Document and Entity Information
Document and Entity Information - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2017 | Feb. 28, 2018 | Jun. 30, 2017 | |
Document And Entity Information [Abstract] | |||
Entity Registrant Name | VITAL THERAPIES INC | ||
Trading Symbol | VTL | ||
Entity Central Index Key | 1,280,776 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Filer Category | Accelerated Filer | ||
Document Type | 10-K | ||
Document Period End Date | Dec. 31, 2017 | ||
Document Fiscal Year Focus | 2,017 | ||
Document Fiscal Period Focus | FY | ||
Amendment Flag | false | ||
Entity Common Stock, Shares Outstanding | 42,368,864 | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Public Float | $ 88.3 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2017 | Dec. 31, 2016 |
Current assets: | ||
Cash and cash equivalents | $ 56,901 | $ 59,991 |
Other current assets and prepaid expenses | 1,220 | 1,472 |
Total current assets | 58,121 | 61,463 |
Property and equipment, net | 2,155 | 2,505 |
Other assets | 108 | 58 |
Total assets | 60,384 | 64,026 |
Current liabilities: | ||
Accounts payable | 1,049 | 780 |
Accrued expenses | 9,141 | 4,656 |
Other current liabilities | 91 | 44 |
Total current liabilities | 10,281 | 5,480 |
Long-term liabilities | 59 | 100 |
Commitments and contingencies (note 4) | ||
Stockholders’ equity: | ||
Preferred stock, $0.0001 par value; 20,000,000 authorized and no shares issued or outstanding at December 31, 2017 and 2016 | 0 | 0 |
Common stock, $0.0001 par value; 130,000,000 shares authorized at December 31, 2017 and 2016; 42,368,864 and 32,143,475 shares issued and outstanding at December 31, 2017 and 2016, respectively | 4 | 3 |
Additional paid-in capital | 345,915 | 302,185 |
Accumulated other comprehensive income | 78 | 83 |
Accumulated deficit | (295,953) | (243,825) |
Total stockholders’ equity | 50,044 | 58,446 |
Total liabilities and stockholders’ equity | $ 60,384 | $ 64,026 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2017 | Dec. 31, 2016 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value (usd per share) | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized | 20,000,000 | 20,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value (usd per share) | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 130,000,000 | 130,000,000 |
Common stock, shares issued | 42,368,864 | 32,143,475 |
Common stock, shares outstanding | 42,368,864 | 32,143,475 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Operating expenses: | |||
Research and development | $ 39,341 | $ 30,046 | $ 39,773 |
General and administrative | 13,314 | 11,220 | 12,347 |
Total operating expenses | 52,655 | 41,266 | 52,120 |
Loss from operations | (52,655) | (41,266) | (52,120) |
Other income: | |||
Interest income | 650 | 284 | 58 |
Other income (expense), net | (73) | 13 | 39 |
Total other income | 577 | 297 | 97 |
Net loss | $ (52,078) | $ (40,969) | $ (52,023) |
Net loss per share, basic and diluted (usd per share) | $ (1.31) | $ (1.31) | $ (2.07) |
Weighted-average common shares outstanding, basic and diluted (in shares) | 39,859,009 | 31,387,579 | 25,152,948 |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive Loss - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Statement of Comprehensive Income [Abstract] | |||
Net loss | $ (52,078) | $ (40,969) | $ (52,023) |
Other comprehensive income (loss): | |||
Unrealized gains (losses) on cash equivalents | (6) | 4 | 0 |
Foreign currency translation | 1 | (1) | (9) |
Total comprehensive loss | $ (52,083) | $ (40,966) | $ (52,032) |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Equity - USD ($) $ in Thousands | Total | Common Stock | Additional Paid-In Capital | Accumulated Other Comprehensive Income (Loss) | Accumulated Deficit |
Beginning balance at Dec. 31, 2014 | $ 97,563 | $ 2 | $ 248,305 | $ 89 | $ (150,833) |
Beginning balance (in shares) at Dec. 31, 2014 | 23,982,786 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | (52,023) | (52,023) | |||
Other comprehensive income (loss) | (9) | (9) | |||
Exercise of stock options and change in stock option early exercise repurchase liability | 615 | 615 | |||
Exercise of stock options and change in stock option early exercise repurchase liability (in shares) | 217,570 | ||||
Stock-based compensation | 4,029 | 4,029 | |||
Issuance of common stock, net of issuance costs | 32,150 | $ 1 | 32,149 | ||
Issuance of common stock, net of issuance costs (in shares) | 6,272,727 | ||||
Ending balance at Dec. 31, 2015 | 82,325 | $ 3 | 285,098 | 80 | (202,856) |
Ending balance (in shares) at Dec. 31, 2015 | 30,473,083 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | (40,969) | (40,969) | |||
Other comprehensive income (loss) | 3 | 3 | |||
Exercise of stock options and change in stock option early exercise repurchase liability | 54 | 54 | |||
Exercise of stock options and change in stock option early exercise repurchase liability (in shares) | 8,098 | ||||
Stock-based compensation | 4,678 | 4,678 | |||
Issuance of common stock, net of issuance costs | 12,355 | 12,355 | |||
Issuance of common stock, net of issuance costs (in shares) | 1,662,294 | ||||
Ending balance at Dec. 31, 2016 | 58,446 | $ 3 | 302,185 | 83 | (243,825) |
Ending balance (in shares) at Dec. 31, 2016 | 32,143,475 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | (52,078) | (52,078) | |||
Other comprehensive income (loss) | (5) | (5) | |||
Exercise of stock options | $ 5 | 5 | |||
Exercise of stock options (in shares) | 2,889 | 2,889 | |||
Stock-based compensation | $ 5,480 | 5,480 | |||
Common stock issued for services | 256 | 256 | |||
Common stock issued for services (in shares) | 60,000 | ||||
Issuance of common stock, net of issuance costs | 37,940 | $ 1 | 37,939 | ||
Issuance of common stock, net of issuance costs (in shares) | 10,162,500 | ||||
Other | 0 | 50 | (50) | ||
Ending balance at Dec. 31, 2017 | $ 50,044 | $ 4 | $ 345,915 | $ 78 | $ (295,953) |
Ending balance (in shares) at Dec. 31, 2017 | 42,368,864 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Cash flows from operating activities: | |||
Net loss | $ (52,078) | $ (40,969) | $ (52,023) |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Depreciation and amortization | 998 | 1,808 | 1,328 |
Stock-based compensation | 5,480 | 4,678 | 4,029 |
Common stock issued for services | 256 | 0 | 0 |
Other | (1) | 85 | 0 |
Changes in operating assets and liabilities: | |||
Other assets and prepaid expenses | 165 | (232) | 143 |
Accounts payable | 287 | (459) | 281 |
Accrued expenses | 4,490 | (587) | (3,584) |
Other liabilities | 6 | (98) | (126) |
Net cash used in operating activities | (40,397) | (35,774) | (49,952) |
Cash flows from investing activities: | |||
Purchases of property and equipment | (685) | (556) | (2,340) |
Change in restricted cash | 0 | 533 | 1,059 |
Proceeds from sale of equipment | 7 | 2 | 0 |
Net cash used in investing activities | (678) | (21) | (1,281) |
Cash flows from financing activities: | |||
Proceeds from issuance of common stock, net of issuance costs | 37,998 | 12,355 | 32,189 |
Proceeds from exercise of stock options | 5 | 32 | 515 |
Deferred financing costs | (19) | (13) | (283) |
Net cash provided by financing activities | 37,984 | 12,374 | 32,421 |
Effect of exchange rate changes on cash and cash equivalents | 1 | (4) | (10) |
Net change in cash and cash equivalents | (3,090) | (23,425) | (18,822) |
Cash and cash equivalents, beginning of period | 59,991 | 83,416 | 102,238 |
Cash and cash equivalents, end of period | 56,901 | 59,991 | 83,416 |
Supplemental disclosure of non-cash investing and financing activities: | |||
Purchase of property and equipment included in liabilities | 16 | 41 | 9 |
Stock issuance costs included in liabilities | 1 | 0 | 39 |
Change in stock option early exercise repurchase liability | $ 0 | $ 23 | $ 108 |
Description of Business and Bas
Description of Business and Basis of Financial Statements | 12 Months Ended |
Dec. 31, 2017 | |
Accounting Policies [Abstract] | |
Description of Business and Basis of Financial Statements | Description of Business and Basis of Financial Statements Description of Business We are a clinical-stage biotechnology company focusing on the discovery, development and commercialization of cell-based therapies capable of transforming the management of life-threatening conditions. Our initial product candidate, the ELAD ® System, or ELAD, is a human-cell-based, bio-artificial liver which is being developed to improve rates of survival among patients with acute forms of liver failure. Since inception, we have devoted essentially all of our efforts to product development, clinical testing and pilot manufacturing and have not recognized revenues from our planned principal operations. In August 2015, we reported that our VTI-208 phase 3 clinical trial of ELAD in severe alcoholic hepatitis failed to reach its primary or secondary endpoints, although medically pertinent pre-specified subsets based on age and disease severity did show trends toward efficacy. Considering the results of the VTI-208 clinical trial and in an effort to focus our personnel and financial resources, we also discontinued our VTI-210 and VTI-212 clinical trials. We are currently completing enrollment of subjects in our new phase 3 clinical trial of ELAD, known as VTL-308, in severe alcoholic hepatitis, based on our analysis of the results of the VTI-208 clinical trial. Our business, operating results, financial condition and growth prospects are subject to significant risks and uncertainties including the failure of our clinical trial to meet its endpoint, failure to obtain regulatory approval to commercialize ELAD and failure to secure additional funding to complete the development and commercialization of ELAD. Liquidity We have a history of incurring losses and negative cash flows from operations and have an accumulated deficit of $296.0 million through December 31, 2017 . Based on the structure and timing of the VTL-308 clinical trial, assuming limited activities related to the submission for a biologics license application, or BLA, and that we do not begin building any significant commercial infrastructure, we believe that our existing cash and cash equivalents of $56.9 million as of December 31, 2017 should be sufficient to fund our operations through the first quarter of 2019, past the expected announcement of topline data for the VTL-308 clinical trial, which we currently anticipate to be in the third quarter of 2018. We have based this estimate on assumptions that may prove to be wrong, and we could utilize our available capital resources sooner than we currently expect. The timing and amount of our actual expenditures will be based on many factors, including, but not limited to, the timing of and enrollment in our clinical trials, the timing of any possible submission of a BLA, decisions with respect to building commercial operations, and any unforeseen cash needs which may deplete current cash and cash equivalents sooner than planned. Furthermore, our operating plans may change, and we may need additional funds earlier to meet operational needs and capital requirements for product development, BLA-related activities and building for commercialization. We plan to address our liquidity needs through pursuing additional funding which we may seek to obtain through a combination of equity or debt financings, or government or other third-party financing, marketing and distribution arrangements and other collaborations, strategic alliances and licensing arrangements. In this regard, we currently have an effective shelf registration statement on Form S-3 on file with the SEC. The shelf registration statement currently permits the offering, issuance and sale by us of up to an aggregate offering price of $112.5 million of common stock, preferred stock, warrants, debt securities or units in one or more offerings and in any combination, of which $62.2 million may be offered, issued and sold under an “at-the-market” sales agreement with Cantor Fitzgerald & Co. However, there is no assurance that we will be able to obtain additional funding on acceptable terms or at all. If the Company is not able to secure adequate additional funding, it will be required to make reductions in certain spending to extend current funds. If we are unable to raise adequate funds, we may have to liquidate some or all of our assets, or we may have to delay, reduce the scope of, or eliminate some or all of our development programs or clinical trials. We may also have to delay development or commercialization of our products or license to third parties the rights to commercialize products or technology that we would otherwise seek to commercialize. Any of these factors could harm our operating results and future prospects. This discussion contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities and Exchange Act of 1934, as amended, that are based on beliefs and assumptions currently available to management, and that involve risks and uncertainties and our actual results could differ materially. Basis of Presentation and Consolidation The accompanying consolidated financial statements have been prepared in conformity with United States generally accepted accounting principles, or GAAP, and include the accounts of Vital Therapies, Inc. and its wholly-owned subsidiaries located in the United Kingdom and China, both of which are currently inactive. All intercompany accounts and transactions have been eliminated in consolidation. We manage our operations as a single reportable segment for the purposes of assessing performance and making operating decisions. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2017 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Summary of Significant Accounting Policies Use of Estimates The preparation of financial statements in conformity with GAAP requires us to make certain estimates and assumptions that affect the amounts reported in the consolidated financial statements and accompanying notes. Actual results could differ materially from those estimates and assumptions. Cash and Cash Equivalents Cash and cash equivalents consist of cash and highly-liquid investments with original maturities of three months or less when acquired. Cash equivalents are stated at cost unless they are securities, in which case they are recorded at fair value, which approximates original cost. Fair Value of Financial Instruments Fair value is defined as the price that would be received to sell an asset or be paid to transfer a liability in an orderly transaction between market participants on the measurement date. Accounting guidance establishes a fair value hierarchy that requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. The standard describes three levels of inputs that may be used to measure fair value: Level 1—Quoted prices in active markets for identical assets or liabilities. Our Level 1 assets consisted of money market funds for the periods presented. We had no Level 1 liabilities for the periods presented. Level 2—Observable inputs other than Level 1 prices, such as quoted prices for similar assets or liabilities, quoted prices in markets with insufficient volume or infrequent transactions (less active markets), or model-derived valuations in which all significant inputs are observable or can be derived principally from or corroborated with observable market data for substantially the full term of the assets or liabilities. We had no Level 2 assets or liabilities for the periods presented. Level 3—Unobservable inputs to the valuation methodology that are significant to the measurement of the fair value of assets or liabilities. We had no Level 3 assets or liabilities for the periods presented. Any transfers into and out of levels within the fair value hierarchy will be recognized at the end of the reporting period in which the actual event or change in circumstances that caused the transfer occurs. The carrying value of cash and cash equivalents, other current assets and prepaid expenses, accounts payable, accrued expenses, and other current liabilities approximates fair value due to the short period of time to maturity. Property and Equipment Property and equipment are recorded at cost and depreciated using the straight-line method over the estimated useful lives of the assets (generally three to five years). Leasehold improvements are stated at cost and depreciated on a straight-line basis over the lesser of the remaining term of the related lease or the estimated useful lives of the assets. Construction in progress is not depreciated until the underlying asset is available to be placed in service. Repairs and maintenance costs are charged to expense as incurred. Impairment of Long-Lived Assets Long-lived assets consist primarily of property and equipment. An impairment loss is recorded if and when events and circumstances indicate that assets might be impaired and the undiscounted cash flows estimated to be generated by those assets are less than the carrying amount of those assets. We have not recognized any impairment losses in the years ended December 31, 2017 , 2016 or 2015 . Clinical Trial Accruals As part of the process of preparing our financial statements, we are required to estimate our accrued expenses. Our clinical trial accrual process seeks to account for expenses resulting from our obligations under agreements with clinical sites, clinical research organizations, or CROs, vendors, and consultants in connection with conducting our clinical trials. We account for these expenses according to the progress of each trial as measured by subject enrollment, the timing of various aspects of the trial and if available, information from our service providers. During the course of a clinical trial, we adjust our rate of clinical expense recognition if actual results differ from our estimates. Although we do not expect our estimates to be materially different from amounts actually incurred, our understanding of the status and timing of services performed relative to the actual status and timing of services performed may vary, and could result in us reporting amounts that may later be determined to be higher or lower than our estimates for a particular period and adjustments to our research and development expenses may be necessary in future periods. Research and Development Research and development costs consist primarily of employee-related expenses, costs of contractors, clinical trial sites and CROs engaged in the development of ELAD, costs related to our investigation of the mechanism of action of ELAD, expenses associated with obtaining regulatory approvals, and the cost of acquiring and manufacturing clinical trial materials. All research and development costs are expensed as incurred. Stock-Based Compensation We measure and recognize compensation expense for all stock-based compensation for employees and directors based on the estimated fair value at the date of grant, and to consultants based on the ongoing estimated fair value. Currently, our stock-based awards consist only of stock options; however, future grants under our equity compensation plan may also consist of shares of restricted stock, restricted stock units, stock appreciation rights, performance awards and performance units. We estimate the fair value of stock options using the Black-Scholes-Merton, or BSM, option pricing model, which requires the use of estimates. We recognize stock-based compensation cost for employees and directors for ratably vesting stock options on a straight-line basis over the requisite service period of the award. For performance-based stock options to employees and directors, we record stock-based compensation expense only when the performance-based milestone is deemed probable of achievement. We utilize both quantitative and qualitative criteria to judge whether milestones are probable of achievement. The fair value of options granted to consultants is estimated using the BSM option pricing model and is re-measured at each reporting date with changes in fair value prior to vesting recognized as expense in the consolidated statements of operations across the applicable vesting period. For performance-based stock options to consultants, we record stock-based compensation expense only when the performance-based milestone is achieved unless there is a performance commitment. Effective in the first quarter of 2017, we began recognizing forfeitures as they occur (see "Recently Issued and/or Adopted Accounting Standards" below). In 2016 and earlier periods, stock-based compensation expense was recognized only for those awards that were ultimately expected to vest. Through 2016, we estimated forfeitures based on an analysis of our historical employee turnover. We revised the forfeiture estimate in subsequent periods if actual forfeitures differed from those estimates. Changes in estimated forfeitures, which were not material, impacted compensation cost in the period in which the change in estimate occurred. The BSM option pricing model requires the input of highly-subjective assumptions, including the risk-free interest rate, the expected dividend yield of our common stock, the expected volatility of the price of our common stock, and the expected term of the option. These estimates involve inherent uncertainties and the application of management’s judgment. If factors change and different assumptions are used, our stock-based compensation expense could be materially different in the future. These assumptions are estimated as follows: Risk-free Interest Rate We base the risk-free interest rate assumption on zero-coupon U.S. treasury instruments appropriate for the expected term of the stock option grants. Expected Dividend Yield We base the expected dividend yield assumption on the fact that we have never paid cash dividends and have no present intention to pay cash dividends. Consequently, we used an expected dividend yield of zero . Expected Volatility The expected stock price volatility for our common stock is estimated based on volatilities of a peer group of similar publicly-traded, biotechnology companies by taking the average historic price volatility for the peers for a period equivalent to the expected term of the stock option grants. We do not use our average historic price volatility as we have only been a publicly-traded company since April 2014. Expected Term The expected term represents the period of time that options are expected to be outstanding. As we do not have sufficient historical experience for determining the expected term of the stock option awards granted, we have determined the expected life assumption for employee and director stock options using the comparable average expected term utilizing those companies in the peer group as noted above. For consultant stock options, we estimate the expected term based on the period we expect each consultant to provide services to us. Leases We lease all of our office space and enter into various other operating lease agreements in conducting our business. At the inception of each lease, we evaluate the lease agreement to determine whether the lease is an operating or capital lease. Some of our lease agreements may contain renewal options, tenant improvement allowances, rent holidays or rent escalation clauses. When such items are included in a lease agreement, we record a deferred rent asset or liability equal to the difference between the rent expense and future minimum lease payments due. The rent expense related to operating leases is recognized on a straight-line basis in the statements of operations over the term of each lease. In cases where our lessor grants us leasehold improvement allowances that reduce our rent expense, we capitalize the improvements as incurred and recognize deferred rent, which is amortized over the shorter of the lease term or the expected useful life of the improvements. Comprehensive Income (Loss) Comprehensive income (loss) is defined as the change in equity during a period from transactions and other events and circumstances from non-owner sources. Accumulated other comprehensive income has been reflected as a separate component of stockholders’ equity in the accompanying consolidated balance sheets. Foreign Currency Translation and Transactions The functional currency of each of our subsidiaries in the United Kingdom and China, both of which are currently inactive, is the local currency. Assets and liabilities of the subsidiaries are translated at the rate of exchange at the balance sheet date. Expenses are translated at the average exchange rates in effect during the reporting period. Gains and losses resulting from foreign currency translation are included in accumulated other comprehensive income in the accompanying consolidated balance sheets. Gains and losses resulting from foreign currency transactions are included in the consolidated statements of operations, which to date have not been significant. Income Taxes We account for income taxes under the asset and liability method, which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the consolidated financial statements. Under this method, deferred tax assets and liabilities are determined on the basis of the differences between the financial statements and tax basis of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse. The effect of a change in tax rates on deferred tax assets and liabilities is recognized in income in the period that includes the enactment date. We recognize net deferred tax assets to the extent we believe these assets are more likely than not to be realized. In making such a determination, management considers all available positive and negative evidence, including future reversals of existing taxable temporary differences, projected future taxable income, tax-planning strategies, and results of recent operations. If management determines that we would be able to realize our deferred tax assets in the future in excess of their net recorded amount, management would make an adjustment to the deferred tax asset valuation allowance, which would reduce the provision for income taxes. As of December 31, 2017 and 2016 , we maintained a full valuation allowance against our entire balance of deferred tax assets. We record uncertain tax positions on the basis of a two-step process whereby (1) management determines whether it is more likely than not that the tax positions will be sustained on the basis of the technical merits of the position and (2) for those tax positions that meet the more-likely-than-not recognition threshold, management recognizes the largest amount of tax benefit that is more than 50 percent likely to be realized upon ultimate settlement with the related tax authority. We recognize interest and penalties related to unrecognized tax benefits, if any, within income tax expense, and any accrued interest and penalties are included within the related tax liability line. Net Loss Per Share Basic net loss per share attributable to common stockholders is calculated by dividing the net loss by the weighted-average number of common shares outstanding for the period, without consideration for common stock equivalents. Diluted net loss per share attributable to common stockholders is computed by dividing the net loss by the weighted-average number of common shares and, if dilutive, common stock equivalents outstanding for the period determined using the treasury-stock method. Common stock equivalents are comprised of options outstanding under our stock option plan and warrants for the purchase of common stock. For all periods presented, there is no difference in the number of shares used to calculate basic and diluted shares outstanding due to our net loss position. Potentially dilutive securities not included in the calculation of diluted net loss per share attributable to common stockholders because to do so would be anti-dilutive are as follows: As of December 31, 2017 2016 2015 Options to purchase common stock 6,083,482 4,841,274 3,716,520 Warrants to purchase common stock 240,620 240,620 250,646 Recently Issued and/or Adopted Accounting Pronouncements In February 2016, the Financial Accounting Standards Board, or FASB, issued Accounting Standards Update, or ASU, No. 2016-02, "Leases," or ASU 2016-02. ASU 2016-02 will require that lease arrangements longer than 12 months result in an entity recognizing an asset and liability equal to the present value of the lease payments in the statement of financial position. ASU 2016-02 is effective for annual periods beginning after December 15, 2018, and interim periods therein. This standard requires a modified retrospective transition approach for all leases existing at, or entered into after, the date of initial application, with an option to use certain transition relief. We expect to adopt ASU 2016-02 in 2019. The adoption of this guidance is expected to result in a significant increase in the total assets and liabilities reported on our consolidated balance sheets. In March 2016, the FASB issued ASU No. 2016-09, " Compensation-Stock Compensation: Improvements to Employee Share-Based Payment Accounting, " or ASU 2016-09. ASU 2016-09 changes how companies account for certain aspects of share-based payments to employees . The amendments in this update cover such areas as the recognition of excess tax benefits and deficiencies, the classification of those excess tax benefits on the statement of cash flows, an accounting policy election for forfeitures, the amount an employer can withhold to cover employee income taxes and still qualify for equity classification and the classification of those taxes paid on the statement of cash flows. Effective in the first quarter of 2017, we adopted the provisions of ASU 2016-09 to recognize forfeitures as they occur. Upon the adoption of this standard, we recorded a cumulative-effect adjustment of $50,000 to increase additional paid-in capital and accumulated deficit reversing our estimate of forfeitures as of December 31, 2016. In November 2016, the FASB issued ASU No. 2016-18, " Statement of Cash Flows: Restricted Cash ," or ASU 2016-18. ASU 2016-18 provides guidance on the classification of restricted cash in the statements of cash flows. This ASU will require that our statements of cash flows explain the change during the period in the total of cash, cash equivalents and amounts generally described as restricted cash or restricted cash equivalents. The amendments in this ASU are effective for interim periods beginning after December 15, 2017, with early adoption permitted. We will adopt this standard in 2018, and ASU 2016-18 will not have a significant impact on our consolidated financial statements at the time of adoption. In May 2017, the FASB issued ASU No. 2017-09, “ Compensation-Stock Compensation (Topic 718): Scope of Modification Accounting,” or ASU 2017-09. The amendments in this update provide guidance on determining which changes to the terms and conditions of share-based payment awards require an entity to apply modification accounting under Topic 718. The guidance is effective for public business entities for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2017. We expect to adopt ASU 2017-09 for fiscal year 2018. The amendments will be applied on a prospective basis to any award modified on or after the adoption date. Consistent with our past practice and ASU 2017-09, we recorded $724,000 for stock option modifications in 2017, including modifications related to the transition of our chief executive officer. |
Other Financial Information
Other Financial Information | 12 Months Ended |
Dec. 31, 2017 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Other Financial Information | Other Financial Information Property and Equipment Property and equipment, leasehold improvements, and related accumulated depreciation and amortization were as follows (in thousands): December 31, 2017 2016 Manufacturing, clinical and laboratory equipment $ 7,500 $ 7,325 Leasehold improvements 4,727 4,450 Office furniture and equipment 234 220 Construction in progress 17 111 12,478 12,106 Less: accumulated depreciation and amortization (10,323 ) (9,601 ) Total $ 2,155 $ 2,505 Depreciation and amortization expense was $998,000 , $1.8 million and $1.3 million for the years ended December 31, 2017 , 2016 and 2015 , respectively. Accrued Expenses Accrued expenses consist of (in thousands): December 31, 2017 2016 Accrued clinical and related costs $ 5,377 $ 2,316 Accrued compensation and related taxes 3,591 2,154 Accrued other 173 186 Total $ 9,141 $ 4,656 |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2017 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Commitments and Contingencies Operating Leases We lease office, manufacturing and research and development facilities, and equipment under various non-cancellable operating lease agreements with expiration dates into 2022. In August 2016, we entered into amendments to extend certain leases for office and research and development space to January 2019. These amended leases do not include renewal options. Our facility leases generally provide for periodic rent increases and many contain escalation clauses. In May 2017, we entered into a new lease, or the Lease, extending the term of our existing manufacturing and research and development facility lease from June 2017 to June 2022. The Lease includes a renewal option and requires the payment of our proportionate share of the facility's operating expenses. Future minimum annual obligations under all non-cancellable operating lease commitments at December 31, 2017 are as follows (in thousands): Total 2018 2019 2020 2021 2022 Thereafter Operating lease obligations $ 2,584 $ 1,073 $ 469 $ 387 $ 434 $ 221 $ — We recognize rent expense for our facility operating leases on a straight-line basis. We account for the difference between the minimum lease payments and the straight-line amount as deferred rent. Total rent, property taxes and routine maintenance expense under our operating leases was $999,000 , $933,000 and $862,000 during the years ended December 31, 2017 , 2016 and 2015 , respectively. Current and long-term deferred rent totaled $91,000 and $59,000 at December 31, 2017 and $44,000 and $99,000 at December 31, 2016 , respectively. Purchase Commitments Some of our most significant clinical trial expenditures are to investigative sites and to CROs. These agreements are cancellable by either party at any time upon written notice and do not have any cancellation penalties, but do obligate us to reimburse the providers for any time or costs incurred through the date of termination and to close out clinical sites. In the course of normal business operations, we also enter into agreements with contract service providers and others. We can elect to discontinue the work under these contracts and purchase orders with notice. These items are not included in the table below. The following table summarizes our purchase obligations at December 31, 2017 (in thousands): Payments Due by Period Total Less Than 2-3 3-5 More Than Purchase obligation $ 431 $ 431 $ — $ — $ — As of December 31, 2017 , our purchase obligations include existing purchase commitments of $288,000 with a vendor for raw materials that will be used in manufacturing on an as needed basis. During the years ended December 31, 2017 , 2016 and 2015 , we purchased $1.1 million , $943,000 and $1.2 million , respectively, of materials from this vendor. Our purchase obligations also include a purchase commitment of $143,000 with a vendor for a component used in our clinical trials that will be manufactured and delivered on an as agreed upon schedule during 2018. During the years ended December 31, 2017 , 2016 and 2015 , we purchased $228,000 , $139,000 and $106,000 , respectively, of materials from this vendor. Legal Proceedings We are not currently a party to any litigation, nor are we aware of any pending or threatened litigation against us, that we believe would materially affect our business, operating results, financial condition or cash flows. However, our industry is characterized by frequent claims and litigation including securities litigation, claims regarding patent and other intellectual property rights and claims for product liability. As a result, in the future, we may be involved in various legal proceedings from time to time. |
Fair Value
Fair Value | 12 Months Ended |
Dec. 31, 2017 | |
Fair Value Disclosures [Abstract] | |
Fair Value | Fair Value The following fair value hierarchy table presents information about each major category of our financial assets and liabilities measured at fair value on a recurring basis (in thousands): Fair Value Measurement at December 31, 2017 Fair Value Level 1 Level 2 Level 3 Assets Money market funds $ 55,245 $ 55,245 $ — $ — Fair Value Measurement at December 31, 2016 Fair Value Level 1 Level 2 Level 3 Assets Money market funds $ 57,715 $ 57,715 $ — $ — There were no liabilities measured at fair value on a recurring basis as of December 31, 2017 or 2016 . The carrying amounts of other current assets and prepaid expenses, accounts payable, accrued expenses, and other current liabilities approximate their fair values due to their short-term nature. For our money market funds, unrealized gains and losses are reported as accumulated other comprehensive income (loss), and realized gains and losses are included in interest income on the consolidated statements of operations. There were no transfers between Level 1, Level 2 or Level 3 for our assets or liabilities during the periods presented. |
Common Stock and Stock Warrants
Common Stock and Stock Warrants | 12 Months Ended |
Dec. 31, 2017 | |
Equity [Abstract] | |
Common Stock and Stock Warrants | Common Stock and Stock Warrants Certificate of Incorporation The material terms of our amended restated certificate of incorporation, which became effective as of the closing of our IPO, are as follows: Authorized Shares Our amended and restated certificate of incorporation authorizes us to issue 150,000,000 shares of stock consisting of 130,000,000 shares of common stock, par value of $0.0001 per share and 20,000,000 shares of preferred stock, par value $0.0001 per share. Dividends Subject to preferences that may be applicable to any then outstanding preferred stock, holders of common stock are entitled to receive ratably those dividends, if any, as may be declared from time to time by our board of directors out of legally available funds. Liquidation Preference In the event of our liquidation, dissolution or winding up, holders of common stock will be entitled to share ratably in the net assets legally available for distribution to stockholders after the payment of all of our debts and other liabilities and the satisfaction of any liquidation preferences that may be granted to the holders of any then outstanding shares of preferred stock. Rights and Preferences Holders of common stock have no preemptive, conversion or subscription rights, and there are no redemption or sinking fund provisions applicable to the common stock. The rights, preferences and privileges of the holders of common stock are subject to, and may be adversely affected by, the rights of the holders of shares of any series of preferred stock, which we may designate and issue in the future. Voting Rights Each holder of common stock is entitled to one vote for each share on all matters submitted to a vote of the stockholders, including the election of directors. Our amended and restated certificate of incorporation and amended and restated bylaws do not provide for cumulative voting rights. Because of this absence of cumulative voting, the holders of a majority of the shares of common stock entitled to vote in any election of directors can elect all of the directors standing for election, if they should so choose. In addition, our amended and restated certificate of incorporation also provides that our directors may be removed only for cause by the affirmative vote of the holders of at least 75% of the combined voting power of all our stockholders entitled to vote on the election of directors, voting together as a single class. Subject to supermajority votes for some matters, matters shall be decided by the affirmative vote of our stockholders having a majority in voting power of the votes cast by the stockholders present or represented and voting on such matter, provided that the holders of our common stock are not allowed to vote on any amendment to our certificate of incorporation that relates solely to the terms of one or more series of preferred stock if the holders of such affected series are entitled, either separately or together with the holders or one or more such series, to approve such amendment. The affirmative vote of the holders of at least 75% of the votes that all of our stockholders would be entitled to cast in any annual election of directors and, in some cases, the affirmative vote of a majority of minority stockholders entitled to vote in any annual election of directors are required to amend or repeal our bylaws, amend or repeal certain provisions of our certificate of incorporation, approve certain transactions with certain affiliates, or approve the sale or liquidation of the company. The vote of a majority of minority stockholders applies when an individual or entity and its affiliates or associates together own more than 50% of the voting power of our then outstanding capital stock, excluding any such person that owned 15% or more of our outstanding voting stock immediately prior to our IPO, and such a vote would require the approval of the majority of our voting stock, excluding the voting stock held by such a majority holder. Public Offerings of Common Stock We currently have an effective shelf registration statement on Form S-3 on file. The shelf registration statement permits: (i) the offering, issuance and sale by us of up to a maximum aggregate offering price of $200.0 million of common stock, preferred stock, warrants, debt securities, and/or units in one or more offerings and in any combination; (ii) sales of up to 2.5 million shares of common stock by certain selling stockholders; and (iii) the offering, issuance and sale by us of up to a maximum aggregate offering price of $75.0 million of our common stock that may be issued and sold under an “at-the-market” sales agreement, or ATM, with Cantor Fitzgerald & Co. In October 2015, we completed a follow-on public offering raising gross proceeds of $34.5 million under the shelf registration statement. The net proceeds to us from the following offering were $32.1 million , after deducting underwriting discounts and commissions of $2.1 million and estimated offering expenses of $280,000 . During the year ended December 31, 2016, we raised gross proceeds of $12.2 million pursuant to the ATM selling 1.5 million shares of our common stock at a weighted average price of $7.90 per share. The net proceeds to us from the ATM were $11.7 million after deducting underwriter commissions of $366,000 and estimated offering expenses of $173,000 . In March 2017, we completed an additional follow-on public offering under the shelf registration statement raising gross proceeds of $40.3 million . Under this follow-on public offering, we sold 10.1 million shares of our common stock at a price of $4.00 per share. The net proceeds to us from the March 2017 follow-on offering were $37.5 million , after deducting underwriting discounts and commissions of $2.4 million and offering expenses of approximately $362,000 . During the year ended December 31, 2017 , we raised gross proceeds of $600,000 pursuant to the ATM selling 100,000 shares of our common stock at a price of $6.00 per share. The net proceeds to us from the ATM were $468,000 after deducting underwriter commissions of $18,000 and estimated offering expenses of $114,000 . At December 31, 2017 , $112.5 million remains available for issuance and sale under the shelf registration statement, $62.2 million of which may be offered, issued and sold under the ATM. The shelf registration statement on Form S-3 expires on May 26, 2018. Private Placement of Common Stock In August 2016, we entered into a securities purchase agreement, or the Securities Purchase Agreement, with a newly-appointed board member pursuant to which we agreed to issue and sell an aggregate of $700,000 of our common stock in a private placement of shares that have not been registered under the Securities Act of 1933, or the Securities Act, by reason of a specific exemption from the registration provisions of the Securities Act. On August 12, 2016, we sold 118,243 shares of common stock under the Securities Purchase Agreement at a price of $5.92 per share. Common Stock Issued for Services On October 30, 2017, we entered into an independent consulting agreement, or the Consulting Agreement, with two consulting groups, or the Consultants, pursuant to which we issued 60,000 restricted shares of our common stock to the Consultants as partial consideration for investor relations services to be rendered. The restricted shares have not been registered based on a specific exemption from the registration requirements of the Securities Act. The terms of the Consulting Agreement state that we have the right to terminate the Consulting Agreement at any time, upon providing written notice. If we elect to terminate this agreement for any reason within 180 days following the effective date, each of the Consultants will be required to promptly surrender to us 40% of the number of restricted shares issued to it. In connection with this transaction, we valued 36,000 shares, or 60% of the shares, at the quoted market price of $207,000 , or $5.75 , per share, on the date of the agreement. The remaining 24,000 shares are being adjusted to fair value based on the closing price at the end of the reporting period with the expense being recorded ratably over the 180 -day period. We recognized expense in connection with these consulting shares of $256,000 during the year ended December 31, 2017 in general and administrative expenses. Warrants We issued warrants in connection with financing activities and for consulting services in years prior to our initial public offering. As of December 31, 2017 and 2016, warrants for 240,620 shares of common stock were outstanding and exercisable at an exercise price of $92.99 and expire in September 2019. Stock Reserved for Future Issuance Shares reserved for future issuance at December 31, 2017 are as follows: Number of Common stock options outstanding 6,083,482 Common stock options available for future grant: 2014 Equity Incentive Plan 125,000 Amended and Restated 2017 Inducement Equity Incentive Plan 1,850,000 Exercise of common stock warrants outstanding 240,620 Total common shares reserved for future issuance 8,299,102 |
Stock Compensation Plans
Stock Compensation Plans | 12 Months Ended |
Dec. 31, 2017 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Stock Compensation Plans | Stock Compensation Plans Equity Incentive Plans Our 2014 Equity Incentive Plan, or the 2014 Plan, became effective in April 2014 and replaced our 2012 Stock Option Plan, or the 2012 Plan, with respect to future awards. The 2014 Plan provides for the grant of stock options, restricted stock, restricted stock units, stock appreciation rights, performance awards and performance units to employees, directors, and consultants. The 2012 Plan provided for the grant of stock options, restricted stock, restricted stock units, stock purchase rights, and performance awards to employees, directors, and consultants. Option grants under our 2012 Plan were exercisable immediately and subject to repurchase rights, all of which have lapsed. Shares available for grant under the 2014 Plan include any shares remaining available or becoming available in the future under the 2012 Plan due to cancellation or forfeiture. In addition, the 2014 Plan provides for annual increases in the number of shares available for issuance thereunder beginning upon its effective date in April 2014, and on each annual anniversary, equal to the lower of: • 1,200,000 shares of our common stock; • 3% of the outstanding shares of our common stock on the second-to-the-last day prior to each anniversary date of the effectiveness date of our initial public offering; or • an amount as our board of directors may determine. Pursuant to such provisions, the number of shares available for issuance under the 2014 Plan was increased by 1,200,000 shares effective April 16, 2017. Shares available for grant under the 2014 Plan totaled 125,000 shares as of December 31, 2017 . In September 2017, our board of directors approved the 2017 Inducement Equity Incentive Plan and amended and restated the plan in November 2017, or the Inducement Plan, which has terms and conditions substantially similar to our 2014 Plan. Under the Inducement Plan, 1,850,000 shares of our common stock were reserved to be used exclusively for grants to individuals who were not previously our employees or directors, as an inducement material to the individual’s entry into employment with us within the meaning of Rule 5635(c)(4) of the Nasdaq Listing Rules. As of December 31, 2017 , we had not made any grants under the Inducement Plan. See Note 10 regarding a subsequent grant under the Inducement Plan. Option grants made under the 2014 Plan and the 2012 Plan generally vest over one or four years except for performance-based stock options. Our performance-based stock options will fully vest and become exercisable only on achievement of the performance conditions while the participant is a continuing service provider. Options generally expire ten years from the grant date or earlier in accordance with the terms of the plans and the related stock option agreement. In 2015, our board of directors (the “Board”) approved grants for performance-based stock options to certain employees and consultants under the 2014 Plan. Performance-based stock options for 647,322 shares remain outstanding at December 31, 2017 . Performance-based stock options that have not been forfeited will fully vest on the third anniversary of the grant date if (i) our VTL-308 clinical trial has achieved statistical significance in its primary efficacy endpoint and (ii) the participant is a continuing service provider through the third anniversary of the grant date (as such terms are defined in the 2014 Plan). Vesting of the performance-based stock options will not be accelerated if the performance goal is achieved in less than three years . As of December 31, 2017 and 2016 , we deemed the performance condition as being probable and are recording stock-based compensation expense over the requisite service period for all performance-based stock options held by employees. The performance-based stock options have exercise prices ranging from $4.57 to $7.69 per share, the closing sales price of our common stock on the grant dates, and expire ten years from the grant date (or earlier in accordance with the terms of the 2014 Plan and the related stock option agreement). The following table summarizes stock option activity under the 2012 and 2014 Plans: Options Weighted- Weighted- Aggregate Outstanding as of January 1, 2017 4,841,274 $ 7.78 Granted 1,405,054 $ 3.28 Exercised (2,889 ) $ 1.84 Forfeited and expired (159,957 ) $ 7.38 Outstanding as of December 31, 2017 6,083,482 $ 6.76 7.0 $ 6,709 Options vested and expected to vest as of December 31, 2017 5,980,525 $ 6.79 6.9 $ 6,530 Options exercisable as of December 31, 2017 3,562,490 $ 7.94 5.7 $ 2,491 The aggregate intrinsic value of options is calculated as the difference between the exercise price of the options and the fair value of our common stock for those shares that had exercise prices lower than the fair value of our common stock as of December 31, 2017 . The number of options vested and expected to vest is calculated as the total number of options vested plus the number of unvested options remaining after applying our estimated forfeiture rate. The following table summarizes information about stock options (in thousands): Year Ended December 31, 2017 2016 2015 Aggregate intrinsic value of options exercised $ 10 $ 39 $ 1,235 We have not capitalized any stock based-compensation into the cost of inventory nor have we recognized an income tax benefit from the exercise of any stock options as we continue to record a full valuation allowance on our deferred tax assets. Stock-based Compensation Expense The weighted-average grant date fair value of stock options granted to employees and directors during the years ended December 31, 2017 , 2016 and 2015 was $2.34 , $5.70 and $5.81 , respectively. The following are the ranges of underlying assumptions used to determine the fair value of stock options granted to employees and non-employees: Years Ended December 31, 2017 2016 2015 Employees and Directors: Risk-free interest rate 1.5% - 2.0% 1.5% - 1.7% 1.7% - 1.9% Expected dividend yield — % — % — % Expected volatility 82% - 85% 77% - 86% 73% - 92% Expected term of options (years) 5.9 - 6.1 5.9 - 6.0 5.8 - 6.0 Range of common stock value $2.75 - $5.80 $5.90 - $8.97 $4.57 - $26.71 Non-Employees: Risk-free interest rate 1.0% - 2.1% 0.5% - 1.9% 0.1% - 1.9% Expected dividend yield — % — % — % Expected volatility 66% - 84% 77% - 97% 56% - 94% Expected term of options (years) 0.5 - 4.5 0.2 - 5.5 0.3 - 6.0 Range of common stock value $2.90 - $5.95 $4.35 - $9.07 $4.04 - $25.01 The following tables summarize the allocation of stock-based compensation expense to employees and non-employees (in thousands): Years Ended December 31, 2017 2016 2015 Employees and Directors: Research and development $ 1,645 $ 1,758 $ 1,412 General and administrative 3,742 2,751 2,012 Total $ 5,387 $ 4,509 $ 3,424 Non-Employees: Research and development $ 93 $ 153 $ 490 General and administrative — 16 115 Total $ 93 $ 169 $ 605 As of December 31, 2017 , there was $6.2 million and $449,000 of total compensation cost related to unvested employee and non-employee stock option awards, respectively, not yet recognized. The fair value of the non-employee stock options is re-measured at each reporting date and, accordingly, the expense to be recognized will change, primarily with changes in the market value of our common stock. Stock-based compensation expense for employee and non-employee stock option awards is expected to be recognized over a remaining weighted-average vesting period of 1.7 years and 2.1 years, respectively. Immediately following the transition described in note 10 to the consolidated financial statements, as of January 3, 2018, there was $12.7 million and $1.3 million of total compensation cost related to unvested employee and non-employee stock option awards, respectively, not yet recognized and expected to be recognized over 2.7 years and 2.0 years, respectively. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2017 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Income Taxes Our net loss before income tax was subject to tax in the following jurisdictions for the following periods (in thousands): Year Ended December 31, 2017 2016 2015 United States $ (52,066 ) $ (40,929 ) $ (51,779 ) Foreign (12 ) (40 ) (244 ) $ (52,078 ) $ (40,969 ) $ (52,023 ) Our rate reconciliation consists of the following: Year Ended December 31, 2017 2016 2015 Federal statutory rate 35.0 % 35.0 % 35.0 % State tax (net of federal benefit) 0.0 % 0.1 % 5.8 % Effects of U.S. tax rate change (47.6 )% 0.0 % 0.0 % Federal and state tax credits 46.8 % 2.9 % 3.0 % Uncertain tax positions (5.3 )% (16.0 )% 0.0 % Stock options (1.4 )% (1.5 )% (1.0 )% Other (0.2 )% (2.5 )% 0.5 % Change in valuation allowance (27.3 )% (18.0 )% (43.3 )% Effective tax rate 0.0 % 0.0 % 0.0 % Deferred income taxes result from temporary differences between the tax basis of assets and liabilities and their reported amounts in the financial statements that will result in taxable or deductible amounts in future years. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in years in which those temporary differences are expected to be recovered or settled. As tax laws and rates change, deferred tax assets and liabilities are adjusted through income tax expense. On December 22, 2017, H.R. 1/Public Law No. 115-97 known as the Tax Cuts and Jobs Act, or the Tax Act, was signed into law. The effects of this new federal legislation are recognized upon enactment, which is the date a bill is signed into law. The Act includes numerous changes in existing tax law, including a permanent reduction in the federal corporate income tax rate from 35% to 21%. The rate reduction takes effect on January 1, 2018. As a result of the Tax Act, we have revalued our net deferred tax assets as of December 31, 2017 to reflect the rate reduction. We recorded a reduction in our net deferred tax assets of $24.8 million in the fourth quarter of 2017 related to the revaluation of our net deferred tax assets as a result of the Tax Act; however, the revaluation does not result in any additional net income tax expense as our net deferred tax assets are fully offset by the valuation allowance. Significant components of our net deferred tax assets are shown below. A valuation allowance has been established as realization of such net deferred tax assets has not met the more likely-than-not threshold requirement. If our judgment changes and it is determined that we will be able to realize these net deferred tax assets, the tax benefits relating to any reversal of the valuation allowance on the net deferred tax assets will be accounted for as a reduction to income tax expense. December 31, 2017 2016 (in thousands) Deferred tax assets: Federal and state tax credits $ 43,600 $ 6,056 Net operating loss carryforwards 35,903 58,722 Stock-based compensation 2,371 2,760 Foreign net operating loss carryforwards 169 256 Other, net 1,809 1,816 Total deferred tax assets 83,852 69,610 Less valuation allowance (83,852 ) (69,610 ) $ — $ — We have incurred net operating losses each year since inception due to our history as a development stage company with no realized revenues from our planned principal operations. These cumulative operating losses provide significant negative evidence in the determination of whether or not we will be able to realize our deferred tax assets such as our net operating losses and other favorable temporary differences. Our product candidate is in clinical trials, and there can be no assurance that it will ever be approved or that we will generate taxable income. As a result, we have maintained a full valuation allowance against the entire balance of our net deferred tax assets since the date of inception. The valuation allowance increased by $14.2 million and $7.3 million for the years ended December 31, 2017 and 2016 , respectively. In 2017, we made the decision to amend our federal tax returns to claim an orphan drug credit for the tax periods from 2013 through 2016. As a result, before consideration of any uncertain tax positions, we recorded orphan drug credit carryforwards of $34.2 million and reductions to our federal research and development credit and NOL carryforwards tax effect of $4.5 million and of $7.3 million , respectively, in 2017. As of December 31, 2017 , we had available net operating loss, or NOL, carryforwards of approximately $167.7 million and $200.8 million for federal and state income tax purposes, respectively. These state NOL carryforwards include $189.8 million in California NOLs generated in 2013 through 2017, which have been determined to be uncertain tax positions and, accordingly, are not included in our deferred tax assets. The federal and unexpired state NOLs begin to expire in 2032. In addition, as of December 31, 2017 , before consideration of any uncertain tax positions, we had federal orphan drug, federal research and development, and state research and development tax credit carryforwards of $43.8 million , $0.8 million and $3.6 million , respectively. Certain federal orphan drug tax credits and federal research and development credits begin to expire in 2033 and 2032, respectively, and the state research and development tax credits do not expire. These carryforwards and tax credits are net of the Section 382 and 383 limitations discussed below. During the year ended December 31, 2017 , $361,000 of NOLs from our Chinese subsidiary expired leaving $677,000 of NOLs from our Chinese subsidiary as of December 31, 2017 . There will be further expirations of this NOL in 2018 and beyond. Sections 382 and 383 of the Internal Revenue Code, or the IRC, limit a company’s ability to utilize certain net operating losses and tax credit carryforwards in the event of a cumulative change in ownership in excess of 50%, as defined. We experienced changes in ownership, as defined in Section 382, in February 2012 and in December 2013. As a result, the deferred tax asset associated with our federal and state net operating loss carryforwards and federal and state tax credits have been reduced based on the Section 382 limitations. The amount of the reduction in our deferred tax assets is based on the estimated amount of the NOL carryforwards and federal and state research credits we believe cannot be used based on the estimated amount of our Section 382 annual limitation. We have reduced our deferred tax assets by $15.0 million and have estimated that approximately $58.7 million and $37.8 million , respectively, of our federal and state NOLs for tax purposes cannot be used in future years as a result of this change in ownership. Additionally, we have estimated that approximately $2.2 million and $1.6 million of our federal and state research and development tax credits, respectively, cannot be used in future years due to the Section 382 limitation. We have not experienced any additional changes as defined in Section 382 through December 31, 2017 . If additional Section 382 changes occur, limitations against the utilization of net operating losses and tax credits could further impact our future cash flows, but would not impact our 2017 consolidated financial statements, due to the existence of a full valuation allowance against our deferred tax assets. The following table summarizes the activity related to our uncertain tax positions (in thousands): Year Ended 2017 2016 Balance at beginning of year $ 16,095 $ 1,422 Additions based on tax positions related to the current year 5,134 4,408 Changes for prior period tax positions 2,041 10,265 Balance at end of year $ 23,270 $ 16,095 Our uncertain tax positions relate to the apportionment of losses to California and to expenses qualifying for federal and state tax credits. In 2013, California adopted a single factor, sales, for apportioning income and losses to the state. However, we have filed our California state tax returns utilizing a multiple factor apportionment based on salaries, property and sales in the state. This position is based on a prior court ruling supporting the use of the multiple factor apportionment; however, this ruling was overturned by the California Supreme Court in December 2015. The ruling was filed with the U.S. Supreme Court, and in October 2016, the U.S. Supreme Court declined to hear the case. California has no regulations or guidance nor have there been any rulings addressing how a company with no sales should apportion losses to California. As most of our operations are in California, we intend to file our tax returns using a multiple factor apportionment until such time as California provides a ruling or guidance on such an apportionment. We do not anticipate any significant changes in the amount of uncertain tax positions as of December 31, 2017 over the next twelve months; however, should California rule or provide guidance on apportionment to companies operating in the state, we would again recognize deferred tax assets for NOL carryforwards for losses apportioned to California based on such rule or guidance. Due to the full valuation allowance that we have on our net deferred tax asset balance, there are no uncertain tax positions that would impact the effective tax rate if recognized. We are subject to U.S. federal, California and various other states and Chinese income taxes. We are no longer subject to U.S. federal or state income tax examination by tax authorities for tax returns filed for the years ended on or before December 31, 2013 and 2012, respectively. However, to the extent allowed by law, the taxing authorities may have the right to examine the period from 2003 through 2017 where NOLs or tax credits were generated and carried forward, and make adjustments to the amount of the NOL or tax credit carryforwards. We are not currently under examination by any federal or state jurisdictions. |
Selected Quarterly Data (unaudi
Selected Quarterly Data (unaudited) | 12 Months Ended |
Dec. 31, 2017 | |
Quarterly Financial Information Disclosure [Abstract] | |
Selected Quarterly Data (unaudited) | Selected Quarterly Data (unaudited) The following financial information reflects all normal recurring adjustments, which are, in the opinion of management, necessary for a fair statement of the results of the interim periods. Summarized quarterly data for 2017 and 2016 are as follows (in thousands, except per share data): For the Quarters Ended March 31 June 30 September 30 December 31 Total Year 2017: Operating expenses $ 12,687 $ 12,549 $ 12,639 $ 14,780 $ 52,655 Net loss $ (12,602 ) $ (12,407 ) $ (12,481 ) $ (14,588 ) $ (52,078 ) Basic and diluted net loss per share (1) $ (0.39 ) $ (0.29 ) $ (0.30 ) $ (0.35 ) $ (1.31 ) 2016: Operating expenses $ 9,656 $ 9,546 $ 10,239 $ 11,825 $ 41,266 Net loss $ (9,589 ) $ (9,468 ) $ (10,178 ) $ (11,734 ) $ (40,969 ) Basic and diluted net loss per share (1) $ (0.31 ) $ (0.30 ) $ (0.32 ) $ (0.37 ) $ (1.31 ) (1) Net loss per share is computed independently for each of the quarters presented. Therefore, the sum of the quarterly per share calculations will not necessarily equal the annual per share calculation. |
Chief Executive Officer Transit
Chief Executive Officer Transition | 12 Months Ended |
Dec. 31, 2017 | |
Compensation Related Costs [Abstract] | |
Chief Executive Officer Transition | Chief Executive Officer Transition On November 30, 2017, the board of directors appointed Russell J. Cox as our Chief Executive Officer with an effective start date of January 3, 2018. Mr. Cox will receive a base salary of $540,000 annually and a cash signing bonus of $330,000 . Mr. Cox is eligible each year for a target bonus of 50% of his base salary as then in effect. Following his start date, Mr. Cox received a nonstatutory stock option to purchase 1,588,832 shares of our common stock under the Inducement Plan. The option has a 10 -year term and an exercise price of $6.30 . The option grant will vest over four years with 25% of the total shares vesting one year from his start date and 1/48th of the total shares vesting monthly for the next three years subject to his continued service. Dr. Terence E. Winters stepped down from being our chief executive officer, and became a consultant on January 1, 2018. As a part of Dr. Winters’ transition and consulting agreements, Dr. Winters’ outstanding stock options were modified (i) to extend the period of exercisability for the full term of the option rather than three months from the termination of the consulting agreement, and (ii) to accelerate the vesting of Dr. Winters’ stock options, including his performance options to the extent applicable, should we terminate the consulting agreement prior to the end of its term including the renewal period. In the period ended December 31, 2017, we recorded $525,000 in severance costs and stock-based compensation expense of $674,000 associated with this stock option modification for Dr. Winters. In future periods, the unvested component of these stock options will be treated in a manner that is consistent with the other options that we have granted to consultants, as is more fully described in note 2 to the consolidated financial statements. |
Summary of Significant Accoun18
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2017 | |
Accounting Policies [Abstract] | |
Basis of Presentation and Consolidation | Basis of Presentation and Consolidation The accompanying consolidated financial statements have been prepared in conformity with United States generally accepted accounting principles, or GAAP, and include the accounts of Vital Therapies, Inc. and its wholly-owned subsidiaries located in the United Kingdom and China, both of which are currently inactive. All intercompany accounts and transactions have been eliminated in consolidation. We manage our operations as a single reportable segment for the purposes of assessing performance and making operating decisions. |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with GAAP requires us to make certain estimates and assumptions that affect the amounts reported in the consolidated financial statements and accompanying notes. Actual results could differ materially from those estimates and assumptions. |
Cash and Cash Equivalents | Cash and Cash Equivalents Cash and cash equivalents consist of cash and highly-liquid investments with original maturities of three months or less when acquired. Cash equivalents are stated at cost unless they are securities, in which case they are recorded at fair value, which approximates original cost. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments Fair value is defined as the price that would be received to sell an asset or be paid to transfer a liability in an orderly transaction between market participants on the measurement date. Accounting guidance establishes a fair value hierarchy that requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. The standard describes three levels of inputs that may be used to measure fair value: Level 1—Quoted prices in active markets for identical assets or liabilities. Our Level 1 assets consisted of money market funds for the periods presented. We had no Level 1 liabilities for the periods presented. Level 2—Observable inputs other than Level 1 prices, such as quoted prices for similar assets or liabilities, quoted prices in markets with insufficient volume or infrequent transactions (less active markets), or model-derived valuations in which all significant inputs are observable or can be derived principally from or corroborated with observable market data for substantially the full term of the assets or liabilities. We had no Level 2 assets or liabilities for the periods presented. Level 3—Unobservable inputs to the valuation methodology that are significant to the measurement of the fair value of assets or liabilities. We had no Level 3 assets or liabilities for the periods presented. Any transfers into and out of levels within the fair value hierarchy will be recognized at the end of the reporting period in which the actual event or change in circumstances that caused the transfer occurs. The carrying value of cash and cash equivalents, other current assets and prepaid expenses, accounts payable, accrued expenses, and other current liabilities approximates fair value due to the short period of time to maturity. |
Property and Equipment | Property and Equipment Property and equipment are recorded at cost and depreciated using the straight-line method over the estimated useful lives of the assets (generally three to five years). Leasehold improvements are stated at cost and depreciated on a straight-line basis over the lesser of the remaining term of the related lease or the estimated useful lives of the assets. Construction in progress is not depreciated until the underlying asset is available to be placed in service. Repairs and maintenance costs are charged to expense as incurred. |
Impairment of Long-lived Assets | Impairment of Long-Lived Assets Long-lived assets consist primarily of property and equipment. An impairment loss is recorded if and when events and circumstances indicate that assets might be impaired and the undiscounted cash flows estimated to be generated by those assets are less than the carrying amount of those assets. |
Clinical Trial Accruals | Clinical Trial Accruals As part of the process of preparing our financial statements, we are required to estimate our accrued expenses. Our clinical trial accrual process seeks to account for expenses resulting from our obligations under agreements with clinical sites, clinical research organizations, or CROs, vendors, and consultants in connection with conducting our clinical trials. We account for these expenses according to the progress of each trial as measured by subject enrollment, the timing of various aspects of the trial and if available, information from our service providers. During the course of a clinical trial, we adjust our rate of clinical expense recognition if actual results differ from our estimates. Although we do not expect our estimates to be materially different from amounts actually incurred, our understanding of the status and timing of services performed relative to the actual status and timing of services performed may vary, and could result in us reporting amounts that may later be determined to be higher or lower than our estimates for a particular period and adjustments to our research and development expenses may be necessary in future periods. |
Research and Development | Research and Development Research and development costs consist primarily of employee-related expenses, costs of contractors, clinical trial sites and CROs engaged in the development of ELAD, costs related to our investigation of the mechanism of action of ELAD, expenses associated with obtaining regulatory approvals, and the cost of acquiring and manufacturing clinical trial materials. All research and development costs are expensed as incurred. |
Stock-based Compensation | Stock-Based Compensation We measure and recognize compensation expense for all stock-based compensation for employees and directors based on the estimated fair value at the date of grant, and to consultants based on the ongoing estimated fair value. Currently, our stock-based awards consist only of stock options; however, future grants under our equity compensation plan may also consist of shares of restricted stock, restricted stock units, stock appreciation rights, performance awards and performance units. We estimate the fair value of stock options using the Black-Scholes-Merton, or BSM, option pricing model, which requires the use of estimates. We recognize stock-based compensation cost for employees and directors for ratably vesting stock options on a straight-line basis over the requisite service period of the award. For performance-based stock options to employees and directors, we record stock-based compensation expense only when the performance-based milestone is deemed probable of achievement. We utilize both quantitative and qualitative criteria to judge whether milestones are probable of achievement. The fair value of options granted to consultants is estimated using the BSM option pricing model and is re-measured at each reporting date with changes in fair value prior to vesting recognized as expense in the consolidated statements of operations across the applicable vesting period. For performance-based stock options to consultants, we record stock-based compensation expense only when the performance-based milestone is achieved unless there is a performance commitment. Effective in the first quarter of 2017, we began recognizing forfeitures as they occur (see "Recently Issued and/or Adopted Accounting Standards" below). In 2016 and earlier periods, stock-based compensation expense was recognized only for those awards that were ultimately expected to vest. Through 2016, we estimated forfeitures based on an analysis of our historical employee turnover. We revised the forfeiture estimate in subsequent periods if actual forfeitures differed from those estimates. Changes in estimated forfeitures, which were not material, impacted compensation cost in the period in which the change in estimate occurred. The BSM option pricing model requires the input of highly-subjective assumptions, including the risk-free interest rate, the expected dividend yield of our common stock, the expected volatility of the price of our common stock, and the expected term of the option. These estimates involve inherent uncertainties and the application of management’s judgment. If factors change and different assumptions are used, our stock-based compensation expense could be materially different in the future. These assumptions are estimated as follows: Risk-free Interest Rate We base the risk-free interest rate assumption on zero-coupon U.S. treasury instruments appropriate for the expected term of the stock option grants. Expected Dividend Yield We base the expected dividend yield assumption on the fact that we have never paid cash dividends and have no present intention to pay cash dividends. Consequently, we used an expected dividend yield of zero . Expected Volatility The expected stock price volatility for our common stock is estimated based on volatilities of a peer group of similar publicly-traded, biotechnology companies by taking the average historic price volatility for the peers for a period equivalent to the expected term of the stock option grants. We do not use our average historic price volatility as we have only been a publicly-traded company since April 2014. Expected Term The expected term represents the period of time that options are expected to be outstanding. As we do not have sufficient historical experience for determining the expected term of the stock option awards granted, we have determined the expected life assumption for employee and director stock options using the comparable average expected term utilizing those companies in the peer group as noted above. For consultant stock options, we estimate the expected term based on the period we expect each consultant to provide services to us. |
Leases | Leases We lease all of our office space and enter into various other operating lease agreements in conducting our business. At the inception of each lease, we evaluate the lease agreement to determine whether the lease is an operating or capital lease. Some of our lease agreements may contain renewal options, tenant improvement allowances, rent holidays or rent escalation clauses. When such items are included in a lease agreement, we record a deferred rent asset or liability equal to the difference between the rent expense and future minimum lease payments due. The rent expense related to operating leases is recognized on a straight-line basis in the statements of operations over the term of each lease. In cases where our lessor grants us leasehold improvement allowances that reduce our rent expense, we capitalize the improvements as incurred and recognize deferred rent, which is amortized over the shorter of the lease term or the expected useful life of the improvements. |
Comprehensive Income (Loss) | Comprehensive Income (Loss) Comprehensive income (loss) is defined as the change in equity during a period from transactions and other events and circumstances from non-owner sources. Accumulated other comprehensive income has been reflected as a separate component of stockholders’ equity in the accompanying consolidated balance sheets. |
Foreign Currency Translation and Transactions | Foreign Currency Translation and Transactions The functional currency of each of our subsidiaries in the United Kingdom and China, both of which are currently inactive, is the local currency. Assets and liabilities of the subsidiaries are translated at the rate of exchange at the balance sheet date. Expenses are translated at the average exchange rates in effect during the reporting period. Gains and losses resulting from foreign currency translation are included in accumulated other comprehensive income in the accompanying consolidated balance sheets. Gains and losses resulting from foreign currency transactions are included in the consolidated statements of operations, which to date have not been significant. |
Income Taxes | Income Taxes We account for income taxes under the asset and liability method, which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the consolidated financial statements. Under this method, deferred tax assets and liabilities are determined on the basis of the differences between the financial statements and tax basis of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse. The effect of a change in tax rates on deferred tax assets and liabilities is recognized in income in the period that includes the enactment date. We recognize net deferred tax assets to the extent we believe these assets are more likely than not to be realized. In making such a determination, management considers all available positive and negative evidence, including future reversals of existing taxable temporary differences, projected future taxable income, tax-planning strategies, and results of recent operations. If management determines that we would be able to realize our deferred tax assets in the future in excess of their net recorded amount, management would make an adjustment to the deferred tax asset valuation allowance, which would reduce the provision for income taxes. As of December 31, 2017 and 2016 , we maintained a full valuation allowance against our entire balance of deferred tax assets. We record uncertain tax positions on the basis of a two-step process whereby (1) management determines whether it is more likely than not that the tax positions will be sustained on the basis of the technical merits of the position and (2) for those tax positions that meet the more-likely-than-not recognition threshold, management recognizes the largest amount of tax benefit that is more than 50 percent likely to be realized upon ultimate settlement with the related tax authority. We recognize interest and penalties related to unrecognized tax benefits, if any, within income tax expense, and any accrued interest and penalties are included within the related tax liability line. |
Net Loss Per Share | Net Loss Per Share Basic net loss per share attributable to common stockholders is calculated by dividing the net loss by the weighted-average number of common shares outstanding for the period, without consideration for common stock equivalents. Diluted net loss per share attributable to common stockholders is computed by dividing the net loss by the weighted-average number of common shares and, if dilutive, common stock equivalents outstanding for the period determined using the treasury-stock method. Common stock equivalents are comprised of options outstanding under our stock option plan and warrants for the purchase of common stock. For all periods presented, there is no difference in the number of shares used to calculate basic and diluted shares outstanding due to our net loss position. |
Recently Issued and/or Adopted Accounting Pronouncements | Recently Issued and/or Adopted Accounting Pronouncements In February 2016, the Financial Accounting Standards Board, or FASB, issued Accounting Standards Update, or ASU, No. 2016-02, "Leases," or ASU 2016-02. ASU 2016-02 will require that lease arrangements longer than 12 months result in an entity recognizing an asset and liability equal to the present value of the lease payments in the statement of financial position. ASU 2016-02 is effective for annual periods beginning after December 15, 2018, and interim periods therein. This standard requires a modified retrospective transition approach for all leases existing at, or entered into after, the date of initial application, with an option to use certain transition relief. We expect to adopt ASU 2016-02 in 2019. The adoption of this guidance is expected to result in a significant increase in the total assets and liabilities reported on our consolidated balance sheets. In March 2016, the FASB issued ASU No. 2016-09, " Compensation-Stock Compensation: Improvements to Employee Share-Based Payment Accounting, " or ASU 2016-09. ASU 2016-09 changes how companies account for certain aspects of share-based payments to employees . The amendments in this update cover such areas as the recognition of excess tax benefits and deficiencies, the classification of those excess tax benefits on the statement of cash flows, an accounting policy election for forfeitures, the amount an employer can withhold to cover employee income taxes and still qualify for equity classification and the classification of those taxes paid on the statement of cash flows. Effective in the first quarter of 2017, we adopted the provisions of ASU 2016-09 to recognize forfeitures as they occur. Upon the adoption of this standard, we recorded a cumulative-effect adjustment of $50,000 to increase additional paid-in capital and accumulated deficit reversing our estimate of forfeitures as of December 31, 2016. In November 2016, the FASB issued ASU No. 2016-18, " Statement of Cash Flows: Restricted Cash ," or ASU 2016-18. ASU 2016-18 provides guidance on the classification of restricted cash in the statements of cash flows. This ASU will require that our statements of cash flows explain the change during the period in the total of cash, cash equivalents and amounts generally described as restricted cash or restricted cash equivalents. The amendments in this ASU are effective for interim periods beginning after December 15, 2017, with early adoption permitted. We will adopt this standard in 2018, and ASU 2016-18 will not have a significant impact on our consolidated financial statements at the time of adoption. In May 2017, the FASB issued ASU No. 2017-09, “ Compensation-Stock Compensation (Topic 718): Scope of Modification Accounting,” or ASU 2017-09. The amendments in this update provide guidance on determining which changes to the terms and conditions of share-based payment awards require an entity to apply modification accounting under Topic 718. The guidance is effective for public business entities for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2017. We expect to adopt ASU 2017-09 for fiscal year 2018. The amendments will be applied on a prospective basis to any award modified on or after the adoption date. Consistent with our past practice and ASU 2017-09, we recorded $724,000 for stock option modifications in 2017, including modifications related to the transition of our chief executive officer. |
Summary of Significant Accoun19
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Accounting Policies [Abstract] | |
Schedule of Potentially Dilutive Securities Not Included in Calculation of Diluted Net Loss per Share | Potentially dilutive securities not included in the calculation of diluted net loss per share attributable to common stockholders because to do so would be anti-dilutive are as follows: As of December 31, 2017 2016 2015 Options to purchase common stock 6,083,482 4,841,274 3,716,520 Warrants to purchase common stock 240,620 240,620 250,646 |
Other Financial Information (Ta
Other Financial Information (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Schedule of Property and Equipment, Leasehold Improvements, and Related Accumulated Depreciation and Amortization | Property and equipment, leasehold improvements, and related accumulated depreciation and amortization were as follows (in thousands): December 31, 2017 2016 Manufacturing, clinical and laboratory equipment $ 7,500 $ 7,325 Leasehold improvements 4,727 4,450 Office furniture and equipment 234 220 Construction in progress 17 111 12,478 12,106 Less: accumulated depreciation and amortization (10,323 ) (9,601 ) Total $ 2,155 $ 2,505 |
Schedule of Accrued Expenses | Accrued expenses consist of (in thousands): December 31, 2017 2016 Accrued clinical and related costs $ 5,377 $ 2,316 Accrued compensation and related taxes 3,591 2,154 Accrued other 173 186 Total $ 9,141 $ 4,656 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Commitments and Contingencies Disclosure [Abstract] | |
Future Minimum Annual Obligations Under All Non-Cancellable Operating Lease Commitments | Future minimum annual obligations under all non-cancellable operating lease commitments at December 31, 2017 are as follows (in thousands): Total 2018 2019 2020 2021 2022 Thereafter Operating lease obligations $ 2,584 $ 1,073 $ 469 $ 387 $ 434 $ 221 $ — |
Summaries of Purchase Obligations | The following table summarizes our purchase obligations at December 31, 2017 (in thousands): Payments Due by Period Total Less Than 2-3 3-5 More Than Purchase obligation $ 431 $ 431 $ — $ — $ — |
Fair Value (Tables)
Fair Value (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Fair Value Disclosures [Abstract] | |
Schedule of Financial Assets and Liabilities Measured at Fair Value on Recurring Basis | The following fair value hierarchy table presents information about each major category of our financial assets and liabilities measured at fair value on a recurring basis (in thousands): Fair Value Measurement at December 31, 2017 Fair Value Level 1 Level 2 Level 3 Assets Money market funds $ 55,245 $ 55,245 $ — $ — Fair Value Measurement at December 31, 2016 Fair Value Level 1 Level 2 Level 3 Assets Money market funds $ 57,715 $ 57,715 $ — $ — |
Common Stock and Stock Warran23
Common Stock and Stock Warrants (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Equity [Abstract] | |
Shares Reserved for Future Issuance | Shares reserved for future issuance at December 31, 2017 are as follows: Number of Common stock options outstanding 6,083,482 Common stock options available for future grant: 2014 Equity Incentive Plan 125,000 Amended and Restated 2017 Inducement Equity Incentive Plan 1,850,000 Exercise of common stock warrants outstanding 240,620 Total common shares reserved for future issuance 8,299,102 |
Stock Compensation Plans (Table
Stock Compensation Plans (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Summary of Stock Option Activity | The following table summarizes stock option activity under the 2012 and 2014 Plans: Options Weighted- Weighted- Aggregate Outstanding as of January 1, 2017 4,841,274 $ 7.78 Granted 1,405,054 $ 3.28 Exercised (2,889 ) $ 1.84 Forfeited and expired (159,957 ) $ 7.38 Outstanding as of December 31, 2017 6,083,482 $ 6.76 7.0 $ 6,709 Options vested and expected to vest as of December 31, 2017 5,980,525 $ 6.79 6.9 $ 6,530 Options exercisable as of December 31, 2017 3,562,490 $ 7.94 5.7 $ 2,491 |
Schedule of Stock Options | The following table summarizes information about stock options (in thousands): Year Ended December 31, 2017 2016 2015 Aggregate intrinsic value of options exercised $ 10 $ 39 $ 1,235 |
Ranges of Underlying Assumptions Used to Determine Fair Value of Stock Options Granted to Employees and Non-Employees | The following are the ranges of underlying assumptions used to determine the fair value of stock options granted to employees and non-employees: Years Ended December 31, 2017 2016 2015 Employees and Directors: Risk-free interest rate 1.5% - 2.0% 1.5% - 1.7% 1.7% - 1.9% Expected dividend yield — % — % — % Expected volatility 82% - 85% 77% - 86% 73% - 92% Expected term of options (years) 5.9 - 6.1 5.9 - 6.0 5.8 - 6.0 Range of common stock value $2.75 - $5.80 $5.90 - $8.97 $4.57 - $26.71 Non-Employees: Risk-free interest rate 1.0% - 2.1% 0.5% - 1.9% 0.1% - 1.9% Expected dividend yield — % — % — % Expected volatility 66% - 84% 77% - 97% 56% - 94% Expected term of options (years) 0.5 - 4.5 0.2 - 5.5 0.3 - 6.0 Range of common stock value $2.90 - $5.95 $4.35 - $9.07 $4.04 - $25.01 |
Schedule of Stock-based Compensation Expense to Employees and Non-Employees | The following tables summarize the allocation of stock-based compensation expense to employees and non-employees (in thousands): Years Ended December 31, 2017 2016 2015 Employees and Directors: Research and development $ 1,645 $ 1,758 $ 1,412 General and administrative 3,742 2,751 2,012 Total $ 5,387 $ 4,509 $ 3,424 Non-Employees: Research and development $ 93 $ 153 $ 490 General and administrative — 16 115 Total $ 93 $ 169 $ 605 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Income Tax Disclosure [Abstract] | |
Net Loss before Income Tax Based on Jurisdictions | Our net loss before income tax was subject to tax in the following jurisdictions for the following periods (in thousands): Year Ended December 31, 2017 2016 2015 United States $ (52,066 ) $ (40,929 ) $ (51,779 ) Foreign (12 ) (40 ) (244 ) $ (52,078 ) $ (40,969 ) $ (52,023 ) |
Income Tax Rate Reconciliation | Our rate reconciliation consists of the following: Year Ended December 31, 2017 2016 2015 Federal statutory rate 35.0 % 35.0 % 35.0 % State tax (net of federal benefit) 0.0 % 0.1 % 5.8 % Effects of U.S. tax rate change (47.6 )% 0.0 % 0.0 % Federal and state tax credits 46.8 % 2.9 % 3.0 % Uncertain tax positions (5.3 )% (16.0 )% 0.0 % Stock options (1.4 )% (1.5 )% (1.0 )% Other (0.2 )% (2.5 )% 0.5 % Change in valuation allowance (27.3 )% (18.0 )% (43.3 )% Effective tax rate 0.0 % 0.0 % 0.0 % |
Deferred Tax Assets | December 31, 2017 2016 (in thousands) Deferred tax assets: Federal and state tax credits $ 43,600 $ 6,056 Net operating loss carryforwards 35,903 58,722 Stock-based compensation 2,371 2,760 Foreign net operating loss carryforwards 169 256 Other, net 1,809 1,816 Total deferred tax assets 83,852 69,610 Less valuation allowance (83,852 ) (69,610 ) $ — $ — |
Unrecognized Tax Benefit | The following table summarizes the activity related to our uncertain tax positions (in thousands): Year Ended 2017 2016 Balance at beginning of year $ 16,095 $ 1,422 Additions based on tax positions related to the current year 5,134 4,408 Changes for prior period tax positions 2,041 10,265 Balance at end of year $ 23,270 $ 16,095 |
Selected Quarterly Data (Tables
Selected Quarterly Data (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Quarterly Financial Information Disclosure [Abstract] | |
Summarized Quarterly Information | Summarized quarterly data for 2017 and 2016 are as follows (in thousands, except per share data): For the Quarters Ended March 31 June 30 September 30 December 31 Total Year 2017: Operating expenses $ 12,687 $ 12,549 $ 12,639 $ 14,780 $ 52,655 Net loss $ (12,602 ) $ (12,407 ) $ (12,481 ) $ (14,588 ) $ (52,078 ) Basic and diluted net loss per share (1) $ (0.39 ) $ (0.29 ) $ (0.30 ) $ (0.35 ) $ (1.31 ) 2016: Operating expenses $ 9,656 $ 9,546 $ 10,239 $ 11,825 $ 41,266 Net loss $ (9,589 ) $ (9,468 ) $ (10,178 ) $ (11,734 ) $ (40,969 ) Basic and diluted net loss per share (1) $ (0.31 ) $ (0.30 ) $ (0.32 ) $ (0.37 ) $ (1.31 ) (1) Net loss per share is computed independently for each of the quarters presented. Therefore, the sum of the quarterly per share calculations will not necessarily equal the annual per share calculation. |
Description of Business and B27
Description of Business and Basis of Financial Statements Description of Business and Basis of Financial Statements - Additional Details (Detail) - USD ($) $ in Thousands | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 |
Accounting Policies [Abstract] | ||||
Accumulated deficit | $ 295,953 | $ 243,825 | ||
Cash and cash equivalents | 56,901 | $ 59,991 | $ 83,416 | $ 102,238 |
Amount available for issuance | 112,500 | |||
At-The-Market Sales Agreement | ||||
Class of Stock [Line Items] | ||||
Maximum aggregate offering price | $ 62,200 |
Summary of Significant Accoun28
Summary of Significant Accounting Policies - Additional Information (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Accounting Policies [Abstract] | |||
Cash equivalents, highly-liquid investments maturity (or less) | 3 months | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Expected dividend yield | 0.00% | 0.00% | 0.00% |
Minimum | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Property and equipment, estimated useful lives | 3 years | ||
Maximum | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Property and equipment, estimated useful lives | 5 years | ||
ASU 2016-09, Forfeiture Rate Component | Additional Paid-In Capital | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Cumulative effect of new accounting principle | $ 50 | ||
ASU 2016-09, Forfeiture Rate Component | Accumulated Deficit | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Cumulative effect of new accounting principle | $ (50) | ||
ASU 2017-09 | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Stock option modifications | $ 724 |
Summary of Significant Accoun29
Summary of Significant Accounting Policies - Schedule of Potentially Dilutive Securities Not Included in Calculation of Diluted Net Loss per Share (Detail) - shares | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Options to purchase common stock | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Options and warrants to purchase common stock (in shares) | 6,083,482 | 4,841,274 | 3,716,520 |
Warrants to purchase common stock | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Options and warrants to purchase common stock (in shares) | 240,620 | 240,620 | 250,646 |
Other Financial Information - S
Other Financial Information - Schedule of Property and Equipment, Leasehold Improvements, and Related Accumulated Depreciation and Amortization (Detail) - USD ($) $ in Thousands | Dec. 31, 2017 | Dec. 31, 2016 |
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 12,478 | $ 12,106 |
Less: accumulated depreciation and amortization | (10,323) | (9,601) |
Property and equipment, net | 2,155 | 2,505 |
Manufacturing, clinical and laboratory equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 7,500 | 7,325 |
Leasehold improvements | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 4,727 | 4,450 |
Office furniture and equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 234 | 220 |
Construction in progress | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 17 | $ 111 |
Other Financial Information - A
Other Financial Information - Additional Information (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |||
Depreciation and amortization expense | $ 998 | $ 1,800 | $ 1,300 |
Other Financial Information -32
Other Financial Information - Schedule of Accrued Expenses (Detail) - USD ($) $ in Thousands | Dec. 31, 2017 | Dec. 31, 2016 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Accrued clinical and related costs | $ 5,377 | $ 2,316 |
Accrued compensation and related taxes | 3,591 | 2,154 |
Accrued other | 173 | 186 |
Total | $ 9,141 | $ 4,656 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Operating Leased Assets [Line Items] | |||
Total rent expense under operating leases | $ 999 | $ 933 | $ 862 |
Current deferred rent | 91 | 44 | |
Noncurrent deferred rent | 59 | 99 | |
Purchase obligations | 431 | ||
Annual purchases, raw materials | 1,100 | 943 | 1,200 |
Annual purchases | 228 | $ 139 | $ 106 |
Clinical Trial Component | |||
Operating Leased Assets [Line Items] | |||
Purchase obligations | 143 | ||
Raw Materials | |||
Operating Leased Assets [Line Items] | |||
Purchase obligations | $ 288 |
Commitments and Contingencies34
Commitments and Contingencies - Future Minimum Annual Obligations Under All Non-Cancellable Operating Lease Commitments (Detail) $ in Thousands | Dec. 31, 2017USD ($) |
Commitments and Contingencies Disclosure [Abstract] | |
Total operating lease obligations | $ 2,584 |
2,018 | 1,073 |
2,019 | 469 |
2,020 | 387 |
2,021 | 434 |
2,022 | 221 |
Thereafter | $ 0 |
Commitments and Contingencies35
Commitments and Contingencies - Summaries of Purchase Obligations (Detail) $ in Thousands | Dec. 31, 2017USD ($) |
Commitments and Contingencies Disclosure [Abstract] | |
Total purchase obligation | $ 431 |
Payments Due, Less Than 1 Year | 431 |
Payments Due, 2-3 Years | 0 |
Payments Due, 3-5 Years | 0 |
Payments Due, More Than 5 Years | $ 0 |
Fair Value - Schedule of Financ
Fair Value - Schedule of Financial Assets and Liabilities Measured at Fair Value on Recurring Basis (Detail) - Fair Value, Measurements, Recurring - Money Market Funds - USD ($) $ in Thousands | Dec. 31, 2017 | Dec. 31, 2016 |
Assets | ||
Assets | $ 55,245 | $ 57,715 |
Level 1 | ||
Assets | ||
Assets | 55,245 | 57,715 |
Level 2 | ||
Assets | ||
Assets | 0 | 0 |
Level 3 | ||
Assets | ||
Assets | $ 0 | $ 0 |
Fair Value - Additional Informa
Fair Value - Additional Information (Detail) - USD ($) | Dec. 31, 2017 | Dec. 31, 2016 |
Fair Value Disclosures [Abstract] | ||
Liabilities, recurring | $ 0 | $ 0 |
Common Stock and Stock Warran38
Common Stock and Stock Warrants - Additional Information (Detail) | Oct. 30, 2017USD ($)$ / sharesshares | Aug. 12, 2016$ / sharesshares | Mar. 31, 2017USD ($)$ / sharesshares | Aug. 31, 2016USD ($) | Oct. 31, 2015USD ($) | Dec. 31, 2017USD ($)vote$ / sharesshares | Dec. 31, 2016USD ($)$ / sharesshares | Dec. 31, 2015USD ($) | May 31, 2015USD ($)shares |
Class of Stock [Line Items] | |||||||||
Shares authorized at incorporation | shares | 150,000,000 | ||||||||
Common stock, shares authorized | shares | 130,000,000 | 130,000,000 | |||||||
Common stock, par value (usd per share) | $ / shares | $ 0.0001 | $ 0.0001 | |||||||
Preferred stock, shares authorized | shares | 20,000,000 | 20,000,000 | |||||||
Preferred stock, par value (usd per share) | $ / shares | $ 0.0001 | $ 0.0001 | |||||||
Common stock, number of votes per share | vote | 1 | ||||||||
Minimum percent of combined voting power | 75.00% | ||||||||
Common stock, voting rights, majority of minority ownership percentage | 50.00% | ||||||||
Common stock, voting rights, majority of minority ownership percentage, threshold for excluding percentage | 15.00% | ||||||||
Maximum aggregate offering price of securities under shelf registration | $ 200,000,000 | ||||||||
Maximum number of shares to be sold under shelf registration | shares | 2,500,000 | ||||||||
Maximum aggregate offering price under the shelf registration | $ 75,000,000 | ||||||||
Value of stock issued during the period | $ 34,500,000 | $ 37,940,000 | $ 12,355,000 | $ 32,150,000 | |||||
Proceeds from issuance of common stock, net of issuance costs | 32,100,000 | 37,998,000 | 12,355,000 | 32,189,000 | |||||
Payments for commissions | 2,100,000 | 0 | |||||||
Total costs | $ 280,000 | 19,000 | 13,000 | 283,000 | |||||
Amount available for issuance | 112,500,000 | ||||||||
Common stock issued for services | 256,000 | ||||||||
Common stock issued for services | $ 256,000 | $ 0 | $ 0 | ||||||
Number of warrants outstanding (in shares) | shares | 240,620 | ||||||||
Exercise price (usd per share) | $ / shares | $ 92.99 | $ 92.99 | |||||||
At-The-Market Sales Agreement | |||||||||
Class of Stock [Line Items] | |||||||||
Maximum aggregate offering price | $ 62,200,000 | ||||||||
Value of stock issued during the period | 600,000 | $ 12,200,000 | |||||||
Proceeds from issuance of common stock, net of issuance costs | 468,000 | 11,700,000 | |||||||
Payments for commissions | 366,000 | ||||||||
Total costs | $ 114,000 | $ 173,000 | |||||||
Common stock sold (in shares) | shares | 100,000 | 1,500,000 | |||||||
Additional Follow-On Offering | |||||||||
Class of Stock [Line Items] | |||||||||
Value of stock issued during the period | $ 40,300,000 | ||||||||
Proceeds from issuance of common stock, net of issuance costs | 37,500,000 | ||||||||
Payments for commissions | 2,400,000 | ||||||||
Total costs | $ 362,000 | ||||||||
Common stock sold (in shares) | shares | 10,100,000 | ||||||||
Common stock sold, price (usd per share) | $ / shares | $ 4 | ||||||||
Private Placement | |||||||||
Class of Stock [Line Items] | |||||||||
Common stock sold (in shares) | shares | 118,243 | ||||||||
Common stock sold, price (usd per share) | $ / shares | $ 5.92 | ||||||||
Proceeds from issuance of private placement | $ 700,000 | ||||||||
Weighted Average | At-The-Market Sales Agreement | |||||||||
Class of Stock [Line Items] | |||||||||
Common stock sold, price (usd per share) | $ / shares | $ 6 | $ 7.90 | |||||||
Restricted Stock | |||||||||
Class of Stock [Line Items] | |||||||||
Common stock issued for services (in shares) | shares | 60,000 | ||||||||
Percent of shares to be surrendered at termination | 40.00% | ||||||||
Shares quoted at market price (in shares) | shares | 36,000 | ||||||||
Percent of shares quoted at market price | 60.00% | ||||||||
Common stock issued for services | $ 207,000 | ||||||||
Market price of shares (in usd per share) | $ / shares | $ 5.75 | ||||||||
Shares adjusted to fair value (in shares) | shares | 24,000 | ||||||||
Expense recognition period | 180 days | ||||||||
Warrants to purchase common stock | |||||||||
Class of Stock [Line Items] | |||||||||
Number of warrants outstanding (in shares) | shares | 240,620 |
Common Stock and Stock Warran39
Common Stock and Stock Warrants - Shares Reserved for Future Issuance (Detail) | Dec. 31, 2017shares |
Class of Stock [Line Items] | |
Total common shares reserved for future issuance (in shares) | 8,299,102 |
Common stock options outstanding | |
Class of Stock [Line Items] | |
Total common shares reserved for future issuance (in shares) | 6,083,482 |
Exercise of common stock warrants outstanding | |
Class of Stock [Line Items] | |
Total common shares reserved for future issuance (in shares) | 240,620 |
2014 Equity Incentive Plan | Common stock options available for future grant: | |
Class of Stock [Line Items] | |
Total common shares reserved for future issuance (in shares) | 125,000 |
Amended and Restated 2017 Inducement Equity Incentive Plan | Common stock options available for future grant: | |
Class of Stock [Line Items] | |
Total common shares reserved for future issuance (in shares) | 1,850,000 |
Stock Compensation Plans - Addi
Stock Compensation Plans - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Thousands | Jan. 03, 2018 | Apr. 16, 2017 | Oct. 31, 2015 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | Nov. 30, 2017 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Options expiration period | 10 years | ||||||
Options outstanding (in shares) | 6,083,482 | 4,841,274 | |||||
Weighted-average grant date fair value of stock options granted to employees and directors (usd per share) | $ 2.34 | $ 5.70 | $ 5.81 | ||||
Non-Employees | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Compensation cost related to unvested stock option awards | $ 449 | ||||||
2014 Equity Incentive Plan | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Shares of common stock for annual increase in shares available for issuance (in shares) | 1,200,000 | ||||||
Percent of outstanding shares of common stock prior to each anniversary | 3.00% | ||||||
Number of additional shares authorized (in shares) | 1,200,000 | ||||||
Aggregate number of shares outstanding or available for grant under the plan (in shares) | 125,000 | ||||||
2014 Equity Incentive Plan | Performance-Based Employee Stock Options | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Options expiration period | 10 years | ||||||
Options outstanding (in shares) | 647,322 | ||||||
Option vesting under Equity Incentive Plans, term | 3 years | ||||||
Options exercise price, minimum (usd per share) | $ 4.57 | ||||||
Options exercise price, maximum (usd per share) | $ 7.69 | ||||||
Amended and Restated 2017 Inducement Equity Incentive Plan | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Aggregate number of shares outstanding or available for grant under the plan (in shares) | 1,850,000 | ||||||
Employee | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Compensation cost related to unvested stock option awards | $ 6,200 | ||||||
Remaining weighted-average vesting period | 1 year 8 months 12 days | ||||||
Non-Employees | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Remaining weighted-average vesting period | 2 years 1 month 6 days | ||||||
Subsequent Event | Non-Employees | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Compensation cost related to unvested stock option awards | $ 1,300 | ||||||
Subsequent Event | Employee | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Compensation cost related to unvested stock option awards | $ 12,700 | ||||||
Remaining weighted-average vesting period | 2 years 8 months 12 days | ||||||
Subsequent Event | Non-Employees | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Remaining weighted-average vesting period | 2 years | ||||||
Minimum | 2014 Plan and 2012 Plan | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Option vesting under Equity Incentive Plans, term | 1 year | ||||||
Maximum | 2014 Plan and 2012 Plan | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Option vesting under Equity Incentive Plans, term | 4 years |
Stock Compensation Plans - Summ
Stock Compensation Plans - Summary of Stock Option Activity (Detail) - USD ($) $ / shares in Units, $ in Thousands | Dec. 31, 2016 | Dec. 31, 2017 |
Options | ||
Options, Outstanding, Beginning balance (shares) | 4,841,274 | |
Granted (in shares) | 1,405,054 | |
Exercised (shares) | (2,889) | |
Forfeited and expired (shares) | (159,957) | |
Options, Outstanding, Ending balance (shares) | 4,841,274 | 6,083,482 |
Options vested and expected to vest, Ending balance (shares) | 5,980,525 | |
Options exercisable, Ending balance (shares) | 3,562,490 | |
Weighted- Average Exercise Price | ||
Outstanding, Weighted-Average Exercise Price, Beginning balance (usd per share) | $ 7.78 | |
Granted, Weighted-Average Exercise Price (usd per share) | 3.28 | |
Exercised, Weighted-Average Exercise Price (usd per share) | 1.84 | |
Forfeited, Weighted-Average Exercise Price (usd per share) | 7.38 | |
Outstanding, Weighted-Average Exercise Price, Ending balance (usd per share) | $ 7.78 | 6.76 |
Options vested and expected to vest, Weighted-Average Exercise Price, Ending balance (usd per share) | 6.79 | |
Options exercisable, Weighted-Average Exercise Price, Ending balance (usd per share) | $ 7.94 | |
Weighted- Average Remaining Contractual Term (Years) | ||
Outstanding, Weighted-Average Remaining Contractual Term (Years), Ending balance | 7 years | |
Options vested and expected to vest , Weighted-Average Remaining Contractual Term (Years), Ending balance | 6 years 11 months 1 day | |
Options exercisable, Weighted-Average Remaining Contractual Term (Years), Ending balance | 5 years 8 months 12 days | |
Outstanding, Aggregate Intrinsic Value, Ending balance | $ 6,709 | |
Options vested and expected to vest , Aggregate Intrinsic Value, Ending balance | 6,530 | |
Options exercisable, Aggregate Intrinsic Value, Ending balance | $ 2,491 |
Stock Compensation Plans - Sche
Stock Compensation Plans - Schedule of Stock Options (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |||
Aggregate intrinsic value of options exercised | $ 10 | $ 39 | $ 1,235 |
Stock Compensation Plans - Rang
Stock Compensation Plans - Ranges of Underlying Assumptions Used to Determine Fair Value of Stock Options Granted to Employees and Non-Employees (Detail) - $ / shares | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Employees and Directors | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Risk-free interest rate, minimum | 1.50% | 1.50% | 1.70% |
Risk-free interest rate, maximum | 2.00% | 1.70% | 1.90% |
Expected dividend yield | 0.00% | 0.00% | 0.00% |
Expected volatility, minimum | 82.00% | 77.00% | 73.00% |
Expected volatility, maximum | 85.00% | 86.00% | 92.00% |
Employees and Directors | Minimum | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Expected term of options (years) | 5 years 10 months 24 days | 5 years 10 months 24 days | 5 years 9 months 18 days |
Range of common stock value (usd per share) | $ 2.75 | $ 5.90 | $ 4.57 |
Employees and Directors | Maximum | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Expected term of options (years) | 6 years 1 month 6 days | 6 years | 6 years |
Range of common stock value (usd per share) | $ 5.80 | $ 8.97 | $ 26.71 |
Non-Employees | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Risk-free interest rate, minimum | 1.00% | 0.45% | 0.10% |
Risk-free interest rate, maximum | 2.10% | 1.93% | 1.93% |
Expected dividend yield | 0.00% | 0.00% | 0.00% |
Expected volatility, minimum | 66.00% | 77.00% | 56.00% |
Expected volatility, maximum | 84.00% | 97.00% | 94.00% |
Non-Employees | Minimum | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Expected term of options (years) | 6 months | 2 months 12 days | 3 months 18 days |
Range of common stock value (usd per share) | $ 2.90 | $ 4.35 | $ 4.04 |
Non-Employees | Maximum | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Expected term of options (years) | 4 years 6 months | 5 years 6 months | 6 years |
Range of common stock value (usd per share) | $ 5.95 | $ 9.07 | $ 25.01 |
Stock Compensation Plans - Sc44
Stock Compensation Plans - Schedule of Stock-based Compensation Expense to Employees and Non-Employees (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Stock-based compensation expense | $ 5,480 | $ 4,678 | $ 4,029 |
Employees and Directors | |||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Stock-based compensation expense | 5,387 | 4,509 | 3,424 |
Non-Employees | |||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Stock-based compensation expense | 93 | 169 | 605 |
Research and Development | Employees and Directors | |||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Stock-based compensation expense | 1,645 | 1,758 | 1,412 |
Research and Development | Non-Employees | |||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Stock-based compensation expense | 93 | 153 | 490 |
General and Administrative | Employees and Directors | |||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Stock-based compensation expense | 3,742 | 2,751 | 2,012 |
General and Administrative | Non-Employees | |||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Stock-based compensation expense | $ 0 | $ 16 | $ 115 |
Income Taxes - Net Loss before
Income Taxes - Net Loss before Income Tax Based on Jurisdictions (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Income Tax Disclosure [Abstract] | |||
United States | $ (52,066) | $ (40,929) | $ (51,779) |
Foreign | (12) | (40) | (244) |
Net loss before income tax | $ (52,078) | $ (40,969) | $ (52,023) |
Income Taxes - Income Tax Rate
Income Taxes - Income Tax Rate Reconciliation (Detail) | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Income Tax Disclosure [Abstract] | |||
Federal statutory rate | 35.00% | 35.00% | 35.00% |
State tax (net of federal benefit) | 0.00% | 0.10% | 5.80% |
Effects of U.S. tax rate change | (47.60%) | 0.00% | 0.00% |
Federal and state tax credits | 46.80% | 2.90% | 3.00% |
Uncertain tax positions | (5.30%) | (16.00%) | 0.00% |
Stock options | (1.40%) | (1.50%) | (1.00%) |
Other | (0.20%) | (2.50%) | 0.50% |
Change in valuation allowance | (27.30%) | (18.00%) | (43.30%) |
Effective tax rate | 0.00% | 0.00% | 0.00% |
Income Taxes - Deferred Tax Ass
Income Taxes - Deferred Tax Assets (Detail) - USD ($) $ in Thousands | Dec. 31, 2017 | Dec. 31, 2016 |
Deferred tax assets: | ||
Federal and state tax credits | $ 43,600 | $ 6,056 |
Net operating loss carryforwards | 35,903 | 58,722 |
Stock-based compensation | 2,371 | 2,760 |
Foreign net operating loss carryforwards | 169 | 256 |
Other, net | 1,809 | 1,816 |
Total deferred tax assets | 83,852 | 69,610 |
Less valuation allowance | (83,852) | (69,610) |
Total deferred tax assets net of valuation allowance | $ 0 | $ 0 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Detail) - USD ($) | 3 Months Ended | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2017 | Dec. 31, 2016 | |
Operating Loss Carryforwards [Line Items] | |||
Reduction in deferred tax assets related to the Tax Act and Jobs Act of 2017 | $ 24,800,000 | ||
Valuation allowance increase | $ 14,200,000 | $ 7,300,000 | |
Deferred tax assets | 83,852,000 | 83,852,000 | $ 69,610,000 |
State Administration of Taxation, China | |||
Operating Loss Carryforwards [Line Items] | |||
Net operating loss carryforwards | 677,000 | 677,000 | |
Orphan Drug Tax Credit Carryforward | |||
Operating Loss Carryforwards [Line Items] | |||
Tax credit carry forward | 43,800,000 | 43,800,000 | |
Federal | |||
Operating Loss Carryforwards [Line Items] | |||
Net operating loss carryforwards | 167,700,000 | 167,700,000 | |
Federal | Research and Development Tax Credit Carryforward | |||
Operating Loss Carryforwards [Line Items] | |||
Tax credit carry forward | 800,000 | 800,000 | |
State | |||
Operating Loss Carryforwards [Line Items] | |||
Net operating loss carryforwards | 200,800,000 | 200,800,000 | |
State | California Franchise Tax Board | |||
Operating Loss Carryforwards [Line Items] | |||
Net operating loss carryforwards | 189,800,000 | 189,800,000 | |
State | Research and Development Tax Credit Carryforward | |||
Operating Loss Carryforwards [Line Items] | |||
Tax credit carry forward | 3,600,000 | 3,600,000 | |
Scenario adjustment | |||
Operating Loss Carryforwards [Line Items] | |||
Net operating loss carryforwards | (7,300,000) | (7,300,000) | |
Deferred tax assets | 15,000,000 | 15,000,000 | |
Scenario adjustment | State Administration of Taxation, China | |||
Operating Loss Carryforwards [Line Items] | |||
Net operating loss carryforwards | 361,000 | 361,000 | |
Scenario adjustment | Research and Development Tax Credit Carryforward | |||
Operating Loss Carryforwards [Line Items] | |||
Tax credit carry forward | (4,500,000) | (4,500,000) | |
Scenario adjustment | Federal | |||
Operating Loss Carryforwards [Line Items] | |||
Net operating loss carryforwards | 58,700,000 | 58,700,000 | |
Scenario adjustment | Federal | Research and Development Tax Credit Carryforward | |||
Operating Loss Carryforwards [Line Items] | |||
Tax credit carry forward | 2,200,000 | 2,200,000 | |
Scenario adjustment | State | |||
Operating Loss Carryforwards [Line Items] | |||
Net operating loss carryforwards | 37,800,000 | 37,800,000 | |
Scenario adjustment | State | Research and Development Tax Credit Carryforward | |||
Operating Loss Carryforwards [Line Items] | |||
Tax credit carry forward | 1,600,000 | 1,600,000 | |
Tax Year 2013 through Tax Year 2016 | Orphan Drug Tax Credit Carryforward | |||
Operating Loss Carryforwards [Line Items] | |||
Tax credit carry forward | $ 34,200,000 | $ 34,200,000 |
Income Taxes - Unrecognized Tax
Income Taxes - Unrecognized Tax Benefit (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Reconciliation of Unrecognized Tax Benefits, Excluding Amounts Pertaining to Examined Tax Returns [Roll Forward] | ||
Balance at beginning of year | $ 16,095 | $ 1,422 |
Additions based on tax positions related to the current year | 5,134 | 4,408 |
Changes for prior period tax positions | 2,041 | 10,265 |
Balance at end of year | $ 23,270 | $ 16,095 |
Selected Quarterly Data - Summa
Selected Quarterly Data - Summarized Quarterly Information (Detail) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2017 | Sep. 30, 2017 | Jun. 30, 2017 | Mar. 31, 2017 | Dec. 31, 2016 | Sep. 30, 2016 | Jun. 30, 2016 | Mar. 31, 2016 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Quarterly Financial Information Disclosure [Abstract] | |||||||||||
Operating expenses | $ 14,780 | $ 12,639 | $ 12,549 | $ 12,687 | $ 11,825 | $ 10,239 | $ 9,546 | $ 9,656 | $ 52,655 | $ 41,266 | $ 52,120 |
Net loss | $ (14,588) | $ (12,481) | $ (12,407) | $ (12,602) | $ (11,734) | $ (10,178) | $ (9,468) | $ (9,589) | $ (52,078) | $ (40,969) | |
Basic and diluted net loss per share (usd per share) | $ (0.35) | $ (0.30) | $ (0.29) | $ (0.39) | $ (0.37) | $ (0.32) | $ (0.30) | $ (0.31) | $ (1.31) | $ (1.31) | $ (2.07) |
Chief Executive Officer Trans51
Chief Executive Officer Transition (Detail) - USD ($) $ / shares in Units, $ in Thousands | Jan. 03, 2018 | Nov. 30, 2017 | Dec. 31, 2016 | Dec. 31, 2017 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Options to purchase common shares (in shares) | 1,405,054 | |||
Option term | 5 years 8 months 12 days | |||
Exercise price (in usd per share) | $ 7.94 | |||
Chief Executive Officer | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Severance costs | $ 525 | |||
Stock-based compensation expense | $ 674 | |||
Percent vesting monthly for the three years following first anniversary of start date | Amended and Restated 2017 Inducement Equity Incentive Plan | Chief Executive Officer | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Vesting percentage | 2.00% | |||
Subsequent Event | Chief Executive Officer | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Base salary | $ 540 | |||
Cash signing bonus | $ 330 | |||
Percent of base salary eligible for cash bonus annually | 50.00% | |||
Subsequent Event | Amended and Restated 2017 Inducement Equity Incentive Plan | Chief Executive Officer | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Options to purchase common shares (in shares) | 1,588,832 | |||
Option term | 10 years | |||
Exercise price (in usd per share) | $ 6.30 | |||
Vesting period | 4 years | |||
Subsequent Event | Percent vesting one year from start date | Amended and Restated 2017 Inducement Equity Incentive Plan | Chief Executive Officer | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Vesting percentage | 25.00% |