Cover page
Cover page - USD ($) | 12 Months Ended | ||
Dec. 31, 2020 | Mar. 09, 2021 | Jun. 30, 2020 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Period End Date | Dec. 31, 2020 | ||
Current Fiscal Year End Date | --12-31 | ||
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, par value $0.0001 per share | ||
Trading Symbol | ZSAN | ||
Security Exchange Name | NASDAQ | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
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 | ||
Auditor Attestation Flag | false | ||
Entity Public Float | $ 49,001,935 | ||
Entity Common Stock, Shares Outstanding | 106,289,885 | ||
Documents Incorporated by Reference | DOCUMENTS INCORPORATED BY REFERENCE The information required by Part III of this Annual Report on Form 10-K, to the extent not set forth herein, is incorporated herein by reference from the registrant’s definitive proxy statement relating to the Annual Meeting of Stockholders to be held in 2021, which definitive proxy statement will be filed with the Securities and Exchange Commission within 120 days after the close of our fiscal year ended December 31, 2020. | ||
Amendment Flag | false | ||
Document Fiscal Year Focus | 2020 | ||
Document Fiscal Period Focus | FY | ||
Entity Central Index Key | 0001587221 |
BALANCE SHEETS
BALANCE SHEETS - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Current assets: | ||
Cash and cash equivalents | $ 35,263 | $ 6,316 |
Prepaid expenses and other current assets | 453 | 497 |
Total current assets | 35,716 | 6,813 |
Restricted cash | 455 | 455 |
Property and equipment, net | 30,909 | 24,636 |
Operating lease right-of-use assets | 4,928 | 5,763 |
Other long-term assets | 3 | 3 |
Total assets | 72,011 | 37,670 |
Current liabilities: | ||
Accounts payable | 1,884 | 4,356 |
Accrued compensation | 2,294 | 2,015 |
Build-to-suit obligation, current portion | 4,779 | 4,554 |
Operating lease liabilities, current portion | 1,378 | 1,140 |
Paycheck Protection Program loan, current portion | 809 | 0 |
Other accrued liabilities | 3,367 | 4,172 |
Total current liabilities | 14,511 | 16,237 |
Build-to-suit obligation, long-term portion, net of debt issuance costs and discount | 4,359 | 6,095 |
Operating lease liabilities, long-term portion | 4,687 | 5,931 |
Paycheck Protection Program loan, long-term portion | 812 | 0 |
Other long-term liabilities | 127 | 15 |
Total liabilities | 24,496 | 28,278 |
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 December 31, 2020 and 2019 | 0 | 0 |
Common stock, $0.0001 par value; 250,000,000 shares authorized as of December 31, 2020 and 2019, respectively; 102,066,218 and 23,503,214 shares issued and outstanding as of December 31, 2020 and 2019, respectively | 10 | 2 |
Additional paid-in capital | 379,695 | 308,211 |
Accumulated deficit | (332,190) | (298,821) |
Total stockholders’ equity | 47,515 | 9,392 |
Total liabilities and stockholders’ equity | $ 72,011 | $ 37,670 |
BALANCE SHEETS (Parenthetical)
BALANCE SHEETS (Parenthetical) - $ / shares | Dec. 31, 2020 | Dec. 31, 2019 |
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) | 102,066,218 | 23,503,214 |
Common stock, shares outstanding (in shares) | 102,066,218 | 23,503,214 |
STATEMENTS OF OPERATIONS AND CO
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) shares in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Income Statement [Abstract] | ||
Service revenue | $ 224,000 | $ 0 |
Revenue from Contract with Customer, Product and Service [Extensible List] | us-gaap:ServiceMember | us-gaap:ServiceMember |
Operating expenses: | ||
Cost of service revenue | $ 171,000 | $ 0 |
Cost, Product and Service [Extensible List] | us-gaap:ServiceMember | us-gaap:ServiceMember |
Research and development | $ 21,622,000 | $ 25,385,000 |
General and administrative | 11,189,000 | 11,812,000 |
Total operating expenses | 32,982,000 | 37,197,000 |
Loss from operations | (32,758,000) | (37,197,000) |
Other income (expense): | ||
Interest income | 18,000 | 207,000 |
Interest expense | (719,000) | (523,000) |
Other income (expense), net | 90,000 | (76,000) |
Loss before provision for income taxes | (33,369,000) | (37,589,000) |
Provision for income taxes | 0 | 0 |
Net loss | (33,369,000) | (37,589,000) |
Unrealized gain on marketable securities, net of tax | 0 | 5,000 |
Comprehensive loss | $ (33,369,000) | $ (37,584,000) |
Net loss per common share – basic and diluted (in USD per share) | $ (0.49) | $ (2.29) |
Weighted-average common shares used in computing net loss per common share – basic and diluted (in shares) | 67,907 | 16,384 |
STATEMENTS OF CHANGES IN STOCKH
STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY - USD ($) $ in Thousands | Total | Series D Warrants | Series C Warrant | Series E Warrant | Common Stock | Common StockSeries D Warrants | Common StockSeries C Warrant | Common StockSeries E Warrant | Additional Paid-In Capital | Additional Paid-In CapitalSeries C Warrant | Additional Paid-In CapitalSeries E Warrant | Accumulated Deficit | Accumulated Other Comprehensive Income (Loss) | Stock Offering | Stock OfferingCommon Stock | Stock OfferingAdditional Paid-In Capital | At-The-Market Offering | At-The-Market OfferingCommon Stock | At-The-Market OfferingAdditional Paid-In Capital | Registered Direct Offering, RDO | Registered Direct Offering, RDOCommon Stock | Registered Direct Offering, RDOAdditional Paid-In Capital | Pre-funded Warrants With Public Stock Offering | Pre-funded Warrants With Public Stock OfferingCommon Stock | Pre-funded Warrants With Public Stock OfferingAdditional Paid-In Capital |
Beginning balance (in shares) at Dec. 31, 2018 | 11,973,039 | ||||||||||||||||||||||||
Beginning balance at Dec. 31, 2018 | $ 18,710 | $ 1 | $ 279,946 | $ (261,232) | $ (5) | ||||||||||||||||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||||||||||||||||||
Issuance of common stock in connection with offering, net (in shares) | 5,750,000 | 3,599,141 | 2,181,034 | ||||||||||||||||||||||
Issuance of common stock in connection with offering, net | $ 18,331 | $ 1 | $ 18,330 | $ 5,233 | $ 5,233 | $ 3,090 | $ 3,090 | ||||||||||||||||||
Stock-based compensation | 1,612 | 1,612 | |||||||||||||||||||||||
Unrealized gain on marketable securities | 5 | 5 | |||||||||||||||||||||||
Net loss | $ (37,589) | (37,589) | |||||||||||||||||||||||
Ending balance (in shares) at Dec. 31, 2019 | 23,503,214 | 23,503,214 | |||||||||||||||||||||||
Ending balance at Dec. 31, 2019 | $ 9,392 | $ 2 | 308,211 | (298,821) | 0 | ||||||||||||||||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||||||||||||||||||
Issuance of common stock in connection with offering, net (in shares) | 15,937,130 | 15,388,372 | 11,903,506 | 11,992,307 | |||||||||||||||||||||
Issuance of common stock in connection with offering, net | $ 20,336 | $ 1 | $ 20,335 | $ 16,234 | $ 2 | $ 16,232 | $ 10,211 | $ 1 | $ 10,210 | $ 8,264 | $ 2 | $ 8,262 | |||||||||||||
Issuance of common stock upon exercise of pre-funded warrants (in shares) | 2,161,539 | 13,986,146 | 7,194,004 | ||||||||||||||||||||||
Issuance of common stock upon exercise of pre-funded warrants | $ 0 | $ 9,091 | $ 5,773 | $ 1 | $ 1 | $ 9,090 | $ 5,772 | ||||||||||||||||||
Stock-based compensation | 1,583 | 1,583 | |||||||||||||||||||||||
Unrealized gain on marketable securities | 0 | ||||||||||||||||||||||||
Net loss | $ (33,369) | (33,369) | |||||||||||||||||||||||
Ending balance (in shares) at Dec. 31, 2020 | 102,066,218 | 102,066,218 | |||||||||||||||||||||||
Ending balance at Dec. 31, 2020 | $ 47,515 | $ 10 | $ 379,695 | $ (332,190) | $ 0 |
STATEMENTS OF CASH FLOWS
STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Cash flows from operating activities: | ||
Net loss | $ (33,369) | $ (37,589) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock-based compensation | 1,583 | 1,612 |
Change in operating lease right-of-use assets | 980 | 841 |
Depreciation and amortization | 1,426 | 683 |
Effective interest on financing obligations | 722 | 860 |
Capitalized effective interest | (447) | (582) |
Accretion of interest on marketable securities | 0 | (55) |
Other | 7 | 93 |
Change in operating assets and liabilities: | ||
Prepaid expenses and other assets | (17) | (193) |
Accounts payable | (1,472) | 1,764 |
Accrued compensation and other accrued liabilities | 21 | (1,288) |
Operating lease liabilities | (1,152) | (963) |
Net cash used in operating activities | (31,718) | (34,817) |
Cash flows from investing activities: | ||
Proceeds from maturities of marketable securities | 0 | 17,400 |
Purchases of marketable securities | 0 | (3,476) |
Purchases of property and equipment | (8,487) | (11,760) |
Net cash (used in) provided by investing activities | (8,487) | 2,164 |
Cash flows from financing activities: | ||
Proceeds from Paycheck Protection Program loan | 1,610 | 0 |
Proceeds from build-to-suit obligation, net of issuance costs | 0 | 6,126 |
Principal payments on financing obligations | (2,240) | (3,079) |
Net cash provided by financing activities | 69,152 | 29,829 |
Net increase (decrease) in cash, cash equivalents and restricted cash | 28,947 | (2,824) |
Cash, cash equivalents and restricted cash at beginning of year | 6,771 | 9,595 |
Cash, cash equivalents and restricted cash at end of year | 35,718 | 6,771 |
Supplemental cash flow information: | ||
Cash paid for interest | 961 | 834 |
Cash paid for income taxes | 13 | 3 |
Non-cash investing and financing activities: | ||
Acquisition of property and equipment under accounts payable and other accrued liabilities | 3,088 | 4,420 |
Asset retirement obligation | 97 | 0 |
Accrued offering costs | 0 | 188 |
Series C Warrant | ||
Cash flows from financing activities: | ||
Proceeds from warrant exercises | 9,091 | 0 |
Series E Warrant | ||
Cash flows from financing activities: | ||
Proceeds from warrant exercises | 5,773 | 0 |
Public Stock Offering | ||
Cash flows from financing activities: | ||
Proceeds from public offering of securities | 20,336 | 18,331 |
At-The-Market Offering | ||
Cash flows from financing activities: | ||
Proceeds from public offering of securities | 16,183 | 5,289 |
Registered Direct Offering | ||
Cash flows from financing activities: | ||
Proceeds from public offering of securities | 10,135 | 3,162 |
Pre-funded Warrants With Public Stock Offering | ||
Cash flows from financing activities: | ||
Proceeds from public offering of securities | $ 8,264 | $ 0 |
Organization
Organization | 12 Months Ended |
Dec. 31, 2020 | |
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 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 pharmacokinetic 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 pharmacokinetic (“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 is included in the proposed study protocol, which has been submitted to the FDA. The Division indicated willingness to review the study protocol and provide comments prior to the initiation of the study. The Company's plans for resubmitting the NDA are based on discussions with the FDA and may be subject to change upon receipt of the FDA’s comments to the proposed study protocol. The Company does not anticipate realizing product revenues unless and until the FDA approves the NDA and the Company begins commercializing Qtrypta, which may never occur. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2020 | |
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"). The preparation of the accompanying financial statements in accordance with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities as of the date of the financial statements, and the reported amounts of expenses during the periods reported. Actual results could differ from those estimates. Assets and liabilities reported in the Company’s balance sheet and expenses and income reported for each of the periods presented are affected by estimates and assumptions, which are used for, but are not limited to, determining the fair value of assets and liabilities, income tax uncertainties, and measurement of stock-based compensation. Actual results could differ from such estimates or assumptions. 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 December 31, 2020, had an accumulated deficit of $332.2 million. As of December 31, 2020, the Company had approximately $35.3 million in cash and cash equivalents. Presently, the Company does not have sufficient cash and cash equivalents to enable it to fund its anticipated level of operations and meet its obligations as they become due within twelve months following the date of issuance of this Annual Report on Form 10-K. The aforementioned factors raise substantial doubt about the Company’s ability to continue as a going concern for a period of one year from the issuance of these financial statements. The financial statements do not include any adjustments that might result from the outcome of this uncertainty. 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 December 31, 2020. 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 year ended December 31, 2020, the Company issued and sold 13,237,026 shares of its common stock at an average price of $1.07 per share under the 2020 ATM with aggregate net proceeds of approximately $13.5 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. Offering - September 2020 On August 31, 2020, the Company entered into an underwriting agreement with BTIG, pursuant to which the Company issued and sold 15,937,130 shares of its common stock to BTIG at a price of $1.304 per share. The offering closed on September 3, 2020. The Company received net proceeds of approximately $20.3 million after deducting expenses payable by the Company in connection with the offering. The shares were sold pursuant to the 2020 Shelf Registration Statement and the prospectus supplement dated August 31, 2020. 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. The aggregate net proceeds from the offering were approximately $10.2 million, after deducting the placement agent fees and other offering expenses. During the year ended December 31, 2020, Series E Warrants to purchase 7,194,004 shares of common stock were exercised at an exercise price of $0.8025 per share for aggregate proceeds of approximately $5.8 million. During the period from January 1, 2021 to March 11, 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. 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 will expire five years from the date of issuance. The Series D Pre-Funded Warrants had an exercise price of $0.0001 per share and were fully exercised in connection with the closing of the offering. The Company granted the underwriter a 30-day option to purchase up to an additional 1,846,153 shares of common stock and/or additional Series C Warrants to purchase up to 1,846,153 shares of common stock. The underwriter fully exercised its option to purchase the shares and the Series C Warrants. The aggregate net proceeds from the offering were $8.3 million after deducting underwriting commissions and other offering expenses. During the year ended December 31, 2020, Series C Warrants to purchase 13,986,146 shares of common stock were exercised at an exercise price of $0.65 per share for aggregate proceeds of approximately $9.1 million. During the period from January 1, 2021 to March 11, 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. The Company plans to raise additional funding through equity or debt financings, licensing or collaboration agreements, or strategic alliances with pharmaceutical partners, or any combination of the above. However, there are no assurances that additional funding will be obtained and that the Company will succeed in its future operations. The Company’s inability to obtain required funding in the near future or its inability to obtain funding on favorable terms will have a material adverse effect on its operations and strategic development plan for future growth. If the Company cannot successfully raise additional capital and implement its strategic development plan, its liquidity, financial condition and business prospects will be materially and adversely affected, and it may have to cease operations. The Company will continue to evaluate its timelines, strategic needs, and working capital requirements. There can be no assurance that if the Company attempts to raise additional capital, it will be successful in doing so on terms acceptable to the Company, or at all. Further, there can be no assurance that it will be able to gain access and/or be able to execute on securing new sources of funding, new development opportunities, successfully obtain regulatory approvals for and commercialize new products, achieve significant product revenues from its products (if approved), or achieve or sustain profitability in the future. COVID-19 Pandemic On March 11, 2020, the World Health Organization designated COVID-19 as a global pandemic. Due to the COVID-19 pandemic, there has been uncertainty in the global financial markets and economic conditions. The Company is closely monitoring the impact of the COVID-19 pandemic on its business, including how it will impact its employees, clinical trials and third-party service providers who perform critical services for the Company's business. In addition, the impact of the COVID-19 pandemic on the global financial markets and economic conditions could impact the Company's ability to raise capital through an equity financing, debt financing, a license or collaboration or a combination of such sources of capital, and as a result, its ability to continue as a going concern. The full extent to which the COVID-19 pandemic will directly or indirectly impact the Company's business, results of operations and financial condition will depend on future developments that are highly uncertain, including as a result of new information that may emerge concerning COVID-19 and the actions taken to contain or treat it. As of the date of issuance of this Annual Report on Form 10-K, 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. Segment Reporting The Company operates in one reportable segment: the development of human pharmaceutical products. All long-lived assets are maintained in the United States. Cash, Cash Equivalents and Restricted Cash The Company considers all highly liquid investments purchased with an original maturity of 90 days or less to be cash equivalents. As of December 31, 2020 and 2019, 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. December 31, 2020 December 31, 2019 (in thousands) Cash and cash equivalents $ 35,263 $ 6,316 Restricted cash 455 455 Total $ 35,718 $ 6,771 Marketable Securities Marketable securities generally consist of debt securities with original maturities greater than 90 days and remaining maturities of less than one year. Marketable securities with an original maturity greater than one year, if any, would be considered long-term investments. All of the Company's investments are classified as available-for-sale and carried at fair value based upon quoted market price. The change in unrealized gains and losses related to fixed maturity debt securities is reported as a separate component of comprehensive loss in the statements of operations and comprehensive loss and as a separate component of stockholders' equity on the balance sheets. Interest income includes interest, dividends, amortization and accretion of purchase premiums and discounts and realized gains and losses on sales of securities, if any. The cost of securities sold is based on the specific-identification method. The Company monitors its investment portfolio for potential impairment on a quarterly basis. If the carrying amount of an investment in available-for-sale debt securities exceeds its fair value and the decline in value is determined to be other-than-temporary, an allowance is recorded in the amount that the carrying amount of the security exceeds its fair value and a loss is recognized in operating results for the amount of such decline. If the carrying amount of an investment in marketable securities, other than available-for-sale debt securities, exceeds its fair value and the decline in value is determined to be other-than-temporary, the carrying amount of the security is reduced to fair value and a loss is recognized in operating results for the amount of such decline. In order to determine whether a decline in value is other-than-temporary, the Company evaluates, among other factors, the cause of the impairment, including the creditworthiness of the security issuers, the number of securities in an unrealized loss position, the severity and duration of the unrealized losses, and its intent and ability to hold the security to maturity or expected recovery. Fair Value Instruments The Company records its financial assets and liabilities at fair value. Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability (an exit price) in an orderly transaction between market participants at the reporting date. The accounting guidance establishes a three-tiered hierarchy, which prioritizes the inputs used in the valuation methodologies in measuring fair value as follows: Level 1: Inputs which include quoted prices in active markets for identical assets and liabilities. Level 2: Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. Level 3: Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. The carrying values of certain assets and liabilities of the Company, such as cash and cash equivalents and accounts payable, approximate fair value due to their relatively short maturities. The carrying value of the Company’s short-term financial obligations approximates their fair value as the terms of the borrowing are consistent with current market rates and the duration to maturity is short. The carrying value of the Company's long-term financial obligations approximates fair value as interest rates approximate market rates that the Company could obtain for debt with similar terms and maturities. Concentrations of Credit Risk Financial instruments that potentially subject the Company to a concentration of credit risk consist primarily of cash, cash equivalents and marketable securities. The Company invests its excess cash in money market funds, U.S. treasuries, corporate notes and commercial paper. The Company’s investment policy limits investments to certain types of debt securities issued by the U.S. government, its agencies and institutions with investment-grade credit ratings and places restrictions on maturities and concentration by type and issuer. Other than for obligations of the U.S. government, the Company’s policy is that no single issuer in the portfolio shall exceed 10% or $1 million, whichever is greater, of the total portfolio at the time of purchase. Bank deposits are held by a single financial institution having a strong credit rating and these deposits may at times be in excess of FDIC insured limits. The Company is exposed to credit risk in the event of a default by the financial institutions holding its cash and cash equivalents to the extent recorded on the balance sheets. Property and Equipment Property and equipment are stated at cost less accumulated depreciation. Depreciation is calculated using the straight-line method over the estimated useful lives of the respective assets, which range from two seven The Company records as construction-in-progress (“CIP”) property and equipment that has not yet been placed in service for its intended use. All costs prior to a project becoming probable of being constructed are expensed as incurred. After the construction is considered probable, all directly identifiable costs related to an asset are capitalized. Interest related to construction of assets is capitalized when the financial statement effect of capitalization is material, construction of the asset has begun, and interest is being incurred. Interest capitalization ends at the earlier of the asset being substantially complete and ready for its intended use or when interest costs are no longer being incurred. When assets are retired or otherwise disposed of, the costs and accumulated depreciation are removed from the balance sheet and any resulting gain or loss is reflected in the statement of operations and comprehensive loss in the period realized. Impairment of Long-Lived Assets The Company evaluates its long-lived assets for indications of possible impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of assets is measured by a comparison of the carrying amount of the asset to the estimated undiscounted future cash flows expected to be generated by the asset. If the carrying amount of the asset exceeds its estimated future cash flows, an impairment charge is recognized for the amount by which the carrying amount of the asset exceeds the fair value of the asset. There was no impairment of long-lived assets during the years ended December 31, 2020 and December 31, 2019. Leases At the inception of an arrangement, the Company determines whether the arrangement is or contains a lease based on the unique facts and circumstances present. Operating lease liabilities and their corresponding right-of-use assets are recorded based on the present value of lease payments over the expected lease term. If the interest rate implicit in the Company's lease contracts is not readily determinable, the Company utilizes its incremental borrowing rate, which is the rate incurred to borrow on a collateralized basis over a similar term, an amount equal to the lease payments in a similar economic environment. Certain adjustments to the right-of-use asset may be required for items such as initial direct costs paid or incentives received. Finance leases are reflected as a liability at the inception of the lease based on the present value of the minimum lease payments or, if lower, the fair value of the property. Assets under finance leases are recorded in property and equipment, net on the balance sheets and depreciated in a manner similar to other property and equipment. Deferred Financing Costs Deferred financing costs represent legal, accounting and other direct costs related to the Company’s efforts to raise capital through a public or private sale of the Company’s common stock. These costs are generally deferred until the completion of the applicable offering, at which time such costs are reclassified to additional paid-in-capital as a reduction of the proceeds. In the instance where costs are incurred for a canceled or delayed offering, the deferred financing costs are recorded as expense in the period the offering is canceled or delayed beyond 90 days. The financing costs and value of any commitment shares incurred to secure an equity line of credit are recorded as deferred financing costs and amortized as interest expense over the term of the equity line of credit. Revenue On October 1, 2020, the Company adopted Accounting Standards Update No. 2014-09, Revenue from Contracts with Customers (“Topic 606”). Topic 606 supersedes the revenue recognition requirements in Topic 605 Revenue Recognition (“Topic 605”) and requires entities to recognize revenue when control of the promised goods or services is transferred to customers at an amount that reflects the consideration to which the entity expects to be entitled to in exchange for those goods or services. The Company adopted Topic 606 using the modified retrospective transition method on October 1, 2020 as the Company did not have revenue from the required adoption date of Topic 606 until October 1, 2020. For all revenue transactions, the Company evaluates its contracts with customers to determine revenue recognition using the following five-step model: 1. Identify the contract(s) with a customer; 2. Identify the performance obligations in the contract; 3. Determine the transaction price; 4. Allocate the transaction price to the identified performance obligations; and 5. Recognize revenue when (or as) the Company satisfies a performance obligation. Currently, the Company's revenue is related to feasibility studies in which the Company provides research and development services to customers to determine the feasibility of using its System in connection with the customers’ pharmaceuticals. All studies are evidenced by signed contracts delineating the terms of the services provided. Performance obligations generally consist of various phases of research and development activities and the agreements may also include provisions for exclusivity, future licensing negotiations options and most favored pricing. Such additional provisions are analyzed on an individual basis to determine whether they represent performance obligations. The transaction price is stipulated in the specific agreement and is allocated to research and development activities using the cost-plus-margin method and to any additional provisions using the residual value method. Revenue for research and development activities is typically recognized over time using a percentage of completion input method as there is open communication and transfer of understanding and know-how between the parties during the research and development activities. Revenue recognition for exclusivity agreements is recognized ratably over the duration of the exclusivity. The Company analyzes its agreements regularly to determine the need for any reserves for unexpected payment. As of December 31, 2020, the Company has not recorded any such reserves. Research and Development Expenses Research and development costs are charged to expense as incurred and consist of costs related to seeking regulatory approval of the Company's primary product candidate, Qtrypta, pre-commercialization efforts for Qtrypta, clinical trial costs and furthering its research and development efforts. Research and development costs include salaries and related employee benefits, fees paid to contract manufacturing organizations ("CMOs") that conduct manufacturing activities on behalf of the Company, costs associated with clinical trials, nonclinical research and development activities, regulatory activities, costs of active pharmaceutical ingredients and raw materials and research and development related overhead expenses. For the year ended December 31, 2020, the Company incurred research and development costs of approximately $7.2 million in connection with the Company's research and development efforts and approximately $14.4 million in the manufacturing of the Company’s System and facility set-up and technology transfer fees to its CMOs. For the year ended December 31, 2019, the Company incurred research and development costs of approximately $11.5 million in connection with the Company’s research and development efforts and approximately $13.9 million in the manufacturing of the Company’s System and facility set-up and technology transfer fees to its CMOs. Clinical Trial Costs Clinical trial costs are a component of research and development expenses. The Company expenses clinical trial activities performed by third-parties based upon actual work completed in accordance with agreements established with clinical research organizations and clinical sites. The Company accrues clinical trial expenses each reporting period. The Company determines the actual costs through discussions with internal personnel and external service providers as to the progress or stage of completion of trials or services and the agreed-upon fee to be paid for such services. Stock-Based Compensation The Company has equity incentive plans under which various types of equity-based awards including, but not limited to, non-qualified stock options and restricted stock awards, may be granted to employees, non-employee directors, and non-employee consultants. The Company’s equity incentive plans also allow incentive stock options to be awarded to employees. The Company has also awarded inducement grants to purchase common stock to new employees outside the existing equity compensation plans in accordance with Nasdaq listing rule 5635(c)(4). The Company accounts for stock-based compensation, based on the fair value of the stock-based awards on the date of grant. The fair value of employee stock option grants is estimated on the date of grant using the Black-Scholes option pricing model and is recognized as expense on a straight-line basis over the awardee’s requisite service period. Prior to 2020, the Company did not have sufficient historical stock price information to meet the expected life of the stock option grants, and therefore, it used a blended volatility rate that included its common stock trading history supplemented with the trading history from the common stock of a set of comparable publicly-traded biopharmaceutical companies. During 2020, the Company determined that a sufficient amount of historical information was available regarding the volatility of its stock price and that it was no longer necessary to utilize a blended volatility rate. Due to the lack of historical exercise data to provide a reasonable basis upon which to estimate an expected term, the Company has opted to use the simplified method, which is the use of the midpoint of the vesting term and the contractual term of the award to estimate the expected term. The Company recognizes the impact of stock option forfeitures on stock-based compensation expense in the period the award is forfeited. Stock-based compensation expense related to stock options granted to non-employees, if any, is recognized based on the fair value of the stock options as determined using the Black-Scholes option pricing model, as earned. Warrants The Company has issued freestanding warrants to purchase shares of common stock in connection with equity offerings, debt agreements and a build-to-suit arrangement. The warrants are recorded at fair value using the Black-Scholes option pricing model. Income Taxes The Company uses the liability method to account for income taxes. Under this method, deferred tax assets and liabilities are determined based on differences between the financial statement carrying amounts of existing assets and liabilities and their tax basis. Deferred tax assets and liabilities are measured using enacted tax rates applied to taxable income in the years in which those temporary differences are expected to be recovered or settled. A valuation allowance is established when necessary to reduce deferred tax assets to the amount expected to be realized. Financial statement effects of uncertain tax positions are recognized when it is more-likely-than-not, based on the technical merits of the position, that they will be sustained upon examination. Interest and penalties related to unrecognized tax benefit, if any, would be included within the provision for income tax. As of December 31, 2020 and 2019, the Company has a full valuation allowance on its net deferred tax assets. Interest Expense Interest expense includes cash and non-cash components with the non-cash components consisting of (i) interest recognized from the amortization of debt discount and issuance costs that are generally derived from cash payments or warrants issued related to financing obligations, (ii) interest recognized from the amortization of purchase option and termination fees related to financing obligations, offset by (iii) interest capitalized for assets constructed for use in operations. The capitalized amounts related to the debt issuance costs and debt discounts are generally amortized to interest expense over the term of the related debt instruments unless they are attributable to assets constructed for use in operations and are therefore capitalized as construction-in-progress until the asset is substantially complete and ready for its intended use. Net Loss Per Common Share Basic net loss per common share is calculated by dividing the net loss by the weighted-average number of common shares outstanding during the period, without consideration for potentially dilutive securities. Diluted net loss per common share is computed by dividing the net loss attributable to common stockholders by the weighted-average number of common shares and potentially dilutive securities outstanding for the period determined using the treasury-stock and if-converted methods. For purposes of the diluted net loss per share calculation, 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: December 31, 2020 December 31, 2019 (shares) Warrants to purchase common stock 5,148,108 274,524 Options to purchase common stock 2,724,537 2,260,307 RSUs 335,004 — Total 8,207,649 2,534,831 Emerging Growth Company (EGC) Status As of December 31, 2020, the Company is no longer an EGC as a result of its status as a public entity for five years. Because the aggregate worldwide market value of the voting and non-voting common equity of the Company held by non-affiliates as of June 30, 2020 was less than $700 million and the Company's revenues for the year ended December 31, 2020 were less than $100 million, the Company will continue as a smaller reporting company as designated by the SEC, and as such, it will be able to use the exemptions from certain reporting requirements available to smaller reporting companies. Recent Accounting Pronouncements Recently Adopted Accounting Pronouncements In May 2014, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2014-09, Revenue from Contracts with Customers (Topic 606). Topic 606 supersedes the revenue recognition requirements in Topic 605 Revenue Recognition (Topic 605) and requires entities to recognize revenue when control of the promised goods or services is transferred to customers at an amount that reflects the consideration to which the entity expects to be entitled to in exchange for those goods or services. The Company adopted Topic 606 using the modified retrospective transition method on October 1, 2020 as the Company did not have revenue from the required adoption date of Topic 606 until October 1, 2020. The Company adopted Topic 606 effective October 1, 2020 using the modified retrospective transition method as the Company has had no revenue since the required adoption date. In November 2018, the FASB issued ASU 2018-18 Collaborative Arrangements (Topic 808), Clarifying the Interaction between Topic 808 and Topic 606, which (1) clarifies that certain transactions between collaborative arrangement participants should be accounted for under ASC Topic 606, Revenue from Contracts with Customers (Topic 606), when the collaborative arrangement participant is a customer in the context of a unit of account, (2) adds unit-of-account guidance in Topic 808 to align with Topic 606 when an entity is assessing whether the collaborative arrangement, or a part of the arrangement, is within the scope of Topic 606, (3) precludes presenting transactions together with revenue when those transactions involve collaborative arrangement participants that are not directly related to third parties and are not customers. The Company adopted ASU 2018-18 in the third quarter of 2020. The adoption of ASU 2018-18 did not have a material impact on the Company's condensed financial statements. The FASB issued ASU 2019-05, Financial Instruments - Credit Losses, Targeted Transi |
Master Services Agreement with
Master Services Agreement with Eversana | 12 Months Ended |
Dec. 31, 2020 | |
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 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 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 December 31, 2020, 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 | 12 Months Ended |
Dec. 31, 2020 | |
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 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 $ — $ — The Company did not hold any cash equivalents and investments in marketable securities as of December 31, 2019. |
Balance Sheet Components
Balance Sheet Components | 12 Months Ended |
Dec. 31, 2020 | |
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: December 31, 2020 December 31, 2019 (in thousands) Unbilled revenue $ 124 $ — Prepaid software and subscriptions 118 61 Prepaid services 97 316 Prepaid insurance 66 49 Deferred offering costs 48 65 Other — 6 Total $ 453 $ 497 Property and Equipment The following table summarizes the Company’s property and equipment for each of the periods presented: December 31, 2020 December 31, 2019 (in thousands) Leasehold improvements $ 24,212 $ 16,932 Manufacturing equipment 14,893 12,173 Laboratory and office equipment 1,641 1,610 Computer equipment and software 172 167 Construction-in-progress 18,239 20,602 Property and equipment at cost 59,157 51,484 Less: accumulated depreciation property and equipment (28,248) (26,848) Total $ 30,909 $ 24,636 Depreciation expense was approximately $1.4 million and $0.7 million for the years ended December 31, 2020 and 2019, respectively. Construction-in-progress included $14.6 million and $12.4 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 December 31, 2020 and 2019, respectively, of which capitalized construction period interest was $2.4 million and $1.5 million as of December 31, 2020 and 2019, 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: December 31, 2020 December 31, 2019 (in thousands) Construction-in-progress obligations $ 2,993 $ 3,422 Professional service fees 175 206 Contract manufacturing 71 250 Pre-clinical and clinical studies 22 43 Accrued taxes — 27 Other 106 224 Total $ 3,367 $ 4,172 |
Leases
Leases | 12 Months Ended |
Dec. 31, 2020 | |
Leases [Abstract] | |
Leases | Leases Operating Leases The Company has a non-cancelable operating lease for office, research and development, and manufacturing facilities in Fremont, California through August 31, 2024, with an option to further extend the lease for an additional 60 months subject to certain terms and conditions. The operating lease right-of-use asset and associated lease liability do not consider the option to extend the term after August 31, 2024, as the Company is not reasonably certain of exercising the extension option. Per the terms of the agreement, the Company does not have any residual value guarantees, restrictions or covenants. In calculating the present value of the lease payments, the Company utilized its incremental borrowing rate, as the rates implicit in the lease were not readily determinable. The Company estimates its incremental borrowing rate based on qualitative factors including company specific credit offers, lease term, general economics and the interest rate environment. The Company accounts for lease and non-lease components separately. The building lease includes non-lease components (i.e. common area maintenance) which are charged and paid separately from rent based on actual costs incurred and therefore are not included in the right-of-use asset and lease liability but reflected in operating expense in the period incurred. As of December 31, 2020, the Company had operating leases for manufacturing space at two of its CMOs. The operating leases are embedded in agreements with these CMOs that include lease and non-lease components. The Company accounts for lease and non-lease components separately and determined the value of the lease and non-lease components of the agreements based upon estimates of relative standalone prices and a residual estimation approach for components that are highly variable or uncertain and where standalone prices were not readily available or estimable. These agreements have initial terms and options to extend that are dependent upon FDA approval of the Company's NDA for Qtrypta. Both agreements have cancellation clauses if the FDA does not approve the NDA for Qtrypta. As the Company does not currently have an intention to cancel the agreements prior to an FDA approval decision, the Company has recorded right-of-use assets and lease liabilities at the present value of the amount in each CMO agreement that was identified as an embedded operating lease. The lease term does not extend past the estimated date of an FDA approval decision, as it is not reasonably certain that the Company would not exercise the cancellation options in the event that Qtrypta was not approved. Pursuant to the terms of the agreements, the Company does not have any residual value guarantees, restrictions or covenants. In calculating the present value of the lease payments, the Company utilized its incremental borrowing rate, as the rates implicit in the leases were not readily determinable. The Company estimates its incremental borrowing rate based on qualitative factors including company specific credit offers, lease term, general economics and the interest rate environment. Prior to the receipt of a discipline review letter from the FDA on September 29, 2020, which indicated that an approval was unlikely, any embedded leases within these agreements were not considered long-term and were not separately disclosed as lease commitments, but included as commitments to CMOs in the commitments and contingencies footnote of the financial statements. The establishment of the embedded leases resulted in $146,000 of right-of-use assets and associated lease liabilities and was reflected as a non-cash operating activity in the statement of cash flows for the year ended December 31, 2020. The following table summarizes the components of lease costs for each of the periods presented: Year ended December 31, 2020 2019 (in thousands) Operating lease costs $ 1,706 $ 1,671 The following table summarizes cash payments for leases for each of the periods presented: Year ended December 31, 2020 2019 (in thousands) Operating cash flows from operating leases - cash paid for operating leases $ 1,877 $ 1,793 The following table summarizes the lease terms and discount rates for the Company's leases as of December 31, 2020: Operating leases Weighted-average remaining lease term (in years) 3.63 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 December 31, 2020: Operating leases (in thousands) 2021 $ 1,976 2022 2,043 2023 2,017 2024 1,371 Total undiscounted cash flows 7,407 Less: amount representing interest (1,342) Present value of lease liabilities $ 6,065 Current portion $ 1,378 Long-term portion 4,687 Total $ 6,065 |
Debt Financing
Debt Financing | 12 Months Ended |
Dec. 31, 2020 | |
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 December 31, 2020 and 2019, the Company had an aggregate commercial coating and primary packaging system CIP balance of $14.6 million and $12.4 million, respectively, that included $2.4 million and $1.5 million, respectively, 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 December 31, 2020. The following table summarizes the debt obligations as of December 31, 2020: Drawdown Date Drawdown Amount Principal Balance Purchase Option Fee Discount on Purchase Option Fee Unamortized Discounts and Issuance Costs Monthly Payment Monthly Payment (interest only period) Stated Interest Rate Amended Effective Interest Rate Maturity Date (in thousands) 09/25/2018 $ 5,000 $ 2,097 $ 600 $ (20) $ (123) $ 160 $ 20 9.43 % 24.38 % 04/01/2022 12/11/2018 2,800 1,412 336 (17) (55) 90 13 9.68 % 18.25 % 07/01/2022 06/06/2019 2,300 1,534 276 (25) (81) 74 14 9.93 % 18.08 % 01/01/2023 09/13/2019 2,300 1,714 276 (32) (105) 74 16 9.93 % 18.04 % 04/01/2023 11/27/2019 1,600 1,273 192 (26) (88) 52 12 9.93 % 18.16 % 06/01/2023 Total $ 14,000 $ 8,030 $ 1,680 $ (120) $ (452) $ 450 $ 75 The following table summarizes of the Company's build-to-suit obligation as of December 31, 2020 (in thousands) : Build-to-suit obligation principal amount $ 8,030 Build-to-suit obligation Purchase Option Fees at present value 1,560 Less: unamortized Purchase Option Fees (352) unamortized fair value of free-standing warrants (33) unamortized debt discount (63) unamortized debt issuance costs (4) Build-to-suit obligation, net of debt issuance costs and discount $ 9,138 Build-to-suit obligation, current portion 4,779 Build-to-suit obligation, long-term portion, net of debt issuance costs and discount 4,359 Build-to-suit obligation, net of debt issuance costs and discount $ 9,138 Future minimum payments on the Company’s build-to-suit obligation, including payment of principal and interest and Purchase Option Fees for each year ending December 31 were as follows: Principal Interest Purchase Option Fees Total (in thousands) 2021 $ 4,779 $ 618 $ — $ 5,397 2022 2,979 189 936 4,104 2023 272 8 744 1,024 Total $ 8,030 $ 815 $ 1,680 $ 10,525 The following table summarizes interest incurred on the Company's build-to-suit obligation for each of the periods presented: Year ended December 31, 2020 2019 (in thousands) Build-to-suit obligation, cash interest expense $ 926 $ 782 Build-to-suit obligation, effective interest expense 711 812 Less: build-to-suit obligation, interest capitalized (965) (1,170) Build-to-suit obligation interest expense $ 672 $ 424 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. 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 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 Lender has modified the Company’s first payment from November 21, 2020 to 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. |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Dec. 31, 2020 | |
Equity [Abstract] | |
Stockholders' Equity | Stockholders’ Equity Shelf Registration The Company filed the 2020 Shelf Registration Statement with the SEC, which was declared effective by the SEC on April 16, 2020. 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 December 31, 2020. Offerings Offering - September 2020 On August 31, 2020, the Company entered into an underwriting agreement with BTIG, pursuant to which the Company issued and sold 15,937,130 shares of its common stock to BTIG at a price of $1.304 per share. The offering closed on September 3, 2020. The Company received net proceeds of approximately $20.3 million after deducting expenses payable by the Company in connection with the offering. The shares were sold pursuant to the 2020 Shelf Registration Statement and the prospectus supplement dated August 31, 2020. 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 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. The aggregate net proceeds from the offering were approximately $10.2 million, after deducting the placement agent fees and other offering expenses. During the year ended December 31, 2020, Series E Warrants to purchase 7,194,004 shares of common stock were exercised at an exercise price of $0.8025 per share for aggregate proceeds of approximately $5.8 million. During the period from January 1, 2021 to March 11, 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. Public Offering - February 2020 On February 14, 2020, the Company closed 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 will expire five years from the date of issuance. The Series D Pre-Funded Warrants had an exercise price of $0.0001 per share and were fully exercised in connection with the closing of the offering. The Company granted the underwriter a 30-day option to purchase up to an additional 1,846,153 shares of common stock and/or additional Series C Warrants to purchase up to 1,846,153 shares of common stock. The underwriter fully exercised its option to purchase the shares and the Series C Warrants. The aggregate net proceeds from the offering were $8.3 million after deducting underwriting commissions and other offering expenses. During the year ended December 31, 2020, Series C Warrants to purchase 13,986,146 shares of common stock were exercised at an exercise price of $0.65 per share for aggregate proceeds of approximately $9.1 million. During the period from January 1, 2021 to March 11, 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. Registered Direct Offering - December 2019 On November 27, 2019, the Company entered into a securities purchase agreement with several institutional investors providing for the issuance and sale of an aggregate of 2,181,034 shares of common stock at a price of $1.45 per share in a registered direct offering. The aggregate net proceeds from the offering were $3.1 million after deducting offering expenses, of which $0.1 million were accrued at December 31, 2019. An affiliate of one of the Company's directors, purchased 689,655 shares in this offering at the same price as other investors. Offering - April 2019 On April 11, 2019, the Company closed an offering of 5,000,000 shares of common stock at a price to the underwriter of $3.29 per share. On May 8, 2019, the underwriter purchased an additional 750,000 shares at a price to the underwriter of $3.29 per share pursuant to the exercise of the underwriter's option to purchase additional shares. The aggregate net proceeds were approximately $18.3 million, after deducting underwriting costs and offering expenses. An affiliate of one of the Company's directors and an executive officer purchased an aggregate of 528,571 shares in this offering at the same price as other investors. At-the-Market Offering Programs At-the-Market Offering Program - 2020 On June 8, 2020, the Company entered into a sales agreement with BTIG, as sales agent, to establish the 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 year ended December 31, 2020, the Company issued and sold 13,237,026 shares of its common stock at an average price of $1.07 per share under the 2020 ATM with aggregate net proceeds of approximately $13.5 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. At-the-Market Offering Program - 2019 On August 19, 2019, the Company entered into a sales agreement with BTIG, as sales agent, to establish an at-the-market offering program ("2019 ATM"), under which the Company was permitted to offer and sell, from time to time, shares of common stock having a maximum aggregate offering price of up to $15.0 million. The Company was required to pay BTIG a commission of 3% of the gross proceeds from the sale of shares and also agreed to provide BTIG with customary indemnification rights. During the year ended December 31, 2020 the Company issued and sold 2,151,346 shares of its common stock at an average price of $1.30 per share under the 2019 ATM. The aggregate net proceeds were approximately $2.7 million after BTIG's commissions and other offering expenses. On March 4, 2020, the Company delivered notice of termination of the sales agreement to BTIG. The Company did not incur any termination penalties as a result of its termination of the sales agreement. Equity Line of Credit On October 20, 2017, the Company entered into a purchase agreement and a registration rights agreement with an accredited investor, Lincoln Park, providing for the purchase of up to $35.0 million worth of the Company’s common stock over a 30-month term that commenced on November 21, 2017 ("Equity Line of Credit"). On August 22, 2019, the Company terminated its purchase agreement with Lincoln Park. No sales of common stock were made under the agreement. On October 20, 2017, the Company issued 11,375 shares of its common stock, as initial commitment shares, to Lincoln Park with a fair value of $15.30 per share. The value of the commitment shares and professional service fees to secure the Equity Line of Credit were recorded as deferred financing costs and were amortized as interest expense over the term of the Equity Line of Credit, as there was no guarantee that additional shares would be sold under the Equity Line of Credit. The remaining unamortized deferred financing costs at the date of termination were recorded as other expense in the statement of operations for the year ended December 31, 2019. Warrants The following table summarizes the Company's issued and outstanding common stock warrants: Warrants Outstanding as of December 31, 2019 Issued Exercised Expired Warrants Outstanding as of December 31, 2020 Exercise Price Expiration Date Series E - March 2020 — 11,903,506 (7,194,004) — 4,709,502 $ 0.8025 03/06/25 Series D - February 2020 — 2,161,539 (2,161,539) — — Series C - February 2020 — 14,153,846 (13,986,146) — 167,700 $ 0.65 02/14/25 Trinity - September 2018 75,000 — — — 75,000 $ 3.5928 09/25/25 Series B - August 2016 195,906 — — — 195,906 $ 31.00 08/19/21 Hercules - June 2015 2,035 — — (2,035) — Hercules - June 2014 1,583 — — (1,583) — Total 274,524 28,218,891 (23,341,689) (3,618) 5,148,108 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. Series C, Pre-Funded D and E Warrants The Company issued Series C Warrants and Series D Pre-funded Warrants in its February 2020 Offering and Series E Warrants in its March 2020 Offering. The Series D Pre-funded Warrants were exercised in full at the close of the February 2020 Offering. The Company evaluated the Series E and Series C Warrants under ASC 480, Distinguishing Liabilities from Equity , and ASC 815, Derivatives and Hedging , and determined permanent equity treatment was appropriate for these freestanding financial instruments. The March 2020 Offering and the February 2020 Offering did not include any embedded features that would require bifurcation. Each Series E and Series C common stock warrant grants the holder the right to purchase one share of common stock, subject to proportional adjustments in the event of stock splits, combinations or similar events. The Series E and Series C Warrants do not have any dividend or liquidation preferences or participation rights. Subject to certain conditions, the warrants are exercisable on a cashless basis, and subject to certain beneficial ownership limitations, any unexercised Series E or Series C Warrants will be automatically exercised via cashless exercise on the expiration date pursuant to the terms of the respective warrant agreements. Trinity Warrants In connection with its build-to-suit arrangement, the Company issued the Trinity Warrants for a total of 75,000 shares of common stock at an exercise price of $3.5928 per share. The Trinity Warrants expire on September 25, 2025. Proceeds allocated to the Trinity Warrants based on their relative fair value approximated $0.2 million and were recorded as a discount to the initial $5.0 million drawdown under the Trinity financing arrangement and are being amortized as interest over the 36-month-term of the September 2018 drawdown. Series B Warrants On August 15, 2016, the Company entered into a Securities Purchase Agreement (“Purchase Agreement”) between the Company and certain investors, including members of the Company’s board of directors and executive management, pursuant to which the Company sold and issued shares of common stock and warrants to purchase shares of common stock for aggregate gross proceeds of $7.5 million. Costs related to the offering were $0.9 million. Pursuant to the Purchase Agreement, the Company sold 239,997 common shares at $26.40 per common share. Additionally, 480,000 warrants were sold, at a price of $2.50 per warrant. Each warrant grants the holder the right to purchase one share of the Company’s common stock. The Company granted 239,997 Series A Warrants, which expired in August 2017. The Company granted 239,997 Series B Warrants, which have a per share exercise price of $31.00 and expire in August 2021. Certain of the Company's board of director and executive officers purchased an aggregate of 13,771 shares of common stock and an aggregate of 27,542 warrants in this offering at the same price as the other investors. As of December 31, 2020, 195,906 warrants, which were issued in conjunction with the PIPE, remain outstanding. Hercules Warrants |
Stock-Based Compensation
Stock-Based Compensation | 12 Months Ended |
Dec. 31, 2020 | |
Share-based Payment Arrangement [Abstract] | |
Stock-Based Compensation | Stock-Based Compensation The 2012 Stock Incentive Plan The 2012 Stock Incentive Plan ("2012 Plan") provided for the granting of stock options and restricted stock awards to employees, directors and consultants of the Company. Options granted under the 2012 Plan were either incentive stock options or nonqualified stock options. Incentive stock options were granted only to Company employees. Nonqualified stock options were granted to Company employees, outside directors and consultants. Options and awards under the 2012 Plan were granted for periods of up to ten years. Employee options granted by the Company generally vested over four years. In connection with the Company’s initial public offering of its common stock, the Company’s Board of Directors terminated the 2012 Plan effective as of January 27, 2015 and no further awards were issued under the 2012 Plan. However, any awards outstanding under the 2012 Plan at January 27, 2015 continue to be governed by the terms of the 2012 Plan. The Amended and Restated 2014 Equity and Incentive Plan The Amended and Restated 2014 Equity and Incentive Plan ("2014 Plan") provides for the issuance of (i) cash awards and (ii) equity-based awards, denominated in shares of the Company’s common stock, including incentive stock options, non-statutory stock options, stock appreciation rights, restricted stock awards, restricted stock units, unrestricted stock awards, performance share awards and dividend equivalent rights. Incentive stock options may be granted only to Company employees. Nonqualified stock options may be granted to Company employees, outside directors and consultants. Options and awards under the 2014 Plan may be granted for periods of up to ten years. Employee options granted by the Company generally vest over four years. During the second quarter of 2020, the Company granted RSUs to its employees and members of the Board of Directors. Upon vesting, each RSU is settled into one share of the Company’s common stock. The value of an RSU award is based on the Company’s closing stock price on the date of grant. The RSUs granted to employees vest annually over four years and are subject to the employee’s continuing service to the Company. The RSUs granted to members of the Board of Directors vest fully after one year and are subject to the director's continuing service to the Company. Stock-based compensation expense is recognized straight-line over the vesting term. On January 1, 2020, the shares of common stock authorized for issuance under the 2014 Plan were increased by 822,612 shares pursuant to the automatic annual increase provisions of the 2014 Plan. As of December 31, 2020, 84,402 shares of common stock were available for issuance under the 2014 Plan. Inducement Grants The Company has granted options to purchase common stock to new employees as inducement grants outside the existing equity compensation plans in accordance with Nasdaq listing rule 5635(c)(4). Such options vest at a rate of 25% of the shares on the first anniversary of the commencement of such employee’s employment with the Company, and then one forty-eighth (1/48) of the shares monthly thereafter subject to such employee’s continued service. The following tables summarize activity under the 2014 Plan, the 2012 Plan and inducement grants issued to new employees for the years ended December 31, 2019 and 2020: Options Number Weighted- Weighted- Balance at January 1, 2019 1,309,994 $ 5.91 7.41 Options granted 1,053,950 $ 2.55 Options canceled/forfeited/expired (103,637) $ 7.14 Balance at December 31, 2019 2,260,307 $ 4.29 7.20 Options granted 923,925 $ 0.97 Options canceled/forfeited/expired (459,695) $ 3.40 Balance at December 31, 2020 2,724,537 $ 3.31 8.19 Options exercisable at December 31, 2020 1,093,712 $ 5.08 7.45 The weighted-average grant-date fair value of options granted during the years ended December 31, 2020 and 2019 was $0.77 and $2.55, respectively. The aggregate intrinsic value of outstanding options at December 31, 2020 was $8,000. The aggregate intrinsic value is calculated as the difference between the exercise price of the option and the estimated fair value of the Company’s common stock for in-the-money options at December 31, 2020. RSUs Number Weighted Average Grant Date Fair Value Balance at January 1, 2020 — Awards granted 343,442 $ 0.84 Awards canceled/forfeited/expired (8,438) $ 0.84 Balance at December 31, 2020 335,004 $ 0.84 The total fair value of options and awards that vested during the years ended December 31, 2020 and 2019 was $1.6 million and $1.3 million, respectively. Stock-Based Compensation Expense Total stock-based compensation expense recognized was as follows: Year Ended December 31, 2020 Year Ended December 31, 2019 (in thousands) Research and development $ 674 $ 742 General and administrative 909 870 Total $ 1,583 $ 1,612 At December 31, 2020, the Company had $2.8 million of total unrecognized stock-based compensation related to outstanding stock options that will be recognized over a weighted-average period of 2.55 years. The following table presents the weighted-average assumptions for the Black-Scholes option-pricing model used in determining the fair value of options granted to employees: Year Ended December 31, 2020 Year Ended December 31, 2019 Risk-free interest rate 0.37% - 0.95% 1.60% - 2.66% Expected volatility 114.58%-120.42% 106.33%-107.76% Expected term (years) 5.50 - 6.08 5.96 - 6.08 Dividend yield —% —% |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2020 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Commitments and Contingencies Equipment Purchase Commitments The Company has a remaining commitment of $4.0 million, of which $2.9 million was recorded as a current liability at December 31, 2020, with an equipment manufacturer to purchase a commercial coating and primary packaging machine for the production of its product candidate, Qtrypta. The terms of the purchase commitment are contingent upon performance of certain milestones. The Company anticipates that the obligation will be paid within the next 6 months. 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 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 New Drug Application approval of Qtrypta in the United States. 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. 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 $3.9 million, of which $0.4 million was a current liability on the balance sheet as of December 31, 2020. On July 31, 2020, the Company entered into an amendment to a Business Understanding Agreement dated September 13, 2018 with a CMO (the “Amended Agreement”). Pursuant to the Amended Agreement, this CMO agreed to provide services related to the manufacture and assembly of a component (the “Product”) of Qtrypta. Under the Amended Agreement, the parties expressed their mutual intent to enter into a commercial supply agreement (“Supply Agreement”) addressing certain of the terms set forth in the Amended Agreement. The Amended 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 December 31, 2020, 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 a 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 December 31, 2020. 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 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 Co-Lead Plaintiffs’ deadline to file a consolidated amended complaint is March 29, 2021. The Company anticipates filing a motion to dismiss. Pursuant to a stipulated court order, the Company expects to file the motion on May 13, 2021; the Co-Lead Plaintiffs are expected to file their opposition on June 14, 2021; and the Company expects to file a reply brief on July 6, 2021. The earliest date upon which the Court may hear the motion is July 20, 2021. These dates are subject to change upon court order or if the Co-Lead Plaintiffs file their consolidated amended complaint prior to the March 29, 2021 deadline. 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 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. 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. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2020 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Income Taxes The Company has incurred cumulative net operating losses ("NOLs") in the United States since inception and, consequently, has not recorded any income tax expense for the years ended December 31, 2020 and 2019 due to its net operating loss position. The reconciliation of the federal statutory income tax rate to the Company’s effective tax rate is as follows: Year Ended December 31, 2020 Year Ended December 31, 2019 Federal statutory tax rate (21.0) % (21.0) % State statutory tax rate, net of federal benefit (1.9) (7.0) Change in effective tax rate 1.0 — Research and development credits, net of uncertain tax positions (2.1) (2.6) Derecognition due to Section 382 and 383 15.2 0.9 Stock-based compensation 0.6 0.7 Permanent items (0.4) — Change in valuation allowance 8.6 29.0 Total — % — % Deferred income taxes reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. Realization of deferred tax assets is dependent upon future earnings, if any, the timing and amount of which are uncertain. Accordingly, the net deferred tax assets have been fully offset by a valuation allowance. The net valuation allowance increased by approximately $2.9 million and $10.9 million during the years ended December 31, 2020 and 2019, respectively. Significant components of the Company’s net deferred tax assets and liabilities are as follows: Year Ended December 31, 2020 Year Ended December 31, 2019 (in thousands) Net operating loss carryforwards $ 24,143 $ 20,717 Research and development credits 4,150 4,809 Depreciation and amortization 508 638 Accruals 517 558 Inventory 239 — Lease liability 1,391 1,980 Stock-based compensation 459 331 Capital loss carryforwards 23 23 Other 4 8 Total gross deferred tax assets 31,434 29,064 Valuation allowance (30,304) (27,450) 1,130 1,614 Right-of-use assets (1,130) (1,614) Net deferred tax assets $ — $ — As of December 31, 2020, the Company had federal net operating loss carryforwards of approximately $106.5 million and state net operating loss carryforwards of approximately $25.8 million. As of December 31, 2019, the Company had federal net operating loss carryforwards of approximately $76.0 million and state net operating loss carryforwards of approximately $68.2 million. If not utilized, certain federal net operating loss carryforwards incurred before January 1, 2018, will expire beginning in 2026, and state net operating loss carryforwards will expire beginning in 2028. The federal net operating losses incurred in 2018 and beyond do not expire. If the Company experiences a greater than 50 percentage point aggregate change in ownership over a 3-year period (a Section 382 ownership change), utilization of its pre-change NOL carryforwards is subject to annual limitation under Section 382 of the Internal Revenue Code (California has similar provisions). The annual limitation is determined by multiplying the value of the Company's stock at the time of such ownership change by the applicable long-term tax-exempt rate. Such limitations may result in expiration of a portion of the NOL carryforwards before utilization. As of December 31, 2020, the Company determined that ownership changes occurred on February 26, 2014, November 30, 2015, March 22, 2017, April 3, 2018, and March 4, 2020. As a result of the ownership changes, approximately $221.7 million and $248.8 million of the NOLs will expire unutilized for federal and California purposes, respectively. As of December 31, 2020, the Company has derecognized NOL related deferred tax assets in the tax effected amounts of $46.6 million and $17.4 million for federal and California purposes, respectively. The ability of the Company to use its remaining NOL carryforwards may be further limited if the Company experiences a Section 382 ownership change as a result of future changes in its stock ownership. As of December 31, 2020, the Company had federal and state research credit carry forwards of approximately $0.5 million and $6.0 million, respectively. As of December 31, 2019, the Company had federal and state research credit carry forwards of approximately $1.6 million and $5.6 million, respectively. If not utilized, the federal tax credits will begin to expire in 2040 and the state tax credits do not expire. Research and development credits are subject to IRC section 383. In the event of a change in ownership as defined by this code section, the usage of the credits may be limited. As a result of the previously mentioned ownership changes, the Company has derecognized approximately $6.9 million of gross federal research and development credit-related deferred tax assets due to the Section 383 limitation as of December 31, 2020. The Company has not derecognized any of the California research and development credit-related deferred tax assets because the credits do not expire. CARES Act and CAA On March 27, 2020 and December 27, 2020, the United States enacted the CARES Act and the Consolidated Appropriation Act ("CAA"), respectively, as a result of the Coronavirus pandemic, which acts contain, among other things, numerous income tax provisions. Some of these tax provisions are expected to be effective retroactively for years ending before the date of enactment. The Company has evaluated the current legislation and, at this time, does not anticipate that the tax provisions in the CARES Act or CCA will have a material impact on its financial statements. Uncertain Income Tax Positions The Company only recognizes tax benefits if it is more likely than not that they will be sustained upon audit by the relevant tax authority based upon their technical merits. An uncertain tax position is not recognized if it has less than a 50% likelihood of being sustained. The Company had approximately $1.3 million of unrecognized tax benefits as of December 31, 2020 and approximately $1.4 million of unrecognized tax benefits as of December 31, 2019. As the Company has a full valuation allowance on its deferred tax assets, the unrecognized tax benefits reduce the deferred tax assets and the valuation allowance in the same amount. The Company does not expect the amount of unrecognized tax benefits to materially change in the next twelve months. A reconciliation of the beginning and ending balance of the unrecognized tax benefits is as follows: Year Ended December 31, 2020 Year Ended December 31, 2019 (in thousands) Balance at the beginning of year $ 1,439 $ 1,128 Increase (decrease) related to prior year tax positions (312) 47 Increase related to current year tax positions 161 264 Balance at the end of year $ 1,288 $ 1,439 As of December 31, 2020 and 2019, the Company had not recognized any tax-related interest or penalties in its financial statements. Any interest and penalties related to unrecognized tax benefits would be included as income tax expense in the Company’s statements of operations. The Company files income tax returns in the U.S. federal jurisdiction and various state jurisdictions. The Company is not currently under audit by the Internal Revenue Service or any other similar state, local, or foreign authority. All tax years remain open to examination by major taxing jurisdictions to which the Company is subject. |
Employee Benefit Plan
Employee Benefit Plan | 12 Months Ended |
Dec. 31, 2020 | |
Postemployment Benefits [Abstract] | |
Employee Benefit Plan | Employee Benefit PlanThe Company has established a 401(k) tax-deferred savings plan (the "401(k) Plan"), which permits participants to make contributions by salary deduction pursuant to Section 401(k) of the Internal Revenue Code. The Company is responsible for administrative costs of the 401(k) Plan. The Company may, at its discretion, make matching contributions to the 401(k) Plan. No employer contributions have been made during the periods ended December 31, 2020 and 2019. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2020 | |
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"). The preparation of the accompanying financial statements in accordance with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities as of the date of the financial statements, and the reported amounts of expenses during the periods reported. Actual results could differ from those estimates. Assets and liabilities reported in the Company’s balance sheet and expenses and income reported for each of the periods presented are affected by estimates and assumptions, which are used for, but are not limited to, determining the fair value of assets and liabilities, income tax uncertainties, and measurement of stock-based compensation. Actual results could differ from such estimates or assumptions. |
Liquidity and Substantial Doubt in Going Concern | Liquidity and Substantial Doubt about Going ConcernSince inception, the Company has incurred recurring operating losses and negative cash flows from operating activitiesPresently, the Company does not have sufficient cash and cash equivalents to enable it to fund its anticipated level of operations and meet its obligations as they become due within twelve months following the date of issuance of this Annual Report on Form 10-K. The aforementioned factors raise substantial doubt about the Company’s ability to continue as a going concern for a period of one year from the issuance of these financial statements. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.The Company plans to raise additional funding through equity or debt financings, licensing or collaboration agreements, or strategic alliances with pharmaceutical partners, or any combination of the above. However, there are no assurances that additional funding will be obtained and that the Company will succeed in its future operations. The Company’s inability to obtain required funding in the near future or its inability to obtain funding on favorable terms will have a material adverse effect on its operations and strategic development plan for future growth. If the Company cannot successfully raise additional capital and implement its strategic development plan, its liquidity, financial condition and business prospects will be materially and adversely affected, and it may have to cease operations.The Company will continue to evaluate its timelines, strategic needs, and working capital requirements. There can be no assurance that if the Company attempts to raise additional capital, it will be successful in doing so on terms acceptable to the Company, or at all. Further, there can be no assurance that it will be able to gain access and/or be able to execute on securing new sources of funding, new development opportunities, successfully obtain regulatory approvals for and commercialize new products, achieve significant product revenues from its products (if approved), or achieve or sustain profitability in the future. |
Segment Reporting | Segment Reporting The Company operates in one reportable segment: the development of human pharmaceutical products. All long-lived assets are maintained in the United States. |
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. |
Marketable Securities | Marketable Securities Marketable securities generally consist of debt securities with original maturities greater than 90 days and remaining maturities of less than one year. Marketable securities with an original maturity greater than one year, if any, would be considered long-term investments. All of the Company's investments are classified as available-for-sale and carried at fair value based upon quoted market price. The change in unrealized gains and losses related to fixed maturity debt securities is reported as a separate component of comprehensive loss in the statements of operations and comprehensive loss and as a separate component of stockholders' equity on the balance sheets. Interest income includes interest, dividends, amortization and accretion of purchase premiums and discounts and realized gains and losses on sales of securities, if any. The cost of securities sold is based on the specific-identification method. The Company monitors its investment portfolio for potential impairment on a quarterly basis. If the carrying amount of an investment in available-for-sale debt securities exceeds its fair value and the decline in value is determined to be other-than-temporary, an allowance is recorded in the amount that the carrying amount of the security exceeds its fair value and a loss is recognized in operating results for the amount of such decline. If the carrying amount of an investment in marketable securities, other than available-for-sale debt securities, exceeds its fair value and the decline in value is determined to be other-than-temporary, the carrying amount of the security is reduced to fair value and a loss is recognized in operating results for the amount of such decline. In order to determine whether a decline in value is other-than-temporary, the Company evaluates, among other factors, the cause of the impairment, including the creditworthiness of the security issuers, the number of securities in an unrealized loss position, the severity and duration of the unrealized losses, and its intent and ability to hold the security to maturity or expected recovery. |
Fair Value Instruments | Fair Value Instruments The Company records its financial assets and liabilities at fair value. Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability (an exit price) in an orderly transaction between market participants at the reporting date. The accounting guidance establishes a three-tiered hierarchy, which prioritizes the inputs used in the valuation methodologies in measuring fair value as follows: Level 1: Inputs which include quoted prices in active markets for identical assets and liabilities. Level 2: Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. Level 3: Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. The carrying values of certain assets and liabilities of the Company, such as cash and cash equivalents and accounts payable, approximate fair value due to their relatively short maturities. The carrying value of the Company’s short-term financial obligations approximates their fair value as the terms of the borrowing are consistent with current market rates and the duration to maturity is short. The carrying value of the Company's long-term financial obligations approximates fair value as interest rates approximate market rates that the Company could obtain for debt with similar terms and maturities. |
Concentrations of Credit Risk | Concentrations of Credit Risk Financial instruments that potentially subject the Company to a concentration of credit risk consist primarily of cash, cash equivalents and marketable securities. The Company invests its excess cash in money market funds, U.S. treasuries, corporate notes and commercial paper. The Company’s investment policy limits investments to certain types of debt securities issued by the U.S. government, its agencies and institutions with investment-grade credit ratings and places restrictions on maturities and concentration by type and issuer. Other than for obligations of the U.S. government, the Company’s policy is that no single issuer in the portfolio shall exceed 10% or $1 million, whichever is greater, of the total portfolio at the time of purchase. Bank deposits are held by a single financial institution having a strong credit rating and these deposits may at times be in excess of FDIC insured limits. The Company is exposed to credit risk in the event of a default by the financial institutions holding its cash and cash equivalents to the extent recorded on the balance sheets. |
Property and Equipment | Property and Equipment Property and equipment are stated at cost less accumulated depreciation. Depreciation is calculated using the straight-line method over the estimated useful lives of the respective assets, which range from two seven The Company records as construction-in-progress (“CIP”) property and equipment that has not yet been placed in service for its intended use. All costs prior to a project becoming probable of being constructed are expensed as incurred. After the construction is considered probable, all directly identifiable costs related to an asset are capitalized. Interest related to construction of assets is capitalized when the financial statement effect of capitalization is material, construction of the asset has begun, and interest is being incurred. Interest capitalization ends at the earlier of the asset being substantially complete and ready for its intended use or when interest costs are no longer being incurred. When assets are retired or otherwise disposed of, the costs and accumulated depreciation are removed from the balance sheet and any resulting gain or loss is reflected in the statement of operations and comprehensive loss in the period realized. |
Impairment of Long-Lived Assets | Impairment of Long-Lived Assets The Company evaluates its long-lived assets for indications of possible impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of assets is measured by a comparison of the carrying amount of the asset to the estimated undiscounted future cash flows expected to be generated by the asset. If the carrying amount of the asset exceeds its estimated future cash flows, an impairment charge is recognized for the amount by which the carrying amount of the asset exceeds the fair value of the asset. |
Leases | Leases At the inception of an arrangement, the Company determines whether the arrangement is or contains a lease based on the unique facts and circumstances present. Operating lease liabilities and their corresponding right-of-use assets are recorded based on the present value of lease payments over the expected lease term. If the interest rate implicit in the Company's lease contracts is not readily determinable, the Company utilizes its incremental borrowing rate, which is the rate incurred to borrow on a collateralized basis over a similar term, an amount equal to the lease payments in a similar economic environment. Certain adjustments to the right-of-use asset may be required for items such as initial direct costs paid or incentives received. Finance leases are reflected as a liability at the inception of the lease based on the present value of the minimum lease payments or, if lower, the fair value of the property. Assets under finance leases are recorded in property and equipment, net on the balance sheets and depreciated in a manner similar to other property and equipment. |
Deferred Financing Costs | Deferred Financing Costs Deferred financing costs represent legal, accounting and other direct costs related to the Company’s efforts to raise capital through a public or private sale of the Company’s common stock. These costs are generally deferred until the completion of the applicable offering, at which time such costs are reclassified to additional paid-in-capital as a reduction of the proceeds. In the instance where costs are incurred for a canceled or delayed offering, the deferred financing costs are recorded as expense in the period the offering is canceled or delayed beyond 90 days. The financing costs and value of any commitment shares incurred to secure an equity line of credit are recorded as deferred financing costs and amortized as interest expense over the term of the equity line of credit. |
Revenue | Revenue On October 1, 2020, the Company adopted Accounting Standards Update No. 2014-09, Revenue from Contracts with Customers (“Topic 606”). Topic 606 supersedes the revenue recognition requirements in Topic 605 Revenue Recognition (“Topic 605”) and requires entities to recognize revenue when control of the promised goods or services is transferred to customers at an amount that reflects the consideration to which the entity expects to be entitled to in exchange for those goods or services. The Company adopted Topic 606 using the modified retrospective transition method on October 1, 2020 as the Company did not have revenue from the required adoption date of Topic 606 until October 1, 2020. For all revenue transactions, the Company evaluates its contracts with customers to determine revenue recognition using the following five-step model: 1. Identify the contract(s) with a customer; 2. Identify the performance obligations in the contract; 3. Determine the transaction price; 4. Allocate the transaction price to the identified performance obligations; and 5. Recognize revenue when (or as) the Company satisfies a performance obligation. |
Research and Development Expenses | Research and Development ExpensesResearch and development costs are charged to expense as incurred and consist of costs related to seeking regulatory approval of the Company's primary product candidate, Qtrypta, pre-commercialization efforts for Qtrypta, clinical trial costs and furthering its research and development efforts. Research and development costs include salaries and related employee benefits, fees paid to contract manufacturing organizations ("CMOs") that conduct manufacturing activities on behalf of the Company, costs associated with clinical trials, nonclinical research and development activities, regulatory activities, costs of active pharmaceutical ingredients and raw materials and research and development related overhead expenses Clinical Trial Costs Clinical trial costs are a component of research and development expenses. The Company expenses clinical trial activities performed by third-parties based upon actual work completed in accordance with agreements established with clinical research organizations and clinical sites. The Company accrues clinical trial expenses each reporting period. The Company determines the actual costs through discussions with internal personnel and external service providers as to the progress or stage of completion of trials or services and the agreed-upon fee to be paid for such services. |
Stock-Based Compensation | Stock-Based Compensation The Company has equity incentive plans under which various types of equity-based awards including, but not limited to, non-qualified stock options and restricted stock awards, may be granted to employees, non-employee directors, and non-employee consultants. The Company’s equity incentive plans also allow incentive stock options to be awarded to employees. The Company has also awarded inducement grants to purchase common stock to new employees outside the existing equity compensation plans in accordance with Nasdaq listing rule 5635(c)(4). The Company accounts for stock-based compensation, based on the fair value of the stock-based awards on the date of grant. The fair value of employee stock option grants is estimated on the date of grant using the Black-Scholes option pricing model and is recognized as expense on a straight-line basis over the awardee’s requisite service period. Prior to 2020, the Company did not have sufficient historical stock price information to meet the expected life of the stock option grants, and therefore, it used a blended volatility rate that included its common stock trading history supplemented with the trading history from the common stock of a set of comparable publicly-traded biopharmaceutical companies. During 2020, the Company determined that a sufficient amount of historical information was available regarding the volatility of its stock price and that it was no longer necessary to utilize a blended volatility rate. Due to the lack of historical exercise data to provide a reasonable basis upon which to estimate an expected term, the Company has opted to use the simplified method, which is the use of the midpoint of the vesting term and the contractual term of the award to estimate the expected term. The Company recognizes the impact of stock option forfeitures on stock-based compensation expense in the period the award is forfeited. |
Warrants | Warrants The Company has issued freestanding warrants to purchase shares of common stock in connection with equity offerings, debt agreements and a build-to-suit arrangement. The warrants are recorded at fair value using the Black-Scholes option pricing model. |
Income Taxes | Income Taxes The Company uses the liability method to account for income taxes. Under this method, deferred tax assets and liabilities are determined based on differences between the financial statement carrying amounts of existing assets and liabilities and their tax basis. Deferred tax assets and liabilities are measured using enacted tax rates applied to taxable income in the years in which those temporary differences are expected to be recovered or settled. A valuation allowance is established when necessary to reduce deferred tax assets to the amount expected to be realized. Financial statement effects of uncertain tax positions are recognized when it is more-likely-than-not, based on the technical merits of the position, that they will be sustained upon examination. Interest and penalties related to unrecognized tax benefit, if any, would be included within the provision for income tax. As of December 31, 2020 and 2019, the Company has a full valuation allowance on its net deferred tax assets. |
Interest Expense | Interest Expense Interest expense includes cash and non-cash components with the non-cash components consisting of (i) interest recognized from the amortization of debt discount and issuance costs that are generally derived from cash payments or warrants issued related to financing obligations, (ii) interest recognized from the amortization of purchase option and termination fees related to financing obligations, offset by (iii) interest capitalized for assets constructed for use in operations. |
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 May 2014, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2014-09, Revenue from Contracts with Customers (Topic 606). Topic 606 supersedes the revenue recognition requirements in Topic 605 Revenue Recognition (Topic 605) and requires entities to recognize revenue when control of the promised goods or services is transferred to customers at an amount that reflects the consideration to which the entity expects to be entitled to in exchange for those goods or services. The Company adopted Topic 606 using the modified retrospective transition method on October 1, 2020 as the Company did not have revenue from the required adoption date of Topic 606 until October 1, 2020. The Company adopted Topic 606 effective October 1, 2020 using the modified retrospective transition method as the Company has had no revenue since the required adoption date. In November 2018, the FASB issued ASU 2018-18 Collaborative Arrangements (Topic 808), Clarifying the Interaction between Topic 808 and Topic 606, which (1) clarifies that certain transactions between collaborative arrangement participants should be accounted for under ASC Topic 606, Revenue from Contracts with Customers (Topic 606), when the collaborative arrangement participant is a customer in the context of a unit of account, (2) adds unit-of-account guidance in Topic 808 to align with Topic 606 when an entity is assessing whether the collaborative arrangement, or a part of the arrangement, is within the scope of Topic 606, (3) precludes presenting transactions together with revenue when those transactions involve collaborative arrangement participants that are not directly related to third parties and are not customers. The Company adopted ASU 2018-18 in the third quarter of 2020. The adoption of ASU 2018-18 did not have a material impact on the Company's condensed financial statements. The FASB issued ASU 2019-05, Financial Instruments - Credit Losses, Targeted Transition Relief in May 2019, ASU 2019-04, Codification Improvements to Topic 326, Financial Instruments — Credit Losses , Topic 815, Derivatives and Hedging , and Topic 825, Financial Instruments in April 2019, and ASU 2018-19, Codification Improvements to Topic 326, Financial Instruments - Credit Losses in November 2018. This new guidance is intended to present credit losses on available-for-sale debt securities as an allowance rather than as a write-down. Entities are required to apply the standards' provisions as a cumulative-effect adjustment to retained earnings as of the beginning of the first reporting period in which the guidance is adopted. The Company adopted ASU 2019-05, ASU 2019-04 and ASU 2018-19 effective January 1, 2020. The adoption of this guidance did not have an impact on the Company's financial statements. In August 2018, the FASB issued ASU 2018-15, Intangible - Goodwill and Other - Internal-Use Software (Subtopic 350-40), which aligns the requirements for capitalizing implementation costs incurred in a hosting arrangement that is a service contract with the requirements for capitalizing implementation costs incurred to develop or obtain internal-use software. The Company adopted ASU 2018-15, Subtopic 350-40 effective January 1, 2020 on a prospective basis. The adoption of this guidance did not have a material impact on the Company's financial statements. In August 2018, the FASB issued ASU 2018-13, Fair Value Measurement (Topic 820). The new guidance modifies the disclosure requirements on fair value measurements. The Company adopted Topic 820 effective January 1, 2020 on a modified retrospective basis. The adoption of this guidance did not have a material impact on the Company's financial statement disclosures. Recent Accounting Pronouncements Not Yet Adopted In December 2019, the FASB issued ASU 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes. This new guidance simplifies the accounting for income taxes by removing certain exceptions to general principles, clarifying requirements and including amendments to improve consistent application of the guidance. The guidance specifically removes the exception to the incremental approach for intra period tax allocation when there is a loss from continuing operations and income or a gain from other items, such as discontinued operations or other comprehensive income. The guidance also requires an entity to recognize a franchise tax that is partially based on income as an income-based tax and to account for any other amounts incurred as a non-income based tax. The guidance is effective for the Company beginning January 1, 2021 using a prospective approach. The Company has evaluated the new guidance and does not anticipate it to have a material impact on its financial statements. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
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. December 31, 2020 December 31, 2019 (in thousands) Cash and cash equivalents $ 35,263 $ 6,316 Restricted cash 455 455 Total $ 35,718 $ 6,771 |
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: December 31, 2020 December 31, 2019 (shares) Warrants to purchase common stock 5,148,108 274,524 Options to purchase common stock 2,724,537 2,260,307 RSUs 335,004 — Total 8,207,649 2,534,831 |
Cash Equivalents and Investme_2
Cash Equivalents and Investments in Marketable Securities (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
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 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) | 12 Months Ended |
Dec. 31, 2020 | |
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: December 31, 2020 December 31, 2019 (in thousands) Unbilled revenue $ 124 $ — Prepaid software and subscriptions 118 61 Prepaid services 97 316 Prepaid insurance 66 49 Deferred offering costs 48 65 Other — 6 Total $ 453 $ 497 |
Schedule of Property and Equipment | The following table summarizes the Company’s property and equipment for each of the periods presented: December 31, 2020 December 31, 2019 (in thousands) Leasehold improvements $ 24,212 $ 16,932 Manufacturing equipment 14,893 12,173 Laboratory and office equipment 1,641 1,610 Computer equipment and software 172 167 Construction-in-progress 18,239 20,602 Property and equipment at cost 59,157 51,484 Less: accumulated depreciation property and equipment (28,248) (26,848) Total $ 30,909 $ 24,636 |
Schedule of Accrued Liabilities | The following table summarizes the Company’s other accrued liabilities for each of the periods presented: December 31, 2020 December 31, 2019 (in thousands) Construction-in-progress obligations $ 2,993 $ 3,422 Professional service fees 175 206 Contract manufacturing 71 250 Pre-clinical and clinical studies 22 43 Accrued taxes — 27 Other 106 224 Total $ 3,367 $ 4,172 |
Leases (Tables)
Leases (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Leases [Abstract] | |
Lease, Cost | The following table summarizes the components of lease costs for each of the periods presented: Year ended December 31, 2020 2019 (in thousands) Operating lease costs $ 1,706 $ 1,671 The following table summarizes cash payments for leases for each of the periods presented: Year ended December 31, 2020 2019 (in thousands) Operating cash flows from operating leases - cash paid for operating leases $ 1,877 $ 1,793 The following table summarizes the lease terms and discount rates for the Company's leases as of December 31, 2020: Operating leases Weighted-average remaining lease term (in years) 3.63 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 December 31, 2020: Operating leases (in thousands) 2021 $ 1,976 2022 2,043 2023 2,017 2024 1,371 Total undiscounted cash flows 7,407 Less: amount representing interest (1,342) Present value of lease liabilities $ 6,065 Current portion $ 1,378 Long-term portion 4,687 Total $ 6,065 |
Debt Financing (Tables)
Debt Financing (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Debt Disclosure [Abstract] | |
Schedule of Long-term Debt Instruments | The following table summarizes the debt obligations as of December 31, 2020: Drawdown Date Drawdown Amount Principal Balance Purchase Option Fee Discount on Purchase Option Fee Unamortized Discounts and Issuance Costs Monthly Payment Monthly Payment (interest only period) Stated Interest Rate Amended Effective Interest Rate Maturity Date (in thousands) 09/25/2018 $ 5,000 $ 2,097 $ 600 $ (20) $ (123) $ 160 $ 20 9.43 % 24.38 % 04/01/2022 12/11/2018 2,800 1,412 336 (17) (55) 90 13 9.68 % 18.25 % 07/01/2022 06/06/2019 2,300 1,534 276 (25) (81) 74 14 9.93 % 18.08 % 01/01/2023 09/13/2019 2,300 1,714 276 (32) (105) 74 16 9.93 % 18.04 % 04/01/2023 11/27/2019 1,600 1,273 192 (26) (88) 52 12 9.93 % 18.16 % 06/01/2023 Total $ 14,000 $ 8,030 $ 1,680 $ (120) $ (452) $ 450 $ 75 The following table summarizes of the Company's build-to-suit obligation as of December 31, 2020 (in thousands) : Build-to-suit obligation principal amount $ 8,030 Build-to-suit obligation Purchase Option Fees at present value 1,560 Less: unamortized Purchase Option Fees (352) unamortized fair value of free-standing warrants (33) unamortized debt discount (63) unamortized debt issuance costs (4) Build-to-suit obligation, net of debt issuance costs and discount $ 9,138 Build-to-suit obligation, current portion 4,779 Build-to-suit obligation, long-term portion, net of debt issuance costs and discount 4,359 Build-to-suit obligation, net of debt issuance costs and discount $ 9,138 |
Schedule of Maturities of Long-term Debt | Future minimum payments on the Company’s build-to-suit obligation, including payment of principal and interest and Purchase Option Fees for each year ending December 31 were as follows: Principal Interest Purchase Option Fees Total (in thousands) 2021 $ 4,779 $ 618 $ — $ 5,397 2022 2,979 189 936 4,104 2023 272 8 744 1,024 Total $ 8,030 $ 815 $ 1,680 $ 10,525 |
Schedule of Debt | The following table summarizes interest incurred on the Company's build-to-suit obligation for each of the periods presented: Year ended December 31, 2020 2019 (in thousands) Build-to-suit obligation, cash interest expense $ 926 $ 782 Build-to-suit obligation, effective interest expense 711 812 Less: build-to-suit obligation, interest capitalized (965) (1,170) Build-to-suit obligation interest expense $ 672 $ 424 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
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, 2019 Issued Exercised Expired Warrants Outstanding as of December 31, 2020 Exercise Price Expiration Date Series E - March 2020 — 11,903,506 (7,194,004) — 4,709,502 $ 0.8025 03/06/25 Series D - February 2020 — 2,161,539 (2,161,539) — — Series C - February 2020 — 14,153,846 (13,986,146) — 167,700 $ 0.65 02/14/25 Trinity - September 2018 75,000 — — — 75,000 $ 3.5928 09/25/25 Series B - August 2016 195,906 — — — 195,906 $ 31.00 08/19/21 Hercules - June 2015 2,035 — — (2,035) — Hercules - June 2014 1,583 — — (1,583) — Total 274,524 28,218,891 (23,341,689) (3,618) 5,148,108 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Share-based Payment Arrangement [Abstract] | |
Summary of Stock Option and Award Activity Excluding Inducement Grants | The following tables summarize activity under the 2014 Plan, the 2012 Plan and inducement grants issued to new employees for the years ended December 31, 2019 and 2020: Options Number Weighted- Weighted- Balance at January 1, 2019 1,309,994 $ 5.91 7.41 Options granted 1,053,950 $ 2.55 Options canceled/forfeited/expired (103,637) $ 7.14 Balance at December 31, 2019 2,260,307 $ 4.29 7.20 Options granted 923,925 $ 0.97 Options canceled/forfeited/expired (459,695) $ 3.40 Balance at December 31, 2020 2,724,537 $ 3.31 8.19 Options exercisable at December 31, 2020 1,093,712 $ 5.08 7.45 |
Disclosure of Share-based Compensation Arrangements by Share-based Payment Award | RSUs Number Weighted Average Grant Date Fair Value Balance at January 1, 2020 — Awards granted 343,442 $ 0.84 Awards canceled/forfeited/expired (8,438) $ 0.84 Balance at December 31, 2020 335,004 $ 0.84 |
Summary of Stock-Based Compensation Expense | Total stock-based compensation expense recognized was as follows: Year Ended December 31, 2020 Year Ended December 31, 2019 (in thousands) Research and development $ 674 $ 742 General and administrative 909 870 Total $ 1,583 $ 1,612 |
Schedule of Weighted-Average Assumptions for the Black-Scholes Option-Pricing Model Used in Determining the Fair Value of Options Granted to Employees | The following table presents the weighted-average assumptions for the Black-Scholes option-pricing model used in determining the fair value of options granted to employees: Year Ended December 31, 2020 Year Ended December 31, 2019 Risk-free interest rate 0.37% - 0.95% 1.60% - 2.66% Expected volatility 114.58%-120.42% 106.33%-107.76% Expected term (years) 5.50 - 6.08 5.96 - 6.08 Dividend yield —% —% |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Income Tax Disclosure [Abstract] | |
Reconciliation of Federal Statutory Income Tax Rate to the Company's Effective Tax Rate | The reconciliation of the federal statutory income tax rate to the Company’s effective tax rate is as follows: Year Ended December 31, 2020 Year Ended December 31, 2019 Federal statutory tax rate (21.0) % (21.0) % State statutory tax rate, net of federal benefit (1.9) (7.0) Change in effective tax rate 1.0 — Research and development credits, net of uncertain tax positions (2.1) (2.6) Derecognition due to Section 382 and 383 15.2 0.9 Stock-based compensation 0.6 0.7 Permanent items (0.4) — Change in valuation allowance 8.6 29.0 Total — % — % |
Components of Net Deferred Tax Assets and Liabilities | Significant components of the Company’s net deferred tax assets and liabilities are as follows: Year Ended December 31, 2020 Year Ended December 31, 2019 (in thousands) Net operating loss carryforwards $ 24,143 $ 20,717 Research and development credits 4,150 4,809 Depreciation and amortization 508 638 Accruals 517 558 Inventory 239 — Lease liability 1,391 1,980 Stock-based compensation 459 331 Capital loss carryforwards 23 23 Other 4 8 Total gross deferred tax assets 31,434 29,064 Valuation allowance (30,304) (27,450) 1,130 1,614 Right-of-use assets (1,130) (1,614) Net deferred tax assets $ — $ — |
Schedule of Unrecognized Tax Benefits | A reconciliation of the beginning and ending balance of the unrecognized tax benefits is as follows: Year Ended December 31, 2020 Year Ended December 31, 2019 (in thousands) Balance at the beginning of year $ 1,439 $ 1,128 Increase (decrease) related to prior year tax positions (312) 47 Increase related to current year tax positions 161 264 Balance at the end of year $ 1,288 $ 1,439 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Additional Information (Detail) | Aug. 31, 2020USD ($)$ / sharesshares | Jun. 08, 2020USD ($)$ / sharesshares | Mar. 04, 2020USD ($)$ / sharesshares | Feb. 14, 2020USD ($)$ / sharesshares | Nov. 27, 2019USD ($)$ / shares | Aug. 19, 2019USD ($)$ / sharesshares | May 08, 2019$ / sharesshares | Apr. 11, 2019$ / sharesshares | Mar. 11, 2021USD ($)$ / sharesshares | Mar. 09, 2021USD ($)$ / sharesshares | Dec. 31, 2020USD ($)segment$ / sharesshares | Dec. 31, 2019USD ($) | Apr. 16, 2020USD ($) |
Summary Of Significant Accounting Policies [Line Items] | |||||||||||||
Accumulated deficit | $ 332,190,000 | $ 298,821,000 | |||||||||||
Cash and cash equivalents | 35,263,000 | 6,316,000 | |||||||||||
Sale of stock offer maximum | 33,700,000 | $ 74,500,000 | |||||||||||
Consideration from sale of stock | $ 33,700,000 | ||||||||||||
Common stock warrants issued (in shares) | shares | 1 | ||||||||||||
Number of reportable segments | segment | 1 | ||||||||||||
Restricted cash | $ 455,000 | 455,000 | |||||||||||
Research and development | 21,622,000 | 25,385,000 | |||||||||||
Series C Warrant | |||||||||||||
Summary Of Significant Accounting Policies [Line Items] | |||||||||||||
Proceeds from warrant exercises | $ 9,091,000 | 0 | |||||||||||
Series D Pre Funded Warrant | |||||||||||||
Summary Of Significant Accounting Policies [Line Items] | |||||||||||||
Exercise price (in USD per share) | $ / shares | $ 0.0001 | ||||||||||||
Series E - March 2020 | |||||||||||||
Summary Of Significant Accounting Policies [Line Items] | |||||||||||||
Exercise price (in USD per share) | $ / shares | $ 0.8025 | ||||||||||||
Series D Preferred Stock | |||||||||||||
Summary Of Significant Accounting Policies [Line Items] | |||||||||||||
Exercise price (in USD per share) | $ / shares | $ 0.0001 | ||||||||||||
Customer Concentration Risk | Total Portfolio Investment | |||||||||||||
Summary Of Significant Accounting Policies [Line Items] | |||||||||||||
Concentration of credit risk | $ 1,000,000 | ||||||||||||
Research and Development | |||||||||||||
Summary Of Significant Accounting Policies [Line Items] | |||||||||||||
Research and development | 7,200,000 | 11,500,000 | |||||||||||
Intracutaneous Delivery System | |||||||||||||
Summary Of Significant Accounting Policies [Line Items] | |||||||||||||
Research and development | 14,400,000 | 13,900,000 | |||||||||||
Laboratory and office equipment | |||||||||||||
Summary Of Significant Accounting Policies [Line Items] | |||||||||||||
Impairment of long-lived assets | 0 | 0 | |||||||||||
Deposit Building Lease | |||||||||||||
Summary Of Significant Accounting Policies [Line Items] | |||||||||||||
Restricted cash | 300,000 | 300,000 | |||||||||||
Deposit Utility Provider | |||||||||||||
Summary Of Significant Accounting Policies [Line Items] | |||||||||||||
Restricted cash | $ 100,000 | $ 100,000 | |||||||||||
Minimum | Software, Computer and Office Equipment | |||||||||||||
Summary Of Significant Accounting Policies [Line Items] | |||||||||||||
Estimated useful lives of property and equipment | 2 years | ||||||||||||
Minimum | Furniture, Fixtures, Manufacturing and Laboratory Equipment | |||||||||||||
Summary Of Significant Accounting Policies [Line Items] | |||||||||||||
Estimated useful lives of property and equipment | 7 years | ||||||||||||
Maximum | Customer Concentration Risk | Total Portfolio Investment | |||||||||||||
Summary Of Significant Accounting Policies [Line Items] | |||||||||||||
Concentration risk percentage | 10.00% | ||||||||||||
Maximum | Software, Computer and Office Equipment | |||||||||||||
Summary Of Significant Accounting Policies [Line Items] | |||||||||||||
Estimated useful lives of property and equipment | 5 years | ||||||||||||
Maximum | Furniture, Fixtures, Manufacturing and Laboratory Equipment | |||||||||||||
Summary Of Significant Accounting Policies [Line Items] | |||||||||||||
Estimated useful lives of property and equipment | 9 years | ||||||||||||
At-The-Market Offering | |||||||||||||
Summary Of Significant Accounting Policies [Line Items] | |||||||||||||
Consideration from sale of stock | $ 13,500,000 | $ 2,700,000 | |||||||||||
Maximum aggregate offering price (up to) | $ 20,000,000 | $ 15,000,000 | |||||||||||
Commissions on proceeds from the sale of shares | 3.00% | 3.00% | |||||||||||
Shares issued in transaction (in shares) | shares | 2,151,346 | ||||||||||||
Sale of stock average price per share (in USD per share) | $ / shares | $ 1.30 | ||||||||||||
Public Stock Offering | |||||||||||||
Summary Of Significant Accounting Policies [Line Items] | |||||||||||||
Consideration from sale of stock | $ 20,300,000 | $ 8,300,000 | |||||||||||
Shares issued in transaction (in shares) | shares | 750,000 | 5,000,000 | |||||||||||
Price of stock sold (in USD per share) | $ / shares | $ 3.29 | $ 3.29 | |||||||||||
Period for additional purchase of stock | 30 days | ||||||||||||
Public Stock Offering | Series C Warrant | |||||||||||||
Summary Of Significant Accounting Policies [Line Items] | |||||||||||||
Class of warrant or right number Of securities (in shares) | shares | 13,986,146 | ||||||||||||
Public Stock Offering | Series C Warrant | Subsequent Event | |||||||||||||
Summary Of Significant Accounting Policies [Line Items] | |||||||||||||
Warrants to purchase common stock (in shares) | shares | 145,000 | ||||||||||||
Proceeds from warrant exercises | $ 100,000 | ||||||||||||
Exercise price (in USD per share) | $ / shares | $ 0.65 | ||||||||||||
Public Stock Offering | Common Class A | |||||||||||||
Summary Of Significant Accounting Policies [Line Items] | |||||||||||||
Shares issued in transaction (in shares) | shares | 10,146,154 | ||||||||||||
Price of stock sold (in USD per share) | $ / shares | $ 0.65 | ||||||||||||
Number of share of common stock Included in the issued combination (in shares) | shares | 1 | ||||||||||||
Public Stock Offering | Common Class A | Series C Warrant | |||||||||||||
Summary Of Significant Accounting Policies [Line Items] | |||||||||||||
Number of share of warrants included in the issued combination (in shares) | shares | 1 | ||||||||||||
Common stock warrants issued (in shares) | shares | 1 | ||||||||||||
Public Stock Offering | Common Class B | |||||||||||||
Summary Of Significant Accounting Policies [Line Items] | |||||||||||||
Shares issued in transaction (in shares) | shares | 2,161,539 | ||||||||||||
Price of stock sold (in USD per share) | $ / shares | $ 0.6499 | ||||||||||||
Warrants expiration term | 5 years | ||||||||||||
Public Stock Offering | Common Class B | Series C Warrant | |||||||||||||
Summary Of Significant Accounting Policies [Line Items] | |||||||||||||
Number of share of warrants included in the issued combination (in shares) | shares | 1 | ||||||||||||
Common stock warrants issued (in shares) | shares | 1 | ||||||||||||
Exercise price (in USD per share) | $ / shares | $ 0.65 | $ 0.65 | |||||||||||
Public Stock Offering | Common Class B | Series D Pre Funded Warrant | |||||||||||||
Summary Of Significant Accounting Policies [Line Items] | |||||||||||||
Number of share of common stock Included in the issued combination (in shares) | shares | 1 | ||||||||||||
Number of share of warrants included in the issued combination (in shares) | shares | 1 | ||||||||||||
Public Stock Offering | Common Class C | |||||||||||||
Summary Of Significant Accounting Policies [Line Items] | |||||||||||||
Shares issued in transaction (in shares) | shares | 1,846,153 | ||||||||||||
Registered Direct Offering | |||||||||||||
Summary Of Significant Accounting Policies [Line Items] | |||||||||||||
Consideration from sale of stock | $ 3,100,000 | ||||||||||||
Shares issued in transaction (in shares) | shares | 11,903,506 | ||||||||||||
Price of stock sold (in USD per share) | $ / shares | $ 0.9275 | ||||||||||||
Proceeds from issuance of common stock and warrants | $ 10,200,000 | ||||||||||||
Warrants expiration term | 5 years | ||||||||||||
Registered Direct Offering | Series E - March 2020 | |||||||||||||
Summary Of Significant Accounting Policies [Line Items] | |||||||||||||
Price of stock sold (in USD per share) | $ / shares | $ 0.8025 | ||||||||||||
Warrants to purchase common stock (in shares) | shares | 7,194,004 | ||||||||||||
Proceeds from warrant exercises | $ 5,800,000 | ||||||||||||
Registered Direct Offering | Series E - March 2020 | Subsequent Event | |||||||||||||
Summary Of Significant Accounting Policies [Line Items] | |||||||||||||
Price of stock sold (in USD per share) | $ / shares | $ 0.8025 | ||||||||||||
Warrants to purchase common stock (in shares) | shares | 4,078,667 | ||||||||||||
Proceeds from warrant exercises | $ 3,300,000 | ||||||||||||
Common Stock | At-The-Market Offering | |||||||||||||
Summary Of Significant Accounting Policies [Line Items] | |||||||||||||
Shares issued in transaction (in shares) | shares | 13,237,026 | ||||||||||||
Sale of stock average price per share (in USD per share) | $ / shares | $ 1.07 | ||||||||||||
Common Stock | Public Stock Offering | |||||||||||||
Summary Of Significant Accounting Policies [Line Items] | |||||||||||||
Shares issued in transaction (in shares) | shares | 15,937,130 | ||||||||||||
Price of stock sold (in USD per share) | $ / shares | $ 1.304 | ||||||||||||
Common Stock | Registered Direct Offering | |||||||||||||
Summary Of Significant Accounting Policies [Line Items] | |||||||||||||
Price of stock sold (in USD per share) | $ / shares | $ 1.45 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Reconciliation of Cash, Cash Equivalents and Restricted Cash (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 |
Accounting Policies [Abstract] | |||
Cash and cash equivalents | $ 35,263 | $ 6,316 | |
Restricted cash | 455 | 455 | |
Total | $ 35,718 | $ 6,771 | $ 9,595 |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies - Schedule of Outstanding Common Stock Equivalents Excluded from Computations of Diluted Net Loss per Common Share (Details) - shares | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
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) | 8,207,649 | 2,534,831,000 |
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) | 5,148,108 | 274,524,000 |
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) | 2,724,537 | 2,260,307,000 |
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) | 335,004 | 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 | Dec. 31, 2020 | Dec. 31, 2019 |
Debt Securities, Available-for-sale [Line Items] | ||
Money market funds classified as cash equivalents | $ 33,918 | |
Quoted prices in active market Level 1 | ||
Debt Securities, Available-for-sale [Line Items] | ||
Money market funds classified as cash equivalents | $ 33,918 | |
Significant other observable inputs Level 2 | ||
Debt Securities, Available-for-sale [Line Items] | ||
Money market funds classified as cash equivalents | $ 0 | |
Significant unobservable inputs Level 3 | ||
Debt Securities, Available-for-sale [Line Items] | ||
Money market funds classified as cash equivalents | $ 0 |
Balance Sheet Components - Prep
Balance Sheet Components - Prepaid Expenses and Other Current Assets (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Balance Sheet Related Disclosures [Abstract] | ||
Unbilled revenue | $ 124 | $ 0 |
Prepaid software and subscriptions | 118 | 61 |
Prepaid services | 97 | 316 |
Prepaid insurance | 66 | 49 |
Deferred offering costs | 48 | 65 |
Other | 0 | 6 |
Total | $ 453 | $ 497 |
Balance Sheet Components - Sche
Balance Sheet Components - Schedule of Property and Equipment (Detail) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Property, Plant and Equipment [Line Items] | ||
Property and equipment at cost | $ 59,157 | $ 51,484 |
Less: accumulated depreciation property and equipment | (28,248) | (26,848) |
Property and equipment, net | 30,909 | 24,636 |
Leasehold improvements | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment at cost | 24,212 | 16,932 |
Manufacturing equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment at cost | 14,893 | 12,173 |
Laboratory and office equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment at cost | 1,641 | 1,610 |
Computer equipment and software | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment at cost | 172 | 167 |
Construction-in-progress | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment at cost | $ 18,239 | $ 20,602 |
Balance Sheet Components - Narr
Balance Sheet Components - Narrative (Detail) - USD ($) $ in Millions | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Property, Plant and Equipment [Line Items] | ||
Depreciation and amortization expense | $ 1.4 | $ 0.7 |
Capitalized interest | 2.4 | 1.5 |
Construction In Progress Buildtosuit Lease Asset | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 14.6 | $ 12.4 |
Balance Sheet Components - Othe
Balance Sheet Components - Other Accrued Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Balance Sheet Related Disclosures [Abstract] | ||
Construction-in-progress obligations | $ 2,993 | $ 3,422 |
Professional service fees | 175 | 206 |
Contract manufacturing | 71 | 250 |
Pre-clinical and clinical studies | 22 | 43 |
Accrued taxes | 0 | 27 |
Other | 106 | 224 |
Total | $ 3,367 | $ 4,172 |
Leases - Narrative (Details)
Leases - Narrative (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Lessee, Lease, Description [Line Items] | ||
Extension period | 60 months | |
Operating lease right-of-use assets | $ 4,928 | $ 5,763 |
Embedded Lease | ||
Lessee, Lease, Description [Line Items] | ||
Operating lease right-of-use assets | $ 146 |
Leases - Description of Lease C
Leases - Description of Lease Costs (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Leases [Abstract] | ||
Operating lease costs | $ 1,706 | $ 1,671 |
Leases - Description of Cash Pa
Leases - Description of Cash Payment (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Leases [Abstract] | ||
Operating cash flows from operating leases - cash paid for operating leases | $ 1,877 | $ 1,793 |
Leases - Description of Other L
Leases - Description of Other Lease Information (Details) | Dec. 31, 2020 |
Operating leases | |
Weighted-average remaining lease term (in years) | 3 years 7 months 17 days |
Weighted average discount rate | 11.00% |
Leases - Future Minimum Lease P
Leases - Future Minimum Lease Payments (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Operating leases | ||
2021 | $ 1,976 | |
2022 | 2,043 | |
2023 | 2,017 | |
2024 | 1,371 | |
Total undiscounted cash flows | 7,407 | |
Less: amount representing interest | (1,342) | |
Current portion | 1,378 | $ 1,140 |
Long-term portion | 4,687 | $ 5,931 |
Present value of lease liabilities | $ 6,065 |
Debt Financing - Narrative (Det
Debt Financing - Narrative (Details) - USD ($) | May 27, 2020 | May 26, 2020 | Apr. 21, 2020 | Sep. 30, 2018 | Dec. 31, 2020 | Oct. 04, 2020 | Dec. 31, 2019 |
Debt Instrument [Line Items] | |||||||
Interest payment period | 6 months | ||||||
Capitalized interest costs | $ 2,400,000 | $ 1,500,000 | |||||
Common stock, shares issued (in shares) | 102,066,218 | 23,503,214 | |||||
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 Buildtosuit Lease Asset | |||||||
Debt Instrument [Line Items] | |||||||
Property and equipment, gross | $ 14,600,000 | $ 12,400,000 | |||||
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 | $ 200,000 | |||||
Build to Suit Obligation | Trinity Capital Fund III, L.P. | |||||||
Debt Instrument [Line Items] | |||||||
Aggregate principal amount | 14,000,000 | ||||||
Proceeds from Lines of Credit | 5,000,000 | ||||||
Borrowing capacity | 500,000 | ||||||
Debt instrument term | 42 months | 36 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 | $ 5,000,000 | $ 14,000,000 |
Debt Financing - Summary of Deb
Debt Financing - Summary of Debt Obligations (Details) - Build to Suit Obligation - USD ($) | 12 Months Ended | ||
Dec. 31, 2020 | May 27, 2020 | Sep. 30, 2018 | |
Debt Instrument [Line Items] | |||
Principal Balance | $ 8,030,000 | ||
Trinity Capital Fund III, L.P. | |||
Debt Instrument [Line Items] | |||
Drawdown Amount | 14,000,000 | $ 5,000,000 | $ 5,000,000 |
Principal Balance | 8,030,000 | ||
Purchase Option Fee | 1,680,000 | ||
Discount on Purchase Option Fee | (120,000) | ||
Unamortized Discounts and Issuance Costs | (452,000) | ||
Monthly Payment | 450,000 | ||
Monthly Payment (interest only period) | 75,000 | ||
Trinity Capital Fund III, L.P. | Drawdown Maturity Date Of April 012022 | |||
Debt Instrument [Line Items] | |||
Principal Balance | 2,097,000 | ||
Purchase Option Fee | 600,000 | ||
Discount on Purchase Option Fee | (20,000) | ||
Unamortized Discounts and Issuance Costs | (123,000) | ||
Monthly Payment | 160,000 | ||
Monthly Payment (interest only period) | $ 20,000 | ||
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 | 1,412,000 | ||
Purchase Option Fee | 336,000 | ||
Discount on Purchase Option Fee | (17,000) | ||
Unamortized Discounts and Issuance Costs | (55,000) | ||
Monthly Payment | 90,000 | ||
Monthly Payment (interest only period) | $ 13,000 | ||
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 | 1,534,000 | ||
Purchase Option Fee | 276,000 | ||
Discount on Purchase Option Fee | (25,000) | ||
Unamortized Discounts and Issuance Costs | (81,000) | ||
Monthly Payment | 74,000 | ||
Monthly Payment (interest only period) | $ 14,000 | ||
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 | 1,714,000 | ||
Purchase Option Fee | 276,000 | ||
Discount on Purchase Option Fee | (32,000) | ||
Unamortized Discounts and Issuance Costs | (105,000) | ||
Monthly Payment | 74,000 | ||
Monthly Payment (interest only period) | $ 16,000 | ||
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 | 1,273,000 | ||
Purchase Option Fee | 192,000 | ||
Discount on Purchase Option Fee | (26,000) | ||
Unamortized Discounts and Issuance Costs | (88,000) | ||
Monthly Payment | 52,000 | ||
Monthly Payment (interest only period) | $ 12,000 | ||
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 | Dec. 31, 2020 | Dec. 31, 2019 |
Debt Instrument [Line Items] | ||
Build-to-suit obligation, long-term portion, net of debt issuance costs and discount | $ 812 | $ 0 |
Build to Suit Obligation | ||
Debt Instrument [Line Items] | ||
Build-to-suit obligation principal amount | 8,030 | |
Build-to-suit obligation Purchase Option Fees at present value | 1,560 | |
Less: unamortized Purchase Option Fees | (352) | |
unamortized fair value of free-standing warrants | (33) | |
unamortized debt discount | (63) | |
unamortized debt issuance costs | (4) | |
Build-to-suit obligation, current portion | 4,779 | |
Build-to-suit obligation, long-term portion, net of debt issuance costs and discount | 4,359 | |
Build-to-suit obligation, net of debt issuance costs and discount | $ 9,138 |
Debt Financing - Future Minimum
Debt Financing - Future Minimum Payments on the Company's Current Debt, Including Payment of Principal and Interest (Detail) $ in Thousands | Dec. 31, 2020USD ($) |
Principal | |
2021 | $ 4,779 |
2022 | 2,979 |
2023 | 272 |
Total | 8,030 |
Interest | |
2021 | 618 |
2022 | 189 |
2023 | 8 |
Total | 815 |
Purchase Option Fees | |
2021 | 0 |
2022 | 936 |
2023 | 744 |
Total | 1,680 |
Total | |
2021 | 5,397 |
2022 | 4,104 |
2023 | 1,024 |
Total | $ 10,525 |
Debt Financing - Summary of Int
Debt Financing - Summary of Interest (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Debt Instrument [Line Items] | ||
Build-to-suit obligation interest expense | $ 719 | $ 523 |
Build to Suit Obligation | ||
Debt Instrument [Line Items] | ||
Build-to-suit obligation, cash interest expense | 926 | 782 |
Build-to-suit obligation, effective interest expense | 711 | 812 |
Less: build-to-suit obligation, interest capitalized | (965) | (1,170) |
Build-to-suit obligation interest expense | $ 672 | $ 424 |
Stockholders' Equity - Shelf Re
Stockholders' Equity - Shelf Registration, Registered Direct Offering and Public Offering (2020) (Details) - USD ($) $ / shares in Units, $ in Thousands | Aug. 31, 2020 | Mar. 04, 2020 | Feb. 14, 2020 | Nov. 27, 2019 | May 08, 2019 | Apr. 11, 2019 | Mar. 11, 2021 | Mar. 09, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | Apr. 16, 2020 |
Class of Stock [Line Items] | |||||||||||
Sale of stock offer maximum | $ 33,700 | $ 74,500 | |||||||||
Consideration from sale of stock | $ 33,700 | ||||||||||
Common stock warrants issued (in shares) | 1 | ||||||||||
Registered Direct Offering | |||||||||||
Class of Stock [Line Items] | |||||||||||
Shares issued in transaction (in shares) | 11,903,506 | ||||||||||
Price of stock sold (in USD per share) | $ 0.9275 | ||||||||||
Consideration from sale of stock | $ 3,100 | ||||||||||
Proceeds from issuance of common stock and warrants | $ 10,200 | ||||||||||
Warrants expiration term | 5 years | ||||||||||
Registered Direct Offering | Common Stock | |||||||||||
Class of Stock [Line Items] | |||||||||||
Price of stock sold (in USD per share) | $ 1.45 | ||||||||||
Public Stock Offering | |||||||||||
Class of Stock [Line Items] | |||||||||||
Shares issued in transaction (in shares) | 750,000 | 5,000,000 | |||||||||
Price of stock sold (in USD per share) | $ 3.29 | $ 3.29 | |||||||||
Consideration from sale of stock | $ 20,300 | $ 8,300 | |||||||||
Period for additional purchase of stock | 30 days | ||||||||||
Public Stock Offering | Common Stock | |||||||||||
Class of Stock [Line Items] | |||||||||||
Shares issued in transaction (in shares) | 15,937,130 | ||||||||||
Price of stock sold (in USD per share) | $ 1.304 | ||||||||||
Series E - March 2020 | |||||||||||
Class of Stock [Line Items] | |||||||||||
Exercise price (in USD per share) | $ 0.8025 | ||||||||||
Series E - March 2020 | Registered Direct Offering | |||||||||||
Class of Stock [Line Items] | |||||||||||
Price of stock sold (in USD per share) | $ 0.8025 | ||||||||||
Warrants to purchase common stock (in shares) | 7,194,004 | ||||||||||
Proceeds from warrant exercises | $ 5,800 | ||||||||||
Series E - March 2020 | Registered Direct Offering | Subsequent Event | |||||||||||
Class of Stock [Line Items] | |||||||||||
Price of stock sold (in USD per share) | $ 0.8025 | ||||||||||
Warrants to purchase common stock (in shares) | 4,078,667 | ||||||||||
Proceeds from warrant exercises | $ 3,300 | ||||||||||
Series C Warrant | |||||||||||
Class of Stock [Line Items] | |||||||||||
Proceeds from warrant exercises | $ 9,091 | $ 0 | |||||||||
Series C Warrant | Public Stock Offering | |||||||||||
Class of Stock [Line Items] | |||||||||||
Class of warrant or right number Of securities (in shares) | 13,986,146 | ||||||||||
Series C Warrant | Public Stock Offering | Subsequent Event | |||||||||||
Class of Stock [Line Items] | |||||||||||
Warrants to purchase common stock (in shares) | 145,000 | ||||||||||
Proceeds from warrant exercises | $ 100 | ||||||||||
Exercise price (in USD per share) | $ 0.65 | ||||||||||
Series D Pre Funded Warrant | |||||||||||
Class of Stock [Line Items] | |||||||||||
Exercise price (in USD per share) | $ 0.0001 | ||||||||||
Common Class A | Public Stock Offering | |||||||||||
Class of Stock [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 | ||||||||||
Common Class A | Series C Warrant | Public Stock Offering | |||||||||||
Class of Stock [Line Items] | |||||||||||
Number of share of warrants included in the issued combination (in shares) | 1 | ||||||||||
Common stock warrants issued (in shares) | 1 | ||||||||||
Common Class B | Public Stock Offering | |||||||||||
Class of Stock [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 | ||||||||||
Common Class B | Series C Warrant | Public Stock Offering | |||||||||||
Class of Stock [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 | $ 0.65 | |||||||||
Common Class B | Series D Pre Funded Warrant | Public Stock Offering | |||||||||||
Class of Stock [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 | ||||||||||
Common Class C | Public Stock Offering | |||||||||||
Class of Stock [Line Items] | |||||||||||
Shares issued in transaction (in shares) | 1,846,153 |
Stockholders' Equity - Register
Stockholders' Equity - Registered Direct Offering and Offering (2019) (Details) - USD ($) $ / shares in Units, $ in Thousands | Aug. 31, 2020 | Mar. 04, 2020 | Feb. 14, 2020 | Nov. 27, 2019 | May 08, 2019 | Apr. 11, 2019 | Dec. 31, 2020 | Dec. 31, 2019 |
Class of Stock [Line Items] | ||||||||
Consideration from sale of stock | $ 33,700 | |||||||
Registered Direct Offering | ||||||||
Class of Stock [Line Items] | ||||||||
Price of stock sold (in USD per share) | $ 0.9275 | |||||||
Consideration from sale of stock | $ 3,100 | |||||||
Offering expense, accrued | $ 100 | |||||||
Shares issued in transaction (in shares) | 11,903,506 | |||||||
Net proceeds from issuance of common stock | 10,135 | 3,162 | ||||||
Registered Direct Offering | Affiliate Of One Of Company's Directors | ||||||||
Class of Stock [Line Items] | ||||||||
Common stock shares issued (in shares) | 689,655 | |||||||
Registered Direct Offering | Common Stock | ||||||||
Class of Stock [Line Items] | ||||||||
Common stock shares issued (in shares) | 2,181,034 | |||||||
Price of stock sold (in USD per share) | $ 1.45 | |||||||
Public Stock Offering | ||||||||
Class of Stock [Line Items] | ||||||||
Price of stock sold (in USD per share) | $ 3.29 | $ 3.29 | ||||||
Consideration from sale of stock | $ 20,300 | $ 8,300 | ||||||
Shares issued in transaction (in shares) | 750,000 | 5,000,000 | ||||||
Net proceeds from issuance of common stock | $ 18,300 | $ 20,336 | $ 18,331 | |||||
Public Stock Offering | Affiliate Of One Of Company's Directors | ||||||||
Class of Stock [Line Items] | ||||||||
Shares issued in transaction (in shares) | 528,571 | |||||||
Public Stock Offering | Common Stock | ||||||||
Class of Stock [Line Items] | ||||||||
Common stock shares issued (in shares) | 15,937,130 | 5,750,000 | ||||||
Price of stock sold (in USD per share) | $ 1.304 | |||||||
Shares issued in transaction (in shares) | 15,937,130 |
Stockholders' Equity - Marketin
Stockholders' Equity - Marketing Offering (Details) - USD ($) $ / shares in Units, $ in Millions | Jun. 08, 2020 | Aug. 19, 2019 | Dec. 31, 2020 |
Class of Stock [Line Items] | |||
Consideration from sale of stock | $ 33.7 | ||
At-The-Market Offering | |||
Class of Stock [Line Items] | |||
Maximum aggregate offering price (up to) | $ 20 | $ 15 | |
Commissions on proceeds from the sale of shares | 3.00% | 3.00% | |
Shares issued in transaction (in shares) | 2,151,346 | ||
Sale of stock average price per share (in USD per share) | $ 1.30 | ||
Consideration from sale of stock | $ 13.5 | $ 2.7 | |
At-The-Market Offering | Common Stock | |||
Class of Stock [Line Items] | |||
Shares issued in transaction (in shares) | 13,237,026 | ||
Sale of stock average price per share (in USD per share) | $ 1.07 |
Stockholders' Equity - Equity L
Stockholders' Equity - Equity Line of Credit (Details) - Equity Lines of Credit - Lincoln Park Capital Fund Llc $ / shares in Units, $ in Millions | Oct. 20, 2017USD ($)$ / sharesshares |
Class of Stock [Line Items] | |
Value of shares obligated to purchase, next thirty months (up to) | $ | $ 35 |
Common stock shares issued (in shares) | shares | 11,375 |
Fair value of share (in USD per share) | $ / shares | $ 15.30 |
Stockholders' Equity - Issued a
Stockholders' Equity - Issued and Outstanding (Details) - $ / shares | 12 Months Ended | |
Dec. 31, 2020 | Jun. 30, 2015 | |
Class of Stock [Line Items] | ||
Warrants outstanding as of December 31,2019 (in shares) | 274,524 | |
Issued (in shares) | 28,218,891 | |
Exercised (in shares) | (23,341,689) | |
Expired (in shares) | (3,618) | |
Warrants outstanding as of December 31,2020 (in shares) | 5,148,108 | |
Series E - March 2020 | ||
Class of Stock [Line Items] | ||
Warrants outstanding as of December 31,2019 (in shares) | 0 | |
Issued (in shares) | 11,903,506 | |
Exercised (in shares) | (7,194,004) | |
Expired (in shares) | 0 | |
Warrants outstanding as of December 31,2020 (in shares) | 4,709,502 | |
Exercise price (in USD per share) | $ 0.8025 | |
Series D - February 2020 | ||
Class of Stock [Line Items] | ||
Warrants outstanding as of December 31,2019 (in shares) | 0 | |
Issued (in shares) | 2,161,539 | |
Exercised (in shares) | (2,161,539) | |
Expired (in shares) | 0 | |
Warrants outstanding as of December 31,2020 (in shares) | 0 | |
Series C - February 2020 | ||
Class of Stock [Line Items] | ||
Warrants outstanding as of December 31,2019 (in shares) | 0 | |
Issued (in shares) | 14,153,846 | |
Exercised (in shares) | (13,986,146) | |
Expired (in shares) | 0 | |
Warrants outstanding as of December 31,2020 (in shares) | 167,700 | |
Exercise price (in USD per share) | $ 0.65 | |
Trinity - September 2018 | ||
Class of Stock [Line Items] | ||
Warrants outstanding as of December 31,2019 (in shares) | 75,000 | |
Issued (in shares) | 0 | |
Exercised (in shares) | 0 | |
Expired (in shares) | 0 | |
Warrants outstanding as of December 31,2020 (in shares) | 75,000 | |
Exercise price (in USD per share) | $ 3.5928 | |
Series B - August 2016 | ||
Class of Stock [Line Items] | ||
Warrants outstanding as of December 31,2019 (in shares) | 195,906 | |
Issued (in shares) | 0 | |
Exercised (in shares) | 0 | |
Expired (in shares) | 0 | |
Warrants outstanding as of December 31,2020 (in shares) | 195,906 | |
Exercise price (in USD per share) | $ 31 | |
Hercules - June 2015 | ||
Class of Stock [Line Items] | ||
Warrants outstanding as of December 31,2019 (in shares) | 2,035 | |
Issued (in shares) | 0 | |
Exercised (in shares) | 0 | |
Expired (in shares) | (2,035) | |
Warrants outstanding as of December 31,2020 (in shares) | 0 | |
Exercise price (in USD per share) | $ 147.40 | |
Hercules - June 2014 | ||
Class of Stock [Line Items] | ||
Warrants outstanding as of December 31,2019 (in shares) | 1,583 | |
Issued (in shares) | 0 | |
Exercised (in shares) | 0 | |
Expired (in shares) | (1,583) | |
Warrants outstanding as of December 31,2020 (in shares) | 0 |
Stockholders' Equity - Warrants
Stockholders' Equity - Warrants (Details) - USD ($) | May 27, 2020 | May 26, 2020 | Aug. 15, 2016 | Sep. 30, 2018 | Dec. 31, 2020 | Dec. 31, 2019 | Jun. 30, 2015 | Jun. 30, 2014 |
Class of Stock [Line Items] | ||||||||
Common stock warrants issued (in shares) | 1 | |||||||
Common stock, shares issued (in shares) | 102,066,218 | 23,503,214 | ||||||
Warrants outstanding (in shares) | 5,148,108 | 274,524 | ||||||
Build to Suit Obligation | Trinity Capital Fund III, L.P. | ||||||||
Class of Stock [Line Items] | ||||||||
Common stock warrant exercise price (in USD per share) | $ 3.5928 | |||||||
Line of credit | $ 5,000,000 | $ 5,000,000 | $ 14,000,000 | |||||
Debt instrument term | 42 months | 36 months | 36 months | |||||
Warrants to purchase common stock | Trinity Capital Fund III, L.P. | ||||||||
Class of Stock [Line Items] | ||||||||
Common stock, shares issued (in shares) | 75,000 | |||||||
Proceeds from issuance of warrants | $ 243,000 | $ 200,000 | ||||||
Series B - August 2016 | ||||||||
Class of Stock [Line Items] | ||||||||
Warrants outstanding (in shares) | 195,906 | 195,906 | ||||||
Exercise price (in USD per share) | $ 31 | |||||||
Hercules - June 2014 | ||||||||
Class of Stock [Line Items] | ||||||||
Warrants outstanding (in shares) | 0 | 1,583 | ||||||
Hercules - June 2014 | Amended Hercules Secured Term Loan | ||||||||
Class of Stock [Line Items] | ||||||||
Common stock warrants issued (in shares) | 1,583 | |||||||
Exercise price (in USD per share) | $ 176.80 | |||||||
Hercules - June 2015 | ||||||||
Class of Stock [Line Items] | ||||||||
Warrants outstanding (in shares) | 0 | 2,035 | ||||||
Exercise price (in USD per share) | $ 147.40 | |||||||
Warrants to purchase common stock (in shares) | 2,035 | |||||||
Private Investment in Public Equity (PIPE) | ||||||||
Class of Stock [Line Items] | ||||||||
Common stock warrants issued (in shares) | 1 | |||||||
Proceeds from issuance of common stock and warrants | $ 7,500,000 | |||||||
Costs related to offering | $ 900,000 | |||||||
Common stock shares issued (in shares) | 239,997 | |||||||
Offering price (in USD per share) | $ 26.40 | |||||||
Warrants outstanding (in shares) | 480,000 | 195,906 | ||||||
Warrant issuance price (in USD per share) | $ 2.50 | |||||||
Private Investment in Public Equity (PIPE) | Directors and Executive Officers | ||||||||
Class of Stock [Line Items] | ||||||||
Common stock shares issued (in shares) | 13,771 | |||||||
Warrants outstanding (in shares) | 27,542 | |||||||
Private Investment in Public Equity (PIPE) | Series A | Warrants to purchase common stock | ||||||||
Class of Stock [Line Items] | ||||||||
Warrants outstanding (in shares) | 239,997 | |||||||
Private Investment in Public Equity (PIPE) | Series B - August 2016 | Warrants to purchase common stock | ||||||||
Class of Stock [Line Items] | ||||||||
Warrants outstanding (in shares) | 239,997 | |||||||
Exercise price (in USD per share) | $ 31 |
Stock-Based Compensation - Narr
Stock-Based Compensation - Narrative (Detail) - USD ($) $ / shares in Units, $ in Thousands | Jan. 01, 2020 | Jun. 30, 2020 | Dec. 31, 2020 | Dec. 31, 2019 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Additional shares reserved (in shares) | 822,612 | |||
Common stock (in shares) | 84,402 | |||
Weighted-average grant-date fair value of options and awards (in USD per share) | $ 0.77 | $ 2.55 | ||
Aggregate intrinsic value | $ 8 | |||
Total fair value of options and awards that vested | 1,600 | $ 1,300 | ||
Unrecognized stock-based compensation expense | $ 2,800 | |||
Weighted-average period of unrecognized stock-based compensation expense | 2 years 6 months 18 days | |||
New Employee | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Vesting percentage | 25.00% | |||
Vesting percentage, thereafter | 2.00% | |||
2012 Stock Incentive Plan | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Options vested period | 4 years | |||
Options or awards issued under the Plan (in shares) | 0 | |||
2012 Stock Incentive Plan | Maximum | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Options grant period | 10 years | |||
2014 Equity and Incentive Plan | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Options vested period | 4 years | |||
2014 Equity and Incentive Plan | Maximum | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Options grant period | 10 years | |||
2014 Equity and Incentive Plan | Employees | RSUs | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Options vested period | 4 years | |||
2014 Equity and Incentive Plan | Non Employee Director | RSUs | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Options vested period | 1 year | |||
2014 Equity and Incentive Plan | Employees and Board of Directors | RSUs | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Shares settled upon vesting | 1 |
Stock-Based Compensation - Summ
Stock-Based Compensation - Summary of Stock Option and Award Activity Excluding Inducement Grants (Detail) - $ / shares | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Number of Options | |||
Beginning balance (in shares) | 2,260,307 | 1,309,994 | |
Options granted (in shares) | 923,925 | 1,053,950 | |
Options canceled/forfeited/expired (in shares) | (459,695) | (103,637) | |
Ending balance (in shares) | 2,724,537 | 2,260,307 | 1,309,994 |
Options exercisable (in shares) | 1,093,712 | ||
Weighted- Average Exercise Price per Share | |||
Beginning balance (in USD per share) | $ 4.29 | $ 5.91 | |
Options granted (in USD per share) | 0.97 | 2.55 | |
Options cancelled/forfeited/expired (in USD per share) | 3.40 | 7.14 | |
Ending balance (in USD per share) | 3.31 | $ 4.29 | $ 5.91 |
Options exercisable (in USD per share) | $ 5.08 | ||
Weighted- Average Remaining Contractual Term (In Years) | |||
Average remaining contractual term | 8 years 2 months 8 days | 7 years 2 months 12 days | 7 years 4 months 28 days |
Exercisable remaining contractual term | 7 years 5 months 12 days |
Stock-Based Compensation - Su_2
Stock-Based Compensation - Summary of Restricted Stock Units (Details) - RSUs | 12 Months Ended |
Dec. 31, 2020$ / sharesshares | |
Number of Awards | |
Beginning balance (in shares) | shares | 0 |
Awards granted (in shares) | shares | 343,442 |
Awards canceled (in shares) | shares | (8,438) |
Ending balance (in shares) | shares | 335,004 |
Weighted Average Grant Date Fair Value | |
Beginning balance (in USD per share) | $ / shares | |
Awards granted (in USD per share) | $ / shares | 840 |
Awards canceled (in USD per share) | $ / shares | 840 |
Ending balance (in USD per share) | $ / shares | $ 840 |
Stock-Based Compensation - Su_3
Stock-Based Compensation - Summary of Stock-Based Compensation Expense (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Total stock-based compensation expense | $ 1,583 | $ 1,612 |
Research and development | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Total stock-based compensation expense | 674 | 742 |
General and administrative | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Total stock-based compensation expense | $ 909 | $ 870 |
Stock-Based Compensation - Sche
Stock-Based Compensation - Schedule of Weighted-Average Assumptions for the Black-Scholes Option-Pricing Model Used in Determining the Fair Value of Options Granted to Employees (Detail) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Risk-free interest rate, minimum | 0.37% | 1.60% |
Risk-free interest rate, maximum | 0.95% | 2.66% |
Expected volatility, minimum | 114.58% | 106.33% |
Expected volatility, maximum | 120.42% | 107.76% |
Dividend yield | 0.00% | 0.00% |
Minimum | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected term (years) | 5 years 6 months | 5 years 11 months 15 days |
Maximum | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected term (years) | 6 years 29 days | 6 years 29 days |
Commitments and Contingencies (
Commitments and Contingencies (Detail) | Nov. 06, 2020lawsuit | Dec. 31, 2020USD ($) |
Other Commitments [Line Items] | ||
Long-term purchase commitment, period | 6 months | |
Cancellation fees | 50.00% | |
Inactivity fee | $ 85,000 | |
Guarantees agreements | 0 | |
Number of class action | lawsuit | 2 | |
Commercial Coating and Primary Packaging System | ||
Other Commitments [Line Items] | ||
Purchase price | 4,000,000 | |
Commitments payable | 2,900,000 | |
Manufacturing Space and Technology | ||
Other Commitments [Line Items] | ||
Purchase price | 3,900,000 | |
Commitments payable | 400,000 | |
Purchase commitment fee | 2,500,000 | |
Additional payment | 4,600,000 | |
Fees Period One | ||
Other Commitments [Line Items] | ||
Annual fees | 2,800,000 | |
Fees Period Two | ||
Other Commitments [Line Items] | ||
Annual fees | $ 14,000,000 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Detail) - USD ($) | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Income Tax Examination [Line Items] | |||
Income tax expense | $ 0 | $ 0 | |
Increase (decrease) in net valuation allowance | 2,900,000 | 10,900,000 | |
Unrecognized tax benefits | 1,288,000 | 1,439,000 | $ 1,128,000 |
Unrecognized tax-related penalties or interest | $ 0 | 0 | |
Minimum | |||
Income Tax Examination [Line Items] | |||
Percentage of change In ownership for operating loss carryforward | 50.00% | ||
Period for change in ownership percentage | 3 years | ||
Federal | |||
Income Tax Examination [Line Items] | |||
Net operating loss carryforwards | $ 106,500,000 | 76,000,000 | |
Net operating loss carryforwards, valuation allowance | 221,700,000 | ||
Deferred tax assets, net operating loss carryforwards derecognized amount | 46,600,000 | ||
Deferred tax assets, tax credit research and development derecognized amount | 6,900,000 | ||
Federal | Research and Development Credit Carry Forwards | |||
Income Tax Examination [Line Items] | |||
Research and development credit carryforwards | 500,000 | 1,600,000 | |
California | |||
Income Tax Examination [Line Items] | |||
Net operating loss carryforwards, valuation allowance | 248,800,000 | ||
Deferred tax assets, net operating loss carryforwards derecognized amount | 17,400,000 | ||
State | |||
Income Tax Examination [Line Items] | |||
Net operating loss carryforwards | 25,800,000 | 68,200,000 | |
State | Research and Development Credit Carry Forwards | |||
Income Tax Examination [Line Items] | |||
Research and development credit carryforwards | $ 6,000,000 | $ 5,600,000 |
Income Taxes - Reconciliation o
Income Taxes - Reconciliation of Federal Statutory Income Tax Rate to the Company's Effective Tax Rate (Detail) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Income Tax Disclosure [Abstract] | ||
Federal statutory tax rate | (21.00%) | (21.00%) |
State statutory tax rate, net of federal benefit | (1.90%) | (7.00%) |
Change in effective tax rate | 1.00% | 0.00% |
Research and development credits, net of uncertain tax positions | (2.10%) | (2.60%) |
Derecognition due to Section 382 and 383 | 15.20% | 0.90% |
Stock-based compensation | 0.60% | 0.70% |
Permanent items | (0.40%) | 0.00% |
Change in valuation allowance | 8.60% | 29.00% |
Total | 0.00% | 0.00% |
Income Taxes - Components of Ne
Income Taxes - Components of Net Deferred Tax Assets and Liabilities (Detail) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Income Tax Disclosure [Abstract] | ||
Net operating loss carryforwards | $ 24,143 | $ 20,717 |
Research and development credits | 4,150 | 4,809 |
Depreciation and amortization | 508 | 638 |
Accruals | 517 | 558 |
Inventory | 239 | 0 |
Lease liability | 1,391 | 1,980 |
Stock-based compensation | 459 | 331 |
Capital loss carryforwards | 23 | 23 |
Other | 4 | 8 |
Total gross deferred tax assets | 31,434 | 29,064 |
Valuation allowance | (30,304) | (27,450) |
Net deferred tax assets | 1,130 | 1,614 |
Right-of-use assets | (1,130) | (1,614) |
Net deferred tax assets | $ 0 | $ 0 |
Income Taxes - Schedule of Unre
Income Taxes - Schedule of Unrecognized Tax Benefits (Detail) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended |
Dec. 31, 2019 | Dec. 31, 2020 | |
Reconciliation of Unrecognized Tax Benefits, Excluding Amounts Pertaining to Examined Tax Returns [Roll Forward] | ||
Balance at the beginning of year | $ 1,439 | |
Increase (decrease) related to prior year tax positions | $ 47 | (312) |
Increase related to current year tax positions | 264 | 161 |
Balance at the end of year | $ 1,439 | $ 1,288 |
Employee Benefit Plan (Detail)
Employee Benefit Plan (Detail) - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
401 (k) Plan | ||
Defined Benefit Plan Disclosure [Line Items] | ||
Employer contribution | $ 0 | $ 0 |