Document and Entity Information
Document and Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2018 | Mar. 07, 2019 | Jun. 30, 2018 | |
Document And Entity Information [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2018 | ||
Document Fiscal Year Focus | 2018 | ||
Document Fiscal Period Focus | FY | ||
Trading Symbol | ZSAN | ||
Entity Registrant Name | Zosano Pharma Corp | ||
Entity Central Index Key | 0001587221 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Emerging Growth Company | true | ||
Entity Ex Transition Period | true | ||
Entity Small Business | true | ||
Entity Shell Company | false | ||
Entity Public Float | $ 42,236,103 | ||
Entity Common Stock, Shares Outstanding | 11,973,039 |
Balance Sheets
Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Current assets: | ||
Cash and cash equivalents | $ 9,140 | $ 11,651 |
Marketable securities at fair value | 13,862 | 0 |
Prepaid expenses and other current assets | 358 | 1,742 |
Total current assets | 23,360 | 13,393 |
Restricted cash | 455 | 455 |
Property and equipment, net | 11,916 | 4,152 |
Other long-term assets | 49 | 0 |
Total assets | 35,780 | 18,000 |
Current liabilities: | ||
Accounts payable | 4,450 | 1,511 |
Accrued compensation | 2,092 | 1,571 |
Capital lease obligation, current portion | 5 | 0 |
Build-to-suit obligation, current portion | 2,326 | 0 |
Secured promissory note (including accrued interest), net of issuance costs | 0 | 6,687 |
Other accrued liabilities | 2,414 | 688 |
Total current liabilities | 11,287 | 10,457 |
Capital lease obligation, long-term portion | 18 | 0 |
Build-to-suit obligation, long-term portion, net of debt issuance costs and discount | 4,478 | 0 |
Deferred rent | 1,287 | 495 |
Total liabilities | 17,070 | 10,952 |
Commitments and contingencies (note 9) | ||
Stockholders’ equity: | ||
Preferred stock, $0.0001 par value, 5,000,000 shares authorized; none issued and outstanding as of December 31, 2018 and 2017 | 0 | 0 |
Common stock, $0.0001 par value; 250,000,000 and 100,000,000 shares authorized as of December 31, 2018 and 2017, respectively; 11,973,039 and 1,973,039 shares issued and outstanding as of December 31, 2018 and 2017, respectively | 1 | 0 |
Additional paid-in capital | 279,946 | 232,922 |
Accumulated deficit | (261,232) | (225,874) |
Accumulated other comprehensive loss | (5) | 0 |
Total stockholders’ equity | 18,710 | 7,048 |
Total liabilities and stockholders’ equity | $ 35,780 | $ 18,000 |
Balance Sheets (Parenthetical)
Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2018 | Dec. 31, 2017 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value (in USD per share) | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized (in shares) | 5,000,000 | 5,000,000 |
Preferred stock, shares issued (in shares) | 0 | 0 |
Preferred stock, shares outstanding (in shares) | 0 | 0 |
Common stock, par value (in USD per share) | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized (in shares) | 250,000,000 | 100,000,000 |
Common stock, shares issued (in shares) | 11,973,039 | 1,973,039 |
Common stock, shares outstanding (in shares) | 11,973,039 | 1,973,039 |
Statements of Operations and Co
Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Income Statement [Abstract] | ||
Revenue | $ 0 | $ 0 |
Operating expenses: | ||
Research and development | 25,508 | 20,118 |
General and administrative | 9,357 | 8,182 |
Impairment loss | 511 | 70 |
Total operating expenses | 35,376 | 28,370 |
Loss from operations | (35,376) | (28,370) |
Other income (expense): | ||
Interest income | 381 | 75 |
Interest expense | (379) | (817) |
Other income, net | 16 | 7 |
Loss before provision for income taxes | (35,358) | (29,105) |
Provision for income taxes | 0 | 0 |
Net loss | (35,358) | (29,105) |
Unrealized loss on marketable securities, net of tax | (5) | 0 |
Comprehensive loss | $ (35,363) | $ (29,105) |
Net loss per common share – basic and diluted (in usd per share) | $ (3.74) | $ (16.82) |
Weighted-average common shares outstanding – basic and diluted (in shares) | 9,452,491 | 1,730,388 |
Statements of Changes in Stockh
Statements of Changes in Stockholders' Equity - USD ($) $ in Thousands | Total | Common Stock | Additional Paid-In Capital | Accumulated Deficit | Accumulated Other Comprehensive Loss |
Beginning balance (in shares) at Dec. 31, 2016 | 840,798 | ||||
Beginning balance at Dec. 31, 2016 | $ 4,484 | $ 0 | $ 201,253 | $ (196,769) | $ 0 |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Issuance of common stock in connection with public offering (in shares) | 977,500 | ||||
Issuance of common stock in connection with public offering | 26,623 | 26,623 | |||
Issuance of common stock in connection with exercise of warrants (in shares) | 136,301 | ||||
Issuance of common stock in connection with exercise of warrants | 4,041 | 4,041 | |||
Issuance of common stock in connection with equity line of credit (in shares) | 11,375 | ||||
Issuance of common stock in connection with equity line of credit | 174 | 174 | |||
Issuance and release of restricted stock to certain board members as remuneration (in shares) | 2,139 | ||||
Issuance and release of restricted stock to certain board members as remuneration | $ 0 | ||||
Issuance of common stock to employees upon the exercise of stock options (in shares) | 0 | 4,926 | |||
Issuance of common stock to employees upon the exercise of stock options | $ 139 | 139 | |||
Stock-based compensation | 692 | 692 | |||
Unrealized loss on marketable securities | 0 | ||||
Net loss | $ (29,105) | (29,105) | |||
Ending balance (in shares) at Dec. 31, 2017 | 1,973,039 | 1,973,039 | |||
Ending balance at Dec. 31, 2017 | $ 7,048 | $ 0 | 232,922 | (225,874) | 0 |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Issuance of common stock in connection with public offering (in shares) | 10,000,000 | ||||
Issuance of common stock in connection with public offering | 45,604 | $ 1 | 45,603 | ||
Issuance of common stock warrants in connection with build-to-suit obligation | 243 | 243 | |||
Stock-based compensation | 1,178 | 1,178 | |||
Unrealized loss on marketable securities | (5) | (5) | |||
Net loss | $ (35,358) | (35,358) | |||
Ending balance (in shares) at Dec. 31, 2018 | 11,973,039 | 11,973,039 | |||
Ending balance at Dec. 31, 2018 | $ 18,710 | $ 1 | $ 279,946 | $ (261,232) | $ (5) |
Statements of Cash Flows
Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Cash flows from operating activities: | ||
Net loss | $ (35,358) | $ (29,105) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock based compensation | 1,178 | 692 |
Deferred rent | 936 | 443 |
Depreciation | 764 | 2,553 |
Effective interest on financing obligations | 304 | 51 |
Capitalized interest | (294) | 0 |
(Accretion) amortization of interest on marketable securities | (131) | 2 |
Impairment loss | 511 | 70 |
Other | (14) | (8) |
Change in operating assets and liabilities: | ||
Prepaid expenses and other assets | 1,208 | (1,279) |
Accounts payable | 98 | (34) |
Accrued compensation and other accrued liabilities | 1,676 | (224) |
Net cash used in operating activities | (29,122) | (26,839) |
Cash flows from investing activities: | ||
Purchase of marketable securities | (29,788) | (8,280) |
Proceeds from maturities of marketable securities | 16,050 | 8,274 |
Purchase of property and equipment | (5,490) | (1,244) |
Proceeds from sale of property and equipment | 15 | 22 |
Net cash used in investing activities | (19,213) | (1,228) |
Cash flows from financing activities: | ||
Proceeds from public offering of securities, net of commissions, discounts and other offering costs | 45,604 | 26,623 |
Proceeds from build-to-suit obligation, net of issuance costs | 7,570 | 0 |
Principal payments made on financing obligations | (6,999) | (5,808) |
Payment of term loan end of term charge | (351) | 0 |
Proceeds from exercise of warrants and issuance of common stock | 0 | 4,041 |
Proceeds from exercise of stock options and issuance of common stock | 0 | 139 |
Net cash provided by financing activities | 45,824 | 24,995 |
Net decrease in cash, cash equivalents, and restricted cash | (2,511) | (3,072) |
Cash, cash equivalents, and restricted cash at beginning of year | 12,106 | 15,178 |
Cash, cash equivalents, and restricted cash at end of year | 9,595 | 12,106 |
Supplemental cash flow information: | ||
Cash paid for interest | 884 | 865 |
Cash paid for income taxes | 2 | 2 |
Non-cash investing activities: | ||
Acquisition of property and equipment under accounts payable and other accrued liabilities | 3,374 | 144 |
Issuance of common stock warrants in connection with a build-to-suit obligation | 243 | 0 |
Issuance of common stock in connection with equity line of credit | 0 | 174 |
Property and equipment acquired through capital lease | $ 25 | $ 0 |
Organization
Organization | 12 Months Ended |
Dec. 31, 2018 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization | Organization The Company Zosano Pharma Corporation (the “Company”) is a clinical stage biopharmaceutical company focused on providing rapid systemic administration of therapeutics to patients using its proprietary Adhesive Dermally-Applied Microarray, or ADAM™, technology. On November 1, 2017, the Company's wholly owned subsidiary, ZP Opco. Inc., through which the Company conducted its primary research and development activities merged with and into Zosano Pharma Corporation, with Zosano Pharma Corporation as the surviving corporation of the merger. |
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 Basis of Presentation and Use of Estimates The accompanying financial statements have been prepared in accordance with accounting principles generally accepted in the United States ("U.S. GAAP"). The preparation of the accompanying financial statements in accordance with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities as of the date of the financial statements, and the reported amounts of revenue and expenses during the reporting periods. Actual results could differ from those estimates. On January 23, 2018, the stockholders approved an increase to the number of authorized shares of the Company’s common stock from 100,000,000 to 250,000,000 shares. On January 23, 2018, the board of directors approved a 1-for-20 reverse stock split of the outstanding common stock, which was effective on January 25, 2018. At the effective time, every twenty shares of common stock issued and outstanding were automatically combined into one share of issued and outstanding common stock. The par value of stock remained unchanged at $0.0001 per share. No fractional shares of the Company's common stock were issued in the reverse stock split, but in lieu thereof, each holder of the Company's common stock who would otherwise have been entitled to a fraction of a share in the reverse stock split received a cash payment. As a result of the reverse stock split, the number of the Company’s outstanding shares of common stock as of January 25, 2018 decreased from 39,460,931 (pre-split) shares to 1,973,039 (post-split) shares. Unless otherwise noted, all share and per share information included in these financial statements have been retroactively adjusted to give effect to the reverse stock split. The reverse stock split did not affect the number of authorized shares of common stock, which, after giving effect to the authorized share increase, is 250,000,000 shares. Liquidity and Substantial Doubt in Going Concern Since inception, the Company has incurred recurring operating losses and negative cash flows from operating activities, and as of December 31, 2018 , had an accumulated deficit of $261.2 million . As of December 31, 2018 , the Company had approximately $23.0 million in cash, cash equivalents and marketable securities. Presently, the Company does not have sufficient cash, cash equivalents and marketable securities to enable it to fund the anticipated level of operations and meet its obligations as they become due within twelve months following the date of issuance of this Annual Report on Form 10-K. The aforementioned factors raise substantial doubt about the Company’s ability to continue as a going concern for a period of one year from the issuance of these financial statements. The financial statements do not include any adjustments that might result from the outcome of this uncertainty. The Company plans to raise additional funding through financing, a capital offering, a license or collaboration agreement or a combination of such sources of capital. However, there are no assurances that additional funding will be achieved and that the Company will succeed in its future operations. The Company’s inability to obtain required funding in the near future or its inability to obtain funding on favorable terms will have a material adverse effect on its operations and strategic development plan for future growth. If the Company cannot successfully raise additional capital and implement its strategic development plan, its liquidity, financial condition and business prospects will be materially and adversely affected, and it may have to cease operations. The Company will continue to evaluate its timelines, strategic needs, and working capital requirements. There can be no assurance that if the Company attempts to raise additional capital, it will be successful in doing so on terms acceptable to the Company, or at all. Further, there can be no assurance that it will be able to gain access and/or be able to execute on securing new sources of funding, new development opportunities, successfully obtain regulatory approvals for and commercialize new products, achieve significant product revenues from its products (if approved), or achieve or sustain profitability in the future. Segment Reporting The Company operates in one reportable segment: the development of human pharmaceutical products. All long-lived assets are maintained in the United States, with the exception of $6.2 million of construction-in-progress related to the Company's commercial coating and primary packaging system that is being manufactured in Germany. Reclassification of Prior Year Presentation Certain prior year amounts have been reclassified for consistency with the current year presentation. These reclassifications had no effect on the reported results of operations. Cash, Cash Equivalents and Restricted Cash The Company considers all highly liquid investments purchased with an original maturity of 90 days or less to be cash equivalents. As of December 31, 2018 and 2017 , the Company had restricted cash of approximately $0.5 million consisting of deposits of $0.3 million to secure its building lease until the end of the lease term, a deposit of approximately $0.1 million to a utility provider and $35,000 to secure corporate purchase cards. The following table provides a reconciliation of cash, cash equivalents and restricted cash reported within the balance sheets and as presented as cash, cash equivalents and restricted cash in the statements of cash flows. December 31, 2018 December 31, 2017 (in thousands) Cash and cash equivalents $ 9,140 $ 11,651 Restricted cash 455 455 Total $ 9,595 $ 12,106 Marketable Securities Marketable securities generally consist of debt securities with original maturities greater than 90 days and remaining maturities of less than one year. All of the Company's investments are classified as available-for-sale and carried at fair value based upon quoted market price. The change in unrealized gains and losses is reported as a separate component of other comprehensive loss on the statements of operations and comprehensive loss and as a separate component of stockholders' equity on the balance sheets. Interest income includes interest, dividends, accretion and amortization of purchase premiums and discounts and realized gains and losses on sales of securities, if any. The cost of securities sold is based on the specific-identification method. The Company monitors its investment portfolio for potential impairment on a quarterly basis. If the carrying amount of an investment in marketable securities exceeds its fair value and the decline in value is determined to be other-than-temporary, the carrying amount of the security is reduced to fair value and a loss is recognized in operating results for the amount of such decline. In order to determine whether a decline in value is other-than-temporary, the Company evaluates, among other factors, the cause of the impairment, including the creditworthiness of the security issuers, the number of securities in an unrealized loss position, the severity and duration of the unrealized losses, and its intent and ability to hold the security to maturity or forecasted recovery. Fair Value Instruments The Company records its financial assets and liabilities at fair value. Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability (an exit price) in an orderly transaction between market participants at the reporting date. The accounting guidance establishes a three-tiered hierarchy, which prioritizes the inputs used in the valuation methodologies in measuring fair value as follows: Level 1: Inputs which include quoted prices in active markets for identical assets and liabilities. Level 2: Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. Level 3: Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. The carrying values of certain assets and liabilities of the Company, such as cash and cash equivalents, accounts receivable, and accounts payable, approximate fair value due to their relatively short maturities. The carrying value of the Company’s short-term financial obligations approximates their fair value as the terms of the borrowing are consistent with current market rates and the duration to maturity is short. Concentrations of Credit Risk Financial instruments that potentially subject the Company to a concentration of credit risk consist primarily of cash, cash equivalents and marketable securities. The Company invests its excess cash in money market funds, U.S. treasuries, corporate notes and commercial paper. The Company’s investment policy limits investments to certain types of debt securities issued by the U.S. government, its agencies and institutions with investment-grade credit ratings and places restrictions on maturities and concentration by type and issuer. Other than for obligations of the U.S. government, the Company’s policy is that no single issuer in the portfolio shall exceed 10% or $1 million , whichever is greater, of the total portfolio at the time of purchase. Bank deposits are held by a single financial institution having a strong credit rating and these deposits may at times be in excess of FDIC insured limits. The Company is exposed to credit risk in the event of a default by the financial institutions holding its cash and cash equivalents to the extent recorded on the balance sheets. Property and Equipment Property and equipment are stated at cost less accumulated depreciation. Depreciation is calculated using the straight-line method over the estimated useful lives of the respective assets, which range from three to five years for computer equipment and software, and nine years for manufacturing, laboratory, and office equipment. Leasehold improvements are depreciated over the shorter of the lease term or the estimated useful lives of the respective assets. The Company records as construction-in-progress (“CIP”) property and equipment that has not yet been placed in service for its intended use. All costs prior to a project becoming probable of being constructed are expensed as incurred. After the construction is considered probable, all directly identifiable costs related to an asset are capitalized. Interest related to construction of assets is capitalized when the financial statement effect of capitalization is material, construction of the asset has begun, and interest is being incurred. Interest capitalization ends at the earlier of the asset being substantially complete and ready for its intended use or when interest costs are no longer being incurred. When assets are retired or otherwise disposed of, the costs and accumulated depreciation are removed from the balance sheet and any resulting gain or loss is reflected in the statement of operations and comprehensive loss in the period realized. Impairment of Long-Lived Assets The Company identifies and records impairment losses on long-lived assets used in operations when events or changes in circumstances indicate that the carrying amount of an asset is likely not recoverable. Recoverability is measured by comparing the fair value to the related asset’s carrying value. If an asset is considered impaired, the asset is written down to fair value. Deferred Offering Costs Deferred offering costs represent legal, accounting and other direct costs related to the Company’s efforts to raise capital through a public or private sale of the Company’s common stock. These costs are deferred until the completion of the applicable offering, at which time such costs are reclassified to additional paid-in-capital as a reduction of the proceeds. Deferred Rent Rent expense is recognized on a straight-line basis over the non-cancelable term of the Company’s operating lease and, accordingly, the Company records the difference between cash rent payments and the recognition of rent expense as deferred rent. The Company also records lessor-funded lease incentives, such as reimbursable leasehold improvements, as deferred rent, which is amortized as a reduction of rent expense over the non-cancelable term of its operating lease. Capital Leases Capital leases are reflected as a liability at the inception of the lease based on the present value of the minimum lease payments or, if lower, the fair value of the property. Assets under capital leases are recorded in property and equipment, net on the balance sheets and depreciated in a manner similar to other property and equipment. Research and Development Expenses Research and development costs are charged to expense as incurred and consist of costs related to furthering the Company’s research and development efforts, seeking regulatory approval of its primary drug candidate, Qtrypta™ (M207) and pre-commercialization efforts for Qtrypta™ (M207). Research and development costs include salaries and related employee benefits, costs associated with clinical trials, nonclinical research and development activities, regulatory activities, costs of active pharmaceutical ingredients and raw materials, research and development related overhead expenses, and fees paid to contract manufacturing organizations ("CMO") that conduct manufacturing activities on behalf of the Company. For the year ended December 31, 2018 , the Company incurred research and development costs of approximately $13.9 million in connection with the Company's research and development efforts and approximately $11.6 million in the manufacturing of the Company’s intracutaneous delivery system and facility set-up and technology transfer fees to its commercial manufacturing organizations. For the year ended December 31, 2017 , the Company incurred research and development costs of approximately $10.3 million in connection with the Company’s research and development efforts and approximately $9.8 million in the manufacturing of the Company’s intracutaneous delivery system for development of the Company’s product candidate. Clinical Trial Costs Clinical trial costs are a component of research and development expenses. The Company expenses clinical trial activities performed by third parties based upon actual work completed in accordance with agreements established with clinical research organizations and clinical sites. The Company accrues clinical trial expenses each reporting period. The Company determines the actual costs through discussions with internal personnel and external service providers as to the progress or stage of completion of trials or services and the agreed-upon fee to be paid for such services. Stock-Based Compensation The Company has equity incentive plans under which various types of equity-based awards including, but not limited to, non-qualified stock options and restricted stock awards, may be granted to employees, non-employee directors, and non-employee consultants. The Company’s equity incentive plans also allow incentive stock options to be awarded to employees. The Company has also awarded inducement grants to purchase common stock to new employees outside the existing equity compensation plans in accordance with Nasdaq listing rule 5635(c)(4). For stock options granted to employees and directors, the Company recognizes compensation expense for all stock-based awards based on the estimated grant-date fair values, net of an estimated forfeiture rate. For restricted stock awards to employees, the fair value is based on the closing price of the Company's common stock on the date of grant. The value of the portion of the award that is ultimately expected to vest is recognized as expense ratably over the requisite service period. The fair value of stock options is determined using the Black-Scholes option pricing model. The Company estimates its forfeiture rate based on an analysis of its actual forfeitures and will continue to evaluate the adequacy of the forfeiture rate assumption based on actual forfeitures, analysis of employee turnover, and other related factors. Stock-based compensation expense related to stock options granted to non-employees is recognized based on the fair value of the stock options, determined using the Black-Scholes option pricing model, as they are earned. Warrants The Company has issued freestanding warrants to purchase shares of common stock in connection with certain debt and a build-to-suit arrangement. The warrants are recorded at fair value using the Black-Scholes option pricing model. Income Taxes The Company uses the liability method to account for income taxes. Under this method, deferred tax assets and liabilities are determined based on differences between the financial statement carrying amounts of existing assets and liabilities and their tax bases. Deferred tax assets and liabilities are measured using enacted tax rates applied to taxable income in the years in which those temporary differences are expected to be recovered or settled. A valuation allowance is established when necessary to reduce deferred tax assets to the amount expected to be realized. Financial statement effects of uncertain tax positions are recognized when it is more-likely-than-not, based on the technical merits of the position, that it will be sustained upon examination. Interest and penalties related to unrecognized tax benefit, if any, will be included within the provision for income tax. Interest Expense Interest expense, includes cash and non-cash components with the non-cash components consisting of (i) interest recognized from the amortization of debt discount and issuance costs, which were capitalized on the balance sheets, that are generally derived from cash payments or warrants issued related to financing obligations, (ii) interest recognized from the amortization of purchase option and termination fees related to financing obligations, which were accrued and capitalized on the balance sheet offset by (iii) interest income recognized from the accretion of debt premiums and (iv) interest capitalized for assets constructed for use in operations. The capitalized amounts related to the debt issuance costs and debt discounts are generally amortized to interest expense over the term of the related debt instruments unless they are attributable to assets constructed for use in operations and are capitalized as construction-in-progress until the asset is substantially complete and ready for its intended use. Net Loss Per Common Share Basic net loss per common share is calculated by dividing the net loss by the weighted-average number of common shares outstanding during the period, without consideration for potentially dilutive securities. Diluted net loss per common share is computed by dividing the net loss attributable to common stockholders by the weighted-average number of common shares and potentially dilutive securities outstanding for the period determined using the treasury-stock and if-converted methods. For purposes of the diluted net loss per share calculation, convertible promissory notes, common stock warrants and stock options are considered to be potential dilutive securities but are excluded from the calculation of diluted net loss per share because their effect would be anti-dilutive and therefore, basic and diluted net loss per share were the same for all periods presented. The following outstanding common stock equivalents were excluded from the computations of diluted net loss per common share for the periods presented as the effect of including such securities would be antidilutive: December 31, 2018 2017 (shares) Warrants to purchase common stock 274,524 199,524 Options to purchase common stock 1,309,994 118,379 Total 1,584,518 317,903 Recent Accounting Pronouncements Recently Adopted Accounting Pronouncements In November 2016, the Financial Accounting Standards Board ("FASB") issued Accounting Standards Update ("ASU") 2016-18, Statement of Cash Flows (Topic 230): Restricted Cash , which requires companies to include amounts generally described as restricted cash and restricted cash equivalents in cash and cash equivalents when reconciling beginning-of-period and end-of-period total amounts shown on the statements of cash flows. The Company adopted this standard effective January 1, 2018, using the retrospective transition approach. Accordingly, as a result of the adoption of this accounting guidance prior period information has been adjusted to include the addition of restricted cash to cash and cash equivalents on the Company’s statements of cash flows. Recent Accounting Pronouncements Not Yet Adopted In August 2018, the FASB issued ASU2018-15, Intangible - Goodwill and Other - Internal-Use Software (Subtopic 350-40) , which aligns the requirements for capitalizing implementation costs incurred in a hosting arrangement that is a service contract with the requirements for capitalizing implementation costs incurred to develop or obtain internal-use software. ASU2018-15 is effective for the Company in the first quarter of 2020. Early adoption is permitted. ASU2018-15 permits either a prospective or retrospective transition approach. The Company is currently evaluating ASU2018-15 to determine the impact to its financial statements and related disclosures. In August 2018, the FASB issued ASU2018-13, Fair Value Measurement (Topic 820) . The new guidance modifies the disclosure requirements on fair value measurements. ASU2018-13 is effective for the Company beginning in the first quarter of 2020 and must be adopted on a modified retrospective basis, with certain exceptions. Early adoption is permitted. The Company does not expect ASU2018-13 to have a significant impact to its financial statements and disclosures. In June 2018, the FASB issued ASU2018-07, Compensation - Stock Compensation (Topic 718); Improvements to Nonemployee Share-Based Payment Accounting which aligned certain aspects of share-based payments accounting between employees and non-employees. Specifically, nonemployee share-based payment awards within the scope of Topic 718 are measured at grant-date fair value of the equity instruments that an entity is obligated to issue when the good has been delivered or the service has been rendered and any other conditions necessary to earn the right to benefit from the instruments have been satisfied and an entity considers the probability of satisfying performance conditions when nonemployee share-based payment awards contain such conditions. ASU2018-07 is effective for the Company beginning in the first quarter of 2019. The new standard will not have a significant impact on the Company's financial statements or disclosures. In June 2016, the FASB issued ASU2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments and in November 2018, issued ASU2018-19, which amended the standard. This new guidance is intended to present credit losses on available for sale debt securities as an allowance rather than as a write-down. Entities are required to apply the standard's provisions as a cumulative-effect adjustment to retained earnings as of the beginning of the first reporting period in which the guidance is adopted. ASU2016-13 is effective for the Company in the first quarter of 2020. The Company is currently evaluating ASU2016-13 and ASU2018-19 to determine the impact to its financial statements and disclosures. In February 2016, the FASB issued authoritative guidance under ASU2016-02, Leases (Topic 842). ASU2016-02 requires lessees to recognize right-of-use assets and lease liabilities for most leases on the balance sheet and to provide expanded disclosures about leasing arrangements. ASU2016-02 is effective for fiscal years beginning after December 15, 2018, with early adoption permitted. The Company will adopt this guidance effective January 1, 2019 using the optional transition method and will not restate comparative periods. The Company's assessment of the impact of the adoption of this standard is substantially complete and will result in the recognition of right-of-use assets of approximately $6.4 million and lease liabilities of approximately $7.8 million with no material impact to the statement of operations and comprehensive loss. Additionally, the Company will no longer have a deferred rent liability of approximately $1.4 million . |
Cash Equivalents and Marketable
Cash Equivalents and Marketable Securities | 12 Months Ended |
Dec. 31, 2018 | |
Cash and Cash Equivalents [Abstract] | |
Cash Equivalents and Marketable Securities | Cash Equivalents and Marketable Securities The following is a summary of the Company’s cash equivalents and marketable securities measured at fair value on a recurring basis: Fair value Measurements Total Quoted prices in active market Level I Significant other observable inputs Level II Significant unobservable inputs Level III (in thousands) As of December 31, 2018: Money market funds $ 4,830 $ 4,830 $ — $ — Commercial paper 1,497 — 1,497 — Corporate notes and bonds 6,989 — 6,989 — U.S. treasuries 8,375 8,375 — — Total $ 21,691 $ 13,205 $ 8,486 $ — Classified as: Cash equivalents $ 7,829 Marketable securities at fair value 13,862 Total $ 21,691 Fair value Measurements Total Quoted prices in active market Level I Significant other observable inputs Level II Significant unobservable inputs Level III (in thousands) As of December 31, 2017: Money market funds $ 6,414 $ 6,414 $ — $ — U.S. government agencies 650 — 650 — Total $ 7,064 $ 6,414 $ 650 $ — Classified as: Cash equivalents $ 7,064 The company did not transfer any marketable securities measured at fair value on a recurring basis to or from Level 1 and Level 2 during the years ended December 31, 2018 and 2017. The following is a summary of the unrealized positions for available-for-sale fixed-maturity debt securities disaggregated by class of instrument: December 31, 2018 (in thousands) Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Money market funds $ 4,830 $ — $ — $ 4,830 Commercial paper 1,497 — — 1,497 Corporate notes and bonds 6,994 — (5 ) 6,989 U.S. treasuries 8,375 — — 8,375 Total $ 21,696 $ — $ (5 ) $ 21,691 December 31, 2017 (in thousands) Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Money market funds $ 6,414 — — 6,414 U.S. government agency bonds 650 — — 650 Total $ 7,064 $ — $ — $ 7,064 As of December 31, 2018 , the maximum contractual maturity of the Company’s available-for-sale investments was within five months. The Company does not intend to sell the investments that are in an unrealized loss position, and it is unlikely that the Company will be required to sell the investments before recovery of their amortized cost basis, which may be at maturity. The Company has determined that the gross unrealized losses on its available-for-sale investments as of December 31, 2018 were temporary in nature. |
Property and Equipment
Property and Equipment | 12 Months Ended |
Dec. 31, 2018 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment | Property and Equipment The following summarizes the Company’s property and equipment for each of the periods presented: December 31, 2018 December 31, 2017 (in thousands) Leasehold improvements $ 16,690 $ 15,660 Manufacturing equipment 10,387 10,387 Laboratory and office equipment 1,434 1,159 Computer equipment and software 206 209 Construction-in-progress 9,558 2,351 38,275 29,766 Less: accumulated depreciation (26,359 ) (25,614 ) Total $ 11,916 $ 4,152 Depreciation expense was approximately $0.8 million and $2.6 million for the years ended December 31, 2018 and 2017 , respectively. The decrease in depreciation expense in 2018 as compared to 2017 was a result of certain leasehold improvements becoming fully depreciated in 2017. The gross property and equipment and accumulated depreciation presented in the above table include property under capital lease and the related accumulated amortization, respectively. Property under capital lease is comprised of office equipment. Capital lease assets included in property and equipment in the balance sheets were $24,000 and zero at December 31, 2018 and 2017 , respectively. Accumulated amortization on the property under capital lease was insignificant at December 31, 2018 and 2017 . At December 31, 2018 , construction-in-progress included $6.2 million of an asset relating to the build-to-suit arrangement for construction of the Company's commercial coating and primary packaging system, of which capitalized construction period interest was $0.3 million (See Note 7. Debt Financing ). Impairment The Company evaluates its long-lived assets for indications of possible impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of assets is measured by a comparison of the carrying amount of the asset to the estimated undiscounted future cash flows expected to be generated by the asset. If the carrying amount of the asset exceeds its estimated future cash flows, an impairment charge is recognized for the amount by which the carrying amount of the asset exceeds the fair value of the asset. Previously, the Company discontinued its D107 research and development program, and concluded that the D107 related assets could be repurposed. In 2018, the Company performed an impairment analysis of the D107 related assets to determine fair value based on highest and best use. The Company concluded that only certain of these assets would be able to be repurposed for other research and development projects. As a result, the Company determined the fair value based on its highest and best use and that for certain D107 related assets, the carrying value of the assets was not entirely recoverable and the fair value, which was calculated using the market or cost approach depending on the specific asset, was lower than the carrying value. Accordingly, the Company recorded an impairment loss of approximately $0.4 million for D107 related assets. In 2018, the Company defined its manufacturing strategy for Qtrypta™ (M207), resulting in the decision to use CMOs for future clinical supply and commercial product production. As a result of this strategy, the Company entered into a drug delivery and supply agreement with a new supplier to design and manufacture the Company’s next generation applicator, obsoleting custom manufacturing equipment that had been used to manufacture the Company’s current applicator. The Company performed an impairment analysis of the manufacturing equipment assets to determine fair value based on highest and best use. The Company concluded that due to the custom nature of the assets that they could not be repurposed and that there was not a secondary market for the assets. As a result, the Company determined the fair value was not entirely recoverable and the fair value, which was calculated using the market or cost approach depending on the specific asset, was lower than the carrying value. Accordingly, the Company recorded an impairment loss of approximately $0.1 million for custom manufacturing assets. For the year ended December 31, 2017 , the Company recognized $0.1 million of impairment losses, primarily related to laboratory equipment with no current or future utility to the Company. |
Other Accrued Liabilities
Other Accrued Liabilities | 12 Months Ended |
Dec. 31, 2018 | |
Payables and Accruals [Abstract] | |
Other Accrued Liabilities | Other Accrued Liabilities The following summarizes the Company’s other accrued liabilities for each of the periods presented: December 31, 2018 December 31, 2017 (in thousands) Contract manufacturing $ 834 $ — Pre-clinical and clinical study 483 88 Construction-in-progress obligations 395 45 Accrued taxes 187 — Professional service fees 112 377 Other 403 178 Total $ 2,414 $ 688 |
Capital Lease Obligation
Capital Lease Obligation | 12 Months Ended |
Dec. 31, 2018 | |
Leases [Abstract] | |
Capital Lease Obligation | Capital Lease Obligation The Company leases certain equipment under a non-cancelable agreement, that was accounted for as a capital lease and expires in 2022 . The effective interest rate on this lease is 25% . The scheduled lease payments of the capital lease obligation for each year ending December 31 were as follows (in thousands): Year 2019 $ 10 2020 10 2021 10 2022 4 34 Less: amount representing interest (11 ) Total $ 23 Capital lease obligation, current $ 5 Capital lease obligation, long-term 18 Total $ 23 |
Debt Financing
Debt Financing | 12 Months Ended |
Dec. 31, 2018 | |
Debt Disclosure [Abstract] | |
Debt Financing | Debt Financing Build-to-Suit Obligation with Trinity In September 2018, the Company entered into a build-to-suit arrangement with Trinity Capital Fund III, L.P., ("Trinity") in order to obtain financing for the third party construction of the Company's commercial coating and primary packaging system (the "Equipment"), expected to be completed in the second quarter of 2020. Under the agreement, Trinity will make available to the Company $14.0 million for equipment costs and associated soft costs ("Total Cost"), with an initial drawdown of $5.0 million and additional drawdowns in increments of not less than $0.5 million , until March 30, 2020. At March 30, 2020, any unused portion of the $14.0 million will be subject to a non-utilization fee equal to 3% of the unused amount. In consideration of the financing arrangement, as collateral, the Company granted Trinity a first-priority lien and security interest in substantially all the Company's assets. The Company determined that it is the deemed owner, for financial reporting purposes, of the Equipment during the construction period due to its involvement in and its obligations related to the construction of the Equipment. Accordingly, construction costs incurred were recorded as construction-in-progress, a component of property and equipment on the balance sheet and the Trinity financing obligation was recorded as a build-to-suit obligation on the balance sheet. Under the financing arrangement, each individual drawdown represents a separate financing arrangement with its own 36 -month-term and stated interest rate. Each drawdown is non-cancelable, with no prepayment options. Each drawdown has embedded optional purchase options to (i) extend the term for an additional three months , with the option to purchase the equipment at 4% of the Total Cost, which is equal to the drawdown amount, following the end of such extended term, or (ii) purchase the equipment at 12% of the Total Cost, which is equal to the drawdown amount, at the end of the 36-month-term. The Company intends to exercise the optional purchase option of 12% at the end of each 36 -month-term ("Purchase Option Fee"). The transfer of title from Trinity to the Company will occur at the end of the final 36 -month-term, provided that the purchase option was executed and the Purchase Option Fee was paid in full at the end of each 36 -month-term. Failure to pay any of the Purchase Option Fees will result in Trinity retaining title to the Equipment and the Company paying a 6% restocking fee. In September 2018, upon commencement of this arrangement, the Company drew its first drawdown of $5.0 million , of which $2.7 million was for the Company’s commercial coating and primary packaging system, $2.0 million was used to extinguish an existing loan (see below), and the remaining $0.3 million was withheld by Trinity for interim interest and a security deposit that will be applied to the final monthly payment. The monthly loan payment is $160,000 , with a stated and effective interest rate of 9.43% and 26.28% , respectively. The Purchase Option Fee of $0.6 million was recorded as a discount to the principal balance. The first drawdown of $5.0 million matures on October 1, 2021. In connection with the build-to-suit arrangement, the Company issued common stock warrants ("Trinity Warrants") for a total of 75,000 shares of common stock at an exercise price of $3.59 per share. The Trinity Warrants expire on September 25, 2025. Proceeds allocated to the Trinity Warrants based on their relative fair value approximated $243,000 and were recorded as a discount to the initial $5.0 million drawdown under the Trinity financing arrangement and are being amortized as interest over the term of the September 2018 drawdown. In December 2018, the Company drew a second drawdown of $2.8 million , of which $2.6 million was for the Company’s commercial coating and primary packaging system, and the remaining $0.2 million was withheld by Trinity for interim interest, the first monthly payment and a security deposit that will be applied to the final monthly payment. The monthly loan payment is approximately $90,000 with a stated and effective interest rate of 9.68% and 19.58% , respectively. The Purchase Option Fee of approximately $0.3 million was recorded as a discount to the principal balance. The second drawdown of $2.8 million matures on January 1, 2022. As of December 31, 2018 , the Company had an aggregate commercial coating and primary packaging system CIP balance of $6.2 million that included $0.3 million of interest related to its build-to-suit obligation, of which $37,000 was attributable to the Trinity Warrants; and a net build-to-suit obligation of $6.8 million . As of December 31, 2018 , $6.2 million remains available to the Company under the Trinity build-to-suit arrangement. The following is a summary of the Company's build-to-suit obligation as of December 31, 2018 (in thousands): Build-to-suit obligation principal amount $ 7,120 Build-to-suit obligation Purchase Option Fees 936 Less: Unamortized Purchase Option Fees (845 ) Unamortized fair value of free-standing warrants (207 ) Unamortized debt discount (178 ) Unamortized debt issuance costs (22 ) Build-to-suit obligation, net of debt issuance costs and discount $ 6,804 Build-to-suit obligation, current portion $ 2,326 Build-to-suit obligation, long-term portion, net of debt issuance costs and discount 4,478 Build-to-suit obligation, net of debt issuance costs and discount $ 6,804 Future minimum payments on the Company’s build-to-suit obligation, including payment of principal and interest and Purchase Option Fees for each year ending December 31 were as follows (in thousands): Year Principal Interest Purchase Option Fees (in thousands) 2019 $ 2,326 $ 583 $ — 2020 2,632 367 — 2021 2,162 107 936 Total $ 7,120 $ 1,057 $ 936 Senior Secured Term Loan with Hercules In June 2014 and June 2015, the Company entered into a loan and security agreement and the first amendment to the loan and security agreement, respectively, with Hercules Capital, Inc. (“Hercules”). Hercules provided the Company a $15.0 million term loan ("Hercules Term Loan") of which equal installment payments of principal and interest were due monthly, with a scheduled maturity date of December 1, 2018 . The Hercules Term Loan bore interest at a variable rate equal to the greater of (i) 7.95% , or (ii) 7.95% plus the prime rate as quoted in the Wall Street Journal minus 5.25% . On June 1, 2017, the Company paid a $0.1 million legacy end of term charge. On September 25, 2018, the Company paid all its outstanding obligations under the Hercules Term Loan, including an end of term charge of approximately $0.4 million . The gain on extinguishment of the Hercules Term Loan was insignificant. |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Dec. 31, 2018 | |
Equity [Abstract] | |
Stockholders' Equity | Stockholders’ Equity On January 24, 2018, the Company amended its certificate of incorporation to increase the number of shares of common stock authorized for issuance from 100,000,000 to 250,000,000 . On January 25, 2018, the Company effected a 1-for- 20 reverse stock split of its outstanding common stock. Public Offering - March 2017 On March 22, 2017, the Company completed a registered public offering of 977,500 shares of common stock at a price of $30.00 per share, which included the exercise in full by the underwriters of their over-allotment option to purchase up to 127,500 additional shares of common stock. The total proceeds from the offering were $26.6 million , net of underwriter’s discounts and commissions and offering expenses. Public Offering - April 2018 On April 3, 2018, the Company completed a registered public offering of 10,000,000 shares of common stock at a price of $5.00 per share. The total proceeds from the offering were approximately $45.6 million , net of underwriter's discounts and commissions and offering expenses. Equity Line of Credit On October 20, 2017, the Company entered into a purchase agreement and a registration rights agreement with an accredited investor, Lincoln Park Capital LLC ("Lincoln Park"), providing for the purchase of up to $35.0 million worth of the Company’s common stock over a 30-month-term that commenced on November 21, 2017 ("Equity Line of Credit"). Under the terms and subject to the conditions of the Equity Line of Credit, the Company has the right, but not the obligation, to sell to Lincoln Park, and Lincoln Park is obligated to purchase, up to $35.0 million worth of shares of the Company’s common stock. The Company’s board of directors reserved 392,104 shares for issuance pursuant to the Equity Line of Credit (inclusive of commitment shares). On October 20, 2017, the Company issued 11,375 shares of its common stock, as initial commitment shares, to Lincoln Park with a fair value of $15.30 per share. The value of the commitment shares and professional service fees to secure the Equity Line of Credit were recorded as deferred financing costs and are being amortized as interest expense over the term of the Equity Line of Credit, as there is no guarantee that additional shares will be sold under the Equity Line of Credit. Deferred financing costs of $0.2 million and $0.3 million were recorded in prepaid expenses and other current assets and long-term assets in the accompanying balance sheets as of December 31, 2018 and 2017 , respectively. The Company will issue, pro rata, up to an additional 11,375 shares of its common stock as additional commitment shares to Lincoln Park in connection with any additional purchases. Such future sales of common stock by the Company, if any, will be subject to certain limitations, and may occur from time to time, at the Company’s option, over the 30-month-term of the Equity Line of Credit. No sales of common stock have been made under the Equity Line of Credit as of December 31, 2018 . Private Investment in Public Equity (“PIPE”) – August 2016 On August 15, 2016, the Company entered into a Securities Purchase Agreement (“Purchase Agreement”) between the Company and certain investors, including members of the Company’s board of directors and executive management, pursuant to which the Company sold and issued shares of common stock and warrants to purchase shares of common stock for aggregate gross proceeds of $7.5 million . Costs related to the offering were $0.9 million . Pursuant to the Purchase Agreement, the Company sold 239,997 common shares at $26.40 per common share. Additionally, 480,000 warrants were sold, at a price of $2.50 per warrant. Each warrant grants the holder the right to purchase one share of the Company’s common stock. The Company granted 239,997 Series A Warrants, which expired in August 2017. The Company granted 239,997 Series B Warrants, which have a per share exercise price of $31.00 and expire in August 2021. Certain of the Company's board of director and executive officers purchased an aggregate of 13,771 shares of common stock and an aggregate of 27,542 warrants in this offering at the same price as the other investors. As of December 31, 2018 , 195,906 warrants, which were issued in conjunction with the PIPE, remain outstanding. Hercules Warrants In connection with the Company’s entry into the Hercules Term Loan in June 2014, the Company issued Hercules warrants to purchase 1,583 shares of the Company’s common stock at an exercise price of $176.80 per share. In June 2015, when the Company entered into the first amendment to the Hercules Term Loan, the Company issued Hercules warrants to purchase 2,035 shares of the Company’s common stock at an exercise price of $147.40 per share. Trinity Warrants In connection with its build-to-suit arrangement, the Company issued the Trinity Warrants for a total of 75,000 shares of common stock at an exercise price of $3.59 per share. The Trinity Warrants expire on September 25, 2025. Proceeds allocated to the Trinity Warrants based on their relative fair value approximated $0.2 million and were recorded as a discount to the initial $5.0 million drawdown under the Trinity financing arrangement and are being amortized over the 36-month-term of the September 2018 drawdown. The following warrants were issued and outstanding as of December 31, 2018 : Warrants Warrants Issued Warrants Exercised Warrants Expired Warrants Exercise Price Expiration Date PIPE Financing - Series B 195,906 — — — 195,906 $ 31.00 8/19/2021 Hercules - June 2014 1,583 — — — 1,583 $ 176.80 1/27/2020 Hercules - June 2015 2,035 — — — 2,035 $ 147.40 6/23/2020 Trinity - September 2018 — 75,000 — — 75,000 $ 3.59 9/25/2025 Total 199,524 75,000 — — 274,524 Each warrant grants the holder the right to purchase one share of common stock. Equity warrants are recorded at their relative fair market value in the stockholders’ equity section of the balance sheet. The Company’s equity warrants can only be settled through the issuance of shares and do not have any anti-dilution or price reset provision. |
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 The Company has a non-cancelable operating lease with BMR-34790 Ardentech Court LP ("BMR") for office, research and development, and manufacturing facilities in Fremont, California. Prior to December 2017, BMR was a related party due to its affiliation with Bruce D. Steel, who served as director of the Company until December 13, 2017. As of December 31, 2018, BMR was no longer a related party. On June 6, 2017, the Company entered into the seventh amendment to the existing lease ("Seventh Amendment"), effective as of May 30, 2017, that extended the term of the lease through August 31, 2024, with an option to further extend the lease for an additional 60 months, subject to certain terms and conditions. The Company agreed to pay a monthly base rent of approximately $136,000 for the period commencing September 1, 2017, and ending on August 31, 2018, with annual increases on September 1 of each subsequent year until the lease year beginning September 1, 2023. The Seventh Amendment also provided for rent abatements, subject to certain conditions, totaling $0.3 million and certain tenant improvements to be completed at the landlord’s expense of approximately $1.0 million by May 30, 2018. The Company entered into the eighth amendment to the existing lease effective as of May 30, 2018, which extended the deadline for the Company to cause certain tenant improvements to be completed at the landlord's expense to September 30, 2018. The Company incurred additional expense of approximately $0.4 million under the lease in connection with roof repairs that are treated as additional rent and paid over the term of the lease. The Company records rent expense under the lease on a straight-line basis over the term of the lease. The difference between the actual lease payments and the expense recognized under the lease, along with the unamortized tenant improvement allowances, resulted in a net deferred rent liability of approximately $1.4 million and $0.5 million as of December 31, 2018 and 2017 , respectively. For the years ended December 31, 2018 and 2017 , rent expense under operating leases was $1.6 million and $1.2 million , respectively. As of December 31, 2018 , future minimum payments under all non-cancelable operating leases for each year ending December 31 were as follows (in thousands): Year 2019 $ 1,762 2020 1,815 2021 1,863 2022 1,914 2023 and thereafter 3,310 Total $ 10,664 Employment Arrangements The Company has entered into employment agreements with some of its executive officers. Generally, the terms of these agreements provide for base salary, health care coverage, annual bonus and stock options. In addition, if the Company terminates the officer other than for cause, death, or disability, or if the officer terminates his or her employment with the Company for good cause, the officer shall be entitled to receive certain severance compensation and benefits as described in each such agreement as well as automatic acceleration of vesting, at a certain percentage ( 25% or 100% ), of their unvested stock options and other equity awards on the date of such termination. The employment agreements with the Company’s Chief Executive Offer ("CEO") and Chief Financial Officer ("CFO") provide for the payment of base salary and healthcare coverage if the Company terminates their employment other than for cause or in the event of their resignation for good reason. Under the terms of his employment agreement, the CEO is entitled to receive base salary for twelve months, healthcare coverage for twelve months, and an amount equal to the amount of the annual bonus awarded to him in the calendar year prior to such termination. Under the terms of his employment agreement, the CFO is entitled to receive base salary for six months and payment or reimbursement for healthcare coverage for up to six months. The employment agreements with both the CEO and CFO also provide for the automatic acceleration of vesting of 25% of their unvested stock options and other equity awards on the date of such termination. During the one-year period following a change in control of the Company, if the Company terminates the CEO or CFO without cause or if the CEO or CFO resign for good reason, the CEO and CFO are entitled to receive additional compensation. In the event of such termination, the CEO is entitled to receive a lump sum severance payment equal to 24 months of base salary, a lump sum payment equal to 229.56% of projected premiums for group medical, dental and vision insurance coverage for 24 months, and an amount equal to the amount of the annual bonus awarded to him in the calendar year prior to such termination. The CFO is entitled to receive a lump sum severance payment equal to twelve months of base salary, payment or reimbursement for healthcare coverage for up to twelve months, and an amount equal to the bonus he earned for the preceding fiscal year. In addition, the employment agreements with both the CEO and CFO provide for the automatic acceleration of vesting of 100% of their unvested stock options and other equity awards on the date of such termination. The Company also has employment agreements with its Vice President of Clinical Development and Medical Affairs ("VPCDMA") and Senior Vice President of Operations ("SVPO"). The agreements provide for the continuation of payment of base salary for six months and payment or reimbursements for healthcare coverage for up to six months in the event of termination of their employment with the Company without cause or their resignation for good reason. The employment agreements also provide for the automatic acceleration of vesting of 25% of their unvested stock options and other equity awards on the date of such termination. If such termination or resignation occurs during the one-year period following a change in control of the Company, the VOCDMA and SVPO are entitled to receive lump sum severance payments equal to 12 months of base salary, payment or reimbursement for healthcare coverage for up to twelve months and an amount equal to their bonus, if any, earned for the immediately proceeding year. In addition, the employment agreements provide for the automatic acceleration of vesting of 100% of their unvested stock options and other equity awards on the date of such termination. Equipment Purchase Commitments In May 2018, the Company entered into a purchase order with an equipment manufacturer to purchase a commercial coating and primary packaging machine for the production of its product candidate, Qtrypta™ (M207), for an aggregate purchase price of $12.2 million . The terms of the purchase commitment are contingent upon performance of certain milestones. The Company anticipates that the obligation will be paid over an 18 month period. As of December 31, 2018 , the Company had made payments totaling $3.0 million . During 2018, the Company also entered into agreements with equipment manufacturers to produce its patch assembly machine and its applicator and retainer machinery. The aggregate purchase price of this equipment is $3.5 million of which $0.9 million was paid in 2018. Contract Manufacturing Organizations In September 2018, the Company entered into a manufacturing and supply agreement with a contract manufacturing organization to provide services related to the manufacture and commercialization of Qtrypta™ (M207). During the term of the agreement, the CMO will provide services related to processing, packaging, labeling and storing Qtrypta™ (M207), in addition to other services such as stability testing, quality control and assurance, and waste disposal. The agreement calls for annual fees of $1.0 million in 2019 escalating to $14.0 million in 2024, to be paid in equal monthly installments. Beginning in 2020, the annual fee includes the production of a defined number of units with an option to purchase additional units at a defined price. The agreement contains negotiated representations and warranties, indemnification, limitations of liability, and other provisions. The initial term of the agreement continues until the seventh anniversary of the date on which the Company receives New Drug Application approval of Qtrypta™ (M207) in the United States. The Company may elect to terminate the agreement at any time prior to certain regulatory approvals or if such regulatory approval is withdrawn under certain circumstances. Upon termination of the contract, the Company would incur cancellation fees of 50% of the annual fee due in the year that the contract is terminated, estimated to be between $1.0 million and $1.4 million , and costs to remove the Company's equipment and restore the CMO's facility to its original condition. The Company or the CMO may terminate the agreement for the other’s uncured material breach, uncured force majeure or bankruptcy or insolvency-related events. At December 31, 2018 , the Company had entered into agreements with CMOs for the construction of dedicated manufacturing space and technology transfer fees of $4.1 million of which $0.2 million had been paid. Indemnification and Guarantees In the normal course of business, the Company enters into contracts and agreements that contain a variety of representations and warranties and provide for general indemnifications. The Company’s exposure under these agreements is unknown because it involves claims that may be made against the Company in the future but have not yet been made. To date, the Company has not paid any claims or been required to defend any action related to its indemnification obligations. However, the Company may record charges in the future as a result of these indemnification obligations. The Company also has indemnification obligations to its officers and directors for specified events or occurrences, subject to some limits, while they are serving at the Company’s request in such capacities. There have been no claims to date and the Company has director and officer insurance that may enable the Company to recover a portion of any amounts paid for future potential claims. The Company believes the fair value of these indemnification agreements is minimal. Accordingly, the Company has not recorded any liabilities for these agreements as of December 31, 2018 . Legal Proceedings The Company is not party to any material pending legal proceedings. However, it may from time to time become involved in litigation relating to claims arising in the ordinary course of business. |
Stock-Based Compensation
Stock-Based Compensation | 12 Months Ended |
Dec. 31, 2018 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Stock-Based Compensation | Stock-Based Compensation The 2012 Stock Incentive Plan The 2012 Stock Incentive Plan ("2012 Plan") provided for the granting of stock options and restricted stock awards to employees, directors and consultants of the Company. Options granted under the 2012 Plan were either incentive stock options or nonqualified stock options. Incentive stock options were granted only to Company employees. Nonqualified stock options were granted to Company employees, outside directors and consultants. Options and awards under the 2012 Plan were granted for periods of up to ten years . Employee options granted by the Company generally vest over four years . In connection with the Company’s initial public offering of its common stock, the Company’s board of directors terminated the 2012 Plan effective as of January 27, 2015 and no further awards were issued under the 2012 Plan. However, any awards outstanding under the 2012 Plan at January 27, 2015 continue to be governed by the terms of the 2012 Plan. The Amended and Restated 2014 Equity and Incentive Plan The Amended and Restated 2014 Equity and Incentive Plan ("2014 Plan") provides for the issuance of (i) cash awards and (ii) equity-based awards, denominated in shares of the Company’s common stock, including incentive stock options, non-statutory stock options, stock appreciation rights, restricted stock awards, restricted stock units, unrestricted stock awards, performance share awards and dividend equivalent rights. Incentive stock options may be granted only to Company employees. Nonqualified stock options may be granted to Company employees, outside directors and consultants. As of December 31, 2018 , the Company had reserved 1,348,173 shares of its common stock for issuance under the 2014 Plan, subject to automatic annual increases as set forth in the plan. Options and awards under the 2014 Plan may be granted for periods of up to ten years . Employee options granted by the Company generally vest over four years . Restricted stock awards granted to employees, directors and consultants can be subject to the same vesting conditions and the right of repurchase by the Company of unvested shares as determined by its board of directors. As of December 31, 2018 , the Company had 55,799 shares available for grant under the 2014 Plan. During the year ended December 31, 2018 , the Company granted stock options to purchase 131,000 shares of common stock to non-employee directors. The following table summarizes option and award activity, excluding inducement grants, for the fiscal years ended December 31, 2017 and 2018 : Shares Available for Grant Outstanding Number of Shares Weighted- Average Exercise Price per Share Weighted- Average Remaining Contractual Term (In Years) Aggregate Intrinsic Value Balance at January 1, 2017 2,826 79,657 $ 38.51 5.62 Additional shares reserved 52,950 — $ — Options granted (55,210 ) 55,210 $ 17.43 Options exercised — (4,926 ) $ 27.94 Options canceled/forfeited/expired 30,912 (30,912 ) $ 39.10 Restricted stock award granted (3,000 ) — $ — Restricted stock award forfeited 1,334 — $ — Shares expired under 2012 Plan (241 ) — $ — Balance at December 31, 2017 29,571 99,029 $ 25.33 8.46 Additional shares reserved 1,225,223 — $ — Options granted (1,212,200 ) 1,212,200 $ 4.24 Options canceled/forfeited/expired 15,072 (15,072 ) $ 12.38 Shares expired under 2012 Plan (1,867 ) — $ — Balance at December 31, 2018 55,799 1,296,157 $ 5.75 9.23 $ — Exercisable at December 31, 2018 225,138 $ 10.43 8.83 $ — Vested or expected to vest at December 31, 2018 1,195,711 $ 5.86 9.22 $ — The aggregate intrinsic value is calculated as the difference between the exercise price of the option and the estimated fair value of the Company’s common stock for in-the-money options at December 31, 2018 . Inducement Grants The Company has also awarded inducement grants to purchase common stock to new employees outside the existing equity compensation plans in accordance with Nasdaq listing rule 5635(c)(4). Such options vest at a rate of 25% of the shares on the first anniversary of the commencement of such employee’s employment with the Company, and then one forty-eighth (1/48) of the shares monthly thereafter subject to such employee’s continued service. The following table summarizes the Company’s inducement grant stock option activities: Outstanding Number of Shares Weighted- Average Exercise Price per Share Remaining Contractual Term (In Years) Aggregate Intrinsic Value Balance at January 1, 2017 12,600 $ 15.40 9.68 Options granted 6,750 $ 26.06 Balance at December 31, 2017 19,350 $ 19.12 8.91 Options granted — $ — Options canceled/forfeited/expired (5,513 ) $ 15.40 Balance at December 31, 2018 13,837 $ 20.60 4.52 $ — Exercisable at December 31, 2018 10,007 $ 18.47 3.05 $ — Vested or expected to vest at December 31, 2018 13,562 $ 20.48 4.44 $ — The following summarizes the composition of stock options outstanding and exercisable within the approved stock option plans, excluding inducement grants, as of December 31, 2018 : Options Outstanding Options Exercisable Exercise Price Number of Shares Weighted- Average Remaining Contractual Life (in years) Weighted Average Exercise Price Number of Shares Weighted Average Exercise Price $3.45 - $4.00 132,500 9.80 $ 3.90 — $ — $4.24 - $4.24 937,637 9.29 $ 4.24 156,409 $ 4.24 $4.27 - $181.00 224,470 8.70 $ 11.93 67,338 $ 21.18 $182.60 - $182.60 150 6.32 $ 182.60 137 $ 182.60 $185.80 - $185.80 1,400 6.39 $ 185.80 1,254 $ 185.80 The weighted-average grant-date fair value of options and awards granted within the approved stock option plans during the years ended December 31, 2018 and 2017 were $4.24 and $17.43 , respectively. The total fair value of options and awards that vested during the years ended December 31, 2018 and 2017 were $1.0 million and $0.4 million , respectively. Stock-Based Compensation Expense Total stock-based compensation expense recognized was as follows: Year Ended December 31, 2018 2017 (in thousands) Research and development $ 529 $ 266 General and administrative 649 426 Total $ 1,178 $ 692 At December 31, 2018 , the Company had $3.5 million of total unrecognized stock-based compensation, net of estimated forfeitures, related to outstanding stock options that will be recognized over a weighted-average period of 3.27 years. The Company’s stock-based compensation expense for stock options is estimated at the grant date based on the award’s fair value as calculated by the Black-Scholes option pricing model and is recognized as expense over the requisite service period. The Black-Scholes option pricing model requires various highly judgmental assumptions including expected volatility and expected term. The expected volatility is based on the historical stock volatilities of several of the Company’s publicly listed peers over a period equal to the expected terms of the options as the Company does not have sufficient trading history to use the volatility of its own common stock. To estimate the expected term, the Company has opted to use the simplified method which is the use of the midpoint of the vesting term and the contractual term. If any of the assumptions used in the Black-Scholes option pricing model changes significantly, stock-based compensation expense may differ materially in the future from that recorded in the current period. In addition, the Company estimates the forfeiture rate based on historical experience and its expectations regarding future pre-vesting termination behavior of employees. To the extent that the actual forfeiture rate is different from this estimate, stock-based compensation expense is adjusted accordingly. The following table presents the weighted-average assumptions for the Black-Scholes option-pricing model used in determining the fair value of options granted to employees: Year Ended December 31, 2018 2017 Dividend yield —% —% Risk-free interest rate 2.46% - 3.11% 1.90% – 2.25% Expected volatility 89% 89% Expected term (years) 6.08 6.08 Estimated forfeiture % rate 6.50% 6.50% |
Severance
Severance | 12 Months Ended |
Dec. 31, 2018 | |
Text Block [Abstract] | |
Severance | Severance In May 2018, the Company's Chief Business and Financial Officer resigned. Pursuant to the terms of a separation agreement, the Company agreed to pay severance totaling approximately $0.2 million , including base salary and benefit continuation coverage, for six months and accelerated 25% of the unvested portion of her outstanding equity awards. Additionally, her vested options remain exercisable for a period of eighteen months following her resignation. As of December 31, 2018 , the Company had paid substantially all severance related to this arrangement. In May 2017, the President and Chief Executive Officer of the Company resigned. Pursuant to the terms of a separation agreement, the Company paid total severance payments and continuation of benefits of approximately $0.3 million . |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Income Taxes The Company has incurred cumulative net operating losses ("NOL") since inception and, consequently, has not recorded any income tax expense for the years ended December 31, 2018 and 2017 due to its net operating loss position. The reconciliation of the federal statutory income tax rate to the Company’s effective tax rate is as follows: Year Ended December 31, 2018 2017 Federal statutory tax rate (1) (21.0 )% (34.0 )% State statutory tax rate, net of federal benefit (7.0 ) (5.8 ) Change in effective tax rate — 18.1 Derecognition due to Section 382 and 383 25.4 30.2 Stock-based compensation 0.5 1.1 Permanent items 3.0 (2.5 ) Change in valuation allowance (0.9 ) (7.1 ) Total — % — % ______________ (1) In December 2017, the United States government enacted tax reform legislation that reduced the U.S. federal statutory tax rate to 21 percent. Deferred income taxes reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. As of December 31, 2018 and 2017 , the Company had net deferred tax assets of $16.5 million and $16.9 million , respectively. Realization of deferred tax assets is dependent upon future earnings, if any, the timing and amount of which are uncertain. Accordingly, the net deferred tax assets have been fully offset by a valuation allowance. The net valuation allowance decreased by approximately $0.3 million and $2.0 million during the years ended December 31, 2018 and 2017 , respectively. Significant components of the Company’s net deferred tax assets and liabilities are as follows: December 31, 2018 2017 (in thousands) Net operating loss carryforwards $ 10,942 $ 12,226 Research and development credits 3,657 3,245 Depreciation and amortization 729 640 Accruals 569 507 Deferred rent 400 113 Stock-based compensation 213 98 Capital loss carryforward 23 23 Other 2 1 Net deferred tax assets 16,535 16,853 Valuation allowance (16,535 ) (16,853 ) Total $ — $ — As of December 31, 2018 , the Company had federal net operating loss carryforwards of approximately $41.1 million and state net operating loss carryforwards of approximately $33.2 million . As of December 31, 2017 , the Company had federal net operating loss carryforwards of approximately $43.8 million and state net operating loss carryforwards of approximately $43.5 million . If not utilized, certain of the federal net operating loss carryforwards will expire beginning in 2026 , and state net operating loss carryforwards will expire beginning in 2028 . If the Company experiences a greater than 50 percentage point aggregate change in ownership over a 3 -year period (a Section 382 ownership change), utilization of its pre-change NOL carryforwards are subject to annual limitation under Section 382 of the Internal Revenue Code (California has similar provisions). The annual limitation is determined by multiplying the value of the Company’s stock at the time of such ownership change by the applicable long-term tax-exempt rate. Such limitations may result in expiration of a portion of the NOL carryforwards before utilization. As of December 31, 2018 , the Company determined that ownership changes occurred on February 26, 2014, November 30, 2015, March 22, 2017 and April 3, 2018. As a result of the ownership changes, approximately $220.5 million and $196.6 million of the NOLs will expire unutilized for federal and California purposes, respectively. As of December 31, 2018 , the Company has derecognized NOL related deferred tax assets in the tax affected amounts of $46.3 million and $13.7 million for federal and California purposes, respectively. The ability of the Company to use its remaining NOL carryforwards may be further limited if the Company experiences a Section 382 ownership change as a result of future changes in its stock ownership. In December 2017, the U.S. government enacted the Tax Reform Act. The Tax Reform Act includes, but is not limited to, reducing the U.S federal corporate tax rate to 21 percent, allowing federal net operating losses generated after December 2017 to be carried over indefinitely and creating a new limitation on deductible interest expense. In February 2018, the SEC staff issued SAB 118 which provided guidance on accounting for the tax effects of the Tax Reform Act. SAB 118 provided a measurement period should not extend beyond one year from the Tax Reform Act enactment date for companies to complete the accounting related to the Tax Reform Act under ASC 740, Income Taxes . The Company completed its assessment of the accounting impact resulting from the Tax Reform Act in the fourth quarter of 2018 and determined there was no adjustment to the Company’s financial statements. As of December 31, 2018 , the Company had federal and state research and development credit carryforwards of approximately $0.6 million and $5.1 million , respectively. As of December 31, 2017 , the Company had federal and state research and development credit carryforwards of approximately $0.4 million and $4.6 million , respectively. If not utilized, the federal tax credits will begin to expire in 2026 and state tax credits currently do not expire. Research and development credits are subject to IRC section 383. In the event of a change in ownership as defined by this code section, the usage of the credits may be limited. As a result of the previously mentioned ownership changes, the Company has derecognized approximately $5.1 million of gross federal research and development credit-related deferred tax assets due to the Section 383 limitation as of December 31, 2018 . The Company has not derecognized any of the California research and development credit-related deferred tax assets because the credits do not expire. Uncertain Income Tax Positions The Company only recognizes tax benefits if it is more likely than not that they will be sustained upon audit by the relevant tax authority based upon their technical merits. An uncertain tax position is not recognized if it has less than a 50% likelihood of being sustained. The Company had approximately $1.1 million of unrecognized tax benefits as of December 31, 2018 and approximately $1.0 million of unrecognized tax benefits as of December 31, 2017 . As the Company has a full valuation allowance on its deferred tax assets, the unrecognized tax benefits reduce the deferred tax assets and the valuation allowance in the same amount. The Company does not expect the amount of unrecognized tax benefits to materially change in the next twelve months. A reconciliation of the beginning and ending balance of the unrecognized tax benefits is as follows: Year Ended December 31, 2018 2017 (in thousands) Balance at the beginning of year $ 1,006 $ 943 Decrease related to prior year tax positions (77 ) — Increase related to current year tax positions 199 63 Balance at the end of year $ 1,128 $ 1,006 As of December 31, 2018 and 2017 , the Company had not recognized any tax-related interest or penalties in its financial statements. Interest and penalties related to unrecognized tax benefits would be included as income tax expense in the Company’s statements of operations. The Company files income tax returns in the U.S. federal jurisdiction and various state jurisdictions. The Company is not currently under audit by the Internal Revenue Service or any other similar state, local, or foreign authority. All tax years remain open to examination by major taxing jurisdictions to which the Company is subject. |
Employee Benefit Plan
Employee Benefit Plan | 12 Months Ended |
Dec. 31, 2018 | |
Postemployment Benefits [Abstract] | |
Employee Benefit Plan | Employee Benefit Plan The Company has established a 401(k) tax-deferred savings plan (the "401(k) Plan"), which permits participants to make contributions by salary deduction pursuant to Section 401(k) of the Internal Revenue Code. The Company is responsible for administrative costs of the 401(k) Plan. The Company may, at its discretion, make matching contributions to the 401(k) Plan. No employer contributions have been made to date. |
Subsequent Event
Subsequent Event | 12 Months Ended |
Dec. 31, 2018 | |
Subsequent Events [Abstract] | |
Subsequent Event | Subsequent Event In February 2019, the Company entered into an amendment to its May 2018 purchase order with the manufacturer of its commercial coating and primary packaging system for the production of its product candidate, Qtrypta™ (M207). The purchase order increased the aggregate purchase price from $12.2 million to $13.5 million . |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2018 | |
Accounting Policies [Abstract] | |
Basis of Presentation and Use of Estimates | Basis of Presentation and Use of Estimates The accompanying financial statements have been prepared in accordance with accounting principles generally accepted in the United States ("U.S. GAAP"). The preparation of the accompanying financial statements in accordance with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities as of the date of the financial statements, and the reported amounts of revenue and expenses during the reporting periods. Actual results could differ from those estimates. On January 23, 2018, the stockholders approved an increase to the number of authorized shares of the Company’s common stock from 100,000,000 to 250,000,000 shares. On January 23, 2018, the board of directors approved a 1-for-20 reverse stock split of the outstanding common stock, which was effective on January 25, 2018. At the effective time, every twenty shares of common stock issued and outstanding were automatically combined into one share of issued and outstanding common stock. The par value of stock remained unchanged at $0.0001 per share. No fractional shares of the Company's common stock were issued in the reverse stock split, but in lieu thereof, each holder of the Company's common stock who would otherwise have been entitled to a fraction of a share in the reverse stock split received a cash payment. As a result of the reverse stock split, the number of the Company’s outstanding shares of common stock as of January 25, 2018 decreased from 39,460,931 (pre-split) shares to 1,973,039 (post-split) shares. Unless otherwise noted, all share and per share information included in these financial statements have been retroactively adjusted to give effect to the reverse stock split. The reverse stock split did not affect the number of authorized shares of common stock, which, after giving effect to the authorized share increase, is 250,000,000 shares. |
Liquidity and Substantial Doubt in Going Concern | Liquidity and Substantial Doubt in Going Concern Since inception, the Company has incurred recurring operating losses and negative cash flows from operating activities, and as of December 31, 2018 , had an accumulated deficit of $261.2 million . As of December 31, 2018 , the Company had approximately $23.0 million in cash, cash equivalents and marketable securities. Presently, the Company does not have sufficient cash, cash equivalents and marketable securities to enable it to fund the anticipated level of operations and meet its obligations as they become due within twelve months following the date of issuance of this Annual Report on Form 10-K. The aforementioned factors raise substantial doubt about the Company’s ability to continue as a going concern for a period of one year from the issuance of these financial statements. The financial statements do not include any adjustments that might result from the outcome of this uncertainty. The Company plans to raise additional funding through financing, a capital offering, a license or collaboration agreement or a combination of such sources of capital. However, there are no assurances that additional funding will be achieved and that the Company will succeed in its future operations. The Company’s inability to obtain required funding in the near future or its inability to obtain funding on favorable terms will have a material adverse effect on its operations and strategic development plan for future growth. If the Company cannot successfully raise additional capital and implement its strategic development plan, its liquidity, financial condition and business prospects will be materially and adversely affected, and it may have to cease operations. The Company will continue to evaluate its timelines, strategic needs, and working capital requirements. There can be no assurance that if the Company attempts to raise additional capital, it will be successful in doing so on terms acceptable to the Company, or at all. Further, there can be no assurance that it will be able to gain access and/or be able to execute on securing new sources of funding, new development opportunities, successfully obtain regulatory approvals for and commercialize new products, achieve significant product revenues from its products (if approved), or achieve or sustain profitability in the future. |
Segment Reporting | Segment Reporting The Company operates in one reportable segment: the development of human pharmaceutical products. All long-lived assets are maintained in the United States, with the exception of $6.2 million of construction-in-progress related to the Company's commercial coating and primary packaging system that is being manufactured in Germany. |
Reclassification of Prior Year Presentation | Reclassification of Prior Year Presentation Certain prior year amounts have been reclassified for consistency with the current year presentation. |
Cash Equivalents and Restricted Cash | Cash, Cash Equivalents and Restricted Cash The Company considers all highly liquid investments purchased with an original maturity of 90 days or less to be cash equivalents. As of December 31, 2018 and 2017 , the Company had restricted cash of approximately $0.5 million consisting of deposits of $0.3 million to secure its building lease until the end of the lease term, a deposit of approximately $0.1 million to a utility provider and $35,000 to secure corporate purchase cards. |
Short-term Investments in Marketable Securities | Marketable Securities Marketable securities generally consist of debt securities with original maturities greater than 90 days and remaining maturities of less than one year. All of the Company's investments are classified as available-for-sale and carried at fair value based upon quoted market price. The change in unrealized gains and losses is reported as a separate component of other comprehensive loss on the statements of operations and comprehensive loss and as a separate component of stockholders' equity on the balance sheets. Interest income includes interest, dividends, accretion and amortization of purchase premiums and discounts and realized gains and losses on sales of securities, if any. The cost of securities sold is based on the specific-identification method. The Company monitors its investment portfolio for potential impairment on a quarterly basis. If the carrying amount of an investment in marketable securities exceeds its fair value and the decline in value is determined to be other-than-temporary, the carrying amount of the security is reduced to fair value and a loss is recognized in operating results for the amount of such decline. In order to determine whether a decline in value is other-than-temporary, the Company evaluates, among other factors, the cause of the impairment, including the creditworthiness of the security issuers, the number of securities in an unrealized loss position, the severity and duration of the unrealized losses, and its intent and ability to hold the security to maturity or forecasted recovery. |
Fair Value Instruments | Fair Value Instruments The Company records its financial assets and liabilities at fair value. Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability (an exit price) in an orderly transaction between market participants at the reporting date. The accounting guidance establishes a three-tiered hierarchy, which prioritizes the inputs used in the valuation methodologies in measuring fair value as follows: Level 1: Inputs which include quoted prices in active markets for identical assets and liabilities. Level 2: Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. Level 3: Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. The carrying values of certain assets and liabilities of the Company, such as cash and cash equivalents, accounts receivable, and accounts payable, approximate fair value due to their relatively short maturities. The carrying value of the Company’s short-term financial obligations approximates their fair value as the terms of the borrowing are consistent with current market rates and the duration to maturity is short. |
Concentrations of Credit Risk | Concentrations of Credit Risk Financial instruments that potentially subject the Company to a concentration of credit risk consist primarily of cash, cash equivalents and marketable securities. The Company invests its excess cash in money market funds, U.S. treasuries, corporate notes and commercial paper. The Company’s investment policy limits investments to certain types of debt securities issued by the U.S. government, its agencies and institutions with investment-grade credit ratings and places restrictions on maturities and concentration by type and issuer. Other than for obligations of the U.S. government, the Company’s policy is that no single issuer in the portfolio shall exceed 10% or $1 million , whichever is greater, of the total portfolio at the time of purchase. Bank deposits are held by a single financial institution having a strong credit rating and these deposits may at times be in excess of FDIC insured limits. The Company is exposed to credit risk in the event of a default by the financial institutions holding its cash and cash equivalents to the extent recorded on the balance sheets. |
Property and Equipment | Property and Equipment Property and equipment are stated at cost less accumulated depreciation. Depreciation is calculated using the straight-line method over the estimated useful lives of the respective assets, which range from three to five years for computer equipment and software, and nine years for manufacturing, laboratory, and office equipment. Leasehold improvements are depreciated over the shorter of the lease term or the estimated useful lives of the respective assets. The Company records as construction-in-progress (“CIP”) property and equipment that has not yet been placed in service for its intended use. All costs prior to a project becoming probable of being constructed are expensed as incurred. After the construction is considered probable, all directly identifiable costs related to an asset are capitalized. Interest related to construction of assets is capitalized when the financial statement effect of capitalization is material, construction of the asset has begun, and interest is being incurred. Interest capitalization ends at the earlier of the asset being substantially complete and ready for its intended use or when interest costs are no longer being incurred. When assets are retired or otherwise disposed of, the costs and accumulated depreciation are removed from the balance sheet and any resulting gain or loss is reflected in the statement of operations and comprehensive loss in the period realized. |
Impairment of Long-Lived Assets | Impairment of Long-Lived Assets The Company identifies and records impairment losses on long-lived assets used in operations when events or changes in circumstances indicate that the carrying amount of an asset is likely not recoverable. Recoverability is measured by comparing the fair value to the related asset’s carrying value. If an asset is considered impaired, the asset is written down to fair value |
Deferred Offering Costs | Deferred Offering Costs Deferred offering costs represent legal, accounting and other direct costs related to the Company’s efforts to raise capital through a public or private sale of the Company’s common stock. These costs are deferred until the completion of the applicable offering, at which time such costs are reclassified to additional paid-in-capital as a reduction of the proceeds. |
Deferred Rent | Deferred Rent Rent expense is recognized on a straight-line basis over the non-cancelable term of the Company’s operating lease and, accordingly, the Company records the difference between cash rent payments and the recognition of rent expense as deferred rent. The Company also records lessor-funded lease incentives, such as reimbursable leasehold improvements, as deferred rent, which is amortized as a reduction of rent expense over the non-cancelable term of its operating lease. |
Capital Leases | Capital Leases Capital leases are reflected as a liability at the inception of the lease based on the present value of the minimum lease payments or, if lower, the fair value of the property. Assets under capital leases are recorded in property and equipment, net on the balance sheets and depreciated in a manner similar to other property and equipment. |
Research and Development Expenses | Research and Development Expenses Research and development costs are charged to expense as incurred and consist of costs related to furthering the Company’s research and development efforts, seeking regulatory approval of its primary drug candidate, Qtrypta™ (M207) and pre-commercialization efforts for Qtrypta™ (M207). Research and development costs include salaries and related employee benefits, costs associated with clinical trials, nonclinical research and development activities, regulatory activities, costs of active pharmaceutical ingredients and raw materials, research and development related overhead expenses, and fees paid to contract manufacturing organizations ("CMO") that conduct manufacturing activities on behalf of the Company. For the year ended December 31, 2018 , the Company incurred research and development costs of approximately $13.9 million in connection with the Company's research and development efforts and approximately $11.6 million in the manufacturing of the Company’s intracutaneous delivery system and facility set-up and technology transfer fees to its commercial manufacturing organizations. For the year ended December 31, 2017 , the Company incurred research and development costs of approximately $10.3 million in connection with the Company’s research and development efforts and approximately $9.8 million in the manufacturing of the Company’s intracutaneous delivery system for development of the Company’s product candidate. Clinical Trial Costs Clinical trial costs are a component of research and development expenses. The Company expenses clinical trial activities performed by third parties based upon actual work completed in accordance with agreements established with clinical research organizations and clinical sites. The Company accrues clinical trial expenses each reporting period. The Company determines the actual costs through discussions with internal personnel and external service providers as to the progress or stage of completion of trials or services and the agreed-upon fee to be paid for such services. |
Stock-Based Compensation | Stock-Based Compensation The Company has equity incentive plans under which various types of equity-based awards including, but not limited to, non-qualified stock options and restricted stock awards, may be granted to employees, non-employee directors, and non-employee consultants. The Company’s equity incentive plans also allow incentive stock options to be awarded to employees. The Company has also awarded inducement grants to purchase common stock to new employees outside the existing equity compensation plans in accordance with Nasdaq listing rule 5635(c)(4). For stock options granted to employees and directors, the Company recognizes compensation expense for all stock-based awards based on the estimated grant-date fair values, net of an estimated forfeiture rate. For restricted stock awards to employees, the fair value is based on the closing price of the Company's common stock on the date of grant. The value of the portion of the award that is ultimately expected to vest is recognized as expense ratably over the requisite service period. The fair value of stock options is determined using the Black-Scholes option pricing model. The Company estimates its forfeiture rate based on an analysis of its actual forfeitures and will continue to evaluate the adequacy of the forfeiture rate assumption based on actual forfeitures, analysis of employee turnover, and other related factors. Stock-based compensation expense related to stock options granted to non-employees is recognized based on the fair value of the stock options, determined using the Black-Scholes option pricing model, as they are earned. |
Warrants | Warrants The Company has issued freestanding warrants to purchase shares of common stock in connection with certain debt and a build-to-suit arrangement. The warrants are recorded at fair value using the Black-Scholes option pricing model. |
Income Taxes | Income Taxes The Company uses the liability method to account for income taxes. Under this method, deferred tax assets and liabilities are determined based on differences between the financial statement carrying amounts of existing assets and liabilities and their tax bases. Deferred tax assets and liabilities are measured using enacted tax rates applied to taxable income in the years in which those temporary differences are expected to be recovered or settled. A valuation allowance is established when necessary to reduce deferred tax assets to the amount expected to be realized. Financial statement effects of uncertain tax positions are recognized when it is more-likely-than-not, based on the technical merits of the position, that it will be sustained upon examination. Interest and penalties related to unrecognized tax benefit, if any, will be included within the provision for income tax. |
Interest Expense | Interest Expense Interest expense, includes cash and non-cash components with the non-cash components consisting of (i) interest recognized from the amortization of debt discount and issuance costs, which were capitalized on the balance sheets, that are generally derived from cash payments or warrants issued related to financing obligations, (ii) interest recognized from the amortization of purchase option and termination fees related to financing obligations, which were accrued and capitalized on the balance sheet offset by (iii) interest income recognized from the accretion of debt premiums and (iv) interest capitalized for assets constructed for use in operations. The capitalized amounts related to the debt issuance costs and debt discounts are generally amortized to interest expense over the term of the related debt instruments unless they are attributable to assets constructed for use in operations and are capitalized as construction-in-progress until the asset is substantially complete and ready for its intended use. |
Net Loss Per Common Share | Net Loss Per Common Share Basic net loss per common share is calculated by dividing the net loss by the weighted-average number of common shares outstanding during the period, without consideration for potentially dilutive securities. Diluted net loss per common share is computed by dividing the net loss attributable to common stockholders by the weighted-average number of common shares and potentially dilutive securities outstanding for the period determined using the treasury-stock and if-converted methods. For purposes of the diluted net loss per share calculation, convertible promissory notes, common stock warrants and stock options are considered to be potential dilutive securities but are excluded from the calculation of diluted net loss per share because their effect would be anti-dilutive and therefore, basic and diluted net loss per share were the same for all periods presented. The following outstanding common stock equivalents were excluded from the computations of diluted net loss per common share for the periods presented as the effect of including such securities would be antidilutive: December 31, 2018 2017 (shares) Warrants to purchase common stock 274,524 199,524 Options to purchase common stock 1,309,994 118,379 Total 1,584,518 317,903 |
Recently Accounting Pronouncements | Recent Accounting Pronouncements Recently Adopted Accounting Pronouncements In November 2016, the Financial Accounting Standards Board ("FASB") issued Accounting Standards Update ("ASU") 2016-18, Statement of Cash Flows (Topic 230): Restricted Cash , which requires companies to include amounts generally described as restricted cash and restricted cash equivalents in cash and cash equivalents when reconciling beginning-of-period and end-of-period total amounts shown on the statements of cash flows. The Company adopted this standard effective January 1, 2018, using the retrospective transition approach. Accordingly, as a result of the adoption of this accounting guidance prior period information has been adjusted to include the addition of restricted cash to cash and cash equivalents on the Company’s statements of cash flows. Recent Accounting Pronouncements Not Yet Adopted In August 2018, the FASB issued ASU2018-15, Intangible - Goodwill and Other - Internal-Use Software (Subtopic 350-40) , which aligns the requirements for capitalizing implementation costs incurred in a hosting arrangement that is a service contract with the requirements for capitalizing implementation costs incurred to develop or obtain internal-use software. ASU2018-15 is effective for the Company in the first quarter of 2020. Early adoption is permitted. ASU2018-15 permits either a prospective or retrospective transition approach. The Company is currently evaluating ASU2018-15 to determine the impact to its financial statements and related disclosures. In August 2018, the FASB issued ASU2018-13, Fair Value Measurement (Topic 820) . The new guidance modifies the disclosure requirements on fair value measurements. ASU2018-13 is effective for the Company beginning in the first quarter of 2020 and must be adopted on a modified retrospective basis, with certain exceptions. Early adoption is permitted. The Company does not expect ASU2018-13 to have a significant impact to its financial statements and disclosures. In June 2018, the FASB issued ASU2018-07, Compensation - Stock Compensation (Topic 718); Improvements to Nonemployee Share-Based Payment Accounting which aligned certain aspects of share-based payments accounting between employees and non-employees. Specifically, nonemployee share-based payment awards within the scope of Topic 718 are measured at grant-date fair value of the equity instruments that an entity is obligated to issue when the good has been delivered or the service has been rendered and any other conditions necessary to earn the right to benefit from the instruments have been satisfied and an entity considers the probability of satisfying performance conditions when nonemployee share-based payment awards contain such conditions. ASU2018-07 is effective for the Company beginning in the first quarter of 2019. The new standard will not have a significant impact on the Company's financial statements or disclosures. In June 2016, the FASB issued ASU2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments and in November 2018, issued ASU2018-19, which amended the standard. This new guidance is intended to present credit losses on available for sale debt securities as an allowance rather than as a write-down. Entities are required to apply the standard's provisions as a cumulative-effect adjustment to retained earnings as of the beginning of the first reporting period in which the guidance is adopted. ASU2016-13 is effective for the Company in the first quarter of 2020. The Company is currently evaluating ASU2016-13 and ASU2018-19 to determine the impact to its financial statements and disclosures. In February 2016, the FASB issued authoritative guidance under ASU2016-02, Leases (Topic 842). ASU2016-02 requires lessees to recognize right-of-use assets and lease liabilities for most leases on the balance sheet and to provide expanded disclosures about leasing arrangements. ASU2016-02 is effective for fiscal years beginning after December 15, 2018, with early adoption permitted. The Company will adopt this guidance effective January 1, 2019 using the optional transition method and will not restate comparative periods. The Company's assessment of the impact of the adoption of this standard is substantially complete and will result in the recognition of right-of-use assets of approximately $6.4 million and lease liabilities of approximately $7.8 million with no material impact to the statement of operations and comprehensive loss. Additionally, the Company will no longer have a deferred rent liability of approximately $1.4 million . |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Accounting Policies [Abstract] | |
Schedule of Outstanding Common Stock Equivalents Excluded From Computations of Diluted Net Loss per Common Share | The following outstanding common stock equivalents were excluded from the computations of diluted net loss per common share for the periods presented as the effect of including such securities would be antidilutive: December 31, 2018 2017 (shares) Warrants to purchase common stock 274,524 199,524 Options to purchase common stock 1,309,994 118,379 Total 1,584,518 317,903 |
Reconciliation of Cash, Cash Equivalents and Restricted Cash | The following table provides a reconciliation of cash, cash equivalents and restricted cash reported within the balance sheets and as presented as cash, cash equivalents and restricted cash in the statements of cash flows. December 31, 2018 December 31, 2017 (in thousands) Cash and cash equivalents $ 9,140 $ 11,651 Restricted cash 455 455 Total $ 9,595 $ 12,106 |
Reconciliation of Cash, Cash Equivalents and Restricted Cash | The following table provides a reconciliation of cash, cash equivalents and restricted cash reported within the balance sheets and as presented as cash, cash equivalents and restricted cash in the statements of cash flows. December 31, 2018 December 31, 2017 (in thousands) Cash and cash equivalents $ 9,140 $ 11,651 Restricted cash 455 455 Total $ 9,595 $ 12,106 |
Cash Equivalents and Marketab_2
Cash Equivalents and Marketable Securities (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Cash and Cash Equivalents [Abstract] | |
Summary of Cash Equivalents and Marketable Securities | The following is a summary of the Company’s cash equivalents and marketable securities measured at fair value on a recurring basis: Fair value Measurements Total Quoted prices in active market Level I Significant other observable inputs Level II Significant unobservable inputs Level III (in thousands) As of December 31, 2018: Money market funds $ 4,830 $ 4,830 $ — $ — Commercial paper 1,497 — 1,497 — Corporate notes and bonds 6,989 — 6,989 — U.S. treasuries 8,375 8,375 — — Total $ 21,691 $ 13,205 $ 8,486 $ — Classified as: Cash equivalents $ 7,829 Marketable securities at fair value 13,862 Total $ 21,691 Fair value Measurements Total Quoted prices in active market Level I Significant other observable inputs Level II Significant unobservable inputs Level III (in thousands) As of December 31, 2017: Money market funds $ 6,414 $ 6,414 $ — $ — U.S. government agencies 650 — 650 — Total $ 7,064 $ 6,414 $ 650 $ — Classified as: Cash equivalents $ 7,064 |
Unrealized Positions for Available-for-sale Debt Securities | The following is a summary of the unrealized positions for available-for-sale fixed-maturity debt securities disaggregated by class of instrument: December 31, 2018 (in thousands) Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Money market funds $ 4,830 $ — $ — $ 4,830 Commercial paper 1,497 — — 1,497 Corporate notes and bonds 6,994 — (5 ) 6,989 U.S. treasuries 8,375 — — 8,375 Total $ 21,696 $ — $ (5 ) $ 21,691 December 31, 2017 (in thousands) Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Money market funds $ 6,414 — — 6,414 U.S. government agency bonds 650 — — 650 Total $ 7,064 $ — $ — $ 7,064 |
Property and Equipment (Tables)
Property and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Property, Plant and Equipment [Abstract] | |
Schedule of Property and Equipment | The following summarizes the Company’s property and equipment for each of the periods presented: December 31, 2018 December 31, 2017 (in thousands) Leasehold improvements $ 16,690 $ 15,660 Manufacturing equipment 10,387 10,387 Laboratory and office equipment 1,434 1,159 Computer equipment and software 206 209 Construction-in-progress 9,558 2,351 38,275 29,766 Less: accumulated depreciation (26,359 ) (25,614 ) Total $ 11,916 $ 4,152 |
Other Accrued Liabilities (Tabl
Other Accrued Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Payables and Accruals [Abstract] | |
Schedule of Accounts Payable and Accrued Liabilities | The following summarizes the Company’s other accrued liabilities for each of the periods presented: December 31, 2018 December 31, 2017 (in thousands) Contract manufacturing $ 834 $ — Pre-clinical and clinical study 483 88 Construction-in-progress obligations 395 45 Accrued taxes 187 — Professional service fees 112 377 Other 403 178 Total $ 2,414 $ 688 |
Capital Lease Obligation (Table
Capital Lease Obligation (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Leases [Abstract] | |
Schedule of Capital Lease Payments | The scheduled lease payments of the capital lease obligation for each year ending December 31 were as follows (in thousands): Year 2019 $ 10 2020 10 2021 10 2022 4 34 Less: amount representing interest (11 ) Total $ 23 Capital lease obligation, current $ 5 Capital lease obligation, long-term 18 Total $ 23 |
Debt Financing (Tables)
Debt Financing (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Debt Disclosure [Abstract] | |
Summary of Long-Term Debt, Net of Unamortized Debt Discount and Issuance Costs | The following is a summary of the Company's build-to-suit obligation as of December 31, 2018 (in thousands): Build-to-suit obligation principal amount $ 7,120 Build-to-suit obligation Purchase Option Fees 936 Less: Unamortized Purchase Option Fees (845 ) Unamortized fair value of free-standing warrants (207 ) Unamortized debt discount (178 ) Unamortized debt issuance costs (22 ) Build-to-suit obligation, net of debt issuance costs and discount $ 6,804 Build-to-suit obligation, current portion $ 2,326 Build-to-suit obligation, long-term portion, net of debt issuance costs and discount 4,478 Build-to-suit obligation, net of debt issuance costs and discount $ 6,804 |
Future Minimum Payments on the Company's Current Debt, Including Payment of Principal and Interest | Future minimum payments on the Company’s build-to-suit obligation, including payment of principal and interest and Purchase Option Fees for each year ending December 31 were as follows (in thousands): Year Principal Interest Purchase Option Fees (in thousands) 2019 $ 2,326 $ 583 $ — 2020 2,632 367 — 2021 2,162 107 936 Total $ 7,120 $ 1,057 $ 936 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Equity [Abstract] | |
Summary of Warrants Issued and Outstanding | The following warrants were issued and outstanding as of December 31, 2018 : Warrants Warrants Issued Warrants Exercised Warrants Expired Warrants Exercise Price Expiration Date PIPE Financing - Series B 195,906 — — — 195,906 $ 31.00 8/19/2021 Hercules - June 2014 1,583 — — — 1,583 $ 176.80 1/27/2020 Hercules - June 2015 2,035 — — — 2,035 $ 147.40 6/23/2020 Trinity - September 2018 — 75,000 — — 75,000 $ 3.59 9/25/2025 Total 199,524 75,000 — — 274,524 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of Future Minimum Payments under Non-Cancellable Related Party Operating Leases | As of December 31, 2018 , future minimum payments under all non-cancelable operating leases for each year ending December 31 were as follows (in thousands): Year 2019 $ 1,762 2020 1,815 2021 1,863 2022 1,914 2023 and thereafter 3,310 Total $ 10,664 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Summary of Stock Option and Award Activity Excluding Inducement Grants | The following table summarizes option and award activity, excluding inducement grants, for the fiscal years ended December 31, 2017 and 2018 : Shares Available for Grant Outstanding Number of Shares Weighted- Average Exercise Price per Share Weighted- Average Remaining Contractual Term (In Years) Aggregate Intrinsic Value Balance at January 1, 2017 2,826 79,657 $ 38.51 5.62 Additional shares reserved 52,950 — $ — Options granted (55,210 ) 55,210 $ 17.43 Options exercised — (4,926 ) $ 27.94 Options canceled/forfeited/expired 30,912 (30,912 ) $ 39.10 Restricted stock award granted (3,000 ) — $ — Restricted stock award forfeited 1,334 — $ — Shares expired under 2012 Plan (241 ) — $ — Balance at December 31, 2017 29,571 99,029 $ 25.33 8.46 Additional shares reserved 1,225,223 — $ — Options granted (1,212,200 ) 1,212,200 $ 4.24 Options canceled/forfeited/expired 15,072 (15,072 ) $ 12.38 Shares expired under 2012 Plan (1,867 ) — $ — Balance at December 31, 2018 55,799 1,296,157 $ 5.75 9.23 $ — Exercisable at December 31, 2018 225,138 $ 10.43 8.83 $ — Vested or expected to vest at December 31, 2018 1,195,711 $ 5.86 9.22 $ — |
Summary of Company's Inducement Grant Stock Option Activities | The following table summarizes the Company’s inducement grant stock option activities: Outstanding Number of Shares Weighted- Average Exercise Price per Share Remaining Contractual Term (In Years) Aggregate Intrinsic Value Balance at January 1, 2017 12,600 $ 15.40 9.68 Options granted 6,750 $ 26.06 Balance at December 31, 2017 19,350 $ 19.12 8.91 Options granted — $ — Options canceled/forfeited/expired (5,513 ) $ 15.40 Balance at December 31, 2018 13,837 $ 20.60 4.52 $ — Exercisable at December 31, 2018 10,007 $ 18.47 3.05 $ — Vested or expected to vest at December 31, 2018 13,562 $ 20.48 4.44 $ — |
Summary of Stock Options Outstanding and Exercisable within the Approved Stock Options Plans, Excludes Inducement Grants | The following summarizes the composition of stock options outstanding and exercisable within the approved stock option plans, excluding inducement grants, as of December 31, 2018 : Options Outstanding Options Exercisable Exercise Price Number of Shares Weighted- Average Remaining Contractual Life (in years) Weighted Average Exercise Price Number of Shares Weighted Average Exercise Price $3.45 - $4.00 132,500 9.80 $ 3.90 — $ — $4.24 - $4.24 937,637 9.29 $ 4.24 156,409 $ 4.24 $4.27 - $181.00 224,470 8.70 $ 11.93 67,338 $ 21.18 $182.60 - $182.60 150 6.32 $ 182.60 137 $ 182.60 $185.80 - $185.80 1,400 6.39 $ 185.80 1,254 $ 185.80 |
Summary of Stock-Based Compensation Expense | Total stock-based compensation expense recognized was as follows: Year Ended December 31, 2018 2017 (in thousands) Research and development $ 529 $ 266 General and administrative 649 426 Total $ 1,178 $ 692 |
Schedule of Weighted-Average Assumptions for the Black-Scholes Option-Pricing Model Used in Determining the Fair Value of Options Granted to Employees | The following table presents the weighted-average assumptions for the Black-Scholes option-pricing model used in determining the fair value of options granted to employees: Year Ended December 31, 2018 2017 Dividend yield —% —% Risk-free interest rate 2.46% - 3.11% 1.90% – 2.25% Expected volatility 89% 89% Expected term (years) 6.08 6.08 Estimated forfeiture % rate 6.50% 6.50% |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | |
Reconciliation of Federal Statutory Income Tax Rate to the Company's Effective Tax Rate | The reconciliation of the federal statutory income tax rate to the Company’s effective tax rate is as follows: Year Ended December 31, 2018 2017 Federal statutory tax rate (1) (21.0 )% (34.0 )% State statutory tax rate, net of federal benefit (7.0 ) (5.8 ) Change in effective tax rate — 18.1 Derecognition due to Section 382 and 383 25.4 30.2 Stock-based compensation 0.5 1.1 Permanent items 3.0 (2.5 ) Change in valuation allowance (0.9 ) (7.1 ) Total — % — % ______________ (1) In December 2017, the United States government enacted tax reform legislation that reduced the U.S. federal statutory tax rate to 21 percent. |
Components of Net Deferred Tax Assets and Liabilities | Significant components of the Company’s net deferred tax assets and liabilities are as follows: December 31, 2018 2017 (in thousands) Net operating loss carryforwards $ 10,942 $ 12,226 Research and development credits 3,657 3,245 Depreciation and amortization 729 640 Accruals 569 507 Deferred rent 400 113 Stock-based compensation 213 98 Capital loss carryforward 23 23 Other 2 1 Net deferred tax assets 16,535 16,853 Valuation allowance (16,535 ) (16,853 ) Total $ — $ — |
Schedule of Unrecognized Tax Benefits | A reconciliation of the beginning and ending balance of the unrecognized tax benefits is as follows: Year Ended December 31, 2018 2017 (in thousands) Balance at the beginning of year $ 1,006 $ 943 Decrease related to prior year tax positions (77 ) — Increase related to current year tax positions 199 63 Balance at the end of year $ 1,128 $ 1,006 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Additional Information (Detail) | Jan. 25, 2018$ / sharesshares | Jan. 24, 2018shares | Jan. 23, 2018shares | Dec. 31, 2018USD ($)Segment$ / sharesshares | Dec. 31, 2017USD ($)$ / sharesshares | Jan. 01, 2019USD ($) |
Summary Of Significant Accounting Policies [Line Items] | ||||||
Common stock, shares authorized (in shares) | shares | 250,000,000 | 100,000,000 | 250,000,000 | 100,000,000 | ||
Reverse stock split | 1-for-20 | |||||
Common stock par value (in USD per share) | $ / shares | $ 0.0001 | $ 0.0001 | $ 0.0001 | |||
Common shares outstanding change due to split (in shares) | shares | 1,973,039 | 39,460,931 | ||||
Accumulated deficit | $ 261,232,000 | $ 225,874,000 | ||||
Cash, cash equivalents, and short-term investments | $ 23,000,000 | |||||
Number of reportable segments | Segment | 1 | |||||
Long-lived assets | $ 38,275,000 | 29,766,000 | ||||
Restricted cash | 455,000 | 455,000 | ||||
Research and development | 25,508,000 | 20,118,000 | ||||
Decrease in deferred rent credit | 1,400,000 | 500,000 | ||||
Customer Concentration Risk | Total Portfolio Investment | ||||||
Summary Of Significant Accounting Policies [Line Items] | ||||||
Concentration of credit risk | 1,000,000 | |||||
Research and Development | ||||||
Summary Of Significant Accounting Policies [Line Items] | ||||||
Research and development | 13,900,000 | 10,300,000 | ||||
Intracutaneous Delivery System | ||||||
Summary Of Significant Accounting Policies [Line Items] | ||||||
Research and development | 11,600,000 | 9,800,000 | ||||
Construction in Progress | ||||||
Summary Of Significant Accounting Policies [Line Items] | ||||||
Long-lived assets | 9,558,000 | 2,351,000 | ||||
Computer equipment and software | ||||||
Summary Of Significant Accounting Policies [Line Items] | ||||||
Long-lived assets | $ 206,000 | 209,000 | ||||
Manufacturing, Laboratory and Office Equipment | ||||||
Summary Of Significant Accounting Policies [Line Items] | ||||||
Estimated useful lives of assets | P9Y | |||||
Deposit, Building Lease | ||||||
Summary Of Significant Accounting Policies [Line Items] | ||||||
Restricted cash | $ 300,000 | 300,000 | ||||
Deposit, Utility Provider | ||||||
Summary Of Significant Accounting Policies [Line Items] | ||||||
Restricted cash | 100,000 | 100,000 | ||||
Corporate Purchasing Cards | ||||||
Summary Of Significant Accounting Policies [Line Items] | ||||||
Restricted cash | 35,000 | $ 35,000 | ||||
Germany | Construction in Progress | ||||||
Summary Of Significant Accounting Policies [Line Items] | ||||||
Long-lived assets | $ 6,200,000 | |||||
ASU 2016-02 | Scenario, Forecast | Subsequent Event | ||||||
Summary Of Significant Accounting Policies [Line Items] | ||||||
Lease liability | $ 7,800,000 | |||||
Right-of-use asset | 6,400,000 | |||||
Decrease in deferred rent credit | $ (1,400,000) | |||||
Minimum | Computer equipment and software | ||||||
Summary Of Significant Accounting Policies [Line Items] | ||||||
Estimated useful lives of assets | P3Y | |||||
Maximum | Customer Concentration Risk | Total Portfolio Investment | ||||||
Summary Of Significant Accounting Policies [Line Items] | ||||||
Concentration risk percentage | 10.00% | |||||
Maximum | Computer equipment and software | ||||||
Summary Of Significant Accounting Policies [Line Items] | ||||||
Estimated useful lives of assets | P5Y |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Schedule of Outstanding Common Stock Equivalents Excluded From Computations of Diluted Net Loss per Common Share (Detail) - shares shares in Thousands | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Common stock equivalents excluded from computation of diluted net loss per share | 1,584,518 | 317,903 |
Warrants to Purchase Common Stock | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Common stock equivalents excluded from computation of diluted net loss per share | 274,524 | 199,524 |
Options to Purchase Common Stock | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Common stock equivalents excluded from computation of diluted net loss per share | 1,309,994 | 118,379 |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies - Reconciliation of Cash, Cash Equivalents and Restricted Cash (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 |
Cash and Cash Equivalents [Abstract] | |||
Cash and cash equivalents | $ 9,140 | $ 11,651 | |
Restricted cash | 455 | 455 | |
Total | $ 9,595 | $ 12,106 | $ 15,178 |
Cash Equivalents and Marketab_3
Cash Equivalents and Marketable Securities - Summary of Cash Equivalents and Marketable Securities (Detail) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Classified as: | ||
Fair Value | $ 21,691 | $ 7,064 |
Cash, cash equivalents, and short-term investments | 23,000 | |
Money market funds | ||
Classified as: | ||
Fair Value | 4,830 | 6,414 |
Commercial paper | ||
Classified as: | ||
Fair Value | 1,497 | |
Corporate notes and bonds | ||
Classified as: | ||
Fair Value | 6,989 | |
U.S. treasuries | ||
Classified as: | ||
Fair Value | 8,375 | |
U.S. government agencies | ||
Classified as: | ||
Fair Value | 650 | |
Fair Value, Measurements, Recurring | ||
Classified as: | ||
Fair Value | 21,691 | 7,064 |
Cash equivalents | 7,829 | 7,064 |
Marketable securities at fair value | 13,862 | |
Cash, cash equivalents, and short-term investments | 21,691 | |
Fair Value, Measurements, Recurring | Money market funds | ||
Classified as: | ||
Fair Value | 4,830 | 6,414 |
Fair Value, Measurements, Recurring | Commercial paper | ||
Classified as: | ||
Fair Value | 1,497 | |
Fair Value, Measurements, Recurring | Corporate notes and bonds | ||
Classified as: | ||
Fair Value | 6,989 | |
Fair Value, Measurements, Recurring | U.S. treasuries | ||
Classified as: | ||
Fair Value | 8,375 | |
Fair Value, Measurements, Recurring | U.S. government agencies | ||
Classified as: | ||
Fair Value | 650 | |
Fair Value, Measurements, Recurring | Level I | ||
Classified as: | ||
Fair Value | 13,205 | 6,414 |
Fair Value, Measurements, Recurring | Level I | Money market funds | ||
Classified as: | ||
Fair Value | 4,830 | 6,414 |
Fair Value, Measurements, Recurring | Level I | Commercial paper | ||
Classified as: | ||
Fair Value | 0 | |
Fair Value, Measurements, Recurring | Level I | Corporate notes and bonds | ||
Classified as: | ||
Fair Value | 0 | |
Fair Value, Measurements, Recurring | Level I | U.S. treasuries | ||
Classified as: | ||
Fair Value | 8,375 | |
Fair Value, Measurements, Recurring | Level I | U.S. government agencies | ||
Classified as: | ||
Fair Value | 0 | |
Fair Value, Measurements, Recurring | Level II | ||
Classified as: | ||
Fair Value | 8,486 | 650 |
Fair Value, Measurements, Recurring | Level II | Money market funds | ||
Classified as: | ||
Fair Value | 0 | 0 |
Fair Value, Measurements, Recurring | Level II | Commercial paper | ||
Classified as: | ||
Fair Value | 1,497 | |
Fair Value, Measurements, Recurring | Level II | Corporate notes and bonds | ||
Classified as: | ||
Fair Value | 6,989 | |
Fair Value, Measurements, Recurring | Level II | U.S. treasuries | ||
Classified as: | ||
Fair Value | 0 | |
Fair Value, Measurements, Recurring | Level II | U.S. government agencies | ||
Classified as: | ||
Fair Value | 650 | |
Fair Value, Measurements, Recurring | Level III | ||
Classified as: | ||
Fair Value | 0 | 0 |
Fair Value, Measurements, Recurring | Level III | Money market funds | ||
Classified as: | ||
Fair Value | 0 | 0 |
Fair Value, Measurements, Recurring | Level III | Commercial paper | ||
Classified as: | ||
Fair Value | 0 | |
Fair Value, Measurements, Recurring | Level III | Corporate notes and bonds | ||
Classified as: | ||
Fair Value | 0 | |
Fair Value, Measurements, Recurring | Level III | U.S. treasuries | ||
Classified as: | ||
Fair Value | $ 0 | |
Fair Value, Measurements, Recurring | Level III | U.S. government agencies | ||
Classified as: | ||
Fair Value | $ 0 |
Cash Equivalents and Marketab_4
Cash Equivalents and Marketable Securities - Unrealized Position on Available-for-sale Debt Securities (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | $ 21,696 | $ 7,064 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | (5) | 0 |
Fair Value | 21,691 | 7,064 |
Money market funds | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 4,830 | 6,414 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | 0 | 0 |
Fair Value | 4,830 | 6,414 |
Commercial paper | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 1,497 | |
Gross Unrealized Gains | 0 | |
Gross Unrealized Losses | 0 | |
Fair Value | 1,497 | |
Corporate notes and bonds | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 6,994 | |
Gross Unrealized Gains | 0 | |
Gross Unrealized Losses | (5) | |
Fair Value | 6,989 | |
U.S. treasuries | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 8,375 | |
Gross Unrealized Gains | 0 | |
Gross Unrealized Losses | 0 | |
Fair Value | $ 8,375 | |
U.S. government agencies | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 650 | |
Gross Unrealized Gains | 0 | |
Gross Unrealized Losses | 0 | |
Fair Value | $ 650 |
Property and Equipment - Schedu
Property and Equipment - Schedule of Property and Equipment (Detail) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 38,275 | $ 29,766 |
Less: accumulated depreciation | (26,359) | (25,614) |
Property and equipment, net | 11,916 | 4,152 |
Leasehold improvements | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 16,690 | 15,660 |
Manufacturing equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 10,387 | 10,387 |
Laboratory and office equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 1,434 | 1,159 |
Computer equipment and software | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 206 | 209 |
Construction-in-progress | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 9,558 | $ 2,351 |
Property and Equipment - Additi
Property and Equipment - Additional Information (Detail) - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Property, Plant and Equipment [Line Items] | ||
Depreciation and amortization expense | $ 800,000 | $ 2,600,000 |
Property and equipment, gross | 38,275,000 | 29,766,000 |
Capitalized interest | 300,000 | |
Construction in Progress | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 9,558,000 | 2,351,000 |
Assets Held under Capital Leases | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 24,000 | 0 |
Construction In Progress, Build-to-suit Lease Asset | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 6,200,000 | |
D107 Assets | ||
Property, Plant and Equipment [Line Items] | ||
Impairment of long-lived assets | 400,000 | |
Custom Manufacturing Assets | ||
Property, Plant and Equipment [Line Items] | ||
Impairment of long-lived assets | 100,000 | |
Laboratory and office equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 1,434,000 | 1,159,000 |
Impairment of long-lived assets | $ 100,000 | |
Germany | Construction in Progress | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 6,200,000 |
Other Accrued Liabilities (Deta
Other Accrued Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Payables and Accruals [Abstract] | ||
Contract manufacturing | $ 834 | $ 0 |
Pre-clinical and clinical study | 483 | 88 |
Construction-in-progress obligations | 395 | 45 |
Accrued taxes | 187 | 0 |
Professional service fees | 112 | 377 |
Other | 403 | 178 |
Other accrued liabilities | $ 2,414 | $ 688 |
Capital Lease Obligation (Detai
Capital Lease Obligation (Details) | 12 Months Ended |
Dec. 31, 2018 | |
Leases [Abstract] | |
Capital lease interest rate | 25.00% |
Capital Lease Obligation Future
Capital Lease Obligation Future Minimum Lease Payments (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Leases [Abstract] | ||
2019 | $ 10 | |
2020 | 10 | |
2021 | 10 | |
2022 | 4 | |
Future minimum capital lease payments | 34 | |
Less: amount representing interest | (11) | |
Capital lease obligations | 23 | |
Capital lease obligations, current | 5 | $ 0 |
Capital lease obligations, long-term | $ 18 | $ 0 |
Debt Financing - Additional Inf
Debt Financing - Additional Information (Detail) - USD ($) | Sep. 03, 2018 | Dec. 31, 2018 | Sep. 30, 2018 | Jun. 30, 2014 | Dec. 31, 2018 | Sep. 25, 2018 | Dec. 31, 2017 | Jun. 01, 2017 |
Debt Instrument [Line Items] | ||||||||
Restocking fee | 6.00% | |||||||
Monthly loan payment | $ 160,000 | |||||||
Common stock, shares issued (in shares) | 11,973,039 | 75,000 | 11,973,039 | 1,973,039 | ||||
Common stock warrant exercise price (in USD per share) | $ 3.59 | |||||||
Proceeds from issuance of warrants | $ 243,000 | |||||||
Property and equipment, gross | $ 38,275,000 | $ 38,275,000 | $ 29,766,000 | |||||
Capitalized interest costs | 300,000 | $ 300,000 | ||||||
Senior Secured Term Loan with Hercules | ||||||||
Debt Instrument [Line Items] | ||||||||
Monthly loan payment | 2,000,000 | |||||||
Amended Hercules Secured Term Loan | ||||||||
Debt Instrument [Line Items] | ||||||||
Debt interest rate | 7.95% | |||||||
Senior Subordinated Notes | Amended Hercules Secured Term Loan | ||||||||
Debt Instrument [Line Items] | ||||||||
Debt effective interest rate | 7.95% | |||||||
Debt face amount | $ 15,000,000 | |||||||
Debt payment terms | Principal balance will be subject to a 12-month interest-only period beginning July 1, 2015, followed by equal monthly installment payments of principal and interest, with all outstanding amounts due and payable on December 1, 2018. | |||||||
Debt payment, due and payable date | Dec. 1, 2018 | |||||||
Debt variable interest rate | 7.95% | |||||||
Debt additional variable interest rate decrease | 5.25% | |||||||
Debt end of term charge | $ 100,000 | |||||||
Additional debt end of term charge | $ 400,000 | |||||||
Trinity Capital Fund III, L.P. | ||||||||
Debt Instrument [Line Items] | ||||||||
Debt instrument term | 3 months | |||||||
Drawdown used for commercial coating and primary packaging system | $ 2,700,000 | 2,600,000 | ||||||
Monthly loan payment | 90,000 | |||||||
Drawdown withheld for interest | $ 200,000 | $ 300,000 | ||||||
Debt interest rate | 9.68% | 9.43% | 9.68% | |||||
Debt effective interest rate | 19.58% | 26.28% | 19.58% | |||||
Build to Suit Obligation | ||||||||
Debt Instrument [Line Items] | ||||||||
Unamortized debt discount | $ 178,000 | $ 178,000 | ||||||
Build-to-suit obligation termination fee | 845,000 | 845,000 | ||||||
Build to Suit Obligation | Trinity Capital Fund III, L.P. | ||||||||
Debt Instrument [Line Items] | ||||||||
Aggregate principal amount | $ 14,000,000 | |||||||
Line of credit | 6,800,000 | 5,000,000 | 6,800,000 | |||||
Incremental drawdown, minimum | $ 500,000 | |||||||
Non-utilization fee | 3.00% | |||||||
Debt instrument term | 36 months | |||||||
Unamortized debt discount | $ 600,000 | |||||||
Incremental drawdown | 2,800,000 | |||||||
Build-to-suit obligation termination fee | 300,000 | $ 300,000 | ||||||
Interest payable | 37,000 | $ 37,000 | ||||||
Build-to-Suit Obligation, Condition One | Trinity Capital Fund III, L.P. | ||||||||
Debt Instrument [Line Items] | ||||||||
Purchase percentage of equipment cost | 12.00% | |||||||
Build-to-Suit Obligation, Condition Two | Trinity Capital Fund III, L.P. | ||||||||
Debt Instrument [Line Items] | ||||||||
Purchase percentage of equipment cost | 4.00% | |||||||
Construction in Progress | ||||||||
Debt Instrument [Line Items] | ||||||||
Property and equipment, gross | $ 9,558,000 | $ 9,558,000 | $ 2,351,000 |
Debt Financing - Summary of Lon
Debt Financing - Summary of Long-Term Debt, Net of Unamortized Debt Discount and Issuance Costs (Detail) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Debt Instrument [Line Items] | ||
Build-to-suit obligation, current portion | $ 2,326 | $ 0 |
Build to Suit Obligation | ||
Debt Instrument [Line Items] | ||
Build-to-suit obligation principal amount | 7,120 | |
Build-to-suit obligation Purchase Option Fees | 936 | |
Less: Unamortized Purchase Option Fees | (845) | |
Unamortized fair value of free-standing warrants | (207) | |
Unamortized debt discount | (178) | |
Unamortized debt issuance costs | 22 | |
Build-to-suit obligation, current portion | 2,326 | |
Build-to-suit obligation, long-term portion, net of debt issuance costs and discount | 4,478 | |
Build-to-suit obligation, net of debt issuance costs and discount | $ 6,804 |
Debt Financing - Future Minimum
Debt Financing - Future Minimum Payments on the Company's Current Debt, Including Payment of Principal and Interest (Detail) $ in Thousands | Dec. 31, 2018USD ($) |
Long-term Debt, Fiscal Year Maturity [Abstract] | |
2019, Principal | $ 2,326 |
2020, Principal | 2,632 |
2021, Principal | 2,162 |
Total, Principal | 7,120 |
2019, Interest | 583 |
2020, Interest | 367 |
2021, Interest | 107 |
Total, Interest | 1,057 |
2019, Termination Fees | 0 |
2020, Termination Fees | 0 |
2021, Termination Fees | 936 |
Total, Termination Fees | $ 936 |
Stockholders' Equity - Addition
Stockholders' Equity - Additional Information (Detail) | Apr. 03, 2018USD ($)$ / sharesshares | Jan. 25, 2018 | Oct. 20, 2017USD ($)$ / sharesshares | Mar. 22, 2017USD ($)$ / sharesshares | Aug. 15, 2016USD ($)$ / sharesshares | Sep. 30, 2018USD ($)$ / sharesshares | Dec. 31, 2018USD ($)$ / sharesshares | Dec. 31, 2017USD ($)shares | Jan. 24, 2018shares | Jan. 23, 2018shares | Jun. 30, 2015$ / sharesshares | Jun. 30, 2014$ / sharesshares |
Class of Stock [Line Items] | ||||||||||||
Common stock, shares authorized (in shares) | 250,000,000 | 100,000,000 | 250,000,000 | 100,000,000 | ||||||||
Stockholders' equity, stock split, conversion ratio | 0.05 | |||||||||||
Common stock shares issued (in shares) | 977,500 | |||||||||||
Offering price (in USD per share) | $ / shares | $ 30 | |||||||||||
Net proceeds from issuance of common stock | $ | $ 26,600,000 | $ 45,604,000 | $ 26,623,000 | |||||||||
Deferred financing costs | $ | $ 200,000 | $ 300,000 | ||||||||||
Equity warrants outstanding | 274,524 | 199,524 | ||||||||||
Common stock warrants issued | 1 | |||||||||||
Common stock, shares issued (in shares) | 75,000 | 11,973,039 | 1,973,039 | |||||||||
Common stock warrant exercise price (in USD per share) | $ / shares | $ 3.59 | |||||||||||
Proceeds from issuance of warrants | $ | $ 243,000 | |||||||||||
Hercules - June 2014 | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Equity warrants outstanding | 1,583 | 1,583 | ||||||||||
Warrant exercise price | $ / shares | $ 176.8 | $ 176.8 | ||||||||||
Warrants to purchase common stock (in shares) | 1,583 | |||||||||||
Hercules - June 2015 | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Equity warrants outstanding | 2,035 | 2,035 | ||||||||||
Warrant exercise price | $ / shares | $ 147.4 | |||||||||||
Hercules - June 2015 | Amended Hercules Secured Term Loan | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Common stock warrants issued | 2,035 | |||||||||||
Warrant exercise price | $ / shares | $ 147.4 | |||||||||||
Over-Allotment | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Common stock shares issued (in shares) | 127,500 | |||||||||||
IPO | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Common stock shares issued (in shares) | 10,000,000 | |||||||||||
Offering price (in USD per share) | $ / shares | $ 5 | |||||||||||
Net proceeds from issuance of common stock | $ | $ 45,600,000 | |||||||||||
Equity Lines of Credit | Lincoln Park Capital Fund Llc | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Common stock shares issued (in shares) | 11,375 | |||||||||||
Value Of Shares Obligated To Purchase, Next Thirty Months | $ | $ 35,000,000 | |||||||||||
Number of shares obligated to purchase | $ | $ 35,000,000 | |||||||||||
Fair value of share | $ / shares | $ 15.30 | |||||||||||
Additional shares committed to issue | 11,375 | |||||||||||
Equity Lines of Credit | Director | Lincoln Park Capital Fund Llc | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Shares reserved for future issuance | 392,104 | |||||||||||
Private Investment in Public Equity (PIPE) | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Common stock shares issued (in shares) | 239,997 | |||||||||||
Offering price (in USD per share) | $ / shares | $ 26.4 | |||||||||||
Proceeds from issuance of common stock and warrants | $ | $ 7,500,000 | |||||||||||
Costs related to offering | $ | $ 900,000 | |||||||||||
Equity warrants outstanding | 480,000 | 195,906 | ||||||||||
Warrant issuance price | $ / shares | $ 2.5 | |||||||||||
Common stock warrants issued | 1 | |||||||||||
Private Investment in Public Equity (PIPE) | Directors and Executive Officers | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Common stock shares issued (in shares) | 13,771 | |||||||||||
Equity warrants outstanding | 27,542 | |||||||||||
Private Investment in Public Equity (PIPE) | Series B | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Equity warrants outstanding | 195,906 | 195,906 | ||||||||||
Warrant exercise price | $ / shares | $ 31 | |||||||||||
Private Investment in Public Equity (PIPE) | Warrants to Purchase Common Stock | Series A | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Equity warrants outstanding | 239,997 | |||||||||||
Private Investment in Public Equity (PIPE) | Warrants to Purchase Common Stock | Series B | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Equity warrants outstanding | 239,997 | |||||||||||
Warrant exercise price | $ / shares | $ 31 | |||||||||||
Trinity Capital Fund III, L.P. | Build to Suit Obligation | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Line of credit | $ | $ 5,000,000 | $ 6,800,000 |
Stockholders' Equity - Summary
Stockholders' Equity - Summary of Warrants Issued and Outstanding (Detail) - $ / shares | 12 Months Ended | |||
Dec. 31, 2018 | Dec. 31, 2017 | Aug. 15, 2016 | Jun. 30, 2014 | |
Class of Warrant or Right [Line Items] | ||||
Warrants Outstanding | 274,524 | 199,524 | ||
Warrants Issued | 75,000 | |||
Warrants Exercised | 0 | |||
Warrants Expired | 0 | |||
Hercules - June 2014 | ||||
Class of Warrant or Right [Line Items] | ||||
Warrants Outstanding | 1,583 | 1,583 | ||
Warrants Issued | 0 | |||
Warrants Exercised | 0 | |||
Warrants Expired | 0 | |||
Exercise Price | $ 176.8 | $ 176.8 | ||
Expiration Date | Jan. 27, 2020 | |||
Hercules - June 2015 | ||||
Class of Warrant or Right [Line Items] | ||||
Warrants Outstanding | 2,035 | 2,035 | ||
Warrants Issued | 0 | |||
Warrants Exercised | 0 | |||
Warrants Expired | 0 | |||
Exercise Price | $ 147.4 | |||
Expiration Date | Jun. 23, 2020 | |||
Trinity Capital Fund III, L.P. | ||||
Class of Warrant or Right [Line Items] | ||||
Warrants Outstanding | 75,000 | 0 | ||
Warrants Issued | 75,000 | |||
Warrants Exercised | 0 | |||
Warrants Expired | 0 | |||
Exercise Price | $ 3.59 | |||
Expiration Date | Sep. 25, 2025 | |||
Private Investment in Public Equity (PIPE) | ||||
Class of Warrant or Right [Line Items] | ||||
Warrants Outstanding | 195,906 | 480,000 | ||
Private Investment in Public Equity (PIPE) | Series B | ||||
Class of Warrant or Right [Line Items] | ||||
Warrants Outstanding | 195,906 | 195,906 | ||
Warrants Issued | 0 | |||
Warrants Exercised | 0 | |||
Warrants Expired | 0 | |||
Exercise Price | $ 31 | |||
Expiration Date | Aug. 19, 2021 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) - USD ($) | Jun. 06, 2017 | Sep. 30, 2018 | May 31, 2018 | Dec. 31, 2018 | Dec. 31, 2017 |
Other Commitments [Line Items] | |||||
Deferred rent liability, net | $ 1,400,000 | $ 500,000 | |||
Rental expense | $ 1,600,000 | $ 1,200,000 | |||
Cancellation fees | 50.00% | ||||
Construction agreement and transfer fees | $ 4,100,000 | ||||
Payment | 200,000 | ||||
Liabilities for indemnification and guarantees agreements | $ 0 | ||||
Options to Purchase Common Stock | CEO and CFO | |||||
Other Commitments [Line Items] | |||||
Percentage of option exercisable upon termination | 25.00% | ||||
Options to Purchase Common Stock | VPCDMA and SVPO | |||||
Other Commitments [Line Items] | |||||
Percentage of option exercisable upon termination | 25.00% | ||||
Minimum | |||||
Other Commitments [Line Items] | |||||
Annual fees | $ 1,000,000 | ||||
Termination fees | $ 1,000,000 | ||||
Minimum | Options to Purchase Common Stock | |||||
Other Commitments [Line Items] | |||||
Percentage of option exercisable upon termination | 25.00% | ||||
Maximum | |||||
Other Commitments [Line Items] | |||||
Annual fees | $ 14,000,000 | ||||
Termination fees | $ 1,400,000 | ||||
Maximum | CEO and CFO | |||||
Other Commitments [Line Items] | |||||
Cash award | 229.56% | ||||
Maximum | Options to Purchase Common Stock | |||||
Other Commitments [Line Items] | |||||
Percentage of option exercisable upon termination | 100.00% | ||||
Maximum | Options to Purchase Common Stock | VPCDMA and SVPO | |||||
Other Commitments [Line Items] | |||||
Percentage of option exercisable upon termination | 100.00% | ||||
Seventh Amendment to Lease Agreement | |||||
Other Commitments [Line Items] | |||||
Lease renewal term | 60 months | ||||
Monthly base rent payable | $ 136,000 | ||||
Rent abatements | 300,000 | ||||
Tenant improvements | 1,000,000 | ||||
Extended lease term | $ 400,000 | ||||
Commercial Coating and Primary Packaging System | |||||
Other Commitments [Line Items] | |||||
Purchase price | $ 12,200,000 | ||||
Purchase Commitment, period | 18 months | ||||
Purchase Commitment, payment | $ 3,000,000 | ||||
Patch Assembly and Applicator and Retainer Machinery | |||||
Other Commitments [Line Items] | |||||
Purchase price | 3,500,000 | ||||
Purchase Commitment, payment | $ 900,000 |
Commitments and Contingencies_2
Commitments and Contingencies - Schedule of Future Minimum Payments under Non-Cancellable Related Party Operating Leases (Detail) $ in Thousands | Dec. 31, 2018USD ($) |
Operating Leases, Future Minimum Payments Due, Fiscal Year Maturity [Abstract] | |
2019 | $ 1,762 |
2020 | 1,815 |
2021 | 1,863 |
2022 | 1,914 |
2023 and thereafter | 3,310 |
Operating lease future minimum payments due | $ 10,664 |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Millions | 12 Months Ended | 47 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2018 | Dec. 31, 2016 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Shares available for grant (in shares) | 55,799 | 29,571 | 55,799 | 2,826 |
Common stock, non-employee directors (in shares) | 1,212,200 | 55,210 | ||
Weighted-average grant-date fair value of options and awards | $ 4.24 | $ 17.43 | ||
Total fair value of options and awards that vested | $ 1 | $ 0.4 | ||
Unrecognized stock-based compensation expense | $ 3.5 | $ 3.5 | ||
Weighted-average period of unrecognized stock-based compensation expense | 3 years 3 months 7 days | |||
Non Employee Director | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Common stock, non-employee directors (in shares) | 131,000 | |||
New Employee | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Vesting rights | Options vest at a rate of 25% of the shares on the first anniversary of the commencement of such employee’s employment with the Company, and then one forty-eighth (1/48) of the shares monthly thereafter subject to such employee’s continued service. | |||
Vesting percentage | 25.00% | |||
2012 Stock Incentive Plan | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Options vested period | 4 years | |||
Options or awards issued under the Plan | 0 | |||
2012 Stock Incentive Plan | Maximum | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Options grant period | 10 years | |||
2014 Equity and Incentive Plan | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Options vested period | 4 years | |||
Common stock reserved for future issuance | 1,348,173 | 1,348,173 | ||
Shares available for grant (in shares) | 55,799 | 55,799 | ||
2014 Equity and Incentive Plan | Maximum | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Options grant period | 10 years |
Stock-Based Compensation - Summ
Stock-Based Compensation - Summary of Stock Option and Award Activity Excluding Inducement Grants (Detail) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Shares Available for Grant | |||
Beginning balance (in shares) | 29,571 | 2,826 | |
Additional shares reserved (in shares) | 1,225,223 | 52,950 | |
Options granted (in shares) | (1,212,200) | (55,210) | |
Options exercised (in shares) | 0 | ||
Options canceled/forfeited/expired (in shares) | 15,072 | 30,912 | |
Restricted stock award forfeited (in shares) | 1,334 | ||
Ending balance (in shares) | 55,799 | 29,571 | 2,826 |
Outstanding Number of Shares | |||
Beginning balance (in shares) | 99,029 | 79,657 | |
Options granted (in shares) | 1,212,200 | 55,210 | |
Options exercised (in shares) | (4,926) | ||
Options canceled/forfeited/expired (in shares) | (15,072) | (30,912) | |
Ending balance (in shares) | 1,296,157 | 99,029 | 79,657 |
Exercisable (in shares) | 225,138 | ||
Vested or expected to vest (in shares) | 1,195,711 | ||
Weighted- Average Exercise Price per Share | |||
Beginning balance (in USD shares) | $ 25.33 | $ 38.51 | |
Options granted (in USD shares) | 4.24 | 17.43 | |
Options exercised (in USD shares) | 27.94 | ||
Options cancelled/forfeited/expired (in USD shares) | 12.38 | 39.10 | |
Ending balance (in USD shares) | 5.75 | $ 25.33 | $ 38.51 |
Exercisable (in USD shares) | 10.43 | ||
Vested or expected to vest (in USD shares) | $ 5.86 | ||
Weighted- Average Remaining Contractual Term (In Years) | |||
Average Remaining Contractual Term | 9 years 2 months 23 days | 8 years 5 months 16 days | 5 years 7 months 13 days |
Exercisable | 8 years 9 months 29 days | ||
Vested or expected to vest | 9 years 2 months 19 days | ||
Aggregate Intrinsic Value | |||
Exercisable | $ 0 | ||
Vested or expected to vest | $ 0 | ||
Restricted Stock | |||
Shares Available for Grant | |||
Restricted stock award granted (in shares) | (3,000) | ||
2012 Stock Incentive Plan | |||
Shares Available for Grant | |||
Shares expired under 2012 Plan (in shares) | (1,867) | (241) |
Stock-Based Compensation - Su_2
Stock-Based Compensation - Summary of Company's Inducement Grant Stock Option Activities (Detail) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Shares Available for Grant | |||
Beginning balance (in shares) | 29,571 | 2,826 | |
Options granted (in shares) | 1,212,200 | 55,210 | |
Options canceled/forfeited/expired (in shares) | (15,072) | (30,912) | |
Ending balance (in shares) | 55,799 | 29,571 | 2,826 |
Outstanding Number of Shares | |||
Beginning balance (in shares) | 99,029 | 79,657 | |
Options granted (in shares) | 1,212,200 | 55,210 | |
Options canceled/forfeited/expired (in shares) | (15,072) | (30,912) | |
Ending balance (in shares) | 1,296,157 | 99,029 | 79,657 |
Exercisable (in shares) | 225,138 | ||
Vested or expected to vest (in shares) | 1,195,711 | ||
Weighted- Average Exercise Price per Share | |||
Beginning balance (in USD shares) | $ 25.33 | $ 38.51 | |
Options granted (in USD shares) | 4.24 | 17.43 | |
Options cancelled/forfeited/expired (in USD shares) | 12.38 | 39.10 | |
Ending balance (in USD shares) | 5.75 | $ 25.33 | $ 38.51 |
Exercisable (in USD shares) | 10.43 | ||
Vested or expected to vest (in USD shares) | $ 5.86 | ||
Weighted- Average Remaining Contractual Term (In Years) | |||
Remaining Contractual Term | 9 years 2 months 23 days | 8 years 5 months 16 days | 5 years 7 months 13 days |
Exercisable | 8 years 9 months 29 days | ||
Vested or expected to vest | 9 years 2 months 19 days | ||
Aggregate Intrinsic Value | |||
Exercisable | $ 0 | ||
Vested or expected to vest | $ 0 | ||
Inducement Grant | |||
Outstanding Number of Shares | |||
Beginning balance (in shares) | 19,350 | 12,600 | |
Options granted (in shares) | 0 | 6,750 | |
Options canceled/forfeited/expired (in shares) | (5,513) | ||
Ending balance (in shares) | 13,837 | 19,350 | 12,600 |
Exercisable (in shares) | 10,007 | ||
Vested or expected to vest (in shares) | 13,562 | ||
Weighted- Average Exercise Price per Share | |||
Beginning balance (in USD shares) | $ 19.12 | $ 15.40 | |
Options granted (in USD shares) | 26.06 | ||
Options cancelled/forfeited/expired (in USD shares) | 15.40 | ||
Ending balance (in USD shares) | 20.60 | $ 19.12 | $ 15.40 |
Exercisable (in USD shares) | 18.47 | ||
Vested or expected to vest (in USD shares) | $ 20.48 | ||
Weighted- Average Remaining Contractual Term (In Years) | |||
Remaining Contractual Term | 4 years 6 months 7 days | 8 years 10 months 28 days | 9 years 8 months 5 days |
Exercisable | 3 years 18 days | ||
Vested or expected to vest | 4 years 5 months 9 days | ||
Aggregate Intrinsic Value | |||
Exercisable | $ 0 | ||
Vested or expected to vest | $ 0 |
Stock-Based Compensation - Su_3
Stock-Based Compensation - Summary of Stock Options Outstanding and Exercisable within the Approved Stock Options Plans, Excludes Inducement Grants (Detail) - 2012 and 2014 Plan Excluding Inducement Grants | 12 Months Ended |
Dec. 31, 2018$ / sharesshares | |
$3.45 - $4.00 | |
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | |
Shares authorized under sock option plans, exercise price range, lower range limit | $ 3.45 |
Shares authorized under stock option plans, exercise price range, upper range limit | $ 4 |
Options outstanding, number of shares (in shares) | shares | 132,500 |
Options outstanding, weighted average remaining contractual life | 9 years 9 months 18 days |
Options outstanding, weighted average exercise price (in USD per share) | $ 3.90 |
Options exercisable, number of shares (in shares) | shares | 0 |
Options exercisable, weighted average exercise price (in USD per share) | $ 0 |
$4.24 - $4.24 | |
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | |
Shares authorized under sock option plans, exercise price range, lower range limit | 4.24 |
Shares authorized under stock option plans, exercise price range, upper range limit | $ 4.24 |
Options outstanding, number of shares (in shares) | shares | 937,637 |
Options outstanding, weighted average remaining contractual life | 9 years 3 months 15 days |
Options outstanding, weighted average exercise price (in USD per share) | $ 4.24 |
Options exercisable, number of shares (in shares) | shares | 156,409 |
Options exercisable, weighted average exercise price (in USD per share) | $ 4.24 |
$4.27 - $181.00 | |
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | |
Shares authorized under sock option plans, exercise price range, lower range limit | 4.27 |
Shares authorized under stock option plans, exercise price range, upper range limit | $ 181 |
Options outstanding, number of shares (in shares) | shares | 224,470 |
Options outstanding, weighted average remaining contractual life | 8 years 8 months 12 days |
Options outstanding, weighted average exercise price (in USD per share) | $ 11.93 |
Options exercisable, number of shares (in shares) | shares | 67,338 |
Options exercisable, weighted average exercise price (in USD per share) | $ 21.18 |
$182.60 - $182.60 | |
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | |
Shares authorized under sock option plans, exercise price range, lower range limit | 182.60 |
Shares authorized under stock option plans, exercise price range, upper range limit | $ 182.60 |
Options outstanding, number of shares (in shares) | shares | 150 |
Options outstanding, weighted average remaining contractual life | 6 years 3 months 26 days |
Options outstanding, weighted average exercise price (in USD per share) | $ 182.60 |
Options exercisable, number of shares (in shares) | shares | 137 |
Options exercisable, weighted average exercise price (in USD per share) | $ 182.60 |
$185.80 - $185.80 | |
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | |
Shares authorized under sock option plans, exercise price range, lower range limit | 185.80 |
Shares authorized under stock option plans, exercise price range, upper range limit | $ 185.80 |
Options outstanding, number of shares (in shares) | shares | 1,400 |
Options outstanding, weighted average remaining contractual life | 6 years 4 months 21 days |
Options outstanding, weighted average exercise price (in USD per share) | $ 185.80 |
Options exercisable, number of shares (in shares) | shares | 1,254 |
Options exercisable, weighted average exercise price (in USD per share) | $ 185.80 |
Stock-Based Compensation - Su_4
Stock-Based Compensation - Summary of Stock-Based Compensation Expense (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Total stock-based compensation expense | $ 1,178 | $ 692 |
Research and development | ||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Total stock-based compensation expense | 529 | 266 |
General and administrative | ||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Total stock-based compensation expense | $ 649 | $ 426 |
Stock-Based Compensation - Sche
Stock-Based Compensation - Schedule of Weighted-Average Assumptions for the Black-Scholes Option-Pricing Model Used in Determining the Fair Value of Options Granted to Employees (Detail) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | ||
Dividend yield | 0.00% | 0.00% |
Risk-free interest rate, minimum | 2.46% | 1.90% |
Risk-free interest rate, maximum | 3.11% | 2.25% |
Expected volatility | 89.00% | 89.00% |
Expected term (years) | 6 years 29 days | 6 years 29 days |
Estimated forfeiture % rate | 6.50% | 6.50% |
Severance - Additional Informat
Severance - Additional Information (Detail) - USD ($) $ in Millions | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Chief Business Officer and Chief Financial Officer | ||
Restructuring Cost and Reserve [Line Items] | ||
Severance | $ 0.2 | |
Unvested equity awards, accelerated at termination | 25.00% | |
President and Chief Executive Officer | ||
Restructuring Cost and Reserve [Line Items] | ||
Payment of postemployment severance and benefits | $ 0.3 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Detail) - USD ($) | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Income Tax [Line Items] | |||
Income tax expense | $ 0 | $ 0 | |
Net deferred tax assets | 16,535,000 | 16,853,000 | |
(Decrease) increase in net valuation allowance | (300,000) | (2,000,000) | |
Unrecognized tax benefits | 1,128,000 | 1,006,000 | $ 943,000 |
Unrecognized tax-related penalties or interest | 0 | 0 | |
California | |||
Income Tax [Line Items] | |||
Net operating loss carryforwards, valuation allowance | 196,600,000 | ||
Deferred tax assets, net operating loss carryforwards derecognized amount | 13,700,000 | ||
Deferred tax assets, tax credit research and development derecognized amount | $ 0 | ||
Minimum | |||
Income Tax [Line Items] | |||
Percentage of change In ownership for operating loss carryforward | 50.00% | ||
Period for change in ownership percentage | 3 years | ||
Federal | |||
Income Tax [Line Items] | |||
Net operating loss carryforwards | $ 41,100,000 | 43,800,000 | |
Net operating loss carryforwards, valuation allowance | 220,500,000 | ||
Deferred tax assets, net operating loss carryforwards derecognized amount | 46,300,000 | ||
Deferred tax assets, tax credit research and development derecognized amount | $ 5,100,000 | ||
Federal | Minimum | |||
Income Tax [Line Items] | |||
Net operating loss carryforwards expiration year | 2026 | ||
Federal | Research and Development Credit Carry Forwards | |||
Income Tax [Line Items] | |||
Research and development credit carryforwards | $ 600,000 | 400,000 | |
Tax credits will begin to expire | 2026 | ||
State | |||
Income Tax [Line Items] | |||
Net operating loss carryforwards | $ 33,200,000 | 43,500,000 | |
State | Minimum | |||
Income Tax [Line Items] | |||
Net operating loss carryforwards expiration year | 2028 | ||
State | Research and Development Credit Carry Forwards | |||
Income Tax [Line Items] | |||
Research and development credit carryforwards | $ 5,100,000 | $ 4,600,000 |
Income Taxes - Reconciliation o
Income Taxes - Reconciliation of Federal Statutory Income Tax Rate to the Company's Effective Tax Rate (Detail) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Effective Income Tax Rate Reconciliation, Percent [Abstract] | ||
Federal statutory tax rate | (21.00%) | (34.00%) |
State statutory tax rate, net of federal benefit | (7.00%) | (5.80%) |
Change in effective tax rate | (0.00%) | 18.10% |
Derecognition due to Section 382 and 383 | 25.40% | 30.20% |
Stock-based compensation | 0.50% | 1.10% |
Permanent items | 3.00% | (2.50%) |
Change in valuation allowance | (0.90%) | (7.10%) |
Effective tax rate | 0.00% | 0.00% |
Income Taxes - Components of Ne
Income Taxes - Components of Net Deferred Tax Assets and Liabilities (Detail) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Components of Deferred Tax Assets and Liabilities [Abstract] | ||
Net operating loss carryforwards | $ 10,942 | $ 12,226 |
Research and development credits | 3,657 | 3,245 |
Depreciation and amortization | 729 | 640 |
Accruals | 569 | 507 |
Deferred rent | 400 | 113 |
Stock-based compensation | 213 | 98 |
Capital loss carryforward | 23 | 23 |
Other | 2 | 1 |
Net deferred tax assets | 16,535 | 16,853 |
Valuation allowance | (16,535) | (16,853) |
Differed tax assets and liabilities | $ 0 | $ 0 |
Income Taxes - Schedule of Unre
Income Taxes - Schedule of Unrecognized Tax Benefits (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 the beginning of year | $ 1,006 | $ 943 |
Decrease related to prior year tax positions | (77) | 0 |
Increase related to current year tax positions | 199 | 63 |
Balance at the end of year | $ 1,128 | $ 1,006 |
Employee Benefit Plan - Additio
Employee Benefit Plan - Additional Information (Detail) | 12 Months Ended |
Dec. 31, 2018USD ($) | |
401 (k) Plan | |
Defined Benefit Plan Disclosure [Line Items] | |
Employer contribution | $ 0 |
Subsequent Event - Additional I
Subsequent Event - Additional Information (Detail) - Commercial Coating and Primary Packaging System - USD ($) $ in Millions | 1 Months Ended | |
Feb. 28, 2019 | May 31, 2018 | |
Subsequent Event [Line Items] | ||
Purchase price | $ 12.2 | |
Subsequent Event | ||
Subsequent Event [Line Items] | ||
Purchase price | $ 13.5 |