Document and Entity Information
Document and Entity Information - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2018 | Feb. 28, 2019 | Jun. 30, 2018 | |
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 | ||
Entity Small Business | true | ||
Entity Emerging Growth | true | ||
Entity Ex Transition Period | true | ||
Entity Shell Company | false | ||
Document Type | 10-K | ||
Document Period End Date | Dec. 31, 2018 | ||
Document Fiscal Year Focus | 2,018 | ||
Document Fiscal Period Focus | FY | ||
Amendment Flag | false | ||
Entity Common Stock, Shares Outstanding | 42,369,694 | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Public Float | $ 208.6 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Current assets: | ||
Cash and cash equivalents | $ 13,324 | $ 56,901 |
Other current assets and prepaid expenses | 908 | 1,220 |
Total current assets | 14,232 | 58,121 |
Property and equipment, net | 709 | 2,155 |
Other assets | 37 | 108 |
Total assets | 14,978 | 60,384 |
Current liabilities: | ||
Accounts payable | 268 | 1,049 |
Accrued expenses | 2,221 | 9,141 |
Other current liabilities | 21 | 91 |
Total current liabilities | 2,510 | 10,281 |
Long-term liabilities | 41 | 59 |
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, 2018 and 2017 | 0 | 0 |
Common stock, $0.0001 par value; 130,000,000 shares authorized at December 31, 2018 and 2017; 42,369,694 and 42,368,864 shares issued and outstanding at December 31, 2018 and 2017, respectively | 4 | 4 |
Additional paid-in capital | 349,771 | 345,915 |
Accumulated other comprehensive income | 80 | 78 |
Accumulated deficit | (337,428) | (295,953) |
Total stockholders’ equity | 12,427 | 50,044 |
Total liabilities and stockholders’ equity | $ 14,978 | $ 60,384 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2018 | Dec. 31, 2017 |
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 | 42,369,694 | 42,368,864 |
Common stock, shares outstanding | 42,369,694 | 42,368,864 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Operating expenses: | |||
Research and development | $ 24,825,000 | $ 39,341,000 | $ 30,046,000 |
General and administrative | 13,585,000 | 13,314,000 | 11,220,000 |
Severance costs | 2,395,000 | 0 | 0 |
Impairment loss | 1,219,000 | 0 | 0 |
Total operating expenses | 42,024,000 | 52,655,000 | 41,266,000 |
Loss from operations | (42,024,000) | (52,655,000) | (41,266,000) |
Other income: | |||
Interest income | 521,000 | 650,000 | 284,000 |
Other income (expense), net | 28,000 | (73,000) | 13,000 |
Total other income | 549,000 | 577,000 | 297,000 |
Net loss | $ (41,475,000) | $ (52,078,000) | $ (40,969,000) |
Net loss per share, basic and diluted (usd per share) | $ (0.98) | $ (1.31) | $ (1.31) |
Weighted-average common shares outstanding, basic and diluted (in shares) | 42,369,245 | 39,859,009 | 31,387,579 |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive Loss - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Statement of Comprehensive Income [Abstract] | |||
Net loss | $ (41,475) | $ (52,078) | $ (40,969) |
Other comprehensive income (loss): | |||
Unrealized gains (losses) on cash equivalents | (2) | (6) | 4 |
Foreign currency translation | 0 | 1 | (1) |
Total comprehensive loss | $ (41,477) | $ (52,083) | $ (40,966) |
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, 2015 | $ 82,325 | $ 3 | $ 285,098 | $ 80 | $ (202,856) |
Beginning 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 | ||||
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 | $ 0 | 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 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | (41,475) | (41,475) | |||
Other comprehensive income (loss) | 2 | 2 | |||
Exercise of stock options | $ 5 | 5 | |||
Exercise of stock options (in shares) | 830 | 830 | |||
Stock-based compensation | $ 3,736 | 3,736 | |||
Common stock issued for services | 115 | 115 | |||
Ending balance at Dec. 31, 2018 | $ 12,427 | $ 4 | $ 349,771 | $ 80 | $ (337,428) |
Ending balance (in shares) at Dec. 31, 2018 | 42,369,694 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Cash flows from operating activities: | |||
Net loss | $ (41,475,000) | $ (52,078,000) | $ (40,969,000) |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Depreciation and amortization | 727,000 | 998,000 | 1,808,000 |
Fixed Asset Impairment | 1,219,000 | 0 | 0 |
Stock-based compensation | 3,736,000 | 5,480,000 | 4,678,000 |
Common stock issued for services | 115,000 | 256,000 | 0 |
Other | 119,000 | (1,000) | 85,000 |
Changes in operating assets and liabilities: | |||
Prepaid expenses and other assets | 165,000 | 165,000 | (232,000) |
Accounts payable | (770,000) | 287,000 | (459,000) |
Accrued expenses | (6,914,000) | 4,490,000 | (587,000) |
Other liabilities | (87,000) | 6,000 | (98,000) |
Net cash used in operating activities | (43,165,000) | (40,397,000) | (35,774,000) |
Cash flows from investing activities: | |||
Purchases of property and equipment | (597,000) | (685,000) | (556,000) |
Change in restricted cash | 0 | 0 | 533,000 |
Proceeds from sale of equipment | 182,000 | 7,000 | 2,000 |
Net Cash Provided by (Used in) Investing Activities | (415,000) | (678,000) | (21,000) |
Cash flows from financing activities: | |||
Proceeds from issuance of common stock, net of issuance costs | 0 | 37,998,000 | 12,355,000 |
Proceeds from exercise of stock options | 4,000 | 5,000 | 32,000 |
Deferred financing costs | 0 | (19,000) | (13,000) |
Net cash provided by financing activities | 4,000 | 37,984,000 | 12,374,000 |
Effect of exchange rate changes on cash and cash equivalents | (1,000) | 1,000 | (4,000) |
Net change in cash and cash equivalents | (43,577,000) | (3,090,000) | (23,425,000) |
Cash and cash equivalents, beginning of period | 56,901,000 | 59,991,000 | 83,416,000 |
Cash and cash equivalents, end of period | 13,324,000 | 56,901,000 | 59,991,000 |
Supplemental disclosure of non-cash investing and financing activities: | |||
Purchase of property and equipment included in liabilities | 0 | 16,000 | 41,000 |
Stock issuance costs included in liabilities | 0 | 1,000 | 0 |
Change in stock option early exercise repurchase liability | $ 0 | $ 0 | $ 23,000 |
Description of Business and Bas
Description of Business and Basis of Financial Statements | 12 Months Ended |
Dec. 31, 2018 | |
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 biotherapeutic company that has been developing a cell-based therapy targeting the treatment of acute forms of liver failure. Our initial product candidate, the ELAD ® System, or ELAD, is a human-cell-based, bio-artificial liver, which was 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 September 2018, we reported top-line data from our phase 3 clinical trial of ELAD, VTL-308, in 151 subjects with severe alcoholic hepatitis. Although there was a numerical improvement in survival in the ELAD-treated group between three months and one year following randomization, the study failed to meet the primary endpoint of a significant improvement in overall survival through at least ninety-one days. The secondary endpoint of the proportion of survivors at study day ninety-one also showed no statistically significant difference between the groups. Considering these results, we do not believe the ELAD System can be approved in the United States or the European Union without additional clinical trials, if ever, and that such clinical trials would require substantial capital and time to complete. Consequently, we have ceased any further development of the ELAD System for the United States and Europe, substantially reduced our workforce, discontinued most of our supply and service agreements, and have shifted our strategic focus to identifying and exploring strategic alternatives including a merger, an acquisition or sale of assets or even a dissolution and liquidation of the company. See Note 11 for events subsequent to the reporting period. Our business, operating results, financial condition and prospects are subject to significant risks and uncertainties. As we currently have no commercial products or products in later stage development, it may be difficult to secure additional funding in light of these risks and circumstances. There can be no assurance any transaction will result from our evaluation of strategic alternatives. Going Concern We have a history of incurring losses and negative cash flows from operations and have an accumulated deficit of $337.4 million through December 31, 2018 . In consideration of the results of the VTL-308 clinical trial and our decision to cease the further development of ELAD in the United States and Europe, we have made reductions in operating expenses as we pursue strategic alternatives for the company. As a result, we believe that our existing cash and cash equivalents of $13.3 million as of December 31, 2018 would be sufficient to meet our known liabilities and commitments at such date based on our current operations; however, we expect our resource requirements to change materially to the extent we enter into and complete any strategic transactions. The timing and amount of our actual expenditures will be based on many factors, including, but not limited to, the strategic options that we pursue, any unforeseen cash needs which may deplete current cash and cash equivalents sooner than planned, or any future research and development efforts we decide to pursue. We currently have an effective shelf registration statement on Form S-3 on file with the Securities and Exchange Commission, or SEC, which expires June 2021. The shelf registration statement permits the offering, issuance and sale by us of up to an aggregate offering price of $200.0 million of common stock, preferred stock, warrants, debt securities or units in one or more offerings and in any combination, of which $60.0 million may be offered, issued and sold under an “at-the-market” sales agreement with Cantor Fitzgerald & Co. However, amounts available under the shelf registration statement are significantly limited as our public float was below $75.0 million as measured on December 31, 2018. Additional funding is not likely at this time due to our past clinical trials not meeting their primary or secondary survival endpoints. In addition, in October 2018, we received a letter from the staff of Nasdaq providing notification that, for the previous 30 consecutive business days, the closing bid price for our common stock was below the minimum $1.00 per share requirement, or the Bid Price Requirement, for continued listing on the Nasdaq Global Market. The notification had no immediate effect on the listing of our common stock. In accordance with Nasdaq listing rules, we are afforded 180 calendar days, or until April 23, 2019, to regain compliance with the Bid Price Requirement. If our common stock is delisted, this would, among other things, substantially impair our ability to raise additional funds to sustain our operations and our ability to successfully enter into strategic transactions, and could result in the loss of investor interest. We believe that due to the factors described above, there is substantial doubt about our ability to continue as a going concern for one year from the date of the issuance of our consolidated financial statements for the twelve months ended December 31, 2018. 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, 2018 | |
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 We evaluate long-lived assets, such as property and equipment, for impairment whenever events or changes in circumstances indicate that the carrying amount of the assets may not be recoverable. Such events or changes in circumstances include, but are not limited to, a significant decrease in the fair value of the underlying asset or asset group, a significant decrease in the benefits realized from the acquired assets, difficulty and delays in integrating the business, or a significant change in the operations of the acquired assets or use of an asset or asset group. A long-lived asset is considered impaired if its carrying amount exceeds the estimated future undiscounted cash flows the asset or asset group is expected to generate. If a long-lived asset is considered to be impaired, the impairment to be recognized is the amount by which the carrying amount of the asset exceeds the fair value of the asset or asset group. Determining the fair value of an asset or asset group is highly judgmental in nature and involves the use of significant estimates and assumptions for market participants. We base our fair value estimates on assumptions we believe to be reasonable but that are unpredictable and inherently uncertain. Actual future results may differ from those estimates. We recognized an impairment charge of $1.2 million on our property and equipment in the consolidated statements of operations for the twelve months ended December 31, 2018 . We did not recognize any impairment losses in the years ended December 31, 2017 or 2016 . 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 are not able to access certain clinical information and must adjust our rate of clinical expense recognition if actual results differ from our estimates. As our understanding of the status and timing of services performed relative to the actual status and timing of services performed may vary, reported 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. As a result of the completion of our VTL-308 clinical trial in September 2018, we gained access to subject-specific and clinical site information used for estimating our clinical trial accruals. This enabled us to further analyze our clinical trial accrual against the actual services performed and to adjust our clinical trial accrual based on such information. As a result of this analysis and our ongoing review with the clinical sites, we reduced our clinical trial accrual and reduced research and development expense for the year ended December 31, 2018 by $670,000 . Research and Development Research and development costs have consisted 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 (see Note 11 to the consolidated financial statements). 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. If performance-based milestones are later determined not to be probable of achievement, then all previously recorded stock-based compensation expense associated with such options is reversed in the period that we make this determination. The fair value of options granted to consultants has been estimated using the BSM option pricing model and 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. 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, 2018 and 2017 , 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, 2018 2017 2016 Options to purchase common stock 6,183,266 6,083,482 4,841,274 Warrants to purchase common stock 240,620 240,620 240,620 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 will 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 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 requires 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. We adopted this standard in the first quarter of 2018, and the adoption did not have any impact on our consolidated financial statements. 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. We adopted this standard in the first quarter of 2018, and the adoption did not have a significant impact on our consolidated financial statements. In June 2018, the FASB issued ASU No. 2018-07, " Improvements to Non-employee Share-Based Payment Accounting, " or ASU 2018-07. ASU 2018-07, which simplifies the accounting for non-employee share-based payment transactions, specifies that Topic 718 applies to all share-based payment transactions in which a grantor acquires goods or services to be used or consumed in a grantor's own operations by issuing share-based payment awards. ASU 2018-07 is effective for public business entities for fiscal years beginning after December 15, 2018, and early adoption is permitted. We currently expect to adopt ASU 2018-07 in the first quarter of 2019. We do not expect the adoption of this standard to have a material impact on our consolidated financial statements. In August 2018, the FASB issued ASU No. 2018-13, " Fair Value Measurement - Disclosure Framework, " or ASU 2018-13. ASU 2018-13, modifies the disclosure requirements for fair value measurements. The amendments relate to disclosures regarding unrealized gains and losses, the range and weighted average of significant unobservable inputs used to develop Level 3 fair value measurements and the narrative description of measurement uncertainty, and are to be applied prospectively for only the most recent interim or annual period presented in the initial fiscal year of adoption. All other amendments should be applied retrospectively to all periods presented upon their effective date. The amendments are effective for fiscal years beginning after December 15, 2019, and interim periods within those fiscal years, and early adoption is permitted. The Company is currently evaluating the impact of ASU 2018-13 on the Company's disclosures. |
Other Financial Information
Other Financial Information | 12 Months Ended |
Dec. 31, 2018 | |
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, 2018 2017 Manufacturing, clinical and laboratory equipment $ 6,480 $ 7,500 Leasehold improvements 4,627 4,727 Office furniture and equipment 105 234 Construction in progress — 17 11,212 12,478 Less: accumulated depreciation and amortization (10,503 ) (10,323 ) Total $ 709 $ 2,155 Depreciation and amortization expense was $727,000 , $998,000 and $1.8 million for the years ended December 31, 2018 , 2017 and 2016 , respectively. In September 2018, we ceased substantially all of our development efforts related to ELAD. This resulted in a substantial change in the expected use of our long-lived assets and a significant decrease in the benefits expected to be realized from these assets. Accordingly, we recognized an impairment charge of $1.2 million on our property and equipment in the consolidated statements of operations for the year ended December 31, 2018 reflecting the difference in the carrying value of such property and equipment and its estimated fair value. The impairment charge is reflected as a reduction in the cost of the related assets. Accrued Expenses Accrued expenses consist of (in thousands): December 31, 2018 2017 Accrued clinical and related costs $ 1,336 $ 5,377 Accrued compensation and related taxes 543 3,591 Accrued other 342 173 Total $ 2,221 $ 9,141 |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2018 | |
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 are being allowed to expire. 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, provides for periodic rent increases and requires the payment of our proportionate share of the facility's operating expenses. Future minimum annual obligations under non-cancellable operating lease commitments at December 31, 2018 are as follows (in thousands): Total 2019 2020 2021 2022 2023 Thereafter Operating lease obligations $ 1,511 $ 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 $1,120,000 , $999,000 and $993,000 during the years ended December 31, 2018 , 2017 and 2016 , respectively. Current and long-term deferred rent totaled $22,000 and $41,000 at December 31, 2018 and $91,000 and $59,000 at December 31, 2017 , respectively. Contractual Commitments In October 2018, we entered into an investment banking agreement, or the Engagement Agreement, with Ladenburg Thalmann & Co. Inc., or Ladenburg, pursuant to which Ladenburg is acting as our strategic financial advisor to assist in the review of our business and assets and exploration of strategic opportunities for enhancing stockholder value, including the potential sale or merger of the company. Under the Engagement Agreement, as compensation for the services provided by Landenburg, we shall pay, or cause to be paid, to Ladenburg, the following nonrefundable fees: (i) if we consummate a transaction, we shall pay Ladenburg a transaction fee of $1,000,000 (the “Transaction Fee”) at the closing of the transaction, (ii) a retainer fee of $75,000 , which was paid in 2018 and is creditable against the Transaction Fee, and (iii) an opinion fee of $250,000 paid in 2019. In January 2019, we entered into an exchange agreement Immunic AG which, if completed, would result in the payment of the Transaction Fee to Ladenburg. Purchase Commitments We have no significant purchase commitments as of December 31, 2018. 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, 2018 | |
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, 2018 Fair Value Level 1 Level 2 Level 3 Assets Money market funds $ 12,940 $ 12,940 $ — $ — Fair Value Measurement at December 31, 2017 Fair Value Level 1 Level 2 Level 3 Assets Money market funds $ 55,245 $ 55,245 $ — $ — There were no liabilities measured at fair value on a recurring basis as of December 31, 2018 or 2017 . 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. We estimated the fair value of certain property and equipment based on third-party market value appraisals, and classified the fair value of such property and equipment as a Level 3 measurement due to the significance of the unobservable inputs. 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, 2018 | |
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 In May 2018 we filed a shelf registration statement on Form S-3, or the 2018 Shelf Registration Statement, which became effective in June 2018. The 2018 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 $60.0 million of our common stock that may be issued and sold under an “at-the-market” sales agreement, or ATM, with Cantor Fitzgerald & Co. However, amounts available under the shelf registration statement are significantly limited as long as our our public float remains below $75.0 million . Under our prior registration statement filed on Form S-3 in May 2015, or the 2015 Shelf Registration Statement, we completed follow-on public offerings in March 2017 and October 2015, and under the ATM in 2017 and 2016. We did not sell any shares under the 2018 or 2015 Shelf Registration Statements during the year ended December 31, 2018. The 2015 Shelf Registration Statement was replaced by the 2018 Shelf Registration Statement in June 2018. In March 2017, we completed follow-on public offering under the 2015 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 also 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 . 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 . 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 In October 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 were not registered based on a specific exemption from the registration requirements of the Securities Act. We had the right to terminate this agreement for any reason within 180 days following the effective date, whereby each of the Consultants would have been 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 were adjusted to fair value based on the closing price at the end of each reporting period with the expense being recorded ratably over the 180 -day period. We recognized expense in connection with these consulting shares of $115,000 and $256,000 during the year ended December 31, 2018 and 2017, respectively, 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, 2018 and 2017, 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, 2018 are as follows: Number of Common stock options outstanding 6,183,266 Common stock options available for future grant: 2014 Equity Incentive Plan 2,813,218 2017 Inducement Equity Incentive Plan 261,168 Common stock reserved for issuance for outstanding warrants 240,620 Total common shares reserved for future issuance 9,498,272 |
Stock Compensation Plans
Stock Compensation Plans | 12 Months Ended |
Dec. 31, 2018 | |
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. 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, 2018. Shares available for grant under the 2014 Plan totaled 2,813,218 shares as of December 31, 2018 . 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 non-qualified 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. During the twelve months ended December 31, 2018 , we granted options to purchase 1,699,636 shares of our common stock under the Inducement Plan and 110,804 shares were forfeited or cancelled, leaving 261,168 shares available for grant under the Inducement Plan. Option grants made under the 2014 Plan and the 2012 Plan generally vest over one year or ratably over four years, except for performance-based stock options. Our performance-based stock options were set to become fully vested and exercisable only on achievement of the performance conditions while the participant was a continuing service provider. Options currently outstanding under the Inducement Plan become 25% vested on the one year anniversary of the grant date and then vest ratably over an additional three years or ratably over four years. 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, the Board approved grants for performance-based stock options to certain employees and consultants under the 2014 Plan. Performance-based stock options that had not been forfeited would have fully vested on the third anniversary of the grant date if (i) our VTL-308 clinical trial had achieved statistical significance in its primary efficacy endpoint and (ii) the participant was a continuing service provider through the third anniversary of the grant date (as such terms are defined in the 2014 Plan). Prior to the announcement of the VTL-308 clinical trial results, we deemed the performance conditions as being probable and recorded stock-based compensation expense over the requisite service period for all performance-based stock options held by employees of $357,000 for the twelve months ended December 31, 2018. In September 2018, we announced that the VTL-308 clinical trial failed to achieve its primary efficacy endpoint. Accordingly, the performance conditions of the performance-based stock options were not met. In connection with this determination, we recorded a reversal of stock-based compensation expense of $1.7 million , including $873,000 to research and development expense and $862,000 to general and administrative expense in the consolidated statements of operations for the year ended December 31, 2018. The following table summarizes stock option activity under the 2012 and 2014 Plans and the 2017 Inducement Plan: Options Weighted- Weighted- Aggregate Outstanding as of January 1, 2018 6,083,482 $ 6.76 Granted 2,815,900 $ 6.05 Exercised (830 ) $ 5.35 Forfeited and expired (2,715,286 ) $ 6.60 Outstanding as of December 31, 2018 6,183,266 $ 6.51 5.6 $ — Options vested and expected to vest as of December 31, 2018 5,599,448 $ 6.57 5.2 $ — Options exercisable as of December 31, 2018 3,908,151 $ 6.80 3.6 $ — 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, 2018 . 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, 2018 2017 2016 Aggregate intrinsic value of options exercised $ 2 $ 10 $ 39 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, 2018 , 2017 and 2016 was $4.26 , $2.34 and $5.70 , 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, 2018 2017 2016 Employees and Directors: Risk-free interest rate 2.0% - 2.5% 1.5% - 2.0% 1.5% - 1.7% Expected dividend yield — % — % — % Expected volatility 80% - 82% 82% - 85% 77% - 86% Expected term of options (years) 5.9 - 6.2 5.9 - 6.1 5.9 - 6.0 Range of common stock value $0.45 - $8.00 $2.75 - $5.80 $5.90 - $8.97 Non-Employees: Risk-free interest rate 2.1% - 3.0% 1.0% - 2.1% 0.5% - 1.9% Expected dividend yield — % — % — % Expected volatility 71% - 82% 66% - 84% 77% - 97% Expected term of options (years) 0.1 - 9.3 0.5 - 4.5 0.2 - 5.5 Range of common stock value $0.19 - $6.85 $2.90 - $5.95 $4.35 - $9.07 The following tables summarize the allocation of stock-based compensation expense to employees and non-employees (in thousands): Years Ended December 31, 2018 2017 2016 Employees and Directors: Research and development $ 364 $ 1,645 $ 1,758 General and administrative 3,160 3,742 2,751 Total $ 3,524 $ 5,387 $ 4,509 Non-Employees: Research and development $ 81 $ 93 $ 153 General and administrative 131 — 16 Total $ 212 $ 93 $ 169 As of December 31, 2018 , there was $7.5 million of total compensation cost related to unvested employee stock option awards not yet recognized. Stock-based compensation expense for employee stock option awards is expected to be recognized over a remaining weighted-average vesting period of 2.7 years, respectively. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2018 | |
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, 2018 2017 2016 United States $ (41,467 ) $ (52,066 ) $ (40,929 ) Foreign (8 ) (12 ) (40 ) $ (41,475 ) $ (52,078 ) $ (40,969 ) Our rate reconciliation consists of the following: Year Ended December 31, 2018 2017 2016 Federal statutory rate 21.0 % 35.0 % 35.0 % State tax (net of federal benefit) 0.0 % 0.0 % 0.1 % Effects of U.S. tax rate change 0.0 % (47.6 )% 0.0 % Federal and state tax credits 0.2 % 46.8 % 2.9 % Uncertain tax positions 0.0 % (5.3 )% (16.0 )% Stock options (1.6 )% (1.4 )% (1.5 )% Other (0.3 )% (0.2 )% (2.5 )% Change in valuation allowance (19.3 )% (27.3 )% (18.0 )% 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 included numerous changes in existing tax law, including a permanent reduction in the federal corporate income tax rate from 35% to 21% effective on January 1, 2018. As a result of the Tax Act, we revalued our net deferred tax assets as of December 31, 2017 to reflect the rate reduction and recorded a reduction in our net deferred tax assets of $24.8 million . However, the revaluation did not result in any change to net income tax expense as our net deferred tax assets are fully offset by a valuation allowance. As of December 22, 2018, the Company’s accounting for the remeasurement of its deferred tax assets and liabilities was complete and there were no changes to the amount previously recorded. 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, 2018 2017 (in thousands) Deferred tax assets: Net operating loss carryforwards $ 44,540 $ 43,600 Federal and state tax credits 43,701 35,903 Stock-based compensation 2,538 2,371 Foreign net operating loss carryforwards 122 169 Other, net 955 1,809 Total deferred tax assets 91,856 83,852 Less valuation allowance (91,856 ) (83,852 ) $ — $ — 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. There can be no assurance that we will ever 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 $8.0 million and $14.2 million for the years ended December 31, 2018 and 2017 , 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 of $4.5 million and $7.3 million , respectively, in 2017. As of December 31, 2018 , we had available net operating loss, or NOL, carryforwards of approximately $208.6 million and $203.0 million for federal and state income tax purposes, respectively. These state NOL carryforwards include $191.1 million in California NOL carryforwards 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 NOL carryforwards generated prior to 2018 and unexpired state NOL carryforwards begin to expire in 2032. The 2018 federal NOL carryforwards do not expire. In addition, as of December 31, 2018 , 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 , $0.9 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, 2018 , $194,000 of NOL carryforwards from our Chinese subsidiary expired leaving $490,000 of NOL carryforwards from our Chinese subsidiary as of December 31, 2018 . There will be further expirations of this NOL carryforward in 2019 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 NOL carryforwards 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. If additional Section 382 changes occur, such as due to a merger or a similar transaction, limitations against the utilization of net operating losses and tax credits could further reduce up to substantially all of our NOL and credit carryforwards and impact our future cash flows, but would not impact our 2018 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 2018 2017 Balance at beginning of year $ 23,270 $ 16,095 Additions based on tax positions related to the current year — 5,134 Changes for prior period tax positions 108 2,041 Balance at end of year $ 23,378 $ 23,270 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 2013 through 2017 California state tax returns utilizing a multiple factor apportionment based on salaries, property and sales in the state as most of our operations are in California. 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. We do not anticipate any significant changes in the amount of uncertain tax positions as of December 31, 2018 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, 2014 and 2013, respectively. However, to the extent allowed by law, the taxing authorities may have the right to examine the period from 2003 through 2018 where NOL carryforwards 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, 2018 | |
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 2018 and 2017 are as follows (in thousands, except per share data): For the Quarters Ended March 31 June 30 September 30 December 31 Total Year 2018: Operating expenses $ 14,492 $ 12,917 $ 12,064 $ 2,551 $ 42,024 Net loss $ (14,388 ) $ (12,682 ) $ (11,941 ) $ (2,464 ) $ (41,475 ) Basic and diluted net loss per share (1) $ (0.34 ) $ (0.30 ) $ (0.28 ) $ (0.06 ) $ (0.98 ) 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 ) (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. |
Severance Costs
Severance Costs | 12 Months Ended |
Dec. 31, 2018 | |
Related Party Transactions [Abstract] | |
Severance Costs | Severance Costs In September 2018, we announced a staff reduction plan in order to reduce operating expenses and to conserve cash resources. The plan reduced our workforce by approximately 85% . As a result, we estimate we will incur approximately $2.4 million in costs for the affected employees, including severance payments, limited reimbursement of medical insurance premiums and outplacement services. The staff reduction plan was completed by the end of September 2018. During the twelve months ended December 31, 2018, we paid $2.1 million in severance benefits to separating employees related to the staff reduction plan. At December 31, 2018, unpaid severance costs of $254,000 are included in current liabilities in the condensed consolidated balance sheet and are expected to be paid by the end of the first quarter of 2019. |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2018 | |
Subsequent Events [Abstract] | |
Subsequent Events | Subsequent Events Exchange Agreement with Immunic AG In January 2019, we entered into an exchange agreement with, Immunic AG, or Immunic, and all of the current shareholders of Immunic, or the Exchange Agreement, pursuant to which all of the Immunic shareholders will exchange all of their Immunic shares for shares of our common stock, with the result of Immunic becoming a wholly-owned subsidiary of the Company, which is referred to as the Transaction. Following the closing of the Transaction, the company, which will be renamed “Immunic, Inc.” and will focus on advancing Immunic’s pipeline of treatments for chronic inflammatory and autoimmune diseases. As a result of the exchange, Immunic shareholders are expected to own approximately 89% of the company subject to adjustment as provided in the Exchange Agreement. Prior to entry into the Exchange Agreement, all current Immunic shareholders as well as certain of Immunic’s executive officers and directors entered into an Investment and Subscription Agreement, or the Subscription Agreement, with Immunic, pursuant to which certain Immunic shareholders have agreed, subject to the terms and conditions of such agreement, to invest, prior to the consummation of the Transaction, an aggregate amount of approximately €26.7 million , or approximately $30.5 million based on the exchange rate at December 31, 2018 . The issuance of the company common stock to be issued under the Exchange Agreement and certain related transactions must be approved by the company’s stockholders. There can be no assurance that such transactions will be approved by the stockholders or that the Transaction will be consummated. Cancellation of Stock Options and Issuance of Stock Equity Awards In an effort to maximize the cash on our balance sheet in the share exchange transaction with Immunic, in January 2019, the compensation committee of the board of directors, or the Committee, agreed and approved the restructuring of our executive officers’ existing severance and change of control agreements. Among other things, the Committee approved (i) the cancellation of options for 3,100,614 shares having a weighted average exercise price of $6.53 and representing all the stock options held by such executive officers; (ii) grants of 5,100,000 restricted stock units, or RSUs, under the 2014 Plan to such executive officers; and (iii) amended the existing change of control and severance agreements with each of the executive officers to include a total reduction of $1.3 million in cash severance payments the executive officers would otherwise receive on a termination as a result of a change of control such as pursuant to the Transaction; all conditioned upon the executive officers agreeing to and entering into each of the agreements necessary to effectuate these transactions. Following Committee approval, each of the executive officers executed the respective amendments to their change of control and severance agreements, executed an option cancellation agreement, and received the RSU grants. The RSU grants vest 25% annually over four years, however, the vesting accelerates and the grants fully vest on termination by the company without cause or the executive officer's resignation for good reason pursuant to the amended change of control and severance agreements. The RSUs can be settled in cash or shares of common stock solely at the company’s discretion and the RSU’s have a ten -year term. CEO Termination In January 2019, in an effort to further reduce operating costs, our board of directors notified Mr. Russell J. Cox, our chief executive officer at the time, that his employment with us would be terminated without cause and Mr. Cox submitted his resignation as a director to coincide with his termination date. Pursuant to his amended change of control and severance agreement, Mr. Cox will receive a lump sum cash payment equivalent to twelve months salary and the 1,854,376 restricted stock units held by Mr. Cox on his termination date vested. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2018 | |
Accounting Policies [Abstract] | |
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 We evaluate long-lived assets, such as property and equipment, for impairment whenever events or changes in circumstances indicate that the carrying amount of the assets may not be recoverable. Such events or changes in circumstances include, but are not limited to, a significant decrease in the fair value of the underlying asset or asset group, a significant decrease in the benefits realized from the acquired assets, difficulty and delays in integrating the business, or a significant change in the operations of the acquired assets or use of an asset or asset group. A long-lived asset is considered impaired if its carrying amount exceeds the estimated future undiscounted cash flows the asset or asset group is expected to generate. If a long-lived asset is considered to be impaired, the impairment to be recognized is the amount by which the carrying amount of the asset exceeds the fair value of the asset or asset group. Determining the fair value of an asset or asset group is highly judgmental in nature and involves the use of significant estimates and assumptions for market participants. We base our fair value estimates on assumptions we believe to be reasonable but that are unpredictable and inherently uncertain. Actual future results may differ from those estimates. |
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 are not able to access certain clinical information and must adjust our rate of clinical expense recognition if actual results differ from our estimates. As our understanding of the status and timing of services performed relative to the actual status and timing of services performed may vary, reported 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. As a result of the completion of our VTL-308 clinical trial in September 2018, we gained access to subject-specific and clinical site information used for estimating our clinical trial accruals. This enabled us to further analyze our clinical trial accrual against the actual services performed and to adjust our clinical trial accrual based on such information. |
Research and Development | Research and Development Research and development costs have consisted 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 (see Note 11 to the consolidated financial statements). 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. If performance-based milestones are later determined not to be probable of achievement, then all previously recorded stock-based compensation expense associated with such options is reversed in the period that we make this determination. The fair value of options granted to consultants has been estimated using the BSM option pricing model and 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. 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, 2018 and 2017 , 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 will 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 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 requires 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. We adopted this standard in the first quarter of 2018, and the adoption did not have any impact on our consolidated financial statements. 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. We adopted this standard in the first quarter of 2018, and the adoption did not have a significant impact on our consolidated financial statements. In June 2018, the FASB issued ASU No. 2018-07, " Improvements to Non-employee Share-Based Payment Accounting, " or ASU 2018-07. ASU 2018-07, which simplifies the accounting for non-employee share-based payment transactions, specifies that Topic 718 applies to all share-based payment transactions in which a grantor acquires goods or services to be used or consumed in a grantor's own operations by issuing share-based payment awards. ASU 2018-07 is effective for public business entities for fiscal years beginning after December 15, 2018, and early adoption is permitted. We currently expect to adopt ASU 2018-07 in the first quarter of 2019. We do not expect the adoption of this standard to have a material impact on our consolidated financial statements. In August 2018, the FASB issued ASU No. 2018-13, " Fair Value Measurement - Disclosure Framework, " or ASU 2018-13. ASU 2018-13, modifies the disclosure requirements for fair value measurements. The amendments relate to disclosures regarding unrealized gains and losses, the range and weighted average of significant unobservable inputs used to develop Level 3 fair value measurements and the narrative description of measurement uncertainty, and are to be applied prospectively for only the most recent interim or annual period presented in the initial fiscal year of adoption. All other amendments should be applied retrospectively to all periods presented upon their effective date. The amendments are effective for fiscal years beginning after December 15, 2019, and interim periods within those fiscal years, and early adoption is permitted. The Company is currently evaluating the impact of ASU 2018-13 on the Company's disclosures. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
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, 2018 2017 2016 Options to purchase common stock 6,183,266 6,083,482 4,841,274 Warrants to purchase common stock 240,620 240,620 240,620 |
Other Financial Information (Ta
Other Financial Information (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
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, 2018 2017 Manufacturing, clinical and laboratory equipment $ 6,480 $ 7,500 Leasehold improvements 4,627 4,727 Office furniture and equipment 105 234 Construction in progress — 17 11,212 12,478 Less: accumulated depreciation and amortization (10,503 ) (10,323 ) Total $ 709 $ 2,155 |
Schedule of Accrued Expenses | Accrued expenses consist of (in thousands): December 31, 2018 2017 Accrued clinical and related costs $ 1,336 $ 5,377 Accrued compensation and related taxes 543 3,591 Accrued other 342 173 Total $ 2,221 $ 9,141 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Commitments and Contingencies Disclosure [Abstract] | |
Future Minimum Annual Obligations Under All Non-Cancellable Operating Lease Commitments | Future minimum annual obligations under non-cancellable operating lease commitments at December 31, 2018 are as follows (in thousands): Total 2019 2020 2021 2022 2023 Thereafter Operating lease obligations $ 1,511 $ 469 $ 387 $ 434 $ 221 $ — $ — |
Fair Value (Tables)
Fair Value (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
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, 2018 Fair Value Level 1 Level 2 Level 3 Assets Money market funds $ 12,940 $ 12,940 $ — $ — Fair Value Measurement at December 31, 2017 Fair Value Level 1 Level 2 Level 3 Assets Money market funds $ 55,245 $ 55,245 $ — $ — |
Common Stock and Stock Warran_2
Common Stock and Stock Warrants (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Equity [Abstract] | |
Shares Reserved for Future Issuance | Shares reserved for future issuance at December 31, 2018 are as follows: Number of Common stock options outstanding 6,183,266 Common stock options available for future grant: 2014 Equity Incentive Plan 2,813,218 2017 Inducement Equity Incentive Plan 261,168 Common stock reserved for issuance for outstanding warrants 240,620 Total common shares reserved for future issuance 9,498,272 |
Stock Compensation Plans (Table
Stock Compensation Plans (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
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 and the 2017 Inducement Plan: Options Weighted- Weighted- Aggregate Outstanding as of January 1, 2018 6,083,482 $ 6.76 Granted 2,815,900 $ 6.05 Exercised (830 ) $ 5.35 Forfeited and expired (2,715,286 ) $ 6.60 Outstanding as of December 31, 2018 6,183,266 $ 6.51 5.6 $ — Options vested and expected to vest as of December 31, 2018 5,599,448 $ 6.57 5.2 $ — Options exercisable as of December 31, 2018 3,908,151 $ 6.80 3.6 $ — |
Schedule of Stock Options | The following table summarizes information about stock options (in thousands): Year Ended December 31, 2018 2017 2016 Aggregate intrinsic value of options exercised $ 2 $ 10 $ 39 |
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, 2018 2017 2016 Employees and Directors: Risk-free interest rate 2.0% - 2.5% 1.5% - 2.0% 1.5% - 1.7% Expected dividend yield — % — % — % Expected volatility 80% - 82% 82% - 85% 77% - 86% Expected term of options (years) 5.9 - 6.2 5.9 - 6.1 5.9 - 6.0 Range of common stock value $0.45 - $8.00 $2.75 - $5.80 $5.90 - $8.97 Non-Employees: Risk-free interest rate 2.1% - 3.0% 1.0% - 2.1% 0.5% - 1.9% Expected dividend yield — % — % — % Expected volatility 71% - 82% 66% - 84% 77% - 97% Expected term of options (years) 0.1 - 9.3 0.5 - 4.5 0.2 - 5.5 Range of common stock value $0.19 - $6.85 $2.90 - $5.95 $4.35 - $9.07 |
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, 2018 2017 2016 Employees and Directors: Research and development $ 364 $ 1,645 $ 1,758 General and administrative 3,160 3,742 2,751 Total $ 3,524 $ 5,387 $ 4,509 Non-Employees: Research and development $ 81 $ 93 $ 153 General and administrative 131 — 16 Total $ 212 $ 93 $ 169 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
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, 2018 2017 2016 United States $ (41,467 ) $ (52,066 ) $ (40,929 ) Foreign (8 ) (12 ) (40 ) $ (41,475 ) $ (52,078 ) $ (40,969 ) |
Income Tax Rate Reconciliation | Our rate reconciliation consists of the following: Year Ended December 31, 2018 2017 2016 Federal statutory rate 21.0 % 35.0 % 35.0 % State tax (net of federal benefit) 0.0 % 0.0 % 0.1 % Effects of U.S. tax rate change 0.0 % (47.6 )% 0.0 % Federal and state tax credits 0.2 % 46.8 % 2.9 % Uncertain tax positions 0.0 % (5.3 )% (16.0 )% Stock options (1.6 )% (1.4 )% (1.5 )% Other (0.3 )% (0.2 )% (2.5 )% Change in valuation allowance (19.3 )% (27.3 )% (18.0 )% Effective tax rate 0.0 % 0.0 % 0.0 % |
Deferred Tax Assets | December 31, 2018 2017 (in thousands) Deferred tax assets: Net operating loss carryforwards $ 44,540 $ 43,600 Federal and state tax credits 43,701 35,903 Stock-based compensation 2,538 2,371 Foreign net operating loss carryforwards 122 169 Other, net 955 1,809 Total deferred tax assets 91,856 83,852 Less valuation allowance (91,856 ) (83,852 ) $ — $ — |
Unrecognized Tax Benefit | The following table summarizes the activity related to our uncertain tax positions (in thousands): Year Ended 2018 2017 Balance at beginning of year $ 23,270 $ 16,095 Additions based on tax positions related to the current year — 5,134 Changes for prior period tax positions 108 2,041 Balance at end of year $ 23,378 $ 23,270 |
Selected Quarterly Data (Tables
Selected Quarterly Data (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Quarterly Financial Information Disclosure [Abstract] | |
Summarized Quarterly Information | Summarized quarterly data for 2018 and 2017 are as follows (in thousands, except per share data): For the Quarters Ended March 31 June 30 September 30 December 31 Total Year 2018: Operating expenses $ 14,492 $ 12,917 $ 12,064 $ 2,551 $ 42,024 Net loss $ (14,388 ) $ (12,682 ) $ (11,941 ) $ (2,464 ) $ (41,475 ) Basic and diluted net loss per share (1) $ (0.34 ) $ (0.30 ) $ (0.28 ) $ (0.06 ) $ (0.98 ) 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 ) (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 B_2
Description of Business and Basis of Financial Statements Description of Business and Basis of Financial Statements - Additional Details (Detail) - USD ($) $ in Thousands | Dec. 31, 2018 | May 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 |
Accounting Policies [Abstract] | |||||
Accumulated deficit | $ 337,428 | $ 295,953 | |||
Cash and cash equivalents | 13,324 | $ 56,901 | $ 59,991 | $ 83,416 | |
Amount available for issuance | 200,000 | ||||
Class of Stock [Line Items] | |||||
Entity public float | 75,000 | $ 75,000 | |||
At-The-Market Sales Agreement | |||||
Class of Stock [Line Items] | |||||
Maximum aggregate offering price | $ 60,000 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Additional Information (Detail) - USD ($) | 6 Months Ended | 12 Months Ended | |||
Dec. 31, 2018 | Dec. 31, 2018 | 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] | |||||
Impairment loss | $ 1,219,000 | $ 0 | $ 0 | $ 0 | |
Reduction in accrued clinical trial cost | $ 670,000 | ||||
Reduction in research and development cost | $ 670,000 | ||||
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 | Accumulated Deficit | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Cumulative effect of new accounting principle | $ (50,000) |
Summary of Significant Accoun_5
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, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
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) | 6,183,266 | 6,083,482 | 4,841,274 |
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 | 240,620 |
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, 2018 | Dec. 31, 2017 |
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 11,212 | $ 12,478 |
Less: accumulated depreciation and amortization | (10,503) | (10,323) |
Property and equipment, net | 709 | 2,155 |
Manufacturing, clinical and laboratory equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 6,480 | 7,500 |
Leasehold improvements | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 4,627 | 4,727 |
Office furniture and equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 105 | 234 |
Construction in progress | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 0 | $ 17 |
Other Financial Information - A
Other Financial Information - Additional Information (Detail) - USD ($) | 12 Months Ended | |||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||||
Depreciation and amortization expense | $ 727,000 | $ 1,000,000 | $ 1,800,000 | |
Impairment loss | $ 1,219,000 | $ 0 | $ 0 | $ 0 |
Other Financial Information -_2
Other Financial Information - Schedule of Accrued Expenses (Detail) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Accrued clinical and related costs | $ 1,336 | $ 5,377 |
Accrued compensation and related taxes | 543 | 3,591 |
Accrued other | 342 | 173 |
Total | $ 2,221 | $ 9,141 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) - USD ($) | 1 Months Ended | 12 Months Ended | ||
Oct. 31, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Commitments and Contingencies Disclosure [Abstract] | ||||
Total rent expense under operating leases | $ 1,120,000 | $ 999,000 | $ 993,000 | |
Current deferred rent | 22,000 | 91,000 | ||
Noncurrent deferred rent | $ 41,000 | $ 59,000 | ||
Transaction fees | $ 1,000,000 | |||
Retainer fees | 75,000 | |||
Opinion fees | $ 250,000 |
Commitments and Contingencies_2
Commitments and Contingencies - Future Minimum Annual Obligations Under All Non-Cancellable Operating Lease Commitments (Detail) | Dec. 31, 2018USD ($) |
Commitments and Contingencies Disclosure [Abstract] | |
Total operating lease obligations | $ 1,511,000 |
2,019 | 469,000 |
2,020 | 387,000 |
2,021 | 434,000 |
2,022 | 221,000 |
2,023 | 0 |
Thereafter | $ 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, 2018 | Dec. 31, 2017 |
Assets | ||
Assets | $ 12,940 | $ 55,245 |
Level 1 | ||
Assets | ||
Assets | 12,940 | 55,245 |
Level 2 | ||
Assets | ||
Assets | 0 | 0 |
Level 3 | ||
Assets | ||
Assets | $ 0 | $ 0 |
Fair Value - Additional Informa
Fair Value - Additional Information (Detail) - USD ($) | Dec. 31, 2018 | Dec. 31, 2017 |
Fair Value, Measurements, Recurring | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Liabilities measured at fair value on a recurring basis | $ 0 | $ 0 |
Common Stock and Stock Warran_3
Common Stock and Stock Warrants - Additional Information (Detail) | Oct. 30, 2017USD ($)$ / sharesshares | Aug. 12, 2016$ / sharesshares | Mar. 31, 2017USD ($)$ / sharesshares | Aug. 31, 2016USD ($) | Dec. 31, 2018USD ($)vote$ / sharesshares | Dec. 31, 2017USD ($)$ / sharesshares | Dec. 31, 2016USD ($)$ / sharesshares | May 31, 2018USD ($)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 | $ 60,000,000 | |||||||
Entity public float | $ 75,000,000 | $ 75,000,000 | ||||||
Value of stock issued during the period | $ 37,940,000 | $ 12,355,000 | ||||||
Proceeds from issuance of common stock, net of issuance costs | 0 | 37,998,000 | 12,355,000 | |||||
Payments for commissions | 0 | |||||||
Total costs | 0 | 19,000 | 13,000 | |||||
Common stock issued for services | 115,000 | 256,000 | ||||||
Expense recognized in connection with consulting shares | $ 115,000 | $ 256,000 | 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] | ||||||||
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 Warran_4
Common Stock and Stock Warrants - Shares Reserved for Future Issuance (Detail) - shares | Dec. 31, 2018 | Nov. 30, 2017 |
Class of Stock [Line Items] | ||
Total common shares reserved for future issuance (in shares) | 9,498,272 | |
Common stock options outstanding | ||
Class of Stock [Line Items] | ||
Total common shares reserved for future issuance (in shares) | 6,183,266 | |
Common stock reserved for issuance for outstanding warrants | ||
Class of Stock [Line Items] | ||
Total common shares reserved for future issuance (in shares) | 240,620 | |
2014 Equity Incentive Plan | ||
Class of Stock [Line Items] | ||
Aggregate number of shares outstanding or available for grant under the plan (in shares) | 2,813,218 | |
2017 Inducement Equity Incentive Plan | ||
Class of Stock [Line Items] | ||
Aggregate number of shares outstanding or available for grant under the plan (in shares) | 261,168 | 1,850,000 |
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) | 261,168 |
Stock Compensation Plans - Addi
Stock Compensation Plans - Additional Information (Detail) - USD ($) | Apr. 16, 2017 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | Nov. 30, 2017 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Options expiration period | 10 years | ||||
Options outstanding (in shares) | 6,183,266 | 6,083,482 | |||
Weighted-average grant date fair value of stock options granted to employees and directors (usd per share) | $ 4.26 | $ 2.34 | $ 5.70 | ||
Granted (in shares) | 2,815,900 | ||||
Forfeited and expired (shares) | 2,715,286 | ||||
Stock-based compensation expense | $ 357,000 | ||||
Reversal of stock-based compensadtion expense | $ 1,700,000 | ||||
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) | 2,813,218 | ||||
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) | 261,168 | 1,850,000 | |||
Granted (in shares) | 1,699,636 | ||||
Forfeited and expired (shares) | 110,804 | ||||
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 | ||||
Minimum | 2017 Inducement Equity Incentive Plan | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Option vesting under Equity Incentive Plans, term | 3 years | ||||
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 | ||||
Maximum | 2017 Inducement Equity Incentive Plan | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Option vesting under Equity Incentive Plans, term | 4 years | ||||
Share-based Compensation Award, Tranche One | 2017 Inducement Equity Incentive Plan | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Award vesting rights, percentage | 25.00% | ||||
Share-based Compensation Award, Tranche Two | 2017 Inducement Equity Incentive Plan | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Award vesting rights, percentage | 25.00% | ||||
Share-based Compensation Award, Tranche Three | 2017 Inducement Equity Incentive Plan | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Award vesting rights, percentage | 25.00% | ||||
Share-Based Compensation Award, Tranche Four | 2017 Inducement Equity Incentive Plan | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Award vesting rights, percentage | 25.00% | ||||
Research and Development | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Reversal of stock-based compensadtion expense | $ 873,000 | ||||
General and Administrative | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Reversal of stock-based compensadtion expense | $ 862,000 | ||||
Employee Stock Option | Employee | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Option vesting under Equity Incentive Plans, term | 2 years 8 months 12 days | ||||
Compensation cost related to unvested stock option awards | $ 7,500,000 |
Stock Compensation Plans - Summ
Stock Compensation Plans - Summary of Stock Option Activity (Detail) - USD ($) $ / shares in Units, $ in Thousands | Dec. 31, 2016 | Dec. 31, 2018 |
Options | ||
Options, Outstanding, Beginning balance (shares) | 6,083,482 | |
Granted (in shares) | 2,815,900 | |
Exercised (shares) | (830) | |
Forfeited and expired (shares) | (2,715,286) | |
Options, Outstanding, Ending balance (shares) | 6,183,266 | |
Options vested and expected to vest, Ending balance (shares) | 5,599,448 | |
Options exercisable, Ending balance (shares) | 3,908,151 | |
Weighted- Average Exercise Price | ||
Outstanding, Weighted-Average Exercise Price, Beginning balance (usd per share) | $ 6.76 | |
Granted, Weighted-Average Exercise Price (usd per share) | 6.05 | |
Exercised, Weighted-Average Exercise Price (usd per share) | 5.35 | |
Forfeited, Weighted-Average Exercise Price (usd per share) | 6.60 | |
Outstanding, Weighted-Average Exercise Price, Ending balance (usd per share) | 6.51 | |
Options vested and expected to vest, Weighted-Average Exercise Price, Ending balance (usd per share) | 6.57 | |
Options exercisable, Weighted-Average Exercise Price, Ending balance (usd per share) | $ 6.80 | |
Weighted- Average Remaining Contractual Term (Years) | ||
Outstanding, Weighted-Average Remaining Contractual Term (Years), Ending balance | 5 years 7 months 6 days | |
Options vested and expected to vest , Weighted-Average Remaining Contractual Term (Years), Ending balance | 5 years 2 months 12 days | |
Options exercisable, Weighted-Average Remaining Contractual Term (Years), Ending balance | 3 years 7 months 6 days | |
Outstanding, Aggregate Intrinsic Value, Ending balance | $ 0 | |
Options vested and expected to vest , Aggregate Intrinsic Value, Ending balance | 0 | |
Options exercisable, Aggregate Intrinsic Value, Ending balance | $ 0 |
Stock Compensation Plans - Sche
Stock Compensation Plans - Schedule of Stock Options (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |||
Aggregate intrinsic value of options exercised | $ 2 | $ 10 | $ 39 |
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, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Expected dividend yield | 0.00% | 0.00% | 0.00% |
Employees and Directors | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Risk-free interest rate, minimum | 2.00% | 1.50% | 1.50% |
Risk-free interest rate, maximum | 2.50% | 2.00% | 1.70% |
Expected dividend yield | 0.00% | 0.00% | 0.00% |
Expected volatility, minimum | 80.00% | 82.00% | 77.00% |
Expected volatility, maximum | 82.00% | 85.00% | 86.00% |
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 10 months 24 days |
Range of common stock value (usd per share) | $ 0.45 | $ 2.75 | $ 5.90 |
Employees and Directors | Maximum | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Expected term of options (years) | 6 years 2 months 12 days | 6 years 1 month 6 days | 6 years |
Range of common stock value (usd per share) | $ 8 | $ 5.80 | $ 8.97 |
Non-Employees | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Risk-free interest rate, minimum | 2.10% | 1.00% | 0.45% |
Risk-free interest rate, maximum | 3.00% | 2.10% | 1.93% |
Expected dividend yield | 0.00% | 0.00% | 0.00% |
Expected volatility, minimum | 71.00% | 66.00% | 77.00% |
Expected volatility, maximum | 82.00% | 84.00% | 97.00% |
Non-Employees | Minimum | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Expected term of options (years) | 1 month 6 days | 6 months | 2 months 12 days |
Range of common stock value (usd per share) | $ 0.19 | $ 2.90 | $ 4.35 |
Non-Employees | Maximum | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Expected term of options (years) | 9 years 3 months 18 days | 4 years 6 months | 5 years 6 months |
Range of common stock value (usd per share) | $ 6.85 | $ 5.95 | $ 9.07 |
Stock Compensation Plans - Sc_2
Stock Compensation Plans - Schedule of Stock-based Compensation Expense to Employees and Non-Employees (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Stock-based compensation expense | $ 3,736 | $ 5,480 | $ 4,678 |
Employees and Directors | |||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Stock-based compensation expense | 3,524 | 5,387 | 4,509 |
Non-Employees | |||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Stock-based compensation expense | 212 | 93 | 169 |
Research and Development | Employees and Directors | |||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Stock-based compensation expense | 364 | 1,645 | 1,758 |
Research and Development | Non-Employees | |||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Stock-based compensation expense | 81 | 93 | 153 |
General and Administrative | Employees and Directors | |||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Stock-based compensation expense | 3,160 | 3,742 | 2,751 |
General and Administrative | Non-Employees | |||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Stock-based compensation expense | $ 131 | $ 0 | $ 16 |
Income Taxes - Net Loss before
Income Taxes - Net Loss before Income Tax Based on Jurisdictions (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Income Tax Disclosure [Abstract] | |||
United States | $ (41,467) | $ (52,066) | $ (40,929) |
Foreign | (8) | (12) | (40) |
Net loss before income tax | $ (41,475) | $ (52,078) | $ (40,969) |
Income Taxes - Income Tax Rate
Income Taxes - Income Tax Rate Reconciliation (Detail) | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Income Tax Disclosure [Abstract] | |||
Federal statutory rate | 21.00% | 35.00% | 35.00% |
State tax (net of federal benefit) | 0.00% | 0.00% | 0.10% |
Effects of U.S. tax rate change | 0.00% | (47.60%) | 0.00% |
Federal and state tax credits | 0.20% | 46.80% | 2.90% |
Uncertain tax positions | 0.00% | (5.30%) | (16.00%) |
Stock options | (1.60%) | (1.40%) | (1.50%) |
Other | (0.30%) | (0.20%) | (2.50%) |
Change in valuation allowance | (19.30%) | (27.30%) | (18.00%) |
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, 2018 | Dec. 31, 2017 |
Deferred tax assets: | ||
Net operating loss carryforwards | $ 44,540 | $ 43,600 |
Federal and state tax credits | 43,701 | 35,903 |
Stock-based compensation | 2,538 | 2,371 |
Foreign net operating loss carryforwards | 122 | 169 |
Other, net | 955 | 1,809 |
Total deferred tax assets | 91,856 | 83,852 |
Less valuation allowance | (91,856) | (83,852) |
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, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | |
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 | $ 8,000,000 | $ 14,200,000 | |
Deferred tax assets | 91,856,000 | 91,856,000 | 83,852,000 |
State Administration of Taxation, China | |||
Operating Loss Carryforwards [Line Items] | |||
Net operating loss carryforwards | 490,000 | 490,000 | |
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 | 208,600,000 | 208,600,000 | |
Federal | Research and Development Tax Credit Carryforward | |||
Operating Loss Carryforwards [Line Items] | |||
Tax credit carry forward | 900,000 | 900,000 | |
State | |||
Operating Loss Carryforwards [Line Items] | |||
Net operating loss carryforwards | 203,000,000 | 203,000,000 | |
State | California Franchise Tax Board | |||
Operating Loss Carryforwards [Line Items] | |||
Net operating loss carryforwards | 191,100,000 | 191,100,000 | |
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 | ||
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 | 194,000 | 194,000 | |
Scenario adjustment | Research and Development Tax Credit Carryforward | |||
Operating Loss Carryforwards [Line Items] | |||
Tax credit carry forward | 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 |
Income Taxes - Unrecognized Tax
Income Taxes - Unrecognized Tax Benefit (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Reconciliation of Unrecognized Tax Benefits, Excluding Amounts Pertaining to Examined Tax Returns [Roll Forward] | ||
Balance at beginning of year | $ 23,270 | $ 16,095 |
Additions based on tax positions related to the current year | 0 | 5,134 |
Changes for prior period tax positions | 108 | 2,041 |
Balance at end of year | $ 23,378 | $ 23,270 |
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, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2017 | Sep. 30, 2017 | Jun. 30, 2017 | Mar. 31, 2017 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Quarterly Financial Information Disclosure [Abstract] | |||||||||||
Operating expenses | $ 2,551 | $ 12,064 | $ 12,917 | $ 14,492 | $ 14,780 | $ 12,639 | $ 12,549 | $ 12,687 | $ 42,024 | $ 52,655 | $ 41,266 |
Net loss | $ (2,464) | $ (11,941) | $ (12,682) | $ (14,388) | $ (14,588) | $ (12,481) | $ (12,407) | $ (12,602) | $ (41,475) | $ (52,078) | $ (40,969) |
Basic and diluted net loss per share (usd per share) | $ (0.06) | $ (0.28) | $ (0.30) | $ (0.34) | $ (0.35) | $ (0.30) | $ (0.29) | $ (0.39) | $ (0.98) | $ (1.31) | $ (1.31) |
Severance Costs - Additional In
Severance Costs - Additional Information (Detail) - USD ($) $ in Thousands | 1 Months Ended | 12 Months Ended | ||
Sep. 30, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Related Party Transaction [Line Items] | ||||
Severance costs | $ 2,395 | $ 0 | $ 0 | |
Staff Reduction Plan | ||||
Related Party Transaction [Line Items] | ||||
Approximate reduction in workforce, percent | 85.00% | |||
Severance costs | 2,100 | |||
Employee Severance | Staff Reduction Plan | ||||
Related Party Transaction [Line Items] | ||||
Total expected cost for staff reduction plan | $ 2,400 | |||
Unpaid severance costs included in other liabilities | $ 254 |
Subsequent Events - Additional
Subsequent Events - Additional Information (Details) $ / shares in Units, $ in Thousands, € in Millions | 1 Months Ended | 12 Months Ended | |||
Jan. 31, 2019USD ($)$ / sharesshares | Jan. 31, 2019EUR (€)shares | Dec. 31, 2018USD ($) | Dec. 31, 2017USD ($) | Dec. 31, 2016USD ($) | |
Subsequent Event [Line Items] | |||||
Severance costs | $ | $ (2,395) | $ 0 | $ 0 | ||
Options expiration period | 10 years | ||||
Subsequent Event | |||||
Subsequent Event [Line Items] | |||||
Severance costs | $ | $ 1,300 | ||||
Employee Stock Option | Subsequent Event | |||||
Subsequent Event [Line Items] | |||||
Options to be canceled (in shares) | 3,100,614 | 3,100,614 | |||
Options to be canceled (usd per share) | $ / shares | $ 6.53 | ||||
Restricted Stock Units (RSUs) | Subsequent Event | |||||
Subsequent Event [Line Items] | |||||
Options expiration period | 10 years | 10 years | |||
2014 Equity Plan | Restricted Stock Units (RSUs) | Subsequent Event | |||||
Subsequent Event [Line Items] | |||||
RSUs to be granted (in shares) | 5,100,000 | 5,100,000 | |||
Year One | Restricted Stock Units (RSUs) | Subsequent Event | |||||
Subsequent Event [Line Items] | |||||
Award vesting rights, percentage | 25.00% | 25.00% | |||
Year Two | Restricted Stock Units (RSUs) | Subsequent Event | |||||
Subsequent Event [Line Items] | |||||
Award vesting rights, percentage | 25.00% | 25.00% | |||
Year Three | Restricted Stock Units (RSUs) | Subsequent Event | |||||
Subsequent Event [Line Items] | |||||
Award vesting rights, percentage | 25.00% | 25.00% | |||
Options vesting, term | 4 years | 4 years | |||
Year Four | Restricted Stock Units (RSUs) | Subsequent Event | |||||
Subsequent Event [Line Items] | |||||
Award vesting rights, percentage | 25.00% | 25.00% | |||
Reverse Merger Investment | Subsequent Event | |||||
Subsequent Event [Line Items] | |||||
Consideration received on transaction | $ 30,500 | € 26.7 | |||
Immunic, Inc. | Vital Therapies, Inc. | Subsequent Event | |||||
Subsequent Event [Line Items] | |||||
Expected approximate ownership percentage | 89.00% | 89.00% | |||
Chief Executive Officer | Restricted Stock Units (RSUs) | Subsequent Event | |||||
Subsequent Event [Line Items] | |||||
Vested restricted stock units to be received by CEO upon termination (in shares) | 1,854,376 | 1,854,376 |