Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2024 | May 06, 2024 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Mar. 31, 2024 | |
Document Fiscal Year Focus | 2024 | |
Document Fiscal Period Focus | Q1 | |
Entity Registrant Name | 89bio, Inc. | |
Entity Central Index Key | 0001785173 | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Large Accelerated Filer | |
Entity Common Stock, Shares Outstanding | 98,383,998 | |
Entity Shell Company | false | |
Entity Small Business | false | |
Entity Emerging Growth Company | false | |
Title of 12(b) Security | Common stock, par value $0.001 per share | |
Trading Symbol | ETNB | |
Security Exchange Name | NASDAQ | |
Entity File Number | 001-39122 | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 36-4946844 | |
Entity Address, Address Line One | 142 Sansome Street | |
Entity Address, Address Line Two | Second Floor | |
Entity Address, City or Town | San Francisco | |
Entity Address, State or Province | CA | |
Entity Address, Postal Zip Code | 94104 | |
City Area Code | 415 | |
Local Phone Number | 432-9270 | |
Document Quarterly Report | true | |
Document Transition Report | false |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Current assets: | ||
Cash and cash equivalents | $ 217,573 | $ 316,161 |
Marketable securities | 344,715 | 262,709 |
Prepaid and other current assets | 12,494 | 14,664 |
Total current assets | 574,782 | 593,534 |
Operating lease right-of-use assets | 2,118 | 2,293 |
Property and equipment, net | 37 | 46 |
Other assets | 385 | 396 |
Total assets | 577,322 | 596,269 |
Current liabilities: | ||
Accounts payable | 15,352 | 8,585 |
Accrued expenses | 20,295 | 20,530 |
Operating lease liabilities, current | 702 | 496 |
Term loan, current | 1,892 | 0 |
Total current liabilities | 38,241 | 29,611 |
Operating lease liability, non-current | 1,640 | 1,817 |
Term loan, noncurrent, net | 23,065 | 24,795 |
Other noncurrent liabilities | 3,837 | 3,740 |
Total liabilities | 66,783 | 59,963 |
Commitments and contingencies (Note 5) | ||
Stockholders’ equity: | ||
Common stock, $0.001 par value: 200,000,000 shares authorized; 95,199,724 and 93,269,377 shares issued and outstanding as of March 31, 2024 and December 31, 2023, respectively | 95 | 93 |
Additional paid-in capital | 1,020,076 | 993,455 |
Accumulated other comprehensive (loss) income | (519) | 190 |
Accumulated deficit | (509,113) | (457,432) |
Total stockholders’ equity | 510,539 | 536,306 |
Total liabilities and stockholders’ equity | $ 577,322 | $ 596,269 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Mar. 31, 2024 | Dec. 31, 2023 |
Statement of Financial Position [Abstract] | ||
Common stock, par value | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 200,000,000 | 200,000,000 |
Common stock, shares issued | 95,199,724 | 93,269,377 |
Common stock, shares outstanding | 95,199,724 | 93,269,377 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Operating expenses: | ||
Research and development | $ 47,428 | $ 22,306 |
General and administrative | 9,849 | 6,218 |
Total operating expenses | 57,277 | 28,524 |
Loss from operations | (57,277) | (28,524) |
Interest expense | (863) | (2,075) |
Interest income and other, net | 6,556 | 1,763 |
Net loss before income tax | (51,584) | (28,836) |
Income tax expense | (97) | 0 |
Net loss | (51,681) | (28,836) |
Other comprehensive (loss) income: | ||
Unrealized (loss) gain on marketable securities | (714) | 114 |
Foreign currency translation adjustments | 5 | (4) |
Total other comprehensive (loss) income | (709) | 110 |
Comprehensive loss | $ (52,390) | $ (28,726) |
Net loss per share, basic | $ (0.54) | $ (0.54) |
Net loss per share, diluted | $ (0.54) | $ (0.54) |
Weighted-average shares used to compute net loss per share, basic | 95,846,740 | 53,171,370 |
Weighted-average shares used to compute net loss per share, diluted | 95,846,740 | 53,171,370 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Stockholders' Equity (Unaudited) - USD ($) $ in Thousands | Total | ATM Facility | Common Stock | Common Stock Public Offerings | Common Stock ATM Facility | Additional Paid-in Capital | Additional Paid-in Capital Public Offerings | Additional Paid-in Capital ATM Facility | Accumulated Other Comprehensive (Loss) Income | Accumulated Deficit |
Beginning balance at Dec. 31, 2022 | $ 151,832 | $ 51 | $ 467,374 | $ (350) | $ (315,243) | |||||
Beginning balance, shares at Dec. 31, 2022 | 50,560,590 | |||||||||
Issuance of common stock | 296,817 | $ 13,422 | $ 19 | $ 1 | $ 296,798 | $ 13,421 | ||||
Issuance of common stock, shares | 19,461,538 | 968,000 | ||||||||
Issuance of common stock upon exercise of common stock warrants | 8,960 | $ 2 | 8,958 | |||||||
Issuance of common stock upon exercise of common stock warrants, shares | 1,682,500 | |||||||||
Issuance of common stock upon exercise of stock options | 185 | 185 | ||||||||
Issuance of common stock upon exercise of stock options, shares | 61,408 | |||||||||
Issuance of common stock upon vesting of restricted stock units, net of withholding taxes | (693) | (693) | ||||||||
Issuance of common stock upon vesting of restricted stock units, net of withholding taxes, shares | 133,669 | |||||||||
Issuance of common stock warrants in connection with term loan | 482 | 482 | ||||||||
Stock-based compensation | 3,551 | 3,551 | ||||||||
Net loss | (28,836) | (28,836) | ||||||||
Other comprehensive income (loss) | 110 | 110 | ||||||||
Ending balance at Mar. 31, 2023 | 445,830 | $ 73 | 790,076 | (240) | (344,079) | |||||
Ending balance, shares at Mar. 31, 2023 | 72,867,705 | |||||||||
Beginning balance at Dec. 31, 2023 | 536,306 | $ 93 | 993,455 | 190 | (457,432) | |||||
Beginning balance, shares at Dec. 31, 2023 | 93,269,377 | |||||||||
Issuance of common stock | $ 21,049 | $ 2 | $ 21,047 | |||||||
Issuance of common stock, shares | 1,396,888 | |||||||||
Issuance of common stock upon exercise of common stock warrants | 1,798 | 1,798 | ||||||||
Issuance of common stock upon exercise of common stock warrants, shares | 337,713 | |||||||||
Issuance of common stock upon exercise of stock options | 7 | 7 | ||||||||
Issuance of common stock upon exercise of stock options, shares | 1,626 | |||||||||
Issuance of common stock upon vesting of restricted stock units, net of tax withholding for net share settlement | (1,229) | (1,229) | ||||||||
Issuance of common stock upon vesting of restricted stock units, net of tax withholding for net share settlement, shares | 194,120 | |||||||||
Stock-based compensation | 4,998 | 4,998 | ||||||||
Net loss | (51,681) | (51,681) | ||||||||
Other comprehensive income (loss) | (709) | (709) | ||||||||
Ending balance at Mar. 31, 2024 | $ 510,539 | $ 95 | $ 1,020,076 | $ (519) | $ (509,113) | |||||
Ending balance, shares at Mar. 31, 2024 | 95,199,724 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Cash flows from operating activities: | ||
Net loss | $ (51,681) | $ (28,836) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock-based compensation | 4,998 | 3,551 |
Net accretion of discounts on investments in marketable securities | (2,822) | (1,040) |
Amortization of debt discount and accretion of deferred debt costs | 162 | 219 |
Loss on extinguishment of debt | 1,208 | |
Noncash operating lease expense | 175 | 41 |
Depreciation | 9 | 14 |
Changes in operating assets and liabilities: | ||
Prepaid and other assets | 2,089 | (4,599) |
Accounts payable | 6,767 | 4,225 |
Accrued expenses | 457 | (4,827) |
Operating lease liabilities | 29 | (41) |
Other noncurrent liabilities | 97 | |
Net cash used in operating activities | (39,720) | (30,085) |
Cash flows from investing activities: | ||
Proceeds from sales and maturities of marketable securities | 72,140 | 37,880 |
Purchases of marketable securities | (152,038) | (33,774) |
Net cash (used in) provided by investing activities | (79,898) | 4,106 |
Cash flows from financing activities: | ||
Proceeds from issuance of common stock in public offerings, net of issuance costs | 296,817 | |
Payments of deferred offering costs | (253) | |
Proceeds from issuance of common stock in at-the-market public offerings, net of issuance costs | 21,067 | 13,422 |
Proceeds from term loan facility, net of issuance costs | 24,363 | |
Proceeds from issuance of common stock upon exercise of common stock warrants | 1,798 | 8,960 |
Proceeds from issuance of common stock upon exercise of stock options | 104 | 185 |
Payments for taxes related to net share settlement upon vesting of restricted stock units | (1,686) | (693) |
Repayment of term loan | (21,400) | |
Net cash provided by financing activities | 21,030 | 321,654 |
Net change in cash and cash equivalents | (98,588) | 295,675 |
Cash and cash equivalents at beginning of period | 316,161 | 55,255 |
Cash and cash equivalents at end of period | 217,573 | 350,930 |
Supplemental disclosures of cash information: | ||
Cash paid for interest | 679 | 542 |
Cash paid related to operating lease liabilities | 46 | 47 |
Supplemental disclosures of noncash information: | ||
Issuance of common stock warrants in connection with term loan | $ 482 | |
Unpaid offering costs included in accrued expenses | $ 18 |
Organization and Liquidity
Organization and Liquidity | 3 Months Ended |
Mar. 31, 2024 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization and Liquidity | 1. Organization and Liquidity 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 metabolic dysfunction-associated steatohepatitis (“MASH”), previously known as nonalcoholic steatohepatitis, and for the treatment of severe hypertriglyceridemia (“SHTG”). 89bio 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 $ 509.1 million as of March 31, 2024. 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 $ 562.3 million as of March 31, 2024 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 | 3 Months Ended |
Mar. 31, 2024 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Basis of Presentation The accompanying interim unaudited condensed consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States (“U.S. GAAP”), the instructions to Form 10-Q and Rule 10-01 of Regulation S-X and applicable rules and regulations of the Securities and Exchange Commission (“SEC”) regarding interim financial reporting. Unaudited Interim Condensed Consolidated Financial Statements The accompanying interim condensed consolidated financial statements are unaudited. The interim unaudited condensed consolidated financial statements have been prepared on the same basis as the audited consolidated financial statements as of and for the year ended December 31, 2023 and reflect all normal recurring adjustments that are necessary to present fairly the results for the interim periods presented. Interim results are not necessarily indicative of the results to be expected for the full year ending December 31, 2024 or for any other future annual or interim period. The condensed consolidated balance sheet as of December 31, 2023 was derived from the audited financial statements as of that date and, due to its summary nature, does not include all the disclosures required by U.S. GAAP in audited financial statements. These condensed consolidated financial statements should be read in conjunction with the Company’s audited consolidated financial statements included in the Annual Report on Form 10-K for the year ended December 31, 2023, which was filed with the SEC on March 1, 2024. Principles of Consolidation The accompanying condensed consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. All intercompany balances and transactions have been eliminated in consolidation. For the Company and its subsidiary in Israel, the functional currency has been determined to be the U.S. Dollar. Use of Estimates The preparation of condensed 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 condensed consolidated financial statements and the reported amounts of expenses during the reporting period. Significant estimates and assumptions made in the accompanying condensed 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. 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 March 31, 2024 and December 31, 2023, cash equivalents and marketable securities were the only financial instruments measured and recorded at fair value on a recurring basis on the Company’s condensed 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. 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 marketable 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 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 a 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. Income Taxes The Company accounts for uncertain tax positions using a more-likely-than-not threshold for recognizing and resolving uncertain tax positions. 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. Interest and penalties related to unrecognized tax benefits are included within income tax expense. For the three months ended March 31, 2024, the Company recorded income tax expense of $ 0.1 million for the accrual of additional interest related to unrecognized tax benefits. 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, restricted stock units (“RSUs”), performance stock units (“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. Recently Adopted Accounting Standards The Company did not adopt any new standards or updates issued by the Financial Accounting Standards Board (“FASB”) during the three months ended March 31, 2024 that had a material impact on the Company’s consolidated financial statements and related disclosures. Accounting Pronouncements Not Yet Adopted 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 chief operating decision maker (“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. All disclosure requirements under this ASU are also required for public entities with a single reportable segment. 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 expects to adopt ASU 2023-07 in its Annual Report on Form 10-K for the year ending December 31, 2024 and in the interim periods thereafter. The Company is in the process of evaluating the requirements of this update, which is expected to result in expanded disclosures within the consolidated financial statements upon adoption. 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. Early adoption is permitted. The Company expects to adopt ASU 2023-09 in its Annual Report on Form 10-K for the year ending December 31, 2025 and in annual periods thereafter. The Company is in the process of evaluating the requirements of this update, which is expected to result in expanded disclosures within the consolidated financial statements upon adoption. |
Fair Value Measurements
Fair Value Measurements | 3 Months Ended |
Mar. 31, 2024 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | 3. Fair Value Measurements The following tables present the Company’s financial assets measured at fair value on a recurring basis by level within the fair value hierarchy for the periods indicated (in thousands): March 31, 2024 Valuation Amortized Unrealized Unrealized Fair Hierarchy Cost Gains Losses Value Money market funds Level 1 $ 4,073 $ — $ — $ 4,073 Commercial paper Level 2 124,016 — ( 71 ) 123,945 U.S. government bonds Level 2 194,344 47 ( 377 ) 194,014 Agency bonds Level 2 53,252 10 ( 107 ) 53,155 Corporate debt securities Level 2 5,184 — ( 22 ) 5,162 U.S. Treasury securities Level 2 49,505 — ( 8 ) 49,497 Total cash equivalents and marketable securities $ 430,374 $ 57 $ ( 585 ) $ 429,846 Classified as: Cash equivalents $ 85,131 Marketable securities 344,715 Total cash equivalents and marketable securities $ 429,846 December 31, 2023 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 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 estimated fair value of investments in marketable securities by effective contractual maturity dates as of March 31, 2024 (in thousands): Within one year $ 314,373 After one year through two years 115,473 Total cash equivalents and marketable securities $ 429,846 As of March 31, 2024, the Company’s marketable securities in an unrealized loss position include primarily fixed-rate debt securities of varying maturities, which are sensitive to changes in the yield curve and other market conditions. Substantially all of the fixed-rate debt securities in a loss position are investment-grade debt securities. The Company has the intent and ability to hold such securities until recovery of the unrealized losses. Based on the Company’s assessment, the unrealized losses as of March 31, 2024 were primarily due to changes in interest rates and not due to increased credit risks associated with specific securities. No allowance for credit losses was recorded as of March 31, 2024 and December 31, 2023. |
Balance Sheet Components
Balance Sheet Components | 3 Months Ended |
Mar. 31, 2024 | |
Balance Sheet Related Disclosures [Abstract] | |
Balance Sheet Components | 4. Balance Sheet Components Prepaid and other current assets consist of the following as of the periods presented (in thousands): March 31, December 31, Prepaid research and development $ 9,009 $ 11,579 Prepaid taxes 615 614 Prepaid other 2,870 2,471 Total prepaid and other current assets $ 12,494 $ 14,664 Accrued expenses consist of the following as of the periods presented (in thousands): March 31, December 31, Accrued research and development expenses $ 15,881 $ 13,017 Accrued employee and related expenses 2,603 6,248 Accrued professional and legal fees 1,776 1,110 Accrued other expenses 35 155 Total accrued expenses $ 20,295 $ 20,530 |
Commitments and Contingencies
Commitments and Contingencies | 3 Months Ended |
Mar. 31, 2024 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 5. Commitments and Contingencies 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. Under each license agreement, 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. Each milestone payment shall be payable once, upon the first occurrence of the applicable milestone. 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 their 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. As of March 31, 2024, the timing and likelihood of achieving any remaining milestones are uncertain. Milestone payment obligations will be recognized when payment becomes probable and reasonably estimable, which is generally upon achievement of the applicable milestone. |
Term Loan Facility
Term Loan Facility | 3 Months Ended |
Mar. 31, 2024 | |
Debt Disclosure [Abstract] | |
Term Loan Facility | 6. Term Loan Facility In January 2023, the Company entered into a Loan and Security Agreement (“the Loan Agreement”) with the lender parties thereto (the “Lenders”), K2 HealthVentures LLC as administrative agent and Ankura Trust Company, LLC as collateral agent. The 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 March 31, 2024, the second $ 15.0 million tranche expired undrawn. The third $ 10.0 million tranche is available through June 30, 2024 and the fourth $ 50.0 million tranche remains available, at the sole discretion of the Lenders. Borrowings under the Loan Agreement are secured by substantially all of the assets of the Company, excluding the Company’s intellectual property. The 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. As of March 31, 2024, the Company was in compliance with all covenants under the Loan Agreement. Borrowings under the Loan Agreement 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. Borrowings under the Loan Agreement 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 term loan was 9.75 % at inception and 10.75 % as of March 31, 2024 . In addition, a final payment fee of 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 borrowings under the Loan Agreement, subject to a prepayment fee ranging from 1.0 % to 3.0 % depending on the timing of such prepayment. A commitment fee equal to 0.6 % of the principal amount of the fourth tranche is also payable if drawn. At any time prior to full repayment of outstanding borrowings under the Loan Agreement, the Lenders may elect to convert up to an aggregate of $ 7.5 million of the principal amount of outstanding borrowings into shares of the Company's common stock at a conversion price of $ 12.6943 per share. The embedded conversion option qualifies for a scope exception from derivative accounting because it is both indexed to the Company’s own stock and met the conditions for equity classification. Total debt issuance costs related to the term loan facility of $ 0.8 million, which includes the fair value of warrants issued in connection with the facility, were recorded as debt discount. The debt discount, together with the final payment fee, are recognized as interest expense using the effective interest method over the term of the loan facility. The expected repayments of principal amount due on borrowings as of March 31, 2024 are as follows (in thousands): 2024 (remaining nine months) $ — 2025 10,774 2026 13,036 2027 1,190 Total principal outstanding 25,000 Plus accumulated accretion of final payment fee 493 Less unamortized debt discount ( 536 ) Total net carrying value 24,957 Term loan, current ( 1,892 ) Term loan, noncurrent, net $ 23,065 In connection with the 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”). The warrant shares become exercisable upon the funding of each tranche and have a 10-year term. In connection with the first tranche 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 met the requirements for equity classification. T he 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 remain outstanding and 30,722 warrant shares associated with the second tranche were forfeited as of March 31, 2024. The contingent warrants did not meet the derivative scope exception or equity classification criteria and were accounted for as a derivative liability. The initial fair value and the fair value as of March 31, 2024 of the contingent warrants was insignificant. The contingent warrants derivative liability is remeasured each reporting period until settled or extinguished with subsequent changes in fair value recorded as interest expense in the condensed consolidated statements of operations and comprehensive loss. The initial fair value of the contingent warrants derivative liability was determined using a probability weighted Black-Scholes option pricing model based on the same Black-Scholes input assumptions described above. |
Stockholders' Equity
Stockholders' Equity | 3 Months Ended |
Mar. 31, 2024 | |
Equity [Abstract] | |
Stockholders' Equity | 7. Stockholders’ Equity Common Stock Reserved for Issuance The Company had the following shares of common stock reserved for future issuance, on an as-if-converted basis, as of the periods presented: March 31, December 31, Stock options outstanding 6,891,349 4,686,577 RSUs and PSUs outstanding 1,508,546 987,550 Shares available for future grants under equity incentive plans 2,600,491 1,790,684 Shares available for future issuance under the employee stock purchase plan 1,207,607 1,207,607 Warrants to purchase common stock outstanding 10,075,092 10,412,806 Pre-funded warrants to purchase common stock outstanding 1,881,081 1,881,081 Conversion feature related to outstanding term loan 590,816 590,816 Total available for future issuance 24,754,982 21,557,121 At-the-Market (“ATM”) Offerings In March 2021, the Company entered into an ATM 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. For the three months ended March 31, 2023, the Company sold 968,000 shares of its common stock under the 2021 ATM Facility and received net proceeds of $ 13.4 million, after deducting commissions and offering costs of $ 0.4 million. In February 2023, the Company entered into an amendment to the Sales Agreement, establishing a new ATM facility with an aggregate offering amount of up to $ 150.0 million of its common stock (the “2023 ATM Facility”) pursuant to an effective registration statement. For the three months ended March 31, 2024, the Company sold 1,396,888 shares of its common stock under the 2023 ATM Facility resulting in net proceeds of $ 21.0 million, after deducting commissions and offering costs of $ 0.5 million. As of March 31, 2024, there was $ 104.4 million remaining for future sales under the 2023 ATM Facility. Underwritten Public Offerings 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 and received net proceeds of $ 296.8 million, net of underwriting discounts and commissions of $ 19.0 million and other offering costs of $ 0.5 million. Common Stock Warrants As of March 31, 2024, 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 174,093 9.76 January 27, 2033 Warrants issued in connection with public offering 9,842,076 5.325 July 1, 2024 Pre-funded warrants issued in connection with public offerings 1,881,081 0.001 Do not expire Total outstanding 11,956,173 |
Stock-Based Compensation
Stock-Based Compensation | 3 Months Ended |
Mar. 31, 2024 | |
Share-Based Payment Arrangement [Abstract] | |
Stock-Based Compensation | 8. Stock-Based Compensation Equity Incentive Plans The Company has issued stock-based awards from various equity incentive and stock purchase plans, as more fully described in Note 8— Stock-Based Compensation of the Company’s Notes to Consolidated Financial Statements section in its Annual Report on Form 10-K for the year ended December 31, 2023. Equity Incentive Plans Activity Stock Options The following table summarizes stock option activity under the Company's equity incentive plans for the three months ended March 31, 2024: 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, 2023 4,686,577 $ 14.11 7.9 $ 11,712 Granted 2,241,000 9.99 Exercised ( 1,626 ) 4.44 Cancelled and forfeited ( 34,602 ) 12.94 Balance outstanding as of March 31, 2024 6,891,349 $ 12.78 8.3 $ 16,139 Exercisable as of March 31, 2024 2,617,844 $ 14.76 6.8 $ 9,011 The fair value of stock option awards granted for the periods indicated was estimated at the date of grant using a Black-Scholes option-pricing model with the following assumptions: Three Months Ended 2024 2023 Expected term (years) 5.5 – 6.1 5.5 – 6.1 Expected volatility 89.4 – 90.4 % 91.6 – 93.2 % Risk-free interest rate 3.8 – 4.1 % 3.4 – 3.8 % Expected dividend — — As of March 31, 2024, total unrecognized stock-based compensation expense related to unvested stock options was $ 34.8 million, which is expected to be recognized over a weighted-average period of 3.0 years. RSU and PSUs 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 three months ended March 31, 2024: RSUs PSUs Number of Weighted-Average Number of Weighted-Average Balance outstanding as of December 31, 2023 688,382 $ 10.72 299,168 $ 5.96 Granted 651,950 9.98 192,000 9.98 Vested ( 157,172 ) 13.43 ( 159,168 ) 7.00 Canceled ( 6,614 ) 10.78 — — Balance outstanding as of March 31, 2024 1,176,546 $ 9.95 332,000 $ 7.79 As of March 31, 2024, total unrecognized stock-based compensation expense related to RSUs and PSUs was $ 12.3 million, which is expected to be recognized over a weighted-average period of 1.9 years. Stock-Based Compensation The Company recorded stock-based compensation expense for the periods indicated as follows (in thousands): Three Months Ended 2024 2023 Research and development $ 2,315 $ 1,486 General and administrative 2,683 2,065 Total stock-based compensation $ 4,998 $ 3,551 |
Net Loss Per Share
Net Loss Per Share | 3 Months Ended |
Mar. 31, 2024 | |
Earnings Per Share [Abstract] | |
Net Loss Per Share | 9. Net Loss Per Share The following table presents the weighted-average shares outstanding used to calculate basic and diluted net loss per share for the periods indicated: Three Months Ended 2024 2023 Common stock 93,965,659 52,371,370 Pre-funded warrants 1,881,081 800,000 Total 95,846,740 53,171,370 The following outstanding potentially dilutive common stock equivalents have been excluded from the calculation of diluted net loss per share for the periods indicated due to their anti-dilutive effect: Three Months Ended 2024 2023 Stock options outstanding 6,891,349 4,463,459 RSUs and PSUs outstanding 1,508,546 1,218,377 Warrants to purchase common stock 10,075,092 11,688,597 Conversion feature related to outstanding term loan 590,816 590,816 ESPP 13,091 7,721 Total 19,078,894 17,968,970 |
Subsequent Events
Subsequent Events | 3 Months Ended |
Mar. 31, 2024 | |
Subsequent Events [Abstract] | |
Subsequent Events | 10. Subsequent Events BiBo Collaboration Agreement On April 4, 2024 , the Company entered into a collaboration agreement (the “Collaboration Agreement”) with BiBo Biopharma Engineering Co., Ltd., a company incorporated under the laws of the People’s Republic of China (“BiBo”), pursuant to which BiBo will construct a production facility specifically designed to supply the Company with pegozafermin for commercialization, if approved (the “Production Facility”). Pursuant to the Collaboration Agreement, BiBo will build the Production Facility at BiBo’s facility in the Lin-gang Special Area of China (Shanghai) Pilot Free Trade Zone to manufacture the bulk active ingredient (the “Drug Substance”) required to produce pegozafermin for commercial supply. The platform is expected to provide the Company with manufacturing capacity to meet its commercial needs based on current projections. Under the Collaboration Agreement, the Company will pay BiBo an aggregate of $ 135.0 million toward the construction of the Production Facility (collectively, the “Payment”), of which 45 % of the Payment will be payable in the third quarter of 2024. The remainder of the Payment will become payable upon achievement of certain specified milestones, of which up to an additional approximately 45 % of the Payment could become payable within the next 12 months, depending on the timing of achievement of certain milestones. If the actual costs of the Production Facility are substantially greater than the estimated budget, the parties will negotiate a means of allocating such cost overruns. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2024 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The accompanying interim unaudited condensed consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States (“U.S. GAAP”), the instructions to Form 10-Q and Rule 10-01 of Regulation S-X and applicable rules and regulations of the Securities and Exchange Commission (“SEC”) regarding interim financial reporting. |
Unaudited Interim Condensed Consolidated Financial Statements | Unaudited Interim Condensed Consolidated Financial Statements The accompanying interim condensed consolidated financial statements are unaudited. The interim unaudited condensed consolidated financial statements have been prepared on the same basis as the audited consolidated financial statements as of and for the year ended December 31, 2023 and reflect all normal recurring adjustments that are necessary to present fairly the results for the interim periods presented. Interim results are not necessarily indicative of the results to be expected for the full year ending December 31, 2024 or for any other future annual or interim period. The condensed consolidated balance sheet as of December 31, 2023 was derived from the audited financial statements as of that date and, due to its summary nature, does not include all the disclosures required by U.S. GAAP in audited financial statements. These condensed consolidated financial statements should be read in conjunction with the Company’s audited consolidated financial statements included in the Annual Report on Form 10-K for the year ended December 31, 2023, which was filed with the SEC on March 1, 2024. |
Principles of Consolidation | Principles of Consolidation The accompanying condensed consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. All intercompany balances and transactions have been eliminated in consolidation. For the Company and its subsidiary in Israel, the functional currency has been determined to be the U.S. Dollar. |
Use of Estimates | Use of Estimates The preparation of condensed 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 condensed consolidated financial statements and the reported amounts of expenses during the reporting period. Significant estimates and assumptions made in the accompanying condensed 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. |
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 March 31, 2024 and December 31, 2023, cash equivalents and marketable securities were the only financial instruments measured and recorded at fair value on a recurring basis on the Company’s condensed 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. |
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 marketable 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 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 a 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. |
Income Taxes | Income Taxes The Company accounts for uncertain tax positions using a more-likely-than-not threshold for recognizing and resolving uncertain tax positions. 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. Interest and penalties related to unrecognized tax benefits are included within income tax expense. For the three months ended March 31, 2024, the Company recorded income tax expense of $ 0.1 million for the accrual of additional interest related to unrecognized tax benefits. |
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, restricted stock units (“RSUs”), performance stock units (“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. |
Recent Adopted And Accounting Pronouncements | Recently Adopted Accounting Standards The Company did not adopt any new standards or updates issued by the Financial Accounting Standards Board (“FASB”) during the three months ended March 31, 2024 that had a material impact on the Company’s consolidated financial statements and related disclosures. Accounting Pronouncements Not Yet Adopted 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 chief operating decision maker (“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. All disclosure requirements under this ASU are also required for public entities with a single reportable segment. 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 expects to adopt ASU 2023-07 in its Annual Report on Form 10-K for the year ending December 31, 2024 and in the interim periods thereafter. The Company is in the process of evaluating the requirements of this update, which is expected to result in expanded disclosures within the consolidated financial statements upon adoption. 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. Early adoption is permitted. The Company expects to adopt ASU 2023-09 in its Annual Report on Form 10-K for the year ending December 31, 2025 and in annual periods thereafter. The Company is in the process of evaluating the requirements of this update, which is expected to result in expanded disclosures within the consolidated financial statements upon adoption. |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Fair Value Disclosures [Abstract] | |
Summary of Financial Assets Measured at Fair Value on Recurring Basis | The following tables present the Company’s financial assets measured at fair value on a recurring basis by level within the fair value hierarchy for the periods indicated (in thousands): March 31, 2024 Valuation Amortized Unrealized Unrealized Fair Hierarchy Cost Gains Losses Value Money market funds Level 1 $ 4,073 $ — $ — $ 4,073 Commercial paper Level 2 124,016 — ( 71 ) 123,945 U.S. government bonds Level 2 194,344 47 ( 377 ) 194,014 Agency bonds Level 2 53,252 10 ( 107 ) 53,155 Corporate debt securities Level 2 5,184 — ( 22 ) 5,162 U.S. Treasury securities Level 2 49,505 — ( 8 ) 49,497 Total cash equivalents and marketable securities $ 430,374 $ 57 $ ( 585 ) $ 429,846 Classified as: Cash equivalents $ 85,131 Marketable securities 344,715 Total cash equivalents and marketable securities $ 429,846 December 31, 2023 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 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. |
Balance Sheet Components (Table
Balance Sheet Components (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
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): March 31, December 31, Prepaid research and development $ 9,009 $ 11,579 Prepaid taxes 615 614 Prepaid other 2,870 2,471 Total prepaid and other current assets $ 12,494 $ 14,664 |
Schedule of Accrued Expenses | Accrued expenses consist of the following as of the periods presented (in thousands): March 31, December 31, Accrued research and development expenses $ 15,881 $ 13,017 Accrued employee and related expenses 2,603 6,248 Accrued professional and legal fees 1,776 1,110 Accrued other expenses 35 155 Total accrued expenses $ 20,295 $ 20,530 |
Term Loan Facility (Tables)
Term Loan Facility (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Debt Disclosure [Abstract] | |
Schedule of Repayment of Principal Amount | The expected repayments of principal amount due on borrowings as of March 31, 2024 are as follows (in thousands): 2024 (remaining nine months) $ — 2025 10,774 2026 13,036 2027 1,190 Total principal outstanding 25,000 Plus accumulated accretion of final payment fee 493 Less unamortized debt discount ( 536 ) Total net carrying value 24,957 Term loan, current ( 1,892 ) Term loan, noncurrent, net $ 23,065 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Equity [Abstract] | |
Schedule of Shares of Common Stock Available for Future Issuance | The Company had the following shares of common stock reserved for future issuance, on an as-if-converted basis, as of the periods presented: March 31, December 31, Stock options outstanding 6,891,349 4,686,577 RSUs and PSUs outstanding 1,508,546 987,550 Shares available for future grants under equity incentive plans 2,600,491 1,790,684 Shares available for future issuance under the employee stock purchase plan 1,207,607 1,207,607 Warrants to purchase common stock outstanding 10,075,092 10,412,806 Pre-funded warrants to purchase common stock outstanding 1,881,081 1,881,081 Conversion feature related to outstanding term loan 590,816 590,816 Total available for future issuance 24,754,982 21,557,121 |
Schedule of Outstanding Warrants to Purchase Shares of Common Stock | As of March 31, 2024, 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 174,093 9.76 January 27, 2033 Warrants issued in connection with public offering 9,842,076 5.325 July 1, 2024 Pre-funded warrants issued in connection with public offerings 1,881,081 0.001 Do not expire Total outstanding 11,956,173 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Share-Based Payment Arrangement [Abstract] | |
Summary of Stock Option Activity | The following table summarizes stock option activity under the Company's equity incentive plans for the three months ended March 31, 2024: 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, 2023 4,686,577 $ 14.11 7.9 $ 11,712 Granted 2,241,000 9.99 Exercised ( 1,626 ) 4.44 Cancelled and forfeited ( 34,602 ) 12.94 Balance outstanding as of March 31, 2024 6,891,349 $ 12.78 8.3 $ 16,139 Exercisable as of March 31, 2024 2,617,844 $ 14.76 6.8 $ 9,011 |
Summary of Estimated Fair Value of Stock Option Awards Granted Using Black-Scholes Option-Pricing Model | The fair value of stock option awards granted for the periods indicated was estimated at the date of grant using a Black-Scholes option-pricing model with the following assumptions: Three Months Ended 2024 2023 Expected term (years) 5.5 – 6.1 5.5 – 6.1 Expected volatility 89.4 – 90.4 % 91.6 – 93.2 % Risk-free interest rate 3.8 – 4.1 % 3.4 – 3.8 % Expected dividend — — As of March 31, 2024, total unrecognized stock-based compensation expense related to unvested stock options was $ 34.8 million, which is expected to be recognized over a weighted-average period of 3.0 years. RSU and PSUs 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. |
Summary of Restricted Stock Unit Activity | The following table summarizes RSU and PSU activity for the three months ended March 31, 2024: RSUs PSUs Number of Weighted-Average Number of Weighted-Average Balance outstanding as of December 31, 2023 688,382 $ 10.72 299,168 $ 5.96 Granted 651,950 9.98 192,000 9.98 Vested ( 157,172 ) 13.43 ( 159,168 ) 7.00 Canceled ( 6,614 ) 10.78 — — Balance outstanding as of March 31, 2024 1,176,546 $ 9.95 332,000 $ 7.79 As of March 31, 2024, total unrecognized stock-based compensation expense related to RSUs and PSUs was $ 12.3 million, which is expected to be recognized over a weighted-average period of 1.9 years. Stock-Based Compensation |
Summary of Stock-Based Compensation Expense | The Company recorded stock-based compensation expense for the periods indicated as follows (in thousands): Three Months Ended 2024 2023 Research and development $ 2,315 $ 1,486 General and administrative 2,683 2,065 Total stock-based compensation $ 4,998 $ 3,551 |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
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 for the periods indicated: Three Months Ended 2024 2023 Common stock 93,965,659 52,371,370 Pre-funded warrants 1,881,081 800,000 Total 95,846,740 53,171,370 |
Schedule of Outstanding Potentially Dilutive Securities Excluded From Calculation of Diluted Net Loss | The following outstanding potentially dilutive common stock equivalents have been excluded from the calculation of diluted net loss per share for the periods indicated due to their anti-dilutive effect: Three Months Ended 2024 2023 Stock options outstanding 6,891,349 4,463,459 RSUs and PSUs outstanding 1,508,546 1,218,377 Warrants to purchase common stock 10,075,092 11,688,597 Conversion feature related to outstanding term loan 590,816 590,816 ESPP 13,091 7,721 Total 19,078,894 17,968,970 |
Organization and Liquidity - Ad
Organization and Liquidity - Additional Information (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Dec. 31, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Date of incorporation | Jun. 30, 2019 | |
Accumulated deficit | $ (509,113) | $ (457,432) |
Cash and cash equivalents and short term available-for-sale securities | $ 562,300 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies - Additional Information (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Summary Of Significant Accounting Policies [Line Items] | ||
Income tax expense | $ 97 | $ 0 |
Fair Value Measurements - Summa
Fair Value Measurements - Summary of Financial Assets Measured at Fair Value on Recurring Basis (Details) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Short-term investments, Aggregated Fair Value | $ 429,846 | |
Recurring | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Short-term investments, Amortized Cost | 430,374 | $ 361,117 |
Short-term investments, Gross Unrealized Holding Gains | 57 | 439 |
Short-term investments, Gross Unrealized Holding Losses | (585) | (254) |
Short-term investments, Aggregated Fair Value | 429,846 | 361,302 |
Total cash equivalents and marketable securities | 429,846 | 361,302 |
Recurring | Marketable securities | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Short-term investments, Aggregated Fair Value | 344,715 | 262,709 |
Recurring | Cash equivalents | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Short-term investments, Aggregated Fair Value | 85,131 | 98,593 |
Recurring | Level 1 | Money Market Funds | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Short-term investments, Amortized Cost | 4,073 | 493 |
Short-term investments, Aggregated Fair Value | 4,073 | 493 |
Recurring | Level 2 | Commercial Paper | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Short-term investments, Amortized Cost | 124,016 | 94,261 |
Short-term investments, Gross Unrealized Holding Losses | (71) | (55) |
Short-term investments, Aggregated Fair Value | 123,945 | 94,206 |
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 | 194,344 | 137,976 |
Short-term investments, Gross Unrealized Holding Gains | 47 | 250 |
Short-term investments, Gross Unrealized Holding Losses | (377) | (142) |
Short-term investments, Aggregated Fair Value | 194,014 | 138,084 |
Recurring | Level 2 | Agency bonds | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Short-term investments, Amortized Cost | 53,252 | 45,481 |
Short-term investments, Gross Unrealized Holding Gains | 10 | 152 |
Short-term investments, Gross Unrealized Holding Losses | (107) | (44) |
Short-term investments, Aggregated Fair Value | 53,155 | 45,589 |
Recurring | Level 2 | Corporate debt securities | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Short-term investments, Amortized Cost | 5,184 | 3,177 |
Short-term investments, Gross Unrealized Holding Losses | (22) | (12) |
Short-term investments, Aggregated Fair Value | 5,162 | 3,165 |
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 | 49,505 | 71,754 |
Short-term investments, Gross Unrealized Holding Gains | 0 | 36 |
Short-term investments, Gross Unrealized Holding Losses | (8) | (1) |
Short-term investments, Aggregated Fair Value | $ 49,497 | 71,789 |
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 | |
Short-term investments, Gross Unrealized Holding Gains | 1 | |
Short-term investments, Aggregated Fair Value | $ 7,976 |
Fair Value Measurements - Sched
Fair Value Measurements - Schedule of Contractual Maturities of Financial Assets Measured at Fair Value (Details) $ in Thousands | Mar. 31, 2024 USD ($) |
Fair Value Disclosures [Abstract] | |
Within one year | $ 314,373 |
After one year through two years | 115,473 |
Total cash equivalents and marketable securities | $ 429,846 |
Balance Sheet Components - Sche
Balance Sheet Components - Schedule of Prepaid and Other Current Assets (Details) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Prepaid Expense and Other Assets, Current [Abstract] | ||
Prepaid research and development | $ 9,009 | $ 11,579 |
Prepaid taxes | 615 | 614 |
Prepaid other | 2,870 | 2,471 |
Total prepaid and other current assets | $ 12,494 | $ 14,664 |
Balance Sheet Components - Sc_2
Balance Sheet Components - Schedule of Accrued Expenses (Details) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Payables and Accruals [Abstract] | ||
Accrued research and development expenses | $ 15,881 | $ 13,017 |
Accrued employee and related expenses | 2,603 | 6,248 |
Accrued professional and legal fees | 1,776 | 1,110 |
Accrued other expenses | 35 | 155 |
Total accrued expenses | $ 20,295 | $ 20,530 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Details) - Teva Agreements - USD ($) $ in Millions | 1 Months Ended | 3 Months Ended | |
Apr. 30, 2018 | Mar. 31, 2024 | Dec. 31, 2023 | |
Loss Contingencies [Line Items] | |||
Nonrefundable upfront payment | $ 6 | ||
Payment upon achievement of certain clinical and commercial milestones | 65 | ||
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 | ||
Milestone payments | $ 2.5 | ||
Teva's Development Program | |||
Loss Contingencies [Line Items] | |||
Payment upon achievement of certain clinical and commercial milestones | $ 2.5 |
Term Loan Facility - Additional
Term Loan Facility - Additional Information (Details) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | ||
Jan. 01, 2027 | Jan. 31, 2023 USD ($) $ / shares shares | Mar. 31, 2024 USD ($) shares | Mar. 31, 2023 USD ($) | |
Debt Instrument [Line Items] | ||||
Debt discount | $ 536 | |||
Loss on extinguishment | $ (1,208) | |||
Tranche One | ||||
Debt Instrument [Line Items] | ||||
Warrants to purchase common stock | shares | 51,204 | |||
2023 Loan Agreement | ||||
Debt Instrument [Line Items] | ||||
Warrant exercise price | $ / shares | $ 9.7649 | |||
Minimum unrestriced cash and cash equivalents to three month average cash and cash equivalents multiplier | 5 | |||
Debt instrument, maturity date | Jan. 01, 2027 | |||
Debt instrument, maturity date, description | Borrowings under the Loan Agreement mature on January 1, 2027 and provide for interest-only payments until February 1, 2025. | |||
Debt instrument, interest rate | 9.75% | 10.75% | ||
Debt instrument, basis spread on variable rate | 2.25% | |||
Conversion price per share | $ / shares | $ 12.6943 | |||
Contingent warrants | shares | 153,611 | |||
Warrant Forfeited | shares | 30,722 | |||
2023 Loan Agreement | Forecast | ||||
Debt Instrument [Line Items] | ||||
Percentage of fee on loan | 5.95% | |||
2023 Loan Agreement | Minimum | ||||
Debt Instrument [Line Items] | ||||
Debt instrument, interest rate | 8.45% | |||
Prepayment fee percentage | 3% | |||
2023 Loan Agreement | Maximum | ||||
Debt Instrument [Line Items] | ||||
Debt Instrument face amount | $ 100,000 | |||
Warrants to purchase common stock | shares | 204,815 | |||
Prepayment fee percentage | 1% | |||
Conversion of principal amount | $ 7,500 | |||
2023 Loan Agreement | Tranche One | ||||
Debt Instrument [Line Items] | ||||
Debt discount | 800 | |||
Line of credit facility fully drawn amount | 25,000 | |||
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 | |||
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% | |||
2024 Loan Agreement | Tranche Two | ||||
Debt Instrument [Line Items] | ||||
Line of credit facility, maximum borrowing capacity | $ 15,000 | |||
2024 Loan Agreement | Tranche Three | ||||
Debt Instrument [Line Items] | ||||
Line of credit facility, maximum borrowing capacity | 10,000 | |||
2024 Loan Agreement | Tranche Four | ||||
Debt Instrument [Line Items] | ||||
Line of credit facility, maximum borrowing capacity | $ 50,000 |
Term Loan Facility - Schedule o
Term Loan Facility - Schedule of Repayment of Principal Amount (Details) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Debt Disclosure [Abstract] | ||
2024 (remaining nine months) | $ 0 | |
2025 | 10,774 | |
2026 | 13,036 | |
2027 | 1,190 | |
Total principal outstanding | 25,000 | |
Plus accumulated accretion of final payment fee | 493 | |
Less: unamortized debt discount | (536) | |
Total net carry value | 24,957 | |
Term loan, current | (1,892) | $ 0 |
Total term loan, noncurrent, net | $ 23,065 | $ 24,795 |
Stockholders' Equity - Schedule
Stockholders' Equity - Schedule of Shares of Common Stock Available for Future Issuance (Details) - shares | Mar. 31, 2024 | Dec. 31, 2023 |
Class Of Stock [Line Items] | ||
Total available for future issuance | 24,754,982 | 21,557,121 |
Stock Options Outstanding | ||
Class Of Stock [Line Items] | ||
Total available for future issuance | 6,891,349 | 4,686,577 |
Rsus And Psus Outstanding | ||
Class Of Stock [Line Items] | ||
Total available for future issuance | 1,508,546 | 987,550 |
Equity Incentive Plan | ||
Class Of Stock [Line Items] | ||
Total available for future issuance | 2,600,491 | 1,790,684 |
Employee Stock Purchase Plan | ||
Class Of Stock [Line Items] | ||
Total available for future issuance | 1,207,607 | 1,207,607 |
Warrants To Purchase Common Stock | ||
Class Of Stock [Line Items] | ||
Total available for future issuance | 10,075,092 | 10,412,806 |
Pre-funded Warrants To Purchase Common Stock | ||
Class Of Stock [Line Items] | ||
Total available for future issuance | 1,881,081 | 1,881,081 |
Conversion Feature Related To Outstanding Term Loan | ||
Class Of Stock [Line Items] | ||
Total available for future issuance | 590,816 | 590,816 |
Stockholders' Equity - Addition
Stockholders' Equity - Additional Information (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | ||||
Feb. 28, 2023 | Mar. 31, 2023 | Mar. 31, 2021 | Mar. 31, 2024 | Mar. 31, 2023 | Dec. 31, 2023 | |
Subsidiary Sale Of Stock [Line Items] | ||||||
Offering costs | $ 253 | |||||
Common stock, par value | $ 0.001 | $ 0.001 | ||||
Public Offerings | ||||||
Subsidiary Sale Of Stock [Line Items] | ||||||
Proceeds from issuance of common stock, net of commissions and offering expenses | $ 296,800 | |||||
Shares issued and sold | 19,461,538 | |||||
Offering price per share | $ 16.25 | $ 16.25 | ||||
Underwriting discounts and commissions | $ 19,000 | |||||
Offering costs | $ 500 | |||||
Public Offerings | Common Stock | ||||||
Subsidiary Sale Of Stock [Line Items] | ||||||
Shares issued and sold | 19,461,538 | |||||
2021 ATM Facility | ||||||
Subsidiary Sale Of Stock [Line Items] | ||||||
Selling commission per shares sold percentage | 3% | |||||
Proceeds from issuance of common stock, net of commissions and offering expenses | $ 13,400 | |||||
Shares issued and sold | 968,000 | |||||
Offering costs | $ 400 | |||||
2021 ATM Facility | Common Stock | ||||||
Subsidiary Sale Of Stock [Line Items] | ||||||
Maximum value of common stock to be issued under agreement | $ 75,000 | |||||
2023 ATM Facility | ||||||
Subsidiary Sale Of Stock [Line Items] | ||||||
Proceeds from issuance of common stock, net of commissions and offering expenses | $ 21,000 | |||||
Shares issued and sold | 1,396,888 | |||||
Offering costs | $ 500 | |||||
Common stock remaining for future sales | $ 104,400 | |||||
2023 ATM Facility | Common Stock | ||||||
Subsidiary Sale Of Stock [Line Items] | ||||||
Maximum value of common stock to be issued under agreement | $ 150,000 |
Stockholders' Equity - Schedu_2
Stockholders' Equity - Schedule of Outstanding Warrants to Purchase Shares of Common Stock (Details) | 3 Months Ended |
Mar. 31, 2024 $ / shares shares | |
Class Of Warrant Or Right [Line Items] | |
Shares of Common Stock Underlying Warrants | 11,956,173 |
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 | 9,842,076 |
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 | 3 Months Ended | ||
Mar. 31, 2024 | Mar. 31, 2023 | Dec. 31, 2023 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Common stock shares reserved for future issuance | 24,754,982 | 21,557,121 | |
Share base compensation expense | $ 4,998 | $ 3,551 | |
Performance Stock Units (PSUs) | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Unrecognized weighted average period | 1 year 10 months 24 days | ||
Total Unrecognised expense | $ 12,300 | ||
Employee Stock Option | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Unrecognized weighted average period | 3 years | ||
Unrecognized unvested stock option | $ 34,800 | ||
Employee Stock Purchase Plan | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Common stock shares reserved for future issuance | 1,207,607 | 1,207,607 | |
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 | ||
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 |
Stock-Based Compensation - Summ
Stock-Based Compensation - Summary of Stock Option Activity (Details) - 2023 Inducement Plan and 2019 Employee Stock Purchase Plan - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended |
Mar. 31, 2024 | Dec. 31, 2023 | |
Number of Options | ||
Outstanding, Beginning Balance | 4,686,577 | |
Granted | 2,241,000 | |
Exercised | (1,626) | |
Cancelled and forfeited | (34,602) | |
Outstanding, Ending Balance | 6,891,349 | 4,686,577 |
Exercisable as of of March 31, 2024 | 2,617,844 | |
Weighted Average Exercise Price | ||
Weighted Average Exercise Price Outstanding, Beginning Balance | $ 14.11 | |
Weighted Average Exercise Price, Granted | 9.99 | |
Weighted Average Exercise Price, Exercised | 4.44 | |
Weighted Average Exercise Price, Cancelled and forfeited | 12.94 | |
Weighted Average Exercise Price Outstanding, Ending Balance | 12.78 | $ 14.11 |
Weighted Average Exercise Price, Exercisable as of March 31, 2024 | $ 14.76 | |
Weighted Average Remaining Contractual Term (In years) | ||
Weighted Average Remaining Contractual Term (In years), Outstanding | 8 years 3 months 18 days | 7 years 10 months 24 days |
Weighted Average Remaining Contractual Term (In years), Exercisable as of March 31, 2024 | 6 years 9 months 18 days | |
Aggregate Intrinsic Value | ||
Aggregate Intrinsic Value | $ 16,139 | $ 11,712 |
Aggregate Intrinsic Value, Exercisable as of March 31, 2024 | $ 9,011 |
Stock-Based Compensation - Su_2
Stock-Based Compensation - Summary of Estimated Fair Value of Stock Option Awards Granted Using Black-Scholes Option-Pricing Model (Details) | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Expected volatility, minimum | 89.40% | 91.60% |
Expected volatility, maximum | 90.40% | 93.20% |
Risk-free interest rate, minimum | 3.80% | 3.40% |
Risk-free interest rate, maximum | 4.10% | 3.80% |
Minimum | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Expected term (years) | 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 1 month 6 days |
Stock-Based Compensation - Su_3
Stock-Based Compensation - Summary of Restricted Stock Unit Activity (Details) | 3 Months Ended |
Mar. 31, 2024 $ / shares shares | |
Restricted Stock Units (RSUs") | |
Number of RSUs | |
Outstanding, Beginning Balance | shares | 688,382 |
Granted | shares | 651,950 |
Vested / released | shares | (157,172) |
Cancelled / forfeited | shares | (6,614) |
Outstanding, Ending Balance | shares | 1,176,546 |
Weighted Average Grant Date Fair Value | |
Weighted Average Grant Date Fair Value Outstanding, Beginning Balance | $ / shares | $ 10.72 |
Weighted Average Grant Date Fair Value Outstanding, Granted | $ / shares | 9.98 |
Weighted Average Grant Date Fair Value Outstanding, Vested/Released | $ / shares | 13.43 |
Weighted Average Grant Date Fair Value Outstanding, Cancelled/Forfeited | $ / shares | 10.78 |
Weighted Average Grant Date Fair Value Outstanding, Ending Balance | $ / shares | $ 9.95 |
Performance Shares (PSUs) | |
Number of RSUs | |
Outstanding, Beginning Balance | shares | 299,168 |
Granted | shares | 192,000 |
Vested / released | shares | (159,168) |
Outstanding, Ending Balance | shares | 332,000 |
Weighted Average Grant Date Fair Value | |
Weighted Average Grant Date Fair Value Outstanding, Beginning Balance | $ / shares | $ 5.96 |
Weighted Average Grant Date Fair Value Outstanding, Granted | $ / shares | 9.98 |
Weighted Average Grant Date Fair Value Outstanding, Vested/Released | $ / shares | 7 |
Weighted Average Grant Date Fair Value Outstanding, Ending Balance | $ / shares | $ 7.79 |
Stock-Based Compensation - Su_4
Stock-Based Compensation - Summary of Stock-Based Compensation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Total stock-based compensation | $ 4,998 | $ 3,551 |
Research and Development | ||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Total stock-based compensation | 2,315 | 1,486 |
General and Administrative | ||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Total stock-based compensation | $ 2,683 | $ 2,065 |
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 | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
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 | 95,846,740 | 53,171,370 |
Weighted-average shares used to compute net loss per share, diluted | 95,846,740 | 53,171,370 |
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 | 93,965,659 | 52,371,370 |
Weighted-average shares used to compute net loss per share, diluted | 93,965,659 | 52,371,370 |
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 | 1,881,081 | 800,000 |
Weighted-average shares used to compute net loss per share, diluted | 1,881,081 | 800,000 |
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 | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Antidilutive common stock equivalents excluded from calculation of diluted net loss per share | 19,078,894 | 17,968,970 |
Stock Options 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 | 6,891,349 | 4,463,459 |
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 | 1,508,546 | 1,218,377 |
Warrants to Purchase Common Stock | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Antidilutive common stock equivalents excluded from calculation of diluted net loss per share | 10,075,092 | 11,688,597 |
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 | 590,816 |
ESPP | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Antidilutive common stock equivalents excluded from calculation of diluted net loss per share | 13,091 | 7,721 |
Subsequent Events - Additional
Subsequent Events - Additional Information (Details) - Subsequent Events - Collaboration Agreement $ in Millions | Apr. 04, 2024 USD ($) |
Subsequent Event [Line Items] | |
Agreement date | Apr. 04, 2024 |
BiBo Biopharma Engineering Co., Ltd. | |
Subsequent Event [Line Items] | |
Aggregate payment of production facility | $ 135 |
Percentage of production facility payment payable | 45% |
Additional percentage of milestones payment payable upon achievement | 45% |