Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2023 | Nov. 03, 2023 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Document Period End Date | Sep. 30, 2023 | |
Securities Act File Number | 001-38944 | |
Entity Registrant Name | Akero Therapeutics, Inc. | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 81-5266573 | |
Entity Address, Address Line One | 601 Gateway Boulevard, Suite 350 | |
Entity Address, City or Town | South San Francisco | |
Entity Address, State or Province | CA | |
Entity Address, Postal Zip Code | 94080 | |
City Area Code | 650 | |
Local Phone Number | 487-6488 | |
Title of 12(b) Security | Common Stock, par value $0.0001 per share | |
Trading Symbol | AKRO | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 55,709,783 | |
Entity Central Index Key | 0001744659 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2023 | |
Document Fiscal Period Focus | Q3 | |
Amendment Flag | false |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 269,546 | $ 249,773 |
Short-term marketable securities | 285,186 | 101,676 |
Prepaid expenses and other current assets | 21,247 | 3,724 |
Total current assets | 575,979 | 355,173 |
Long-term marketable securities | 58,264 | |
Property and equipment, net | 20 | 47 |
Right of use asset | 1,068 | 1,242 |
Other assets, noncurrent | 108 | |
Total assets | 635,331 | 356,570 |
Current liabilities: | ||
Accounts payable | 11,454 | 7,968 |
Accrued expenses and other current liabilities | 14,917 | 11,115 |
Loan Payable - current | 2,076 | |
Total current liabilities | 28,447 | 19,083 |
Loan payable, noncurrent | 22,768 | 9,541 |
Warrant liability | 93 | 305 |
Operating lease liability, noncurrent | 888 | 1,079 |
Total liabilities | 52,196 | 30,008 |
Commitments and contingencies (Note 12) | ||
Stockholders' equity: | ||
Common stock, $0.0001 par value, 150,000,000 shares authorized as of September 30, 2023 and December 31, 2022; 55,681,026 and 46,865,206 shares issued and outstanding as of September 30, 2023 and December 31, 2022, respectively | 6 | 5 |
Additional paid-in capital | 1,102,545 | 748,857 |
Accumulated other comprehensive (loss) income | (506) | 37 |
Accumulated deficit | (518,910) | (422,337) |
Total stockholders' equity | 583,135 | 326,562 |
Total liabilities and stockholders' equity | $ 635,331 | $ 356,570 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Nov. 03, 2023 | Sep. 30, 2023 | Dec. 31, 2022 |
Statement of Financial Position [Abstract] | |||
Common stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 150,000,000 | 150,000,000 | |
Common stock, shares issued | 55,681,026 | 46,865,206 | |
Common stock, shares outstanding | 55,681,026 | 46,865,206 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss - 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 | $ 38,634 | $ 25,087 | $ 88,406 | $ 66,964 |
General and administrative | 7,981 | 11,004 | 22,591 | 22,772 |
Total operating expenses | 46,615 | 36,091 | 110,997 | 89,736 |
Loss from operations | (46,615) | (36,091) | (110,997) | (89,736) |
Interest expense | (888) | (324) | (2,202) | (377) |
Other income, net | 7,844 | 873 | 16,626 | 1,139 |
Net loss | (39,659) | (35,542) | (96,573) | (88,974) |
Net unrealized (loss) gain on marketable securities | (255) | 3 | (543) | 27 |
Comprehensive loss | $ (39,914) | $ (35,539) | $ (97,116) | $ (88,947) |
Net loss per share, basic | $ (0.71) | $ (0.92) | $ (1.87) | $ (2.45) |
Net loss per share, diluted | $ (0.71) | $ (0.92) | $ (1.87) | $ (2.45) |
Weighted-average number of shares used in computing net loss per common share, basic | 55,613,120 | 38,663,469 | 51,506,766 | 36,364,284 |
Weighted-average number of shares used in computing net loss per common share, diluted | 55,613,120 | 38,663,469 | 51,506,766 | 36,364,284 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Stockholders' Equity (Deficit) - USD ($) | Total | ATM Offering | Direct Offering | Common Stock | Common Stock ATM Offering | Common Stock Direct Offering | Additional Paid-In-Capital | Additional Paid-In-Capital ATM Offering | Additional Paid-In-Capital Direct Offering | Accumulated Other Comprehensive Gain (Loss) | Accumulated Deficit |
Balance at beginning at Dec. 31, 2021 | $ 169,109,000 | $ 4,000 | $ 479,436,000 | $ (27,000) | $ (310,304,000) | ||||||
Balance at beginning (in shares) at Dec. 31, 2021 | 34,900,727 | ||||||||||
Exercise of stock options | 147,000 | 147,000 | |||||||||
Exercise of stock options (in shares) | 122,208 | ||||||||||
Stock-based compensation expense | 3,311,000 | 3,311,000 | |||||||||
Net unrealized (loss) gain on marketable securities | (3,000) | (3,000) | |||||||||
Net loss | (26,029,000) | (26,029,000) | |||||||||
Balance at ending at Mar. 31, 2022 | 146,535,000 | $ 4,000 | 482,894,000 | (30,000) | (336,333,000) | ||||||
Balance at ending (in shares) at Mar. 31, 2022 | 35,022,935 | ||||||||||
Balance at beginning at Dec. 31, 2021 | 169,109,000 | $ 4,000 | 479,436,000 | (27,000) | (310,304,000) | ||||||
Balance at beginning (in shares) at Dec. 31, 2021 | 34,900,727 | ||||||||||
Vested warrants issued pursuant to loan agreement | 227,000 | ||||||||||
Balance at ending at Jun. 30, 2022 | 148,372,000 | $ 4,000 | 512,107,000 | (3,000) | (363,736,000) | ||||||
Balance at ending (in shares) at Jun. 30, 2022 | 37,570,326 | ||||||||||
Balance at beginning at Dec. 31, 2021 | 169,109,000 | $ 4,000 | 479,436,000 | (27,000) | (310,304,000) | ||||||
Balance at beginning (in shares) at Dec. 31, 2021 | 34,900,727 | ||||||||||
Net unrealized (loss) gain on marketable securities | 27,000 | ||||||||||
Net loss | (88,974,000) | ||||||||||
Balance at ending at Sep. 30, 2022 | 343,508,000 | $ 5,000 | 742,781,000 | (399,278,000) | |||||||
Balance at ending (in shares) at Sep. 30, 2022 | 46,657,478 | ||||||||||
Balance at beginning at Dec. 31, 2021 | 169,109,000 | $ 4,000 | 479,436,000 | (27,000) | (310,304,000) | ||||||
Balance at beginning (in shares) at Dec. 31, 2021 | 34,900,727 | ||||||||||
Net loss | (112,033,000) | ||||||||||
Balance at ending at Dec. 31, 2022 | 326,562,000 | $ 5,000 | 748,857,000 | 37,000 | (422,337,000) | ||||||
Balance at ending (in shares) at Dec. 31, 2022 | 46,865,206 | ||||||||||
Balance at beginning at Mar. 31, 2022 | 146,535,000 | $ 4,000 | 482,894,000 | (30,000) | (336,333,000) | ||||||
Balance at beginning (in shares) at Mar. 31, 2022 | 35,022,935 | ||||||||||
Issuance of common stock pursuant to ESPP purchases | 178,000 | 178,000 | |||||||||
Issuance of common stock pursuant to ESPP purchases (in shares) | 22,139 | ||||||||||
Issuance of common stock, net of issuance costs | 24,647,000 | 24,647,000 | |||||||||
Issuance of common stock (in shares) | 2,525,252 | ||||||||||
Vested warrants issued pursuant to loan agreement | 227,000 | ||||||||||
Stock-based compensation expense | 4,161,000 | 4,161,000 | |||||||||
Net unrealized (loss) gain on marketable securities | 27,000 | 27,000 | |||||||||
Net loss | (27,403,000) | (27,403,000) | |||||||||
Balance at ending at Jun. 30, 2022 | 148,372,000 | $ 4,000 | 512,107,000 | (3,000) | (363,736,000) | ||||||
Balance at ending (in shares) at Jun. 30, 2022 | 37,570,326 | ||||||||||
Issuance of common stock upon closing of follow-on public offering, net of issuance costs and underwriting fees | 215,836,000 | $ 1,000 | 215,835,000 | ||||||||
Issuance of common stock upon closing of follow-on public offering, net of issuance costs and underwriting fees (shares) | 8,846,154 | ||||||||||
Exercise of stock options | 3,108,000 | 3,108,000 | |||||||||
Exercise of stock options (in shares) | 240,998 | ||||||||||
Stock-based compensation expense | 11,731,000 | 11,731,000 | |||||||||
Net unrealized (loss) gain on marketable securities | 3,000 | 3,000 | |||||||||
Net loss | (35,542,000) | (35,542,000) | |||||||||
Balance at ending at Sep. 30, 2022 | 343,508,000 | $ 5,000 | 742,781,000 | (399,278,000) | |||||||
Balance at ending (in shares) at Sep. 30, 2022 | 46,657,478 | ||||||||||
Balance at beginning at Dec. 31, 2022 | 326,562,000 | $ 5,000 | 748,857,000 | 37,000 | (422,337,000) | ||||||
Balance at beginning (in shares) at Dec. 31, 2022 | 46,865,206 | ||||||||||
Exercise of stock options | 456,000 | 456,000 | |||||||||
Exercise of stock options (in shares) | 105,783 | ||||||||||
Common stock issued for vested restricted stock units, Shares | 8,067 | ||||||||||
Vested warrants issued pursuant to loan agreement | 330,000 | 330,000 | |||||||||
Stock-based compensation expense | 4,844,000 | 4,844,000 | |||||||||
Net unrealized (loss) gain on marketable securities | (16,000) | (16,000) | |||||||||
Net loss | (25,831,000) | (25,831,000) | |||||||||
Balance at ending at Mar. 31, 2023 | 306,345,000 | $ 5,000 | 754,487,000 | 21,000 | (448,168,000) | ||||||
Balance at ending (in shares) at Mar. 31, 2023 | 46,979,056 | ||||||||||
Balance at beginning at Dec. 31, 2022 | $ 326,562,000 | $ 5,000 | 748,857,000 | 37,000 | (422,337,000) | ||||||
Balance at beginning (in shares) at Dec. 31, 2022 | 46,865,206 | ||||||||||
Exercise of stock options (in shares) | 535,387 | ||||||||||
Vested warrants issued pursuant to loan agreement | $ 330,000 | ||||||||||
Net unrealized (loss) gain on marketable securities | (543,000) | ||||||||||
Net loss | (96,573,000) | ||||||||||
Balance at ending at Sep. 30, 2023 | 583,135,000 | $ 6,000 | 1,102,545,000 | (506,000) | (518,910,000) | ||||||
Balance at ending (in shares) at Sep. 30, 2023 | 55,681,026 | ||||||||||
Balance at beginning at Mar. 31, 2023 | 306,345,000 | $ 5,000 | 754,487,000 | 21,000 | (448,168,000) | ||||||
Balance at beginning (in shares) at Mar. 31, 2023 | 46,979,056 | ||||||||||
Exercise of stock options | 1,556,000 | 1,556,000 | |||||||||
Exercise of stock options (in shares) | 306,510 | ||||||||||
Common stock issued for vested restricted stock units, Shares | 9,956 | ||||||||||
Issuance of common stock pursuant to ESPP purchases | 313,000 | 313,000 | |||||||||
Issuance of common stock pursuant to ESPP purchases (in shares) | 7,885 | ||||||||||
Issuance of common stock, net of issuance costs | $ 123,824,000 | $ 210,956,000 | $ 1,000 | $ 123,824,000 | $ 210,955,000 | ||||||
Issuance of common stock (in shares) | 3,006,052 | 5,238,500 | |||||||||
Stock-based compensation expense | 4,798,000 | 4,798,000 | |||||||||
Net unrealized (loss) gain on marketable securities | (272,000) | (272,000) | |||||||||
Net loss | (31,083,000) | (31,083,000) | |||||||||
Balance at ending at Jun. 30, 2023 | 616,437,000 | $ 6,000 | 1,095,933,000 | (251,000) | (479,251,000) | ||||||
Balance at ending (in shares) at Jun. 30, 2023 | 55,547,959 | ||||||||||
Exercise of stock options | 873,000 | 873,000 | |||||||||
Exercise of stock options (in shares) | 123,094 | ||||||||||
Common stock issued for vested restricted stock units, Shares | 9,973 | ||||||||||
Stock-based compensation expense | 5,739,000 | 5,739,000 | |||||||||
Net unrealized (loss) gain on marketable securities | (255,000) | (255,000) | |||||||||
Net loss | (39,659,000) | (39,659,000) | |||||||||
Balance at ending at Sep. 30, 2023 | $ 583,135,000 | $ 6,000 | $ 1,102,545,000 | $ (506,000) | $ (518,910,000) | ||||||
Balance at ending (in shares) at Sep. 30, 2023 | 55,681,026 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
CASH FLOWS FROM OPERATING ACTIVITIES | ||
Net loss | $ (96,573) | $ (88,974) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock-based compensation expense | 15,381 | 19,203 |
Depreciation | 27 | 33 |
Non-cash lease expense | 174 | 162 |
Net amortization of premiums and discounts on short-term investments | (5,908) | 182 |
Amortization of debt issuance costs and discount | 328 | 110 |
Fair value change in warrant liability | 118 | 29 |
Write-off of deferred offering costs | 337 | |
Unrealized foreign exchange gain and loss | (26) | (12) |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other assets | (17,793) | 2,657 |
Accounts payable | 3,584 | (708) |
Accrued expenses and other current liabilities | 3,782 | 460 |
Operating lease liability | (171) | (151) |
Net cash used in operating activities | (96,740) | (67,009) |
CASH FLOWS FROM INVESTING ACTIVITIES | ||
Purchase of short-term and long-term marketable securities | (374,909) | |
Proceeds from maturities of short-term marketable securities | 138,500 | 37,620 |
Net cash (used in) provided by investing activities | (236,409) | 37,620 |
CASH FLOWS FROM FINANCING ACTIVITIES | ||
Proceeds from the exercise of stock options | 2,817 | 2,229 |
Proceeds from the issuance of common stock pursuant to employee stock purchase plan purchases | 313 | 178 |
Proceeds from the issuance of common in a follow-on public offering | 216,200 | |
Proceeds from the issuance of common stock pursuant to the ATM offering | 124,212 | |
Proceeds from the issuance of common stock pursuant to registered direct offering | 211,217 | |
Proceeds from the issuance of common stock pursuant to private offering | 25,000 | |
Proceeds from loan payable | 15,000 | 10,000 |
Payment of debt and equity issuance costs | (745) | (698) |
Net cash provided by financing activities | 352,814 | 252,909 |
Net increase in cash, cash equivalents and restricted cash | 19,665 | 223,520 |
Cash, cash equivalents and restricted cash at the beginning of the period | 249,881 | 150,591 |
Cash, cash equivalents and restricted cash at the end of the period | 269,546 | 374,111 |
SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION: | ||
Cash paid for interest | 1,715 | 189 |
NON-CASH INVESTING AND FINANCING INFORMATION: | ||
Change in net unrealizable (loss) gain on marketable securities | $ (543) | 27 |
Warrant liability costs reclassified to additional paid-in equity on vested warrants issued | 330 | |
Debt and equity issuance costs included in accounts payable and accrued expenses and other current liabilities | 371 | |
Deferred offering costs reclassified to additional paid-in equity | $ 364 | $ 150 |
Stock options exercises included in other current assets | $ 67 |
Nature of the business and basi
Nature of the business and basis of presentation | 9 Months Ended |
Sep. 30, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Nature of the business and basis of presentation | 1. Nature of the business and basis of presentation Akero Therapeutics, Inc., together with its wholly owned subsidiary Akero Securities Corporation, (“Akero” or the “Company”) is a clinical-stage company dedicated to developing transformational treatments for patients with serious metabolic diseases marked by high unmet medical need, including metabolic dysfunction-associated steatohepatitis ("NASH/MASH") a disease without any approved therapies. NASH/MASH is a severe form of metabolic dysfunction-associated steatotic liver disease ("MASLD") characterized by inflammation and fibrosis in the liver that can progress to cirrhosis, liver failure, cancer and death. The Company’s lead product candidate is efruxifermin ("EFX"), an analog of fibroblast growth factor 21 ("FGF21") which is an endogenously expressed hormone that protects against cellular stress and regulates metabolism of lipids, carbohydrates and proteins throughout the body. The Company has initiated a Phase 3 program called SYNCHRONY, for which the first two of three planned clinical trials evaluating EFX have begun screening. EFX is also being evaluated in two ongoing, 96-week Phase 2b clinical trials in patients with biopsy-confirmed NASH /MASH: the HARMONY study in patients with pre-cirrhotic NASH/MASH (F2-F3 fibrosis) and the SYMMETRY study in patients with cirrhotic NASH/MASH (F4 fibrosis, compensated). In the third quarter of 2022, the Company reported Week 24 results from the 96-Week HARMONY study, which showed statistically significant response rates for both the 50mg and 28mg dose groups on both fibrosis regression and NASH resolution among patients with biopsy-confirmed NASH/MASH. In October 2023, the Company reported Week 36 results of the 96-week Phase 2b SYMMETRY study in biopsy-confirmed NASH/MASH patients with compensated cirrhosis (F4, Child-Pugh class A), which showed a trend of 22 % and 24 % of patients in the 28mg and 50mg EFX-treated groups, respectively, experiencing at least a one-stage improvement in liver fibrosis and no worsening of NASH, compared with 14 % for placebo and statistically significant response rates for NASH resolution observed in 67 % and 60 % of patents in the 28mg and 50mg EFX-treated groups, respectively, compared with 26 % for placebo. Based on these and other data, the Company believes EFX has the potential, if approved, to be an important medicine for treating NASH /MASH. The Company is subject to risks and uncertainties common to early-stage companies in the biotechnology industry, including, but not limited to, completion and success of clinical testing, development by competitors of new technological innovations, compliance with governmental regulations, dependence on key personnel and protection of proprietary technology and the ability to secure additional capital to fund operations. EFX will require extensive clinical testing prior to regulatory approval and commercialization. These efforts require significant amounts of additional capital, adequate personnel, and infrastructure and extensive compliance-reporting capabilities. Even if the Company’s drug development efforts are successful, it is uncertain when, if ever, the Company will realize significant revenue from product sales. Basis of presentation The accompanying condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) and include the accounts of the Company after elimination of all intercompany accounts and transactions. All adjustments necessary for the fair presentation of the Company’s condensed consolidated financial statements for the periods presented have been reflected. Liquidity In accordance with Accounting Standards Update (“ASU”) No. 2014-15, Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern (Subtopic 205-40) , the Company has evaluated whether there are certain conditions and events, considered in the aggregate, that raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date that the condensed consolidated financial statements are issued. Since its inception, the Company has funded its operations primarily with $ 90,500 in proceeds from the sale of redeemable convertible preferred stock, $ 105,800 in proceeds from its initial public offering (“IPO”) in June 2019, and $ 818,900 in proceeds from the sales of common stock in equity offerings, including a $ 25,000 equity investment from Pfizer, Inc., in 2020, 2022 and 2023. The Company has incurred recurring losses since its inception, including net losses of $ 96,573 and $ 88,974 for the nine months ended September 30, 2023 and 2022, respectively, and net losses of $ 112,033 and $ 100,777 for the years ended December 31, 2022 and 2021, respectively. In addition, as of September 30, 2023, the Company had an accumulated deficit of $ 518,910 . The Company expects to continue to generate operating losses for the foreseeable future. As of November 13, 2023, the issuance date of these condensed consolidated financial statements, the Company expects that its existing cash, cash equivalents, short-term and long-term marketable securities of $ 612,996 as of September 30, 2023, will be sufficient to fund its operating expenses and capital expenditure requirements for at least 12 months from the issuance date of these condensed consolidated financial statements. The Company expects that it will require additional funding to complete the clinical development of EFX, commercialize EFX, if it receives regulatory approval, and pursue in-licenses or acquisitions of other product candidates. If the Company is unable to obtain funding, the Company will be forced to delay, reduce or eliminate some or all of its research and development programs, product portfolio expansion or commercialization efforts, which could adversely affect its business prospects, or the Company may be unable to continue operations. Although management continues to pursue these plans, there is no assurance that the Company will be successful in obtaining sufficient funding on terms acceptable to the Company to fund continuing operations, if at all. |
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 interim financial statements The accompanying unaudited condensed consolidated financial statements have been prepared by the Company in accordance with GAAP for interim financial reporting and as required by Regulation S-X, Rule 10-01. The unaudited condensed consolidated financial statements have been prepared on the same basis as the Company’s audited annual financial statements and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary for a fair statement of the Company’s condensed consolidated balance sheet as of September 30, 2023, the condensed consolidated statements of operations and comprehensive loss for the three and nine months ended September 30, 2023 and 2022, the condensed consolidated statement of stockholders’ equity (deficit) as of September 30, 2023 and the condensed consolidated statements of cash flows for the nine months ended September 30, 2023. The financial data and other information disclosed in these notes related to the three and nine months ended September 30, 2023 and 2022 are unaudited. The results for the three and nine months ended September 30, 2023 are not necessarily indicative of results to be expected for the year ending December 31, 2023, any other interim periods, or any future year or period. Use of estimates The preparation of the Company's condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements, and the reported amounts of expenses during the reporting period. Significant estimates and assumptions reflected in these condensed consolidated financial statements include, but are not limited to, the recognition of research and development expenses, stock-based compensation expense, warrant liabilities and the valuation allowance for deferred tax assets. The Company bases its estimates on historical experience, known trends and other market-specific or other relevant factors that it believes to be reasonable under the circumstances. On an ongoing basis, management evaluates its estimates when there are changes in circumstances, facts and experience. Changes in estimates are recorded in the period in which they become known. Actual results could differ from those estimates. Cash and cash equivalents The Company considers all highly liquid investments with original maturities of three months or less at the time of purchase to be cash equivalents. Cash equivalents consist primarily of amounts invested in money market accounts. Short-term and long-term marketable securities The Company invests in short and long-term marketable securities, primarily money market funds, commercial paper, U.S. treasury securities and corporate debt securities. The Company continually evaluates the credit ratings of its investment portfolio and underlying securities. The Company invests in accordance with its investment policy and invests at the date of purchase in securities with high ratings from top rating agencies. The Company classifies its short-term and long-term marketable securities as available-for-sale securities and reports them at fair value in short-term and long-term marketable securities on the condensed consolidated balance sheets with related unrealized gains and losses included within accumulated other comprehensive gain (loss) on the condensed consolidated balance sheets. The amortized cost of marketable securities is adjusted for amortization of premiums and accretion of discounts to maturity, which is included in other income on the condensed consolidated statements of operations and comprehensive loss. When the fair value is below the amortized cost of a marketable security, the Company reviews and determines whether the impairment is due to credit-related factors or noncredit-related factors. The credit-related impairment amount is recognized in other income on the condensed consolidated statements of operations and comprehensive loss, with a corresponding allowance for credit losses account in the condensed consolidated balance sheet. Subsequent improvements in expected credit losses are recognized as a reversal of an amount in the allowance account. If the Company has the intent to sell the security or it is more likely than not that the Company will be required to sell the security prior to recovery of its amortized cost basis, then the allowance for the credit loss is written-off and the excess of the amortized cost basis of the asset over its fair value is recorded in the condensed consolidated statements of operations. There were no credit losses recorded during the periods ended September 30, 2023 and December 31, 2022. Restricted cash As of December 31, 2022, the Company was required to maintain a separate cash balance of $ 108 for the benefit of the landlord in connection with the Company’s Gateway office space lease in South San Francisco, California (the “Gateway Lease”), which is classified within other assets (non-current) on the condensed consolidated balance sheets (see Note 12). The Company was not required to maintain a separate cash balance for the benefit of the landlord as of September 30, 2023. Concentrations of credit risk Financial instruments that potentially subject the Company to concentrations of credit risk consist principally of cash, cash equivalents, short and long-term marketable securities. Periodically, the Company maintains deposits in accredited financial institutions in excess of federally insured limits. The Company deposits its cash investments in financial institutions that it believes have high credit quality and has not experienced any losses on such accounts and does not believe it is exposed to any unusual credit risk beyond the normal credit risk associated with commercial banking relationships. At September 30, 2023, all of the Company's cash, cash equivalents, short and long-term investments were held at four accredited financial institutions. As of December 31, 2022, the Company held cash deposits at Silicon Valley Bank ("SVB") in excess of government insured limits. On March 10, 2023, SVB was closed by the California Department of Financial Protection and Innovation, and the Federal Deposit Insurance Corporation (“FDIC”) was appointed as receiver. No losses were incurred by the Company on deposits that were held at SVB. Management believes that the Company is not currently exposed to significant credit risk as the vast majority of the Company’s deposits were either owned directly by the Company and held in custody at a third-party financial institution or, subsequent to March 10, 2023, have been transferred to a third-party financial institution. On March 27, 2023, SVB was acquired by First-Citizen BancShares, Inc ("First-Citizen"). As of September 30, 2023, the Company did not have any significant deposits on account at or relationships with SVB or First-Citizen. Leases The Company determines whether an arrangement is or contains a lease at inception by assessing whether the arrangement contains an identified asset and whether the Company has the right to control the identified asset. Right-of-use ("ROU") assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent the Company’s obligation to make lease payments arising from the lease. Lease liabilities are recognized at the lease commencement date based on the present value of future lease payments over the lease term. ROU assets are based on the measurement of the lease liability and are further adjusted by any lease payments made prior to or on lease commencement, lease incentives received and initial direct costs incurred, as applicable. The Company has elected not to recognize leases with a lease term of one year or less on its balance sheet. Operating lease costs included in the measurement of the lease are recognized on a straight-line basis over the lease term. Variable lease costs are expensed as incurred as an operating expense. The Company determines the lease classification and the present value of future lease payments at the time of the lease commencement using an incremental borrowing rate that it estimates based upon the Company’s credit risk and term of the lease. The interest rate implicit in lease contracts has not historically been readily determinable and the Company must therefore use the appropriate incremental borrowing rate to measure its leases. To estimate the incremental borrowing rate, a credit rating applicable to the Company is estimated using a synthetic credit rating analysis since the Company does not currently have a rating agency-based credit rating. Research and development costs Research and development costs are expensed as incurred. Research and development expenses consist of costs incurred to discover, research and develop drug candidates, including personnel expenses, stock-based compensation expense, third-party license fees and external costs including fees paid to consultants, contract manufacturing organizations ("CMOs") and clinical research organizations ("CROs") in connection with drug product manufacturing, nonclinical studies and clinical trials, and other related clinical trial fees, such as for investigator grants, patient screening, laboratory work, clinical trial database management, clinical trial material management and statistical compilation and analysis. Non-refundable prepayments for goods or services that will be used or rendered for future research and development activities are recorded as prepaid expenses. Such amounts are recognized as an expense as the goods are delivered or the related services are performed, or until it is no longer expected that the goods will be delivered or the services rendered. Foreign currency transaction gains and losses related to the purchase of contract manufacturing services are included as a component of research and development expense. Costs incurred in obtaining technology licenses are charged immediately to research and development expense if the technology licensed has not reached technological feasibility and has no alternative future uses. Research contract costs and accruals The Company has entered into various research and development and other agreements with commercial firms, researchers and others for provisions of goods and services. These agreements are generally cancelable, and the related costs are recorded as research and development expenses as incurred. The Company records accruals for estimated ongoing research and development costs. When evaluating the adequacy of the accrued liabilities, the Company analyzes progress of the studies or clinical trials, including the phase or completion of events, invoices received and contracted costs. Significant judgments and estimates are made in determining the accrued balances at the end of any reporting period. Actual results could differ materially from the Company's estimates . Stock-based compensation The Company grants stock-based awards from its stock compensation plans (see Note 8). The Company measures all stock-based awards granted to employees and nonemployees based on the fair value on the date of the grant and recognizes compensation expense for those awards over the requisite service period, which is generally the vesting period of the respective award, on a straight-line basis. The Company recognizes stock-based compensation expense for awards that contain performance-based conditions using the accelerated attribution method when management determines it is probable that the performance condition will be satisfied. The Company accounts for forfeitures as they occur. Stock-based compensation for restricted stock units is measured based on the market closing price of our common stock on the grant date. Stock-based compensation expense is recognized on a straight-line basis over the requisite service period, generally four years. The fair value of each stock option grant is estimated on the date of grant using the Black-Scholes option-pricing model, which requires inputs based on certain subjective assumptions, including the expected stock price volatility, the expected term of the option, the risk-free interest rate for a period that approximates the expected term of the option, and the Company's expected dividend yield. The Company went public in June 2019 and accordingly, lacks sufficient company-specific historical and implied volatility information for its shares traded in the public markets. Therefore, it estimates its expected share price volatility based on the historical volatility of publicly traded peer companies and expects to continue to do so until such time as it has adequate historical data regarding the volatility of its own traded share price. The expected term of the Company's stock options has been determined utilizing the "simplified" method for awards that qualify as "plain-vanilla" options. The risk-free interest rate is determined by reference to the U.S. Treasury yield curve in effect at the time of grant of the award for time periods approximately equal to the expected term of the award. Expected dividend yield is based on the fact that the Company has never paid cash dividends on common stock and does not expect to pay any cash dividends in the foreseeable future. The fair value of each common stock award is estimated on the date of grant based on the fair value of the Company's common stock on that same date. Compensation expense for purchases under the Employee Stock Purchase Plan is recognized based on the fair value of the common stock estimated based on the closing price of our common stock as reported on the date of offering, less the purchase discount percentage provided for in the plan. The Company classifies stock-based compensation expense in its condensed consolidated statement of operations and comprehensive loss in the same manner in which the award recipient's payroll costs are classified or in which the award recipient's service payments are classified. Loan Payable Loan Payable represents the Loan and Security Agreement, dated June 15, 2022 (“Loan Agreement”) with Hercules Capital, Inc. (“Hercules”), which the Company has accounted for as a debt financing arrangement. Interest expense is accrued using the effective interest rate method over the estimated period the loan will be repaid. Loan issuance costs have been recorded as a debt discount in the condensed consolidated balance sheets and are being amortized and recorded as interest expense throughout the life of the Loan Agreement using the effective interest rate method. The Company determined that there are not any embedded features in the Loan Agreement that require bifurcation and separate accounting as derivative financial instruments pursuant to Accounting Standards Codification ("ASC") Topic 815, Derivatives and Hedging . Warrant Liabilities The Company accounts for warrants anticipated to be issued in the future under the Loan Agreement as liabilities and measures them at fair value using the Black-Scholes valuation model. The warrants are subject to remeasurement at each prospective balance sheet date, with any changes in the fair value recorded in the condensed consolidated statements of operations. Comprehensive loss Comprehensive loss includes net loss as well as other changes in stockholders' equity (deficit) that result from transactions and economic events other than those with stockholders. The Company’s comprehensive loss is comprised of net loss and changes in unrealized gains and losses on its short and long-term marketable securities . Recently adopted accounting pronouncements As of September 30, 2023, and for the period then ended, there were no recently adopted accounting standards that had a material impact on the Company’s condensed consolidated financial statements. There were no recently issued accounting standards not yet adopted which would have a material effect on the Company’s condensed consolidated financial statements. |
Fair value measurements
Fair value measurements | 9 Months Ended |
Sep. 30, 2023 | |
Fair Value Disclosures [Abstract] | |
Fair value measurements | 3. Fair value measurements Certain assets and liabilities of the Company are carried at fair value under GAAP. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. Financial assets and liabilities carried at fair value are to be classified and disclosed in one of the following three levels of the fair value hierarchy, of which the first two are considered observable and the last is considered unobservable: • Level 1—Quoted prices in active markets for identical assets or liabilities. • Level 2—Observable inputs (other than Level 1 quoted prices), such as quoted prices in active markets for similar assets or liabilities, quoted prices in markets that are no t active for identical or similar assets or liabilities, or other inputs that are observable or can be corroborated by observable market data. • Level 3—Unobservable inputs that are supported by little or no market activity that are significant to determining the fair value of the assets or liabilities, including pricing models, discounted cash flow methodologies and similar techniques. The following is a summary of our financial assets and liabilities measured at fair value on a recurring basis as of September 30, 2023 and December 31, 2022: September 30, 2023 Total Level 1 Level 2 Level 3 Money market funds $ 261,202 $ 261,202 $ — $ — U.S. Treasury securities 96,766 96,766 — — U.S. Government agency securities 144,418 — 144,418 — Commercial paper 86,678 — 86,678 — Corporate debt securities 15,589 — 15,589 — Total assets $ 604,653 $ 357,968 $ 246,685 $ — Warrant liabilities $ 93 $ — $ — $ 93 Total liabilities $ 93 $ — $ — $ 93 December 31, 2022 Total Level 1 Level 2 Level 3 Money market funds $ 137,286 $ 137,286 $ — $ — U.S. Treasury securities 58,721 58,721 — — Corporate debt securities 5,476 — 5,476 — U.S. Government agency securities 62,955 — 62,955 — Commercial paper 27,738 — 27,738 — Total assets $ 292,176 $ 196,007 $ 96,169 $ — Warrant liabilities $ 305 $ — $ — $ 305 Total liabilities $ 305 $ — $ — $ 305 Corporate debt, commercial paper and U.S. Government agency securities were valued by the Company using quoted prices in active markets for similar securities, which represent a Level 2 measurement within the fair value hierarchy. The carrying values of the Company’s prepaid expenses and other current assets, accounts payable and accrued expenses approximate their fair values due to the short-term nature of these assets and liabilities. During the three and nine months ended September 30, 2023 and the twelve months ended December 31, 2022, there were no transfers between Level 1, Level 2 and Level 3. The Loan Payable is classified as a Level 3 liability. As of September 30, 2023, the carrying value of the Loan Payable approximates its fair value. The Company estimated the fair value of the warrant liabilities using the Black-Scholes model based on key assumption and inputs (see Note 6). The Company utilizes a probability assessment to estimate the likelihood of vesting for the remaining Loan Agreement warrants and allocated the probability of occurrence percentage to the fair values calculated. |
Marketable securities
Marketable securities | 9 Months Ended |
Sep. 30, 2023 | |
Debt Securities [Abstract] | |
Marketable securities | 4. Marketable securities The following is a summary of marketable securities as of September 30, 2023 and December 31, 2022 : September 30, 2023 Amortized cost Gross unrealized gains Gross unrealized losses Credit losses Fair value Money market funds $ 261,202 $ — $ — $ — $ 261,202 U.S. Treasury securities 96,945 — ( 179 ) — 96,766 U.S. Government agency securities 144,551 14 ( 147 ) — 144,418 Commercial paper 86,852 — ( 174 ) — 86,678 Corporate debt securities 15,608 — ( 19 ) — 15,589 $ 605,158 $ 14 $ ( 519 ) $ — $ 604,653 Cash equivalents $ 261,202 Short-term marketable securities 285,186 Long-term marketable securities 58,264 $ 604,652 December 31, 2022 Amortized cost Gross unrealized gains Gross unrealized losses Credit losses Fair value Money market funds $ 137,286 $ — $ — $ — $ 137,286 U.S. Treasury securities 58,698 23 — — 58,721 Corporate debt securities 5,478 — ( 2 ) — 5,476 U.S. Government agency securities 62,939 15 — — 62,954 Commercial paper 27,739 — — — 27,739 $ 292,140 $ 38 $ ( 2 ) $ — $ 292,176 Cash equivalents $ 190,500 Short-term marketable securities 101,676 $ 292,176 The following table presents the contractual maturities of our short and long-term marketable securities as of September 30, 2023 and December 31, 2022. September 30, 2023 December 31, 2022 Due within one year $ 285,186 $ 101,676 Due after one year through five years 58,264 — Total $ 343,450 $ 101,676 |
Accrued expenses and other curr
Accrued expenses and other current liabilities | 9 Months Ended |
Sep. 30, 2023 | |
Accrued expenses and other current liabilities | |
Accrued expenses and other current liabilities | 5. Accrued expenses and other current liabilities The following is a summary of accrued expenses and other current liabilities as of September 30, 2023 and December 31, 2022 : September 30, 2023 December 31, 2022 Accrued external research and development expenses $ 10,734 $ 9,789 Accrued employee compensation and benefits 3,404 804 Accrued legal and professional fees 274 197 Short-term lease liability and other 505 325 $ 14,917 $ 11,115 |
Loan Payable and Warrant Liabil
Loan Payable and Warrant Liability | 9 Months Ended |
Sep. 30, 2023 | |
Debt Disclosure [Abstract] | |
Loan Payable and Warrant Liability | 6. Loan Payable and Warrant Liability On June 15, 2022, the Company entered into the Loan Agreement with Hercules for an aggregate principal amount of $ 100,000 (“Term Loan”). Pursuant to the Loan Agreement, the Term Loan is available to the Company in four tranches, subject to certain terms and conditions. Under the terms of the Loan Agreement, the Company received $ 10,000 upon closing, $ 15,000 was borrowed on March 10, 2023 and an additional $ 10,000 is available to the Company at its sole discretion until December 15, 2023. An additional $ 20,000 will become available to the Company upon the achievement of certain clinical and financial milestones. An additional $ 45,000 may become available to the Company at Hercules' sole discretion. The Term Loan will mature on January 1, 2027 (the “Maturity Date”). The Term Loan bears interest at a variable annual rate equal to the greater of (a) 7.65 % and (b) the Prime Rate (as reported in the Wall Street Journal) plus 3.65 % (the “Interest Rate”). The Company may make payments of interest only through July 1, 2024, which may be extended to July 1, 2025 upon the achievement of the third tranche milestones (the “interest-only period”). After the interest-only period, the principal balance and related interest will be required to be repaid in equal monthly installments and continuing until the Maturity Date. The Loan Agreement contains customary closing fees, events of default, and representations, warranties and covenants, including a financial covenant requiring the Company to maintain a minimum cash balance in relation to the outstanding principal balance of the Term Loan. The Loan Agreement provides for a prepayment charge equal to 3 % of the outstanding principal balance of the Term Loan if prepayment is made within the first twelve months after closing, 2 % if within the second twelve months after closing and 1 % thereafter. In addition, the Loan Agreement provides for an End of Term Charge that will be the greater of 5.85 % of the outstanding principal balance or $ 1,463 , which is recognized as a debt discount and is being accreted into the amortization of debt issuance costs and discount using the effective interest rate method over the term of the loan payable. Upon closing, the Company issued warrants to Hercules to purchase shares of the Company’s common stock, par value $ 0.0001 per share ("common stock"). The amount of shares that may be purchased for the Warrants will not exceed 1.5 % multiplied by the greater of Tranche I and the aggregate original amount of the term loan advances, divided by the exercise price of the Warrants. The Company was in compliance with all covenants of the Loan Agreement as of September 30, 2023. The Company determined in accordance with ASC 480-10 that the initial tranche one advance of $ 10,000 , the additional Term Loan advances available under tranches one, two, three and four and the warrants issued upon closing shall be accounted for as freestanding financial instruments as they are legally detachable and separately exercisable. The Company also determined in accordance with ASC 815-10 that the additional Term Loan advances available under tranches one, two, three and four do not qualify as derivative instruments and that the value associated with these commitments is immaterial. Upon closing, the Company issued to Hercules warrants to purchase 36,718 shares of Company’s common stock and recognized the initial warrants at their relative fair value of $ 227 in shareholders equity. In accordance with ASC 815-40, the additional remaining warrants to purchase shares of the Company’s common stock at the closing of the Loan Agreement were recognized at their fair value of $ 41 as warrant liabilities given the variable settlement amount of the warrant shares. The additional remaining warrants under the Loan Agreement are considered an outstanding instrument at close of the Loan Agreement. The total fair value of $ 268 associated with these equity and liability classified warrants, is recognized as a debt discount and is being accreted into the amortization of debt issuance costs and discount using the effective interest rate method over the term of the loan payable. The Company reassesses the fair value of the warrant liability at the end of each reporting period. On March 10, 2023, the Company borrowed an additional $ 15,000 and issued warrants to Hercules to purchase an additional 9,180 shares of Company's common stock. The fair value associated with these additional warrants of $ 330 were reclassified from warrant liability to additional paid in capital. The warrant liabilities were valued at $ 93 as of September 30, 2023. Future principal debt payments on the currently outstanding loan payable as of September 30, 2023 are as follows (in thousands): 2023 (remaining period) $ — 2024 4,225 2025 9,278 2026 10,488 2027 1,009 Total principal outstanding 25,000 End of term charge 1,463 Total principal outstanding and end of term charge 26,463 Unamortized discount and issuance costs ( 1,619 ) Loan Payable $ 24,844 Loan Payable - current 2,076 Loan Payable - noncurrent 22,768 Loan Payable $ 24,844 The Company estimated the fair value of the warrant liability as of September 30, 2023 using probability assumptions of achieving the future milestones and using the Black-Scholes model based on the following key assumptions: As of September 30, 2023 Expected term (in years) 5.7 Expected volatility 79.55 % Risk-free interest rate 4.60 % Expected dividend yield 0.00 % |
Stockholder's equity (deficit)
Stockholder's equity (deficit) | 9 Months Ended |
Sep. 30, 2023 | |
Stockholders' Equity Note [Abstract] | |
Stockholder's equity (deficit) | 7. Stockholder’s equity (deficit) Common stock As of September 30, 2023 and December 31, 2022, the Company’s certificate of incorporation, as amended and restated, authorized the Company to issue 150,000,000 shares of $ 0.0001 par value common stock. Each share of common stock entitles the holder to one vote on all matters submitted to a vote of the Company’s stockholders. The holders of common stock, voting exclusively and as a separate class, have the exclusive right to vote for the election of directors of the Company. Common stockholders are entitled to receive dividends, as may be declared by the board of directors. Through September 30, 2023, no cash dividends had been declared or paid. On June 24, 2019, the Company completed its IPO at which time the Company issued 6,612,500 shares of common stock, including the exercise in full by the underwriters of their option to purchase up to 862,500 additional shares of common stock, at a public offering price of $ 16.00 per share. The Company received $ 98,394 , net of underwriting discounts and commissions, but before deducting offering costs paid by the Company, which were $ 2,942 . Upon the closing of the IPO, all outstanding shares of convertible preferred stock converted into 21,056,136 shares of common stock. On July 10, 2020, the Company completed a follow-on public offering at which time the Company issued 6,012,390 shares of common stock, including the exercise in full by the underwriters of their option to purchase up to 784,224 additional shares of common stock, at a public offering price of $ 36.00 per share. The Company received $ 203,460 net of underwriting discounts and commissions, but before deducting offering costs paid by the Company. On May 18, 2021, the Company filed a Form S-3 Registration Statement and the accompanying prospectus activating an At-The-Market ("ATM"), facility by entering into a sales agreement with J.P. Morgan Securities LLC, relating to shares of the Company’s common stock offered. Pursuant to the terms of the sales agreement, the Company may offer and sell shares of common stock, having an aggregate price of up to $ 100,000 , from time to time. The Company reserved 5,000,000 shares of common stock related to the ATM offering. In March 2023, the Company terminated the sales agreement with J.P. Morgan Securities LLC and separately entered into a sales agreement with Jefferies LLC (the "Sales Agreement"). Pursuant to the Sales Agreement, the Company filed a prospectus supplement on March 17, 2023, under which the Company may offer and sell shares of common stock, having an aggregate value of up to $ 200,000 . In April and May 2023, the Company sold 3,006,052 shares of common stock under the Sales Agreement, at an average price of $ 42.38 per share. The Company received net proceeds of $ 123,824 , after deducting sales agent commissions and issuance costs incurred by the Company of approximately $ 3,578 . On June 15, 2022, the Company entered into a securities purchase agreement for the sale of 2,525,252 shares of the Company's common stock to Pfizer Inc. at $ 9.90 per share in a registered direct offering conducted without an underwriter or placement agent and pursuant to the Company’s effective shelf registration statement on Form S-3ASR and a related prospectus supplement filed with the SEC. The offering closed on June 17, 2022 for net proceeds of $ 24,647 , after deducting offering costs paid by the Company. On September 19, 2022, the Company completed a follow-on public offering at which time the Company issued 8,846,154 shares of common stock, including the exercise in full by the underwriters of their option to purchase up to 1,153,846 additional shares of common stock, at a public offering price of $ 26.00 per share. The Company received $ 216,200 net of underwriting discounts and commissions of $ 13,800 , but before deducting offering costs incurred by the Company. On May 16, 2023, the Company entered into an underwriting agreement (the "Underwriting Agreement") with Jefferies LLC, ("Jefferies"), as a representative of the several underwriters, pursuant to which the Company agreed to issue and sell 5,238,500 shares of the Company's common stock at $ 42.00 per share in a registered direct offering pursuant to the Company’s effective shelf registration statement on Form S-3ASR and a related prospectus supplement filed with the SEC. The offering closed on May 16, 2023. The Company received net proceeds of $ 210,956 , after deducting underwriters commissions and offering costs incurred by the Company of approximately $ 9,061 . As of September 30, 2023 and December 31, 2022, there were 55,681,026 and 46,865,206 shares of common stock issued and outstanding, respectively. The following shares of common stock were reserved for issuance as follows: September 30, 2023 December 31, 2022 Options outstanding under the 2018 Stock Option and Grant Plan 1,171,581 1,633,173 Options outstanding under the 2019 Stock Option and Incentive Plan 4,579,020 4,146,831 Restricted stock units outstanding under the 2019 Stock Option and Incentive Plan 142,498 129,131 Warrants to purchase common stock associated with Loan Agreement 45,898 36,718 Options available for future grant 3,365,403 2,038,142 Warrants available for future grant 137,700 146,880 Common stock available for ATM program 2,708,234 5,000,000 2019 Employee Stock Purchase Plan 1,590,426 1,187,508 13,740,760 14,318,383 Undesignated preferred stock The Company’s fourth amended and restated certificate of incorporation authorizes the Company to issue up to 10,000,000 shares of undesignated preferred stock, par value $ 0.0001 per share. There were no undesignated preferred shares issued or outstanding as of September 30, 2023. Warrants Associated with Loan Agreement In connection with the entry into the Loan Agreement, the Company issued to Hercules warrants to purchase shares of the Company’s common stock. The amount of shares that may be purchased for the Warrants will not exceed 1.5 % multiplied by the greater of Tranche I and the aggregate original amount of the term loan advances, divided by the exercise price of the Warrants. Upon execution of the Loan Agreement on June 15, 2022, the Company issued 36,718 warrants to purchase shares of the Company’s common stock and recorded the initial warrants at their relative fair value in shareholder's equity. In March 2023, the Company issued an additional 9,180 warrants to purchase shares of the Company’s common stock to Hercules in connection with the borrowing on March 10, 2023. |
Stock-based awards
Stock-based awards | 9 Months Ended |
Sep. 30, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Stock-based awards | 8. Stock-based awards 2018 Stock option and grant plan The Company’s 2018 Stock Option and Grant Plan (the “2018 Plan”) provided for the Company to grant incentive stock options or nonqualified stock options, restricted stock awards and other stock-based awards to employees, directors and consultants of the Company. The 2018 Plan was administered by the board of directors or, at the discretion of the board of directors, by a committee of the board of directors. The exercise prices, vesting and other restrictions were determined at the discretion of the board of directors, or its committee if so delegated. The total number of shares of common stock that could have been issued under the 2018 Plan was 3,071,960 shares, of which 107,635 shares remained available for grant on June 18, 2019, the date that the Company’s 2019 Stock Option and Incentive Plan (the “2019 Plan”) became effective. Upon the effectiveness of the 2019 Plan, the 107,635 remaining shares available under the 2018 Plan were transferred and became available for issuance under the 2019 Plan. Shares of common stock underlying outstanding awards under the 2018 Plan that are forfeited, cancelled, held back upon exercise or settlement of an award to satisfy the exercise price or tax withholding, reacquired by the Company prior to vesting, satisfied without the issuance of stock, expire or are otherwise terminated (other than by exercise) will be added to the shares of common stock available for issuance under the 2019 Plan. 2019 Stock option and incentive plan The 2019 Plan was adopted and approved by the Company’s board of directors in May 2019 and by the Company’s stockholders in June 2019. The 2019 Plan became effective on June 18, 2019 and replaced the Company’s 2018 Plan on that date. The 2019 Plan allows the board of directors or the compensation committee of the board of directors to make equity-based incentive awards to the Company’s officers, employees, directors or other key persons (including consultants). The number of shares initially reserved for issuance under the 2019 Plan was 2,572,457 , which included the 107,635 shares transferred from the 2018 Plan, and shall be cumulatively increased on each January 1 by 4 % of the number of shares of the Company’s common stock outstanding on the immediately preceding December 31 or such lesser number of shares determined by the Company’s board of directors or compensation committee of the board of directors. The 2019 Plan was increased by 1,396,029 shares on January 1, 2022 and by 1,874,608 shares on January 1, 2023. The 2019 Plan is administered by the board of directors or, at the discretion of the board of directors, by a committee of the board of directors. The exercise prices, vesting and other restrictions are determined at the discretion of the board of directors, or its committee if so delegated, except that the exercise price per share of stock options may not be less than 100 % of the fair market value of the share of common stock on the date of grant and the term of stock option may not be greater than ten years . All incentive options granted to any person possessing more than 10% of the total combined voting power of all classes of shares may not have an exercise price of less than 110 % of the fair market value of the common stock on the grant date. Stock options granted to employees, officers, members of the board of directors and consultants will typically vest over a four-year period. Shares that are expired, terminated, surrendered or canceled under the 2019 Plan without having been fully exercised will be available for future awards. 2019 Employee stock purchase plan The 2019 Employee Stock Purchase Plan (the “2019 ESPP”) was adopted and approved by the Company’s board of directors in May 2019 and by the Company’s stockholders in June 2019. The 2019 ESPP became effective on June 18, 2019, at which time 273,869 shares were reserved for issuance. The 2019 ESPP provides that the number of shares reserved and available for issuance will automatically increase each January 1, beginning on January 1, 2020 and each January 1 through January 1, 2029, by the least of (i) 1 % of the outstanding number of shares of the Company’s common stock on the immediately preceding December 31, (ii) 410,803 shares or (iii) such number of shares as determined by the compensation committee. The 2019 ESPP was increased by 349,007 shares on January 1, 2022 and by 410,803 shares on January 1, 2023. Stock option valuation The assumptions that the Company used to determine the grant-date fair value of stock options granted to employees, directors and consultants as follows, presented on a weighted average basis: Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 Expected term (in years) 5.85 6.03 5.88 4.86 Expected volatility 79.75 % 74.20 % 78.37 % 73.18 % Weighted average risk-free interest rate 4.18 % 2.90 % 3.91 % 1.90 % Expected dividend yield 0.00 % 0.00 % 0.00 % 0.00 % Stock options The following table summarizes the Company’s stock option activity since December 31, 2022: Weighted- Weighted- Average Average Aggregate Exercise remaining Intrinsic Number Price per contractual Value of Options Share term (years) (000's) Balance outstanding, December 31, 2022 5,780,004 $ 18.88 7.80 $ 207,611 Options granted 505,984 $ 47.45 Options exercised ( 535,387 ) $ 5.39 Options cancelled — Balance outstanding, September 30, 2023 5,750,601 $ 22.65 7.42 $ 160,636 Vested and expected to vest, September 30, 2023 5,750,601 $ 22.65 7.42 $ 160,636 Exercisable, September 30, 2023 3,963,342 $ 17.52 6.86 $ 131,032 The aggregate intrinsic value of stock options is calculated as the difference between the exercise price of the stock options and the fair value of the Company’s common stock for those stock options that had exercise prices lower than the fair value of the Company’s common stock. The weighted average grant-date fair value per share of stock options granted during the three months ended September 30, 2023 and 2022 was $ 46.01 and $ 6.78 , respectively. Additionally, the weighted average grant-date fair value per share of stock options granted during the nine months ended September 30, 2023 and 2022 was $ 47.45 and $ 11.17 , respectively. Awards with performance-based vesting conditions granted under the 2019 Plan In December 2021, the Company granted 610,546 stock options to management at an exercise price of $ 21.10 , which would vest upon the achievement on or before December 31, 2022 of three pre-determined milestones regarding progress related to the HARMONY study, progress related to the SYMMETRY study, and progress related to availability of drug product for use in Phase 3 clinical trials. One-third of the options were to vest upon achievement of each of the milestones. In January 2022, the Company granted an additional 248,376 stock options to Company employees with the same performance-based milestones and vesting terms at an exercise price of $ 21.70 . In September 2022, two of the three performance-based awards milestones were achieved and were deemed vested. In December 2022, the third portion of the performance-based awards milestones was achieved and was deemed vested. During the three and nine months ended September 30, 2023, the Company did not have any outstanding performance awards or recognize any performance-based stock compensation expense. Restricted Stock Units The 2019 Plan allows for the grants of Restricted Stock Units ("RSUs"). Generally, the RSUs are subject to a four-year vesting period, vesting in equal quarterly installments over the vesting period. In December 2022, the Company granted 129,131 RSUs to executive management with a total grant date fair value of $ 5,546 . In 2023, The Company granted 41,363 RSUs to executive and non-executive employees with a total grant date fair value of $ 1,992 . The following table summarizes the Company’s RSUs activity since December 31, 2022: Weighted- Weighted- Average Average Aggregate Grant Date remaining Intrinsic Underlying Fair Value per contractual Value shares Share term (years) (000's) Balance outstanding, December 31, 2022 129,131 $ 42.95 2.07 $ 7,076 Granted 41,363 $ 48.17 Vested ( 27,996 ) $ 43.83 Cancelled or forfeited — $ — Balance outstanding, September 30, 2023 142,498 $ 44.29 1.69 $ 7,208 The weighted average grant-date fair value per share of RSUs granted during the three months ended September 30, 2023 and 2022 was $ 44.52 and $ 0 , respectively. The weighted average grant-date fair value per share of RSUs granted during the nine months ended September 30, 2023 and 2022 was $ 48.17 and $ 0 , respectively. Stock-based compensation The following table summarizes the Company’s stock-based compensation expense during the three and nine months ended September 30, 2023 and 2022: Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 Classified within research and development expense $ 1,986 $ 4,195 $ 5,485 $ 6,780 Classified within general and administrative expense 3,753 7,536 9,896 12,423 Total stock-based compensation expense $ 5,739 $ 11,731 $ 15,381 $ 19,203 As of September 30, 2023, total unrecognized compensation cost related to unvested stock options and RSUs was $ 38,933 and $ 6,110 , respectively. These unvested stock options and RSUs are expected to be recognized over a weighted average period of 2.33 years and 3.25 years, respectively. |
Amgen license agreement
Amgen license agreement | 9 Months Ended |
Sep. 30, 2023 | |
Amgen license agreement | |
Amgen license agreement | 9. Amgen license agreement In June 2018, the Company entered into a license agreement (the “Amgen Agreement”) with Amgen, Inc. (“Amgen”) pursuant to which the Company was granted an exclusive license to certain patents and intellectual property related to a long-acting FGF21 analog in order to commercially develop, manufacture, use and distribute FGF21 as a treatment for NASH/MASH and other serious metabolic diseases. The Amgen Agreement provides the Company with exclusive global rights to the licensed products and the right to grant sublicenses that cover EFX to third parties. In exchange for these rights, the Company made an upfront payment of $ 5,000 and issued 2,653,333 shares of Series A Preferred Stock with a fair value of $ 1,353 to Amgen. Amgen was also entitled to maintain a 10 % ownership interest of the outstanding shares of the Company’s common stock, on a fully diluted and converted basis, through the second closing of the Company’s Series A Preferred Stock financing. In November 2018, in connection with the second closing of the Company’s Series A Preferred Stock financing, the Company issued 3,205,128 shares of Series A Preferred Stock to Amgen for a total value of $ 7,404 , satisfying its anti-dilution obligation under the Amgen Agreement. Under the Amgen Agreement, the Company made a milestone payment in the third quarter of 2019 of $ 2,500 in connection with dosing the first patient in the BALANCED study and is obligated to pay Amgen $ 7,500 in connection with dosing the first patient in a Phase 3 clinical trial, up to $ 30,000 in connection with marketing approvals, and aggregate milestone payments of up to $ 75,000 upon the achievement of specified commercial milestones for all products licensed under the Amgen Agreement. Under the Amgen Agreement, the Company is obligated to pay Amgen tiered royalties ranging from a low to high single-digit percentages on annual net sales of the licensed products, beginning on the first commercial sale of such licensed products in each country and expiring on a country-by-country basis on the latest of (i) the expiration of the last valid patent claim covering such licensed products in such country, (ii) the loss of regulatory exclusivity in such country, and (iii) ten years after the first commercial sale of such licensed product in such country. The royalty payments are subject to reduction under specified conditions set forth in the Amgen Agreement. The Company is solely responsible for all development, manufacturing, and commercial activities and costs of the licensed products, including clinical studies or other tests necessary to support the use of a licensed product. The Company is also responsible for costs related to the filing, prosecution and maintenance of the licensed patent rights. The Amgen Agreement will remain in effect until the expiration of the royalty term in all countries for all licensed products. The Amgen Agreement may be terminated by either party with at least 90 days' notice in the event of material breach by the other party that remains uncured for 90 days, by either party for insolvency or bankruptcy of the other party and immediately by Amgen if the Company challenges the licensed patents. The Company may also terminate the Amgen Agreement with 90 days' written notice for discretionary reasons such as scientific, technical, regulatory or commercial issues, as defined in the Amgen Agreement. During the three and nine months ended September 30, 2023 and 2022, the Company did no t record any research and development expense in connection with the Amgen Agreement. |
Income taxes
Income taxes | 9 Months Ended |
Sep. 30, 2023 | |
Income Tax Disclosure [Abstract] | |
Income taxes | 10. Income taxes During the three and nine months ended September 30, 2023 and 2022, the Company did no t record any income tax benefits for the net operating losses incurred or for the research and development tax credits generated in each period due to its uncertainty of realizing a benefit from those items. All of the Company’s operating losses since inception have been generated in the United States. On August 16, 2022, the Inflation Reduction Act of 2022 (“IRA”) was signed into law. The IRA includes implementation of a new alternative minimum tax, an excise tax on stock buybacks, and significant tax incentives for energy and climate initiatives, among other provisions. The Company is evaluating the provisions included under the IRA and does not expect the provisions to have a material impact to the Company’s condensed consolidated financial statements. Beginning in 2022, the Tax Cuts and Jobs Act of 2017 eliminates the option to deduct research and development expenditures in the period incurred and requires amortization over five years or fifteen years pursuant to IRC Section 174. Although Congress is considering legislation that would defer the amortization requirement to later years, there is no assurance that the requirement to amortize will be repealed or otherwise modified. In general, for taxable years beginning on or after January 1, 2015, California law conforms to the IRC as of January 1, 2015. California has not conformed to the federal changes made to the IRC by the Tax Cuts and Jobs Act (Public Law 115-97, enacted on December 22, 2017). In the context of IRC 174, California allows taxpayers to immediately expense R&D costs or capitalize and amortize R&D expenditures over a 5-year recovery period. Thus, the new requirements to capitalize R&D will have no material impact on the state income tax provision. |
Net loss per share
Net loss per share | 9 Months Ended |
Sep. 30, 2023 | |
Earnings Per Share [Abstract] | |
Net loss per share | 11. Net loss per share Basic and diluted net loss per share attributable to common stockholders was calculated as follows: Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 Numerator: Net loss $ ( 39,659 ) $ ( 35,542 ) $ ( 96,573 ) $ ( 88,974 ) Denominator: Weighted average common shares outstanding, basic and diluted 55,613,120 38,663,469 51,506,766 36,364,284 Net loss per share, basic and diluted $ ( 0.71 ) $ ( 0.92 ) $ ( 1.87 ) $ ( 2.45 ) The Company’s potentially dilutive securities, which include stock options, warrants and unvested restricted stock units, have been excluded from the computation of diluted net loss per share as the effect would be to reduce the net loss per share. Therefore, the weighted average number of common shares outstanding used to calculate both basic and diluted net loss per share is the same. The Company excluded the following potential common shares, presented based on amounts outstanding at each period end, from the computation of diluted net loss per share for the periods indicated because including them would have had an anti-dilutive effect: Three and nine months ended September 30, 2023 2022 Options to purchase common stock 5,750,601 5,390,277 Unvested restricted stock units 142,498 — Warrants to purchase common stock 45,898 36,718 Warrants available for future grant 137,700 146,880 6,076,697 5,573,875 |
Commitments and contingencies
Commitments and contingencies | 9 Months Ended |
Sep. 30, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and contingencies | 12. Commitments and contingencies Operating lease In February 2020, the Company entered into a seven-year agreement to occupy 6,647 square feet of office space in South San Francisco, California. The lease commenced on July 10, 2020 when the Company took occupancy of the leased space and the lease was determined to be operating classified. Under the agreement, the Company is required to make approximately $ 2,300 in total minimum payments during the term. The Company is also required to pay its proportionate share of building operating and tax costs after the first year under lease which are not included in the measurement of the lease and treated as variable lease cost and expensed when incurred. As of September 30, 2023, maturities of the Company’s operating lease liability was as follows: 2023 (remaining) $ 82 2024 331 2025 341 2026 351 2027 208 Total future minimum lease payments 1,313 Less imputed interest ( 173 ) Present value of operating lease liabilities $ 1,140 As of September 30, 2023, the total lease liability was $ 1,140 , of which $ 888 was noncurrent and $ 252 was short-term and classified within “ Accrued expenses and other current liabilities ” on the condensed consolidated balance sheet. For the three and nine months ended September 30, 2023 and 2022, the components of operating lease cost were as follows: Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 Lease cost: Statement of Operations Classification: Operating lease cost General and administrative expense $ 81 $ 81 $ 243 $ 243 Short-term lease cost General and administrative expense 36 — 125 29 Variable operating lease cost General and administrative expense 8 9 27 52 Total operating lease cost $ 125 $ 90 $ 395 $ 324 Other information: Cash paid for amounts included in the measurement of operating lease liability $ 81 79 $ 240 $ 233 Weighted average remaining lease term (years) 3.8 4.8 3.8 4.8 Weighted average discount rate 7.6 % 7.6 % 7.6 % 7.6 % Research and manufacturing and other commitments The Company has entered into agreements with contract research organizations and contract manufacturing organizations to provide services in connection with its nonclinical studies and clinical trials and to manufacture clinical development materials. As of September 30, 2023, the Company had non-cancelable purchase and other commitments under these agreements totaling $ 21,083 . Indemnification agreements In the ordinary course of business, the Company may provide indemnification of varying scope and terms to vendors, lessors, business partners and other parties with respect to certain matters including, but not limited to, losses arising out of breach of such agreements or from intellectual property infringement claims made by third parties. In addition, the Company has entered into indemnification agreements with members of its board of directors and its executive officers that will require the Company, among other things, to indemnify them against certain liabilities that may arise by reason of their status or service as directors or officers. The maximum potential amount of future payments the Company could be required to make under these indemnification agreements is, in many cases, unlimited. To date, the Company has not incurred any material costs as a result of such indemnifications. The Company is not currently aware of any indemnification claims and has not accrued any liabilities related to such obligations in its condensed consolidated financial statements as of September 30, 2023. Legal proceedings The Company is not a party to any litigation and does not have contingency reserves established for any litigation liabilities. At each reporting date, the Company evaluates whether or not a potential loss amount or a potential range of loss is probable and reasonably estimable under the provisions of the authoritative guidance that addresses accounting for contingencies. The Company expenses as incurred the costs related to such legal proceedings. |
Subsequent event
Subsequent event | 9 Months Ended |
Sep. 30, 2023 | |
Subsequent Events [Abstract] | |
Subsequent event | 13. Subsequent event The Company evaluated subsequent events through November 13, 2023, the date on which these condensed consolidated financial statements were issued. Based on this evaluation, it was determined that no subsequent events occurred that require recognition or disclosure in its financial statements for the three months and nine months ended September 30, 2023. |
Summary of significant accoun_2
Summary of significant accounting policies (Policies) | 9 Months Ended |
Sep. 30, 2023 | |
Accounting Policies [Abstract] | |
Unaudited interim financial statements | Unaudited interim financial statements The accompanying unaudited condensed consolidated financial statements have been prepared by the Company in accordance with GAAP for interim financial reporting and as required by Regulation S-X, Rule 10-01. The unaudited condensed consolidated financial statements have been prepared on the same basis as the Company’s audited annual financial statements and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary for a fair statement of the Company’s condensed consolidated balance sheet as of September 30, 2023, the condensed consolidated statements of operations and comprehensive loss for the three and nine months ended September 30, 2023 and 2022, the condensed consolidated statement of stockholders’ equity (deficit) as of September 30, 2023 and the condensed consolidated statements of cash flows for the nine months ended September 30, 2023. The financial data and other information disclosed in these notes related to the three and nine months ended September 30, 2023 and 2022 are unaudited. The results for the three and nine months ended September 30, 2023 are not necessarily indicative of results to be expected for the year ending December 31, 2023, any other interim periods, or any future year or period. |
Use of estimates | Use of estimates The preparation of the Company's condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements, and the reported amounts of expenses during the reporting period. Significant estimates and assumptions reflected in these condensed consolidated financial statements include, but are not limited to, the recognition of research and development expenses, stock-based compensation expense, warrant liabilities and the valuation allowance for deferred tax assets. The Company bases its estimates on historical experience, known trends and other market-specific or other relevant factors that it believes to be reasonable under the circumstances. On an ongoing basis, management evaluates its estimates when there are changes in circumstances, facts and experience. Changes in estimates are recorded in the period in which they become known. Actual results could differ from those estimates. |
Cash and cash equivalents | Cash and cash equivalents The Company considers all highly liquid investments with original maturities of three months or less at the time of purchase to be cash equivalents. Cash equivalents consist primarily of amounts invested in money market accounts. |
Short-term marketable securities | Short-term and long-term marketable securities The Company invests in short and long-term marketable securities, primarily money market funds, commercial paper, U.S. treasury securities and corporate debt securities. The Company continually evaluates the credit ratings of its investment portfolio and underlying securities. The Company invests in accordance with its investment policy and invests at the date of purchase in securities with high ratings from top rating agencies. The Company classifies its short-term and long-term marketable securities as available-for-sale securities and reports them at fair value in short-term and long-term marketable securities on the condensed consolidated balance sheets with related unrealized gains and losses included within accumulated other comprehensive gain (loss) on the condensed consolidated balance sheets. The amortized cost of marketable securities is adjusted for amortization of premiums and accretion of discounts to maturity, which is included in other income on the condensed consolidated statements of operations and comprehensive loss. When the fair value is below the amortized cost of a marketable security, the Company reviews and determines whether the impairment is due to credit-related factors or noncredit-related factors. The credit-related impairment amount is recognized in other income on the condensed consolidated statements of operations and comprehensive loss, with a corresponding allowance for credit losses account in the condensed consolidated balance sheet. Subsequent improvements in expected credit losses are recognized as a reversal of an amount in the allowance account. If the Company has the intent to sell the security or it is more likely than not that the Company will be required to sell the security prior to recovery of its amortized cost basis, then the allowance for the credit loss is written-off and the excess of the amortized cost basis of the asset over its fair value is recorded in the condensed consolidated statements of operations. There were no credit losses recorded during the periods ended September 30, 2023 and December 31, 2022. |
Restricted cash | Restricted cash As of December 31, 2022, the Company was required to maintain a separate cash balance of $ 108 for the benefit of the landlord in connection with the Company’s Gateway office space lease in South San Francisco, California (the “Gateway Lease”), which is classified within other assets (non-current) on the condensed consolidated balance sheets (see Note 12). The Company was not required to maintain a separate cash balance for the benefit of the landlord as of September 30, 2023. |
Concentrations of credit risk | Concentrations of credit risk Financial instruments that potentially subject the Company to concentrations of credit risk consist principally of cash, cash equivalents, short and long-term marketable securities. Periodically, the Company maintains deposits in accredited financial institutions in excess of federally insured limits. The Company deposits its cash investments in financial institutions that it believes have high credit quality and has not experienced any losses on such accounts and does not believe it is exposed to any unusual credit risk beyond the normal credit risk associated with commercial banking relationships. At September 30, 2023, all of the Company's cash, cash equivalents, short and long-term investments were held at four accredited financial institutions. As of December 31, 2022, the Company held cash deposits at Silicon Valley Bank ("SVB") in excess of government insured limits. On March 10, 2023, SVB was closed by the California Department of Financial Protection and Innovation, and the Federal Deposit Insurance Corporation (“FDIC”) was appointed as receiver. No losses were incurred by the Company on deposits that were held at SVB. Management believes that the Company is not currently exposed to significant credit risk as the vast majority of the Company’s deposits were either owned directly by the Company and held in custody at a third-party financial institution or, subsequent to March 10, 2023, have been transferred to a third-party financial institution. On March 27, 2023, SVB was acquired by First-Citizen BancShares, Inc ("First-Citizen"). As of September 30, 2023, the Company did not have any significant deposits on account at or relationships with SVB or First-Citizen. |
Leases | Leases The Company determines whether an arrangement is or contains a lease at inception by assessing whether the arrangement contains an identified asset and whether the Company has the right to control the identified asset. Right-of-use ("ROU") assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent the Company’s obligation to make lease payments arising from the lease. Lease liabilities are recognized at the lease commencement date based on the present value of future lease payments over the lease term. ROU assets are based on the measurement of the lease liability and are further adjusted by any lease payments made prior to or on lease commencement, lease incentives received and initial direct costs incurred, as applicable. The Company has elected not to recognize leases with a lease term of one year or less on its balance sheet. Operating lease costs included in the measurement of the lease are recognized on a straight-line basis over the lease term. Variable lease costs are expensed as incurred as an operating expense. The Company determines the lease classification and the present value of future lease payments at the time of the lease commencement using an incremental borrowing rate that it estimates based upon the Company’s credit risk and term of the lease. The interest rate implicit in lease contracts has not historically been readily determinable and the Company must therefore use the appropriate incremental borrowing rate to measure its leases. To estimate the incremental borrowing rate, a credit rating applicable to the Company is estimated using a synthetic credit rating analysis since the Company does not currently have a rating agency-based credit rating. |
Research and development costs | Research and development costs Research and development costs are expensed as incurred. Research and development expenses consist of costs incurred to discover, research and develop drug candidates, including personnel expenses, stock-based compensation expense, third-party license fees and external costs including fees paid to consultants, contract manufacturing organizations ("CMOs") and clinical research organizations ("CROs") in connection with drug product manufacturing, nonclinical studies and clinical trials, and other related clinical trial fees, such as for investigator grants, patient screening, laboratory work, clinical trial database management, clinical trial material management and statistical compilation and analysis. Non-refundable prepayments for goods or services that will be used or rendered for future research and development activities are recorded as prepaid expenses. Such amounts are recognized as an expense as the goods are delivered or the related services are performed, or until it is no longer expected that the goods will be delivered or the services rendered. Foreign currency transaction gains and losses related to the purchase of contract manufacturing services are included as a component of research and development expense. Costs incurred in obtaining technology licenses are charged immediately to research and development expense if the technology licensed has not reached technological feasibility and has no alternative future uses. |
Research contract costs and accruals | Research contract costs and accruals The Company has entered into various research and development and other agreements with commercial firms, researchers and others for provisions of goods and services. These agreements are generally cancelable, and the related costs are recorded as research and development expenses as incurred. The Company records accruals for estimated ongoing research and development costs. When evaluating the adequacy of the accrued liabilities, the Company analyzes progress of the studies or clinical trials, including the phase or completion of events, invoices received and contracted costs. Significant judgments and estimates are made in determining the accrued balances at the end of any reporting period. Actual results could differ materially from the Company's estimates . |
Stock-based compensation | Stock-based compensation The Company grants stock-based awards from its stock compensation plans (see Note 8). The Company measures all stock-based awards granted to employees and nonemployees based on the fair value on the date of the grant and recognizes compensation expense for those awards over the requisite service period, which is generally the vesting period of the respective award, on a straight-line basis. The Company recognizes stock-based compensation expense for awards that contain performance-based conditions using the accelerated attribution method when management determines it is probable that the performance condition will be satisfied. The Company accounts for forfeitures as they occur. Stock-based compensation for restricted stock units is measured based on the market closing price of our common stock on the grant date. Stock-based compensation expense is recognized on a straight-line basis over the requisite service period, generally four years. The fair value of each stock option grant is estimated on the date of grant using the Black-Scholes option-pricing model, which requires inputs based on certain subjective assumptions, including the expected stock price volatility, the expected term of the option, the risk-free interest rate for a period that approximates the expected term of the option, and the Company's expected dividend yield. The Company went public in June 2019 and accordingly, lacks sufficient company-specific historical and implied volatility information for its shares traded in the public markets. Therefore, it estimates its expected share price volatility based on the historical volatility of publicly traded peer companies and expects to continue to do so until such time as it has adequate historical data regarding the volatility of its own traded share price. The expected term of the Company's stock options has been determined utilizing the "simplified" method for awards that qualify as "plain-vanilla" options. The risk-free interest rate is determined by reference to the U.S. Treasury yield curve in effect at the time of grant of the award for time periods approximately equal to the expected term of the award. Expected dividend yield is based on the fact that the Company has never paid cash dividends on common stock and does not expect to pay any cash dividends in the foreseeable future. The fair value of each common stock award is estimated on the date of grant based on the fair value of the Company's common stock on that same date. Compensation expense for purchases under the Employee Stock Purchase Plan is recognized based on the fair value of the common stock estimated based on the closing price of our common stock as reported on the date of offering, less the purchase discount percentage provided for in the plan. The Company classifies stock-based compensation expense in its condensed consolidated statement of operations and comprehensive loss in the same manner in which the award recipient's payroll costs are classified or in which the award recipient's service payments are classified. |
Loan Payable | Loan Payable Loan Payable represents the Loan and Security Agreement, dated June 15, 2022 (“Loan Agreement”) with Hercules Capital, Inc. (“Hercules”), which the Company has accounted for as a debt financing arrangement. Interest expense is accrued using the effective interest rate method over the estimated period the loan will be repaid. Loan issuance costs have been recorded as a debt discount in the condensed consolidated balance sheets and are being amortized and recorded as interest expense throughout the life of the Loan Agreement using the effective interest rate method. The Company determined that there are not any embedded features in the Loan Agreement that require bifurcation and separate accounting as derivative financial instruments pursuant to Accounting Standards Codification ("ASC") Topic 815, Derivatives and Hedging . |
Warrant Liabilities | Warrant Liabilities The Company accounts for warrants anticipated to be issued in the future under the Loan Agreement as liabilities and measures them at fair value using the Black-Scholes valuation model. The warrants are subject to remeasurement at each prospective balance sheet date, with any changes in the fair value recorded in the condensed consolidated statements of operations. |
Comprehensive loss | Comprehensive loss Comprehensive loss includes net loss as well as other changes in stockholders' equity (deficit) that result from transactions and economic events other than those with stockholders. The Company’s comprehensive loss is comprised of net loss and changes in unrealized gains and losses on its short and long-term marketable securities . |
Recently adopted accounting pronouncements | Recently adopted accounting pronouncements As of September 30, 2023, and for the period then ended, there were no recently adopted accounting standards that had a material impact on the Company’s condensed consolidated financial statements. There were no recently issued accounting standards not yet adopted which would have a material effect on the Company’s condensed consolidated financial statements. |
Fair value of financial assets
Fair value of financial assets and liabilities (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Fair Value Disclosures [Abstract] | |
Summary of assets and liabilities measured at fair value on a recurring basis | The following is a summary of our financial assets and liabilities measured at fair value on a recurring basis as of September 30, 2023 and December 31, 2022: September 30, 2023 Total Level 1 Level 2 Level 3 Money market funds $ 261,202 $ 261,202 $ — $ — U.S. Treasury securities 96,766 96,766 — — U.S. Government agency securities 144,418 — 144,418 — Commercial paper 86,678 — 86,678 — Corporate debt securities 15,589 — 15,589 — Total assets $ 604,653 $ 357,968 $ 246,685 $ — Warrant liabilities $ 93 $ — $ — $ 93 Total liabilities $ 93 $ — $ — $ 93 December 31, 2022 Total Level 1 Level 2 Level 3 Money market funds $ 137,286 $ 137,286 $ — $ — U.S. Treasury securities 58,721 58,721 — — Corporate debt securities 5,476 — 5,476 — U.S. Government agency securities 62,955 — 62,955 — Commercial paper 27,738 — 27,738 — Total assets $ 292,176 $ 196,007 $ 96,169 $ — Warrant liabilities $ 305 $ — $ — $ 305 Total liabilities $ 305 $ — $ — $ 305 |
Marketable securities (Tables)
Marketable securities (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Debt Securities [Abstract] | |
Summary of marketable securities | The following is a summary of marketable securities as of September 30, 2023 and December 31, 2022 : September 30, 2023 Amortized cost Gross unrealized gains Gross unrealized losses Credit losses Fair value Money market funds $ 261,202 $ — $ — $ — $ 261,202 U.S. Treasury securities 96,945 — ( 179 ) — 96,766 U.S. Government agency securities 144,551 14 ( 147 ) — 144,418 Commercial paper 86,852 — ( 174 ) — 86,678 Corporate debt securities 15,608 — ( 19 ) — 15,589 $ 605,158 $ 14 $ ( 519 ) $ — $ 604,653 Cash equivalents $ 261,202 Short-term marketable securities 285,186 Long-term marketable securities 58,264 $ 604,652 December 31, 2022 Amortized cost Gross unrealized gains Gross unrealized losses Credit losses Fair value Money market funds $ 137,286 $ — $ — $ — $ 137,286 U.S. Treasury securities 58,698 23 — — 58,721 Corporate debt securities 5,478 — ( 2 ) — 5,476 U.S. Government agency securities 62,939 15 — — 62,954 Commercial paper 27,739 — — — 27,739 $ 292,140 $ 38 $ ( 2 ) $ — $ 292,176 Cash equivalents $ 190,500 Short-term marketable securities 101,676 $ 292,176 |
Schedule of contractual maturities of short and long term marketable securities | The following table presents the contractual maturities of our short and long-term marketable securities as of September 30, 2023 and December 31, 2022. September 30, 2023 December 31, 2022 Due within one year $ 285,186 $ 101,676 Due after one year through five years 58,264 — Total $ 343,450 $ 101,676 |
Accrued expenses and other cu_2
Accrued expenses and other current liabilities (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Accrued expenses and other current liabilities | |
Schedule of accrued expenses and other current liabilities | The following is a summary of accrued expenses and other current liabilities as of September 30, 2023 and December 31, 2022 : September 30, 2023 December 31, 2022 Accrued external research and development expenses $ 10,734 $ 9,789 Accrued employee compensation and benefits 3,404 804 Accrued legal and professional fees 274 197 Short-term lease liability and other 505 325 $ 14,917 $ 11,115 |
Loan Payable and Warrant Liab_2
Loan Payable and Warrant Liability (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Debt Disclosure [Abstract] | |
Schedule of Future principal Debt Payments on Loan Payable | Future principal debt payments on the currently outstanding loan payable as of September 30, 2023 are as follows (in thousands): 2023 (remaining period) $ — 2024 4,225 2025 9,278 2026 10,488 2027 1,009 Total principal outstanding 25,000 End of term charge 1,463 Total principal outstanding and end of term charge 26,463 Unamortized discount and issuance costs ( 1,619 ) Loan Payable $ 24,844 Loan Payable - current 2,076 Loan Payable - noncurrent 22,768 Loan Payable $ 24,844 |
Schedule of Assumptions Used to Determine Estimated Fair Value of Warrant Liability | The Company estimated the fair value of the warrant liability as of September 30, 2023 using probability assumptions of achieving the future milestones and using the Black-Scholes model based on the following key assumptions: As of September 30, 2023 Expected term (in years) 5.7 Expected volatility 79.55 % Risk-free interest rate 4.60 % Expected dividend yield 0.00 % |
Stockholder's equity (deficit)
Stockholder's equity (deficit) (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Stockholders' Equity Note [Abstract] | |
Schedule of common stock reserved for issuance | The following shares of common stock were reserved for issuance as follows: September 30, 2023 December 31, 2022 Options outstanding under the 2018 Stock Option and Grant Plan 1,171,581 1,633,173 Options outstanding under the 2019 Stock Option and Incentive Plan 4,579,020 4,146,831 Restricted stock units outstanding under the 2019 Stock Option and Incentive Plan 142,498 129,131 Warrants to purchase common stock associated with Loan Agreement 45,898 36,718 Options available for future grant 3,365,403 2,038,142 Warrants available for future grant 137,700 146,880 Common stock available for ATM program 2,708,234 5,000,000 2019 Employee Stock Purchase Plan 1,590,426 1,187,508 13,740,760 14,318,383 |
Summary of restricted stock activity | The following table summarizes the Company’s RSUs activity since December 31, 2022: Weighted- Weighted- Average Average Aggregate Grant Date remaining Intrinsic Underlying Fair Value per contractual Value shares Share term (years) (000's) Balance outstanding, December 31, 2022 129,131 $ 42.95 2.07 $ 7,076 Granted 41,363 $ 48.17 Vested ( 27,996 ) $ 43.83 Cancelled or forfeited — $ — Balance outstanding, September 30, 2023 142,498 $ 44.29 1.69 $ 7,208 |
Stock-based awards (Tables)
Stock-based awards (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Schedule of assumptions used to determine grant-date fair value of stock options granted | The assumptions that the Company used to determine the grant-date fair value of stock options granted to employees, directors and consultants as follows, presented on a weighted average basis: Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 Expected term (in years) 5.85 6.03 5.88 4.86 Expected volatility 79.75 % 74.20 % 78.37 % 73.18 % Weighted average risk-free interest rate 4.18 % 2.90 % 3.91 % 1.90 % Expected dividend yield 0.00 % 0.00 % 0.00 % 0.00 % |
Summary of stock option activity | The following table summarizes the Company’s stock option activity since December 31, 2022: Weighted- Weighted- Average Average Aggregate Exercise remaining Intrinsic Number Price per contractual Value of Options Share term (years) (000's) Balance outstanding, December 31, 2022 5,780,004 $ 18.88 7.80 $ 207,611 Options granted 505,984 $ 47.45 Options exercised ( 535,387 ) $ 5.39 Options cancelled — Balance outstanding, September 30, 2023 5,750,601 $ 22.65 7.42 $ 160,636 Vested and expected to vest, September 30, 2023 5,750,601 $ 22.65 7.42 $ 160,636 Exercisable, September 30, 2023 3,963,342 $ 17.52 6.86 $ 131,032 |
Summary of restricted stock activity | The following table summarizes the Company’s RSUs activity since December 31, 2022: Weighted- Weighted- Average Average Aggregate Grant Date remaining Intrinsic Underlying Fair Value per contractual Value shares Share term (years) (000's) Balance outstanding, December 31, 2022 129,131 $ 42.95 2.07 $ 7,076 Granted 41,363 $ 48.17 Vested ( 27,996 ) $ 43.83 Cancelled or forfeited — $ — Balance outstanding, September 30, 2023 142,498 $ 44.29 1.69 $ 7,208 |
Summary of stock-based compensation expense | The following table summarizes the Company’s stock-based compensation expense during the three and nine months ended September 30, 2023 and 2022: Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 Classified within research and development expense $ 1,986 $ 4,195 $ 5,485 $ 6,780 Classified within general and administrative expense 3,753 7,536 9,896 12,423 Total stock-based compensation expense $ 5,739 $ 11,731 $ 15,381 $ 19,203 |
Net loss per share (Tables)
Net loss per share (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Earnings Per Share [Abstract] | |
Schedule of basic and diluted net loss per share attributable to common stockholders | Basic and diluted net loss per share attributable to common stockholders was calculated as follows: Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 Numerator: Net loss $ ( 39,659 ) $ ( 35,542 ) $ ( 96,573 ) $ ( 88,974 ) Denominator: Weighted average common shares outstanding, basic and diluted 55,613,120 38,663,469 51,506,766 36,364,284 Net loss per share, basic and diluted $ ( 0.71 ) $ ( 0.92 ) $ ( 1.87 ) $ ( 2.45 ) |
Schedule of computation of diluted net loss per share attributable to common stockholders | Three and nine months ended September 30, 2023 2022 Options to purchase common stock 5,750,601 5,390,277 Unvested restricted stock units 142,498 — Warrants to purchase common stock 45,898 36,718 Warrants available for future grant 137,700 146,880 6,076,697 5,573,875 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of maturity of the Company's operating lease liabilities | As of September 30, 2023, maturities of the Company’s operating lease liability was as follows: 2023 (remaining) $ 82 2024 331 2025 341 2026 351 2027 208 Total future minimum lease payments 1,313 Less imputed interest ( 173 ) Present value of operating lease liabilities $ 1,140 |
Schedule of components of operating lease expense | For the three and nine months ended September 30, 2023 and 2022, the components of operating lease cost were as follows: Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 Lease cost: Statement of Operations Classification: Operating lease cost General and administrative expense $ 81 $ 81 $ 243 $ 243 Short-term lease cost General and administrative expense 36 — 125 29 Variable operating lease cost General and administrative expense 8 9 27 52 Total operating lease cost $ 125 $ 90 $ 395 $ 324 Other information: Cash paid for amounts included in the measurement of operating lease liability $ 81 79 $ 240 $ 233 Weighted average remaining lease term (years) 3.8 4.8 3.8 4.8 Weighted average discount rate 7.6 % 7.6 % 7.6 % 7.6 % |
Nature of the business and ba_2
Nature of the business and basis of presentation (Details) $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||||||
Oct. 31, 2023 | Sep. 30, 2023 USD ($) | Jun. 30, 2023 USD ($) | Mar. 31, 2023 USD ($) | Sep. 30, 2022 USD ($) | Jun. 30, 2022 USD ($) | Mar. 31, 2022 USD ($) | Sep. 30, 2023 USD ($) Clinicaltrial | Sep. 30, 2022 USD ($) | Dec. 31, 2022 USD ($) | Dec. 31, 2021 USD ($) | |
Organization, consolidation and presentation of financial statements [Line Items] | |||||||||||
Proceeds from the sale of redeemable convertible preferred stock | $ 90,500 | ||||||||||
Proceeds from its initial public offering | 105,800 | ||||||||||
Proceeds from the sales of common stock in equity offerings | 818,900 | ||||||||||
Proceeds from equity investment from Pfizer, Inc. | 25,000 | ||||||||||
Net loss | $ 39,659 | $ 31,083 | $ 25,831 | $ 35,542 | $ 27,403 | $ 26,029 | 96,573 | $ 88,974 | $ 112,033 | $ 100,777 | |
Accumulated deficit | (518,910) | (518,910) | (422,337) | ||||||||
Cash and cash equivalents | 269,546 | 269,546 | $ 249,773 | ||||||||
Cash, cash equivalents and short-term marketable securities | $ 612,996 | $ 612,996 | |||||||||
SYMMETRY Study | NASH Patients with Compensated Cirrhosis | |||||||||||
Organization, consolidation and presentation of financial statements [Line Items] | |||||||||||
Number of planned clinical trials | Clinicaltrial | 3 | ||||||||||
SYMMETRY Study | NASH Patients with Compensated Cirrhosis | Subsequent Event | |||||||||||
Organization, consolidation and presentation of financial statements [Line Items] | |||||||||||
Percentage of trend of patients using 28 mg EFX in 36 week result | 22% | ||||||||||
Percentage of trend of patients using 50 mg EFX in 36 week result | 24% | ||||||||||
Percentage of trend of patients using placebo in 36 week result | 14% | ||||||||||
Percentage of patents for 28 mg EFX treated group | 67% | ||||||||||
Percentage of patents for 50 mg EFX treated group | 60% | ||||||||||
Percentage of patents for placebo | 26% |
Summary of significant accoun_3
Summary of significant accounting policies - Restricted cash (Details) $ in Thousands | Dec. 31, 2022 USD ($) |
Accounting Policies [Abstract] | |
Separate cash balance for the landlord | $ 108 |
Fair value of financial asset_2
Fair value of financial assets and liabilities - Textual (Details) - USD ($) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Transfers into level 3 Assets | $ 0 | $ 0 |
Transfers out of level 3 Assets | 0 | 0 |
Transfers into level 3 liabilities | 0 | 0 |
Transfers out of level 3 liabilities | $ 0 | $ 0 |
Fair value of financial asset_3
Fair value of financial assets and liabilities - Recurring (Details) - Recurring - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets | $ 604,653 | $ 292,176 |
Liabilities | 93 | 305 |
Money market funds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets | 261,202 | 137,286 |
U.S. Treasury securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets | 96,766 | 58,721 |
Corporate debt securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets | 15,589 | 5,476 |
U.S. Government agency securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets | 144,418 | 62,955 |
Commercial paper | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets | 86,678 | 27,738 |
Warrant liabilities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Liabilities | 93 | 305 |
Level 1 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets | 357,968 | 196,007 |
Level 1 | Money market funds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets | 261,202 | 137,286 |
Level 1 | U.S. Treasury securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets | 96,766 | 58,721 |
Level 2 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets | 246,685 | 96,169 |
Level 2 | Corporate debt securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets | 15,589 | 5,476 |
Level 2 | U.S. Government agency securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets | 144,418 | 62,955 |
Level 2 | Commercial paper | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets | 86,678 | 27,738 |
Level 3 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Liabilities | 93 | 305 |
Level 3 | Warrant liabilities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Liabilities | $ 93 | $ 305 |
Marketable securities - Summary
Marketable securities - Summary of marketable securities (Details) - USD ($) $ in Thousands | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Debt Securities, Available-for-Sale [Line Items] | ||
Amortized cost | $ 605,158 | $ 292,140 |
Gross unrealized gains | 14 | 38 |
Gross unrealized losses | (519) | (2) |
Fair value | 604,653 | 292,176 |
Cash equivalents | 261,202 | 190,500 |
Short-term marketable securities | 285,186 | 101,676 |
Long-term marketable securities | 58,264 | |
Total | 604,652 | 292,176 |
Money market funds | ||
Debt Securities, Available-for-Sale [Line Items] | ||
Amortized cost | 261,202 | 137,286 |
Fair value | 261,202 | 137,286 |
U.S. Treasury securities | ||
Debt Securities, Available-for-Sale [Line Items] | ||
Amortized cost | 96,945 | 58,698 |
Gross unrealized gains | 23 | |
Gross unrealized losses | (179) | |
Fair value | 96,766 | 58,721 |
U.S. Government agency securities | ||
Debt Securities, Available-for-Sale [Line Items] | ||
Amortized cost | 144,551 | 62,939 |
Gross unrealized gains | 14 | 15 |
Gross unrealized losses | (147) | |
Fair value | 144,418 | 62,954 |
Commercial paper | ||
Debt Securities, Available-for-Sale [Line Items] | ||
Amortized cost | 86,852 | 27,739 |
Gross unrealized losses | (174) | |
Fair value | 86,678 | 27,739 |
Corporate debt securities | ||
Debt Securities, Available-for-Sale [Line Items] | ||
Amortized cost | 15,608 | 5,478 |
Gross unrealized losses | (19) | (2) |
Fair value | $ 15,589 | $ 5,476 |
Marketable securities - Schedul
Marketable securities - Schedule of contractual maturities of short and long term marketable securities (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Debt Securities [Abstract] | ||
Due within one year | $ 285,186 | $ 101,676 |
Due after one year through five years | 58,264 | |
Total | $ 343,450 | $ 101,676 |
Accrued expenses and other cu_3
Accrued expenses and other current liabilities (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Accrued expenses and other current liabilities | ||
Accrued external research and development expenses | $ 10,734 | $ 9,789 |
Accrued employee compensation and benefits | 3,404 | 804 |
Accrued legal and professional fees | 274 | 197 |
Short-term lease liability and other | 505 | 325 |
Total accrued expenses and other current liabilities | $ 14,917 | $ 11,115 |
Loan Payable and Warrant Liab_3
Loan Payable and Warrant Liability - Textual (Details) | 9 Months Ended | |||||
Mar. 10, 2023 USD ($) shares | Jun. 15, 2022 USD ($) Tranche | Sep. 30, 2023 USD ($) $ / shares shares | Sep. 30, 2022 USD ($) | Nov. 03, 2023 $ / shares | Dec. 31, 2022 $ / shares | |
Debt Instrument [Line Items] | ||||||
Proceeds from term loan | $ 15,000,000 | $ 10,000,000 | ||||
Amortization of debt issuance costs and discount | $ 328,000 | 110,000 | ||||
Common stock, par value (in dollars per share) | $ / shares | $ 0.0001 | $ 0.0001 | $ 0.0001 | |||
Fair value change in warrant liability | $ 118,000 | $ 29,000 | ||||
Hercules | ||||||
Debt Instrument [Line Items] | ||||||
Issued warrants to purchase shares of common stock | shares | 9,180 | |||||
Loan Agreement | ||||||
Debt Instrument [Line Items] | ||||||
End of term charge of outstanding principal balance, in percentage | 5.85% | |||||
Amortization of debt issuance costs and discount | $ 1,463,000 | |||||
Issued warrants to purchase shares of common stock | shares | 36,718 | |||||
Recognized initial warrants at relative fair value | $ 227,000 | |||||
Additional remaining warrants were recognized at relative fair value at closing of agreement | 41,000 | |||||
Fair value associated with equity and liability classified warrants | 268,000 | |||||
Warrant liabilities | $ 93,000 | |||||
Loan Agreement | First Twelve Months After Closing | ||||||
Debt Instrument [Line Items] | ||||||
Percentage of prepayment charge of outstanding principal balance | 3% | |||||
Loan Agreement | Second Twelve Months After Closing | ||||||
Debt Instrument [Line Items] | ||||||
Percentage of prepayment charge of outstanding principal balance | 2% | |||||
Loan Agreement | Thereafter | ||||||
Debt Instrument [Line Items] | ||||||
Percentage of prepayment charge of outstanding principal balance | 1% | |||||
Loan Agreement | Term Loan | Hercules | ||||||
Debt Instrument [Line Items] | ||||||
Maximum borrowing capacity | $ 100,000,000 | |||||
Number of tranches available for loan | Tranche | 4 | |||||
Proceeds from term loan | $ 10,000,000 | |||||
Term loan, description | Under the terms of the Loan Agreement, the Company received $10,000 upon closing, $15,000 was borrowed on March 10, 2023 and an additional $10,000 is available to the Company at its sole discretion until December 15, 2023. An additional $20,000 will become available to the Company upon the achievement of certain clinical and financial milestones. An additional $45,000 may become available to the Company at Hercules' sole discretion. | |||||
Maturity date | Jan. 01, 2027 | |||||
Variable annual rate | 7.65% | |||||
Loan Agreement | Term Loan | Hercules | Prime Rate | ||||||
Debt Instrument [Line Items] | ||||||
Variable annual rate | 3.65% | |||||
Loan Agreement | Term Loan First Tranche | ||||||
Debt Instrument [Line Items] | ||||||
Additional loan advances available | $ 10,000,000 | |||||
Loan Agreement | Term Loan First Tranche | Hercules | ||||||
Debt Instrument [Line Items] | ||||||
Maximum borrowing capacity | $ 10,000,000 | |||||
Proceeds from term loan | $ 15,000,000 | |||||
Loan Agreement | Term Loan Second Tranche | Hercules | ||||||
Debt Instrument [Line Items] | ||||||
Maximum borrowing capacity | 20,000,000 | |||||
Loan Agreement | Term Loan Third Tranche | Hercules | ||||||
Debt Instrument [Line Items] | ||||||
Maximum borrowing capacity | $ 45,000,000 | |||||
Warrants to Purchase Common Stock | Loan Agreement | Term Loan | Hercules | ||||||
Debt Instrument [Line Items] | ||||||
Common stock, par value (in dollars per share) | $ / shares | $ 0.0001 | |||||
Maximum percentage of warrants purchased | 1.50% |
Loan Payable and Warrant Liab_4
Loan Payable and Warrant Liability - Schedule of Future principal Debt Payments on Loan Payable (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Long-Term Debt, Fiscal Year Maturity [Abstract] | ||
2024 | $ 4,225 | |
2025 | 9,278 | |
2026 | 10,488 | |
2027 | 1,009 | |
Total principal outstanding | 25,000 | |
End of term charge | 1,463 | |
Total principal outstanding and end of term charge | 26,463 | |
Unamortized discount and issuance costs | (1,619) | |
Loan Payable | 24,844 | |
Loan Payable - current | 2,076 | |
Loan Payable - noncurrent | $ 22,768 | $ 9,541 |
Loan Payable and Warrant Liab_5
Loan Payable and Warrant Liability - Schedule of Assumptions Used to Determine Estimated Fair Value of Warrant Liability (Details) | Sep. 30, 2023 |
Measurement Input, Expected Term | |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |
Expected term (in years) | 5 years 8 months 12 days |
Measurement Input, Price Volatility | |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |
Fair value of the Warrants, Measurement input | 0.7955 |
Measurement Input, Risk-Free Interest Rate | |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |
Fair value of the Warrants, Measurement input | 0.046 |
Measurement Input, Expected Dividend Yield | |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |
Fair value of the Warrants, Measurement input | 0 |
Stockholder's equity (deficit_2
Stockholder's equity (deficit) - Common stock (Details) | 1 Months Ended | 3 Months Ended | 9 Months Ended | ||||||||||||
May 16, 2023 USD ($) $ / shares shares | Mar. 17, 2023 USD ($) | Sep. 19, 2022 USD ($) $ / shares shares | Jun. 17, 2022 USD ($) | Jun. 15, 2022 $ / shares shares | May 18, 2021 USD ($) shares | Jul. 10, 2020 USD ($) $ / shares shares | Jun. 24, 2019 USD ($) $ / shares shares | May 31, 2023 $ / shares shares | Apr. 30, 2023 $ / shares shares | Jun. 30, 2022 USD ($) | Sep. 30, 2023 USD ($) Vote $ / shares shares | Nov. 03, 2023 $ / shares | Dec. 31, 2022 $ / shares shares | Jun. 18, 2019 shares | |
Class of Stock [Line Items] | |||||||||||||||
Common stock, shares authorized | 150,000,000 | 150,000,000 | |||||||||||||
Common stock, par value (in dollars per share) | $ / shares | $ 0.0001 | $ 0.0001 | $ 0.0001 | ||||||||||||
Number of votes per share | Vote | 1 | ||||||||||||||
Cash dividend declared | $ / shares | $ 0 | ||||||||||||||
Cash dividend paid | $ / shares | $ 0 | ||||||||||||||
Net proceeds from the sales of common stock in equity offerings | $ | $ 818,900,000 | ||||||||||||||
Share Issued value under agreement | $ | $ 24,647,000 | ||||||||||||||
Common stock, shares issued | 55,681,026 | 46,865,206 | |||||||||||||
Common stock, shares outstanding | 55,681,026 | 46,865,206 | |||||||||||||
Common stock were reserved for issuance | |||||||||||||||
Options available for future grant | 13,740,760 | 14,318,383 | |||||||||||||
Jeffries | |||||||||||||||
Class of Stock [Line Items] | |||||||||||||||
Net proceeds from the sales of common stock in equity offerings | $ | $ 210,956,000 | ||||||||||||||
Offering costs | $ | $ 9,061,000 | ||||||||||||||
Common stock, shares issued | 5,238,500 | ||||||||||||||
Sale of stock under agreement | 5,238,500 | ||||||||||||||
Sale of stock, price per share | $ / shares | $ 42 | ||||||||||||||
Options available for future grant | |||||||||||||||
Common stock were reserved for issuance | |||||||||||||||
Options available for future grant | 3,365,403 | 2,038,142 | |||||||||||||
Common stock Available under ATM Offering | |||||||||||||||
Class of Stock [Line Items] | |||||||||||||||
Net proceeds from the sales of common stock in equity offerings | $ | $ 24,647,000 | $ 123,824,000 | |||||||||||||
Offering costs | $ | $ 3,578,000 | ||||||||||||||
Sale of stock under agreement | 3,006,052 | 3,006,052 | |||||||||||||
Sale of stock, price per share | $ / shares | $ 42.38 | $ 42.38 | |||||||||||||
Common stock were reserved for issuance | |||||||||||||||
Options available for future grant | 5,000,000 | 2,708,234 | 5,000,000 | ||||||||||||
Common stock Available under ATM Offering | Pfizer Inc | |||||||||||||||
Class of Stock [Line Items] | |||||||||||||||
Sale of stock under agreement | 2,525,252 | ||||||||||||||
Sale of stock, price per share | $ / shares | $ 9.9 | ||||||||||||||
Warrants to Purchase Common Stock | |||||||||||||||
Common stock were reserved for issuance | |||||||||||||||
Options available for future grant | 45,898 | 36,718 | |||||||||||||
Warrants Available for Future Grant | |||||||||||||||
Common stock were reserved for issuance | |||||||||||||||
Options available for future grant | 137,700 | 146,880 | |||||||||||||
2018 Stock option and grant plan | |||||||||||||||
Common stock were reserved for issuance | |||||||||||||||
Options available for future grant | 1,171,581 | 1,633,173 | 107,635 | ||||||||||||
2019 Stock Option and Incentive plan | |||||||||||||||
Common stock were reserved for issuance | |||||||||||||||
Options available for future grant | 4,579,020 | 4,146,831 | |||||||||||||
2019 Stock Option and Incentive plan | Restricted Stock Units | |||||||||||||||
Common stock were reserved for issuance | |||||||||||||||
Options available for future grant | 142,498 | 129,131 | |||||||||||||
2019 Employee Stock Purchase Plan | |||||||||||||||
Common stock were reserved for issuance | |||||||||||||||
Options available for future grant | 1,590,426 | 1,187,508 | |||||||||||||
Maximum | Common stock Available under ATM Offering | |||||||||||||||
Class of Stock [Line Items] | |||||||||||||||
Share Issued value under agreement | $ | $ 200,000 | $ 100,000 | |||||||||||||
IPO | |||||||||||||||
Class of Stock [Line Items] | |||||||||||||||
Public offering price | $ / shares | $ 16 | ||||||||||||||
Net proceeds from the sales of common stock in equity offerings | $ | $ 98,394,000 | ||||||||||||||
Offering costs | $ | $ 2,942,000 | ||||||||||||||
Number of shares converted | 21,056,136 | ||||||||||||||
Common stock, shares issued | 6,612,500 | ||||||||||||||
Follow Up Public Offering | |||||||||||||||
Class of Stock [Line Items] | |||||||||||||||
Share Issued under agreement | 8,846,154 | 6,012,390 | |||||||||||||
Public offering price | $ / shares | $ 26 | $ 36 | |||||||||||||
Net proceeds from the sales of common stock in equity offerings | $ | $ 216,200,000 | $ 203,460,000 | |||||||||||||
Offering costs | $ | $ 13,800,000 | ||||||||||||||
Over allotment | Maximum | |||||||||||||||
Class of Stock [Line Items] | |||||||||||||||
Share Issued under agreement | 1,153,846 | 784,224 | |||||||||||||
Common stock, shares issued | 862,500 |
Stockholder's equity (deficit_3
Stockholder's equity (deficit) - Undesignated preferred stock and Restricted common stock (Details) - Undesignated Preferred Stock | Sep. 30, 2023 $ / shares shares |
Class of Stock [Line Items] | |
Preferred stock, par value (in dollars per share) | $ / shares | $ 0.0001 |
Preferred stock, shares issued | 0 |
Preferred stock, shares outstanding | 0 |
Maximum | |
Class of Stock [Line Items] | |
Preferred stock, shares authorized | 10,000,000 |
Stockholder's equity (deficit_4
Stockholder's equity (deficit) - Warrants Associated with Loan Agreement (Details) - USD ($) | 3 Months Ended | 6 Months Ended | 9 Months Ended | |
Mar. 31, 2023 | Jun. 30, 2022 | Sep. 30, 2023 | Jun. 15, 2022 | |
Class of Stock [Line Items] | ||||
Additional warrants to purchase shares | $ 330,000 | $ 227,000 | $ 330,000 | |
Hercules Capital Inc and Hercules Private Global Venture Growth Fund I L.P. | ||||
Class of Stock [Line Items] | ||||
Maximum percentage of warrants purchased | 1.50% | |||
Issued warrants to purchase shares of common stock | 9,180 | 36,718 |
Stock-based awards - Textual (D
Stock-based awards - Textual (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||||||
Jun. 18, 2019 | Jan. 31, 2022 | Jun. 30, 2019 | Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | Jan. 31, 2023 | |
Share-based awards | ||||||||||
Number of shares remained available for grant | 13,740,760 | 13,740,760 | 14,318,383 | |||||||
Weighted average grant-date fair value per share of stock options granted | $ 46.01 | $ 6.78 | $ 47.45 | $ 11.17 | ||||||
Stock options granted ( in shares) | 505,984 | |||||||||
Exercise price | $ 47.45 | |||||||||
Stock compensation expense | $ 5,739 | $ 11,731 | $ 15,381 | $ 19,203 | ||||||
Total unrecognized compensation cost related to unvested stock-based awards | 38,933 | $ 38,933 | ||||||||
Weighted average period of recognition for unrecognized compensation cost | 2 years 3 months 29 days | |||||||||
Total unrecognized compensation cost related to RSU | $ 6,110 | $ 6,110 | ||||||||
Performance Shares | ||||||||||
Share-based awards | ||||||||||
Stock options granted ( in shares) | 610,546 | |||||||||
Additional stock options granted (in shares) | 248,376 | |||||||||
Exercise price | $ 21.7 | $ 21.1 | ||||||||
Options vesting description | One-third of the options were to vest upon achievement of each of the milestones. | |||||||||
Description of milestones achieved and deemed vested | In September 2022, two of the three performance-based awards milestones were achieved and were deemed vested. | |||||||||
Restricted Stock Units | ||||||||||
Share-based awards | ||||||||||
Weighted average period of recognition for unrecognized compensation cost | 3 years 3 months | |||||||||
RSU granted (shares) | 41,363 | 129,131 | ||||||||
Total grant date fair value of RSU | $ 5,546 | |||||||||
Weighted average grant-date fair value per share of RSUs granted | $ 44.52 | $ 0 | $ 48.17 | $ 0 | ||||||
Restricted Stock Units | Executive and Non-executive Employees | ||||||||||
Share-based awards | ||||||||||
RSU granted (shares) | 41,363 | |||||||||
Total grant date fair value of RSU | $ 1,992 | |||||||||
2018 Stock option and grant plan | ||||||||||
Share-based awards | ||||||||||
Number of shares of common stock issued | 3,071,960 | |||||||||
Number of shares remained available for grant | 107,635 | 1,171,581 | 1,171,581 | 1,633,173 | ||||||
2019 Stock option and incentive plan | ||||||||||
Share-based awards | ||||||||||
Number of shares remained available for grant | 107,635 | |||||||||
Number of shares initially reserved for issuance | 2,572,457 | |||||||||
Number of additional shares reserved for issuance | 1,396,029 | 1,874,608 | ||||||||
Percent of shares reserved and available for issuance automatically increase annually on January 1 | 4% | |||||||||
Percentage of exercise price per share of stock options | 100% | |||||||||
Percentage of minimum exercise price, holding more than 10% of voting power | 110% | |||||||||
Stock options vesting period | 4 years | |||||||||
2019 Employee stock purchase plan | ||||||||||
Share-based awards | ||||||||||
Number of shares initially reserved for issuance | 273,869 | |||||||||
Number of additional shares reserved for issuance | 349,007 | 410,803 | ||||||||
Percent of shares reserved and available for issuance automatically increase annually on January 1 | 1% | |||||||||
Number of shares reserved and available for issuance automatically increase annually on January 1 (in shares) | 410,803 | |||||||||
Maximum | 2019 Stock option and incentive plan | ||||||||||
Share-based awards | ||||||||||
Term of stock option | 10 years |
Stock-based awards - Stock opti
Stock-based awards - Stock option valuation (Details) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Assumptions to determine grant-date fair value of stock options granted | ||||
Expected term (in years) | 5 years 10 months 6 days | 6 years 10 days | 5 years 10 months 17 days | 4 years 10 months 9 days |
Expected volatility | 79.75% | 74.20% | 78.37% | 73.18% |
Weighted average risk-free interest rate | 4.18% | 2.90% | 3.91% | 1.90% |
Expected dividend yield | 0% | 0% | 0% | 0% |
Stock based awards - Stock opti
Stock based awards - Stock option activity (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | |
Number of Options | |||||
Balance Outstanding, Beginning of the period (in shares) | 5,780,004 | ||||
Options granted ( in shares) | 505,984 | ||||
Options exercised ( in shares) | (535,387) | ||||
Balance Outstanding, End of the period (in shares) | 5,750,601 | 5,750,601 | 5,780,004 | ||
Vested and expected to vest ( in shares) | 5,750,601 | 5,750,601 | |||
Exercisable ( in shares) | 3,963,342 | 3,963,342 | |||
Weighted-Average Exercise Price per Share | |||||
Weighted-average exercise price, Beginning of the period (in dollars per share) | $ 18.88 | ||||
Weighted-average exercise price, Granted (in dollars per share) | 47.45 | ||||
Weighted-average exercise price, Exercised (in dollars per share) | 5.39 | ||||
Weighted-average exercise price, End of the period (in dollars per share) | $ 22.65 | 22.65 | $ 18.88 | ||
Weighted-average exercise price, Vested and expected to vest at end of the period (in dollars per share) | 22.65 | 22.65 | |||
Weighted-average exercise price, Exercisable ( in dollars per share ) | $ 17.52 | $ 17.52 | |||
Weighted-Average remaining contractual term (years) and Aggregate Intrinsic Value | |||||
Weighted-average remaining contractual term outstanding (in years) | 7 years 5 months 1 day | 7 years 9 months 18 days | |||
Weighted-average remaining contractual term vested and expected to vest (in years) | 7 years 5 months 1 day | ||||
Weighted-average remaining contractual term , Options Exercisable(in years) | 6 years 10 months 9 days | ||||
Aggregate Intrinsic Value Balance outstanding | $ 160,636 | $ 160,636 | $ 207,611 | ||
Aggregate Intrinsic Value Vested and Expected to vest | 160,636 | 160,636 | |||
Aggregate Intrinsic Value Exercisable | $ 131,032 | $ 131,032 | |||
Weighted average grant-date fair value per share of stock options granted | $ 46.01 | $ 6.78 | $ 47.45 | $ 11.17 |
Stock-based awards - Summary of
Stock-based awards - Summary of restricted stock activity (Details) - Restricted Stock Units (RSUs) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | |
Share-Based Compensation Arrangement by Share-Based Payment Award, Equity Instruments Other than Options, Nonvested, Number of Shares [Roll Forward] | |||||
Balance Outstanding, Beginning of the period (in shares) | 142,498 | 142,498 | 129,131 | ||
Underlying shares, Granted | 41,363 | 129,131 | |||
Underlying shares, vested | (27,996) | ||||
Balance Outstanding, End of the period (in shares) | 142,498 | 142,498 | 129,131 | ||
Share-Based Compensation Arrangement by Share-Based Payment Award, Equity Instruments Other than Options, Nonvested, Weighted Average Grant Date Fair Value [Abstract] | |||||
Weighted average grant date fair value per share beginning balance | $ 42.95 | ||||
Weighted average grant date fair value per share granted | $ 44.52 | $ 0 | 48.17 | $ 0 | |
Weighted average grant date fair value per share vested | 43.83 | ||||
Weighted average grant date fair value per share ending balance | $ 44.29 | $ 44.29 | $ 42.95 | ||
Share-Based Compensation Arrangement by Share-Based Payment Award, Equity Instruments Other than Options, Additional Disclosures [Abstract] | |||||
Weighted-Average remaining contractual term (years) | 1 year 8 months 8 days | 2 years 25 days | |||
Share-Based Compensation Arrangement by Share-Based Payment Award, Equity Instruments Other than Options, Aggregate Intrinsic Value [Abstract] | |||||
Aggregate Intrinsic Value (000's) | $ 7,208 | $ 7,208 | $ 7,076 |
Stock based awards - Stock-base
Stock based awards - 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 | |
Stock-based compensation | ||||
Total stock-based compensation expense | $ 5,739 | $ 11,731 | $ 15,381 | $ 19,203 |
Research and development expense | ||||
Stock-based compensation | ||||
Total stock-based compensation expense | 1,986 | 4,195 | 5,485 | 6,780 |
General and administrative expense | ||||
Stock-based compensation | ||||
Total stock-based compensation expense | $ 3,753 | $ 7,536 | $ 9,896 | $ 12,423 |
Amgen license agreement (Detail
Amgen license agreement (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 9 Months Ended | |||||
Nov. 30, 2018 | Jun. 30, 2018 | Sep. 30, 2023 | Sep. 30, 2022 | Jun. 30, 2022 | Sep. 30, 2019 | Sep. 30, 2023 | Sep. 30, 2022 | |
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||||
Share Issued value under agreement | $ 24,647,000 | |||||||
Research and development expense | $ 38,634,000 | $ 25,087,000 | $ 88,406,000 | $ 66,964,000 | ||||
Amgen Agreement | ||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||||
Initial fair value of the anti-dilution right liability | $ 7,404,000 | |||||||
Payment for clinical trail | $ 2,500,000 | |||||||
Obligation for payment in connection with dosing of the first patient | 7,500,000 | |||||||
Amgen Agreement | Maximum | ||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||||
Aggregate milestone payments upon the achievement of specified commercial milestones | 75,000,000 | |||||||
Payment in connection with dosing of the first patient | $ 30,000,000 | |||||||
Amgen Agreement | Research and development expense | ||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||||
Research and development expense | $ 0 | $ 0 | $ 0 | $ 0 | ||||
Amgen Agreement | Amgen | ||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||||
Upfront payment | $ 5,000,000 | |||||||
Amgen Agreement | Series A Preferred Stock | ||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||||
Share Issued under agreement | 3,205,128 | |||||||
Amgen Agreement | Series A Preferred Stock | Amgen | ||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||||
Share Issued under agreement | 2,653,333 | |||||||
Share Issued value under agreement | $ 1,353,000 | |||||||
Ownership Interest [Member] | Amgen Agreement | Amgen | ||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||||
Ownership interest of the outstanding shares (as a percent) | 10% |
Income taxes - Textual (Details
Income taxes - Textual (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Operating Loss Carryforwards [Line Items] | ||||
Income tax benefit related to operating losses and research and development tax credits | $ 0 | $ 0 | $ 0 | $ 0 |
Net loss per share - Basic and
Net loss per share - Basic and Diluted (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||||||
Sep. 30, 2023 | Jun. 30, 2023 | Mar. 31, 2023 | Sep. 30, 2022 | Jun. 30, 2022 | Mar. 31, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | |
Numerator: | ||||||||||
Net loss | $ (39,659) | $ (31,083) | $ (25,831) | $ (35,542) | $ (27,403) | $ (26,029) | $ (96,573) | $ (88,974) | $ (112,033) | $ (100,777) |
Denominator: | ||||||||||
Weighted average common shares outstanding, basic | 55,613,120 | 38,663,469 | 51,506,766 | 36,364,284 | ||||||
Weighted average common shares outstanding, diluted | 55,613,120 | 38,663,469 | 51,506,766 | 36,364,284 | ||||||
Net loss per share, basic | $ (0.71) | $ (0.92) | $ (1.87) | $ (2.45) | ||||||
Net loss per share, diluted | $ (0.71) | $ (0.92) | $ (1.87) | $ (2.45) |
Net loss per share - Anti-Dilut
Net loss per share - Anti-Diluted (Details) - shares | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Antidilutive shares excluded from the calculation of diluted earnings per share, total | 6,076,697 | 5,573,875 | 6,076,697 | 5,573,875 |
Options to Purchase Common Stock | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Antidilutive shares excluded from the calculation of diluted earnings per share, total | 5,750,601 | 5,390,277 | 5,750,601 | 5,390,277 |
Unvested Restricted Stock Units | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Antidilutive shares excluded from the calculation of diluted earnings per share, total | 142,498 | 142,498 | ||
Warrants to Purchase Common Stock | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Antidilutive shares excluded from the calculation of diluted earnings per share, total | 45,898 | 36,718 | 45,898 | 36,718 |
Warrants Available for Future Grant | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Antidilutive shares excluded from the calculation of diluted earnings per share, total | 137,700 | 146,880 | 137,700 | 146,880 |
Commitments and contingencies_2
Commitments and contingencies (Details) $ in Thousands | Sep. 30, 2023 USD ($) | Dec. 31, 2022 USD ($) | Jul. 10, 2020 ft² | Feb. 29, 2020 USD ($) |
Lease agreement term | 7 years | |||
Square feet of office | ft² | 6,647 | |||
Minimum payments during the term | $ 2,300 | |||
Non-cancelable purchase and other commitments with contract research organizations and contract manufacturing organizations | $ 21,083 | |||
Total lease liability | 1,140 | |||
Operating lease liability, noncurrent | $ 888 | $ 1,079 | ||
Accounting Standards Update 2016-13 [Member] | ||||
Operating Lease, Liability, Statement of Financial Position [Extensible Enumeration] | Operating lease liability, noncurrent, Prepaid Expense and Other Assets, Current | |||
Short-term Liabilities | $ 252 |
Commitments and contingencies -
Commitments and contingencies - Maturities Of Operating Leases (Details) $ in Thousands | Sep. 30, 2023 USD ($) |
Lessee, Operating Lease, Liability, to be Paid, Fiscal Year Maturity [Abstract] | |
2023 (remaining) | $ 82 |
2024 | 331 |
2025 | 341 |
2026 | 351 |
2027 | 208 |
Total future minimum lease payments | 1,313 |
Less imputed interest | (173) |
Present value of operating lease liabilities | $ 1,140 |
Commitments and contingencies_3
Commitments and contingencies - Components of operating lease expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Operating lease expense: | ||||
Short-term lease cost | $ 36 | $ 125 | ||
Total operating lease cost | 125 | $ 90 | 395 | $ 324 |
Other information: | ||||
Cash paid for amounts included in the measurement of operating lease liability | $ 81 | $ 79 | $ 240 | $ 233 |
Weighted average remaining lease term (years) | 3 years 9 months 18 days | 4 years 9 months 18 days | 3 years 9 months 18 days | 4 years 9 months 18 days |
Weighted average discount rate | 7.60% | 7.60% | 7.60% | 7.60% |
General and administrative expense | ||||
Operating lease expense: | ||||
Operating lease cost | $ 81 | $ 81 | $ 243 | $ 243 |
Short-term lease cost | 29 | |||
Variable operating lease cost | $ 8 | $ 9 | $ 27 | $ 52 |