Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2017 | Aug. 08, 2017 | |
Document And Entity Information [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Jun. 30, 2017 | |
Document Fiscal Year Focus | 2,017 | |
Document Fiscal Period Focus | Q2 | |
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 | 118,307,820 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets (Unaudited) - USD ($) $ in Thousands | Jun. 30, 2017 | Dec. 31, 2016 |
Current assets: | ||
Cash and cash equivalents | $ 30,860 | $ 15,096 |
Marketable securities | 9,267 | 8,252 |
Accounts receivable | 445 | 1,027 |
Clinical trial retainers | 1,274 | 1,702 |
Other prepaid expenses and other current assets | 294 | 238 |
Total current assets | 42,140 | 26,315 |
Clinical trial retainers | 330 | 940 |
Other assets | 22 | 30 |
Total assets | 42,492 | 27,285 |
Current liabilities: | ||
Accounts payable | 3,361 | 2,186 |
Accrued clinical trial costs and contract research | 6,243 | 3,998 |
Other accrued liabilities | 1,360 | 1,531 |
Loans payable, net of discount | 3,055 | 2,124 |
Deferred revenue | 395 | 510 |
Other liabilities | 540 | |
Total current liabilities | 14,954 | 10,349 |
Loans payable, net of current portion and discount | 16,067 | 11,879 |
Deferred revenue | 1,499 | 1,697 |
Warrant liability (Note 7) | 29,002 | 4,593 |
Other liabilities | 300 | 690 |
Total liabilities | 61,822 | 29,208 |
Stockholders' deficit: | ||
Preferred stock, $.001 par value: 5,000 shares authorized at June 30, 2017 and December 31, 2016; no shares issued and outstanding as of June 30, 2017 and December 31, 2016 | ||
Common stock, $.001 par value: 250,000 shares authorized and 116,833 shares issued and outstanding at June 30, 2017; and 200,000 shares authorized and 75,863 shares issued and outstanding at December 31, 2016 | 117 | 76 |
Additional paid-in capital | 544,626 | 519,911 |
Accumulated other comprehensive income (loss) | (2) | 6 |
Accumulated deficit | (564,071) | (521,916) |
Total stockholders' deficit | (19,330) | (1,923) |
Total liabilities and stockholders' deficit | $ 42,492 | $ 27,285 |
Condensed Consolidated Balance3
Condensed Consolidated Balance Sheets (Unaudited) (Parenthetical) - $ / shares | Jun. 30, 2017 | Dec. 31, 2016 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 5,000,000 | 5,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 250,000,000 | 200,000,000 |
Common stock, shares issued | 116,833,000 | 75,863,000 |
Common stock, shares outstanding | 116,833,000 | 75,863,000 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations (Unaudited) - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2017 | Jun. 30, 2016 | Jun. 30, 2017 | Jun. 30, 2016 | |
Income Statement [Abstract] | ||||
Collaboration and licensing revenue | $ 351 | $ 193 | $ 2,883 | $ 1,396 |
Operating expenses: | ||||
Research and development | 6,881 | 5,604 | 14,837 | 11,576 |
General and administrative | 2,302 | 1,731 | 4,633 | 4,203 |
Operating Expenses, Total | 9,183 | 7,335 | 19,470 | 15,779 |
Loss from operations | (8,832) | (7,142) | (16,587) | (14,383) |
Other expense, net: | ||||
Interest expense, net | (530) | (468) | (1,081) | (837) |
Change in fair value of warrant liability | (23,925) | (996) | (24,409) | (996) |
Other expense, net | (24,455) | (1,464) | (25,490) | (1,833) |
Loss before provision for income taxes | (33,287) | (8,606) | (42,077) | (16,216) |
Provision for income taxes | (50) | (100) | ||
Net loss | $ (33,287) | $ (8,606) | $ (42,127) | $ (16,316) |
Net loss per share - basic and diluted | $ (0.30) | $ (0.13) | $ (0.45) | $ (0.26) |
Weighted average number of common shares outstanding | 110,550 | 66,917 | 93,493 | 62,566 |
Condensed Consolidated Stateme5
Condensed Consolidated Statements of Comprehensive Loss (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2017 | Jun. 30, 2016 | Jun. 30, 2017 | Jun. 30, 2016 | |
Statement of Comprehensive Income [Abstract] | ||||
Net loss | $ (33,287) | $ (8,606) | $ (42,127) | $ (16,316) |
Other comprehensive income (loss): | ||||
Unrealized gain (loss) on available-for-sale securities | (3) | 8 | (8) | 13 |
Comprehensive loss | $ (33,290) | $ (8,598) | $ (42,135) | $ (16,303) |
Condensed Consolidated Stateme6
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2017 | Jun. 30, 2016 | |
Operating activities | ||
Net loss | $ (42,127) | $ (16,316) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 7 | |
Stock-based compensation | 483 | 624 |
Non-cash interest expense | 268 | 196 |
Non-cash change in fair value of warrant liability | 24,409 | 996 |
Amortization of premium and discount on investments | 12 | 13 |
Changes in operating assets and liabilities: | ||
Accounts receivable | 582 | 3,339 |
Prepaid expenses and other current assets | 372 | 179 |
Other noncurrent assets | 618 | (267) |
Accounts payable | 1,175 | 656 |
Accrued contract research | 2,245 | 806 |
Other accrued liabilities | (171) | (695) |
Settlement liability | (4,000) | |
Deferred revenue | (313) | (369) |
Other liabilities | (78) | |
Net cash used in operating activities | (12,447) | (14,909) |
Investing activities | ||
Purchases of marketable securities | (9,286) | (19,949) |
Proceeds from maturities and sales of marketable securities | 8,252 | 13,250 |
Net cash used in investing activities | (1,034) | (6,699) |
Financing activities | ||
Proceeds from issuance of common stock, net of issuance costs | 21,035 | 14,862 |
Proceeds from issuance of common stock to related parties | 3,210 | 525 |
Proceeds from issuance of stock for stock-based compensation arrangements | 33 | |
Proceeds from issuance of loan payable | 5,000 | |
Proceeds from issuance of loan payable and warrants | 5,000 | |
Debt issuance costs | (115) | |
Net cash provided by financing activities | 29,245 | 20,305 |
Net increase (decrease) in cash and cash equivalents | 15,764 | (1,303) |
Cash and cash equivalents at beginning of period | 15,096 | 26,634 |
Cash and cash equivalents at end of period | 30,860 | 25,331 |
Supplemental cash flow information | ||
Cash paid for interest | $ 902 | 631 |
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 | 6 Months Ended |
Jun. 30, 2017 | |
Accounting Policies [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 is focused on developing its lead candidate tivozanib in North America as a treatment for renal cell carcinoma, or RCC. In addition, the Company has entered into partnerships to fund the further development and commercialization of its pre-clinical AV-380, AV-203, AV-353 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. Liquidity and Going Concern The Company has financed its operations to date primarily through private placements and public offerings of its common stock and preferred stock, license fees, milestone payments and research and development funding from strategic partners, and loan proceeds. The Company has devoted substantially all of its resources to its drug development efforts, comprising research and development, manufacturing, conducting clinical trials for its product candidates, protecting its intellectual property and general and administrative functions relating to these operations. The future success of the Company is dependent on its ability to develop its product candidates and ultimately upon its ability to attain profitable operations. As of June 30, 2017, the Company had cash, cash equivalents and marketable securities totaling approximately $40.1 million, working capital of $27.2 million and an accumulated deficit of $564.1 million. The Company 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 (the “Loan Agreement”) with Hercules Technology II, L.P. and Hercules Technology III, L.P., affiliates of Hercules Technology Growth (collectively, “Hercules”), which requires the Company to maintain unrestricted cash (defined as cash and liquid cash, including marketable securities) greater than or equal to $10.0 million through the date of completion of the Company’s TIVO-3 Non-compliance During the six months ended June 30, 2017, the Company raised approximately $29.2 million in net cash proceeds, including $15.4 million from an underwritten public offering of 34.5 million shares of its common stock in March 2017, and $8.8 million from sales of 6.5 million shares of its common stock under its at-the-market Based upon the Company’s approximate $40.1 million in existing cash, cash equivalents and marketable securities as of June 30, 2017, the Company believes it has sufficient cash on hand to support operations for at least the next twelve months from the date of filing this Quarterly Report on Form 10-Q. TIVO-3 10-Q. If the results from the TIVO-3 trial are not satisfactory to Hercules, Management’s plans to alleviate this condition that raises substantial doubt regarding the Company’s ability to continue as a going concern include pursuing one or more of the following options to secure additional funding, none of which can be guaranteed or are entirely within the Company’s control: • Earn milestone payments pursuant to the collaboration and license agreements described in Note 4 or restructure / monetize existing potential milestone and/or royalty payments under those collaboration and license agreements. • Raise funding through the possible additional sales of the Company’s common stock, including public or private equity financings. • Continue to seek a partner to advance development of the AV-353 There can be no assurance, however, that the Company will obtain results from the TIVO-3 trial that are satisfactory to Hercules or receive cash proceeds from any of these potential resources or, to the extent cash proceeds are received, those proceeds would be sufficient to maintain compliance with the financial covenant with Hercules for at least the next twelve months from the date of filing this Quarterly Report on Form 10-Q. In August 2014, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2014-15, Presentation of Financial Statements-Going Concern (Subtopic 205-40): 2015-14”). Under the new accounting standard, the future receipt of potential funding from the Company’s collaborators and other resources cannot be considered probable at this time because none of the Company’s current plans have been finalized at the time of filing this Quarterly Report on Form 10-Q The Company believes that its approximate $40.1 million in cash, cash equivalents and marketable securities at June 30, 2017 would allow it to fund its planned operations into the fourth quarter of 2018. This estimate assumes no receipt of milestone payments from its partners or related payment of potential licensing milestones to third parties, no additional funding from new partnership agreements, no additional equity financings, no debt financings and no further sales of equity under its Sales Agreement with FBR. This estimate also assumes no acceleration in repayment of the Company’s term loan with Hercules that could result due to an event of default for non-compliance with the $10.0 million financial covenant. Accordingly, the timing and nature of activities contemplated for the remainder of 2017 and thereafter will be conducted subject to the availability of sufficient financial resources. If the Company is unable to obtain sufficient capital to continue to advance its programs and to maintain compliance with the financial covenant in the Loan Agreement, the Company would be forced to delay, reduce or eliminate its research and development programs and any future commercialization efforts. The accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the ordinary course of business. The financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result from the outcome of the uncertainties described above. |
Basis of Presentation
Basis of Presentation | 6 Months Ended |
Jun. 30, 2017 | |
Accounting Policies [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 S-X. The information presented in the condensed consolidated financial statements and related footnotes at June 30, 2017, and for the three months and six months ended June 30, 2017 and 2016, is unaudited, and the condensed consolidated balance sheet amounts and related footnotes as of December 31, 2016 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 Certain reclassifications have been made to prior periods to conform to current period presentation. Reclassification of prior year amounts have been made to separately present clinical trial retainers from other prepaid expenses and other current assets, and other non-current The Company’s significant accounting polices related to revenue recognition and stock-based compensation are fully described in Note 3, “Significant Accounting Policies”, in the 2016 annual report on Form 10-K. |
Significant Accounting Policies
Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2017 | |
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 non-refundable, Collaborations and License Agreements Research and Development Expenses Research and development expenses are charged to expense as incurred. Research and development expenses consist of costs incurred in performing research and development activities, including internal costs for salaries, bonuses, benefits, stock-based compensation, facilities, and research-related overhead, and external costs for clinical trials, drug manufacturing and distribution, license fees, consultants and other contracted services. Warrants Issued in Connection with Private Placement In May 2016, the Company issued warrants to purchase an aggregate of 17,642,482 shares of common stock in connection with a private placement financing and recorded the warrants as a liability (the “PIPE Warrants”). The Company accounts for warrant instruments that either conditionally or unconditionally obligate the issuer to transfer assets as liabilities regardless of the timing of the redemption feature or price, even though the underlying shares may be classified as permanent or temporary equity. As of June 30, 2017, none of the PIPE Warrants had been exercised. Refer to Note 7, “Common Stock—Private Placement / PIPE Warrants” for further discussion of the private placement financing. 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 non-cash non-cash 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 three months and six months ended June 30, 2017 (in thousands): Fair value at January 1, 2017 $ 4,593 Increase in fair value 484 Fair value at March 31, 2017 $ 5,077 Increase in fair value 23,925 Fair value at June 30, 2017 $ 29,002 The key assumptions used to value the PIPE Warrants were as follows: Issuance December 31, 2016 March 31, 2017 June 30, 2017 Expected price volatility 76.25 % 78.18 % 79.01 % 79.30 % Expected term (in years) 5.00 4.50 4.25 4.00 Risk-free interest rates 1.22 % 1.93 % 1.72 % 1.72 % Stock price $ 0.89 $ 0.54 $ 0.59 $ 2.22 Dividend yield — — — — 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 U.S. government money market fund to be cash equivalents. Changes in the balance of cash and cash equivalents may be affected by changes in investment portfolio maturities, as well as actual cash disbursements to fund operations. The Company’s cash is deposited in highly-rated financial institutions in the United States. The Company invests in U.S. government money market funds, high-grade, short-term commercial paper, corporate bonds and other U.S. government agency securities, which management believes are subject to minimal credit and market risk. The carrying values of the Company’s cash and cash equivalents approximate fair value due to their short term maturities. 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. 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. Realized gains and losses are determined on the specific identification method. Unrealized gains and losses are included in other comprehensive loss until realized, at which point they would be recorded as a component of interest expense, net. Below is a summary of cash, cash equivalents and marketable securities at June 30, 2017 and December 31, 2016 (in thousands): Amortized Cost Unrealized Gains Unrealized Losses Fair Value June 30, 2017 Cash and cash equivalents: Cash and money market funds $ 29,101 $ — $ — $ 29,101 Corporate debt securities 1,759 — — 1,759 Total cash and cash equivalents 30,860 — — 30,860 Marketable securities: Corporate debt securities due within 1 year $ 7,765 $ 1 $ (2 ) $ 7,764 Government agency securities due within 1 year 1,504 — (1 ) 1,503 Total marketable securities 9,269 1 (3 ) 9,267 Total cash, cash equivalents and marketable securities $ 40,129 $ 1 $ (3 ) $ 40,127 December 31, 2016: Cash and cash equivalents: Cash and money market funds $ 14,091 $ — $ — $ 14,091 Corporate debt securities 1,005 — — 1,005 Total cash and cash equivalents 15,096 — — 15,096 Marketable securities: Corporate debt securities due within 1 year $ 8,246 $ 6 $ — $ 8,252 Total marketable securities 8,246 6 — 8,252 Total cash, cash equivalents and marketable securities $ 23,342 $ 6 $ — $ 23,348 Concentrations of Credit Risk Financial instruments that potentially subject the Company to credit risk primarily consist of cash and cash equivalents, marketable securities and accounts receivable. The Company maintains deposits in highly-rated federally-insured financial institutions in excess of federally insured limits. The Company’s investment strategy is focused on capital preservation. The Company invests in instruments that meet the high credit quality standards outlined in the Company’s investment policy. This policy also limits the amount of credit exposure to any one issue or type of instrument. The Company’s accounts receivable primarily consists of amounts due to the Company from licensees and collaborators. The Company has not experienced any material losses related to accounts receivable from individual licensees or collaborators. Fair Value Measurements The fair value of the Company’s financial assets and liabilities reflects the Company’s estimate of amounts that it would have received in connection with the sale of the assets or paid in connection with the transfer of the liabilities in an orderly transaction between market participants at the measurement date. In connection with measuring the fair value of its assets and liabilities, the Company seeks to maximize the use of observable inputs (market data obtained from sources independent from the Company) and to minimize the use of unobservable inputs (the Company’s assumptions about how market participants would price assets and liabilities). The following fair value hierarchy is used to classify assets and liabilities based on the observable inputs and unobservable inputs used in order to value the assets and liabilities: Level 1: Quoted prices in active markets for identical assets or liabilities. An active market for an asset or liability is a market in which transactions for the asset or liability occur with sufficient frequency and volume to provide pricing information on an ongoing basis. Level 2: Observable inputs other than Level 1 inputs. Examples of Level 2 inputs include quoted prices in active markets for similar assets or liabilities and quoted prices for identical assets or liabilities in markets that are not active. Level 3: Unobservable inputs based on the Company’s assessment of the assumptions that market participants would use in pricing the asset or liability. Financial assets and liabilities are classified in their entirety within the fair value hierarchy based on the lowest level of input that is significant to the fair value measurement. The Company measures the fair value of its marketable securities by taking into consideration valuations obtained from third-party pricing sources. The pricing services utilize industry standard valuation models, including both income and market based approaches, for which all significant inputs are observable, either directly or indirectly, to estimate fair value. These inputs include reported trades of and broker-dealer quotes on the same or similar securities, issuer credit spreads, benchmark securities and other observable inputs. As of June 30, 2017, the Company’s financial assets valued based on Level 1 inputs consisted of cash and cash equivalents in a U.S. government money market fund and its financial assets valued based on Level 2 inputs consisted of high-grade corporate debt securities, including commercial paper, and U.S. government agency securities. During the three months and six months ended June 30, 2017, the Company did not have any transfers of financial assets between Levels 1 and 2. As of June 30, 2017, 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 June 30, 2017 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 June 30, 2017 and December 31, 2016 (in thousands): Fair Value Measurements as of June 30, 2017 Level 1 Level 2 Level 3 Total Financial assets carried at fair value: Cash and money market funds $ 29,101 $ — $ — $ 29,101 Corporate debt securities — 1,759 — 1,759 Total cash and cash equivalents $ 29,101 $ 1,759 $ — $ 30,860 Marketable securities: Corporate debt securities due within 1 year $ — $ 7,764 $ — $ 7,764 U.S. government agency securities due within 1 year — 1,503 — 1,503 Total marketable securities $ — $ 9,267 $ — $ 9,267 Total cash, cash equivalents and marketable securities $ 29,101 $ 11,026 $ — $ 40,127 Financial liabilities carried at fair value: Warrant liability $ — $ — $ 29,002 $ 29,002 Total warrant liability $ — $ — $ 29,002 $ 29,002 Fair Value Measurements as of December 31, 2016 Level 1 Level 2 Level 3 Total Financial assets carried at fair value: Cash and money market funds $ 14,091 $ — $ — $ 14,091 Corporate debt securities — 1,005 — 1,005 Total cash and cash equivalents $ 14,091 $ 1,005 $ — $ 15,096 Marketable securities: Corporate debt securities due within 1 year $ 8,252 $ 8,252 Total marketable securities $ — $ 8,252 $ — $ 8,252 Total cash, cash equivalents and marketable securities $ 14,091 $ 9,257 $ — $ 23,348 Financial liabilities carried at fair value: Warrant liability $ — $ — $ 4,593 $ 4,593 Total warrant liability $ — $ — $ 4,593 $ 4,593 Basic and Diluted Loss per Common Share Basic net loss per share is computed using the weighted average number of common shares outstanding during the period, excluding restricted stock that has been issued but is not yet vested. Diluted net loss per common share is computed using the weighted average number of common shares outstanding and the weighted average dilutive potential common shares outstanding using the treasury stock method. However, for the three months and six months ended June 30, 2017 and 2016, diluted net loss per share is the same as basic net loss per share as the inclusion of weighted average shares of unvested restricted common stock and common stock issuable upon the exercise of stock options and warrants would be anti-dilutive. The following table summarizes outstanding securities not included in the computation of diluted net loss per common share as their inclusion would be anti-dilutive for the three months and six months ended June 30, 2017 and 2016, respectively (in thousands): Outstanding at June 30, 2017 2016 Options outstanding 6,568 5,828 Warrants outstanding 19,453 19,453 26,021 25,281 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 uses the Black-Scholes option pricing model to value its stock option awards without market conditions, which requires the Company to make certain assumptions regarding the expected volatility of its common stock price, the expected term of the option grants, the risk-free interest rate and the dividend yield with respect to its common stock. Refer to Note 8 “Stock Based-Compensation” for a further discussion. 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 Three Months Ended June 30, Six Months Ended June 30, 2017 2016 2017 2016 Research and development $ 71 $ 56 $ 123 $ 182 General and administrative 205 177 360 442 $ 276 $ 233 $ 483 $ 624 Stock-based compensation expense is allocated to research and development and general and administrative expense based upon the department of the employee to whom each award was granted. No related tax benefits of the stock-based compensation expense have been recognized. Income Taxes 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 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 in the United States. As of June 30, 2017, the Company has no net assets located outside of the United States. Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect certain reported amounts of assets and liabilities, disclosure of contingent assets and liabilities at the date of the financial statements, and the reported amounts of revenues and expenses during the reporting periods. Significant items subject to such estimates and assumptions include revenue recognition, contract research accruals, measurement of the warrant liability 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. Actual results could differ from those estimates. Recent Accounting Pronouncements In May 2014, the FASB issued ASU No. 2014-09, Revenue from Contracts with Customers (Topic 606) 2014-09”) 2014-09 2014-09 In March 2016, the FASB issued ASU No. 2016-09, Compensation—Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting 2016-09 |
Collaborations and License Agre
Collaborations and License Agreements | 6 Months Ended |
Jun. 30, 2017 | |
Text Block [Abstract] | |
Collaborations and License Agreements | (4) Collaborations and License Agreements Out-License 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, Pursuant to the CANbridge Agreement, CANbridge made an upfront payment to the Company of $1.0 million in April 2016, net of $0.1 million of withholding taxes. CANbridge has agreed to reimburse the Company $1.0 million for certain manufacturing costs and expenses incurred by the Company prior to the Effective Date with respect to AV-203. country-by-country CANbridge is obligated to use commercially reasonable efforts to develop and commercialize AV-203 AV-203 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 were evaluated under ASC 605-25 Revenue Recognition—Multiple Element Arrangements 605-25”) non-contingent AV-203 AV-203 proof-of-concept de minimis know-how The Company believes the development and regulatory milestones that may be achieved under the CANbridge Agreement are consistent with the definition of a milestone included in ASC 605-28, Revenue Recognition—Milestone Method The Company recognized the $0.5 million payment by CANbridge in March 2017 for the cost reimbursement related to the validation of certain manufacturing development activities conducted by the Company prior to the Effective Date as revenue during the three months ended March 31, 2017 as the amount was fixed and determinable and non-refundable. EUSA In December 2015, the Company entered into a license agreement with EUSA Pharma (UK) Limited (“EUSA”) under which the Company granted to EUSA the exclusive, sublicensable right to develop, manufacture and commercialize tivozanib in the territories of Europe (excluding Russia, Ukraine and the Commonwealth of Independent States), Latin America (excluding Mexico), Africa, Australasia and New Zealand (the “EUSA Licensed Territories”) for all diseases and conditions in humans, excluding non-oncologic 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 an additional research and development funding payment of $4.0 million if the European Medicines Agency (the “EMA”) grants marketing approval for tivozanib for treatment of RCC. The Company is eligible to receive additional research funding from EUSA of fifty percent (50%) of the total costs for its clinical trials for which EUSA elects to utilize the trial data for regulatory or commercial purposes, including up to $20.0 million for the Company’s TIVO-3 mid-twenty non-research EUSA is obligated to use commercially reasonable efforts to seek regulatory approval for and commercialize tivozanib throughout the EUSA Licensed Territories in RCC. 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 EUSA Licensed Territories. Activities under the agreement were evaluated under ASC 605-25 non-contingent The Company believes the regulatory milestones that may be achieved under the EUSA agreement are consistent with the definition of a milestone included in ASC 605-28, Revenue Recognition—Milestone Method Novartis In August 2015, the Company entered into a license agreement with Novartis. Under the license agreement, the Company granted to Novartis the exclusive right to develop and commercialize worldwide the Company’s proprietary antibody AV-380 Pursuant to the license agreement, Novartis made an upfront payment to the Company of $15.0 million in September 2015. Novartis also acquired the Company’s inventory of clinical quality, AV-380 biological Certain milestones achieved by Novartis or timelines associated with the development plan 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 non-contingent 90-day The Company determined the delivered license and obligation to transfer technical knowledge and data have standalone value from the undelivered cooperation. The Company allocated the upfront 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. In February 2017, Novartis agreed to pay the Company $1.8 million out of its future payment obligations to the Company under the license agreement. The funds were provided in order to satisfy a $1.8 million time-based milestone obligation that the Company owed to St. Vincent’s on March 2, 2017. Novartis will reduce any subsequent payment obligations to the Company by $1.8 million plus accrued interest. The Company recognized the $1.8 million of consideration as revenue during the three months ended March 31, 2017, as the amount was fixed and determinable and non-refundable, 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 right to develop, manufacture and commercialize tivozanib in the territories of Russia, Ukraine and the Commonwealth of Independent States for all diseases and conditions in humans, excluding non-oncologic 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 the effective date of the termination, the remaining deferred revenue of approximately $0.9 million was recognized. The Company recognized approximately $37 thousand and $75 thousand as revenue during the three months and six months ended June 30, 2016, respectively. 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 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 was recording the deferred revenue over the Company’s period of performance, which was estimated to be through December 2017. Upon the effective date of the termination, the remaining deferred revenue of approximately $0.1 million was recognized. The Company recorded approximately $29 thousand and $58 thousand of revenue during the three months and six months ended June 30, 2016, respectively, and $87 thousand and $115 thousand during the three months and six months ended June 30, 2017, respectively. Biodesix In April 2014, the Company entered into a worldwide co-development non-exclusive ® non-exclusive proof-of-concept ® Under the Biodesix Agreement, with the exception of the costs incurred for the FOCAL trial, 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 trial up to a cap of $15 million, following which all costs of the FOCAL trial would be shared equally. In connection with the discontinuation of the FOCAL trial on October 14, 2016, the Company and Biodesix amended the Biodesix Agreement. Under the amendment, the Company agreed to share 50% of the shutdown costs for the FOCAL trial after August 1, 2016. In return for bearing these shutdown costs, the Company will be entitled to recover an agreed multiple of the additional costs borne by the Company out of any income Biodesix receives from the partnership in connection with the licensing 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. In addition, the Company and Biodesix are funding investigator-sponsored clinical trials, including ficlatuzumab in combination with ERBITUX ® Pending marketing approval or the sublicense of ficlatuzumab, and subject to the negotiation of a commercialization agreement, each party would share equally in commercialization profits and losses, subject to the Company’s right to be the lead commercialization party. Prior to the first commercial sale of ficlatuzumab, each party has the right to elect to discontinue participating in further development or commercialization efforts with respect to ficlatuzumab, which is referred to as an “Opt-Out”. Opt-Out, “Opting-Out Opting-Out Opt-Out, Opt-Out, non-opting Opting-Out Prior to any Opt-Out, Opt-Out, Opting-Out Activities under the Biodesix Agreement were evaluated under ASC 605-25 non-contingent non-exclusive The Company determined that the perpetual, non-exclusive The Company records the consideration earned in connection with the FOCAL trial and investigator-sponsored trials and drug manufacturing, which consists of reimbursements from Biodesix for expenses related to these trials and drug manufacturing, 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 ($0.1) million and $0.6 million during the three months ended June 30, 2017 and 2016, respectively, and by approximately $0.2 million and $1.5 million during the six months ended June 30, 2017 and 2016, respectively. The amount due to the Company from Biodesix pursuant to the cost-sharing provision was approximately $0.1 million as of June 30, 2017. 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”) with Astellas Pharma Inc. and certain of its subsidiaries (together, “Astellas”), pursuant to which the Company and Astellas intended to develop and commercialize tivozanib for the treatment of a broad range of cancers. Astellas elected to terminate the agreement effective on August 11, 2014, at which time the tivozanib rights were returned to the Company. In accordance with the Astellas Agreement, committed development costs, including the costs of completing certain tivozanib clinical development activities, continue to be shared equally. The Company accounted for the joint development and commercialization activities in North America and Europe as a joint risk-sharing collaboration in accordance with ASC 808, Collaborative Arrangements Biogen Idec International GmbH In March 2009, the Company entered into an exclusive option and license agreement with Biogen regarding the development and commercialization of the Company’s discovery-stage ErbB3-targeted antibodies, AV-203, In March 2014, the Company and Biogen amended the exclusive option and license agreement (the “Amendment”). Pursuant to the Amendment, Biogen agreed to the termination of its rights and obligations under the agreement, including Biogen’s option to (i) obtain a co-exclusive AV-203. The Company concluded that the Amendment materially modified the terms of the agreement and, as a result, required the application of ASC 605-25. Upon modifying the arrangement, the Company had $14.7 million of deferred revenue remaining to be amortized. The Company is not entitled to receive any further consideration from Biogen Idec under the agreement, as amended. The Company allocated a portion of the remaining deferred revenue to the undelivered unit of accounting based upon the Company’s best estimate of the selling price, as the Company determined that neither VSOE nor TPE were available. The Company determined the best estimate of the selling price to be approximately $0.6 million and recognized the remaining $14.1 million as collaboration revenue in March 2014. The deferred revenue associated with the undelivered unit of accounting was recognized on a straight-line basis over the period of performance, or through March 2016, when the Company executed its agreement with CANbridge. The Company recorded the final $38 thousand of revenue in the three months ended March 31, 2016. In March 2016, the Company entered into a collaboration and license agreement for AV-203 In-License 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, non-exclusive 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 $16.7 million in connection with development and regulatory milestones and /or defined timelines 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 three months ended March 31, 2016, the Company recognized approximately $0.4 million in research and development expense in connection with a milestone obligation due to St. Vincent’s related to the selection of a development candidate. During the three months ended March 31, 2017, the Company recognized $1.8 million in research and development expense in connection with a time-based milestone obligation due to St. Vincent’s. Kyowa Hakko Kirin (KHK) In December 2006, the Company entered into a license agreement with KHK under which it obtained an exclusive license, with the right to grant sublicenses subject to certain restrictions, to research, develop, manufacture and commercialize tivozanib, pharmaceutical compositions thereof and associated biomarkers. Its exclusive license covers all territories in the world except for Asia and the Middle East, where KHK has retained the rights to tivozanib. Under the license agreement, the Company obtained exclusive rights in its territory under certain KHK patents, patent applications and know-how Under the license agreement, the Company is obligated to use commercially reasonable efforts to develop and commercialize tivozanib in its territory. Prior to the first anniversary of the first post-marketing approval sale of tivozanib in its territory, neither the Company nor any of its subsidiaries has the right to conduct certain clinical trials of, seek marketing approval for or commercialize any other cancer product that also works by inhibiting the activity of a VEGF receptor. The Company has upfront, milestone and royalty payment obligations to KHK under the license agreement. Upon entering into the license agreement with KHK, the Company made an upfront payment in the amount of $5.0 million. In March 2010, the Company made a milestone payment to KHK in the amount of $10.0 million in connection with the dosing of the first patient in the Company’s first phase 3 clinical trial of tivozanib (TIVO-1). one-time TIVO-3 TIVO-3 one-time If the Company sublicenses any of its rights to tivozanib to a third party, as it has done with EUSA, the sublicense defines the payment obligations of the sublicensee, which may vary from the milestone and royalty payment obligations under the KHK license relating to rights the Company retains. The Company is required to pay KHK a fixed 30% of amounts the Company receives from its sublicensees, including upfront license fees, milestone payments and royalties, but excluding amounts the Company receives in respect of research and development funding or equity investments, subject to certain limitations. If tivozanib is approved in the EU, the $4.0 million research and development reimbursement payment that would be owed to the Company by EUSA would not be subject to a sublicense revenue payment to KHK, nor would a research and development reimbursement payment of fifty percent (50%) of the related trial costs upon an election by EUSA to use the data generated from the TIVO-3 TIVO-3 non-R&D The Company is also required to pay tiered royalty payments on net sales it makes of tivozanib in its territory, which range from the low to mid-teens The license agreement will remain in effect until the expiration of all of the Company’s royalty and sublicense revenue obligations to KHK, determined on a product-by-product country-by-country |
Other Accrued Liabilities
Other Accrued Liabilities | 6 Months Ended |
Jun. 30, 2017 | |
Payables and Accruals [Abstract] | |
Other Accrued Liabilities | (5) Other Accrued Liabilities Other accrued expenses consisted of the following (in thousands): June 30, 2017 December 31, 2016 Professional fees $ 460 $ 464 Compensation and benefits 729 891 Other 171 176 Total $ 1,360 $ 1,531 |
Loans Payable
Loans Payable | 6 Months Ended |
Jun. 30, 2017 | |
Debt Disclosure [Abstract] | |
Loans Payable | (6) Loans Payable On May 28, 2010, the Company entered into the Loan Agreement with Hercules. The Loan Agreement was subsequently amended in March 2012 (the “2012 Amendment”), September 2014 (the “2014 Amendment”) and May 2016 (the “2016 Amendment”). Amounts borrowed under the 2012 Amendment were repaid in full in 2015. Pursuant to the 2014 Amendment, the Company received additional loan proceeds from Hercules in the amount of $10.0 million and was not required to commence principal payments until May 1, 2016, with the last principal payment due on January 1, 2018. An end-of-term 470-50, Debt—Modifications and Extinguishments 470-50”) . 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. As of June 30, 2017, none of these warrants had been exercised. In July 2017, Hercules exercised all 608,696 warrants. Pursuant to the terms of the warrant, Hercules, at their election, exercised the warrants via a non-cash In May 2016, pursuant to the 2016 Amendment, the Company received additional loan proceeds from Hercules in the amount of $5.0 million, which increased the aggregate outstanding principal balance under the Loan Agreement to $15.0 million. The Company was not required to commence principal payments on the $15 million loan until July 1, 2017, at which time the Company would have been required to make 30 equal monthly payments of principal and interest through December 2019. An end-of-term 470-50 . TIVO-3 Under the 2016 Amendment, from March 1, 2017 through June 30, 2017, the Company could draw down an additional $5.0 million in funding upon confirmation by Hercules, in its reasonable discretion, that the Company had achieved the following conditions: (i) satisfactory developmental progression on a minimum of two (2) clinical programs (other than the TIVO-3 In June 2017, pursuant to the 2016 Amendment, the Company received the additional $5.0 million in loan proceeds from Hercules, which increased the aggregate outstanding principal balance under the Loan Agreement to $20.0 million and resulted in a six-month end-of-term end-of-term In connection with the 2016 Amendment, the Company issued warrants to Hercules to purchase up to 1,202,117 shares of the Company’s common stock at an exercise price equal to $0.87 per share. The Company recorded the fair value of the warrants of approximately $0.7 million as a component of 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. As of June 30 2017, none of these warrants had been exercised. In July 2017, Hercules exercised all 1,202,117 warrants. Pursuant to the terms of the warrant, Hercules, at their election, exercised the warrants via a non-cash The unamortized discount to be recognized over the remainder of the loan period was approximately $0.9 million and $1.0 million as of June 30, 2017 and December 31, 2016, respectively. The Company must make interest payments on the loan balance each month it remains outstanding. 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 June 30, 2017). 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. Each unit in the May 2016 private placement included one share of the Company’s common stock and a PIPE Warrant to purchase one share of the Company’s common stock at an exercise price of $1.00 per share. In July 2017, Hercules exercised all 259,067 PIPE Warrants. The Company issued Hercules 259,067 shares of its common stock and received approximately $0.3 million in cash proceeds. 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 events of default, including the occurrence of an event that results in a material adverse effect upon the Company’s business operations, properties, assets or condition (financial or otherwise), its ability to perform its obligations or upon the ability of the lenders to enforce any of their rights or remedies with respect to such obligations, or upon the collateral under the Loan Agreement, the related liens or the priority thereof. As of June 30, 2017, the Company was in compliance with all loan covenants, Hercules has not asserted any events of default and the Company does not believe that there has been a material adverse change as defined in the Loan Agreement. The Company has determined that the risk of subjective acceleration under the material adverse events clause is remote and therefore has classified the outstanding principal in current and long-term liabilities based on the timing of scheduled principal payments. Future minimum payments under the loans payable outstanding as of June 30, 2017 are as follows (amounts in thousands): Year Ending December 31: 2017 (remaining 6 months) $ 1,167 2018 9,828 2019 14,123 25,118 Less amount representing interest (4,278 ) Less unamortized discount (878 ) Less deferred charges (840 ) Less loans payable current, net of discount (3,055 ) Loans payable, net of current portion and discount $ 16,067 |
Common Stock
Common Stock | 6 Months Ended |
Jun. 30, 2017 | |
Equity [Abstract] | |
Common Stock | (7) Common Stock In June 2017, the Company filed an amendment to its certificate of incorporation, which increased the number of authorized shares of common stock, $0.001 par value, by 50,000,000 from 200,000,000 shares to 250,000,000 shares. The amendment was adopted by the Board of Directors in April 2017 and approved by stockholders at the Annual Meeting of Stockholders held on June 21, 2017. Public Offering On March 31, 2017, the Company closed an underwritten public offering of 34,500,000 shares of its common stock, including the exercise in full by the underwriter of its option to purchase 4,500,000 shares, at the public offering price of $0.50 per share for gross proceeds of approximately $17.3 million. Certain of the Company’s executive officers and a director purchased an aggregate of 420,000 shares and an entity affiliated with New Enterprise Associates, a greater than 5% stockholder of the Company, purchased 6,000,000 shares in this offering at the same public offering price per share as the other investors. The net offering proceeds to the Company were approximately $15.4 million after deducting underwriting discounts and estimated offering expenses payable by the Company. The Company sold these shares pursuant to the 2015 Shelf (as defined below). 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. As of June 30, 2017, none of the PIPE Warrants had been exercised. In July 2017, Hercules exercised all 259,067 of its PIPE Warrants. The Company issued Hercules 259,067 shares of its common stock and received approximately $0.3 million in cash proceeds. ATM Sales Agreement In February 2015, the Company entered into an at-the-market “at-the-market” Form S-3. On May 7, 2015, the Company filed a shelf registration statement on Form S-3 |
Stock-based Compensation
Stock-based Compensation | 6 Months Ended |
Jun. 30, 2017 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Stock-based Compensation | (8) Stock-based Compensation Stock Incentive Plan The Company maintains the 2010 Stock Incentive Plan (the “Plan”) for employees, consultants, advisors, and directors, as amended in March 2013, June 2014 and June 2017. The Plan provides for the grant of equity awards such as stock options and restricted stock. In June 2017, the Company amended the Plan to increase the total number of shares reserved under the Plan by 3,500,000 from 8,500,000 shares to 12,000,000 shares. The amendment was adopted by the Board of Directors in February 2017 and approved by stockholders at the Annual Meeting of Stockholders held on June 21, 2017. The Plan provides that the exercise price of incentive stock options cannot be less than 100% of the fair market value of the common stock on the date of the award for participants who own less than 10% of the total combined voting power of stock of the Company and not less than 110% for participants who own more than 10% of the total combined voting power of the stock of the Company. Options and restricted stock granted under the Plan vest over periods as determined by the Board, which generally are equal to four years. Options generally expire ten years from the date of grant. As of June 30, 2017, there were 4,536,965 shares available for future issuance under the Plan. The following table summarizes stock option activity during the six months ended June 30, 2017: Options Weighted- Average Exercise Price Weighted- Average Remaining Contractual Term Aggregate Intrinsic Value Outstanding at January 1, 2017 4,858,678 $ 2.31 Granted 2,228,135 $ 0.61 Exercised — $ — Forfeited (518,587 ) $ 1.05 Outstanding at June 30, 2017 6,568,226 $ 1.84 7.61 $ 7,540,000 Exercisable at June 30, 2017 2,976,696 $ 3.06 6.16 $ 2,520,000 Stock options to purchase 197,650 shares of common stock contain market conditions, which were not deemed probable of vesting at June 30, 2017. Stock options to purchase 220,774 shares of common stock contain performance-based milestone conditions, which were not deemed probable of vesting at June 30, 2017. The aggregate intrinsic value is based upon the Company’s closing stock price of $2.22 on June 30, 2017. 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 June 30, 2017 2016 Volatility factor 73.20% - 76.07% 73.24% - 74.47% Expected term (in years) 5.50 – 6.25 5.50 – 6.25 Risk-free interest rates 1.84% - 1.95% 0.94% -1.03% Dividend yield — — Six Months Ended June 30, 2017 2016 Volatility factor 71.82% - 76.07% 73.24% - 74.47% Expected term (in years) 5.50 - 6.25 5.50 - 6.25 Risk-free interest rates 1.84% - 2.10% 0.94% - 1.38% Dividend yield — — The risk-free interest rate is determined based upon the United States Treasury’s rates for U.S. Treasury zero-coupon In July 2016, the Company began calculating volatility using its historical data. Previously, the Company did not have sufficient history to support a calculation of volatility using only its historical data. As such, prior to July 2016, the Company used a weighted-average volatility considering the Company’s own volatility since March 2010 and the volatilities of several peer companies. For purposes of identifying similar entities, the Company considered characteristics such as industry, length of trading history, similar vesting terms and in-the-money On January 1, 2017, the Company adopted ASU No. 2016-09, Compensation–Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting As of June 30, 2017, there was $1.6 million of total unrecognized stock-based compensation expense related to stock options granted to employees under the Plan. The expense is expected to be recognized over a weighted-average period of 2.5 years. |
Legal Proceedings
Legal Proceedings | 6 Months Ended |
Jun. 30, 2017 | |
Commitments and Contingencies Disclosure [Abstract] | |
Legal Proceedings | (9) Legal Proceedings Two class action lawsuits have been filed against the Company and certain of its former officers and directors, (Tuan Ha-Ngoc, No. 1:13-cv-11157-JLT, No. 1:13-cv-11320-JLT, In re AVEO Pharmaceuticals, Inc. Securities Litigation et al No. 1:13-cv-11157-DJC, 10b-5 TIVO-1 On July 3, 2013, the staff, or SEC Staff, of the United States Securities and Exchange Commission, or 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 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 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 it. On March 31, 2016, the District Court entered a final judgment which (i) approved the settlement; (ii) permanently enjoined the Company from violating Section 17(a) of the Securities Act of 1933, as amended, Sections 10(b) and 13(a) of the Securities Exchange Act of 1934, as amended, and rules 10b-5, 12b-20, 13a-1, 13a-11 13a-13 agreed-to |
Significant Accounting Polici16
Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2017 | |
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 non-refundable, Collaborations and License Agreements |
Research and Development Expenses | Research and Development Expenses Research and development expenses are charged to expense as incurred. Research and development expenses consist of costs incurred in performing research and development activities, including internal costs for salaries, bonuses, benefits, stock-based compensation, facilities, and research-related overhead, and external costs for clinical trials, drug manufacturing and distribution, license fees, consultants and other contracted services. |
Warrants Issued in Connection with Private Placement | Warrants Issued in Connection with Private Placement In May 2016, the Company issued warrants to purchase an aggregate of 17,642,482 shares of common stock in connection with a private placement financing and recorded the warrants as a liability (the “PIPE Warrants”). The Company accounts for warrant instruments that either conditionally or unconditionally obligate the issuer to transfer assets as liabilities regardless of the timing of the redemption feature or price, even though the underlying shares may be classified as permanent or temporary equity. As of June 30, 2017, none of the PIPE Warrants had been exercised. Refer to Note 7, “Common Stock—Private Placement / PIPE Warrants” for further discussion of the private placement financing. 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 non-cash non-cash 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 three months and six months ended June 30, 2017 (in thousands): Fair value at January 1, 2017 $ 4,593 Increase in fair value 484 Fair value at March 31, 2017 $ 5,077 Increase in fair value 23,925 Fair value at June 30, 2017 $ 29,002 The key assumptions used to value the PIPE Warrants were as follows: Issuance December 31, 2016 March 31, 2017 June 30, 2017 Expected price volatility 76.25 % 78.18 % 79.01 % 79.30 % Expected term (in years) 5.00 4.50 4.25 4.00 Risk-free interest rates 1.22 % 1.93 % 1.72 % 1.72 % Stock price $ 0.89 $ 0.54 $ 0.59 $ 2.22 Dividend yield — — — — |
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 U.S. government money market fund to be cash equivalents. Changes in the balance of cash and cash equivalents may be affected by changes in investment portfolio maturities, as well as actual cash disbursements to fund operations. The Company’s cash is deposited in highly-rated financial institutions in the United States. The Company invests in U.S. government money market funds, high-grade, short-term commercial paper, corporate bonds and other U.S. government agency securities, which management believes are subject to minimal credit and market risk. The carrying values of the Company’s cash and cash equivalents approximate fair value due to their short term maturities. |
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. 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. Realized gains and losses are determined on the specific identification method. Unrealized gains and losses are included in other comprehensive loss until realized, at which point they would be recorded as a component of interest expense, net. Below is a summary of cash, cash equivalents and marketable securities at June 30, 2017 and December 31, 2016 (in thousands): Amortized Cost Unrealized Gains Unrealized Losses Fair Value June 30, 2017 Cash and cash equivalents: Cash and money market funds $ 29,101 $ — $ — $ 29,101 Corporate debt securities 1,759 — — 1,759 Total cash and cash equivalents 30,860 — — 30,860 Marketable securities: Corporate debt securities due within 1 year $ 7,765 $ 1 $ (2 ) $ 7,764 Government agency securities due within 1 year 1,504 — (1 ) 1,503 Total marketable securities 9,269 1 (3 ) 9,267 Total cash, cash equivalents and marketable securities $ 40,129 $ 1 $ (3 ) $ 40,127 December 31, 2016: Cash and cash equivalents: Cash and money market funds $ 14,091 $ — $ — $ 14,091 Corporate debt securities 1,005 — — 1,005 Total cash and cash equivalents 15,096 — — 15,096 Marketable securities: Corporate debt securities due within 1 year $ 8,246 $ 6 $ — $ 8,252 Total marketable securities 8,246 6 — 8,252 Total cash, cash equivalents and marketable securities $ 23,342 $ 6 $ — $ 23,348 |
Concentrations of Credit Risk | Concentrations of Credit Risk Financial instruments that potentially subject the Company to credit risk primarily consist of cash and cash equivalents, marketable securities and accounts receivable. The Company maintains deposits in highly-rated federally-insured financial institutions in excess of federally insured limits. The Company’s investment strategy is focused on capital preservation. The Company invests in instruments that meet the high credit quality standards outlined in the Company’s investment policy. This policy also limits the amount of credit exposure to any one issue or type of instrument. The Company’s accounts receivable primarily consists of amounts due to the Company from licensees and collaborators. The Company has not experienced any material losses related to accounts receivable from individual licensees or collaborators. |
Fair Value Measurements | Fair Value Measurements The fair value of the Company’s financial assets and liabilities reflects the Company’s estimate of amounts that it would have received in connection with the sale of the assets or paid in connection with the transfer of the liabilities in an orderly transaction between market participants at the measurement date. In connection with measuring the fair value of its assets and liabilities, the Company seeks to maximize the use of observable inputs (market data obtained from sources independent from the Company) and to minimize the use of unobservable inputs (the Company’s assumptions about how market participants would price assets and liabilities). The following fair value hierarchy is used to classify assets and liabilities based on the observable inputs and unobservable inputs used in order to value the assets and liabilities: Level 1: Quoted prices in active markets for identical assets or liabilities. An active market for an asset or liability is a market in which transactions for the asset or liability occur with sufficient frequency and volume to provide pricing information on an ongoing basis. Level 2: Observable inputs other than Level 1 inputs. Examples of Level 2 inputs include quoted prices in active markets for similar assets or liabilities and quoted prices for identical assets or liabilities in markets that are not active. Level 3: Unobservable inputs based on the Company’s assessment of the assumptions that market participants would use in pricing the asset or liability. Financial assets and liabilities are classified in their entirety within the fair value hierarchy based on the lowest level of input that is significant to the fair value measurement. The Company measures the fair value of its marketable securities by taking into consideration valuations obtained from third-party pricing sources. The pricing services utilize industry standard valuation models, including both income and market based approaches, for which all significant inputs are observable, either directly or indirectly, to estimate fair value. These inputs include reported trades of and broker-dealer quotes on the same or similar securities, issuer credit spreads, benchmark securities and other observable inputs. As of June 30, 2017, the Company’s financial assets valued based on Level 1 inputs consisted of cash and cash equivalents in a U.S. government money market fund and its financial assets valued based on Level 2 inputs consisted of high-grade corporate debt securities, including commercial paper, and U.S. government agency securities. During the three months and six months ended June 30, 2017, the Company did not have any transfers of financial assets between Levels 1 and 2. As of June 30, 2017, 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 June 30, 2017 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 June 30, 2017 and December 31, 2016 (in thousands): Fair Value Measurements as of June 30, 2017 Level 1 Level 2 Level 3 Total Financial assets carried at fair value: Cash and money market funds $ 29,101 $ — $ — $ 29,101 Corporate debt securities — 1,759 — 1,759 Total cash and cash equivalents $ 29,101 $ 1,759 $ — $ 30,860 Marketable securities: Corporate debt securities due within 1 year $ — $ 7,764 $ — $ 7,764 U.S. government agency securities due within 1 year — 1,503 — 1,503 Total marketable securities $ — $ 9,267 $ — $ 9,267 Total cash, cash equivalents and marketable securities $ 29,101 $ 11,026 $ — $ 40,127 Financial liabilities carried at fair value: Warrant liability $ — $ — $ 29,002 $ 29,002 Total warrant liability $ — $ — $ 29,002 $ 29,002 Fair Value Measurements as of December 31, 2016 Level 1 Level 2 Level 3 Total Financial assets carried at fair value: Cash and money market funds $ 14,091 $ — $ — $ 14,091 Corporate debt securities — 1,005 — 1,005 Total cash and cash equivalents $ 14,091 $ 1,005 $ — $ 15,096 Marketable securities: Corporate debt securities due within 1 year $ 8,252 $ 8,252 Total marketable securities $ — $ 8,252 $ — $ 8,252 Total cash, cash equivalents and marketable securities $ 14,091 $ 9,257 $ — $ 23,348 Financial liabilities carried at fair value: Warrant liability $ — $ — $ 4,593 $ 4,593 Total warrant liability $ — $ — $ 4,593 $ 4,593 |
Basic and Diluted Loss per Common Share | Basic and Diluted Loss per Common Share Basic net loss per share is computed using the weighted average number of common shares outstanding during the period, excluding restricted stock that has been issued but is not yet vested. Diluted net loss per common share is computed using the weighted average number of common shares outstanding and the weighted average dilutive potential common shares outstanding using the treasury stock method. However, for the three months and six months ended June 30, 2017 and 2016, diluted net loss per share is the same as basic net loss per share as the inclusion of weighted average shares of unvested restricted common stock and common stock issuable upon the exercise of stock options and warrants would be anti-dilutive. The following table summarizes outstanding securities not included in the computation of diluted net loss per common share as their inclusion would be anti-dilutive for the three months and six months ended June 30, 2017 and 2016, respectively (in thousands): Outstanding at June 30, 2017 2016 Options outstanding 6,568 5,828 Warrants outstanding 19,453 19,453 26,021 25,281 |
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 uses the Black-Scholes option pricing model to value its stock option awards without market conditions, which requires the Company to make certain assumptions regarding the expected volatility of its common stock price, the expected term of the option grants, the risk-free interest rate and the dividend yield with respect to its common stock. Refer to Note 8 “Stock Based-Compensation” for a further discussion. 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 Three Months Ended June 30, Six Months Ended June 30, 2017 2016 2017 2016 Research and development $ 71 $ 56 $ 123 $ 182 General and administrative 205 177 360 442 $ 276 $ 233 $ 483 $ 624 Stock-based compensation expense is allocated to research and development and general and administrative expense based upon the department of the employee to whom each award was granted. No related tax benefits of the stock-based compensation expense have been recognized. |
Income Taxes | Income Taxes The Company provides for income taxes using the asset-liability method. Under this method, deferred tax assets and liabilities are recognized based on differences between financial reporting and tax bases of assets and liabilities, and are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. The Company calculates its provision for income taxes on ordinary income based on its projected annual tax rate for the year. Uncertain tax positions are recognized if the position is more-likely-than-not |
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 in the United States. As of June 30, 2017, the Company has no net assets located outside of the United States. |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect certain reported amounts of assets and liabilities, disclosure of contingent assets and liabilities at the date of the financial statements, and the reported amounts of revenues and expenses during the reporting periods. Significant items subject to such estimates and assumptions include revenue recognition, contract research accruals, measurement of the warrant liability 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. Actual results could differ from those estimates. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements In May 2014, the FASB issued ASU No. 2014-09, Revenue from Contracts with Customers (Topic 606) 2014-09”) 2014-09 2014-09 In March 2016, the FASB issued ASU No. 2016-09, Compensation—Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting 2016-09 |
Significant Accounting Polici17
Significant Accounting Policies (Tables) | 6 Months Ended |
Jun. 30, 2017 | |
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 three months and six months ended June 30, 2017 (in thousands): Fair value at January 1, 2017 $ 4,593 Increase in fair value 484 Fair value at March 31, 2017 $ 5,077 Increase in fair value 23,925 Fair value at June 30, 2017 $ 29,002 |
Key Assumptions Used to Value the PIPE Warrants | The key assumptions used to value the PIPE Warrants were as follows: Issuance December 31, 2016 March 31, 2017 June 30, 2017 Expected price volatility 76.25 % 78.18 % 79.01 % 79.30 % Expected term (in years) 5.00 4.50 4.25 4.00 Risk-free interest rates 1.22 % 1.93 % 1.72 % 1.72 % Stock price $ 0.89 $ 0.54 $ 0.59 $ 2.22 Dividend yield — — — — |
Summary of Cash, Cash Equivalents and Marketable Securities | Below is a summary of cash, cash equivalents and marketable securities at June 30, 2017 and December 31, 2016 (in thousands): Amortized Cost Unrealized Gains Unrealized Losses Fair Value June 30, 2017 Cash and cash equivalents: Cash and money market funds $ 29,101 $ — $ — $ 29,101 Corporate debt securities 1,759 — — 1,759 Total cash and cash equivalents 30,860 — — 30,860 Marketable securities: Corporate debt securities due within 1 year $ 7,765 $ 1 $ (2 ) $ 7,764 Government agency securities due within 1 year 1,504 — (1 ) 1,503 Total marketable securities 9,269 1 (3 ) 9,267 Total cash, cash equivalents and marketable securities $ 40,129 $ 1 $ (3 ) $ 40,127 December 31, 2016: Cash and cash equivalents: Cash and money market funds $ 14,091 $ — $ — $ 14,091 Corporate debt securities 1,005 — — 1,005 Total cash and cash equivalents 15,096 — — 15,096 Marketable securities: Corporate debt securities due within 1 year $ 8,246 $ 6 $ — $ 8,252 Total marketable securities 8,246 6 — 8,252 Total cash, cash equivalents and marketable securities $ 23,342 $ 6 $ — $ 23,348 |
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 June 30, 2017 and December 31, 2016 (in thousands): Fair Value Measurements as of June 30, 2017 Level 1 Level 2 Level 3 Total Financial assets carried at fair value: Cash and money market funds $ 29,101 $ — $ — $ 29,101 Corporate debt securities — 1,759 — 1,759 Total cash and cash equivalents $ 29,101 $ 1,759 $ — $ 30,860 Marketable securities: Corporate debt securities due within 1 year $ — $ 7,764 $ — $ 7,764 U.S. government agency securities due within 1 year — 1,503 — 1,503 Total marketable securities $ — $ 9,267 $ — $ 9,267 Total cash, cash equivalents and marketable securities $ 29,101 $ 11,026 $ — $ 40,127 Financial liabilities carried at fair value: Warrant liability $ — $ — $ 29,002 $ 29,002 Total warrant liability $ — $ — $ 29,002 $ 29,002 Fair Value Measurements as of December 31, 2016 Level 1 Level 2 Level 3 Total Financial assets carried at fair value: Cash and money market funds $ 14,091 $ — $ — $ 14,091 Corporate debt securities — 1,005 — 1,005 Total cash and cash equivalents $ 14,091 $ 1,005 $ — $ 15,096 Marketable securities: Corporate debt securities due within 1 year $ 8,252 $ 8,252 Total marketable securities $ — $ 8,252 $ — $ 8,252 Total cash, cash equivalents and marketable securities $ 14,091 $ 9,257 $ — $ 23,348 Financial liabilities carried at fair value: Warrant liability $ — $ — $ 4,593 $ 4,593 Total warrant liability $ — $ — $ 4,593 $ 4,593 |
Summary of Outstanding Securities Not Included in Computation of Diluted Net Loss Per Common Share | The following table summarizes outstanding securities not included in the computation of diluted net loss per common share as their inclusion would be anti-dilutive for the three months and six months ended June 30, 2017 and 2016, respectively (in thousands): Outstanding at June 30, 2017 2016 Options outstanding 6,568 5,828 Warrants outstanding 19,453 19,453 26,021 25,281 |
Stock-Based Compensation Expense | During the three months and six months ended June 30, 2017 and 2016, the Company recorded the following stock-based compensation expense (in thousands): Three Months Ended June 30, Six Months Ended June 30, 2017 2016 2017 2016 Research and development $ 71 $ 56 $ 123 $ 182 General and administrative 205 177 360 442 $ 276 $ 233 $ 483 $ 624 |
Other Accrued Liabilities (Tabl
Other Accrued Liabilities (Tables) | 6 Months Ended |
Jun. 30, 2017 | |
Payables and Accruals [Abstract] | |
Other Accrued Liabilities | Other accrued expenses consisted of the following (in thousands): June 30, 2017 December 31, 2016 Professional fees $ 460 $ 464 Compensation and benefits 729 891 Other 171 176 Total $ 1,360 $ 1,531 |
Loans Payable (Tables)
Loans Payable (Tables) | 6 Months Ended |
Jun. 30, 2017 | |
Debt Disclosure [Abstract] | |
Future Minimum Payments Under Loans Payable | Future minimum payments under the loans payable outstanding as of June 30, 2017 are as follows (amounts in thousands): Year Ending December 31: 2017 (remaining 6 months) $ 1,167 2018 9,828 2019 14,123 25,118 Less amount representing interest (4,278 ) Less unamortized discount (878 ) Less deferred charges (840 ) Less loans payable current, net of discount (3,055 ) Loans payable, net of current portion and discount $ 16,067 |
Stock-based Compensation (Table
Stock-based Compensation (Tables) | 6 Months Ended |
Jun. 30, 2017 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Stock Option Activity | The following table summarizes stock option activity during the six months ended June 30, 2017: Options Weighted- Average Exercise Price Weighted- Average Remaining Contractual Term Aggregate Intrinsic Value Outstanding at January 1, 2017 4,858,678 $ 2.31 Granted 2,228,135 $ 0.61 Exercised — $ — Forfeited (518,587 ) $ 1.05 Outstanding at June 30, 2017 6,568,226 $ 1.84 7.61 $ 7,540,000 Exercisable at June 30, 2017 2,976,696 $ 3.06 6.16 $ 2,520,000 |
Assumptions used in Black-Scholes Pricing Model for New Grants | The fair value of stock options subject only to service or performance conditions that are granted to employees is estimated on the date of grant using the Black-Scholes option-pricing model using the assumptions noted in the following table: Three Months Ended June 30, 2017 2016 Volatility factor 73.20% - 76.07% 73.24% - 74.47% Expected term (in years) 5.50 – 6.25 5.50 – 6.25 Risk-free interest rates 1.84% - 1.95% 0.94% -1.03% Dividend yield — — Six Months Ended June 30, 2017 2016 Volatility factor 71.82% - 76.07% 73.24% - 74.47% Expected term (in years) 5.50 - 6.25 5.50 - 6.25 Risk-free interest rates 1.84% - 2.10% 0.94% - 1.38% Dividend yield — — |
Organization - Additional Infor
Organization - Additional Information (Detail) | Aug. 31, 2015USD ($)shares | Jun. 30, 2017USD ($)shares | Mar. 31, 2017USD ($)shares | May 31, 2016USD ($) | Jun. 30, 2017USD ($)Subsidiaryshares | Jun. 30, 2016USD ($) | Dec. 31, 2016USD ($)shares |
Organization [Line Items] | |||||||
Number of subsidiaries | Subsidiary | 2 | ||||||
Cash, cash equivalents and marketable securities | $ 40,100,000 | $ 40,100,000 | |||||
Working capital | 27,200,000 | 27,200,000 | |||||
Accumulated deficit | $ (564,071,000) | (564,071,000) | $ (521,916,000) | ||||
Net proceeds from public offering | 29,200,000 | ||||||
Gross proceeds from public offering | $ 21,035,000 | $ 14,862,000 | |||||
Common stock, sold | shares | 116,833,000 | 116,833,000 | 75,863,000 | ||||
Proceeds from additional borrowing capacity | $ 5,000,000 | ||||||
F B R Co | |||||||
Organization [Line Items] | |||||||
Proceeds from additional borrowing capacity | $ 10,200,000 | $ 8,800,000 | |||||
Common stock, sold | shares | 5,900,000 | 6,500,000 | 6,500,000 | ||||
Underwritten Public Offering | |||||||
Organization [Line Items] | |||||||
Net proceeds from public offering | $ 15,400,000 | ||||||
Gross proceeds from public offering | $ 17,300,000 | $ 15,400,000 | |||||
Common stock, shares issued | shares | 34,500,000 | ||||||
Common stock, sold | shares | 34,500,000 | ||||||
Loans Payable | Hercules May 2016 Loan Agreement | |||||||
Organization [Line Items] | |||||||
Unrestricted and unencumbered cash and cash equivalents | $ 25,000,000 | $ 25,000,000 | |||||
Proceeds from additional borrowing capacity | 5,000,000 | $ 5,000,000 | 5,000,000 | ||||
Loans Payable | Hercules May 2016 Loan Agreement | Financial covenant | Minimum | |||||||
Organization [Line Items] | |||||||
Unrestricted and unencumbered cash and cash equivalents | $ 10,000,000 | $ 10,000,000 | $ 10,000,000 |
Significant Accounting Polici22
Significant Accounting Policies - Additional Information (Detail) $ in Thousands | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2017USD ($)shares | Jun. 30, 2017USD ($)Segmentshares | Jun. 30, 2016USD ($) | Dec. 31, 2016shares | May 31, 2016shares | |
Significant Accounting Policies [Line Items] | |||||
Common stock, shares issued | shares | 116,833,000 | 116,833,000 | 75,863,000 | ||
Increase in the fair value of warrant liability | $ 23,900 | $ 24,400 | |||
Income tax provision or expense | $ 50 | $ 100 | |||
Number of operating segments | Segment | 1 | ||||
PIPE Warrants | |||||
Significant Accounting Policies [Line Items] | |||||
Warrant liability | $ 9,300 | $ 9,300 | |||
PIPE Warrants | Private Placement | |||||
Significant Accounting Policies [Line Items] | |||||
Common stock, shares issued | shares | 17,642,482 | ||||
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 | |
Jun. 30, 2017 | Mar. 31, 2017 | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | ||
Fair value, beginning of period | $ 5,077 | $ 4,593 |
Increase in fair value | 23,925 | 484 |
Fair value, end of period | $ 29,002 | $ 5,077 |
Key Assumptions Used to Value t
Key Assumptions Used to Value the PIPE Warrants (Detail) - $ / shares | 1 Months Ended | 3 Months Ended | 6 Months Ended | 12 Months Ended |
May 31, 2016 | Mar. 31, 2017 | Jun. 30, 2017 | Dec. 31, 2016 | |
Fair Value Measurements, Recurring and Nonrecurring, Valuation Techniques [Line Items] | ||||
Stock price | $ 2.22 | |||
PIPE Warrants | ||||
Fair Value Measurements, Recurring and Nonrecurring, Valuation Techniques [Line Items] | ||||
Expected price volatility | 76.25% | 79.01% | 79.30% | 78.18% |
Expected term (in years) | 5 years | 4 years 2 months 30 days | 4 years | 4 years 6 months |
Risk-free interest rates | 1.22% | 1.72% | 1.72% | 1.93% |
Stock price | $ 0.89 | $ 0.59 | $ 2.22 | $ 0.54 |
Dividend yield | 0.00% | 0.00% | 0.00% | 0.00% |
Summary of Cash, Cash Equivalen
Summary of Cash, Cash Equivalents and Marketable Securities (Detail) - USD ($) $ in Thousands | Jun. 30, 2017 | Dec. 31, 2016 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Amortized Cost | $ 40,129 | $ 23,342 |
Unrealized Gains | 1 | 6 |
Unrealized Losses | (3) | |
Fair Value | 40,127 | 23,348 |
Cash and money market funds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Amortized Cost | 29,101 | 14,091 |
Fair Value | 29,101 | 14,091 |
Corporate debt securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Amortized Cost | 1,759 | 1,005 |
Fair Value | 1,759 | 1,005 |
Government agency securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Amortized Cost | 1,504 | |
Unrealized Losses | (1) | |
Fair Value | 1,503 | |
Marketable securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Amortized Cost | 9,269 | 8,246 |
Unrealized Gains | 1 | 6 |
Unrealized Losses | (3) | |
Fair Value | 9,267 | 8,252 |
Level 2 | Due within 1 year | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Amortized Cost | 7,765 | |
Unrealized Gains | 1 | |
Unrealized Losses | (2) | |
Fair Value | 7,764 | |
Level 2 | Corporate debt securities | Due within 1 year | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Amortized Cost | 8,246 | |
Unrealized Gains | 6 | |
Fair Value | 8,252 | |
Cash and Cash Equivalents | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Amortized Cost | 30,860 | 15,096 |
Fair Value | $ 30,860 | $ 15,096 |
Summary of Assets And Liabiliti
Summary of Assets And Liabilities Measured at Fair Value on Recurring Basis (Detail) - USD ($) $ in Thousands | Jun. 30, 2017 | Dec. 31, 2016 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable securities | $ 9,267 | $ 8,252 |
Fair Value Measurements Recurring | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents | 30,860 | 15,096 |
Marketable securities | 9,267 | 8,252 |
Total cash, cash equivalents and marketable securities | 40,127 | 23,348 |
Warrant liability | 29,002 | 4,593 |
Total warrant liability | 29,002 | 4,593 |
Fair Value Measurements Recurring | Corporate debt securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents | 1,759 | 1,005 |
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 | 7,764 | 8,252 |
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 | 1,503 | |
Fair Value Measurements Recurring | Level 1 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents | 29,101 | 14,091 |
Total cash, cash equivalents and marketable securities | 29,101 | 14,091 |
Fair Value Measurements Recurring | Level 2 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents | 1,759 | 1,005 |
Marketable securities | 9,267 | 8,252 |
Total cash, cash equivalents and marketable securities | 11,026 | 9,257 |
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 | 1,759 | 1,005 |
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 | 7,764 | 8,252 |
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 | 1,503 | |
Fair Value Measurements Recurring | Level 3 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Warrant liability | 29,002 | 4,593 |
Total warrant liability | 29,002 | 4,593 |
Fair Value Measurements Recurring | Cash and money market funds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents | 29,101 | 14,091 |
Fair Value Measurements Recurring | Cash and money market funds | Level 1 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents | $ 29,101 | $ 14,091 |
Summary of Outstanding Securiti
Summary of Outstanding Securities Not Included in Computation of Diluted Net Loss Per Common Share (Detail) - shares shares in Thousands | 6 Months Ended | |
Jun. 30, 2017 | Jun. 30, 2016 | |
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share amount, outstanding | 26,021 | 25,281 |
Stock Options | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share amount, outstanding | 6,568 | 5,828 |
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 | 19,453 |
Stock Based Compensation Expens
Stock Based Compensation Expense for Equity-Classified Awards (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2017 | Jun. 30, 2016 | Jun. 30, 2017 | Jun. 30, 2016 | |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Stock-based compensation expense | $ 276 | $ 233 | $ 483 | $ 624 |
Research and development | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Stock-based compensation expense | 71 | 56 | 123 | 182 |
General and administrative | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Stock-based compensation expense | $ 205 | $ 177 | $ 360 | $ 442 |
Collaborations and License Ag29
Collaborations and License Agreements - Additional Information (Detail) | Sep. 16, 2017USD ($) | Apr. 30, 2016USD ($) | Sep. 30, 2015USD ($) | Aug. 31, 2015USD ($) | Mar. 31, 2014USD ($) | Dec. 31, 2012USD ($) | Mar. 31, 2010USD ($) | Dec. 31, 2006USD ($) | Jun. 30, 2017USD ($) | Mar. 31, 2017USD ($) | Jun. 30, 2016USD ($) | Mar. 31, 2016USD ($) | Jun. 30, 2017USD ($)Indication | Jun. 30, 2016USD ($) | Dec. 31, 2016USD ($) | Dec. 31, 2015USD ($) | Dec. 31, 2014USD ($) | Oct. 14, 2016 | Apr. 30, 2014USD ($) |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||
Collaboration revenue | $ 351,000 | $ 193,000 | $ 2,883,000 | $ 1,396,000 | |||||||||||||||
Amounts due from pursuant to the cost-sharing provisions | 445,000 | 445,000 | $ 1,027,000 | ||||||||||||||||
Research and development | 6,881,000 | 5,604,000 | $ 14,837,000 | 11,576,000 | |||||||||||||||
CANbridge | |||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||
License agreement date | Mar. 16, 2016 | ||||||||||||||||||
Collaborations and license agreements, expected milestone receivable | $ 0 | ||||||||||||||||||
Revenue recognized from reimbursement of manufacturing development activities | $ 500,000 | ||||||||||||||||||
CANbridge | Licensing Agreements | |||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||
Collaborations and license agreements, expected milestone receivable | $ 1,000,000 | 500,000 | |||||||||||||||||
Upfront payment, withholding taxes | 100,000 | 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 | ||||||||||||||||||
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 | ||||||||||||||||||
Collaborations and license agreements, expected milestone receivable | 0 | ||||||||||||||||||
Novartis | |||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||
Collaborations and license agreements, expected milestone receivable | $ 15,000,000 | ||||||||||||||||||
Collaborations and license agreements, expected milestone receivable | 0 | ||||||||||||||||||
Collaboration revenue | 1,800,000 | ||||||||||||||||||
Reimbursable inventory | $ 3,500,000 | ||||||||||||||||||
License and service revenue | $ 3,500,000 | ||||||||||||||||||
Research and development | $ 1,800,000 | ||||||||||||||||||
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 | 51,200,000 | ||||||||||||||||||
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 | ||||||||||||||||||
Ophthotech Corporation | |||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||
Upfront license payment | 500,000 | ||||||||||||||||||
Ophthotech Corporation | Option and License Agreement | |||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||
Collaborations and license agreements, payment received | $ 500,000 | ||||||||||||||||||
Collaborations and license agreements, revenue recognized | 87,000 | 29,000 | 115,000 | 58,000 | |||||||||||||||
Remaining deferred revenue to be recognized | 100,000 | ||||||||||||||||||
Biodesix | FOCAL study | |||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||
Contribution percentage of clinical, regulatory, manufacturing and other costs | 50.00% | ||||||||||||||||||
Percentage of closeout project cost | 50.00% | ||||||||||||||||||
Biodesix | FOCAL study | Maximum | |||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||
Funding | $ 15,000,000 | ||||||||||||||||||
Biodesix | FOCAL trial | |||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||
Collaborations and license agreements, royalties payment on net sales | 10.00% | ||||||||||||||||||
Amounts due from pursuant to the cost-sharing provisions | 100,000 | 100,000 | |||||||||||||||||
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 | $ (100,000) | 600,000 | $ 200,000 | 1,500,000 | |||||||||||||||
St Vincent's Hospital Sydney Limited | |||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||
Amendment agreement date | 2015-08 | ||||||||||||||||||
License fees payable | $ 16,700,000 | ||||||||||||||||||
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 | ||||||||||||||||||
Kyowa Hakko Kirin | Utilization of Data Generated by Planned Phase Three Study | Maximum | |||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||
Research and development reimbursement payment not required to be paid | $ 20,000,000 | ||||||||||||||||||
Kyowa Hakko Kirin | Phase One Combination Study | Maximum | |||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||
Research and development reimbursement payment not required to be paid | 2,000,000 | ||||||||||||||||||
Kyowa Hakko Kirin | Licensing Agreements | |||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||
Collaborations and license agreements, cash payment | $ 5,000,000 | ||||||||||||||||||
Collaborations and license agreements, milestone payment | $ 10,000,000 | ||||||||||||||||||
Collaborations and license agreements, potential future milestone payments, maximum amount | $ 18,000,000 | ||||||||||||||||||
Collaborations and license agreements, potential future payment as percentage of certain amounts the Company receives under sublicense agreements | 30.00% | 30.00% | |||||||||||||||||
Reimbursement of Research and development milestone | $ 4,000,000 | ||||||||||||||||||
Term of royalty payment obligations | 12 years | ||||||||||||||||||
Kyowa Hakko Kirin | Licensing Agreements | FDA Marketing Approval | |||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||
Collaborations and license agreements, milestone payment | $ 12,000,000 | ||||||||||||||||||
EUSA | |||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||
Collaborations and license agreements, expected milestone receivable | $ 4,000,000 | ||||||||||||||||||
Collaborations and license agreements, expected milestone receivable | $ 100,000 | 100,000 | 200,000 | 200,000 | |||||||||||||||
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 | ||||||||||||||||||
Percentage of additional proceeds from research and development funding | 50.00% | ||||||||||||||||||
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 | 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 | |||||||||||||||||
Pharmstandard | |||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||
Collaboration revenue | 37,000 | 75,000 | |||||||||||||||||
Collaborations and license agreements, deferred revenue | $ 900,000 | $ 900,000 | |||||||||||||||||
Astellas Pharma Inc. | Astellas Agreement | |||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||
Amounts due from pursuant to the cost-sharing provisions | $ 100,000 | $ 100,000 | |||||||||||||||||
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 | $ 38,000 | |||||||||||||||||
Collaborations and license agreements, relative selling price of the deliverable | $ 600,000 | ||||||||||||||||||
Subsequent Event | CANbridge | Licensing Agreements | |||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||
Collaborations and license agreements, expected milestone receivable | $ 500,000 |
Other Accrued Liabilities (Deta
Other Accrued Liabilities (Detail) - USD ($) $ in Thousands | Jun. 30, 2017 | Dec. 31, 2016 |
Payables and Accruals [Abstract] | ||
Professional fees | $ 460 | $ 464 |
Compensation and benefits | 729 | 891 |
Other | 171 | 176 |
Other accrued liabilities | $ 1,360 | $ 1,531 |
Loans Payable - Additional Info
Loans Payable - Additional Information (Detail) | Jul. 31, 2017USD ($)shares | Jul. 31, 2017USD ($)shares | Jun. 30, 2017USD ($)Installmentshares | May 31, 2016USD ($)Installment$ / sharesshares | Sep. 30, 2014USD ($)$ / sharesshares | Jun. 30, 2017USD ($)Installmentshares | Jun. 30, 2016USD ($)$ / sharesshares | Dec. 31, 2016USD ($)shares |
Debt Instrument [Line Items] | ||||||||
Proceeds from additional borrowing capacity | $ 5,000,000 | |||||||
Loan payable, end-of-term payment due | $ 840,000 | $ 840,000 | ||||||
Warrants issued to lenders as part of new loan agreement, shares of common stock to purchase | shares | 1,202,117 | 608,696 | ||||||
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 | ||||||
Number of common stock shared issued | shares | 116,833,000 | 116,833,000 | 75,863,000 | |||||
Approximate payment of principle and interest | $ 14,123,000 | $ 14,123,000 | ||||||
Unamortized discount recognized | 878,000 | 878,000 | $ 1,000,000 | |||||
Maximum amount of debt conversion | 2,000,000 | 2,000,000 | ||||||
Cash proceeds | 3,210,000 | $ 525,000 | ||||||
Private Placement | PIPE Warrants | ||||||||
Debt Instrument [Line Items] | ||||||||
Warrants issued to lenders as part of new loan agreement, shares of common stock to purchase | shares | 259,067 | |||||||
Number of common stock shared issued | shares | 17,642,482 | |||||||
Cash proceeds from issue of units | $ 200,000 | |||||||
Exchange of unit to share | shares | 1 | 1 | ||||||
Common stock warrant exercise price | $ / shares | $ 1 | $ 1 | ||||||
Private Placement | PIPE Warrants | Director and Executive Officer | ||||||||
Debt Instrument [Line Items] | ||||||||
Number of common stock shared issued | shares | 544,039 | |||||||
Subsequent Event | Private Placement | PIPE Warrants | ||||||||
Debt Instrument [Line Items] | ||||||||
Number of warrants exercised | shares | 259,067 | 259,067 | ||||||
Number of common stock shared issued | shares | 259,067 | 259,067 | ||||||
Cash proceeds | $ 300,000 | |||||||
Subsequent Event | Private Placement | PIPE Warrants | Director and Executive Officer | ||||||||
Debt Instrument [Line Items] | ||||||||
Number of common stock shared issued | shares | 259,067 | 259,067 | ||||||
Cash proceeds | $ 300,000 | |||||||
Loans Payable | Minimum | ||||||||
Debt Instrument [Line Items] | ||||||||
Option to purchase equity, net cash proceeds of equity securities | 10,000,000 | $ 10,000,000 | ||||||
Hercules Amended Loan Agreement | Loans Payable | ||||||||
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 | $ 500,000 | ||||||
Loan issuance costs paid | $ 200,000 | |||||||
Loan payable, interest rate, base rate | 11.90% | 11.90% | ||||||
Loan payable, interest rate, additional rate deducted from base rate | 4.75% | 4.75% | ||||||
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 June 30, 2017) | |||||||
Loan payable, interest rate | 11.90% | 11.90% | ||||||
Debt instrument convertible beneficial conversion feature | $ 0 | |||||||
Hercules Amended Loan Agreement | Loans Payable | Minimum | ||||||||
Debt Instrument [Line Items] | ||||||||
Loan payable, interest rate | 11.90% | 11.90% | ||||||
Hercules Amended Loan Agreement | Loans Payable | Maximum | ||||||||
Debt Instrument [Line Items] | ||||||||
Loan payable, interest rate | 15.00% | 15.00% | ||||||
Hercules May 2016 Loan Agreement | Loans Payable | ||||||||
Debt Instrument [Line Items] | ||||||||
Proceeds from additional borrowing capacity | $ 5,000,000 | $ 5,000,000 | $ 5,000,000 | |||||
Loan payable, Commencement date | Jan. 1, 2018 | Jul. 1, 2017 | ||||||
Loan payable, due date | Dec. 1, 2019 | Dec. 1, 2019 | ||||||
Loan payable, end-of-term payment due | $ 300,000 | 200,000 | $ 300,000 | |||||
Loan issuance costs paid | 100,000 | |||||||
Unrestricted and unencumbered cash and cash equivalents | 25,000,000 | 25,000,000 | ||||||
Loan outstanding principal amount | $ 20,000,000 | $ 15,000,000 | $ 20,000,000 | |||||
Loan payable, number of installments of principal and interest | Installment | 23 | 30 | 23 | |||||
Loan payable, frequency of installments of principal and interest | Monthly payments of principal and interest | Monthly payments of principal and interest | ||||||
Debt instrument, covenant description | The Company has achieved the following conditions: (i) satisfactory developmental progression on a minimum of two (2) clinical programs (other than the 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. | |||||||
Additional borrowing capacity | $ 5,000,000 | $ 5,000,000 | ||||||
Loan payable, Commencement date deferred by six months | Jan. 1, 2018 | |||||||
Additional, end-of-term payment | $ 100,000 | |||||||
Percentage of loan outstanding | 26.00% | 26.00% | ||||||
Hercules May 2016 Loan Agreement | Loans Payable | November 2019 [Member] | ||||||||
Debt Instrument [Line Items] | ||||||||
Approximate payment of principle and interest | $ 800,000 | $ 800,000 | ||||||
Hercules May 2016 Loan Agreement | Loans Payable | December 2019 [Member] | ||||||||
Debt Instrument [Line Items] | ||||||||
Approximate payment of principle and interest | 5,300,000 | 5,300,000 | ||||||
Hercules May 2016 Loan Agreement | Loans Payable | Minimum | Financial covenant | ||||||||
Debt Instrument [Line Items] | ||||||||
Unrestricted and unencumbered cash and cash equivalents | $ 10,000,000 | $ 10,000,000 | $ 10,000,000 | |||||
Hercules May 2016 Loan Agreement | Amendment Two [Member] | ||||||||
Debt Instrument [Line Items] | ||||||||
Number of warrants exercised | shares | 0 | 0 | ||||||
Hercules May 2016 Loan Agreement | Amendment Two [Member] | Subsequent Event | ||||||||
Debt Instrument [Line Items] | ||||||||
Number of warrants exercised | shares | 1,202,117 | 1,202,117 | ||||||
Number of common stock shared issued | shares | 846,496 | 846,496 | ||||||
Cash proceeds in connection with warrants exercised | $ 0 | |||||||
Hercules September Two Thousand Fourteen Loan Agreement | Amendment One [Member] | ||||||||
Debt Instrument [Line Items] | ||||||||
Number of warrants exercised | shares | 0 | 0 | ||||||
Number of common stock shared issued | shares | 369,297 | |||||||
Cash proceeds in connection with warrants exercised | $ 0 | |||||||
Hercules September Two Thousand Fourteen Loan Agreement | Amendment One [Member] | Subsequent Event | ||||||||
Debt Instrument [Line Items] | ||||||||
Number of warrants exercised | shares | 608,696 | 608,696 |
Future Minimum Payments Under L
Future Minimum Payments Under Loans Payable (Detail) - USD ($) $ in Thousands | Jun. 30, 2017 | Dec. 31, 2016 |
Debt Disclosure [Abstract] | ||
2017 (remaining 6 months) | $ 1,167 | |
2,018 | 9,828 | |
2,019 | 14,123 | |
Long-term Debt, Gross, Total | 25,118 | |
Less amount representing interest | (4,278) | |
Less unamortized discount | (878) | $ (1,000) |
Less deferred charges | (840) | |
Less loans payable current, net of discount | (3,055) | (2,124) |
Loans payable, net of current portion and discount | $ 16,067 | $ 11,879 |
Common Stock - Additional Infor
Common Stock - Additional Information (Detail) - USD ($) | Jul. 31, 2017 | Aug. 31, 2015 | Jul. 31, 2017 | Mar. 31, 2017 | May 31, 2016 | Jun. 30, 2017 | Jun. 30, 2016 | Jun. 30, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | May 07, 2015 | Mar. 31, 2015 | Feb. 28, 2015 |
Class of Stock [Line Items] | |||||||||||||
Common stock, par value | $ 0.001 | $ 0.001 | $ 0.001 | ||||||||||
Common stock, shares authorized | 50,000,000 | 50,000,000 | |||||||||||
Common stock, shares authorized | 250,000,000 | 250,000,000 | 200,000,000 | 200,000,000 | |||||||||
Common stock, shares issued | 116,833,000 | 116,833,000 | 75,863,000 | ||||||||||
Underwriters' option to purchase shares | 0 | ||||||||||||
Gross proceeds from public offering | $ 21,035,000 | $ 14,862,000 | |||||||||||
Net proceeds from public offering | 29,200,000 | ||||||||||||
Cash proceeds | 3,210,000 | $ 525,000 | |||||||||||
Common stock sales agreement, aggregate offering amount | 117,000 | $ 117,000 | $ 76,000 | ||||||||||
Offering, issuance and sale of stocks and securities, shelf registration | $ 250,000,000 | ||||||||||||
Sale of stock | 0 | ||||||||||||
Underwritten Public Offering | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Common stock, shares issued | 34,500,000 | ||||||||||||
Underwriters' option to purchase shares | 4,500,000 | ||||||||||||
Gross proceeds from public offering | $ 17,300,000 | $ 15,400,000 | |||||||||||
Percentage of affiliates stock holders | 5.00% | ||||||||||||
Net proceeds from public offering | $ 15,400,000 | ||||||||||||
PIPE Warrants | Private Placement | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Common stock, shares issued | 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 | 1 | |||||||||||
Warrants exercise price | $ 1 | $ 1 | |||||||||||
Warrants exercisable period | 5 years | ||||||||||||
PIPE Warrants | Private Placement | Subsequent Event | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Common stock, shares issued | 259,067 | 259,067 | |||||||||||
Number of warrants exercised | 259,067 | 259,067 | |||||||||||
Cash proceeds | $ 300,000 | ||||||||||||
PIPE Warrants | Private Placement | Director and Executive Officer | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Common stock, shares issued | 544,039 | ||||||||||||
Net offering proceeds to the company | $ 15,400,000 | ||||||||||||
PIPE Warrants | Private Placement | Director and Executive Officer | Subsequent Event | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Common stock, shares issued | 259,067 | 259,067 | |||||||||||
Cash proceeds | $ 300,000 | ||||||||||||
New Enterprise Associates | Underwritten Public Offering | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Common stock, shares issued | 420,000 | ||||||||||||
Other Investors | Underwritten Public Offering | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Common stock, shares issued | 6,000,000 | ||||||||||||
F B R Co | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Common stock, shares issued | 5,900,000 | 6,500,000 | 6,500,000 | ||||||||||
proceeds from sale of shares | $ 10,200,000 | $ 8,800,000 | |||||||||||
Common stock available for sale under Sales Agreement | $ 100,000 | $ 100,000 | |||||||||||
Minimum | Underwritten Public Offering | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Shares issued, price per share | $ 0.50 | ||||||||||||
Maximum | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Offering, issuance and sale of stocks and securities, shelf registration | $ 100,000,000 | ||||||||||||
Maximum | F B R Co | |||||||||||||
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% |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Millions | 6 Months Ended | ||
Jun. 30, 2017 | Jun. 30, 2016 | Dec. 31, 2016 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Common stock reserved for issuance | 3,500,000 | ||
Shares available for future issuance under the Plan | 4,536,965 | ||
Stock options issued to purchase common stock | 6,568,226 | 4,858,678 | |
Stock price | $ 2.22 | ||
Total unrecognized stock-based compensation expense related to stock options granted | $ 1.6 | ||
Stock Options | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Awards, vesting period | 4 years | ||
Awards, Expiration period | 10 years | ||
Weighted-average grant date fair value of stock options granted | $ 0.40 | $ 1.03 | |
Share based payment award forfeiture rates | 76.00% | ||
Total unrecognized stock-based compensation expense, weighted-average period Recognition | 2 years 6 months | ||
Awards With Market Conditions | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Stock options issued to purchase common stock | 197,650 | ||
Awards With Performance-Based Milestone Conditions | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Stock options issued to purchase common stock | 220,774 | ||
Minimum | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Common stock reserved for issuance | 8,500,000 | ||
Minimum | Stock Options | Participants Who Own Less than 10% of Total Combined Voting Power | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Exercise price of incentive stock options as percentage of fair market value of common stock on the date of the award | 100.00% | ||
Minimum | Stock Options | Participants Who Own More than 10% of Total Combined Voting Power | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Exercise price of incentive stock options as percentage of fair market value of common stock on the date of the award | 110.00% | ||
Maximum | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Common stock reserved for issuance | 12,000,000 |
Stock Option Activity (Detail)
Stock Option Activity (Detail) | 6 Months Ended |
Jun. 30, 2017USD ($)$ / sharesshares | |
Options | |
Outstanding at beginning of period | shares | 4,858,678 |
Granted | shares | 2,228,135 |
Exercised | shares | 0 |
Forfeited | shares | (518,587) |
Outstanding at end of period | shares | 6,568,226 |
Exercisable at June 30, 2017 | shares | 2,976,696 |
Weighted-Average Exercise Price | |
Outstanding at beginning of period | $ / shares | $ 2.31 |
Granted | $ / shares | 0.61 |
Exercised | $ / shares | 0 |
Forfeited | $ / shares | 1.05 |
Outstanding at end of period | $ / shares | 1.84 |
Exercisable at March 31, 2017 | $ / shares | $ 3.06 |
Weighted-Average Remaining Contractual Term | |
Outstanding at June 30, 2017 | 7 years 7 months 10 days |
Exercisable at June 30, 2017 | 6 years 1 month 27 days |
Aggregate Intrinsic Value | |
Outstanding at end of year | $ | $ 7,540,000 |
Exercisable at end of year | $ | $ 2,520,000 |
Assumptions Used in Black Schol
Assumptions Used in Black Scholes Pricing Model for New Grants (Detail) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2017 | Jun. 30, 2016 | Jun. 30, 2017 | Jun. 30, 2016 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Volatility factor, minimum | 73.20% | 73.24% | 71.82% | 73.24% |
Volatility factor, maximum | 76.07% | 74.47% | 76.07% | 74.47% |
Risk-free interest rates, minimum | 1.84% | 0.94% | 1.84% | 0.94% |
Risk-free interest rates, maximum | 1.95% | 1.03% | 2.10% | 1.38% |
Dividend yield | 0.00% | 0.00% | 0.00% | 0.00% |
Minimum | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Expected term (in years) | 5 years 6 months | 5 years 6 months | 5 years 6 months | 5 years 6 months |
Maximum | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Expected term (in years) | 6 years 2 months 30 days | 6 years 2 months 30 days | 6 years 2 months 30 days | 6 years 2 months 30 days |
Legal Proceedings -Additional I
Legal Proceedings -Additional Information (Detail) $ in Millions | Jun. 30, 2017LegalMatter | Mar. 29, 2016USD ($) |
Commitments and Contingencies Disclosure [Abstract] | ||
Class action lawsuits | LegalMatter | 2 | |
Reserve for settlement of fines | $ | $ 4 |