Document and Entity Information
Document and Entity Information - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2023 | Feb. 21, 2024 | Jun. 30, 2023 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2023 | ||
Document Fiscal Year Focus | 2023 | ||
Document Fiscal Period Focus | FY | ||
Entity Registrant Name | 89bio, Inc. | ||
Entity Central Index Key | 0001785173 | ||
Entity Current Reporting Status | Yes | ||
Entity Voluntary Filers | No | ||
Entity Interactive Data Current | Yes | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Filer Category | Large Accelerated Filer | ||
Entity Well-known Seasoned Issuer | Yes | ||
Entity Public Float | $ 1,175.6 | ||
Entity Common Stock, Shares Outstanding | 93,501,210 | ||
ICFR Auditor Attestation Flag | true | ||
Entity Shell Company | false | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | false | ||
Document Financial Statement Error Correction [Flag] | false | ||
Title of 12(b) Security | Common stock, par value $0.001 per share | ||
Trading Symbol | ETNB | ||
Security Exchange Name | NASDAQ | ||
Entity File Number | 001-39122 | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Tax Identification Number | 36-4946844 | ||
Entity Address, Address Line One | 142 Sansome Street | ||
Entity Address Address Line Two | Second Floor | ||
Entity Address, City or Town | San Francisco | ||
Entity Address, State or Province | CA | ||
Entity Address, Postal Zip Code | 94104 | ||
City Area Code | 415 | ||
Local Phone Number | 432-9270 | ||
Document Annual Report | true | ||
Document Transition Report | false | ||
Documents Incorporated by Reference | Portions of the registrant’s proxy statement for the 2024 Annual Meeting of Stockholders, to be held on or about May 29, 2024, are incorporated by reference into Part III of this Annual Report on Form 10-K to the extent stated herein. Such proxy statement will be filed with the Securities and Exchange Commission within 120 days of the registrant’s fiscal year ended December 31, 2023. | ||
Auditor Firm ID | 185 | ||
Auditor Name | KPMG LLP | ||
Auditor Location | San Francisco, California, USA |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 316,161 | $ 55,255 |
Marketable securities | 262,709 | 132,905 |
Prepaid and other current assets | 14,664 | 7,920 |
Total current assets | 593,534 | 196,080 |
Operating lease right-of-use assets | 2,293 | 363 |
Property and equipment, net | 46 | 92 |
Other assets | 396 | 289 |
Total assets | 596,269 | 196,824 |
Current liabilities: | ||
Accounts payable | 8,585 | 12,502 |
Accrued expenses | 20,530 | 11,944 |
Operating lease liabilities, current | 496 | 168 |
Total current liabilities | 29,611 | 24,614 |
Operating lease liabilities, non-current | 1,817 | 186 |
Term loan, non-current, net | 24,795 | 20,192 |
Other non-current liabilities | 3,740 | |
Total liabilities | 59,963 | 44,992 |
Commitments and contingencies (Note 5) | ||
Stockholders’ equity: | ||
Preferred stock, $0.001 par value; 10,000,000 shares authorized, none issued and outstanding | ||
Common stock, $0.001 par value; 200,000,000 and 100,000,000 shares authorized and 93,269,377 and 50,560,590 shares issued and outstanding as of December 31, 2023 and 2022, respectively | 93 | 51 |
Additional paid-in capital | 993,455 | 467,374 |
Accumulated other comprehensive income (loss) | 190 | (350) |
Accumulated deficit | (457,432) | (315,243) |
Total stockholders’ equity | 536,306 | 151,832 |
Total liabilities and stockholders’ equity | $ 596,269 | $ 196,824 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2023 | Dec. 31, 2022 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 200,000,000 | 100,000,000 |
Common stock, shares issued | 93,269,377 | 50,560,590 |
Common stock, shares outstanding | 93,269,377 | 50,560,590 |
Consolidated Statements of Oper
Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Operating expenses: | |||
Research and development | $ 122,230 | $ 80,796 | $ 70,330 |
General and administrative | 28,974 | 21,453 | 19,413 |
Total operating expenses | 151,204 | 102,249 | 89,743 |
Loss from operations | (151,204) | (102,249) | (89,743) |
Interest expense | (4,794) | (1,922) | (674) |
Interest income and other, net | 17,676 | 2,164 | 148 |
Net loss before income tax | (138,322) | (102,007) | (90,269) |
Income tax (expense) benefit | (3,867) | (19) | 147 |
Net loss | (142,189) | (102,026) | (90,122) |
Other comprehensive income (loss): | |||
Unrealized gain (loss) on marketable securities | 547 | (299) | (71) |
Foreign currency translation adjustments | (7) | 13 | 17 |
Total other comprehensive income (loss) | 540 | (286) | (54) |
Comprehensive loss | $ (141,649) | $ (102,312) | $ (90,176) |
Net loss per share, basic | $ (2) | $ (2.93) | $ (4.48) |
Net loss per share, diluted | $ (2) | $ (2.93) | $ (4.48) |
Weighted-average shares used to compute net loss per share, basic | 71,172,870 | 34,806,349 | 20,098,340 |
Weighted-average shares used to compute net loss per share, diluted | 71,172,870 | 34,806,349 | 20,098,340 |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Equity (Deficit) - USD ($) $ in Thousands | Total | A T M Facility | Public Offerings | Common Stock | Common Stock A T M Facility | Common Stock Public Offerings | Additional Paid-in Capital | Additional Paid-in Capital A T M Facility | Additional Paid-in Capital Public Offerings | Accumulated Other Comprehensive (Loss) Income | Accumulated Deficit |
Beginning balance at Dec. 31, 2020 | $ 202,961 | $ 20 | $ 326,046 | $ (10) | $ (123,095) | ||||||
Beginning balance, shares at Dec. 31, 2020 | 19,931,660 | ||||||||||
Issuance of common stock | $ 3,289 | $ 3,289 | |||||||||
Issuance of common stock, shares | 186,546 | ||||||||||
Issuance of common stock warrants related to term loan facility | 574 | 574 | |||||||||
Issuance of common stock upon exercise of stock options | 487 | 487 | |||||||||
Issuance of common stock upon exercise of stock options, shares | 188,286 | ||||||||||
Issuance of common stock upon ESPP purchase | 144 | 144 | |||||||||
Issuance of common stock upon ESPP purchase, shares | 10,712 | ||||||||||
Stock-based compensation | 8,678 | 8,678 | |||||||||
Net loss | (90,122) | (90,122) | |||||||||
Other comprehensive income (loss) | (54) | (54) | |||||||||
Ending balance at Dec. 31, 2021 | 125,957 | $ 20 | 339,218 | (64) | (213,217) | ||||||
Ending balance, shares at Dec. 31, 2021 | 20,317,204 | ||||||||||
Issuance of common stock | 28,453 | $ 88,239 | $ 4 | $ 20 | 28,449 | $ 88,219 | |||||
Issuance of common stock, shares | 3,948,611 | 18,675,466 | |||||||||
Issuance of common stock upon exercise of warrants | 1,082 | $ 4 | 1,078 | ||||||||
Issuance of common stock upon exercise of warrants | 4,202,499 | ||||||||||
Issuance of common stock upon cashless exercise of warrants | $ 3 | (3) | |||||||||
Issuance of common stock upon cashless exercise of warrants, shares | 3,143,682 | ||||||||||
Issuance of common stock upon exercise of stock options | 305 | 305 | |||||||||
Issuance of common stock upon exercise of stock options, shares | 151,061 | ||||||||||
Issuance of common stock upon vesting of restricted stock units, net of tax withholding for net share settlement | (298) | (298) | |||||||||
Issuance of common stock upon vesting of restricted stock units, net of tax withholding for net share settlement, shares | 103,703 | ||||||||||
Issuance of common stock upon ESPP purchase | 50 | 50 | |||||||||
Issuance of common stock upon ESPP purchase, shares | 18,364 | ||||||||||
Stock-based compensation | 10,356 | 10,356 | |||||||||
Net loss | (102,026) | (102,026) | |||||||||
Other comprehensive income (loss) | (286) | (286) | |||||||||
Ending balance at Dec. 31, 2022 | 151,832 | $ 51 | 467,374 | (350) | (315,243) | ||||||
Ending balance, shares at Dec. 31, 2022 | 50,560,590 | ||||||||||
Issuance of common stock | $ 37,089 | $ 458,590 | $ 2 | $ 37 | $ 37,087 | $ 458,553 | |||||
Issuance of common stock, shares | 2,168,539 | 37,029,105 | |||||||||
Issuance of common stock warrants related to term loan facility | 482 | 482 | |||||||||
Issuance of common stock upon exercise of warrants | 15,590 | $ 3 | 15,587 | ||||||||
Issuance of common stock upon exercise of warrants | 2,927,570 | ||||||||||
Issuance of common stock upon exercise of stock options | 730 | 730 | |||||||||
Issuance of common stock upon exercise of stock options, shares | 247,162 | ||||||||||
Issuance of common stock upon vesting of restricted stock units, net of tax withholding for net share settlement | (2,732) | (2,732) | |||||||||
Issuance of common stock upon vesting of restricted stock units, net of tax withholding for net share settlement, shares | 309,194 | ||||||||||
Issuance of common stock upon ESPP purchase | 268 | 268 | |||||||||
Issuance of common stock upon ESPP purchase, shares | 27,217 | ||||||||||
Stock-based compensation | 16,106 | 16,106 | |||||||||
Net loss | (142,189) | (142,189) | |||||||||
Other comprehensive income (loss) | 540 | 540 | |||||||||
Ending balance at Dec. 31, 2023 | $ 536,306 | $ 93 | $ 993,455 | $ 190 | $ (457,432) | ||||||
Ending balance, shares at Dec. 31, 2023 | 93,269,377 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Cash flows from operating activities: | |||
Net loss | $ (142,189) | $ (102,026) | $ (90,122) |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Stock-based compensation | 16,106 | 10,356 | 8,678 |
Net (accretion) amortization of investments in marketable securities | (6,242) | (980) | 865 |
Amortization of debt discount and accretion of deferred debt costs | 874 | 764 | 617 |
Loss on extinguishment of debt | 1,208 | ||
Non-cash operating lease expense | 223 | 175 | |
Depreciation | 50 | 65 | 79 |
Deferred tax assets | 127 | (150) | |
Changes in operating assets and liabilities: | |||
Prepaid and other assets | (6,921) | 3,331 | (5,672) |
Accounts payable | (3,917) | 5,659 | 4,778 |
Accrued expenses | 7,876 | 1,750 | 4,146 |
Operating lease liabilities | (121) | (184) | |
Other non-current liabilities | 3,740 | ||
Net cash used in operating activities | (129,186) | (81,090) | (76,781) |
Cash flows from investing activities: | |||
Proceeds from sales and maturities of marketable securities | 218,133 | 118,760 | 148,422 |
Purchases of marketable securities | (341,148) | (152,696) | (141,200) |
Purchases of property and equipment | (4) | (7) | (63) |
Net cash (used in) provided by investing activities | (123,019) | (33,943) | 7,159 |
Cash flows from financing activities: | |||
Proceeds from issuance of common stock and warrants in public offerings, net of issuance costs | 458,843 | 88,239 | |
Proceeds from issuance of common stock in at-the-market public offering, net of issuance costs | 37,089 | 28,453 | 3,289 |
Proceeds from term loan facility, net of issuance costs | 24,363 | 19,951 | |
Proceeds from issuance of common stock upon exercise of common stock warrants | 15,590 | 1,082 | |
Proceeds from issuance of common stock upon exercise of stock options | 633 | 305 | 487 |
Proceeds from issuance of common stock upon ESPP purchases | 268 | 50 | 144 |
Payments for taxes related to net share settlement upon vesting of restricted stock units | (2,275) | (298) | |
Repayment of term loan | (21,400) | ||
Net cash provided by financing activities | 513,111 | 117,831 | 23,871 |
Net change in cash and cash equivalents, and restricted cash | 260,906 | 2,798 | (45,751) |
Cash and cash equivalents, and restricted cash at beginning of period | 55,255 | 52,457 | 98,208 |
Cash and cash equivalents, and restricted cash at end of period | 316,161 | 55,255 | 52,457 |
Components of cash and cash equivalents, and restricted cash: | |||
Cash and cash equivalents | 316,161 | 55,255 | 52,432 |
Restricted cash | 25 | ||
Total cash and cash equivalents, and restricted cash | 316,161 | 55,255 | 52,457 |
Supplemental disclosures of cash information: | |||
Cash paid for interest | 2,593 | 1,076 | 16 |
Cash paid for amounts included in the measurement of lease liabilities | 185 | 234 | |
Supplemental disclosures of noncash information: | |||
Unpaid offering costs included in accrued expenses | 253 | ||
Right-of-use assets obtained in exchange for new operating lease liabilities | 2,080 | ||
Remeasurement of lease liability and right of use asset in connection with lease modification | $ 338 | ||
Issuance of common stock warrant in connection with term loan facility | $ 482 | $ 574 |
Pay vs Performance Disclosure
Pay vs Performance Disclosure - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Pay vs Performance Disclosure | |||
Net Income (Loss) | $ (142,189) | $ (102,026) | $ (90,122) |
Insider Trading Arrangements
Insider Trading Arrangements | 3 Months Ended |
Dec. 31, 2023 | |
Trading Arrangements, by Individual | |
Rule 10b5-1 Arrangement Adopted | false |
Non-Rule 10b5-1 Arrangement Adopted | false |
Rule 10b5-1 Arrangement Terminated | false |
Non-Rule 10b5-1 Arrangement Terminated | false |
Organization and Basis of Prese
Organization and Basis of Presentation | 12 Months Ended |
Dec. 31, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization and Basis of Presentation | 1. Organization and Basis of Presentation Description of Business 89bio, Inc. (“89bio” or the “Company”) is a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and cardio-metabolic diseases. The Company’s lead product candidate, pegozafermin, a specifically engineered glycoPEGylated analog of fibroblast growth factor 21 (“FGF21”), is currently being developed for the treatment of nonalcoholic steatohepatitis (“NASH”) (also known as metabolic dysfunction-associated steatohepatitis (“MASH”)) and for the treatment of severe hypertriglyceridemia (“SHTG”). 89bio, Inc. was formed as a Delaware corporation in June 2019 to carry on the business of 89Bio Ltd., which was incorporated in Israel in January 2018. Liquidity The Company has incurred significant losses and negative cash flows from operations since inception and had an accumulated deficit of $ 457.4 million as of December 31, 2023. The Company has historically financed its operations primarily through the sale of equity securities, including warrants, and from borrowings under term loan facilities. To date, none of the Company’s product candidates have been approved for sale, and the Company has not generated any revenue from commercial products. The Company expects operating losses to continue and increase for the foreseeable future as the Company progresses its clinical development activities for its product candidates. The Company believes its existing cash, cash equivalents and marketable securities of $ 578.9 million as of December 31, 2023 will be sufficient to fund its planned operating expense and capital expenditure requirements for a period of at least one year from the date of the issuance of these financial statements. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2023 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policie s Basis of Presentation The consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States (“U.S. GAAP”). Reclassifications Certain reclassifications of previously reported amounts have been made to conform to the current year presentation. Specifically, the final payment fee of $ 0.5 million related to borrowings under the Company’s 2021 Loan Agreement (see Note 6) was previously presented separately from “Term loan, non-current, net” under the caption “Other non-current liability” in the Form 10-K as of December 31, 2022. These captions have been combined in the consolidated balance sheet as of December 31, 2022 included within these financial statements. Principles of Consolidation The accompanying consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. 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 as of the date of the consolidated financial statements and the reported amounts of expenses during the reporting period. Significant estimates and assumptions made in the accompanying consolidated financial statements include but are not limited to accruals for uncertain tax positions, accrued research and development expenses and the valuation of stock options. The Company evaluates its estimates and assumptions on an ongoing basis using historical experience and other factors and adjusts those estimates and assumptions when facts and circumstances dictate. Actual results could differ from those estimates. Foreign Currencies The Company engages in foreign-currency-denominated transactions with certain vendors, as well as between subsidiaries with different functional currencies. The Company’s subsidiary in Israel uses the U.S. dollar as its functional currency for financial reporting. Gains and losses from foreign-currency-denominated transactions, primarily denominated in New Israeli Shekels, were not material for all periods presented and are reflected in the consolidated statements of operations and comprehensive loss as a component of interest income and other, net. The Company’s subsidiary in Lithuania uses the Euro as its functional currency for financial reporting. The re-measurement from Euros to U.S. dollars results in translation gain and loss adjustments, which are included in the consolidated balance sheets as part of accumulated other comprehensive loss. Fair Value Measurements Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability (an exit price) in an orderly transaction between market participants at the reporting date. Assets and liabilities recorded at fair value are categorized based upon the level of judgment associated with the inputs used to measure their fair value. Hierarchical levels are directly related to the amount of subjectivity with the inputs to the valuation of these assets or liabilities as follows: Level 1 —Observable inputs such as unadjusted, quoted prices in active markets for identical assets or liabilities at the measurement date; Level 2 —Inputs (other than quoted prices included in Level 1) are either directly or indirectly observable inputs for similar assets or liabilities. These include quoted prices for identical or similar assets or liabilities in active markets and quoted prices for identical or similar assets or liabilities in markets that are not active; and Level 3 —Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. Assets Measured at Fair Value on a Recurring Basis As of December 31, 2023 and 2022, marketable securities were the only financial instruments measured and recorded at fair value on a recurring basis on the Company’s consolidated balance sheets. Financial Instruments Not Carried at Fair Value The Company’s financial instruments, including cash, other current assets, accounts payable and accrued expenses are carried at cost which approximates their fair value because of the short-term nature of these financial instruments. The fair value of the Company’s term loan approximates its carrying value, or amortized cost, due to the prevailing market rates of interest it bears. Concentrations of Credit Risk Financial instruments that potentially subject the Company to a concentration of credit risk consist primarily of cash, cash equivalents and marketable securities. Bank deposits are held by accredited financial institutions and these deposits may at times be in excess of insured limits. The Company limits its credit risk associated with cash and cash equivalents by placing them with financial institutions that it believes are of high quality. The Company has not experienced any losses on its deposits of cash or cash equivalents. The Company has established guidelines relative to diversification and maturities to maintain safety and liquidity and limits amounts invested in marketable securities by credit rating, maturity, industry group, investment type and issuer, except for securities issued by the U.S. government. The Company does not believe a significant risk of loss from a concentration of credit risk exists with respect to its marketable securities portfolio. Other Risks and Uncertainties The Company’s future results of operations involve a number of other risks and uncertainties. Factors that could affect the Company’s future operating results and cause actual results to vary materially from expectations include, but are not limited to, the Company’s early stages of clinical drug development; the Company’s ability to advance product candidates into, and successfully complete, clinical trials on the timelines it projects; the Company’s ability to adequately demonstrate sufficient safety and efficacy of its product candidates; the Company’s ability to enroll patients in its ongoing and future clinical trials; the Company’s ability to successfully manufacture and supply its product candidates for clinical trials; the Company’s ability to obtain additional capital to finance its operations; uncertainties related to the projections of the size of patient populations suffering from the diseases the Company is targeting; the Company’s ability to obtain, maintain, and protect its intellectual property rights; developments relating to the Company’s competitors and its industry, including competing product candidates and therapies; general economic and market conditions; and other risks and uncertainties. The Company’s product candidates will require approvals from the U.S. Food and Drug Administration and comparable foreign regulatory agencies prior to commercial sales in their respective jurisdictions. There can be no assurance that any product candidates will receive the necessary approvals. If the Company is denied approval, approval is delayed or the Company is unable to maintain approval for any product candidate, it could have a materially adverse impact on the Company. Segment Reporting Operating segments are defined as components of an enterprise that have the following characteristics: (i) they engage in business activities from which they may earn revenue and incur expense, (ii) their operating results are regularly reviewed by the chief operating decision maker (“CODM”) for resource allocation decisions and performance assessment, and (iii) their discrete financial information is available. The Company’s CODM is its Chief Executive Officer. The Company and the CODM view the Company’s operations and manage its business in one operating segment. Cash and Cash Equivalents The Company considers all highly-liquid investments purchased with original maturities of three months or less from the purchase date to be cash equivalents. Cash equivalents primarily consist of amounts invested in money market funds, commercial paper and U.S. government treasury securities and are carried at fair value. Marketable Securities The Company invests its excess cash in marketable securities with high credit ratings including money market funds, commercial paper, securities issued by the U.S. government and its agencies and corporate debt securities. The Company accounts for all marketable securities as available-for-sale, as the sale of such securities may be required prior to maturity. These marketable securities are carried at fair value, with unrealized gains and losses reported as accumulated other comprehensive income (loss) until realized. The cost of debt securities is adjusted for accretion of premiums and amortization of discounts to maturity. Such amortization and accretion, as well as interest and dividends, are included in interest income and other, net. Realized gains and losses from the sale of available-for-sale securities, if any, are determined on a specific identification basis and are also included in interest income and other, net. The Company’s marketable securities are classified as current assets, which reflects management’s intention to use the proceeds from sales of these securities to fund its operations, as necessary, even though the stated maturity date may be one year or more beyond the current balance sheet date. The Company periodically assesses its available-for-sale marketable securities for impairment. For marketable securities in an unrealized loss position, this assessment first takes into account the Company’s intent to sell, or whether it is more likely than not that it will be required to sell the security before recovery of its amortized cost basis. If either of these criteria are met, the marketable security’s amortized cost basis is written down to fair value through interest income and other, net. For marketable securities in an unrealized loss position that do not meet the aforementioned criteria, the Company assesses whether the decline in fair value has resulted from credit losses or other factors. In making this assessment, the Company considers the extent to which fair value is less than amortized cost, any changes to the rating of the security by a rating agency, and any adverse conditions specifically related to the security, among other factors. If this assessment indicates that a credit loss may exist, the present value of cash flows expected to be collected from the security are compared to the amortized cost basis of the security. If the present value of cash flows expected to be collected is less than the amortized cost basis, a credit loss exists and an allowance for credit losses will be recorded in interest income and other, net, limited by the amount that the fair value is less than the amortized cost basis. Any additional impairment not recorded through an allowance for credit losses is recognized in other comprehensive loss. Changes in the allowance for credit losses are recorded as provision for (or reversal of) credit loss expense. Losses are charged against the allowance when management believes the uncollectability of an available-for-sale security is confirmed or when either of the criteria regarding intent or requirement to sell is met. These changes are recorded in interest income and other, net. Leases The Company has noncancellable operating leases for office space. Beginning in 2022, the Company accounts for leases in accordance with Accounting Standards Update (“ASU”) 2016-02, Leases ( Topic 842 ). The Company determines if an arrangement is a lease or contains an embedded lease at inception. The Company accounts for a contract as a lease when it has the right to control the asset for a period of time while obtaining substantially all of the asset’s economic benefits. For arrangements that meet the definition of a lease, the Company determines the initial classification and measurement of its right-of-use (“ROU”) asset and lease liability at the lease commencement date and thereafter if modified. Operating lease ROU assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent the Company’s obligation to make the contractual lease payments over the lease term. The ROU asset is initially measured at cost, which comprises the initial amount of the lease liability adjusted for lease payments made at or before the lease commencement date, plus any initial direct costs incurred less any lease incentives received. The operating lease liability is initially measured at the present value of the unpaid lease payments at the lease commencement date. The lease liability is subsequently measured at amortized cost using the effective-interest method. The lease term includes any renewal 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 estimated collateralized incremental borrowing rate that the Company would pay for a similar amount and term. The Company has elected not to record leases with an original term of twelve months or less on its consolidated balance sheets. The Company does not have any material short-term leases. In addition, the Company’s leases may require the Company to pay additional costs, such as utilities, maintenance, and other operating costs, which are generally referred to as non-lease components and vary based on future outcomes. The Company has elected to not separate lease and non-lease components. Only the fixed costs for lease components and their associated non-lease components are accounted for as a single lease component and recognized as part of a ROU asset and lease liability. Any variable expenses are recognized in operating expenses as incurred. Lease expense for an operating lease liability is recognized on a straight-line basis over the lease term and is included in operating expenses in the consolidated statements of operations and comprehensive loss. Property and Equipment, Net Property and equipment are stated at cost, less accumulated depreciation. Depreciation is calculated on a straight-line basis over the estimated useful lives of the related assets, generally ranging from three to seven years . Leasehold improvements are amortized on a straight-line basis over the shorter of the assets’ estimated useful life or the remaining term of the lease. Upon retirement or sale of the assets, the cost and related accumulated depreciation and amortization are removed from the consolidated balance sheets and the resulting gains or losses are recorded in the consolidated statements of operations and comprehensive loss. Maintenance and repair costs are expensed as incurred. Impairment of Long-Lived Assets The Company periodically evaluates its long-lived assets, including property and equipment, for impairment whenever events or changes in business circumstances indicate that the carrying amount of the assets or group of assets may not be fully recoverable. If indicators of impairment exist and the undiscounted future cash flows that the assets are expected to generate are less than the carrying value of the assets, then the Company will reduce the carrying amount of the assets through an impairment charge, to their estimated fair values based on a discounted cash flow approach or, when available and appropriate, to comparable market values. There were no such indicators for the periods presented. Accrued Research and Development Expenses The Company records preclinical and clinical study and research expenses based on the services performed, pursuant to contracts with research institutions that conduct and manage preclinical and clinical studies and research services on its behalf. The majority of these expenses are recorded based on invoices and statements received from these vendors. The Company also records these expenses based upon the estimated services provided but not yet invoiced. Liabilities associated with these expenses are included in accrued expenses in the consolidated balance sheets. These costs are a component of the Company’s research and development expenses. In making these estimates of services provided but not yet invoiced or for which statements have not been received from vendors, the Company considers factors such as estimates of the progress of work completed in accordance with agreements established with its third-party service providers. As actual costs become known, the Company adjusts its accrued expenses. The Company has not experienced any material differences between accrued costs and actual costs incurred. However, the status and timing of actual services performed may vary from the Company’s estimates, resulting in adjustments to expense in future periods. Changes in these estimates that result in material changes to the Company’s accrued expenses could materially affect the Company’s results of operations. Contingent milestone payments, if any, are recognized when payment becomes probable and reasonably estimable, which is generally upon achievement of the milestone. Warrants to Purchase Common Stock The Company classifies warrants indexed to its common stock and meeting the requirements for equity classification within stockholders’ equity. This assessment is conducted at the time of warrant issuance and as of each reporting period that the warrants remain outstanding. Research and Development Expenses Research and development expenses consist primarily of costs incurred for the development of the Company’s lead product candidate, pegozafermin. Research and development expenses consist primarily of external costs related to preclinical and clinical development and related supplies and personnel costs. Personnel costs consist of salaries, employee benefits and stock-based compensation for individuals involved in research and development efforts. Payments associated with agreements to acquire licenses to develop, use, manufacture and commercialize products and purchases of pegozafermin from contract manufacturing organizations that have not reached technological feasibility and do not have alternate future commercial use are expensed as incurred. Stock-Based Compensation The Company utilizes stock options, restricted stock units (“RSUs”) and performance stock units (“PSUs”) for equity compensation. The Company measures its equity awards made to employees, directors, and non-employee service providers based on estimated fair values and recognizes stock-based compensation over the requisite service period. The Company accounts for forfeitures as they occur. The Company estimates the fair value of stock option awards on the date of grant using a Black-Scholes option pricing model. The Company recognizes compensation for stock option awards, including awards with graded-vesting, on a straight-line basis over the requisite service period. The Black-Scholes option pricing model requires a number of assumptions, of which the most significant are expected volatility, expected option term (the time from the grant date until the options are exercised or expire), risk-free rate, and expected dividend rate. These assumptions include: • Expected volatility—The Company has a limited trading history for its common stock. As a result, the Company estimates expected volatility based on a combination of its own historical stock price volatility and that of a publicly traded set of peer companies such that the time period over which historical volatility data used is at least equal to the expected term of the option award. The peer companies were chosen based on their similar size, stage in the life cycle, or area of specialty. • Expected term—The expected term of options granted to employees and directors is determined using the “simplified” method. Under this approach, the expected term is presumed to be the midpoint between the weighted-average vesting term and the contractual term of the option. The simplified method makes the assumption that the employee will exercise stock options evenly over the period when the stock options are vested and ending on the date when the stock options would expire. The expected option term for options granted to non-employees is estimated on a grant-by-grant basis. • Risk-free interest rate—The risk-free interest rate is based on the U.S. Treasury zero coupon bonds in effect on the grant date for periods with an equivalent expected term as the option. • Expected dividend—The Company has never paid dividends and has no foreseeable plans to pay dividends on its shares of common stock. Therefore, an expected dividend of zero is used. The grant date fair value of RSUs and PSUs are based on the closing price of the Company’s common stock on the date of grant. RSUs are service-based awards and are recognized over the requisite service period on a straight-line basis. Compensation expense for PSUs is recognized over the estimated service period for each tranche of an award (the accelerated attribution method) when its performance condition is deemed probable of achievement. For PSUs containing performance conditions which were not deemed probable of achievement, no stock compensation expense is recognized. Additionally, at each reporting period, the Company evaluates the probable outcome of the performance conditions and as applicable, recognizes the cumulative effect of the change in estimate in the period of the change. Income Taxes Income taxes are accounted for under the asset and liability method. Under this method, deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the consolidated financial statements carrying amounts of existing assets and liabilities and their respective tax bases and operating loss and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates applied to taxable income in the years in which those temporary differences are expected to be realized. The effect on deferred tax assets and liabilities of a change in tax rates is recognized as income or loss in the period that includes the enactment date. A valuation allowance is established when necessary to reduce deferred tax assets to the amount expected to be realized. The Company has established full valuation allowances on its U.S. deferred tax assets because realization of these tax benefits through future taxable income is not more likely than not as of December 31, 2023 and 2022. The Company intends to maintain the valuation allowances until sufficient positive evidence exists to support the reversal of the valuation allowances. The calculation of the Company’s accruals for tax contingencies involves dealing with uncertainties in the application of complex tax laws. The Company’s estimates for the potential outcome of any uncertain tax issue are based on the detailed facts and circumstances of each issue. Resolution of these uncertainties in a manner inconsistent with the Company’s expectations could have a material impact on its results of operations and financial condition. The Company recognizes liabilities for uncertain tax positions based on a two-step process. The first step is to evaluate the tax position for recognition by determining if the weight of available evidence indicates that it is more likely than not that the position will be sustained on audit, including resolution of related appeals or litigation processes, if any. The second step is to estimate and measure the tax benefit as the largest amount that is more than 50% likely of being realized upon ultimate settlement. It is inherently difficult and subjective to estimate such amounts, as this requires the Company to determine the probability of various possible outcomes. The Company reevaluates these uncertain tax positions on a quarterly basis. This evaluation is based on factors including, but not limited to, changes in facts or circumstances, changes in tax law, effectively settled issues under audit, and new audit activity. Such a change in recognition or measurement would result in the recognition of a tax benefit or an additional charge to tax expense in the period. Interest and penalties related to unrecognized tax benefits are included within income tax (expense) benefit. Basic and Diluted Net Loss per Share Basic and diluted net loss per share is calculated based upon the weighted-average number of shares of common stock outstanding during the period . Shares of common stock that are potentially issuable for little or no cash consideration at issuance, such as the Company’s pre-funded warrants issued in July 2022 and December 2023 are included in the calculation of basic and diluted net loss per share , even if they are antidilutive. During periods of income, participating securities are allocated a proportional share of income determined by dividing total weighted-average participating securities by the sum of the total weighted-average common shares and participating securities (the “two-class method”). Shares of the Company’s common stock warrants participate in any dividends that may be declared by the Company and are therefore considered to be participating securities. Participating securities have the effect of diluting both basic and diluted earnings per share during periods of income. During periods of loss, no loss is allocated to participating securities since they have no contractual obligation to share in the losses of the Company. Diluted loss per share is computed after giving consideration to the dilutive effect of stock options, RSUs, PSUs and common stock warrants, except where such non-participating securities would be anti-dilutive. As the Company incurred net losses for the periods presented, basic net loss per share is the same as diluted net loss per share since the effects of potentially dilutive securities are antidilutive. Comprehensive Loss The Company’s comprehensive loss is comprised of net loss and changes in unrealized gains or losses on marketable securities and foreign currency translation adjustments. Recently Adopted Accounting Standards In August 2020, the FASB issued ASU No. 2020-06, Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging-Contracts in Entity’s Own Equity (Subtopic 815-40)—Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity (“ASU 2020-06”), which simplifies the accounting for convertible instruments, amends the guidance on derivative scope exceptions for contracts in an entity’s own equity, and modifies the guidance on diluted earnings per share calculations as a result of these changes. The Company early adopted ASU 2020-06 as of January 1, 2023 , using a modified retrospective approach and the adoption did no t have a material impact on the Company’s consolidated financial statements and related disclosures. Recently Issued Accounting Pronouncements In November 2023, the FASB issued ASU No. 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures (“ASU 2023-07”), which is intended to improve reportable segment disclosure requirements, primarily through enhanced disclosures about significant expenses. ASU 2023-07 requires disclosures to include significant segment expenses that are regularly provided to the CODM, a description of other segment items by reportable segment, and any additional measures of a segment's profit or loss used by the CODM when deciding how to allocate resources. The ASU also requires all annual disclosures required by Topic 280 to be included in interim periods. The ASU is effective for the Company’s annual periods beginning on January 1, 2024 and interim periods beginning on January 1, 2025. Early adoption is permitted and requires retrospective application to all prior periods presented in the financial statements. The Company is currently evaluating the effect of adopting this new accounting guidance on its financial statement disclosures. In December 2023, the FASB issued ASU No. 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures (“ASU 2023-09”), which requires companies to disclose, on an annual basis, specific categories in the effective tax rate reconciliation and provide additional information for reconciling items that meet a quantitative threshold. In addition, ASU 2023-09 requires companies to disclose additional information about income taxes paid. The ASU is effective for the Company’s annual periods beginning on January 1, 2025 and will be applied on a prospective basis with the option to apply the standard retrospectively. The Company is currently evaluating the effect of adopting this new accounting guidance on its financial statement disclosures. |
Fair Value Measurements
Fair Value Measurements | 12 Months Ended |
Dec. 31, 2023 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | 3. Fair Value Measurements The following table presents the Company’s financial assets measured at fair value on a recurring basis by level within the fair value hierarchy as of December 31, 2023 (in thousands): Valuation Amortized Unrealized Unrealized Fair Hierarchy Cost Gains Losses Value Money market funds Level 1 $ 493 $ — $ — $ 493 Commercial paper Level 2 94,261 — ( 55 ) 94,206 U.S. government bonds Level 2 137,976 250 ( 142 ) 138,084 Agency bonds Level 2 45,481 152 ( 44 ) 45,589 Corporate debt securities Level 2 3,177 — ( 12 ) 3,165 U.S. Treasury securities Level 2 71,754 36 ( 1 ) 71,789 Agency discount securities Level 2 7,975 1 — 7,976 Total cash equivalents and marketable securities $ 361,117 $ 439 $ ( 254 ) $ 361,302 Classified as: Cash equivalents $ 98,593 Marketable securities 262,709 Total cash equivalents and marketable securities $ 361,302 The following table presents the Company’s financial assets measured at fair value on a recurring basis by level within the fair value hierarchy as of December 31, 2022 (in thousands): Valuation Amortized Unrealized Unrealized Fair Hierarchy Cost Gains Losses Value Money market funds Level 1 $ 18,224 $ — $ — $ 18,224 Commercial paper Level 2 104,279 1 ( 84 ) 104,196 U.S. government bonds Level 2 18,225 1 ( 109 ) 18,117 Agency bonds Level 2 13,986 — ( 78 ) 13,908 Corporate debt securities Level 2 10,488 — ( 62 ) 10,426 U.S. Treasury securities Level 2 7,414 1 ( 21 ) 7,394 Agency discount securities Level 2 5,216 9 — 5,225 Non-U.S. debt securities Level 2 3,975 — ( 20 ) 3,955 Total cash equivalents and marketable securities $ 181,807 $ 12 $ ( 374 ) $ 181,445 Classified as: Cash equivalents $ 48,540 Marketable securities 132,905 Total cash equivalents and marketable securities $ 181,445 The valuation techniques used to measure the fair values of the Company’s Level 2 financial instruments, which generally have counterparties with high credit ratings, are based on quoted market prices when available. If quoted market prices are not available, the fair value for the security is estimated under the market or income approach using pricing models with market observable inputs. The following table summarizes the Company’s cash equivalents and marketable securities by contractual maturity as of December 31, 2023 (in thousands): Within one year $ 290,756 After one year through two years 70,546 Total cash equivalents and marketable securities $ 361,302 During 2023 and 2022, the Company did not recognize an allowance for credit-related losses or an other-than-temporary impairment charge for any of its investments, respectively. |
Consolidated Balance Sheet Comp
Consolidated Balance Sheet Components | 12 Months Ended |
Dec. 31, 2023 | |
Balance Sheet Related Disclosures [Abstract] | |
Consolidated Balance Sheet Components | 4. Consolidated Balance Sheet Components Prepaid and other current assets consist of the following as of the periods presented (in thousands): As of December 31, 2023 2022 Prepaid research and development $ 11,579 $ 5,727 Prepaid taxes 614 646 Prepaid other 2,471 1,547 Total prepaid and other current assets $ 14,664 $ 7,920 Accrued expenses consist of the following as of the periods presented (in thousands): As of December 31, 2023 2022 Accrued research and development expenses $ 13,017 $ 6,499 Accrued employee and related expenses 6,248 4,165 Accrued professional and legal fees 1,110 1,052 Accrued other expenses 155 228 Total accrued expenses $ 20,530 $ 11,944 |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 5. Commitments and Contingencies Leases The Company’s operating lease obligations consist of leases for office space in two buildings in San Francisco. In November 2023, the Company entered into a lease (“2023 Lease”) with respect to approximately 17,616 square feet of office space in San Francisco, California for a lease term commencing in the fourth quarter of 2023 and ending in March 2027. The 2023 Lease does not provide for any extension or renewal options. The 2023 Lease includes an abatement period in which the Company is not required to remit monthly rent payments until April 2024 and has escalating rent payments during the lease term. In addition, the fixed lease payments also cover the Company’s proportionate share of certain operating expenses. The Company recognizes lease expense on a straight-line basis over the term of the 2023 Lease, including any rent-free periods. All fixed lease payments have been included in the measurement of right-of-use assets and lease liabilities in accordance with the Company’s accounting policy to not separate lease and nonlease components of contracts. The Company also has a lease for approximately 3,600 square feet of office space in San Francisco that expires in January 2025 with an option to renew for an additional year. For the years ended December 31, 2023 and 2022, lease expense was $ 0.3 million and $ 0.2 million, respectively. Rent expense was not material in 2021. Variable lease payments and short-term lease costs were not material for all periods presented. As of December 31, 2023, the weighted-average remaining lease term was 3.1 years and the Company’s weighted-average incremental borrowing rate used to determine operating lease liabilities was 12.9 % . As of December 31, 2023, the undiscounted future minimum lease payments due under the Company’s non-cancellable operating leases were as follows (in thousands): 2024 $ 774 2025 917 2026 937 2027 240 Total undiscounted future minimum lease payments $ 2,868 Less: imputed interest ( 555 ) Present value of operating lease liabilities $ 2,313 Asset Transfer and License Agreement with Teva Pharmaceutical Industries Ltd In April 2018, the Company concurrently entered into two Asset Transfer and License Agreements (the “Teva Agreements”) with Teva Pharmaceutical Industries Ltd (“Teva”) under which it acquired certain patents and intellectual property relating to two programs: (1) Teva’s glycoPEGylated FGF21 program, including the compound TEV-47948 (pegozafermin), a glycoPEGylated long-acting FGF21 and (2) Teva’s development program of small molecule inhibitors of Fatty Acid Synthase. Pursuant to the Teva Agreements, the Company paid Teva an initial nonrefundable upfront payment of $ 6.0 million. In addition, with respect to each product candidate covered by the Teva Agreements, the Company is required to pay Teva $ 2.5 million upon the achievement of a specified clinical development milestone, and additional payments totaling up to $ 65.0 million upon achievement of certain commercial milestones. The Company is also obligated to pay Teva tiered royalties at percentages in the low-to-mid single-digits on worldwide net sales on all products containing the Teva compounds. The Teva Agreements can be terminated (i) by the Company without cause upon 120 days ’ written notice to Teva, (ii) by either party, if the other party materially breaches any of its obligations under the Teva Agreements and fails to cure such breach within 60 days after receiving notice thereof, or (iii) by either party, if a bankruptcy petition is filed against the other party and is not dismissed within 60 days . In addition, Teva can also terminate the agreement related to the Company’s glycoPEGylated FGF21 program in the event the Company, or any of its affiliates or sublicensees, challenges any of the Teva patents licensed to the Company, and the challenge is not withdrawn within 30 days of written notice from Teva. In the fourth quarter of 2023, the Company made a $ 2.5 million milestone payment to Teva following the achievement of a clinical development milestone under the FGF21 program in SHTG, and accordingly, the Company recorded research and development expense of $ 2.5 million. |
Term Loan Facilities
Term Loan Facilities | 12 Months Ended |
Dec. 31, 2023 | |
Debt Disclosure [Abstract] | |
Term Loan Facilities | 6. Term Loan Facilities 2021 Loan Agreement In April 2020, the Company entered into a Loan and Security Agreement, (the “Loan Agreement”) with the lenders referred to therein, and Silicon Valley Bank (“SVB”), as collateral agent. The Loan Agreement as amended in May 2021 (the “2021 Loan Agreement”) provided for (i) a secured term A loan facility (the “Term A Loan Facility”) of up to $ 20.0 million and (ii) a secured term B loan facility (the “Term B Loan Facility”) of up to $ 5.0 million. The Term A Loan Facility of $ 20.0 million was fully drawn as of December 2022 and the Term B Loan Facility expired undrawn. In January 2023, the Company executed a loan and security agreement with new lenders (the “2023 Loan Agreement”) and used the borrowings to repay in full the outstanding principal, final payment fee, prepayment fee and interest due under the 2021 Loan Agreement of $ 21.4 million. The Company recorded a loss on debt extinguishment of $ 1.2 million, which was recognized as a component of interest expense on the Company’s consolidated statements of operations and comprehensive loss. 2023 Loan Agreement In January 2023, the Company executed the 2023 Loan Agreement with the lenders referred to therein, K2 HealthVentures LLC (“K2HV”) as administrative agent and Ankura Trust Company, LLC as collateral agent. The 2023 Loan Agreement provides for up to $ 100.0 million in aggregate principal in term loans, consisting of an initial tranche of $ 25.0 million that was funded at closing, second and third tranches of $ 15.0 million and $ 10.0 million, respectively, that may be funded upon the achievement of certain time-based, clinical and regulatory milestones, and a fourth tranche of up to $ 50.0 million that may be funded upon discretionary approval by the lenders. As of December 31, 2023 , the second tranche of $ 15.0 million expired undrawn. Borrowings under term loans are secured by substantially all of the assets of the Company, excluding the Company’s intellectual property. The 2023 Loan Agreement contains customary representations and warranties, restricts certain activities and includes customary events of default, including payment default, breach of covenants, change of control, and material adverse effects. In addition, starting January 1, 2024, the Company is required to maintain minimum unrestricted cash and cash equivalents equal to 5.0 times the average change in cash and cash equivalents measured over the trailing three-month period. Borrowings under the term loan facility mature on January 1, 2027 and provide for interest-only payments until February 1, 2025. Consecutive equal payments of principal and interest are due once the interest-only period has elapsed. The term loans bear interest equal to the greater of (i) 8.45 % and (ii) the sum of (a) the Prime Rate as reported in The Wall Street Journal plus (b) 2.25 %. The interest rate on the first term loan was 9.75 % at inception and 10.75 % as of December 31, 2023. In addition, a final payment fee equal to 5.95 % of the principal amount of the term loans is due upon the earlier of prepayment or maturity of the term loans. The Company has the option to prepay the entire outstanding balance of the term loans subject to a prepayment fee ranging from 1.0 % to 3.0 % depending on the timing and circumstances of such prepayment. A commitment fee equal to 0.6 % of the principal amount of the fourth term loan is also payable if drawn. K2HV has an option to convert up to an aggregate of $ 7.5 million of the principal amount of the term loans then outstanding into shares of the Company’s common stock at a conversion price of $ 12.6943 per share at any time prior to full repayment of the term loans. This embedded conversion option qualifies for a scope exception from derivative accounting because it is both indexed to the Company’s own stock and meets the conditions for equity classification. Total debt issuance costs related to the first term loan of $ 0.8 million, which includes the fair value of the warrant that became exercisable as a result of the funding of the first term loan (discussed below), were recorded as debt discount. The debt discount, together with the final payment fee, are recognized as interest expense using the effective interest method. For the year ended December 31, 2023, the weighted-average effective interest rate on outstanding borrowings under the 2023 Loan Agreement was approximately 13.3 %. As of December 31, 2023, the Company’s maturities of principal obligations under the term loan were as follows (in thousands): 2024 $ — 2025 10,774 2026 13,036 2027 1,190 Total principal outstanding 25,000 Plus accumulated accretion of final payment fee 388 Less unamortized debt discount ( 593 ) Total net carry value 24,795 Term loan, current portion — Term loan, non-current, net $ 24,795 Warrants In January 2023, in connection with the 2023 Loan Agreement, the Company issued the lenders a warrant to purchase up to an aggregate of 204,815 shares of the Company’s common stock at an exercise price of $ 9.7649 per share (the “warrant shares”) that expires in January 2033 . The warrant shares become exercisable upon the funding of each term loan. In connection with the first term loan that was funded at closing, 51,204 of the warrant shares became exercisable. The warrant shares cannot be settled for cash and include a cashless exercise feature allowing the holder to receive shares net of shares withheld in lieu of the exercise price. The warrant shares also provide for automatic cashless exercise under certain specific conditions and settlement is permitted in unregistered shares. The 51,204 warrant shares meet the requirements for equity classification. The Company determined the fair value of the 51,204 warrant shares issued using the Black-Scholes option-pricing model with the following assumptions: risk-free interest rate of 3.9 %, no dividends, expected volatility of 93.8 % and expected term of 10.0 years. Of the remaining 153,611 warrant shares (the “contingent warrants”), 122,889 warrant shares are contingently exercisable upon the funding of each subsequent term loan drawn and have the same exercise price and contractual term and 30,722 warrant shares associated with the second term loan facility expired on September 30, 2023 . The contingent warrants did not meet the derivative scope exception or equity classification criteria and were accounted for as a derivative liability. The contingent warrants’ initial fair value and fair value as of December 31, 2023, determined using a probability weighted Black-Scholes option pricing model, was insignificant. The contingent warrants derivative liability is remeasured at each reporting period until settled or extinguished with subsequent changes in fair value recorded as interest expense in the consolidated statements of operations and comprehensive loss. |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Dec. 31, 2023 | |
Equity [Abstract] | |
Stockholders' Equity | 7. Stockholders’ Equity Changes in Authorized Capital Stock On June 5, 2023, the Company’s stockholders approved and, on June 8, 2023, the Company filed a Certificate of Amendment to the Second Amended and Restated Certificate of Incorporation to increase the total number of authorized shares of common stock from 100.0 million to 200.0 million. T he total number of shares of preferred stock authorized for issuance by the Company remained unchanged at 10.0 million. As of December 31, 2023, common stock reserved for future issuance, on an as-if-converted basis, were as follows: Stock options outstanding 4,686,577 RSUs and PSUs outstanding 987,550 Shares available for future grants under equity incentive plans 1,790,684 Shares available for future issuance under the employee stock purchase plan 1,207,607 Warrants to purchase common stock outstanding 10,412,806 Pre-funded warrants to purchase common stock outstanding 1,881,081 Conversion feature related to outstanding term loan 590,816 Total shares of common stock reserved 21,557,121 At-the-Market Offerings In March 2021, the Company entered into an at-the-market sales agreement (as amended, the “Sales Agreement”) with Leerink Partners LLC and Cantor Fitzgerald & Co. (the “Sales Agents”) pursuant to which the Company may offer and sell shares up to $ 75.0 million of its common stock (the “2021 ATM Facility”) from time to time pursuant to an effective registration statement. The Sales Agents are entitled to compensation at a commission of up to 3.0 % of the aggregate gross sales price per share sold under the Sales Agreement. In 2021 and 2022, the Company sold 186,546 and 3,948,611 shares of its common stock under the 2021 ATM Facility and received net proceeds of $ 3.3 million and $ 28.5 million, respectively. In February 2023, the Company sold 968,000 shares of its common stock under the 2021 ATM Facility and received net proceeds of $ 13.4 million. In February 2023, the Company entered into an amendment to the Sales Agreement, pursuant to which the Company may offer and sell up to $ 150.0 million of its common stock (the “2023 ATM Facility”) pursuant to an effective registration statement. In June 2023, the Company sold 1,200,539 shares of its common stock under the 2023 ATM Facility and received net proceeds of $ 23.7 million. As of December 31, 2023, there was $ 125.9 million remaining for future sales under the 2023 ATM Facility. Underwritten Public Offerings In July 2022, the Company completed an underwritten public offering of its common stock, warrants to purchase shares of its common stock and pre-funded warrants to purchase shares of its common stock. The Company sold 18,675,466 shares of its common stock with accompanying warrants to purchase up to 9,337,733 shares of its common stock at a combined public offering price of $ 3.55 per share. The Company also sold 7,944,252 pre-funded warrants to purchase shares of its common stock with accompanying warrants to purchase up to 3,972,126 shares of its common stock at a combined public offering price of $ 3.549 per pre-funded warrant, which represents the per share public offering price for the common stock less $ 0.001 per share, the exercise price for each pre-funded warrant. The Company raised net proceeds of $ 88.2 million, after deducting underwriting discounts and commissions of $ 5.7 million and other offering costs of $ 0.6 million. The exercise of the outstanding warrants is subject to a beneficial ownership limitation of 9.99 %, or at the election of the holder prior to the issuance of the warrant, 4.99 %. The exercise of the outstanding pre-funded warrants is subject to a beneficial ownership limitation of 9.99 %, or at the election of the holder prior to the issuance of the pre-funded warrant, 4.99 %, which a holder may increase or decrease from time to time but shall not exceed 19.99 %. The exercise price and number of shares of common stock issuable upon the exercise of the warrants and pre-funded warrants are subject to adjustment in the event of any stock dividends, stock splits, reverse stock split, recapitalization, or reorganization or similar transaction, as described in the agreements. Under certain circumstances, the warrants and pre-funded warrants may be exercisable on a “cashless” basis. The warrants and pre-funded warrants were classified as a component of stockholders’ equity and additional paid-in capital because such warrants and pre-funded warrants (i) are freestanding financial instruments that are legally detachable and separately exercisable from the equity instruments, (ii) are immediately exercisable, (iii) do not embody an obligation for the Company to repurchase its shares, (iv) permit the holders to receive a fixed number of common shares upon exercise, (v) are indexed to the Company’s common stock and (vi) meet the equity classification criteria. In addition, the warrants and pre-funded warrants do not provide any guarantee of value or return. In March 2023, the Company completed an underwritten public offering of its common stock. The Company sold 19,461,538 shares of its common stock at a public offering price of $ 16.25 per share. The Company raised aggregate proceeds of $ 296.8 million, net of underwriting discounts and commissions of $ 19.0 million and other offering costs of $ 0.5 million. In December 2023, the Company completed an underwritten public offering of its common stock and pre-funded warrants to purchase shares of its common stock. The Company sold 17,567,567 shares of its common stock at a public offering price of $ 9.25 per share. The Company also sold 1,081,081 pre-funded warrants to purchase shares of its common stock at $ 9.249 per share, which represents the per share public offering price for the common stock less $ 0.001 per share, the exercise price for each pre-funded warrant. The Company raised net proceeds of $ 161.8 million, after deducting underwriting discounts and commissions of $ 10.4 million and other offering costs of $ 0.4 million. The terms and conditions of the pre-funded warrants and rights and obligations of the holder are the same as the pre-funded warrants sold in the July 2022 public offering and are described above. Common Stock Warrants As of December 31, 2023, the Company’s outstanding warrants to purchase shares of its common stock were as follows: Shares of Exercise Price Expiration Warrant issued in connection with term loan (SVB) 25,000 $ 22.06 June 30, 2025 Warrant issued in connection with term loan (SVB) 33,923 $ 19.12 May 28, 2031 Warrants issued in connection with term loan facility (K2HV) 174,093 $ 9.76 January 27, 2033 Warrants issued in public offering 10,179,790 $ 5.325 July 1, 2024 Pre-funded warrants issued in public offerings 1,881,081 $ 0.001 Do not expire Total outstanding 12,293,887 |
Stock-Based Compensation
Stock-Based Compensation | 12 Months Ended |
Dec. 31, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Stock-Based Compensation | 8 . Stock-Based Compensation Summary of Equity Incentive Plans 2019 Plan In September 2019, the Company’s board of directors adopted the 2019 Equity Incentive Plan (the “2019 Plan”), which also became effective in September 2019. The Company initially reserved 2,844,193 shares of common stock for issuance under the 2019 Plan. In addition, the number of shares of common stock reserved for issuance under the 2019 Plan will automatically increase on the first day of January for a period of up to ten years in an amount equal to 4 % of the total number of shares of the Company’s capital stock outstanding on the immediately preceding December 31, or a lesser number of shares determined by the Company’s board of directors. The board of directors determines the period over which options become exercisable and options generally vest over a four-year period, with 25 % of options vesting on the first anniversary of employment, and thereafter, the remaining options vesting quarterly, over the following 36-month period. The options expire within ten years from the date of grant. The exercise price of awards granted will not be less than the estimated fair value of the shares on the date of grant. The 2019 Plan also permits the board of directors to grant restricted stock units, which are subject to continued service conditions. Inducement Plan In February 2023, the Company’s board of directors adopted the 2023 Inducement Plan (the “Inducement Plan”) and reserved 1,500,000 shares of common stock for issuance. The Inducement Plan is a non-stockholder approved stock plan adopted pursuant to the “inducement exception” provided under Nasdaq listing rules. Under the Inducement Plan, the Company may grant RSUs, PSUs, nonstatutory stock options, stock appreciation rights and restricted stock awards to new hires who satisfy the requirements to be granted inducement grants under Nasdaq rules as an inducement material to the individual’s entry into employment with the Company. The terms of the Inducement Plan are substantially similar to the terms of the 2019 Plan. Employee Stock Purchase Plan In October 2019, the Company’s board of directors adopted the 2019 Employee Stock Purchase Plan (“ESPP”), which became effective in November 2019. The Company initially reserved 225,188 shares of common stock for purchase under the ESPP. The number of shares of common stock reserved for issuance under the ESPP will automatically increase on the first day of January for a period of up to ten years in an amount equal to 1 % of the total number of shares of the Company’s common stock outstanding on the immediately preceding December 31, or a lesser number of shares determined by the Company’s board of directors. The Company typically makes two offerings each year to eligible employees to purchase stock under the ESPP and each offering has a duration of approximately six months. For each offering period, ESPP participants will purchase shares of common stock at a price per share equal to 85 % of the lesser of the fair market value of the Company’s common stock on (1) the first trading day of the applicable offering period or (2) the last trading day of the applicable offering period. Equity Incentive Plans Activity Stock Options The following table summarizes stock option activity for the year ended December 31, 2023: Weighted- Weighted- Average Average Remaining Aggregate Number of Exercise Contractual Intrinsic Options Price Term Value (In years) (In thousands) Balance outstanding as of December 31, 2022 3,161,917 $ 12.80 7.9 $ 16,612 Granted 1,952,900 14.65 Exercised ( 247,162 ) 2.95 Cancelled and forfeited ( 181,078 ) 12.40 Balance outstanding as of December 31, 2023 4,686,577 $ 14.11 7.9 $ 11,712 Exercisable as of December 31, 2023 2,043,280 $ 14.70 6.6 $ 8,123 The following table presents the weighted-average grant date fair value of options granted for the periods presented and the assumptions used to estimate those values using a Black-Scholes option pricing model: Year Ended December 31, 2023 2022 2021 Weighted-average grant date fair value $ 11.43 $ 3.38 $ 16.18 Expected term (years) 5.5 - 6.1 5.5 - 6.3 5.5 - 6.1 Expected volatility 91.5 - 99.2 % 89.9 - 91.0 % 86.9 - 91.9 % Risk-free interest rate 3.4 - 4.6 % 1.6 - 3.9 % 0.7 - 1.3 % Expected dividend — — — Compensation expense related to stock option awards were $ 11.7 million, $ 7.6 million and $ 7.5 million for the years ended December 31, 2023, 2022 and 2021, respectively. The intrinsic value of stock options exercised during the years ended December 31, 2023, 2022 and 2021 was $ 3.2 million, $ 0.6 million and $ 3.6 million, respectively. As of December 31, 2023 , there was $ 21.7 million of unrecognized stock-based compensation related to unvested stock options, which is expected to be recognized over a weighted-average period of 2.6 years. Restricted Stock Units and Performance Stock Units RSUs generally vest annually over a two or three-year period. PSUs generally contain performance conditions associated with corporate goals, such as achievement of certain development milestones, that vests upon achievement over a one to three-year period. The following table summarizes RSU and PSU activity for the year ended December 31, 2023: RSUs PSUs Number of Weighted-Average Number of Weighted-Average Balance outstanding as of December 31, 2022 645,986 $ 5.43 449,752 $ 6.25 Granted 379,075 15.02 — — Vested ( 334,688 ) 5.36 ( 150,584 ) 6.82 Canceled ( 1,991 ) 11.80 — — Balance outstanding as of December 31, 2023 688,382 10.72 299,168 5.96 Compensation expense related to RSUs and PSUs were $ 4.3 million, $ 2.7 million and $ 1.1 million for the years ended December 31, 2023, 2022 and 2021, respectively. The total fair value of RSUs and PSUs that vested during the years ended December 31, 2023, 2022, and 2021 was $ 7.5 million, $ 0.9 million and nil , respectively. As of December 31, 2023, total unrecognized stock-based compensation expense related to RSUs and PSUs was $ 5.3 million, which is expected to be recognized over a weighted-average period of 1.5 years. ESPP For the years ended December 31, 2023, 2022 and 2021, the number of shares of common stock issued under the Company’s ESPP were 27,217 , 18,364 and 10,712 , respectively. Stock-Based Compensation Expense Allocation The Company recorded stock-based compensation for the periods indicated as follows (in thousands): Year Ended December 31, 2023 2022 2021 Research and development $ 7,010 $ 4,094 $ 2,966 General and administrative 9,096 6,262 5,712 Total stock-based compensation $ 16,106 $ 10,356 $ 8,678 |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2023 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 9 . Income Taxes Tax Rates Applicable to the Income of the Company and its Subsidiaries The Company is taxed according to U.S. federal and state tax laws and Israeli tax laws. The statutory tax rates applicable to the income of the Company and its subsidiaries for the periods presented were as follows: Year Ended December 31, 2023 2022 2021 89bio, Inc. 21 % 21 % 21 % 89Bio Ltd. 23 % 23 % 23 % 89bio Management, Inc. 21 % 21 % 21 % UAB 89bio Lithuania 15 % 15 % 15 % The income tax (expense) benefit for the periods presented is comprised of (in thousands): Year Ended December 31, 2023 2022 2021 Current: Federal $ — $ — $ — State — ( 3 ) ( 2 ) Foreign ( 3,740 ) ( 16 ) ( 1 ) Total current ( 3,740 ) ( 19 ) ( 3 ) Deferred: Federal — — 150 State — — — Foreign ( 127 ) — — Total deferred ( 127 ) — 150 Income tax (expense) benefit $ ( 3,867 ) $ ( 19 ) $ 147 Deferred Income Taxes Deferred income taxes reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. Significant components of the Company’s deferred tax assets for the periods presented were as follows (in thousands): As of December 31, 2023 2022 U.S. net operating loss carryforwards $ 62,873 $ 45,002 Research and development expenses 41,834 18,927 Israel net operating loss carryforwards — 7,385 Stock-based compensation 2,924 4,328 Accrued expenses 307 317 Operating lease liabilities 629 98 Other 378 244 Gross deferred tax assets 108,945 76,301 Less: valuation allowance ( 108,230 ) ( 75,982 ) Total deferred tax assets $ 715 $ 319 Operating lease right-of-use assets ( 623 ) ( 100 ) Total deferred tax liabilities ( 623 ) ( 100 ) Net deferred tax assets 92 219 As of December 31, 2023 and 2022, the Company recorded a valuation allowance of $ 108.2 million and $ 76.0 million, respectively, in respect of deferred tax assets resulting from tax loss carryforwards and other temporary differences. Realization of deferred tax assets is dependent upon future earnings, if any, the time and amount of which are uncertain. The Company regularly assesses the likelihood that its deferred tax assets will be recovered from future taxable income and, to the extent it believes based upon the weight of available evidence that it is more likely than not that all or a portion of deferred tax assets will not be realized, a valuation allowance is established through an adjustment to income tax expense. The valuation allowance increased by $ 32.2 million in 2023, which primarily relates to significant taxable losses. Available Carryforward Tax Losses and Credits As of December 31, 2023, the Company had an accumulated tax loss carryforward of approximately $ 195.0 million , $ 302.8 million , and $ 30.4 million for federal, state and Israeli tax purposes, respectively. As of December 31, 2022 , the Company had an accumulated tax loss carryforward of approximately $ 160.9 million, $ 169.8 million, and $ 32.1 million for federal, state and Israeli tax purposes, respectively. Federal net operating losses generated after 2017 can be carried forward indefinitely but utilization will be limited to 80% of taxable income in the period that net operating losses are being utilized. Carryforward tax losses in California will begin to expire in 2039 . Carryforward tax losses in Israel have no expiration date. As of December 31, 2023 and 2022, the Company had federal research and development credit carryforwards of approximately $ 7.5 million and $ 4.3 million, respectively, which expire beginning in 2040 . As of December 31, 2023 and 2022, the Company had state research and development credit carryforwards of approximately $ 3.2 million and $ 1.8 million, respectively, which will carry forward indefinitely. Loss from Operations, Before Income Tax The Company recorded a loss from operations, before income tax for the periods presented as follows (in thousands): Year Ended December 31, 2023 2022 2021 United States $ ( 138,293 ) $ ( 101,938 ) $ ( 91,141 ) Lithuania ( 59 ) ( 7 ) 10 Israel 30 ( 62 ) 862 Net loss before income tax $ ( 138,322 ) $ ( 102,007 ) $ ( 90,269 ) Reconciliation of Income Tax (Expense) Benefit The reconciliation of income tax (expense) benefit based on the statutory tax rate to the effective tax rate for the periods presented is as follows (in thousands): Year Ended December 31, 2023 2022 2021 Income tax benefit computed at statutory rates $ 29,054 $ 21,429 $ 18,757 Change in valuation allowance ( 32,248 ) ( 33,936 ) ( 20,111 ) Foreign rate differential ( 2 ) 1 ( 19 ) State income taxes, net of federal benefit 7,653 5,824 — State deferred tax true-up due to change in apportionment 2,030 6,517 — Unrecognized tax benefits ( 9,940 ) — — Research and development credits, net of uncertain tax position 3,275 2,130 1,331 Executive compensation limitation ( 3,971 ) — — Other 282 ( 1,984 ) 189 Income tax (expense) benefit $ ( 3,867 ) $ ( 19 ) $ 147 Utilization of U.S. federal and state net operating losses and credit carryforwards may be subject to an annual limitation provided for in Section 382 of the Internal Revenue Code and similar state codes. Any annual limitation could result in a deferral of the utilization of the net operating loss and credit carryforwards. Unrecognized Tax Benefits A reconciliation of the beginning and ending amount of gross unrecognized tax benefits for the years ended December 31, 2023, 2022 and 2021 is as follows (in thousands): As of December 31, 2023 2022 2021 Balance beginning of year 1,584 851 329 Increase (decrease) related to prior year positions 9,351 ( 19 ) ( 35 ) Increase related to current year positions 1,163 752 557 Balance end of year 12,098 1,584 851 The Company’s unrecognized tax benefits, exclusive of interest, totaled $ 12.1 million at December 31, 2023, of which $ 3.1 million, if recognized, would reduce income tax expense. A material portion of the Company’s gross unrecognized tax benefits, if recognized, would increase the Company’s net operating loss carryforward and would not have an impact to the effective tax rate as it would be offset by a full valuation allowance. For the year ended December 31, 2023, the amount of gross unrecognized tax benefits related to prior year tax positions increased by $ 9.4 million. The increase relates primarily to unresolved issues associated with tax returns for tax years 2018 through 2021 being audited by the Israel Tax Authority (“ITA”). In December 2023, the Company received a primary assessment from the ITA related to the Company’s 2019 reorganization and intercompany transaction to license the intellectual property rights from the Company’s Israeli subsidiary. The ITA has alleged that the transaction is deemed to be a sale of intellectual property rights. Although management believes that the Company has adequately accounted for its uncertain tax positions, the ultimate resolution of the ITA audit may result in payments that are materially different from what was originally recognized in the Company’s financial statements . The Company does not expect a resolution to this matter to be finalized within the next 12 months. Based on the information currently available, the Company does not anticipate significant increases or decreases to unrecognized tax benefits in the next twelve months. However, it is possible that such increases or decreases may occur. The Company classifies interest and penalties related to uncertain tax positions as income tax expense. As of December 31, 2023, the interest related to uncertain tax positions was approximately $ 0.6 million. The Company is subject to taxation in the United States, California, Colorado, Indiana, Maryland, North Carolina, New Jersey, Virginia and certain foreign jurisdictions. To date, the Company has not been subject to any federal or state income tax audits. As of December 31, 2023, all tax years remain open to examination. The Tax Cuts and Jobs Act included a change in the treatment of research and development (“R&D”) expenditures for tax purposes under Section 174. Effective for tax years beginning after December 31, 2021, specified R&D expenditures must undergo a five-year amortization period for domestic spend and a 15-year amortization period for foreign spend. Prior to the effective date (2021 tax year and prior), taxpayers were able to immediately expense R&D costs under Section 174(a) or had the option to capitalize and amortize R&D expenditures over a five-year recovery period under Section 174(b). The Company has evaluated the current legislation at this time and prepared the provision by following the treatment of R&D expenditures for tax purposes under Section 174. |
Net Loss Per Share
Net Loss Per Share | 12 Months Ended |
Dec. 31, 2023 | |
Earnings Per Share [Abstract] | |
Net Loss Per Share | 10. Net Loss Per Share The following table presents the weighted-average shares outstanding used to calculate basic and diluted net loss per share: Year Ended December 31, 2023 2022 2021 Common stock 70,310,671 31,767,914 20,098,340 Pre-funded warrants 862,199 3,038,435 — Total 71,172,870 34,806,349 20,098,340 The following table presents potentially dilutive common stock equivalents that have been excluded from the calculation of diluted net loss per share for the periods indicated due to their anti-dilutive effect: December 31, 2023 2022 2021 Stock options outstanding 4,686,577 3,161,917 2,406,668 RSUs and PSUs outstanding 987,550 1,095,738 106,394 Warrants to purchase common stock outstanding 1 10,412,806 13,166,283 58,923 Conversion feature related to outstanding term loan 590,816 — — Total 16,677,749 17,423,938 2,571,985 1 Excludes pre-funded warrants to purchase 1,881,081 common shares as they are required to be included in basic and diluted net loss per share . |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2023 | |
Subsequent Events [Abstract] | |
Subsequent Events | 11. Subsequent Events The Company has evaluated events subsequent to December 31, 2023 and through the financial statement issuance date of March 1, 2024, and concluded that no material events occurred that would require disclosure. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2023 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States (“U.S. GAAP”). |
Reclassification | Reclassifications Certain reclassifications of previously reported amounts have been made to conform to the current year presentation. Specifically, the final payment fee of $ 0.5 million related to borrowings under the Company’s 2021 Loan Agreement (see Note 6) was previously presented separately from “Term loan, non-current, net” under the caption “Other non-current liability” in the Form 10-K as of December 31, 2022. These captions have been combined in the consolidated balance sheet as of December 31, 2022 included within these financial statements. |
Principles of Consolidation | Principles of Consolidation The accompanying consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. 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 as of the date of the consolidated financial statements and the reported amounts of expenses during the reporting period. Significant estimates and assumptions made in the accompanying consolidated financial statements include but are not limited to accruals for uncertain tax positions, accrued research and development expenses and the valuation of stock options. The Company evaluates its estimates and assumptions on an ongoing basis using historical experience and other factors and adjusts those estimates and assumptions when facts and circumstances dictate. Actual results could differ from those estimates. |
Foreign Currencies | Foreign Currencies The Company engages in foreign-currency-denominated transactions with certain vendors, as well as between subsidiaries with different functional currencies. The Company’s subsidiary in Israel uses the U.S. dollar as its functional currency for financial reporting. Gains and losses from foreign-currency-denominated transactions, primarily denominated in New Israeli Shekels, were not material for all periods presented and are reflected in the consolidated statements of operations and comprehensive loss as a component of interest income and other, net. The Company’s subsidiary in Lithuania uses the Euro as its functional currency for financial reporting. The re-measurement from Euros to U.S. dollars results in translation gain and loss adjustments, which are included in the consolidated balance sheets as part of accumulated other comprehensive loss. |
Fair Value Measurements | Fair Value Measurements Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability (an exit price) in an orderly transaction between market participants at the reporting date. Assets and liabilities recorded at fair value are categorized based upon the level of judgment associated with the inputs used to measure their fair value. Hierarchical levels are directly related to the amount of subjectivity with the inputs to the valuation of these assets or liabilities as follows: Level 1 —Observable inputs such as unadjusted, quoted prices in active markets for identical assets or liabilities at the measurement date; Level 2 —Inputs (other than quoted prices included in Level 1) are either directly or indirectly observable inputs for similar assets or liabilities. These include quoted prices for identical or similar assets or liabilities in active markets and quoted prices for identical or similar assets or liabilities in markets that are not active; and Level 3 —Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. Assets Measured at Fair Value on a Recurring Basis As of December 31, 2023 and 2022, marketable securities were the only financial instruments measured and recorded at fair value on a recurring basis on the Company’s consolidated balance sheets. Financial Instruments Not Carried at Fair Value The Company’s financial instruments, including cash, other current assets, accounts payable and accrued expenses are carried at cost which approximates their fair value because of the short-term nature of these financial instruments. The fair value of the Company’s term loan approximates its carrying value, or amortized cost, due to the prevailing market rates of interest it bears. |
Concentrations of Credit Risk | Concentrations of Credit Risk Financial instruments that potentially subject the Company to a concentration of credit risk consist primarily of cash, cash equivalents and marketable securities. Bank deposits are held by accredited financial institutions and these deposits may at times be in excess of insured limits. The Company limits its credit risk associated with cash and cash equivalents by placing them with financial institutions that it believes are of high quality. The Company has not experienced any losses on its deposits of cash or cash equivalents. The Company has established guidelines relative to diversification and maturities to maintain safety and liquidity and limits amounts invested in marketable securities by credit rating, maturity, industry group, investment type and issuer, except for securities issued by the U.S. government. The Company does not believe a significant risk of loss from a concentration of credit risk exists with respect to its marketable securities portfolio. |
Other Risks and Uncertainties | Other Risks and Uncertainties The Company’s future results of operations involve a number of other risks and uncertainties. Factors that could affect the Company’s future operating results and cause actual results to vary materially from expectations include, but are not limited to, the Company’s early stages of clinical drug development; the Company’s ability to advance product candidates into, and successfully complete, clinical trials on the timelines it projects; the Company’s ability to adequately demonstrate sufficient safety and efficacy of its product candidates; the Company’s ability to enroll patients in its ongoing and future clinical trials; the Company’s ability to successfully manufacture and supply its product candidates for clinical trials; the Company’s ability to obtain additional capital to finance its operations; uncertainties related to the projections of the size of patient populations suffering from the diseases the Company is targeting; the Company’s ability to obtain, maintain, and protect its intellectual property rights; developments relating to the Company’s competitors and its industry, including competing product candidates and therapies; general economic and market conditions; and other risks and uncertainties. The Company’s product candidates will require approvals from the U.S. Food and Drug Administration and comparable foreign regulatory agencies prior to commercial sales in their respective jurisdictions. There can be no assurance that any product candidates will receive the necessary approvals. If the Company is denied approval, approval is delayed or the Company is unable to maintain approval for any product candidate, it could have a materially adverse impact on the Company. |
Segment Reporting | Segment Reporting Operating segments are defined as components of an enterprise that have the following characteristics: (i) they engage in business activities from which they may earn revenue and incur expense, (ii) their operating results are regularly reviewed by the chief operating decision maker (“CODM”) for resource allocation decisions and performance assessment, and (iii) their discrete financial information is available. The Company’s CODM is its Chief Executive Officer. The Company and the CODM view the Company’s operations and manage its business in one operating segment. |
Cash and Cash Equivalents | Cash and Cash Equivalents The Company considers all highly-liquid investments purchased with original maturities of three months or less from the purchase date to be cash equivalents. Cash equivalents primarily consist of amounts invested in money market funds, commercial paper and U.S. government treasury securities and are carried at fair value. |
Marketable Securities | Marketable Securities The Company invests its excess cash in marketable securities with high credit ratings including money market funds, commercial paper, securities issued by the U.S. government and its agencies and corporate debt securities. The Company accounts for all marketable securities as available-for-sale, as the sale of such securities may be required prior to maturity. These marketable securities are carried at fair value, with unrealized gains and losses reported as accumulated other comprehensive income (loss) until realized. The cost of debt securities is adjusted for accretion of premiums and amortization of discounts to maturity. Such amortization and accretion, as well as interest and dividends, are included in interest income and other, net. Realized gains and losses from the sale of available-for-sale securities, if any, are determined on a specific identification basis and are also included in interest income and other, net. The Company’s marketable securities are classified as current assets, which reflects management’s intention to use the proceeds from sales of these securities to fund its operations, as necessary, even though the stated maturity date may be one year or more beyond the current balance sheet date. The Company periodically assesses its available-for-sale marketable securities for impairment. For marketable securities in an unrealized loss position, this assessment first takes into account the Company’s intent to sell, or whether it is more likely than not that it will be required to sell the security before recovery of its amortized cost basis. If either of these criteria are met, the marketable security’s amortized cost basis is written down to fair value through interest income and other, net. For marketable securities in an unrealized loss position that do not meet the aforementioned criteria, the Company assesses whether the decline in fair value has resulted from credit losses or other factors. In making this assessment, the Company considers the extent to which fair value is less than amortized cost, any changes to the rating of the security by a rating agency, and any adverse conditions specifically related to the security, among other factors. If this assessment indicates that a credit loss may exist, the present value of cash flows expected to be collected from the security are compared to the amortized cost basis of the security. If the present value of cash flows expected to be collected is less than the amortized cost basis, a credit loss exists and an allowance for credit losses will be recorded in interest income and other, net, limited by the amount that the fair value is less than the amortized cost basis. Any additional impairment not recorded through an allowance for credit losses is recognized in other comprehensive loss. Changes in the allowance for credit losses are recorded as provision for (or reversal of) credit loss expense. Losses are charged against the allowance when management believes the uncollectability of an available-for-sale security is confirmed or when either of the criteria regarding intent or requirement to sell is met. These changes are recorded in interest income and other, net. |
Leases | Leases The Company has noncancellable operating leases for office space. Beginning in 2022, the Company accounts for leases in accordance with Accounting Standards Update (“ASU”) 2016-02, Leases ( Topic 842 ). The Company determines if an arrangement is a lease or contains an embedded lease at inception. The Company accounts for a contract as a lease when it has the right to control the asset for a period of time while obtaining substantially all of the asset’s economic benefits. For arrangements that meet the definition of a lease, the Company determines the initial classification and measurement of its right-of-use (“ROU”) asset and lease liability at the lease commencement date and thereafter if modified. Operating lease ROU assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent the Company’s obligation to make the contractual lease payments over the lease term. The ROU asset is initially measured at cost, which comprises the initial amount of the lease liability adjusted for lease payments made at or before the lease commencement date, plus any initial direct costs incurred less any lease incentives received. The operating lease liability is initially measured at the present value of the unpaid lease payments at the lease commencement date. The lease liability is subsequently measured at amortized cost using the effective-interest method. The lease term includes any renewal 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 estimated collateralized incremental borrowing rate that the Company would pay for a similar amount and term. The Company has elected not to record leases with an original term of twelve months or less on its consolidated balance sheets. The Company does not have any material short-term leases. In addition, the Company’s leases may require the Company to pay additional costs, such as utilities, maintenance, and other operating costs, which are generally referred to as non-lease components and vary based on future outcomes. The Company has elected to not separate lease and non-lease components. Only the fixed costs for lease components and their associated non-lease components are accounted for as a single lease component and recognized as part of a ROU asset and lease liability. Any variable expenses are recognized in operating expenses as incurred. Lease expense for an operating lease liability is recognized on a straight-line basis over the lease term and is included in operating expenses in the consolidated statements of operations and comprehensive loss. |
Property and Equipment, Net | Property and Equipment, Net Property and equipment are stated at cost, less accumulated depreciation. Depreciation is calculated on a straight-line basis over the estimated useful lives of the related assets, generally ranging from three to seven years . Leasehold improvements are amortized on a straight-line basis over the shorter of the assets’ estimated useful life or the remaining term of the lease. Upon retirement or sale of the assets, the cost and related accumulated depreciation and amortization are removed from the consolidated balance sheets and the resulting gains or losses are recorded in the consolidated statements of operations and comprehensive loss. Maintenance and repair costs are expensed as incurred. |
Impairment of Long-Lived Assets | Impairment of Long-Lived Assets The Company periodically evaluates its long-lived assets, including property and equipment, for impairment whenever events or changes in business circumstances indicate that the carrying amount of the assets or group of assets may not be fully recoverable. If indicators of impairment exist and the undiscounted future cash flows that the assets are expected to generate are less than the carrying value of the assets, then the Company will reduce the carrying amount of the assets through an impairment charge, to their estimated fair values based on a discounted cash flow approach or, when available and appropriate, to comparable market values. There were no such indicators for the periods presented. |
Accrued Research and Development Expenses | Accrued Research and Development Expenses The Company records preclinical and clinical study and research expenses based on the services performed, pursuant to contracts with research institutions that conduct and manage preclinical and clinical studies and research services on its behalf. The majority of these expenses are recorded based on invoices and statements received from these vendors. The Company also records these expenses based upon the estimated services provided but not yet invoiced. Liabilities associated with these expenses are included in accrued expenses in the consolidated balance sheets. These costs are a component of the Company’s research and development expenses. In making these estimates of services provided but not yet invoiced or for which statements have not been received from vendors, the Company considers factors such as estimates of the progress of work completed in accordance with agreements established with its third-party service providers. As actual costs become known, the Company adjusts its accrued expenses. The Company has not experienced any material differences between accrued costs and actual costs incurred. However, the status and timing of actual services performed may vary from the Company’s estimates, resulting in adjustments to expense in future periods. Changes in these estimates that result in material changes to the Company’s accrued expenses could materially affect the Company’s results of operations. Contingent milestone payments, if any, are recognized when payment becomes probable and reasonably estimable, which is generally upon achievement of the milestone. |
Warrants To Purchase Common Stock | Warrants to Purchase Common Stock The Company classifies warrants indexed to its common stock and meeting the requirements for equity classification within stockholders’ equity. This assessment is conducted at the time of warrant issuance and as of each reporting period that the warrants remain outstanding. |
Research and Development Expenses | Research and Development Expenses Research and development expenses consist primarily of costs incurred for the development of the Company’s lead product candidate, pegozafermin. Research and development expenses consist primarily of external costs related to preclinical and clinical development and related supplies and personnel costs. Personnel costs consist of salaries, employee benefits and stock-based compensation for individuals involved in research and development efforts. Payments associated with agreements to acquire licenses to develop, use, manufacture and commercialize products and purchases of pegozafermin from contract manufacturing organizations that have not reached technological feasibility and do not have alternate future commercial use are expensed as incurred. |
Stock-Based Compensation | Stock-Based Compensation The Company utilizes stock options, restricted stock units (“RSUs”) and performance stock units (“PSUs”) for equity compensation. The Company measures its equity awards made to employees, directors, and non-employee service providers based on estimated fair values and recognizes stock-based compensation over the requisite service period. The Company accounts for forfeitures as they occur. The Company estimates the fair value of stock option awards on the date of grant using a Black-Scholes option pricing model. The Company recognizes compensation for stock option awards, including awards with graded-vesting, on a straight-line basis over the requisite service period. The Black-Scholes option pricing model requires a number of assumptions, of which the most significant are expected volatility, expected option term (the time from the grant date until the options are exercised or expire), risk-free rate, and expected dividend rate. These assumptions include: • Expected volatility—The Company has a limited trading history for its common stock. As a result, the Company estimates expected volatility based on a combination of its own historical stock price volatility and that of a publicly traded set of peer companies such that the time period over which historical volatility data used is at least equal to the expected term of the option award. The peer companies were chosen based on their similar size, stage in the life cycle, or area of specialty. • Expected term—The expected term of options granted to employees and directors is determined using the “simplified” method. Under this approach, the expected term is presumed to be the midpoint between the weighted-average vesting term and the contractual term of the option. The simplified method makes the assumption that the employee will exercise stock options evenly over the period when the stock options are vested and ending on the date when the stock options would expire. The expected option term for options granted to non-employees is estimated on a grant-by-grant basis. • Risk-free interest rate—The risk-free interest rate is based on the U.S. Treasury zero coupon bonds in effect on the grant date for periods with an equivalent expected term as the option. • Expected dividend—The Company has never paid dividends and has no foreseeable plans to pay dividends on its shares of common stock. Therefore, an expected dividend of zero is used. The grant date fair value of RSUs and PSUs are based on the closing price of the Company’s common stock on the date of grant. RSUs are service-based awards and are recognized over the requisite service period on a straight-line basis. Compensation expense for PSUs is recognized over the estimated service period for each tranche of an award (the accelerated attribution method) when its performance condition is deemed probable of achievement. For PSUs containing performance conditions which were not deemed probable of achievement, no stock compensation expense is recognized. Additionally, at each reporting period, the Company evaluates the probable outcome of the performance conditions and as applicable, recognizes the cumulative effect of the change in estimate in the period of the change. |
Income Taxes | Income Taxes Income taxes are accounted for under the asset and liability method. Under this method, deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the consolidated financial statements carrying amounts of existing assets and liabilities and their respective tax bases and operating loss and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates applied to taxable income in the years in which those temporary differences are expected to be realized. The effect on deferred tax assets and liabilities of a change in tax rates is recognized as income or loss in the period that includes the enactment date. A valuation allowance is established when necessary to reduce deferred tax assets to the amount expected to be realized. The Company has established full valuation allowances on its U.S. deferred tax assets because realization of these tax benefits through future taxable income is not more likely than not as of December 31, 2023 and 2022. The Company intends to maintain the valuation allowances until sufficient positive evidence exists to support the reversal of the valuation allowances. The calculation of the Company’s accruals for tax contingencies involves dealing with uncertainties in the application of complex tax laws. The Company’s estimates for the potential outcome of any uncertain tax issue are based on the detailed facts and circumstances of each issue. Resolution of these uncertainties in a manner inconsistent with the Company’s expectations could have a material impact on its results of operations and financial condition. The Company recognizes liabilities for uncertain tax positions based on a two-step process. The first step is to evaluate the tax position for recognition by determining if the weight of available evidence indicates that it is more likely than not that the position will be sustained on audit, including resolution of related appeals or litigation processes, if any. The second step is to estimate and measure the tax benefit as the largest amount that is more than 50% likely of being realized upon ultimate settlement. It is inherently difficult and subjective to estimate such amounts, as this requires the Company to determine the probability of various possible outcomes. The Company reevaluates these uncertain tax positions on a quarterly basis. This evaluation is based on factors including, but not limited to, changes in facts or circumstances, changes in tax law, effectively settled issues under audit, and new audit activity. Such a change in recognition or measurement would result in the recognition of a tax benefit or an additional charge to tax expense in the period. Interest and penalties related to unrecognized tax benefits are included within income tax (expense) benefit. |
Basic and Diluted Net Loss per Share | Basic and Diluted Net Loss per Share Basic and diluted net loss per share is calculated based upon the weighted-average number of shares of common stock outstanding during the period . Shares of common stock that are potentially issuable for little or no cash consideration at issuance, such as the Company’s pre-funded warrants issued in July 2022 and December 2023 are included in the calculation of basic and diluted net loss per share , even if they are antidilutive. During periods of income, participating securities are allocated a proportional share of income determined by dividing total weighted-average participating securities by the sum of the total weighted-average common shares and participating securities (the “two-class method”). Shares of the Company’s common stock warrants participate in any dividends that may be declared by the Company and are therefore considered to be participating securities. Participating securities have the effect of diluting both basic and diluted earnings per share during periods of income. During periods of loss, no loss is allocated to participating securities since they have no contractual obligation to share in the losses of the Company. Diluted loss per share is computed after giving consideration to the dilutive effect of stock options, RSUs, PSUs and common stock warrants, except where such non-participating securities would be anti-dilutive. As the Company incurred net losses for the periods presented, basic net loss per share is the same as diluted net loss per share since the effects of potentially dilutive securities are antidilutive. |
Comprehensive Loss | Comprehensive Loss The Company’s comprehensive loss is comprised of net loss and changes in unrealized gains or losses on marketable securities and foreign currency translation adjustments. |
Recently Adopted Accounting Standards | Recently Adopted Accounting Standards In August 2020, the FASB issued ASU No. 2020-06, Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging-Contracts in Entity’s Own Equity (Subtopic 815-40)—Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity (“ASU 2020-06”), which simplifies the accounting for convertible instruments, amends the guidance on derivative scope exceptions for contracts in an entity’s own equity, and modifies the guidance on diluted earnings per share calculations as a result of these changes. The Company early adopted ASU 2020-06 as of January 1, 2023 , using a modified retrospective approach and the adoption did no t have a material impact on the Company’s consolidated financial statements and related disclosures. Recently Issued Accounting Pronouncements In November 2023, the FASB issued ASU No. 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures (“ASU 2023-07”), which is intended to improve reportable segment disclosure requirements, primarily through enhanced disclosures about significant expenses. ASU 2023-07 requires disclosures to include significant segment expenses that are regularly provided to the CODM, a description of other segment items by reportable segment, and any additional measures of a segment's profit or loss used by the CODM when deciding how to allocate resources. The ASU also requires all annual disclosures required by Topic 280 to be included in interim periods. The ASU is effective for the Company’s annual periods beginning on January 1, 2024 and interim periods beginning on January 1, 2025. Early adoption is permitted and requires retrospective application to all prior periods presented in the financial statements. The Company is currently evaluating the effect of adopting this new accounting guidance on its financial statement disclosures. In December 2023, the FASB issued ASU No. 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures (“ASU 2023-09”), which requires companies to disclose, on an annual basis, specific categories in the effective tax rate reconciliation and provide additional information for reconciling items that meet a quantitative threshold. In addition, ASU 2023-09 requires companies to disclose additional information about income taxes paid. The ASU is effective for the Company’s annual periods beginning on January 1, 2025 and will be applied on a prospective basis with the option to apply the standard retrospectively. The Company is currently evaluating the effect of adopting this new accounting guidance on its financial statement disclosures. |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Fair Value Disclosures [Abstract] | |
Summary of Financial Assets Measured at Fair Value on Recurring Basis | The following table presents the Company’s financial assets measured at fair value on a recurring basis by level within the fair value hierarchy as of December 31, 2023 (in thousands): Valuation Amortized Unrealized Unrealized Fair Hierarchy Cost Gains Losses Value Money market funds Level 1 $ 493 $ — $ — $ 493 Commercial paper Level 2 94,261 — ( 55 ) 94,206 U.S. government bonds Level 2 137,976 250 ( 142 ) 138,084 Agency bonds Level 2 45,481 152 ( 44 ) 45,589 Corporate debt securities Level 2 3,177 — ( 12 ) 3,165 U.S. Treasury securities Level 2 71,754 36 ( 1 ) 71,789 Agency discount securities Level 2 7,975 1 — 7,976 Total cash equivalents and marketable securities $ 361,117 $ 439 $ ( 254 ) $ 361,302 Classified as: Cash equivalents $ 98,593 Marketable securities 262,709 Total cash equivalents and marketable securities $ 361,302 The following table presents the Company’s financial assets measured at fair value on a recurring basis by level within the fair value hierarchy as of December 31, 2022 (in thousands): Valuation Amortized Unrealized Unrealized Fair Hierarchy Cost Gains Losses Value Money market funds Level 1 $ 18,224 $ — $ — $ 18,224 Commercial paper Level 2 104,279 1 ( 84 ) 104,196 U.S. government bonds Level 2 18,225 1 ( 109 ) 18,117 Agency bonds Level 2 13,986 — ( 78 ) 13,908 Corporate debt securities Level 2 10,488 — ( 62 ) 10,426 U.S. Treasury securities Level 2 7,414 1 ( 21 ) 7,394 Agency discount securities Level 2 5,216 9 — 5,225 Non-U.S. debt securities Level 2 3,975 — ( 20 ) 3,955 Total cash equivalents and marketable securities $ 181,807 $ 12 $ ( 374 ) $ 181,445 Classified as: Cash equivalents $ 48,540 Marketable securities 132,905 Total cash equivalents and marketable securities $ 181,445 The valuation techniques used to measure the fair values of the Company’s Level 2 financial instruments, which generally have counterparties with high credit ratings, are based on quoted market prices when available. If quoted market prices are not available, the fair value for the security is estimated under the market or income approach using pricing models with market observable inputs. |
Schedule of Contractual Maturities of Cash Equivalents and Marketable Securities | The following table summarizes the Company’s cash equivalents and marketable securities by contractual maturity as of December 31, 2023 (in thousands): Within one year $ 290,756 After one year through two years 70,546 Total cash equivalents and marketable securities $ 361,302 |
Consolidated Balance Sheet Co_2
Consolidated Balance Sheet Components (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Balance Sheet Related Disclosures [Abstract] | |
Schedule of Prepaid and Other Current Assets | Prepaid and other current assets consist of the following as of the periods presented (in thousands): As of December 31, 2023 2022 Prepaid research and development $ 11,579 $ 5,727 Prepaid taxes 614 646 Prepaid other 2,471 1,547 Total prepaid and other current assets $ 14,664 $ 7,920 |
Schedule of Accrued Expenses | Accrued expenses consist of the following as of the periods presented (in thousands): As of December 31, 2023 2022 Accrued research and development expenses $ 13,017 $ 6,499 Accrued employee and related expenses 6,248 4,165 Accrued professional and legal fees 1,110 1,052 Accrued other expenses 155 228 Total accrued expenses $ 20,530 $ 11,944 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of Future Minimum Lease Payments Under Non-cancellable Operating Lease Obligations | As of December 31, 2023, the undiscounted future minimum lease payments due under the Company’s non-cancellable operating leases were as follows (in thousands): 2024 $ 774 2025 917 2026 937 2027 240 Total undiscounted future minimum lease payments $ 2,868 Less: imputed interest ( 555 ) Present value of operating lease liabilities $ 2,313 |
Term Loan Facilities (Tables)
Term Loan Facilities (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Debt Disclosure [Abstract] | |
Schedule of Maturities of Principal Obligations | As of December 31, 2023, the Company’s maturities of principal obligations under the term loan were as follows (in thousands): 2024 $ — 2025 10,774 2026 13,036 2027 1,190 Total principal outstanding 25,000 Plus accumulated accretion of final payment fee 388 Less unamortized debt discount ( 593 ) Total net carry value 24,795 Term loan, current portion — Term loan, non-current, net $ 24,795 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Equity [Abstract] | |
Schedule of Shares of Common Stock Available for Future Issuance | As of December 31, 2023, common stock reserved for future issuance, on an as-if-converted basis, were as follows: Stock options outstanding 4,686,577 RSUs and PSUs outstanding 987,550 Shares available for future grants under equity incentive plans 1,790,684 Shares available for future issuance under the employee stock purchase plan 1,207,607 Warrants to purchase common stock outstanding 10,412,806 Pre-funded warrants to purchase common stock outstanding 1,881,081 Conversion feature related to outstanding term loan 590,816 Total shares of common stock reserved 21,557,121 |
Schedule of Outstanding Warrants to Purchase Shares of Common Stock | As of December 31, 2023, the Company’s outstanding warrants to purchase shares of its common stock were as follows: Shares of Exercise Price Expiration Warrant issued in connection with term loan (SVB) 25,000 $ 22.06 June 30, 2025 Warrant issued in connection with term loan (SVB) 33,923 $ 19.12 May 28, 2031 Warrants issued in connection with term loan facility (K2HV) 174,093 $ 9.76 January 27, 2033 Warrants issued in public offering 10,179,790 $ 5.325 July 1, 2024 Pre-funded warrants issued in public offerings 1,881,081 $ 0.001 Do not expire Total outstanding 12,293,887 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Summary of Stock Option Activity | The following table summarizes stock option activity for the year ended December 31, 2023: Weighted- Weighted- Average Average Remaining Aggregate Number of Exercise Contractual Intrinsic Options Price Term Value (In years) (In thousands) Balance outstanding as of December 31, 2022 3,161,917 $ 12.80 7.9 $ 16,612 Granted 1,952,900 14.65 Exercised ( 247,162 ) 2.95 Cancelled and forfeited ( 181,078 ) 12.40 Balance outstanding as of December 31, 2023 4,686,577 $ 14.11 7.9 $ 11,712 Exercisable as of December 31, 2023 2,043,280 $ 14.70 6.6 $ 8,123 |
Summary of Estimated Weighted-Average Grant Date Fair Value of Options Granted Using Black-Scholes Option-Pricing Model | The following table presents the weighted-average grant date fair value of options granted for the periods presented and the assumptions used to estimate those values using a Black-Scholes option pricing model: Year Ended December 31, 2023 2022 2021 Weighted-average grant date fair value $ 11.43 $ 3.38 $ 16.18 Expected term (years) 5.5 - 6.1 5.5 - 6.3 5.5 - 6.1 Expected volatility 91.5 - 99.2 % 89.9 - 91.0 % 86.9 - 91.9 % Risk-free interest rate 3.4 - 4.6 % 1.6 - 3.9 % 0.7 - 1.3 % Expected dividend — — — |
Summary of RSU and PSU Activity | The following table summarizes RSU and PSU activity for the year ended December 31, 2023: RSUs PSUs Number of Weighted-Average Number of Weighted-Average Balance outstanding as of December 31, 2022 645,986 $ 5.43 449,752 $ 6.25 Granted 379,075 15.02 — — Vested ( 334,688 ) 5.36 ( 150,584 ) 6.82 Canceled ( 1,991 ) 11.80 — — Balance outstanding as of December 31, 2023 688,382 10.72 299,168 5.96 |
Summary of Stock-Based Compensation | The Company recorded stock-based compensation for the periods indicated as follows (in thousands): Year Ended December 31, 2023 2022 2021 Research and development $ 7,010 $ 4,094 $ 2,966 General and administrative 9,096 6,262 5,712 Total stock-based compensation $ 16,106 $ 10,356 $ 8,678 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Income Tax Disclosure [Abstract] | |
Summary of Statutory Tax Rates Applicable to Income of Company and Subsidiaries | The Company is taxed according to U.S. federal and state tax laws and Israeli tax laws. The statutory tax rates applicable to the income of the Company and its subsidiaries for the periods presented were as follows: Year Ended December 31, 2023 2022 2021 89bio, Inc. 21 % 21 % 21 % 89Bio Ltd. 23 % 23 % 23 % 89bio Management, Inc. 21 % 21 % 21 % UAB 89bio Lithuania 15 % 15 % 15 % |
Summary of Income Tax (Expense) Benefit | The income tax (expense) benefit for the periods presented is comprised of (in thousands): Year Ended December 31, 2023 2022 2021 Current: Federal $ — $ — $ — State — ( 3 ) ( 2 ) Foreign ( 3,740 ) ( 16 ) ( 1 ) Total current ( 3,740 ) ( 19 ) ( 3 ) Deferred: Federal — — 150 State — — — Foreign ( 127 ) — — Total deferred ( 127 ) — 150 Income tax (expense) benefit $ ( 3,867 ) $ ( 19 ) $ 147 |
Summary of Components of Deferred Tax Assets | Significant components of the Company’s deferred tax assets for the periods presented were as follows (in thousands): As of December 31, 2023 2022 U.S. net operating loss carryforwards $ 62,873 $ 45,002 Research and development expenses 41,834 18,927 Israel net operating loss carryforwards — 7,385 Stock-based compensation 2,924 4,328 Accrued expenses 307 317 Operating lease liabilities 629 98 Other 378 244 Gross deferred tax assets 108,945 76,301 Less: valuation allowance ( 108,230 ) ( 75,982 ) Total deferred tax assets $ 715 $ 319 Operating lease right-of-use assets ( 623 ) ( 100 ) Total deferred tax liabilities ( 623 ) ( 100 ) Net deferred tax assets 92 219 |
Summary of Loss from Operations Before Taxes on Income | The Company recorded a loss from operations, before income tax for the periods presented as follows (in thousands): Year Ended December 31, 2023 2022 2021 United States $ ( 138,293 ) $ ( 101,938 ) $ ( 91,141 ) Lithuania ( 59 ) ( 7 ) 10 Israel 30 ( 62 ) 862 Net loss before income tax $ ( 138,322 ) $ ( 102,007 ) $ ( 90,269 ) |
Summary of Reconciliation of Income Tax (Expense) Benefit Statutory Tax Rate to Effective Tax Rate | The reconciliation of income tax (expense) benefit based on the statutory tax rate to the effective tax rate for the periods presented is as follows (in thousands): Year Ended December 31, 2023 2022 2021 Income tax benefit computed at statutory rates $ 29,054 $ 21,429 $ 18,757 Change in valuation allowance ( 32,248 ) ( 33,936 ) ( 20,111 ) Foreign rate differential ( 2 ) 1 ( 19 ) State income taxes, net of federal benefit 7,653 5,824 — State deferred tax true-up due to change in apportionment 2,030 6,517 — Unrecognized tax benefits ( 9,940 ) — — Research and development credits, net of uncertain tax position 3,275 2,130 1,331 Executive compensation limitation ( 3,971 ) — — Other 282 ( 1,984 ) 189 Income tax (expense) benefit $ ( 3,867 ) $ ( 19 ) $ 147 |
Summary of Reconciliation of Beginning and Ending Amount of Gross Unrecognized Tax Benefits | A reconciliation of the beginning and ending amount of gross unrecognized tax benefits for the years ended December 31, 2023, 2022 and 2021 is as follows (in thousands): As of December 31, 2023 2022 2021 Balance beginning of year 1,584 851 329 Increase (decrease) related to prior year positions 9,351 ( 19 ) ( 35 ) Increase related to current year positions 1,163 752 557 Balance end of year 12,098 1,584 851 |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Earnings Per Share [Abstract] | |
Schedule of Weighted-average Shares Outstanding Used to Calculate Basic and Diluted Net Loss Per Share | The following table presents the weighted-average shares outstanding used to calculate basic and diluted net loss per share: Year Ended December 31, 2023 2022 2021 Common stock 70,310,671 31,767,914 20,098,340 Pre-funded warrants 862,199 3,038,435 — Total 71,172,870 34,806,349 20,098,340 |
Schedule of Outstanding Potentially Dilutive Securities Excluded From Calculation of Diluted Net Loss | The following table presents potentially dilutive common stock equivalents that have been excluded from the calculation of diluted net loss per share for the periods indicated due to their anti-dilutive effect: December 31, 2023 2022 2021 Stock options outstanding 4,686,577 3,161,917 2,406,668 RSUs and PSUs outstanding 987,550 1,095,738 106,394 Warrants to purchase common stock outstanding 1 10,412,806 13,166,283 58,923 Conversion feature related to outstanding term loan 590,816 — — Total 16,677,749 17,423,938 2,571,985 1 Excludes pre-funded warrants to purchase 1,881,081 common shares as they are required to be included in basic and diluted net loss per share . |
Organization and Basis of Pre_2
Organization and Basis of Presentation - Additional Information (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Date of incorporation | Jun. 30, 2019 | |
Accumulated deficit | $ (457,432) | $ (315,243) |
Cash and cash equivalents and short term available-for-sale securities | $ 578,900 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies - Additional Information (Details) | 12 Months Ended | ||
Dec. 31, 2023 USD ($) Segment | Dec. 31, 2022 USD ($) | Dec. 31, 2021 USD ($) | |
Summary Of Significant Accounting Policies [Line Items] | |||
Number of operating segments | Segment | 1 | ||
Stock compensation expense recognized | $ 16,106,000 | $ 10,356,000 | $ 8,678,000 |
2021 Loan Agreement | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Debt instrument, final payment fee | 500,000 | ||
Performance Stock Units (PSUs) | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Stock compensation expense recognized | $ 0 | ||
ASU 2020-06 | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Change in accounting principle, accounting standards update, adoption date | Jan. 01, 2023 | ||
Change in accounting principle, accounting standards update, immaterial effect [true false] | true | ||
Change in accounting principle, accounting standards update, early adopted [true false] | true | ||
Leasehold Improvements | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Property, Plant and Equipment, Estimated Useful Lives | us-gaap:UsefulLifeShorterOfTermOfLeaseOrAssetUtilityMember | ||
Minimum | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Property and equipment, estimated useful lives | 3 years | ||
Maximum | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Property and equipment, estimated useful lives | 7 years |
Fair Value Measurements - Summa
Fair Value Measurements - Summary of Financial Assets Measured at Fair Value on Recurring Basis (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Short-term investments, Aggregated Fair Value | $ 361,302 | |
Recurring | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Short-term investments, Amortized Cost | 361,117 | $ 181,807 |
Short-term investments, Gross Unrealized Holding Gains | 439 | 12 |
Short-term investments, Gross Unrealized Holding Losses | (254) | (374) |
Short-term investments, Aggregated Fair Value | 361,302 | 181,445 |
Recurring | Cash equivalents | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Short-term investments, Aggregated Fair Value | 98,593 | 48,540 |
Recurring | Marketable Securities | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Short-term investments, Aggregated Fair Value | 262,709 | 132,905 |
Recurring | Level 1 | Money Market Funds | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Short-term investments, Amortized Cost | 493 | 18,224 |
Short-term investments, Aggregated Fair Value | 493 | 18,224 |
Recurring | Level 2 | Commercial Paper | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Short-term investments, Amortized Cost | 94,261 | 104,279 |
Short-term investments, Gross Unrealized Holding Gains | 1 | |
Short-term investments, Gross Unrealized Holding Losses | (55) | (84) |
Short-term investments, Aggregated Fair Value | 94,206 | 104,196 |
Recurring | Level 2 | U.S. government bonds | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Short-term investments, Amortized Cost | 137,976 | 18,225 |
Short-term investments, Gross Unrealized Holding Gains | 250 | 1 |
Short-term investments, Gross Unrealized Holding Losses | (142) | (109) |
Short-term investments, Aggregated Fair Value | 138,084 | 18,117 |
Recurring | Level 2 | Agency bonds | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Short-term investments, Amortized Cost | 45,481 | 13,986 |
Short-term investments, Gross Unrealized Holding Gains | 152 | |
Short-term investments, Gross Unrealized Holding Losses | (44) | (78) |
Short-term investments, Aggregated Fair Value | 45,589 | 13,908 |
Recurring | Level 2 | Corporate debt securities | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Short-term investments, Amortized Cost | 3,177 | 10,488 |
Short-term investments, Gross Unrealized Holding Losses | (12) | (62) |
Short-term investments, Aggregated Fair Value | 3,165 | 10,426 |
Recurring | Level 2 | U.S. Treasury securities | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Short-term investments, Amortized Cost | 71,754 | 7,414 |
Short-term investments, Gross Unrealized Holding Gains | 36 | 1 |
Short-term investments, Gross Unrealized Holding Losses | (1) | (21) |
Short-term investments, Aggregated Fair Value | 71,789 | 7,394 |
Recurring | Level 2 | Non-US debt securities | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Short-term investments, Amortized Cost | 3,975 | |
Short-term investments, Gross Unrealized Holding Losses | (20) | |
Short-term investments, Aggregated Fair Value | 3,955 | |
Recurring | Level 2 | Agency discount securities | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Short-term investments, Amortized Cost | 7,975 | 5,216 |
Short-term investments, Gross Unrealized Holding Gains | 1 | 9 |
Short-term investments, Gross Unrealized Holding Losses | 0 | |
Short-term investments, Aggregated Fair Value | $ 7,976 | $ 5,225 |
Fair Value Measurements - Sched
Fair Value Measurements - Schedule of Contractual Maturities of Cash Equivalents and Marketable Securities (Details) $ in Thousands | Dec. 31, 2023 USD ($) |
Fair Value Disclosures [Abstract] | |
Within one year | $ 290,756 |
After one year through two years | 70,546 |
Total cash equivalents and marketable securities | $ 361,302 |
Consolidated Balance Sheet Co_3
Consolidated Balance Sheet Components - Schedule of Prepaid and Other Current Assets (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Prepaid Expense and Other Assets, Current [Abstract] | ||
Prepaid research and development | $ 11,579 | $ 5,727 |
Prepaid taxes | 614 | 646 |
Prepaid other | 2,471 | 1,547 |
Total prepaid and other current assets | $ 14,664 | $ 7,920 |
Consolidated Balance Sheet Co_4
Consolidated Balance Sheet Components - Schedule of Accrued Expenses (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Payables and Accruals [Abstract] | ||
Accrued research and development expenses | $ 13,017 | $ 6,499 |
Accrued employee and related expenses | 6,248 | 4,165 |
Accrued professional and legal fees | 1,110 | 1,052 |
Accrued other expenses | 155 | 228 |
Total accrued expenses | $ 20,530 | $ 11,944 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Details) $ in Thousands | 1 Months Ended | 3 Months Ended | 12 Months Ended | |||
Apr. 30, 2018 USD ($) | Dec. 31, 2023 USD ($) ft² | Dec. 31, 2023 USD ($) ft² | Dec. 31, 2022 USD ($) | Dec. 31, 2021 USD ($) | Nov. 30, 2023 ft² | |
Loss Contingencies [Line Items] | ||||||
Operating leases, rent expense | $ 300 | $ 200 | ||||
Remaining lease term | 3 years 1 month 6 days | 3 years 1 month 6 days | ||||
Incremental borrowing rate used to determine operating lease liability | 12.90% | 12.90% | ||||
Research and development | $ 122,230 | $ 80,796 | $ 70,330 | |||
Teva Agreements | ||||||
Loss Contingencies [Line Items] | ||||||
Nonrefundable upfront payment | $ 6,000 | |||||
Payment upon achievement of certain clinical and commercial milestones | 65,000 | |||||
Asset transfer and license agreement, termination period after written notice | 120 days | |||||
Asset transfer and license agreement, termination period notice of breach | 60 days | |||||
Asset transfer and license agreement termination notice period if bankruptcy petition filed | 60 days | |||||
Research and development | $ 2,500 | |||||
Milestone payments | $ 2,500 | |||||
Teva Agreements | Teva's Development Program | ||||||
Loss Contingencies [Line Items] | ||||||
Payment upon achievement of certain clinical and commercial milestones | $ 2,500 | |||||
San Francisco Office | ||||||
Loss Contingencies [Line Items] | ||||||
Operating lease expiration month and year | 2025-01 | |||||
Office space | ft² | 3,600 | 3,600 | 17,616 |
Commitments and Contingencies_2
Commitments and Contingencies - Schedule of Future Minimum Lease Payments Under Non-cancellable Operating Lease Obligations (Details) $ in Thousands | Dec. 31, 2023 USD ($) |
Commitments and Contingencies Disclosure [Abstract] | |
2024 | $ 774 |
2025 | 917 |
2026 | 937 |
2027 | 240 |
Total undiscounted future minimum lease payments | 2,868 |
Less: imputed interest | (555) |
Present value of operating lease liability | $ 2,313 |
Term Loan Facilities - Addition
Term Loan Facilities - Additional Information (Details) $ / shares in Units, $ in Thousands | 1 Months Ended | 12 Months Ended | ||
Jan. 31, 2023 USD ($) $ / shares shares | Dec. 31, 2022 USD ($) | Apr. 30, 2020 USD ($) | Dec. 31, 2023 USD ($) shares | |
Debt Instrument [Line Items] | ||||
Loss on extinguishment | $ (1,208) | |||
Debt discount | $ 593 | |||
Tranche One | ||||
Debt Instrument [Line Items] | ||||
Warrants to purchase common stock | shares | 51,204 | |||
Loan Agreement | ||||
Debt Instrument [Line Items] | ||||
Line of credit facility, description | In April 2020, the Company entered into a Loan and Security Agreement, (the “Loan Agreement”) with the lenders referred to therein, and Silicon Valley Bank (“SVB”), as collateral agent. The Loan Agreement as amended in May 2021 (the “2021 Loan Agreement”) provided for (i) a secured term A loan facility (the “Term A Loan Facility”) of up to $20.0 million and (ii) a secured term B loan facility (the “Term B Loan Facility”) of up to $5.0 million. The Term A Loan Facility of $20.0 million was fully drawn as of December 2022 and the Term B Loan Facility expired undrawn. | |||
Loan Agreement | Term A Loan Facility | ||||
Debt Instrument [Line Items] | ||||
Line of credit facility, maximum borrowing capacity | $ 20,000 | |||
Line of credit facility fully drawn amount | $ 20,000 | |||
Loan Agreement | Term B Loan Facility | ||||
Debt Instrument [Line Items] | ||||
Line of credit facility, maximum borrowing capacity | $ 5,000 | |||
2023 Loan Agreement | ||||
Debt Instrument [Line Items] | ||||
Line of credit facility, maximum borrowing capacity | $ 100,000 | |||
Line of credit facility, description | In January 2023, the Company executed a loan and security agreement with new lenders (the “2023 Loan Agreement”) and used the borrowings to repay in full the outstanding principal, final payment fee, prepayment fee and interest due under the 2021 Loan Agreement of $21.4 million. The Company recorded a loss on debt extinguishment of $1.2 million, which was recognized as a component of interest expense on the Company’s consolidated statements of operations and comprehensive loss. | |||
Warrant exercise price | $ / shares | $ 9.7649 | |||
Warrant expiration date | Sep. 30, 2023 | |||
Minimum unrestriced cash and cash equivalents to three month average cash and cash equivalents multiplier | 5 | |||
Debt instrument, maturity date, description | Borrowings under the term loan facility mature on January 1, 2027 and provide for interest-only payments until February 1, 2025. | |||
Debt instrument, maturity date | Jan. 01, 2027 | |||
Warrants expiration month and year | 2033-01 | |||
Debt instrument, interest rate | 9.75% | 10.75% | ||
Debt instrument, basis spread on variable rate | 2.25% | |||
Percentage of fee on loan | 5.95% | |||
Conversion price per share | $ / shares | $ 12.6943 | |||
Contingent warrants | shares | 153,611 | |||
Warrant Forfeited | shares | 30,722 | |||
2023 Loan Agreement | Maximum | ||||
Debt Instrument [Line Items] | ||||
Warrants to purchase common stock | shares | 204,815 | |||
Prepayment fee percentage | 3% | |||
Conversion of principal amount | $ 7,500 | |||
2023 Loan Agreement | Minimum | ||||
Debt Instrument [Line Items] | ||||
Debt instrument, interest rate | 8.45% | |||
Debt instrument, effective interest rate | 13.30% | |||
Prepayment fee percentage | 1% | |||
2023 Loan Agreement | Tranche One | ||||
Debt Instrument [Line Items] | ||||
Line of credit facility fully drawn amount | $ 25,000 | |||
Debt discount | 800 | |||
2023 Loan Agreement | Tranche One | Measurement Input, Expected Dividend Payment | ||||
Debt Instrument [Line Items] | ||||
Fair value of warrant assumptions, dividends | $ 0 | |||
2023 Loan Agreement | Tranche One | Valuation Technique, Option Pricing Model | Measurement Input, Risk Free Interest Rate | ||||
Debt Instrument [Line Items] | ||||
Fair measurement input | 0.039 | |||
2023 Loan Agreement | Tranche One | Valuation Technique, Option Pricing Model | Measurement Input, Price Volatility | ||||
Debt Instrument [Line Items] | ||||
Fair measurement input | 0.938 | |||
2023 Loan Agreement | Tranche One | Valuation Technique, Option Pricing Model | Measurement Input, Expected Term | ||||
Debt Instrument [Line Items] | ||||
Fair measurement input | 10 years | |||
2023 Loan Agreement | Tranche Two | ||||
Debt Instrument [Line Items] | ||||
Line of credit facility, maximum borrowing capacity | $ 15,000 | |||
Credit facility maturity date | Dec. 31, 2023 | |||
Line of credit facility, expired unused | $ 15,000 | |||
Warrant contingently exercisable upon funding of each subsequent term loan | shares | 122,889 | |||
2023 Loan Agreement | Tranche Three | ||||
Debt Instrument [Line Items] | ||||
Line of credit facility, maximum borrowing capacity | 10,000 | |||
2023 Loan Agreement | Tranche Four | ||||
Debt Instrument [Line Items] | ||||
Line of credit facility, maximum borrowing capacity | 50,000 | |||
Commitment fee percentage | 0.60% | |||
2021 Loan Agreement | ||||
Debt Instrument [Line Items] | ||||
Repaid line of credit | $ 21,400 |
Term Loan Facilities - Schedule
Term Loan Facilities - Schedule of Maturities of Principal Obligations (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Debt Disclosure [Abstract] | ||
2024 | $ 0 | |
2025 | 10,774 | |
2026 | 13,036 | |
2027 | 1,190 | |
Total principal outstanding | 25,000 | |
Plus accumulated accretion of final payment fee | 388 | |
Less unamortized debt discount | (593) | |
Long-Term Debt, Total | 24,795 | |
Term loan, current portion | 0 | |
Term loan, non-current, net | $ 24,795 | $ 20,192 |
Stockholders' Equity - Schedule
Stockholders' Equity - Schedule of Shares of Common Stock Available for Future Issuance (Details) | Dec. 31, 2023 shares |
Class Of Stock [Line Items] | |
Total available for future issuance | 21,557,121 |
Stock Options Outstanding | |
Class Of Stock [Line Items] | |
Total available for future issuance | 4,686,577 |
Rsus And Psus Outstanding | |
Class Of Stock [Line Items] | |
Total available for future issuance | 987,550 |
Equity Incentive Plan | |
Class Of Stock [Line Items] | |
Total available for future issuance | 1,790,684 |
Employee Stock Purchase Plan | |
Class Of Stock [Line Items] | |
Total available for future issuance | 1,207,607 |
Warrants To Purchase Common Stock | |
Class Of Stock [Line Items] | |
Total available for future issuance | 10,412,806 |
Pre-funded Warrants To Purchase Common Stock | |
Class Of Stock [Line Items] | |
Total available for future issuance | 1,881,081 |
Conversion Feature Related To Outstanding Term Loan | |
Class Of Stock [Line Items] | |
Total available for future issuance | 590,816 |
Stockholders' Equity - Addition
Stockholders' Equity - Additional Information (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2023 | Jun. 30, 2023 | Mar. 31, 2023 | Feb. 28, 2023 | Jul. 31, 2022 | Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | Jun. 08, 2023 | Jun. 05, 2023 | Mar. 31, 2021 | |
Subsidiary Sale Of Stock [Line Items] | |||||||||||
Authorized shares of common stock | 200,000,000 | 200,000,000 | 100,000,000 | 200,000,000 | 100,000,000 | ||||||
Authorized shares of preferred stock | 10,000,000 | 10,000,000 | 10,000,000 | 10,000,000 | |||||||
Proceeds from issuance of common stock, net of commissions and offering expenses | $ 268 | $ 50 | $ 144 | ||||||||
Common stock, par value | $ 0.001 | $ 0.001 | $ 0.001 | ||||||||
Pre-funded Warrants | |||||||||||
Subsidiary Sale Of Stock [Line Items] | |||||||||||
Percentage of ownership limitation | 9.99% | ||||||||||
Percentage of ownership prior to issuance | 4.99% | ||||||||||
Warrants | |||||||||||
Subsidiary Sale Of Stock [Line Items] | |||||||||||
Percentage of ownership limitation | 9.99% | ||||||||||
Percentage of ownership prior to issuance | 4.99% | ||||||||||
Maximum | Pre-funded Warrants | |||||||||||
Subsidiary Sale Of Stock [Line Items] | |||||||||||
Percentage of ownership limitation | 19.99% | ||||||||||
Maximum | Warrants | |||||||||||
Subsidiary Sale Of Stock [Line Items] | |||||||||||
Percentage of ownership limitation | 19.99% | ||||||||||
Public Offerings | |||||||||||
Subsidiary Sale Of Stock [Line Items] | |||||||||||
Proceeds from issuance of common stock, net of commissions and offering expenses | $ 161,800 | $ 296,800 | $ 88,200 | ||||||||
Public offering description | In July 2022, the Company completed an underwritten public offering of its common stock, warrants to purchase shares of its common stock and pre-funded warrants to purchase shares of its common stock. The Company sold 18,675,466 shares of its common stock with accompanying warrants to purchase up to 9,337,733 shares of its common stock at a combined public offering price of $3.55 per share. The Company also sold 7,944,252 pre-funded warrants to purchase shares of its common stock with accompanying warrants to purchase up to 3,972,126 shares of its common stock at a combined public offering price of $3.549 per pre-funded warrant, which represents the per share public offering price for the common stock less $0.001 per share, the exercise price for each pre-funded warrant. The Company raised net proceeds of $88.2 million, after deducting underwriting discounts and commissions of $5.7 million and other offering costs of $0.6 million. | ||||||||||
Shares issued and sold | 17,567,567 | 19,461,538 | 18,675,466 | ||||||||
Offering price per share | $ 3.55 | ||||||||||
Underwriting discounts and commissions | $ 10,400 | $ 19,000 | $ 5,700 | ||||||||
Other offering costs | $ 400 | $ 500 | $ 600 | ||||||||
Common stock, par value | $ 0.001 | $ 0.001 | 0.001 | ||||||||
Offering price per share | $ 9.25 | $ 16.25 | 9.25 | ||||||||
Public Offerings | Pre-funded Warrants | |||||||||||
Subsidiary Sale Of Stock [Line Items] | |||||||||||
Number of prefunded warrants issued during period | 1,081,081 | 7,944,252 | |||||||||
Combined price of prefunded and common stock warrant | $ 3.549 | ||||||||||
Offering price per share | $ 9.249 | $ 9.249 | |||||||||
Public Offerings | Maximum | |||||||||||
Subsidiary Sale Of Stock [Line Items] | |||||||||||
Warrants to purchase shares of common stock | 9,337,733 | ||||||||||
Public Offerings | Maximum | Pre-funded Warrants | |||||||||||
Subsidiary Sale Of Stock [Line Items] | |||||||||||
Warrants to purchase shares of common stock | 3,972,126 | ||||||||||
Public Offerings | A T M Facility | |||||||||||
Subsidiary Sale Of Stock [Line Items] | |||||||||||
Maximum value of common stock to be issued under agreement | $ 150,000 | $ 75,000 | |||||||||
Public Offerings | Leerink Partners LLC and Cantor Fitzgerald & Co | |||||||||||
Subsidiary Sale Of Stock [Line Items] | |||||||||||
Proceeds from issuance of common stock, net of commissions and offering expenses | $ 23,700 | $ 13,400 | $ 28,500 | $ 3,300 | |||||||
Shares issued and sold | 1,200,539 | 968,000 | 3,948,611 | 186,546 | |||||||
Common stock remaining for future sales | $ 125,900 | ||||||||||
Public Offerings | Leerink Partners LLC and Cantor Fitzgerald & Co | Maximum | |||||||||||
Subsidiary Sale Of Stock [Line Items] | |||||||||||
Selling commission per shares sold percentage | 3% |
Stockholders' Equity - Schedu_2
Stockholders' Equity - Schedule of Outstanding Warrants to Purchase Shares of Common Stock (Details) | 12 Months Ended |
Dec. 31, 2023 $ / shares shares | |
Class Of Warrant Or Right [Line Items] | |
Shares of Common Stock Underlying Warrants | 12,293,887 |
Warrants Term Loan | |
Class Of Warrant Or Right [Line Items] | |
Shares of Common Stock Underlying Warrants | 25,000 |
Warrant exercise price | $ / shares | $ 22.06 |
Warrant expiration date | Jun. 30, 2025 |
Warrants Term Loan | |
Class Of Warrant Or Right [Line Items] | |
Shares of Common Stock Underlying Warrants | 33,923 |
Warrant exercise price | $ / shares | $ 19.12 |
Warrant expiration date | May 28, 2031 |
Warrants Term Loan | |
Class Of Warrant Or Right [Line Items] | |
Shares of Common Stock Underlying Warrants | 174,093 |
Warrant exercise price | $ / shares | $ 9.76 |
Warrant expiration date | Jan. 27, 2033 |
Warrants Public Offerings | |
Class Of Warrant Or Right [Line Items] | |
Shares of Common Stock Underlying Warrants | 10,179,790 |
Warrant exercise price | $ / shares | $ 5.325 |
Warrant expiration date | Jul. 01, 2024 |
Pre-funded Warrants | |
Class Of Warrant Or Right [Line Items] | |
Shares of Common Stock Underlying Warrants | 1,881,081 |
Warrant exercise price | $ / shares | $ 0.001 |
Expiration Date | Do not expire |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional Information (Details) - USD ($) $ in Thousands | 1 Months Ended | 12 Months Ended | ||||
Oct. 31, 2019 | Sep. 30, 2019 | Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | Feb. 28, 2023 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Intrinsic value of stock options exercised | $ 3,200 | $ 600 | $ 3,600 | |||
Common stock shares reserved for future issuance | 21,557,121 | |||||
Unrecognized unvested stock option | $ 21,700 | |||||
Unrecognized weighted average period | 2 years 7 months 6 days | |||||
Compensation expense | $ 16,106 | 10,356 | 8,678 | |||
Stock Option Awards | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Compensation expense | 11,700 | 7,600 | 7,500 | |||
Restricted Stock Units (RSUs) | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Fair value, vested | $ 7,500 | 900 | 0 | |||
Unrecognized weighted average period | 1 year 6 months | |||||
Compensation expense | $ 4,300 | 2,700 | 1,100 | |||
Total Unrecognised expense | 5,300 | |||||
Performance Stock Units (PSUs) | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Fair value, vested | $ 7,500 | 900 | 0 | |||
Unrecognized weighted average period | 1 year 6 months | |||||
Compensation expense | $ 4,300 | $ 2,700 | $ 1,100 | |||
Total Unrecognised expense | $ 5,300 | |||||
Employee Stock Purchase Plan | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Number of common shares issuable under the plan (in shares) | 225,188 | |||||
Percentage of increase in number of shares of capital stock issued and outstanding | 1% | |||||
Percent of purchase shares of common stock | 85% | |||||
Common stock shares reserved for future issuance | 1,207,607 | |||||
Common Stock | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Number of shares, common stock issued under ESPP | 27,217 | 18,364 | 10,712 | |||
2019 Plan and 2023 Plan | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Number of common shares issuable under the plan (in shares) | 2,844,193 | |||||
Percentage of increase in number of shares of capital stock issued and outstanding | 4% | |||||
Vesting period | 4 years | |||||
Percentage of option vesting | 25% | |||||
Terms of award | The board of directors determines the period over which options become exercisable and options generally vest over a four-year period, with 25% of options vesting on the first anniversary of employment, and thereafter, the remaining options vesting quarterly, over the following 36-month period. The options expire within ten years from the date of grant. The exercise price of awards granted will not be less than the estimated fair value of the shares on the date of grant. The 2019 Plan also permits the board of directors to grant restricted stock units, which are subject to continued service conditions. | |||||
Remaining option vesting period | 36 months | |||||
Expiration period | 10 years | |||||
2023 Plan | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Common stock shares reserved for future issuance | 1,500,000 | |||||
Maximum | Restricted Stock Units (RSUs) | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Vesting period | 3 years | |||||
Maximum | Performance Stock Units (PSUs) | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Vesting period | 3 years | |||||
Maximum | Employee Stock Purchase Plan | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Period for increase in number of shares of common stock reserved for issuance | 10 years | |||||
Maximum | 2019 Plan and 2023 Plan | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Period for increase in number of shares of common stock reserved for issuance | 10 years | |||||
Minimum | Restricted Stock Units (RSUs) | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Vesting period | 2 years | |||||
Minimum | Performance Stock Units (PSUs) | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Vesting period | 1 year |
Stock-Based Compensation - Summ
Stock-Based Compensation - Summary of Stock Option Activity (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Two Thousand And Nineteen Equity Incentive Plan [Member] and Two Thousand And Twenty Three Equity Inducement Plan | ||
Weighted Average Exercise Price | ||
Weighted Average Exercise Price, Exercisable as of December 31, 2023 | $ 14.7 | |
Weighted Average Remaining Contractual Term (In years) | ||
Weighted Average Remaining Contractual Term (In years), Exercisable as of December 31, 2023 | 6 years 7 months 6 days | |
Aggregate Intrinsic Value | ||
Aggregate Intrinsic Value, Exercisable as of December 31, 2023 | $ 8,123 | |
2023 Inducement Plan and 2019 Employee Stock Purchase Plan | ||
Number of Options | ||
Outstanding, Beginning Balance | 3,161,917 | |
Granted | 1,952,900 | |
Exercised | (247,162) | |
Cancelled and forfeited | (181,078) | |
Outstanding, Ending Balance | 4,686,577 | 3,161,917 |
Exercisable as of December 31, 2023 | 2,043,280 | |
Weighted Average Exercise Price | ||
Weighted Average Exercise Price Outstanding, Beginning Balance | $ 12.8 | |
Weighted Average Exercise Price, Granted | 14.65 | |
Weighted Average Exercise Price, Exercised | 2.95 | |
Weighted Average Exercise Price, Cancelled and forfeited | 12.4 | |
Weighted Average Exercise Price Outstanding, Ending Balance | $ 14.11 | $ 12.8 |
Weighted Average Remaining Contractual Term (In years) | ||
Weighted Average Remaining Contractual Term (In years), Outstanding | 7 years 10 months 24 days | 7 years 10 months 24 days |
Aggregate Intrinsic Value | ||
Aggregate Intrinsic Value | $ 11,712 | $ 16,612 |
Stock-Based Compensation - Su_2
Stock-Based Compensation - Summary of Estimated Fair Value of Stock Options Granted Using Black-Scholes Option-Pricing Model (Details) - $ / shares | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Weighted average grant date fair value | $ 11.43 | $ 3.38 | $ 16.18 |
Expected volatility, minimum | 91.50% | 89.90% | 86.90% |
Expected volatility, maximum | 99.20% | 91% | 91.90% |
Risk-free interest rate, minimum | 3.40% | 1.60% | 0.70% |
Risk-free interest rate, maximum | 4.60% | 3.90% | 1.30% |
Minimum | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Expected term (years) | 5 years 6 months | 5 years 6 months | 5 years 6 months |
Maximum | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Expected term (years) | 6 years 1 month 6 days | 6 years 3 months 18 days | 6 years 1 month 6 days |
Stock-Based Compensation - Su_3
Stock-Based Compensation - Summary of Restricted Stock and Performance Stock Unit Activity (Details) - $ / shares | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Restricted Stock Units (RSUs) | ||
Share-Based Compensation Arrangement by Share-Based Payment Award, Equity Instruments Other than Options, Nonvested, Number of Shares [Roll Forward] | ||
Outstanding, Beginning Balance | 645,986 | |
Granted | 379,075 | |
Vested | (334,688) | |
Canceled | (1,991) | |
Outstanding, Ending Balance | 688,382 | |
Weighted Average Grant Date Fair Value | ||
Weighted Average Grant Date Fair Value Outstanding, Beginning Balance | $ 10.72 | $ 5.43 |
Weighted Average Grant Date Fair Value Outstanding, Granted | 15.02 | |
Weighted Average Grant Date Fair Value Outstanding, Vested | 5.36 | |
Weighted Average Grant Date Fair Value Outstanding, Canceled | 11.8 | |
Weighted Average Grant Date Fair Value Outstanding, Ending Balance | $ 10.72 | |
Performance Stock Units (PSUs) | ||
Share-Based Compensation Arrangement by Share-Based Payment Award, Equity Instruments Other than Options, Nonvested, Number of Shares [Roll Forward] | ||
Outstanding, Beginning Balance | 449,752 | |
Vested | (150,584) | |
Outstanding, Ending Balance | 299,168 | |
Weighted Average Grant Date Fair Value | ||
Weighted Average Grant Date Fair Value Outstanding, Beginning Balance | $ 5.96 | $ 6.25 |
Weighted Average Grant Date Fair Value Outstanding, Vested | 6.82 | |
Weighted Average Grant Date Fair Value Outstanding, Ending Balance | $ 5.96 |
Stock-Based Compensation - Su_4
Stock-Based Compensation - Summary of Stock-Based Compensation (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | |||
Total stock-based compensation | $ 16,106 | $ 10,356 | $ 8,678 |
Research and Development | |||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | |||
Total stock-based compensation | 7,010 | 4,094 | 2,966 |
General and Administrative | |||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | |||
Total stock-based compensation | $ 9,096 | $ 6,262 | $ 5,712 |
Income Taxes - Summary of Statu
Income Taxes - Summary of Statutory Tax Rates Applicable to Income of Company and Subsidiaries (Details) | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Income Tax Disclosure [Line Items] | |||
Effective income tax rate | 21% | 21% | 21% |
89Bio Ltd | |||
Income Tax Disclosure [Line Items] | |||
Effective income tax rate | 23% | 23% | 23% |
89bio Management, Inc. | |||
Income Tax Disclosure [Line Items] | |||
Effective income tax rate | 21% | 21% | 21% |
UAB 89bio Lithuania | |||
Income Tax Disclosure [Line Items] | |||
Effective income tax rate | 15% | 15% | 15% |
Income Taxes - Summary of Incom
Income Taxes - Summary of Income Tax (Expense) Benefit (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Current: | |||
State | $ (3) | $ (2) | |
Foreign | $ (3,740) | (16) | (1) |
Total current | (3,740) | (19) | (3) |
Deferred: | |||
Federal | 150 | ||
Foreign | (127) | ||
Total deferred | (127) | 150 | |
Income tax (expense) benefit | $ (3,867) | $ (19) | $ 147 |
Income Taxes - Summary of Compo
Income Taxes - Summary of Components of Deferred Tax Assets (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Income Tax Disclosure [Line Items] | ||
Research and development expenses | $ 41,834 | $ 18,927 |
Stock-based compensation | 2,924 | 4,328 |
Accrued expenses | 307 | 317 |
Operating lease liabilities | 629 | 98 |
Other | 378 | 244 |
Gross deferred tax assets | 108,945 | 76,301 |
Less: valuation allowance | (108,230) | (75,982) |
Total deferred tax assets | 715 | 319 |
Operating lease right-of-use assets | (623) | (100) |
Total deferred tax liabilities | (623) | (100) |
Net deferred tax assets | 92 | 219 |
United States | ||
Income Tax Disclosure [Line Items] | ||
Net operating loss carryforwards | $ 62,873 | 45,002 |
Israel | ||
Income Tax Disclosure [Line Items] | ||
Net operating loss carryforwards | $ 7,385 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Details) - USD ($) $ in Thousands | 12 Months Ended | |||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Income Tax Disclosure [Line Items] | ||||
Deferred tax assets, valuation allowance | $ 108,230 | $ 75,982 | ||
Deferred tax assets, change in valuation allowance | 32,200 | |||
Unrecognized tax benefits, exclusive of interest | 12,098 | 1,584 | $ 851 | $ 329 |
Increase related to prior year positions | 9,400 | |||
Decrease in income tax expense due to unrecognized tax benefits if recognized | (3,100) | |||
Interest related to uncertain tax positions | $ 600 | |||
Israel Tax Authority | Earliest Tax Year | ||||
Income Tax Disclosure [Line Items] | ||||
Tax year under examination | 2018 | |||
Israel Tax Authority | Latest Tax Year | ||||
Income Tax Disclosure [Line Items] | ||||
Tax year under examination | 2021 | |||
Federal | ||||
Income Tax Disclosure [Line Items] | ||||
Accumulated tax loss carryforward | $ 195,000 | 160,900 | ||
Federal | Research and Development Credit Carryforwards | ||||
Income Tax Disclosure [Line Items] | ||||
Carryforward tax losses expiration year | 2040 | |||
Credit carryforwards | $ 7,500 | 4,300 | ||
State | ||||
Income Tax Disclosure [Line Items] | ||||
Accumulated tax loss carryforward | 302,800 | 169,800 | ||
State | Research and Development Credit Carryforwards | ||||
Income Tax Disclosure [Line Items] | ||||
Credit carryforwards | 3,200 | 1,800 | ||
Israel | ||||
Income Tax Disclosure [Line Items] | ||||
Accumulated tax loss carryforward | $ 30,400 | $ 32,100 | ||
California | State | ||||
Income Tax Disclosure [Line Items] | ||||
Carryforward tax losses expiration year | 2039 |
Income Taxes - Summary of Loss
Income Taxes - Summary of Loss from Operations Before Taxes on Income (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Income Tax Disclosure [Line Items] | |||
Net loss before income tax | $ (138,322) | $ (102,007) | $ (90,269) |
United States | |||
Income Tax Disclosure [Line Items] | |||
Net loss before income tax | (138,293) | (101,938) | (91,141) |
LITHUANIA | |||
Income Tax Disclosure [Line Items] | |||
Net loss before income tax | (59) | (7) | 10 |
Israel | |||
Income Tax Disclosure [Line Items] | |||
Net loss before income tax | $ 30 | $ (62) | $ 862 |
Income Taxes - Summary of Recon
Income Taxes - Summary of Reconciliation of Income Tax (Expense) Benefit Statutory Tax Rate to Effective Tax Rate (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | |||
Income tax benefit computed at statutory rates | $ 29,054 | $ 21,429 | $ 18,757 |
Change in valuation allowance | (32,248) | (33,936) | (20,111) |
Foreign rate differential | (2) | 1 | (19) |
State income taxes, net of federal benefit | 7,653 | 5,824 | |
State deferred tax true-up due to change in apportionment | 2,030 | 6,517 | |
Unrecognized tax benefits | (9,940) | ||
Research and development credits, net of uncertain tax position | 3,275 | 2,130 | 1,331 |
Executive compensation limitation | (3,971) | ||
Other | 282 | (1,984) | 189 |
Income tax (expense) benefit | $ (3,867) | $ (19) | $ 147 |
Income Taxes - Summary of a Rec
Income Taxes - Summary of a Reconciliation of The Beginning And Ending Amount of Unrecognized Tax Benefits (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | |||
Balance, beginning of year | $ 1,584 | $ 851 | $ 329 |
Increase (decrease) related to prior year positions | 9,351 | (19) | (35) |
Increase related to current year positions | 1,163 | 752 | 557 |
Balance, end of year | $ 12,098 | $ 1,584 | $ 851 |
Net Loss Per Share - Schedule o
Net Loss Per Share - Schedule of Weighted-average Shares Outstanding Used to Calculate Basic and Diluted Net Loss Per Share (Details) - shares | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
The Weighted-average Shares Outstanding Used To Calculate Basic And Diluted Net Loss Per Share [Line Items] | |||
Weighted-average shares used to compute net loss per share, basic | 71,172,870 | 34,806,349 | 20,098,340 |
Weighted-average shares used to compute net loss per share, diluted | 71,172,870 | 34,806,349 | 20,098,340 |
Common Stock | |||
The Weighted-average Shares Outstanding Used To Calculate Basic And Diluted Net Loss Per Share [Line Items] | |||
Weighted-average shares used to compute net loss per share, basic | 70,310,671 | 31,767,914 | 20,098,340 |
Weighted-average shares used to compute net loss per share, diluted | 70,310,671 | 31,767,914 | 20,098,340 |
Pre-funded Warrants | |||
The Weighted-average Shares Outstanding Used To Calculate Basic And Diluted Net Loss Per Share [Line Items] | |||
Weighted-average shares used to compute net loss per share, basic | 862,199 | 3,038,435 | |
Weighted-average shares used to compute net loss per share, diluted | 862,199 | 3,038,435 |
Net Loss Per Share - Schedule_2
Net Loss Per Share - Schedule of Outstanding Potentially Dilutive Securities Excluded From Calculation of Diluted Net Loss (Details) - shares | 12 Months Ended | |||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||||
Antidilutive common stock equivalents excluded from calculation of diluted net loss per share | 16,677,749 | 17,423,938 | 2,571,985 | |
Employee Stock Option | ||||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||||
Antidilutive common stock equivalents excluded from calculation of diluted net loss per share | 4,686,577 | 3,161,917 | 2,406,668 | |
RSUs and PSUs Outstanding | ||||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||||
Antidilutive common stock equivalents excluded from calculation of diluted net loss per share | 987,550 | 1,095,738 | 106,394 | |
Warrants to Purchase Common Stock Outstanding | ||||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||||
Antidilutive common stock equivalents excluded from calculation of diluted net loss per share | [1] | 10,412,806 | 13,166,283 | 58,923 |
Conversion Feature Related To Outstanding Term Loan | ||||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||||
Antidilutive common stock equivalents excluded from calculation of diluted net loss per share | 590,816 | |||
[1] Excludes pre-funded warrants to purchase 1,881,081 common shares as they are required to be included in basic and diluted net loss per share . |
Net Loss Per Share -Schedule of
Net Loss Per Share -Schedule of Outstanding Potentially Dilutive Securities Excluded From Calculation of Diluted Net Loss (Parenthetical) (Details) | Dec. 31, 2023 shares |
Class Of Warrant Or Right [Line Items] | |
Pre- Funded Warrants excluded | 12,293,887 |
Pre-funded Warrants | |
Class Of Warrant Or Right [Line Items] | |
Pre- Funded Warrants excluded | 1,881,081 |