Bicara Therapeutics 2025年季度报告

FORM10-Q_________________________ For the quarterly period endedSeptember 30, 2025OR oTRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934For the transition period from ____________ to _______________Commission file number001-42271_________________________ BICARA THERAPEUTICS INC. (Exact name of registrant as specified in its charter)_________________________ Delaware83-2903745 (State or other jurisdiction ofincorporation or organization)(I.R.S. EmployerIdentification No.) 116 Huntington AveSuite 703Boston,Massachusetts (Address of Principal Executive Offices)(Zip Code) Securities registered pursuant to Section 12(b) of the Act: Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the SecuritiesExchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports),and (2) has been subject to such filing requirements for the past 90 days. Yes☒Noo Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submittedpursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that theregistrant was required to submit such files). Yes☒Noo Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smallerreporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smallerreporting company,” and "emerging growth company" in Rule 12b-2 of the Exchange Act. If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period forcomplying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yeso No☒ As of November 5, 2025, the registrant had54,781,950shares of common stock, $0.0001 par value per share outstanding. PART I:FINANCIAL INFORMATION6Item 1.Financial Statements (Unaudited)6Condensed Consolidated Balance Sheets as of September 30, 2025 and December 31, 20246Condensed Consolidated Statements ofComprehensive Lossfor the Three and Nine Months EndedSeptember 30, 2025 and 20247Condensed Consolidated Statements of Stockholders’ Equity for the Three and Nine Months EndedSeptember 30, 2025 and Condensed Consolidated Statements of Redeemable Convertible Preferred Stock andStockholders’ Deficit for the Three and Nine Months Ended September 30, 20248Condensed Consolidated Statements of Cash Flows for the Nine Months Ended September 30, 2025 and 202410Notes to Unaudited Condensed Consolidated Financial Statements11Item 2.Management’s Discussion and Analysis of Financial Condition and Results of Operations25Item 3.Quantitative and Qualitative Disclosures About Market Risk35Item 4.Controls and Procedures35PART II:OTHER INFORMATION37Item 1.Legal Proceedings37Item 1A.Risk Factors38Item 2.Unregistered Sales of Equity Securities, Use of Proceeds, and Issuer Purchases of Equity Securities96Item 3.Defaults Upon Senior Securities96Item 4.Mine Safety Disclosures96Item 5.Other Information96Item 6.Exhibits97Signatures98 SUMMARY OF THE MATERIAL RISKS ASSOCIATED WITH OUR BUSINESS We are subject to numerous risks and uncertainties, including those further described below in the section entitled “Risk Factors” inthis Quarterly Report on Form 10-Q, that represent challenges that we face in connection with the successful implementation of ourstrategy and the growth of our business. In particular, the following considerations, among others, may offset our competitive strengthsor have a negative effect on our business strategy, which could materially adversely affect our business, financial conditions, results ofoperations, future growth prospects, or cause a decline in the price of our common stock: •We are a clinical-stage biopharmaceutical company with a limited operating history, which may make it difficult to evaluateour current business and predict our future success and viability. We have incurred significant financial losses since ourinception and anticipate that we will continue to incur significant financial losses for the foreseeable future.•We will require additional funding in order to finance operations. If we are unable to raise capital when needed, or onacceptable terms, we could be forced to delay, reduce or eliminate our product development programs or commercializationefforts.•Our business is highly dependent on the success of ficerafusp alfa. If we are unable to successfully complete clinicaldevelopment, obtain regulatory approval for or commercialize ficerafusp alfa, or if we experience delays in doing so, ourbusiness will be materially harmed.•The regulatory approval proces