Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2023 | May 01, 2023 | |
Cover [Abstract] | ||
Entity Registrant Name | SCYNEXIS, Inc. | |
Trading Symbol | SCYX | |
Entity Central Index Key | 0001178253 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Document Type | 10-Q | |
Document Period End Date | Mar. 31, 2023 | |
Document Fiscal Year Focus | 2023 | |
Document Fiscal Period Focus | Q1 | |
Amendment Flag | false | |
Entity Common Stock, Shares Outstanding | 36,517,442 | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Shell Company | false | |
Entity File Number | 001-36365 | |
Entity Tax Identification Number | 56-2181648 | |
Entity Incorporation, State or Country Code | DE | |
Entity Address, Address Line One | 1 Evertrust Plaza | |
Entity Address, Address Line Two | 13th Floor | |
Entity Address, City or Town | Jersey City | |
Entity Address, State or Province | NJ | |
Entity Address, Postal Zip Code | 07302-6548 | |
City Area Code | 201 | |
Local Phone Number | 884-5485 | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Title of Each Class | Common Stock, par value $0.001 per share | |
Name of Each Exchange on Which Registered | NASDAQ |
Unaudited Condensed Consolidate
Unaudited Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 26,913 | $ 45,814 |
Short-term investments | 27,908 | 27,689 |
Prepaid expenses and other current assets | 1,726 | 2,503 |
Accounts receivable, net | 2,060 | 2,101 |
Inventory, net | 1,105 | 899 |
Restricted cash | 55 | 55 |
Total current assets | 59,767 | 79,061 |
Other assets | 7,444 | 5,511 |
Deferred offering costs | 73 | 73 |
Restricted cash | 163 | 163 |
Intangible assets, net | 309 | 408 |
Operating lease right-of-use asset (See Note 8) | 2,540 | 2,594 |
Total assets | 70,296 | 87,810 |
Current liabilities: | ||
Accounts payable | 5,925 | 5,937 |
Accrued expenses | 4,775 | 5,628 |
Other liabilities, current portion (See Note 7) | 0 | 5,771 |
Operating lease liability, current portion (See Note 8) | 296 | 282 |
Loan payable, current portion | 34,648 | 0 |
Total current liabilities | 45,644 | 17,618 |
Warrant liabilities | 40,317 | 18,644 |
Convertible debt and derivative liability (See Note 7) | 11,407 | 11,001 |
Loan payable | 0 | 34,393 |
Operating lease liability (See Note 7) | 2,842 | 2,921 |
Total liabilities | 100,210 | 84,577 |
Commitments and contingencies | ||
Stockholders’ equity: | ||
Preferred stock, $0.001 par value, authorized 5,000,000 shares as of March 31, 2023 and December 31, 2022; 0 shares issued and outstanding as of March 31, 2023 and December 31, 2022 | 0 | 0 |
Common stock, $0.001 par value, 150,000,000 shares authorized as of March 31, 2023 and December 31, 2022; 33,327,627 and 32,682,342 shares issued and outstanding as of March 31, 2023 and December 31, 2022, respectively | 36 | 36 |
Additional paid-in capital | 426,214 | 425,485 |
Accumulated deficit | (456,164) | (422,288) |
Total stockholders' (deficit) equity | (29,914) | 3,233 |
Total liabilities and stockholders’ equity | $ 70,296 | $ 87,810 |
Unaudited Condensed Consolida_2
Unaudited Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Mar. 31, 2023 | Dec. 31, 2022 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
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 dollars per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized (in shares) | 150,000,000 | 150,000,000 |
Common stock, shares issued (in shares) | 33,327,627 | 32,682,342 |
Common stock, shares outstanding (in shares) | 33,327,627 | 32,682,342 |
Unaudited Condensed Consolida_3
Unaudited Condensed Consolidated Statements of Operations - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Revenue: | ||
Product revenue, net | $ 1,130 | $ 687 |
Revenue, Product and Service [Extensible Enumeration] | Product [Member] | Product [Member] |
Operating expenses: | ||
Cost of product revenues | $ 137 | $ 99 |
Research and development | 6,835 | 5,735 |
Selling, general and administrative | 4,840 | 14,591 |
Total operating expenses | 11,812 | 20,425 |
Loss from operations | (10,682) | (19,738) |
Other expense (income): | ||
Amortization of debt issuance costs and discount | 255 | 390 |
Interest income | (587) | (13) |
Interest expense | 1,447 | 1,059 |
Other income | 0 | (13) |
Warrant liabilities fair value adjustment | 21,673 | (10,030) |
Derivative liabilities fair value adjustment | 406 | (980) |
Total other expense (income) | 23,194 | (9,587) |
Loss before taxes | (33,876) | (10,151) |
Income tax benefit | 0 | (4,700) |
Net loss | $ (33,876) | $ (5,451) |
Net loss per share attributable to common stockholders - basic | ||
Net loss per share - basic | $ (0.71) | $ (0.17) |
Net loss per share attributable to common stockholders – diluted | ||
Net loss per share – diluted | $ (0.71) | $ (0.18) |
Weighted average common shares outstanding – basic and diluted | ||
Basic | 47,757,246 | 32,051,228 |
Diluted | 47,757,246 | 33,189,428 |
Unaudited Condensed Consolida_4
Unaudited Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Cash flows from operating activities: | ||
Net loss | $ (33,876) | $ (5,451) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 151 | 155 |
Stock-based compensation expense | 707 | 922 |
Accretion of short-term investment discount | (219) | 0 |
Amortization of debt issuance costs and discount | 255 | 390 |
Change in fair value of warrant liabilities | 21,673 | (10,030) |
Change in fair value of derivative liabilities | 406 | (980) |
Noncash operating lease expense for right-of-use asset | 54 | 52 |
Write off of deferred asset for commitment fees | 514 | 0 |
Changes in operating assets and liabilities: | ||
Prepaid expenses, accounts receivable, inventory, and other | (1,887) | (1,429) |
Accounts payable, accrued expenses, other liabilities, and other | (6,701) | 383 |
Net cash used in operating activities | (18,923) | (15,988) |
Cash flows from investing activities: | ||
Purchase of intangible assets | 0 | (9) |
Net cash used in investing activities | 0 | (9) |
Cash flows from financing activities: | ||
Proceeds from common stock issued | 0 | 2,164 |
Payments of offering costs and underwriting discounts and commissions | 0 | (451) |
Proceeds from loan payable | 0 | 5,000 |
Proceeds from employee stock purchase plan issuances | 4 | 10 |
Repurchase of shares to satisfy tax withholdings | 18 | 0 |
Net cash provided by financing activities | 22 | 6,723 |
Net decrease in cash, cash equivalents, and restricted cash | (18,901) | (9,274) |
Cash, cash equivalents, and restricted cash at beginning of period | 46,032 | 104,702 |
Cash, cash equivalents, and restricted cash at end of period | 27,131 | 95,428 |
Supplemental cash flow information: | ||
Cash paid for interest | 1,658 | 1,099 |
Cash received for interest | 373 | 12 |
Noncash financing and investing activities: | ||
Deferred offering and issuance costs included in accounts payable and accrued expenses | 0 | 26 |
Deferred offering costs reclassified to additional paid-in capital | 0 | 27 |
Reclass of warrant liability to additional paid-in capital | 0 | 71 |
Reclass of deferred asset associated with issuance of loan payable to debt discount | $ 0 | $ 206 |
Description of Business and Bas
Description of Business and Basis of Preparation | 3 Months Ended |
Mar. 31, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Description of Business and Basis of Preparation | 1. Description of Business and Basis of Preparation Organization SCYNEXIS, Inc. (“SCYNEXIS” or the “Company”) is a Delaware corporation formed on November 4, 1999. SCYNEXIS is a biotechnology company, headquartered in Jersey City, New Jersey, and is pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections. The Company is developing its lead product candidate, ibrexafungerp, as a broad-spectrum, intravenous (“IV”)/oral agent for severe, hospital-based indications. In June 2021, the U.S. Food and Drug Administration (“FDA”) approved BREXAFEMME® (ibrexafungerp tablets) for treatment of patients with vulvovaginal candidiasis (“VVC”), also known as vaginal yeast infection. In December 2022, the Company announced that the FDA approved a second indication for BREXAFEMME for the reduction in the incidence of recurrent vulvovaginal candidiasis ("RVVC"). In March 2023, the Company entered into a license agreement (the "License Agreement") with GlaxoSmithKline Intellectual Property (No. 3) Limited ("GSK"), subject to customary closing conditions, in which the Company granted GSK an exclusive (even as to the Company and its affiliates), royalty-bearing, sublicensable license for the development and commercialization of ibrexafungerp, including the approved product BREXAFEMME, for all indications, in all countries other than Greater China and certain other countries already licensed to third parties (See Note 12). The parties expect the transactions contemplated by the License Agreement to close in the second quarter of 2023. The Company is party to a Loan and Security Agreement, dated May 13, 2021, with Hercules Capital, Inc. ("Hercules Capital") and Silicon Valley Bridge Bank, N.A. (now a division of First Citizens Bank, “SVB”) (the "Loan Agreement"), pursuant to which Hercules Capital, SVB and each of the other lenders from time-to-time party to the Loan Agreement (collectively, the “Lenders”) loaned to the Company $ 35.0 million as of March 31, 2023. In connection with the entering into of the License Agreement, the Company entered into a First Amendment and Consent to Loan and Security Agreement with the Lenders pursuant to the Lenders consented to the Company entering into the License Agreement and the Company agreed to pay to the Lenders an amount equal to the sum of (i) all outstanding principal plus all accrued and unpaid interest with respect to the amounts loaned under the Loan Agreement, (ii) the prepayment fee payable under the Loan Agreement (approximately $ 0.3 million), (iii) the final payment payable under the Loan Agreement (approximately $ 1.4 million), and (iv) all other sums, if any, that shall have become due and payable with respect to loan advances under the Loan Agreement. These payments by the Company will become due upon the earliest of (A) one business day following receipt by the Company of the $ 90 million upfront payment payable to the Company under the License Agreement, (B) June 1, 2023, or (C) the termination of the License Agreement. The unaudited condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiary. Intercompany balances and transactions are eliminated in consolidation. Liquidity and Going Concern The Company has funded its operations primarily through a combination of net proceeds from equity offerings, debt financings, and other non-dilutive third-party funding (e.g., grants), strategic alliances and licensing arrangements. To date, the Company has generated minimal revenue from product sales. The Company does not know if or when the Company will be able to generate significant revenue from product sales. In addition, the Company expects to incur expenses in connection with the Company's ongoing development activities, particularly as the Company continues the research, development and clinical trials of, and seek regulatory approval for, its product candidates. The Company anticipates that it will need substantial additional funding in connection with its continuing future operations. As of the date the accompanying unaudited condensed consolidated financial statements were issued (the “issuance date”), management evaluated the significance of the following negative financial conditions in accordance with ASC 205-40, Going Concern : • The Company has incurred recurring losses since its inception, including net losses of $ 33.9 million for the three months ended March 31, 2023, and $ 62.8 million for the year ended December 31, 2022. In addition, as of March 31, 2023, the Company had an accumulated deficit of $ 456.2 million . The Company expects to continue to generate operating losses for the foreseeable future. • As of March 31, 2023, the Company had approximately $ 54.8 million of unrestricted cash, cash equivalents and short-term investments available to fund the Company’s operations. • The Company expects to incur substantial expenditures to fund its operations and ongoing development activities for the foreseeable future. In order to fund its operations and ongoing development activities, the Company will need to secure additional sources of outside capital. As noted above and as further disclosed in Note 12, the Company entered into a License Agreement with GSK in March 2023, in which the Company granted GSK with an exclusive license for the development and commercialization of ibrexafungerp, including the approved product BREXAFEMME. The closing of the License Agreement is subject to the satisfaction of customary closing conditions, including the expiration or termination of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, and therefore the related cash flows, including the upfront payment of $ 90.0 million, were not included in the Company’s ASC 205-40 analysis as of the issuance date. Management expects the License Agreement to close during the second quarter of 2023. • In the event the License Agreement does not close, the Company may be unable to meet its obligations as they become due over the next twelve months beyond the issuance date. In that regard, management will be required to seek other strategic alternatives, which may include, raising additional capital through equity offerings, including utilizing our existing facility, debt financings, or other non-dilutive third-party funding. While the Company has a history of successfully raising capital in this manner, management can provide no assurance that additional capital will be secured or on terms that are acceptable to the Company. In the event the Company is unable to secure additional capital, management will be required to seek other strategic alternatives, which may include, among others, delaying expenditures, reducing the scope of its research and development programs, significant changes to its operating plan, a sale of certain of the Company’s assets, a sale of the entire Company to strategic or financial investors, and/or allowing the Company to become insolvent by filing for bankruptcy. • As disclosed in Note 7, the Company is required to maintain compliance with certain covenants prescribed by the Term Loan. The first covenant pertains to a minimum cash requirement whereby the Company must maintain a minimum amount of unrestricted and unencumbered cash in accounts with the lenders at all times that represents at least 50 % of the outstanding principal on the Term Loan (the “minimum cash”). In the event the minimum cash is not maintained, the second covenant requires the Company to maintain compliance with a trailing three-month net product revenue threshold (the “revenue covenant”). As of March 31, 2023 and through the issuance date, the Company met the minimum cash requirement. However, management can provide no assurance that the minimum cash will be maintained for at least twelve months beyond the issuance date. If the Company does not meet the minimum cash requirement and, as such, must maintain compliance with the revenue covenant, management does not expect the Company will be able to comply with the revenue covenant for any period over the next twelve months beyond the issuance date. If the Company is required to comply with, but does not maintain compliance with, the revenue covenant, management may seek a waiver from the lender or refinance the outstanding borrowings under the Term Loan with another lender. However, management can provide no assurance a waiver will be granted by the lender or on terms that are acceptable to the Company. Similarly, management can provide no assurance that the Company will be able to refinance the amounts outstanding on the Term Loan or obtain a new loan on terms that are acceptable to the Company. In the event a waiver is not granted, or the Term Loan is not refinanced, the lender may exercise any and all of its rights and remedies provided for under the borrowing agreement which may include, among others, entering into a forbearance agreement, demanding payment, and/or seizing the underlying assets secured by the Term Loan. • Further, as noted above, the Company entered into an amendment to the Loan Agreement in March 2023, which amends the original terms of the Loan Agreement to require that the outstanding principal and accrued and unpaid interest amounts, the prepayment fee and the final payment will become due and payable at the earliest of (A) one business day following receipt by the Company of the upfront payment payable to the Company under the License Agreement, (B) June 1, 2023, or (C) the termination of the License Agreement. While management expects that the License Agreement will close during the second quarter of 2023, if the License Agreement were unable to close or were to close at a later date than originally expected, the amendment to the Loan agreement would require the Company to repay the amounts due under the Loan Agreement potentially prior to the close of the License Agreement. These uncertainties raise substantial doubt about the Company’s ability to continue as a going concern. The accompanying unaudited condensed consolidated financial statements have been prepared on the basis that the Company will continue to operate as a going concern, which contemplates that the Company will be able to realize assets and settle liabilities and commitments in the normal course of business for twelve months following the issuance date. Accordingly, the accompanying unaudited condensed consolidated financial statements do not include any adjustments that may result from the outcome of these uncertainties. Use of Estimates The preparation of the unaudited condensed consolidated financial statements in conformity with U.S. GAAP requires the Company to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities as of the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. Significant estimates and judgments include: revenue recognition including gross to net estimates and the identification of performance obligations in licensing arrangements; determination of the fair value of stock-based compensation grants; the estimate of services and effort expended by third-party research and development service providers used to recognize research and development expense; and the estimates and assumptions utilized in measuring the fair values of the warrant and derivative liabilities each reporting period. Unaudited Condensed Consolidated Financial Information The accompanying unaudited condensed consolidated financial statements and notes have been prepared in accordance with accounting principles generally accepted in the United States (“US GAAP”), as contained in the Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (the “Codification” or “ASC”) for interim financial information. In the opinion of management, the interim financial information includes all adjustments of a normal recurring nature necessary for a fair presentation of the results of operations, financial position, and cash flows. The results of operations for the three months ended March 31, 2023, are not necessarily indicative of the results for the full year or the results for any future periods. These unaudited condensed consolidated financial statements should be read in conjunction with the financial statements and notes set forth in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (“SEC”) on March 31, 2023. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2023 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies The accompanying unaudited condensed consolidated financial statements and notes follow the same significant accounting policies as those described in the notes to the audited consolidated financial statements of the Company for the year ended December 31, 2022, except as described below. Allowance for Credit Losses The Company reviews its held-to-maturity short-term investments for credit losses on a collective basis by major security type and in line with the Company's investment policy. As of March 31, 2023, the Company's held-to-maturity short-term investments were in securities that are issued by the U.S. government, are highly rated, and have a history of zero credit losses. The Company reviews the credit quality of its accounts receivables by monitoring the aging of its accounts receivable, the history of write offs for uncollectible accounts, and the credit quality of its significant customers, the current economic environment/macroeconomic trends, supportable forecasts, and other relevant factors. The Company's accounts receivable are with customers that do not have a history of uncollectibility nor a history of significantly aged accounts receivables. As of March 31, 2023, the Company did no t recognize a credit loss allowance for its short-term investments or accounts receivable. Basic and Diluted Net Loss per Share of Common Stock The Company calculates net loss per common share in accordance with ASC 260, Earnings Per Share . Basic net loss per common share for the three months ended March 31, 2023 and 2022 was determined by dividing net loss applicable to common stockholders by the weighted average number of common shares outstanding during the period. Per ASC 260, Earnings Per Share, the weighted average number of common shares outstanding utilized for determining the basic net loss per common share for the three months ended March 31, 2023 includes the outstanding pre-funded warrants to purchase 11,303,667 and 3,200,000 shares of common stock issued in the April 2022 public offering and December 2020 public offering, respectively. The outstanding pre-funded warrants to purchase 3,200,000 shares of common stock issued in the December 2020 public offering were included in the three months ended March 31, 2022. Diluted net loss per common share for the three months ended March 31, 2023 and 2022 was determined as follows (in thousands, except share and per share amounts): Three Months Ended March 31, 2023 2022 Net loss $ ( 33,876 ) $ ( 5,451 ) Dilutive effect of convertible debt — ( 584 ) Net loss allocated to common shares $ ( 33,876 ) $ ( 6,035 ) Weighted average common shares outstanding – basic 47,757,246 32,051,228 Dilutive effect of convertible debt — 1,138,200 Weighted average common shares outstanding – diluted 47,757,246 33,189,428 Net loss per share – diluted $ ( 0.71 ) $ ( 0.18 ) The following potentially dilutive shares of common stock have not been included in the computation of diluted net loss per share for the three months ended March 31, 2023 and 2022, as the result would be anti-dilutive: Three Months Ended March 31, 2023 2022 Outstanding stock options 1,931,389 2,050,094 Outstanding restricted stock units 2,214,490 981,841 Warrants to purchase common stock associated with March 2018 public offering – Series 2 — 798,810 Warrants to purchase common stock associated with December 2020 public offering - Series 2 6,800,000 6,800,000 Warrants to purchase common stock associated with April 2022 Public Offering 15,000,000 — Warrants to purchase common stock associated with Loan Agreement 198,811 198,819 Common stock associated with March 2019 Notes 1,138,200 — Warrants to purchase common stock associated with Danforth 50,000 50,000 Total 27,332,890 10,879,564 Recently Adopted Accounting Pronouncements In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments—Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments (“ASU 2016-13”). The amendments in ASU 2016-13 require a financial asset (or a group of financial assets) measured at amortized cost basis to be presented at the net amount expected to be collected. In November 2019, the FASB issued ASU No. 2019-10, Financial Instruments – Credit Losses (Topic 326), Derivatives and Hedging (Topic 815), and Leases (Topic 842) (“ASU 2019-10”), which revised the effective dates for ASU 2016-13 for public business entities that meet the SEC definition of a smaller reporting company to fiscal years, and interim periods within those fiscal years, beginning after December 15, 2022, with early adoption permitted . The Company adopted ASU 2016-13 during the three months ended March 31, 2023 and the adoption did no t materially impact the unaudited condensed consolidated financial statements. Recently Issued Accounting Pronouncements In August 2020, the FASB issued ASU No. 2020-06, Debt—Debt with Conversion and Other Options and Derivatives and Hedging—Contracts in Entity’s Own Equity: Accounting for Convertible Instruments and Contracts in and Entity’s Own Equity (“ASU 2020-06”). The amendments in ASU 2020-06 reduce the number of accounting models for convertible debt instruments and revises certain guidance relating to the derivative scope exception and earnings per share. The amendments in ASU 2020-06 are effective for public business entities that meet the definition of a SEC filer and a smaller reporting company for fiscal years beginning after December 15, 2023, and interim periods within those years. As a smaller reporting company, the Company is currently evaluating the impact ASU 2020-06 will have on its unaudited condensed consolidated financial statements. |
Short-term Investments
Short-term Investments | 3 Months Ended |
Mar. 31, 2023 | |
Investments, Debt and Equity Securities [Abstract] | |
Short-term Investments | 3. Short-term Investments The following table summarizes the short-term investments at March 31, 2023 (in thousands): Amortized Unrealized Unrealized Fair Value As of March 31, 2023 U.S. government securities $ 27,908 $ — $ ( 64 ) $ 27,844 Total short-term investments $ 27,908 $ — $ ( 64 ) $ 27,844 As of December 31, 2022 U.S. government securities $ 27,689 $ — $ ( 160 ) $ 27,529 Total short-term investments $ 27,689 $ — $ ( 160 ) $ 27,529 As of March 31, 2023, the Company has $ 27.9 million of held-to-maturity investments with contractual maturities less than one year. The Company carries short-term investments at amortized cost. The fair value of the short-term investments is determined based on “Level 1” inputs, which consist of quoted prices in active markets for identical assets. The Company has evaluated the unrealized loss position in the U.S. government securities as of the balance sheet date and did not consider it to be indicative of an other-than-temporary impairment as the securities are highly-rated and the Company expects to realize the full principal amount at maturity |
Prepaid Expenses and Other Curr
Prepaid Expenses and Other Current Assets | 3 Months Ended |
Mar. 31, 2023 | |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | |
Prepaid Expenses and Other Current Assets | 4. Prepaid Expenses and Other Current Assets Prepaid expenses and other current assets consisted of the following (in thousands): March 31, 2023 December 31, 2022 Prepaid research and development services $ 569 $ 635 Prepaid insurance 328 622 Other prepaid expenses 538 1,184 Other current assets 291 62 Total prepaid expenses and other current assets $ 1,726 $ 2,503 |
Inventory
Inventory | 3 Months Ended |
Mar. 31, 2023 | |
Inventory Disclosure [Abstract] | |
Inventory | 5. Inventory Inventory consisted of the following (in thousands): March 31, 2023 December 31, 2022 Raw materials $ 7,724 $ 5,093 Work in process 698 610 Finished goods 11 24 Total inventory $ 8,433 $ 5,727 As of March 31, 2023 and December 31, 2022, the Company’s inventory consisted of $ 7.3 million and $ 4.9 million, respectively, of raw material that is not expected to be sold in one year and is classified as long term within other assets on the accompanying unaudited condensed consolidated balance sheet. |
Accrued Expenses
Accrued Expenses | 3 Months Ended |
Mar. 31, 2023 | |
Payables and Accruals [Abstract] | |
Accrued Expenses | 6. Accrued Expenses Accrued expenses consisted of the following (in thousands): March 31, 2023 December 31, 2022 Accrued research and development expenses $ 1,249 $ 786 Accrued employee bonus compensation 498 1,628 Other accrued expenses 1,543 1,313 Accrued severance 28 688 Accrued co-pay rebates 760 595 Accrued other rebates 697 618 Total accrued expenses $ 4,775 $ 5,628 |
Borrowings
Borrowings | 3 Months Ended |
Mar. 31, 2023 | |
Debt Disclosure [Abstract] | |
Borrowings | 7. Borrowings Loan Agreement On May 13, 2021 (the “Closing Date”), the Company entered into the Loan Agreement with Hercules and SVB for an aggregate principal amount of $ 60.0 million (the “Term Loan”). Pursuant to the Loan Agreement, the Term Loan is available to the Company in four tranches, subject to certain terms and conditions. In connection with the entering into of the License Agreement, the Company entered into a First Amendment and Consent to Loan and Security Agreement with the Lenders pursuant to which the Lenders consented to the Company entering into the License Agreement and the Company agreed to pay to the Lenders an amount equal to the sum of (i) all outstanding principal plus all accrued and unpaid interest with respect to the amounts loaned under the Loan Agreement (approximately $ 35.4 million), (ii) the prepayment fee payable under the Loan Agreement ($ 262,500 ), (iii) the final payment payable under the Loan Agreement ($ 1,382,500 ), and (iv) all other sums, if any, that shall have become due and payable with respect to loan advances under the Loan Agreement. These payments by the Company will become due upon the earliest of (A) one business day following receipt by the Company of the $ 90 million upfront payment payable to the Company under the License Agreement, (B) June 1, 2023, or (C) the termination of the License Agreement. Under the terms of the Loan Agreement, the Company received an initial tranche of $ 20.0 million from the Lenders on the closing date. The second tranche of the Term Loan, consisting of up to an additional $ 10.0 million, became available to the Company upon receipt of approval from the FDA of ibrexafungerp for the treatment of vaginal yeast infections (the “First Performance Milestone”) and was fully funded in June 2021. The third tranche of the Term Loan, consisting of an additional $ 5.0 million, became available to the Company upon (a) the First Performance Milestone and (b) the achievement of the primary endpoint from the Phase 3 study of ibrexafungerp in patients with recurrent vulvovaginal candidiasis, and was fully funded in March 2022. The fourth tranche of the Term Loan, consisting of up to an additional $ 25.0 million, will be available to the Company from January 1, 2022 through December 31, 2023 in $ 5.0 million increments, subject to certain terms and conditions, including in maintaining a ratio of total outstanding Term Loan principal to net product revenues for BREXAFEMME below a certain specified level for a given draw period. The Company estimated the fair value of the loan payable as of March 31, 2023 using a credit spread valuation model and Level 3 inputs which included an implied secured spread, risk free rate, and secured yield of 9.48 %, 4.80 %, and 14.28 %, respectively. As of December 31, 2022, the implied secured spread, risk free rate, and secured yield were 9.84 %, 4.37 %, and 14.21 %. At March 31, 2023 and December 31, 2022, the fair value of the loan payable is $ 36.6 million and $ 34.4 million, respectively. The Term Loan bears interest at a variable annual rate equal to the greater of (a) 9.05 % and (b) the Prime Rate (as reported in the Wall Street Journal) plus 5.80 % (the “Interest Rate”). The Company is currently making payments of interest only. The Loan Agreement contains customary closing fees, prepayment fees and provisions, events of default, and representations, warranties and covenants, including a financial covenant requiring the Company to maintain certain levels of trailing three-month net product revenue solely from the sale of ibrexafungerp commencing on September 30, 2022. The financial covenant will be waived at any time in which the Company maintains unrestricted and unencumbered cash in accounts maintained with SVB and another financial institution equal to at least 50.0 % of the total outstanding Term Loan principal amount, subject to certain requirements. Future principal debt payments on the currently outstanding loan payable as of March 31, 2023 are as follows (in thousands): 2023 $ 35,000 Total principal payments 35,000 Final fee due at maturity 1,383 Total principal and final fee payment 36,383 Unamortized discount and debt issuance costs ( 1,735 ) Loan payable, current portion $ 34,648 March 2019 Note Purchase Agreement On March 7, 2019 , the Company entered into a Senior Convertible Note Purchase Agreement (the “March 2019 Note Purchase Agreement”) with Puissance. Pursuant to the March 2019 Note Purchase Agreement, on March 7, 2019, the Company issued and sold to Puissance $ 16.0 million aggregate principal amount of its 6.0% Senior Convertible Notes due 2025 (“March 2019 Notes”), resulting in $ 14.7 million in net proceeds after deducting $ 1.3 million for an advisory fee and other issuance costs. As of March 31, 2023 and December 31, 2022, the Company’s March 2019 Notes consists of the convertible debt balance of $ 11.0 million and the bifurcated embedded conversion option derivative liability of $ 0.4 million and $ 42,000 , respectively. In connection with the Company’s issuance of its March 2019 Notes, the Company bifurcated the embedded conversion option, inclusive of the interest make-whole provision and make-whole fundamental change provision, and recorded the embedded conversion option as a long-term derivative liability in the Company’s balance sheet in accordance with ASC 815, Derivatives and Hedging , at its initial fair value of $ 7.0 million as the interest make-whole provision is settled in shares of common stock. The convertible debt and derivative liability associated with the March 2019 Notes are presented in total on the accompanying unaudited condensed consolidated balance sheets as the convertible debt and derivative liability. The derivative liability will be remeasured at each reporting period using the binomial lattice model with changes in fair value recorded in the statements of operations in other (income) expense. For the three months ended March 31, 2023 and 2022, the Company recognized a loss of $ 0.4 million and a gain of $ 1.0 million, respectively, on the fair value adjustment for the derivative liability. For the three months ended March 31, 2023 and 2022, the Company recognized zero and $ 0.2 million in amortization of debt issuance costs and discount related to the March 2019 Notes. The Company estimated the fair value of the convertible debt and derivative liability for the March 2019 Notes using a binomial lattice valuation model and Level 3 inputs. At March 31, 2023 and December 31, 2022, the fair value of the convertible debt and derivative liability for the March 2019 Notes is $ 11.7 million and $ 10.8 million, respectively. The March 2019 Notes bear interest at a rate of 6.0 % per annum payable semiannually in arrears on March 15 and September 15 of each year, beginning September 15, 2019. The March 2019 Notes will mature on March 15, 2025 , unless earlier converted, redeemed or repurchased. The March 2019 Notes constitute general, senior unsecured obligations of the Company. Other Liabilities In February 2021, the Company partnered with Amplity for the commercial launch of BREXAFEMME for the treatment of VVC. Under the terms of the agreement with Amplity, the Company was to utilize Amplity’s commercial execution and resources for sales force, remote engagement, training, market access and select operations services. In October 2022, the Company announced that it was actively pursuing a U.S. commercialization partner to out-license BREXAFEMME in order to refocus the Company's resources on the further clinical development of ibrexafungerp for severe, hospital-based indications. As a result, the Company wound down its promotional activities associated with BREXAFEMME, while keeping BREXAFEMME on the market and available to patients. On November 30, 2022, the Company terminated the agreement with Amplity. Under the terms of the original agreement, Amplity deferred a portion of its direct service fees in the first two years (2021 and 2022) that accrued interest at an annual rate of 12.75 % (“Deferred Fees”). The Deferred Fees of $ 5.8 million as of December 31, 2022 were fully paid as of February 2023. |
Commitments and Contingencies
Commitments and Contingencies | 3 Months Ended |
Mar. 31, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 8. Commitments and Contingencies Leases On March 1, 2018, the Company entered into a long-term lease agreement for approximately 19,275 square feet of office space in Jersey City, New Jersey, that the Company identified as an operating lease under ASC 842 (the “Lease”). The lease term is eleven years from August 1, 2018, the commencement date, with total lease payments of $ 7.3 million over the lease term. The Company has the option to renew for two consecutive five-year periods from the end of the first term and the Company is not reasonably certain that the option to renew the Lease will be exercised. Under the Lease, the Company furnished a security deposit in the form of a standby letter of credit in the amount of $ 0.3 million, which was reduced by fifty-five thousand dollars on the first anniversary of the commencement date. The security deposit will continue to be reduced by fifty-five thousand dollars every two years on the commencement date anniversary for eight years. The security deposit is classified as restricted cash in the accompanying unaudited condensed consolidated balance sheets. The following table summarizes certain quantitative information associated with the amounts recognized in the unaudited condensed consolidated financial statements for the Lease (dollars in thousands): Three Months Ended March 31, 2023 2022 Operating lease cost $ 166 $ 166 Variable lease cost 58 ( 3 ) Total operating lease expense $ 224 $ 163 Cash paid for amounts included in the measurement of operating lease liability $ 177 $ 174 March 31, 2023 December 31, 2022 Remaining Lease term (years) 6.34 6.59 Discount rate 15 % 15 % Future minimum lease payments for the Lease as of March 31, 2023 are as follows (in thousands): March 31, 2023 2023 $ 538 2024 730 2025 744 2026 759 2027 774 Thereafter 1,256 Total $ 4,801 The presentations of the operating lease liability as of March 31, 2023 are as follows (in thousands): March 31, 2023 Present value of future minimum lease payments $ 3,138 Operating lease liability, current portion $ 296 Operating lease liability, long-term portion 2,842 Total operating lease liability $ 3,138 Difference between future minimum lease payments and discounted cash flows $ 1,663 License Arrangement with Potential Future Expenditures As of March 31, 2023, the Company had a license arrangement with Merck Sharp & Dohme Corp., or Merck, as amended, that involves potential future expenditures. Under the license arrangement, executed in May 2013, the Company exclusively licensed from Merck its rights to ibrexafungerp in the field of human health. In January 2014, Merck assigned the patents related to ibrexafungerp that it had exclusively licensed to the Company. Ibrexafungerp is the Company's lead product candidate. Pursuant to the terms of the license agreement, Merck was originally eligible to receive milestone payments from the Company that could total $ 19.0 million upon occurrence of specific events, including initiation of a Phase 2 clinical study, new drug application, and marketing approvals in each of the U.S., major European markets, and Japan. In addition, Merck is eligible to receive tiered royalties from the Company based on a percentage of worldwide net sales of ibrexafungerp. The aggregate royalties are mid- to high-single digits. In December 2014, the Company and Merck entered into an amendment to the license agreement that deferred the remittance of a milestone payment due to Merck, such that no amount would be due upon initiation of the first Phase 2 clinical trial of a product containing the ibrexafungerp compound (the “Deferred Milestone”). The amendment also increased, in an amount equal to the Deferred Milestone, the milestone payment that would be due upon initiation of the first Phase 3 clinical trial of a product containing the ibrexafungerp compound. In December 2016 and January 2018, the Company entered into second and third amendments to the license agreement with Merck which clarified what would constitute the initiation of a Phase 3 clinical trial for the purpose of milestone payment. In January 2019, a milestone payment became due to Merck as a result of the initiation of the VANISH Phase 3 VVC program and was paid in March 2019. On December 2, 2020, the Company entered into a fourth amendment to the license agreement with Merck. The amendment eliminates two cash milestone payments that the Company would have paid to Merck upon the first filing of an NDA, triggered by the FDA acceptance for filing of the Company’s NDA for ibrexafungerp for the treatment of VVC, and first marketing approval in the U.S. Such cash milestone payments would have been creditable against future royalties owed to Merck on net sales of ibrexafungerp. With the amendment, these milestones will not be paid in cash and, accordingly, credits will not accrue. Pursuant to the amendment, the Company will also forfeit the credits against future royalties that it had accrued from a prior milestone payment already paid to Merck. All other key terms of the license agreement are unchanged. |
Stockholders' Equity
Stockholders' Equity | 3 Months Ended |
Mar. 31, 2023 | |
Equity [Abstract] | |
Stockholders' Equity | 9. Stockholders’ Equity Authorized, Issued, and Outstanding Common Stock The Company’s authorized common stock has a par value of $ 0.001 per share and consists of 150,000,000 shares as of March 31, 2023, and December 31, 2022; 33,327,627 and 32,682,342 shares were issued and outstanding at March 31, 2023, and December 31, 2022, respectively. In January 2023 and April 2023, 363,000 and 3,189,815 of the prefunded warrants from the April 2022 public offering were exercised for total proceeds of $ 3,553 . T he following table summarizes common stock share activity for the three months ended March 31, 2023 and 2022 (dollars in thousands): Three Months Ended March 31, 2023 Shares of Common Additional Accumulated Total Balance, December 31, 2022 32,682,342 $ 36 $ 425,485 $ ( 422,288 ) $ 3,233 Net loss — — — ( 33,876 ) ( 33,876 ) Stock-based compensation expense — — 707 — 707 Common stock issued through employee stock purchase plan 2,662 — 4 — 4 Common stock issued, net of expenses 363,000 — — — — Common stock issued for vested restricted stock units 279,623 — 18 — 18 Balance, March 31, 2023 33,327,627 $ 36 $ 426,214 $ ( 456,164 ) $ ( 29,914 ) Three Months Ended March 31, 2022 Shares of Common Additional Accumulated Total Balance, December 31, 2021 28,705,334 $ 32 $ 400,705 $ ( 359,479 ) $ 41,258 Net loss — — — ( 5,451 ) ( 5,451 ) Stock-based compensation expense — — 922 — 922 Common stock issued, net of expenses 487,610 — 2,135 — 2,135 Common stock issued through employee stock purchase plan 3,120 — 10 — 10 Common stock issued for vested restricted stock units 25,094 — ( 18 ) — ( 18 ) Vested Loan Agreement warrants — — 71 — 71 Balance, March 31, 2022 29,221,158 $ 32 $ 403,825 $ ( 364,930 ) $ 38,927 Shares Reserved for Future Issuance The Company had reserved shares of common stock for future issuance as follows: March 31, 2023 December 31, 2022 Outstanding stock options 1,931,389 1,740,308 Outstanding restricted stock units 2,214,490 633,270 Warrants to purchase common stock associated with March 2018 public offering – Series 2 — 798,810 Warrants to purchase common stock associated with December 2020 public offering - Series 2 6,800,000 6,800,000 Prefunded warrants to purchase common stock associated with December 2020 public offering 3,200,000 3,200,000 Warrants to purchase common stock associated with April 2022 Public Offering 15,000,000 15,000,000 Prefunded warrants to purchase common stock associated with April 2022 Public Offering 11,303,667 11,666,667 Warrants to purchase common stock associated with Loan Agreement 198,811 198,811 Warrant to purchase common stock associated with Danforth 50,000 50,000 For possible future issuance for the conversion of the March 2019 Notes 1,138,200 1,138,200 For possible future issuance under 2014 Plan (Note 10) 590,207 712,020 For possible future issuance under employee stock purchase plan 279 — For possible future issuance under 2015 Plan (Note 10) 566,413 550,964 Total common shares reserved for future issuance 42,993,456 42,489,050 Common Stock Purchase Agreement and Sales Agreements On April 10, 2020, the Company entered into the Common Stock Purchase Agreement with Aspire Capital (the “Common Stock Purchase Agreement”) pursuant to which the Company had the right to sell to Aspire Capital from time to time in its sole discretion up to $ 20.0 million in shares of the Company’s common stock, subject to certain limitations and conditions set forth in the Common Stock Purchase Agreement. The Common Stock Purchase Agreement expired in October 2022. During the three months ended March 31, 2022, the Company sold 350,000 shares of its common stock under the Common Stock Purchase Agreement for gross proceeds of $ 1.5 million. During the three months ended March 31, 2023 and 2022, the Company sold zero and 137,610 shares of its common stock and received net proceeds of zero and $ 0.7 million, respectively, under the Controlled Equity Offering SM Sales Agreements with Cantor Fitzgerald & Co. and Ladenburg Thalmann & Co. Inc. (the “Sales Agreements”). Warrants Associated with the March 2018, December 2020, and April 2022 Public Offerings The outstanding warrants associated with the March 2018 and December 2020 public offerings contain a provision where the warrant holder has the option to receive cash, equal to the Black-Scholes fair value of the remaining unexercised portion of the warrant, as cash settlement in the event that there is a fundamental transaction (contractually defined to include various merger, acquisition or stock transfer activities). Due to this provision, ASC 480, Distinguishing Liabilities from Equity, requires that these warrants be classified as liabilities. The fair values of these warrants have been determined using the Black-Scholes valuation model, and the changes in the fair value are recorded in the accompanying unaudited condensed consolidated statements of operations. The outstanding warrants associated with the April 2022 public offering meet the definition of a derivative pursuant to ASC 815, Derivatives and Hedging , and do not meet the derivative scope exception given the warrants do not qualify under the indexation guidance. As a result, the April 2022 public offering warrants were initially recognized as liabilities and measured at fair value using the Black-Scholes valuation model. During the three months ended March 31, 2023 and 2022, the Company recognized a loss of $ 21.7 million and a gain of $ 10.0 million on the warrant liabilities fair value adjustment, respectively. As of March 31, 2023 and December 31, 2022, the fair value of the warrant liabilities was $ 40.3 million and $ 18.6 million, respectively. |
Stock-based Compensation
Stock-based Compensation | 3 Months Ended |
Mar. 31, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Stock-based Compensation | 10. Stock-based Compensation Pursuant to the terms of the Company’s 2014 Equity Incentive Plan (“2014 Plan”), on January 1, 2023 and 2022, the Company automatically added 1,901,960 and 1,148,213 shares to the total number shares of common stock available for future issuance under the 2014 Plan, respectively. As of March 31, 2023, there were 590,207 shares of common stock available for future issuance under the 2014 Plan. As of March 31, 2023, there were 566,413 shares of common stock available for future issuance under the Company’s 2015 Inducement Award Plan (“2015 Plan”). During the three months ended March 31, 2023 and 2022, there were options to purchase zero and 69,000 shares of the Company’s common stock granted under the 2015 Plan, respectively. The activity for the Company’s 2009 Stock Option Plan, 2014 Plan, and 2015 Plan, for the three months ended March 31, 2023, is summarized as follows: Number of Weighted- Weighted- Aggregate Outstanding — December 31, 2022 1,740,308 $ 12.21 6.16 $ — Granted 225,000 $ 1.54 Forfeited/Cancelled ( 33,919 ) $ 7.35 Outstanding — March 31, 2023 1,931,389 $ 11.05 6.45 $ 544 Exercisable — March 31, 2023 1,202,326 $ 15.70 4.82 $ 10 Vested or expected to vest — March 31, 2023 1,931,389 $ 11.05 6.45 $ 544 Restricted stock unit (“RSU”) activity under the 2014 Plan and 2015 Plan for the three months ended March 31, 2023, is summarized as follows: Number of Weighted Non-vested at December 31, 2022 633,270 $ 5.29 Granted 1,819,575 $ 1.73 Vested ( 236,023 ) $ 5.87 Forfeited ( 2,332 ) $ 5.13 Non-vested at March 31, 2023 2,214,490 $ 2.30 The fair value of RSUs is based on the market price of the Company’s common stock on the date of grant. RSUs generally vest 25 % annually over a four-year period from the date of grant. Upon vesting, the RSUs generally are net share settled to cover the required withholding tax with the remaining shares issued to the holder. The Company recognizes compensation expense for such awards ratably over the corresponding vesting period. Compensation Cost The compensation cost that has been charged against income for stock awards under the 2014 Plan and the 2015 Plan was $ 0.7 million and $ 0.9 million for the three months ended March 31, 2023 and 2022, respectively. The total income tax benefit recognized in the statements of operations for share-based compensation arrangements was zero for each of the three months ended March 31, 2023 and 2022. Stock-based compensation expense related to stock options is included in the following line items in the accompanying unaudited condensed consolidated statements of operations (in thousands): Three Months Ended March 31, 2023 2022 Research and development $ 374 $ 285 Selling, general and administrative 333 637 Total $ 707 $ 922 |
Fair Value Measurements
Fair Value Measurements | 3 Months Ended |
Mar. 31, 2023 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | 11. Fair Value Measurements The carrying amounts of certain financial instruments, including cash and cash equivalents, restricted cash, accounts receivable, prepaid expenses and other current assets, accounts payable, and accrued expenses approximate their respective fair values due to the short-term nature of such instruments. Assets and Liabilities Measured at Fair Value on a Recurring Basis The Company evaluates its financial assets and liabilities subject to fair value measurements on a recurring basis to determine the appropriate level in which to classify them for each reporting period. This determination requires significant judgments to be made. The following table summarizes the conclusions reached as of March 31, 2023 and December 31, 2022 for financial instruments measured at fair value on a recurring basis (in thousands): Fair Value Hierarchy Classification Balance Quoted Significant Significant March 31, 2023 Cash $ 563 $ 563 — — Restricted cash 218 218 — — Money market funds 26,350 26,350 — — Total assets $ 27,131 $ 27,131 — — Warrant liabilities $ 40,317 — — $ 40,317 Derivative liability 448 — — 448 Total liabilities $ 40,765 — — $ 40,765 December 31, 2022 Cash $ 415 $ 415 — — Restricted cash 218 218 — — Money market funds 45,399 45,399 — — Total assets $ 46,032 $ 46,032 — — Warrant liabilities $ 18,644 — — $ 18,644 Derivative liability 42 — — 42 Total liabilities $ 18,686 — — $ 18,686 The Company measures cash equivalents at fair value on a recurring basis. The fair value of cash equivalents is determined based on “Level 1” inputs, which consist of quoted prices in active markets for identical assets. Level 3 financial liabilities consist of the warrant liabilities for which there is no current market such that the determination of fair value requires significant judgment or estimation. Changes in fair value measurements categorized within Level 3 of the fair value hierarchy are analyzed each period based on changes in estimates or assumptions and recorded as appropriate. The Company uses the Black-Scholes option valuation model to value the Level 3 warrant liabilities at inception and on subsequent valuation dates. This model incorporates transaction details such as the Company’s stock price, contractual terms, maturity, risk free rates, as well as volatility. The unobservable input for all of the Level 3 warrant liabilities includes volatility. The historical and implied volatility of the Company, using its closing common stock prices and market data, is utilized to reflect future volatility over the expected term of the warrants. At March 31, 2023, the range and weighted average of the Level 3 volatilities utilized in the Black-Scholes model to fair value the warrant liabilities were 100.8 % to 111.9 % and 102.1 %, respectively. The Company uses the binomial lattice valuation model to value the Level 3 derivative liabilities at inception and on subsequent valuation dates. This model incorporates transaction details such as the Company’s stock price, contractual terms, dividend yield, risk-free rate, adjusted equity volatility, credit rating, market credit spread, and estimated effective yield. The unobservable inputs associated with the Level 3 derivative liabilities are adjusted equity volatility, market credit spread, and estimated yield. As of March 31, 2023, these inputs were 82.3 %, 1,454 basis points, and 18.6 %, respectively. The senior convertible notes are initially fair valued using the binomial lattice model and with the straight debt fair value calculated using the discounted cash flow method. The residual difference represents the fair value of the embedded derivative liabilities and the fair value of the embedded derivative liabilities are reassessed using the binomial lattice valuation model on a quarterly basis. A reconciliation of the beginning and ending balances for liabilities measured at fair value on a recurring basis using significant unobservable inputs (Level 3) is as follows (in thousands): Warrant Liabilities Balance – December 31, 2022 $ 18,644 Loss adjustment to fair value 21,673 Balance – March 31, 2023 $ 40,317 Derivative Liability Balance – December 31, 2022 $ 42 Loss adjustment to fair value 406 Balance – March 31, 2023 $ 448 |
Revenue
Revenue | 3 Months Ended |
Mar. 31, 2023 | |
Revenue from Contract with Customer [Abstract] | |
Revenue | 12. Revenue Product Revenue, Net Net product revenue was $ 1.1 million and $ 0.7 million for the three months ended March 31, 2023 and 2022, respectively. Products are sold primarily to wholesalers and specialty pharmacies. Revenue is reduced from wholesaler list price at the time of recognition for expected chargebacks, rebates, discounts, incentives, and returns, which are referred to as gross to net (“GTN”) adjustments. These reductions are currently attributed to various commercial arrangements. Chargebacks and discounts are recognized as a reduction in accounts receivable or as accrued expenses based on their nature and settled through the issuance of credits to the customer or through cash payments to the customer, respectively. All other returns, rebates, and incentives are reflected as accrued expenses and settled through cash payments to the customer. Revenue attributed to sales to three wholesalers comprised 46 %, 26 %, and 25 % of the Company’s gross revenue for the three months ended March 31, 2023. The following table summarizes activity in each of the Company’s product revenue provision and allowance categories as of March 31, 2023 and 2022 (in thousands): Discounts and Chargebacks (1) Product Returns (2) Rebates and Incentives (3) Total Balance as of December 31, 2022 $ 255 $ 73 $ 1,213 $ 1,541 Provision related to current period revenue 392 12 943 1,347 Changes in estimate related to prior period revenue — — — — Credit/payments ( 324 ) ( 2 ) ( 699 ) ( 1,025 ) Balance as of March 31, 2023 $ 323 $ 83 $ 1,457 $ 1,863 Discounts and Chargebacks (1) Product Returns (2) Rebates and Incentives (3) Total Balance as of December 31, 2021 $ 249 $ 21 $ 1,110 $ 1,380 Provision related to current period revenue 272 10 1,092 1,374 Changes in estimate related to prior period revenue — — — — Credit/payments ( 122 ) — ( 1,040 ) ( 1,162 ) Balance as of March 31, 2022 $ 399 $ 31 $ 1,162 $ 1,592 (1) Discounts and chargebacks include fees for wholesaler fees, prompt pay and other discounts, and chargebacks. Discounts and chargebacks are deducted from gross revenue at the time revenues are recognized and are included as a reduction in accounts receivable or as an accrued expense based on their nature on the Company’s unaudited condensed consolidated balance sheet. (2) Provisions for product returns are deducted from gross revenues at the time revenues are recognized and are included in accrued expenses on the Company’s unaudited condensed consolidated balance sheet. (3) Rebates and incentives include rebates and co-pay program incentives. Provisions for rebates and incentives are deducted from gross revenues at the time revenues are recognized and are included in accrued expenses on the Company’s unaudited condensed consolidated balance sheets. License Agreement with GSK On March 30, 2023, the Company entered into a License Agreement with GSK. Pursuant to the terms of the License Agreement, the Company granted GSK an exclusive (even as to the Company and its affiliates), royalty-bearing, sublicensable license for the development, manufacture, and commercialization of ibrexafungerp, including the approved product BREXAFEMME, for all indications, in all countries other than Greater China and certain other countries already licensed to third parties (the “GSK Territory”). If the existing licenses granted to or agreements with third parties are terminated with respect to any country, GSK will have an exclusive first right to negotiate with the Company to add those additional countries to the GSK Territory. The consummation of the transactions under the License Agreement is subject to the satisfaction of customary closing conditions, including the expiration or termination of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended (the "HSR Act”); provided, that either the Company or GSK may terminate the License Agreement if expiration or termination of the applicable waiting period under the HSR Act has not occurred within nine months of the signing of the License Agreement. The parties expect the transactions contemplated by the License Agreement to close in the second quarter of 2023. The Company retains rights to all other assets, with GSK receiving a right of first negotiation (“ROFN”) to any other enfumafungin-derived compounds or products that the Company may control. Under the terms of the License Agreement, the Company will receive an upfront payment of $ 90 million. The Company is also eligible to receive potential: • regulatory approval milestone payments of up to $ 70 million; • commercial milestone payments of up to $ 115 million based on first commercial sale in invasive candidiasis (U.S./EU); • and sales milestone payments of up to $ 242.5 million based on annual net sales, with a total of $ 77.5 million to be paid upon achievement of multiple thresholds up through $200 million; a total of $ 65 million to be paid upon achievement of multiple thresholds between $300 million and $500 million; and $ 50 million to be paid at each threshold of $750 million and $1 billion. The Company will be responsible for the execution and costs of the ongoing clinical studies of ibrexafungerp but will have the potential to receive up to $ 75.5 million in success-based development milestones, which are comprised of up to $ 65 million for the achievement of three interim milestones associated with the Company's continued performance of the ongoing MARIO Study and $ 10.5 million for the successful completion of the MARIO Study. In the case of each of the above milestones, such milestone events are defined in the License Agreement. GSK will also pay royalties based on cumulative annual sales to the Company in the mid-single digit to mid-teen range. These royalty rates are subject to reduction, including in the event of third-party licenses, entry of a generic product, or the expiration of licensed patents. A joint development committee will be established between GSK and the Company to coordinate and review ongoing development activities of ibrexafungerp. Unless earlier terminated, the License Agreement will expire on a product-by-product and country-by-country basis at the end of the royalty term for such product in such country. The Company has the right to terminate the License Agreement upon an uncured material breach by, or bankruptcy of, GSK. GSK has the right to terminate the License Agreement at any time for convenience in its entirety or on a product-by-product and country-by-country basis, upon an uncured material breach by, or bankruptcy of, the Company, or for safety reasons. License Agreement with Hansoh In February 2021, the Company entered into an Exclusive License and Collaboration Agreement (the “Agreement”) with Hansoh (Shanghai) Health Technology Co., Ltd., and Jiangsu Hansoh Pharmaceutical Group Company Limited (collectively, “Hansoh”), pursuant to which the Company granted to Hansoh an exclusive license to research, develop and commercialize ibrexafungerp in the Greater China region, including mainland China, Hong Kong, Macau, and Taiwan (the “Territory”). The Company also granted to Hansoh a non-exclusive license to manufacture ibrexafungerp solely for development and commercialization in the Territory. For the three months ended March 31, 2023 and 2022, there was no license agreement revenue recognized associated with the Agreement given the variable consideration was fully constrained as of March 31, 2023 and 2022, respectively. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2023 | |
Accounting Policies [Abstract] | |
Allowance for Credit Losses | Allowance for Credit Losses The Company reviews its held-to-maturity short-term investments for credit losses on a collective basis by major security type and in line with the Company's investment policy. As of March 31, 2023, the Company's held-to-maturity short-term investments were in securities that are issued by the U.S. government, are highly rated, and have a history of zero credit losses. The Company reviews the credit quality of its accounts receivables by monitoring the aging of its accounts receivable, the history of write offs for uncollectible accounts, and the credit quality of its significant customers, the current economic environment/macroeconomic trends, supportable forecasts, and other relevant factors. The Company's accounts receivable are with customers that do not have a history of uncollectibility nor a history of significantly aged accounts receivables. As of March 31, 2023, the Company did no t recognize a credit loss allowance for its short-term investments or accounts receivable. |
Basic and Diluted Net Loss per Share of Common Stock | Basic and Diluted Net Loss per Share of Common Stock The Company calculates net loss per common share in accordance with ASC 260, Earnings Per Share . Basic net loss per common share for the three months ended March 31, 2023 and 2022 was determined by dividing net loss applicable to common stockholders by the weighted average number of common shares outstanding during the period. Per ASC 260, Earnings Per Share, the weighted average number of common shares outstanding utilized for determining the basic net loss per common share for the three months ended March 31, 2023 includes the outstanding pre-funded warrants to purchase 11,303,667 and 3,200,000 shares of common stock issued in the April 2022 public offering and December 2020 public offering, respectively. The outstanding pre-funded warrants to purchase 3,200,000 shares of common stock issued in the December 2020 public offering were included in the three months ended March 31, 2022. Diluted net loss per common share for the three months ended March 31, 2023 and 2022 was determined as follows (in thousands, except share and per share amounts): Three Months Ended March 31, 2023 2022 Net loss $ ( 33,876 ) $ ( 5,451 ) Dilutive effect of convertible debt — ( 584 ) Net loss allocated to common shares $ ( 33,876 ) $ ( 6,035 ) Weighted average common shares outstanding – basic 47,757,246 32,051,228 Dilutive effect of convertible debt — 1,138,200 Weighted average common shares outstanding – diluted 47,757,246 33,189,428 Net loss per share – diluted $ ( 0.71 ) $ ( 0.18 ) The following potentially dilutive shares of common stock have not been included in the computation of diluted net loss per share for the three months ended March 31, 2023 and 2022, as the result would be anti-dilutive: Three Months Ended March 31, 2023 2022 Outstanding stock options 1,931,389 2,050,094 Outstanding restricted stock units 2,214,490 981,841 Warrants to purchase common stock associated with March 2018 public offering – Series 2 — 798,810 Warrants to purchase common stock associated with December 2020 public offering - Series 2 6,800,000 6,800,000 Warrants to purchase common stock associated with April 2022 Public Offering 15,000,000 — Warrants to purchase common stock associated with Loan Agreement 198,811 198,819 Common stock associated with March 2019 Notes 1,138,200 — Warrants to purchase common stock associated with Danforth 50,000 50,000 Total 27,332,890 10,879,564 |
Recently Adopted Accounting Pronouncements | Recently Adopted Accounting Pronouncements In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments—Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments (“ASU 2016-13”). The amendments in ASU 2016-13 require a financial asset (or a group of financial assets) measured at amortized cost basis to be presented at the net amount expected to be collected. In November 2019, the FASB issued ASU No. 2019-10, Financial Instruments – Credit Losses (Topic 326), Derivatives and Hedging (Topic 815), and Leases (Topic 842) (“ASU 2019-10”), which revised the effective dates for ASU 2016-13 for public business entities that meet the SEC definition of a smaller reporting company to fiscal years, and interim periods within those fiscal years, beginning after December 15, 2022, with early adoption permitted . The Company adopted ASU 2016-13 during the three months ended March 31, 2023 and the adoption did no t materially impact the unaudited condensed consolidated financial statements. |
Recently Issued Accounting Pronouncements | Recently Issued Accounting Pronouncements In August 2020, the FASB issued ASU No. 2020-06, Debt—Debt with Conversion and Other Options and Derivatives and Hedging—Contracts in Entity’s Own Equity: Accounting for Convertible Instruments and Contracts in and Entity’s Own Equity (“ASU 2020-06”). The amendments in ASU 2020-06 reduce the number of accounting models for convertible debt instruments and revises certain guidance relating to the derivative scope exception and earnings per share. The amendments in ASU 2020-06 are effective for public business entities that meet the definition of a SEC filer and a smaller reporting company for fiscal years beginning after December 15, 2023, and interim periods within those years. As a smaller reporting company, the Company is currently evaluating the impact ASU 2020-06 will have on its unaudited condensed consolidated financial statements. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Accounting Policies [Abstract] | |
Schedule of Diluted Net Loss Per Common Share | The Company calculates net loss per common share in accordance with ASC 260, Earnings Per Share . Basic net loss per common share for the three months ended March 31, 2023 and 2022 was determined by dividing net loss applicable to common stockholders by the weighted average number of common shares outstanding during the period. Per ASC 260, Earnings Per Share, the weighted average number of common shares outstanding utilized for determining the basic net loss per common share for the three months ended March 31, 2023 includes the outstanding pre-funded warrants to purchase 11,303,667 and 3,200,000 shares of common stock issued in the April 2022 public offering and December 2020 public offering, respectively. The outstanding pre-funded warrants to purchase 3,200,000 shares of common stock issued in the December 2020 public offering were included in the three months ended March 31, 2022. Diluted net loss per common share for the three months ended March 31, 2023 and 2022 was determined as follows (in thousands, except share and per share amounts): Three Months Ended March 31, 2023 2022 Net loss $ ( 33,876 ) $ ( 5,451 ) Dilutive effect of convertible debt — ( 584 ) Net loss allocated to common shares $ ( 33,876 ) $ ( 6,035 ) Weighted average common shares outstanding – basic 47,757,246 32,051,228 Dilutive effect of convertible debt — 1,138,200 Weighted average common shares outstanding – diluted 47,757,246 33,189,428 Net loss per share – diluted $ ( 0.71 ) $ ( 0.18 ) |
Summary of Antidilutive Securities Excluded from Computation of Weighted Average Common Stock Outstanding | The following potentially dilutive shares of common stock have not been included in the computation of diluted net loss per share for the three months ended March 31, 2023 and 2022, as the result would be anti-dilutive: Three Months Ended March 31, 2023 2022 Outstanding stock options 1,931,389 2,050,094 Outstanding restricted stock units 2,214,490 981,841 Warrants to purchase common stock associated with March 2018 public offering – Series 2 — 798,810 Warrants to purchase common stock associated with December 2020 public offering - Series 2 6,800,000 6,800,000 Warrants to purchase common stock associated with April 2022 Public Offering 15,000,000 — Warrants to purchase common stock associated with Loan Agreement 198,811 198,819 Common stock associated with March 2019 Notes 1,138,200 — Warrants to purchase common stock associated with Danforth 50,000 50,000 Total 27,332,890 10,879,564 |
Short-term Investments (Tables)
Short-term Investments (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Investments, Debt and Equity Securities [Abstract] | |
summary of short-term investments | The following table summarizes the short-term investments at March 31, 2023 (in thousands): Amortized Unrealized Unrealized Fair Value As of March 31, 2023 U.S. government securities $ 27,908 $ — $ ( 64 ) $ 27,844 Total short-term investments $ 27,908 $ — $ ( 64 ) $ 27,844 As of December 31, 2022 U.S. government securities $ 27,689 $ — $ ( 160 ) $ 27,529 Total short-term investments $ 27,689 $ — $ ( 160 ) $ 27,529 |
Prepaid Expenses and Other Cu_2
Prepaid Expenses and Other Current Assets (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | |
Schedule of Prepaid Expenses and Other Current Assets | Prepaid expenses and other current assets consisted of the following (in thousands): March 31, 2023 December 31, 2022 Prepaid research and development services $ 569 $ 635 Prepaid insurance 328 622 Other prepaid expenses 538 1,184 Other current assets 291 62 Total prepaid expenses and other current assets $ 1,726 $ 2,503 |
Inventory (Tables)
Inventory (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Inventory Disclosure [Abstract] | |
Schedule of Inventory | Inventory consisted of the following (in thousands): March 31, 2023 December 31, 2022 Raw materials $ 7,724 $ 5,093 Work in process 698 610 Finished goods 11 24 Total inventory $ 8,433 $ 5,727 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Payables and Accruals [Abstract] | |
Schedule of Accrued Expenses | Accrued expenses consisted of the following (in thousands): March 31, 2023 December 31, 2022 Accrued research and development expenses $ 1,249 $ 786 Accrued employee bonus compensation 498 1,628 Other accrued expenses 1,543 1,313 Accrued severance 28 688 Accrued co-pay rebates 760 595 Accrued other rebates 697 618 Total accrued expenses $ 4,775 $ 5,628 |
Borrowings (Tables)
Borrowings (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Debt Disclosure [Abstract] | |
Schedule of Future Principal Debt Payments On Currently Outstanding Loan Payable | Future principal debt payments on the currently outstanding loan payable as of March 31, 2023 are as follows (in thousands): 2023 $ 35,000 Total principal payments 35,000 Final fee due at maturity 1,383 Total principal and final fee payment 36,383 Unamortized discount and debt issuance costs ( 1,735 ) Loan payable, current portion $ 34,648 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Summary of Quantitative Information Associated with Amounts Recognized in Unaudited Condensed Consolidated Financial Statements for Lease | The following table summarizes certain quantitative information associated with the amounts recognized in the unaudited condensed consolidated financial statements for the Lease (dollars in thousands): Three Months Ended March 31, 2023 2022 Operating lease cost $ 166 $ 166 Variable lease cost 58 ( 3 ) Total operating lease expense $ 224 $ 163 Cash paid for amounts included in the measurement of operating lease liability $ 177 $ 174 March 31, 2023 December 31, 2022 Remaining Lease term (years) 6.34 6.59 Discount rate 15 % 15 % |
Future Minimum Lease Payments | Future minimum lease payments for the Lease as of March 31, 2023 are as follows (in thousands): March 31, 2023 2023 $ 538 2024 730 2025 744 2026 759 2027 774 Thereafter 1,256 Total $ 4,801 |
Presentation of Operating Lease Liability | The presentations of the operating lease liability as of March 31, 2023 are as follows (in thousands): March 31, 2023 Present value of future minimum lease payments $ 3,138 Operating lease liability, current portion $ 296 Operating lease liability, long-term portion 2,842 Total operating lease liability $ 3,138 Difference between future minimum lease payments and discounted cash flows $ 1,663 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Equity [Abstract] | |
Summary of Common Stock Shares Activity | he following table summarizes common stock share activity for the three months ended March 31, 2023 and 2022 (dollars in thousands): Three Months Ended March 31, 2023 Shares of Common Additional Accumulated Total Balance, December 31, 2022 32,682,342 $ 36 $ 425,485 $ ( 422,288 ) $ 3,233 Net loss — — — ( 33,876 ) ( 33,876 ) Stock-based compensation expense — — 707 — 707 Common stock issued through employee stock purchase plan 2,662 — 4 — 4 Common stock issued, net of expenses 363,000 — — — — Common stock issued for vested restricted stock units 279,623 — 18 — 18 Balance, March 31, 2023 33,327,627 $ 36 $ 426,214 $ ( 456,164 ) $ ( 29,914 ) Three Months Ended March 31, 2022 Shares of Common Additional Accumulated Total Balance, December 31, 2021 28,705,334 $ 32 $ 400,705 $ ( 359,479 ) $ 41,258 Net loss — — — ( 5,451 ) ( 5,451 ) Stock-based compensation expense — — 922 — 922 Common stock issued, net of expenses 487,610 — 2,135 — 2,135 Common stock issued through employee stock purchase plan 3,120 — 10 — 10 Common stock issued for vested restricted stock units 25,094 — ( 18 ) — ( 18 ) Vested Loan Agreement warrants — — 71 — 71 Balance, March 31, 2022 29,221,158 $ 32 $ 403,825 $ ( 364,930 ) $ 38,927 |
Common Stock Reserved For Future Issuances | The Company had reserved shares of common stock for future issuance as follows: March 31, 2023 December 31, 2022 Outstanding stock options 1,931,389 1,740,308 Outstanding restricted stock units 2,214,490 633,270 Warrants to purchase common stock associated with March 2018 public offering – Series 2 — 798,810 Warrants to purchase common stock associated with December 2020 public offering - Series 2 6,800,000 6,800,000 Prefunded warrants to purchase common stock associated with December 2020 public offering 3,200,000 3,200,000 Warrants to purchase common stock associated with April 2022 Public Offering 15,000,000 15,000,000 Prefunded warrants to purchase common stock associated with April 2022 Public Offering 11,303,667 11,666,667 Warrants to purchase common stock associated with Loan Agreement 198,811 198,811 Warrant to purchase common stock associated with Danforth 50,000 50,000 For possible future issuance for the conversion of the March 2019 Notes 1,138,200 1,138,200 For possible future issuance under 2014 Plan (Note 10) 590,207 712,020 For possible future issuance under employee stock purchase plan 279 — For possible future issuance under 2015 Plan (Note 10) 566,413 550,964 Total common shares reserved for future issuance 42,993,456 42,489,050 |
Stock-based Compensation (Table
Stock-based Compensation (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Stock Option Activity | The activity for the Company’s 2009 Stock Option Plan, 2014 Plan, and 2015 Plan, for the three months ended March 31, 2023, is summarized as follows: Number of Weighted- Weighted- Aggregate Outstanding — December 31, 2022 1,740,308 $ 12.21 6.16 $ — Granted 225,000 $ 1.54 Forfeited/Cancelled ( 33,919 ) $ 7.35 Outstanding — March 31, 2023 1,931,389 $ 11.05 6.45 $ 544 Exercisable — March 31, 2023 1,202,326 $ 15.70 4.82 $ 10 Vested or expected to vest — March 31, 2023 1,931,389 $ 11.05 6.45 $ 544 |
Schedule of Restricted Stock Units ("RSU") Activity | Restricted stock unit (“RSU”) activity under the 2014 Plan and 2015 Plan for the three months ended March 31, 2023, is summarized as follows: Number of Weighted Non-vested at December 31, 2022 633,270 $ 5.29 Granted 1,819,575 $ 1.73 Vested ( 236,023 ) $ 5.87 Forfeited ( 2,332 ) $ 5.13 Non-vested at March 31, 2023 2,214,490 $ 2.30 |
Stock-Based Compensation Expense Related to Stock Options | Stock-based compensation expense related to stock options is included in the following line items in the accompanying unaudited condensed consolidated statements of operations (in thousands): Three Months Ended March 31, 2023 2022 Research and development $ 374 $ 285 Selling, general and administrative 333 637 Total $ 707 $ 922 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Fair Value Disclosures [Abstract] | |
Summary of Financial Instruments Measured on a Recurring Basis | The following table summarizes the conclusions reached as of March 31, 2023 and December 31, 2022 for financial instruments measured at fair value on a recurring basis (in thousands): Fair Value Hierarchy Classification Balance Quoted Significant Significant March 31, 2023 Cash $ 563 $ 563 — — Restricted cash 218 218 — — Money market funds 26,350 26,350 — — Total assets $ 27,131 $ 27,131 — — Warrant liabilities $ 40,317 — — $ 40,317 Derivative liability 448 — — 448 Total liabilities $ 40,765 — — $ 40,765 December 31, 2022 Cash $ 415 $ 415 — — Restricted cash 218 218 — — Money market funds 45,399 45,399 — — Total assets $ 46,032 $ 46,032 — — Warrant liabilities $ 18,644 — — $ 18,644 Derivative liability 42 — — 42 Total liabilities $ 18,686 — — $ 18,686 |
Summary of Reconciliation of Beginning and Ending Balances for Liabilities Measured at Fair Value on Recurring Basis | A reconciliation of the beginning and ending balances for liabilities measured at fair value on a recurring basis using significant unobservable inputs (Level 3) is as follows (in thousands): Warrant Liabilities Balance – December 31, 2022 $ 18,644 Loss adjustment to fair value 21,673 Balance – March 31, 2023 $ 40,317 Derivative Liability Balance – December 31, 2022 $ 42 Loss adjustment to fair value 406 Balance – March 31, 2023 $ 448 |
Revenue (Tables)
Revenue (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Revenue from Contract with Customer [Abstract] | |
Summary of Activity in Each of Product Revenue Provision and Allowance Categories | The following table summarizes activity in each of the Company’s product revenue provision and allowance categories as of March 31, 2023 and 2022 (in thousands): Discounts and Chargebacks (1) Product Returns (2) Rebates and Incentives (3) Total Balance as of December 31, 2022 $ 255 $ 73 $ 1,213 $ 1,541 Provision related to current period revenue 392 12 943 1,347 Changes in estimate related to prior period revenue — — — — Credit/payments ( 324 ) ( 2 ) ( 699 ) ( 1,025 ) Balance as of March 31, 2023 $ 323 $ 83 $ 1,457 $ 1,863 Discounts and Chargebacks (1) Product Returns (2) Rebates and Incentives (3) Total Balance as of December 31, 2021 $ 249 $ 21 $ 1,110 $ 1,380 Provision related to current period revenue 272 10 1,092 1,374 Changes in estimate related to prior period revenue — — — — Credit/payments ( 122 ) — ( 1,040 ) ( 1,162 ) Balance as of March 31, 2022 $ 399 $ 31 $ 1,162 $ 1,592 (1) Discounts and chargebacks include fees for wholesaler fees, prompt pay and other discounts, and chargebacks. Discounts and chargebacks are deducted from gross revenue at the time revenues are recognized and are included as a reduction in accounts receivable or as an accrued expense based on their nature on the Company’s unaudited condensed consolidated balance sheet. (2) Provisions for product returns are deducted from gross revenues at the time revenues are recognized and are included in accrued expenses on the Company’s unaudited condensed consolidated balance sheet. (3) Rebates and incentives include rebates and co-pay program incentives. Provisions for rebates and incentives are deducted from gross revenues at the time revenues are recognized and are included in accrued expenses on the Company’s unaudited condensed consolidated balance sheets. |
Description of Business and B_2
Description of Business and Basis of Preparation - Additional Information (Detail) - USD ($) | 3 Months Ended | 12 Months Ended | ||
Mar. 31, 2023 | Mar. 31, 2022 | Dec. 31, 2022 | Mar. 30, 2023 | |
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | ||||
Accumulated deficit | $ 456,164,000 | $ 422,288,000 | ||
Net loss | (33,876,000) | $ (5,451,000) | $ (62,800,000) | |
Cash and cash equivalents and short-term investments | $ 54,800,000 | |||
Minimum outstanding term loan principal percentage for financial covenant waived | 50% | |||
Loan Agreement Amendment | ||||
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | ||||
Prepayment fee payable | $ 262,500 | |||
Upfront fee receivable | 90,000,000 | |||
Hercules Capital and Silicon Valley Bridge Bank [Member] | Loan Agreement Amendment | ||||
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | ||||
Prepayment fee payable | $ 35,000,000 | 300,000 | ||
Final payment payable under loan agreement | $ 1,400,000 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Additional Information (Detail) - USD ($) | Mar. 31, 2023 | Jan. 31, 2023 | Mar. 31, 2022 |
Subsidiary Sale Of Stock [Line Items] | |||
Credit loss allowance of short-term investments | $ 0 | ||
Credit loss allowance of accounts receivable | $ 0 | ||
ASU 2016-13 | |||
Subsidiary Sale Of Stock [Line Items] | |||
Change in Accounting Principle, Accounting Standards Update, Adopted [true false] | true | ||
Change in Accounting Principle, Accounting Standards Update, Early Adoption [true false] | true | ||
Change in Accounting Principle, Accounting Standards Update, Adoption Date | Mar. 31, 2023 | ||
Change in Accounting Principle, Accounting Standards Update, Immaterial Effect [true false] | true | ||
December 2020 Public Offering | Pre-funded Warrants | |||
Subsidiary Sale Of Stock [Line Items] | |||
Number of outstanding warrants issued to purchase common stock (in shares) | 3,200,000 | 3,200,000 | |
April 2022 Public Offering | |||
Subsidiary Sale Of Stock [Line Items] | |||
Number of outstanding warrants issued to purchase common stock (in shares) | 363,000 | ||
April 2022 Public Offering | Pre-funded Warrants | |||
Subsidiary Sale Of Stock [Line Items] | |||
Number of outstanding warrants issued to purchase common stock (in shares) | 11,303,667 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Schedule of Diluted Net Loss Per Common Share (Detail) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | Dec. 31, 2022 | |
Accounting Policies [Abstract] | |||
Net loss | $ (33,876) | $ (5,451) | $ (62,800) |
Dilutive effect of convertible debt | 0 | (584) | |
Net loss allocated to common shares | $ (33,876) | $ (6,035) | |
Weighted average common shares outstanding – basic | 47,757,246 | 32,051,228 | |
Dilutive effect of convertible debt | 0 | 1,138,200 | |
Weighted average common shares outstanding – diluted | 47,757,246 | 33,189,428 | |
Net loss per share – diluted | $ (0.71) | $ (0.18) |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies - Schedule of Potentially Dilutive Shares (Detail) - shares | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive securities (in shares) | 27,332,890 | 10,879,564 |
Outstanding stock options | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive securities (in shares) | 1,931,389 | 2,050,094 |
Outstanding restricted stock units | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive securities (in shares) | 2,214,490 | 981,841 |
December 2020 Public Offering Series 2 | Warrant | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive securities (in shares) | 6,800,000 | 6,800,000 |
April 2022 Public Offering | Warrant | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive securities (in shares) | 15,000,000 | 0 |
March 2018 Public Offering Series 2 | Warrant | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive securities (in shares) | 0 | 798,810 |
Warrants to purchase common stock associated with Loan Agreement | Warrant | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive securities (in shares) | 198,811 | 198,819 |
Common stock associated with March 2019 Notes | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive securities (in shares) | 1,138,200 | 0 |
Warrants to purchase common stock associated with Danforth | Warrant | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive securities (in shares) | 50,000 | 50,000 |
Short-term investments - Summar
Short-term investments - Summary of Short-term Investments (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Schedule of Held-to-Maturity Securities [Line Items] | ||
Amortized Cost | $ 27,908 | $ 27,689 |
Unrealized Gains | 0 | 0 |
Unrealized Losses | (64) | (160) |
Fair Value | 27,844 | 27,529 |
U.S. government securities | ||
Schedule of Held-to-Maturity Securities [Line Items] | ||
Amortized Cost | 27,908 | 27,689 |
Unrealized Gains | 0 | 0 |
Unrealized Losses | (64) | (160) |
Fair Value | $ 27,844 | $ 27,529 |
Short-term Investments - Additi
Short-term Investments - Additional Information (Details) $ in Millions | Mar. 31, 2023 USD ($) |
Investments, Debt and Equity Securities [Abstract] | |
Held-to-maturity investments | $ 27.9 |
Prepaid Expenses and Other Cu_3
Prepaid Expenses and Other Current Assets - Schedule of Prepaid Expenses and Other Current Assets (Detail) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | ||
Prepaid research and development services | $ 569 | $ 635 |
Prepaid insurance | 328 | 622 |
Other prepaid expenses | 538 | 1,184 |
Other current assets | 291 | 62 |
Total prepaid expenses and other current assets | $ 1,726 | $ 2,503 |
Inventory - Schedule of Invento
Inventory - Schedule of Inventory (Detail) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 7,724 | $ 5,093 |
Work in process | 698 | 610 |
Finished goods | 11 | 24 |
Total inventory | $ 8,433 | $ 5,727 |
Inventory - Additional Informat
Inventory - Additional Information (Detail) - USD ($) $ in Millions | Mar. 31, 2023 | Dec. 31, 2022 |
Other Assets | ||
Inventory [Line Items] | ||
Raw material classified as long term | $ 7.3 | $ 4.9 |
Accrued Expenses - Schedule of
Accrued Expenses - Schedule of Accrued Expenses (Detail) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Payables and Accruals [Abstract] | ||
Accrued research and development expenses | $ 1,249 | $ 786 |
Accrued employee bonus compensation | 498 | 1,628 |
Other accrued expenses | 1,543 | 1,313 |
Accrued severance | 28 | 688 |
Accrued co-pay rebates | 760 | 595 |
Accrued other rebates | 697 | 618 |
Total accrued expenses | $ 4,775 | $ 5,628 |
Borrowings - Additional Informa
Borrowings - Additional Information (Detail) | 1 Months Ended | 3 Months Ended | ||||||
May 13, 2021 USD ($) Tranche | Mar. 07, 2019 USD ($) | Feb. 28, 2023 USD ($) | Mar. 31, 2023 USD ($) | Mar. 31, 2022 USD ($) | Mar. 30, 2023 USD ($) | Dec. 31, 2022 USD ($) | Dec. 31, 2021 | |
Debt Instrument [Line Items] | ||||||||
Face amount | $ 36,383,000 | |||||||
Outstanding principal plus all accrued and unpaid interest amount payable to lenders | $ 0 | $ 34,393,000 | ||||||
Minimum outstanding term loan principal percentage for financial covenant waived | 50% | |||||||
Amortization of debt issuance costs and discount | $ 255,000 | $ 390,000 | ||||||
Deferred fees, fully paid | $ 5,800,000 | |||||||
Other Liabilities | ||||||||
Debt Instrument [Line Items] | ||||||||
Interest rate, deferred fees | 12.75% | 12.75% | ||||||
SVB | ||||||||
Debt Instrument [Line Items] | ||||||||
Minimum outstanding term loan principal percentage for financial covenant waived | 50% | |||||||
Loan and Security Agreement | ||||||||
Debt Instrument [Line Items] | ||||||||
Fair value of loan payable | $ 36,600,000 | $ 34,400,000 | ||||||
Loan and Security Agreement | Level 3 Inputs | Secured Spread | ||||||||
Debt Instrument [Line Items] | ||||||||
Debt instrument, measurement input | 9.48 | 9.84 | ||||||
Loan and Security Agreement | Level 3 Inputs | Risk Free Rate | ||||||||
Debt Instrument [Line Items] | ||||||||
Debt instrument, measurement input | 4.80 | 4.37 | ||||||
Loan and Security Agreement | Level 3 Inputs | Secured Yield | ||||||||
Debt Instrument [Line Items] | ||||||||
Debt instrument, measurement input | 14.28 | 14.21 | ||||||
Loan Agreement Amendment | ||||||||
Debt Instrument [Line Items] | ||||||||
Prepayment fee payable | $ 262,500 | |||||||
Final payment payable under loan agreement | 1,382,500 | |||||||
Upfront fee receivable | 90,000,000 | |||||||
Loan Agreement Amendment | Hercules Capital Incorporated And Silicon Valley Bank And Other Lenders | ||||||||
Debt Instrument [Line Items] | ||||||||
Outstanding principal plus all accrued and unpaid interest amount payable to lenders | $ 35,400,000 | |||||||
Term Loan | Loan and Security Agreement | ||||||||
Debt Instrument [Line Items] | ||||||||
Basis spread on variable rate (as a percent) | 9.05% | |||||||
Term Loan | Loan and Security Agreement | Prime Rate | ||||||||
Debt Instrument [Line Items] | ||||||||
Basis spread on variable rate (as a percent) | 5.80% | |||||||
Term Loan | Loan and Security Agreement | Hercules Capital Inc. and Silicon Valley Bank | ||||||||
Debt Instrument [Line Items] | ||||||||
Number of available tranches | Tranche | 4 | |||||||
Term Loan | Loan Agreement Amendment | ||||||||
Debt Instrument [Line Items] | ||||||||
Face amount | $ 60,000,000 | |||||||
Initial Tranche of Term Loan | Loan and Security Agreement | ||||||||
Debt Instrument [Line Items] | ||||||||
Additional borrowing amount available | 20,000,000 | |||||||
Second Tranche of Term Loan | Loan and Security Agreement | ||||||||
Debt Instrument [Line Items] | ||||||||
Additional borrowing amount available | 10,000,000 | |||||||
Third Tranche of Term Loan | Loan and Security Agreement | ||||||||
Debt Instrument [Line Items] | ||||||||
Additional borrowing amount available | 5,000,000 | |||||||
Fourth Tranche of Term Loan | Loan and Security Agreement | ||||||||
Debt Instrument [Line Items] | ||||||||
Additional borrowing amount available | 25,000,000 | |||||||
Increment debt amount | $ 5,000,000 | |||||||
Senior Convertible Note Purchase Agreement | ||||||||
Debt Instrument [Line Items] | ||||||||
Face amount | $ 16,000,000 | |||||||
Notes maturity date | Mar. 15, 2025 | |||||||
Date of issuance and sale of notes | Mar. 07, 2019 | |||||||
Proceeds from debt, net of issuance costs | $ 14,700,000 | |||||||
Payment of debt issuance costs | $ 1,300,000 | |||||||
Senior convertible notes | $ 11,000,000 | $ 11,000,000 | ||||||
Bifurcated embedded conversion option derivative liability | 400,000 | 42,000,000 | ||||||
Derivative, fair value | 7,000,000 | |||||||
Gain (loss) on fair value adjustment of derivative liability | (400,000) | 1,000,000 | ||||||
Amortization of debt issuance costs and discount | 0 | $ 200,000 | ||||||
Fair value of convertible debt and derivative liability | $ 11,700,000 | $ 10,800,000 | ||||||
Interest rate | 6% | |||||||
Payment terms | The March 2019 Notes bear interest at a rate of 6.0% per annum payable semiannually in arrears on March 15 and September 15 of each year, beginning September 15, 2019. The March 2019 Notes will mature on March 15, 2025, unless earlier converted, redeemed or repurchased. |
Borrowings - Schedule of Future
Borrowings - Schedule of Future Principal Debt Payments On Currently Outstanding Loan Payable (Detail) $ in Thousands | Mar. 31, 2023 USD ($) |
Debt Disclosure [Abstract] | |
2023 | $ 35,000 |
Total principal payments | 35,000 |
Final fee due at maturity | 1,383 |
Total principal and final fee payment | 36,383 |
Unamortized discount and debt issuance costs | (1,735) |
Loan payable, current portion | $ 34,648 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) | 3 Months Ended | ||
Mar. 01, 2018 USD ($) ft² | Mar. 31, 2023 USD ($) | Mar. 31, 2022 USD ($) | |
Commitment And Contingencies [Line Items] | |||
Long-term lease agreement, area of office space | ft² | 19,275 | ||
Lease term | 11 years | ||
Total lease payments | $ 7,300,000 | $ 177,000 | $ 174,000 |
Lessee, operating lease, existence of option to extend | true | ||
Renewal term | 5 years | ||
Renewal term, description | The Company has the option to renew for two consecutive five-year periods from the end of the first term and the Company is not reasonably certain that the option to renew the Lease will be exercised. Under the Lease, the Company furnished a security deposit in the form of a standby letter of credit in the amount of $0.3 million, which was reduced by fifty-five thousand dollars on the first anniversary of the commencement date. The security deposit will continue to be reduced by fifty-five thousand dollars every two years on the commencement date anniversary for eight years. | ||
Security deposit in the form of a standby letter of credit | $ 300,000 | ||
Decrease in security deposit | $ 55,000 | ||
Maximum | |||
Commitment And Contingencies [Line Items] | |||
Milestone payments from the Company | $ 19,000,000 |
Commitments and Contingencies_2
Commitments and Contingencies - Summary of Quantitative Information Associated with Amounts Recognized in Unaudited Condensed Consolidated Financial Statements for Lease (Detail) - USD ($) $ in Thousands | 3 Months Ended | |||
Mar. 01, 2018 | Mar. 31, 2023 | Mar. 31, 2022 | Dec. 31, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | ||||
Operating lease cost | $ 166 | $ 166 | ||
Variable lease cost | 58 | (3) | ||
Total operating lease expense | 224 | 163 | ||
Total lease payments | $ 7,300 | $ 177 | $ 174 | |
Remaining Lease term (years) | 6 years 4 months 2 days | 6 years 7 months 2 days | ||
Discount rate | 15% | 15% |
Commitments and Contingencies_3
Commitments and Contingencies - Future Minimum Lease Payments (Detail) $ in Thousands | Mar. 31, 2023 USD ($) |
Commitments and Contingencies Disclosure [Abstract] | |
2023 | $ 538 |
2024 | 730 |
2025 | 744 |
2026 | 759 |
2027 | 774 |
Thereafter | 1,256 |
Total | $ 4,801 |
Commitments and Contingencies_4
Commitments and Contingencies - Presentation of Operating Lease Liability (Detail) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Commitments and Contingencies Disclosure [Abstract] | ||
Present value of future minimum lease payments | $ 3,138 | |
Operating lease liability, current portion | 296 | $ 282 |
Operating lease liability, long-term portion | 2,842 | $ 2,921 |
Total operating lease liability | 3,138 | |
Difference between future minimum lease payments and discounted cash flows | $ 1,663 |
Stockholders' Equity - Addition
Stockholders' Equity - Additional Information (Detail) - USD ($) | 3 Months Ended | |||||
Apr. 10, 2020 | Mar. 31, 2023 | Mar. 31, 2022 | Apr. 30, 2023 | Jan. 31, 2023 | Dec. 31, 2022 | |
Schedule Of Capitalization Equity [Line Items] | ||||||
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 | ||||
Common stock, shares authorized (in shares) | 150,000,000 | 150,000,000 | ||||
Common stock, shares issued (in shares) | 33,327,627 | 32,682,342 | ||||
Common stock, shares outstanding (in shares) | 33,327,627 | 32,682,342 | ||||
Proceeds from common stock issued | $ 0 | $ 2,164,000 | ||||
Warrant liabilities fair value adjustment | 21,673,000 | $ (10,030,000) | ||||
Warrant liabilities | $ 40,300,000 | $ 18,600,000 | ||||
Cantor Fitzgerald & Co. and Ladenburg Thalmann & Co. Inc. | Sales Agreement | ||||||
Schedule Of Capitalization Equity [Line Items] | ||||||
Common stock issued, net of expenses (in shares) | 0 | 137,610 | ||||
Proceeds from common stock issued | $ 0 | $ 700,000 | ||||
Aspire Capital | Common Stock Purchase Agreement | ||||||
Schedule Of Capitalization Equity [Line Items] | ||||||
Common stock issued, net of expenses (in shares) | 350,000 | |||||
Proceeds from common stock issued | $ 1,500,000 | |||||
Maximum | Aspire Capital | Common Stock Purchase Agreement | ||||||
Schedule Of Capitalization Equity [Line Items] | ||||||
Sale of common stock at sole discretion | $ 20,000,000 | |||||
April 2022 Public Offering | ||||||
Schedule Of Capitalization Equity [Line Items] | ||||||
Number of warrants issued to purchase common stock (in shares) | 363,000 | |||||
Pre-funded warrants were exercised for proceeds | $ 3,553,000 | |||||
April 2022 Public Offering | Subsequent Event | ||||||
Schedule Of Capitalization Equity [Line Items] | ||||||
Number of warrants issued to purchase common stock (in shares) | 3,189,815 |
Stockholders' Equity - Summary
Stockholders' Equity - Summary of Common Stock Shares Activity (Detail) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | Dec. 31, 2022 | |
Common Stock Outstanding Roll Forward [Roll Forward] | |||
Beginning balance | $ 3,233 | $ 41,258 | $ 41,258 |
Beginning balance (in shares) | 32,682,342 | ||
Net loss | $ (33,876) | (5,451) | (62,800) |
Stock-based compensation expense | 707 | 922 | |
Common stock issued through employee stock purchase plan | 4 | 10 | |
Common stock issued, net of expenses | 0 | 2,135 | |
Common stock issued for vested restricted stock units | 18 | (18) | |
Vested Loan Agreement warrants | 71 | ||
Ending balance | $ (29,914) | 38,927 | $ 3,233 |
Ending balance (in shares) | 33,327,627 | 32,682,342 | |
Common Stock | |||
Common Stock Outstanding Roll Forward [Roll Forward] | |||
Beginning balance | $ 36 | $ 32 | $ 32 |
Beginning balance (in shares) | 32,682,342 | 28,705,334 | 28,705,334 |
Net loss | $ 0 | $ 0 | |
Stock-based compensation expense | 0 | 0 | |
Common stock issued through employee stock purchase plan | $ 0 | $ 0 | |
Common stock issued through employee stock purchase (in shares) | 2,662 | 3,120 | |
Common stock issued, net of expenses | $ 0 | $ 0 | |
Common stock issued, net of expenses (in shares) | 363,000 | 487,610 | |
Common stock issued for vested restricted stock units | $ 0 | $ 0 | |
Common stock issued for vested restricted stock units (in shares) | 279,623 | 25,094 | |
Vested Loan Agreement warrants | $ 0 | ||
Ending balance | $ 36 | $ 32 | $ 36 |
Ending balance (in shares) | 33,327,627 | 29,221,158 | 32,682,342 |
Additional Paid-in Capital | |||
Common Stock Outstanding Roll Forward [Roll Forward] | |||
Beginning balance | $ 425,485 | $ 400,705 | $ 400,705 |
Net loss | 0 | 0 | |
Stock-based compensation expense | 707 | 922 | |
Common stock issued through employee stock purchase plan | 4 | 10 | |
Common stock issued, net of expenses | 0 | 2,135 | |
Common stock issued for vested restricted stock units | 18 | (18) | |
Vested Loan Agreement warrants | 71 | ||
Ending balance | 426,214 | 403,825 | 425,485 |
Accumulated Deficit | |||
Common Stock Outstanding Roll Forward [Roll Forward] | |||
Beginning balance | (422,288) | (359,479) | (359,479) |
Net loss | (33,876) | (5,451) | |
Stock-based compensation expense | 0 | 0 | |
Common stock issued through employee stock purchase plan | 0 | 0 | |
Common stock issued, net of expenses | 0 | 0 | |
Common stock issued for vested restricted stock units | 0 | 0 | |
Vested Loan Agreement warrants | 0 | ||
Ending balance | $ (456,164) | $ (364,930) | $ (422,288) |
Stockholders' Equity - Schedule
Stockholders' Equity - Schedule of Reserved Shares of Common Stock for Future Issuance (Detail) - shares | Mar. 31, 2023 | Dec. 31, 2022 |
Class of Stock [Line Items] | ||
Common shares reserved for future issuance | 42,993,456 | 42,489,050 |
Stock options | ||
Class of Stock [Line Items] | ||
Common shares reserved for future issuance | 1,931,389 | 1,740,308 |
Restricted Stock Units | ||
Class of Stock [Line Items] | ||
Common shares reserved for future issuance | 2,214,490 | 633,270 |
Warrant | March 2018 Public Offering | ||
Class of Stock [Line Items] | ||
Common shares reserved for future issuance | 0 | 798,810 |
Warrant | December 2020 Public Offering Series 2 | ||
Class of Stock [Line Items] | ||
Common shares reserved for future issuance | 6,800,000 | 6,800,000 |
Warrant | Prefunded Warrants to Purchase Common Stock Associated with December 2020 Public Offering | ||
Class of Stock [Line Items] | ||
Common shares reserved for future issuance | 3,200,000 | 3,200,000 |
Warrant | Warrants to Purchase Common Stock Associated With April 2022 Public Offering | ||
Class of Stock [Line Items] | ||
Common shares reserved for future issuance | 15,000,000 | 15,000,000 |
Warrant | April 2022 Public Offering | ||
Class of Stock [Line Items] | ||
Common shares reserved for future issuance | 11,303,667 | 11,666,667 |
Warrant | Warrant to purchase common stock associated with Danforth | ||
Class of Stock [Line Items] | ||
Common shares reserved for future issuance | 50,000 | 50,000 |
Warrant | Warrants to purchase common stock associated with Loan Agreement | ||
Class of Stock [Line Items] | ||
Common shares reserved for future issuance | 198,811 | 198,811 |
March 2019 Notes | ||
Class of Stock [Line Items] | ||
Common shares reserved for future issuance | 1,138,200 | 1,138,200 |
2014 Employee Stock Purchase Plan | ||
Class of Stock [Line Items] | ||
Common shares reserved for future issuance | 279 | 0 |
2014 Plan | ||
Class of Stock [Line Items] | ||
Common shares reserved for future issuance | 590,207 | 712,020 |
2015 Plan | ||
Class of Stock [Line Items] | ||
Common shares reserved for future issuance | 566,413 | 550,964 |
Stock-based Compensation - 2014
Stock-based Compensation - 2014 Equity Incentive Plan (Detail) - 2014 Equity Incentive Plan - shares | Jan. 01, 2023 | Jan. 01, 2022 | Mar. 31, 2023 |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Share-based compensation arrangement by share-based payment award, number of additional shares authorized | 1,901,960 | 1,148,213 | |
Possible future issuance under equity compensation plan (in shares) | 590,207 |
Stock-based Compensation - 2015
Stock-based Compensation - 2015 Inducement Award Plan (Detail) - shares | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Option to purchase (shares) | 225,000 | |
2015 Inducement Award Plan | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Possible future issuance under equity compensation plan (in shares) | 566,413 | |
Option to purchase (shares) | 0 | 69,000 |
Stock-based Compensation - Stoc
Stock-based Compensation - Stock Option Activity (Detail) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended |
Mar. 31, 2023 | Dec. 31, 2022 | |
Number of Shares | ||
Beginning balance - Outstanding (shares) | 1,740,308 | |
Granted (shares) | 225,000 | |
Forfeited/Cancelled (shares) | (33,919) | |
Ending balance - Outstanding (shares) | 1,931,389 | 1,740,308 |
Exercisable (shares) | 1,202,326 | |
Vested or expected to vest (shares) | 1,931,389 | |
Weighted- Average Exercise Price | ||
Beginning balance - Outstanding (in dollars per share) | $ 12.21 | |
Granted (in dollars per share) | 1.54 | |
Forfeited/Cancelled (in dollars per share) | 7.35 | |
Ending balance - Outstanding (in dollars per share) | 11.05 | $ 12.21 |
Exercisable (in dollars per share) | 15.70 | |
Vested or expected to vest (in dollars per share) | $ 11.05 | |
Weighted- Average Remaining Contractual Life (in years) | ||
Balance - Outstanding | 6 years 5 months 12 days | 6 years 1 month 28 days |
Exercisable | 4 years 9 months 25 days | |
Vested or expected to vest | 6 years 5 months 12 days | |
Aggregate Intrinsic Value ($000) | ||
Balance - Outstanding | $ 544 | $ 0 |
Exercisable | 10 | |
Vested and expected to vest | $ 544 |
Stock-based Compensation - Sche
Stock-based Compensation - Schedule of Restricted Stock Units ("RSU") Activity (Detail) - Outstanding restricted stock units | 3 Months Ended |
Mar. 31, 2023 $ / shares shares | |
Number of Shares | |
Beginning balance - Outstanding (shares) | shares | 633,270 |
Options granted in period (shares) | shares | 1,819,575 |
Vested (shares) | shares | (236,023) |
Forfeited (shares) | shares | (2,332) |
Ending balance - Outstanding (shares) | shares | 2,214,490 |
Weighted Average Grant Date Fair Value Per Share | |
Beginning balance - Outstanding (in dollars per share) | $ / shares | $ 5.29 |
Granted (in dollars per share) | $ / shares | 1.73 |
Vested (in dollars per share) | $ / shares | 5.87 |
Forfeited (in dollars per share) | $ / shares | 5.13 |
Ending balance - Outstanding (in dollars per share) | $ / shares | $ 2.30 |
Vesting percentage | 25% |
Vesting period of options | 4 years |
Stock-based Compensation - Comp
Stock-based Compensation - Compensation Cost (Detail) - USD ($) | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Share-Based Payment Arrangement [Abstract] | ||
Stock-based compensation expense | $ 707,000 | $ 922,000 |
Tax benefit from compensation expense | $ 0 | $ 0 |
Stock-based Compensation - St_2
Stock-based Compensation - Stock-Based Compensation Expense Related to Stock Options (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Stock-based compensation expense | $ 707 | $ 922 |
Research and development | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Stock-based compensation expense | 374 | 285 |
Selling, general and administrative | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Stock-based compensation expense | $ 333 | $ 637 |
Fair Value Measurements - Summa
Fair Value Measurements - Summary of Financial Instruments Measured on a Recurring Basis (Detail) - Fair Value, Measurements, Recurring - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | ||
Fair value of financial assets | $ 27,131 | $ 46,032 |
Fair value of financial liabilities | 40,765 | 18,686 |
Warrant liabilities | ||
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | ||
Fair value of financial liabilities | 40,317 | 18,644 |
Derivative liabilities | ||
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | ||
Fair value of financial liabilities | 448 | 42 |
Cash | ||
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | ||
Fair value of financial assets | 563 | 415 |
Restricted cash | ||
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | ||
Fair value of financial assets | 218 | 218 |
Money market funds | ||
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | ||
Fair value of financial assets | 26,350 | 45,399 |
Quoted Prices in Active Markets for Identical Assets (Level 1) | ||
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | ||
Fair value of financial assets | 27,131 | 46,032 |
Fair value of financial liabilities | 0 | 0 |
Quoted Prices in Active Markets for Identical Assets (Level 1) | Warrant liabilities | ||
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | ||
Fair value of financial liabilities | 0 | 0 |
Quoted Prices in Active Markets for Identical Assets (Level 1) | Derivative liabilities | ||
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | ||
Fair value of financial liabilities | 0 | 0 |
Quoted Prices in Active Markets for Identical Assets (Level 1) | Cash | ||
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | ||
Fair value of financial assets | 563 | 415 |
Quoted Prices in Active Markets for Identical Assets (Level 1) | Restricted cash | ||
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | ||
Fair value of financial assets | 218 | 218 |
Quoted Prices in Active Markets for Identical Assets (Level 1) | Money market funds | ||
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | ||
Fair value of financial assets | 26,350 | 45,399 |
Significant Other Observable Inputs (Level 2) | ||
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | ||
Fair value of financial assets | 0 | 0 |
Fair value of financial liabilities | 0 | 0 |
Significant Other Observable Inputs (Level 2) | Warrant liabilities | ||
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | ||
Fair value of financial liabilities | 0 | 0 |
Significant Other Observable Inputs (Level 2) | Derivative liabilities | ||
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | ||
Fair value of financial liabilities | 0 | 0 |
Significant Other Observable Inputs (Level 2) | Cash | ||
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | ||
Fair value of financial assets | 0 | 0 |
Significant Other Observable Inputs (Level 2) | Restricted cash | ||
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | ||
Fair value of financial assets | 0 | 0 |
Significant Other Observable Inputs (Level 2) | Money market funds | ||
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | ||
Fair value of financial assets | 0 | 0 |
Significant Unobservable Inputs (Level 3) | ||
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | ||
Fair value of financial assets | 0 | 0 |
Fair value of financial liabilities | 40,765 | 18,686 |
Significant Unobservable Inputs (Level 3) | Warrant liabilities | ||
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | ||
Fair value of financial liabilities | 40,317 | 18,644 |
Significant Unobservable Inputs (Level 3) | Derivative liabilities | ||
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | ||
Fair value of financial liabilities | 448 | 42 |
Significant Unobservable Inputs (Level 3) | Cash | ||
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | ||
Fair value of financial assets | 0 | 0 |
Significant Unobservable Inputs (Level 3) | Restricted cash | ||
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | ||
Fair value of financial assets | 0 | 0 |
Significant Unobservable Inputs (Level 3) | Money market funds | ||
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | ||
Fair value of financial assets | $ 0 | $ 0 |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Detail) - Significant Unobservable Inputs (Level 3) | Mar. 31, 2023 |
Stock Price Volatility | |
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | |
Derivative liabilities, unobservable inputs rate | 82.3 |
Stock Price Volatility | Minimum | |
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | |
Warrant liabilities, stock price volatility rate | 100.8 |
Stock Price Volatility | Maximum | |
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | |
Warrant liabilities, stock price volatility rate | 111.9 |
Stock Price Volatility | Weighted Average | |
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | |
Warrant liabilities, stock price volatility rate | 102.1 |
Market Credit Spread | |
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | |
Derivative liabilities, unobservable inputs rate | 1,454 |
Estimated Yield | |
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | |
Derivative liabilities, unobservable inputs rate | 18.6 |
Fair Value Measurements - Sum_2
Fair Value Measurements - Summary of Reconciliation of Beginning and Ending Balances for Liabilities Measured at Fair Value on Recurring Basis (Detail) $ in Thousands | 3 Months Ended |
Mar. 31, 2023 USD ($) | |
Warrant | |
Fair Value Liabilities Measured On Recurring Basis Unobservable Input Reconciliation [Line Items] | |
Beginning balance | $ 18,644 |
Loss adjustment to fair value | 21,673 |
Ending balance | 40,317 |
Derivative liabilities | |
Fair Value Liabilities Measured On Recurring Basis Unobservable Input Reconciliation [Line Items] | |
Beginning balance | 42 |
Loss adjustment to fair value | 406 |
Ending balance | $ 448 |
Revenue - Additional Informatio
Revenue - Additional Information (Detail) - USD ($) | 3 Months Ended | ||
Mar. 30, 2023 | Mar. 31, 2023 | Mar. 31, 2022 | |
Disaggregation Of Revenue [Line Items] | |||
Net product revenue | $ 1,130,000 | $ 687,000 | |
Revenue, Product and Service [Extensible Enumeration] | Product [Member] | Product [Member] | |
License Agreement | GlaxoSmithKline Intellectual Property | |||
Disaggregation Of Revenue [Line Items] | |||
Upfront payment | $ 90,000,000 | ||
Exclusive License And Collaboration Agreement | |||
Disaggregation Of Revenue [Line Items] | |||
Revenue recognized | $ 0 | $ 0 | |
Achivement of Threshold Upto 200 Million | License Agreement | GlaxoSmithKline Intellectual Property | |||
Disaggregation Of Revenue [Line Items] | |||
Sales milestone payable upon achievement of threshold limit | 77,500,000 | ||
Achivement of Threshold Upto 300 million to 500 Million | License Agreement | GlaxoSmithKline Intellectual Property | |||
Disaggregation Of Revenue [Line Items] | |||
Sales milestone payable upon achievement of threshold limit | 65,000,000 | ||
Achivement of Threshold Upto 750 million to 1 Billion | License Agreement | GlaxoSmithKline Intellectual Property | |||
Disaggregation Of Revenue [Line Items] | |||
Sales milestone payable upon achievement of threshold limit | 50,000,000 | ||
Successful Completion of Mario Study | License Agreement | GlaxoSmithKline Intellectual Property | |||
Disaggregation Of Revenue [Line Items] | |||
Success-based development milestones receivable | 10,500,000 | ||
Maximum | License Agreement | GlaxoSmithKline Intellectual Property | |||
Disaggregation Of Revenue [Line Items] | |||
Regulatory milestone payments receivable | 70,000,000 | ||
Commercial milestones payments receivable | 115,000,000 | ||
Sales milestone payments receivable | 242,500,000 | ||
Success-based development milestones receivable | 75,500,000 | ||
Maximum | Achivement of Three Interim Milestone of Ongoing Mario Study | License Agreement | GlaxoSmithKline Intellectual Property | |||
Disaggregation Of Revenue [Line Items] | |||
Success-based development milestones receivable | $ 65,000,000 | ||
Sales Revenue Net | Customer Concentration Risk | Wholesaler One | |||
Disaggregation Of Revenue [Line Items] | |||
Percentage of gross revenue | 46% | ||
Sales Revenue Net | Customer Concentration Risk | Wholesaler Two | |||
Disaggregation Of Revenue [Line Items] | |||
Percentage of gross revenue | 26% | ||
Sales Revenue Net | Customer Concentration Risk | Wholesaler Three | |||
Disaggregation Of Revenue [Line Items] | |||
Percentage of gross revenue | 25% |
Revenue - Summary of Activity i
Revenue - Summary of Activity in Each of Product Revenue Provision and Allowance Categories (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Disaggregation Of Revenue [Line Items] | ||
Balance | $ 1,541 | $ 1,380 |
Provision related to current period revenue | 1,347 | 1,374 |
Changes in estimate related to prior period revenue | 0 | 0 |
Credit/payments | (1,025) | (1,162) |
Balance | 1,863 | 1,592 |
Discounts and Chargebacks | ||
Disaggregation Of Revenue [Line Items] | ||
Balance | 255 | 249 |
Provision related to current period revenue | 392 | 272 |
Changes in estimate related to prior period revenue | 0 | 0 |
Credit/payments | (324) | (122) |
Balance | 323 | 399 |
Product Returns | ||
Disaggregation Of Revenue [Line Items] | ||
Balance | 73 | 21 |
Provision related to current period revenue | 12 | 10 |
Changes in estimate related to prior period revenue | 0 | 0 |
Credit/payments | (2) | 0 |
Balance | 83 | 31 |
Rebates and Incentives | ||
Disaggregation Of Revenue [Line Items] | ||
Balance | 1,213 | 1,110 |
Provision related to current period revenue | 943 | 1,092 |
Changes in estimate related to prior period revenue | 0 | 0 |
Credit/payments | (699) | (1,040) |
Balance | $ 1,457 | $ 1,162 |