Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2023 | Dec. 11, 2023 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Entity Registrant Name | CARGO Therapeutics, Inc. | |
Document Period End Date | Sep. 30, 2023 | |
Entity Central Index Key | 0001966494 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2023 | |
Document Fiscal Period Focus | Q3 | |
Entity File Number | 001-41859 | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 84-4080422 | |
Entity Address, Address Line One | 1900 Alameda Las Pulgas | |
Entity Address, Address Line Two | Suite 350 | |
Entity Address, City or Town | San Mateo | |
Entity Address, State or Province | CA | |
Entity Address, Postal Zip Code | 94403 | |
City Area Code | 650 | |
Local Phone Number | 379-6143 | |
Title of 12(b) Security | Common stock, par value $0.001 per share | |
Trading Symbol | CRGX | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | No | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | true | |
Entity Ex Transition Period | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 41,205,142 |
Condensed Balance Sheets
Condensed Balance Sheets - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 60,344 | $ 1,872 |
Prepaid expenses and other current assets | 3,072 | 2,055 |
Total current assets | 63,416 | 3,927 |
Operating lease right-of-use assets | 2,825 | 2,165 |
Property and equipment, net | 9,150 | 3,368 |
Other non-current assets | 7,021 | 783 |
Total assets | 82,412 | 10,243 |
Current liabilities: | ||
Accounts payable | 7,430 | 3,483 |
Accrued clinical and research and development expenses | 6,766 | 1,646 |
Accrued expenses and other current liabilities | 6,777 | 3,391 |
Operating lease liabilities, current | 2,591 | 1,006 |
Redeemable convertible preferred stock tranche liability | 17,570 | |
Convertible notes-related party | 11,635 | |
Convertible notes | 9,619 | |
Derivative liabilities | 12,705 | |
Financial commitment liabilities-related party | 412 | |
Financial commitment liabilities | 240 | |
Total current liabilities | 41,134 | 44,137 |
Operating lease liabilities, non-current | 300 | 1,092 |
Other non-current liabilities | 225 | 250 |
Total liabilities | 41,659 | 45,479 |
Redeemable convertible preferred stock, $0.001 par value; 255,584,255 shares authorized and 12,495,411 shares issued and outstanding at September 30, 2023, respectively, (aggregate liquidation preference of $158,588 at September 30, 2023) | 150,088 | |
Stockholders' deficit: | ||
Convertible preferred stock, $0.001 par value; 11,000,000 shares authorized and 810,700 issued and outstanding at December 31, 2022 (aggregate liquidation preference of $11,000 at December 31, 2022) | 1 | |
Common stock, $0.001 par value; 320,000,000 and 29,000,000 shares authorized at September 30, 2023 and December 31, 2022, respectively; 1,086,262 and 1,091,800 shares issued and outstanding at September 30, 2023 and December 31, 2022, respectively | 1 | 1 |
Additional paid-in capital | 3,733 | 11,761 |
Accumulated deficit | (113,069) | (46,999) |
Total stockholders' deficit | (109,335) | (35,236) |
Total liabilities, redeemable convertible preferred stock and stockholders' deficit | $ 82,412 | $ 10,243 |
Condensed Balance Sheets (Paren
Condensed Balance Sheets (Parenthetical) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Redeemable convertible preferred stock, par value | $ 0.001 | |
Redeemable convertible preferred stock, shares authorized | 255,584,255 | |
Redeemable convertible preferred stock, shares issued | 12,495,411 | |
Redeemable convertible preferred stock, shares outstanding | 12,495,411 | |
Redeemable convertible preferred stock, aggregate liquidation preference | $ 158,588 | |
Convertible preferred stock, par value | $ 0.001 | |
Convertible preferred stock, shares authorized | 11,000,000 | 11,000,000 |
Convertible preferred stock, shares issued | 810,700 | 810,700 |
Convertible preferred stock, shares outstanding | 810,700 | 810,700 |
Convertible preferred stock, aggregate liquidation preference | $ 11,000 | $ 11,000 |
Common Stock, par value | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 320,000,000 | 29,000,000 |
Common stock, shares issued | 1,086,262 | 1,091,800 |
Common stock, shares outstanding | 1,086,262 | 1,091,800 |
Condensed Statements of Operati
Condensed 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 | $ 22,233 | $ 8,469 | $ 48,724 | $ 20,142 |
General and administrative | 6,478 | 1,580 | 13,030 | 3,624 |
Total operating expenses | 28,711 | 10,049 | 61,754 | 23,766 |
Loss from operations | (28,711) | (10,049) | (61,754) | (23,766) |
Interest expense | (1,458) | (1,604) | (2,234) | |
Net change in fair value of redeemable convertible preferred stock tranche obligations | (7,651) | (8,343) | ||
Change in fair value of derivative liabilities | (779) | 6,453 | (1,186) | |
Loss on extinguishment of convertible notes | (2,316) | |||
Other income (expense), net | 891 | 1 | 1,494 | (16) |
Net loss and comprehensive loss | $ (35,471) | $ (12,285) | $ (66,070) | $ (27,202) |
Net loss per share attributable to common stockholders, basic | $ (47.37) | $ (28.38) | $ (98.15) | $ (79.16) |
Net loss per share attributable to common stockholders, diluted | $ (47.37) | $ (28.38) | $ (98.15) | $ (79.16) |
Weighted-average shares used in computing net loss per share attributable to common stockholders, basic | 748,862 | 432,835 | 673,175 | 343,635 |
Weighted-average shares used in computing net loss per share attributable to common stockholders, diluted | 748,862 | 432,835 | 673,175 | 343,635 |
Condensed Statements of Redeema
Condensed Statements of Redeemable Convertible Preferred Stock and Stockholders' Deficit - USD ($) $ in Thousands | Total | Common Stock | Additional Paid-In Capital | Accumulated Deficit | Redeemable Convertible Preferred Stock | Convertible Preferred Stock Preferred Stock | Series A-1 Redeemable Convertible Preferred Stock | Series A-2 Redeemable Convertible Preferred Stock |
Beginning balance, shares at Dec. 31, 2021 | 810,699 | 405,350 | ||||||
Beginning balance, amount at Dec. 31, 2021 | $ (175) | $ 1 | $ 5,871 | $ (6,048) | $ 1 | |||
Issuance of Series Seed convertible preferred stock, shares | 405,350 | |||||||
Issuance of Series Seed convertible preferred stock, amount | 5,500 | 5,500 | ||||||
Net loss | (4,755) | (4,755) | ||||||
Ending balance, shares at Mar. 31, 2022 | 810,699 | 810,700 | ||||||
Ending balance, amount at Mar. 31, 2022 | 570 | $ 1 | 11,371 | (10,803) | $ 1 | |||
Beginning balance, shares at Dec. 31, 2021 | 810,699 | 405,350 | ||||||
Beginning balance, amount at Dec. 31, 2021 | (175) | $ 1 | 5,871 | (6,048) | $ 1 | |||
Net loss | (27,202) | |||||||
Ending balance, shares at Sep. 30, 2022 | 1,080,745 | 810,700 | ||||||
Ending balance, amount at Sep. 30, 2022 | (21,527) | $ 1 | 11,721 | (33,250) | $ 1 | |||
Beginning balance, shares at Mar. 31, 2022 | 810,699 | 810,700 | ||||||
Beginning balance, amount at Mar. 31, 2022 | 570 | $ 1 | 11,371 | (10,803) | $ 1 | |||
Issuance of restricted stock awards, shares | 139,649 | |||||||
Issuance of restricted stock awards, amount | 2 | 2 | ||||||
Stock-based compensation | 241 | 241 | ||||||
Net loss | (10,162) | (10,162) | ||||||
Ending balance, shares at Jun. 30, 2022 | 950,348 | 810,700 | ||||||
Ending balance, amount at Jun. 30, 2022 | (9,349) | $ 1 | 11,614 | (20,965) | $ 1 | |||
Issuance of common shares for license, shares | 67,605 | |||||||
Issuance of common shares for license, amount | 72 | 72 | ||||||
Issuance of restricted stock awards, shares | 62,792 | |||||||
Issuance of restricted stock awards, amount | 1 | 1 | ||||||
Vesting of restricted stock | 10 | 10 | ||||||
Stock-based compensation | 24 | 24 | ||||||
Net loss | (12,285) | (12,285) | ||||||
Ending balance, shares at Sep. 30, 2022 | 1,080,745 | 810,700 | ||||||
Ending balance, amount at Sep. 30, 2022 | (21,527) | $ 1 | 11,721 | (33,250) | $ 1 | |||
Beginning balance, shares at Dec. 31, 2022 | 0 | |||||||
Beginning balance, amount at Dec. 31, 2022 | $ 0 | |||||||
Beginning balance, shares at Dec. 31, 2022 | 1,091,800 | 810,700 | ||||||
Beginning balance, amount at Dec. 31, 2022 | (35,236) | $ 1 | 11,761 | (46,999) | $ 1 | |||
Reclassification of Series Seed redeemable convertible preferred stock, shares | 810,700 | |||||||
Reclassification of Series Seed redeemable convertible preferred stock, amount | $ 9,830 | |||||||
Reclassification of series seed redeemable convertible preferred stock, shares | (810,700) | |||||||
Reclassification of series seed redeemable convertible preferred stock, amount | (9,830) | (9,829) | $ (1) | |||||
Issuance of redeemable convertible preferred stock, shares | 5,072,919 | |||||||
Issuance of redeemable convertible preferred stock, amount | $ 60,760 | |||||||
Issuance of redeemable convertible preferred stock upon conversion of convertible notes, shares | 3,229,851 | |||||||
Issuance of redeemable convertible preferred stock upon conversion of convertible notes, amount | $ 35,576 | |||||||
Issuance of restricted stock awards, shares | 1,874 | |||||||
Vesting of restricted stock | 18 | 18 | ||||||
Repurchase of restricted stock | (4,698) | |||||||
Stock-based compensation | 31 | 31 | ||||||
Net loss | (12,715) | (12,715) | ||||||
Ending balance, shares at Mar. 31, 2023 | 9,113,470 | |||||||
Ending balance, amount at Mar. 31, 2023 | $ 106,166 | |||||||
Ending balance, shares at Mar. 31, 2023 | 1,088,976 | |||||||
Ending balance, amount at Mar. 31, 2023 | (57,732) | $ 1 | 1,981 | (59,714) | ||||
Beginning balance, shares at Dec. 31, 2022 | 0 | |||||||
Beginning balance, amount at Dec. 31, 2022 | $ 0 | |||||||
Beginning balance, shares at Dec. 31, 2022 | 1,091,800 | 810,700 | ||||||
Beginning balance, amount at Dec. 31, 2022 | $ (35,236) | $ 1 | 11,761 | (46,999) | $ 1 | |||
Exercise of stock options, shares | 7,240 | |||||||
Net loss | $ (66,070) | |||||||
Ending balance, shares at Sep. 30, 2023 | 12,495,411 | 12,495,411 | ||||||
Ending balance, amount at Sep. 30, 2023 | $ 150,088 | $ 150,088 | ||||||
Ending balance, shares at Sep. 30, 2023 | 1,086,262 | |||||||
Ending balance, amount at Sep. 30, 2023 | (109,335) | $ 1 | 3,733 | (113,069) | ||||
Beginning balance, shares at Mar. 31, 2023 | 9,113,470 | |||||||
Beginning balance, amount at Mar. 31, 2023 | $ 106,166 | |||||||
Beginning balance, shares at Mar. 31, 2023 | 1,088,976 | |||||||
Beginning balance, amount at Mar. 31, 2023 | (57,732) | $ 1 | 1,981 | (59,714) | ||||
Exercise of stock options, shares | 1,695 | |||||||
Exercise of stock options, amount | 2 | 2 | ||||||
Vesting of restricted stock | 43 | 43 | ||||||
Repurchase of restricted stock | (4,686) | |||||||
Stock-based compensation | 592 | 592 | ||||||
Net loss | (17,884) | (17,884) | ||||||
Ending balance, shares at Jun. 30, 2023 | 9,113,470 | |||||||
Ending balance, amount at Jun. 30, 2023 | $ 106,166 | |||||||
Ending balance, shares at Jun. 30, 2023 | 1,085,985 | |||||||
Ending balance, amount at Jun. 30, 2023 | (74,979) | $ 1 | 2,618 | (77,598) | ||||
Issuance of redeemable convertible preferred stock, shares | 3,381,941 | |||||||
Issuance of redeemable convertible preferred stock, amount | $ 42,012 | |||||||
Reclassification of tranche obligation asset to Series A-1 redeemable convertible preferred stock | $ 1,910 | |||||||
Exercise of stock options, shares | 5,545 | |||||||
Exercise of stock options, amount | 6 | 6 | ||||||
Vesting of restricted stock | 25 | 25 | ||||||
Repurchase of restricted stock | (5,268) | |||||||
Stock-based compensation | 1,084 | 1,084 | ||||||
Net loss | $ (35,471) | (35,471) | ||||||
Ending balance, shares at Sep. 30, 2023 | 12,495,411 | 12,495,411 | ||||||
Ending balance, amount at Sep. 30, 2023 | $ 150,088 | $ 150,088 | ||||||
Ending balance, shares at Sep. 30, 2023 | 1,086,262 | |||||||
Ending balance, amount at Sep. 30, 2023 | $ (109,335) | $ 1 | $ 3,733 | $ (113,069) |
Condensed Statements of Redee_2
Condensed Statements of Redeemable Convertible Preferred Stock and Stockholders' Deficit (Parenthetical) - USD ($) $ in Thousands | 3 Months Ended | |
Sep. 30, 2023 | Mar. 31, 2023 | |
Convertible Preferred Stock | ||
Issuance of tranche asset and liability | $ 7,317 | |
Series A-1 Redeemable Convertible Preferred Stock | ||
Stock Issuance Costs | $ 55 | $ 755 |
Condensed Statements of Cash Fl
Condensed Statements of Cash Flows - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
OPERATING ACTIVITIES | ||
Net loss | $ (66,070) | $ (27,202) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Loss on extinguishment of convertible notes | 2,316 | |
Amortization of operating lease right-of-use assets | 1,631 | 780 |
Noncash interest expense | 1,604 | 2,234 |
Net change in fair value of redeemable convertible preferred stock tranche obligations | 8,343 | |
Acquired in-process research and development | 1,225 | 1,004 |
Stock-based compensation expense | 1,707 | 265 |
Depreciation | 960 | 234 |
Change in fair value of derivative liabilities | (6,453) | 1,186 |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other current assets | (1,017) | (2,753) |
Other non-current assets | (3,550) | (455) |
Accounts payable | 3,297 | 5,782 |
Accrued clinical and research and development expenses | 5,120 | 1,002 |
Accrued expenses and other current liabilities | 203 | 1,015 |
Operating lease liabilities | (1,498) | (814) |
Net cash used in operating activities | (52,182) | (17,722) |
INVESTING ACTIVITIES | ||
Purchase of property and equipment | (5,660) | (1,738) |
Purchase of in-process research and development | (358) | (520) |
Net cash used in investing activities | (6,018) | (2,258) |
FINANCING ACTIVITIES | ||
Proceeds from issuance of convertible notes, net of issuance costs - related party | 2,212 | 8,459 |
Proceeds from issuance of convertible notes, net of issuance costs | 1,286 | 7,503 |
Proceeds from issuance of convertible preferred stock and tranche commitment, net of issuance costs | 5,500 | |
Proceeds from issuance of redeemable convertible preferred stock and tranche obligations, net of issuance costs | 113,909 | |
Proceeds from issuance of restricted stock awards | 3 | |
Proceeds from exercise of stock options | 8 | |
Payment of deferred initial public offering costs | (743) | |
Net cash provided by financing activities | 116,672 | 21,465 |
Net increase in cash and cash equivalents | 58,472 | 1,485 |
Cash and cash equivalents at beginning of period | 1,872 | 41 |
Cash and cash equivalents at end of period | 60,344 | 1,526 |
SUPPLEMENTAL NON-CASH INVESTING AND FINANCING ACTIVITIES | ||
Reclassification of tranche obligation asset to Series A-1 redeemable convertible preferred stock | 1,910 | |
Conversion of convertible notes to shares of Series A-2 redeemable convertible preferred stock | 35,576 | |
Reclassification of shares of Series Seed redeemable convertible preferred stock to mezzanine equity | 9,830 | |
Purchase of property and equipment in accounts payable and accrued expenses and other current liabilities | 1,741 | 1,289 |
In-process research and development costs in accounts payable, accrued expenses and other current liabilities, and other non-current liabilities | 1,250 | 412 |
Issuance of shares in exchange for in-process research and development | 72 | |
Deferred offering costs related to initial public offering included in accounts payable and accrued expenses and other current liabilities | $ 1,945 | |
Deferred issuance costs for second tranche of Series A-1 redeemable convertible preferred stock in accounts payable and accrued expenses and other current liabilities | $ 19 |
Organization
Organization | 9 Months Ended |
Sep. 30, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization | 1. Organization Description of the business CARGO Therapeutics, Inc. (the “Company”) was incorporated in the state of Delaware in December 2019 as Syncopation Life Sciences, Inc. and changed its name to CARGO Therapeutics, Inc. in September 2022. It is a clinical-stage biotechnology company positioned to advance next generation, potentially curative cell therapies for cancer patients. The Company’s programs, platform technologies, and manufacturing strategy are designed to directly address the key limitations of approved cell therapies, including limited durability of effect, suboptimal safety and unreliable supply. The Company’s lead program, CRG-022, an autologous CD22 chimeric antigen receptor (“CAR”) T-cell therapy, has demonstrated robust safety, activity and manufacturability in clinical trials and is currently being studied in a potentially pivotal Phase 2 clinical trial for the treatment of large B-cell lymphoma (“LBCL”). The Company is also leveraging its proprietary cell engineering platform technologies to develop a pipeline of programs that incorporate multi-functional genetic “cargo” designed to enhance CAR T-cell persistence and trafficking to tumor lesions, as well as help safeguard against tumor resistance and T-cell exhaustion. Since its founding, the Company has devoted substantially all of its resources to organizing and staffing the Company, business planning, raising capital, establishing licensing arrangements, building its proprietary platform technologies, discovering its product candidates, establishing its intellectual property portfolio, conducting research, preclinical studies, and clinical trials, establishing arrangements with third parties for the manufacture of its product candidates and related raw materials, and providing general and administrative support for these operations. Reverse Stock Split On November 1, 2023, the Company’s Board of Directors approved an amended and restated certificate of incorporation to effect a reverse split of shares of the Company’s common stock and redeemable convertible preferred stock on a 13.5685-for-1 basis (the “Reverse Stock Split”) which was effected on November 3, 2023. The par value and authorized number of shares of common stock and redeemable convertible preferred stock were not adjusted as a result of the Reverse Stock Split. All share data and per share data amounts for all periods presented in the condensed financial statements and notes thereto have been retrospectively adjusted to reflect the effect of the Reverse Stock Split. Initial Public Offering On November 14, 2023, the Company closed its initial public offering (“IPO”), pursuant to which it issued and sold an aggregate of 18,750,000 shares of its common stock at a public offering price of $ 15.00 per share and on November 21, 2023, the Company issued and sold 2,512,181 additional shares of its common stock to the underwriters of the IPO pursuant to the partial exercise of their option to purchase additional shares, resulting in net proceeds of approximately $ 291.3 million, after deducting underwriting discounts, commissions and other offering expenses. Upon the closing of the IPO, the Company’s outstanding redeemable convertible preferred stock automatically converted into 18,836,559 shares of common stock. Converted redeemable convertible preferred stock outstanding as of the date of IPO consisted of 12,495,411 shares that were outstanding as of September 30, 2023 (see Note 7) and 6,341,148 shares that were issued in October 2023 (see Note 13). Following the closing of the IPO, no shares of redeemable convertible preferred stock were authorized or outstanding. In connection with the closing of its IPO, on November 14, 2023, the Company’s certificate of incorporation was amended and restated to authorize 500,000,000 shares of common stock, par value $ 0.001 per share and 50,000,000 shares of preferred stock, par value of $ 0.001 per share. The unaudited condensed financial statements as of September 30, 2023, including share and per share amounts, do not give effect to the IPO as it closed subsequent to September 30, 2023. Liquidity Since inception, the Company has incurred significant operating losses and negative cash flows, and it expects that it will continue to incur losses and negative cash flows for the foreseeable future as it continues its research and development efforts, advances its product candidates through preclinical and clinical development, enhances its platforms and programs, expands its product pipeline, seeks regulatory approval, prepares for commercialization, hires additional personnel, protects its intellectual property and grows its business. As of and for the nine months ended September 30, 2023, the Company had an accumulated deficit of $ 113.1 million, cash and cash equivalents of $ 60.3 million and negative cash flows from operations of $ 52.2 million. The Company believes its existing cash, cash equivalents, proceeds received from the sale of its Series A-1 redeemable convertible preferred stock in October 2023 (see Note 13) and proceeds received from its IPO (see Note 13) will be sufficient to support operations for at least 12 months from the issuance of these unaudited condensed financial statements. |
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 Basis of presentation The Company has prepared the accompanying condensed financial statements in accordance with U.S. generally accepted accounting principles (“GAAP”) and the requirements of the Securities and Exchange Commission (“SEC”) for interim reporting. As permitted under those rules, certain footnotes or other financial information that are normally required by GAAP can be condensed or omitted. The financial statements are presented in U.S. dollars. Use of estimates The preparation of 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 financial statements, and the reported amounts of expenses during the reporting period. The Company bases its estimates on historical experience and on various other assumptions believed to be reasonable. Actual results could differ from those estimates and such differences could be material to the financial position and results of operations. Significant estimates and assumptions reflected in these financial statements include, but are not limited to, the accrual of research and development expenses, the fair value of derivative liabilities, the initial fair value of the financial commitment liabilities related to the convertible notes, valuation of the redeemable convertible preferred stock tranche asset and liability, valuation of deferred tax assets, the fair value of equity instruments, equity-based instruments, stock-based compensation, and the determination of the incremental borrowing rate. Unaudited interim condensed financial statements The condensed balance sheet as of September 30, 2023 and the condensed statements of operations and comprehensive loss, redeemable convertible preferred stock and stockholders’ deficit, and cash flows for the nine months ended September 30, 2023 and 2022 are unaudited. These unaudited condensed financial statements have been prepared on the same basis as the Company’s annual financial statements and, in the opinion of management, reflect all adjustments (consisting only of normal recurring adjustments) that are necessary for the fair statement of the Company’s financial position, results of operations and cash flows for the interim periods presented. The condensed results of operations for the nine months ended September 30, 2023 are not necessarily indicative of the results to be expected for the full year or for any other future annual or interim period. The condensed balance sheet as of December 31, 2022 included herein was derived from the audited financial statements as of that date. These condensed financial statements should be read in conjunction with the Company’s audited financial statements included in the Company’s prospectus related to its IPO filed pursuant to Rule 424(b)(4) under the Securities Act with the SEC on November 13, 2023. Cash and cash equivalents The Company considers all highly liquid investments purchased with an original maturity of three months or less on the date of purchase to be cash equivalents. Cash equivalents primarily consist of money market funds that are stated at fair value. Issuance costs related to equity The Company allocates issuance costs between the individual freestanding instruments identified on a relative fair value basis. Issuance costs associated with the issuance of stock or equity contracts (i.e., redeemable convertible preferred stock) are recorded as a charge against the gross proceeds of the offering. The Company capitalizes certain legal, accounting, and other third-party fees that are directly related to the Company’s equity offering until such offering is consummated. As of September 30, 2023, a total of $ 2.7 million in deferred offering costs related to the Company’s IPO were classified as other non-current assets in the condensed balance sheet. As of December 31, 2022, there were no deferred issuance costs related to the IPO. The Company closed its IPO on November 14, 2023, accordingly these costs will be recorded in stockholders’ equity as a reduction of the proceeds from the offering subsequent to September 30, 2023. Financial commitment liabilities The Company’s convertible note purchase agreements executed in April 2022 and October 2022 (“2022 Convertible Notes”) included financial commitments to issue additional convertible notes to the noteholders in tranches (see Note 6) that were determined to be freestanding instruments that should be classified as liabilities. The freestanding instruments met the scope exception from derivative accounting. The proceeds of issuance of the first tranche of each of the 2022 Convertible Notes were allocated to the convertible notes and financial commitment liabilities based on their relative fair value at the date of issuance and not subsequently remeasured. The proceeds allocated to the financial commitment liabilities create a discount on the respective convertible note that is amortized as interest expense in the statements of operations and comprehensive loss using the effective interest rate method over the term of the respective convertible note. Upon settlement of each tranche, the respective portion of the financial commitment liabilities is reclassified to the carrying amount of the respective convertible note. Derivative liabilities The 2022 Convertible Notes contain certain embedded redemption features that are not clearly and closely related to the debt host instruments (see Note 6). These features are bifurcated from the host instruments and recorded at fair value on the date of issuance as derivative liabilities in accordance with Accounting Standards Codification (“ASC”) 815-15, Derivatives and Hedging—Embedded Derivatives . The derivative liabilities are remeasured to fair value each reporting period until settlement or extinguishment, with changes in the fair value recorded as a change in fair value of derivative liabilities in the condensed statements of operations and comprehensive loss. Derivative liabilities are classified in the condensed balance sheets as current or non-current based on whether or not net-cash settlement of the derivative instrument could be required within 12 months of the balance sheet date. Redeemable convertible preferred stock tranche obligations The obligations to issue additional shares of the Company’s Series A-1 redeemable convertible preferred stock in two tranches at a fixed price at future dates were determined to be freestanding financial instruments within the scope of ASC 480, Distinguishing Liabilities From Equity (“ASC 480”). On issuance, the Company recorded the redeemable convertible preferred stock tranche asset and liability on the condensed balance sheet at their respective fair values. These tranche obligations are subject to remeasurement at each balance sheet date, with the net change in fair value recognized as a gain or loss on remeasurement within net change in fair value of redeemable convertible preferred stock tranche obligations in the condensed statements of operations and comprehensive loss until settlement or extinguishment. Recently adopted accounting pronouncements In June 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2016-13, Financial Instruments—Credit Losses (Topic 326) : Measurement of Credit Losses on Financial Instruments (“ASU 2016-13”), which replaces the existing incurred loss impairment model with an expected credit loss model and requires a financial asset measured at amortized cost to be presented at the net amount expected to be collected. The Company adopted ASU 2016-13 on January 1, 2023, using a modified retrospective approach. The adoption did not have a material impact on the Company ’ s financial statements. Recently issued accounting pronouncements not yet adopted From time to time, new accounting pronouncements are issued by the FASB or other standard-setting bodies and adopted by the Company as of the specified effective date. Unless otherwise discussed, the Company believes that the impact of recently issued standards that are not yet effective will not have a material impact on the accompanying financial statements and disclosures. |
Fair Value Measurement
Fair Value Measurement | 9 Months Ended |
Sep. 30, 2023 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurement | 3. Fair Value Measurement The Company utilizes valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible. The Company determines fair value based on assumptions that market participants would use in pricing an asset or liability in the principal or most advantageous market. When considering market participant assumptions in fair value measurements, the following fair value hierarchy distinguishes between observable and unobservable inputs, which are categorized in one of the following levels: Level 1 – Quoted prices in active markets for identical assets or liabilities. Level 2 – Observable inputs other than Level 1 prices such as quoted prices for similar assets or liabilities, quoted prices in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. Level 3 – Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. Carrying amounts of certain of the Company’s financial instruments including, cash and cash equivalents, prepaid expenses and other current assets, accounts payable and accrued expenses and other current liabilities approximate fair value due to the short-term nature of these instruments. On a recurring basis, the Company measures certain financial liabilities at fair value. There were no transfers between levels during the nine months ended September 30, 2023 and year ended December 31, 2022. The following tables summarize the Company’s financial assets and financial liabilities measured at fair value on a recurring basis by level within the fair value hierarchy: September 30, 2023 Level 1 Level 2 Level 3 Total (in thousands) Assets: Money market funds $ 56,790 $ — $ — $ 56,790 Total financial assets $ 56,790 $ — $ — $ 56,790 Liabilities: Redeemable convertible preferred stock tranche $ — $ — $ 17,570 $ 17,570 Total financial liabilities $ — $ — $ 17,570 $ 17,570 December 31, 2022 Level 1 Level 2 Level 3 Total (in thousands) Liabilities: Derivative liabilities $ — $ — $ 12,705 $ 12,705 Total financial liabilities $ — $ — $ 12,705 $ 12,705 Derivative liabilities In April and October 2022, the Company executed convertible note purchase agreements with its existing investors (see Note 6). The 2022 Convertible Notes contained certain embedded features requiring bifurcation as a single compound derivative instrument for each tranche funded. The derivative liabilities were measured at fair value using Level 3 inputs. The fair value of the derivative liabilities was estimated using a “with-and-without” method. The “with-and-without” methodology involves valuing the whole instrument on an as-is basis and then valuing the instrument without the embedded derivative. The difference between the entire instrument with the embedded derivatives and the instrument without the embedded derivatives is the fair value of the derivative liabilities. The estimated probability and timing of underlying events triggering the exercisability of the put option and conversion features contained within the 2022 Convertible Notes, forecasted cash flows and the discount rate were significant unobservable inputs used to determine the estimated fair value of the entire instrument with the embedded derivative. Significant increases (decreases) in any of those inputs in isolation would result in a significantly lower (higher) fair value measurement. The derivative liabilities are remeasured at each reporting period and the changes are recognized as a change in fair value of derivative liabilities on the statement of operations and comprehensive loss. The derivative liabilities were settled in February 2023 upon conversion of the 2022 Convertible Notes into Series A-2 redeemable convertible preferred stock (see Note 6). The following table summarizes the significant inputs used in the valuation of the derivative liabilities: On Issuance February 9, Expected term to achievement underlying 0.1 – 0.2 — Probability of achievement of triggering 0.0 % - 95.0 % 100.0 % Discount rate 75.0 % 75.0 % The following table summarizes the changes in the derivative liabilities: Derivative (in thousands) Balance as of December 31, 2022 $ 12,705 Additions (1) 2,133 Change in fair value ( 6,453 ) Settlement ( 8,385 ) Balance as of September 30, 2023 $ — (1) The additions to derivative liabilities in the nine months ended September 30, 2023 relate to the embedded derivative bifurcated from the final tranche of the 2022 Convertible Notes that was issued in January 2023. Redeemable convertible preferred stock tranche obligations The fair value of the Company’s redeemable convertible preferred stock tranche asset and liability (see Note 7) was calculated using an option pricing model using Level 3 inputs not observable in the market. Significant increases (decreases) in any of those inputs in isolation would result in a significantly lower (higher) fair value measurement. As of September 30, 2023, the fair value of the redeemable convertible preferred stock tranche liability was calculated based on two scenarios, stay-private and IPO with early and late exit dates, each of which were probability weighted. The stay private scenario, weighted at a 30 % probability, estimated the fair value using an option pricing model. The IPO scenario, weighted at a 70 % probability, estimated the value of the Company upon an IPO at $ 380.0 million with an early IPO exit in 0.1 years and a late IPO exit in 0.4 years. The redeemable convertible preferred stock tranche obligations are considered a contingent forward and the standard forward pricing model was used for the option pricing model with the following key assumptions: Redeemable Convertible Redeemable Convertible On On Settlement On As of Expected term to achievement of 0.4 — 0.8 0.1 Probability of achievement of milestone 90.0 % 100 % 63.0 % 95.0 % Discount rate 4.9 % — 4.9 % 5.6 % The following table summarizes the changes in the fair value of the redeemable convertible preferred stock tranche asset and liability: Redeemable Redeemable (in thousands) Balance as of December 31, 2022 $ — $ — Initial recognition 1,788 ( 9,105 ) Change in fair value 122 ( 8,465 ) Settlement ( 1,910 ) — Balance as of September 30, 2023 $ — $ ( 17,570 ) |
Balance Sheet Components
Balance Sheet Components | 9 Months Ended |
Sep. 30, 2023 | |
Balance Sheet Components [Abstract] | |
Balance Sheet Components | 4. Balance Sheet Components Prepaid expenses and other current assets Prepaid expenses and other current assets consisted of the following: September 30, December 31, (in thousands) Prepaid research and development $ 2,403 $ 1,428 Other receivables 475 476 Prepaid other 194 151 Total prepaid expenses and other current assets $ 3,072 $ 2,055 Property and equipment, net Property and equipment, net consisted of the following: September 30, December 31, (in thousands) Furniture and equipment $ 10,417 $ 2,793 Leasehold improvements 112 105 Construction in progress 2 891 Property and equipment at cost 10,531 3,789 Less: accumulated depreciation ( 1,381 ) ( 421 ) Property and equipment, net $ 9,150 $ 3,368 Depreciation expense for the three months ended September 30, 2023 and 2022 was $ 0.5 million and $ 0.1 million, respectively, and for the nine months ended September 30, 2023 and 2022 was $ 1.0 million and $ 0.2 million, respectively. Other non-current assets Other non-current assets consisted of the following: September 30, December 31, (in thousands) Prepaid clinical $ 3,217 $ — Deferred offering costs related to the initial public offering 2,689 — Other non-current assets 1,115 783 Total other non-current assets $ 7,021 $ 783 Accrued expenses and other current liabilities Accrued expenses and other current liabilities consisted of the following: September 30, December 31, (in thousands) Accrued compensation and related expenses $ 2,609 $ 2,385 Accrued purchases of property and equipment 1,429 623 Accrued deferred offering costs related to the initial public offering 1,599 — Other 1,140 383 Total accrued expenses and other current liabilities $ 6,777 $ 3,391 |
Leases
Leases | 9 Months Ended |
Sep. 30, 2023 | |
Leases [Abstract] | |
Leases | 5. Leases In November 2021, the Company entered into a three-year operating lease for 15,400 square feet of lab and office space in San Mateo, California. The agreement provides for one option to renew for one year which the Company is not reasonably certain to exercise. In February 2023, the operating lease commenced for an additional premises for 15,717 square feet of lab and office space, increasing the total leased premises to 31,117 square feet at the existing San Mateo, California location. The new lease has a term of two years . The Company paid an additional $ 0.3 million in deposits upon commencement of the new lease which is recorded in other assets on the balance sheet. The Company is a sublessor in two agreements with initial terms of six months for a combined 2,300 square feet of the Company’s leased premises. The future payments associated with the Company’s operating lease liabilities as of September 30, 2023 were as follows: Amount (in thousands) 2023 (remaining three months) $ 691 2024 2,404 Total undiscounted lease payments 3,095 Less: imputed interest ( 204 ) Total operating lease liabilities $ 2,891 A summary of total lease costs and other information for the periods relating to the Company’s operating leases was as follows: Three months ended September 30, Nine months ended 2023 2022 2023 2022 (in thousands) Operating lease cost $ 683 $ 323 $ 1,929 $ 959 Variable lease cost 168 78 476 239 Sublease income ( 60 ) ( 120 ) ( 280 ) ( 120 ) Total lease cost $ 791 $ 281 $ 2,125 $ 1,078 September 30, December 31, Other information: Weighted-average remaining lease term (in years) 1.3 1.9 Weighted-average discount rate 11.6 % 9.6 % Supplemental cash flow and noncash information related to the Company’s operating leases were as follows: Nine months ended 2023 2022 (in thousands) Cash flows from operating activities: Cash paid for amounts included in the measurement of $ 1,804 $ 992 Right-of-use assets obtained in exchange for lease Total right-of-use assets capitalized $ 2,291 $ — |
Convertible Notes
Convertible Notes | 9 Months Ended |
Sep. 30, 2023 | |
Convertible Notes [Abstract] | |
Convertible Notes | 6. Convertible Notes In April 2022, the Company executed a convertible note purchase agreement with its existing investors for total proceeds of up to $ 25.0 million (the “April 2022 Convertible Notes”). The investors committed to purchase the notes in three tranches upon achievement of certain milestones, which occurred in April, August and October 2022 for aggregate gross proceeds of $ 20.0 million, of which $ 10.6 million was from a related party (see Note 11). The Company incurred $ 0.1 million in issuance costs for the April 2022 Convertible Notes. All three tranches had a maturity date of April 26, 2023 . The Company had the option to request a fourth tranche of up to $ 5.0 million at the discretion of the investors under certain specific criteria. In February 2023, the April 2022 Convertible Notes were settled in connection with the Series A redeemable convertible preferred stock financing (see Note 7) and the option to request the fourth tranche expired. In October 2022, the Company executed a convertible note purchase agreement with the same terms and with the same investors in the April 2022 Convertible Notes for total proceeds of up to $ 12.0 million (the “October 2022 Convertible Notes”), of which $ 5.4 million was from a related party. The investors committed to purchase the notes in three tranches upon achievement of certain milestones, of which the first two tranches were issued in October and December 2022 for aggregate gross proceeds of $ 8.5 million. The Company incurred $ 16,000 in issuance costs for the funded October 2022 Convertible Notes. In January 2023, the third tranche was issued upon achieving the third milestone for gross proceeds of $ 3.5 million, including $ 2.2 million issued to a related party. All three tranches had a maturity date of October 28, 2023 . In February 2023, the October 2022 Convertible Notes were settled in connection with the Series A redeemable convertible preferred stock financing (see Note 7). The 2022 Convertible Notes bear simple interest at 6.0 % per annum. The principal and accrued interest can only be repaid prior to maturity upon consent of a majority of the investors or immediately upon demand. The 2022 Convertible Notes are subject to automatic conversion upon the next financing whereby the Company issues its preferred equity securities and raises aggregate gross proceeds of at least $ 50.0 million (a “Qualified Financing”). On automatic conversion, the outstanding principal and accrued interest automatically convert into the convertible preferred stock issued in the Qualified Financing at 75 % of the lowest cash price per share. The 2022 Convertible Notes are also subject to settlement by way of voluntary conversion that is not a Qualified Financing (a “Non-Qualified Financing”) where a majority of the active investors (investors who have fulfilled their funding commitments) may elect to convert the outstanding principal and interest into convertible preferred stock issued at 75 % of the lowest cash price per share. In the event of a “Strategic Transaction” such as upon a change in control whereby another entity acquires the Company or the Company disposes of substantially all its assets upon sale, lease, liquidation, dissolution or winding up, whether voluntary or involuntary or an IPO, then each active investor may choose to convert the note into the Company’s common stock at a conversion price of $ 20.36 per share or redeem the note in cash for 200 % of the outstanding balance and 100 % of accrued and unpaid interest. For investors who have not fulfilled their funding commitments related to the second and third tranches, where the respective milestone conditions have been met, upon a Qualified Financing, a Non-Qualified Financing or a Strategic Transaction, the outstanding principal and interest of the note will automatically convert into shares of common stock at 10 % of the then current common stock price. The Company determined that the financial commitments to issue future tranches were freestanding instruments that do not meet the definition of a derivative and should be classified as liabilities. Upon issuance of the first tranche of the April 2022 Convertible Notes and October 2022 Convertible Notes, the Company recognized $ 0.7 million and $ 1.2 million, respectively, for the relative fair value of the financial commitment liabilities, of which $ 0.4 million and $ 0.7 million, respectively, were associated with a related party (see Note 3). Upon settlement of the financial commitments, for the year ended December 31, 2022 and the nine months ended September 30, 2023, $ 1.2 million and $ 0.7 million in financial commitment liabilities, respectively, were reclassified to the carrying amount of the respective convertible notes. Due to the conversion and redemption features embedded within the 2022 Convertible Notes, the Company bifurcated compound derivative liabilities related to all tranches issued through to September 30, 2023 (see Note 3). The aggregate fair value at issuance of the derivative liabilities was $ 13.6 million and is subsequently remeasured each reporting period. The allocation of proceeds of the 2022 Convertible Notes to the financial commitment liabilities and embedded derivatives created a discount on the respective convertible note that is amortized using the effective interest rate method over the term of the respective note. For the three months ended September 30, 2022 and for the nine months ended September 30, 2023 and 2022, the Company recognized $ 1.5 million, $ 1.6 million, and $ 2.2 million, respectively, of interest expense, including accrued interest, amortization of the debt discount and amortization of debt issuance costs, in the condensed statements of operations and comprehensive loss. There was no interest expense in the three months ended September 30, 2023. In February 2023, concurrent with the Series A redeemable convertible preferred stock financing (see Note 7), the terms of the 2022 Convertible Notes were amended to specify that the notes would convert into Series A-2 redeemable convertible preferred stock. The other contractual terms including the settlement method and the conversion price of $ 10.18 per share remained unchanged. Pursuant to the share settled redemption features as per the original contractual terms of the 2022 Convertible Notes, the Company issued 3,229,851 shares thereby settling $ 32.9 million in outstanding principal and accrued interest. Upon settlement, the carrying values of the 2022 Convertible Notes of $ 24.9 million and the derivative liabilities of $ 8.4 million were derecognized and the Series A-2 redeemable convertible preferred stock was recorded at its fair value of $ 35.6 million. The Company recognized a loss on extinguishment of $ 2.3 million in the condensed statement of operations and comprehensive loss for the nine months ended September 30, 2023. |
License and Research and Develo
License and Research and Development Agreements | 9 Months Ended |
Sep. 30, 2023 | |
Research and Development [Abstract] | |
License and Research and Development Agreements | 10. License and Research and Development Agreements Stanford license agreement In August 2022, the Company entered into a license agreement with the Board of Trustees of the Leland Stanford Junior University (“Stanford University”) relating to the Company’s platform technologies relating to CAR T-cell therapies (the “Stanford License Agreement”). Pursuant to the Stanford License Agreement, Stanford University granted the Company a worldwide, exclusive license under certain patent rights, and a worldwide non-exclusive license under certain technology, in each case, owned or controlled by Stanford University, to make, use and sell products, methods or services in the field of human therapeutic and diagnostic products. As consideration for the licenses granted under the Stanford License Agreement, the Company made an upfront payment of $ 50,000 and issued 67,605 shares of its common stock with a fair value of $ 0.1 million, of which 22,317 shares were issued to Stanford University, 27,100 shares were issued to two non-profit organizations that supported the research, and 18,188 shares were issued to various Stanford University inventors. The Company determined that the purchase of the licenses under the Stanford License Agreement represented an asset acquisition as it did not meet the definition of a business. As the acquired licenses represented in-process research and development (“IPR&D”) assets with no alternative future use, the Company recorded the upfront consideration of $ 0.2 million as research and development expense in August 2022, upon entering into the Stanford License Agreement. The Company recorded research and development expense pursuant to the Stanford License Agreement in the amount of $ 10,000 during the three and nine months ended September 30, 2023 and $ 0.2 million during the three and nine months ended September 30, 2022. In addition to annual license maintenance fees of up to $ 0.1 million per year, the Company may be required to pay up to $ 7.5 million for sales milestone payments, up to $ 4.0 million in development milestone payments for each product covered by licensed patent rights that achieves specific clinical trials or regulatory approvals, up to $ 0.6 million in milestone payments upon achievement of commercial milestone events and double-digit percentage milestone payments on non-patented products, and, subject to certain royalty reductions, low single-digit percentage royalties on net sales of products. Subject to the terms of the Stanford License Agreement, the Company also agreed to pay Stanford University a certain percentage of non-royalty sublicense-related revenue that the Company receives from third-party sublicenses. Crystal Mackall and Robbie Majzner, who were the Company’s principal owners and directors when the Company entered into the Stanford License Agreement, are employees and faculty members leading CAR T-cell therapy research programs at Stanford University. Oxford license and supply agreement In June 2022, the Company entered into a License and Supply Agreement (the “Oxford Agreement”), with Oxford Biomedica (UK) Limited (“Oxford”) for the manufacture and supply of lentiviral vectors for clinical and potentially commercial purposes by the Company. Pursuant to the Oxford Agreement, Oxford granted to the Company a non-exclusive worldwide, sub-licensable, royalty-bearing license under certain intellectual property rights for the purposes of research, development and commercialization of products transduced with the vectors manufactured by Oxford or by the Company following a technology transfer by Oxford, which products are directed against certain initial targets, and upon payment of certain fees, additional targets as agreed by Oxford and the Company. As consideration for the license granted under the Oxford Agreement, the Company paid an upfront license fee of $ 0.2 million. The Company determined that the purchase of the license under the Oxford Agreement represented an asset acquisition as it did not meet the definition of a business. As the acquired license represented IPR&D assets with no alternative future use, the Company recorded the upfront payment of $ 0.2 million as research and development expense in June 2022, upon entering into the Oxford Agreement. The Company recorded research and development expense related to the achievement of certain development milestones in the amount of $ 0.3 million during the three and nine months ended September 30, 2023 and $ 0.2 million during the nine months ended September 30, 2022. The Company may be required to pay up to an aggregate of $ 0.3 million of development milestones, $ 1.0 million of regulatory milestones and $ 8.0 million of commercial milestones for each target if such milestones are achieved by licensed products directed to such target. Additionally, the Company is obligated to pay an earned royalty on net sales of products manufactured with the Oxford vector at a low single-digit percentage. Unless terminated earlier, the Oxford Agreement will expire when no further payments are due to Oxford. The Company can terminate the agreement at will upon advance written notice and may be subject to certain manufacturing slot cancellation fees. National Cancer Institute In March 2022, the Company entered into an exclusive license agreement (the “2022 NCI License Agreement”) with the U.S. Department of Health and Human Services, as represented by The National Cancer Institute (the “NCI”), pursuant to which the Company obtained a worldwide, royalty-bearing, exclusive license under certain patent rights to make, use, sell, offer for sale, and import certain autologous products covered by such licensed patents in the field of CAR-T immunotherapies for the treatment of B-cell malignancies that express CD22, and a non-sublicenseable exclusive license to make, use, and import, but not sell, certain allogenic products and to practice processes in the field of certain CAR-T immunotherapies for the treatment of B-cell malignancies that express CD22 for evaluation purposes, with an exclusive option to negotiate a non-exclusive or exclusive commercialization license. As consideration for the licenses granted under the 2022 NCI License Agreement, the Company is required to pay NCI a non-refundable license fee of $ 0.6 million, of which $ 0.2 million was paid in 2022 and $ 0.1 million was paid in 2023, and the remaining balance of $ 0.3 million is payable in two equal annual installments beginning on the second anniversary of the effective date of the agreement. The Company accrued the non-refundable upfront fees of $ 0.4 million upon entering into the 2022 NCI License Agreement. As of September 30, 2023 and December 31, 2022, $ 0.1 million and $ 0.1 million, respectively, of non-refundable upfront fees were accrued in accrued expenses and other current liabilities and $ 0.1 million and $ 0.3 million, respectively, are classified as other non-current liabilities on the condensed balance sheet. The Company determined that the purchase of the license under the 2022 NCI License Agreement represented an asset acquisition as it did not meet the definition of a business. As the acquired license represented IPR&D assets with no alternative future use, the Company recorded the initial consideration of $ 0.6 million under the 2022 NCI License Agreement as research and development expense in March 2022, upon entering into the 2022 NCI License Agreement. During the three and nine months ended September 30, 2023, the Company recorded research and development expense of $ 0.5 million and $ 0.6 million related to the minimum annual royalty and the achievement of certain development milestones and during the nine months ended September 30, 2022, the Company recorded research and development expense of $ 0.6 million related to the non-refundable license fee. The Company agreed to pay up to $ 0.2 million in regulatory milestone payments upon achieving specific regulatory filings, up to $ 1.8 million in development milestone payments upon achieving specific clinical trials or registration trials, and up to $ 16.0 million in sales milestones upon achievement of specific commercial milestone events for up to three distinct licensed products, and an earned royalty on net sales of autologous cell therapy products covered by the licensed patent rights at a low single-digit percentage, depending on the amount of annual net sales and subject to the terms of the 2022 NCI License Agreement. The Company is also required to make minimum annual royalty payments of $ 50,000 per year, which will be creditable against royalties due for sales in that year. In addition, the Company is obligated to pay the NCI a percentage of non-royalty revenue received by the Company from its right to sublicense. Additionally, in the event the Company is granted a priority review voucher (“PRV”), the Company would be obligated to pay NCI a minimum of $ 5.0 million upon the sale, transfer or lease of the PRV or $ 0.5 million upon submission of the PRV for use by the U.S. Food and Drug Administration (“FDA”). The Company is also obligated to pay NCI a percentage of the fair market value of the consideration the Company receives for any assignment of the 2022 NCI License Agreement to a non-affiliate (upon NCI’s prior written consent) or an allocated portion of the fair value of consideration received in connection with a change in control. NCI may terminate or modify the 2022 NCI License Agreement in the event of an uncured material breach, including, but not limited to, if the Company does not meet certain milestones by certain dates, or upon certain insolvency events that remain uncured following the date that is 90 days following written notice of such breach or insolvency event. The Company may terminate the license, or any portion thereof, at its sole discretion at any time upon 60 days written notice to NCI. In February 2023, the Company entered into an exclusive license agreement (the “2023 NCI License Agreement”) with NCI, pursuant to which the Company obtained a worldwide, royalty-bearing, exclusive license under certain patent rights owned by NCI to make, use, sell and import products and to practice processes in the field of certain CAR-T immunotherapies for the treatment of B-cell malignancies, wherein the T cells are engineered to express CD22 in combination with both: receptors targeting CD19, CD20, and/or CD79b; and using STASH platform and/or a technology to activate CD2 signaling in the CAR T cell. As consideration for the licenses granted under the 2023 NCI License Agreement, the Company must pay NCI a non-refundable license fee of $ 0.3 million in three installments whereby the first installment is payable within 60 days of the execution of the agreement and the remaining two payments due on the first and second anniversaries of the effective date of the agreement. Additionally, the Company must reimburse NCI for $ 0.1 million in expenses incurred by NCI prior to January 1, 2022 related to the preparation, filing, prosecution, and maintenance of all patent applications and patents included in the license under the 2023 NCI Agreement. The Company determined that the purchase of the license under the 2023 NCI License Agreement represented an asset acquisition as it did not meet the definition of a business. As the acquired license represented IPR&D assets with no alternative future use, the Company recorded the initial consideration of $ 0.4 million under the 2023 NCI Agreement, consisting of the non-refundable upfront fees and patent expense reimbursement, as research and development expense in February 2023, upon entering the 2023 NCI License Agreement. The Company accrued these amounts upon entering into the 2023 NCI License Agreement, of which $ 0.1 million is classified as other non-current liabilities on the condensed balance sheet as of September 30, 2023. During the nine months ended September 30, 2023, the Company recorded research and development expense of $ 0.3 million related to the minimum annual royalty. The Company agreed to pay up to $ 0.1 million in regulatory milestone payments upon achieving specific regulatory filings, up to $ 1.7 million in development milestone payments upon achieving specific clinical trials or registration trials, and up to $ 16.0 million in sales milestones upon achievement of specific commercial milestone events. Subject to the terms of the 2023 NCI License Agreement, the Company also agreed to pay a low single-digit percentage on earned royalties on net sales of products covered by the licensed patent rights. The Company also agreed to make minimum annual royalty payments of $ 50,000 per year, which will be creditable against royalties due for sales in that year. In addition, the Company is obligated to pay the NCI a percentage of non-royalty revenue received by the Company from its right to sublicense at defined percentages. Additionally, if the Company is granted a PRV, the Company would be obligated to pay NCI a minimum of $ 5.0 million upon the sale, transfer or lease of the PRV or $ 0.5 million upon submission of the PRV for use by the FDA. The Company is also obligated to pay NCI a percentage of the fair market value of the consideration the Company receives for any assignment of the 2023 NCI License Agreement to a non-affiliate (upon NCI’s prior written consent) or an allocated portion of the fair value of consideration received in connection with a change in control. Unless earlier terminated, the 2023 NCI License Agreement will expire upon the expiration of the last to expire licensed patent right. NCI may terminate or modify the 2023 NCI License Agreement in the event of an uncured material breach, including, but not limited to, if the Company does not meet certain milestones by certain dates, or upon certain insolvency events that remain uncured following the date that is 90 days following written notice of such breach or insolvency event. The Company may terminate the license, or any portion thereof, at its sole discretion at any time upon 60 days written notice to NCI. |
Convertible Preferred Stock
Convertible Preferred Stock | 9 Months Ended |
Sep. 30, 2023 | |
Class of Stock Disclosures [Abstract] | |
Convertible Preferred Stock | 7. Convertible Preferred Stock In February 2023, the Company’s existing and new investors executed the Series A Preferred Stock Purchase Agreement (the “Series A Agreement”) pursuant to which the Company is obligated to sell shares of its redeemable convertible preferred stock immediately at execution and through a second and third tranche. In February 2023, the Company received net proceeds of $ 68.1 million from the issue and sale of 5,072,919 shares of Series A-1 redeemable convertible preferred stock and issued 3,229,851 shares of Series A-2 redeemable convertible preferred stock upon conversion of the 2022 Convertible Notes (see Note 6). Pursuant to the Series A Agreement, through the second tranche, the Company is obligated to sell 3,381,941 shares of its Series A-1 redeemable convertible preferred stock for $ 13.57 per share (“Series A-1 Tranche 2”) upon the satisfaction of certain developmental milestones by the end of the third quarter of 2023. Additionally, the Company is obligated to sell 6,341,148 shares of its Series A-1 redeemable convertible preferred stock for $ 13.57 per share (“Series A-1 Tranche 3”) upon the satisfaction of certain developmental milestones by the middle of the first quarter of 2024. In July 2023, the Company achieved the milestone under the Series A-1 Tranche 2 and issued and sold 3,381,941 shares of its Series A-1 redeemable convertible preferred stock for net proceeds of $ 45.8 million. In October 2023, the Company issued and sold for 6,341,148 shares of its Series A-1 redeemable convertible preferred stock as a part of the Series A-1 Tranche 3 closing for proceeds of $ 86.0 million (see Note 13). On issuance, the Company determined that its obligation to issue additional shares of its Series A-1 redeemable convertible preferred stock in future closings were freestanding instruments in accordance with ASC 480. The Series A-1 Tranche 2 obligation was determined to be an asset as the issuance price was deemed to be in excess of the estimated fair value of the stock on the expected milestone achievement date. Conversely, the Series A-1 Tranche 3 obligation was determined to be a liability as the estimated fair value of the stock on the expected milestone achievement date was deemed to be in excess of the issuance price. Accordingly, the Company recognized $ 1.8 million and $ 9.1 million for the fair value of the redeemable convertible preferred stock tranche asset and liability, respectively, on the condensed balance sheet and the remaining proceeds were allocated to the first tranche of Series A-1 redeemable convertible preferred stock. Changes in fair value of redeemable convertible preferred stock tranche asset and liability in subsequent reporting periods are recognized as a component of change in fair value of preferred stock tranche obligations in the condensed statement of operations and comprehensive loss (see Note 3). In connection with the closing of Series A-1 Tranche 2 in July 2023, the fair value of the redeemable convertible preferred stock tranche asset of $ 1.9 million was reclassified to carrying amount of Series A-1 redeemable convertible preferred stock. Redeemable convertible preferred stock consisted of the following: September 30, 2023 Shares Shares Issued Original Liquidation Carrying (in thousands, except shares and per share amounts) Series Seed 11,000,000 810,700 $ 13.57 $ 11,000 $ 9,830 Series A-1 200,760,000 8,454,860 $ 13.57 114,720 104,682 Series A-2 43,824,255 3,229,851 $ 10.18 32,868 35,576 Total 255,584,255 12,495,411 $ 158,588 $ 150,088 Convertible preferred stock consisted of the following: December 31, 2022 Shares Shares Issued Original Liquidation Carrying (in thousands, except shares and per share amounts) Series Seed 11,000,000 810,700 $ 13.57 $ 11,000 $ 10,855 Total 11,000,000 810,700 $ 11,000 $ 10,855 The holders of redeemable convertible preferred stock have various rights, preferences and privileges as follows: Voting rights The holders of redeemable convertible preferred stock shares are entitled to vote on all matters on which the common stockholders are entitled to vote. Each holder of redeemable convertible preferred stock is entitled to the number of votes equal to the number of whole shares of common stock into which the shares held by such holder are convertible. Holders of the shares of Series A-1 redeemable convertible preferred stock, as a separate class, are entitled to elect two directors of the Company. Holders of the shares of Series Seed convertible preferred stock, as a separate class, are entitled to elect (i) prior to the issuance of the third tranche, two directors of the Company and (ii) on or after the issuance of the third tranche, one director of the Company. The holders of common stock are entitled to elect one director and one director will be the Company’s Chief Executive Officer. The remaining two directors will be independent directors that are elected by stockholder vote and must be mutually acceptable to the other directors. As long as at least 1,909,071 shares of redeemable convertible preferred stock shares remain outstanding, the Company must obtain approval from a majority of the holders of the then outstanding shares of redeemable convertible preferred stock, provided that prior to the issuance of third tranche such approval must include the affirmative vote of the holders of a majority of the outstanding shares of Series A-1 redeemable convertible preferred stock, to alter or change the rights, preferences and privileges of redeemable convertible preferred stock, change the authorized number of redeemable convertible preferred and common stock, create a new class or series of shares having any rights, preferences or privileges superior to or on parity with any outstanding shares of redeemable convertible preferred stock, declare or pay any distribution, merge, consolidate with or implement a reorganization that would result in the transfer of 50 % of the voting power of the Company, sell all or substantially all of the Company’s assets, voluntarily dissolve or liquidate the Company, change the authorized number of directors, incur indebtedness greater than $ 0.3 million and appoint or remove the chief executive officer. Dividends The Company’s certificate of incorporation permits the holders of shares of redeemable convertible preferred stock to receive, only when, as and if declared by the Board of Directors, dividends at a rate of 8 % of the applicable original issuance price of $ 13.57 per share for shares of Series Seed and Series A-1 redeemable convertible preferred stock and $ 10.18 per share for shares of Series A-2 redeemable convertible preferred stock, as adjusted for stock dividend, stock split, combination or other similar recapitalization (the “Original Issue Price”). Such dividend may be received prior and in preference to any declaration or payment of any other dividend (other than dividends on shares of common stock payable in common stock). Such dividends are non-cumulative. The Company shall not declare, pay or set aside any dividends on shares of any other class or series of capital stock of the Company (other than dividends on shares of common stock payable in common stock) unless the holders of redeemable convertible preferred stock then outstanding shall first receive, or simultaneously received, in addition to the 8 % dividend noted above, an equal dividend on an as converted basis, if the dividend is declared on common stock or securities convertible in common stock. If the dividend is declared on non-common stock or securities not convertible in common stock, the holders of redeemable convertible preferred stock then outstanding must also receive an equal dividend to the dividend of such class, divided by its issuance price and multiplied by the applicable Original Issue Price, provided that if the Company declares a dividend on the same date on shares on more than one class or series of stock the dividend payable to the redeemable convertible preferred stockholders shall be based on the dividend on the class or series that would result in the highest preferred dividend. No dividends were declared as of December 31, 2022 and September 30, 2023. Liquidation In the event of any liquidation, dissolution or winding up of the Company, including a merger or consolidation in which the Company or a subsidiary of the Company is a constituent party and the Company issues its shares as a part of such merger of consolidation, or the sale of substantially all of the assets of the Company, or any other transaction or series of transactions in which more than 50 % of the voting power of the Company is disposed of, the holders of redeemable convertible preferred stock will receive in preference to any distribution of assets to the holders of common stock, an amount per share equal to the greater of (i) per share equal the Original Issue Price, plus any declared and unpaid dividends, or (ii) such amount as would have been payable had all shares of the redeemable convertible preferred stock been converted into common stock. If the assets available for distribution are insufficient, then proceeds will be distributed ratably among the holders of redeemable convertible preferred stock in proportion to the full preferential amount that each such holder is entitled to receive. If there are remaining assets of the Company legally available for distribution after the payment of the full liquidation preference of the preferred stock, those remaining assets shall be distributed ratably to the holders of common stock based on the number of shares held by each common stockholder. Conversion Each share of redeemable convertible preferred stock is convertible, at the option of the holder, into the number of shares of common stock into which such shares are convertible at the then-effective conversion ratio. The conversion ratio is determined by dividing the applicable Original Issue Price by the then applicable conversion price. The initial conversion price per share is $ 13.57 for Series Seed preferred stock, $ 13.57 for Series A-1 preferred stock, and $ 10.18 for the Series A-2 preferred stock. The initial conversion price is subject to adjustment from time to time. Each share of redeemable convertible preferred stock shall automatically be converted into fully‑paid, non‑assessable shares of common stock at the then‑effective conversion rate for such share (i) immediately prior to the closing of a firm commitment underwritten IPO pursuant to an effective registration statement filed under the Securities Act of 1933, as amended , resulting in at least $ 50.0 million of gross proceeds and in which the pre-money valuation of the Company is at least $ 400.0 million and in connection with such offering the common stock is listed for trading on the Nasdaq Stock Market’s National Market or the New York Stock Exchange (ii) immediately prior to the consummation of a transaction by merger, consolidation, share exchange or otherwise in which the pre-money valuation of the Company is at least $ 400.0 million, with a publicly-traded special purpose acquisition company (a “SPAC”), immediately following the consummation of which the common stock or share capital of the SPAC or its successor entity is listed on the Nasdaq Stock Market or the New York Stock Exchange or another exchange approved by the Board of Directors, or (iii) at the date and time, or occurrence, of an event specified in a vote or written consent of the holders of the majority of the outstanding shares of redeemable convertible preferred stock. Classification A liquidation or winding up of the Company, including a merger or consolidation in which the Company or a subsidiary of the Company is a constituent party and the Company issues its shares as a part of such merger of consolidation, or the sale of substantially all of the assets, sales or exclusive license of all or substantially all of the intellectual property of the Company, or any other transaction or series of transactions in which more than 50 % of the voting power of the Company is disposed of would constitute a redemption event. As of December 31, 2022, these redemption events were deemed to be within the control of the Company; therefore, in accordance with ASC 480, all shares of Series Seed convertible preferred stock were presented within permanent equity. Upon closing of the first tranche of shares of Series A-1 redeemable preferred stock and conversion of the 2022 Convertible Notes to shares of Series A-2 redeemable preferred stock on February 7, 2023, the convertible preferred stockholders collectively had the ability to elect a majority of the directors on the Company’s Board of Directors such that a redemption event pursuant to the various rights of shares of the convertible preferred stock was no longer within the control of the Company. In accordance with ASC 480, all shares of Series Seed convertible preferred stock were reclassified from permanent equity to mezzanine equity at fair value, and, on issuance, all shares of Series A-1 and A-2 redeemable convertible preferred stock were classified as mezzanine equity. The Company has elected not to adjust the carrying values of the redeemable convertible preferred stock to the redemption value of such shares, since it is not probable that a redemption event will occur. Subsequent adjustments to increase the carrying value to the redemption values will be made when it becomes probable that such redemption will occur. |
Common Stock
Common Stock | 9 Months Ended |
Sep. 30, 2023 | |
Equity [Abstract] | |
Common Stock | 8. Common stock Each share of common stock is entitled to one vote. The holders of common stock are also entitled to receive dividends whenever funds are legally available and when declared by the Board of Directors, subject to prior rights of the redeemable convertible preferred stockholders. In February 2023, the Company amended and restated its certificate of incorporation to increase the authorized shares of common stock to 320,000,000 . Common stock issued and outstanding on the balance sheets and statements of stockholders’ deficit includes shares related to restricted stock that are subject to repurchase and therefore are excluded from the reserved common stock in the table below. The Company’s reserved common stock, on an as-converted basis for issuance was as follows: September 30, December 31, Redeemable convertible preferred stock 12,495,411 — Convertible preferred stock — 810,700 Common stock options issued and outstanding under the Plan 3,048,512 167,882 Remaining shares available for issuance under the Plan 373,362 22,928 Total reserved common stock 15,917,285 1,001,510 The 2022 Convertible Notes, which are excluded from the table above as of December 31, 2022, converted into shares of Series A-2 redeemable convertible preferred stock in February 2023 (see Notes 6 and 7). |
Stock-Based Compensation
Stock-Based Compensation | 9 Months Ended |
Sep. 30, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Stock-Based Compensation | 9. Stock-Based Compensation 2021 Stock Option and Grant Plan In July 2021, the Company established its 2021 Stock Option and Grant Plan (the “Plan”) which provides for the granting of stock options, restricted and unrestricted stock units and restricted and unrestricted stock awards to employees and consultants of the Company. In October 2022 and February 2023, the Board of Directors amended shares authorized for issuance under the Plan. As of September 30, 2023 and December 31, 2022, shares authorized for issuance under the Plan were 3,618,904 and 393,268 , respectively. Stock options Stock option activity for the nine months ended September 30, 2023 was as follows: Number of Options Weighted-Average Exercise Price Weighted- Average Remaining Contractual Term Aggregate Intrinsic Value (in thousands) Outstanding at December 31, 2022 167,882 $ 1.09 9.65 $ — Granted 3,230,713 6.66 Exercised ( 7,240 ) 1.12 Cancelled and forfeited ( 342,843 ) 5.27 Outstanding at September 30, 2023 3,048,512 $ 6.52 9.66 $ 16,390 Vested and expected to vest, September 30, 2023 3,048,512 $ 6.52 9.66 $ 16,390 Exercisable at September 30, 2023 116,008 $ 3.15 9.25 $ 1,015 Aggregate intrinsic value in the above table is calculated as the difference between the exercise price of the options and the Company’s estimated fair value of its common stock as of September 30, 2023. The aggregate intrinsic value of options exercised during the nine months ended September 30, 2023 was $ 46,000 . No options were exercised during the nine months ended September 30, 2022. The estimated weighted-average grant-date fair value of options granted during the nine months ended September 30, 2022 and 2023 was $ 0.79 and $ 5.17 per share, respectively. As of September 30, 2023, there was $ 13.5 million of unrecognized stock-based compensation related to stock options, which is expected to be recognized over a weighted-average period of 3.4 years. Restricted stock awards The Company has issued restricted stock awards to certain employees, directors and consultants in exchange for cash consideration equal to the fair value of common stock on the grant date. The restricted stock awards are subject to the repurchase right upon termination of services at a repurchase price lower of (i) the fair market value on the date of repurchase or (ii) their original purchase price no later than nine months after such termination. Shares purchased by employees pursuant to restricted stock awards are not deemed, for accounting purposes, to be issued until those shares vest according to their respective vesting schedules . Proceeds received from issuance of restricted stock awards are recorded as a share repurchase liability within accrued expenses and other current liabilities on the balance sheet and reclassified to additional paid-in capital as such awards vest. The following table summarizes the Company’s restricted stock activity. Number of Weighted-Average Grant Date Unvested as of December 31, 2022 529,110 $ 0.93 Issued 1,874 3.94 Repurchased ( 14,652 ) 0.63 Vested ( 215,418 ) 1.90 Unvested as of September 30, 2023 300,914 $ 0.26 The purchase price of the restricted stock awards is the fair value of common stock as determined by the Board of Directors at the issuance date. The shares generally vest monthly over four years from the grant date. The Company recorded $ 0.1 million and $ 0.2 million as a share repurchase liability for restricted stock awards in accrued expenses and other current liabilities on the balance sheets as of September 30, 2023 and December 31, 2022, respectively. As of September 30, 2023, unrecognized stock-based compensation expense related to outstanding unvested restricted stock awards was $ 0.1 million, which is expected to be recognized over a weighted-average period of 2.5 years. Stock‑based compensation expense Total stock-based compensation expense recorded in the unaudited condensed statements of operations and comprehensive loss was as follows: Three months ended Nine months ended 2023 2022 2023 2022 (in thousands) General and administrative $ 587 $ 9 $ 1,014 $ 209 Research and development 497 15 693 56 Total stock-based compensation expense $ 1,084 $ 24 $ 1,707 $ 265 The estimated grant-date fair value of awards granted during the nine months ended September 30, 2023 and 2022 was calculated based on the following assumptions: Nine months ended September 30, 2023 2022 Expected term (in years) 1.3 – 6.4 2.8 – 6.1 Expected volatility 84.6 % - 87.2 % 84.6 % - 89.8 % Expected dividend — — Risk-free interest rate 3.2 % - 4.6 % 0.4 % - 3.2 % |
Related Parties
Related Parties | 9 Months Ended |
Sep. 30, 2023 | |
Related Party Transactions [Abstract] | |
Related Parties | 11. Related Parties The 2022 Convertible Notes (see Note 6) were issued in part to a related party, a significant investor, for an aggregate principal amount of $ 16.0 million. As of December 31, 2022, $ 16.4 million in principal and accrued interest was outstanding to the related party. In February 2023, $ 18.7 million in principal and accrued interest outstanding to the related party was settled through conversion into 1,833,623 shares of Series A-2 redeemable convertible preferred stock (see Note 7). Apart from the transactions and balances detailed in Note 6, Note 7 and Note 11, the Company has no other significant or material related party transactions during the three and nine months ended September 30, 2022 and 2023. |
Net Loss Per Share
Net Loss Per Share | 9 Months Ended |
Sep. 30, 2023 | |
Earnings Per Share [Abstract] | |
Net Loss Per Share | 12. Net Loss Per Share A reconciliation of net loss attributable to common stockholders and the number of shares in the calculation of basic and diluted loss per share was as follows: Three months ended Nine months ended 2023 2022 2023 2022 (in thousands, except share and per share amounts) Numerator: Net loss attributable to common stockholders $ ( 35,471 ) $ ( 12,285 ) $ ( 66,070 ) $ ( 27,202 ) Denominator: Weighted-average shares used in computing net 748,862 432,835 673,175 343,635 Net loss per share attributable to common $ ( 47.37 ) $ ( 28.38 ) $ ( 98.15 ) $ ( 79.16 ) The following potentially dilutive shares were excluded from the computation of diluted net loss per share attributable to common stockholders for the periods presented, because including them would have been anti-dilutive (on an as-converted basis): September 30, September 30, Redeemable convertible preferred stock, 12,495,411 — Convertible preferred stock, as converted — 810,700 2022 Convertible Notes, as converted — 1,606,124 Outstanding stock options 3,048,512 75,281 Restricted stock awards subject to repurchase 300,914 571,184 Total 15,844,837 3,063,289 |
Subsequent Events
Subsequent Events | 9 Months Ended |
Sep. 30, 2023 | |
Subsequent Events [Abstract] | |
Subsequent Events | 13. Subsequent Events Series A redeemable convertible preferred stock financing In October 2023, the Company issued and sold 6,341,148 shares of its Series A-1 redeemable convertible preferred stock for net proceeds of approximately $ 86.0 million under its obligation for Series A-1 Tranche 3 pursuant to the Series A Agreement (see Note 7). Reverse Stock Split On November 1, 2023, the Company’s Board of Directors approved an amended and restated certificate of incorporation to effect a reverse split of shares of the Company’s common stock and redeemable convertible preferred stock on a 13.5685-for-1 basis which was effected on November 3, 2023. The par value and authorized number of shares of common stock and redeemable convertible preferred stock were not adjusted as a result of the Reverse Stock Split. All share data and per share data amounts for all periods presented in the condensed financial statements and notes thereto have been retrospectively adjusted to reflect the effect of the Reverse Stock Split. Initial Public Offering On November 14, 2023, the Company closed its initial public offering, pursuant to which it issued and sold an aggregate of 18,750,000 shares of its common stock at a public offering price of $ 15.00 per share and on November 21, 2023, the Company issued and sold 2,512,181 additional shares of its common stock to the underwriters of the IPO pursuant to the partial exercise of their option to purchase additional shares. The Company received net proceeds of approximately $ 291.3 million, after deducting underwriting discounts, commissions and offering expenses. Upon the closing of the IPO, the Company’s outstanding redeemable convertible preferred stock automatically converted into 18,836,559 shares of common stock. Converted redeemable convertible preferred stock outstanding as of the date of IPO consisted of 12,495,411 shares that were outstanding as of September 30, 2023 (see Note 7) and 6,341,148 shares that were issued in October 2023. In connection with the completion of its IPO, on November 14, 2023, the Company’s certificate of incorporation was amended and restated to authorize 500,000,000 shares of common stock, par value $ 0.001 per share and 50,000,000 shares of preferred stock, par value of $ 0.001 per share with terms to be set by the Board of Directors. Lease In December 2023, the Company entered into a lease for 99,557 square feet of lab and office space in San Carlos, California. The lease is expected to commence in January 2024. The lease has an initial term through March 31, 2031 and provides options to renew the lease for two additional three year terms. The total undiscounted lease payments related to the initial term of the lease are $ 45.7 million, of which no payments are due within 12 months . |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2023 | |
Accounting Policies [Abstract] | |
Basis of presentation | Basis of presentation The Company has prepared the accompanying condensed financial statements in accordance with U.S. generally accepted accounting principles (“GAAP”) and the requirements of the Securities and Exchange Commission (“SEC”) for interim reporting. As permitted under those rules, certain footnotes or other financial information that are normally required by GAAP can be condensed or omitted. The financial statements are presented in U.S. dollars. |
Use of estimates | Use of estimates The preparation of 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 financial statements, and the reported amounts of expenses during the reporting period. The Company bases its estimates on historical experience and on various other assumptions believed to be reasonable. Actual results could differ from those estimates and such differences could be material to the financial position and results of operations. Significant estimates and assumptions reflected in these financial statements include, but are not limited to, the accrual of research and development expenses, the fair value of derivative liabilities, the initial fair value of the financial commitment liabilities related to the convertible notes, valuation of the redeemable convertible preferred stock tranche asset and liability, valuation of deferred tax assets, the fair value of equity instruments, equity-based instruments, stock-based compensation, and the determination of the incremental borrowing rate. |
Unaudited interim condensed financial statements | Unaudited interim condensed financial statements The condensed balance sheet as of September 30, 2023 and the condensed statements of operations and comprehensive loss, redeemable convertible preferred stock and stockholders’ deficit, and cash flows for the nine months ended September 30, 2023 and 2022 are unaudited. These unaudited condensed financial statements have been prepared on the same basis as the Company’s annual financial statements and, in the opinion of management, reflect all adjustments (consisting only of normal recurring adjustments) that are necessary for the fair statement of the Company’s financial position, results of operations and cash flows for the interim periods presented. The condensed results of operations for the nine months ended September 30, 2023 are not necessarily indicative of the results to be expected for the full year or for any other future annual or interim period. The condensed balance sheet as of December 31, 2022 included herein was derived from the audited financial statements as of that date. These condensed financial statements should be read in conjunction with the Company’s audited financial statements included in the Company’s prospectus related to its IPO filed pursuant to Rule 424(b)(4) under the Securities Act with the SEC on November 13, 2023. |
Cash and cash equivalents | Cash and cash equivalents The Company considers all highly liquid investments purchased with an original maturity of three months or less on the date of purchase to be cash equivalents. Cash equivalents primarily consist of money market funds that are stated at fair value. |
Issuance costs related to equity | Issuance costs related to equity The Company allocates issuance costs between the individual freestanding instruments identified on a relative fair value basis. Issuance costs associated with the issuance of stock or equity contracts (i.e., redeemable convertible preferred stock) are recorded as a charge against the gross proceeds of the offering. The Company capitalizes certain legal, accounting, and other third-party fees that are directly related to the Company’s equity offering until such offering is consummated. As of September 30, 2023, a total of $ 2.7 million in deferred offering costs related to the Company’s IPO were classified as other non-current assets in the condensed balance sheet. As of December 31, 2022, there were no deferred issuance costs related to the IPO. The Company closed its IPO on November 14, 2023, accordingly these costs will be recorded in stockholders’ equity as a reduction of the proceeds from the offering subsequent to September 30, 2023. |
Financial commitment liabilities | Financial commitment liabilities The Company’s convertible note purchase agreements executed in April 2022 and October 2022 (“2022 Convertible Notes”) included financial commitments to issue additional convertible notes to the noteholders in tranches (see Note 6) that were determined to be freestanding instruments that should be classified as liabilities. The freestanding instruments met the scope exception from derivative accounting. The proceeds of issuance of the first tranche of each of the 2022 Convertible Notes were allocated to the convertible notes and financial commitment liabilities based on their relative fair value at the date of issuance and not subsequently remeasured. The proceeds allocated to the financial commitment liabilities create a discount on the respective convertible note that is amortized as interest expense in the statements of operations and comprehensive loss using the effective interest rate method over the term of the respective convertible note. Upon settlement of each tranche, the respective portion of the financial commitment liabilities is reclassified to the carrying amount of the respective convertible note. |
Derivative liabilities | Derivative liabilities The 2022 Convertible Notes contain certain embedded redemption features that are not clearly and closely related to the debt host instruments (see Note 6). These features are bifurcated from the host instruments and recorded at fair value on the date of issuance as derivative liabilities in accordance with Accounting Standards Codification (“ASC”) 815-15, Derivatives and Hedging—Embedded Derivatives . The derivative liabilities are remeasured to fair value each reporting period until settlement or extinguishment, with changes in the fair value recorded as a change in fair value of derivative liabilities in the condensed statements of operations and comprehensive loss. Derivative liabilities are classified in the condensed balance sheets as current or non-current based on whether or not net-cash settlement of the derivative instrument could be required within 12 months of the balance sheet date. |
Redeemable convertible preferred stock tranche obligations | Redeemable convertible preferred stock tranche obligations The obligations to issue additional shares of the Company’s Series A-1 redeemable convertible preferred stock in two tranches at a fixed price at future dates were determined to be freestanding financial instruments within the scope of ASC 480, Distinguishing Liabilities From Equity (“ASC 480”). On issuance, the Company recorded the redeemable convertible preferred stock tranche asset and liability on the condensed balance sheet at their respective fair values. These tranche obligations are subject to remeasurement at each balance sheet date, with the net change in fair value recognized as a gain or loss on remeasurement within net change in fair value of redeemable convertible preferred stock tranche obligations in the condensed statements of operations and comprehensive loss until settlement or extinguishment. |
Recently adopted accounting pronouncements / Recently issued accounting pronouncements not yet adopted | Recently adopted accounting pronouncements In June 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2016-13, Financial Instruments—Credit Losses (Topic 326) : Measurement of Credit Losses on Financial Instruments (“ASU 2016-13”), which replaces the existing incurred loss impairment model with an expected credit loss model and requires a financial asset measured at amortized cost to be presented at the net amount expected to be collected. The Company adopted ASU 2016-13 on January 1, 2023, using a modified retrospective approach. The adoption did not have a material impact on the Company ’ s financial statements. Recently issued accounting pronouncements not yet adopted From time to time, new accounting pronouncements are issued by the FASB or other standard-setting bodies and adopted by the Company as of the specified effective date. Unless otherwise discussed, the Company believes that the impact of recently issued standards that are not yet effective will not have a material impact on the accompanying financial statements and disclosures. |
Fair Value Measurement (Tables)
Fair Value Measurement (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Fair Value Disclosures [Abstract] | |
Summary of Financial Assets and Liabilities Measured at Fair Value on a Recurring Basis | The following tables summarize the Company’s financial assets and financial liabilities measured at fair value on a recurring basis by level within the fair value hierarchy: September 30, 2023 Level 1 Level 2 Level 3 Total (in thousands) Assets: Money market funds $ 56,790 $ — $ — $ 56,790 Total financial assets $ 56,790 $ — $ — $ 56,790 Liabilities: Redeemable convertible preferred stock tranche $ — $ — $ 17,570 $ 17,570 Total financial liabilities $ — $ — $ 17,570 $ 17,570 December 31, 2022 Level 1 Level 2 Level 3 Total (in thousands) Liabilities: Derivative liabilities $ — $ — $ 12,705 $ 12,705 Total financial liabilities $ — $ — $ 12,705 $ 12,705 |
Summary of Significant Assumptions Used in Valuation of Derivative Liability | The following table summarizes the significant inputs used in the valuation of the derivative liabilities: On Issuance February 9, Expected term to achievement underlying 0.1 – 0.2 — Probability of achievement of triggering 0.0 % - 95.0 % 100.0 % Discount rate 75.0 % 75.0 % |
Summary of Changes in Derivative Liabilities | The following table summarizes the changes in the derivative liabilities: Derivative (in thousands) Balance as of December 31, 2022 $ 12,705 Additions (1) 2,133 Change in fair value ( 6,453 ) Settlement ( 8,385 ) Balance as of September 30, 2023 $ — (1) The additions to derivative liabilities in the nine months ended September 30, 2023 relate to the embedded derivative bifurcated from the final tranche of the 2022 Convertible Notes that was issued in January 2023. |
Summary of Assumptions used to Redeemable Convertible Preferred Stock Tranche Asset and Liability | The redeemable convertible preferred stock tranche obligations are considered a contingent forward and the standard forward pricing model was used for the option pricing model with the following key assumptions: Redeemable Convertible Redeemable Convertible On On Settlement On As of Expected term to achievement of 0.4 — 0.8 0.1 Probability of achievement of milestone 90.0 % 100 % 63.0 % 95.0 % Discount rate 4.9 % — 4.9 % 5.6 % |
Summary of Changes in Fair Value of Redeemable Convertible Preferred Stock Tranche | The following table summarizes the changes in the fair value of the redeemable convertible preferred stock tranche asset and liability: Redeemable Redeemable (in thousands) Balance as of December 31, 2022 $ — $ — Initial recognition 1,788 ( 9,105 ) Change in fair value 122 ( 8,465 ) Settlement ( 1,910 ) — Balance as of September 30, 2023 $ — $ ( 17,570 ) |
Balance Sheet Components (Table
Balance Sheet Components (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Balance Sheet Components [Abstract] | |
Summary of Prepaid Expenses and Other Current Assets | Prepaid expenses and other current assets consisted of the following: September 30, December 31, (in thousands) Prepaid research and development $ 2,403 $ 1,428 Other receivables 475 476 Prepaid other 194 151 Total prepaid expenses and other current assets $ 3,072 $ 2,055 |
Summary of Property and Equipment, Net | Property and equipment, net consisted of the following: September 30, December 31, (in thousands) Furniture and equipment $ 10,417 $ 2,793 Leasehold improvements 112 105 Construction in progress 2 891 Property and equipment at cost 10,531 3,789 Less: accumulated depreciation ( 1,381 ) ( 421 ) Property and equipment, net $ 9,150 $ 3,368 |
Summary of Other Non-Current Assets | Other non-current assets consisted of the following: September 30, December 31, (in thousands) Prepaid clinical $ 3,217 $ — Deferred offering costs related to the initial public offering 2,689 — Other non-current assets 1,115 783 Total other non-current assets $ 7,021 $ 783 |
Summary of Accrued Expenses and Other Current Liabilities | Accrued expenses and other current liabilities consisted of the following: September 30, December 31, (in thousands) Accrued compensation and related expenses $ 2,609 $ 2,385 Accrued purchases of property and equipment 1,429 623 Accrued deferred offering costs related to the initial public offering 1,599 — Other 1,140 383 Total accrued expenses and other current liabilities $ 6,777 $ 3,391 |
Leases (Tables)
Leases (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Lessee Disclosure [Abstract] | |
Summary of Future Payments Associated with Company's Operating Lease Liabilities | The future payments associated with the Company’s operating lease liabilities as of September 30, 2023 were as follows: Amount (in thousands) 2023 (remaining three months) $ 691 2024 2,404 Total undiscounted lease payments 3,095 Less: imputed interest ( 204 ) Total operating lease liabilities $ 2,891 |
Summary of Total Lease Costs and Other Information | A summary of total lease costs and other information for the periods relating to the Company’s operating leases was as follows: Three months ended September 30, Nine months ended 2023 2022 2023 2022 (in thousands) Operating lease cost $ 683 $ 323 $ 1,929 $ 959 Variable lease cost 168 78 476 239 Sublease income ( 60 ) ( 120 ) ( 280 ) ( 120 ) Total lease cost $ 791 $ 281 $ 2,125 $ 1,078 |
Summary of Weighted-average Remaining Lease Term and Discount Rate | September 30, December 31, Other information: Weighted-average remaining lease term (in years) 1.3 1.9 Weighted-average discount rate 11.6 % 9.6 % |
Schedule of Supplemental Cash Flow and Noncash Information Related to Operating Leases | Supplemental cash flow and noncash information related to the Company’s operating leases were as follows: Nine months ended 2023 2022 (in thousands) Cash flows from operating activities: Cash paid for amounts included in the measurement of $ 1,804 $ 992 Right-of-use assets obtained in exchange for lease Total right-of-use assets capitalized $ 2,291 $ — |
Convertible Preferred Stock (Ta
Convertible Preferred Stock (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Class of Stock Disclosures [Abstract] | |
Summary of Redeemable Convertible Preferred Stock | Redeemable convertible preferred stock consisted of the following: September 30, 2023 Shares Shares Issued Original Liquidation Carrying (in thousands, except shares and per share amounts) Series Seed 11,000,000 810,700 $ 13.57 $ 11,000 $ 9,830 Series A-1 200,760,000 8,454,860 $ 13.57 114,720 104,682 Series A-2 43,824,255 3,229,851 $ 10.18 32,868 35,576 Total 255,584,255 12,495,411 $ 158,588 $ 150,088 |
Summary of Convertible Preferred Stock | Convertible preferred stock consisted of the following: December 31, 2022 Shares Shares Issued Original Liquidation Carrying (in thousands, except shares and per share amounts) Series Seed 11,000,000 810,700 $ 13.57 $ 11,000 $ 10,855 Total 11,000,000 810,700 $ 11,000 $ 10,855 |
Common Stock (Tables)
Common Stock (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Equity [Abstract] | |
Summary of Reserved Common Stock For Issuance | The Company’s reserved common stock, on an as-converted basis for issuance was as follows: September 30, December 31, Redeemable convertible preferred stock 12,495,411 — Convertible preferred stock — 810,700 Common stock options issued and outstanding under the Plan 3,048,512 167,882 Remaining shares available for issuance under the Plan 373,362 22,928 Total reserved common stock 15,917,285 1,001,510 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Summary of Stock Option Activity | Stock option activity for the nine months ended September 30, 2023 was as follows: Number of Options Weighted-Average Exercise Price Weighted- Average Remaining Contractual Term Aggregate Intrinsic Value (in thousands) Outstanding at December 31, 2022 167,882 $ 1.09 9.65 $ — Granted 3,230,713 6.66 Exercised ( 7,240 ) 1.12 Cancelled and forfeited ( 342,843 ) 5.27 Outstanding at September 30, 2023 3,048,512 $ 6.52 9.66 $ 16,390 Vested and expected to vest, September 30, 2023 3,048,512 $ 6.52 9.66 $ 16,390 Exercisable at September 30, 2023 116,008 $ 3.15 9.25 $ 1,015 |
Summary of Restricted Stock Activity | The following table summarizes the Company’s restricted stock activity. Number of Weighted-Average Grant Date Unvested as of December 31, 2022 529,110 $ 0.93 Issued 1,874 3.94 Repurchased ( 14,652 ) 0.63 Vested ( 215,418 ) 1.90 Unvested as of September 30, 2023 300,914 $ 0.26 |
Summary of Stock Based Compensation Expense | Total stock-based compensation expense recorded in the unaudited condensed statements of operations and comprehensive loss was as follows: Three months ended Nine months ended 2023 2022 2023 2022 (in thousands) General and administrative $ 587 $ 9 $ 1,014 $ 209 Research and development 497 15 693 56 Total stock-based compensation expense $ 1,084 $ 24 $ 1,707 $ 265 |
Summary of Estimated Grant Date Fair Value of Awards | The estimated grant-date fair value of awards granted during the nine months ended September 30, 2023 and 2022 was calculated based on the following assumptions: Nine months ended September 30, 2023 2022 Expected term (in years) 1.3 – 6.4 2.8 – 6.1 Expected volatility 84.6 % - 87.2 % 84.6 % - 89.8 % Expected dividend — — Risk-free interest rate 3.2 % - 4.6 % 0.4 % - 3.2 % |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Earnings Per Share [Abstract] | |
Summary of Computation of Diluted Net Loss per Share Attributable to Common Stockholders | A reconciliation of net loss attributable to common stockholders and the number of shares in the calculation of basic and diluted loss per share was as follows: Three months ended Nine months ended 2023 2022 2023 2022 (in thousands, except share and per share amounts) Numerator: Net loss attributable to common stockholders $ ( 35,471 ) $ ( 12,285 ) $ ( 66,070 ) $ ( 27,202 ) Denominator: Weighted-average shares used in computing net 748,862 432,835 673,175 343,635 Net loss per share attributable to common $ ( 47.37 ) $ ( 28.38 ) $ ( 98.15 ) $ ( 79.16 ) |
Summary of Potentially Dilutive Shares | The following potentially dilutive shares were excluded from the computation of diluted net loss per share attributable to common stockholders for the periods presented, because including them would have been anti-dilutive (on an as-converted basis): September 30, September 30, Redeemable convertible preferred stock, 12,495,411 — Convertible preferred stock, as converted — 810,700 2022 Convertible Notes, as converted — 1,606,124 Outstanding stock options 3,048,512 75,281 Restricted stock awards subject to repurchase 300,914 571,184 Total 15,844,837 3,063,289 |
Organization - Additional Infor
Organization - Additional Information (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 9 Months Ended | ||||||
Nov. 21, 2023 | Nov. 14, 2023 | Nov. 03, 2023 | Oct. 31, 2023 | Sep. 30, 2023 | Sep. 30, 2022 | Feb. 28, 2023 | Dec. 31, 2022 | |
Organization [Line Items] | ||||||||
Stockholders' equity, reverse stock split | 13.5685-for-1 basis | |||||||
Redeemable convertible preferred stock, shares outstanding | 0 | 12,495,411 | ||||||
Redeemable convertible preferred stock, shares authorized | 0 | 255,584,255 | ||||||
Common stock, shares authorized | 320,000,000 | 320,000,000 | 29,000,000 | |||||
Common Stock, par value | $ 0.001 | $ 0.001 | ||||||
Convertible preferred stock, shares authorized | 11,000,000 | 11,000,000 | ||||||
Convertible preferred stock, par value | $ 0.001 | |||||||
Accumulated deficit | $ (113,069) | $ (46,999) | ||||||
Cash and cash equivalents | 60,344 | $ 1,872 | ||||||
Cash flows from operations | $ (52,182) | $ (17,722) | ||||||
IPO | ||||||||
Organization [Line Items] | ||||||||
Redeemable convertible preferred stock, shares outstanding | 12,495,411 | |||||||
Subsequent Events | ||||||||
Organization [Line Items] | ||||||||
Stockholders' equity, reverse stock split | 13.5685-for-1 basis | |||||||
Aggregate shares issued at public offering | 18,750,000 | |||||||
Public offering price of shares | $ 15 | |||||||
Shares converted (in shares) | 18,836,559 | |||||||
Shares issued (in shares) | 6,341,148 | |||||||
Common stock, shares authorized | 500,000,000 | |||||||
Common Stock, par value | $ 0.001 | |||||||
Convertible preferred stock, shares authorized | 50,000,000 | |||||||
Convertible preferred stock, par value | $ 0.001 | |||||||
Subsequent Events | IPO | ||||||||
Organization [Line Items] | ||||||||
Aggregate shares issued at public offering | 18,750,000 | |||||||
Additional shares issued to underwriters of IPO | 2,512,181 | |||||||
Public offering price of shares | $ 15 | |||||||
Net proceeds from issuance of initial public offering | $ 291,300 | |||||||
Shares converted (in shares) | 18,836,559 | |||||||
Shares issued (in shares) | 6,341,148 | |||||||
Common stock, shares authorized | 500,000,000 | |||||||
Common Stock, par value | $ 0.001 | |||||||
Convertible preferred stock, shares authorized | 50,000,000 | |||||||
Convertible preferred stock, par value | $ 0.001 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies - Additional Information (Details) - IPO - USD ($) | Sep. 30, 2023 | Dec. 31, 2022 |
Debt Instrument [Line Items] | ||
Deferred offering costs | $ 2,689,000 | $ 0 |
Other Noncurrent Assets | ||
Debt Instrument [Line Items] | ||
Deferred offering costs | $ 2,700,000 |
Fair Value Measurement - Financ
Fair Value Measurement - Financial Assets and Liabilities Measured on a Recurring Basis (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Feb. 28, 2023 | Dec. 31, 2022 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Derivative liabilities | $ 0 | $ 8,400 | $ 12,705 |
Fair Value, Recurring | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Money market funds | 56,790 | ||
Total financial assets | 56,790 | ||
Redeemable convertible preferred stock tranche liability | 17,570 | ||
Derivative liabilities | 12,705 | ||
Total financial liabilities | 17,570 | 12,705 | |
Fair Value, Recurring | Level 1 | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Money market funds | 56,790 | ||
Total financial assets | 56,790 | ||
Fair Value, Recurring | Level 3 | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Redeemable convertible preferred stock tranche liability | 17,570 | ||
Derivative liabilities | 12,705 | ||
Total financial liabilities | $ 17,570 | $ 12,705 |
Fair Value Measurement - Summar
Fair Value Measurement - Summary of Significant Assumptions Used in Valuation of Derivative Liability (Details) | Jan. 18, 2023 | Feb. 09, 2023 |
Probability of Achievement of Triggering Event | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Derivative liability, measurement input | 1 | |
Discount Rate | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Derivative liability, measurement input | 0.75 | 0.75 |
Minimum | Expected Term to Achievement Underlying Triggering Event | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Derivative liability, measurement input, expected term | 1 month 6 days | |
Minimum | Probability of Achievement of Triggering Event | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Derivative liability, measurement input | 0 | |
Maximum | Expected Term to Achievement Underlying Triggering Event | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Derivative liability, measurement input, expected term | 2 months 12 days | |
Maximum | Probability of Achievement of Triggering Event | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Derivative liability, measurement input | 0.95 |
Fair Value Measurement - Summ_2
Fair Value Measurement - Summary of Changes in Derivative Liabilities (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |||
Balance, start | $ 12,705 | ||
Additions | 2,133 | ||
Change in fair value | $ 779 | (6,453) | $ 1,186 |
Settlement | (8,385) | ||
Balance, end | $ 0 |
Fair Value Measurement - Additi
Fair Value Measurement - Additional Information (Details) $ in Millions | 9 Months Ended |
Sep. 30, 2023 USD ($) | |
Stay-Private Scenario | |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |
Probability weighted percentage | 30% |
IPO Scenario | |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |
Probability weighted percentage | 70% |
Estimated value of redeemable convertible preferred stock | $ 380 |
Duration of early IPO exit | 1 month 6 days |
Duration of late IPO exit | 4 months 24 days |
Fair Value Measurement - Summ_3
Fair Value Measurement - Summary of Assumptions used to Redeemable Convertible Preferred Stock Tranche Asset and Liability (Details) | Sep. 30, 2023 | Feb. 09, 2023 | Jul. 07, 2023 |
Redeemable Convertible Preferred Stock Tranche Liability | |||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |||
Expected term to achievement of milestone | 1 month 6 days | 9 months 18 days | |
Probability of achievement of milestone | 95% | 63% | |
Discount rate | 5.60% | 4.90% | |
Redeemable Convertible Preferred Stock Tranche Asset | |||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |||
Expected term to achievement of milestone | 4 months 24 days | ||
Probability of achievement of milestone | 90% | 100% | |
Discount rate | 4.90% |
Fair Value Measurement - Summ_4
Fair Value Measurement - Summary of Changes in Fair Value of Redeemable Convertible Preferred Stock Tranche (Details) $ in Thousands | 9 Months Ended |
Sep. 30, 2023 USD ($) | |
Redeemable Convertible Preferred Stock Tranche Liability | |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |
Balance, Start | $ 0 |
Initial recognition | (9,105) |
Change in fair value | (8,465) |
Balance, End | (17,570) |
Redeemable Convertible Preferred Stock Tranche Asset | |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |
Balance, Start | 0 |
Initial recognition | 1,788 |
Change in fair value | 122 |
Settlement | (1,910) |
Balance, End | $ 0 |
Balance Sheet Components - Summ
Balance Sheet Components - Summary of Prepaid Expenses and Other Current Assets (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Prepaid Expense and Other Assets, Current [Abstract] | ||
Prepaid research and development | $ 2,403 | $ 1,428 |
Other receivables | 475 | 476 |
Prepaid other | 194 | 151 |
Total prepaid expenses and other current assets | $ 3,072 | $ 2,055 |
Balance Sheet Components - Su_2
Balance Sheet Components - Summary of Property and Equipment, Net (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Property, Plant and Equipment [Line Items] | ||
Property and equipment at cost | $ 10,531 | $ 3,789 |
Less: accumulated depreciation | (1,381) | (421) |
Property and equipment, net | 9,150 | 3,368 |
Furniture and Equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment at cost | 10,417 | 2,793 |
Leasehold Improvements | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment at cost | 112 | 105 |
Construction in Progress | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment at cost | $ 2 | $ 891 |
Balance Sheet Components - Addi
Balance Sheet Components - Additional Information (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Balance Sheet Components [Abstract] | ||||
Depreciation expense | $ 500 | $ 100 | $ 960 | $ 234 |
Balance Sheet Components - Su_3
Balance Sheet Components - Summary of Other Non-Current Assets (Details) - USD ($) | Sep. 30, 2023 | Dec. 31, 2022 |
Other Assets Noncurrent [Line Items] | ||
Prepaid clinical | $ 3,217,000 | |
Other non-current assets | 1,115,000 | $ 783,000 |
Total other non-current assets | 7,021,000 | 783,000 |
Initial Public Offering | ||
Other Assets Noncurrent [Line Items] | ||
Deferred offering costs related to the initial public offering | $ 2,689,000 | $ 0 |
Balance Sheet Components - Su_4
Balance Sheet Components - Summary of Accrued Expenses and Other Current Liabilities (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Accrued Expenses and Other Current Liabilities [Abstract] | ||
Accrued compensation and related expenses | $ 2,609 | $ 2,385 |
Accrued purchases of property and equipment | 1,429 | 623 |
Accrued deferred offering costs related to the initial public offering | 1,599 | |
Other | 1,140 | 383 |
Total accrued expenses and other current liabilities | $ 6,777 | $ 3,391 |
Leases - Additional Information
Leases - Additional Information (Details) $ in Millions | 9 Months Ended | ||
Sep. 30, 2023 ft² SubleaseAgreement | Feb. 28, 2023 USD ($) ft² | Nov. 30, 2021 ft² | |
Leases [Abstract] | |||
Leases, term of contract | 2 years | 3 years | |
Lease space | 31,117 | 15,717 | 15,400 |
Lessee, Operating Lease, Existence of Option to Extend [true false] | true | ||
Lease renewal term | 1 year | ||
Deposits upon commencement of new lease | $ | $ 0.3 | ||
Number of sublease agreements | SubleaseAgreement | 2 | ||
Sublease initial term | 6 months | ||
Area subleased | 2,300 |
Leases - Summary of Future Paym
Leases - Summary of Future Payments Associated with Company's Operating Lease Liabilities (Details) $ in Thousands | Sep. 30, 2023 USD ($) |
Leases [Abstract] | |
2023 (remaining three months) | $ 691 |
2024 | 2,404 |
Total undiscounted lease payments | 3,095 |
Less: imputed interest | (204) |
Total operating lease liabilities | $ 2,891 |
Leases - Summary of Total Lease
Leases - Summary of Total Lease Costs and Other Information (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Leases [Abstract] | ||||
Operating lease cost | $ 683 | $ 323 | $ 1,929 | $ 959 |
Variable lease cost | 168 | 78 | 476 | 239 |
Sublease income | (60) | (120) | (280) | (120) |
Total lease cost | $ 791 | $ 281 | $ 2,125 | $ 1,078 |
Leases - Summary of Weighted-av
Leases - Summary of Weighted-average Remaining Lease Term and Discount Rate (Details) | Sep. 30, 2023 | Dec. 31, 2022 |
Leases [Abstract] | ||
Weighted-average remaining lease term (in years) | 1 year 3 months 18 days | 1 year 10 months 24 days |
Weighted-average discount rate | 11.60% | 9.60% |
Leases - Schedule of Supplement
Leases - Schedule of Supplemental Cash Flow and Noncash Information Related to Operating Leases (Details) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Leases [Abstract] | ||
Cash paid for amounts included in the measurement of lease liabilities | $ 1,804 | $ 992 |
Total right-of-use assets capitalized | $ 2,291 |
Convertible Notes - Additional
Convertible Notes - Additional Information (Details) | 1 Months Ended | 3 Months Ended | 7 Months Ended | 9 Months Ended | ||||||||
Feb. 28, 2023 USD ($) $ / shares shares | Jan. 31, 2023 USD ($) | Oct. 31, 2022 USD ($) Tranche | Apr. 30, 2022 USD ($) Tranche | Sep. 30, 2023 USD ($) $ / shares | Mar. 31, 2023 shares | Dec. 31, 2022 USD ($) | Sep. 30, 2022 USD ($) | Oct. 31, 2022 USD ($) | Sep. 30, 2023 USD ($) $ / shares | Sep. 30, 2022 USD ($) | Jan. 31, 2022 USD ($) | |
Convertible Notes [Line Items] | ||||||||||||
Derivative liabilities | $ 8,400,000 | $ 0 | $ 12,705,000 | $ 0 | ||||||||
Interest expense | $ 0 | 1,600,000 | $ 2,200,000 | |||||||||
Loss on extinguishment of convertible notes | $ (2,316,000) | |||||||||||
Series A-2 Redeemable Convertible Preferred Stock | ||||||||||||
Convertible Notes [Line Items] | ||||||||||||
Preferred stock, convertible, conversion price | $ / shares | $ 10.18 | $ 10.18 | $ 10.18 | |||||||||
Issuance of redeemable convertible preferred stock upon conversion of convertible notes, shares | shares | 3,229,851 | 3,229,851 | ||||||||||
Outstanding principal and accrued interest | $ 32,900,000 | |||||||||||
Redeemable convertible preferred stock | 35,600,000 | |||||||||||
Interest Expense | ||||||||||||
Convertible Notes [Line Items] | ||||||||||||
Interest expense | $ 1,500,000 | |||||||||||
October 2022 Convertible Notes | ||||||||||||
Convertible Notes [Line Items] | ||||||||||||
Number of tranches | Tranche | 3 | |||||||||||
Payments of debt issuance costs | $ 16,000 | |||||||||||
Maturity date | Oct. 28, 2023 | |||||||||||
Proceeds from convertible notes | $ 12,000,000 | |||||||||||
Fair value of financial commitment liabilities | 1,200,000 | $ 1,200,000 | ||||||||||
Carrying value of financial commitment liabilities | $ 700,000 | $ 700,000 | ||||||||||
2022 Convertible Notes | ||||||||||||
Convertible Notes [Line Items] | ||||||||||||
Convertible notes, interest rate | 6% | 6% | ||||||||||
Conversion price | $ / shares | $ 20.36 | $ 20.36 | ||||||||||
Convertible preferred stock issued at lowest cash price per share | 75% | |||||||||||
Percentage outstanding convertible debt redeemable in cash | 200% | 200% | ||||||||||
Percentage outstanding interest on convertible debt redeemable in cash | 100% | |||||||||||
Percentage of common stock convertible debt other investors | 10% | |||||||||||
Derivative liabilities | $ 13,600,000 | |||||||||||
Convertible notes | $ 24,900,000 | |||||||||||
2022 Convertible Notes | Minimum | ||||||||||||
Convertible Notes [Line Items] | ||||||||||||
Qualified financing amount for conversion of convertible debt | $ 50,000,000 | |||||||||||
First Two Tranche | October 2022 Convertible Notes | ||||||||||||
Convertible Notes [Line Items] | ||||||||||||
Proceeds from convertible notes | 8,500,000 | |||||||||||
Third Tranche | October 2022 Convertible Notes | ||||||||||||
Convertible Notes [Line Items] | ||||||||||||
Proceeds from convertible notes | $ 3,500,000 | |||||||||||
Investor [Member] | Series A-2 Redeemable Convertible Preferred Stock | ||||||||||||
Convertible Notes [Line Items] | ||||||||||||
Issuance of redeemable convertible preferred stock upon conversion of convertible notes, shares | shares | 1,833,623 | |||||||||||
Related Party | October 2022 Convertible Notes | ||||||||||||
Convertible Notes [Line Items] | ||||||||||||
Financial commitment liabilities | 700,000 | 700,000 | ||||||||||
Related Party | Three Tranches | October 2022 Convertible Notes | ||||||||||||
Convertible Notes [Line Items] | ||||||||||||
Proceeds from convertible notes | $ 5,400,000 | |||||||||||
Related Party | Third Tranche | October 2022 Convertible Notes | ||||||||||||
Convertible Notes [Line Items] | ||||||||||||
Proceeds from convertible notes | $ 2,200,000 | |||||||||||
April 2022 Convertible Notes | ||||||||||||
Convertible Notes [Line Items] | ||||||||||||
Number of tranches | Tranche | 3 | |||||||||||
Payments of debt issuance costs | $ 100,000 | |||||||||||
Maturity date | Apr. 26, 2023 | |||||||||||
Fair value of financial commitment liabilities | $ 700,000 | |||||||||||
Carrying value of financial commitment liabilities | $ 1,200,000 | |||||||||||
April 2022 Convertible Notes | Fourth Tranche | ||||||||||||
Convertible Notes [Line Items] | ||||||||||||
Debt instrument, available for issuance | 5,000,000 | |||||||||||
April 2022 Convertible Notes | Investor [Member] | ||||||||||||
Convertible Notes [Line Items] | ||||||||||||
Proceeds from convertible notes | 25,000,000 | |||||||||||
April 2022 Convertible Notes | Investor [Member] | Three Tranches | ||||||||||||
Convertible Notes [Line Items] | ||||||||||||
Proceeds from convertible notes | $ 20,000,000 | |||||||||||
April 2022 Convertible Notes | Related Party | ||||||||||||
Convertible Notes [Line Items] | ||||||||||||
Financial commitment liabilities | 400,000 | |||||||||||
April 2022 Convertible Notes | Related Party | Three Tranches | ||||||||||||
Convertible Notes [Line Items] | ||||||||||||
Proceeds from convertible notes | $ 10,600,000 |
Convertible Preferred Stock - A
Convertible Preferred Stock - Additional Information (Details) | 1 Months Ended | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||||
Oct. 31, 2023 USD ($) shares | Jul. 31, 2023 USD ($) shares | Feb. 28, 2023 USD ($) $ / shares shares | Sep. 30, 2023 USD ($) Director $ / shares shares | Mar. 31, 2023 shares | Sep. 30, 2023 USD ($) Director $ / shares shares | Dec. 31, 2022 USD ($) shares | Nov. 14, 2023 shares | Jun. 30, 2023 shares | |
Class of Stock [Line Items] | |||||||||
Minimum gross proceeds from IPO to convert preferred stock | $ 50,000,000 | ||||||||
Redeemable convertible preferred stock, par value | $ / shares | $ 0.001 | $ 0.001 | |||||||
Number of directors | Director | 2 | 2 | |||||||
Preferred stock, voting rights | The holders of redeemable convertible preferred stock shares are entitled to vote on all matters on which the common stockholders are entitled to vote. Each holder of redeemable convertible preferred stock is entitled to the number of votes equal to the number of whole shares of common stock into which the shares held by such holder are convertible. Holders of the shares of Series A-1 redeemable convertible preferred stock, as a separate class, are entitled to elect two directors of the Company. Holders of the shares of Series Seed convertible preferred stock, as a separate class, are entitled to elect (i) prior to the issuance of the third tranche, two directors of the Company and (ii) on or after the issuance of the third tranche, one director of the Company. The holders of common stock are entitled to elect one director and one director will be the Company’s Chief Executive Officer. The remaining two directors will be independent directors that are elected by stockholder vote and must be mutually acceptable to the other directors. | ||||||||
Redeemable convertible preferred stock, shares outstanding | shares | 12,495,411 | 12,495,411 | 0 | ||||||
Percentage of voting power transferred | 50% | ||||||||
Dividend rate, percentage | 8% | ||||||||
Dividends declared | $ 0 | $ 0 | |||||||
Minimum | |||||||||
Class of Stock [Line Items] | |||||||||
Indebtedness incurred | $ 300,000 | $ 300,000 | |||||||
Percentage of voting power disposed of | 50% | 50% | |||||||
Pre-money valuation amount related to IPO to convert preferred stock | $ 400,000,000 | $ 400,000,000 | |||||||
Percentage of voting power disposed of redemption event | 50% | 50% | |||||||
Series A Preferred Stock Purchase Agreement | Series A-1 Tranche 2 | |||||||||
Class of Stock [Line Items] | |||||||||
Fair value of redeemable convertible preferred stock tranche asset | $ 1,800,000 | ||||||||
Series A Preferred Stock Purchase Agreement | Series A-1 Tranche 3 | |||||||||
Class of Stock [Line Items] | |||||||||
Fair value of redeemable convertible preferred stock tranche liability | 9,100,000 | ||||||||
Publicly-traded Special Purpose Acquisition Company | Minimum | |||||||||
Class of Stock [Line Items] | |||||||||
Pre-money valuation amount related to non IPO to convert preferred stock | $ 400,000,000 | $ 400,000,000 | |||||||
Series A-1 Redeemable Convertible Preferred Stock | |||||||||
Class of Stock [Line Items] | |||||||||
Issuance of redeemable convertible preferred stock, shares | shares | 3,381,941 | 5,072,919 | |||||||
Redeemable convertible preferred stock, par value | $ / shares | $ 13.57 | $ 13.57 | |||||||
Preferred stock, convertible, conversion price | $ / shares | $ 13.57 | 13.57 | |||||||
Series A-1 Redeemable Convertible Preferred Stock | Subsequent Events | |||||||||
Class of Stock [Line Items] | |||||||||
Proceeds from the issue and sale of redeemable convertible preferred stock | $ 86,000,000 | ||||||||
Series A-1 Redeemable Convertible Preferred Stock | Series A Preferred Stock Purchase Agreement | |||||||||
Class of Stock [Line Items] | |||||||||
Proceeds from the issue and sale of redeemable convertible preferred stock | $ 68,100,000 | ||||||||
Issuance of redeemable convertible preferred stock, shares | shares | 5,072,919 | ||||||||
Series A-1 Redeemable Convertible Preferred Stock | Series A Preferred Stock Purchase Agreement | Series A-1 Tranche 2 | |||||||||
Class of Stock [Line Items] | |||||||||
Proceeds from the issue and sale of redeemable convertible preferred stock | $ 45,800,000 | ||||||||
Issuance of redeemable convertible preferred stock, shares | shares | 3,381,941 | 3,381,941 | |||||||
Redeemable convertible preferred stock, par value | $ / shares | $ 13.57 | ||||||||
Series A-1 Redeemable Convertible Preferred Stock | Series A Preferred Stock Purchase Agreement | Series A-1 Tranche 3 | |||||||||
Class of Stock [Line Items] | |||||||||
Issuance of redeemable convertible preferred stock, shares | shares | 6,341,148 | ||||||||
Redeemable convertible preferred stock, par value | $ / shares | $ 13.57 | ||||||||
Fair value of redeemable convertible preferred stock tranche asset | $ 1,900,000 | ||||||||
Series A-1 Redeemable Convertible Preferred Stock | Series A Preferred Stock Purchase Agreement | Series A-1 Tranche 3 | Subsequent Events | |||||||||
Class of Stock [Line Items] | |||||||||
Proceeds from the issue and sale of redeemable convertible preferred stock | $ 86,000,000 | ||||||||
Issuance of redeemable convertible preferred stock, shares | shares | 6,341,148 | ||||||||
Series A-2 Redeemable Convertible Preferred Stock | |||||||||
Class of Stock [Line Items] | |||||||||
Issuance of redeemable convertible preferred stock upon conversion of convertible notes, shares | shares | 3,229,851 | 3,229,851 | |||||||
Redeemable convertible preferred stock, par value | $ / shares | 10.18 | 10.18 | |||||||
Preferred stock, convertible, conversion price | $ / shares | $ 10.18 | $ 10.18 | $ 10.18 | ||||||
Redeemable Convertible Preferred Stock | |||||||||
Class of Stock [Line Items] | |||||||||
Redeemable convertible preferred stock, shares outstanding | shares | 12,495,411 | 9,113,470 | 12,495,411 | 0 | 9,113,470 | ||||
Redeemable Convertible Preferred Stock | Minimum | |||||||||
Class of Stock [Line Items] | |||||||||
Redeemable convertible preferred stock, shares outstanding | shares | 1,909,071 | 1,909,071 | |||||||
Series Seed Preferred Stock | |||||||||
Class of Stock [Line Items] | |||||||||
Preferred stock, convertible, conversion price | $ / shares | $ 13.57 | $ 13.57 |
Convertible Preferred Stock - S
Convertible Preferred Stock - Summary of Redeemable Convertible Preferred Stock (Details) - USD ($) $ / shares in Units, $ in Thousands | Nov. 14, 2023 | Sep. 30, 2023 |
Temporary Equity [Line Items] | ||
Redeemable convertible preferred stock, shares authorized | 0 | 255,584,255 |
Redeemable convertible preferred stock, shares issued | 12,495,411 | |
Redeemable convertible preferred stock, shares outstanding | 0 | 12,495,411 |
Redeemable convertible preferred stock, original issuance price | $ 0.001 | |
Redeemable convertible preferred stock, liquidation preference | $ 158,588 | |
Redeemable convertible preferred stock, carrying value | $ 150,088 | |
Series Seed | ||
Temporary Equity [Line Items] | ||
Redeemable convertible preferred stock, shares authorized | 11,000,000 | |
Redeemable convertible preferred stock, shares issued | 810,700 | |
Redeemable convertible preferred stock, shares outstanding | 810,700 | |
Redeemable convertible preferred stock, original issuance price | $ 13.57 | |
Redeemable convertible preferred stock, liquidation preference | $ 11,000 | |
Redeemable convertible preferred stock, carrying value | $ 9,830 | |
Series A-1 | ||
Temporary Equity [Line Items] | ||
Redeemable convertible preferred stock, shares authorized | 200,760,000 | |
Redeemable convertible preferred stock, shares issued | 8,454,860 | |
Redeemable convertible preferred stock, shares outstanding | 8,454,860 | |
Redeemable convertible preferred stock, original issuance price | $ 13.57 | |
Redeemable convertible preferred stock, liquidation preference | $ 114,720 | |
Redeemable convertible preferred stock, carrying value | $ 104,682 | |
Series A-2 | ||
Temporary Equity [Line Items] | ||
Redeemable convertible preferred stock, shares authorized | 43,824,255 | |
Redeemable convertible preferred stock, shares issued | 3,229,851 | |
Redeemable convertible preferred stock, shares outstanding | 3,229,851 | |
Redeemable convertible preferred stock, original issuance price | $ 10.18 | |
Redeemable convertible preferred stock, liquidation preference | $ 32,868 | |
Redeemable convertible preferred stock, carrying value | $ 35,576 |
Convertible Preferred Stock -_2
Convertible Preferred Stock - Summary of Convertible Preferred Stock (Details) - USD ($) $ / shares in Units, $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Class of Stock [Line Items] | ||
Convertible preferred stock, shares authorized | 11,000,000 | 11,000,000 |
Convertible preferred stock, shares issued | 810,700 | 810,700 |
Convertible preferred stock, shares outstanding | 810,700 | 810,700 |
Convertible preferred stock, original issuance price | $ 0.001 | |
Convertible preferred stock, liquidation preference | $ 11,000 | $ 11,000 |
Convertible preferred stock, carrying value | $ 10,855 | |
Series Seed | ||
Class of Stock [Line Items] | ||
Convertible preferred stock, shares authorized | 11,000,000 | |
Convertible preferred stock, shares issued | 810,700 | |
Convertible preferred stock, shares outstanding | 810,700 | |
Convertible preferred stock, original issuance price | $ 13.57 | |
Convertible preferred stock, liquidation preference | $ 11,000 | |
Convertible preferred stock, carrying value | $ 10,855 |
Common Stock - Additional Infor
Common Stock - Additional Information (Details) - shares | 9 Months Ended | ||
Sep. 30, 2023 | Feb. 28, 2023 | Dec. 31, 2022 | |
Common Stock, Number of Shares, Par Value and Other Disclosure [Abstract] | |||
Common stock voting rights | one | ||
Common stock, shares authorized | 320,000,000 | 320,000,000 | 29,000,000 |
Common Stock - Summary of Reser
Common Stock - Summary of Reserved Common Stock For Issuance (Details) - shares | Sep. 30, 2023 | Dec. 31, 2022 |
Class of Stock [Line Items] | ||
Total reserved common stock | 15,917,285 | 1,001,510 |
Redeemable Convertible Preferred Stock | ||
Class of Stock [Line Items] | ||
Total reserved common stock | 12,495,411 | |
Convertible Preferred Stock | ||
Class of Stock [Line Items] | ||
Total reserved common stock | 810,700 | |
Common Stock Options Issued And Outstanding Under The Plan | ||
Class of Stock [Line Items] | ||
Total reserved common stock | 3,048,512 | 167,882 |
Remaining Shares Available For Issuance Under The Plan | ||
Class of Stock [Line Items] | ||
Total reserved common stock | 373,362 | 22,928 |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional Information (Details) - USD ($) | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||
Option granted | $ 6.66 | ||
Unrecognized compensation expense | $ 100,000 | ||
Unrecognized stock-based compensation expense, weighted average period of recognition | 2 years 6 months | ||
Restricted stock award description | The restricted stock awards are subject to the repurchase right upon termination of services at a repurchase price lower of (i) the fair market value on the date of repurchase or (ii) their original purchase price no later than nine months after such termination. Shares purchased by employees pursuant to restricted stock awards are not deemed, for accounting purposes, to be issued until those shares vest according to their respective vesting schedules | ||
Share repurchase liability | $ 100,000 | $ 200,000 | |
2021 Stock Option and Grant Plan | |||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||
Shares authorized for issuance | 3,618,904 | 393,268 | |
Stock Options | |||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||
Aggregate intrinsic value option exercised | $ 46,000 | $ 0 | |
Weighted-average grant-date per share fair value of options | $ 0.79 | $ 5.17 | |
Unrecognized compensation expense | $ 13,500,000 | ||
Unrecognized stock-based compensation expense, weighted average period of recognition | 3 years 4 months 24 days |
Stock-Based Compensation - Summ
Stock-Based Compensation - Summary of Stock Option Activity (Details) $ / shares in Units, $ in Thousands | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 USD ($) $ / shares shares | Dec. 31, 2022 $ / shares shares | |
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Outstanding [Roll Forward] | ||
Outstanding, Beginning balance | shares | 167,882 | |
Granted | shares | 3,230,713 | |
Exercised | shares | (7,240) | |
Cancelled and forfeited | shares | (342,843) | |
Outstanding, Ending balance | shares | 3,048,512 | 167,882 |
Vested and expected to vest, September 30, 2023 | shares | 3,048,512 | |
Exercisable at September 30, 2023 | shares | 116,008 | |
Weighted Average Exercise Price | ||
Beginning balance | $ / shares | $ 1.09 | |
Granted | $ / shares | 6.66 | |
Exercised | $ / shares | 1.12 | |
Cancelled and forfeited | $ / shares | 5.27 | |
Ending balance | $ / shares | 6.52 | $ 1.09 |
Vested and expected to vest, September 30, 2023 | $ / shares | 6.52 | |
Exercisable at September 30, 2023 | $ / shares | $ 3.15 | |
Weighted Average Remaining Contractual Term (in years) | ||
Outstanding | 9 years 7 months 28 days | 9 years 7 months 24 days |
Vested and expected to vest, September 30, 2023 | 9 years 7 months 28 days | |
Exercisable at September 30, 2023 | 9 years 3 months | |
Aggregate Intrinsic Value | ||
Ending balance | $ | $ 16,390 | |
Vested and expected to vest, September 30, 2023 | $ | 16,390 | |
Exercisable at September 30, 2023 | $ | $ 1,015 |
Stock-Based Compensation - Su_2
Stock-Based Compensation - Summary of Restricted Stock Activity (Details) - Restricted Stock Award | 9 Months Ended |
Sep. 30, 2023 $ / shares shares | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Unvested, Number of Awards, Beginning balance | shares | 529,110 |
Number of Awards, Issued | shares | 1,874 |
Number of Awards, Repurchased | shares | (14,652) |
Number of Awards, Vested | shares | (215,418) |
Unvested, Number of Awards, Ending balance | shares | 300,914 |
Unvested, Weighted Average Grant Date Fair Value, Beginning balance | $ / shares | $ 0.93 |
Weighted Average Grant Date Fair Value, Issued | $ / shares | 3.94 |
Repurchased, Weighted Average Grant Date Fair Value | $ / shares | 0.63 |
Vested, Weighted Average Grant Date Fair Value | $ / shares | 1.9 |
Unvested, Weighted Average Grant Date Fair Value, Ending balance | $ / shares | $ 0.26 |
Stock-Based Compensation - Su_3
Stock-Based Compensation - Summary of Stock Based Compensation Expense (Details) - Restricted Stock Award - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||
Total stock-based compensation expense | $ 1,084 | $ 24 | $ 1,707 | $ 265 |
General and Administrative | ||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||
Total stock-based compensation expense | 587 | 9 | 1,014 | 209 |
Research and Development | ||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||
Total stock-based compensation expense | $ 497 | $ 15 | $ 693 | $ 56 |
Stock-Based Compensation - Su_4
Stock-Based Compensation - Summary of Estimated Grant Date Fair Value of Awards (Details) - Stock Options and Restricted Stock Awards | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Expected volatility, Minimum | 84.60% | 84.60% |
Expected volatility, Maximum | 87.20% | 89.80% |
Risk-free interest rate, Minimum | 3.20% | 0.40% |
Risk-free interest rate, Maximum | 4.60% | 3.20% |
Minimum | ||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Expected term (in years) | 1 year 3 months 18 days | 2 years 9 months 18 days |
Maximum | ||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Expected term (in years) | 6 years 4 months 24 days | 6 years 1 month 6 days |
License and Research and Deve_2
License and Research and Development Agreements - Additional Information (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||||
Feb. 28, 2023 | Aug. 31, 2022 | Jun. 30, 2022 | Mar. 31, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | |
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||||||
Research and development expense | $ 22,233,000 | $ 8,469,000 | $ 48,724,000 | $ 20,142,000 | |||||
Other non-current liabilities | 225,000 | 225,000 | $ 250,000 | ||||||
Stanford License Agreement | |||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||||||
Upfront payment | $ 50,000 | ||||||||
Issuance of common shares for license, shares | 67,605 | ||||||||
Issuance of common shares for license, fair value | $ 100,000 | ||||||||
Research and development expense | 200,000 | 10,000 | $ 200,000 | 10,000 | 200,000 | ||||
Stanford License Agreement | Maximum | |||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||||||
Annual license maintenance fees | 100,000 | ||||||||
Milestone payments | 600,000 | ||||||||
Stanford License Agreement | Maximum | Development Milestones | |||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||||||
Milestone payments | 4,000,000 | ||||||||
Stanford License Agreement | Maximum | Sales Milestones | |||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||||||
Milestone payments | $ 7,500,000 | ||||||||
Oxford License and Supply Agreement | |||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||||||
Upfront license fee | $ 200,000 | ||||||||
Oxford License and Supply Agreement | Development Milestones | |||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||||||
Research and development expense | 300,000 | 300,000 | 200,000 | ||||||
Oxford License and Supply Agreement | Regulatory Milestones | |||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||||||
Milestone payments | 1,000,000 | ||||||||
Oxford License and Supply Agreement | Commercial Milestones | |||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||||||
Milestone payments | 8,000,000 | ||||||||
Oxford License and Supply Agreement | Research and Development | |||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||||||
Upfront license fee | 200,000 | ||||||||
Oxford License and Supply Agreement | Maximum | Development Milestones | |||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||||||
Milestone payments | $ 300,000 | ||||||||
2022 NCI License Agreement | |||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||||||
Non-refundable license fee | $ 600,000 | 100,000 | 200,000 | ||||||
Remaining balance of non refundable license fee | $ 300,000 | ||||||||
Accrued non refundable license fee | 400,000 | ||||||||
Minimum payment on sale, transfer or lease of PRV | 5,000,000 | ||||||||
Termination and expiration clause | NCI may terminate or modify the 2022 NCI License Agreement in the event of an uncured material breach, including, but not limited to, if the Company does not meet certain milestones by certain dates, or upon certain insolvency events that remain uncured following the date that is 90 days following written notice of such breach or insolvency event. The Company may terminate the license, or any portion thereof, at its sole discretion at any time upon 60 days written notice to NCI. | ||||||||
2022 NCI License Agreement | Accrued Expenses and Other Current Liabilities Member | |||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||||||
Accrued non-refundable upfront fees | 100,000 | $ 100,000 | 100,000 | ||||||
2022 NCI License Agreement | Other Noncurrent Liabilities | |||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||||||
Accrued non-refundable upfront fees | 100,000 | 100,000 | $ 300,000 | ||||||
2022 NCI License Agreement | Research and Development | |||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||||||
Non-refundable license fee | 600,000 | ||||||||
2022 NCI License Agreement | Minimum Annual Royalty | |||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||||||
Research and development expense | 500,000 | $ 600,000 | |||||||
2022 NCI License Agreement | Non-refundable License Fee | |||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||||||
Research and development expense | $ 600,000 | ||||||||
2022 NCI License Agreement | Maximum | Development Milestones | |||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||||||
Milestone payments | 1,800,000 | ||||||||
2022 NCI License Agreement | Maximum | Regulatory Milestones | |||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||||||
Milestone payments | 200,000 | ||||||||
2022 NCI License Agreement | Maximum | Sales Milestones | |||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||||||
Milestone payments | 16,000,000 | ||||||||
2022 NCI License Agreement | Minimum | |||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||||||
Minimum annual royalty payments | 50,000 | ||||||||
Minimum payment on submission of PRV | $ 500,000 | ||||||||
2023 NCI License Agreement | |||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||||||
Minimum payment on sale, transfer or lease of PRV | $ 5,000,000 | ||||||||
Termination and expiration clause | Unless earlier terminated, the 2023 NCI License Agreement will expire upon the expiration of the last to expire licensed patent right. NCI may terminate or modify the 2023 NCI License Agreement in the event of an uncured material breach, including, but not limited to, if the Company does not meet certain milestones by certain dates, or upon certain insolvency events that remain uncured following the date that is 90 days following written notice of such breach or insolvency event. The Company may terminate the license, or any portion thereof, at its sole discretion at any time upon 60 days written notice to NCI. | ||||||||
Non-refundable license fee | 300,000 | ||||||||
Payment of reimburse in expense incurred on patent | 100,000 | ||||||||
Other non-current liabilities | $ 100,000 | $ 100,000 | |||||||
2023 NCI License Agreement | Research and Development | |||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||||||
Non-refundable license fee | 400,000 | ||||||||
2023 NCI License Agreement | Minimum Annual Royalty | |||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||||||
Research and development expense | $ 300,000 | ||||||||
2023 NCI License Agreement | Maximum | Development Milestones | |||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||||||
Milestone payments | 1,700,000 | ||||||||
2023 NCI License Agreement | Maximum | Regulatory Milestones | |||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||||||
Milestone payments | 100,000 | ||||||||
2023 NCI License Agreement | Maximum | Sales Milestones | |||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||||||
Milestone payments | 16,000,000 | ||||||||
2023 NCI License Agreement | Minimum | |||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||||||
Minimum annual royalty payments | 50,000 | ||||||||
Minimum payment on submission of PRV | $ 500,000 | ||||||||
Stanford University | Stanford License Agreement | |||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||||||
Issuance of common shares for license, shares | 22,317 | ||||||||
Non-profit Organizations | Stanford License Agreement | |||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||||||
Issuance of common shares for license, shares | 27,100 | ||||||||
Stanford University Inventors | Stanford License Agreement | |||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||||||
Issuance of common shares for license, shares | 18,188 |
Related Parties - Additional In
Related Parties - Additional Information (Details) - USD ($) $ in Millions | 1 Months Ended | 3 Months Ended | ||
Feb. 28, 2023 | Mar. 31, 2023 | Sep. 30, 2023 | Dec. 31, 2022 | |
Series A-2 Redeemable Convertible Preferred Stock | ||||
Related Party Transaction [Line Items] | ||||
Issuance of redeemable convertible preferred stock upon conversion of convertible notes, shares | 3,229,851 | 3,229,851 | ||
Investor | Series A-2 Redeemable Convertible Preferred Stock | ||||
Related Party Transaction [Line Items] | ||||
Issuance of redeemable convertible preferred stock upon conversion of convertible notes, shares | 1,833,623 | |||
Investor | 2022 Convertible Notes | ||||
Related Party Transaction [Line Items] | ||||
Aggregate principal amount | $ 16 | |||
Related party transaction principal and accrued interest outstanding | $ 18.7 | $ 16.4 |
Net Loss Per Share - Summary of
Net Loss Per Share - Summary of Computation of Diluted Net Loss per Share Attributable to Common Stockholders (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 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 | |
Numerator: | ||||||||
Net loss attributable to common stockholders | $ (35,471) | $ (17,884) | $ (12,715) | $ (12,285) | $ (10,162) | $ (4,755) | $ (66,070) | $ (27,202) |
Denominator: | ||||||||
Weighted-average shares used in computing net loss per share attributable to common stockholders, basic | 748,862 | 432,835 | 673,175 | 343,635 | ||||
Weighted-average shares used in computing net loss per share attributable to common stockholders, diluted | 748,862 | 432,835 | 673,175 | 343,635 | ||||
Net loss per share attributable to common stockholders, basic | $ (47.37) | $ (28.38) | $ (98.15) | $ (79.16) | ||||
Net loss per share attributable to common stockholders, diluted | $ (47.37) | $ (28.38) | $ (98.15) | $ (79.16) |
Net Loss Per Share - Summary _2
Net Loss Per Share - Summary of Potentially Dilutive Shares (Details) - shares | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive potentially dilutive shares excluded from computation of diluted net loss per share | 15,844,837 | 3,063,289 |
Redeemable Convertible Preferred Stock | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive potentially dilutive shares excluded from computation of diluted net loss per share | 12,495,411 | |
Convertible Preferred Stock | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive potentially dilutive shares excluded from computation of diluted net loss per share | 810,700 | |
2022 Convertible Notes | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive potentially dilutive shares excluded from computation of diluted net loss per share | 1,606,124 | |
Outstanding Stock Options | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive potentially dilutive shares excluded from computation of diluted net loss per share | 3,048,512 | 75,281 |
Restricted Stock Awards Subject to Repurchase | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive potentially dilutive shares excluded from computation of diluted net loss per share | 300,914 | 571,184 |
Subsequent Events - Additional
Subsequent Events - Additional Information (Details) | 1 Months Ended | 3 Months Ended | 9 Months Ended | ||||||||
Nov. 21, 2023 USD ($) shares | Nov. 14, 2023 $ / shares shares | Nov. 03, 2023 | Dec. 31, 2023 USD ($) ft² LeaseRenewal | Oct. 31, 2023 USD ($) shares | Sep. 30, 2023 USD ($) ft² $ / shares shares | Mar. 31, 2023 shares | Sep. 30, 2023 USD ($) ft² $ / shares shares | Feb. 28, 2023 ft² shares | Dec. 31, 2022 $ / shares shares | Nov. 30, 2021 ft² | |
Subsequent Event [Line Items] | |||||||||||
Number of options granted to purchase common stock | 3,230,713 | ||||||||||
Option granted | $ / shares | $ 6.66 | ||||||||||
Stockholders' equity, reverse stock split | 13.5685-for-1 basis | ||||||||||
Redeemable convertible preferred stock, shares outstanding | 0 | 12,495,411 | 12,495,411 | ||||||||
Common Stock, Shares Authorized | 320,000,000 | 320,000,000 | 320,000,000 | 29,000,000 | |||||||
Common Stock, Par or Stated Value Per Share | $ / shares | $ 0.001 | $ 0.001 | $ 0.001 | ||||||||
Preferred Stock, Shares Authorized | 11,000,000 | 11,000,000 | 11,000,000 | ||||||||
Preferred Stock, Par or Stated Value Per Share | $ / shares | $ 0.001 | ||||||||||
Lease space | ft² | 31,117 | 31,117 | 15,717 | 15,400 | |||||||
Total undiscounted lease payments | $ | $ 3,095,000 | $ 3,095,000 | |||||||||
Lessee, Operating Lease, Existence of Option to Extend [true false] | true | ||||||||||
Lease renewal term | 1 year | ||||||||||
Payments due within 12 months | $ | $ 2,404,000 | $ 2,404,000 | |||||||||
Initial Public Offering | |||||||||||
Subsequent Event [Line Items] | |||||||||||
Redeemable convertible preferred stock, shares outstanding | 12,495,411 | 12,495,411 | |||||||||
Series A-1 Redeemable Convertible Preferred Stock | |||||||||||
Subsequent Event [Line Items] | |||||||||||
Issuance of redeemable convertible preferred stock, shares | 3,381,941 | 5,072,919 | |||||||||
Subsequent Events | |||||||||||
Subsequent Event [Line Items] | |||||||||||
Shares issued (in shares) | 6,341,148 | ||||||||||
Stockholders' equity, reverse stock split | 13.5685-for-1 basis | ||||||||||
Aggregate shares issued at public offering | 18,750,000 | ||||||||||
Public offering price of shares | $ / shares | $ 15 | ||||||||||
Shares converted (in shares) | 18,836,559 | ||||||||||
Common Stock, Shares Authorized | 500,000,000 | ||||||||||
Common Stock, Par or Stated Value Per Share | $ / shares | $ 0.001 | ||||||||||
Preferred Stock, Shares Authorized | 50,000,000 | ||||||||||
Preferred Stock, Par or Stated Value Per Share | $ / shares | $ 0.001 | ||||||||||
Lease space | ft² | 99,557 | ||||||||||
Total undiscounted lease payments | $ | $ 45,700,000 | ||||||||||
Lessee, Operating Lease, Existence of Option to Extend [true false] | true | ||||||||||
Number of lease renewables | LeaseRenewal | 2 | ||||||||||
Lease renewal term | 3 years | ||||||||||
Payments due within 12 months | $ | $ 0 | ||||||||||
Subsequent Events | Initial Public Offering | |||||||||||
Subsequent Event [Line Items] | |||||||||||
Shares issued (in shares) | 6,341,148 | ||||||||||
Aggregate shares issued at public offering | 18,750,000 | ||||||||||
Additional shares issued to underwriters of IPO | 2,512,181 | ||||||||||
Public offering price of shares | $ / shares | $ 15 | ||||||||||
Net proceeds from issuance of initial public offering | $ | $ 291,300,000 | ||||||||||
Shares converted (in shares) | 18,836,559 | ||||||||||
Common Stock, Shares Authorized | 500,000,000 | ||||||||||
Common Stock, Par or Stated Value Per Share | $ / shares | $ 0.001 | ||||||||||
Preferred Stock, Shares Authorized | 50,000,000 | ||||||||||
Preferred Stock, Par or Stated Value Per Share | $ / shares | $ 0.001 | ||||||||||
Subsequent Events | Series A-1 Redeemable Convertible Preferred Stock | |||||||||||
Subsequent Event [Line Items] | |||||||||||
Shares issued (in shares) | 6,341,148 | ||||||||||
Proceeds from the issue and sale of redeemable convertible preferred stock | $ | $ 86,000,000 |