in overall survival in the Company’s pivotal phase 3 trial. In May 2016, the Company initiated enrollment and treatment of patients in new The Company expects to report top line data from the study in the first quarter of 2018. The Company has also initiated a phase 1/2 trial of tivozanib in combination with Opdivo (nivolumab), an (the “TiNivo” study) Bristol-Myers Squibb is supplying Opdivo for the TiNivo trial, which is expected to begin enrolling patients in the fourth quarter of 2016 or the first quarter of 2017. The Company expects to report initial safety data from the phase 1 portion of the TiNivo study in the first half of 2017. In February 2016, EUSA Pharma (UK) Ltd. (“EUSA”), the Company’s strategic partner, submitted a Marketing Authorization Application (“MAA”) for tivozanib with the European Medicines Agency (“EMA”) for the treatment of RCC. The application was validated in March 2016, confirming that the submission was complete and that the EMA would initiate its review process. EUSA received the Day 120 List of Questions from the EMA on July 21, 2016, and has received a standard extension of time to respond. EUSA expects to submit its 120-day responses before the end of 2016 and to receive a decision on the MAA from the EMA in the first half of 2017. The Company also has a pipeline of monoclonal antibodies, including: (i) Ficlatuzumab, a potent hepatocyte growth factor (“HGF”) antibody that inhibits the activity of the HGF/c-Met pathway. Ficlatuzumab is in early stage clinical development in partnership with Biodesix, Inc. (“Biodesix”). The Company and Biodesix will share equally in all future costs and profits relating to the development of ficlatuzumab. (ii) AV-203, a potent, high-affinity inhibitor of the ErbB3 pathway. The Company’s partner CANbridge Life Sciences Ltd. (“CANbridge”) will fund manufacturing and clinical development through proof-of-concept in Esophageal Squamous Cell Carcinoma. (iii) AV-380, a potent, humanized IgG1 inhibitory monoclonal antibody targeting growth differentiating factor-15, or GDF15, a divergent member of the TGF-ß family, for the potential treatment or prevention of cachexia. The Company has licensed AV-380 to Novartis International Pharmaceutical Ltd. (“Novartis”), which will fund all development, manufacturing and commercialization; and (iv) AV-353, a potent inhibitory antibody specific to Notch 3. AV-353, which has demonstrated an ability in preclinical models to potentially reverse disease phenotype for pulmonary arterial hypertension (“PAH”). The Company is currently seeking a partner to advance development of AV-353 for the potential treatment of PAH. As used throughout these condensed consolidated financial statements, the terms “AVEO,” and the “Company” refer to the business of AVEO Pharmaceuticals, Inc. and its two wholly-owned subsidiaries, AVEO Pharma Limited and AVEO Securities Corporation. 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 Company has an accumulated deficit as of September 30, 2016 of approximately $516.3 million and is subject to a number of risks, including the need for substantial additional capital for clinical research and product development and the risk that it is unable to maintain compliance with its financial covenant pursuant to its loan and security agreement (refer to Note 6). The Company will need additional funding to support its planned operating activities and maintain compliance with its financial covenant. Accordingly, the timing and nature of activities contemplated for 2017 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, or if it is unable to procure partnership arrangements to advance its programs, 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 | 9 Months Ended |
Sep. 30, 2016 | |
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 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 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 generally accepted accounting principles 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 and nine months ended September 30, 2016 are not necessarily indicative of the results that may be expected for the fiscal year ending December 31, 2016 or any other future period. The information presented in the condensed consolidated financial statements and related footnotes at September 30, 2016, and for the three months and nine months ended September 30, 2016 and 2015, is unaudited, and the condensed consolidated balance sheet amounts and related footnotes as of December 31, 2015 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, 2015, which was filed with the U.S. Securities and Exchange Commission (“SEC”) on March 15, 2016. Certain reclassifications have been made to prior periods to conform to current period presentation. Reclassification of prior year amounts has been made to separately present accrued contract research from accrued expenses on the consolidated balance sheets and to present interest expense net of interest income on the consolidated statements of operations. There was no impact on total liabilities, total other expenses or net income (loss) resulting from these reclassifications. |
Significant Accounting Policies
Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2016 | |
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 elements, or deliverables, 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 pre-clinical and clinical material. Payments to the Company under these arrangements typically include one or more of the following: non-refundable, up-front license fees; option exercise fees; funding of research and/or development efforts; milestone payments; and royalties on future product sales. When evaluating multiple element arrangements, the Company considers whether the deliverables under the arrangement represent separate units of accounting. This evaluation requires subjective determinations and requires management to make judgments about the individual deliverables and whether such deliverables are separable from the other aspects of the contractual relationship. In determining the units of accounting, management evaluates certain criteria, including whether the deliverables have standalone value, based on the relevant facts and circumstances for each arrangement. The consideration received is allocated among the separate units of accounting using the relative selling price method, and the applicable revenue recognition criteria are applied to each of the separate units. The Company determines the estimated selling price for deliverables within each agreement using vendor-specific objective evidence (“VSOE”) of selling price, if available, third-party evidence (“TPE”) of selling price if VSOE is not available, or best estimate of selling price if neither VSOE nor TPE is available. Determining the best estimate of selling price for a deliverable requires significant judgment. The Company typically uses best estimate of selling price to estimate the selling price for licenses to the Company’s proprietary technology, since the Company often does not have VSOE or TPE of selling price for these deliverables. In those circumstances where the Company utilizes best estimate of selling price to determine the estimated selling price of a license to the Company’s proprietary technology, the Company considers market conditions as well as entity-specific factors, including those factors contemplated in negotiating the agreements and internally developed models that include assumptions related to the market opportunity, estimated development costs, probability of success and the time needed to commercialize a product candidate pursuant to the license. In validating the Company’s best estimate of selling price, the Company evaluates whether changes in the key assumptions used to determine the best estimate of selling price will have a significant effect on the allocation of arrangement consideration among multiple deliverables. The Company typically receives non-refundable, up-front payments when licensing its intellectual property in conjunction with a research and development agreement. When management believes the license to its intellectual property does not have stand-alone value from the other deliverables to be provided in the arrangement, the Company generally recognizes revenue attributed to the license on a straight-line basis over the Company’s contractual or estimated performance period, which is typically the term of the Company’s research and development obligations. If management cannot reasonably estimate when the Company’s performance obligation ends, then revenue is deferred until management can reasonably estimate when the performance obligation ends. When management believes the license to its intellectual property has stand-alone value, the Company generally recognizes revenue attributed to the license upon delivery. The periods over which revenue should be recognized are subject to estimates by management and may change over the course of the research and development agreement. Such a change could have a material impact on the amount of revenue the Company records in future periods. Payments or reimbursements resulting from the Company’s research and development efforts for those arrangements where such efforts are considered as deliverables are recognized as the services are performed and are presented on a gross basis so long as there is persuasive evidence of an arrangement, the fee is fixed or determinable, and collection of the related receivable is reasonably assured. Amounts received prior to satisfying the above revenue recognition criteria are recorded as deferred revenue in the accompanying balance sheets. At the inception of each agreement that includes milestone payments, the Company evaluates whether each milestone is substantive and at risk to both parties on the basis of the contingent nature of the milestone. This evaluation includes an assessment of whether (a) the consideration is commensurate with either (1) the entity’s performance to achieve the milestone, or (2) the enhancement of the value of the delivered item(s) as a result of a specific outcome resulting from the entity’s performance to achieve the milestone, (b) the consideration relates solely to past performance, and (c) the consideration is reasonable relative to all of the deliverables and payment terms within the arrangement. The Company evaluates factors such as the scientific, regulatory, commercial and other risks that must be overcome to achieve the respective milestone, the level of effort and investment required to achieve the respective milestone and whether the milestone consideration is reasonable relative to all deliverables and payment terms in the arrangement in making this assessment. The Company aggregates its milestones into four categories: (i) clinical and development milestones, (ii) regulatory milestones, (iii) commercial milestones, and (iv) patent-related milestones. Clinical and development milestones are typically achieved when a product candidate advances into a defined phase of clinical research or completes such phase. For example, a milestone payment may be due to the Company upon the initiation of a phase 3 clinical trial for a new indication, which is the last phase of clinical development and could eventually contribute to marketing approval by the U.S. Food and Drug Administration (“FDA”) or other global regulatory authorities. Regulatory milestones are typically achieved upon acceptance of the submission for marketing approval of a product candidate or upon approval to market the product candidate by the FDA or other global regulatory authorities. For example, a milestone payment may be due to the Company upon the FDA’s acceptance of a New Drug Application (“NDA”). Commercial milestones are typically achieved when an approved pharmaceutical product reaches certain defined levels of net sales by the licensee, such as when a product first achieves global sales or annual sales of a specified amount. Patent-related milestones are typically achieved when a patent application is filed or a patent is issued with respect to certain intellectual property related to the applicable collaboration. Revenues from clinical and development, regulatory, and patent-related milestone payments, if the milestones are deemed substantive and the milestone payments are nonrefundable, are recognized upon successful accomplishment of the milestones. The Company has concluded that the clinical and development, regulatory and patent-related milestones pursuant to its current research and development arrangements are substantive. Milestones that are not considered substantive are accounted for as license payments and recognized on a straight-line basis over the remaining period of performance. Revenues from commercial milestone payments are accounted for as royalties and are recorded as revenue upon achievement of the milestone, assuming all other revenue recognition criteria are met. 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 personnel-related costs such as salaries and stock-based compensation, facilities, research-related overhead, clinical trial costs, manufacturing costs and costs of other contracted services, license fees, and other external costs. Nonrefundable advance payments for goods and services that will be used in future research and development activities are expensed when the activity has been performed or when the goods have been received. Warrants Issued in Connection with Private Placement 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. These warrants are subject to revaluation at each balance sheet date, and any changes in fair value are recorded as a non-cash component of other income (expense), net until the earlier of their exercise or expiration or upon the completion of a liquidation event. During the three months and nine months ended September 30, 2016, as a result of the fair value adjustment of the warrant liability, the Company recorded a decrease in the fair value of the warrant liability of approximately $1.2 million and $0.2 million, respectively, in its Statements of Operations and Comprehensive Income (Loss). Refer to Note 7, “Common Stock - Private Placement / PIPE Warrants” for further discussion on the calculation of the fair value of the warrant liability. The following table rolls forward the fair value of the Company’s warrant liability, the fair value of which is determined by Level 3 inputs for the nine months ended September 30, 2016 (in thousands): Nine Months Ended September 30, 2016 Fair value at January 1, 2016 $ — Issuance of warrants on May 13, 2016 9,344 Change in fair value 996 Fair value at June 30, 2016 10,340 Change in fair value (1,178 ) Fair value at September 30, 2016 $ 9,162 Cash and Cash Equivalents 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 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 and high-grade, short-term corporate bonds and U.S. government agency securities, which management believes are subject to minimal credit and market risk. Marketable Securities 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. Since these securities are available to fund current operations they are classified as current assets on the consolidated balance sheets. Marketable securities are stated at fair value, including accrued interest, with their unrealized gains and losses included as a component of accumulated other comprehensive income or loss, which is a separate component of stockholders’ equity. The fair value of these securities is based on quoted prices and observable inputs on a recurring basis. The cost of marketable securities is adjusted for amortization of premiums and accretion of discounts to maturity, with such amortization and accretion recorded as a component of interest expense, net. 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. There were no realized gains or losses recognized on the sale or maturity of marketable securities during the three months and nine months ended September 30, 2016 and 2015. Below is a summary of cash, cash equivalents and marketable securities at September 30, 2016 and December 31, 2015: Amortized Cost Unrealized Gains Unrealized Losses Fair Value (in thousands) September 30, 2016: Cash and cash equivalents: Cash and money market funds $ 12,370 $ — $ — $ 12,370 Government agency securities - — — - Corporate debt securities - — — - Total cash and cash equivalents 12,370 — — 12,370 Marketable securities: Corporate debt securities due within 1 year 13,420 27 (1 ) 13,446 Government agency securities due within 1 year 5,013 2 — 5,015 Total marketable securities 18,433 29 (1 ) 18,461 Total cash, cash equivalents and marketable securities $ 30,803 $ 29 $ (1 ) $ 30,831 December 31, 2015: Cash and cash equivalents: Cash and money market funds $ 21,822 $ — $ — $ 21,822 Corporate debt securities 4,812 — — 4,812 Total cash and cash equivalents 26,634 — — 26,634 Marketable securities: Corporate debt securities due within 1 year $ 6,504 $ — $ (3 ) $ 6,501 Government agency securities due within 1 year 1,000 — — 1,000 Total marketable securities 7,504 — (3 ) 7,501 Total cash, cash equivalents and marketable securities $ 34,138 $ — $ (3 ) $ 34,135 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. As of September 30, 2016, the Company had $1.0 million of accounts receivable outstanding, primarily due 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 September 30, 2016, the Company’s financial assets valued based on Level 1 inputs consisted of cash and cash equivalents in a money market fund and its financial assets valued based on Level 2 inputs consisted of high-grade corporate bonds, commercial paper and U.S. government agency securities. During the three months and nine months ended September 30, 2016, the Company did not have any transfers of financial assets between Levels 1 and 2. As of September 30, 2016, the Company’s financial liabilities that were recorded at fair value consisted of a warrant liability. The fair value of the Company’s loans payable at September 30, 2016 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 September 30, 2016 and December 31, 2015: Fair Value Measurements of Cash Equivalents and Marketable Securities as of September 30, 2016 Level 1 Level 2 Level 3 Total (in thousands) Financial assets carried at fair value: Cash equivalents $ 12,370 $ — $ — $ 12,370 Corporate debt securities — - — - Government agency securities — - — - Total cash and cash equivalents $ 12,370 $ — $ — $ 12,370 Marketable securities: Corporate debt securities due within 1 year $ — $ 13,446 $ — $ 13,446 Government agency securities due within 1 year — 5,015 — 5,015 Total marketable securities $ — $ 18,461 $ — $ 18,461 Total cash, cash equivalents and marketable securities $ 12,370 $ 18,461 $ — $ 30,831 Financial liabilities carried at fair value: Warrant liability $ — $ — $ 9,162 $ 9,162 Total warrant liability $ — $ — $ 9,162 $ 9,162 Fair Value Measurements of Cash Equivalents and Marketable Securities as of December 31, 2015 Level 1 Level 2 Level 3 Total (in thousands) Financial assets carried at fair value: Cash equivalents $ 21,822 $ — $ — $ 21,822 Corporate debt securities — 4,812 4,812 Total cash and cash equivalents $ 21,822 $ 4,812 $ — $ 26,634 Marketable securities: Corporate debt securities due within 1 year $ — $ 6,501 $ — $ 6,501 Government agency securities due within 1 year — 1,000 — 1,000 Total marketable securities $ — $ 7,501 $ — $ 7,501 Total cash, cash equivalents and marketable securities $ 21,822 $ 12,313 $ — $ 34,135 Financial liabilities carried at fair value: Warrant liability $ — $ — $ — $ — $ — $ — $ — $ — Property and Equipment Property and equipment are stated at cost and are depreciated using the straight-line method over the estimated useful lives of the respective assets. Maintenance and repair costs are charged to expense as incurred. During the quarter ended June 30, 2015, the Company transitioned to new office space and, as a result, revised the estimated useful life of its office furniture, resulting in an increase in depreciation expense of approximately $0.4 million during the nine months ended September 30, 2015. Long-lived Assets The Company reviews long-lived assets, including property and equipment, for impairment whenever changes in business circumstances indicate that the carrying amount of the asset may not be fully recoverable. No impairment charges were recognized during the three months and nine months ended September 30, 2016. The Company recognized $0.2 million of impairment from losses for the nine months ended September 30, 2015 related to leasehold improvements. Basic and Diluted Loss per Common Share Basic earnings (loss) per share is computed by dividing net income (loss) available to common stockholders by the weighted-average number of common shares outstanding during the period. Diluted earnings (loss) per share is computed by dividing net income (loss) available to common stockholders by the weighted-average number of common shares and dilutive common share equivalents then outstanding which exclude unvested restricted stock. Potential common share equivalents consist of the incremental common shares issuable upon the exercise of stock options and warrants. After applying the treasury stock method for those instruments that were “in-the-money,” the dilutive effect of stock options and warrants resulted in an increase in the weighted-average number of common shares of 222,000 used in calculating diluted earnings per common share for the three months ending September 30, 2015. For periods presented during which the Company had a net loss, the effect of all potentially dilutive securities is anti-dilutive. Accordingly, basic and diluted net loss per common share is the same for those periods. The following table sets forth the potential common shares excluded from the calculation of net loss per common share-diluted for the three months and nine months ended September 30, 2016 and the nine months ended September 30, 2015 because their inclusion would have been anti-dilutive: Outstanding at September 30, 2016 2015 (in thousands) Options outstanding 5,811 5,826 Warrants outstanding 19,453 609 25,264 6,435 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 Accounting Standards Codification (“ASC”) 718 Share-Based Payments, The fair value of equity-classified awards to employees and directors are measured at fair value on the date the awards are granted. Awards to nonemployee consultants are recorded at their fair values and are re-measured as of each balance sheet date until the recipient’s services are complete. During the three months and nine months ended September 30, 2016 and 2015, the Company recorded the following stock-based compensation expense: Three Months Ended September 30, Nine Months Ended September 30, 2016 2015 2016 2015 (in thousands) (in thousands) Research and development $ 56 $ 50 $ 238 $ 238 General and administrative 149 294 591 873 Restructuring — — — 69 $ 205 $ 344 $ 829 $ 1,180 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. Expenses recognized in connection with the modification of awards in connection with the Company’s strategic restructurings are allocated to restructuring expense. No related tax benefits of the stock-based compensation expense have been recognized. 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 September 30, 2016, the Company is forecasting a net loss for the year ended December 31, 2016. The Company maintains a full valuation allowance on all deferred tax assets. For the nine months ended September 30, 2016, the Company recorded a $0.1 million provision for income taxes related to withholding taxes incurred in a foreign jurisdiction. 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 September 30, 2016, the Company has $0.8 million of net assets located in the United Kingdom. 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 , and the reported amounts of revenues and expenses during the reporting periods. Significant items subject to such estimates and assumptions include contract research accruals and measurement of stock-based compensation. The Company bases its estimates on historical experience and various other assumptions that management believes to be reasonable under the circumstances. Changes in estimates are recorded in the period in which they become known Recent Accounting Pronouncements The Company did not adopt any new accounting pronouncements during the nine months ended September 30, 2016 that had a material effect on the Company’s condensed consolidated financial statements. In May 2014, the Financial Accounting Standards Board (“FASB”) issued a comprehensive new revenue recognition standard that will supersede nearly all existing revenue recognition guidance under US GAAP. The standard was originally scheduled to be effective for public entities for annual and interim periods beginning after December 15, 2016. In July 2015, the standard was deferred and will now be effective for annual and interim periods beginning after December 15, 2017. Early adoption is permitted for annual and interim periods beginning after December 15, 2016. The Company will adopt this standard on January 1, 2018 and is currently evaluating the effect this standard will have on its revenue recognition policies and its financial statements, including how the standard will be adopted. In August 2014, the FASB issued Accounting Standards Update (“ASU”) No. 2014-15, Presentation of Financial Statements—Going Concern (Subtopic 205-40): Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern. In March 2016, the FASB issued ASU No. 2016-09, Compensation─Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting |
Collaborations and License Agre
Collaborations and License Agreements | 9 Months Ended |
Sep. 30, 2016 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Collaborations and License Agreements | (4) Collaborations and License Agreements CANbridge In March 2016, the Company entered into a collaboration and license agreement (the “CANbridge Agreement”) with CANbridge Life Sciences Ltd. (“CANbridge”). Under the terms of the CANbridge Agreement, the Company granted CANbridge the exclusive right to develop, manufacture and commercialize AV-203, the Company’s proprietary ErbB3 (HER3) inhibitory antibody, for the diagnosis, treatment and prevention of disease in humans and animals in all countries other than the United States, Canada and Mexico (the “Licensed Territory”). Under the terms of the CANbridge Agreement, if the Company determines to grant a license to any ErbB3 inhibitory antibody in the United States, Canada or Mexico, the Company is obligated to first negotiate with CANbridge for the grant to CANbridge of a license to such rights. The effective date of the license agreement is March 16, 2016 (the “Effective Date”). CANbridge made an upfront payment to the Company of $1.0 million in April 2016. This amount was included in accounts receivable on the Company’s balance sheet as of March 31, 2016 net of $0.1 million of withholding taxes. CANbridge has agreed to reimburse the Company $1.0 million for certain manufacturing costs and expenses previously incurred by the Company with respect to AV-203, $0.5 million of which will be due to the Company on the earlier of (i) the date of validation by CANbridge of certain manufacturing development activities conducted by the Company prior to the Effective Date or (ii) twelve months from the Effective Date, and the remaining $0.5 million of which will be due to the Company on the earlier of (i) the date of validation by CANbridge of such manufacturing development activities or (ii) eighteen months from the Effective Date. The Company is also eligible to receive up to $42.0 million in potential development and regulatory milestone payments and up to $90.0 million in potential sales based milestone payments based on annual net sales of licensed products. Upon commercialization, the Company is eligible to receive a tiered royalty, with a percentage range in the low double-digits, on net sales of approved licensed products. CANbridge’s obligation to pay royalties for each licensed product expires on a country-by-country basis on the later of the expiration of patent rights covering such licensed product in such country, the expiration of regulatory data exclusivity in such country and ten years after the first commercial sale of such licensed product in such country. No milestone payments have been earned as of September 30, 2016. 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, regulatory filings and commercialization of AV-203 in the Licensed Territory. The term of the CANbridge Agreement commenced on the Effective Date and will continue until the last to expire royalty term applicable to licensed products. Either party may terminate the CANbridge Agreement in the event of a material breach by the other party that remains uncured for a period of 45 days, in the case of a material breach of a payment obligation, and 90 days in the case of any other material breach. CANbridge may terminate the CANbridge Agreement without cause at any time upon 180 days’ prior written notice to the Company. The Company may terminate the CANbridge Agreement upon thirty days’ prior written notice if CANbridge challenges any of the patent rights licensed to CANbridge under the CANbridge Agreement. The Company and CANbridge have each agreed to not directly or indirectly develop or commercialize any ErbB3 inhibitory antibody product during the term of the CANbridge Agreement other than pursuant to the CANbridge Agreement. A percentage of any milestone and royalty payments received by the Company, 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. Activities under the CANbridge Agreement Revenue Recognition—Multiple Element Arrangements The CANbridge Agreement includes the following non-contingent deliverables: (i) the Company’s grant of an exclusive license to develop and commercialize AV-203 in the licensed territories, (ii) the Company’s obligation to transfer all technical knowledge and data useful in the development and manufacture of AV-203 and (iii) the Company’s obligation to participate on a joint steering committee during the proof-of-concept development period. The relative selling price of the Company’s joint steering committee participation had de minimis value. The Company determined that the delivered license and know-how did have stand-alone value from the undelivered element and have accounted for these items as separate deliverables. The Company allocated the up-front consideration of $1.0 million to the units of accounting and recognized the $1.0 million attributed to the delivered license and know-how during the three months ended March 31, 2016. The Company believes the regulatory milestones that may be achieved under the are consistent with the definition of a milestone included in ASU 2010-17, Revenue Recognition—Milestone Method , and, accordingly, the Company will recognize payments related to the achievement of such milestones, if any, when each such milestone is achieved. Factors considered in this determination included scientific and regulatory risks that must be overcome to achieve each milestone, the level of effort and investment required to achieve each milestone, and the monetary value attributed to each milestone. EUSA In December 2015, the Company entered into a license agreement with EUSA Pharma (UK) Limited (“EUSA”) Under the license agreement, EUSA made a research and development funding payment to the Company of $2.5 million during the year ended December 31, 2015. EUSA is required to make a further research and development funding payment of $4.0 million upon the grant by the European Medicines Agency (“EMA”) of marketing approval for tivozanib for treatment of RCC. The Company is eligible to receive additional research funding from EUSA, including up to $20.0 million for the Company’s phase 3 study in third-line RCC if EUSA elects to utilize data generated by the study and up to $2.0 million for a potential phase 1 combination study with a checkpoint inhibitor if EUSA elects to utilize data generated by the study. The Company will be entitled to receive milestone payments of $2.0 million per country upon reimbursement approval for RCC in each of France, Germany, Italy, Spain and the United Kingdom, and an additional $2.0 million for the grant of marketing approval in three of the following five countries: Argentina, Australia, Brazil, South Africa and Venezuela. The Company is also eligible to receive a payment of $2.0 million in connection with EUSA’s filing with the EMA for marketing approval 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 Licensed Territories ranging from a low double digit up to mid-twenty percent depending on the level of annual net sales. A percentage of any milestone and royalty payments received by AVEO is due to Kyowa Hakko Kirin Co., Ltd. (formerly Kirin Brewery Co., Ltd.) (“KHK”) as a sublicensing fee under the license agreement between AVEO and KHK dated as of December 21, 2006 , pursuant to which the Company acquired exclusive rights to develop and commercialize tivozanib for all human diseases outside of Asia and the Middle East. The research and development funding payments under the EUSA license agreement are not subject to sublicensing payment to KHK. EUSA is obligated to use commercially reasonable efforts to develop and commercialize tivozanib throughout the Licensed Territories. With the exception of certain support to be provided by the Company in connection with the application for marketing approval by the EMA, EUSA has responsibility for all activities and costs associated with the further development, manufacture, regulatory filings and commercialization of tivozanib in the Licensed Territories. Activities under the agreement were evaluated under ASC 605-25 to determine whether such activities represented a multiple element revenue arrangement. The agreement with EUSA includes the following non-contingent deliverables: (i) the Company’s grant of an exclusive license to develop and commercialize the tivozanib in the Licensed Territories; (ii) the Company’s obligation to transfer all technical knowledge and data useful in the development and manufacture of tivozanib; (iii) the Company’s obligation to cooperate with EUSA and support its efforts to file for marketing approval in the Licensed Territories, (iv) the Company’s obligation to provide access to certain regulatory information resulting from the Company’s ongoing development activities outside of the Licensed Territories and (v) the Company’s participation in a joint steering committee. The Company determined that the delivered license did not have stand-alone value from the undelivered elements and have accounted for these items as a single bundled deliverable. The Company allocated up-front consideration of $2.5 million to the bundled unit of accounting and is recognizing it over the Company’s performance period through April 2022, the remaining patent life of tivozanib. The Company recognized approximately $0.1 million and $0.3 million as revenue during the three months and nine months ended September 30, 2016, respectively. The Company believes the regulatory milestones that may be achieved under the EUSA agreement are consistent with the definition of a milestone included in ASU 2010-17, Revenue Recognition—Milestone Method , and, accordingly, the Company will recognize payments related to the achievement of such milestones, if any, when each such milestone is achieved. Factors considered in this determination included scientific and regulatory risks that must be overcome to achieve each milestone, the level of effort and investment required to achieve each milestone, and the monetary value attributed to each milestone. No milestone payments have been earned as of September 30, 2016. Novartis In August 2015, the Company entered into a license agreement with Novartis. Under the license agreement, the Company has granted to Novartis the exclusive right to develop and commercialize worldwide the Company’s proprietary antibody AV-380 and related AVEO antibodies that bind to Growth Differentiation Factor 15 (“GDF15”) for the treatment and prevention of diseases and other conditions in all indications in humans (the “Product”). Pursuant to the license agreement, Novartis made an upfront payment to the Company of $15.0 million in September 2015. Novartis also has acquired the Company’s inventory of clinical quality, AV-380 biological drug substance and reimbursed the Company for approximately $3.5 million for such existing inventory. The Company is also eligible to receive up to $53.0 million in potential clinical and development milestone payments and up to $105.0 million in potential regulatory milestone payments tied to the commencement of clinical trials and to regulatory approvals of products developed under the license agreement in the United States, the European Union and Japan, and it is eligible to receive up to $150.0 million in potential commercial milestone payments based on annual net sales of such products. Upon commercialization, the Company is eligible to receive tiered royalties on net sales of approved products ranging from the high single digits to the low double-digits. Certain milestones achieved by Novartis would trigger milestone payment obligations from the Company to St. Vincent’s Hospital Sydney Limited (“St. Vincent’s”) under the Company’s amended and restated license agreement with St. Vincent’s. In addition, royalties on approved products will be payable to St. Vincent’s, and the Company and Novartis will share that obligation equally. Novartis has responsibility under the license agreement for the development, manufacture and commercialization of the Company’s antibodies and any resulting approved therapeutic products. The Company has agreed that it will not directly or indirectly develop, manufacture or commercialize any GDF15 modulator as a human therapeutic during the term of the license agreement. Activities under the agreement with Novartis were evaluated under ASC 605-25 to determine whether such activities represented a multiple element revenue arrangement. The agreement with Novartis includes the following non-contingent deliverables: (i) the Company’s grant of an exclusive, worldwide license to develop and commercialize the Product; (ii) the Company’s obligation to transfer all technical knowledge and data useful in the development and manufacture of the Product; and (iii) the Company’s obligation to cooperate with Novartis’ requests for transition assistance during a 90 day period. The Company determined that the option to purchase the Company’s existing inventory was a contingent deliverable. The Company determined the delivered license and obligation to transfer technical knowledge and data have standalone value from the undelivered cooperation. The Company allocated up-front consideration of $15.0 million to the delivered license and technical knowledge and recognized this amount as revenue during the year ended December 31, 2015. The relative selling price of the undelivered cooperation had de minimis The Company received a cash payment of $3.5 million related to the delivery of its inventory of clinical quality drug substance to Novartis during the three months ended March 31, 2016. No milestone payments have been earned as of September 30, 2016. Pharmstandard In August 2015, the Company entered into a license agreement with JSC “Pharmstandard-Ufimskiy Vitamin Plant,” a company registered under the laws of the Russian Federation (“Pharmstandard”). Pharmstandard is a subsidiary of Pharmstandard OJSC. Under the license agreement, the Company granted to Pharmstandard the exclusive, sublicensable right to develop, manufacture and commercialize tivozanib in the territories of Russia, Ukraine and the Commonwealth of Independent States (the “Licensed Territories”) for all diseases and conditions in humans, excluding non-oncologic ocular conditions. In June 2016, following unsuccessful efforts to renegotiate certain terms of the Pharmstandard license agreement, Pharmstandard notified the Company that due to economic and market changes in Russia it was exercising its right to terminate the license agreement effective September 9, 2016. Upon termination of the license agreement, the licenses to tivozanib granted to Pharmstandard were terminated, all product rights and regulatory documents were transferred to the Company and Pharmstandard is no longer responsible for the development and commercialization of tivozanib in the Licensed Territories. Pharmstandard filed an application for marketing authorization in Russia for tivozanib for the treatment of renal cell carcinoma that was accepted by the Ministry of Health of the Russian Federation in February 2016. This application was withdrawn following Pharmstandard’s termination notice. Activities under the agreement with Pharmstandard were evaluated under ASC 605-25 to determine whether such activities represented a multiple element revenue arrangement. The agreement with Pharmstandard includes the following non-contingent deliverables: (i) the Company’s grant of an exclusive license to develop and commercialize tivozanib in the Licensed Territories, (ii) the Company’s obligation to provide access , upon request, to all clinical data, regulatory filings, safety data and manufacturing data to Pharmstandard for use in the development and commercialization of tivozanib in the Licensed Territories The Company determined the delivered license did not have standalone value from the undelivered items and that the arrangement should be treated as a single unit of accounting. The Company allocated the upfront payment of $1.0 million to the bundled unit of accounting and was recognizing it over the Company’s performance period through April 2022, the remaining patent life of tivozanib. Upon the effective date of the termination, the remaining deferred revenue of approximately $0.9 million was recognized. Ophthotech In November 2014 the Company entered into a research and exclusive option agreement (the “Option Agreement”), with Ophthotech Corporation (“Ophthotech”) pursuant to which the Company provided Ophthotech an exclusive option to enter into a definitive license agreement whereby the Company would grant Ophthotech the right to develop and commercialize tivozanib outside of Asia and the Middle East for the potential diagnosis, prevention and treatment of non-oncologic diseases or conditions of the eye in humans. Pursuant to this Option Agreement, the Company granted to Ophthotech an exclusive, royalty-free license or sublicense, as applicable, under intellectual property rights controlled by the Company solely to perform the research and development activities related to the use of tivozanib for the specific purposes outlined in the agreement during the Option Period (as defined below). These activities include formulation work for ocular administration, preclinical research and the conduct of a phase 1/2a proof-of-concept clinical trial of a product containing tivozanib in patients with wet age-related macular degeneration (the “POC Study”). Ophthotech paid the Company $0.5 million in consideration for the grant of the option. Such amount is non-refundable and not creditable against any other amounts due under the agreement. Under the Option Agreement, the Company would receive a one-time milestone payment of $2.0 million upon acceptance of the first Investigational New Drug application filed by Ophthotech for the purpose of conducting a human clinical study of tivozanib in ocular diseases or conditions (the “IND Submission Milestone Payment”). The Company is also entitled to receive a one-time milestone payment of $6.0 million (the “Clinical Efficacy Milestone Payment”), on the earlier of (a) December 31, 2016 and (b) the later to occur of: (i) the achievement of a clinical milestone in the POC Study (the “Clinical Efficacy Milestone”) and (ii) the earlier of (A) the date twelve (12) months after our and Ophthotech’s agreement as to the form and substance of the KHK Amendment (as defined below) or (B) the date ninety (90) days after the entry into the KHK Amendment, subject to Ophthotech’s right to terminate the Option Agreement on 90 days’ written notice and certain other conditions (the date on which such payment is due, referred to as the “Clinical Efficacy Milestone Payment Trigger Date”); provided, however, that the Clinical Efficacy Milestone Payment will not be payable if Ophthotech gives AVEO a notice of termination of the Option Agreement within thirty (30) days after the Clinical Efficacy Milestone Payment Trigger Date. Ophthotech may exercise the option at any time until the latest to occur of: (i) twelve (12) months after the achievement of the Clinical Efficacy Milestone, (ii) ninety (90) days after the Clinical Efficacy Milestone Payment Trigger Date, and (iii) thirty (30) days after the Company and Ophthotech agree as to the definitive form of license agreement (the “Option Period”). During the Option Period, the Company will not grant a license to any third party that would preclude the Company from being able to grant to Ophthotech the rights and licenses that are contemplated by the definitive license agreement, and the Company will not engage in any research, development or commercialization of tivozanib in the field covered by the contemplated definitive license agreement, except as specified in the Option Agreement. The terms of the Option Agreement are subject to the Company’s obligations to KHK under the KHK license agreement. A percentage of all payments received by the Company under the Option Agreement and any definitive license agreement must be paid to KHK. The Company is required to maintain the KHK license agreement in effect, and not enter into any amendment or termination thereof that would adversely affect the Company’s rights, during the Option Period. During the Option Period, the Company and Ophthotech are obligated to negotiate in good faith the form and substance of a definitive license agreement, as well as the form and substance of an amendment to the KHK license agreement (the “KHK Amendment”) to modify certain rights and obligations of the parties and sublicensees thereunder, particularly with respect to rights to improvements that are not specifically related to tivozanib, and regulatory affairs matters. If Ophthotech exercises the option, Ophthotech is required to pay the Company a one-time option exercise fee of $2.0 million in addition to the IND Submission Milestone Payment if such payment has not then been previously paid. If upon exercise of the option, the Clinical Efficacy Milestone Payment Trigger Date has not yet occurred, the Company shall be entitled to the Clinical Efficacy Milestone Payment at such time that the Clinical Efficacy Milestone Payment Date does occur if the license agreement remains in effect as of such date. The license agreement, if entered into upon Ophthotech’s exercise of the option, will provide for the Company to be entitled to receive (i) $10.0 million upon meeting certain efficacy and safety endpoints in phase 2 clinical trials that would enable the commencement of a phase 3 clinical trial, (ii) $20.0 million upon marketing approval in the United States, (iii) $20.0 million upon marketing approval in the UK, Germany, Spain, Italy and France and (iv) up to $45.0 million in sales-based milestone payments. Ophthotech would also be required to pay tiered, double-digit royalties, up to the mid-teens, on net sales of tivozanib or products containing tivozanib. Activities under the agreement with Ophthotech were evaluated under ASC 605-25 to determine whether such activities represented a multiple element revenue arrangement. The agreement with Ophthotech includes the following non-contingent deliverables: (i) the Company’s obligation to grant an exclusive option to Ophthotech to enter into a license agreement to develop and commercialize products incorporating tivozanib for treatment of diseases or conditions of the eye outside of Asia and the Middle East during the Option Period (the “Option Grant Deliverable”); (ii) the Company’s obligation to enter into an amendment with KHK to modify the terms of the existing KHK license agreement to negotiate a mutually acceptable form of license agreement; and (iii) the Company’s obligation to transfer research-grade tivozanib drug substance for Ophthotech to conduct the Option Period research. The Company determined that the delivered Option Grant Deliverable did not have standalone value from the remaining deliverables since Ophthotech could not obtain the intended benefit of the option without the remaining deliverables. Similarly, the remaining deliverables have no standalone value without the Option Grant Deliverable. The Company is accounting for the deliverables as one unit of accounting. Under the Option Agreement, the Company received a cash payment of $0.5 million during the year ended December 31, 2014. The Company deferred the payment and is recording the deferred revenue over the Company’s period of performance, which is currently estimated to be through December 2017. The Company recorded approximately $29,000 of revenue in each of the three months ended September 30, 2016 and 2015, and approximately $87,000 of revenue in each of the nine months ended September 30, 2016 and 2015. 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 ® proof-of-concept Under the Biodesix Agreement, with the exception of the costs incurred for the FOCAL study, the Company and Biodesix are each required to contribute 50% of all clinical, regulatory, manufacturing and other costs to develop ficlatuzumab. Pursuant to the Biodesix Agreement, Biodesix was obligated to fund all costs of the FOCAL study up to a cap of $15 million, following which all costs of the FOCAL study would be shared equally. In connection with the discontinuation of the FOCAL study, on October 14, 2016 the Company and Biodesix amended the Biodesix Agreement. Under the amendment, the Company agreed to share 50% of the cost of the FOCAL study from August 1, 2016 through its closeout. The Company does not anticipate that these remaining costs will be material. In return for bearing 50% of the FOCAL costs after August 1, 2016, the Company will be entitled to recover an agreed multiple of the additional costs borne by the Company out of any income received by the partnership in connection with the development or commercialization of ficlatuzumab. Following such recovery, the payment structure under the original Biodesix Agreement, which generally provides that the parties share equally in any costs and revenue, will resume without such modification. 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 AVEO 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. If AVEO elects to Opt-Out, it will continue to make the existing supply of ficlatuzumab available to Biodesix for the purposes of enabling Biodesix to complete the development of ficlatuzumab, and Biodesix will have the right to commercialize ficlatuzumab. After election of an Opt-Out, 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 be entitled to receive, if ficlatuzumab is successfully developed and commercialized, a royalty equal to 10% of net sales of ficlatuzumab throughout the world, if any, subject to offsets under certain circumstances. 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. Activities under the Biodesix Agreement were evaluated under ASC 605-25 to determine whether such activities represented a multiple element revenue arrangement. The Biodesix Agreement includes the following non-contingent deliverables: (i) the Company’s obligation to deliver perpetual, non-exclusive rights to certain intellectual property including clinical and biomarker data related to ficlatuzumab for use in developing and commercializing Veristrat; (ii) the Company’s obligation to participate in the joint steering committee; and (iii) the Company’s obligation to provide its existing supply of ficlatuzumab for development purposes. [The Company concluded that any deliverables that would be delivered after the FOCAL trial is complete are contingent deliverables because these services are contingent upon the results of the FOCAL trial. As these deliverables are contingent, and are not at an incremental discount, they are not evaluated as deliverables at the inception of the arrangement. These contingent deliverables will be evaluated and accounted for separately as each related contingency is resolved. As of September 30, 2016, no contingent deliverables had been provided by the Company. The Company determined that the perpetual, non-exclusive rights to certain intellectual property for use in developing and commercializing Veristrat did not have standalone value from the remaining deliverables since Biodesix could not obtain the intended benefit of the license without the remaining deliverables. Since the remaining deliverables will be performed over the same period of performance, there is no difference in accounting for the deliverables as one unit or multiple units of accounting, and therefore, the Company is accounting for the deliverables as one unit of accounting. The Company records the consideration earned in connection with the FOCAL trial, which consists of reimbursements from Biodesix for expenses related to the trial, as a reduction to 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 $0.4 million and $1.9 million during the three months and nine months ended September 30, 2016, respectively, and by approximately $0.8 million and $2.7 million during the three months and nine months ended September 30, 2015, respectively. The amount due to the Company from Biodesix pursuant to the cost-sharing provision was approximately $0.9 million at September 30, 2016, which is expected to be paid in the fourth quarter of 2016. 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 license to research, develop, manufacture and commercialize products for human therapeutic, preventative and palliative applications that benefit from inhibition or decreased expression or activity of MIC-1, which is also referred to as GDF15. Under the agreement, the Company has the right to grant sublicenses subject to certain restrictions. Under the license 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 and St. Vincent’s amended and restated the license agreement (the “Amended St. Vincent’s Agreement”). Under the Amended St. Vincent’s Agreement, the Company was required to make an upfront payment to St. Vincent’s of $1.5 million. St. Vincent’s is also eligible to receive up to approximately $18.9 million in connection with development and regulatory milestones under the Amended St. Vincent’s Agreement. Royalties for approved products resulting from the Amended St. Vincent’s Agreement will also be payable to St. Vincent’s, and the Company and Novartis will share that obligation equally. Under the license agreement with Novartis, the Company is required to maintain the Amended St. Vincent’s Agreement in effect, and not enter into any amendment that would adversely affect Novartis’ rights during the term of the license agreement with Novartis. During the nine months ended September 30, 2016, the Company made a $0.4 million milestone payment to St. Vincent’s related to the selection of a development candidate. Astellas Pharma In February 2011, the Company, together with its wholly-owned subsidiary AVEO Pharma Limited, entered into a collaboration and license agreement (the “Astellas Agreement”) |
Other Accrued Liabilities
Other Accrued Liabilities | 9 Months Ended |
Sep. 30, 2016 | |
Payables And Accruals [Abstract] | |
Other Accrued Liabilities | (5) Other Accrued Liabilities Other accrued expenses consisted of the following as of September 30, 2016 and December 31, 2015: September 30, 2016 December 31, 2015 (in thousands) Professional fees $ 593 $ 573 Compensation and benefits 763 938 Restructuring — 357 Other 169 272 Total $ 1,525 $ 2,140 |
Loans Payable
Loans Payable | 9 Months Ended |
Sep. 30, 2016 | |
Debt Disclosure [Abstract] | |
Loans Payable | (6) Loans Payable On May 28, 2010, the Company entered into a loan and security agreement (the “Loan Agreement”) with Hercules Technology II, L.P. and Hercules Technology III, L.P., affiliates of Hercules Technology Growth (collectively, “Hercules ”). The Loan Agreement was subsequently amended in March 2012 (the “2012 Amendment , September 2014 (the “2014 Amendment May 2016 Pursuant to the 2014 Amendment additional loan proceeds from Hercules amount of $10.0 million and continues to be The 2014 Amendment was Debt—Modifications and Extinguishments . In connection with the 2014 Amendment, the Company issued warrants to the lenders to purchase up to 608,696 shares of the Company’s common stock at an exercise price equal to $1.15 per share. The Company recorded the fair value of the warrants of approximately $0.4 million as stockholders’ equity and as a discount to the related loan outstanding and is amortizing the value of the discount to interest expense over the term of the loan using the effective interest method. Pursuant to the 2016 the Company received loan from Hercules in the amount of $5.0 million outstanding principal balance $15.0 million. The Company is not required to principal on the $15 million loan until July 1, 2017, at which time the Company will be required to make 30 principal and interest December 2019. An end-of-term payment of approximately $0.2 million is due 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 accounted for as a loan modification in accordance with ASC 470-50 . The 2016 a financial covenant that requires the Company to maintain an unrestricted cash position greater than or equal to $10.0 million through the date of completion of the Company’s Phase 3 TIVO-3 trial. Under the 2016 , the Company may, at its request during any time from March 1, 2017 through June 30, 2017, draw down an additional $5.0 million in funding. This funding is contingent upon the Company: (i) achieving satisfactory developmental progression on a minimum of two (2) clinical programs (other than the Phase 3 TIVO-3 trial) that are either managed directly by the Company or funded, in whole or in part, by the Company and (ii) having an unrestricted cash position greater than or equal to $25.0 million on the date of the draw down request. If the Company draws down the additional $5.0 million in funding, the commencement of principal payments deferred by six months from July 1, 2017 until January 1, 2018. In connection with the 2016 The unamortized discount to be recognized over the remainder of the loan period was approximately $1.1 million and $0.5 million as of September 30, 2016 and December 31, 2015, respectively. The Company must make interest payments on the loan balance each month it remains As part of the Loan Agreement, 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. The Company has evaluated the embedded conversion option, and has concluded that it does not need to be bifurcated and separately accounted for. No amount will be recognized for the conversion feature until such time as the conversion feature is exercised and it can be determined whether a beneficial conversion feature exists. In connection with the Company’s May 2016 private placement (refer to Note 7), Hercules purchased 259,067 units for cash proceeds of $0.2 million to the Company. This purchase was separate from the $2.0 million equity purchase option under the Loan Agreement. 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 Loan Agreement. The Loan Agreement defines , the Company was in compliance with all loan covenants 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 September 30, 2016 are as follows (amounts in thousands): Years Ending December 31: 2016 (3 months remaining) $ 451 2017 4,386 2018 7,506 2019 7,159 19,502 Less amount representing interest (3,812 ) Less unamortized discount (1,131 ) Less deferred charges (690 ) Less loans payable current, net of discount (766) Loans payable, net of current portion and discount $ 13,103 |
Common Stock
Common Stock | 9 Months Ended |
Sep. 30, 2016 | |
Equity [Abstract] | |
Common Stock | (7) Common Stock Private Placement / PIPE Warrants 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. 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 key assumptions used to value the PIPE Warrants were as follows: Original Issuance June 30, 2016 September 30, 2016 Expected price volatility 76.25% 76.51% 76.60% Expected term (in years) 5.00 4.90 4.75 Risk-free interest rates 1.22% 1.01% 1.14% Stock price $ 0.89 $ 0.96 $ 0.89 Dividend yield — — — ATM Sales Agreement In February 2015, the Company entered into an at-the-market issuance sales agreement (the “Sales Agreement”) with FBR & Co. (formerly MLV & Co. LLC) (“FBR”), pursuant to which the Company could issue and sell shares of its common stock from time to time up to an aggregate amount of $17.9 million, at the Company’s option, through FBR as its sales agent. Sales of common stock through FBR may be 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, including by means On May 7, 2015, the Company filed a shelf registration statement on Form S-3 with the SEC, which covers the offering, issuance and sale by the Company of up to $100.0 million of its common stock, preferred stock, debt securities, warrants and/or units (the “2015 Shelf”). The 2015 Shelf was filed to replace the Company’s existing $250.0 million shelf registration statement (the “2012 Shelf”). On May 7, 2015, the Company also amended its Sales Agreement with FBR to provide for the offering, issuance and sale by the Company of up to $15.0 million of its common stock under the 2015 Shelf, which replaced the Company’s existing $17.9 million offering that expired along with the expired 2012 Shelf. As of September 30, 2016, the Company has sold approximately 5.9 million shares pursuant to the Sales Agreement, as amended, resulting in proceeds of approximately $10.2 million, net of commissions and issuance costs. No shares have been sold during the three and nine months ended September 30, 2016. Approximately $9.1 million remains available for sale under the Sales Agreement. |
Stock-based Compensation
Stock-based Compensation | 9 Months Ended |
Sep. 30, 2016 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Stock-based Compensation | (8) Stock-based Compensation Stock Plans The following table summarizes stock option activity during the nine months ended September 30, 2016. Options Weighted- Average Exercise Price Weighted- Average Remaining Contractual Term Aggregate Intrinsic Value Outstanding at December 31, 2015 4,796,005 $ 3.78 Granted 1,705,134 $ 1.03 Exercised (38,749 ) $ 0.84 Forfeited (651,407 ) $ 1.96 Outstanding at September 30, 2016 5,810,983 $ 3.20 7.08 $ 51 Vested or expected to vest at September 30, 2016 3,771,566 $ 4.32 6.16 $ 30 Exercisable at September 30, 2016 2,977,166 $ 5.17 5.47 $ 21 Stock options to purchase 197,650 shares of common stock contain market conditions which were not deemed probable of vesting at September 30, 2016. The fair value of stock options subject only to service or performance conditions that are granted to employees is estimated on the date of grant using the Black-Scholes option-pricing model using the assumptions noted in the following table: Three Months Ended September 30, 2016 2015 Volatility factor 73.60% - 73.94% 74.53% - 74.54% Expected term (in years) 6.25 6.25 Risk-free interest rates 1.07% - 1.22% 1.56% Dividend yield — — Nine Months Ended September 30, 2016 2015 Volatility factor 73.26% - 74.47% 73.04% - 78.7% Expected term (in years) 5.50 - 6.25 5.50 - 6.25 Risk-free interest rates 0.94% - 1.38% 1.54% - 1.85% Dividend yield — — The risk-free interest rate is determined based upon the United States Treasury’s rates for U.S. Treasury zero-coupon bonds with maturities similar to those of the expected term of the options being valued. The Company does not expect to pay dividends in the foreseeable future. The Company calculates volatility and expected term using its historical data. Based upon these assumptions, the weighted-average grant date fair value of stock options granted to employees during the nine months ended September 30, 2016 and 2015 was $0.67 per share and $0.75 per share, respectively. The Company is required to include an estimate of the value of the awards that will be forfeited in calculating compensation costs, which the Company estimates based upon actual historical forfeitures. The forfeiture estimates are recognized over the requisite service period of the awards on a straight-line basis. The Company estimated its forfeiture rate to be approximately 76% and 70% as of September 30, 2016 and 2015, respectively. As of September 30, 2016, there was $0.8 million of total unrecognized stock-based compensation expense related to stock options granted to employees under the Company’s 2002 Stock Incentive Plan and 2010 Stock Incentive Plan (collectively, the “Plans”). The expense is expected to be recognized over a weighted-average period of 2.6 years. The intrinsic value of options exercised during the nine months ended September 30, 2016 and 2015 was $35,000 and $57,000, respectively. The restricted stock activity for the nine months ended September 30, 2016 is as follows: Number of Shares Weighted- Average Fair-Value Unvested at December 31, 2015 42,750 $ 1.61 Granted — — Vested/Released (42,750 ) 1.61 Unvested at September 30, 2016 — — As of September 30, 2016, there was no unrecognized stock-based compensation expense related to restricted stock awards granted under the Plan. |
Strategic Restructuring
Strategic Restructuring | 9 Months Ended |
Sep. 30, 2016 | |
Restructuring And Related Activities [Abstract] | |
Strategic Restructuring | (9) Strategic Restructuring On January 6, 2015, the Board of the Company approved a strategic restructuring of the Company that eliminated the Company’s internal research function and aligned the Company’s resources with the Company’s future strategic plans. As part of this restructuring, the Company eliminated approximately two-thirds of the Company’s workforce, or 40 positions across the organization. The Company substantially completed the restructuring during the quarter-ended March 31, 2015. The following table summarizes the components of the Company’s restructuring activity recorded in operating expenses and in accrued expenses in the accompanying consolidated balance sheet: Restructuring amounts at December 31, 2015 Restructuring expense incurred during the nine months ended September 30, 2016 Restructuring amounts paid during the nine months ended September 30, 2016 Restructuring amounts accrued at September 30, 2016 (in thousands) Employee severance, benefits and related costs. $ 357 — $ (357 ) — |
Facility Lease Exit
Facility Lease Exit | 9 Months Ended |
Sep. 30, 2016 | |
Facility Lease Exit [Abstract] | |
Facility Lease Exit | (10) Facility Lease Exit In September 2014, the Company entered into the Lease Termination Agreement pursuant to which the Company immediately surrendered leased space at 650 East Kendall Street in Cambridge, Massachusetts that it had previously ceased using earlier in 2014. In connection with the Lease Termination Agreement, the Company agreed to pay the landlord a termination fee totaling $15.6 million. The Company also agreed to surrender its remaining leased space upon 90 days written notice prior to September 24, 2015. In February 2015, the Company provided notice that it would surrender the remaining space on May 29, 2015. Accordingly, the Company revised the estimated useful life of its leasehold improvements related to this office space and amortized such assets through May 2015, resulting in an additional $2.9 million of depreciation expense during the six months ended June 30, 2015. Similarly, the Company accelerated the amortization of its deferred rent and leasehold improvement allowance associated with this office space through May 2015, resulting in an additional $3.5 million of amortization during the six months ended June 30, 2015. |
Legal Proceedings
Legal Proceedings | 9 Months Ended |
Sep. 30, 2016 | |
Commitments And Contingencies Disclosure [Abstract] | |
Legal Proceedings | (11) Legal Proceedings Two class action lawsuits have been filed against the Company and certain of its former officers and members of its board of directors (Tuan Ha-Ngoc, David N. Johnston, William Slichenmyer and Ronald DePinho) in the United States District Court for the District of Massachusetts, one captioned Paul Sanders v. Aveo Pharmaceuticals, Inc., et al., No. 1:13-cv-11157-JLT, filed on May 9, 2013, and the other captioned Christine Krause v. AVEO Pharmaceuticals, Inc., et al., No. 1:13-cv-11320-JLT, filed on May 31, 2013. On December 4, 2013, the District Court consolidated the complaints as In re AVEO Pharmaceuticals, Inc. Securities Litigation et al., No. 1:13-cv-11157-DJC, and an amended complaint was filed on February 3, 2014. The amended complaint purported to be brought on behalf of shareholders who purchased the Company’s common stock between January 3, 2012 and May 1, 2013. The amended complaint generally alleged that the Company and certain of its present and former officers and directors violated Sections 10(b) and/or 20(a) of the Securities Exchange Act of 1934 and Rule 10b-5 promulgated thereunder by making allegedly false and/or misleading statements concerning the phase 3 trial design and results for the Company’s TIVO-1 study in an effort to lead investors to believe that the drug would receive approval from the FDA. The lawsuit seeks unspecified damages, interest, attorneys’ fees, and other costs. The consolidated amended complaint was dismissed without prejudice on March 20, 2015, and the lead plaintiffs then filed a second amended complaint bringing similar allegations. The Company moved to dismiss again, and after a second round of briefing and oral argument, the court ruled in the Company’s favor and dismissed the second amended complaint with prejudice on November 18, 2015. The lead plaintiffs have appealed the court’s decision to the United States Court of Appeals for the First Circuit. They have also filed a motion to vacate and reconsider the district court’s judgment, which the Company has opposed. The Company denies any allegations of wrongdoing and intends to continue to vigorously defend against this lawsuit. However, there is no assurance that the Company will be successful in its defense or that insurance will be available or adequate to fund any settlement or judgment or the litigation costs of the action. Moreover, the Company is unable to predict the outcome or reasonably estimate a range of possible loss at this time. On April 4, 2014, Karen J. van Ingen, a purported purchaser of AVEO stock, filed a derivative complaint allegedly on behalf of AVEO in the United States District Court for the District of Massachusetts (the “Court”), Civil Action No. 1:14-cv-11672-DJC, naming AVEO, as a nominal defendant and also naming as defendants present and former members of the Company’s board of directors, including Tuan Ha-Ngoc, Henri A. Termeer, Kenneth M. Bate, Anthony B. Evnin, Robert Epstein, Raju Kucherlapati, Robert C. Young, and Kenneth E. Weg. The complaint alleged breach of fiduciary duty and abuse of control between January 2012 and May 2013 with respect to allegedly misleading statements and omissions regarding tivozanib. The lawsuit seeks, among other relief, unspecified damages, costs and expenses, including attorneys’ fees, an order requiring us to implement certain corporate governance reforms, restitution from the defendants and such other relief as the court might find just and proper. The Company filed a motion to dismiss the derivative complaint, and after briefing and oral argument, on March 18, 2015 the Court ruled in the Company’s favor and dismissed the case with prejudice. The plaintiff then filed a motion seeking to vacate the Court’s order of dismissal and permit filing of an amended complaint, which the Company opposed, and which the Court denied on June 30, 2015. The plaintiff has appealed the Court’s decision to the United States Court of Appeals for the First Circuit. The parties have reached an agreement in principle to settle this matter. The settlement involves certain corporate governance changes and other non-monetary relief. The plaintiffs are seeking an award of attorney’s fees, costs, and expenses in the amount of $822,116, as well as an incentive award of $2,500. The Company reserved the right to contest the award of attorney’s fees, costs and expenses and expect both the fees, costs and expenses and incentive award to be paid by insurance in the amounts ordered by the Court. On September 16, 2016, the Court granted preliminary approval to the proposed settlement, but the settlement remains subject to final Court approval. The Court set a hearing on December 19, 2016 to determine whether: (i) the terms of the Proposed Settlement are fair, reasonable, and adequate, (ii) whether, and, if so, in what amount, attorneys’ fees and expenses should be awarded to plaintiff’s counsel; and (iii) whether any incentive award to plaintiff should be approved. There can be no assurance that the settlement will be approved by the Court. On July 3, 2013, the staff (the “SEC Staff”) of the United States Securities and Exchange Commission (the “Commission”) 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 Staff 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 made to the Company 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 Commission filed a complaint against the Company and three of its former officers in the U.S. District Court for the District of Massachusetts (the “Court”) alleging that the Company misled investors about its efforts to obtain FDA approval for tivozanib. Without admitting or denying the allegations in the Commission’s complaint, the Company consented to the entry of a final judgment pursuant to which the Company paid the Commission a $4.0 million civil penalty to settle the Commission’s claims against the Company. On March 31, 2016, the 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 Securities Exchange Act of 1934, as amended, 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. The Commission’s action against the Company’s three former officers is still pending. The Company is not a party to any litigation or discussions between the SEC Staff and the former officers, and the Company can make no assurance regarding the outcome of that action or the Commission’s claims against those individuals. |
Significant Accounting Polici18
Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2016 | |
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 elements, or deliverables, 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 pre-clinical and clinical material. Payments to the Company under these arrangements typically include one or more of the following: non-refundable, up-front license fees; option exercise fees; funding of research and/or development efforts; milestone payments; and royalties on future product sales. When evaluating multiple element arrangements, the Company considers whether the deliverables under the arrangement represent separate units of accounting. This evaluation requires subjective determinations and requires management to make judgments about the individual deliverables and whether such deliverables are separable from the other aspects of the contractual relationship. In determining the units of accounting, management evaluates certain criteria, including whether the deliverables have standalone value, based on the relevant facts and circumstances for each arrangement. The consideration received is allocated among the separate units of accounting using the relative selling price method, and the applicable revenue recognition criteria are applied to each of the separate units. The Company determines the estimated selling price for deliverables within each agreement using vendor-specific objective evidence (“VSOE”) of selling price, if available, third-party evidence (“TPE”) of selling price if VSOE is not available, or best estimate of selling price if neither VSOE nor TPE is available. Determining the best estimate of selling price for a deliverable requires significant judgment. The Company typically uses best estimate of selling price to estimate the selling price for licenses to the Company’s proprietary technology, since the Company often does not have VSOE or TPE of selling price for these deliverables. In those circumstances where the Company utilizes best estimate of selling price to determine the estimated selling price of a license to the Company’s proprietary technology, the Company considers market conditions as well as entity-specific factors, including those factors contemplated in negotiating the agreements and internally developed models that include assumptions related to the market opportunity, estimated development costs, probability of success and the time needed to commercialize a product candidate pursuant to the license. In validating the Company’s best estimate of selling price, the Company evaluates whether changes in the key assumptions used to determine the best estimate of selling price will have a significant effect on the allocation of arrangement consideration among multiple deliverables. The Company typically receives non-refundable, up-front payments when licensing its intellectual property in conjunction with a research and development agreement. When management believes the license to its intellectual property does not have stand-alone value from the other deliverables to be provided in the arrangement, the Company generally recognizes revenue attributed to the license on a straight-line basis over the Company’s contractual or estimated performance period, which is typically the term of the Company’s research and development obligations. If management cannot reasonably estimate when the Company’s performance obligation ends, then revenue is deferred until management can reasonably estimate when the performance obligation ends. When management believes the license to its intellectual property has stand-alone value, the Company generally recognizes revenue attributed to the license upon delivery. The periods over which revenue should be recognized are subject to estimates by management and may change over the course of the research and development agreement. Such a change could have a material impact on the amount of revenue the Company records in future periods. Payments or reimbursements resulting from the Company’s research and development efforts for those arrangements where such efforts are considered as deliverables are recognized as the services are performed and are presented on a gross basis so long as there is persuasive evidence of an arrangement, the fee is fixed or determinable, and collection of the related receivable is reasonably assured. Amounts received prior to satisfying the above revenue recognition criteria are recorded as deferred revenue in the accompanying balance sheets. At the inception of each agreement that includes milestone payments, the Company evaluates whether each milestone is substantive and at risk to both parties on the basis of the contingent nature of the milestone. This evaluation includes an assessment of whether (a) the consideration is commensurate with either (1) the entity’s performance to achieve the milestone, or (2) the enhancement of the value of the delivered item(s) as a result of a specific outcome resulting from the entity’s performance to achieve the milestone, (b) the consideration relates solely to past performance, and (c) the consideration is reasonable relative to all of the deliverables and payment terms within the arrangement. The Company evaluates factors such as the scientific, regulatory, commercial and other risks that must be overcome to achieve the respective milestone, the level of effort and investment required to achieve the respective milestone and whether the milestone consideration is reasonable relative to all deliverables and payment terms in the arrangement in making this assessment. The Company aggregates its milestones into four categories: (i) clinical and development milestones, (ii) regulatory milestones, (iii) commercial milestones, and (iv) patent-related milestones. Clinical and development milestones are typically achieved when a product candidate advances into a defined phase of clinical research or completes such phase. For example, a milestone payment may be due to the Company upon the initiation of a phase 3 clinical trial for a new indication, which is the last phase of clinical development and could eventually contribute to marketing approval by the U.S. Food and Drug Administration (“FDA”) or other global regulatory authorities. Regulatory milestones are typically achieved upon acceptance of the submission for marketing approval of a product candidate or upon approval to market the product candidate by the FDA or other global regulatory authorities. For example, a milestone payment may be due to the Company upon the FDA’s acceptance of a New Drug Application (“NDA”). Commercial milestones are typically achieved when an approved pharmaceutical product reaches certain defined levels of net sales by the licensee, such as when a product first achieves global sales or annual sales of a specified amount. Patent-related milestones are typically achieved when a patent application is filed or a patent is issued with respect to certain intellectual property related to the applicable collaboration. Revenues from clinical and development, regulatory, and patent-related milestone payments, if the milestones are deemed substantive and the milestone payments are nonrefundable, are recognized upon successful accomplishment of the milestones. The Company has concluded that the clinical and development, regulatory and patent-related milestones pursuant to its current research and development arrangements are substantive. Milestones that are not considered substantive are accounted for as license payments and recognized on a straight-line basis over the remaining period of performance. Revenues from commercial milestone payments are accounted for as royalties and are recorded as revenue upon achievement of the milestone, assuming all other revenue recognition criteria are met. |
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 personnel-related costs such as salaries and stock-based compensation, facilities, research-related overhead, clinical trial costs, manufacturing costs and costs of other contracted services, license fees, and other external costs. Nonrefundable advance payments for goods and services that will be used in future research and development activities are expensed when the activity has been performed or when the goods have been received. |
Warrants Issued in Connection with Private Placement | Warrants Issued in Connection with Private Placement 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. These warrants are subject to revaluation at each balance sheet date, and any changes in fair value are recorded as a non-cash component of other income (expense), net until the earlier of their exercise or expiration or upon the completion of a liquidation event. During the three months and nine months ended September 30, 2016, as a result of the fair value adjustment of the warrant liability, the Company recorded a decrease in the fair value of the warrant liability of approximately $1.2 million and $0.2 million, respectively, in its Statements of Operations and Comprehensive Income (Loss). Refer to Note 7, “Common Stock - Private Placement / PIPE Warrants” for further discussion on the calculation of the fair value of the warrant liability. The following table rolls forward the fair value of the Company’s warrant liability, the fair value of which is determined by Level 3 inputs for the nine months ended September 30, 2016 (in thousands): Nine Months Ended September 30, 2016 Fair value at January 1, 2016 $ — Issuance of warrants on May 13, 2016 9,344 Change in fair value 996 Fair value at June 30, 2016 10,340 Change in fair value (1,178 ) Fair value at September 30, 2016 $ 9,162 |
Cash and Cash Equivalents | Cash and Cash Equivalents 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 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 and high-grade, short-term corporate bonds and U.S. government agency securities, which management believes are subject to minimal credit and market risk. |
Marketable Securities | Marketable Securities 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. Since these securities are available to fund current operations they are classified as current assets on the consolidated balance sheets. Marketable securities are stated at fair value, including accrued interest, with their unrealized gains and losses included as a component of accumulated other comprehensive income or loss, which is a separate component of stockholders’ equity. The fair value of these securities is based on quoted prices and observable inputs on a recurring basis. The cost of marketable securities is adjusted for amortization of premiums and accretion of discounts to maturity, with such amortization and accretion recorded as a component of interest expense, net. 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. There were no realized gains or losses recognized on the sale or maturity of marketable securities during the three months and nine months ended September 30, 2016 and 2015. Below is a summary of cash, cash equivalents and marketable securities at September 30, 2016 and December 31, 2015: Amortized Cost Unrealized Gains Unrealized Losses Fair Value (in thousands) September 30, 2016: Cash and cash equivalents: Cash and money market funds $ 12,370 $ — $ — $ 12,370 Government agency securities - — — - Corporate debt securities - — — - Total cash and cash equivalents 12,370 — — 12,370 Marketable securities: Corporate debt securities due within 1 year 13,420 27 (1 ) 13,446 Government agency securities due within 1 year 5,013 2 — 5,015 Total marketable securities 18,433 29 (1 ) 18,461 Total cash, cash equivalents and marketable securities $ 30,803 $ 29 $ (1 ) $ 30,831 December 31, 2015: Cash and cash equivalents: Cash and money market funds $ 21,822 $ — $ — $ 21,822 Corporate debt securities 4,812 — — 4,812 Total cash and cash equivalents 26,634 — — 26,634 Marketable securities: Corporate debt securities due within 1 year $ 6,504 $ — $ (3 ) $ 6,501 Government agency securities due within 1 year 1,000 — — 1,000 Total marketable securities 7,504 — (3 ) 7,501 Total cash, cash equivalents and marketable securities $ 34,138 $ — $ (3 ) $ 34,135 |
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. As of September 30, 2016, the Company had $1.0 million of accounts receivable outstanding, primarily due |
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 September 30, 2016, the Company’s financial assets valued based on Level 1 inputs consisted of cash and cash equivalents in a money market fund and its financial assets valued based on Level 2 inputs consisted of high-grade corporate bonds, commercial paper and U.S. government agency securities. During the three months and nine months ended September 30, 2016, the Company did not have any transfers of financial assets between Levels 1 and 2. As of September 30, 2016, the Company’s financial liabilities that were recorded at fair value consisted of a warrant liability. The fair value of the Company’s loans payable at September 30, 2016 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 September 30, 2016 and December 31, 2015: Fair Value Measurements of Cash Equivalents and Marketable Securities as of September 30, 2016 Level 1 Level 2 Level 3 Total (in thousands) Financial assets carried at fair value: Cash equivalents $ 12,370 $ — $ — $ 12,370 Corporate debt securities — - — - Government agency securities — - — - Total cash and cash equivalents $ 12,370 $ — $ — $ 12,370 Marketable securities: Corporate debt securities due within 1 year $ — $ 13,446 $ — $ 13,446 Government agency securities due within 1 year — 5,015 — 5,015 Total marketable securities $ — $ 18,461 $ — $ 18,461 Total cash, cash equivalents and marketable securities $ 12,370 $ 18,461 $ — $ 30,831 Financial liabilities carried at fair value: Warrant liability $ — $ — $ 9,162 $ 9,162 Total warrant liability $ — $ — $ 9,162 $ 9,162 Fair Value Measurements of Cash Equivalents and Marketable Securities as of December 31, 2015 Level 1 Level 2 Level 3 Total (in thousands) Financial assets carried at fair value: Cash equivalents $ 21,822 $ — $ — $ 21,822 Corporate debt securities — 4,812 4,812 Total cash and cash equivalents $ 21,822 $ 4,812 $ — $ 26,634 Marketable securities: Corporate debt securities due within 1 year $ — $ 6,501 $ — $ 6,501 Government agency securities due within 1 year — 1,000 — 1,000 Total marketable securities $ — $ 7,501 $ — $ 7,501 Total cash, cash equivalents and marketable securities $ 21,822 $ 12,313 $ — $ 34,135 Financial liabilities carried at fair value: Warrant liability $ — $ — $ — $ — $ — $ — $ — $ — |
Property and Equipment | Property and Equipment Property and equipment are stated at cost and are depreciated using the straight-line method over the estimated useful lives of the respective assets. Maintenance and repair costs are charged to expense as incurred. During the quarter ended June 30, 2015, the Company transitioned to new office space and, as a result, revised the estimated useful life of its office furniture, resulting in an increase in depreciation expense of approximately $0.4 million during the nine months ended September 30, 2015. |
Long-lived Assets | Long-lived Assets The Company reviews long-lived assets, including property and equipment, for impairment whenever changes in business circumstances indicate that the carrying amount of the asset may not be fully recoverable. No impairment charges were recognized during the three months and nine months ended September 30, 2016. The Company recognized $0.2 million of impairment from losses for the nine months ended September 30, 2015 related to leasehold improvements. |
Basic and Diluted Loss per Common Share | Basic and Diluted Loss per Common Share Basic earnings (loss) per share is computed by dividing net income (loss) available to common stockholders by the weighted-average number of common shares outstanding during the period. Diluted earnings (loss) per share is computed by dividing net income (loss) available to common stockholders by the weighted-average number of common shares and dilutive common share equivalents then outstanding which exclude unvested restricted stock. Potential common share equivalents consist of the incremental common shares issuable upon the exercise of stock options and warrants. After applying the treasury stock method for those instruments that were “in-the-money,” the dilutive effect of stock options and warrants resulted in an increase in the weighted-average number of common shares of 222,000 used in calculating diluted earnings per common share for the three months ending September 30, 2015. For periods presented during which the Company had a net loss, the effect of all potentially dilutive securities is anti-dilutive. Accordingly, basic and diluted net loss per common share is the same for those periods. The following table sets forth the potential common shares excluded from the calculation of net loss per common share-diluted for the three months and nine months ended September 30, 2016 and the nine months ended September 30, 2015 because their inclusion would have been anti-dilutive: Outstanding at September 30, 2016 2015 (in thousands) Options outstanding 5,811 5,826 Warrants outstanding 19,453 609 25,264 6,435 |
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 Accounting Standards Codification (“ASC”) 718 Share-Based Payments, The fair value of equity-classified awards to employees and directors are measured at fair value on the date the awards are granted. Awards to nonemployee consultants are recorded at their fair values and are re-measured as of each balance sheet date until the recipient’s services are complete. During the three months and nine months ended September 30, 2016 and 2015, the Company recorded the following stock-based compensation expense: Three Months Ended September 30, Nine Months Ended September 30, 2016 2015 2016 2015 (in thousands) (in thousands) Research and development $ 56 $ 50 $ 238 $ 238 General and administrative 149 294 591 873 Restructuring — — — 69 $ 205 $ 344 $ 829 $ 1,180 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. Expenses recognized in connection with the modification of awards in connection with the Company’s strategic restructurings are allocated to restructuring expense. 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 September 30, 2016, the Company is forecasting a net loss for the year ended December 31, 2016. The Company maintains a full valuation allowance on all deferred tax assets. For the nine months ended September 30, 2016, the Company recorded a $0.1 million provision for income taxes related to withholding taxes incurred in a foreign jurisdiction. |
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 September 30, 2016, the Company has $0.8 million of net assets located in the United Kingdom. |
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 , and the reported amounts of revenues and expenses during the reporting periods. Significant items subject to such estimates and assumptions include contract research accruals and measurement of stock-based compensation. The Company bases its estimates on historical experience and various other assumptions that management believes to be reasonable under the circumstances. Changes in estimates are recorded in the period in which they become known |
Recent Accounting Pronouncements | Recent Accounting Pronouncements The Company did not adopt any new accounting pronouncements during the nine months ended September 30, 2016 that had a material effect on the Company’s condensed consolidated financial statements. In May 2014, the Financial Accounting Standards Board (“FASB”) issued a comprehensive new revenue recognition standard that will supersede nearly all existing revenue recognition guidance under US GAAP. The standard was originally scheduled to be effective for public entities for annual and interim periods beginning after December 15, 2016. In July 2015, the standard was deferred and will now be effective for annual and interim periods beginning after December 15, 2017. Early adoption is permitted for annual and interim periods beginning after December 15, 2016. The Company will adopt this standard on January 1, 2018 and is currently evaluating the effect this standard will have on its revenue recognition policies and its financial statements, including how the standard will be adopted. In August 2014, the FASB issued Accounting Standards Update (“ASU”) No. 2014-15, Presentation of Financial Statements—Going Concern (Subtopic 205-40): Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern. In March 2016, the FASB issued ASU No. 2016-09, Compensation─Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting |
Significant Accounting Polici19
Significant Accounting Policies (Tables) | 9 Months Ended |
Sep. 30, 2016 | |
Accounting Policies [Abstract] | |
Summary of Fair Value of Company's Warrant Liability | The following table rolls forward the fair value of the Company’s warrant liability, the fair value of which is determined by Level 3 inputs for the nine months ended September 30, 2016 (in thousands): Nine Months Ended September 30, 2016 Fair value at January 1, 2016 $ — Issuance of warrants on May 13, 2016 9,344 Change in fair value 996 Fair value at June 30, 2016 10,340 Change in fair value (1,178 ) Fair value at September 30, 2016 $ 9,162 |
Summary of Cash, Cash Equivalents and Marketable Securities | Below is a summary of cash, cash equivalents and marketable securities at September 30, 2016 and December 31, 2015: Amortized Cost Unrealized Gains Unrealized Losses Fair Value (in thousands) September 30, 2016: Cash and cash equivalents: Cash and money market funds $ 12,370 $ — $ — $ 12,370 Government agency securities - — — - Corporate debt securities - — — - Total cash and cash equivalents 12,370 — — 12,370 Marketable securities: Corporate debt securities due within 1 year 13,420 27 (1 ) 13,446 Government agency securities due within 1 year 5,013 2 — 5,015 Total marketable securities 18,433 29 (1 ) 18,461 Total cash, cash equivalents and marketable securities $ 30,803 $ 29 $ (1 ) $ 30,831 December 31, 2015: Cash and cash equivalents: Cash and money market funds $ 21,822 $ — $ — $ 21,822 Corporate debt securities 4,812 — — 4,812 Total cash and cash equivalents 26,634 — — 26,634 Marketable securities: Corporate debt securities due within 1 year $ 6,504 $ — $ (3 ) $ 6,501 Government agency securities due within 1 year 1,000 — — 1,000 Total marketable securities 7,504 — (3 ) 7,501 Total cash, cash equivalents and marketable securities $ 34,138 $ — $ (3 ) $ 34,135 |
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 September 30, 2016 and December 31, 2015: Fair Value Measurements of Cash Equivalents and Marketable Securities as of September 30, 2016 Level 1 Level 2 Level 3 Total (in thousands) Financial assets carried at fair value: Cash equivalents $ 12,370 $ — $ — $ 12,370 Corporate debt securities — - — - Government agency securities — - — - Total cash and cash equivalents $ 12,370 $ — $ — $ 12,370 Marketable securities: Corporate debt securities due within 1 year $ — $ 13,446 $ — $ 13,446 Government agency securities due within 1 year — 5,015 — 5,015 Total marketable securities $ — $ 18,461 $ — $ 18,461 Total cash, cash equivalents and marketable securities $ 12,370 $ 18,461 $ — $ 30,831 Financial liabilities carried at fair value: Warrant liability $ — $ — $ 9,162 $ 9,162 Total warrant liability $ — $ — $ 9,162 $ 9,162 Fair Value Measurements of Cash Equivalents and Marketable Securities as of December 31, 2015 Level 1 Level 2 Level 3 Total (in thousands) Financial assets carried at fair value: Cash equivalents $ 21,822 $ — $ — $ 21,822 Corporate debt securities — 4,812 4,812 Total cash and cash equivalents $ 21,822 $ 4,812 $ — $ 26,634 Marketable securities: Corporate debt securities due within 1 year $ — $ 6,501 $ — $ 6,501 Government agency securities due within 1 year — 1,000 — 1,000 Total marketable securities $ — $ 7,501 $ — $ 7,501 Total cash, cash equivalents and marketable securities $ 21,822 $ 12,313 $ — $ 34,135 Financial liabilities carried at fair value: Warrant liability $ — $ — $ — $ — $ — $ — $ — $ — |
Potential Common Shares Excluded from Calculation of Net Loss Per Common Share | The following table sets forth the potential common shares excluded from the calculation of net loss per common share-diluted for the three months and nine months ended September 30, 2016 and the nine months ended September 30, 2015 because their inclusion would have been anti-dilutive: Outstanding at September 30, 2016 2015 (in thousands) Options outstanding 5,811 5,826 Warrants outstanding 19,453 609 25,264 6,435 |
Stock-Based Compensation Expense | During the three months and nine months ended September 30, 2016 and 2015, the Company recorded the following stock-based compensation expense: Three Months Ended September 30, Nine Months Ended September 30, 2016 2015 2016 2015 (in thousands) (in thousands) Research and development $ 56 $ 50 $ 238 $ 238 General and administrative 149 294 591 873 Restructuring — — — 69 $ 205 $ 344 $ 829 $ 1,180 |
Other Accrued Liabilities (Tabl
Other Accrued Liabilities (Tables) | 9 Months Ended |
Sep. 30, 2016 | |
Payables And Accruals [Abstract] | |
Other Accrued Liabilities | Other accrued expenses consisted of the following as of September 30, 2016 and December 31, 2015: September 30, 2016 December 31, 2015 (in thousands) Professional fees $ 593 $ 573 Compensation and benefits 763 938 Restructuring — 357 Other 169 272 Total $ 1,525 $ 2,140 |
Loans Payable (Tables)
Loans Payable (Tables) | 9 Months Ended |
Sep. 30, 2016 | |
Debt Disclosure [Abstract] | |
Future Minimum Payments Under Loans Payable | Future minimum payments under the loans payable outstanding as of September 30, 2016 are as follows (amounts in thousands): Years Ending December 31: 2016 (3 months remaining) $ 451 2017 4,386 2018 7,506 2019 7,159 19,502 Less amount representing interest (3,812 ) Less unamortized discount (1,131 ) Less deferred charges (690 ) Less loans payable current, net of discount (766) Loans payable, net of current portion and discount $ 13,103 |
Common Stock (Tables)
Common Stock (Tables) | 9 Months Ended |
Sep. 30, 2016 | |
Equity [Abstract] | |
Key Assumptions Used to Value the PIPE Warrants | The key assumptions used to value the PIPE Warrants were as follows: Original Issuance June 30, 2016 September 30, 2016 Expected price volatility 76.25% 76.51% 76.60% Expected term (in years) 5.00 4.90 4.75 Risk-free interest rates 1.22% 1.01% 1.14% Stock price $ 0.89 $ 0.96 $ 0.89 Dividend yield — — — |
Stock-based Compensation (Table
Stock-based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2016 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Stock Option Activity | The following table summarizes stock option activity during the nine months ended September 30, 2016. Options Weighted- Average Exercise Price Weighted- Average Remaining Contractual Term Aggregate Intrinsic Value Outstanding at December 31, 2015 4,796,005 $ 3.78 Granted 1,705,134 $ 1.03 Exercised (38,749 ) $ 0.84 Forfeited (651,407 ) $ 1.96 Outstanding at September 30, 2016 5,810,983 $ 3.20 7.08 $ 51 Vested or expected to vest at September 30, 2016 3,771,566 $ 4.32 6.16 $ 30 Exercisable at September 30, 2016 2,977,166 $ 5.17 5.47 $ 21 |
Assumptions used in Black-Scholes Pricing Model for New Grants | The fair value of stock options subject only to service or performance conditions that are granted to employees is estimated on the date of grant using the Black-Scholes option-pricing model using the assumptions noted in the following table: Three Months Ended September 30, 2016 2015 Volatility factor 73.60% - 73.94% 74.53% - 74.54% Expected term (in years) 6.25 6.25 Risk-free interest rates 1.07% - 1.22% 1.56% Dividend yield — — Nine Months Ended September 30, 2016 2015 Volatility factor 73.26% - 74.47% 73.04% - 78.7% Expected term (in years) 5.50 - 6.25 5.50 - 6.25 Risk-free interest rates 0.94% - 1.38% 1.54% - 1.85% Dividend yield — — |
Restricted Stock Activity | The restricted stock activity for the nine months ended September 30, 2016 is as follows: Number of Shares Weighted- Average Fair-Value Unvested at December 31, 2015 42,750 $ 1.61 Granted — — Vested/Released (42,750 ) 1.61 Unvested at September 30, 2016 — — |
Strategic Restructuring (Tables
Strategic Restructuring (Tables) | 9 Months Ended |
Sep. 30, 2016 | |
Restructuring And Related Activities [Abstract] | |
Restructuring Activity Recorded in Operating Expenses and in Accrued Expenses | The following table summarizes the components of the Company’s restructuring activity recorded in operating expenses and in accrued expenses in the accompanying consolidated balance sheet: Restructuring amounts at December 31, 2015 Restructuring expense incurred during the nine months ended September 30, 2016 Restructuring amounts paid during the nine months ended September 30, 2016 Restructuring amounts accrued at September 30, 2016 (in thousands) Employee severance, benefits and related costs. $ 357 — $ (357 ) — |
Organization - Additional Infor
Organization - Additional Information (Detail) $ in Thousands | 9 Months Ended | |
Sep. 30, 2016USD ($)Subsidiary | Dec. 31, 2015USD ($) | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | ||
Number of subsidiaries | Subsidiary | 2 | |
Accumulated deficit | $ | $ (516,311) | $ (495,029) |
Significant Accounting Polici26
Significant Accounting Policies - Additional Information (Detail) | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2016USD ($) | Sep. 30, 2015shares | Sep. 30, 2016USD ($)Segment | Sep. 30, 2015USD ($) | Dec. 31, 2015USD ($) | |
Significant Accounting Policies [Line Items] | |||||
Decrease in the fair value of warrant liability | $ 1,200,000 | $ 200,000 | |||
Realized gain (loss) recognized on sale of marketable securities | 0 | $ 0 | |||
Accounts receivable | 990,000 | 990,000 | $ 4,641,000 | ||
Increase in depreciation expense | 400,000 | ||||
Impairment losses | 0 | 0 | $ 200,000 | ||
Common shares used in calculating diluted earnings per common share | shares | 222,000 | ||||
Tax benefits of the stock based compensation expenses recognized | 0 | ||||
Income tax provision or expense | $ 100,000 | ||||
Number of operating segments | Segment | 1 | ||||
United Kingdom | |||||
Significant Accounting Policies [Line Items] | |||||
Net assets located in the United Kingdom | $ 800,000 | $ 800,000 | |||
Minimum | |||||
Significant Accounting Policies [Line Items] | |||||
Marketable securities maturity term | 3 months | ||||
Maximum | |||||
Significant Accounting Policies [Line Items] | |||||
Marketable securities maturity term | 24 months |
Summary of Fair Value of Compan
Summary of Fair Value of Company's Warrant Liability (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended |
Sep. 30, 2016 | Jun. 30, 2016 | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | ||
Fair value, beginning of period | $ 10,340 | |
Issuance of warrants on May 13, 2016 | $ 9,344 | |
Change in fair value | (1,178) | 996 |
Fair value, end of period | $ 9,162 | $ 10,340 |
Summary of Cash Equivalents and
Summary of Cash Equivalents and Marketable Securities (Detail) - USD ($) $ in Thousands | Sep. 30, 2016 | Dec. 31, 2015 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Amortized Cost | $ 30,803 | $ 34,138 |
Unrealized Gains | 29 | |
Unrealized Losses | (1) | (3) |
Fair Value | 30,831 | 34,135 |
Corporate debt securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Amortized Cost | 4,812 | |
Fair Value | 4,812 | |
Marketable securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Amortized Cost | 18,433 | 7,504 |
Unrealized Gains | 29 | |
Unrealized Losses | (1) | (3) |
Fair Value | 18,461 | 7,501 |
Cash and money market funds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Amortized Cost | 12,370 | 21,822 |
Fair Value | 12,370 | 21,822 |
Level 2 | Government agency securities | Due within 1 year | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Amortized Cost | 5,013 | 1,000 |
Unrealized Gains | 2 | |
Fair Value | 5,015 | 1,000 |
Level 2 | Corporate debt securities | Due within 1 year | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Amortized Cost | 13,420 | 6,504 |
Unrealized Gains | 27 | |
Unrealized Losses | (1) | (3) |
Fair Value | 13,446 | 6,501 |
Cash and Cash Equivalents | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Amortized Cost | 12,370 | 26,634 |
Fair Value | $ 12,370 | $ 26,634 |
Summary of Assets And Liabiliti
Summary of Assets And Liabilities Measured at Fair Value on Recurring Basis (Detail) - USD ($) $ in Thousands | Sep. 30, 2016 | Dec. 31, 2015 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable securities | $ 18,461 | $ 7,501 |
Fair Value Measurements Recurring | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents | 12,370 | 26,634 |
Marketable securities | 18,461 | 7,501 |
Total cash, cash equivalents and marketable securities | 30,831 | 34,135 |
Warrant liability | 9,162 | |
Total warrant liability | 9,162 | |
Fair Value Measurements Recurring | Corporate debt securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents | 4,812 | |
Fair Value Measurements Recurring | Due within 1 year | Corporate debt securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable securities | 13,446 | 6,501 |
Fair Value Measurements Recurring | Due within 1 year | Government agency securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable securities | 5,015 | 1,000 |
Fair Value Measurements Recurring | Level 1 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents | 12,370 | 21,822 |
Total cash, cash equivalents and marketable securities | 12,370 | 21,822 |
Fair Value Measurements Recurring | Level 2 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents | 4,812 | |
Marketable securities | 18,461 | 7,501 |
Total cash, cash equivalents and marketable securities | 18,461 | 12,313 |
Fair Value Measurements Recurring | Level 2 | Corporate debt securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents | 4,812 | |
Fair Value Measurements Recurring | Level 2 | Due within 1 year | Corporate debt securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable securities | 13,446 | 6,501 |
Fair Value Measurements Recurring | Level 2 | Due within 1 year | Government agency securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable securities | 5,015 | 1,000 |
Fair Value Measurements Recurring | Level 3 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Warrant liability | 9,162 | |
Total warrant liability | 9,162 | |
Fair Value Measurements Recurring | Cash Equivalents | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents | 12,370 | 21,822 |
Fair Value Measurements Recurring | Cash Equivalents | Level 1 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents | $ 12,370 | $ 21,822 |
Potential Common Shares Exclude
Potential Common Shares Excluded from Calculation of Net Loss Per Common Share (Detail) - shares shares in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2016 | Sep. 30, 2015 | Sep. 30, 2016 | Sep. 30, 2015 | |
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||||
Antidilutive securities excluded from computation of earnings per share amount, outstanding | 25,264 | 6,435 | 25,264 | 6,435 |
Stock Option | ||||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||||
Antidilutive securities excluded from computation of earnings per share amount, outstanding | 5,811 | 5,826 | 5,811 | 5,826 |
Warrant | ||||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||||
Antidilutive securities excluded from computation of earnings per share amount, outstanding | 19,453 | 609 | 19,453 | 609 |
Stock Based Compensation Expens
Stock Based Compensation Expense for Equity-Classified Awards (Detail) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2016 | Sep. 30, 2015 | Sep. 30, 2016 | Sep. 30, 2015 | |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Stock-based compensation expense | $ 205 | $ 344 | $ 829 | $ 1,180 |
Research and development | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Stock-based compensation expense | 56 | 50 | 238 | 238 |
General and administrative | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Stock-based compensation expense | $ 149 | $ 294 | $ 591 | 873 |
Restructuring | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Stock-based compensation expense | $ 69 |
Collaborations and License Ag32
Collaborations and License Agreements - Additional Information (Detail) | 1 Months Ended | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||||||||||
Apr. 30, 2016USD ($) | Sep. 30, 2015USD ($) | Aug. 31, 2015USD ($) | Nov. 30, 2014USD ($) | Mar. 31, 2014USD ($) | Sep. 30, 2016USD ($) | Mar. 31, 2016USD ($) | Sep. 30, 2015USD ($) | Sep. 30, 2016USD ($)Indication | Sep. 30, 2015USD ($) | Dec. 31, 2015USD ($) | Dec. 31, 2014USD ($) | Oct. 14, 2016 | Apr. 30, 2014USD ($) | |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||
Collaboration revenue | $ 992,000 | $ 15,158,000 | $ 2,388,000 | $ 15,426,000 | ||||||||||
Amounts due from pursuant to the cost-sharing provisions | 990,000 | 990,000 | $ 4,641,000 | |||||||||||
Sales Based Milestone Payments | ||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||
Collaborations and license agreements, expected milestone receivable | 0 | |||||||||||||
Clinical Efficacy Milestone | Option and License Agreement | ||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||
Collaborations and license agreements, expected milestone receivable | $ 6,000,000 | |||||||||||||
CANbridge | ||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||
License agreement date | Mar. 16, 2016 | |||||||||||||
Collaborations and license agreements, milestone payment received | $ 0 | |||||||||||||
CANbridge | Licensing Agreements | ||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||
Collaborations and license agreements, expected milestone receivable | $ 1,000,000 | |||||||||||||
Accounts receivable, net | 100,000 | |||||||||||||
Reimbursable amount for manufacturing costs and expenses. | $ 1,000,000 | |||||||||||||
Collaborations and license agreements, time period from first commercial sale of certain product upon which the agreement expires | 10 years | |||||||||||||
Collaborations and license agreements, written notice period for termination | 30 days | |||||||||||||
Collaborations and license agreements, written notice period for termination other material breach | 90 days | |||||||||||||
Collaborations and license agreements, written notice period for termination without cause | 180 days | |||||||||||||
Allocation of upfront payment | $ 1,000,000 | |||||||||||||
Collaboration revenue | 1,000,000 | |||||||||||||
CANbridge | Licensing Agreements | Sales Based Milestone Payments | ||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||
Collaborations and license agreements, expected milestone receivable | $ 90,000,000 | |||||||||||||
CANbridge | Licensing Agreements | Development and Regulatory Milestone Events | ||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||
Collaborations and license agreements, expected milestone receivable | $ 42,000,000 | |||||||||||||
CANbridge | Licensing Agreements | Clinical Efficacy Milestone | ||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||
Collaborations and license agreements, written notice period for termination | 45 days | |||||||||||||
CANbridge | Licensing Agreements | Due Within Twelve Months From Effective Date | ||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||
Reimbursable amount for manufacturing costs and expenses. | $ 500,000 | |||||||||||||
CANbridge | Licensing Agreements | Due Within Eighteen Months From Effective Date | ||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||
Reimbursable amount for manufacturing costs and expenses. | $ 500,000 | |||||||||||||
EUSA | ||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||
License agreement date | Dec. 21, 2006 | |||||||||||||
Collaborations and license agreements, expected milestone receivable | $ 4,000,000 | |||||||||||||
Research and development funding received | 2,500,000 | 2,500,000 | ||||||||||||
Payments received in connection with indications | $ 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, milestone payment received | 100,000 | 300,000 | ||||||||||||
EUSA | Utilization of Data Generated by Planned Phase Three Study | ||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||
Milestone payment to be received | 20,000,000 | 20,000,000 | ||||||||||||
EUSA | Potential Phase One Combination Study | ||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||
Milestone payment to be received | 2,000,000 | 2,000,000 | ||||||||||||
EUSA | Marketing Approval in France, Germany, Italy, Spain and the United Kingdom | ||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||
Milestone payment to be received | 2,000,000 | 2,000,000 | ||||||||||||
EUSA | Marketing Approval in Argentina, Australia, Brazil, South Africa and Venezuela | ||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||
Milestone payment to be received | 2,000,000 | 2,000,000 | ||||||||||||
Novartis | ||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||
Collaborations and license agreements, expected milestone receivable | $ 15,000,000 | |||||||||||||
Collaborations and license agreements, milestone payment received | 0 | |||||||||||||
Reimbursable inventory | $ 3,500,000 | |||||||||||||
License and service revenue | 3,500,000 | |||||||||||||
Novartis | Sales Based Milestone Payments | ||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||
Collaborations and license agreements, expected milestone receivable | 150,000,000 | |||||||||||||
Novartis | Clinical Efficacy Milestone | ||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||
Collaborations and license agreements, expected milestone receivable | 53,000,000 | |||||||||||||
Novartis | Regulatory Milestone Events | ||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||
Collaborations and license agreements, expected milestone receivable | 105,000,000 | |||||||||||||
Novartis | License and Technical Knowledge | ||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||
Collaboration revenue | $ 15,000,000 | |||||||||||||
Pharmstandard | ||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||
Allocation of upfront payment | 1,000,000 | |||||||||||||
Collaboration revenue | 900,000 | 900,000 | ||||||||||||
Collaborations and license agreements, deferred revenue | 900,000 | 900,000 | ||||||||||||
Ophthotech Corporation | ||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||
One time option exercise fee | 2,000,000 | |||||||||||||
Ophthotech Corporation | Sales Based Milestone Payments | ||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||
Collaborations and license agreements, milestone payment received | 45,000,000 | |||||||||||||
Ophthotech Corporation | Option and License Agreement | ||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||
Upfront license payment | $ 500,000 | |||||||||||||
License expiration period | 2017-02 | |||||||||||||
Collaborations and license agreements, payment received | $ 500,000 | |||||||||||||
Collaborations and license agreements, revenue recognized | 29,000 | 29,000 | 87,000 | 87,000 | ||||||||||
Ophthotech Corporation | Phase Two Clinical Trials | ||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||
Collaborations and license agreements, milestone payment received | 10,000,000 | |||||||||||||
Ophthotech Corporation | Marketing Approval in the United States | ||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||
Collaborations and license agreements, milestone payment received | 20,000,000 | |||||||||||||
Ophthotech Corporation | Marketing Approval in the UK, Germany, Spain, Italy and France | ||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||
Collaborations and license agreements, milestone payment received | $ 20,000,000 | |||||||||||||
Ophthotech Corporation | Clinical Efficacy Milestone | ||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||
Collaborations and license agreements, written notice period for termination | 90 days | |||||||||||||
Ophthotech Corporation | Ind Submission Milestone Payment | Option and License Agreement | ||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||
Collaborations and license agreements, expected milestone receivable | $ 2,000,000 | |||||||||||||
Biodesix | FOCAL study | ||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||
Contribution percentage of clinical, regulatory, manufacturing and other costs | 50.00% | |||||||||||||
Biodesix | FOCAL study | Maximum | ||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||
Funding | $ 15,000,000 | |||||||||||||
Biodesix | FOCAL study | Subsequent Event | ||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||
Percentage of closeout project cost | 50.00% | |||||||||||||
Biodesix | FOCAL trial | ||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||
Collaborations and license agreements, royalties payment on net sales | 10.00% | |||||||||||||
Amounts due from pursuant to the cost-sharing provisions | 900,000 | 900,000 | ||||||||||||
Cash received related to cost reimbursements | 2,100,000 | 2,700,000 | ||||||||||||
Biodesix | FOCAL 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 | 400,000 | 800,000 | $ 1,900,000 | 2,700,000 | ||||||||||
St Vincent's Hospital Sydney Limited | ||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||
Amendment agreement date | 2015-08 | |||||||||||||
License fees payable | $ 18,900,000 | |||||||||||||
Collaborations and license agreements, milestone payment | $ 400,000 | |||||||||||||
St Vincent's Hospital Sydney Limited | Licensing Agreements | Up-front Payment Arrangement | ||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||
Collaborations and license agreements, cash payment | 1,500,000 | |||||||||||||
Astellas Pharma Inc. | Astellas Agreement | ||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||
Amounts due from pursuant to the cost-sharing provisions | 0 | 0 | ||||||||||||
Astellas Pharma Inc. | Astellas Agreement | 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 | 0 | 500,000 | 200,000 | 700,000 | ||||||||||
Astellas Pharma Inc. | Collaboration and License Agreement | ||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||
Collaborations and license agreements, payment received | 0 | 400,000 | 300,000 | 1,000,000 | ||||||||||
Biogen Idec International GmbH | ||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||
Collaborations and license agreements, deferred revenue | $ 14,700,000 | |||||||||||||
Collaborations and license agreements, revenue recognized | 14,100,000 | |||||||||||||
Collaborations and license agreements, relative selling price of the deliverable | $ 600,000 | |||||||||||||
Biogen Idec International GmbH | Maximum | ||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||
Royalty payments | 50,000,000 | |||||||||||||
Biogen Idec International GmbH | Option and License Agreement | ||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||
Collaborations and license agreements, revenue recognized | $ 0 | $ 100,000 | $ 38,000 | $ 200,000 |
Other Accrued Liabilities (Deta
Other Accrued Liabilities (Detail) - USD ($) $ in Thousands | Sep. 30, 2016 | Dec. 31, 2015 |
Payables And Accruals [Abstract] | ||
Professional fees | $ 593 | $ 573 |
Compensation and benefits | 763 | 938 |
Restructuring | 357 | |
Other | 169 | 272 |
Other accrued liabilities | $ 1,525 | $ 2,140 |
Loans Payable - Additional Info
Loans Payable - Additional Information (Detail) | 1 Months Ended | 9 Months Ended | ||
May 31, 2016USD ($)$ / sharesshares | Sep. 30, 2014USD ($)$ / sharesshares | Sep. 30, 2016USD ($)Installmentshares | Dec. 31, 2015USD ($) | |
Debt Instrument [Line Items] | ||||
Loan payable, end-of-term payment due | $ 690,000 | |||
Warrants issued to lenders as part of new loan agreement, shares of common stock to purchase | shares | 1,202,117 | 608,696 | 259,067 | |
Warrants issued to lenders as part of new loan agreement, exercise price | $ / shares | $ 0.87 | $ 1.15 | ||
Warrants issued to lenders as part of new loan agreement, fair value | $ 700,000 | $ 400,000 | ||
Unamortized discount recognized | $ 1,131,000 | $ 500,000 | ||
Maximum amount of debt conversion | 2,000,000 | |||
Cash proceeds from issue of units | 200,000 | |||
Loans Payable | Minimum | ||||
Debt Instrument [Line Items] | ||||
Option to purchase equity, net cash proceeds of equity securities | $ 10,000,000 | |||
Loans Payable | Hercules Amended Loan Agreement | ||||
Debt Instrument [Line Items] | ||||
Proceeds from additional borrowing capacity | $ 10,000,000 | |||
Loan payable, Commencement date | May 1, 2016 | |||
Loan payable, due date | Jan. 1, 2018 | |||
Loan payable, end-of-term payment due | $ 500,000 | |||
Loan issuance costs paid | $ 200,000 | |||
Loan payable, description of interest rate terms | Per annum interest is payable on the principal balance of the loan each month it remains outstanding at the greater of 11.9% and an amount equal to 11.9% plus the prime rate minus 4.75% as determined daily, provided however, that the per annum interest rate shall not exceed 15.0% (11.9% as of September 30, 2016). | |||
Loan payable, interest rate, base rate | 11.90% | |||
Loan payable, interest rate, additional rate deducted from base rate | 4.75% | |||
Loan payable, interest rate | 11.90% | |||
Debt instrument convertible beneficial conversion feature | $ 0 | |||
Loans Payable | Hercules Amended Loan Agreement | Minimum | ||||
Debt Instrument [Line Items] | ||||
Loan payable, interest rate | 11.90% | |||
Loans Payable | Hercules Amended Loan Agreement | Maximum | ||||
Debt Instrument [Line Items] | ||||
Loan payable, interest rate | 15.00% | |||
Loans Payable | Hercules May 2016 Loan Agreement | ||||
Debt Instrument [Line Items] | ||||
Proceeds from additional borrowing capacity | 5,000,000 | |||
Loan payable, Commencement date | Jul. 1, 2017 | |||
Loan payable, due date | Dec. 1, 2019 | |||
Loan payable, end-of-term payment due | $ 200,000 | |||
Loan issuance costs paid | 100,000 | |||
Loan outstanding principal amount | $ 15,000,000 | $ 20,000,000 | ||
Loan payable, number of installments of principal and interest | Installment | 30 | |||
Loan payable, frequency of installments of principal and interest | Monthly payments of principal and interest | |||
Unrestricted and unencumbered cash and cash equivalents | $ 25,000,000 | |||
Additional borrowing capacity | $ 5,000,000 | |||
Loan payable, Commencement date deferred by six months | Jan. 1, 2018 | |||
Loans Payable | Hercules May 2016 Loan Agreement | Financial covenant | ||||
Debt Instrument [Line Items] | ||||
Unrestricted and unencumbered cash and cash equivalents | $ 10,000,000 |
Future Minimum Payments Under L
Future Minimum Payments Under Loans Payable (Detail) - USD ($) $ in Thousands | Sep. 30, 2016 | Dec. 31, 2015 |
Debt Disclosure [Abstract] | ||
2016 (3 months remaining) | $ 451 | |
2,017 | 4,386 | |
2,018 | 7,506 | |
2,019 | 7,159 | |
Long-term Debt, Gross, Total | 19,502 | |
Less amount representing interest | (3,812) | |
Less unamortized discount | (1,131) | $ (500) |
Less deferred charges | (690) | |
Less loans payable current, net of discount | (766) | (2,053) |
Loans payable, net of current portion and discount | $ 13,103 | $ 7,418 |
Common Stock - Additional Infor
Common Stock - Additional Information (Detail) - USD ($) | 1 Months Ended | 3 Months Ended | 9 Months Ended | ||||
May 31, 2016 | Sep. 30, 2016 | Sep. 30, 2016 | Dec. 31, 2015 | May 07, 2015 | Mar. 31, 2015 | Feb. 28, 2015 | |
Class Of Stock [Line Items] | |||||||
Common stock, sold | 75,863,000 | 75,863,000 | 58,182,000 | ||||
Warrants exercise price | $ 0 | $ 0 | |||||
Warrant liability | $ 9,300,000 | $ 9,300,000 | |||||
Decrease in the fair value of warrant liability | 1,200,000 | 200,000 | |||||
Common stock sales agreement, aggregate offering amount | $ 76,000 | $ 76,000 | $ 58,000 | ||||
Offering, issuance and sale of stocks and securities, shelf registration | $ 250,000,000 | ||||||
Sale of stock | 0 | 0 | |||||
Maximum | |||||||
Class Of Stock [Line Items] | |||||||
Offering, issuance and sale of stocks and securities, shelf registration | $ 100,000,000 | ||||||
F B R Co | |||||||
Class Of Stock [Line Items] | |||||||
Common stock, sold | 5,900,000 | 5,900,000 | |||||
proceeds from sale of shares | $ 10,200,000 | ||||||
Common Stock Available For Sale Under Sales Agreement | $ 9,100,000 | $ 9,100,000 | |||||
F B R Co | Maximum | |||||||
Class Of Stock [Line Items] | |||||||
Common stock sales agreement, aggregate offering amount | $ 15,000,000 | $ 17,900,000 | |||||
Common stock sales agreement commission, percentage | 3.00% | ||||||
PIPE Warrants [Member] | Private Placement | |||||||
Class Of Stock [Line Items] | |||||||
Common stock, sold | 17,642,482 | ||||||
Shares issued, price per share | $ 0.965 | ||||||
Gross proceeds from issuance of private placement | $ 17,000,000 | ||||||
Exchange of unit to share | 1 | ||||||
Warrants exercise price | $ 1 | ||||||
Warrants exercisable period | 5 years | ||||||
Director and Executive Officer | PIPE Warrants [Member] | Private Placement | |||||||
Class Of Stock [Line Items] | |||||||
Common stock, sold | 544,039 | ||||||
Net offering proceeds to the company | $ 15,400,000 |
Key Assumptions Used to Value t
Key Assumptions Used to Value the PIPE Warrants (Detail) - PIPE Warrants [Member] - $ / shares | 1 Months Ended | 6 Months Ended | 9 Months Ended |
May 31, 2016 | Jun. 30, 2016 | Sep. 30, 2016 | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items] | |||
Expected price volatility | 76.25% | 76.51% | 76.60% |
Expected term (in years) | 5 years | 4 years 10 months 24 days | 4 years 9 months |
Risk-free interest rates | 1.22% | 1.01% | 1.14% |
Stock price | $ 0.89 | $ 0.96 | $ 0.89 |
Stock Option Activity (Detail)
Stock Option Activity (Detail) $ / shares in Units, $ in Thousands | 9 Months Ended |
Sep. 30, 2016USD ($)$ / sharesshares | |
Options | |
Outstanding at beginning of period | shares | 4,796,005 |
Granted | shares | 1,705,134 |
Exercised | shares | (38,749) |
Forfeited | shares | (651,407) |
Outstanding at end of period | shares | 5,810,983 |
Vested or expected to vest at September 30, 2016 | shares | 3,771,566 |
Exercisable at September 30, 2016 | shares | 2,977,166 |
Weighted-Average Exercise Price | |
Outstanding at beginning of period | $ / shares | $ 3.78 |
Granted | $ / shares | 1.03 |
Exercised | $ / shares | 0.84 |
Forfeited | $ / shares | 1.96 |
Outstanding at end of period | $ / shares | 3.20 |
Vested or expected to vest at September 30, 2016 | $ / shares | 4.32 |
Exercisable at September 30, 2016 | $ / shares | $ 5.17 |
Weighted-Average Remaining Contractual Term | |
Outstanding at September 30, 2016 | 7 years 29 days |
Vested or expected to vest at September 30, 2016 | 6 years 1 month 28 days |
Exercisable at September 30, 2016 | 5 years 5 months 19 days |
Aggregate Intrinsic Value | |
Outstanding at end of year | $ | $ 51 |
Vested or expected to vest at end of year | $ | 30 |
Exercisable at end of year | $ | $ 21 |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional Information (Detail) - USD ($) | 9 Months Ended | ||
Sep. 30, 2016 | Sep. 30, 2015 | Dec. 31, 2015 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Stock options issued to purchase common stock | 5,810,983 | 4,796,005 | |
Total unrecognized stock-based compensation expense related to stock options granted | $ 800,000 | ||
Total unrecognized stock-based compensation expense related to restricted stock awards granted | $ 0 | ||
Awards With Market Conditions | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Stock options issued to purchase common stock | 197,650 | ||
Stock Options | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Weighted-average grant date fair value of stock options granted | $ 0.67 | $ 0.75 | |
Share based payment award forfeiture rates | 76.00% | 70.00% | |
Total unrecognized stock-based compensation expense, weighted-average period Recognition | 2 years 7 months 6 days | ||
Intrinsic value of options exercised | $ 35,000 | $ 57,000 |
Assumptions Used in Black Schol
Assumptions Used in Black Scholes Pricing Model for New Grants (Detail) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2016 | Sep. 30, 2015 | Sep. 30, 2016 | Sep. 30, 2015 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Volatility factor, minimum | 73.60% | 74.53% | 73.26% | 73.04% |
Volatility factor, maximum | 73.94% | 74.54% | 74.47% | 78.70% |
Expected term (in years) | 6 years 3 months | 6 years 3 months | ||
Risk-Free Interest Rates, minimum | 1.07% | 0.94% | 1.54% | |
Risk-Free Interest Rates, maximum | 1.22% | 1.38% | 1.85% | |
Risk-free interest rates | 1.56% | |||
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 |
Restricted Stock Activity (Deta
Restricted Stock Activity (Detail) | 9 Months Ended |
Sep. 30, 2016$ / sharesshares | |
Number of Shares | |
Unvested at beginning of period | shares | 42,750 |
Vested/Released | shares | (42,750) |
Weighted-Average Grant-Date Fair Value | |
Unvested at beginning of period | $ / shares | $ 1.61 |
Vested/Released | $ / shares | $ 1.61 |
Strategic Restructuring - Addit
Strategic Restructuring - Additional Information (Detail) | 9 Months Ended |
Sep. 30, 2016Position | |
Restructuring And Related Activities [Abstract] | |
Restructuring plan, completion date | Mar. 31, 2015 |
Restructuring plan, percentage of number of positions eliminated | 66.67% |
Restructuring plan, number of positions eliminated | 40 |
Restructuring Activity Recorded
Restructuring Activity Recorded in Operating Expenses and Accrued Expenses (Detail) $ in Thousands | 9 Months Ended |
Sep. 30, 2016USD ($) | |
Restructuring Cost And Reserve [Line Items] | |
Restructuring amounts accrued, beginning balance | $ 357 |
Employee Severance | |
Restructuring Cost And Reserve [Line Items] | |
Restructuring amounts accrued, beginning balance | 357 |
Restructuring amounts paid | $ (357) |
Facility Lease Exit - Additiona
Facility Lease Exit - Additional Information (Detail) - USD ($) $ in Millions | 1 Months Ended | 9 Months Ended |
Sep. 30, 2014 | Sep. 30, 2016 | |
Facility Lease Exit Disclosure [Line Items] | ||
Notice period to surrender remaining leased space | 90 days | |
3rd Amendment, Lease exit costs associated with 650 E. Kendall. | ||
Facility Lease Exit Disclosure [Line Items] | ||
Lease exit expense incurred | $ 15.6 | |
Leased space surrendering date | May 29, 2015 | |
3rd Amendment, Lease exit costs associated with 650 E. Kendall. | Leasehold Improvements | ||
Facility Lease Exit Disclosure [Line Items] | ||
Additional charge to depreciation expense due to revision of estimated useful life | $ 2.9 | |
3rd Amendment, Lease exit costs associated with 650 E. Kendall. | Deferred Rent And Leasehold Improvement | ||
Facility Lease Exit Disclosure [Line Items] | ||
Additional charge to depreciation expense due to revision of estimated useful life | $ 3.5 |
Legal Proceedings -Additional I
Legal Proceedings -Additional Information (Detail) | 9 Months Ended | |
Sep. 30, 2016USD ($)LegalMatter | Dec. 31, 2015USD ($) | |
Commitments And Contingencies Disclosure [Abstract] | ||
Class action lawsuits | LegalMatter | 2 | |
Attorney fees cost and expenses | $ 822,116 | |
Amount of damages awarded to plaintiff | 2,500 | |
Reserve for settlement of fines | $ 4,000,000 | $ 4,000,000 |