Cover page
Cover page - shares | 3 Months Ended | |
Mar. 31, 2021 | May 07, 2021 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Mar. 31, 2021 | |
Document Transition Report | false | |
Entity File Number | 001-36570 | |
Entity Registrant Name | ZOSANO PHARMA CORPORATION | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 45-4488360 | |
Entity Address, Address Line One | 34790 Ardentech Court | |
Entity Address, City or Town | Fremont | |
Entity Address, State or Province | CA | |
Entity Address, Postal Zip Code | 94555 | |
City Area Code | 510 | |
Local Phone Number | 745-1200 | |
Title of 12(b) Security | Common Stock, $0.0001 par value | |
Trading Symbol | ZSAN | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 106,728,371 | |
Amendment Flag | false | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2021 | |
Document Fiscal Period Focus | Q1 | |
Entity Central Index Key | 0001587221 |
BALANCE SHEETS
BALANCE SHEETS - USD ($) $ in Thousands | Mar. 31, 2021 | Dec. 31, 2020 |
Current assets: | ||
Cash and cash equivalents | $ 26,882 | $ 35,263 |
Prepaid expenses and other current assets | 1,591 | 453 |
Total current assets | 28,473 | 35,716 |
Restricted cash | 455 | 455 |
Property and equipment, net | 32,128 | 30,909 |
Operating lease right-of-use assets | 4,651 | 4,928 |
Other long-term assets | 3 | 3 |
Total assets | 65,710 | 72,011 |
Current liabilities: | ||
Accounts payable | 2,661 | 1,884 |
Accrued compensation | 2,703 | 2,294 |
Build-to-suit obligation, current portion, net of debt issuance costs and discount | 4,697 | 4,779 |
Operating lease liabilities, current portion | 1,434 | 1,378 |
Paycheck Protection Program loan, current portion | 1,422 | 809 |
Other accrued liabilities | 1,491 | 3,367 |
Total current liabilities | 14,408 | 14,511 |
Build-to-suit obligation, long-term portion, net of debt issuance costs and discount | 3,426 | 4,359 |
Operating lease liabilities, long-term portion | 4,304 | 4,687 |
Paycheck Protection Program loan, long-term portion | 204 | 812 |
Other long-term liabilities | 217 | 127 |
Total liabilities | 22,559 | 24,496 |
Commitments and contingencies (see note 10) | ||
Stockholders’ equity: | ||
Preferred stock, $0.0001 par value; 5,000,000 shares authorized; none issued and outstanding as of March 31, 2021 and December 31, 2020, respectively | 0 | 0 |
Common stock, $0.0001 par value; 250,000,000 shares authorized as of March 31, 2021 and December 31, 2020, respectively; 106,372,820 and 102,066,218 shares issued and outstanding as of March 31, 2021 and December 31, 2020, respectively | 11 | 10 |
Additional paid-in capital | 383,472 | 379,695 |
Accumulated deficit | (340,332) | (332,190) |
Total stockholders’ equity | 43,151 | 47,515 |
Total liabilities and stockholders’ equity | $ 65,710 | $ 72,011 |
BALANCE SHEETS (Parenthetical)
BALANCE SHEETS (Parenthetical) - $ / shares | Mar. 31, 2021 | Dec. 31, 2020 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value (in USD per share) | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized (in shares) | 5,000,000 | 5,000,000 |
Preferred stock, shares issued (in shares) | 0 | 0 |
Preferred stock, shares outstanding (in shares) | 0 | 0 |
Common stock, par value (in USD per share) | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized (in shares) | 250,000,000 | 250,000,000 |
Common stock, shares issued (in shares) | 106,372,820 | 102,066,218 |
Common stock, shares outstanding (in shares) | 106,372,820 | 102,066,218 |
STATEMENTS OF OPERATIONS AND CO
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Income Statement [Abstract] | ||
Service revenue | $ 258 | $ 0 |
Operating expenses: | ||
Cost of service revenue | 162 | 0 |
Research and development | 5,330 | 5,514 |
General and administrative | 2,814 | 3,082 |
Total operating expenses | 8,306 | 8,596 |
Loss from operations | (8,048) | (8,596) |
Other income (expense): | ||
Interest income | 1 | 10 |
Interest expense | (97) | (206) |
Other income (expense), net | 2 | 103 |
Loss before provision for income taxes | (8,142) | (8,689) |
Provision for income taxes | 0 | 0 |
Net loss and comprehensive loss | $ (8,142) | $ (8,689) |
Net loss per common share – basic and diluted (in USD per share) | $ (0.08) | $ (0.24) |
Weighted-average common shares used in computing net loss per common share – basic and diluted (in shares) | 104,356 | 36,266 |
Revenue from Contract with Customer, Product and Service [Extensible List] | us-gaap:ServiceMember | us-gaap:ServiceMember |
Cost, Product and Service [Extensible List] | us-gaap:ServiceMember | us-gaap:ServiceMember |
STATEMENTS OF CHANGES IN STOCKH
STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY - USD ($) $ in Thousands | Total | Registered Direct Offering, RDO | Pre-funded Warrants With Public Stock Offering | At-The-Market Offering | Series E Warrant | Series C Warrant | Common Stock | Common StockRegistered Direct Offering, RDO | Common StockPre-funded Warrants With Public Stock Offering | Common StockAt-The-Market Offering | Common StockSeries E Warrant | Common StockSeries C Warrant | Common StockSeries D Warrants | Additional Paid-In Capital | Additional Paid-In CapitalRegistered Direct Offering, RDO | Additional Paid-In CapitalPre-funded Warrants With Public Stock Offering | Additional Paid-In CapitalAt-The-Market Offering | Additional Paid-In CapitalSeries E Warrant | Additional Paid-In CapitalSeries C Warrant | Accumulated Deficit |
Beginning balance (in shares) at Dec. 31, 2019 | 23,503,214 | |||||||||||||||||||
Beginning balance at Dec. 31, 2019 | $ 9,392 | $ 2 | $ 308,211 | $ (298,821) | ||||||||||||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||||||||||||||
Issuance of common stock upon exercise (in shares) | 2,649,723 | 2,161,539 | ||||||||||||||||||
Issuance of common stock upon exercise | $ 1,722 | $ 1,722 | ||||||||||||||||||
Issuance of common stock in connection with offering, net (in shares) | 11,903,506 | 11,992,307 | 2,151,346 | |||||||||||||||||
Issuance of common stock in connection with offering, net | $ 10,211 | $ 8,264 | $ 2,706 | $ 1 | $ 2 | $ 10,210 | $ 8,262 | $ 2,706 | ||||||||||||
Stock-based compensation | 364 | 364 | ||||||||||||||||||
Net loss | (8,689) | (8,689) | ||||||||||||||||||
Ending balance (in shares) at Mar. 31, 2020 | 54,361,635 | |||||||||||||||||||
Ending balance at Mar. 31, 2020 | $ 23,970 | $ 5 | 331,475 | (307,510) | ||||||||||||||||
Beginning balance (in shares) at Dec. 31, 2020 | 102,066,218 | 102,066,218 | ||||||||||||||||||
Beginning balance at Dec. 31, 2020 | $ 47,515 | $ 10 | 379,695 | (332,190) | ||||||||||||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||||||||||||||
Issuance of common stock upon exercise (in shares) | 4,078,667 | 145,000 | ||||||||||||||||||
Issuance of common stock upon exercise | $ 3,274 | $ 94 | $ 1 | $ 3,273 | $ 94 | |||||||||||||||
Issuance of common stock in connection with offering, net (in shares) | 82,935 | |||||||||||||||||||
Stock-based compensation | 410 | 410 | ||||||||||||||||||
Net loss | $ (8,142) | (8,142) | ||||||||||||||||||
Ending balance (in shares) at Mar. 31, 2021 | 106,372,820 | 106,372,820 | ||||||||||||||||||
Ending balance at Mar. 31, 2021 | $ 43,151 | $ 11 | $ 383,472 | $ (340,332) |
STATEMENTS OF CASH FLOWS
STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Cash flows from operating activities: | ||
Net loss | $ (8,142) | $ (8,689) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock-based compensation | 410 | 364 |
Change in operating lease right-of-use assets | 277 | 230 |
Depreciation and amortization | 435 | 172 |
Effective interest on financing obligations | 141 | 243 |
Capitalized effective interest | (102) | (157) |
Other | 3 | 0 |
Change in operating assets and liabilities: | ||
Prepaid expenses and other assets | (1,138) | (79) |
Accounts payable | 332 | (617) |
Accrued compensation and other accrued liabilities | 651 | 358 |
Operating lease liabilities | (327) | (269) |
Net cash used in operating activities | (7,460) | (8,444) |
Cash flows from investing activities: | ||
Purchases of property and equipment | (3,236) | (1,384) |
Net cash used in investing activities | (3,236) | (1,384) |
Cash flows from financing activities: | ||
Principal payments on financing obligations | (1,158) | (1,102) |
Net cash provided by financing activities | 2,315 | 22,069 |
Net (decrease) increase in cash, cash equivalents and restricted cash | (8,381) | 12,241 |
Cash, cash equivalents and restricted cash at beginning of year | 35,718 | 6,771 |
Cash, cash equivalents and restricted cash at end of year | 27,337 | 19,012 |
Supplemental cash flow information: | ||
Cash paid for interest | 198 | 254 |
Non-cash investing and financing activities: | ||
Acquisition of property and equipment under accounts payable and other accrued liabilities | 1,750 | 8,579 |
Accrued offering costs | 105 | 396 |
Asset retirement obligation | 89 | 0 |
Registered Direct Offering | ||
Cash flows from financing activities: | ||
Proceeds from public offering of securities | 0 | 10,298 |
Pre-funded Warrants With Public Stock Offering | ||
Cash flows from financing activities: | ||
Proceeds from public offering of securities | 0 | 8,483 |
At-The-Market Offering | ||
Cash flows from financing activities: | ||
Proceeds from public offering of securities | 105 | 2,668 |
Series E Warrant | ||
Cash flows from financing activities: | ||
Proceeds from warrant exercises | 3,274 | 0 |
Series C Warrant | ||
Cash flows from financing activities: | ||
Proceeds from warrant exercises | $ 94 | $ 1,722 |
Organization
Organization | 3 Months Ended |
Mar. 31, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization | Organization The Company Zosano Pharma Corporation (the “Company”) is a clinical-stage biopharmaceutical company focused on providing rapid systemic administration of therapeutics and other bioactive molecules to patients using its proprietary transdermal microneedle system ("System"). The Company submitted a 505(b)(2) New Drug Application (“NDA”) for Qtrypta™ (M207) (“Qtrypta”) to the U.S. Food and Drug Administration (the “FDA”) on December 20, 2019, and on October 20, 2020, the Company received a Complete Response Letter (“CRL”) from the FDA with respect to the NDA. The CRL cited inconsistent zolmitriptan exposure levels observed across clinical pharmacology studies, which had been previously identified in the FDA’s discipline review letter received by the Company on September 29, 2020. Specifically, the CRL noted differences in zolmitriptan exposures observed between subjects receiving different lots of Qtrypta in the Company’s trials and inadequate pharmacokinetic ("PK") bridging between the lots that made interpretation of some safety data unclear. The CRL referenced unexpected high plasma concentrations of zolmitriptan observed in five study subjects enrolled in the Company’s PK studies. The FDA recommended that the Company conduct a repeat bioequivalence study comparing lots manufactured with the equipment used during development. The CRL noted that additional product quality validation data, which were planned to be submitted following approval, if received, were required to be submitted with the application. In addition, the CRL mentioned that due to U.S. Government and/or Agency-wide restrictions on travel, inspections of the Company’s contract manufacturing facilities were not able to be conducted but would be required before the application may be approved. On January 29, 2021, the Company held a Type A meeting with the FDA Division of Neurology II (the “Division”) regarding the requirements for resubmission of the Qtrypta NDA. Based on feedback from the Type A meeting held with the Division, the Company plans to conduct an additional PK study for inclusion in an NDA resubmission package. During the meeting, the Division did not request that the Company conduct any further clinical efficacy studies to support the resubmission. On February 19, 2021, the Company received the official Type A meeting minutes from the FDA. The Type A meeting minutes were generally consistent with the Company's expectations to conduct an additional PK study for inclusion in an NDA resubmission package. In a post-meeting comment, the FDA recommended a skin assessment on patients in the planned PK study to generate additional safety information. This assessment was included in the proposed study protocol submitted to the FDA for review. On April 12, 2021, the Company received FDA comments and recommendations to the Company’s proposed PK study protocol for Qtrypta. The Company has made the recommended changes to the study protocol and established an agreement with a contract research organization to conduct the PK study required to support the resubmission of the Qtrypta 505(b)(2) NDA. The study is expected to involve 48 healthy volunteers to generate comparative PK and safety data. The Company expects the study to begin in June 2021 and to be completed with data available in the third quarter of 2021. Subject to positive data, the Company expects to resubmit its NDA for Qtrypta by the end of 2021. The Company does not anticipate realizing product revenues unless and until the FDA approves the Qtrypta NDA and the Company begins commercializing Qtrypta, which events may never occur. Liquidity and Substantial Doubt about Going Concern Since inception, the Company has incurred recurring operating losses and negative cash flows from operating activities, and as of March 31, 2021, had an accumulated deficit of approximately $340.3 million. As of March 31, 2021, the Company had approximately $26.9 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 filing 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. Shelf Registration The Company filed a shelf registration statement on Form S-3 with the U.S. Securities and Exchange Commission (the "SEC"), which was declared effective by the SEC on April 16, 2020 ("2020 Shelf Registration Statement"). The 2020 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, of which approximately $33.7 million is available at March 31, 2021. At-the-Market Offering Program - 2020 On June 8, 2020, the Company entered into a sales agreement with BTIG, LLC ("BTIG") as sales agent, to establish an at-the-market offering program (“2020 ATM”), under which the Company is permitted to offer and sell, from time to time, shares of common stock having a maximum aggregate offering price of up to $20.0 million. The Company is required to pay BTIG a commission of 3% of the gross proceeds from the sale of shares and has also agreed to provide BTIG with customary indemnification rights. During the three months ended March 31, 2021, the Company issued and sold 82,935 shares of its common stock at an average price of $1.31 per share under the 2020 ATM with aggregate net proceeds of less than $1,000 after deducting commissions and offering expenses payable by the Company. In April 2021, the Company issued and sold 355,551 shares of its common stock at an average price of $1.26 per share under the 2020 ATM with aggregate net proceeds of approximately $0.4 million after deducting commissions and offering expenses payable by the Company. The shares were sold pursuant to the Company’s 2020 Shelf Registration Statement and a prospectus supplement dated June 8, 2020. As of the date of this Quarterly Report on Form 10-Q, the Company has approximately $5.3 million available to be offered and sold under the 2020 ATM. Registered Direct Offering - March 2020 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, were immediately exercisable and expire five years from the date of issuance. During the three months ended March 31, 2021, Series E Warrants to purchase 4,078,667 shares of common stock were exercised at an exercise price of $0.8025 per share for aggregate proceeds of approximately $3.3 million. The shares were sold pursuant to an effective shelf registration statement and a prospectus supplement dated March 4, 2020. As of the date of this Quarterly Report on Form 10-Q, the Company has Series E Warrants to purchase 630,835 shares of common stock outstanding. Public Offering - February 2020 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, were immediately exercisable and 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. During the three months ended March 31, 2021, Series C Warrants to purchase 145,000 shares of common stock were exercised at an exercise price of $0.65 per share for aggregate proceeds of approximately $0.1 million. The shares were sold pursuant to an effective shelf registration statement and a prospectus supplement dated February 12, 2020. As of the date of this Quarterly Report on Form 10-Q, the Company has Series C Warrants to purchase 22,700 shares of common stock outstanding. The Company intends to raise additional capital through the issuance of additional equity through public or private offerings, debt financings or strategic alliances with pharmaceutical partners, or any combination of the above. However, there can be no assurances 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. 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 its operations. 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. The Company will continue to evaluate its timelines, strategic needs and working capital requirements. 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. The pandemic did appear to negatively impact enrollment and conduct of the Company's cluster headache study. 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. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2021 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Summary of Significant Accounting Policies Basis of Presentation and Use of Estimates The accompanying financial statements have been prepared in accordance with 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, 2021 are not necessarily indicative of the results that may be expected for the year ending December 31, 2021 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, 2020, included in the Company’s annual report on Form 10-K and filed with the United States Securities and Exchange Commission (“SEC”) on March 11, 2021. The preparation of the accompanying financial statements in accordance with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities as of the date of the financial statements, and the reported amounts of expenses during the periods reported. Actual results could differ from those estimates or assumptions. 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, 2020. Cash, Cash Equivalents and Restricted Cash The Company considers all highly liquid investments purchased with an original maturity of 90 days or less to be cash equivalents. As of March 31, 2021 and December 31, 2020, the Company had restricted cash of approximately $0.5 million primarily consisting of deposits of $0.3 million to secure its building lease until the end of the lease term and a deposit of approximately $0.1 million to a utility provider. 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, 2021 March 31, 2020 (unaudited; in thousands) Cash and cash equivalents $ 26,882 $ 18,557 Restricted cash 455 455 Total $ 27,337 $ 19,012 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 as 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, stock options and restricted stock units ("RSUs") 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, 2021 March 31, 2020 (unaudited; shares) Options to purchase common stock 4,317,692 2,097,401 Warrants to purchase common stock 924,441 23,680,570 RSUs 922,941 — Total 6,165,074 25,777,971 Recent Accounting Pronouncements Recently Adopted Accounting Pronouncements In December 2019, the Financial Accounting Standards Board issued Accounting Standards Update 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 |
Master Services Agreement with
Master Services Agreement with Eversana | 3 Months Ended |
Mar. 31, 2021 | |
Related Party Transactions [Abstract] | |
Master Services Agreement with Eversana | Master Services Agreement with Eversana On August 6, 2020, the Company entered into a master services agreement (the “Eversana Agreement”) with Eversana Life Science Services, LLC (“Eversana”) for the commercialization of Qtrypta in the United States, if approved by the FDA. Under the terms of the Eversana Agreement, Eversana and the Company will cooperate to conduct activities over the term of the Eversana Agreement. The Company maintains ownership of the Qtrypta NDA as well as all legal, regulatory and manufacturing responsibilities for Qtrypta. Eversana receives an exclusive right to conduct agreed commercialization activities and will utilize its internal sales organization along with its other commercial capabilities for market access, marketing, distribution and patient support services for Qtrypta. Eversana will receive reimbursement of certain commercialization costs pursuant to a commercialization budget estimated at approximately $250.0 million and a low double digit to mid-teen percentage of product profits if and when Company net sales of Qtrypta surpass certain costs incurred by the parties pursuant to the commercialization budget. The term of the Eversana Agreement is five years following the date, if any, that the FDA approves the Qtrypta NDA. Upon expiration or termination of the Eversana Agreement, the Company will retain all profits from product sales consummated after expiration or termination and assume all future corresponding commercialization responsibilities. The Company may terminate the Eversana Agreement if Eversana fails to provide pre-commercial or commercial plans and budgets by specified dates, if the Company decides to discontinue development or commercialization efforts for Qtrypta in the United States (subject to a termination payment if such termination occurs within a specified time period), or upon a change of control of the Company. Either party may terminate the Eversana Agreement if FDA approval is not received by July 31, 2021, if net profits are not realized within a specified time period following commercial launch, for material breach of the Eversana Agreement by the other party that is not cured within a defined time period, for insolvency of the other party, if Qtrypta is subject to a safety recall in the United States or if Qtrypta is not commercially launched within a specified time period after FDA approval of the NDA (other than by reason of the terminating party’s failure to perform its obligations under the Eversana Agreement). In addition, under the Eversana Agreement, following FDA approval of the Qtrypta NDA, Eversana has agreed to provide a revolving credit facility of up to $5.0 million (the “Credit Facility”) to the Company pursuant to a loan agreement to be entered into between Eversana and the Company on a subsequent date. The loan will bear interest at an annual rate equal to 10.0%, to be paid monthly, and the Company will be able to prepay any amounts borrowed under the Credit Facility at any time without penalty or premium. The Credit Facility will be secured by substantially all of the Company’s assets, subject to prior liens and security interests. The Company is accounting for the Eversana Agreement as a collaborative arrangement. As of March 31, 2021, no material accruals, expenses, payments, or revenues were recorded by the Company in connection with the Eversana Agreement. |
Cash Equivalents and Investment
Cash Equivalents and Investments in Marketable Securities | 3 Months Ended |
Mar. 31, 2021 | |
Cash and Cash Equivalents [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 at fair value on a recurring basis: As of March 31, 2021: Fair Value Measurements Total Quoted prices in active market Significant other observable inputs Significant unobservable inputs (unaudited; in thousands) Money market funds classified as cash equivalents $ 24,419 $ 24,419 $ — $ — As of December 31, 2020: Fair Value Measurements Total Quoted prices in active market Significant other observable inputs Significant unobservable inputs (in thousands) Money market funds classified as cash equivalents $ 33,918 $ 33,918 $ — $ — |
Balance Sheet Components
Balance Sheet Components | 3 Months Ended |
Mar. 31, 2021 | |
Balance Sheet Related Disclosures [Abstract] | |
Balance Sheet Components | Balance Sheet Components 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, 2021 December 31, 2020 (unaudited; in thousands) (in thousands) Prepaid insurance $ 807 $ 66 Unbilled revenue 157 124 Prepaid services 120 97 Accounts receivable 86 — Prepaid software and subscriptions 81 118 Deferred offering costs 70 48 Other 270 — Total $ 1,591 $ 453 Property and Equipment The following table summarizes the Company’s property and equipment for each of the periods presented: March 31, 2021 December 31, 2020 (unaudited; in thousands) (in thousands) Leasehold improvements $ 24,212 $ 24,212 Manufacturing equipment 14,893 14,893 Laboratory and office equipment 1,641 1,641 Computer equipment and software 172 172 Construction-in-progress 19,893 18,239 Property and equipment at cost 60,811 59,157 Less: accumulated depreciation property and equipment (28,683) (28,248) Total $ 32,128 $ 30,909 Depreciation expense was approximately $0.4 million and $0.2 million for the three months ended March 31, 2021 and March 31, 2020, respectively. Construction-in-progress ("CIP") included $15.4 million and $14.6 million of an asset relating to the build-to-suit arrangement for construction of the Company's commercial coating and primary packaging system as of March 31, 2021 and December 31, 2020, respectively, of which capitalized construction period interest was $2.7 million and $2.4 million as of March 31, 2021 and December 31, 2020, respectively (See Note 7. Debt Financing ). Other Accrued Liabilities The following table summarizes the Company’s other accrued liabilities for each of the periods presented: March 31, 2021 December 31, 2020 (unaudited; in thousands) (in thousands) Construction-in-progress obligations $ 874 $ 2,993 Professional service fees 315 175 Contract manufacturing 176 71 Deferred revenue 47 — Pre-clinical and clinical studies 10 22 Other 69 106 Total $ 1,491 $ 3,367 |
Leases
Leases | 3 Months Ended |
Mar. 31, 2021 | |
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 Company also has operating leases for manufacturing space at two of its contract manufacturing organizations ("CMOs"). The operating leases are embedded in agreements with these CMOs that include lease and non-lease components. The following table summarizes information regarding the Company's leases for each of the periods presented: Three Months Ended March 31, 2021 2020 (unaudited; in thousands) Operating lease costs $ 439 $ 422 Operating cash flows from operating leases - cash paid for operating leases $ 489 $ 461 The following table summarizes the lease terms and discount rates for the Company's leases as of March 31, 2021: (unaudited) Weighted-average remaining lease term (in years) 3.38 Weighted average discount rate 11 % The following table summarizes the maturities of the Company's lease liabilities for each year ending December 31, as of March 31, 2021: (unaudited; in thousands) 2021 $ 1,485 2022 2,043 2023 2,017 2024 1,371 Total undiscounted cash flows 6,916 Less: amount representing interest (1,178) Present value of lease liabilities $ 5,738 Current portion $ 1,434 Long-term portion 4,304 Total $ 5,738 |
Debt Financing
Debt Financing | 3 Months Ended |
Mar. 31, 2021 | |
Debt Disclosure [Abstract] | |
Debt Financing | Debt Financing Build-to-Suit Obligation with Trinity The Company has a build-to-suit arrangement (the "Agreement") with Trinity Funding 1, LLC (successor to Trinity Capital Fund III, L.P.) ("Trinity") to finance the third-party construction of the Company's commercial coating and primary packaging system (the "Equipment"), expected to be completed in 2021. Under the Agreement, Trinity provided 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. Under the Agreement, each individual drawdown represents a separate financing arrangement with its own term and stated interest rate. Each drawdown is non-cancelable, with no prepayment options. 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. On May 27, 2020, the Company entered into the First Amendment to Lease Documents (the “Trinity Amendment”). The Trinity Amendment, among other things, extended each individual drawdown term from 36 months to 42 months by providing for an interest-only period from May 2020 through October 2020. Principal payments recommenced November 1, 2020. Additionally, the Trinity Amendment removed all end-of-term options other than the option to purchase the equipment at 12% of the Total Cost, which is equal to the drawdown amount (“Purchase Option Fee”), which the Company intends to exercise at the end of each 42-month-term. The transfer of title from Trinity to the Company will occur at the end of the final 42-month-term, provided that the purchase option was executed, and the Purchase Option Fee was paid in full at the end of each 42-month-term. The security interest will terminate on the earlier to occur of (i) the date that falls six (6) months after the delivery and installation of the Equipment or (ii) payment in full of all amounts owed. The Company accounted for the Trinity Amendment as a debt modification under ASC 470-50, as the amended terms were not substantially different from the terms of the Agreement. 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, 2021, the Company had an aggregate commercial coating and primary packaging system CIP balance of $15.4 million, that included $2.7 million of interest related to its build-to-suit obligation. 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 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, 2021. The following table summarizes the debt obligations as of March 31, 2021: Drawdown Date Drawdown Amount Principal Balance Purchase Option Fee Discount on Purchase Option Fee Unamortized Discounts and Issuance Costs Monthly Payment Stated Interest Rate Amended Effective Interest Rate Maturity Date (unaudited; in thousands) 09/25/2018 $ 5,000 $ 1,667 $ 600 $ (14) $ (82) $ 160 9.43 % 24.38 % 04/01/2022 12/11/2018 2,800 1,177 336 (12) (39) 90 9.68 % 18.25 % 07/01/2022 06/06/2019 2,300 1,350 276 (20) (64) 74 9.93 % 18.08 % 01/01/2023 09/13/2019 2,300 1,534 276 (26) (86) 74 9.93 % 18.04 % 04/01/2023 11/27/2019 1,600 1,151 192 (21) (72) 52 9.93 % 18.16 % 06/01/2023 Total $ 14,000 $ 6,879 $ 1,680 $ (93) $ (343) $ 450 The following table summarizes the Company's build-to-suit obligation as of March 31, 2021 (unaudited; in thousands) : Build-to-suit obligation principal amount $ 6,879 Build-to-suit obligation Purchase Option Fees at present value 1,587 Less: unamortized Purchase Option Fees (271) unamortized warrants, discounts and issuance costs (72) Build-to-suit obligation, net of debt issuance costs and discount $ 8,123 Build-to-suit obligation, current portion $ 4,697 Build-to-suit obligation, long-term portion, net of debt issuance costs and discount 3,426 Build-to-suit obligation, net of debt issuance costs and discount $ 8,123 The following table summarizes future minimum payments on the Company’s build-to-suit obligation, including payments of principal and interest and Purchase Option Fees for each year ending December 31 as of March 31, 2021: Principal Interest Purchase Option Fees Total (unaudited; in thousands) 2021 $ 3,628 $ 420 $ — $ 4,048 2022 2,979 189 936 4,104 2023 272 8 744 1,024 Total $ 6,879 $ 617 $ 1,680 $ 9,176 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, 2021 2020 (unaudited; in thousands) Build-to-suit obligation, cash interest expense $ 197 $ 252 Build-to-suit obligation, effective interest expense 137 243 Less: build-to-suit obligation, interest capitalized (242) (298) Build-to-suit obligation interest expense $ 92 $ 197 PPP Loan On April 21, 2020, the Company executed a promissory note (the “PPP Note”) evidencing an unsecured loan in the amount of $1.6 million under the Paycheck Protection Program (the “PPP Loan”). The Paycheck Protection Program (“PPP”) was established under the Coronavirus Aid, Relief and Economic Security Act (the “CARES Act”) and is administered by the U.S. Small Business Administration (“SBA”). The Loan was made through Silicon Valley Bank (the "Lender"). 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 the Company's payroll levels. The PPP Loan has a two-year term and bears interest at a rate of 1.0% per annum. Under the terms of the CARES Act, PPP loan recipients can apply for and be granted forgiveness for all or a portion of the loan granted under the PPP. The Company applied for forgiveness of the entire $1.6 million loan amount and accrued interest on October 4, 2020. The Lender reviewed the application and submitted it to the SBA on October 7, 2020. No assurance is provided that forgiveness for any portion of the PPP Loan or accrued interest will be obtained. The Paycheck Protection Flexibility Act of 2020, P.L. 116-142, extended the deferral period for loan payments to either (1) the date that the SBA remits the borrower’s loan forgiveness amount to the lender or (2) if the borrower does not apply for loan forgiveness, ten months after the end of the borrower’s loan forgiveness covered period. The Company’s first payment is due on September 21, 2021 and if the loan is fully forgiven, the Company is not responsible for any payments. If only a portion of the loan is forgiven, or if the forgiveness application is denied, any remaining balance due on the loan must be repaid by the Company on or before April 21, 2022, the maturity date of the loan. Interest accrues during the time between the disbursement of the loan and SBA remittance of the forgiveness amount. The Company is responsible for paying the accrued interest on any amount of the loan that is not forgiven. The PPP Note contains customary events of default relating to, among other things, payment defaults, providing materially false and misleading representation to the SBA or Lender or breaching the terms of the PPP Note. The occurrence of an event of default may result in the immediate repayment of all amounts outstanding, collection of all amounts owing from the Company or filing suit and obtaining judgment against the Company. |
Common Stock Warrants
Common Stock Warrants | 3 Months Ended |
Mar. 31, 2021 | |
Equity [Abstract] | |
Common Stock Warrants | Common Stock Warrants The following table summarizes the Company's issued and outstanding common stock warrants: Warrants Outstanding as of December 31, 2020 Issued Exercised Expired Warrants Outstanding as of March 31, 2021 Exercise Price per Share Expiration Date unaudited Series E - March 2020 4,709,502 — (4,078,667) — 630,835 $ 0.8025 03/06/25 Series C - February 2020 167,700 — (145,000) — 22,700 $ 0.6500 02/14/25 Trinity - September 2018 75,000 — — — 75,000 $ 3.5928 09/25/25 Series B - August 2016 195,906 — — — 195,906 $ 31.0000 08/19/21 Total 5,148,108 — (4,223,667) — 924,441 Each warrant grants the holder the right to purchase one share of common stock. Equity warrants are recorded at their relative fair market value in the stockholders’ equity section of the balance sheet. The Company’s equity warrants can only be settled through the issuance of shares and do not have any anti-dilution or price reset provision. |
Stock-Based Compensation
Stock-Based Compensation | 3 Months Ended |
Mar. 31, 2021 | |
Share-based Payment Arrangement [Abstract] | |
Stock-Based Compensation | Stock-Based Compensation The following table summarizes activity under the Amended and Restated 2014 Equity and Incentive Plan (“2014 Plan”), the 2012 Stock Incentive 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, 2021 (unaudited): Number of Shares Subject to Outstanding Stock Options Weighted-Average Exercise Price per Share Number of RSUs Outstanding Weighted-Average Grant Date Fair Value per Share Outstanding at January 1, 2021 2,724,537 $ 3.31 335,004 $ 0.84 Granted 1,640,500 $ 1.25 595,250 $ 1.20 Canceled/forfeited/expired (47,345) $ 2.54 (7,313) $ 0.84 Outstanding at March 31, 2021 4,317,692 $ 2.54 922,941 $ 1.07 On January 1, 2021, the shares of common stock authorized for issuance under the 2014 Plan were increased by 3,572,317 shares pursuant to the automatic annual increase provisions of the 2014 Plan. As of March 31, 2021, 1,475,534 shares of common stock were available for issuance under the 2014 Plan. 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, 2021 2020 (unaudited; in thousands) Research and development $ 138 $ 169 General and administrative 272 195 Total $ 410 $ 364 |
Commitments and Contingencies
Commitments and Contingencies | 3 Months Ended |
Mar. 31, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Commitments and Contingencies Equipment Purchase Commitments The Company has a remaining commitment of approximately $1.1 million recorded as a current liability on the balance sheet at March 31, 2021, with an equipment manufacturer to purchase a commercial coating and primary packaging machine for the production of its product candidate, Qtrypta. Contract Manufacturing Organizations The Company has a technology transfer agreement and a manufacturing and supply agreement with a 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 $2.8 million in 2021 escalating to $14.0 million in 2024, to be paid in equal monthly installments. The annual fee includes the production of a defined number of units with an option to purchase additional units at a defined price, the transfer of technology in 2021 and other operating expenses. The agreement contains negotiated representations and warranties, indemnification, limitations of liability, and other provisions. The initial term of the manufacturing and supply agreement continues until the seventh anniversary of the date on which the Company receives NDA approval of Qtrypta in the United States. As of March 31, 2021, the Company had recorded a right-of-use asset and associated lease liability at the present value of the amount of the manufacturing and supply agreement identified as an embedded operating lease (See Note 6. Leases). The Company may terminate the agreements upon denial of regulatory approvals or if regulatory approvals are withdrawn under certain circumstances for the cost to remove the Company's equipment and restore the CMO's facility, which is recorded as a liability on the balance sheet. 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. 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 non-cancelable commitments with this CMO for the construction of manufacturing space and technology transfer fees totaling $3.3 million, of which $0.8 million was a current liability on the balance sheet as of March 31, 2021. The Company has an agreement with another CMO (the “Agreement”) to provide services related to the manufacture and assembly of a component (the “Product”) of Qtrypta. Under the Agreement, the parties expressed their mutual intent to enter into a commercial supply agreement (“Supply Agreement”). The Agreement provides that if the Company does not enter into a Supply Agreement with this CMO or ceases to purchase the Product from this CMO prior to reaching a minimum commitment level, then the Company would be required to pay the CMO up to $2.5 million; however, no such payment will be required in the event of this CMO’s material breach. The Company may be required to pay an additional payment of up to $4.6 million if the Company ceases to purchase the Product from this CMO and a Supply Agreement is not entered into, except that no such payment will be required in the event of this CMO’s material breach or if the FDA does not approve Qtrypta. As of March 31, 2021, the Company had recorded a right-of-use asset and associated lease liability at the present value of the amount of the Agreement identified as an embedded operating lease (See Note 6. Leases). The Company has a manufacturing and supply agreement through September 2023 with another supplier for a component part that includes an inactivity fee of up to $85,000 annually. 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, 2021. Legal Proceedings On October 29, 2020 and November 6, 2020, two stockholders filed alleged class action lawsuits against the Company and certain of its current and former executive officers in the United States District Court for the Northern District of California: Carr v. Zosano Pharma Corporation, et al., Case No. 3:20-cv-07625, and Becerra v. Zosano Pharma Corporation, et al., Case No. 3:20-cv-07850. The complaints were filed purportedly on behalf of all persons who purchased or otherwise acquired the Company's securities between February 13, 2017 and September 30, 2020 (the "Class Period"). The complaints allege that the Company and certain of its current and former executive officers made false and/or misleading statements and failed to disclose material adverse facts about the Company's business, operations and prospects in violation of Sections 10(b) (and Rule 10b-5 promulgated thereunder) and 20(a) of the Securities Exchange Act of 1934, as amended (the "Exchange Act"). The plaintiffs seek damages, interest, costs, attorneys’ fees and other unspecified relief. On February 4, 2021, the Carr and Becerra actions were consolidated and the court appointed two Co-Lead Plaintiffs and two law firms as Co-Lead Counsel in the consolidated action (the “Securities Action”). The Co-Lead Plaintiffs filed their consolidated amended complaint on March 30, 2021, which alleges the same claims as the previous complaints and extends the Class Period through October 20, 2020. The Company anticipates filing a motion to dismiss the consolidated amended complaint. Pursuant to a stipulated court order, the Company expects to file the motion by May 14, 2021; the Co-Lead Plaintiffs are expected to file their opposition by June 14, 2021; and the Company expects to file a reply brief by July 6, 2021. The earliest date upon which the Court may hear the motion is July 20, 2021. On February 9, 2021, a stockholder filed a derivative action, purportedly on behalf of the Company (named as a nominal defendant), against certain of the Company's current and former executive officers and directors in the United States District Court for the District of Delaware: Gensemer v. Lo, et al., Case No. 1:21-cv-00168 (the “Derivative Action”). The complaint alleges breaches of the defendants’ fiduciary duties as the Company's directors and/or officers, unjust enrichment, abuse of control, gross mismanagement, waste of corporate assets, violations of Section 14(a) of the Exchange Act, and for contribution under Sections 10(b) and 21D of the Exchange Act. The plaintiff seeks damages, restitution, interest, attorneys’ fees and costs, and other unspecified relief. Pursuant to stipulation of the parties, on March 24, 2021, the Court entered an order staying the Derivative Action, including all deadlines, conferences and hearings, until the final resolution of the Company's anticipated motion to dismiss in the Securities Action, including through any amendments and/or appeals. The Company believes the cases are without merit and it intends to vigorously defend itself against the claims. Given the uncertainty of litigation and the preliminary stage of the cases, the Company cannot predict the outcome of or estimate the possible loss or range of loss that may result from these actions. The Company, from time to time, may be involved in other lawsuits and legal proceedings, which arise, in the ordinary course of business. Lawsuits and legal proceedings are subject to inherent uncertainties and an adverse result in any lawsuit or legal proceeding may materially adversely affect our business, financial condition and results of operations. 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. |
Subsequent Event
Subsequent Event | 3 Months Ended |
Mar. 31, 2021 | |
Subsequent Events [Abstract] | |
Subsequent Event | Subsequent Event On April 5, 2021, the Company signed a Master Services Agreement with a contract research organization to perform services related to clinical trials for the Company. On April 21, 2021, the Company and the contract research organization signed a work order in association with the Master Services Agreement, under which the contract research organization will perform the PK study required to support the resubmission of the Qtrypta 505(b)(2) NDA. The total estimated budget for the PK study is $1.4 million. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2021 | |
Accounting Policies [Abstract] | |
Basis of Presentation and Use of Estimates | Basis of Presentation and Use of Estimates The accompanying financial statements have been prepared in accordance with 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, 2021 are not necessarily indicative of the results that may be expected for the year ending December 31, 2021 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, 2020, included in the Company’s annual report on Form 10-K and filed with the United States Securities and Exchange Commission (“SEC”) on March 11, 2021. The preparation of the accompanying financial statements in accordance with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities as of the date of the financial statements, and the reported amounts of expenses during the periods reported. Actual results could differ from those estimates or assumptions. |
Cash, Cash Equivalents and Restricted Cash | Cash, Cash Equivalents and Restricted Cash The Company considers all highly liquid investments purchased with an original maturity of 90 days or less to be cash equivalents. |
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 as interest rates approximate market rates that the Company could obtain for debt with similar terms and maturities. |
Net Loss Per Common Share | Net Loss Per Common Share Basic net loss per common share is calculated by dividing the net loss by the weighted-average number of common shares outstanding during the period, without consideration for potentially dilutive securities. Diluted net loss per common share is computed by dividing the net loss attributable to common stockholders by the weighted-average number of common shares and potentially dilutive securities outstanding for the period determined using the treasury-stock and if-converted methods. For purposes of the diluted net loss per share calculation, common stock warrants, stock options and restricted stock units ("RSUs") 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. |
Recently Accounting Pronouncements | Recent Accounting Pronouncements Recently Adopted Accounting Pronouncements In December 2019, the Financial Accounting Standards Board issued Accounting Standards Update 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 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Accounting Policies [Abstract] | |
Reconciliation 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, 2021 March 31, 2020 (unaudited; in thousands) Cash and cash equivalents $ 26,882 $ 18,557 Restricted cash 455 455 Total $ 27,337 $ 19,012 |
Schedule of Outstanding Common Stock Equivalents | 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, 2021 March 31, 2020 (unaudited; shares) Options to purchase common stock 4,317,692 2,097,401 Warrants to purchase common stock 924,441 23,680,570 RSUs 922,941 — Total 6,165,074 25,777,971 |
Cash Equivalents and Investme_2
Cash Equivalents and Investments in Marketable Securities (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Cash and Cash Equivalents [Abstract] | |
Summary of Cash Equivalents and Investments in Marketable Securities | The following table summarizes the Company's cash equivalents and investments in marketable securities at fair value on a recurring basis: As of March 31, 2021: Fair Value Measurements Total Quoted prices in active market Significant other observable inputs Significant unobservable inputs (unaudited; in thousands) Money market funds classified as cash equivalents $ 24,419 $ 24,419 $ — $ — As of December 31, 2020: Fair Value Measurements Total Quoted prices in active market Significant other observable inputs Significant unobservable inputs (in thousands) Money market funds classified as cash equivalents $ 33,918 $ 33,918 $ — $ — |
Balance Sheet Components (Table
Balance Sheet Components (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Balance Sheet Related Disclosures [Abstract] | |
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, 2021 December 31, 2020 (unaudited; in thousands) (in thousands) Prepaid insurance $ 807 $ 66 Unbilled revenue 157 124 Prepaid services 120 97 Accounts receivable 86 — Prepaid software and subscriptions 81 118 Deferred offering costs 70 48 Other 270 — Total $ 1,591 $ 453 |
Schedule of Property and Equipment | The following table summarizes the Company’s property and equipment for each of the periods presented: March 31, 2021 December 31, 2020 (unaudited; in thousands) (in thousands) Leasehold improvements $ 24,212 $ 24,212 Manufacturing equipment 14,893 14,893 Laboratory and office equipment 1,641 1,641 Computer equipment and software 172 172 Construction-in-progress 19,893 18,239 Property and equipment at cost 60,811 59,157 Less: accumulated depreciation property and equipment (28,683) (28,248) Total $ 32,128 $ 30,909 |
Schedule of Accrued Liabilities | The following table summarizes the Company’s other accrued liabilities for each of the periods presented: March 31, 2021 December 31, 2020 (unaudited; in thousands) (in thousands) Construction-in-progress obligations $ 874 $ 2,993 Professional service fees 315 175 Contract manufacturing 176 71 Deferred revenue 47 — Pre-clinical and clinical studies 10 22 Other 69 106 Total $ 1,491 $ 3,367 |
Leases (Tables)
Leases (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Leases [Abstract] | |
Lease, Cost | The following table summarizes information regarding the Company's leases for each of the periods presented: Three Months Ended March 31, 2021 2020 (unaudited; in thousands) Operating lease costs $ 439 $ 422 Operating cash flows from operating leases - cash paid for operating leases $ 489 $ 461 The following table summarizes the lease terms and discount rates for the Company's leases as of March 31, 2021: (unaudited) Weighted-average remaining lease term (in years) 3.38 Weighted average discount rate 11 % |
Operating Leases, Scheduled Lease Payments | The following table summarizes the maturities of the Company's lease liabilities for each year ending December 31, as of March 31, 2021: (unaudited; in thousands) 2021 $ 1,485 2022 2,043 2023 2,017 2024 1,371 Total undiscounted cash flows 6,916 Less: amount representing interest (1,178) Present value of lease liabilities $ 5,738 Current portion $ 1,434 Long-term portion 4,304 Total $ 5,738 |
Debt Financing (Tables)
Debt Financing (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Debt Disclosure [Abstract] | |
Schedule of Long-term Debt Instruments | The following table summarizes the debt obligations as of March 31, 2021: Drawdown Date Drawdown Amount Principal Balance Purchase Option Fee Discount on Purchase Option Fee Unamortized Discounts and Issuance Costs Monthly Payment Stated Interest Rate Amended Effective Interest Rate Maturity Date (unaudited; in thousands) 09/25/2018 $ 5,000 $ 1,667 $ 600 $ (14) $ (82) $ 160 9.43 % 24.38 % 04/01/2022 12/11/2018 2,800 1,177 336 (12) (39) 90 9.68 % 18.25 % 07/01/2022 06/06/2019 2,300 1,350 276 (20) (64) 74 9.93 % 18.08 % 01/01/2023 09/13/2019 2,300 1,534 276 (26) (86) 74 9.93 % 18.04 % 04/01/2023 11/27/2019 1,600 1,151 192 (21) (72) 52 9.93 % 18.16 % 06/01/2023 Total $ 14,000 $ 6,879 $ 1,680 $ (93) $ (343) $ 450 The following table summarizes the Company's build-to-suit obligation as of March 31, 2021 (unaudited; in thousands) : Build-to-suit obligation principal amount $ 6,879 Build-to-suit obligation Purchase Option Fees at present value 1,587 Less: unamortized Purchase Option Fees (271) unamortized warrants, discounts and issuance costs (72) Build-to-suit obligation, net of debt issuance costs and discount $ 8,123 Build-to-suit obligation, current portion $ 4,697 Build-to-suit obligation, long-term portion, net of debt issuance costs and discount 3,426 Build-to-suit obligation, net of debt issuance costs and discount $ 8,123 |
Schedule of Maturities of Long-term Debt | The following table summarizes future minimum payments on the Company’s build-to-suit obligation, including payments of principal and interest and Purchase Option Fees for each year ending December 31 as of March 31, 2021: Principal Interest Purchase Option Fees Total (unaudited; in thousands) 2021 $ 3,628 $ 420 $ — $ 4,048 2022 2,979 189 936 4,104 2023 272 8 744 1,024 Total $ 6,879 $ 617 $ 1,680 $ 9,176 |
Schedule of Debt | 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, 2021 2020 (unaudited; in thousands) Build-to-suit obligation, cash interest expense $ 197 $ 252 Build-to-suit obligation, effective interest expense 137 243 Less: build-to-suit obligation, interest capitalized (242) (298) Build-to-suit obligation interest expense $ 92 $ 197 |
Common Stock Warrants (Tables)
Common Stock Warrants (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Equity [Abstract] | |
Summary of Warrants Issued and Outstanding | The following table summarizes the Company's issued and outstanding common stock warrants: Warrants Outstanding as of December 31, 2020 Issued Exercised Expired Warrants Outstanding as of March 31, 2021 Exercise Price per Share Expiration Date unaudited Series E - March 2020 4,709,502 — (4,078,667) — 630,835 $ 0.8025 03/06/25 Series C - February 2020 167,700 — (145,000) — 22,700 $ 0.6500 02/14/25 Trinity - September 2018 75,000 — — — 75,000 $ 3.5928 09/25/25 Series B - August 2016 195,906 — — — 195,906 $ 31.0000 08/19/21 Total 5,148,108 — (4,223,667) — 924,441 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Share-based Payment Arrangement [Abstract] | |
Disclosure of Share-based Compensation Arrangements by Share-based Payment Award | The following table summarizes activity under the Amended and Restated 2014 Equity and Incentive Plan (“2014 Plan”), the 2012 Stock Incentive 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, 2021 (unaudited): Number of Shares Subject to Outstanding Stock Options Weighted-Average Exercise Price per Share Number of RSUs Outstanding Weighted-Average Grant Date Fair Value per Share Outstanding at January 1, 2021 2,724,537 $ 3.31 335,004 $ 0.84 Granted 1,640,500 $ 1.25 595,250 $ 1.20 Canceled/forfeited/expired (47,345) $ 2.54 (7,313) $ 0.84 Outstanding at March 31, 2021 4,317,692 $ 2.54 922,941 $ 1.07 |
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, 2021 2020 (unaudited; in thousands) Research and development $ 138 $ 169 General and administrative 272 195 Total $ 410 $ 364 |
Organization (Details)
Organization (Details) - USD ($) $ / shares in Units, $ in Thousands | Jun. 08, 2020 | Mar. 04, 2020 | Feb. 14, 2020 | Apr. 30, 2021 | Mar. 31, 2021 | Mar. 31, 2020 | Dec. 31, 2020 | Apr. 16, 2020 |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
Accumulated deficit | $ 340,332 | $ 332,190 | ||||||
Cash and cash equivalents | 26,882 | $ 18,557 | $ 35,263 | |||||
Sale of stock offer maximum | $ 74,500 | |||||||
Consideration from sale of stock | 33,700 | |||||||
Maximum aggregate offering price (up to) | $ 5,300 | |||||||
Warrants outstanding (in shares) | 924,441 | 5,148,108 | ||||||
Common stock warrants issued (in shares) | 1 | |||||||
Series E - March 2020 | ||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
Warrants outstanding (in shares) | 630,835 | 4,709,502 | ||||||
Exercise price (in USD per share) | $ 0.8025 | |||||||
Series C Warrant | ||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
Proceeds from warrant exercises | $ 94 | $ 1,722 | ||||||
Series D Preferred Stock | ||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
Exercise price (in USD per share) | $ 0.0001 | |||||||
Series C - February 2020 | ||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
Warrants outstanding (in shares) | 22,700 | 167,700 | ||||||
Exercise price (in USD per share) | $ 0.6500 | |||||||
At-The-Market Offering | ||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
Consideration from sale of stock | $ 1 | |||||||
Maximum aggregate offering price (up to) | $ 20,000 | |||||||
Commissions on proceeds from the sale of shares | 3.00% | |||||||
At-The-Market Offering | Subsequent Event | ||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
Consideration from sale of stock | $ 400 | |||||||
At-The-Market Offering | Common Stock | ||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
Shares issued in transaction (in shares) | 82,935 | |||||||
Sale of stock average price per share (in USD per share) | $ 1.31 | |||||||
At-The-Market Offering | Common Stock | Subsequent Event | ||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
Shares issued in transaction (in shares) | 355,551 | |||||||
Sale of stock average price per share (in USD per share) | $ 1.26 | |||||||
Registered Direct Offering | ||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
Shares issued in transaction (in shares) | 11,903,506 | |||||||
Price of stock sold (in USD per share) | $ 0.9275 | |||||||
Warrants expiration term | 5 years | |||||||
Registered Direct Offering | Series E - March 2020 | ||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
Price of stock sold (in USD per share) | $ 0.8025 | $ 0.8025 | ||||||
Warrants to purchase common stock (in shares) | 4,078,667 | |||||||
Proceeds from warrant exercises | $ 3,300 | |||||||
Public Stock Offering | ||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
Period for additional purchase of stock | 30 days | |||||||
Public Stock Offering | Common Class A | ||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
Shares issued in transaction (in shares) | 10,146,154 | |||||||
Price of stock sold (in USD per share) | $ 0.65 | |||||||
Number of share of common stock Included in the issued combination (in shares) | 1 | |||||||
Public Stock Offering | Common Class B | ||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
Shares issued in transaction (in shares) | 2,161,539 | |||||||
Price of stock sold (in USD per share) | $ 0.6499 | |||||||
Warrants expiration term | 5 years | |||||||
Public Stock Offering | Common Class C | ||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
Shares issued in transaction (in shares) | 1,846,153 | |||||||
Public Stock Offering | Series C Warrant | ||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
Warrants to purchase common stock (in shares) | 145,000 | |||||||
Proceeds from warrant exercises | $ 100 | |||||||
Exercise price (in USD per share) | $ 0.65 | |||||||
Public Stock Offering | Series C Warrant | Common Class A | ||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
Number of share of warrants included in the issued combination (in shares) | 1 | |||||||
Common stock warrants issued (in shares) | 1 | |||||||
Public Stock Offering | Series C Warrant | Common Class B | ||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
Number of share of warrants included in the issued combination (in shares) | 1 | |||||||
Common stock warrants issued (in shares) | 1 | |||||||
Exercise price (in USD per share) | $ 0.65 | |||||||
Public Stock Offering | Series D Pre Funded Warrant | Common Class B | ||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
Number of share of common stock Included in the issued combination (in shares) | 1 | |||||||
Number of share of warrants included in the issued combination (in shares) | 1 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Additional Information (Detail) - USD ($) $ in Thousands | Mar. 31, 2021 | Dec. 31, 2020 | Mar. 31, 2020 |
Summary Of Significant Accounting Policies [Line Items] | |||
Restricted cash | $ 455 | $ 455 | $ 455 |
Deposit Building Lease | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Restricted cash | 300 | 300 | |
Deposit Utility Provider | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Restricted cash | $ 100 | $ 100 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Reconciliation of Cash, Cash Equivalents and Restricted Cash (Details) - USD ($) $ in Thousands | Mar. 31, 2021 | Dec. 31, 2020 | Mar. 31, 2020 | Dec. 31, 2019 |
Accounting Policies [Abstract] | ||||
Cash and cash equivalents | $ 26,882 | $ 35,263 | $ 18,557 | |
Restricted cash | 455 | 455 | 455 | |
Total | $ 27,337 | $ 35,718 | $ 19,012 | $ 6,771 |
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 (Details) - shares | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Common stock equivalents excluded from computation of diluted net loss per share (in shares) | 6,165,074 | 25,777,971,000 |
Options to purchase common stock | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Common stock equivalents excluded from computation of diluted net loss per share (in shares) | 4,317,692 | 2,097,401,000 |
Warrants to purchase common stock | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Common stock equivalents excluded from computation of diluted net loss per share (in shares) | 924,441 | 23,680,570,000 |
RSUs | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Common stock equivalents excluded from computation of diluted net loss per share (in shares) | 922,941 | 0 |
Master Services Agreement wit_2
Master Services Agreement with Eversana (Details) - Eversana Life Services L L C - Commercialization Of Ortypta $ in Millions | Aug. 06, 2020USD ($) |
Related Party Transaction [Line Items] | |
Commercialization budged | $ 250 |
Affiliated Entity | |
Related Party Transaction [Line Items] | |
Term of the agreement | 5 years |
Revolving Credit Facility | Affiliated Entity | |
Related Party Transaction [Line Items] | |
Amounts of transaction | $ 5 |
Annual rate | 10.00% |
Cash Equivalents and Investme_3
Cash Equivalents and Investments in Marketable Securities (Details) - Fair Value, Measurements, Recurring - Money Market Funds - USD ($) $ in Thousands | Mar. 31, 2021 | Dec. 31, 2020 |
Debt Securities, Available-for-sale [Line Items] | ||
Money market funds classified as cash equivalents | $ 24,419 | $ 33,918 |
Quoted prices in active market Level 1 | ||
Debt Securities, Available-for-sale [Line Items] | ||
Money market funds classified as cash equivalents | 24,419 | 33,918 |
Significant other observable inputs Level 2 | ||
Debt Securities, Available-for-sale [Line Items] | ||
Money market funds classified as cash equivalents | 0 | 0 |
Significant unobservable inputs Level 3 | ||
Debt Securities, Available-for-sale [Line Items] | ||
Money market funds classified as cash equivalents | $ 0 | $ 0 |
Balance Sheet Components - Prep
Balance Sheet Components - Prepaid Expenses and Other Current Assets (Details) - USD ($) $ in Thousands | Mar. 31, 2021 | Dec. 31, 2020 |
Balance Sheet Related Disclosures [Abstract] | ||
Prepaid insurance | $ 807 | $ 66 |
Unbilled revenue | 157 | 124 |
Prepaid services | 120 | 97 |
Accounts receivable | 86 | 0 |
Prepaid software and subscriptions | 81 | 118 |
Deferred offering costs | 70 | 48 |
Other | 270 | 0 |
Prepaid expenses and other current assets | $ 1,591 | $ 453 |
Balance Sheet Components - Sche
Balance Sheet Components - Schedule of Property and Equipment (Detail) - USD ($) $ in Thousands | Mar. 31, 2021 | Dec. 31, 2020 |
Property, Plant and Equipment [Line Items] | ||
Property and equipment at cost | $ 60,811 | $ 59,157 |
Less: accumulated depreciation property and equipment | (28,683) | (28,248) |
Property and equipment, net | 32,128 | 30,909 |
Leasehold improvements | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment at cost | 24,212 | 24,212 |
Manufacturing equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment at cost | 14,893 | 14,893 |
Laboratory and office equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment at cost | 1,641 | 1,641 |
Computer equipment and software | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment at cost | 172 | 172 |
Construction-in-progress | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment at cost | $ 19,893 | $ 18,239 |
Balance Sheet Components - Narr
Balance Sheet Components - Narrative (Detail) - USD ($) $ in Thousands | 3 Months Ended | ||
Mar. 31, 2021 | Mar. 31, 2020 | Dec. 31, 2020 | |
Property, Plant and Equipment [Line Items] | |||
Depreciation and amortization expense | $ 435 | $ 172 | |
Capitalized interest | 2,700 | $ 2,400 | |
Construction In Progress Build-to-Suit Lease Asset | |||
Property, Plant and Equipment [Line Items] | |||
Property and equipment, gross | $ 15,400 | $ 14,600 |
Balance Sheet Components - Othe
Balance Sheet Components - Other Accrued Liabilities (Details) - USD ($) $ in Thousands | Mar. 31, 2021 | Dec. 31, 2020 |
Balance Sheet Related Disclosures [Abstract] | ||
Construction-in-progress obligations | $ 874 | $ 2,993 |
Professional service fees | 315 | 175 |
Contract manufacturing | 176 | 71 |
Deferred revenue | 47 | 0 |
Pre-clinical and clinical studies | 10 | 22 |
Other | 69 | 106 |
Total | $ 1,491 | $ 3,367 |
Leases - Narrative (Details)
Leases - Narrative (Details) | 3 Months Ended |
Mar. 31, 2021 | |
Leases [Abstract] | |
Extension period | 60 months |
Leases - Description of Lease C
Leases - Description of Lease Costs (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Leases [Abstract] | ||
Operating lease costs | $ 439 | $ 422 |
Operating cash flows from operating leases - cash paid for operating leases | $ 489 | $ 461 |
Leases - Description of Other L
Leases - Description of Other Lease Information (Details) | Mar. 31, 2021 |
Leases [Abstract] | |
Weighted-average remaining lease term (in years) | 3 years 4 months 17 days |
Weighted average discount rate | 11.00% |
Leases - Future Minimum Lease P
Leases - Future Minimum Lease Payments (Details) - USD ($) $ in Thousands | Mar. 31, 2021 | Dec. 31, 2020 |
Lessee, Operating Lease, Liability, Payment, Due [Abstract] | ||
2021 | $ 1,485 | |
2022 | 2,043 | |
2023 | 2,017 | |
2024 | 1,371 | |
Total undiscounted cash flows | 6,916 | |
Less: amount representing interest | (1,178) | |
Present value of lease liabilities | 5,738 | |
Current portion | 1,434 | $ 1,378 |
Long-term portion | $ 4,304 | $ 4,687 |
Debt Financing - Narrative (Det
Debt Financing - Narrative (Details) - USD ($) | May 27, 2020 | May 26, 2020 | Apr. 21, 2020 | Mar. 31, 2021 | Dec. 31, 2020 | Oct. 04, 2020 |
Debt Instrument [Line Items] | ||||||
Interest payment period | 6 months | |||||
Capitalized interest costs | $ 2,700,000 | $ 2,400,000 | ||||
Common stock, shares issued (in shares) | 106,372,820 | 102,066,218 | ||||
Paycheck Protection Program Loan | Forgivable Loan | ||||||
Debt Instrument [Line Items] | ||||||
Debt instrument term | 2 years | |||||
Line of credit | $ 1,600,000 | $ 1,600,000 | ||||
Stated Interest Rate | 1.00% | |||||
Construction In Progress Build-to-Suit Lease Asset | ||||||
Debt Instrument [Line Items] | ||||||
Property and equipment, gross | $ 15,400,000 | $ 14,600,000 | ||||
Trinity Capital Fund III, L.P. | Warrants to purchase common stock | ||||||
Debt Instrument [Line Items] | ||||||
Common stock, shares issued (in shares) | 75,000 | |||||
Proceeds from issuance of warrants | $ 243,000 | |||||
Build to Suit Obligation | Trinity Capital Fund III, L.P. | ||||||
Debt Instrument [Line Items] | ||||||
Aggregate principal amount | 14,000,000 | |||||
Borrowing capacity | 500,000 | |||||
Debt instrument term | 42 months | 36 months | ||||
Purchase percentage of equipment cost | 12.00% | |||||
Common stock warrant exercise price (in USD per share) | $ 3.5928 | |||||
Line of credit | $ 5,000,000 | $ 14,000,000 |
Debt Financing - Summary of Deb
Debt Financing - Summary of Debt Obligations (Details) - Build to Suit Obligation - USD ($) | 3 Months Ended | |
Mar. 31, 2021 | May 27, 2020 | |
Debt Instrument [Line Items] | ||
Principal Balance | $ 6,879,000 | |
Trinity Capital Fund III, L.P. | ||
Debt Instrument [Line Items] | ||
Drawdown Amount | 14,000,000 | $ 5,000,000 |
Principal Balance | 6,879,000 | |
Purchase Option Fee | 1,680,000 | |
Discount on Purchase Option Fee | (93,000) | |
Unamortized Discounts and Issuance Costs | (343,000) | |
Monthly Payment | 450,000 | |
Trinity Capital Fund III, L.P. | Drawdown Maturity Date Of April 012022 | ||
Debt Instrument [Line Items] | ||
Drawdown Amount | 5,000,000 | |
Principal Balance | 1,667,000 | |
Purchase Option Fee | 600,000 | |
Discount on Purchase Option Fee | (14,000) | |
Unamortized Discounts and Issuance Costs | (82,000) | |
Monthly Payment | $ 160,000 | |
Stated Interest Rate | 9.43% | |
Amended Effective Interest Rate | 24.38% | |
Trinity Capital Fund III, L.P. | Drawdown Maturity Date Of July 1, 2022 | ||
Debt Instrument [Line Items] | ||
Drawdown Amount | $ 2,800,000 | |
Principal Balance | 1,177,000 | |
Purchase Option Fee | 336,000 | |
Discount on Purchase Option Fee | (12,000) | |
Unamortized Discounts and Issuance Costs | (39,000) | |
Monthly Payment | $ 90,000 | |
Stated Interest Rate | 9.68% | |
Amended Effective Interest Rate | 18.25% | |
Trinity Capital Fund III, L.P. | Drawdown Maturity Date Of January 1 2023 | ||
Debt Instrument [Line Items] | ||
Drawdown Amount | $ 2,300,000 | |
Principal Balance | 1,350,000 | |
Purchase Option Fee | 276,000 | |
Discount on Purchase Option Fee | (20,000) | |
Unamortized Discounts and Issuance Costs | (64,000) | |
Monthly Payment | $ 74,000 | |
Stated Interest Rate | 9.93% | |
Amended Effective Interest Rate | 18.08% | |
Trinity Capital Fund III, L.P. | Drawdown Maturity Date Of April 1 2023 | ||
Debt Instrument [Line Items] | ||
Drawdown Amount | $ 2,300,000 | |
Principal Balance | 1,534,000 | |
Purchase Option Fee | 276,000 | |
Discount on Purchase Option Fee | (26,000) | |
Unamortized Discounts and Issuance Costs | (86,000) | |
Monthly Payment | $ 74,000 | |
Stated Interest Rate | 9.93% | |
Amended Effective Interest Rate | 18.04% | |
Trinity Capital Fund III, L.P. | Drawdown Maturity Date Of June 01 2023 | ||
Debt Instrument [Line Items] | ||
Drawdown Amount | $ 1,600,000 | |
Principal Balance | 1,151,000 | |
Purchase Option Fee | 192,000 | |
Discount on Purchase Option Fee | (21,000) | |
Unamortized Discounts and Issuance Costs | (72,000) | |
Monthly Payment | $ 52,000 | |
Stated Interest Rate | 9.93% | |
Amended Effective Interest Rate | 18.16% |
Debt Financing - Summary of Lon
Debt Financing - Summary of Long-Term Debt, Net of Unamortized Debt Discount and Issuance Costs (Detail) - USD ($) $ in Thousands | Mar. 31, 2021 | Dec. 31, 2020 |
Debt Instrument [Line Items] | ||
Build-to-suit obligation, long-term portion, net of debt issuance costs and discount | $ 204 | $ 812 |
Build to Suit Obligation | ||
Debt Instrument [Line Items] | ||
Build-to-suit obligation principal amount | 6,879 | |
Build-to-suit obligation Purchase Option Fees at present value | 1,587 | |
Less: unamortized Purchase Option Fees | (271) | |
unamortized warrants, discounts and issuance costs | (72) | |
Build-to-suit obligation, current portion | 4,697 | |
Build-to-suit obligation, long-term portion, net of debt issuance costs and discount | 3,426 | |
Build-to-suit obligation, net of debt issuance costs and discount | $ 8,123 |
Debt Financing - Future Minimum
Debt Financing - Future Minimum Payments on the Company's Current Debt, Including Payment of Principal and Interest (Detail) $ in Thousands | Mar. 31, 2021USD ($) |
Principal | |
2021 | $ 3,628 |
2022 | 2,979 |
2023 | 272 |
Total | 6,879 |
Interest | |
2021 | 420 |
2022 | 189 |
2023 | 8 |
Total | 617 |
Purchase Option Fees | |
2021 | 0 |
2022 | 936 |
2023 | 744 |
Total | 1,680 |
Total | |
2021 | 4,048 |
2022 | 4,104 |
2023 | 1,024 |
Total | $ 9,176 |
Debt Financing - Summary of Int
Debt Financing - Summary of Interest (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Debt Instrument [Line Items] | ||
Build-to-suit obligation interest expense | $ 97 | $ 206 |
Build to Suit Obligation | ||
Debt Instrument [Line Items] | ||
Build-to-suit obligation, cash interest expense | 197 | 252 |
Build-to-suit obligation, effective interest expense | 137 | 243 |
Less: build-to-suit obligation, interest capitalized | (242) | (298) |
Build-to-suit obligation interest expense | $ 92 | $ 197 |
Common Stock Warrants- Issued a
Common Stock Warrants- Issued and Outstanding (Details) | 3 Months Ended |
Mar. 31, 2021$ / sharesshares | |
Class of Stock [Line Items] | |
Warrants Outstanding as of December 31, 2020 (in shares) | 5,148,108 |
Issued (in shares) | 0 |
Exercised (in shares) | (4,223,667) |
Expired (in shares) | 0 |
Warrants outstanding as of March 31,2021 (in shares) | 924,441 |
Series E - March 2020 | |
Class of Stock [Line Items] | |
Warrants Outstanding as of December 31, 2020 (in shares) | 4,709,502 |
Issued (in shares) | 0 |
Exercised (in shares) | (4,078,667) |
Expired (in shares) | 0 |
Warrants outstanding as of March 31,2021 (in shares) | 630,835 |
Exercise price (in USD per share) | $ / shares | $ 0.8025 |
Series C - February 2020 | |
Class of Stock [Line Items] | |
Warrants Outstanding as of December 31, 2020 (in shares) | 167,700 |
Issued (in shares) | 0 |
Exercised (in shares) | (145,000) |
Expired (in shares) | 0 |
Warrants outstanding as of March 31,2021 (in shares) | 22,700 |
Exercise price (in USD per share) | $ / shares | $ 0.6500 |
Trinity - September 2018 | |
Class of Stock [Line Items] | |
Warrants Outstanding as of December 31, 2020 (in shares) | 75,000 |
Issued (in shares) | 0 |
Exercised (in shares) | 0 |
Expired (in shares) | 0 |
Warrants outstanding as of March 31,2021 (in shares) | 75,000 |
Exercise price (in USD per share) | $ / shares | $ 3.5928 |
Series B - August 2016 | |
Class of Stock [Line Items] | |
Warrants Outstanding as of December 31, 2020 (in shares) | 195,906 |
Issued (in shares) | 0 |
Exercised (in shares) | 0 |
Expired (in shares) | 0 |
Warrants outstanding as of March 31,2021 (in shares) | 195,906 |
Exercise price (in USD per share) | $ / shares | $ 31 |
Common Stock Warrants - Narrati
Common Stock Warrants - Narrative (Details) | Mar. 31, 2021shares |
Equity [Abstract] | |
Common stock warrants issued (in shares) | 1 |
Stock-Based Compensation - Summ
Stock-Based Compensation - Summary of Stock Option and Award Activity Excluding Inducement Grants (Detail) | 3 Months Ended |
Mar. 31, 2021$ / sharesshares | |
Number of Shares Subject to Outstanding Stock Options | |
Beginning balance (in shares) | shares | 2,724,537 |
Granted (in shares) | shares | 1,640,500 |
Canceled/forfeited/expired (in shares) | shares | (47,345) |
Ending balance (in shares) | shares | 4,317,692 |
Weighted-Average Exercise Price per Share | |
Beginning balance (in USD per share) | $ / shares | $ 3.31 |
Granted (in USD per share) | $ / shares | 1.25 |
Cancelled/forfeited/expired (in USD per share) | $ / shares | 2.54 |
Ending balance (in USD per share) | $ / shares | $ 2.54 |
RSUs | |
Number of RSUs Outstanding | |
Beginning balance (in shares) | shares | 335,004 |
Awards granted (in shares) | shares | 595,250 |
Awards canceled/forfeited/expired (in shares) | shares | (7,313) |
Ending balance (in shares) | shares | 922,941 |
Weighted-Average Grant Date Fair Value per Share | |
Beginning balance (in USD per share) | $ / shares | $ 0.84 |
Awards granted (in USD per share) | $ / shares | 1.20 |
Awards canceled/forfeited/expired (in USD per share) | $ / shares | 0.84 |
Ending balance (in USD per share) | $ / shares | $ 1.07 |
Stock-Based Compensation - Narr
Stock-Based Compensation - Narrative (Detail) - shares | Jan. 01, 2021 | Mar. 31, 2021 |
Share-based Payment Arrangement [Abstract] | ||
Additional shares reserved (in shares) | 3,572,317 | |
Common stock (in shares) | 1,475,534 |
Stock-Based Compensation - Su_2
Stock-Based Compensation - Summary of Stock-Based Compensation Expense (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Stock-based compensation | $ 410 | $ 364 |
Research and development | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Stock-based compensation | 138 | 169 |
General and administrative | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Stock-based compensation | $ 272 | $ 195 |
Commitments and Contingencies (
Commitments and Contingencies (Detail) | Nov. 06, 2020lawsuit | Mar. 31, 2021USD ($) |
Other Commitments [Line Items] | ||
Cancellation fees | 50.00% | |
Inactivity fee | $ 85,000 | |
Guarantees agreements | 0 | |
Number of class action | lawsuit | 2 | |
Fees Period One | ||
Other Commitments [Line Items] | ||
Annual fees | 2,800,000 | |
Fees Period Two | ||
Other Commitments [Line Items] | ||
Annual fees | 14,000,000 | |
Commercial Coating and Primary Packaging System | ||
Other Commitments [Line Items] | ||
Purchase price | 1,100,000 | |
Manufacturing Space and Technology | ||
Other Commitments [Line Items] | ||
Purchase price | 3,300,000 | |
Commitments payable | 800,000 | |
Purchase commitment fee | 2,500,000 | |
Additional payment | $ 4,600,000 |
Subsequent Events (Detail)
Subsequent Events (Detail) $ in Millions | Apr. 21, 2021USD ($) |
Subsequent Event | Worldwide | |
Subsequent Event [Line Items] | |
Total estimated budget | $ 1.4 |