Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2020 | May 12, 2020 | |
Document And Entity Information [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Mar. 31, 2020 | |
Document Fiscal Year Focus | 2020 | |
Document Fiscal Period Focus | Q1 | |
Entity Registrant Name | Zosano Pharma Corp | |
Entity Central Index Key | 0001587221 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | true | |
Entity Ex Transition Period | true | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 54,361,635 |
Condensed Balance Sheets
Condensed Balance Sheets - USD ($) $ in Thousands | Mar. 31, 2020 | Dec. 31, 2019 |
Current assets: | ||
Cash and cash equivalents | $ 18,557 | $ 6,316 |
Prepaid expenses and other current assets | 623 | 497 |
Total current assets | 19,180 | 6,813 |
Restricted cash | 455 | 455 |
Property and equipment, net | 30,164 | 24,636 |
Operating lease right-of-use assets | 5,533 | 5,763 |
Other long-term assets | 3 | 3 |
Total assets | 55,335 | 37,670 |
Current liabilities: | ||
Accounts payable | 3,263 | 4,356 |
Accrued compensation | 2,553 | 2,015 |
Build-to-suit obligation, current portion | 4,665 | 4,554 |
Operating lease liabilities, current portion | 1,184 | 1,140 |
Other accrued liabilities | 8,943 | 4,172 |
Total current liabilities | 20,608 | 16,237 |
Build-to-suit obligation, long-term portion, net of debt issuance costs and discount | 5,129 | 6,095 |
Operating lease liabilities, long-term portion | 5,618 | 5,931 |
Other liabilities | 10 | 15 |
Total liabilities | 31,365 | 28,278 |
Commitments and contingencies | ||
Stockholders’ equity: | ||
Preferred stock, $0.0001 par value; 5,000,000 shares authorized; none issued and outstanding as of March 31, 2020 and December 31, 2019 | 0 | 0 |
Common stock, $0.0001 par value; 250,000,000 shares authorized; 54,361,635 and 23,503,214 shares issued and outstanding as of March 31, 2020 and December 31, 2019, respectively | 5 | 2 |
Additional paid-in capital | 331,475 | 308,211 |
Accumulated deficit | (307,510) | (298,821) |
Total stockholders’ equity | 23,970 | 9,392 |
Total liabilities and stockholders’ equity | $ 55,335 | $ 37,670 |
Condensed Balance Sheets (Paren
Condensed Balance Sheets (Parenthetical) - $ / shares | Mar. 31, 2020 | Dec. 31, 2019 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value (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 (usd per share) | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized (in shares) | 250,000,000 | 250,000,000 |
Common stock, shares issued (in shares) | 54,361,635 | 23,503,214 |
Common stock, shares outstanding (in shares) | 54,361,635 | 23,503,214 |
Condensed Statements of Operati
Condensed Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Income Statement [Abstract] | ||
Revenue | $ 0 | $ 0 |
Operating expenses | ||
Research and development | 5,514 | 6,616 |
General and administrative | 3,082 | 2,871 |
Total operating expenses | 8,596 | 9,487 |
Loss from operations | (8,596) | (9,487) |
Other income (expense) | ||
Interest income | 10 | 80 |
Interest expense | (206) | (41) |
Other income, net | 103 | 22 |
Loss before provision for income taxes | (8,689) | (9,426) |
Provision for income taxes | 0 | 0 |
Net loss | (8,689) | (9,426) |
Unrealized gain on marketable securities, net of tax | 0 | 6 |
Comprehensive loss | $ (8,689) | $ (9,420) |
Net loss per common share – basic and diluted (in USD per share) | $ (0.24) | $ (0.79) |
Weighted-average shares used in computing net loss per common share – basic and diluted (in shares) | 36,266,018 | 11,973,039 |
Condensed Statement of Changes
Condensed Statement of Changes in Stockholders' Equity - USD ($) $ in Thousands | Total | Common Stock | Additional Paid-In Capital | Accumulated Deficit | Accumulated Other Comprehensive Income (Loss) | Registered Direct Offering | Registered Direct OfferingCommon Stock | Registered Direct OfferingAdditional Paid-In Capital | Public Stock Offering | Public Stock OfferingCommon Stock | Public Stock OfferingAdditional Paid-In Capital | At-the-market Offering | At-the-market OfferingCommon Stock | At-the-market OfferingAdditional Paid-In Capital | Series C Warrant | Series C WarrantCommon Stock | Series C WarrantAdditional Paid-In Capital | Series D Warrants | Series D WarrantsCommon Stock | Series D WarrantsAdditional Paid-In Capital |
Beginning balance (in shares) at Dec. 31, 2018 | 11,973,039 | |||||||||||||||||||
Beginning balance at Dec. 31, 2018 | $ 18,710 | $ 1 | $ 279,946 | $ (261,232) | $ (5) | |||||||||||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||||||||||||||
Stock-based compensation | 361 | 361 | ||||||||||||||||||
Unrealized gain on marketable securities | 6 | 6 | ||||||||||||||||||
Net loss | (9,426) | (9,426) | ||||||||||||||||||
Ending balance (in shares) at Mar. 31, 2019 | 11,973,039 | |||||||||||||||||||
Ending balance at Mar. 31, 2019 | $ 9,651 | $ 1 | 280,307 | (270,658) | 1 | |||||||||||||||
Beginning balance (in shares) at Dec. 31, 2019 | 23,503,214 | 23,503,214 | ||||||||||||||||||
Beginning balance at Dec. 31, 2019 | $ 9,392 | $ 2 | 308,211 | (298,821) | 0 | |||||||||||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||||||||||||||
Issuance of common stock (in shares) | 11,903,506 | 11,992,307 | 2,151,346 | |||||||||||||||||
Issuance of common stock | $ 10,211 | $ 1 | $ 10,210 | $ 8,264 | $ 2 | $ 8,262 | $ 2,706 | $ 0 | $ 2,706 | |||||||||||
Issuance of common stock upon exercise of warrants (in shares) | 2,649,723 | 2,161,539 | ||||||||||||||||||
Issuance of common stock upon exercise of warrants | $ 1,722 | $ 1,722 | $ 0 | $ 0 | ||||||||||||||||
Stock-based compensation | 364 | 364 | ||||||||||||||||||
Unrealized gain on marketable securities | 0 | |||||||||||||||||||
Net loss | $ (8,689) | (8,689) | ||||||||||||||||||
Ending balance (in shares) at Mar. 31, 2020 | 54,361,635 | 54,361,635 | ||||||||||||||||||
Ending balance at Mar. 31, 2020 | $ 23,970 | $ 5 | $ 331,475 | $ (307,510) | $ 0 |
Condensed Statements of Cash Fl
Condensed Statements of Cash Flows - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Cash flows from operating activities | ||
Net loss | $ (8,689) | $ (9,426) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock-based compensation | 364 | 361 |
Change in operating lease right-of-use assets | 230 | 196 |
Depreciation and amortization | 172 | 164 |
Effective interest on financing obligations | 243 | 229 |
Capitalized effective interest | (157) | (201) |
Accretion of interest on marketable securities | 0 | (27) |
Change in operating assets and liabilities | ||
Prepaid expenses and other assets | (79) | (180) |
Accounts payable | (617) | 654 |
Accrued compensation and other accrued liabilities | 358 | 983 |
Operating lease liabilities | (269) | (222) |
Net cash used in operating activities | (8,444) | (7,469) |
Cash flows from investing activities | ||
Proceeds from maturities of marketable securities | 0 | 9,000 |
Purchases of property and equipment | (1,384) | (4,016) |
Net cash (used in) provided by investing activities | (1,384) | 4,984 |
Cash flows used in financing activities | ||
Proceeds from exercise of Series C warrants | 1,722 | 0 |
Principal payments on financing obligations | (1,102) | (513) |
Net cash provided by (used in) financing activities | 22,069 | (513) |
Net increase (decrease) in cash, cash equivalents and restricted cash | 12,241 | (2,998) |
Cash, cash equivalents and restricted cash at beginning of period | 6,771 | 9,595 |
Cash, cash equivalents and restricted cash at end of period | 19,012 | 6,597 |
Supplemental cash flow information | ||
Cash paid for interest | 254 | 185 |
Non-cash investing and financing activities | ||
Acquisition of property and equipment under accounts payable and other accrued liabilities | 8,579 | 4,252 |
Unpaid offering costs | 396 | 382 |
Right-of-use assets acquired under finance lease obligations | 0 | 22 |
Registered Direct Offering | ||
Cash flows used in financing activities | ||
Proceeds from offering of securities, net of costs | 10,298 | 0 |
Public Stock Offering | ||
Cash flows used in financing activities | ||
Proceeds from offering of securities, net of costs | 8,483 | 0 |
At-the-market Offering | ||
Cash flows used in financing activities | ||
Proceeds from offering of securities, net of costs | $ 2,668 | $ 0 |
Organization and Basis of Prese
Organization and Basis of Presentation | 3 Months Ended |
Mar. 31, 2020 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization and Basis of Presentation | Organization and Basis of Presentation The Company Zosano Pharma Corporation (the “Company”) is a clinical-stage biopharmaceutical company focused on providing rapid systemic administration of therapeutics and other bioactive molecules to patients using its proprietary intracutaneous microneedle patch system. Basis of Presentation The accompanying condensed financial statements have been prepared in accordance with United States generally accepted accounting principles (“U.S. GAAP”) for interim financial information, the instructions to Form 10-Q and Regulation S-X. They do not include all the information and notes required by U.S. GAAP for complete financial statements. In the opinion of management, all adjustments (consisting of normal and recurring accruals) considered necessary for a fair presentation have been included. Operating results for the three months ended March 31, 2020 are not necessarily indicative of the results that may be expected for the year ending December 31, 2020 , or any other subsequent period. These financial statements should be read in conjunction with the Company’s audited financial statements for the year ended December 31, 2019 , included in the Company’s annual report on Form 10-K and filed with the United States Securities and Exchange Commission (“SEC”) on March 13, 2020. Use of Estimates The preparation of the accompanying condensed financial statements in accordance with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities as of the date of the condensed financial statements, and the reported amounts of expenses during the periods reported. Actual results could differ from those estimates. 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 March 31, 2020 , had an accumulated deficit of $307.5 million . As of March 31, 2020 , the Company had approximately $18.6 million in cash and cash equivalents. Presently, the Company does not have sufficient cash and cash equivalents to enable it to fund its anticipated level of operations and meet its obligations as they become due within twelve months following the date of issuance of this Quarterly Report on Form 10-Q. 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. On March 4, 2020, the Company entered into a securities purchase agreement with certain institutional investors for the issuance and sale in a registered direct offering (the "March 2020 Offering") of (i) 11,903,506 shares of the Company's common stock and (ii) Series E Warrants to purchase up to a total of 11,903,506 shares of common stock at an offering price of $0.9275 per share and accompanying warrant. The Series E Warrants have an exercise price of $0.8025 per share, are immediately exercisable and will expire five years from the date of issuance. The aggregate net proceeds from the offering were approximately $10.2 million , after deducting the placement agent fees and estimated offering expenses. On August 19, 2019, the Company entered into a sales agreement with BTIG, LLC, as sales agent (“BTIG”), to establish an at-the-market ("ATM") offering program, under which the Company was permitted to offer and sell, from time to time, shares of common stock having a maximum aggregate offering price of up to $15.0 million . The Company was required to pay BTIG a commission of 3% of the gross proceeds from the sale of shares and also agreed to provide BTIG with customary indemnification rights. During the quarter ended March 31, 2020 , the Company issued and sold 2,151,346 shares of its common stock at an average price of $ 1.30 per share under the ATM program. The aggregate net proceeds were approximately $2.7 million after BTIG's commission of $0.1 million and other offering expenses. On March 4, 2020, the Company delivered notice of termination of the sales agreement to BTIG. The Company did not incur any penalties as a result of its termination of the sales agreement. On February 14, 2020, the Company closed an underwritten offering (the "February 2020 Offering") for the issuance and sale of (i) 10,146,154 Class A Units, each consisting of one share of common stock and one Series C Warrant to purchase one share of common stock, at a public offering price of $0.65 per Class A Unit, and (ii) 2,161,539 Class B Units, each consisting of one Series D Pre-Funded Warrant to purchase one share of common stock and one Series C Warrant to purchase one share of common stock, at a public offering price of $0.6499 per Class B Unit. The Series C Warrants have an exercise price of $0.65 per share, are immediately exercisable and will expire five years from the date of issuance. The Series D Pre-Funded Warrants had an exercise price of $0.0001 per share and were fully exercised in connection with the closing of the offering. The Company granted the underwriter a 30 -day option to purchase up to an additional 1,846,153 shares of common stock and/or additional Series C Warrants to purchase up to 1,846,153 shares of common stock. The underwriter fully exercised its option to purchase the shares and the Series C Warrants. The aggregate net proceeds from the offering were $8.3 million after deducting underwriting commissions and estimated offering expenses. As of March 31, 2020 , 2,649,723 shares of common stock have been issued pursuant to the exercise of the Series C Warrants at an exercise price of $0.65 per share for aggregate net proceeds of $1.7 million . 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 obtained 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. COVID-19 Pandemic On March 11, 2020, the World Health Organization designated COVID-19 as a global pandemic. Due to the COVID-19 pandemic, there has been uncertainty in the global financial markets and economic conditions. The Company is closely monitoring the impact of the COVID-19 pandemic on its business, including how it will impact its employees, clinical trials and third-party service providers who perform critical services for the Company's business. In addition, the impact of the COVID-19 pandemic on the global financial markets and economic conditions could impact the Company's ability to raise capital through an equity financing, debt financing, a license or collaboration or a combination of such sources of capital, and as a result, its ability to continue as a going concern. The full extent to which the COVID-19 pandemic will directly or indirectly impact the Company's business, results of operations and financial condition will depend on future developments that are highly uncertain, including as a result of new information that may emerge concerning COVID-19 and the actions taken to contain or treat it. As of the date of issuance of this Quarterly Report on Form 10-Q, management is not aware of any specific event or circumstances that would require an update to its estimates or a revision of the carrying value of its assets or liabilities. These estimates may change, as new events occur, and additional information is obtained. On March 27, 2020, the Coronavirus Aid, Relief, and Economic Security Act (the ‘‘CARES Act’’) was signed into law. The CARES Act includes provisions relating to refundable payroll tax credits, deferment of the employer portion of certain payroll taxes, net operating loss carryback periods, alternative minimum tax credit refunds, modifications to the net interest deduction limitations and technical corrections to tax depreciation methods for qualified improvement property. The Company analyzed the provisions of the CARES Act and determined there was no significant impact on the Company's provision for income taxes for the three months ended March 31, 2020 . |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2020 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Summary of Significant Accounting Policies Significant Accounting Policies The Company’s significant accounting policies are included in Note 2. Summary of Significant Accounting Policies to the financial statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2019 . Cash, Cash Equivalents and Restricted Cash The Company considers all highly liquid investments with an original maturity of 90 days or less to be cash equivalents. As of March 31, 2020 , and December 31, 2019 , 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 purchasing 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: March 31, 2020 March 31, 2019 (unaudited; in thousands) Cash and cash equivalents $ 18,557 $ 6,142 Restricted cash 455 455 Total $ 19,012 $ 6,597 Marketable Securities Marketable securities generally consist of debt securities with original maturities greater than 90 days and remaining maturities of less than one year. Marketable securities with an original maturity greater than one year, if any, would be considered long-term investments. 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 related to fixed maturity debt securities is reported as a separate component of other comprehensive loss in the statements of operations and comprehensive loss and as a separate component of stockholders' equity on the balance sheets. Interest income includes interest, dividends, amortization and accretion 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 available-for-sale debt securities exceeds its fair value and the decline in value is determined to be other-than-temporary, an allowance is recorded in the amount that the carrying amount of the security exceeds its fair value and a loss is recognized in operating results for the amount of such decline. If the carrying amount of an investment in marketable securities, other than available-for-sale debt 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 expected 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 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. The carrying value of the Company's long-term financial obligations approximates fair value because interest rates approximate market rates that the Company could obtain for debt with similar terms and maturities. 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, 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: March 31, 2020 March 31, 2019 (unaudited) Warrants to purchase common stock 23,680,570 274,524 Options to purchase common stock 2,097,401 1,456,126 Total 25,777,971 1,730,650 Recent Accounting Pronouncements Recently Adopted Accounting Pronouncements The Financial Accounting Standards Board ("FASB") issued Accounting Standards Update ("ASU") 2019-05, Financial Instruments - Credit Losses, Targeted Transition Relief in May 2019, ASU 2019-04, Codification Improvements to Topic 326, Financial Instruments — Credit Losses, Topic 815, Derivatives and Hedging, and Topic 825, Financial Instruments in April 2019, and ASU 2018-19, Codification Improvements to Topic 326, Financial Instruments - Credit Losses in November 2018. 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 standards' provisions as a cumulative-effect adjustment to retained earnings as of the beginning of the first reporting period in which the guidance is adopted. The Company adopted ASU 2019-05, ASU 2019-04 and ASU 2018-19 effective January 1, 2020. The adoption of this guidance did not have an impact on the Company's financial statements. In August 2018, the FASB issued ASU 2018-15, 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. The Company adopted ASU 2018-15, Subtopic 350-40 effective January 1, 2020 on a prospective basis and recorded $35,000 of capitalized implementation costs for the quarter ended March 31, 2020. In August 2018, the FASB issued ASU 2018-13, Fair Value Measurement (Topic 820) . The new guidance modifies the disclosure requirements on fair value measurements. The Company adopted Topic 820 effective January 1, 2020 on a modified retrospective basis. The adoption of this guidance did not have a material impact on the Company's financial statement disclosures. Recent Accounting Pronouncements Not Yet Adopted In December 2019, the FASB issued ASU 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes. This new guidance simplifies the accounting for income taxes by removing certain exceptions to general principles, clarifying requirements and including amendments to improve consistent application of the guidance. The guidance specifically removes the exception to the incremental approach for intraperiod tax allocation when there is a loss from continuing operations and income or a gain from other items, such as discontinued operations or other comprehensive income. The guidance also requires an entity to recognize a franchise tax that is partially based on income as an income-based tax and to account for any other amounts incurred as a non-income based tax. The guidance is effective for the Company beginning January 1, 2021 using a prospective approach. Early adoption is permitted. The Company is evaluating the effect of implementation on its financial statements and disclosures. |
Cash Equivalents and Investment
Cash Equivalents and Investments in Marketable Securities | 3 Months Ended |
Mar. 31, 2020 | |
Cash, Cash Equivalents, and Short-term Investments [Abstract] | |
Cash Equivalents and Investments in Marketable Securities | Cash Equivalents and Investments in Marketable Securities The following table summarizes the Company's cash equivalents and investments in marketable securities measured at fair value on a recurring basis as of March 31, 2020: Fair Value Measurements Total Quoted prices Significant Significant (unaudited; in thousands) Money market funds classified as cash equivalents $ 17,410 $ 17,410 $ — $ — The Company did not hold any cash equivalents and investments in marketable securities as of December 31, 2019. |
Balance Sheet Components
Balance Sheet Components | 3 Months Ended |
Mar. 31, 2020 | |
Balance Sheet Related Disclosures [Abstract] | |
Balance Sheet Components | Balance Sheet Components The following table summarizes the Company’s prepaid expenses and other current assets for each of the periods presented: March 31, 2020 December 31, 2019 (unaudited; in thousands) (in thousands) Prepaid insurance $ 266 $ 49 Prepaid services 163 316 Deferred offering costs 107 65 Prepaid software, subscriptions and deferred implementation costs 87 61 Other — 6 Total $ 623 $ 497 The following table summarizes the Company’s property and equipment for each of the periods presented: March 31, 2020 December 31, 2019 (unaudited; in thousands) (in thousands) Leasehold improvements $ 16,932 $ 16,932 Manufacturing equipment 12,255 12,173 Laboratory and office equipment 1,585 1,585 Right-of-use laboratory and office equipment 25 25 Computer equipment and software 138 138 Right-of-use computer equipment and software 29 29 Construction-in-progress 26,221 20,602 Property and equipment at cost 57,185 51,484 Less: accumulated depreciation property and equipment (26,990 ) (26,821 ) Less: accumulated amortization right-of-use assets (31 ) (27 ) Total $ 30,164 $ 24,636 As of March 31, 2020 , construction-in-progress included $13.5 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 $1.8 million (See Note 6. Debt Financing ). The following table summarizes the Company's depreciation and amortization expense for each of the periods presented: Three Months Ended March 31, 2020 2019 (unaudited; in thousands) Depreciation and amortization expense $ 172 $ 164 The following table summarizes the Company’s other accrued liabilities for each of the periods presented: March 31, 2020 December 31, 2019 (unaudited; in thousands) (in thousands) Construction-in-progress obligations $ 8,323 $ 3,422 Professional service fees 345 206 Contract manufacturing 106 250 Accrued taxes 42 27 Pre-clinical and clinical study 12 43 Other 115 224 Total $ 8,943 $ 4,172 |
Leases
Leases | 3 Months Ended |
Mar. 31, 2020 | |
Leases [Abstract] | |
Leases | Leases Operating Leases The Company has a non-cancelable operating lease for office, research and development, and manufacturing facilities in Fremont, California through August 31, 2024, with an option to further extend the lease for an additional 60 months subject to certain terms and conditions. The operating lease right-of-use asset and associated lease liability do not consider the option to extend the term after August 31, 2024, as the Company is not reasonably certain of exercising the extension option. The Company entered into a three year, non-cancelable lease for telephone equipment in January 2018. Per the terms of the agreements, the Company does not have any residual value guarantees, restrictions or covenants. In calculating the present value of the lease payments, the Company utilized its incremental borrowing rate, as the rates implicit in the leases were not readily determinable. The Company accounts for lease and non-lease components separately. The building lease includes non-lease components (i.e. common area maintenance) which are charged and paid separately from rent based on actual costs incurred and therefore are not included in the right-of-use asset and lease liability but reflected in operating expense in the period incurred. Finance Leases The Company leases certain equipment under non-cancelable agreements which expire between 2021 and 2022. The following table summarizes the components of lease costs for each of the periods presented: Three Months Ended March 31, 2020 2019 (unaudited; in thousands) Operating lease costs $ 422 $ 410 Finance lease costs: Amortization of finance lease right-of-use assets 4 15 Interest on finance lease obligations 2 9 Total $ 428 $ 434 The following table summarizes cash payments for leases for each of the periods presented: Three Months Ended March 31, 2020 2019 (unaudited; in thousands) Operating cash flows from operating leases - cash paid for operating leases $ 461 $ 436 Operating cash flows from finance leases - cash paid for interest $ 2 $ 3 Financing cash flows from finance leases - cash paid for principal $ 4 $ 3 The following table summarizes the lease terms and discount rates for the Company's leases as of March 31, 2020: Operating leases Finance leases (unaudited) Weighted-average remaining lease term (in years) 4.41 1.61 Weighted average discount rate 11 % 27 % The following table summarizes the Company's annual scheduled lease payments for each year ending December 31, as of March 31, 2020 : Operating leases Finance leases (unaudited; in thousands) Remainder of 2020 $ 1,400 $ 18 2021 1,909 14 2022 1,961 3 2023 2,017 — 2024 1,372 — Total undiscounted cash flows 8,659 35 Less: amount representing interest (1,857 ) (6 ) Present value of lease liabilities $ 6,802 $ 29 Current portion $ 1,184 $ 19 Long-term portion 5,618 10 Total $ 6,802 $ 29 |
Leases | Leases Operating Leases The Company has a non-cancelable operating lease for office, research and development, and manufacturing facilities in Fremont, California through August 31, 2024, with an option to further extend the lease for an additional 60 months subject to certain terms and conditions. The operating lease right-of-use asset and associated lease liability do not consider the option to extend the term after August 31, 2024, as the Company is not reasonably certain of exercising the extension option. The Company entered into a three year, non-cancelable lease for telephone equipment in January 2018. Per the terms of the agreements, the Company does not have any residual value guarantees, restrictions or covenants. In calculating the present value of the lease payments, the Company utilized its incremental borrowing rate, as the rates implicit in the leases were not readily determinable. The Company accounts for lease and non-lease components separately. The building lease includes non-lease components (i.e. common area maintenance) which are charged and paid separately from rent based on actual costs incurred and therefore are not included in the right-of-use asset and lease liability but reflected in operating expense in the period incurred. Finance Leases The Company leases certain equipment under non-cancelable agreements which expire between 2021 and 2022. The following table summarizes the components of lease costs for each of the periods presented: Three Months Ended March 31, 2020 2019 (unaudited; in thousands) Operating lease costs $ 422 $ 410 Finance lease costs: Amortization of finance lease right-of-use assets 4 15 Interest on finance lease obligations 2 9 Total $ 428 $ 434 The following table summarizes cash payments for leases for each of the periods presented: Three Months Ended March 31, 2020 2019 (unaudited; in thousands) Operating cash flows from operating leases - cash paid for operating leases $ 461 $ 436 Operating cash flows from finance leases - cash paid for interest $ 2 $ 3 Financing cash flows from finance leases - cash paid for principal $ 4 $ 3 The following table summarizes the lease terms and discount rates for the Company's leases as of March 31, 2020: Operating leases Finance leases (unaudited) Weighted-average remaining lease term (in years) 4.41 1.61 Weighted average discount rate 11 % 27 % The following table summarizes the Company's annual scheduled lease payments for each year ending December 31, as of March 31, 2020 : Operating leases Finance leases (unaudited; in thousands) Remainder of 2020 $ 1,400 $ 18 2021 1,909 14 2022 1,961 3 2023 2,017 — 2024 1,372 — Total undiscounted cash flows 8,659 35 Less: amount representing interest (1,857 ) (6 ) Present value of lease liabilities $ 6,802 $ 29 Current portion $ 1,184 $ 19 Long-term portion 5,618 10 Total $ 6,802 $ 29 |
Debt Financing
Debt Financing | 3 Months Ended |
Mar. 31, 2020 | |
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 2020. Under the agreement, Trinity made 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 . In consideration of the financing arrangement, as collateral, the Company granted Trinity a first-priority lien and security interest in substantially all of the Company's assets. The Company determined that it controls 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. As of March 31, 2020 , the Company had an aggregate commercial coating and primary packaging system construction-in-progress balance of $13.5 million that included $1.8 million of interest related to its build-to-suit obligation. 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 12% purchase option 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 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 $3.5928 per share. The Trinity Warrants will 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. The Trinity build-to-suit arrangement requires compliance with various affirmative and restrictive covenants in regard to making certain investments and other restricted payments, engaging in mergers or consolidations, and the sale or transfer of certain assets. Failure to comply with any of these covenants, or pay principal, interest or other amounts when due, would constitute an event of default under the applicable agreement. The Company was in compliance with its covenants with respect to the Trinity build-to-suit arrangement as of March 31, 2020 . The following table summarizes the debt obligations as of March 31, 2020 : Drawdown Date Drawdown Amount Principal Balance Purchase Option Fee Discount on Purchase Option Fee Unamortized Discounts and Issuance Costs Monthly Payment Stated Interest Rate Effective Interest Rate Maturity Date (unaudited; in thousands) 09/25/18 $ 5,000 $ 2,517 $ 600 $ (45 ) $ (272 ) $ 160 9.43 % 26.28 % 10/01/21 12/11/18 2,800 1,641 336 (33 ) (110 ) 90 9.68 % 19.58 % 01/01/22 06/06/19 2,300 1,713 276 (43 ) (139 ) 74 9.93 % 19.77 % 07/01/22 09/13/19 2,300 1,889 276 (52 ) (170 ) 74 9.93 % 19.93 % 10/01/22 11/27/19 1,600 1,394 192 (40 ) (136 ) 52 9.93 % 20.20 % 12/01/22 Total $ 14,000 $ 9,154 $ 1,680 $ (213 ) $ (827 ) $ 450 The following table summarizes the Company's build-to-suit obligation as of March 31, 2020 (unaudited; in thousands) : Build-to-suit obligation principal amount $ 9,154 Build-to-suit obligation Purchase Option Fees at present value 1,467 Less: unamortized Purchase Option Fees (627 ) unamortized fair value of free-standing warrants (74 ) unamortized debt discount (118 ) unamortized debt issuance costs (8 ) Build-to-suit obligation, net of debt issuance costs and discount $ 9,794 Build-to-suit obligation, current portion $ 4,665 Build-to-suit obligation, long-term portion, net of debt issuance costs and discount 5,129 Build-to-suit obligation, net of debt issuance costs and discount $ 9,794 The following table summarizes the future minimum payments on the Company’s build-to-suit obligation for each year ending December 31, including payment of principal, interest and Purchase Option Fees as of March 31, 2020: Principal Interest Purchase Option Fees (unaudited; in thousands) Remainder of 2020 $ 3,455 $ 592 $ — 2021 4,284 384 600 2022 1,415 65 1080 Total $ 9,154 $ 1,041 $ 1,680 The following table summarizes interest incurred on the Company's build-to-suit obligation for each of the periods presented: Three Months Ended March 31, 2020 2019 (unaudited; in thousands) Build-to-suit obligation, cash interest expense $ 252 $ 172 Build-to-suit obligation, effective interest expense 243 201 Less: build-to-suit obligation, interest capitalized (298 ) (373 ) Build-to-suit obligation interest expense $ 197 $ — |
Commitments and Contingencies
Commitments and Contingencies | 3 Months Ended |
Mar. 31, 2020 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Commitments and Contingencies Equipment Purchase Commitments The Company has a remaining commitment of $4.0 million , of which $2.6 million was recorded as a current liability as of March 31, 2020 , with an equipment manufacturer for the construction and purchase of a commercial coating and primary packaging system for the production of its product candidate, Qtrypta™ (M207) ("Qtrypta"). The terms of the purchase commitment are contingent upon performance of certain milestones. The Company anticipates that the obligation will be paid within the next 9 months. Contract Manufacturing Organizations In September 2018, the Company entered into a technology transfer agreement and a manufacturing and supply agreement with a contract manufacturing organization ("CMO") to provide services related to the manufacture and commercialization of Qtrypta. During the term of the agreement, the CMO will provide services related to processing, packaging, labeling and storing Qtrypta, in addition to other services such as stability testing, quality control and assurance, and waste disposal. The agreements call for annual fees of $2.0 million in 2020 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 in the United States. The Company may terminate the agreements upon denial of regulatory approvals or if regulatory approvals are withdrawn under certain circumstances. The Company may also elect to terminate the contracts for convenience, which would result in cancellation fees in the amount of 50% of the annual fee due in the year that the contract is terminated, 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. The Company has commitments with this CMO for the construction of manufacturing space and technology transfer fees totaling $10.0 million , of which $5.8 million was a current liability on the balance sheet as of March 31, 2020 . 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 March 31, 2020 . 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. Such matters are subject to many uncertainties and outcomes and are not predictable with assurance. The Company accrues for contingencies when it believes that a loss is probable and that it can reasonably estimate the amount of any such loss. To the extent that there is a reasonable possibility that a loss exceeding amounts already recognized may be incurred and the amount of such additional loss would be material, the Company will either disclose the estimated additional loss or state that such an estimate cannot be made. |
Common Stock Warrants
Common Stock Warrants | 3 Months Ended |
Mar. 31, 2020 | |
Stockholders' Equity Note [Abstract] | |
Common Stock Warrants | Common Stock Warrants The following table summarizes the Company’s common stock warrants issued and outstanding as of the periods presented: Warrants Issued Exercised Expired Warrants Exercise Price Expiration Date (unaudited) Series E - March 2020 — 11,903,506 — — 11,903,506 $ 0.8025 03/06/25 Series D - February 2020 — 2,161,539 (2,161,539 ) — — Series C - February 2020 — 14,153,846 (2,649,723 ) — 11,504,123 $ 0.65 02/14/25 Trinity - September 2018 75,000 — — — 75,000 $ 3.5928 09/25/25 Series B - August 2016 195,906 — — — 195,906 $ 31.00 08/19/21 Amendment to Hercules Term Loan - June 2015 2,035 — — — 2,035 $ 147.40 06/23/20 Hercules Term Loan - June 2014 1,583 — — (1,583 ) — Total 274,524 28,218,891 (4,811,262 ) (1,583 ) 23,680,570 The Company evaluated the Series E and Series C common stock warrants under ASC 480, Distinguishing Liabilities from Equity, and ASC 815, Derivatives and Hedging, and determined permanent equity treatment was appropriate for these freestanding financial instruments. The March 2020 Offering and the February 2020 Offering did not include any embedded features that would require bifurcation. Each Series E and Series C common stock warrant grants the holder the right to purchase one share of common stock, subject to proportional adjustments in the event of stock splits, combinations or similar events. The Series E and Series C common stock warrants do not have any dividend or liquidation preferences or participation rights. Subject to certain conditions, the warrants are exercisable on a cashless basis, and subject to certain beneficial ownership limitations, any unexercised Series E or Series C common stock warrants will be automatically exercised via cashless exercise on the expiration date pursuant to the terms of the respective warrant agreements. |
Stock-Based Compensation
Stock-Based Compensation | 3 Months Ended |
Mar. 31, 2020 | |
Share-based Payment Arrangement [Abstract] | |
Stock-Based Compensation | Stock-Based Compensation The following table summarizes stock option activity under the Amended and Restated 2014 Equity and Incentive Plan ("2014 Plan"), the 2012 Stock Incentive Plan ("2012 Plan") and inducement grants issued to new employees outside of the 2014 Plan in accordance with Nasdaq Listing Rule 5635(c)(4) for the three months ended March 31, 2020 (unaudited) : Shares Available for Grant Under the 2014 Plan Number of Shares Subject to Outstanding Stock Options Weighted-Average Exercise Price per Share Stock options outstanding at January 1, 2020 63,404 2,260,307 $ 4.29 Additional shares reserved 822,612 — Stock options granted (7,000 ) 7,000 $ 0.99 Stock options canceled/forfeited/expired (1) 168,292 (169,906 ) $ 4.16 Stock options outstanding at March 31, 2020 1,047,308 2,097,401 $ 4.29 (1) Stock options canceled, forfeited or expired that were granted under the 2012 Plan or as an inducement grant are not available for future grant, as the 2012 Plan was terminated, and inducement grants are issued outside of the 2014 Plan. The following table summarizes the Company's stock compensation expense for each of the periods presented: Three Months Ended March 31, 2020 2019 (unaudited; in thousands) Research and development $ 169 $ 165 General and administrative 195 196 Total $ 364 $ 361 |
Subsequent Event
Subsequent Event | 3 Months Ended |
Mar. 31, 2020 | |
Subsequent Events [Abstract] | |
Subsequent Events | Subsequent Events Paycheck Protection Program Loan On April 21, 2020, the Company entered into a note (the “Note”) with Silicon Valley Bank pursuant to the Paycheck Protection Program (“PPP”), which provides for a loan in the amount of $1,610,000 (the “PPP Loan”). The PPP, established as part of the CARES Act, provides for loans to qualifying businesses and is administered by the U.S. Small Business Administration. The term of the PPP Loan is two years . The annual interest rate on the PPP Loan is 1.0% and no payments of principal or interest are due during the six-month period beginning on the date of the PPP Loan. The Company may prepay the PPP Loan at any time prior to maturity with no prepayment penalties. Under the terms of the CARES Act, PPP loan recipients can apply for and be granted forgiveness for all or a portion of loans granted under the PPP. Such forgiveness will be determined, subject to limitations, based on the use of loan proceeds for eligible purposes, including payroll, benefits, rent and utilities, and the maintenance of its payroll levels. No assurance is provided that the Company will obtain forgiveness of the PPP Loan in whole or in part. The Note contains events of default and other provisions customary for a loan of this type. The occurrence of an event of default may result in the repayment of all amounts outstanding, collection of all amounts owing from the Company, or filing suit and obtaining judgment against the Company. Shelf Registration On March 16, 2020, the Company filed a shelf registration statement on Form S-3 with the SEC, which was declared effective by the SEC on April 16, 2020. This shelf registration statement provides the Company with the ability to issue common stock and other securities as described in the registration statement from time to time up to an aggregate amount of $74.5 million . |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2020 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The accompanying condensed financial statements have been prepared in accordance with United States generally accepted accounting principles (“U.S. GAAP”) for interim financial information, the instructions to Form 10-Q and Regulation S-X. They do not include all the information and notes required by U.S. GAAP for complete financial statements. In the opinion of management, all adjustments (consisting of normal and recurring accruals) considered necessary for a fair presentation have been included. Operating results for the three months ended March 31, 2020 are not necessarily indicative of the results that may be expected for the year ending December 31, 2020 , or any other subsequent period. These financial statements should be read in conjunction with the Company’s audited financial statements for the year ended December 31, 2019 , included in the Company’s annual report on Form 10-K and filed with the United States Securities and Exchange Commission (“SEC”) on March 13, 2020. |
Use of Estimates | Use of Estimates The preparation of the accompanying condensed financial statements in accordance with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities as of the date of the condensed financial statements, and the reported amounts of expenses during the periods reported. |
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 March 31, 2020 , had an accumulated deficit of $307.5 million . As of March 31, 2020 , the Company had approximately $18.6 million in cash and cash equivalents. Presently, the Company does not have sufficient cash and cash equivalents to enable it to fund its anticipated level of operations and meet its obligations as they become due within twelve months following the date of issuance of this Quarterly Report on Form 10-Q. 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. On March 4, 2020, the Company entered into a securities purchase agreement with certain institutional investors for the issuance and sale in a registered direct offering (the "March 2020 Offering") of (i) 11,903,506 shares of the Company's common stock and (ii) Series E Warrants to purchase up to a total of 11,903,506 shares of common stock at an offering price of $0.9275 per share and accompanying warrant. The Series E Warrants have an exercise price of $0.8025 per share, are immediately exercisable and will expire five years from the date of issuance. The aggregate net proceeds from the offering were approximately $10.2 million , after deducting the placement agent fees and estimated offering expenses. On August 19, 2019, the Company entered into a sales agreement with BTIG, LLC, as sales agent (“BTIG”), to establish an at-the-market ("ATM") offering program, under which the Company was permitted to offer and sell, from time to time, shares of common stock having a maximum aggregate offering price of up to $15.0 million . The Company was required to pay BTIG a commission of 3% of the gross proceeds from the sale of shares and also agreed to provide BTIG with customary indemnification rights. During the quarter ended March 31, 2020 , the Company issued and sold 2,151,346 shares of its common stock at an average price of $ 1.30 per share under the ATM program. The aggregate net proceeds were approximately $2.7 million after BTIG's commission of $0.1 million and other offering expenses. On March 4, 2020, the Company delivered notice of termination of the sales agreement to BTIG. The Company did not incur any penalties as a result of its termination of the sales agreement. On February 14, 2020, the Company closed an underwritten offering (the "February 2020 Offering") for the issuance and sale of (i) 10,146,154 Class A Units, each consisting of one share of common stock and one Series C Warrant to purchase one share of common stock, at a public offering price of $0.65 per Class A Unit, and (ii) 2,161,539 Class B Units, each consisting of one Series D Pre-Funded Warrant to purchase one share of common stock and one Series C Warrant to purchase one share of common stock, at a public offering price of $0.6499 per Class B Unit. The Series C Warrants have an exercise price of $0.65 per share, are immediately exercisable and will expire five years from the date of issuance. The Series D Pre-Funded Warrants had an exercise price of $0.0001 per share and were fully exercised in connection with the closing of the offering. The Company granted the underwriter a 30 -day option to purchase up to an additional 1,846,153 shares of common stock and/or additional Series C Warrants to purchase up to 1,846,153 shares of common stock. The underwriter fully exercised its option to purchase the shares and the Series C Warrants. The aggregate net proceeds from the offering were $8.3 million after deducting underwriting commissions and estimated offering expenses. As of March 31, 2020 , 2,649,723 shares of common stock have been issued pursuant to the exercise of the Series C Warrants at an exercise price of $0.65 per share for aggregate net proceeds of $1.7 million . 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 obtained 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. |
Cash, Cash Equivalents, and Restricted Cash | Cash, Cash Equivalents and Restricted Cash The Company considers all highly liquid investments with an original maturity of 90 days or less to be cash equivalents. |
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. Marketable securities with an original maturity greater than one year, if any, would be considered long-term investments. 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 related to fixed maturity debt securities is reported as a separate component of other comprehensive loss in the statements of operations and comprehensive loss and as a separate component of stockholders' equity on the balance sheets. Interest income includes interest, dividends, amortization and accretion 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 available-for-sale debt securities exceeds its fair value and the decline in value is determined to be other-than-temporary, an allowance is recorded in the amount that the carrying amount of the security exceeds its fair value and a loss is recognized in operating results for the amount of such decline. If the carrying amount of an investment in marketable securities, other than available-for-sale debt 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 expected 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 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. The carrying value of the Company's long-term financial obligations approximates fair value because interest rates approximate market rates that the Company could obtain for debt with similar terms and maturities. |
Net Loss Per Common Share | The carrying values of certain assets and liabilities of the Company, such as cash and cash equivalents 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. The carrying value of the Company's long-term financial obligations approximates fair value because interest rates approximate market rates that the Company could obtain for debt with similar terms and maturities. 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 c |
Recent Accounting Pronouncements | Recently Adopted Accounting Pronouncements The Financial Accounting Standards Board ("FASB") issued Accounting Standards Update ("ASU") 2019-05, Financial Instruments - Credit Losses, Targeted Transition Relief in May 2019, ASU 2019-04, Codification Improvements to Topic 326, Financial Instruments — Credit Losses, Topic 815, Derivatives and Hedging, and Topic 825, Financial Instruments in April 2019, and ASU 2018-19, Codification Improvements to Topic 326, Financial Instruments - Credit Losses in November 2018. 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 standards' provisions as a cumulative-effect adjustment to retained earnings as of the beginning of the first reporting period in which the guidance is adopted. The Company adopted ASU 2019-05, ASU 2019-04 and ASU 2018-19 effective January 1, 2020. The adoption of this guidance did not have an impact on the Company's financial statements. In August 2018, the FASB issued ASU 2018-15, 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. The Company adopted ASU 2018-15, Subtopic 350-40 effective January 1, 2020 on a prospective basis and recorded $35,000 of capitalized implementation costs for the quarter ended March 31, 2020. In August 2018, the FASB issued ASU 2018-13, Fair Value Measurement (Topic 820) . The new guidance modifies the disclosure requirements on fair value measurements. The Company adopted Topic 820 effective January 1, 2020 on a modified retrospective basis. The adoption of this guidance did not have a material impact on the Company's financial statement disclosures. Recent Accounting Pronouncements Not Yet Adopted In December 2019, the FASB issued ASU 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes. This new guidance simplifies the accounting for income taxes by removing certain exceptions to general principles, clarifying requirements and including amendments to improve consistent application of the guidance. The guidance specifically removes the exception to the incremental approach for intraperiod tax allocation when there is a loss from continuing operations and income or a gain from other items, such as discontinued operations or other comprehensive income. The guidance also requires an entity to recognize a franchise tax that is partially based on income as an income-based tax and to account for any other amounts incurred as a non-income based tax. The guidance is effective for the Company beginning January 1, 2021 using a prospective approach. Early adoption is permitted. The Company is evaluating the effect of implementation on its financial statements and disclosures. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
Accounting Policies [Abstract] | |
Schedule of Cash and Cash Equivalents | 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: March 31, 2020 March 31, 2019 (unaudited; in thousands) Cash and cash equivalents $ 18,557 $ 6,142 Restricted cash 455 455 Total $ 19,012 $ 6,597 |
Schedule of 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: March 31, 2020 March 31, 2019 (unaudited; in thousands) Cash and cash equivalents $ 18,557 $ 6,142 Restricted cash 455 455 Total $ 19,012 $ 6,597 |
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: March 31, 2020 March 31, 2019 (unaudited) Warrants to purchase common stock 23,680,570 274,524 Options to purchase common stock 2,097,401 1,456,126 Total 25,777,971 1,730,650 |
Cash Equivalents and Investme_2
Cash Equivalents and Investments in Marketable Securities (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
Cash, Cash Equivalents, and Short-term Investments [Abstract] | |
Summary of Cash Equivalents and Marketable Securities | The following table summarizes the Company's cash equivalents and investments in marketable securities measured at fair value on a recurring basis as of March 31, 2020: Fair Value Measurements Total Quoted prices Significant Significant (unaudited; in thousands) Money market funds classified as cash equivalents $ 17,410 $ 17,410 $ — $ — |
Balance Sheet Components (Table
Balance Sheet Components (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
Balance Sheet Related Disclosures [Abstract] | |
Schedule of Prepaid Expenses and Other Current Assets | The following table summarizes the Company’s prepaid expenses and other current assets for each of the periods presented: March 31, 2020 December 31, 2019 (unaudited; in thousands) (in thousands) Prepaid insurance $ 266 $ 49 Prepaid services 163 316 Deferred offering costs 107 65 Prepaid software, subscriptions and deferred implementation costs 87 61 Other — 6 Total $ 623 $ 497 |
Schedule of Property and Equipment | The following table summarizes the Company’s property and equipment for each of the periods presented: March 31, 2020 December 31, 2019 (unaudited; in thousands) (in thousands) Leasehold improvements $ 16,932 $ 16,932 Manufacturing equipment 12,255 12,173 Laboratory and office equipment 1,585 1,585 Right-of-use laboratory and office equipment 25 25 Computer equipment and software 138 138 Right-of-use computer equipment and software 29 29 Construction-in-progress 26,221 20,602 Property and equipment at cost 57,185 51,484 Less: accumulated depreciation property and equipment (26,990 ) (26,821 ) Less: accumulated amortization right-of-use assets (31 ) (27 ) Total $ 30,164 $ 24,636 As of March 31, 2020 , construction-in-progress included $13.5 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 $1.8 million (See Note 6. Debt Financing ). The following table summarizes the Company's depreciation and amortization expense for each of the periods presented: Three Months Ended March 31, 2020 2019 (unaudited; in thousands) Depreciation and amortization expense $ 172 $ 164 |
Schedule of Other Accrued Liabilities | The following table summarizes the Company’s other accrued liabilities for each of the periods presented: March 31, 2020 December 31, 2019 (unaudited; in thousands) (in thousands) Construction-in-progress obligations $ 8,323 $ 3,422 Professional service fees 345 206 Contract manufacturing 106 250 Accrued taxes 42 27 Pre-clinical and clinical study 12 43 Other 115 224 Total $ 8,943 $ 4,172 |
Leases (Tables)
Leases (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
Leases [Abstract] | |
Lease, Cost | The following table summarizes the lease terms and discount rates for the Company's leases as of March 31, 2020: Operating leases Finance leases (unaudited) Weighted-average remaining lease term (in years) 4.41 1.61 Weighted average discount rate 11 % 27 % The following table summarizes cash payments for leases for each of the periods presented: Three Months Ended March 31, 2020 2019 (unaudited; in thousands) Operating cash flows from operating leases - cash paid for operating leases $ 461 $ 436 Operating cash flows from finance leases - cash paid for interest $ 2 $ 3 Financing cash flows from finance leases - cash paid for principal $ 4 $ 3 The following table summarizes the components of lease costs for each of the periods presented: Three Months Ended March 31, 2020 2019 (unaudited; in thousands) Operating lease costs $ 422 $ 410 Finance lease costs: Amortization of finance lease right-of-use assets 4 15 Interest on finance lease obligations 2 9 Total $ 428 $ 434 |
Operating Leases, Scheduled Lease Payments | The following table summarizes the Company's annual scheduled lease payments for each year ending December 31, as of March 31, 2020 : Operating leases Finance leases (unaudited; in thousands) Remainder of 2020 $ 1,400 $ 18 2021 1,909 14 2022 1,961 3 2023 2,017 — 2024 1,372 — Total undiscounted cash flows 8,659 35 Less: amount representing interest (1,857 ) (6 ) Present value of lease liabilities $ 6,802 $ 29 Current portion $ 1,184 $ 19 Long-term portion 5,618 10 Total $ 6,802 $ 29 |
Operating Leases, Scheduled Lease Payments | The following table summarizes the Company's annual scheduled lease payments for each year ending December 31, as of March 31, 2020 : Operating leases Finance leases (unaudited; in thousands) Remainder of 2020 $ 1,400 $ 18 2021 1,909 14 2022 1,961 3 2023 2,017 — 2024 1,372 — Total undiscounted cash flows 8,659 35 Less: amount representing interest (1,857 ) (6 ) Present value of lease liabilities $ 6,802 $ 29 Current portion $ 1,184 $ 19 Long-term portion 5,618 10 Total $ 6,802 $ 29 |
Debt Financing (Tables)
Debt Financing (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
Debt Disclosure [Abstract] | |
Schedule of Long-term Debt Instruments | The following table summarizes the debt obligations as of March 31, 2020 : Drawdown Date Drawdown Amount Principal Balance Purchase Option Fee Discount on Purchase Option Fee Unamortized Discounts and Issuance Costs Monthly Payment Stated Interest Rate Effective Interest Rate Maturity Date (unaudited; in thousands) 09/25/18 $ 5,000 $ 2,517 $ 600 $ (45 ) $ (272 ) $ 160 9.43 % 26.28 % 10/01/21 12/11/18 2,800 1,641 336 (33 ) (110 ) 90 9.68 % 19.58 % 01/01/22 06/06/19 2,300 1,713 276 (43 ) (139 ) 74 9.93 % 19.77 % 07/01/22 09/13/19 2,300 1,889 276 (52 ) (170 ) 74 9.93 % 19.93 % 10/01/22 11/27/19 1,600 1,394 192 (40 ) (136 ) 52 9.93 % 20.20 % 12/01/22 Total $ 14,000 $ 9,154 $ 1,680 $ (213 ) $ (827 ) $ 450 The following table summarizes the Company's build-to-suit obligation as of March 31, 2020 (unaudited; in thousands) : Build-to-suit obligation principal amount $ 9,154 Build-to-suit obligation Purchase Option Fees at present value 1,467 Less: unamortized Purchase Option Fees (627 ) unamortized fair value of free-standing warrants (74 ) unamortized debt discount (118 ) unamortized debt issuance costs (8 ) Build-to-suit obligation, net of debt issuance costs and discount $ 9,794 Build-to-suit obligation, current portion $ 4,665 Build-to-suit obligation, long-term portion, net of debt issuance costs and discount 5,129 Build-to-suit obligation, net of debt issuance costs and discount $ 9,794 |
Schedule of Maturities of Long-term Debt | The following table summarizes the future minimum payments on the Company’s build-to-suit obligation for each year ending December 31, including payment of principal, interest and Purchase Option Fees as of March 31, 2020: Principal Interest Purchase Option Fees (unaudited; in thousands) Remainder of 2020 $ 3,455 $ 592 $ — 2021 4,284 384 600 2022 1,415 65 1080 Total $ 9,154 $ 1,041 $ 1,680 |
Schedule of Interest | The following table summarizes interest incurred on the Company's build-to-suit obligation for each of the periods presented: Three Months Ended March 31, 2020 2019 (unaudited; in thousands) Build-to-suit obligation, cash interest expense $ 252 $ 172 Build-to-suit obligation, effective interest expense 243 201 Less: build-to-suit obligation, interest capitalized (298 ) (373 ) Build-to-suit obligation interest expense $ 197 $ — |
Warrants (Tables)
Warrants (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
Stockholders' Equity Note [Abstract] | |
Summary of Warrants Issued and Outstanding | The following table summarizes the Company’s common stock warrants issued and outstanding as of the periods presented: Warrants Issued Exercised Expired Warrants Exercise Price Expiration Date (unaudited) Series E - March 2020 — 11,903,506 — — 11,903,506 $ 0.8025 03/06/25 Series D - February 2020 — 2,161,539 (2,161,539 ) — — Series C - February 2020 — 14,153,846 (2,649,723 ) — 11,504,123 $ 0.65 02/14/25 Trinity - September 2018 75,000 — — — 75,000 $ 3.5928 09/25/25 Series B - August 2016 195,906 — — — 195,906 $ 31.00 08/19/21 Amendment to Hercules Term Loan - June 2015 2,035 — — — 2,035 $ 147.40 06/23/20 Hercules Term Loan - June 2014 1,583 — — (1,583 ) — Total 274,524 28,218,891 (4,811,262 ) (1,583 ) 23,680,570 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
Share-based Payment Arrangement [Abstract] | |
Summary of Stock Option and Award Activity Excluding Inducement Grants | The following table summarizes stock option activity under the Amended and Restated 2014 Equity and Incentive Plan ("2014 Plan"), the 2012 Stock Incentive Plan ("2012 Plan") and inducement grants issued to new employees outside of the 2014 Plan in accordance with Nasdaq Listing Rule 5635(c)(4) for the three months ended March 31, 2020 (unaudited) : Shares Available for Grant Under the 2014 Plan Number of Shares Subject to Outstanding Stock Options Weighted-Average Exercise Price per Share Stock options outstanding at January 1, 2020 63,404 2,260,307 $ 4.29 Additional shares reserved 822,612 — Stock options granted (7,000 ) 7,000 $ 0.99 Stock options canceled/forfeited/expired (1) 168,292 (169,906 ) $ 4.16 Stock options outstanding at March 31, 2020 1,047,308 2,097,401 $ 4.29 (1) Stock options canceled, forfeited or expired that were granted under the 2012 Plan or as an inducement grant are not available for future grant, as the 2012 Plan was terminated, and inducement grants are issued outside of the 2014 Plan. |
Summary of Stock-Based Compensation Expense | The following table summarizes the Company's stock compensation expense for each of the periods presented: Three Months Ended March 31, 2020 2019 (unaudited; in thousands) Research and development $ 169 $ 165 General and administrative 195 196 Total $ 364 $ 361 |
Organization and Basis of Pre_2
Organization and Basis of Presentation - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Thousands | Mar. 04, 2020 | Feb. 14, 2020 | Aug. 19, 2019 | Mar. 31, 2020 | Mar. 31, 2019 | Dec. 31, 2019 |
Subsequent Event [Line Items] | ||||||
Accumulated deficit | $ 307,510 | $ 298,821 | ||||
Money market funds classified as cash equivalents | 18,600 | |||||
Proceeds from exercise of Series C warrants | $ 1,722 | $ 0 | ||||
At-the-market Offering | ||||||
Subsequent Event [Line Items] | ||||||
Shares issued in transaction (in shares) | 2,151,346 | |||||
Maximum aggregate offering price | $ 15,000 | |||||
Commissions on proceeds from the sale of shares | 3.00% | |||||
Price of stock sold (in USD per share) | $ 1.30 | |||||
Commissions and other offering expenses | $ 100 | |||||
Consideration from sale of stock | $ 2,700 | |||||
Public Stock Offering | ||||||
Subsequent Event [Line Items] | ||||||
Shares issued in transaction (in shares) | 11,903,506 | |||||
Price of stock sold (in USD per share) | $ 0.9275 | |||||
Over-Allotment Option | ||||||
Subsequent Event [Line Items] | ||||||
Shares issued in transaction (in shares) | 11,903,506 | |||||
Price of stock sold (in USD per share) | $ 0.8025 | |||||
Consideration from sale of stock | $ 8,300 | |||||
Exercise Price (in USD per share) | $ 0.65 | |||||
Option to purchase period | 30 days | |||||
Number of shares issued (in shares) | 2,649,723 | |||||
Private Investment In Public Equity | ||||||
Subsequent Event [Line Items] | ||||||
Term of warrants | 5 years | |||||
Proceeds from issuance | $ 10,200 | |||||
Common Class A | Over-Allotment Option | ||||||
Subsequent Event [Line Items] | ||||||
Shares issued in transaction (in shares) | 10,146,154 | |||||
Price of stock sold (in USD per share) | $ 0.65 | |||||
Number of shares of common stock issued (in shares) | 1 | |||||
Common Class B | Over-Allotment Option | ||||||
Subsequent Event [Line Items] | ||||||
Shares issued in transaction (in shares) | 2,161,539 | |||||
Term of warrants | 5 years | |||||
Price of stock sold (in USD per share) | $ 0.6499 | |||||
Exercise Price (in USD per share) | $ 0.65 | |||||
Common Class C | Over-Allotment Option | ||||||
Subsequent Event [Line Items] | ||||||
Shares issued in transaction (in shares) | 1,846,153 | |||||
Series C Warrant | Common Class A | Over-Allotment Option | ||||||
Subsequent Event [Line Items] | ||||||
Number of shares of warrants issued (in shares) | 1 | |||||
Number of securities called by each warrant (in shares) | 1 | |||||
Series C Warrant | Common Class B | Over-Allotment Option | ||||||
Subsequent Event [Line Items] | ||||||
Number of shares of warrants issued (in shares) | 1 | |||||
Number of securities called by each warrant (in shares) | 1 | |||||
Series D Pre Funded Warrant | ||||||
Subsequent Event [Line Items] | ||||||
Exercise Price (in USD per share) | $ 0.0001 | |||||
Series D Pre Funded Warrant | Common Class B | Over-Allotment Option | ||||||
Subsequent Event [Line Items] | ||||||
Number of shares of common stock issued (in shares) | 1 | |||||
Number of shares of warrants issued (in shares) | 1 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Restricted Cash (Detail) - USD ($) $ in Thousands | Mar. 31, 2020 | Dec. 31, 2019 | Mar. 31, 2019 |
Cash and Cash Equivalents [Line Items] | |||
Restricted cash | $ 455 | $ 455 | $ 455 |
Deposit, Building Lease | |||
Cash and Cash Equivalents [Line Items] | |||
Restricted cash | 300 | 300 | |
Deposit, Utility Provider | |||
Cash and Cash Equivalents [Line Items] | |||
Restricted cash | 100 | 100 | |
Corporate Purchasing Cards | |||
Cash and Cash Equivalents [Line Items] | |||
Restricted cash | $ 35 | $ 35 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Summary of Reconciliation of Cash and Cash Equivalents, and Restricted Cash (Detail) - USD ($) $ in Thousands | Mar. 31, 2020 | Dec. 31, 2019 | Mar. 31, 2019 | Dec. 31, 2018 |
Accounting Policies [Abstract] | ||||
Cash and cash equivalents | $ 18,557 | $ 6,316 | $ 6,142 | |
Restricted cash | 455 | 455 | 455 | |
Total | $ 19,012 | $ 6,771 | $ 6,597 | $ 9,595 |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies - Schedule of Outstanding Common Stock Equivalents Excluded From Computations of Diluted Net Loss per Common Share (Detail) - shares | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Common stock excluded from computation of diluted net loss per share (in shares) | 25,777,971 | 1,730,650 |
Warrants to purchase common stock | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Common stock excluded from computation of diluted net loss per share (in shares) | 23,680,570 | 274,524 |
Options to purchase common stock | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Common stock excluded from computation of diluted net loss per share (in shares) | 2,097,401 | 1,456,126 |
Summary of Significant Accoun_7
Summary of Significant Accounting Policies Summary of Significant Accounting Policies - Recent Accounting Pronouncements (Details) $ in Thousands | Mar. 31, 2020USD ($) |
Accounting Standards Update 2018-15 | |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |
Capitalized implementation costs | $ 35 |
Cash Equivalents and Investme_3
Cash Equivalents and Investments in Marketable Securities - Summary of Cash Equivalents and Investments Carried at Fair Value (Detail) $ in Thousands | Mar. 31, 2020USD ($) |
Schedule Of Cash Equivalents And Available For Sale Investments [Line Items] | |
Money market funds classified as cash equivalents | $ 18,600 |
Money market funds | Recurring | |
Schedule Of Cash Equivalents And Available For Sale Investments [Line Items] | |
Money market funds classified as cash equivalents | 17,410 |
Money market funds | Recurring | Level I | |
Schedule Of Cash Equivalents And Available For Sale Investments [Line Items] | |
Money market funds classified as cash equivalents | 17,410 |
Money market funds | Recurring | Level II | |
Schedule Of Cash Equivalents And Available For Sale Investments [Line Items] | |
Money market funds classified as cash equivalents | 0 |
Money market funds | Recurring | Level III | |
Schedule Of Cash Equivalents And Available For Sale Investments [Line Items] | |
Money market funds classified as cash equivalents | $ 0 |
Balance Sheet Components - Prep
Balance Sheet Components - Prepaid Expenses and Other Current Assets (Details) - USD ($) $ in Thousands | Mar. 31, 2020 | Dec. 31, 2019 |
Balance Sheet Related Disclosures [Abstract] | ||
Prepaid insurance | $ 266 | $ 49 |
Prepaid services | 163 | 316 |
Deferred offering costs | 107 | 65 |
Prepaid software and subscriptions | 87 | 61 |
Other | 0 | 6 |
Prepaid expenses and other current assets | $ 623 | $ 497 |
Balance Sheet Components - Sche
Balance Sheet Components - Schedule of Property and Equipment (Detail) - USD ($) $ in Thousands | 3 Months Ended | ||
Mar. 31, 2020 | Mar. 31, 2019 | Dec. 31, 2019 | |
Property, Plant and Equipment [Line Items] | |||
Property and equipment at cost | $ 57,185 | $ 51,484 | |
Less: accumulated depreciation property and equipment | (26,990) | (26,821) | |
Less: accumulated amortization right-of-use assets | (31) | (27) | |
Total | 30,164 | 24,636 | |
Depreciation and amortization expense | 172 | $ 164 | |
Accumulated capitalized interest costs | 1,800 | ||
Leasehold improvements | |||
Property, Plant and Equipment [Line Items] | |||
Property and equipment, gross | 16,932 | 16,932 | |
Manufacturing equipment | |||
Property, Plant and Equipment [Line Items] | |||
Property and equipment, gross | 12,255 | 12,173 | |
Laboratory and office equipment | |||
Property, Plant and Equipment [Line Items] | |||
Property and equipment, gross | 1,585 | 1,585 | |
Right-of-use asset, gross | 25 | 25 | |
Computer equipment and software | |||
Property, Plant and Equipment [Line Items] | |||
Property and equipment, gross | 138 | 138 | |
Right-of-use asset, gross | 29 | 29 | |
Construction-in-progress | |||
Property, Plant and Equipment [Line Items] | |||
Property and equipment, gross | 26,221 | $ 20,602 | |
Construction In Progress, Build-to-suit | |||
Property, Plant and Equipment [Line Items] | |||
Property and equipment, gross | $ 13,500 |
Balance Sheet Components - Othe
Balance Sheet Components - Other Accrued Liabilities (Details) - USD ($) $ in Thousands | Mar. 31, 2020 | Dec. 31, 2019 |
Balance Sheet Related Disclosures [Abstract] | ||
Construction-in-progress obligations | $ 8,323 | $ 3,422 |
Contract manufacturing | 106 | 250 |
Professional service fees | 345 | 206 |
Pre-clinical and clinical study | 12 | 43 |
Accrued taxes | 42 | 27 |
Other | 115 | 224 |
Total | $ 8,943 | $ 4,172 |
Leases - Narrative (Details)
Leases - Narrative (Details) | Mar. 31, 2020 | Jan. 31, 2018 |
Lessee, Lease, Description [Line Items] | ||
Renewal term | 60 months | |
Telephone Equipment | ||
Lessee, Lease, Description [Line Items] | ||
Term of lease | 3 years |
Leases - Description of Lease C
Leases - Description of Lease Costs (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Leases [Abstract] | ||
Operating lease costs | $ 422 | $ 410 |
Amortization of finance lease right-of-use assets | 4 | 15 |
Interest on finance lease obligations | 2 | 9 |
Total | $ 428 | $ 434 |
Leases - Description of Cash Pa
Leases - Description of Cash Payment (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Leases [Abstract] | ||
Operating cash flows from operating leases - cash paid for operating leases | $ 461 | $ 436 |
Operating cash flows from finance leases - cash paid for interest | 2 | 3 |
Financing cash flows from finance leases - cash paid for principal | $ 4 | $ 3 |
Leases - Description of Other L
Leases - Description of Other Lease Information (Details) | Mar. 31, 2020 |
Leases [Abstract] | |
Weighted average remaining lease term, operating lease | 4 years 4 months 28 days |
Weighted average remaining lease term, financing lease | 1 year 7 months 10 days |
Weighted average discount rate, operating lease | 11.00% |
Weighted average discount rate, finance lease | 27.00% |
Leases - Future Minimum Lease P
Leases - Future Minimum Lease Payments (Details) - USD ($) $ in Thousands | Mar. 31, 2020 | Dec. 31, 2019 |
Operating leases | ||
Remainder of 2020 | $ 1,400 | |
2021 | 1,909 | |
2022 | 1,961 | |
2023 | 2,017 | |
2024 | 1,372 | |
Total undiscounted cash flows | 8,659 | |
Less: amount representing interest | (1,857) | |
Present value of lease liabilities | 6,802 | |
Operating lease liabilities, current portion | 1,184 | $ 1,140 |
Operating lease liabilities, long-term portion | 5,618 | $ 5,931 |
Finance leases | ||
Remainder of 2020 | 18 | |
2021 | 14 | |
2022 | 3 | |
2023 | 0 | |
2024 | 0 | |
Total undiscounted cash flows | 35 | |
Less: amount representing interest | (6) | |
Present value of lease liabilities | 29 | |
Finance lease obligations, current portion | 19 | |
Finance lease obligations, long-term portion | $ 10 |
Debt Financing - Additional Inf
Debt Financing - Additional Information (Detail) - USD ($) | 1 Months Ended | 3 Months Ended | |
Sep. 30, 2018 | Mar. 31, 2020 | Dec. 31, 2019 | |
Debt Instrument [Line Items] | |||
Restocking fee | 6.00% | ||
Accumulated capitalized interest costs | $ 1,800,000 | ||
Common stock issued (in shares) | 54,361,635 | 23,503,214 | |
Trinity Capital Fund III, L.P. | |||
Debt Instrument [Line Items] | |||
Proceeds from issuance of warrants | $ 243,000 | ||
Trinity Capital Fund III, L.P. | Warrants to purchase common stock | |||
Debt Instrument [Line Items] | |||
Common stock issued (in shares) | 75,000 | ||
Build to Suit Obligation | Trinity Capital Fund III, L.P. | |||
Debt Instrument [Line Items] | |||
Build-to-suit obligation, aggregate principal amount | $ 14,000,000 | ||
Drawdown amount | 5,000,000 | ||
Incremental drawdowns, minimum | 500,000 | ||
Debt instrument term | 36 months | ||
Drawdown amount | $ 14,000,000 | ||
Build-to-suit obligation | $ 5,000,000 | ||
Common stock warrant exercise price (in USD per share) | $ 3.5928 | ||
Build-to-Suit Obligation, Condition Two | Trinity Capital Fund III, L.P. | |||
Debt Instrument [Line Items] | |||
Purchase percentage of equipment cost | 4.00% | ||
Build-to-Suit Obligation, Condition One | Trinity Capital Fund III, L.P. | |||
Debt Instrument [Line Items] | |||
Purchase percentage of equipment cost | 12.00% | ||
Construction In Progress, Build-to-suit | |||
Debt Instrument [Line Items] | |||
Property and equipment, gross | $ 13,500,000 |
Debt Financing - Summary of Deb
Debt Financing - Summary of Debt Obligations (Details) - Build to Suit Obligation $ in Thousands | 3 Months Ended |
Mar. 31, 2020USD ($) | |
Debt Instrument [Line Items] | |
Principal Balance | $ 9,154 |
Trinity Capital Fund III, L.P. | |
Debt Instrument [Line Items] | |
Drawdown Amount | 14,000 |
Principal Balance | 9,154 |
Purchase Option Fee | 1,680 |
Discount on Purchase Option Fee | (213) |
Unamortized Discounts and Issuance Costs | (827) |
Monthly Payment | 450 |
Drawdown Maturity Date Of October 1, 2021 | Trinity Capital Fund III, L.P. | |
Debt Instrument [Line Items] | |
Drawdown Amount | 5,000 |
Principal Balance | 2,517 |
Purchase Option Fee | 600 |
Discount on Purchase Option Fee | (45) |
Unamortized Discounts and Issuance Costs | (272) |
Monthly Payment | $ 160 |
Stated Interest Rate | 9.43% |
Effective Interest Rate | 26.28% |
Drawdown Maturity Date Of January 1, 2022 | Trinity Capital Fund III, L.P. | |
Debt Instrument [Line Items] | |
Drawdown Amount | $ 2,800 |
Principal Balance | 1,641 |
Purchase Option Fee | 336 |
Discount on Purchase Option Fee | (33) |
Unamortized Discounts and Issuance Costs | (110) |
Monthly Payment | $ 90 |
Stated Interest Rate | 9.68% |
Effective Interest Rate | 19.58% |
Drawdown Maturity Date Of July 1, 2022 | Trinity Capital Fund III, L.P. | |
Debt Instrument [Line Items] | |
Drawdown Amount | $ 2,300 |
Principal Balance | 1,713 |
Purchase Option Fee | 276 |
Discount on Purchase Option Fee | (43) |
Unamortized Discounts and Issuance Costs | (139) |
Monthly Payment | $ 74 |
Stated Interest Rate | 9.93% |
Effective Interest Rate | 19.77% |
Drawdown Maturity Date Of October 1, 2022 | Trinity Capital Fund III, L.P. | |
Debt Instrument [Line Items] | |
Drawdown Amount | $ 2,300 |
Principal Balance | 1,889 |
Purchase Option Fee | 276 |
Discount on Purchase Option Fee | (52) |
Unamortized Discounts and Issuance Costs | (170) |
Monthly Payment | $ 74 |
Stated Interest Rate | 9.93% |
Effective Interest Rate | 19.93% |
Drawdown Maturity Date of December 1, 2022 | Trinity Capital Fund III, L.P. | |
Debt Instrument [Line Items] | |
Drawdown Amount | $ 1,600 |
Principal Balance | 1,394 |
Purchase Option Fee | 192 |
Discount on Purchase Option Fee | (40) |
Unamortized Discounts and Issuance Costs | (136) |
Monthly Payment | $ 52 |
Stated Interest Rate | 9.93% |
Effective Interest Rate | 20.20% |
Debt Financing - Schedule of L
Debt Financing - Schedule of Long-term Debt Instruments (Details) - Build to Suit Obligation $ in Thousands | Mar. 31, 2020USD ($) |
Debt Instrument [Line Items] | |
Build-to-suit obligation principal amount | $ 9,154 |
Build-to-suit obligation Purchase Option Fees at present value | 1,467 |
Less: unamortized Purchase Option Fees | (627) |
unamortized fair value of free-standing warrants | (74) |
unamortized debt discount | (118) |
unamortized debt issuance costs | (8) |
Build-to-suit obligation, net of debt issuance costs and discount | 9,794 |
Build-to-suit obligation, current portion | 4,665 |
Build-to-suit obligation, long-term portion, net of debt issuance costs and discount | $ 5,129 |
Debt Financing - Future Minimu
Debt Financing - Future Minimum Payments (Details) $ in Thousands | Mar. 31, 2020USD ($) |
Principal | |
Remainder of 2020 | $ 3,455 |
2021 | 4,284 |
2022 | 1,415 |
Total | 9,154 |
Interest | |
Remainder of 2020 | 592 |
2021 | 384 |
2022 | 65 |
Total | 1,041 |
Purchase Option Fees | |
Remainder of 2020 | 0 |
2021 | 600 |
2022 | 1,080 |
Total | $ 1,680 |
Debt Financing - Interest Expen
Debt Financing - Interest Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Debt Instrument [Line Items] | ||
Build-to-suit obligation interest expense | $ 206 | $ 41 |
Build to Suit Obligation | ||
Debt Instrument [Line Items] | ||
Build-to-suit obligation, cash interest expense | 252 | 172 |
Build-to-suit obligation, effective interest expense | 243 | 201 |
Less: build-to-suit obligation, interest capitalized | (298) | (373) |
Build-to-suit obligation interest expense | $ 197 | $ 0 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) - USD ($) $ in Millions | 1 Months Ended | 3 Months Ended |
Sep. 30, 2018 | Mar. 31, 2020 | |
Other Commitments [Line Items] | ||
Cancellation fees | 50.00% | |
Commercial Coating and Primary Packaging System | ||
Other Commitments [Line Items] | ||
Purchase commitments related to fixed assets | $ 4 | |
Commitment liability | 2.6 | |
Manufacturing Space and Technology | ||
Other Commitments [Line Items] | ||
Purchase commitments related to fixed assets | 10 | |
Commitment liability | $ 5.8 | |
Minimum | ||
Other Commitments [Line Items] | ||
Annual fees | $ 2 | |
Maximum | ||
Other Commitments [Line Items] | ||
Annual fees | $ 14 |
Warrants (Detail)
Warrants (Detail) | 3 Months Ended |
Mar. 31, 2020$ / sharesshares | |
Warrants Outstanding Rollforward [Roll Forward] | |
Warrants Outstanding as of December 31, 2019 (in shares) | 274,524 |
Issued (in shares) | 28,218,891 |
Exercised (in shares) | (4,811,262) |
Expired (in shares) | (1,583) |
Warrants Outstanding as of March 31, 2020 (in shares) | 23,680,570 |
Series E - March 2020 | |
Warrants Outstanding Rollforward [Roll Forward] | |
Warrants Outstanding as of December 31, 2019 (in shares) | 0 |
Issued (in shares) | 11,903,506 |
Exercised (in shares) | 0 |
Expired (in shares) | 0 |
Warrants Outstanding as of March 31, 2020 (in shares) | 11,903,506 |
Exercise Price (in USD per share) | $ / shares | $ 0.8025 |
Series D - February 2020 | |
Warrants Outstanding Rollforward [Roll Forward] | |
Warrants Outstanding as of December 31, 2019 (in shares) | 0 |
Issued (in shares) | 2,161,539 |
Exercised (in shares) | (2,161,539) |
Expired (in shares) | 0 |
Warrants Outstanding as of March 31, 2020 (in shares) | 0 |
Series C - February 2020 | |
Warrants Outstanding Rollforward [Roll Forward] | |
Warrants Outstanding as of December 31, 2019 (in shares) | 0 |
Issued (in shares) | 14,153,846 |
Exercised (in shares) | (2,649,723) |
Expired (in shares) | 0 |
Warrants Outstanding as of March 31, 2020 (in shares) | 11,504,123 |
Exercise Price (in USD per share) | $ / shares | $ 0.65 |
Trinity - September 2018 | |
Warrants Outstanding Rollforward [Roll Forward] | |
Warrants Outstanding as of December 31, 2019 (in shares) | 75,000 |
Issued (in shares) | 0 |
Exercised (in shares) | 0 |
Expired (in shares) | 0 |
Warrants Outstanding as of March 31, 2020 (in shares) | 75,000 |
Exercise Price (in USD per share) | $ / shares | $ 3.5928 |
Series B - August 2016 | |
Warrants Outstanding Rollforward [Roll Forward] | |
Warrants Outstanding as of December 31, 2019 (in shares) | 195,906 |
Issued (in shares) | 0 |
Exercised (in shares) | 0 |
Expired (in shares) | 0 |
Warrants Outstanding as of March 31, 2020 (in shares) | 195,906 |
Exercise Price (in USD per share) | $ / shares | $ 31 |
Amendment to Hercules Term Loan - June 2015 | |
Warrants Outstanding Rollforward [Roll Forward] | |
Warrants Outstanding as of December 31, 2019 (in shares) | 2,035 |
Issued (in shares) | 0 |
Exercised (in shares) | 0 |
Expired (in shares) | 0 |
Warrants Outstanding as of March 31, 2020 (in shares) | 2,035 |
Exercise Price (in USD per share) | $ / shares | $ 147.40 |
Hercules Term Loan - June 2014 | |
Warrants Outstanding Rollforward [Roll Forward] | |
Warrants Outstanding as of December 31, 2019 (in shares) | 1,583 |
Issued (in shares) | 0 |
Exercised (in shares) | 0 |
Expired (in shares) | (1,583) |
Warrants Outstanding as of March 31, 2020 (in shares) | 0 |
Stock-Based Compensation - Summ
Stock-Based Compensation - Summary of Stock Option and Award Activity Excluding Inducement Grants (Detail) | 3 Months Ended |
Mar. 31, 2020$ / sharesshares | |
Share-based Payment Arrangement [Abstract] | |
Shares available for grant (in shares) | 63,404 |
Additional shares reserved (in shares) | 822,612 |
Stock options granted (in shares) | (7,000) |
Stock options canceled/forfeited/expired (in shares) | 168,292 |
Shares available for grant (in shares) | 1,047,308 |
Number of Shares Subject to Outstanding Options | |
Beginning balance (in shares) | 2,260,307 |
Options granted (in shares) | 7,000 |
Options canceled/forfeited/expired (in shares) | (169,906) |
Ending balance (in shares) | 2,097,401 |
Weighted-Average Exercise Price per Share | |
Beginning balance (in USD per share) | $ / shares | $ 4.29 |
Options granted (in USD per share) | $ / shares | 0.99 |
Option canceled/forfeited/expired (in USD per share) | $ / shares | 4.16 |
Ending balance (in USD per share) | $ / shares | $ 4.29 |
Stock-Based Compensation - Su_2
Stock-Based Compensation - Summary of Stock-Based Compensation Expense (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Total stock-based compensation expense | $ 364 | $ 361 |
Research and development | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Total stock-based compensation expense | 169 | 165 |
General and administrative | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Total stock-based compensation expense | $ 195 | $ 196 |
Subsequent Event (Details)
Subsequent Event (Details) - Subsequent Event - USD ($) | Apr. 21, 2020 | Apr. 16, 2020 |
Shelf Registration | ||
Subsequent Event [Line Items] | ||
Shelf registration, ability to offer securities | $ 74,500,000 | |
Forgivable Loan | Paycheck Protection Program Loan | ||
Subsequent Event [Line Items] | ||
Drawdown amount | $ 1,610,000 | |
Loan term | 2 years | |
Stated Interest Rate | 1.00% |