Cover
Cover - USD ($) | 12 Months Ended | ||
Dec. 31, 2022 | Mar. 13, 2023 | Jun. 30, 2022 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Period End Date | Dec. 31, 2022 | ||
Current Fiscal Year End Date | --12-31 | ||
Document Transition Report | false | ||
Entity File Number | 001-36183 | ||
Entity Registrant Name | Eiger BioPharmaceuticals, Inc. | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Tax Identification Number | 33-0971591 | ||
Entity Address, Address Line One | 2155 Park Boulevard | ||
Entity Address, City or Town | Palo Alto | ||
Entity Address, State or Province | CA | ||
Entity Address, Postal Zip Code | 94306 | ||
City Area Code | 650 | ||
Local Phone Number | 272 6138 | ||
Title of 12(b) Security | Common Stock, par value $0.001 per share | ||
Trading Symbol | EIGR | ||
Security Exchange Name | NASDAQ | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | false | ||
ICFR Auditor Attestation Flag | false | ||
Entity Shell Company | false | ||
Entity Public Float | $ 274,107,513 | ||
Entity Common Stock, Shares Outstanding | 44,158,437 | ||
Documents Incorporated by Reference | DOCUMENTS INCORPORATED BY REFERENCE Part III incorporates certain information by reference from the registrant’s proxy statement for the 2023 Annual Meeting of Shareholders. Such proxy statement will be filed no later than 120 days after the close of the registrant’s fiscal year ended December 31, 2022. | ||
Amendment Flag | false | ||
Document Fiscal Period Focus | FY | ||
Entity Central Index Key | 0001305253 | ||
Document Fiscal Year Focus | 2022 |
Audit Information
Audit Information | 12 Months Ended |
Dec. 31, 2022 | |
Audit Information [Abstract] | |
Auditor Firm ID | 185 |
Auditor Name | KPMG LLP |
Auditor Location | San Francisco, CA |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash and cash equivalents | $ 25,798 | $ 22,221 |
Short-term debt securities | 73,150 | 66,594 |
Accounts receivable, net | 1,749 | 2,576 |
Inventories | 2,853 | 2,612 |
Prepaid expenses and other current assets | 13,985 | 9,361 |
Total current assets | 117,535 | 103,364 |
Long-term debt securities | 0 | 17,262 |
Property and equipment, net | 696 | 613 |
Operating lease right-of-use assets | 561 | 653 |
Other assets | 1,347 | 4,510 |
Total assets | 120,139 | 126,402 |
Current liabilities: | ||
Accounts payable | 8,975 | 7,765 |
Accrued liabilities | 15,655 | 13,699 |
Current portion of operating lease liabilities | 491 | 628 |
Debt, current portion | 0 | 7,809 |
Total current liabilities | 25,121 | 29,901 |
Debt, net of current portion | 39,625 | 23,986 |
Operating lease liabilities | 83 | 116 |
Total liabilities | 64,829 | 54,003 |
Stockholders’ equity: | ||
Common stock, $0.001 par value, 200,000,000 shares authorized as of December 31, 2022 and 2021; 44,074,284 and 34,568,821 shares issued and outstanding as of December 31, 2022 and 2021, respectively | 44 | 35 |
Additional paid-in capital | 492,759 | 412,930 |
Accumulated other comprehensive loss | (300) | (149) |
Accumulated deficit | (437,193) | (340,417) |
Total stockholders’ equity | 55,310 | 72,399 |
Total liabilities and stockholders’ equity | $ 120,139 | $ 126,402 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Revenues [Abstract] | |||
Total revenue | $ 13,484,000 | $ 12,142,000 | $ 0 |
Costs and operating expenses: | |||
Cost of sales | 1,837,000 | 745,000 | 0 |
Research and development | 75,282,000 | 64,436,000 | 41,590,000 |
Selling, general and administrative | 29,105,000 | 23,900,000 | 20,559,000 |
Total costs and operating expenses | 106,224,000 | 89,081,000 | 62,149,000 |
Loss from operations | (92,740,000) | (76,939,000) | (62,149,000) |
Interest expense | (4,132,000) | (3,559,000) | (3,594,000) |
Interest income | 1,082,000 | 158,000 | 704,000 |
Other (expense) income, net | (963,000) | 46,487,000 | (12,000) |
Loss before provision for income taxes | (96,753,000) | (33,853,000) | (65,051,000) |
Provision for income taxes | 23,000 | 64,000 | 0 |
Net loss | $ (96,776,000) | $ (33,917,000) | $ (65,051,000) |
Earnings Per Share, Basic and Diluted [Abstract] | |||
Net loss per common share, basic (in USD per share) | $ (2.32) | $ (1) | $ (2.31) |
Net loss per common share, diluted (in USD per share) | $ (2.32) | $ (1) | $ (2.31) |
Earnings Per Share, Basic and Diluted, Other Disclosures [Abstract] | |||
Weighted-average common shares outstanding, basic (in shares) | 41,628,207 | 33,944,342 | 28,143,391 |
Weighted-average common shares outstanding, diluted (in shares) | 41,628,207 | 33,944,342 | 28,143,391 |
Product revenue, net | |||
Revenues [Abstract] | |||
Total revenue | $ 12,734,000 | $ 12,142,000 | $ 0 |
Other revenue | |||
Revenues [Abstract] | |||
Total revenue | $ 750,000 | $ 0 | $ 0 |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive Loss - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Statement of Comprehensive Income [Abstract] | |||
Net loss | $ (96,776) | $ (33,917) | $ (65,051) |
Other comprehensive loss: | |||
Unrealized loss on available-for-sale debt securities, net | (51) | (141) | (50) |
Foreign currency translation adjustment | (100) | 0 | 0 |
Comprehensive loss | $ (96,927) | $ (34,058) | $ (65,101) |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders’ Equity - USD ($) $ in Thousands | Total | Common Stock | Additional Paid-In Capital | Accumulated Other Comprehensive Income (Loss) | Accumulated Deficit |
Balance, beginning of period (in shares) at Dec. 31, 2019 | 24,523,381 | ||||
Balance, beginning of period at Dec. 31, 2019 | $ 56,480 | $ 24 | $ 297,863 | $ 42 | $ (241,449) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Issuance of common stock (in shares) | 9,267,760 | ||||
Issuance of common stock | 96,760 | $ 10 | 96,750 | ||
Issuance of common stock upon ESPP purchase (in shares) | 25,645 | ||||
Issuance of common stock upon ESPP purchase | 186 | 186 | |||
Issuance of common stock upon exercise of stock options (in shares) | 61,700 | ||||
Issuance of common stock upon stock option exercise | 520 | 520 | |||
Vesting of common stock under Product Development Agreement | 217 | 217 | |||
Stock-based compensation expense | 5,973 | 5,973 | |||
Unrealized gain/(loss) on available-for-sale debt securities, net | (50) | (50) | |||
Cumulative translation adjustment | 0 | ||||
Net loss | (65,051) | (65,051) | |||
Balance, end of period (in shares) at Dec. 31, 2020 | 33,878,486 | ||||
Balance, end of period at Dec. 31, 2020 | 95,035 | $ 34 | 401,509 | (8) | (306,500) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Issuance of common stock (in shares) | 565,938 | ||||
Issuance of common stock | 2,685 | $ 1 | 2,684 | ||
Issuance of common stock upon ESPP purchase (in shares) | 37,619 | ||||
Issuance of common stock upon ESPP purchase | 257 | 257 | |||
Issuance of common stock upon exercise of stock options (in shares) | 53,028 | ||||
Issuance of common stock upon stock option exercise | 361 | 361 | |||
Vesting of common stock under Product Development Agreement | 218 | 218 | |||
Stock-based compensation expense | 7,901 | 7,901 | |||
Unrealized gain/(loss) on available-for-sale debt securities, net | (141) | (141) | |||
Issuance of common stock upon release of restricted stock units (in shares) | 33,750 | ||||
Issuance of common stock upon release of restricted stock units | 0 | ||||
Cumulative translation adjustment | 0 | ||||
Net loss | $ (33,917) | (33,917) | |||
Balance, end of period (in shares) at Dec. 31, 2021 | 34,568,821 | 34,568,821 | |||
Balance, end of period at Dec. 31, 2021 | $ 72,399 | $ 35 | 412,930 | (149) | (340,417) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Issuance of common stock (in shares) | 8,528,074 | ||||
Issuance of common stock | 66,110 | $ 8 | 66,102 | ||
Issuance of common stock upon ESPP purchase (in shares) | 48,115 | ||||
Issuance of common stock upon ESPP purchase | $ 158 | 158 | |||
Issuance of common stock upon exercise of stock options (in shares) | 47,367 | 47,367 | |||
Issuance of common stock upon stock option exercise | $ 234 | 234 | |||
Vesting of common stock under Product Development Agreement | 19 | 19 | |||
Stock-based compensation expense | 8,317 | 8,317 | |||
Unrealized gain/(loss) on available-for-sale debt securities, net | (51) | (51) | |||
Issuance of common stock to lender (in shares) | 749,053 | ||||
Issuance of common stock to lender | 5,000 | $ 1 | 4,999 | ||
Issuance of common stock upon release of restricted stock units (in shares) | 132,854 | ||||
Issuance of common stock upon release of restricted stock units | 0 | ||||
Cumulative translation adjustment | (100) | (100) | |||
Net loss | $ (96,776) | (96,776) | |||
Balance, end of period (in shares) at Dec. 31, 2022 | 44,074,284 | 44,074,284 | |||
Balance, end of period at Dec. 31, 2022 | $ 55,310 | $ 44 | $ 492,759 | $ (300) | $ (437,193) |
Consolidated Statements of St_2
Consolidated Statements of Stockholders’ Equity (Parenthetical) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Statement of Stockholders' Equity [Abstract] | |||
Stock issuance costs | $ 2,068 | $ 417 | $ 3,231 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Operating activities | |||
Net loss | $ (96,776,000) | $ (33,917,000) | $ (65,051,000) |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Gain from sale of priority review voucher | 0 | (46,493,000) | 0 |
Income related to asset purchase agreement | 0 | (281,000) | 0 |
Depreciation and amortization | 292,000 | 276,000 | 167,000 |
Inventory write down | 1,043,000 | 0 | 0 |
Amortization of debt securities premiums and discounts | 682,000 | 996,000 | 124,000 |
Loss on extinguishment of debt | 1,144,000 | 0 | 0 |
Non-cash interest expense | 1,238,000 | 776,000 | 804,000 |
Reduction in the carrying amount of right-of-use assets | 550,000 | 523,000 | 478,000 |
Common stock issued under Product Development Agreement | 19,000 | 218,000 | 217,000 |
Stock-based compensation | 8,317,000 | 7,901,000 | 5,973,000 |
Change in operating assets and liabilities: | |||
Accounts receivable | 828,000 | (2,576,000) | 0 |
Inventories | (1,367,000) | (2,424,000) | 0 |
Prepaid expenses and other current assets | (196,000) | (701,000) | (3,563,000) |
Other assets | (1,265,000) | (607,000) | (1,392,000) |
Accounts payable | 1,152,000 | 3,234,000 | (1,899,000) |
Accrued liabilities | 1,957,000 | 2,309,000 | 1,491,000 |
Operating lease liabilities | (628,000) | (576,000) | (534,000) |
Net cash used in operating activities | (83,010,000) | (71,342,000) | (63,185,000) |
Investing activities | |||
Purchase of debt securities available-for-sale | (75,101,000) | (84,647,000) | (128,295,000) |
Proceeds from maturities of debt securities available-for-sale | 85,073,000 | 99,630,000 | 83,766,000 |
Proceeds related to asset purchase agreement | 0 | 281,000 | 0 |
Proceeds from sale of priority review voucher | 0 | 95,000,000 | 0 |
Payments related to priority review voucher | 0 | (48,507,000) | 0 |
Purchase of property and equipment | (340,000) | (225,000) | (258,000) |
Net cash provided by (used in) investing activities | 9,632,000 | 61,532,000 | (44,787,000) |
Financing activities | |||
Issuance of common stock upon offering at-the-market, net of commissions | 66,402,000 | 3,040,000 | 96,779,000 |
Proceeds from issuance of common stock to lender | 5,000,000 | 0 | 0 |
Proceeds from debt | 39,841,000 | 0 | 0 |
Repayment of debt | (33,277,000) | 0 | 0 |
Proceeds from issuance of common stock upon stock option exercises | 234,000 | 361,000 | 520,000 |
Proceeds from issuance of common stock upon ESPP purchase | 157,000 | 257,000 | 186,000 |
Payment of debt issuance costs | (1,116,000) | (175,000) | 0 |
Common stock offering costs | (286,000) | (316,000) | (22,000) |
Net cash provided by financing activities | 76,955,000 | 3,167,000 | 97,463,000 |
Net increase (decrease) in cash and cash equivalents | 3,577,000 | (6,643,000) | (10,509,000) |
Cash and cash equivalents at beginning of period | 22,221,000 | 28,864,000 | 39,373,000 |
Cash and cash equivalents at end of period | 25,798,000 | 22,221,000 | 28,864,000 |
Supplemental disclosure of cash flow information: | |||
Interest paid | 2,885,000 | 2,783,000 | 2,791,000 |
Income taxes paid | 64,000 | 0 | 0 |
Property and equipment purchases included in accounts payable and accrual | 36,000 | 0 | 0 |
Common stock offering costs included in accounts payable and accrual | 6,000 | 0 | 0 |
Right-of-Use Asset Obtained in Exchange for Operating Lease Liability | $ 458,000 | $ 0 | $ 0 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2022 | Dec. 31, 2021 |
Statement of Financial Position [Abstract] | ||
Common stock, par value (in USD per share) | $ 0.001 | $ 0.001 |
Common Stock, shares authorized (in shares) | 200,000,000 | 200,000,000 |
Common stock, issued (in shares) | 44,074,284 | 34,568,821 |
Common stock, outstanding (in shares) | 44,074,284 | 34,568,821 |
Description of Business
Description of Business | 12 Months Ended |
Dec. 31, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Description of Business | Description of Business Eiger BioPharmaceuticals, Inc. (the Company or Eiger) was incorporated in the State of Delaware on November 6, 2008. Eiger is a commercial-stage biopharmaceutical company focused on the development of innovative therapies for hepatitis delta virus (HDV), the most severe form of viral hepatitis, and other serious diseases. All five of the Company’s rare disease programs have been granted Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA). The Eiger HDV platform includes two first-in-class therapies in Phase 3 that target critical host processes involved in viral replication. Lonafarnib is a first-in-class, oral farnesylation inhibitor and peginterferon lambda is a first-in-class, type III, interferon. The FDA approved the Company’s first commercial product, Zokinvy ® (lonafarnib), to reduce risk of mortality of Hutchinson-Gilford progeria syndrome (HGPS) and for treatment of processing-deficient progeroid laminopathies (PL), collectively known as progeria, with either heterozygous LMNA mutation with progerin-like protein accumulation, or homozygous or compound heterozygous ZMPSTE24 mutations, on November 20, 2020. The Company announced that the European Commission approved its Marketing Authorization Application (MAA) for Zokinvy, under exceptional circumstances procedure on July 20, 2022. The Company is also developing avexitide, a well-characterized peptide, as a treatment for congenital hyperinsulinism (HI), an ultra-rare pediatric metabolic disorder, and post-bariatric hypoglycemia (PBH), a debilitating and potentially life-threatening condition. There are currently no approved therapies for these disorders. The Company’s principal operations are based in Palo Alto, California, with subsidiaries in Delaware, Ireland, England and Wales. The Company operates in one segment. Liquidity As of December 31, 2022, the Company had $98.9 million of cash, cash equivalents and short-term securities, comprised of $25.8 million of cash and cash equivalents and $73.1 million of short-term debt securities available-for-sale. The Company had an accumulated deficit of $437.2 million and negative cash flows from operating activities as of December 31, 2022. As the Company continues to incur losses, its transition to profitability will depend on the successful development, approval, and commercialization of product candidates and on the achievement of sufficient revenues to support its cost structure. The Company may never achieve profitability, and until it does, the Company will need to continue to raise additional capital. Management believes that the currently available resources will be sufficient to fund its planned operations for at least the next 12 months following the issuance date of these consolidated financial statements. However, if the Company’s anticipated operating results are not achieved in future periods, the Company believes that planned expenditures may need to be reduced or it would be required to raise funding in order to fund the operations. Additionally, the Company’s ability to raise additional capital may be adversely impacted by potential worsening global economic conditions and disruptions to, and volatility in, the credit and financial markets in the United States and worldwide resulting from the ongoing COVID-19 pandemic, among other events. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2022 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Summary of Significant Accounting Policies Basis of Presentation The consolidated financial statements include the accounts of Eiger BioPharmaceuticals, Inc. and its wholly owned subsidiaries, EBPI Merger Inc., EB Pharma LLC, Eiger BioPharmaceuticals Europe Limited, and EigerBio Europe Limited, have been prepared in accordance with accounting principles generally accepted in the United States of America, (U.S. GAAP) and follow the requirements of the Securities and Exchange Commission (the SEC) for annual reporting. All intercompany balances and transactions have been eliminated in consolidation. Use of Estimates The preparation of consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenue and expenses during the reporting period. On an ongoing basis, the Company evaluates its estimates. The Company bases its estimates on historical experience and on various other market-specific and relevant assumptions that the Company believes to be reasonable under the circumstances. Actual results could differ from those estimates. Concentrations of Risk Financial instruments that potentially subject the Company to a concentration of credit risk consists of cash, cash equivalents and investments. The Company’s cash is held by a financial institution in the United States. Amounts on deposit may at times exceed federally insured limits. Management believes that the financial institution is financially sound, and accordingly, minimal credit risk exists with respect to the financial institution. The Company relies on one supply chain for each of its product candidates. If any of the single source suppliers in any of the supply chains fail to satisfy the Company’s requirements on a timely basis, it could suffer delays in its clinical development programs and activities, which could adversely affect its operating results. Two customers accounted for approximately 58 percent and 42 percent of the Company’s accounts receivable as of December 31, 2022. One customer accounted for approximately 93 percent of product revenue during the year ended December 31, 2022. Two customers accounted for approximately 66 percent and 34 percent of the Company’s accounts receivable as of December 31, 2021. One customer accounted for approximately 94 percent of product revenue during the year ended December 31, 2021. The Company did not have accounts receivable or revenue in 2020. Foreign Currency Exchange Foreign Currency Transaction Risk The foreign currency transaction risk relates to changes in exchange rates on monetary assets, liabilities, revenues and expenses held at Eiger BioPharmaceuticals Europe Limited . Gains and losses on foreign currency transactions result primarily from monetary assets, liabilities, revenues and expenses denominated in Euro. Aggregated transaction gains for 2022 were $0.1 million. The Company expects the foreign currency gain/loss to continue to fluctuate as long as the Company continue to hold monetary assets and liabilities at the subsidiary. Market uncertainty could potentially lead to significant volatility with foreign currency exchange rates, which could result in additional foreign currency gain/loss. Foreign Currency Translation Risk The foreign currency translation risk relates to the translation of the foreign consolidated subsidiary's assets, liabilities, revenues and expenses from the subsidiary's functional currency to the U.S. dollar at each reporting date. Fluctuations in exchange rates may impact the amount of assets, liabilities, revenues and expenses reported on the consolidated balance sheets and consolidated statements of operations. The financial statements of the foreign subsidiary, which has a functional currency other than the U.S. dollar are translated into U.S. dollars using a current exchange rate. Gains and losses resulting from this translation are recognized as a foreign currency translation adjustment within accumulated other comprehensive loss, which is a component of stockholders' equity and comprehensive income (loss). Aggregate translation losses, net of tax, for 2022 were $0.1 million. Cash and Cash Equivalents Cash and cash equivalents include all cash balances and highly liquid investments with original maturities of three months or less from the date of purchase. Cash equivalents consists primarily of amounts invested in money market funds held at financial institutions and corporate debt securities. The recorded carrying amount of cash equivalents approximates their fair value. Debt Securities Short-term securities consist of debt securities classified as available-for-sale and have maturities greater than 90 days, but less than 365 days from the date of acquisition. Long-term securities consist of debt securities classified as available-for- sale and have maturities greater than 365 days from the date of acquisition. The Company’s debt securities consist of available-for-sale securities that are classified as Level 2 because their value is based on valuations using significant inputs derived from, or corroborated by, observable market data. Unrealized gains and losses on available-for-sale debt securities are excluded from earnings and are reported as a component of accumulated other comprehensive loss. The cost of available-for-sale securities sold is based on the specific-identification method . Realized gains and losses on the sale of debt securities are determined using the specific-identification method and recorded in other (expense) income, net on the accompanying consolidated statements of operations. Property and Equipment Property and equipment are stated at cost, less accumulated depreciation. Depreciation expense is computed using the straight-line method over the estimated useful lives of the assets. Depreciation begins at the time the asset is placed into service. Maintenance and repairs are charged to operations as incurred. Property and equipment purchased for specific research and development projects with no alternative uses are expensed as incurred. The useful lives of the property and equipment are as follows: Lab equipment 5 years Furniture 5 years Leasehold improvements Shorter of remaining lease term or 5 years Computer equipment and software 3 years Impairment of Long-Lived Assets The Company evaluates its long-lived assets, including property and equipment, for impairment whenever events or changes in circumstances indicate that the carrying value of these assets may not be recoverable. The Company assesses the recoverability of long-lived assets by determining whether or not the carrying value of such assets will be recovered through undiscounted expected future cash flows. If the asset is considered to be impaired, the amount of any impairment is measured as the difference between the carrying value and the fair value of the impaired asset. Through December 31, 2022, the Company has not impaired any long-lived assets. Accounts Receivable Accounts receivable represent amounts billed to the Company’s customers, net of an allowance for doubtful accounts. Trade accounts receivable are recorded at invoiced amounts and do not bear interest. The expectation of collectability is based on a review of credit profiles of customers, contractual terms and conditions, current economic trends, and historical payment experience. The Company regularly reviews the adequacy of the allowance for doubtful accounts by considering the age of each outstanding invoice and the collection history of each customer to determine the appropriate amount of allowance for doubtful accounts. The Company had no allowance as of December 31, 2022 and 2021. The Company had no bad debt expense for the years ended December 31, 2022 and 2021. Inventories Inventories are stated at the lower of cost, determined based on actual costs, or estimated net realizable value, on a first-in, first-out basis. Inventories consist of raw materials, work-in-process, and finished goods. Prior to regulatory approval of the Company’s product candidates, expenses incurred to manufacture drug products are recorded as research and development expense. The Company begins capitalizing these expenses as inventory upon regulatory approval. The Company periodically assesses the recoverability of its inventory and reduces the carrying value of the inventory when items are determined to be obsolete, defective or in excess of forecasted sales requirements. Inventory write-downs for excess, defective, and obsolete inventory are recorded as a cost of sales. The Company wrote-down $1.0 million of inventories for the year ended December 31, 2022. There were no write-downs in prior periods. Revenue Recognition The Company recognizes revenue upon transfer of control of promised products to customers in an amount that reflects the consideration it expects to receive in exchange for those products. To determine revenue recognition for contracts with customers, the Company performs the following five-step approach: (i) identify the contract, or contracts, with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when, or as, the performance obligation is satisfied. The five-step model is only applied to contracts when it is probable that the Company will collect substantially all of the consideration it is entitled to in exchange for the goods transferred to a customer. Product Revenue The Company’s product revenue consists of sales of Zokinvy, which received FDA approval in November 2020 and was launched commercially in the United States in January 2021 and in Europe in November 2022 . Prior to 2021, the Company had no product revenue. In the United States, the Company sells Zokinvy to a single specialty pharmacy provider that subsequently dispenses the product directly to patients. The Company discloses revenue on a total basis without further disaggregation. Additionally, the Company does not have any contract assets or liabilities, other than accounts receivable, related to its product revenue. In June 2021, the French National Agency for Medicines and Health Products Safety (ANSM) granted Zokinvy (lonafarnib) a Temporary Authorizations for Use (Autorisation Temporaire d'Utilisation or ATU) for an early access program for a term of one year. The Company has received a one year extension of the ATU program and expects the program to continue until commercial reimbursement of Zokinvy is approved in France. In the context of this program, the Company sells product to a distributor who in turn ships product to pharmacies after receiving requests from physicians for patients in France. In November 2021, the Company began distributing and recognizing revenue from sales of Zokinvy (lonafarnib) through a reimbursed early access program in France. The Company recorded revenue of $0.2 million from sales of product under the ATU program for the year ended December 31, 2022. The Company recognizes product revenue when a customer obtains control of its product, which occurs at a point in time, typically upon delivery to a customer as the delivery of the product is the Company’s only performance obligation. Shipping and handling activities are fulfillment activities rather than a separate performance obligation and are recorded in cost of sales. Product revenue is recorded at the net sales price (transaction price), which includes estimates of variable consideration resulting from rebates, prompt payment discounts, co-payment assistance, and returns. Amounts related to such items are estimated at contract inception and updated at the end of each reporting period as additional information becomes available. The amount of variable consideration may be constrained and is included in the transaction price only to the extent it is probable that a significant reversal of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is resolved. Product revenue is recorded after considering the impact of the following variable consideration amounts along with the constraint at the time of revenue recognition: Rebates: The Company’s product is subject to government mandated rebates for Medicaid Drug Rebate Program, Medicare Part D Prescription Drug Benefit Program, and other government health care programs in the United States. Rebate amounts are based upon contractual agreements or legal requirements with public sector benefit providers. The Company uses the expected-value method for estimating these rebates based on statutory discount rates and expected utilization. The expected utilization of rebates is estimated based on expected coverage of identified patients. Estimates for these rebates are adjusted quarterly to reflect the most recent information. The Company records an accrued liability for unpaid rebates related to products for which control has been transferred to a customer. Prompt payment discounts: The Company provides a discount to a customer if it pays for purchases within 30 days. The Company expects that its customers will earn prompt payment discounts and uses the most likely amount method for estimating such discounts. As a result, when revenues are recognized, the Company deducts the full amount of the prompt payment discounts from total product revenues and records these discounts as a reduction of accounts receivable. Co-payment assistance: The Company provides co-payment assistance to patients who have commercial insurance and meet certain eligibility requirements. The Company uses the expected-value method for estimating co-payment assistance based on estimates of program redemption using data provided by third-party administrators. Estimates for the co-payment assistance are adjusted quarterly to reflect actual experience. The Company records an accrued liability for unredeemed co-payment assistance related to products for which control has been transferred to a customer. Product returns: The Company offers limited product return rights and generally allows for the return of product that is damaged or defective, or within a few months prior to and up to a few months after the product expiration date. The Company considers several factors in the estimation of potential product returns, including expiration dates of the product shipped, the limited product return rights, third-party data in monitoring channel inventory levels, shelf life of the product, and other relevant factors. Other Revenue The Company’s other revenue consists of milestone payments from the Marketing and Distribution Agreement (MDA) with AnGes, Inc., which was executed in May 2022. The agreement provides AnGes with a right to use the Company's intellectual property (IP) and seek regulatory approval for and commercialization of Zokinvy in Japan. The Company will receive additional payments upon achievement of certain regulatory milestones. Cost of Sales Cost of sales consists primarily of direct and indirect costs related to the manufacturing of Zokinvy for commercial sale, including third-party manufacturing costs, packaging services, freight, storage costs, and write down of inventories. Accrued Research and Development Costs The Company accrues for estimated costs of research and development activities conducted by third-party service providers, which include the conduct of preclinical and clinical studies, and contract manufacturing activities. The Company records the estimated costs of research and development activities based upon the estimated amount of services provided but not yet invoiced and includes these costs in accrued liabilities in the accompanying consolidated balance sheets and within research and development expenses in the accompanying consolidated statements of operations. The Company accrues for these costs based on factors such as estimates of the work completed and in accordance with agreements established with its third-party service providers. The Company makes judgments and estimates in determining the accrued liabilities balance in each reporting period. As actual costs become known, the Company adjusts its accrued liabilities. Leases The Company determines if an arrangement is or contains a lease at inception. Material leases with a term greater than one year are recognized in right-of-use assets and current and noncurrent lease liabilities, as applicable, in the Company’s consolidated balance sheets. The Company has a real estate lease for its office space in Palo Alto, California. The Company determines the initial classification and measurement of its right-of-use assets (ROU assets) and lease liabilities at the lease commencement date and thereafter if modified. The lease term includes any renewal options and termination options that the Company is reasonably assured to exercise. The present value of lease payments is determined by using the interest rate implicit in the lease, if that rate is readily determinable; otherwise, the Company uses its incremental borrowing rate. The incremental borrowing rate is determined by using the rate of interest that the Company would pay to borrow on a collateralized basis an amount equal to the lease payments for a similar term and in a similar economic environment. Rent expense for operating leases is recognized on a straight-line basis, unless the operating lease ROU assets have been impaired, over the reasonably assured lease term based on the total lease payments and is included in operating expenses in the consolidated statements of operations. For operating leases that reflect impairment, the Company will recognize the amortization of the operating lease ROU assets on a straight-line basis over the remaining lease term with rent expense still included in selling, general and administrative expenses in the consolidated statements of operations. The Company has elected the practical expedient to not separate lease and non-lease components. The Company’s non-lease components are primarily related to property maintenance and insurance, which varies based on future outcomes, and thus is recognized in selling, general and administrative expenses when incurred. Deferred Financing Costs Financing costs incurred with securing a term debt are recorded in the Company’s consolidated balance sheets as an offset to the term debt and amortized to interest expense in the Company’s consolidated statements of operations over the contractual life of the loan using the effective interest method. Research and Development Costs Research and development costs are expensed as incurred and consist of payroll expenses, stock-based compensation expense, lab supplies and allocated facility costs, as well as fees paid to third parties that conduct certain research and development and manufacturing activities on the Company’s behalf. Amounts incurred in connection with license and asset purchase agreements are also included in research and development expenses. Manufacturing costs related to products undergoing regulatory approval are expensed as research and development costs until receipt of such approval. Advance payments for research and development activities are deferred as prepaid expenses. The prepaid amounts are expensed as the related services are performed. Stock-Based Compensation Stock-based awards to employees and directors, including stock options, are recorded at fair value as of the grant date using the Black-Scholes option pricing model and recognized as expense on a straight line-basis over the employee’s or director’s requisite service period (generally the vesting period). Stock-based awards to non-employees are recorded at their fair value as of the grant date, using the Black-Scholes option pricing model and recognized as expense over the period in which the related services are received. The determination of fair value for stock-based awards on the date of grant using an option pricing model requires management to make certain assumptions for Black-Scholes option pricing model inputs. The Company accounts for forfeitures of stock-based awards when they occur. Income Taxes The Company uses the asset and liability method of accounting for income taxes. Under this method, deferred tax assets and liabilities are determined based on the differences between the financial reporting and the tax bases of assets and liabilities and are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. The Company must then assess the likelihood that the resulting deferred tax assets will be realized. A valuation allowance is provided when it is more likely than not that some portion or all of a deferred tax asset will not be realized. Due to the Company’s lack of earnings history, the net deferred tax assets have been fully offset by a valuation allowance. The Company recognizes benefits of uncertain tax positions if it is more likely than not that such positions will be sustained upon examination based solely on their technical merits, as the largest amount of benefit that is more likely than not to be realized upon the ultimate settlement. The Company’s policy is to recognize interest and penalties related to the underpayment of income taxes as a component of income tax expense or benefit. To date, there have been no interest or penalties charged in relation to unrecognized tax benefits. Internal Revenue Code Section 382 limits the use of net operating loss and tax credit carryforwards in certain situations where changes occur in the stock ownership of a company. In the event that the Company experiences a change of ownership, utilization of the net operating loss and tax credit carryforwards may be restricted. Comprehensive Loss Comprehensive loss represents all changes in stockholders' equity except those resulting from and distributions to stockholders. The Company’s unrealized gains and losses on debt securities and foreign currency translation adjustment represent the components of other comprehensive loss that are excluded from the reported net loss and that are presented in the consolidated statements of comprehensive loss. Net Loss per Share Basic net loss per share of common stock is calculated by dividing the net loss by the weighted average number of shares of common stock outstanding during the period, without consideration for potentially dilutive securities. Since the Company was in a loss position for all periods presented, diluted net loss per share is the same as basic net loss per share for all periods as the inclusion of all potential common shares outstanding would have been anti-dilutive. The following table sets forth the outstanding potentially dilutive securities which have been excluded in the calculation of diluted net loss per share because including such securities would be anti-dilutive (in common stock equivalent shares): December 31, 2022 2021 2020 Options to purchase common stock 6,143,183 5,262,185 3,697,075 Restricted stock units (unvested) 641,407 623,000 37,500 ESPP 334,751 48,159 81,169 Total 7,119,341 5,933,344 3,815,744 Recent Accounting Pronouncements In June 2016, the Financial Accounting Standards Board (FASB) issued Accounting Standards Updates (ASU) No. 2016-13, Financial Instruments—Credit Losses (Topic 326) . The standard changes how entities will measure credit losses for most financial assets and certain other instruments that are not measured at fair value through net income. Financial assets measured at amortized cost will be presented at the net amount expected to be collected by using an allowance for credit losses. In April 2019, the FASB issued ASU No. 2019-04, Codification Improvements to Topic 326, Financial Instruments – Credit Losses, Topic 815, Derivatives and Hedging, and Topic 825, Financial Instruments, which clarifies and corrects certain unintended applications of the guidance contained in each of the amended Topics. Additionally, in May 2019, the FASB issued ASU No. 2019-05, Financial Instruments – Credit Losses (Topic 326), which provides an option to irrevocably elect to measure certain individual financial assets at fair value instead of amortized cost. 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) , which defers the effective date for ASU No. 2016-13 for smaller reporting companies to fiscal years beginning after December 15, 2022, including interim periods within those fiscal years. The Company does not expect the impact of adopting this standard to be material. In March 2020, the FASB issued ASU No. 2020-04, Reference Rate Reform (Topic 848) . The standard provides optional expedients for facilitating the effects of the reference rate reform on financial reporting. For the Company, there are two applicable optional expedients for contract modifications permitted for contracts that are modified because of the reference rate reform and meet the scope guidance. The modifications of contracts within the scope of ASC Topic 470 should be accounted for prospectively adjusting the effective interest rate. The modifications of contracts within the scope of ASC Topic 842 should be accounted for as a continuation of the existing contracts with no reassessments of the lease classification and the discount rate or remeasurements of lease payments that otherwise would be required under ASC Topic 842 for modifications not accounted for as separate contracts. The pronouncement is effective for all entities as of March 12, 2020 through December 31, 2022. In October 2021, the Company amended its Oxford Loan to replace its floating interest rate with the LIBOR replacement rate (see Note 8). The Company adopted this standard when LIBOR was about to be discontinued and the adoption did not have a material impact on its consolidated financial statements. |
Fair Value Measurements
Fair Value Measurements | 12 Months Ended |
Dec. 31, 2022 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | Fair Value Measurements Fair value accounting is applied for all financial assets and liabilities that are recognized or disclosed at fair value in the financial statements on a recurring basis (at least annually). As of December 31, 2022 and 2021, the carrying amount of cash equivalents, accounts receivable, prepaid expenses and other current assets, accounts payable and accrued liabilities approximated their estimated fair value due to their relatively short maturities. Management believes the terms of its long-term debt reflect current market conditions for an instrument with similar terms and maturity, therefore the carrying value of the Company’s debt approximated its fair value. Assets and liabilities recorded at fair value on a recurring basis in the consolidated balance sheets are categorized based upon the level of judgment associated with the inputs used to measure their fair values. Fair value is defined as the exchange price that would be received for an asset or an exit price that would be paid to transfer a liability in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. The authoritative guidance on fair value measurements establishes a three-tier fair value hierarchy for disclosure of fair value measurements as follows: Level 1 : Inputs are unadjusted, quoted prices in active markets for identical assets or liabilities at the measurement date; Level 2 : Inputs are observable, unadjusted quoted prices in active markets for similar assets or liabilities, unadjusted quoted prices for identical or similar assets or liabilities in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the related assets or liabilities; and Level 3 : Unobservable inputs that are significant to the measurement of the fair value of the assets or liabilities that are supported by little or no market data. The Company’s money market funds are classified as Level 1 because they are valued using quoted market prices. The Company’s debt securities and commercial paper consist of available-for-sale securities and are classified as Level 2 because their value is based on valuations using significant inputs derived from or corroborated by observable market data. There were no assets or liabilities classified as Level 3 as of December 31, 2022 and 2021. There were no transfers into or out of Level 3 of the fair value hierarchy during the periods presented. The following tables present the fair value hierarchy for assets and liabilities measured at fair value (in thousands): December 31, 2022 Level 1 Level 2 Level 3 Total Financial assets: Money market funds $ 11,546 $ — $ — $ 11,546 Commercial paper — 8,913 — 8,913 Corporate debt securities — 28,642 — 28,642 U.S. government bonds — 39,563 — 39,563 Total $ 11,546 $ 77,118 $ — $ 88,664 December 31, 2021 Level 1 Level 2 Level 3 Total Financial assets: Money market funds $ 13,520 $ — $ — $ 13,520 Corporate debt securities — 41,511 — 41,511 U.S. government bonds — 42,345 — 42,345 Total $ 13,520 $ 83,856 $ — $ 97,376 There were no financial liabilities measured at fair value on a recurring basis as of December 31, 2022 and 2021. The following tables summarize the estimated value of the Company’s cash equivalents and debt securities and the gross unrealized holding gains and losses (in thousands): December 31, 2022 Amortized cost Unrealized gain Unrealized loss Estimated Fair Cash equivalents: Money market funds $ 11,546 $ — $ — $ 11,546 Commercial paper 3,968 — — 3,968 Total cash equivalents $ 15,514 $ — $ — $ 15,514 Debt securities: U.S. government bonds $ 39,646 $ 3 $ (86) $ 39,563 Corporate debt securities 28,759 — (117) 28,642 Commercial paper 4,945 — — 4,945 Total debt securities $ 73,350 $ 3 $ (203) $ 73,150 Classified as: Cash equivalents $ 15,514 Short-term debt securities 73,150 $ 88,664 December 31, 2021 Amortized cost Unrealized gain Unrealized loss Estimated Fair Cash equivalents: Money market funds $ 13,520 $ — $ — $ 13,520 Total cash equivalents $ 13,520 $ — $ — $ 13,520 Debt securities: Corporate debt securities $ 41,576 $ — $ (65) $ 41,511 U.S. government bonds 42,429 — (84) 42,345 Total debt securities $ 84,005 $ — $ (149) $ 83,856 Classified as: Cash equivalents $ 13,520 Short-term debt securities 66,594 Long-term debt securities 17,262 $ 97,376 The Company periodically reviews the available-for-sale securities for other-than-temporary impairment loss. The Company considers factors such as the duration, severity and the reason for the decline in value, the potential recovery period and its intent to sell. For debt securities, it also considers whether (i) it is more likely than n ot that the Company will be required to sell the debt securities before recovery of their amortized cost basis, and (ii) the amortized cost basis cannot be recovered as a result of credit losses. During the year ended December 31, 2022, the Company did not recognize any other-than-temporary impairment losses. T |
Balance Sheet Components
Balance Sheet Components | 12 Months Ended |
Dec. 31, 2022 | |
Balance Sheet Related Disclosures [Abstract] | |
Balance Sheet Components | Balance Sheet Components Inventories Inventories consist of the following (in thousands): December 31, 2022 2021 Raw materials $ 1,703 $ 1,056 Work-in-progress 884 1,468 Finished goods 266 88 Total inventories $ 2,853 $ 2,612 Property and Equipment, Net Property and equipment, net consist of the following (in thousands): December 31, 2022 2021 Computer equipment and software $ 736 $ 669 Furniture 116 116 Leasehold improvements 101 101 Lab equipment 271 271 Construction in progress 367 59 Total property and equipment 1,591 1,216 Less: accumulated depreciation (895) (603) Property and equipment, net $ 696 $ 613 Depreciation expense for the years ended December 31, 2022 , 2021 and 2020 was approximately $0.3 million, $0.3 million and $0.2 million, respectively. Prepaid Expenses and Other Current Assets Prepaid expenses and other current assets consist of the following (in thousands): December 31, 2022 2021 Prepaid contract manufacturing costs $ 3,542 $ 3,695 Short term deposits 4,542 54 Prepaid research costs 2,822 3,253 Prepaid insurance 586 631 Prepaid marketing 753 469 Other 1,740 1,259 Total prepaid expenses and other current assets $ 13,985 $ 9,361 Accrued Liabilities Accrued liabilities consist of the following (in thousands): December 31, 2022 2021 Compensation and related benefits $ 6,167 $ 3,131 Contract research costs 4,188 4,760 Contract manufacturing costs 2,101 3,288 Product revenue reserves 1,373 1,846 Other 1,826 674 Total accrued liabilities $ 15,655 $ 13,699 |
License, Collaboration, and Pro
License, Collaboration, and Product Development Agreements | 12 Months Ended |
Dec. 31, 2022 | |
Product Development Agreement [Abstract] | |
License, Collaboration, and Product Development Agreements | License, Collaboration, and Product Development Agreements License Agreement with the Trustees of the University of Pennsylvania and the Children’s Hospital of Philadelphia In May 2019, the Company entered into a license agreement (the UPenn/CHOP Agreement) with the Trustees of the University of Pennsylvania (UPenn) and the Children’s Hospital of Philadelphia (CHOP), under which the Company obtained an exclusive, royalty-bearing, worldwide license to develop, manufacture and sell certain Glucagon Like Peptide-1 (GLP-1) receptor antagonist(s) products to treat all human and animal conditions. The Company also obtained an exclusive, royalty-bearing, sublicensable, worldwide license to certain data developed by CHOP. The Company is responsible for the development and commercialization of the licensed products at its sole cost and expense. As part of the consideration for the rights granted to the Company under the UPenn/CHOP Agreement, the Company paid UPenn a one-time, non-refundable issue fee of $1.0 million, which is recorded in research and development expenses for the year ended December 31, 2019. In addition, the Company is obligated to pay UPenn a specified annual license maintenance fee, up to $2.5 million upon marketing authorization in one or more countries, and up to $18.0 million in commercial milestones. The Company will also be required to pay UPenn a flat royalty in the low-single digits on net sales of all licensed products by the Company, subject to specified reductions and offsets, and specified minimum annual royalty payments. The Company’s obligation to pay royalties expires on a product-by-product and country-by-country basis, on the later of: (i) the expiration of the last valid claim in the licensed patents in any country, or (ii) the tenth anniversary of the first commercial sale of the product in such country. No milestones have been achieved as of December 31, 2022 . The Company may terminate the UPenn/CHOP Agreement in its entirety for any reason by providing prior written notice to UPenn and CHOP. UPenn or CHOP may terminate the UPenn/CHOP Agreement, upon a written notice, for the Company’s failure to achieve the specified diligence milestones within the specified periods, subject to the Company’s extension rights. Product Development Agreement On August 11, 2018, the Company entered into a Product Development Agreement and a First Project Agreement (the Product Agreements), pursuant to which the Company will receive development program support services for its HDV program. The services are to be provided from July 1, 2018 through the new drug application (NDA) filing. As consideration, the Company has committed to pay fees of approximately $10.0 million in cash and stock over four years, including approximately $0.8 million for expert consultant fees and pass through costs to vendors, plus certain incentive-based regulatory milestone fees up to $1.0 million. As part of the aggregate payment, the Company issued 115,526 shares of common stock subject to quarterly vesting requirements related to successful performance of the services and achievement of budget timeline set forth in the Product Agreements. The Product Agreements can be terminated by either party due to material breach or by the Company without cause with 90 days prior written notice. For the years ended December 31, 2022, 2021 and 2020, the Company recognized research and development expense of $19,000, $0.2 million and $0.2 million, respectively, related to the shares issued under the Product Agreements . As of December 31, 2022, the restricted shares were fully vested. Progeria Research Foundation (PRF) Collaboration Agreement On May 15, 2018, the Company entered into a Collaboration and Supply Agreement (the PRF Collaboration Agreement) with PRF. Under the PRF Collaboration Agreement, the parties agreed to collaborate with respect to the development and pursuit of regulatory approval of lonafarnib for the treatment of HGPS and processing-deficient progeroid laminopathies, collectively called progeria, in humans. PRF granted the Company a non-exclusive, world-wide, royalty-free, sub-licensable license pertaining to all intellectual property and data controlled by PRF to prepare and file any NDA for a product containing lonafarnib for progeria. The Company is obligated to: (i) exclusively supply lonafarnib to PRF for use in clinical trials and non-clinical research in progeria at the Company’s expense, (ii) prepare and be the sponsor of any NDA submission for lonafarnib for the treatment of progeria to the FDA, (iii) use commercially reasonable efforts to file a NDA for progeria by a specified date, (iv) submit a Rare Pediatric Disease designation and a request for expedited approval in connection with a NDA filing, (v) establish a patient support program in progeria, and (vi) use commercially reasonable efforts to develop a pediatric formulation of lonafarnib for use in progeria. Under the PRF Collaboration Agreement, the Company is solely responsible for any additional studies necessary for obtaining an NDA for progeria and is also responsible for any additional costs for such studies up to $2.0 million. The PRF Collaboration Agreement continues for an initial term of ten years and automatically renews for subsequent renewal terms of two years each unless either party terminates earlier. Bristol-Meyers Squibb License Agreement On April 20, 2016, the Company and Bristol-Myers Squibb Company (BMS) entered into a License Agreement (the BMS License Agreement) and a Common Stock Purchase Agreement (the BMS Purchase Agreement). Under the BMS License Agreement, BMS granted the Company an exclusive, worldwide, license to research, develop, manufacture, and sell products containing PEG-interferon Lambda-1a (peginterferon lambda or the Licensed Product) for all therapeutic and diagnostic uses in humans and animals. The Company is responsible for the development and commercialization of the Licensed Product at its sole cost and expense. The Company paid BMS $2.0 million and issued 157,587 shares of its common stock at an aggregate fair value of $3.2 million in April 2016. The BMS License Agreement also includes development and regulatory milestone payments totaling $61.0 million and commercial sales milestones of up to $128.0 million. The Company is obligated to pay BMS annual net sales royalties in the range of mid-single to mid-teens, depending on net sales levels. In the fourth quarter of 2020, the Company recorded in research and development expense a $3.0 million milestone, triggered on successful demonstration of proof of concept, as defined by the BMS License Agreement, in a Phase 2 clinical trial. In March 2022, the Company recorded a $5.0 million milestone expense in research and development, which was related to the initiation of a Phase 3 clinical trial, as defined under the BMS License Agreement. Merck License Agreement In September 2010, the Company entered into an exclusive license agreement with Schering Corporation, subsequently acquired by Merck & Co., Inc. (Merck), which provides the Company with the exclusive right to develop, manufacture, and sell products containing the compounds lonafarnib for the treatment of all human viruses except certain specified viruses such as hepatitis B and hepatitis C alone. As part of consideration, the Company issued 27,350 shares of common stock with a fair value of $0.5 million. The Company is obligated to pay Merck up to an aggregate of $27.0 million in development milestones and will be required to pay tiered royalties based on aggregate annual net sales of all licensed products ranging from mid-single to low double-digit royalties on net sales. In May 2015, the first regulatory milestone was achieved and the Company paid the related milestone payment of $1.0 million to Merck. No additional milestones have been achieved as of December 31, 2022. The next milestone of $1.0 million is due upon successful completion of the Phase 3 study, which is expected by end of 2023. On May 15, 2018, the Company entered into an amendment to the exclusive license agreement with Merck, which provides for expansion of the existing exclusively licensed field of use under the license agreement with Merck to include all uses of lonafarnib related to the treatment of Hutchinson-Gilford progeria syndrome (HGPS) in humans at no cost to the Company. On November 3, 2020, the Company entered into an amendment to the exclusive license agreement with Merck which expanded the indication to also include progeroid laminopathies, collectively called progeria. The Company has the sole responsibility and the continuing obligation for the manufacture and supply of lonafarnib to the PRF. Merck will not receive milestone payments in relation to lonafarnib for the treatment of progeria or any royalty payments for sales of a specified quantity of lonafarnib to treat the currently estimated progeria patient population worldwide. |
Asset Purchase Agreements and R
Asset Purchase Agreements and Related License Agreements | 12 Months Ended |
Dec. 31, 2022 | |
Asset Purchase Agreements And Related License Agreements [Abstract] | |
Asset Purchase Agreements and Related License Agreements | Asset Purchase Agreements and Related License Agreements EGI Asset Purchase Agreement In December 2010, the Company entered into an asset purchase agreement with Eiger Group International, Inc. (EGI). Dr. Jeffrey Glenn, a founder and director of the Company, is the sole owner of EGI. Pursuant to the agreement, the Company purchased all of the assets including the intellectual property rights related to the use of farnesyltransferase inhibitors as anti-viral agents and methods to treat viral infections with those inhibitors and inhibitors of prenylation, prenyl cysteine methyltransferase and a protease as anti-viral agents and methods to treat viral infection with those inhibitors. The Company paid EGI an upfront payment of $0.4 million when the agreement was executed in December 2010. Additionally, the Company will pay EGI a low single-digit royalty based on aggregate annual net sales of products developed using the intellectual property. Within the first ten years after commercialization, the Company may make a one-time payment of $0.5 million for each contract for the three types of product related to such intellectual property that would reduce the payment term for the three products to the tenth anniversary of the first commercial sale. The obligation to pay royalties expires on a country-by-country and product-by-product basis on the later of either when the product is no longer sold in any country or the earliest of the tenth anniversary of the first commercial sale of the product. The product is currently not under development. Avexitide Purchase Agreement and Related Stanford License Agreement In September 2015, the Company entered into an asset purchase agreement with two individuals, Dr. Tracey McLaughlin and Dr. Colleen Craig, (the Sellers), whereby the Company purchased all of the assets related to the compound avexitide (formerly known as exendin 9-39) including any related intellectual property from the Sellers (the Exendin APA). The Company also entered into a consulting agreement with the Sellers as part of the agreement. The Company issued 15,378 shares of common stock that were valued at $0.2 million and with the option to purchase 46,134 shares of common stock with an exercise price of $2.06 per share when the agreement was executed in September 2015. Of the 46,134 options to purchase common stock, 15,378 shares vest monthly over four years as services are provided by the Sellers and 30,756 vest upon the earlier of the first commercial sale of the product or the approval of new drug application by the U.S. FDA (the milestone-vested options). On March 22, 2016, immediately following the closing of the merger, the Company issued additional top-up options to the Sellers to purchase an aggregate of 48,544 shares of common stock, pursuant to the terms of the Exendin APA, with an exercise price of $17.25 per share. The top-up options consist of both time-vested and milestone-vested options. The fair value of the time-vested options is recognized as stock-based compensation expense as the awards vest over time. The fair value of the milestone-vested options will be recognized as research and development expense when it is probable that the earliest milestone will be achieved at their fair value as of the ASU 2018-07 adoption date. During the years ended December 31, 2022, 2021 and 2020, the Company recognized $0 million, $0.1 million and $0.1 million of compensation expense related to the time-vested options, respectively. No expense was recognized for the milestone vested options during the years ended December 31, 2022, 2021, and 2020. The Company is also obligated to pay development milestone payments in an aggregate amount of up to $1.0 million to each Seller. Additionally, the Company is obligated to pay each Seller royalties of low single-digits based on aggregate annual net sales of all products developed based on avexitide, subject to certain reductions and exceptions. The Company’s obligation to pay royalties expires on the expiration of the last to expire patent assigned to the Company under the agreement. Additionally, the Company has assumed the license agreement the Sellers had previously entered into with the Board of Trustees of the Leland Stanford Junior University (Stanford). The Company is obligated to pay a royalty to Stanford in the low single-digits on annual net sales after the first commercial sale of any products developed based on avexitide. As of December 31, 2022, the Company has paid a total of $0.1 million in milestone payments to each of the Sellers related to the successful completion of the Phase 2 trials. Asset Purchase Agreement with AbbVie Inc. On November 20, 2020, Eiger entered into the AbbVie Agreement with AbbVie to sell its rare pediatric disease priority review voucher (the PRV), which was awarded on November 20, 2020 upon FDA approval of Zokinvy. The AbbVie Agreement contains customary representations, warranties, covenants, and indemnification provisions subject to certain limitations. |
Sale of Assets
Sale of Assets | 12 Months Ended |
Dec. 31, 2022 | |
Discontinued Operations and Disposal Groups [Abstract] | |
Sale of Assets | Sale of Assets In May 2017, the Company and Theragene Pharmaceuticals, Inc. (Theragene) entered into an asset purchase agreement (Theragene APA), whereby the Company sold all of the assets related to MYDICAR including any related intellectual property for a cash payment of $0.2 million and 475,000 shares of common stock of Theragene. At any time after the Theragene APA execution date and until Theragene has received cumulative gross proceeds of $4.0 million (Proceeds Date) from all equity financing transactions occurring after the Theragene APA execution date, if Theragene issues additional shares of its common stock without consideration or for a consideration per share less than $6.00 per share then Theragene will issue additional shares of its common stock to the Company concurrently with such issue, in an amount such that the per share consideration multiplied by the aggregate number of common stock shares issued to the Company will equal $2.9 million. Additionally, the Company may exercise a put option at any time after the Proceeds Date, where upon written notice from the Company, Theragene will repurchase the 225,000 shares of its common stock held by the Company (Option Shares) at an aggregate purchase price equal to the greater of $1.4 million or the aggregate fair market value of the Option Shares as of the date of the receipt of such notice. The Company is also eligible to receive contingent consideration up to a maximum $45.0 million in cash, based upon Theragene achieving certain specified future milestones. In addition, the Company is also eligible to receive up to 8% royalties on net sales of any future Theragene products covered by or involving the related patents or know-how until the twentieth anniversary of the Theragene APA. To-date, no consideration has been earned or is expected to be earned. The Company has determined that the sale of the MYDICAR assets qualify as an asset sale and not a business. Concurrently with the execution of the Theragene APA, the Company became the owner of 475,000 shares of common stock of Theragene and held a put option for 225,000 shares of common stock of Theragene, which were recognized as a cost method investment with carrying value of zero. In September 2020, Theragene entered into an Asset Purchase Agreement with a third party for the sale of MYDICAR. Under the terms of the Theragene APA between the Company and Theragene, the Company is eligible to receive 25% of any upfront, licensee fee, milestone or other payment (other than royalty payments) received by Theragene from the sale or sublicense of MYDICAR, within 30 days of receipt of such payments by Theragene. As such, during the year ended December 31, 2021, the Company recognized $0.3 million in other (expense) income, net. The Company expects to receive a de minimis amount subsequent to December 31, 2022. |
Debt
Debt | 12 Months Ended |
Dec. 31, 2022 | |
Debt Disclosure [Abstract] | |
Debt | Debt Innovatus Term Loan On June 1, 2022 (Closing Date), the Company entered into a term loan and security agreement (Innovatus Loan) with Innovatus Life Sciences Lending Fund I, LP (Innovatus), providing for up to $75.0 million funded in three tranches with a maturity date of August 31, 2027. The floating per annum interest rate of the Innovatus Loan is equal to the sum of (a) the greater of (i) the Prime Rate published in the Money Rates section of the Wall Street Journal (or any successor thereto) and (ii) 3.5%, plus (b) 3.75%; provided that, at the election of the Borrower, up to 2.25% of such rate shall be payable in-kind until the third anniversary of the closing date. The Company is required to make monthly interest-only payments through July 1, 2027, after which the Company is required to make monthly amortizing payments, with the remaining balance of the principal plus accrued and unpaid interest due at maturity. 2.25% of the interest is payable in-kind for the first three years of the term by increasing the principal balance. Prepayments of the loan, in whole or in part, will be subject to an early prepayment fee which declines each year until the third anniversary date of the Closing Date, after which no prepayment fee is required. The Company is also required to pay an exit fee upon any payment or prepayment equal to 6.5% of the aggregate principal amount of the tranches funded under the Innovatus Loan. The Innovatus Loan contains customary representations, warranties, events of default and covenants of the Company and its subsidiaries, including a requirement to maintain a cash balance of not less than 5% of the aggregate principal amount of funded and outstanding loan terms at all times. The Innovatus Loan is secured by perfected first priority liens on the Company's assets, including a commitment by the Company to not allow any liens to be placed upon the Company's intellectual property. The Company was funded $40.0 million in June 2022 on the Closing Date under Tranche A. The remaining $35.0 million is divided into two tranches (Tranche B and Tranche C). The $17.5 million under each of Tranche B and Tranche C will be available for a period commencing on the later of (a) the first date that the Company achieves certain development and regulatory milestones applicable to each Tranche and (b) November 1, 2022. Both Tranche B and Tranche C draw periods end on the earlier of (a) June 30, 2024 or (b) an event of default. The Company believes it is currently eligible to draw the $17.5 million under Tranche B, but has not done so as of December 31, 2022. The Company identified a number of embedded derivatives that require bifurcation from the Innovatus Loan. These embedded features include mandatory prepayment upon an event of default or change in control and contingent rate increases. However, the fair value of these embedded features was deemed to be immaterial on the date of issuance and at December 31, 2022. At each subsequent reporting period, the Company will reassess the fair value of the embedded features and will record a liability if the fair value of the features becomes material. In connection with the issuance of the Innovatus Loan, the Company recorded a debt discount of $0.2 million and capitalized debt issuance costs of $1.1 million. The discount and issuance costs will be amortized over the life of the loan. Interest expense for the Innovatus Loan for the year ended December 31, 2022 was $2.6 million, and is inclusive of non-cash amortization of the debt discount and debt issuance costs and accretion of final payment. The carrying value of the Innovatus Loan at December 31, 2022 was $39.6 million. The carrying amount of the Innovatus Loan approximates fair value given its recent issuance. The effective interest rate for the Innovatus Loan was 12.86% as of December 31, 2022. Additionally, in connection with entering into the Innovatus Loan, the Company entered into a Stock Purchase Agreement with Innovatus for the sale of common stock with an aggregate value of $5.0 million. On June 1, 2022, the Company issued 749,053 shares of common stock to Innovatus at a per share purchase price of $6.6751, the preceding five-day volume weighted average price per share. A portion of the loan proceeds were used to repay in full the approximately $33.5 million of aggregate principal amount, unpaid interest, and exit fees in connection with loans outstanding owed to Oxford Finance LLC by the Company. Oxford Term Loan In December 2016, the Company entered into an aggregate $25.0 million loan with Oxford Finance LLC (the Oxford Loan) with a maturity date of July 1, 2021. The Company borrowed $15.0 million in December 2016 (Tranche A). In May 2018, the Company entered into an amendment to the Oxford Loan and borrowed $5.0 million (Tranche B). On August 3, 2018, the Company borrowed the remaining $5.0 million (Tranche C) under the Oxford Loan. On March 5, 2019, the Company entered into the third amendment to the Oxford Loan (the Amended Oxford Loan) to refinance the Oxford Loan. The Amended Oxford Loan increased the aggregate amount available to be borrowed to $35.0 million and extended the maturity date to March 1, 2024. On March 5, 2019, prior to entering into the Amended Oxford Loan, the outstanding balance of the Oxford Loan was $23.3 million. At the time of entering into the Amended Oxford Loan, the Company borrowed an additional $6.7 million in principal under the Amended Oxford Loan, which increased the total amount borrowed to $30.0 million (Amended Tranche A). The remaining $5.0 million (Amended Tranche B) was available to the Company provided that certain milestones are achieved by February 2021. The Company did not draw down the Amended Tranche B. On February 23, 2021, the Company entered into the fifth amendment to the Oxford Loan. The amendment extended the interest only period by 17 months until September 1, 2022, followed by 19 equal monthly payments of principal and interest. The Company paid an amendment fee of $0.2 million to the lender on the effective date of the fifth amendment, which was recorded as an additional debt discount and was being amortized over the remaining term of the Amended Oxford Loan. Interest expense for the Oxford Loan for the year ended December 31, 2022 was $1.5 million. On October 6, 2021, the Company entered into the sixth amendment to the Oxford Loan, which amended the interest to be the LIBOR replacement rate which is the sum of the alternate benchmark rate and the LIBOR replacement spread. At the time of final payment, the Company was required to pay an exit fee of 7.50% of the original principal balance of borrowed funds, or $2.3 million. In addition, the Company was required to pay an additional exit fee of $1.0 million. The Company recorded as a liability and debt discount the exit fee for the Amended Oxford Loan. At the date of the Amended Oxford Loan, the Company paid $0.9 million for the accrued portion of the Oxford Loan exit fee and the Tranche B additional exit fee. On June 1, 2022, upon entering into the Innovatus Loan, the Company repaid the Oxford Loan, including (i) the $30.0 million outstanding principal balances, (ii) $0.2 million in accrued and unpaid interest, and (iii) other final payments consisting of $3.3 million, for a total payment of $33.5 million. The Company recorded a loss of $1.1 million on early extinguishment of the debt related to the unamortized debt premium, discount, and cost of issuance, which was recognized as a component of other (expense) income, net in the consolidated statement of operations. The Company accounts for the amortization of the debt discount utilizing the effective interest method. Debt and unamortized discount balances are as follows (in thousands): December 31, 2022 2021 Face value of debt $ 40,531 $ 30,000 Exit fee 2,600 3,277 Unamortized debt discount associated with exit fee, debt issuance costs and loan origination fees (3,506) (1,482) Total debt, net 39,625 31,795 Less: current portion of debt — (7,809) Debt, net $ 39,625 $ 23,986 As of December 31, 2022, future minimum payments of principal, exit fee and interest expense under the Innovatus Loan were as follows (in thousands): Year ending December 31, 2023 $ 3,686 2024 3,780 2025 4,407 2026 4,814 2027 48,185 Total future payments 64,872 Less: unamortized interest (21,741) Less: exit fee (3,506) Face value of term loan $ 39,625 |
Stockholders_ Equity
Stockholders’ Equity | 12 Months Ended |
Dec. 31, 2022 | |
Share-based Payment Arrangement [Abstract] | |
Stockholders’ Equity | Stockholders’ Equity Common Stock The holders of the Company’s common stock have one vote for each share of common stock. Common stockholders are entitled to dividends when, as, and if declared by the Board of Directors, subject to the prior rights of the convertible preferred stockholders. As of December 31, 2022, no dividends had been declared by the Board of Directors. In December 2020, the Company filed a shelf registration statement on Form S-3 (File No. 333-251497) with the Securities and Exchange Commission, which permits the offering, issuance and sale by the Company up to a maximum aggregate offering price of $200.0 million of its common stock, preferred stock, debt securities and warrants. Up to a maximum of $50.0 million of the maximum aggregate offering price of $200.0 million may be issued and sold pursuant to an ATM financing facility (the 2020 ATM Facility) under a sales agreement with Jefferies. In December 2021, the Company completed ATM offerings for a total of 565,938 shares of common stock under the 2020 ATM Facility. The offerings were made under the Company’s effective shelf registration statement and resulted in net proceeds to the Company of $3.0 million, after deducting commissions. In January and March 2022, the Company completed ATM offerings for a total of 5,841,786 shares of common stock under the 2020 ATM Facility. The offerings were made under the Company’s effective shelf registration statement and resulted in net proceeds to the Company of $45.6 million, after deducting commissions. As of December 31, 2022, the Company completed the sale of all shares available for sale under the 2020 ATM Facility, and the 2020 ATM Facility was terminated. On March 25, 2022, the Company entered into a new Open Market Sale Agreement SM with Jefferies, pursuant to which the Company can sell up to a maximum of $50.0 million of our common stock in offerings that are deemed “at the market” offerings as defined in Rule 415 under the Securities Act, under the Company’s effective shelf registration statement (the 2022 ATM Facility). In April 2022, the Company completed offerings from the 2022 ATM facility for a total of 2,686,288 shares of our common stock resulting in net proceeds of $20.8 million , after deducting commissions costs. No additional offerings were completed since April 2022. As of December 31, 2022 , there was approximately $28.7 million remaining under the 2022 ATM Facility for future issuance. The Company had reserved shares of common stock for issuance as follows: December 31, 2022 2021 Options issued and outstanding 6,143,183 5,262,185 Options available for future grants 1,976,460 1,327,645 Restricted and performance stock units outstanding 641,407 623,000 Shares available for issuance under ESPP 788,057 671,172 Total 9,549,107 7,884,002 |
Stock-Based Compensation
Stock-Based Compensation | 12 Months Ended |
Dec. 31, 2022 | |
Share-based Payment Arrangement [Abstract] | |
Stock-Based Compensation | Stock-Based Compensation Restated 2013 Equity Incentive Plan In June 2016, the Company’s Board of Directors adopted and in August 2016 the Company’s stockholders approved the Amended and Restated 2013 Equity Incentive Plan (the Restated 2013 Plan). Under the terms of the Restated 2013 Plan, the Company may grant stock options, stock appreciation rights, restricted stock, restricted stock units and other awards to individuals who are then employees, officers, non-employee directors or consultants of the Company. Under the terms of the Restated 2013 Plan, options may be granted at an exercise price not less than fair market value. For employees holding more than 10% of the voting rights of all classes of stock, the exercise prices for incentive and non-statutory stock options may not be less than 110% of fair market value, as determined by the Board of Directors. The terms of options granted under the Restated 2013 Plan may not exceed ten years. The vesting schedule of newly issued option grants is generally four years. As of December 31, 2022, the Company is authorized to issue up to 8,127,807 shares under the Restated 2013 Plan. 2021 Inducement Plan During the second quarter of 2021, the Company approved the 2021 Inducement Plan to reserve 850,000 shares of its common stock to be used exclusively for grants of awards to individuals that were not previously employees or directors of the Company as a material inducement to such individuals’ entry into employment with the Company within the meaning of Rule 5635(c)(4) of the Nasdaq Listing Rules. As of December 31, 2022, there were 380,000 shares remaining available to be issued under the 2021 Inducement Plan. The following table summarizes stock option activity, including restricted stock units (RSUs) and performance stock units (PSUs) available for grant activity, under the Company’s stock-based compensation plans during the year ended December 31, 2022 (in thousands, except option and share data): Shares Number of Weighted- Weighted- Aggregate Outstanding as of December 31, 2021 1,327,645 5,262,185 $ 10.24 7.25 $ 530 Additional options authorized 1,728,441 Granted (2,061,100) 2,061,100 $ 5.74 Restricted stock units granted (298,150) — Performance stock units granted (30,000) — Exercised (47,367) $ 4.93 Forfeited 1,132,735 (1,132,735) $ 9.03 Restricted stock units forfeited 126,889 — Performance stock units cancelled 50,000 — Outstanding as of December 31, 2022 1,976,460 6,143,183 $ 9.00 6.00 $ — Vested and exercisable as of December 31, 2022 3,726,809 $ 10.30 4.50 $ — The aggregate intrinsic values of options outstanding, exercisable, vested and expected to vest were calculated as the difference between the exercise price of the options and the closing price of the Company’s common stock of $1.18 as of December 31, 2022. The aggregate intrinsic value of stock options exercised in 2022, 2021 and 2020 was $0.1 million, $0.1 million and $0.3 million, respectively. During the years ended December 31, 2022, 2021 and 2020, the weighted-average grant date fair value of options granted were $3.65, $5.58 and $4.78 per share, respectively. The total grant date fair value of options that vested during the years ended December 31, 2022, 2021 and 2010 was $7.3 million, $6.9 million and $5.6 million, respectively. The Company records stock-based compensation of stock options granted by estimating the fair value of stock-based awards using the Black-Scholes option pricing model and amortizes the fair value of the stock-based awards granted over the applicable vesting period of the awards on a straight-line basis. The fair value of stock options was estimated using the following weighted-average assumptions: Year Ended December 31, 2022 2021 2020 Expected term (in years) 5.27-6.08 5.27-6.08 5.00-6.08 Contractual term (in years) — — 10.00 Volatility 68.71%-88.51% 68.96%-71.40% 73.00%-77.00% Risk free interest rate 1.76%-4.23% 0.62%-1.35% 0.39%-1.37% Dividend yield — — — Expected Term : The expected term represents the number of years the Company estimates, based primarily on historical experience, that the options will be outstanding prior to exercise. Expected Volatility : The expected volatility for stock options is based on the Company's historical stock price volatility. Risk-Free Interest Rate : The risk-free interest rate is based on the U.S. Treasury zero coupon issues in effect at the time of grant for periods corresponding with the expected term of option. Expected Dividend : The Company has never paid dividends on its common stock and has no plans to pay dividends on its common stock. Therefore, the Company used an expected dividend yield of zero. 2013 Employee Stock Purchase Plan In 2013, the Company’s board of directors adopted and in 2016, upon the merger with Celladon, the Company amended and approved the 2013 Employee Stock Purchase Plan (2013 ESPP). The 2013 ESPP is intended to qualify as an employee stock purchase plan under Section 423 of the U.S. Internal Revenue Code and is administered by the Company’s board of directors. The number of shares of common stock initially reserved for issuance under the 2013 ESPP was 100,000 shares with an automatic annual increase to the shares issuable under the 2013 ESPP to the lower of (i) 1% of the total number of shares of common stock outstanding on December 31 of the preceding calendar year, and (ii) 165,000 shares of common stock, unless a lower number determined by the board of directors. As of December 31, 2022, a total of 948,831 shares are reserved for issuance and 788,057 shares available for future issuance under the 2013 ESPP. During the years ended December 31, 2022, 2021 and 2020, employees purchased 48,115 shares for $0.2 million, 37,619 shares for $0.3 million and 25,645 shares for $0.2 million, respectively, under the 2013 ESPP. Restricted Stock Units and Performance Stock Units In the first quarter of 2020, the Company revised its non-employee director compensation policy to approve the granting of RSUs in accordance with the Restated 2013 Equity Incentive Plan (the Restated 2013 Plan). Each eligible director who has served for at least six months during the prior calendar year and continues to serve as a non-employee member of the board of Directors (the Board) is granted RSUs. Each eligible director who has served on the Board for less than six months during the prior calendar year and who continues to serve as a non-employee member of the Board, is granted RSUs which are pro-rated for the period served during the prior calendar year. The RSUs granted to non-employee directors will vest on the one-year anniversary of the grant date, subject to the eligible director’s continuous services through the vesting date, and will vest in full upon a change in control, as defined under the Restated 2013 Plan. The RSUs granted to employees will vest annually on the one-year, two-year, and three-year anniversaries of the grant date. The fair value of all RSUs is measured at the grant date based on the closing market price of the Company’s common stock and is recognized as stock-based compensation expense on a straight-line basis over the vesting period. The PSUs are also available for grant pursuant to the Restated 2013 Plan. Each PSU, which is a stock award, is earned through the achievement of performance-based metrics over a defined performance period. The length of the defined performance period, the performance-based metric to be achieved during the defined performance period, and the measure of whether and to what degree such performance-based metric has been achieved will be conclusively determined by the compensation committee of the Company’s Board, in its sole discretion. The estimated fair value of equity awards that contain performance conditions is expensed over the term of the award once the Company has determined that it is probable that performance conditions will be satisfied. During the year ended December 31, 2022 and 2021 the Company granted 30,000 and 270,000 PSUs, with a weighted-average grant date fair value of $6.87 and $7.92 per share, respectively. The performance-based metrics include the achievement of certain revenue targets and clinical and regulatory milestones. During the year ended December 31, 2022 and 2021, the Company recorded $0.5 million and $0.2 million of stock-based compensation expense related to the PSUs as it is expected that all milestones will be achieved by the target dates, respectively. This expense is included in selling, general and administrative expenses. As of December 31, 2022, no PSUs have vested as the performance-based metrics of the PSUs have not yet been achieved. During the year ended December 31, 2022 and 2021, the Company granted 298,150 and 371,500 RSUs, respectively, with a weighted-average grant date fair value of $5.22 and $9.16 per share, respectively. In relation to the RSUs granted, the Company recognized $1.2 million and $0.9 million in stock-based compensation expense for the year ended December 31, 2022 and 2021, respectively, which were included in selling, general and administrative expenses. As of December 31, 2022, the total unrecognized compensation expense related to unvested RSUs and PSUs was $3.0 million, which the Company expects to recognize over an estimated weighted-average period of 2.0 years. The following table summarizes RSU and PSU activity and weighted average grant date fair value for the year ended December 31, 2022: Shares Weighted- Unvested shares as of December 31, 2021 623,000 $ 8.63 Granted 328,150 $ 5.37 Vested (132,854) $ 9.40 Forfeited (176,889) $ 7.63 Unvested shares as of December 31, 2022 641,407 $ 7.08 Stock-Based Compensation Expense Total stock-based compensation expense recognized was as follows (in thousands): Year Ended December 31, 2022 2021 2020 Research and development $ 3,159 $ 2,252 $ 1,494 Selling, general and administrative 5,158 5,649 4,479 Total $ 8,317 $ 7,901 $ 5,973 As of December 31, 2022, the total unrecognized compensation expense related to unvested options was $10.1 million, which the Company expects to recognize over an estimated weighted average period of 2.70 years. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Income Taxes The Company’s provision for income taxes was approximately $23,000 and $64,000 for the year ended December 31, 2022 and 2021 respectively, with an effective tax rate of (0.02)% and (0.19)% for the year ended December 31, 2022 and 2021. No provision for income taxes was recorded for the years ended December 31, 2020. The effective tax rate in each period differs from the U.S. statutory tax rate primarily due to the valuation allowances on the Company’s deferred tax assets as it is more likely than not that some or all of the Company’s deferred tax assets will not be realized. The tax expense recorded for the year ended December 31, 2022 relates to state taxes. The effective tax rate of the provision for income taxes differs from the federal statutory rate as follows: Year Ended December 31, 2022 2021 2020 Federal statutory income tax rate 21.00 % 21.00 % 21.00 % Change in valuation allowance (25.99) (31.07) (26.75) Tax credits 4.15 12.14 6.43 State income taxes, net of federal benefit 2.39 0.73 0.33 Stock-based compensation (0.98) (3.02) (1.00) Other, net (0.59) 0.03 (0.01) Provision for income taxes (0.02) % (0.19) % — % The components of the deferred tax assets and liabilities are as follows (in thousands): December 31, 2022 2021 Deferred tax assets: Net operating loss carryforwards $ 63,069 $ 60,273 Tax credits 9,985 5,486 Depreciation and amortization 2,920 1,863 Stock-based compensation 3,429 3,004 Section 174 Capitalization 15,581 — Accruals and reserves 1,431 646 Lease liabilities 131 156 Gross deferred tax assets 96,546 71,428 Valuation allowance (96,418) (71,291) Total deferred tax assets 128 137 Deferred tax liabilities: Right-of-use assets (128) (137) Total deferred tax liabilities (128) (137) Net deferred tax assets $ — $ — Due to the Company’s lack of earnings history, the deferred tax assets have been fully offset by a valuation allowance as of December 31, 2022 and 2021. The net change in the valuation allowance for the years ended December 31, 2022 and 2021 increased by $25.1 million and $10.5 million, respectively. As of December 31, 2022, the Company had approximately $292.3 million and $25.4 million, respectively, of federal and state operating loss carryforwards available to reduce future taxable income that will begin to expire in 2030 and 2028, respectively, for federal and state tax purposes. The Company had $10.8 million of federal Orphan Drug credit carryforwards available to reduce future taxable income that will begin to expire in 12/31/2041. As of December 31, 2022, the Company also had research and development tax credit carryforwards of approximately $0 million and $3.1 million for federal and state purposes available to offset future taxable income tax, respectively. If not utilized, the state credits can be carried forward indefinitely. The Company’s ability to utilize NOL carryforwards or other tax attributes, such as research tax credits, in any taxable year may be limited if the Company has experienced an ownership change under Section 382 of the Internal Revenue Code (the Code) of 1986, as amended. The Company’s merger with Celladon resulted in such an ownership change and, accordingly, Celladon’s NOL carryforwards and certain other tax attributes will be subject to further limitations on their use. The Company assessed whether it had an ownership change, as defined by Section 382 of the Code from its formation through December 31, 2021. Based upon this assessment, the Company experienced ownership changes on April 20, 2016, October 18, 2018 and December 31, 2020. Due to the April 20, 2016 and October 18, 2018 ownership changes, reductions were made to the Company’s NOL and tax credit carryforwards under these rules. Additional ownership changes in the future could result in additional limitations on the Company’s NOL and tax credit carryforwards. Tax benefits from uncertain tax positions are recognized when it is more likely than not that the position will be sustained upon examination, including resolutions of any related appeals or litigation processes, based on the technical merits. The amount recognized is measured as the largest amount of tax benefit that is greater than 50 percent likely of being realized upon effective settlement. Uncertain Tax Positions A reconciliation of the Company’s unrecognized tax benefits for the years ended December 31, 2022, 2021 and 2020 is as follows (in thousands): Year Ended December 31, 2022 2021 2020 Balance at beginning of year $ 1,950 $ 451 $ 3,277 Additions based on tax positions related to prior year — — — Additions based on tax positions related to current year 1,586 1,499 81 Reductions based on tax positions related to prior year (44) — (2,907) Reductions based on tax positions related to current year — — — Balance at end of year $ 3,492 $ 1,950 $ 451 If the $3.5 million of unrecognized tax benefits is recognized, there would not be an effect on the effective tax rate. The Company does not expect the unrecognized tax benefits to change significantly over the next 12 months. As of December 31, 2022, the unrecognized tax benefits for uncertain tax positions were offset against deferred tax assets and would not affect the income tax rate if recognized due to the Company being in a full valuation allowance position. The Company’s policy is to account for interest and penalties in tax expense on the consolidated statements of operations. The Company files income tax returns in the U.S. federal and state jurisdictions. All periods since inception are subject to examination by U.S. federal and state jurisdictions. There were no such interest or penalties during the years ended December 31, 2022, 2021 and 2020. |
Legal Matters
Legal Matters | 12 Months Ended |
Dec. 31, 2022 | |
Legal Matters [Abstract] | |
Legal Matters | Legal Matters From time to time in the ordinary course of business, the Company may be involved in various legal claims and litigation, including those pertaining to the defense and enforcement of the Company's patent or other intellectual property rights and contractual rights. The Company is defending all current litigation matters, including the litigation matters discussed below. Although there can be no assurances and the outcome of these matters is currently not determinable, the Company currently believes that none of these claims or proceedings are likely to have a material adverse effect on the Company's financial position. The Company records accruals for outstanding legal proceedings, claims or investigations when it is probable that a liability will be incurred, and the amount of loss can be reasonably estimated. The Company evaluated developments in legal proceedings, claims or investigations that could affect the amount of any accrual, as well as any developments that would result in a loss contingency to become both probable and reasonably estimable. The Company has not recorded any accrual for loss contingencies associated with such legal claims or litigation discussed herein as they are in the early stages and an estimate of loss, if any, cannot be made. On November 8, 2022 a putative securities class action complaint was filed in the United States District Court for the Northern District of California alleging that the company and two former executives violated Sections 10(b) and 20(a) of the Securities Exchange Act and SEC Rule 10b-5. The complaint alleges generally that between March 2021 and October 2022 material misstatements and omissions were made to shareholders regarding the TOGETHER study of peginterferon lambda for the treatment of COVID-19 as well as the likelihood of FDA approval of an Emergency Use Authorization for peginterferon lambda. The Court appointed a lead plaintiff on March 2, 2023. The litigation is currently ongoing. On November 15, 2022, the Company received a demand for arbitration (Demand) from claimant The Progeria Research Foundation, Inc. (PRF) asserting two claims under a May 15, 2018 Collaboration and Supply Agreement (the PRF Collaboration Agreement) between the parties. PRF has alleged that the Company breached an obligation to supply quantities of a drug as requested by PRF. PRF also has a claim for declaratory relief regarding the grant of licenses under the PRF Collaboration Agreement. On January 18, 2023, the Company filed a response to the Demand denying PRF’s claims, contesting the arbitrability of PRF’s claim for declaratory relief, and asserting a counterclaim for declaratory relief related to the contractual provision underlying PRF’s original drug supply claim. To give the parties an opportunity to discuss a potential negotiated resolution of their dispute, the arbitration has been suspended through the end of 2023. As a result, all arbitration activities are now on hold, and the final hearing, originally scheduled for May 9 – 12, 2023, in Boston, Massachusetts, has been taken off calendar. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2022 | |
Leases [Abstract] | |
Commitments and Contingencies | Commitments and Contingencies Lease Agreements In October 2017, the Company entered into a non-cancelable operating facility lease agreement for 8,029 square feet of office space located at 2155 Park Blvd. in Palo Alto, California. The lease commenced on March 1, 2018 and was to expire in February 2023. The lease had a three-year renewal option prior to expiration. The lease included rent escalation clauses throughout the lease term. In October 2017, the Company provided a security deposit of $0.3 million. In February 2023, the Company amended the lease to extend the lease by one year with a one year renewal option. The extended lease will commence on March 1, 2023 and expire on February 28, 2024. The Company accounted for the amendment as a lease modification in accordance with ASC Topic 842. The Company also has additional operating leases that are included in its lease accounting but are not considered significant for disclosure. The maturities of the Company’s operating lease liabilities as of December 31, 2022 were as follows (in thousands): Undiscounted lease payments December 31, 2022 2023 528 2024 84 2025 1 Total undiscounted payments 613 Less: imputed interest 39 Present value of future lease payments 574 Less: current portion of operating lease liabilities 491 Operating lease liabilities $ 83 Rent expense recognized for the Company’s operating leases was $0.6 million for the years ended December 31, 2022, 2021 and 2020, respectively. Under the terms of the lease agreements, the Company is also responsible for certain variable lease payments that are not included in the measurement of the lease liability. Variable lease payments for the operating leases were $0.1 million for the years ended December 31, 2022, 2021 and 2020, respectively. The operating cash outflows for the operating lease liabilities were $0.7 million, $0.6 million and $0.7 million for the years ended December 31, 2022, 2021 and 2020, respectively. As of December 31, 2022, the weighted-average remaining lease term and weighted-average discount rate were 1.2 years and 12.82%, respectively. Other Commitments The Company is obligated to make future payments to third parties under asset purchase and license agreements, including royalties and payments that become due and payable on the achievement of certain development and commercialization milestones. However, the amount and timing of these payments are not known. Manufacturing Service Agreement In 2020, the Company entered into a Master Manufacturing Services Agreement (MMSA) and Product Agreement with Patheon, Inc. (Patheon) for the manufacturing of lonafarnib capsules and packaging of bottles for commercial sale. Under the terms of the agreements, the Company is required to provide Patheon with annual volume forecasts of capsules and Patheon will manufacture 80% of actual manufacturing volume. If the Company orders more than 20 percent of manufacturing volume from other manufacturers, the Company is required to pay 70% of purchase price to Patheon for the shortfall. The initial terms of the MMSA and Product Agreement end on December 31, 2025 with automatic renewal for successive two-year terms, unless earlier terminated pursuant to the terms of each agreement, or upon either party’s notice of termination to the other . |
Related Party Disclosures
Related Party Disclosures | 12 Months Ended |
Dec. 31, 2022 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | Related Party TransactionsAs disclosed in Note 6, the Company entered into license agreements with EGI, which is owned by the founder of the Company. |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2022 | |
Subsequent Events [Abstract] | |
Subsequent Events | Subsequent Event Departure of Directors or Certain Officers On February 6, 2023, the Company entered into a separation agreement and general release with David Cory, the Company's former President and Chief Executive Officer. Pursuant to the separation agreement, Mr. Cory will be entitled to receive, (i) $1.5 million continuation of his base salary and target bonus for a period of 18 months; (ii) $0.4 million cash payment equal to Mr. Cory's target bonus for 2022; (iii) reimbursement for COBRA continuation coverage for Mr. Cory and his eligible dependents for a period of 18 months; (iv) accelerated vesting of 50% of Mr. Cory's unvested stock options, performance-based restricted stock units, and time-based RSUs outstanding as of the separation date; (v) reimbursement of Mr. Cory's legal fees associated with the negotiation of the Separation Agreement up to $10,000. The Company accrued $2.0 million related to David Cory's separation for salary and benefits as of December 31, 2022. Expense related to stock options acceleration will be recorded in Q1 2023. Silicon Valley Bank Closure As of March 10, 2023, the Company maintained two accounts at Silicon Valley Bank ( SVB) holding cash deposits of approximately $8.3 million. On March 10, 2023, SVB was closed by the California Department of Financial Protection and Innovation, and the Federal Deposit Insurance Corporation (FDIC) was appointed receiver. The FDIC initially announced that a ll insured depositors will have full access to their insured deposits no later than, March 13, 2023, with uninsured depositors receiving an advance dividend a receivership certificate for their uninsured funds. On March 12, 2023, the U.S. Treasury Department, the Federal Reserve and the FDIC jointly announced enabling actions that fully protect all SVB depositors’ insured and uninsured deposits, and that such depositors would have access to all of their funds starting March 13, 2023. On March 13, 2023, the Company was able to access its full deposits with SVB. The cash was subsequently moved to another financial institution. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2022 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The consolidated financial statements include the accounts of Eiger BioPharmaceuticals, Inc. and its wholly owned subsidiaries, EBPI Merger Inc., EB Pharma LLC, Eiger BioPharmaceuticals Europe Limited, and EigerBio Europe Limited, have been prepared in accordance with accounting principles generally accepted in the United States of America, (U.S. GAAP) and follow the requirements of the Securities and Exchange Commission (the SEC) for annual reporting. All intercompany balances and transactions have been eliminated in consolidation. |
Use of Estimates | Use of Estimates The preparation of consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenue and expenses during the reporting period. On an ongoing basis, the Company evaluates its estimates. The Company bases its estimates on historical experience and on various other market-specific and relevant assumptions that the Company believes to be reasonable under the circumstances. Actual results could differ from those estimates. |
Concentrations of Risk | Concentrations of Risk Financial instruments that potentially subject the Company to a concentration of credit risk consists of cash, cash equivalents and investments. The Company’s cash is held by a financial institution in the United States. Amounts on deposit may at times exceed federally insured limits. Management believes that the financial institution is financially sound, and accordingly, minimal credit risk exists with respect to the financial institution. The Company relies on one supply chain for each of its product candidates. If any of the single source suppliers in any of the supply chains fail to satisfy the Company’s requirements on a timely basis, it could suffer delays in its clinical development programs and activities, which could adversely affect its operating results. |
Foreign Currency Exchange | Foreign Currency Exchange Foreign Currency Transaction Risk The foreign currency transaction risk relates to changes in exchange rates on monetary assets, liabilities, revenues and expenses held at Eiger BioPharmaceuticals Europe Limited . Gains and losses on foreign currency transactions result primarily from monetary assets, liabilities, revenues and expenses denominated in Euro. Aggregated transaction gains for 2022 were $0.1 million. The Company expects the foreign currency gain/loss to continue to fluctuate as long as the Company continue to hold monetary assets and liabilities at the subsidiary. Market uncertainty could potentially lead to significant volatility with foreign currency exchange rates, which could result in additional foreign currency gain/loss. Foreign Currency Translation Risk |
Cash and Cash Equivalents | Cash and Cash Equivalents Cash and cash equivalents include all cash balances and highly liquid investments with original maturities of three months or less from the date of purchase. Cash equivalents consists primarily of amounts invested in money market funds held at financial institutions and corporate debt securities. The recorded carrying amount of cash equivalents approximates their fair value. |
Debt Securities | Debt Securities Short-term securities consist of debt securities classified as available-for-sale and have maturities greater than 90 days, but less than 365 days from the date of acquisition. Long-term securities consist of debt securities classified as available-for- sale and have maturities greater than 365 days from the date of acquisition. The Company’s debt securities consist of available-for-sale securities that are classified as Level 2 because their value is based on valuations using significant inputs derived from, or corroborated by, observable market data. Unrealized gains and losses on available-for-sale debt securities are excluded from earnings and are reported as a component of accumulated other comprehensive loss. The cost of available-for-sale securities sold is based on the specific-identification method . Realized gains and losses on the sale of debt securities are determined using the specific-identification method and recorded in other (expense) income, net on the accompanying consolidated statements of operations. |
Property and Equipment | Property and Equipment Property and equipment are stated at cost, less accumulated depreciation. Depreciation expense is computed using the straight-line method over the estimated useful lives of the assets. Depreciation begins at the time the asset is placed into service. Maintenance and repairs are charged to operations as incurred. Property and equipment purchased for specific research and development projects with no alternative uses are expensed as incurred. The useful lives of the property and equipment are as follows: Lab equipment 5 years Furniture 5 years Leasehold improvements Shorter of remaining lease term or 5 years Computer equipment and software 3 years |
Impairment of Long-Lived Assets | Impairment of Long-Lived AssetsThe Company evaluates its long-lived assets, including property and equipment, for impairment whenever events or changes in circumstances indicate that the carrying value of these assets may not be recoverable. The Company assesses the recoverability of long-lived assets by determining whether or not the carrying value of such assets will be recovered through undiscounted expected future cash flows. If the asset is considered to be impaired, the amount of any impairment is measured as the difference between the carrying value and the fair value of the impaired asset. |
Accounts Receivable | Accounts Receivable Accounts receivable represent amounts billed to the Company’s customers, net of an allowance for doubtful accounts. Trade accounts receivable are recorded at invoiced amounts and do not bear interest. The expectation of collectability is based on a review of credit profiles of customers, contractual terms and conditions, current economic trends, and historical payment experience. The Company regularly reviews the adequacy of the allowance for doubtful accounts by considering the age of each outstanding invoice and the collection history of each customer to determine the appropriate amount of allowance for doubtful accounts. |
Inventories | Inventories Inventories are stated at the lower of cost, determined based on actual costs, or estimated net realizable value, on a first-in, first-out basis. Inventories consist of raw materials, work-in-process, and finished goods. Prior to regulatory approval of the Company’s product candidates, expenses incurred to manufacture drug products are recorded as research and development expense. The Company begins capitalizing these expenses as inventory upon regulatory approval. |
Revenue Recognition | Revenue Recognition The Company recognizes revenue upon transfer of control of promised products to customers in an amount that reflects the consideration it expects to receive in exchange for those products. To determine revenue recognition for contracts with customers, the Company performs the following five-step approach: (i) identify the contract, or contracts, with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when, or as, the performance obligation is satisfied. The five-step model is only applied to contracts when it is probable that the Company will collect substantially all of the consideration it is entitled to in exchange for the goods transferred to a customer. Product Revenue The Company’s product revenue consists of sales of Zokinvy, which received FDA approval in November 2020 and was launched commercially in the United States in January 2021 and in Europe in November 2022 . Prior to 2021, the Company had no product revenue. In the United States, the Company sells Zokinvy to a single specialty pharmacy provider that subsequently dispenses the product directly to patients. The Company discloses revenue on a total basis without further disaggregation. Additionally, the Company does not have any contract assets or liabilities, other than accounts receivable, related to its product revenue. In June 2021, the French National Agency for Medicines and Health Products Safety (ANSM) granted Zokinvy (lonafarnib) a Temporary Authorizations for Use (Autorisation Temporaire d'Utilisation or ATU) for an early access program for a term of one year. The Company has received a one year extension of the ATU program and expects the program to continue until commercial reimbursement of Zokinvy is approved in France. In the context of this program, the Company sells product to a distributor who in turn ships product to pharmacies after receiving requests from physicians for patients in France. In November 2021, the Company began distributing and recognizing revenue from sales of Zokinvy (lonafarnib) through a reimbursed early access program in France. The Company recorded revenue of $0.2 million from sales of product under the ATU program for the year ended December 31, 2022. The Company recognizes product revenue when a customer obtains control of its product, which occurs at a point in time, typically upon delivery to a customer as the delivery of the product is the Company’s only performance obligation. Shipping and handling activities are fulfillment activities rather than a separate performance obligation and are recorded in cost of sales. Product revenue is recorded at the net sales price (transaction price), which includes estimates of variable consideration resulting from rebates, prompt payment discounts, co-payment assistance, and returns. Amounts related to such items are estimated at contract inception and updated at the end of each reporting period as additional information becomes available. The amount of variable consideration may be constrained and is included in the transaction price only to the extent it is probable that a significant reversal of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is resolved. Product revenue is recorded after considering the impact of the following variable consideration amounts along with the constraint at the time of revenue recognition: Rebates: The Company’s product is subject to government mandated rebates for Medicaid Drug Rebate Program, Medicare Part D Prescription Drug Benefit Program, and other government health care programs in the United States. Rebate amounts are based upon contractual agreements or legal requirements with public sector benefit providers. The Company uses the expected-value method for estimating these rebates based on statutory discount rates and expected utilization. The expected utilization of rebates is estimated based on expected coverage of identified patients. Estimates for these rebates are adjusted quarterly to reflect the most recent information. The Company records an accrued liability for unpaid rebates related to products for which control has been transferred to a customer. Prompt payment discounts: The Company provides a discount to a customer if it pays for purchases within 30 days. The Company expects that its customers will earn prompt payment discounts and uses the most likely amount method for estimating such discounts. As a result, when revenues are recognized, the Company deducts the full amount of the prompt payment discounts from total product revenues and records these discounts as a reduction of accounts receivable. Co-payment assistance: The Company provides co-payment assistance to patients who have commercial insurance and meet certain eligibility requirements. The Company uses the expected-value method for estimating co-payment assistance based on estimates of program redemption using data provided by third-party administrators. Estimates for the co-payment assistance are adjusted quarterly to reflect actual experience. The Company records an accrued liability for unredeemed co-payment assistance related to products for which control has been transferred to a customer. Product returns: The Company offers limited product return rights and generally allows for the return of product that is damaged or defective, or within a few months prior to and up to a few months after the product expiration date. The Company considers several factors in the estimation of potential product returns, including expiration dates of the product shipped, the limited product return rights, third-party data in monitoring channel inventory levels, shelf life of the product, and other relevant factors. Other Revenue |
Cost of Sales | Cost of SalesCost of sales consists primarily of direct and indirect costs related to the manufacturing of Zokinvy for commercial sale, including third-party manufacturing costs, packaging services, freight, storage costs, and write down of inventories. |
Accrued Research and Development Costs | Accrued Research and Development Costs The Company accrues for estimated costs of research and development activities conducted by third-party service providers, which include the conduct of preclinical and clinical studies, and contract manufacturing activities. The Company records the estimated costs of research and development activities based upon the estimated amount of services provided but not yet invoiced and includes these costs in accrued liabilities in the accompanying consolidated balance sheets and within research and development expenses in the accompanying consolidated statements of operations. The Company accrues for these costs based on factors such as estimates of the work completed and in accordance with agreements established with its third-party service providers. The Company makes judgments and estimates in determining the accrued liabilities balance in each reporting period. As actual costs become known, the Company adjusts its accrued liabilities. |
Leases | Leases The Company determines if an arrangement is or contains a lease at inception. Material leases with a term greater than one year are recognized in right-of-use assets and current and noncurrent lease liabilities, as applicable, in the Company’s consolidated balance sheets. The Company has a real estate lease for its office space in Palo Alto, California. The Company determines the initial classification and measurement of its right-of-use assets (ROU assets) and lease liabilities at the lease commencement date and thereafter if modified. The lease term includes any renewal options and termination options that the Company is reasonably assured to exercise. The present value of lease payments is determined by using the interest rate implicit in the lease, if that rate is readily determinable; otherwise, the Company uses its incremental borrowing rate. The incremental borrowing rate is determined by using the rate of interest that the Company would pay to borrow on a collateralized basis an amount equal to the lease payments for a similar term and in a similar economic environment. Rent expense for operating leases is recognized on a straight-line basis, unless the operating lease ROU assets have been impaired, over the reasonably assured lease term based on the total lease payments and is included in operating expenses in the consolidated statements of operations. For operating leases that reflect impairment, the Company will recognize the amortization of the operating lease ROU assets on a straight-line basis over the remaining lease term with rent expense still included in selling, general and administrative expenses in the consolidated statements of operations. The Company has elected the practical expedient to not separate lease and non-lease components. The Company’s non-lease components are primarily related to property maintenance and insurance, which varies based on future outcomes, and thus is recognized in selling, general and administrative expenses when incurred. |
Deferred Financing Costs | Deferred Financing CostsFinancing costs incurred with securing a term debt are recorded in the Company’s consolidated balance sheets as an offset to the term debt and amortized to interest expense in the Company’s consolidated statements of operations over the contractual life of the loan using the effective interest method. |
Stock-Based Compensation | Stock-Based CompensationStock-based awards to employees and directors, including stock options, are recorded at fair value as of the grant date using the Black-Scholes option pricing model and recognized as expense on a straight line-basis over the employee’s or director’s requisite service period (generally the vesting period). Stock-based awards to non-employees are recorded at their fair value as of the grant date, using the Black-Scholes option pricing model and recognized as expense over the period in which the related services are received. The determination of fair value for stock-based awards on the date of grant using an option pricing model requires management to make certain assumptions for Black-Scholes option pricing model inputs. The Company accounts for forfeitures of stock-based awards when they occur. |
Income Taxes | Income Taxes The Company uses the asset and liability method of accounting for income taxes. Under this method, deferred tax assets and liabilities are determined based on the differences between the financial reporting and the tax bases of assets and liabilities and are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. The Company must then assess the likelihood that the resulting deferred tax assets will be realized. A valuation allowance is provided when it is more likely than not that some portion or all of a deferred tax asset will not be realized. Due to the Company’s lack of earnings history, the net deferred tax assets have been fully offset by a valuation allowance. The Company recognizes benefits of uncertain tax positions if it is more likely than not that such positions will be sustained upon examination based solely on their technical merits, as the largest amount of benefit that is more likely than not to be realized upon the ultimate settlement. The Company’s policy is to recognize interest and penalties related to the underpayment of income taxes as a component of income tax expense or benefit. To date, there have been no interest or penalties charged in relation to unrecognized tax benefits. Internal Revenue Code Section 382 limits the use of net operating loss and tax credit carryforwards in certain situations where changes occur in the stock ownership of a company. In the event that the Company experiences a change of ownership, utilization of the net operating loss and tax credit carryforwards may be restricted. |
Comprehensive Loss | Comprehensive LossComprehensive loss represents all changes in stockholders' equity except those resulting from and distributions to stockholders. The Company’s unrealized gains and losses on debt securities and foreign currency translation adjustment represent the components of other comprehensive loss that are excluded from the reported net loss and that are presented in the consolidated statements of comprehensive loss. |
Net Loss per Share | Net Loss per ShareBasic net loss per share of common stock is calculated by dividing the net loss by the weighted average number of shares of common stock outstanding during the period, without consideration for potentially dilutive securities. Since the Company was in a loss position for all periods presented, diluted net loss per share is the same as basic net loss per share for all periods as the inclusion of all potential common shares outstanding would have been anti-dilutive. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements In June 2016, the Financial Accounting Standards Board (FASB) issued Accounting Standards Updates (ASU) No. 2016-13, Financial Instruments—Credit Losses (Topic 326) . The standard changes how entities will measure credit losses for most financial assets and certain other instruments that are not measured at fair value through net income. Financial assets measured at amortized cost will be presented at the net amount expected to be collected by using an allowance for credit losses. In April 2019, the FASB issued ASU No. 2019-04, Codification Improvements to Topic 326, Financial Instruments – Credit Losses, Topic 815, Derivatives and Hedging, and Topic 825, Financial Instruments, which clarifies and corrects certain unintended applications of the guidance contained in each of the amended Topics. Additionally, in May 2019, the FASB issued ASU No. 2019-05, Financial Instruments – Credit Losses (Topic 326), which provides an option to irrevocably elect to measure certain individual financial assets at fair value instead of amortized cost. 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) , which defers the effective date for ASU No. 2016-13 for smaller reporting companies to fiscal years beginning after December 15, 2022, including interim periods within those fiscal years. The Company does not expect the impact of adopting this standard to be material. In March 2020, the FASB issued ASU No. 2020-04, Reference Rate Reform (Topic 848) . The standard provides optional expedients for facilitating the effects of the reference rate reform on financial reporting. For the Company, there are two applicable optional expedients for contract modifications permitted for contracts that are modified because of the reference rate reform and meet the scope guidance. The modifications of contracts within the scope of ASC Topic 470 should be accounted for prospectively adjusting the effective interest rate. The modifications of contracts within the scope of ASC Topic 842 should be accounted for as a continuation of the existing contracts with no reassessments of the lease classification and the discount rate or remeasurements of lease payments that otherwise would be required under ASC Topic 842 for modifications not accounted for as separate contracts. The pronouncement is effective for all entities as of March 12, 2020 through December 31, 2022. In October 2021, the Company amended its Oxford Loan to replace its floating interest rate with the LIBOR replacement rate (see Note 8). The Company adopted this standard when LIBOR was about to be discontinued and the adoption did not have a material impact on its consolidated financial statements. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Accounting Policies [Abstract] | |
Schedule of Estimated Useful Lives of Property and Equipment | The useful lives of the property and equipment are as follows: Lab equipment 5 years Furniture 5 years Leasehold improvements Shorter of remaining lease term or 5 years Computer equipment and software 3 years |
Summary of Potentially Dilutive Shares Excluded from Computation of Diluted Net Loss Per Share | The following table sets forth the outstanding potentially dilutive securities which have been excluded in the calculation of diluted net loss per share because including such securities would be anti-dilutive (in common stock equivalent shares): December 31, 2022 2021 2020 Options to purchase common stock 6,143,183 5,262,185 3,697,075 Restricted stock units (unvested) 641,407 623,000 37,500 ESPP 334,751 48,159 81,169 Total 7,119,341 5,933,344 3,815,744 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Fair Value Disclosures [Abstract] | |
Summary of Assets and Liabilities Measured at Fair Value | The following tables present the fair value hierarchy for assets and liabilities measured at fair value (in thousands): December 31, 2022 Level 1 Level 2 Level 3 Total Financial assets: Money market funds $ 11,546 $ — $ — $ 11,546 Commercial paper — 8,913 — 8,913 Corporate debt securities — 28,642 — 28,642 U.S. government bonds — 39,563 — 39,563 Total $ 11,546 $ 77,118 $ — $ 88,664 December 31, 2021 Level 1 Level 2 Level 3 Total Financial assets: Money market funds $ 13,520 $ — $ — $ 13,520 Corporate debt securities — 41,511 — 41,511 U.S. government bonds — 42,345 — 42,345 Total $ 13,520 $ 83,856 $ — $ 97,376 |
Summary of Estimated Value of Cash Equivalents and Debt Securities and Gross Unrealized Holding Gains and Losses | The following tables summarize the estimated value of the Company’s cash equivalents and debt securities and the gross unrealized holding gains and losses (in thousands): December 31, 2022 Amortized cost Unrealized gain Unrealized loss Estimated Fair Cash equivalents: Money market funds $ 11,546 $ — $ — $ 11,546 Commercial paper 3,968 — — 3,968 Total cash equivalents $ 15,514 $ — $ — $ 15,514 Debt securities: U.S. government bonds $ 39,646 $ 3 $ (86) $ 39,563 Corporate debt securities 28,759 — (117) 28,642 Commercial paper 4,945 — — 4,945 Total debt securities $ 73,350 $ 3 $ (203) $ 73,150 Classified as: Cash equivalents $ 15,514 Short-term debt securities 73,150 $ 88,664 December 31, 2021 Amortized cost Unrealized gain Unrealized loss Estimated Fair Cash equivalents: Money market funds $ 13,520 $ — $ — $ 13,520 Total cash equivalents $ 13,520 $ — $ — $ 13,520 Debt securities: Corporate debt securities $ 41,576 $ — $ (65) $ 41,511 U.S. government bonds 42,429 — (84) 42,345 Total debt securities $ 84,005 $ — $ (149) $ 83,856 Classified as: Cash equivalents $ 13,520 Short-term debt securities 66,594 Long-term debt securities 17,262 $ 97,376 |
Balance Sheet Components (Table
Balance Sheet Components (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Balance Sheet Related Disclosures [Abstract] | |
Schedule of Inventory | Inventories consist of the following (in thousands): December 31, 2022 2021 Raw materials $ 1,703 $ 1,056 Work-in-progress 884 1,468 Finished goods 266 88 Total inventories $ 2,853 $ 2,612 |
Schedule of Property, Plant and Equipment | Property and equipment, net consist of the following (in thousands): December 31, 2022 2021 Computer equipment and software $ 736 $ 669 Furniture 116 116 Leasehold improvements 101 101 Lab equipment 271 271 Construction in progress 367 59 Total property and equipment 1,591 1,216 Less: accumulated depreciation (895) (603) Property and equipment, net $ 696 $ 613 |
Schedule of Prepaid Expenses and Other Current Assets | Prepaid expenses and other current assets consist of the following (in thousands): December 31, 2022 2021 Prepaid contract manufacturing costs $ 3,542 $ 3,695 Short term deposits 4,542 54 Prepaid research costs 2,822 3,253 Prepaid insurance 586 631 Prepaid marketing 753 469 Other 1,740 1,259 Total prepaid expenses and other current assets $ 13,985 $ 9,361 |
Schedule of Components of Accrued Liabilities | Accrued liabilities consist of the following (in thousands): December 31, 2022 2021 Compensation and related benefits $ 6,167 $ 3,131 Contract research costs 4,188 4,760 Contract manufacturing costs 2,101 3,288 Product revenue reserves 1,373 1,846 Other 1,826 674 Total accrued liabilities $ 15,655 $ 13,699 |
Debt (Tables)
Debt (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Debt Disclosure [Abstract] | |
Schedule of Long-Term Debt and Unamortized Discount Balances | Debt and unamortized discount balances are as follows (in thousands): December 31, 2022 2021 Face value of debt $ 40,531 $ 30,000 Exit fee 2,600 3,277 Unamortized debt discount associated with exit fee, debt issuance costs and loan origination fees (3,506) (1,482) Total debt, net 39,625 31,795 Less: current portion of debt — (7,809) Debt, net $ 39,625 $ 23,986 |
Schedule of Maturities of Long-term Debt | As of December 31, 2022, future minimum payments of principal, exit fee and interest expense under the Innovatus Loan were as follows (in thousands): Year ending December 31, 2023 $ 3,686 2024 3,780 2025 4,407 2026 4,814 2027 48,185 Total future payments 64,872 Less: unamortized interest (21,741) Less: exit fee (3,506) Face value of term loan $ 39,625 |
Stockholders_ Equity (Tables)
Stockholders’ Equity (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Share-based Payment Arrangement [Abstract] | |
Common Stock Reserved For Future Issuances | The Company had reserved shares of common stock for issuance as follows: December 31, 2022 2021 Options issued and outstanding 6,143,183 5,262,185 Options available for future grants 1,976,460 1,327,645 Restricted and performance stock units outstanding 641,407 623,000 Shares available for issuance under ESPP 788,057 671,172 Total 9,549,107 7,884,002 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Share-based Payment Arrangement [Abstract] | |
Stock Option Activity | The following table summarizes stock option activity, including restricted stock units (RSUs) and performance stock units (PSUs) available for grant activity, under the Company’s stock-based compensation plans during the year ended December 31, 2022 (in thousands, except option and share data): Shares Number of Weighted- Weighted- Aggregate Outstanding as of December 31, 2021 1,327,645 5,262,185 $ 10.24 7.25 $ 530 Additional options authorized 1,728,441 Granted (2,061,100) 2,061,100 $ 5.74 Restricted stock units granted (298,150) — Performance stock units granted (30,000) — Exercised (47,367) $ 4.93 Forfeited 1,132,735 (1,132,735) $ 9.03 Restricted stock units forfeited 126,889 — Performance stock units cancelled 50,000 — Outstanding as of December 31, 2022 1,976,460 6,143,183 $ 9.00 6.00 $ — Vested and exercisable as of December 31, 2022 3,726,809 $ 10.30 4.50 $ — |
Weighted-average assumptions used in Black-Scholes Model to estimate fair value of stock options granted | The fair value of stock options was estimated using the following weighted-average assumptions: Year Ended December 31, 2022 2021 2020 Expected term (in years) 5.27-6.08 5.27-6.08 5.00-6.08 Contractual term (in years) — — 10.00 Volatility 68.71%-88.51% 68.96%-71.40% 73.00%-77.00% Risk free interest rate 1.76%-4.23% 0.62%-1.35% 0.39%-1.37% Dividend yield — — — Expected Term : The expected term represents the number of years the Company estimates, based primarily on historical experience, that the options will be outstanding prior to exercise. Expected Volatility : The expected volatility for stock options is based on the Company's historical stock price volatility. Risk-Free Interest Rate : The risk-free interest rate is based on the U.S. Treasury zero coupon issues in effect at the time of grant for periods corresponding with the expected term of option. Expected Dividend : The Company has never paid dividends on its common stock and has no plans to pay dividends on its common stock. Therefore, the Company used an expected dividend yield of zero. |
Schedule of Nonvested Restricted Stock Units and Performance Stock Units Activity and Weighted Average Grant Date Fair Value | The following table summarizes RSU and PSU activity and weighted average grant date fair value for the year ended December 31, 2022: Shares Weighted- Unvested shares as of December 31, 2021 623,000 $ 8.63 Granted 328,150 $ 5.37 Vested (132,854) $ 9.40 Forfeited (176,889) $ 7.63 Unvested shares as of December 31, 2022 641,407 $ 7.08 |
Summary of Non-cash Stock Based Compensation Expense | Total stock-based compensation expense recognized was as follows (in thousands): Year Ended December 31, 2022 2021 2020 Research and development $ 3,159 $ 2,252 $ 1,494 Selling, general and administrative 5,158 5,649 4,479 Total $ 8,317 $ 7,901 $ 5,973 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | |
Schedule of Effective Income Tax Rate Reconciliation | The effective tax rate of the provision for income taxes differs from the federal statutory rate as follows: Year Ended December 31, 2022 2021 2020 Federal statutory income tax rate 21.00 % 21.00 % 21.00 % Change in valuation allowance (25.99) (31.07) (26.75) Tax credits 4.15 12.14 6.43 State income taxes, net of federal benefit 2.39 0.73 0.33 Stock-based compensation (0.98) (3.02) (1.00) Other, net (0.59) 0.03 (0.01) Provision for income taxes (0.02) % (0.19) % — % |
Schedule of Deferred Tax Assets and Liabilities | The components of the deferred tax assets and liabilities are as follows (in thousands): December 31, 2022 2021 Deferred tax assets: Net operating loss carryforwards $ 63,069 $ 60,273 Tax credits 9,985 5,486 Depreciation and amortization 2,920 1,863 Stock-based compensation 3,429 3,004 Section 174 Capitalization 15,581 — Accruals and reserves 1,431 646 Lease liabilities 131 156 Gross deferred tax assets 96,546 71,428 Valuation allowance (96,418) (71,291) Total deferred tax assets 128 137 Deferred tax liabilities: Right-of-use assets (128) (137) Total deferred tax liabilities (128) (137) Net deferred tax assets $ — $ — |
Schedule of Unrecognized Tax Benefits Roll Forward | A reconciliation of the Company’s unrecognized tax benefits for the years ended December 31, 2022, 2021 and 2020 is as follows (in thousands): Year Ended December 31, 2022 2021 2020 Balance at beginning of year $ 1,950 $ 451 $ 3,277 Additions based on tax positions related to prior year — — — Additions based on tax positions related to current year 1,586 1,499 81 Reductions based on tax positions related to prior year (44) — (2,907) Reductions based on tax positions related to current year — — — Balance at end of year $ 3,492 $ 1,950 $ 451 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Leases [Abstract] | |
Maturity of Operating Leases Liabilities and Future Minimum Lease Payments | The maturities of the Company’s operating lease liabilities as of December 31, 2022 were as follows (in thousands): Undiscounted lease payments December 31, 2022 2023 528 2024 84 2025 1 Total undiscounted payments 613 Less: imputed interest 39 Present value of future lease payments 574 Less: current portion of operating lease liabilities 491 Operating lease liabilities $ 83 |
Description of Business - Addit
Description of Business - Additional Information (Detail) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 USD ($) segment | Dec. 31, 2021 USD ($) | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Number of operating segments | segment | 1 | |
Cash, cash equivalents and short-term investments | $ 98,900 | |
Cash and cash equivalents | 25,798 | $ 22,221 |
Short-term debt securities available-for-sale | 73,100 | |
Accumulated deficit | $ (437,193) | $ (340,417) |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Additional Information (Detail) - USD ($) | 1 Months Ended | 3 Months Ended | 12 Months Ended | ||
Jun. 30, 2021 | Mar. 31, 2021 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Product Information [Line Items] | |||||
Aggregated transaction gains | $ 100,000 | ||||
Foreign currency translation adjustment | (100,000) | $ 0 | $ 0 | ||
Accounts receivable, allowance for doubtful accounts | 0 | 0 | |||
Bad debt expense | 0 | 0 | |||
Inventory write down | 1,043,000 | 0 | 0 | ||
Early access program term (in years) | 1 year | ||||
Total revenue | $ 13,484,000 | $ 12,142,000 | $ 0 | ||
Anti-dilutive securities (in shares) | 7,119,341 | 5,933,344 | 3,815,744 | ||
Impairment, Long-Lived Asset, Held-for-Use | $ 0 | ||||
Options to purchase common stock | |||||
Product Information [Line Items] | |||||
Anti-dilutive securities (in shares) | 6,143,183 | 5,262,185 | 3,697,075 | ||
Restricted stock units (unvested) | |||||
Product Information [Line Items] | |||||
Anti-dilutive securities (in shares) | 641,407 | 623,000 | 37,500 | ||
ESPP | |||||
Product Information [Line Items] | |||||
Anti-dilutive securities (in shares) | 334,751 | 48,159 | 81,169 | ||
Customer A | Customer Concentration Risk | Financing Receivable | |||||
Product Information [Line Items] | |||||
Concentration risk | 58% | 66% | |||
Customer A | Customer Concentration Risk | Revenue Benchmark | |||||
Product Information [Line Items] | |||||
Concentration risk | 93% | 94% | |||
Customer B | Customer Concentration Risk | Financing Receivable | |||||
Product Information [Line Items] | |||||
Concentration risk | 42% | 34% | |||
Product revenue, net | |||||
Product Information [Line Items] | |||||
Total revenue | $ 0 | $ 12,734,000 | $ 12,142,000 | $ 0 | |
Autorisation Temporaire D Utlisation Member | |||||
Product Information [Line Items] | |||||
Total revenue | $ 200,000 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Schedule of Estimated Useful Lives of Property and Equipment (Details) | 12 Months Ended |
Dec. 31, 2022 | |
Lab equipment | |
Property, Plant and Equipment [Line Items] | |
Useful life | 5 years |
Furniture | |
Property, Plant and Equipment [Line Items] | |
Useful life | 5 years |
Leasehold improvements | |
Property, Plant and Equipment [Line Items] | |
Useful life | 5 years |
Computer equipment and software | |
Property, Plant and Equipment [Line Items] | |
Useful life | 3 years |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Detail) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Financial assets | $ 88,664,000 | $ 97,376,000 |
Financial liabilities | 0 | 0 |
Other-than-temporary impairment losses | 0 | |
Debt securities, unrealized loss | 203,000 | 149,000 |
Debt securities, unrealized loss position for more than 12 months | 21,000 | |
Level 3 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Financial assets | 0 | 0 |
Financial liabilities | 0 | 0 |
Transfers in or out of level 3 | $ 0 | $ 0 |
Fair Value Measurements - Summa
Fair Value Measurements - Summary of Assets and Liabilities Measured at Fair Value (Detail) - USD ($) | Dec. 31, 2022 | Dec. 31, 2021 |
Financial assets: | ||
Financial assets | $ 88,664,000 | $ 97,376,000 |
Corporate debt securities | ||
Financial assets: | ||
Financial assets | 28,642,000 | 41,511,000 |
Commercial paper | ||
Financial assets: | ||
Financial assets | 8,913,000 | |
U.S. government bonds | ||
Financial assets: | ||
Financial assets | 39,563,000 | 42,345,000 |
Money market funds | ||
Financial assets: | ||
Financial assets | 11,546,000 | 13,520,000 |
Level 1 | ||
Financial assets: | ||
Financial assets | 11,546,000 | 13,520,000 |
Level 1 | Corporate debt securities | ||
Financial assets: | ||
Financial assets | 0 | 0 |
Level 1 | Commercial paper | ||
Financial assets: | ||
Financial assets | 0 | |
Level 1 | U.S. government bonds | ||
Financial assets: | ||
Financial assets | 0 | 0 |
Level 1 | Money market funds | ||
Financial assets: | ||
Financial assets | 11,546,000 | 13,520,000 |
Level 2 | ||
Financial assets: | ||
Financial assets | 77,118,000 | 83,856,000 |
Level 2 | Corporate debt securities | ||
Financial assets: | ||
Financial assets | 28,642,000 | 41,511,000 |
Level 2 | Commercial paper | ||
Financial assets: | ||
Financial assets | 8,913,000 | |
Level 2 | U.S. government bonds | ||
Financial assets: | ||
Financial assets | 39,563,000 | 42,345,000 |
Level 2 | Money market funds | ||
Financial assets: | ||
Financial assets | 0 | 0 |
Level 3 | ||
Financial assets: | ||
Financial assets | 0 | 0 |
Level 3 | Corporate debt securities | ||
Financial assets: | ||
Financial assets | 0 | 0 |
Level 3 | Commercial paper | ||
Financial assets: | ||
Financial assets | 0 | |
Level 3 | U.S. government bonds | ||
Financial assets: | ||
Financial assets | 0 | 0 |
Level 3 | Money market funds | ||
Financial assets: | ||
Financial assets | $ 0 | $ 0 |
Fair Value Measurements - Estim
Fair Value Measurements - Estimated Value of Cash Equivalents and Debt Securities and Gross Unrealized Holding Gains and Losses (Detail) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Cash Equivalents and Investment Securities [Line Items] | ||
Cash equivalents, Amortized cost | $ 15,514 | $ 13,520 |
Cash equivalents, Estimated Fair Value | 15,514 | 13,520 |
Debt securities, Amortized cost | 73,350 | 84,005 |
Debt securities, Unrealized gain | 3 | 0 |
Debt securities, unrealized loss | 203 | 149 |
Debt securities, Estimated Fair Value | 73,150 | 83,856 |
Assets, Fair Value | 88,664 | 97,376 |
Corporate debt securities | ||
Cash Equivalents and Investment Securities [Line Items] | ||
Debt securities, Amortized cost | 28,759 | 41,576 |
Debt securities, Unrealized gain | 0 | 0 |
Debt securities, unrealized loss | 117 | 65 |
Debt securities, Estimated Fair Value | 28,642 | 41,511 |
Assets, Fair Value | 28,642 | 41,511 |
Commercial paper | ||
Cash Equivalents and Investment Securities [Line Items] | ||
Debt securities, Amortized cost | 4,945 | |
Debt securities, Unrealized gain | 0 | |
Debt securities, unrealized loss | 0 | |
Debt securities, Estimated Fair Value | 4,945 | |
Assets, Fair Value | 8,913 | |
U.S. government bonds | ||
Cash Equivalents and Investment Securities [Line Items] | ||
Debt securities, Amortized cost | 39,646 | 42,429 |
Debt securities, Unrealized gain | 3 | 0 |
Debt securities, unrealized loss | 86 | 84 |
Debt securities, Estimated Fair Value | 39,563 | 42,345 |
Assets, Fair Value | 39,563 | 42,345 |
Short-term debt securities | ||
Cash Equivalents and Investment Securities [Line Items] | ||
Debt securities, Estimated Fair Value | 73,150 | 66,594 |
Long-term debt securities | ||
Cash Equivalents and Investment Securities [Line Items] | ||
Debt securities, Estimated Fair Value | 17,262 | |
Money market funds | ||
Cash Equivalents and Investment Securities [Line Items] | ||
Cash equivalents, Amortized cost | 11,546 | 13,520 |
Cash equivalents, Estimated Fair Value | 11,546 | 13,520 |
Assets, Fair Value | 11,546 | 13,520 |
Cash equivalents | ||
Cash Equivalents and Investment Securities [Line Items] | ||
Cash equivalents, Estimated Fair Value | 15,514 | $ 13,520 |
Commercial paper | ||
Cash Equivalents and Investment Securities [Line Items] | ||
Cash equivalents, Amortized cost | 3,968 | |
Cash equivalents, Estimated Fair Value | $ 3,968 |
Balance Sheet Components - Sche
Balance Sheet Components - Schedule of Inventory (Detail) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Balance Sheet Related Disclosures [Abstract] | ||
Raw materials | $ 1,703 | $ 1,056 |
Work-in-progress | 884 | 1,468 |
Finished goods | 266 | 88 |
Total inventories | $ 2,853 | $ 2,612 |
Balance Sheet Components - Sc_2
Balance Sheet Components - Schedule of Property, Plant and Equipment (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Property, Plant and Equipment [Line Items] | |||
Total property and equipment | $ 1,591 | $ 1,216 | |
Less: accumulated depreciation | (895) | (603) | |
Property and equipment, net | 696 | 613 | |
Depreciation | 300 | 300 | $ 200 |
Computer equipment and software | |||
Property, Plant and Equipment [Line Items] | |||
Total property and equipment | 736 | 669 | |
Furniture | |||
Property, Plant and Equipment [Line Items] | |||
Total property and equipment | 116 | 116 | |
Leasehold improvements | |||
Property, Plant and Equipment [Line Items] | |||
Total property and equipment | 101 | 101 | |
Lab equipment | |||
Property, Plant and Equipment [Line Items] | |||
Total property and equipment | 271 | 271 | |
Construction in progress | |||
Property, Plant and Equipment [Line Items] | |||
Total property and equipment | $ 367 | $ 59 |
Balance Sheet Components - Sc_3
Balance Sheet Components - Schedule of Prepaid Expenses and Other Current Assets (Detail) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Balance Sheet Related Disclosures [Abstract] | ||
Prepaid contract manufacturing costs | $ 3,542 | $ 3,695 |
Short term deposits | 4,542 | 54 |
Prepaid research costs | 2,822 | 3,253 |
Prepaid insurance | 586 | 631 |
Prepaid marketing | 753 | 469 |
Other | 1,740 | 1,259 |
Total prepaid expenses and other current assets | $ 13,985 | $ 9,361 |
Balance Sheet Components - Sc_4
Balance Sheet Components - Schedule of Components of Accrued Liabilities (Detail) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Balance Sheet Related Disclosures [Abstract] | ||
Compensation and related benefits | $ 6,167 | $ 3,131 |
Contract research costs | 4,188 | 4,760 |
Contract manufacturing costs | 2,101 | 3,288 |
Product revenue reserves | 1,373 | 1,846 |
Other | 1,826 | 674 |
Total accrued liabilities | $ 15,655 | $ 13,699 |
License, Collaboration, and P_2
License, Collaboration, and Product Development Agreements - Additional Information (Detail) - USD ($) | 1 Months Ended | 12 Months Ended | ||||||||
Aug. 11, 2018 | May 15, 2018 | Mar. 31, 2022 | Apr. 30, 2016 | Sep. 30, 2010 | Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||
Research and development | $ 75,282,000 | $ 64,436,000 | $ 41,590,000 | |||||||
Value of common stock issued during period | $ 66,110,000 | $ 2,685,000 | 96,760,000 | |||||||
Common stock, issued (in shares) | 44,074,284 | 34,568,821 | ||||||||
Common stock, $0.001 par value, 200,000,000 shares authorized as of December 31, 2022 and 2021; 44,074,284 and 34,568,821 shares issued and outstanding as of December 31, 2022 and 2021, respectively | $ 44,000 | $ 35,000 | ||||||||
UPennCHOPAgreement | ||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||
Non refundable issue fee | $ 1,000,000 | |||||||||
Research and development | 2,000,000 | |||||||||
Product Development Agreement | ||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||
Product development fees | $ 10,000,000 | |||||||||
Period of committed payment of fees | 4 years | |||||||||
Expert consultant fees and pass through costs | $ 800,000 | |||||||||
Incentive-based regulatory milestone fees | $ 1,000,000 | |||||||||
Number of common stock issued subject to quarterly vesting requirements (in shares) | 115,526 | |||||||||
Research and development | 19,000 | $ 200,000 | $ 200,000 | |||||||
Progeria Research Foundation (PRF) Collaboration Agreement | ||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||
Collaboration agreement initial term | 10 years | |||||||||
Collaborative arrangement renewal term | 2 years | |||||||||
Maximum | UPennCHOPAgreement | ||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||
License maintenance fee | 2,500,000 | |||||||||
Commercial Sales | Maximum | UPennCHOPAgreement | ||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||
Milestone obligations | $ 0 | $ 18,000,000 | ||||||||
Common Stock | ||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||
Issuance of common stock (in shares) | 8,528,074 | 565,938 | 9,267,760 | |||||||
Value of common stock issued during period | $ 8,000 | $ 1,000 | $ 10,000 | |||||||
Licensing Agreements | ||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||
Up front cash payments | $ 2,000,000 | |||||||||
Licensing Agreements | Merck Transaction | ||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||
Milestone payments | $ 1,000,000 | $ 0 | ||||||||
Licensing Agreements | Merck Transaction | Subsequent Event | ||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||
Milestone payments | $ 1,000,000 | |||||||||
Licensing Agreements | Research and development | Maximum | Merck Transaction | ||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||
Development milestone obligations | $ 27,000,000 | |||||||||
Contract-Based Intangible Assets | Merck Transaction | ||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||
Common stock, issued (in shares) | 27,350 | |||||||||
Common stock, $0.001 par value, 200,000,000 shares authorized as of December 31, 2022 and 2021; 44,074,284 and 34,568,821 shares issued and outstanding as of December 31, 2022 and 2021, respectively | $ 500,000 | |||||||||
BMS Transaction | Common Stock | Purchase Agreement | ||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||
Issuance of common stock (in shares) | 157,587 | |||||||||
Value of common stock issued during period | $ 3,200,000 | |||||||||
BMS Transaction | Licensing Agreements | Development And Regulatory Milestones | ||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||
Milestone obligations | 61,000,000 | |||||||||
BMS Transaction | Licensing Agreements | Commercial Sales | Maximum | ||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||
Milestone obligations | 128,000,000 | |||||||||
BMS Transaction | Licensing Agreements | Development Phase Two | ||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||
Milestone obligations | $ 3,000,000 | |||||||||
BMS Transaction | Licensing Agreements | Development Phase Three | ||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||
Milestone obligations | $ 5,000,000 |
Asset Purchase Agreements and_2
Asset Purchase Agreements and Related License Agreements - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 12 Months Ended | |||||
Nov. 20, 2020 | Mar. 22, 2016 | Sep. 30, 2015 | Dec. 31, 2010 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Asset Purchase Agreement And Related License Agreement [Line Items] | |||||||
Vesting period of options | 4 years | ||||||
Stock-based compensation expense | $ 8,317 | $ 7,901 | $ 5,973 | ||||
AbbVie Asset Purchase Agreement | |||||||
Asset Purchase Agreement And Related License Agreement [Line Items] | |||||||
Payment for asset purchase agreement | $ 95,000 | ||||||
AbbVie Asset Purchase Agreement | Progeria Research Foundation (PRF) Collaboration Agreement | |||||||
Asset Purchase Agreement And Related License Agreement [Line Items] | |||||||
Proceeds from sale | 46,500 | ||||||
Asset Purchase Agreement | EIG Transaction | |||||||
Asset Purchase Agreement And Related License Agreement [Line Items] | |||||||
Up front cash payments | $ 400 | ||||||
One time payment | $ 500 | ||||||
Avexitide Purchase Agreement | |||||||
Asset Purchase Agreement And Related License Agreement [Line Items] | |||||||
Issued stocks (in shares) | 15,378 | ||||||
Stock issued during period | $ 200 | ||||||
Options to purchase of common stock (in shares) | 48,544 | 46,134 | |||||
Exercise price (in usd per share) | $ 17.25 | $ 2.06 | |||||
Vesting of options to purchase common stock (in shares) | 30,756 | ||||||
Stock-based compensation expense | $ 0 | 100 | $ 100 | ||||
License agreement milestone payments paid | $ 100 | ||||||
Avexitide Purchase Agreement | Maximum | |||||||
Asset Purchase Agreement And Related License Agreement [Line Items] | |||||||
License agreement potential milestone payments | $ 1,000 | ||||||
Avexitide Purchase Agreement | Share-based Payment Arrangement, Tranche One | |||||||
Asset Purchase Agreement And Related License Agreement [Line Items] | |||||||
Issued stocks (in shares) | 15,378 | ||||||
Avexitide Purchase Agreement | Share-based Payment Arrangement, Tranche Two | |||||||
Asset Purchase Agreement And Related License Agreement [Line Items] | |||||||
Issued stocks (in shares) | 15,378 | ||||||
Avexitide Purchase Agreement | Share-based Payment Arrangement, Tranche Three | |||||||
Asset Purchase Agreement And Related License Agreement [Line Items] | |||||||
Issued stocks (in shares) | 15,378 | ||||||
Avexitide Purchase Agreement | Share-based Payment Arrangement, Tranche Four | |||||||
Asset Purchase Agreement And Related License Agreement [Line Items] | |||||||
Issued stocks (in shares) | 15,378 |
Sale of Assets - Additional Inf
Sale of Assets - Additional Information (Detail) - Disposal Group Not Discontinued Operations - MYDICAR - Theragene Pharmaceuticals, Inc. - USD ($) | 1 Months Ended | 12 Months Ended | |
Sep. 30, 2020 | May 31, 2017 | Dec. 31, 2021 | |
Income Statement Balance Sheet And Additional Disclosures By Disposal Groups Including Discontinued Operations [Line Items] | |||
Cash payment received for sale of assets under asset purchase agreement | $ 200,000 | ||
Sale of assets number of common stock shares received | 475,000 | 475,000 | |
Maximum cumulative cash proceeds of counter party for issuance of additional shares | $ 4,000,000 | ||
Maximum consideration per share of counter party for issuance of additional shares (in usd per share) | $ 6 | ||
Aggregate common stock consideration value | $ 2,900,000 | ||
Shares repurchase by counterparty based on exercise of put options | 225,000 | 225,000 | |
Cost method investment with carrying value | $ 0 | ||
Upfront, licensee fee, milestone and other payments (excluding royalty payments) received, percentage | 25% | ||
Proceeds from upfront, licensee fee, milestone and other payments (excluding royalty payments) received | $ 300,000 | ||
Minimum | |||
Income Statement Balance Sheet And Additional Disclosures By Disposal Groups Including Discontinued Operations [Line Items] | |||
Shares repurchase by counterparty based on exercise of put option value | $ 1,400,000 | ||
Maximum | |||
Income Statement Balance Sheet And Additional Disclosures By Disposal Groups Including Discontinued Operations [Line Items] | |||
Asset purchase agreement contingent consideration receivable | $ 45,000,000 | ||
Royalty receivable percentage on net sales | 8% |
Debt - Additional Information (
Debt - Additional Information (Detail) $ / shares in Units, $ in Thousands | 12 Months Ended | ||||||||||
Jun. 01, 2022 USD ($) $ / shares shares | Oct. 06, 2021 USD ($) | Feb. 23, 2021 USD ($) | Mar. 05, 2019 USD ($) | Dec. 31, 2022 USD ($) | Dec. 31, 2021 USD ($) | Dec. 31, 2020 USD ($) | Jun. 30, 2022 USD ($) | Aug. 03, 2018 USD ($) | May 31, 2018 USD ($) | Dec. 31, 2016 USD ($) | |
Debt Instrument [Line Items] | |||||||||||
Face value of term loan | $ 40,531 | $ 30,000 | |||||||||
Interest expense | 4,132 | 3,559 | $ 3,594 | ||||||||
Carrying value of debt | 39,625 | 23,986 | |||||||||
Value of common stock issued during period | 66,110 | 2,685 | 96,760 | ||||||||
Loan final repayment exit fees payable | 2,600 | 3,277 | |||||||||
Loss on extinguishment of debt | 1,144 | $ 0 | $ 0 | ||||||||
Oxford Loan | |||||||||||
Debt Instrument [Line Items] | |||||||||||
Interest expense | 1,500 | ||||||||||
Oxford Loan | Amended Tranche A | |||||||||||
Debt Instrument [Line Items] | |||||||||||
Loan outstanding | $ 30,000 | ||||||||||
Amended Oxford Loan | |||||||||||
Debt Instrument [Line Items] | |||||||||||
Loan agreement, aggregate borrowing capacity | 35,000 | ||||||||||
Percentage of exit fee on principal balance | 7.50% | ||||||||||
Loan outstanding | 23,300 | ||||||||||
Borrowings from loan agreement | 6,700 | ||||||||||
Loan final repayment exit fees payable | $ 2,300 | ||||||||||
Loan final repayment additional exit fees payable | 1,000 | ||||||||||
Amended Oxford Loan | Secured Debt, Tranche B | |||||||||||
Debt Instrument [Line Items] | |||||||||||
Repayments of loan agreement exit fee | $ 900 | ||||||||||
Amended Oxford Loan | Secured Debt, Amended Tranche B | |||||||||||
Debt Instrument [Line Items] | |||||||||||
Loan agreement, remaining borrowing capacity | $ 5,000 | ||||||||||
Fifth Amended Oxford Loan | |||||||||||
Debt Instrument [Line Items] | |||||||||||
Interest payment period | 17 months | ||||||||||
Principal and interest payment period | 19 months | ||||||||||
Amendment fees payment | $ 200 | ||||||||||
Line of Credit | Secured Debt | Innovatus Stock Purchase Agreement | |||||||||||
Debt Instrument [Line Items] | |||||||||||
Value of common stock issued during period | $ 5,000 | ||||||||||
Sale of common stock, shares issued (in shares) | shares | 749,053 | ||||||||||
Sale of common stock (in USD per share) | $ / shares | $ 6.6751 | ||||||||||
Line of Credit | Innovatus Loan | Secured Debt | |||||||||||
Debt Instrument [Line Items] | |||||||||||
Loan agreement, aggregate borrowing capacity | $ 75,000 | ||||||||||
Debt Instrument, percent of interest due (in percent) | 0.0225 | ||||||||||
Percentage of exit fee on principal balance | 6.50% | ||||||||||
Minimum cash balance of face value of loan (in percent) | 0.05 | ||||||||||
Debt discount | 200 | ||||||||||
Capitalized debt issuance costs | 1,100 | ||||||||||
Interest expense | 2,600 | ||||||||||
Carrying value of debt | $ 39,600 | ||||||||||
Effective interest rate | 12.86% | ||||||||||
Line of Credit | Innovatus Loan | Secured Debt | Variable Rate Component One | Minimum | |||||||||||
Debt Instrument [Line Items] | |||||||||||
Minimum prime rate | 3.50% | ||||||||||
Line of Credit | Innovatus Loan | Secured Debt | Variable Rate Component Two | |||||||||||
Debt Instrument [Line Items] | |||||||||||
Minimum prime rate | 3.75% | ||||||||||
Line of Credit | Innovatus Loan | Secured Debt, Tranche A | |||||||||||
Debt Instrument [Line Items] | |||||||||||
Face value of term loan | $ 40,000 | ||||||||||
Line of Credit | Innovatus Loan | Secured Debt, Tranche B | |||||||||||
Debt Instrument [Line Items] | |||||||||||
Face value of term loan | $ 17,500 | 17,500 | |||||||||
Line of Credit | Innovatus Loan | Secured Debt, Tranche B and C | |||||||||||
Debt Instrument [Line Items] | |||||||||||
Face value of term loan | $ 35,000 | ||||||||||
Line of Credit | Oxford Loan | |||||||||||
Debt Instrument [Line Items] | |||||||||||
Loan agreement, aggregate borrowing capacity | $ 25,000 | ||||||||||
Line of Credit | Oxford Loan | Secured Debt | |||||||||||
Debt Instrument [Line Items] | |||||||||||
Face value of term loan | $ 33,500 | ||||||||||
Line of Credit | Oxford Loan | Secured Debt, Tranche A | |||||||||||
Debt Instrument [Line Items] | |||||||||||
Face value of term loan | $ 15,000 | ||||||||||
Line of Credit | Amendment | Secured Debt, Tranche B | |||||||||||
Debt Instrument [Line Items] | |||||||||||
Face value of term loan | $ 5,000 | ||||||||||
Line of Credit | Amendment | Secured Debt, Tranche C | |||||||||||
Debt Instrument [Line Items] | |||||||||||
Face value of term loan | $ 5,000 | ||||||||||
Line of Credit | Amended Oxford Loan | Amended Tranche A | |||||||||||
Debt Instrument [Line Items] | |||||||||||
Loan agreement, aggregate borrowing capacity | 30,000 | ||||||||||
Repayments of loan agreement exit fee | 33,500 | ||||||||||
Accrued and unpaid interest | 200 | ||||||||||
Loss on extinguishment of debt | $ 1,100 | ||||||||||
Other final payments | $ 3,300 |
Debt - Schedule of Long-Term De
Debt - Schedule of Long-Term Debt and Unamortized Discount Balances (Detail) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Debt Disclosure [Abstract] | ||
Face value of debt | $ 40,531 | $ 30,000 |
Exit fee | 2,600 | 3,277 |
Unamortized debt discount associated with exit fee, debt issuance costs and loan origination fees | (3,506) | (1,482) |
Total debt, net | 39,625 | 31,795 |
Less: current portion of debt | 0 | (7,809) |
Debt, net of current portion | $ 39,625 | $ 23,986 |
Debt - Schedule of Maturities o
Debt - Schedule of Maturities of Long-term Debt (Detail) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Debt Instrument [Line Items] | ||
Less: unamortized interest | $ 3,506 | $ 1,482 |
Face value of term loan | 40,531 | $ 30,000 |
Amended Tranche A | Innovatus Loan | ||
Debt Instrument [Line Items] | ||
Long-Term Debt, Maturity, Year One | 3,686 | |
Long-Term Debt, Maturity, Year Two | 3,780 | |
Long-Term Debt, Maturity, Year Three | 4,407 | |
Long-Term Debt, Maturity, Year Four | 4,814 | |
Long-Term Debt, Maturity, Year Five | 48,185 | |
Total future payments | 64,872 | |
Less: unamortized interest | 21,741 | |
Less: exit fee | 3,506 | |
Face value of term loan | $ 39,625 |
Stockholders_ Equity - Addition
Stockholders’ Equity - Additional Information (Detail) - USD ($) | 1 Months Ended | 3 Months Ended | 12 Months Ended | ||||
Mar. 31, 2022 | Mar. 25, 2022 | Dec. 31, 2020 | Mar. 31, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||
Dividends declared | $ 0 | ||||||
Aggregate offering amount | $ 200,000,000 | ||||||
Issuance of common stock upon offering at-the-market, net of commissions | 66,402,000 | $ 3,040,000 | $ 96,779,000 | ||||
Maximum | |||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||
Common stock available for future issuance | $ 50,000,000 | ||||||
At The Market Offering | |||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||
Aggregate offering amount | 200,000,000 | ||||||
Maximum shares issued during the period | $ 50,000,000 | ||||||
Issuance of common stock (in shares) | 565,938 | 5,841,786 | |||||
Issuance of common stock upon offering at-the-market, net of commissions | $ 45,600,000 | $ 3,000,000 | |||||
Common stock available for future issuance | $ 28,700,000 | ||||||
Sale of common stock, shares issued (in shares) | 2,686,288 | ||||||
Consideration received on sale of stock | $ 20,800,000 |
Stockholders_ Equity - Common S
Stockholders’ Equity - Common Stock Reserved For Future Issuances (Details) - shares | Dec. 31, 2022 | Dec. 31, 2021 |
Share-based Payment Arrangement [Abstract] | ||
Options issued and outstanding (in shares) | 6,143,183 | 5,262,185 |
Options available for future grants (in shares) | 1,976,460 | 1,327,645 |
Restricted and performance stock units outstanding (in shares) | 641,407 | 623,000 |
Shares available for issuance under ESPP (in shares) | 788,057 | 671,172 |
Total (in shares) | 9,549,107 | 7,884,002 |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional Information (Details) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | |||||
Dec. 31, 2021 $ / shares shares | Jun. 30, 2021 shares | Mar. 31, 2020 | Dec. 31, 2022 USD ($) $ / shares shares | Dec. 31, 2021 USD ($) $ / shares shares | Dec. 31, 2020 USD ($) $ / shares shares | Dec. 31, 2013 shares | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||
Total unrecognized compensation expense | $ | $ 10,100 | ||||||
Closing price of common stock (in usd per share) | $ / shares | $ 1.18 | ||||||
Aggregate intrinsic value of options exercised | $ | $ 100 | $ 100 | $ 300 | ||||
Aggregate intrinsic value of options exercised | $ | $ 7,300 | $ 6,900 | 5,600 | ||||
Common stock reserved for issuance | 7,884,002 | 9,549,107 | 7,884,002 | ||||
Percentage increase in number of shares of common stock reserved for issuance | 1% | ||||||
Additional options authorized (in shares) | 1,728,441 | 165,000 | |||||
Options available for future grants (in shares) | 1,327,645 | 1,976,460 | 1,327,645 | ||||
Issuance of common stock upon ESPP purchase | $ | $ 158 | $ 257 | 186 | ||||
Total stock-based compensation expense | $ | $ 8,317 | $ 7,901 | $ 5,973 | ||||
Weighted-average period for recognition (in years) | 2 years 8 months 12 days | ||||||
Common Stock | |||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||
Issuance of common stock upon ESPP purchase (in shares) | 48,115 | 37,619 | 25,645 | ||||
Additional Paid-In Capital | |||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||
Issuance of common stock upon ESPP purchase | $ | $ 158 | $ 257 | $ 186 | ||||
Stock Options | |||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||
Weighted-average grant date fair value of employee option grants (in USD per share) | $ / shares | $ 3.65 | $ 5.58 | $ 4.78 | ||||
Performance Stock Units (PSU) | |||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||
Common stock available for grant (in shares) | 30,000 | 270,000 | |||||
Total unrecognized compensation expense | $ | $ 3,000 | ||||||
Weighted-average grant date fair value of employee option grants (in usd per share) | $ / shares | $ 6.87 | $ 7.92 | |||||
Total stock-based compensation expense | $ | $ 500 | $ 200 | |||||
Vested (in shares) | 0 | ||||||
Weighted-average period for recognition (in years) | 2 years | ||||||
Restricted stock units (unvested) | |||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||
Common stock available for grant (in shares) | 298,150 | 371,500 | |||||
Total unrecognized compensation expense | $ | $ 3,000 | ||||||
Period of service threshold | 6 months | ||||||
Weighted-average grant date fair value of employee option grants (in usd per share) | $ / shares | $ 5.22 | $ 9.16 | |||||
Total stock-based compensation expense | $ | $ 1,200 | $ 900 | |||||
Weighted-average period for recognition (in years) | 2 years | ||||||
Restricted stock units (unvested) | Share-based Payment Arrangement, Tranche One | |||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||
Vesting period of new grants | 1 year | ||||||
Restricted stock units (unvested) | Share-based Payment Arrangement, Tranche Two | |||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||
Vesting period of new grants | 2 years | ||||||
Restricted stock units (unvested) | Share-based Payment Arrangement, Tranche Three | |||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||
Vesting period of new grants | 3 years | ||||||
Restated Two Thousand Thirteen Equity Incentive Plan Member | |||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||
Vesting period of new grants | 4 years | ||||||
Number of shares available to be issued (in shares) | 8,127,807 | ||||||
Inducement Plan 2021 | |||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||
Number of shares available to be issued (in shares) | 380,000 | ||||||
Common stock available for grant (in shares) | 850,000 | ||||||
Two Thousand Thirteen Employee Stock Purchase Plan | |||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||
Common stock reserved for issuance | 948,831 | 100,000 | |||||
Options available for future grants (in shares) | 788,057 | ||||||
Minimum | Restated Two Thousand Thirteen Equity Incentive Plan Member | |||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||
Threshold ownership percentage of shareholder for grant of options at pre determined exercise price | 0.10 | ||||||
Minimum | Restated Two Thousand Thirteen Equity Incentive Plan Member | Holders Of Ten Percent Or More Of Voting Power | |||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||
Employee holding percentage | 110% | ||||||
Maximum | Restated Two Thousand Thirteen Equity Incentive Plan Member | |||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||
Contractual terms of options granted under the Plan | 10 years |
Stock-Based Compensation - Stoc
Stock-Based Compensation - Stock Option Activity (Detail) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Shares Available for Grants | ||
Outstanding, beginning balance (in shares) | 1,327,645 | |
Additional options authorized (in shares) | 1,728,441 | 165,000 |
Granted (in shares) | (2,061,100) | |
Restricted stock units granted (in shares) | (298,150) | |
Performance stock units granted (in shares) | (30,000) | |
Forfeited (in shares) | 1,132,735 | |
Restricted stock units forfeited (in shares) | 126,889 | |
Performance stock units cancelled (in shares) | 50,000 | |
Outstanding, ending balance (in shares) | 1,976,460 | 1,327,645 |
Number of Options | ||
Outstanding, beginning balance (in shares) | 5,262,185 | |
Granted (in shares) | 2,061,100 | |
Exercised (in shares) | (47,367) | |
Forfeited (in shares) | (1,132,735) | |
Outstanding, ending balance (in shares) | 6,143,183 | 5,262,185 |
Vested and exercisable (in shares) | 3,726,809 | |
Weighted- Average Exercise Price | ||
Weighted-average exercise price, outstanding, beginning balance (in USD per share) | $ 10.24 | |
Weighted-average exercise price, granted (in USD per share) | 5.74 | |
Weighted-average exercise price, exercised (in USD per share) | 4.93 | |
Weighted-average exercise price, forfeited (in USD per share) | 9.03 | |
Weighted-average exercise price, outstanding, ending balance (in USD per share) | 9 | $ 10.24 |
Weighted-average exercise price, vested and exercisable (in USD per share) | $ 10.30 | |
Stock Options Additional Disclosures | ||
SharebasedCompensationArrangementBySharebasedPaymentAwardOptionsOutstandingWeightedAverageRemainingContractualTerm2 | 6 years | 7 years 3 months |
Aggregate intrinsic value, beginning balance | $ 530 | |
SharebasedCompensationArrangementBySharebasedPaymentAwardOptionsOutstandingWeightedAverageRemainingContractualTerm2 | 6 years | 7 years 3 months |
Aggregate intrinsic value, ending balance | $ 0 | $ 530 |
Weighted average remaining contractual life, vested and exercisable (in years) | 4 years 6 months | |
Aggregate intrinsic value, vested and exercisable | $ 0 |
Stock-Based Compensation - Weig
Stock-Based Compensation - Weighted-average assumptions used in Black-Scholes Model to estimate fair value of stock options granted (Detail) | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Contractual term (in years) | 6 years | 7 years 3 months | |
Stock Options | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Volatility, minimum | 68.71% | 68.96% | 73% |
Volatility, maximum | 88.51% | 71.40% | 77% |
Risk free interest rate, minimum | 1.76% | 0.62% | 0.39% |
Risk free interest rate, maximum | 4.23% | 1.35% | 1.37% |
Dividend yield | 0% | 0% | 0% |
Stock Options | Minimum | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Expected term (in years) | 5 years 3 months 7 days | 5 years 3 months 7 days | 5 years |
Stock Options | Maximum | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Expected term (in years) | 6 years 29 days | 6 years 29 days | 6 years 29 days |
Non-Employees Stock Option | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Contractual term (in years) | 0 years | 0 years | 10 years |
Stock Based Compensation - Sche
Stock Based Compensation - Schedule of Nonvested Restricted Stock Units and Performance Stock Units Activity and Weighted Average Grant Date Fair Value (Detail) - Restricted Stock Units and Performance Stock Unit | 12 Months Ended |
Dec. 31, 2022 $ / shares shares | |
Shares | |
Unvested shares, beginning balance (in shares) | shares | 623,000 |
Stock options granted (in shares) | shares | 328,150 |
Vested (in shares) | shares | (132,854) |
Forfeited (in shares) | shares | (176,889) |
Unvested shares, ending balance (in shares) | shares | 641,407 |
Weighted- Average Grant Date Fair Value | |
Weighted average grant-date fair value of options beginning balance (in USD per share) | $ / shares | $ 8.63 |
Weighted-average grant date fair value of employee option grants (in usd per share) | $ / shares | 5.37 |
Weighted average grant-date fair value of options vested (in USD per share) | $ / shares | 9.40 |
Weighted average grant-date fair value of options forfeited (in USD per share) | $ / shares | 7.63 |
Weighted average grant-date fair value of options ending balance (in USD per share) | $ / shares | $ 7.08 |
Stock-Based Compensation - Summ
Stock-Based Compensation - Summary of Non-cash Stock Based Compensation Expense (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Total stock-based compensation expense | $ 8,317 | $ 7,901 | $ 5,973 |
Research and development | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Total stock-based compensation expense | 3,159 | 2,252 | 1,494 |
Selling, general and administrative | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Total stock-based compensation expense | $ 5,158 | $ 5,649 | $ 4,479 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Detail) - USD ($) | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Tax Credit Carryforward [Line Items] | |||
Provision for income taxes | $ 23,000 | $ 64,000 | $ 0 |
Provision for income taxes | (0.02%) | (0.19%) | 0% |
State income taxes, net of federal benefit | 2.39% | 0.73% | 0.33% |
Valuation allowance | $ 25,100,000 | $ 10,500,000 | |
Unrecognized tax benefits impact on effective tax rate | 3,500,000 | ||
Accrued interest and penalties associated with uncertain tax positions | 0 | $ 0 | $ 0 |
State and Local Jurisdiction | |||
Tax Credit Carryforward [Line Items] | |||
Net operating loss carryforwards | 25,400,000 | ||
Research and development tax credit carryforwards | 3,100,000 | ||
Domestic Tax Authority | |||
Tax Credit Carryforward [Line Items] | |||
Net operating loss carryforwards | 292,300,000 | ||
Research and development tax credit carryforwards | 0 | ||
Domestic Tax Authority | Orphan Drug Credit Carryforward | |||
Tax Credit Carryforward [Line Items] | |||
Research and development tax credit carryforwards | $ 10,800,000 |
Income Taxes - Schedule of Effe
Income Taxes - Schedule of Effective Income Tax Rate Reconciliation (Detail) | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Income Tax Disclosure [Abstract] | |||
Federal statutory income tax rate | 21% | 21% | 21% |
Change in valuation allowance | (25.99%) | (31.07%) | (26.75%) |
Tax credits | 4.15% | 12.14% | 6.43% |
State income taxes, net of federal benefit | 2.39% | 0.73% | 0.33% |
Stock-based compensation | (0.98%) | (3.02%) | (1.00%) |
Other, net | (0.59%) | 0.03% | (0.01%) |
Provision for income taxes | (0.02%) | (0.19%) | 0% |
Income Taxes - Schedule of Defe
Income Taxes - Schedule of Deferred Tax Assets and Liabilities (Detail) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Income Tax Disclosure [Abstract] | ||
Net operating loss carryforwards | $ 63,069 | $ 60,273 |
Tax credits | 9,985 | 5,486 |
Depreciation and amortization | 2,920 | 1,863 |
Stock-based compensation | 3,429 | 3,004 |
Section 174 Capitalization | 15,581 | 0 |
Accruals and reserves | 1,431 | 646 |
Lease liabilities | 131 | 156 |
Gross deferred tax assets | 96,546 | 71,428 |
Valuation allowance | (96,418) | (71,291) |
Total deferred tax assets | 128 | 137 |
Right-of-use assets | (128) | (137) |
Total deferred tax liabilities | (128) | (137) |
Net deferred tax assets | $ 0 | $ 0 |
Income Taxes - Schedule of Unre
Income Taxes - Schedule of Unrecognized Tax Benefits Roll Forward (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Reconciliation of Unrecognized Tax Benefits, Excluding Amounts Pertaining to Examined Tax Returns [Roll Forward] | |||
Balance at beginning of year | $ 1,950 | $ 451 | $ 3,277 |
Additions based on tax positions related to prior year | 0 | 0 | 0 |
Additions based on tax positions related to current year | 1,586 | 1,499 | 81 |
Reductions based on tax positions related to prior year | (44) | 0 | (2,907) |
Reductions based on tax positions related to current year | 0 | 0 | 0 |
Balance at end of year | $ 3,492 | $ 1,950 | $ 451 |
Legal Matters (Details)
Legal Matters (Details) | Nov. 08, 2022 segment |
Legal Matters [Abstract] | |
Number of former executives | 2 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) $ in Millions | 12 Months Ended | ||||
Dec. 31, 2022 USD ($) | Dec. 31, 2021 USD ($) | Dec. 31, 2020 USD ($) | Feb. 28, 2023 | Oct. 31, 2017 USD ($) ft² | |
Other Commitments [Line Items] | |||||
Rent expense recognized for company's operating leases | $ 0.6 | $ 0.6 | $ 0.6 | ||
Variable lease payments for operating leases | 0.1 | 0.1 | 0.1 | ||
Operating cash outflows for operating lease liabilities | $ 0.7 | $ 0.6 | $ 0.7 | ||
Weighted-average remaining lease term (in years) | 1 year 2 months 12 days | ||||
Weighted-average discount rate (in percent) | 12.82% | ||||
Patheon Inc | Master Manufacturing Services Agreement | |||||
Other Commitments [Line Items] | |||||
Percentage of product manufactured on the basics of annual forecasts | 0.80 | ||||
Percentage of purchase price | 0.70 | ||||
Patheon Inc | Master Manufacturing Services Agreement | Maximum | |||||
Other Commitments [Line Items] | |||||
Percentage of product manufactured on the basics of annual forecasts | 20 | ||||
Palo Alto, California | |||||
Other Commitments [Line Items] | |||||
Total leased space | ft² | 8,029 | ||||
Lease renewal term | 3 years | ||||
Security deposit of collateral for lease | $ 0.3 | ||||
Palo Alto, California | Subsequent Event | |||||
Other Commitments [Line Items] | |||||
Lease renewal term | 1 year |
Commitments and Contingencies_2
Commitments and Contingencies - Maturity of Operating Leases Liabilities and Future Minimum Lease Payments (Detail) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Leases [Abstract] | ||
2023 | $ 528 | |
2024 | 84 | |
2025 | 1 | |
Total undiscounted payments | 613 | |
Less: imputed interest | 39 | |
Present value of future lease payments | 574 | |
Less: current portion of operating lease liabilities | 491 | $ 628 |
Operating lease liabilities | $ 83 | $ 116 |
Subsequent Events - Additional
Subsequent Events - Additional Information (Detail) $ in Thousands | Feb. 06, 2023 USD ($) | Mar. 10, 2023 USD ($) account | Dec. 31, 2022 USD ($) | Dec. 31, 2021 USD ($) |
Subsequent Event [Line Items] | ||||
Cash and cash equivalents | $ 25,798 | $ 22,221 | ||
Former CEO | ||||
Subsequent Event [Line Items] | ||||
Salary continuation | $ 2,000 | |||
Subsequent Event | ||||
Subsequent Event [Line Items] | ||||
Number of accounts | account | 2 | |||
Subsequent Event | Silicon Valley Bank | ||||
Subsequent Event [Line Items] | ||||
Cash and cash equivalents | $ 8,300 | |||
Subsequent Event | Former CEO | ||||
Subsequent Event [Line Items] | ||||
Salary continuation | $ 1,500 | |||
Base salary and target bonus continuation period | 18 months | |||
Cash payment | $ 400 | |||
COBRA continuation coverage period | 18 months | |||
Legal fees reimbursement threshold | $ 10 | |||
Subsequent Event | Unvested Stock Options, Performance-Based Restricted Stock Units, And Time-Based RSUs | Former CEO | ||||
Subsequent Event [Line Items] | ||||
Accelerated vesting | 0.50 |