Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2023 | Oct. 26, 2023 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Sep. 30, 2023 | |
Document Fiscal Year Focus | 2023 | |
Document Fiscal Period Focus | Q3 | |
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 | Non-accelerated Filer | |
Entity Common Stock, Shares Outstanding | 75,638,516 | |
Entity Shell Company | false | |
Entity Small Business | true | |
Entity Emerging Growth Company | true | |
Entity Ex Transition Period | false | |
Title of 12(b) Security | Common stock, par value $0.001 per share | |
Trading Symbol | ETNB | |
Security Exchange Name | NASDAQ | |
Entity File Number | 001-39122 | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 36-4946844 | |
Entity Address, Address Line One | 142 Sansome Street | |
Entity Address, Address Line Two | Second Floor | |
Entity Address, City or Town | San Francisco | |
Entity Address, State or Province | CA | |
Entity Address, Postal Zip Code | 94104 | |
City Area Code | 415 | |
Local Phone Number | 432-9270 | |
Document Quarterly Report | true | |
Document Transition Report | false |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets (Unaudited) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 251,926 | $ 55,255 |
Short-term available-for-sale securities | 196,378 | 132,905 |
Prepaid and other current assets | 11,222 | 7,920 |
Total current assets | 459,526 | 196,080 |
Operating lease right-of-use asset | 238 | 363 |
Property and equipment, net | 58 | 92 |
Other assets | 289 | 289 |
Total assets | 460,111 | 196,824 |
Current liabilities: | ||
Accounts payable | 10,903 | 12,502 |
Accrued expenses | 14,133 | 11,944 |
Operating lease liability, current | 176 | 168 |
Total current liabilities | 25,212 | 24,614 |
Operating lease liability, non-current | 53 | 186 |
Term loan, non-current, net | 24,637 | 20,192 |
Total liabilities | 49,902 | 44,992 |
Commitments and contingencies (Note 5) | ||
Stockholders’ equity: | ||
Common stock | 75 | 51 |
Additional paid-in capital | 827,878 | 467,374 |
Accumulated other comprehensive loss | (547) | (350) |
Accumulated deficit | (417,197) | (315,243) |
Total stockholders’ equity | 410,209 | 151,832 |
Total liabilities and stockholders’ equity | $ 460,111 | $ 196,824 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Operating expenses: | ||||
Research and development | $ 31,417 | $ 22,197 | $ 88,638 | $ 61,732 |
General and administrative | 7,928 | 4,844 | 21,360 | 15,155 |
Total operating expenses | 39,345 | 27,041 | 109,998 | 76,887 |
Loss from operations | (39,345) | (27,041) | (109,998) | (76,887) |
Interest expense | (959) | (535) | (3,928) | (1,377) |
Interest income and other, net | 5,579 | 773 | 11,972 | 843 |
Net loss before income tax | (34,725) | (26,803) | (101,954) | (77,421) |
Income tax expense | (2) | (3) | ||
Net loss | (34,725) | (26,805) | (101,954) | (77,424) |
Other comprehensive income (loss): | ||||
Unrealized gain (loss) on available-for-sale securities | 41 | (136) | (200) | (408) |
Foreign currency translation adjustments | 6 | 14 | 3 | 32 |
Total other comprehensive income (loss) | 47 | (122) | (197) | (376) |
Comprehensive loss | $ (34,678) | $ (26,927) | $ (102,151) | $ (77,800) |
Net loss per share, basic | $ (0.45) | $ (0.57) | $ (1.5) | $ (2.63) |
Net loss per share, diluted | $ (0.45) | $ (0.57) | $ (1.5) | $ (2.63) |
Weighted-average shares used to compute net loss per share, basic | 76,336,050 | 47,253,527 | 67,962,848 | 29,413,421 |
Weighted-average shares used to compute net loss per share, diluted | 76,336,050 | 47,253,527 | 67,962,848 | 29,413,421 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Stockholders' Equity (Unaudited) - USD ($) $ in Thousands | Total | Public Offerings | A T M Facility | Common Stock | Common Stock Public Offerings | Common Stock A T M Facility | Additional Paid-in Capital | Additional Paid-in Capital Public Offerings | Additional Paid-in Capital A T M Facility | Accumulated Other Comprehensive (Loss) Income | Accumulated Deficit |
Beginning balance at Dec. 31, 2021 | $ 125,957 | $ 20 | $ 339,218 | $ (64) | $ (213,217) | ||||||
Beginning balance, shares at Dec. 31, 2021 | 20,317,204 | ||||||||||
Issuance of common stock upon exercise of stock options | 29 | 29 | |||||||||
Issuance of common stock upon exercise of stock options, shares | 12,065 | ||||||||||
Issuance of common stock upon vesting of restricted stock units, net, shares | 22,115 | ||||||||||
Stock-based compensation | 2,512 | 2,512 | |||||||||
Net loss | (25,565) | (25,565) | |||||||||
Other comprehensive income (loss) | (192) | (192) | |||||||||
Ending balance at Mar. 31, 2022 | 102,741 | $ 20 | 341,759 | (256) | (238,782) | ||||||
Ending balance, shares at Mar. 31, 2022 | 20,351,384 | ||||||||||
Beginning balance at Dec. 31, 2021 | 125,957 | $ 20 | 339,218 | (64) | (213,217) | ||||||
Beginning balance, shares at Dec. 31, 2021 | 20,317,204 | ||||||||||
Net loss | (77,424) | ||||||||||
Other comprehensive income (loss) | (376) | ||||||||||
Ending balance at Sep. 30, 2022 | 152,575 | $ 44 | 443,612 | (440) | (290,641) | ||||||
Ending balance, shares at Sep. 30, 2022 | 43,624,625 | ||||||||||
Beginning balance at Mar. 31, 2022 | 102,741 | $ 20 | 341,759 | (256) | (238,782) | ||||||
Beginning balance, shares at Mar. 31, 2022 | 20,351,384 | ||||||||||
Issuance of common stock upon ESPP purchases | 43 | 43 | |||||||||
Issuance of common stock upon ESPP purchase, Shares | 15,979 | ||||||||||
Withholding taxes related to restricted stock units | (69) | (69) | |||||||||
Stock-based compensation | 2,586 | 2,586 | |||||||||
Net loss | (25,054) | (25,054) | |||||||||
Other comprehensive income (loss) | (62) | (62) | |||||||||
Ending balance at Jun. 30, 2022 | 80,185 | $ 20 | 344,319 | (318) | (263,836) | ||||||
Ending balance, shares at Jun. 30, 2022 | 20,367,363 | ||||||||||
Issuance of common stock | $ 88,239 | $ 8,370 | $ 20 | $ 1 | $ 88,219 | $ 8,369 | |||||
Issuance of common stock, shares | 18,675,466 | 1,242,132 | |||||||||
Issuance of common stock upon cashless exercise of warrants | $ 3 | (3) | |||||||||
Issuance of common stock upon cashless exercise of warrants, shares | 3,143,682 | ||||||||||
Issuance of common stock upon exercise of warrants | 53 | 53 | |||||||||
Issuance of common stock upon exercise of warrants, shares | 10,000 | ||||||||||
Issuance of common stock upon exercise of stock options | 208 | 208 | |||||||||
Issuance of common stock upon exercise of stock options, shares | 114,203 | ||||||||||
Issuance of common stock upon vesting of restricted stock units, net of withholding taxes | (53) | (53) | |||||||||
Issuance of common stock upon vesting of restricted stock units, net of withholding taxes, shares | 71,779 | ||||||||||
Stock-based compensation | 2,500 | 2,500 | |||||||||
Net loss | (26,805) | (26,805) | |||||||||
Other comprehensive income (loss) | (122) | (122) | |||||||||
Ending balance at Sep. 30, 2022 | 152,575 | $ 44 | 443,612 | (440) | (290,641) | ||||||
Ending balance, shares at Sep. 30, 2022 | 43,624,625 | ||||||||||
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 warrants | 8,960 | $ 2 | 8,958 | ||||||||
Issuance of common stock upon exercise of 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, 2022 | 151,832 | $ 51 | 467,374 | (350) | (315,243) | ||||||
Beginning balance, shares at Dec. 31, 2022 | 50,560,590 | ||||||||||
Issuance of common stock warrants in connection with term loan | 482 | ||||||||||
Net loss | (101,954) | ||||||||||
Other comprehensive income (loss) | (197) | ||||||||||
Ending balance at Sep. 30, 2023 | 410,209 | $ 75 | 827,878 | (547) | (417,197) | ||||||
Ending balance, shares at Sep. 30, 2023 | 75,638,516 | ||||||||||
Beginning balance at Mar. 31, 2023 | 445,830 | $ 73 | 790,076 | (240) | (344,079) | ||||||
Beginning balance, shares at Mar. 31, 2023 | 72,867,705 | ||||||||||
Issuance of common stock | $ 23,667 | $ 1 | $ 23,666 | ||||||||
Issuance of common stock, shares | 1,200,539 | ||||||||||
Issuance of common stock upon exercise of warrants | 6,630 | $ 1 | 6,629 | ||||||||
Issuance of common stock upon exercise of warrants, shares | 1,245,070 | ||||||||||
Issuance of common stock upon exercise of stock options | 327 | 327 | |||||||||
Issuance of common stock upon exercise of stock options, shares | 107,832 | ||||||||||
Issuance of common stock upon ESPP purchases | 142 | 142 | |||||||||
Issuance of common stock upon ESPP purchase, Shares | 13,927 | ||||||||||
Issuance of common stock upon vesting of restricted stock units, net of withholding taxes, shares | 31,527 | ||||||||||
Stock-based compensation | 4,137 | 4,137 | |||||||||
Net loss | (38,393) | (38,393) | |||||||||
Other comprehensive income (loss) | (354) | (354) | |||||||||
Ending balance at Jun. 30, 2023 | 441,986 | $ 75 | 824,977 | (594) | (382,472) | ||||||
Ending balance, shares at Jun. 30, 2023 | 75,466,600 | ||||||||||
Issuance of common stock upon exercise of stock options | 117 | 117 | |||||||||
Issuance of common stock upon exercise of stock options, shares | 27,372 | ||||||||||
Issuance of common stock upon vesting of restricted stock units, net of withholding taxes | (1,597) | (1,597) | |||||||||
Issuance of common stock upon vesting of restricted stock units, net of withholding taxes, shares | 144,544 | ||||||||||
Stock-based compensation | 4,381 | 4,381 | |||||||||
Net loss | (34,725) | (34,725) | |||||||||
Other comprehensive income (loss) | 47 | 47 | |||||||||
Ending balance at Sep. 30, 2023 | $ 410,209 | $ 75 | $ 827,878 | $ (547) | $ (417,197) | ||||||
Ending balance, shares at Sep. 30, 2023 | 75,638,516 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Cash flows from operating activities: | ||
Net loss | $ (101,954) | $ (77,424) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock-based compensation | 12,069 | 7,598 |
Net accretion on available-for-sale securities | (4,297) | (183) |
Accretion of final payment fee on term loan | 285 | 365 |
Amortization of debt issuance costs | 410 | 227 |
Loss on extinguishment of term loan facility | 1,208 | |
Noncash operating lease expense | 125 | 135 |
Depreciation | 34 | 50 |
Changes in operating assets and liabilities: | ||
Prepaid and other current assets | (3,238) | 4,756 |
Other assets | 72 | |
Accounts payable | (1,599) | 7,308 |
Accrued expenses | 2,189 | 3,243 |
Operating lease liability | (125) | (141) |
Net cash used in operating activities | (94,893) | (53,994) |
Cash flows from investing activities: | ||
Proceeds from sales and maturities of available-for-sale securities | 157,428 | 87,260 |
Purchases of available-for-sale securities | (216,804) | (110,137) |
Purchases of property and equipment | (5) | |
Net cash used in investing activities | (59,376) | (22,882) |
Cash flows from financing activities: | ||
Proceeds from issuance of common stock in public offering, net of issuance costs | 296,817 | 88,239 |
Proceeds from issuance of common stock in at-the-market public offering, net of issuance costs | 37,089 | 8,370 |
Proceeds from term loan facility, net of issuance costs | 24,363 | |
Proceeds from issuance of common stock upon exercise of warrants | 15,590 | 53 |
Proceeds from issuance of common stock upon exercise of stock options | 629 | 237 |
Proceeds from issuance of common stock upon ESPP purchases | 142 | 43 |
Payment of withholding taxes related to restricted stock units | (2,290) | (122) |
Repayment of term loan facility | (21,400) | |
Net cash provided by financing activities | 350,940 | 96,820 |
Net change in cash and cash equivalents, and restricted cash | 196,671 | 19,944 |
Cash and cash equivalents, and restricted cash at beginning of period | 55,255 | 52,457 |
Cash and cash equivalents at end of period | 251,926 | 72,401 |
Supplemental disclosures of cash information: | ||
Cash paid for interest | 1,913 | 706 |
Cash paid for operating leases | 139 | 187 |
Supplemental disclosures of noncash information: | ||
Issuance of common stock warrants in connection with term loan | $ 482 | |
Remeasurement of lease liability and right of use asset in connection with lease modification | $ 338 |
Organization and Basis of Prese
Organization and Basis of Presentation | 9 Months Ended |
Sep. 30, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization and Basis of Presentation | 1. Organization and Basis of Presentation Description of Business 89bio, Inc. (“89bio” or the “Company”) is a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and cardio-metabolic diseases. The Company’s lead product candidate, pegozafermin, a specifically engineered glycoPEGylated analog of fibroblast growth factor 21, is currently being developed for the treatment of nonalcoholic steatohepatitis and for the treatment of severe hypertriglyceridemia. 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 accompanying condensed consolidated financial statements have been prepared assuming the Company will continue as a going concern, which contemplates the realization of assets and liquidation of liabilities in the normal course of business. To date, the Company has not generated revenues from its activities and has incurred substantial operating losses. Management expects the Company to continue to generate substantial operating losses for the foreseeable future until it completes development of its products and seeks regulatory approvals to market such products. The Company had cash and cash equivalents and short-term available-for-sale securities of $ 448.3 million as of September 30, 2023. The Company expects that its cash and cash equivalents and short-term available-for-sale securities as of September 30, 2023 will be sufficient to fund operating expenses and capital expenditure requirements for a period of at least one year from the date these unaudited condensed consolidated financial statements are filed with the Securities and Exchange Commission (“SEC”). |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2023 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Unaudited Condensed Consolidated Financial Statements The accompanying interim unaudited condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States (“U.S. GAAP”) and applicable rules and regulations of the SEC regarding interim financial reporting. 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, 2022 and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary to present fairly the Company’s consolidated financial position, results of operations and comprehensive loss, and cash flows. The results of operations for the three and nine months ended September 30, 2023 are not necessarily indicative of the results to be expected for the year ending December 31, 2023 or for any other future annual or interim period. The condensed consolidated balance sheet as of December 31, 2022 was derived from the audited financial statements as of that date. 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, 2022, which was filed with the SEC on March 15, 2023. Reclassification Certain prior period amounts in the Company’s condensed consolidated statements of operations and comprehensive loss have been reclassified to conform to the current period presentation. Specifically, interest expense is disclosed separately on the Company’s condensed consolidated statements of operations and comprehensive loss, which had no impact on reported net loss, comprehensive loss, or loss per share. 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. 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 accrued research and development expenses, the fair value of stock options and unrecognized tax benefits. 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. There was no change in unrecognized tax benefits during the three months ended September 30, 2023. Unrecognized tax benefits increased by approximately $ 6.7 million during the nine months ended September 30, 2023. This change had no impact on the effective tax rate because of corresponding deductions from deferred tax assets. Fair Value Measurements Financial assets and liabilities are recorded at fair value on a recurring basis in the condensed consolidated balance sheets. The carrying values of Company’s financial assets and liabilities, including cash and cash equivalents, restricted cash, prepaid and other current assets, accounts payable and accrued expenses approximate to their fair value due to the short-term nature of these 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. 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. 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 consist primarily of amounts invested in money market funds and commercial paper that are stated at fair value. Investments Investments have been classified as available-for-sale and are carried at estimated fair value as determined based upon quoted market prices or pricing models for similar securities. Management determines the appropriate classification of its available-for-sale investments in debt securities at the time of purchase. Generally, investments with original maturities beyond three months at the date of purchase are classified as short-term because it is management’s intent to use the investments to fund current operations or to make them available for current operations. Realized gains and losses, if any, on available-for-sale securities are included in interest income and other, net. The cost of investments sold is based on the specific-identification method. The Company has no t experienced any material realized gains or losses in the periods presented. The Company periodically evaluates whether declines in fair values of its available-for-sale securities below amortized cost are due to credit-related factors or other factors. This evaluation consists of several qualitative and quantitative factors regarding the creditworthiness of the issuers of the security, the severity and duration of the unrealized loss as well as the Company’s ability and intent to hold the available-for-sale security until a forecasted recovery occurs. Additionally, the Company assesses whether it has plans to sell the security or it is more likely than not it will be required to sell any available-for-sale securities before recovery of its amortized cost basis. If a credit loss exists, an allowance for credit losses is recorded in interest income and other, net. To date, the Company has not recorded any impairment charges on its available-for-sale securities related to expected credit losses. Any remaining losses related to other factors are excluded from earnings and are reported as a component of comprehensive loss as an unrealized loss. Comprehensive Loss The Company’s comprehensive loss is comprised of net loss and changes in unrealized gains or losses on available-for-sale securities and foreign currency translation adjustments. Recently Adopted Accounting Standards In June 2016, the Financial Accounting Standards Board (“FASB”) issued ASU 2016-13, Financial Instruments—Credit Losses (Topic 326) : Measurement of Credit Losses on Financial Instruments (“ASU 2016-13”), which replaces the existing incurred loss impairment model with an expected credit loss model and requires a financial asset measured at amortized cost to be presented at the net amount expected to be collected. The Company adopted this new guidance on January 1, 2023 , using a modified retrospective approach and adoption did no t have a material impact on the Company's consolidated financial statements and related disclosures. In August 2020, the FASB issued ASU No. 2020-06 , Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging-Contracts in Entity's Own Equity (Subtopic 815-40)—Accounting for Convertible Instruments and Contracts in an Entity's Own Equity , which simplifies the accounting for convertible instruments, amends the guidance on derivative scope exceptions for contracts in an entity's own equity, and modifies the guidance on diluted earnings per share calculations as a result of these changes. The Company early adopted ASU 2020-06 as of January 1, 2023 , using a modified retrospective approach and adoption did no t have a material impact on the Company’s consolidated financial statements and related disclosures. |
Fair Value Measurements
Fair Value Measurements | 9 Months Ended |
Sep. 30, 2023 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | 3. Fair Value Measurements The Company’s financial assets measured at fair value on a recurring basis by level within the fair value hierarchy as of September 30, 2023 were as follows (in thousands): Valuation Amortized Unrealized Unrealized Fair Hierarchy Cost Gains Losses Value Money market funds Level 1 $ 8,947 $ — $ — $ 8,947 Commercial paper Level 2 104,151 — ( 50 ) 104,101 U.S. treasury bills Level 2 115,237 11 ( 12 ) 115,236 U.S. government bonds Level 2 89,910 1 ( 278 ) 89,633 Agency bonds Level 2 32,660 — ( 197 ) 32,463 Agency discount securities Level 2 2,479 — ( 3 ) 2,476 Corporate debt securities Level 2 3,159 — ( 34 ) 3,125 Total cash equivalents and available- $ 356,543 $ 12 $ ( 574 ) $ 355,981 Classified as: Cash equivalents $ 159,603 Short-term available-for-sale securities 196,378 Total cash equivalents and available- $ 355,981 The Company’s financial assets measured at fair value by contractual maturity as of September 30, 2023 were as follows (in thousands): Within one year $ 316,468 After one year through two years 39,513 Total cash equivalents and available-for-sale securities $ 355,981 The Company’s financial assets measured at fair value on a recurring basis by level within the fair value hierarchy as of December 31, 2022 were as follows (in thousands): Valuation Amortized Unrealized Unrealized Fair Hierarchy Cost Gains Losses Value Money market funds Level 1 $ 18,224 $ — $ — $ 18,224 Commercial paper Level 2 104,279 1 ( 84 ) 104,196 U.S. government bonds Level 2 18,225 1 ( 109 ) 18,117 Agency bonds Level 2 13,986 — ( 78 ) 13,908 Corporate debt securities Level 2 10,488 — ( 62 ) 10,426 U.S. treasury bills Level 2 7,414 1 ( 21 ) 7,394 Agency discount securities Level 2 5,216 9 — 5,225 Non-U.S. debt securities Level 2 3,975 — ( 20 ) 3,955 Total cash equivalents and available- $ 181,807 $ 12 $ ( 374 ) $ 181,445 Classified as: Cash equivalents $ 48,540 Short-term available-for-sale securities 132,905 Total cash equivalents and available- $ 181,445 The Company’s financial assets measured at fair value by contractual maturity as of December 31, 2022 were as follows (in thousands): Within one year $ 175,243 After one year through two years 6,202 Total cash equivalents and available-for-sale securities $ 181,445 |
Balance Sheet Components
Balance Sheet Components | 9 Months Ended |
Sep. 30, 2023 | |
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 indicated (in thousands): September 30, December 31, Prepaid research and development $ 9,193 $ 5,727 Prepaid taxes 611 646 Prepaid other 1,418 1,547 Total prepaid and other current assets $ 11,222 $ 7,920 Accrued expenses consist of the following as of the periods indicated (in thousands): September 30, December 31, Accrued research and development expenses $ 8,684 $ 6,499 Accrued employee and related expenses 3,937 4,165 Accrued professional and legal fees 1,432 1,052 Accrued other expenses 80 228 Total accrued expenses $ 14,133 $ 11,944 |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2023 | |
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 and the Company could be obligated to pay Teva up to $ 67.5 million under each program, for a total of $ 135.0 million, upon the achievement of certain clinical development and commercial milestones. In addition, the Company is obligated to pay Teva tiered royalties at percentages in the low-to-mid single-digits on worldwide net sales on all products containing the Teva compounds. The Teva Agreements can be terminated (i) by the Company without cause upon 120 days’ written notice to Teva, (ii) by either party, if the other party materially breaches any of its obligations under the Teva Agreements and fails to cure such breach within 60 days after receiving notice thereof, or (iii) by either party, if a bankruptcy petition is filed against the other party and is not dismissed within 60 days. In addition, Teva can also terminate the agreement related to the Company’s glycoPEGylated FGF21 program in the event the Company, or any of its affiliates or sublicensees, challenges any of the Teva patents licensed to the Company, and the challenge is not withdrawn within 30 days of written notice from Teva. During the three and nine months ended September 30, 2023 and 2022 , no ne of the development and commercial milestones were met and accordingly, there were no milestone payments related to the Teva Agreements (see Note 10). |
Term Loan
Term Loan | 9 Months Ended |
Sep. 30, 2023 | |
Debt Disclosure [Abstract] | |
Term Loan | 6. Term Loan 2021 Loan Agreement In April 2020, the Company entered into a Loan and Security Agreement, (the “Loan Agreement”) with the lenders referred to therein, and Silicon Valley Bank (“SVB”), as collateral agent. The Loan Agreement as amended in May 2021 (the “2021 Loan Agreement”) provided for (i) a secured term A loan facility (the “Term A Loan Facility”) of up to $ 20.0 million and (ii) a secured term B loan facility (the “Term B Loan Facility”) of up to $ 5.0 million. The Term A Loan Facility of $ 20.0 million was fully drawn as of December 2022 and the Term B Loan Facility expired unused. In January 2023, the Company executed a loan and security agreement with new lenders (the “2023 Loan Agreement”) and from the proceeds repaid $ 21.4 million in outstanding principal, final payment fee, prepayment fee and interest due under the 2021 Loan Agreement. Repayment of the 2021 Loan Agreement was accounted for as an extinguishment as the 2023 Loan Agreement was with new lenders. The Company recorded a loss on extinguishment of $ 1.2 million, which was recognized as a component of interest expense on the Company’s condensed consolidated statements of operations and comprehensive loss. 2023 Loan Agreement In January 2023, the Company executed the 2023 Loan Agreement with the lenders referred to therein, K2 HealthVentures LLC (“K2HV”) as administrative agent and Ankura Trust Company, LLC as collateral agent. The 2023 Loan Agreement provides for up to $ 100.0 million in aggregate principal in term loans, consisting of a first term loan of $ 25.0 million that was funded at closing, two subsequent term loans totaling $ 25.0 million that may be funded upon the achievement of certain time-based, clinical and regulatory milestones, and a fourth term loan of up to $ 50.0 million that may be funded upon discretionary approval by the lenders. As of September 30, 2023 , the second term loan of $ 15.0 million expired unused. The term loans are secured by substantially all of the assets of the Company, excluding the Company’s intellectual property. The 2023 Loan Agreement contains customary representations and warranties, restricts certain activities and includes customary events of default, including payment default, breach of covenants, change of control, and material adverse effects. In addition, starting January 1, 2024, the Company is required to maintain minimum unrestricted cash and cash equivalents equal to 5.0 times the average change in cash and cash equivalents measured over the trailing three-month period. The term loans mature on January 1, 2027 and provide for interest-only payments until February 1, 2025. Consecutive equal payments of principal and interest are due once the interest-only period has elapsed. The term loans bear interest equal to the greater of (i) 8.45 % and (ii) the sum of (a) the Prime Rate as reported in The Wall Street Journal plus (b) 2.25 %. The interest rate on the term loan was 9.75 % at inception and 10.75 % as of September 30, 2023 . 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 the term loans subject to a prepayment fee ranging from 3.0 % to 1.0 % depending on the timing of such prepayment. A commitment fee equal to 0.6 % of the principal amount of the fourth term loan is also payable should such loan be funded. At any time prior to full repayment of the term loans, the lenders may elect to convert up to an aggregate of $ 7.5 million of the principal amount of the term loans then outstanding into shares of the Company's common stock at a conversion price of $ 12.6943 per share. The embedded conversion option qualifies for a scope exception from derivative accounting because it is both indexed to the Company’s own stock and meets the conditions for equity classification. Total debt issuance costs related to the first term loan were $ 0.8 million, including the fair value of the warrant related to the first term loan (discussed below) were recorded as a debt discount since the first term loan was funded at inception. 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. The expected repayments of principal amount due on the term loans as of September 30, 2023 are as follows (in thousands): Remainder of 2023 $ — 2024 — 2025 10,774 2026 13,036 2027 1,190 Total principal repayments 25,000 Final payment fee 285 Total principal repayments and final payment fee 25,285 Unamortized debt discount ( 648 ) Total term loan, non-current, net $ 24,637 Warrants In January 2023, in connection with the 2023 Loan Agreement, the Company issued the lenders a warrant to purchase up to an aggregate of 204,815 shares of the Company’s common stock at an exercise price of $ 9.7649 per share (the “warrant shares”) that expires in January 2033 . The warrant shares become exercisable upon the funding of each term loan. In connection with the first term loan that was funded at closing , 51,204 of the warrant shares became exercisable. The warrant shares cannot be settled for cash and include a cashless exercise feature allowing the holder to receive shares net of shares withheld in lieu of the exercise price. The warrant shares also provide for automatic cashless exercise under certain specific conditions and settlement is permitted in unregistered shares. The 51,204 warrant shares meet the requirements for equity classification. 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”), 122,839 warrant shares are contingently exercisable upon the funding of each subsequent term loan and have the same exercise price and contractual term and 30,722 warrant shares associated with the second term loan were forfeited as of September 30, 2023. The contingent warrants did not meet the derivative scope exception or equity classification criteria and were accounted for as a derivative liability. The initial fair value and the fair value as of September 30, 2023 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 input assumptions above. |
Stockholders' Equity
Stockholders' Equity | 9 Months Ended |
Sep. 30, 2023 | |
Equity [Abstract] | |
Stockholders' Equity | 7. Stockholders’ Equity As of September 30, 2023, the Company’s shares of common stock available for future issuance were as follows: Shares available for future grant under the equity incentive plans 1,848,784 Shares available for future issuance under the employee stock purchase plan 1,220,897 Shares available for future issuance upon the exercise of warrants and pre-funded warrants 11,212,805 Total available for future issuance 14,282,486 Public Offerings At-the-Market Offerings In March 2021, the Company entered into a sales agreement (as amended, the “Sales Agreement”) with SVB Securities LLC and Cantor Fitzgerald & Co. (the “Sales Agents”) pursuant to which it may offer and sell up to $ 75.0 million of the Company’s common stock, from time to time, in “at-the-market” offerings (the “ATM Facility”). The Sales Agents are entitled to compensation at a commission equal to 3.0 % of the aggregate gross sales price per share sold under the Sales Agreement. During the three months ended March 31, 2023, the Company received aggregate proceeds of $ 13.4 million, net of commissions, from sales of 968,000 shares of its common stock pursuant to the ATM Facility. On February 15, 2023, the Company entered into Amendment No. 1 to the Sales Agreement with the Sales Agents, pursuant to which the Company may offer and sell up to $ 150.0 million of its common stock, from time to time, through the ATM Facility at a commission of up to 3.0 % of the aggregate gross sales price per share sold under the Sales Agreement. During the three months ended June 30, 2023, the Company received aggregate proceeds of $ 23.7 million, net of commissions, from sales of 1,200,539 shares of its common stock pursuant to the ATM Facility. July 2022 Public Offering In July 2022, the Company completed an underwritten public offering of its common stock, warrants to purchase shares of its common stock and pre-funded warrants to purchase shares of its common stock. The Company sold 18,675,466 shares of its common stock with accompanying warrants to purchase up to 9,337,733 shares of its common stock at a combined public offering price of $ 3.55 per share. The Company also sold 7,944,252 pre-funded warrants to purchase shares of its common stock with accompanying warrants to purchase up to 3,972,126 shares of its common stock at a combined public offering price of $ 3.549 per pre-funded warrant, which represents the per share public offering price for the common stock less $ 0.001 per share, the exercise price for each pre-funded warrant. The Company raised aggregate proceeds of $ 88.2 million, net of underwriting discounts and commissions of $ 5.7 million and other offering costs of $ 0.6 million. The exercise of the outstanding warrants is subject to a beneficial ownership limitation of 9.99 %, or at the election of the holder prior to the issuance of the warrant, 4.99 %. The exercise of the outstanding pre-funded warrants is subject to a beneficial ownership limitation of 9.99 %, or at the election of the holder prior to the issuance of the pre-funded warrant, 4.99 %, which a holder may increase or decrease from time to time but shall not exceed 19.99 %. The exercise price and number of shares of common stock issuable upon the exercise of the warrants and pre-funded warrants are subject to adjustment in the event of any stock dividends, stock splits, reverse stock split, recapitalization, or reorganization or similar transaction, as described in the agreements. Under certain circumstances, the warrants and pre-funded warrants may be exercisable on a “cashless” basis. The warrants and pre-funded warrants were classified as a component of stockholders’ equity and additional paid-in capital because such warrants and pre-funded warrants (i) are freestanding financial instruments that are legally detachable and separately exercisable from the equity instruments, (ii) are immediately exercisable, (iii) do not embody an obligation for the Company to repurchase its shares, (iv) permit the holders to receive a fixed number of common shares upon exercise, (v) are indexed to the Company’s common stock and (vi) meet the equity classification criteria. In addition, the warrants and pre-funded warrants do not provide any guarantee of value or return. March 2023 Public Offering In March 2023, the Company completed an underwritten public offering of its common stock. The Company sold 19,461,538 shares of its common stock at a public offering price of $ 16.25 per share. The Company raised aggregate proceeds of $ 296.8 million, net of underwriting discounts and commissions of $ 19.0 million and other offering costs of $ 0.5 million. Common Stock Warrants As of September 30, 2023, the Company’s outstanding warrants to purchase shares of its common stock were as follows: Shares of Exercise Price Expiration Warrant issued with term loan to SVB 25,000 $ 22.06 June 30, 2025 Warrant issued with term loan to SVB 33,923 19.12 May 28, 2031 Warrants issued with term loan to K2HV 174,093 9.76 January 27, 2033 Warrants issued in public offering 10,179,789 5.325 July 1, 2024 Pre-funded warrants issued in public offering 800,000 0.001 Do Not Expire Total outstanding 11,212,805 |
Stock-Based Compensation
Stock-Based Compensation | 9 Months Ended |
Sep. 30, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Stock-Based Compensation | 8. Stock-Based Compensation Equity Incentive Plans In September 2019, the Company’s board of directors adopted the 2019 Equity Incentive Plan (the “2019 Plan”), which also became effective in September 2019. The Company initially reserved 2,844,193 shares of common stock for issuance under the 2019 Plan. In addition, the number of shares of common stock reserved for issuance under the 2019 Plan will automatically increase on the first day of January for a period of up to ten years in an amount equal to 4 % of the total number of shares of the Company’s capital stock outstanding on the immediately preceding December 31, or a lesser number of shares determined by the Company’s board of directors. In February 2023, the Company’s board of directors adopted the 2023 Inducement Plan (the “2023 Plan”), which also became effective in February 2023. The Company initially reserved 1,500,000 shares of common stock for issuance under the 2023 Plan. Under the 2023 Plan, new employees are eligible to receive equity awards as a material inducement to the commencement of employment with the Company. During the three and nine months ended September 30, 2023 , options to purchase an aggregate of 279,600 and 417,700 shares, respectively, were granted to 14 and 20 new employees, respectively, under the 2023 Plan. Employee Stock Purchase Plan In October 2019, the Company’s board of directors adopted the 2019 Employee Stock Purchase Plan (“ESPP”), which became effective in November 2019. The Company initially reserved 225,188 shares of common stock for purchase under the ESPP. The number of shares of common stock reserved for issuance under the ESPP will automatically increase on the first day of January for a period of up to ten years in an amount equal to 1 % of the total number of shares of the Company’s common stock outstanding on the immediately preceding December 31, or a lesser number of shares determined by the Company’s board of directors. Purchases are accomplished through the participation of discrete offering periods and each offering is expected to be six months in duration. For each offering period, ESPP participants will purchase shares of common stock at a price per share equal to 85 % of the lesser of the fair market value of the Company’s common stock on (1) the first trading day of the applicable offering period or (2) the last trading day of the applicable offering period. Stock Options The following table summarizes stock option activity under the Company's equity incentive plans for the nine months ended September 30, 2023: Weighted Weighted Average Average Remaining Aggregate Number of Exercise Contractual Intrinsic Options Price Term Value (In years) (In thousands) Balance outstanding as of December 31, 2022 3,161,917 $ 12.80 7.9 $ 16,612 Granted 1,783,900 15.18 Exercised ( 196,612 ) 3.20 Cancelled and forfeited ( 70,178 ) 10.77 Balance outstanding as of September 30, 2023 4,679,027 $ 14.14 8.0 $ 19,912 Exercisable as of September 30, 2023 2,005,286 $ 14.22 6.8 $ 12,824 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: Nine Months Ended 2023 2022 Expected term (years) 5.5 - 6.1 5.5 - 6.1 Expected volatility 91.6 - 99.2 % 89.9 - 91.0 % Risk-free interest rate 3.4 - 4.6 % 1.6 - 3.4 % Expected dividend — — Restricted Stock Units (“RSUs”) The Company has granted certain employees service-based RSUs that generally vest annually over a two or three-year period. The restrictions lapse over time for these service-based RSUs. In the event of termination of the holder’s continuous service to the Company, any unvested portion of the service-based RSUs is cancelled. For the three months ended September 30, 2023 and 2022 , the Company recognized $ 0.9 million and $ 0.3 million, respectively, in expense related to the service-based RSUs. For the nine months ended September 30, 2023 and 2022 , the Company recognized $ 2.4 million and $ 0.7 million, respectively, in expense related to the service-based RSUs. In February 2021, the Company granted performance-based RSUs that vest as to one-third on each one-year anniversary date, subject to achievement of a development milestone and continued service to the Company. In each of February 2022 and 2023, a portion of the performance-based RSUs vested upon achievement of the development milestone and satisfaction of the continued service condition. In February and September 2022, the Company granted performance-based RSUs that vest during the applicable performance period, subject to the achievement of certain corporate or department targets and continued service to the Company. In September 2022, March 2023 and June 2023, a portion of the performance-based RSUs that were granted in February 2022 vested upon achievement of specific targets and satisfaction of the continued service condition. As of September 30, 2023, it was probable that the remaining performance conditions would be met for the Company’s performance-based RSUs and expense was recognized using the accelerated attribution method. For the three months ended September 30, 2023 and 2022 , the Company recognized expense of $ 0.2 million and $ 0.3 million, respectively, related to performance-based RSUs. For the nine months ended September 30, 2023 and 2022 , the Company recognized $ 0.8 million and $ 1.1 million, respectively, in expense related to the performance-based RSUs. The following table summarizes RSU activity for the nine months ended September 30, 2023: Number of Weighted Average Balance outstanding as of December 31, 2022 1,095,738 $ 5.77 Granted 379,075 15.02 Vested / released ( 309,740 ) 5.82 Cancelled / forfeited ( 177,523 ) $ 5.89 Balance outstanding as of September 30, 2023 987,550 $ 9.28 The Company recorded stock-based compensation for the periods indicated as follows (in thousands): Three Months Ended Nine Months Ended 2023 2022 2023 2022 Research and development $ 1,938 $ 1,019 $ 5,136 $ 2,917 General and administrative 2,443 1,481 6,933 4,681 Total stock-based compensation $ 4,381 $ 2,500 $ 12,069 $ 7,598 |
Net Loss Per Share
Net Loss Per Share | 9 Months Ended |
Sep. 30, 2023 | |
Earnings Per Share [Abstract] | |
Net Loss Per Share | 9. Net Loss Per Share 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: Nine Months Ended 2023 2022 Stock options to purchase common stock 4,679,027 3,123,221 Unvested RSUs 987,550 1,118,735 Warrants to purchase common stock 1 10,412,805 13,358,782 Conversion shares under the term loan with K2HV 590,816 — ESPP 9,758 20,353 Total 16,679,956 17,621,091 1 The table above excludes pre-funded warrants issued in connection with the July 2022 public offering (see Note 7). |
Subsequent Events
Subsequent Events | 9 Months Ended |
Sep. 30, 2023 | |
Subsequent Events [Abstract] | |
Subsequent Events | 10. Subsequent Events Teva Agreements In October 2023, the Company achieved a clinical development milestone related to the enrollment of patients pursuant to the Teva Agreements. As a result, a $ 2.5 million milestone payment became due and payable (see Note 5). |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2023 | |
Accounting Policies [Abstract] | |
Unaudited Condensed Consolidated Financial Statements | Unaudited Condensed Consolidated Financial Statements The accompanying interim unaudited condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States (“U.S. GAAP”) and applicable rules and regulations of the SEC regarding interim financial reporting. 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, 2022 and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary to present fairly the Company’s consolidated financial position, results of operations and comprehensive loss, and cash flows. The results of operations for the three and nine months ended September 30, 2023 are not necessarily indicative of the results to be expected for the year ending December 31, 2023 or for any other future annual or interim period. The condensed consolidated balance sheet as of December 31, 2022 was derived from the audited financial statements as of that date. 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, 2022, which was filed with the SEC on March 15, 2023. |
Reclassification | Reclassification Certain prior period amounts in the Company’s condensed consolidated statements of operations and comprehensive loss have been reclassified to conform to the current period presentation. Specifically, interest expense is disclosed separately on the Company’s condensed consolidated statements of operations and comprehensive loss, which had no impact on reported net loss, comprehensive loss, or loss per share. |
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. |
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 accrued research and development expenses, the fair value of stock options and unrecognized tax benefits. 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. There was no change in unrecognized tax benefits during the three months ended September 30, 2023. Unrecognized tax benefits increased by approximately $ 6.7 million during the nine months ended September 30, 2023. This change had no impact on the effective tax rate because of corresponding deductions from deferred tax assets. |
Fair Value Measurements | Fair Value Measurements Financial assets and liabilities are recorded at fair value on a recurring basis in the condensed consolidated balance sheets. The carrying values of Company’s financial assets and liabilities, including cash and cash equivalents, restricted cash, prepaid and other current assets, accounts payable and accrued expenses approximate to their fair value due to the short-term nature of these 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. 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. |
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 consist primarily of amounts invested in money market funds and commercial paper that are stated at fair value. |
Investments | Investments Investments have been classified as available-for-sale and are carried at estimated fair value as determined based upon quoted market prices or pricing models for similar securities. Management determines the appropriate classification of its available-for-sale investments in debt securities at the time of purchase. Generally, investments with original maturities beyond three months at the date of purchase are classified as short-term because it is management’s intent to use the investments to fund current operations or to make them available for current operations. Realized gains and losses, if any, on available-for-sale securities are included in interest income and other, net. The cost of investments sold is based on the specific-identification method. The Company has no t experienced any material realized gains or losses in the periods presented. The Company periodically evaluates whether declines in fair values of its available-for-sale securities below amortized cost are due to credit-related factors or other factors. This evaluation consists of several qualitative and quantitative factors regarding the creditworthiness of the issuers of the security, the severity and duration of the unrealized loss as well as the Company’s ability and intent to hold the available-for-sale security until a forecasted recovery occurs. Additionally, the Company assesses whether it has plans to sell the security or it is more likely than not it will be required to sell any available-for-sale securities before recovery of its amortized cost basis. If a credit loss exists, an allowance for credit losses is recorded in interest income and other, net. To date, the Company has not recorded any impairment charges on its available-for-sale securities related to expected credit losses. Any remaining losses related to other factors are excluded from earnings and are reported as a component of comprehensive loss as an unrealized loss. |
Comprehensive Loss | Comprehensive Loss The Company’s comprehensive loss is comprised of net loss and changes in unrealized gains or losses on available-for-sale securities and foreign currency translation adjustments. |
Recent Adopted And Accounting Pronouncements | Recently Adopted Accounting Standards In June 2016, the Financial Accounting Standards Board (“FASB”) issued ASU 2016-13, Financial Instruments—Credit Losses (Topic 326) : Measurement of Credit Losses on Financial Instruments (“ASU 2016-13”), which replaces the existing incurred loss impairment model with an expected credit loss model and requires a financial asset measured at amortized cost to be presented at the net amount expected to be collected. The Company adopted this new guidance on January 1, 2023 , using a modified retrospective approach and adoption did no t have a material impact on the Company's consolidated financial statements and related disclosures. In August 2020, the FASB issued ASU No. 2020-06 , Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging-Contracts in Entity's Own Equity (Subtopic 815-40)—Accounting for Convertible Instruments and Contracts in an Entity's Own Equity , which simplifies the accounting for convertible instruments, amends the guidance on derivative scope exceptions for contracts in an entity's own equity, and modifies the guidance on diluted earnings per share calculations as a result of these changes. The Company early adopted ASU 2020-06 as of January 1, 2023 , using a modified retrospective approach and adoption did no t have a material impact on the Company’s consolidated financial statements and related disclosures. |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Fair Value Disclosures [Abstract] | |
Summary of Financial Assets Measured at Fair Value on Recurring Basis | The Company’s financial assets measured at fair value on a recurring basis by level within the fair value hierarchy as of September 30, 2023 were as follows (in thousands): Valuation Amortized Unrealized Unrealized Fair Hierarchy Cost Gains Losses Value Money market funds Level 1 $ 8,947 $ — $ — $ 8,947 Commercial paper Level 2 104,151 — ( 50 ) 104,101 U.S. treasury bills Level 2 115,237 11 ( 12 ) 115,236 U.S. government bonds Level 2 89,910 1 ( 278 ) 89,633 Agency bonds Level 2 32,660 — ( 197 ) 32,463 Agency discount securities Level 2 2,479 — ( 3 ) 2,476 Corporate debt securities Level 2 3,159 — ( 34 ) 3,125 Total cash equivalents and available- $ 356,543 $ 12 $ ( 574 ) $ 355,981 Classified as: Cash equivalents $ 159,603 Short-term available-for-sale securities 196,378 Total cash equivalents and available- $ 355,981 The Company’s financial assets measured at fair value on a recurring basis by level within the fair value hierarchy as of December 31, 2022 were as follows (in thousands): Valuation Amortized Unrealized Unrealized Fair Hierarchy Cost Gains Losses Value Money market funds Level 1 $ 18,224 $ — $ — $ 18,224 Commercial paper Level 2 104,279 1 ( 84 ) 104,196 U.S. government bonds Level 2 18,225 1 ( 109 ) 18,117 Agency bonds Level 2 13,986 — ( 78 ) 13,908 Corporate debt securities Level 2 10,488 — ( 62 ) 10,426 U.S. treasury bills Level 2 7,414 1 ( 21 ) 7,394 Agency discount securities Level 2 5,216 9 — 5,225 Non-U.S. debt securities Level 2 3,975 — ( 20 ) 3,955 Total cash equivalents and available- $ 181,807 $ 12 $ ( 374 ) $ 181,445 Classified as: Cash equivalents $ 48,540 Short-term available-for-sale securities 132,905 Total cash equivalents and available- $ 181,445 |
Schedule of Contractual Maturities of Financial Assets Measured at Fair Value | The Company’s financial assets measured at fair value by contractual maturity as of September 30, 2023 were as follows (in thousands): Within one year $ 316,468 After one year through two years 39,513 Total cash equivalents and available-for-sale securities $ 355,981 The Company’s financial assets measured at fair value by contractual maturity as of December 31, 2022 were as follows (in thousands): Within one year $ 175,243 After one year through two years 6,202 Total cash equivalents and available-for-sale securities $ 181,445 |
Balance Sheet Components (Table
Balance Sheet Components (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Balance Sheet Related Disclosures [Abstract] | |
Schedule of Prepaid and Other Current Assets | Prepaid and other current assets consist of the following as of the periods indicated (in thousands): September 30, December 31, Prepaid research and development $ 9,193 $ 5,727 Prepaid taxes 611 646 Prepaid other 1,418 1,547 Total prepaid and other current assets $ 11,222 $ 7,920 |
Schedule of Accrued Expenses | Accrued expenses consist of the following as of the periods indicated (in thousands): September 30, December 31, Accrued research and development expenses $ 8,684 $ 6,499 Accrued employee and related expenses 3,937 4,165 Accrued professional and legal fees 1,432 1,052 Accrued other expenses 80 228 Total accrued expenses $ 14,133 $ 11,944 |
Term Loan (Tables)
Term Loan (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Debt Disclosure [Abstract] | |
Schedule of Repayment of Principal Amount | The expected repayments of principal amount due on the term loans as of September 30, 2023 are as follows (in thousands): Remainder of 2023 $ — 2024 — 2025 10,774 2026 13,036 2027 1,190 Total principal repayments 25,000 Final payment fee 285 Total principal repayments and final payment fee 25,285 Unamortized debt discount ( 648 ) Total term loan, non-current, net $ 24,637 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Equity [Abstract] | |
Schedule of Shares of Common Stock Available for Future Issuance | As of September 30, 2023, the Company’s shares of common stock available for future issuance were as follows: Shares available for future grant under the equity incentive plans 1,848,784 Shares available for future issuance under the employee stock purchase plan 1,220,897 Shares available for future issuance upon the exercise of warrants and pre-funded warrants 11,212,805 Total available for future issuance 14,282,486 |
Schedule of Outstanding Warrants to Purchase Shares of Common Stock | As of September 30, 2023, the Company’s outstanding warrants to purchase shares of its common stock were as follows: Shares of Exercise Price Expiration Warrant issued with term loan to SVB 25,000 $ 22.06 June 30, 2025 Warrant issued with term loan to SVB 33,923 19.12 May 28, 2031 Warrants issued with term loan to K2HV 174,093 9.76 January 27, 2033 Warrants issued in public offering 10,179,789 5.325 July 1, 2024 Pre-funded warrants issued in public offering 800,000 0.001 Do Not Expire Total outstanding 11,212,805 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
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 nine months ended September 30, 2023: Weighted Weighted Average Average Remaining Aggregate Number of Exercise Contractual Intrinsic Options Price Term Value (In years) (In thousands) Balance outstanding as of December 31, 2022 3,161,917 $ 12.80 7.9 $ 16,612 Granted 1,783,900 15.18 Exercised ( 196,612 ) 3.20 Cancelled and forfeited ( 70,178 ) 10.77 Balance outstanding as of September 30, 2023 4,679,027 $ 14.14 8.0 $ 19,912 Exercisable as of September 30, 2023 2,005,286 $ 14.22 6.8 $ 12,824 |
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: Nine Months Ended 2023 2022 Expected term (years) 5.5 - 6.1 5.5 - 6.1 Expected volatility 91.6 - 99.2 % 89.9 - 91.0 % Risk-free interest rate 3.4 - 4.6 % 1.6 - 3.4 % Expected dividend — — |
Summary of Restricted Stock Unit Activity | The following table summarizes RSU activity for the nine months ended September 30, 2023: Number of Weighted Average Balance outstanding as of December 31, 2022 1,095,738 $ 5.77 Granted 379,075 15.02 Vested / released ( 309,740 ) 5.82 Cancelled / forfeited ( 177,523 ) $ 5.89 Balance outstanding as of September 30, 2023 987,550 $ 9.28 |
Summary of Stock-Based Compensation | The Company recorded stock-based compensation for the periods indicated as follows (in thousands): Three Months Ended Nine Months Ended 2023 2022 2023 2022 Research and development $ 1,938 $ 1,019 $ 5,136 $ 2,917 General and administrative 2,443 1,481 6,933 4,681 Total stock-based compensation $ 4,381 $ 2,500 $ 12,069 $ 7,598 |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Earnings Per Share [Abstract] | |
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: Nine Months Ended 2023 2022 Stock options to purchase common stock 4,679,027 3,123,221 Unvested RSUs 987,550 1,118,735 Warrants to purchase common stock 1 10,412,805 13,358,782 Conversion shares under the term loan with K2HV 590,816 — ESPP 9,758 20,353 Total 16,679,956 17,621,091 1 The table above excludes pre-funded warrants issued in connection with the July 2022 public offering (see Note 7). |
Organization and Basis of Pre_2
Organization and Basis of Presentation - Additional Information (Details) $ in Millions | 9 Months Ended |
Sep. 30, 2023 USD ($) | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Date of incorporation | Jun. 30, 2019 |
Cash and cash equivalents and short term available-for-sale securities | $ 448.3 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies - Additional Information (Details) | 3 Months Ended | 9 Months Ended |
Sep. 30, 2023 USD ($) | Sep. 30, 2023 USD ($) | |
Summary Of Significant Accounting Policies [Line Items] | ||
Realized gains or losses on investments | $ 0 | |
Increase in unrecognized tax benefits | $ 0 | $ 6,700,000 |
ASU 2016-13 | ||
Summary Of Significant Accounting Policies [Line Items] | ||
Change in accounting principle, accounting standards update, adopted [true false] | true | true |
Change in accounting principle, accounting standards update, adoption date | Jan. 01, 2023 | Jan. 01, 2023 |
Change in accounting principle, accounting standards update, immaterial effect [true false] | true | true |
ASU 2020-06 | ||
Summary Of Significant Accounting Policies [Line Items] | ||
Change in accounting principle, accounting standards update, early adopted [true false] | true | true |
Change in accounting principle, accounting standards update, adoption date | Jan. 01, 2023 | Jan. 01, 2023 |
Change in accounting principle, accounting standards update, immaterial effect [true false] | true | true |
Fair Value Measurements - Summa
Fair Value Measurements - Summary of Financial Assets Measured at Fair Value on Recurring Basis (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Short-term investments, Aggregated Fair Value | $ 355,981 | $ 181,445 |
Recurring | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Short-term investments, Amortized Cost | 356,543 | 181,807 |
Short-term investments, Gross Unrealized Holding Gains | 12 | 12 |
Short-term investments, Gross Unrealized Holding Losses | (574) | (374) |
Short-term investments, Aggregated Fair Value | 355,981 | 181,445 |
Recurring | Cash equivalents | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Short-term investments, Aggregated Fair Value | 159,603 | 48,540 |
Recurring | Short-term available for sale securities | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Short-term investments, Aggregated Fair Value | 196,378 | 132,905 |
Recurring | Level 1 | Money Market Funds | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Short-term investments, Amortized Cost | 8,947 | 18,224 |
Short-term investments, Aggregated Fair Value | 8,947 | 18,224 |
Recurring | Level 2 | Commercial Paper | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Short-term investments, Amortized Cost | 104,151 | 104,279 |
Short-term investments, Gross Unrealized Holding Gains | 1 | |
Short-term investments, Gross Unrealized Holding Losses | (50) | (84) |
Short-term investments, Aggregated Fair Value | 104,101 | 104,196 |
Recurring | Level 2 | U.S. treasury bills | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Short-term investments, Amortized Cost | 115,237 | 7,414 |
Short-term investments, Gross Unrealized Holding Gains | 11 | 1 |
Short-term investments, Gross Unrealized Holding Losses | (12) | (21) |
Short-term investments, Aggregated Fair Value | 115,236 | 7,394 |
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 | 89,910 | 18,225 |
Short-term investments, Gross Unrealized Holding Gains | 1 | 1 |
Short-term investments, Gross Unrealized Holding Losses | (278) | (109) |
Short-term investments, Aggregated Fair Value | 89,633 | 18,117 |
Recurring | Level 2 | Agency bonds | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Short-term investments, Amortized Cost | 32,660 | 13,986 |
Short-term investments, Gross Unrealized Holding Losses | (197) | (78) |
Short-term investments, Aggregated Fair Value | 32,463 | 13,908 |
Recurring | Level 2 | Non-US debt securities | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Short-term investments, Amortized Cost | 3,975 | |
Short-term investments, Gross Unrealized Holding Losses | (20) | |
Short-term investments, Aggregated Fair Value | 3,955 | |
Recurring | Level 2 | Agency discount securities | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Short-term investments, Amortized Cost | 2,479 | 5,216 |
Short-term investments, Gross Unrealized Holding Gains | 9 | |
Short-term investments, Gross Unrealized Holding Losses | (3) | |
Short-term investments, Aggregated Fair Value | 2,476 | 5,225 |
Recurring | Level 2 | Corporate Debt | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Short-term investments, Amortized Cost | 3,159 | 10,488 |
Short-term investments, Gross Unrealized Holding Losses | (34) | (62) |
Short-term investments, Aggregated Fair Value | $ 3,125 | $ 10,426 |
Fair Value Measurements - Sched
Fair Value Measurements - Schedule of Contractual Maturities of Financial Assets Measured at Fair Value (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Fair Value Disclosures [Abstract] | ||
Within one year | $ 316,468 | $ 175,243 |
After one year through two years | 39,513 | 6,202 |
Total cash equivalents and available-for-sale securities | $ 355,981 | $ 181,445 |
Balance Sheet Components - Sche
Balance Sheet Components - Schedule of Prepaid and Other Current Assets (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Prepaid Expense and Other Assets, Current [Abstract] | ||
Prepaid research and development | $ 9,193 | $ 5,727 |
Prepaid taxes | 611 | 646 |
Prepaid other | 1,418 | 1,547 |
Total prepaid and other current assets | $ 11,222 | $ 7,920 |
Balance Sheet Components - Sc_2
Balance Sheet Components - Schedule of Accrued Expenses (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Payables and Accruals [Abstract] | ||
Accrued research and development expenses | $ 8,684 | $ 6,499 |
Accrued employee and related expenses | 3,937 | 4,165 |
Accrued professional and legal fees | 1,432 | 1,052 |
Accrued other expenses | 80 | 228 |
Total accrued expenses | $ 14,133 | $ 11,944 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Details) - Teva Agreement - USD ($) | 1 Months Ended | 3 Months Ended | 9 Months Ended | ||
Apr. 30, 2018 | Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Loss Contingencies [Line Items] | |||||
Nonrefundable upfront payment | $ 6,000,000 | ||||
Payment upon achievement of certain clinical and commercial milestones | 135,000,000 | ||||
Asset transfer and license agreement, termination period after written notice | 120 days | ||||
Asset transfer and license agreement, termination period notice of breach | 60 days | ||||
Asset transfer and license agreement termination notice period if bankruptcy petition filed | 60 days | ||||
Milestone payments | $ 0 | $ 0 | $ 0 | $ 0 | |
Research and Development Expenses | |||||
Loss Contingencies [Line Items] | |||||
Milestone payments | $ 0 | $ 0 | $ 0 | $ 0 | |
Teva's GlycoPEGylated FGF21 Program | |||||
Loss Contingencies [Line Items] | |||||
Payment upon achievement of certain clinical and commercial milestones | 67,500,000 | ||||
Teva's Development Program | |||||
Loss Contingencies [Line Items] | |||||
Payment upon achievement of certain clinical and commercial milestones | $ 67,500,000 |
Term Loan - Additional Informat
Term Loan - Additional Information (Details) $ / shares in Units, $ in Thousands | 1 Months Ended | 9 Months Ended | ||
Jan. 31, 2023 USD ($) $ / shares shares | Dec. 31, 2022 USD ($) | Apr. 30, 2020 USD ($) | Sep. 30, 2023 USD ($) shares | |
Debt Instrument [Line Items] | ||||
Debt discount | $ 648 | |||
Loss on extinguishment | (1,208) | |||
Tranche one | ||||
Debt Instrument [Line Items] | ||||
Warrants to purchase common stock | shares | 51,204 | |||
Loan Agreement | ||||
Debt Instrument [Line Items] | ||||
Line of credit facility, description | In April 2020, the Company entered into a Loan and Security Agreement, (the “Loan Agreement”) with the lenders referred to therein, and Silicon Valley Bank (“SVB”), as collateral agent. The Loan Agreement as amended in May 2021 (the “2021 Loan Agreement”) provided for (i) a secured term A loan facility (the “Term A Loan Facility”) of up to $20.0 million and (ii) a secured term B loan facility (the “Term B Loan Facility”) of up to $5.0 million. The Term A Loan Facility of $20.0 million was fully drawn as of December 2022 and the Term B Loan Facility expired unused. | |||
Loss on extinguishment | $ (1,200) | |||
Loan Agreement | Term A Loan Facility | ||||
Debt Instrument [Line Items] | ||||
Line of credit facility, maximum borrowing capacity | $ 20,000 | |||
Line of credit facility fully drawn amount | $ 20,000 | |||
Loan Agreement | Term B Loan Facility | ||||
Debt Instrument [Line Items] | ||||
Line of credit facility, maximum borrowing capacity | $ 5,000 | |||
2021 Loan Agreement | ||||
Debt Instrument [Line Items] | ||||
Repaid line of credit | $ 21,400 | |||
2023 Loan Agreement | ||||
Debt Instrument [Line Items] | ||||
Line of credit facility, maximum borrowing capacity | $ 100,000 | |||
Line of credit facility, description | In January 2023, the Company executed a loan and security agreement with new lenders (the “2023 Loan Agreement”) and from the proceeds repaid $21.4 million in outstanding principal, final payment fee, prepayment fee and interest due under the 2021 Loan Agreement. Repayment of the 2021 Loan Agreement was accounted for as an extinguishment as the 2023 Loan Agreement was with new lenders. The Company recorded a loss on extinguishment of $1.2 million, which was recognized as a component of interest expense on the Company’s condensed consolidated statements of operations and comprehensive loss. | |||
Warrant exercise price | $ / shares | $ 9.7649 | |||
Warrants expiration month and year | 2033-01 | |||
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 | The term loans 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% | |||
Percentage of fee on loan | 5.95% | |||
Conversion price per share | $ / shares | $ 12.6943 | |||
Contingent warrants | shares | 153,611 | |||
Warrant Forfeited | shares | 30,722 | |||
2023 Loan Agreement | Minimum | ||||
Debt Instrument [Line Items] | ||||
Debt instrument, interest rate | 8.45% | |||
Prepayment fee percentage. | 1% | |||
2023 Loan Agreement | Maximum | ||||
Debt Instrument [Line Items] | ||||
Warrants to purchase common stock | shares | 204,815 | |||
Prepayment fee percentage. | 3% | |||
Conversion of principal amount | $ 7,500 | |||
2023 Loan Agreement | 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, expired unused | $ 15,000 | |||
Credit facility maturity date | Sep. 30, 2023 | |||
2023 Loan Agreement | Tranche two and three | ||||
Debt Instrument [Line Items] | ||||
Line of credit facility, maximum borrowing capacity | $ 25,000 | |||
Warrant contingently exercisable upon funding of each subsequent term loan | shares | 122,839 | |||
2023 Loan Agreement | Tranche Four | ||||
Debt Instrument [Line Items] | ||||
Line of credit facility, maximum borrowing capacity | $ 50,000 | |||
Commitment fee percentage | 0.60% |
Term Loan - Schedule of Repayme
Term Loan - Schedule of Repayment of Principal Amount (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Debt Disclosure [Abstract] | ||
Remainder of 2023 | $ 0 | |
2024 | 0 | |
2025 | 10,774 | |
2026 | 13,036 | |
2027 | 1,190 | |
Total principal repayments | 25,000 | |
Final payment fee | 285 | |
Total principal repayments and final payment fee | 25,285 | |
Less: unamortized debt discount | (648) | |
Total term loan, non-current, net | $ 24,637 | $ 20,192 |
Stockholders' Equity - Schedule
Stockholders' Equity - Schedule of Shares of Common Stock Available for Future Issuance (Details) | Sep. 30, 2023 shares |
Class Of Stock [Line Items] | |
Total available for future issuance | 14,282,486 |
Equity Incentive Plans | |
Class Of Stock [Line Items] | |
Total available for future issuance | 1,848,784 |
Employee Stock Purchase Plan | |
Class Of Stock [Line Items] | |
Total available for future issuance | 1,220,897 |
Exercise of Warrants and Pre-funded Warrants | |
Class Of Stock [Line Items] | |
Total available for future issuance | 11,212,805 |
Stockholders' Equity - Addition
Stockholders' Equity - Additional Information (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | ||||||
Mar. 31, 2023 | Jul. 31, 2022 | Jun. 30, 2023 | Mar. 31, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Feb. 15, 2023 | Mar. 31, 2021 | |
Subsidiary Sale Of Stock [Line Items] | |||||||||
Proceeds from issuance of common stock, net of commissions and offering expenses | $ 142 | $ 43 | |||||||
Pre-funded Warrants | |||||||||
Subsidiary Sale Of Stock [Line Items] | |||||||||
Percentage of ownership limitation | 9.99% | ||||||||
Percentage of ownership prior to issuance | 4.99% | ||||||||
Warrants | |||||||||
Subsidiary Sale Of Stock [Line Items] | |||||||||
Percentage of ownership limitation | 9.99% | ||||||||
Percentage of ownership prior to issuance | 4.99% | ||||||||
Maximum | Pre-funded Warrants | |||||||||
Subsidiary Sale Of Stock [Line Items] | |||||||||
Percentage of ownership limitation | 19.99% | ||||||||
Maximum | Warrants | |||||||||
Subsidiary Sale Of Stock [Line Items] | |||||||||
Percentage of ownership limitation | 19.99% | ||||||||
A T M Facility | |||||||||
Subsidiary Sale Of Stock [Line Items] | |||||||||
Issuance of common stock | $ 23,667 | $ 13,422 | $ 8,370 | ||||||
Public Offerings | |||||||||
Subsidiary Sale Of Stock [Line Items] | |||||||||
Public offering description | In July 2022, the Company completed an underwritten public offering of its common stock, warrants to purchase shares of its common stock and pre-funded warrants to purchase shares of its common stock. The Company sold 18,675,466 shares of its common stock with accompanying warrants to purchase up to 9,337,733 shares of its common stock at a combined public offering price of $3.55 per share. The Company also sold 7,944,252 pre-funded warrants to purchase shares of its common stock with accompanying warrants to purchase up to 3,972,126 shares of its common stock at a combined public offering price of $3.549 per pre-funded warrant, which represents the per share public offering price for the common stock less $0.001 per share, the exercise price for each pre-funded warrant. The Company raised aggregate proceeds of $88.2 million, net of underwriting discounts and commissions of $5.7 million and other offering costs of $0.6 million. | ||||||||
Proceeds from issuance of common stock, net of commissions and offering expenses | $ 296,800 | $ 88,200 | |||||||
Issuance of common stock | $ 296,817 | $ 88,239 | |||||||
Shares issued and sold | 19,461,538 | 18,675,466 | |||||||
Offering price per share | $ 16.25 | $ 16.25 | |||||||
Offering price per share | $ 3.55 | ||||||||
Underwriting discounts and commissions | $ 19,000 | $ 5,700 | |||||||
Other offering costs | $ 500 | $ 600 | |||||||
Common stock, par value | $ 0.001 | ||||||||
Public Offerings | Pre-funded Warrants | |||||||||
Subsidiary Sale Of Stock [Line Items] | |||||||||
Number of prefunded warrants issued during period | 7,944,252 | ||||||||
Combined price of prefunded and common stock warrant | $ 3.549 | ||||||||
Public Offerings | Maximum | |||||||||
Subsidiary Sale Of Stock [Line Items] | |||||||||
Warrants to purchase shares of common stock | 9,337,733 | ||||||||
Public Offerings | Maximum | Pre-funded Warrants | |||||||||
Subsidiary Sale Of Stock [Line Items] | |||||||||
Warrants to purchase shares of common stock | 3,972,126 | ||||||||
Public Offerings | A T M Facility | |||||||||
Subsidiary Sale Of Stock [Line Items] | |||||||||
Maximum value of common stock to be issued under agreement | $ 150,000 | $ 75,000 | |||||||
Public Offerings | SVB Leerink LLC | |||||||||
Subsidiary Sale Of Stock [Line Items] | |||||||||
Selling commission per shares sold percentage | 3% | 3% | |||||||
Proceeds from issuance of common stock, net of commissions and offering expenses | $ 23,700 | $ 13,400 | |||||||
Shares issued and sold | 1,200,539 | 968,000 |
Stockholders' Equity - Schedu_2
Stockholders' Equity - Schedule of Outstanding Warrants to Purchase Shares of Common Stock (Details) | 9 Months Ended |
Sep. 30, 2023 $ / shares shares | |
Class Of Warrant Or Right [Line Items] | |
Shares of Common Stock Underlying Warrants | 11,212,805 |
Warrants Term Loan | |
Class Of Warrant Or Right [Line Items] | |
Shares of Common Stock Underlying Warrants | 25,000 |
Warrant exercise price | $ / shares | $ 22.06 |
Warrant expiration date | Jun. 30, 2025 |
Warrants Term Loan | |
Class Of Warrant Or Right [Line Items] | |
Shares of Common Stock Underlying Warrants | 33,923 |
Warrant exercise price | $ / shares | $ 19.12 |
Warrant expiration date | May 28, 2031 |
Warrants Term Loan | |
Class Of Warrant Or Right [Line Items] | |
Shares of Common Stock Underlying Warrants | 174,093 |
Warrant exercise price | $ / shares | $ 9.76 |
Warrant expiration date | Jan. 27, 2033 |
Warrants Public Offerings | |
Class Of Warrant Or Right [Line Items] | |
Shares of Common Stock Underlying Warrants | 10,179,789 |
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 | 800,000 |
Warrant exercise price | $ / shares | $ 0.001 |
Expiration Date | Do Not Expire |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional Information (Details) $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | |||||
Feb. 28, 2021 | Oct. 31, 2019 shares | Sep. 30, 2019 shares | Sep. 30, 2023 USD ($) Employee shares | Sep. 30, 2022 USD ($) | Sep. 30, 2023 USD ($) Employee shares | Sep. 30, 2022 USD ($) | Feb. 28, 2023 shares | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||
Common stock shares reserved for future issuance | 14,282,486 | 14,282,486 | ||||||
Share base compensation expense | $ | $ 4,381 | $ 2,500 | $ 12,069 | $ 7,598 | ||||
Service-based RSUs | Employee | ||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||
Share base compensation expense | $ | 900 | 300 | 2,400 | 700 | ||||
Performance RSUs | Executive Officer and Certain Employees | ||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||
Share base compensation expense | $ | $ 200 | $ 300 | $ 800 | $ 1,100 | ||||
Vesting period | 1 year | |||||||
Employee Stock Purchase Plan | ||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||
Number of common shares issuable under the plan (in shares) | 225,188 | |||||||
Common stock shares reserved for future issuance | 1,220,897 | 1,220,897 | ||||||
Percentage of increase in number of shares of capital stock issued and outstanding | 1% | |||||||
Percent of purchase shares of common stock | 85% | |||||||
2019 Plan | ||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||
Number of common shares issuable under the plan (in shares) | 2,844,193 | |||||||
Percentage of increase in number of shares of capital stock issued and outstanding | 4% | |||||||
Granted | 1,783,900 | |||||||
2023 Plan | ||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||
Common stock shares reserved for future issuance | 1,500,000 | |||||||
Granted | 279,600 | 417,700 | ||||||
Number of new employees granted shares under the plan | Employee | 14 | 20 | ||||||
Minimum | Service-based RSUs | Employee | ||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||
Vesting period | 2 years | |||||||
Maximum | Service-based RSUs | Employee | ||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||
Vesting period | 3 years | |||||||
Maximum | Employee Stock Purchase Plan | ||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||
Period for increase in number of shares of common stock reserved for issuance | 10 years | |||||||
Maximum | 2019 Plan | ||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||
Period for increase in number of shares of common stock reserved for issuance | 10 years |
Stock-Based Compensation - Summ
Stock-Based Compensation - Summary of Stock Option Activity (Details) - 2019 Plan $ / shares in Units, $ in Thousands | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 USD ($) $ / shares shares | Dec. 31, 2022 USD ($) $ / shares shares | |
Number of Options | ||
Outstanding, Beginning Balance | shares | 3,161,917 | |
Granted | shares | 1,783,900 | |
Exercised | shares | (196,612) | |
Cancelled and forfeited | shares | (70,178) | |
Outstanding, Ending Balance | shares | 4,679,027 | 3,161,917 |
Exercisable as of September 30, 2023 | shares | 2,005,286 | |
Weighted Average Exercise Price | ||
Weighted Average Exercise Price Outstanding, Beginning Balance | $ / shares | $ 12.8 | |
Weighted Average Exercise Price, Granted | $ / shares | 15.18 | |
Weighted Average Exercise Price, Exercised | $ / shares | 3.2 | |
Weighted Average Exercise Price, Cancelled and forfeited | $ / shares | 10.77 | |
Weighted Average Exercise Price Outstanding, Ending Balance | $ / shares | 14.14 | $ 12.8 |
Weighted Average Exercise Price, Exercisable as of September 30, 2023 | $ / shares | $ 14.22 | |
Weighted Average Remaining Contractual Term (In years) | ||
Weighted Average Remaining Contractual Term (In years), Outstanding | 8 years | 7 years 10 months 24 days |
Weighted Average Remaining Contractual Term (In years), Exercisable as of September 30, 2023 | 6 years 9 months 18 days | |
Aggregate Intrinsic Value | ||
Aggregate Intrinsic Value | $ | $ 19,912 | $ 16,612 |
Aggregate Intrinsic Value, Exercisable as of September 30, 2023 | $ | $ 12,824 |
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) | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Expected volatility, minimum | 91.60% | 89.90% |
Expected volatility, maximum | 99.20% | 91% |
Risk-free interest rate, minimum | 3.40% | 1.60% |
Risk-free interest rate, maximum | 4.60% | 3.40% |
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) - Restricted Stock Units (RSUs") | 9 Months Ended |
Sep. 30, 2023 $ / shares shares | |
Number of RSUs | |
Outstanding, Beginning Balance | shares | 1,095,738 |
Granted | shares | 379,075 |
Vested / released | shares | (309,740) |
Cancelled / forfeited | shares | (177,523) |
Outstanding, Ending Balance | shares | 987,550 |
Weighted Average Grant Date Fair Value | |
Weighted Average Grant Date Fair Value Outstanding, Beginning Balance | $ / shares | $ 5.77 |
Weighted Average Grant Date Fair Value Outstanding, Granted | $ / shares | 15.02 |
Weighted Average Grant Date Fair Value Outstanding, Vested/Released | $ / shares | 5.82 |
Weighted Average Grant Date Fair Value Outstanding, Cancelled/Forfeited | $ / shares | 5.89 |
Weighted Average Grant Date Fair Value Outstanding, Ending Balance | $ / shares | $ 9.28 |
Stock-Based Compensation - Su_4
Stock-Based Compensation - Summary of Stock-Based Compensation (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Total stock-based compensation | $ 4,381 | $ 2,500 | $ 12,069 | $ 7,598 |
Research and Development | ||||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Total stock-based compensation | 1,938 | 1,019 | 5,136 | 2,917 |
General and Administrative | ||||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Total stock-based compensation | $ 2,443 | $ 1,481 | $ 6,933 | $ 4,681 |
Net Loss Per Share - Schedule o
Net Loss Per Share - Schedule of Outstanding Potentially Dilutive Securities Excluded From Calculation of Diluted Net Loss (Details) - shares | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | |||
Antidilutive common stock equivalents excluded from calculation of diluted net loss per share | 16,679,956 | 17,621,091 | |
Stock Options 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 | 4,679,027 | 3,123,221 | |
Unvested RSUs | |||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | |||
Antidilutive common stock equivalents excluded from calculation of diluted net loss per share | 987,550 | 1,118,735 | |
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 | [1] | 10,412,805 | 13,358,782 |
Conversion Shares Under the Term Loan with K2hv | |||
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 | ||
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 | 9,758 | 20,353 | |
[1] The table above excludes pre-funded warrants issued in connection with the July 2022 public offering (see Note 7). |
Subsequent Events - Additional
Subsequent Events - Additional Information (Details) $ in Millions | 1 Months Ended |
Oct. 31, 2023 USD ($) | |
Subsequent Events | Teva Agreement | |
Subsequent Event [Line Items] | |
Milestone payment due, payable | $ 2.5 |