Source: sec Source ID: 0001628280-26-055765 URL: https://www.sec.gov/Archives/edgar/data/2023658/000162828026055765/bcax-20260630.htm Symbol: (BCAX) Published: 2026-08-11 16:46:02 EDT Time precision: minute Title: 10-Q 10-Q 0002023658 12/31 2026 Q2 FALSE P1Y xbrli:shares iso4217:USD iso4217:USD xbrli:shares bcax:segment bcax:debtSecurity utr:sqft xbrli:pure 0002023658 2026-01-01 2026-06-30 0002023658 2026-08-06 0002023658 2026-06-30 0002023658 2025-12-31 0002023658 us-gaap:NonrelatedPartyMember 2026-06-30 0002023658 us-gaap:NonrelatedPartyMember 2025-12-31 0002023658 us-gaap:RelatedPartyMember 2026-06-30 0002023658 us-gaap:RelatedPartyMember 2025-12-31 0002023658 us-gaap:RelatedPartyMember 2026-04-01 2026-06-30 0002023658 us-gaap:RelatedPartyMember 2025-04-01 2025-06-30 0002023658 us-gaap:RelatedPartyMember 2026-01-01 2026-06-30 0002023658 us-gaap:RelatedPartyMember 2025-01-01 2025-06-30 0002023658 us-gaap:NonrelatedPartyMember 2026-04-01 2026-06-30 0002023658 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2026-04-01 2026-06-30 0002023658 bcax:ReportableSegmentMember 2025-04-01 2025-06-30 0002023658 bcax:ReportableSegmentMember 2026-01-01 2026-06-30 0002023658 bcax:ReportableSegmentMember 2025-01-01 2025-06-30 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 _________________________ FORM 10-Q _________________________ (Mark One) x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2026 OR o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ____________ to _______________ Commission file number 001-42271 _________________________ BICARA THERAPEUTICS INC. (Exact name of registrant as specified in its charter) _________________________ Delaware 83-2903745 (State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identification No.) 116 Huntington Ave Suite 703 Boston , Massachusetts 02116 (Address of Principal Executive Offices) (Zip Code) 617 - 468-4219 Registrant’s telephone number, including area code Securities registered pursuant to Section 12(b) of the Act: Title of each class Trading Symbol(s) Name of each exchange on which registered Common Stock, par value $0.0001 BCAX Nasdaq Global Market Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange 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 ☒ No o Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No o Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act. Large accelerated filer o Accelerated filer o Non-accelerated filer ☒ Smaller reporting company ☒ Emerging growth company ☒ If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. o Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes o No ☒ As of August 6, 2026, the registrant had 66,172,934 shares of common stock, $0.0001 par value per share, outstanding. Table of Contents Page PART I : FINANCIAL INFORMATION 9 Item 1. Financial Statements (Unaudited) 9 Condensed Consolidated Balance Sheets as of June 30 , 2026 and December 31, 2025 9 Condensed Consolidated Statements of Operation s and Comprehensive Loss for the Three and Six Months Ended June 30 , 2026 and 202 5 10 Condensed Consolidated Statements of Stockholders’ Equity for the Three and Six Months Ended June 30 , 2026 and 2025 11 Condensed Consolidated Statements of Cash Flows for the Six Months Ended J une 30 , 2026 and 202 5 13 Notes to Unaudited Condensed Consolidated Financial Statements 14 Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations 27 Item 3. Quantitative and Qualitative Disclosures About Market Risk 38 Item 4. Controls and Procedures 38 PART II : OTHER INFORMATION 39 Item 1. Legal Proceedings 39 Item 1A. Risk Factors 40 Item 2. Unregistered Sales of Equity Securities, Use of Proceeds, and Issuer Purchases of Equity Securities 89 Item 3. Defaults Upon Senior Securities 89 Item 4. Mine Safety Disclosures 89 Item 5. Other Information 89 Item 6. Exhibits 92 Signatures 94 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 titled “Risk Factors” in this Quarterly Report on Form 10-Q, that represent challenges that we face in connection with the successful implementation of our strategy and the growth of our business. In particular, the following considerations, among others, may offset our competitive strengths or have a negative effect on our business strategy, which could materially adversely affect our business, financial conditions, results of operations, 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 evaluate our current business and predict our future success and viability. We have incurred significant financial losses since our inception and anticipate that we will continue to incur significant financial losses for the foreseeable future. • If we are unable to raise capital when needed, or on acceptable terms, we may be unable to complete the development and commercialization of ficerafusp alfa or any future product candidates. • Our business is highly dependent on the success of ficerafusp alfa. If we are unable to successfully complete clinical development, obtain regulatory approval for or commercialize ficerafusp alfa, or if we experience delays in doing so, our business will be materially harmed. • We face significant competition from other biotechnology and pharmaceutical companies, and our operating results will suffer if we fail to compete effectively. • Our business is dependent on our ability to advance ficerafusp alfa and future product candidates through clinical trials, obtain marketing approval and ultimately commercialize them. • Clinical development involves a lengthy and expensive process with uncertain outcomes. We may incur additional costs and experience delays in developing and commercializing or be unable to develop or commercialize ficerafusp alfa and any future product candidates. • Ficerafusp alfa or any future product candidates may cause undesirable side effects or have other properties when used alone or in combination with other approved products or investigational new drugs that could halt their clinical development, delay or prevent their regulatory approval, limit their commercial potential or result in significant negative consequences. • We rely, and expect to continue to rely, on third parties, including independent clinical investigators and contract research organizations to conduct our preclinical studies and clinical trials. If these third parties do not successfully carry out their contractual duties or meet expected deadlines, we may not be able to obtain regulatory approval for or commercialize our product candidates and our business could be substantially harmed. • We currently and in the future may depend on other third-party collaborators for the discovery, development and commercialization of ficerafusp alfa and any of our future product candidates. If our collaborations are not successful, we may not be able to capitalize on the market potential of these product candidates. • The regulatory approval processes of the U.S. Food and Drug Administration and comparable foreign authorities are lengthy, time-consuming and inherently unpredictable, and if we are ultimately unable to obtain regulatory approval for our product candidates, our business will be materially harmed. • The commercial success of ficerafusp alfa or any future product candidates will depend upon the degree of market acceptance of such product candidates by physicians, patients, healthcare payors and others in the medical community. • Our ability to compete may decline if we do not adequately protect our proprietary rights. • Unfavorable global economic and geopolitical conditions could adversely affect our business, financial condition, stock price and results of operations. 4 • Our ability to develop product candidates, leverage our potential and our future growth depends on attracting, hiring and retaining our key personnel and recruiting additional qualified personnel. If we are not successful in attracting, motivating and retaining highly qualified personnel, we may not be able to successfully implement our business strategy. Additionally, we will need to grow the size of our organization, and we may experience difficulties in managing this growth. The summary risk factors described above should be read together with the text of the full risk factors in the section titled “Risk Factors” and the other information set forth in this Quarterly Report, including our condensed consolidated financial statements and the related notes, as well as in other documents that we file with the Securities and Exchange Commission, or SEC. The risks summarized above or described in full elsewhere in this Quarterly Report are not the only risks that we face. Additional risks and uncertainties not presently known to us, or that we currently deem to be immaterial may also materially adversely affect our business, financial condition, results of operations and future growth prospects. 5 SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS This Quarterly Report on Form 10-Q contains express or implied forward-looking statements that are based on our management’s belief and assumptions and on information currently available to our management. Although we believe that the expectations reflected in these forward-looking statements are reasonable, these statements relate to future events or our future operational or financial performance, and involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by these forward-looking statements. Forward-looking statements in this Quarterly Report on Form 10-Q include, but are not limited to, statements about: • the timing, progress, results and cost of our development activities for ficerafusp alfa, including the FORTIFI-HN01 Phase 2/3 pivotal trial, the expansion cohorts of our Phase 1/1b trial, and our alternate dose study, as well as our research and development programs and any current and future preclinical and clinical studies; • the ability and the potential to secure pembrolizumab for our clinical trials and successfully manufacture our drug substances and ficerafusp alfa for preclinical use, for clinical trials and on a larger scale for commercial use, if approved; • our expectations for the potential safety, efficacy and therapeutic effects of ficerafusp alfa, and the ability of our clinical trials to demonstrate such results; • our expectations for the development of ficerafusp alfa with a loading and every-three-week maintenance dosing regimen; • the timing, scope and likelihood of regulatory filings and approvals, including potential accelerated approval, for ficerafusp alfa and future product candidates; • our ability to initiate, recruit and enroll patients in and conduct and successfully complete our clinical trials at the pace that we project; • our ability to maintain and further develop the specific shipping, storage, handling and administration of ficerafusp alfa at the clinical sites; • the ability and willingness of our third-party strategic collaborators to continue research and development activities relating to our development candidates and ficerafusp alfa; • our ability to obtain funding to continue development and commercialization of ficerafusp alfa; • our ability to obtain and maintain regulatory approval of ficerafusp alfa; • our ability to commercialize ficerafusp alfa, if approved; • the potential pricing and reimbursement of ficerafusp alfa, if approved; • the implementation of our business model, and strategic plans for our business, ficerafusp alfa and technology; • the scope of protection we are able to establish and maintain for intellectual property rights covering ficerafusp alfa and other product candidate we may develop, including the extensions of existing patent terms where available, the validity of intellectual property rights held by third parties and our ability not to infringe, misappropriate or otherwise violate any third-party intellectual property rights; • estimates of our future expenses, revenues and capital requirements, our needs for additional financing and ability to raise capital, including under our “at-the-market” offering program; • future agreements with third parties in connection with the development and commercialization of ficerafusp alfa and any other approved product; • the size and growth potential of the markets for ficerafusp alfa and our ability to serve those markets; 6 • the rate and degree of market acceptance of ficerafusp alfa; • regulatory developments in the U.S., Canada, European Union and other foreign countries; • our ability to contract with third-party suppliers and manufacturers and their ability to perform adequately; • the success of competing therapies that are or may become available and ficerafusp alfa’s differentiation from competitors; • our ability to attract and retain key personnel; • the impact of laws and regulations; • developments relating to our competitors and our industry; and • other risks and uncertainties, including those listed under the caption “Risk Factors.” In some cases, forward-looking statements can be identified by terminology such as “may,” “should,” “expects,” “intends,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue,” or the negative of these terms or other comparable terminology. These statements are only predictions. You should not place undue reliance on forward-looking statements because they involve known and unknown risks, uncertainties and other factors, which are, in some cases, beyond our control and which could materially affect results. Factors that may cause actual results to differ materially from current expectations include, among other things, those listed under the section titled “Risk Factors” and elsewhere in this Quarterly Report. If one or more of these risks or uncertainties occur, or if our underlying assumptions prove to be incorrect, actual events or results may vary significantly from those implied or projected by the forward-looking statements. No forward-looking statement is a guarantee of future performance. You should read this Quarterly Report and the documents that we reference in this Quarterly Report and have filed with the SEC, as exhibits hereto completely and with the understanding that our actual future results may be materially different from any future results expressed or implied by these forward-looking statements. The forward-looking statements in this Quarterly Report represent our views as of the date of this Quarterly Report. We anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we have no current intention of doing so except to the extent required by applicable law. You should therefore not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this Quarterly Report. In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this Quarterly Report, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain and you are cautioned not to unduly rely upon these statements. This Quarterly Report also contains estimates, projections and other information concerning our industry, our business and the markets for our product candidates. Information that is based on estimates, forecasts, projections, market research or similar methodologies is inherently subject to uncertainties and actual events or circumstances may differ materially from events and circumstances that are assumed in this information. Unless otherwise expressly stated, we obtained this industry, business, market, and other data from our own internal estimates and research as well as from reports, research surveys, studies, and similar data prepared by market research firms and other third parties, industry, medical and general publications, government data and similar sources. While we are not aware of any misstatements regarding any third-party information presented in this Quarterly Report, their estimates, in particular as they relate to projections, involve numerous assumptions, are subject to risks and uncertainties and are subject to change based on various factors, including those discussed under the section titled “Risk Factors” and elsewhere in this Quarterly Report. 7 NOTE REGARDING TRADEMARKS Bicara Therapeutics Inc. is the owner of the Bicara trademark, as well as certain other registered trademarks, trademark applications and unregistered trademarks and service marks, including design versions of some of these trademarks. The symbols ™ and ® are not used in connection with the presentation of these trademarks in this report and their absence does not indicate a lack of trademark rights. Certain other trademarks used in this report are the property of third-party trademark owners and may be presented with or without trademark references. All brand names or trademarks appearing in this report are the property of their respective owners. Unless the context requires otherwise, references in this report to “Bicara,” the “Company,” “we,” “us” and “our” refer to Bicara Therapeutics Inc. and its subsidiary. 8 PART I - FINANCIAL INFORMATION Item 1. Financial Statements (Unaudited) BICARA THERAPEUTICS INC. CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited, in thousands, except shares and per share data) June 30, 2026 December 31, 2025 Assets Current assets Cash and cash equivalents $ 96,599 $ 96,685 Prepaid expenses and other assets 6,561 7,252 Marketable securities 400,660 318,116 Total current assets 503,820 422,053 Property and equipment, net 362 330 Right of use asset – operating lease 1,151 1,701 Other assets 6,910 6,910 Total assets $ 512,243 $ 430,994 Liabilities and stockholders’ equity Current liabilities Accounts payable $ 7,431 $ 5,515 Accounts payable – related party 1,032 2,278 Accrued expenses and other current liabilities 33,666 18,898 Accrued expenses and other current liabilities – related party 183 1,141 Operating lease liability – current portion 1,163 1,117 Total current liabilities 43,475 28,949 Operating lease liability – net of current portion — 593 Total liabilities 43,475 29,542 Commitments and Contingencies (Note 7) Stockholders' equity: Preferred stock $ 0.0001 par value, 10,000,000 shares authorized; 0 shares issued and outstanding as of June 30, 2026 and December 31, 2025 — — Common stock, $ 0.0001 par value, 500,000,000 shares authorized; 65,931,128 and 56,600,724 shares issued and outstanding as of June 30, 2026 and December 31, 2025, respectively 8 7 Additional paid-in capital 939,940 760,168 Accumulated other comprehensive (loss) income ( 567 ) 243 Accumulated deficit ( 470,613 ) ( 358,966 ) Total stockholders' equity 468,768 401,452 Total liabilities and stockholders’ equity $ 512,243 $ 430,994 See accompanying notes to unaudited condensed consolidated financial statements. 9 BICARA THERAPEUTICS INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (Unaudited, in thousands except shares and per share data) Three Months Ended June 30, Six Months Ended June 30, 2026 2025 2026 2025 Operating expenses Research and development - related party $ 911 $ 2,932 $ 2,892 $ 9,507 Research and development 44,862 21,866 90,345 49,624 General and administrative 14,178 7,220 26,954 14,675 Total operating expenses 59,951 32,018 120,191 73,806 Loss from operations ( 59,951 ) ( 32,018 ) ( 120,191 ) ( 73,806 ) Other income Interest income 4,576 4,682 8,659 9,696 Total other income 4,576 4,682 8,659 9,696 Net loss before income taxes ( 55,375 ) ( 27,336 ) ( 111,532 ) ( 64,110 ) Income tax expense ( 61 ) ( 52 ) ( 115 ) ( 124 ) Net loss $ ( 55,436 ) $ ( 27,388 ) $ ( 111,647 ) $ ( 64,234 ) Net Loss per share, basic and diluted $ ( 0.82 ) $ ( 0.50 ) $ ( 1.73 ) $ ( 1.18 ) Weighted-average number of common shares outstanding, basic and diluted 67,925,963 54,539,230 64,360,558 54,496,862 Other comprehensive loss Unrealized loss on marketable securities, net of tax ( 324 ) — ( 810 ) — Total other comprehensive loss ( 324 ) — ( 810 ) — Total comprehensive loss $ ( 55,760 ) $ ( 27,388 ) $ ( 112,457 ) $ ( 64,234 ) See accompanying notes to unaudited condensed consolidated financial statements. 10 BICARA THERAPEUTICS INC. CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY (Unaudited, in thousands except shares) Common Equity Additional Paid in Capital Accumulated Deficit Total Stockholders' Equity Shares Amount December 31, 2024 54,440,013 $ 7 $ 712,884 $ ( 221,016 ) $ 491,875 Issuance of common stock upon exercise of stock options 88,962 — 477 — 477 Stock-based compensation — — 3,451 — 3,451 Net loss — — — ( 36,846 ) ( 36,846 ) March 31, 2025 54,528,975 $ 7 $ 716,812 $ ( 257,862 ) $ 458,957 Issuance of common stock upon exercise of stock options 27,103 — 135 — 135 Stock-based compensation — — 3,492 — 3,492 Net loss — — ( 27,388 ) ( 27,388 ) June 30, 2025 54,556,078 $ 7 $ 720,439 $ ( 285,250 ) $ 435,196 See accompanying notes to unaudited condensed consolidated financial statements. 11 BICARA THERAPEUTICS INC. CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY (Unaudited, in thousands except shares) Common Equity Additional Paid in Capital Accumulated Accumulated Deficit Total Stockholders' Equity Shares Amount Other Comprehensive Income (Loss) December 31, 2025 56,600,724 $ 7 $ 760,168 $ 243 $ ( 358,966 ) $ 401,452 Issuance of common stock, and accompanying pre-funded warrants, net of issuance cost 8,581,250 1 161,762 — — 161,763 Issuance of common stock upon exercise of stock options 365,063 — 1,582 — — 1,582 Stock-based compensation — — 5,858 — — 5,858 Unrealized loss on marketable securities, net of tax — — — ( 486 ) — ( 486 ) Net loss — — — – ( 56,211 ) ( 56,211 ) March 31, 2026 65,547,037 $ 8 $ 929,370 $ ( 243 ) $ ( 415,177 ) $ 513,958 Issuance of common stock upon exercise of stock options 384,091 — 2,332 — — 2,332 Stock-based compensation — — 8,238 — — 8,238 Unrealized loss on marketable securities, net of tax — — — ( 324 ) — ( 324 ) Net loss — — — — ( 55,436 ) $ ( 55,436 ) June 30, 2026 65,931,128 $ 8 $ 939,940 $ ( 567 ) $ ( 470,613 ) $ 468,768 See accompanying notes to unaudited condensed consolidated financial statements. 12 BICARA THERAPEUTICS INC. CONDENSED CONSOLIDATED STATEMENT OF CASH FLOWS (Unaudited, in thousands) Six Months Ended June 30, 2026 2025 Operating activities: Net loss $ ( 111,647 ) $ ( 64,234 ) Adjustments to reconcile net loss to cash used in operating activities: Stock-based compensation 14,096 6,943 Depreciation 88 38 Non-cash lease expense 550 349 Net amortization of premiums and discounts on marketable securities 575 — Changes in operating assets and liabilities: Prepaid expenses and other assets 689 4,743 Accounts payable and accrued expenses 16,686 ( 2,715 ) Accounts payable and accrued expenses – related party ( 2,204 ) 1,499 Operating lease liabilities ( 547 ) ( 323 ) Net cash used in operating activities ( 81,714 ) ( 53,700 ) Investing activities: Purchase of marketable securities ( 244,929 ) — Proceeds from maturities and sales of marketable securities 161,000 — Purchase of property and equipment ( 120 ) — Net cash used in investing activities ( 84,049 ) — Financing activities: Proceeds from issuance of common stock and accompanying pre-funded warrants, net of issuance costs 161,763 — Proceeds from exercise of options 3,914 595 Net cash provided by financing activities 165,677 595 Net decrease in cash and cash equivalents ( 86 ) ( 53,105 ) Cash and cash equivalents at beginning of period 96,685 489,711 Cash and cash equivalents at end of period $ 96,599 $ 436,606 Supplemental disclosure of cash flow information: Cash paid for taxes $ 155 $ 124 Non-cash investing and financing activities: Right-of-use asset obtained in exchange for lease liability $ — $ 1,878 Vesting of early exercise stock options $ — $ 17 See accompanying notes to unaudited condensed consolidated financial statements. 13 Notes to Unaudited Condensed Consolidated Financial Statements 1. Description of Business, Organization, and Liquidity Bicara Therapeutics Inc. (“Bicara” or the “Company”) was incorporated in the state of Delaware in December 2018 and is a clinical-stage biopharmaceutical company based in Boston, Massachusetts. The Company is committed to bringing transformative bifunctional therapies to patients with solid tumors. Its lead program ficerafusp alfa is a bifunctional antibody that combines a clinically validated epidermal growth factor receptor directed monoclonal antibody bound to a human transforming growth factor beta ligand trap. Since inception, the Company has operated in the preclinical and clinical stages and has devoted substantially all of its time and efforts to performing research and development activities, raising capital, and recruiting management and technical staff to support these operations. The Company is subject to risks and uncertainties common to early-stage companies in the biotechnology industry including, but not limited to, risks associated with the successful research, development and manufacturing of product candidates, competition from other companies, dependence on key personnel, protection of intellectual property, compliance with government regulations and the ability to secure additional capital to fund operations. Current and future programs will require significant research and development efforts, including extensive preclinical and clinical testing and regulatory approval prior to commercialization. These efforts require significant amounts of additional capital, adequate personnel, and infrastructure. Even if our product development efforts are successful, it is uncertain when, if ever, the Company will realize significant revenue from product sales. The Company historically has funded its operations from the issuance of common stock in connection with its initial public offering (“IPO”), issuance of common stock in connection with its at-the-market offering program (the “ATM Program”), issuance of equity securities in a public offering in February 2026, redeemable convertible preferred stock and through debt financing. On September 16, 2024, the Company closed its IPO, through which it issued 20,125,000 shares of common stock with par value of $ 0.0001 per share and a purchase price of $ 18.00 per share. The Company raised net proceeds of $ 332.4 million from the issuance of common stock. In December 2025, the Company issued 1,604,000 shares of common stock with par value of $ 0.0001 per share through the ATM Program and raised net proceeds of $ 29.5 million. In February 2026, the Company issued and sold 8,581,250 shares of its common stock, including 1,406,250 shares pursuant to the exercise of the underwriters’ option to purchase additional shares, at a price to the public of $ 16.00 per share. Further, in lieu of common stock to certain investors, the Company sold pre-funded warrants to purchase 2,200,000 shares of common stock at a public offering price of $ 15.9999 per pre-funded warrant, which represents the per share public offering price of each share of common stock less the $ 0.0001 per share exercise price for each pre-funded warrant. As a result of the offering, the Company received approximately $ 161.8 million in net proceeds. The Company has incurred operating losses since inception and expects such losses and negative operating cash flows to continue for the foreseeable future. As of June 30, 2026, the Company had cash, cash equivalents and marketable securities of $ 497.3 million and an accumulated deficit of $ 470.6 million . The Company expects that its cash, cash equivalents and marketable securities as of June 30, 2026 of $ 497.3 million will be sufficient to fund the operating expenditures and capital expenditure requirements necessary to advance its research efforts and clinical trials for at least one year from the date of issuance of these unaudited condensed consolidated financial statements. 14 Notes to Unaudited Condensed Consolidated Financial Statements 2. Summary of Significant Accounting Policies Basis of Presentation The accompanying unaudited condensed consolidated financial statements are prepared in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”). Any reference in these notes to applicable guidance is meant to refer to the authoritative GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Updates (“ASU”) of the Financial Accounting Standards Board (“FASB”). The accompanying condensed consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities and commitments in the ordinary course of business. The Company’s unaudited condensed consolidated financial statements include the financial position, results of operations and cash flows of Bicara. The Company’s unaudited condensed consolidated financial statements are denominated in U.S. dollars. The unaudited condensed consolidated financial statements include the accounts of the Company and its wholly owned, controlled subsidiary. All intercompany transactions and balances have been eliminated in consolidation. Unaudited Interim Condensed Consolidated Financial Statements The condensed consolidated balance sheet as of June 30, 2026, condensed consolidated statements of operations and comprehensive loss, condensed consolidated statement of stockholders' equity for the three and six months ended June 30, 2026 and 2025, and condensed consolidated cash flows for the six months ended June 30, 2026 and 2025 and related notes to condensed consolidated financial statements are unaudited. These unaudited interim condensed consolidated financial statements have been prepared on the same basis as the Company’s annual consolidated 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 condensed consolidated financial position, results of operations and cash flows for the periods presented. The condensed consolidated results of operations for the three and six months ended June 30, 2026 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 consolidated balance sheet as of December 31, 2025, included herein, was derived from the audited consolidated financial statements as of that date. As permitted under U.S. GAAP, certain notes and other information have been omitted from the interim unaudited condensed consolidated financial statements presented in this Quarterly Report on Form 10-Q. Therefore, these unaudited condensed consolidated financial statements should be read in conjunction with the Company’s most recent Annual Report on Form 10-K for the year ended December 31, 2025 (the "Form 10-K"). Emerging Growth Company Status Bicara is an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act of 2012 (the "JOBS Act"), and we may take advantage of reduced reporting requirements that are otherwise applicable to public companies. The Company may take advantage of these exemptions until it is no longer an emerging growth company. Section 107 of the JOBS Act provides that an emerging growth company can take advantage of the extended transition period afforded by the JOBS Act for the implementation of new or revised accounting standards. Bicara has elected to use the extended transition period for complying with new or revised accounting standards, and as a result of this election, its financial statements may not be comparable to companies that comply with public company effective dates. The Company may take advantage of these exemptions up until the last day of the fiscal year following the fifth anniversary of its IPO or such earlier time that Bicara is no longer an emerging growth company. Bicara would cease to be an emerging growth company if it has more than $1.235 billion in total annual gross revenue, it has more than $700.0 million in market value of its stock held by non-affiliates (and it has been a public company for at least 12 months and has filed one annual report on Form 10-K), or it issues more than $1.0 billion of non-convertible debt securities over a three-year period. Use of Estimates The preparation of unaudited condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenue, expenses and the related disclosure of contingent assets and liabilities as of and during the reporting period. The Company bases its estimates on historical experience when available and on other assumptions that management believes are reasonable under the circumstances. Significant estimates and assumptions reflected in these unaudited condensed consolidated financial statements include but are not limited to: the estimated costs of research and development activities, and the fair values of pre-IPO common stock and stock awards and associated stock-based compensation expense. The Company assesses estimates on an ongoing basis; however, actual results could materially differ from those estimates. 15 Notes to Unaudited Condensed Consolidated Financial Statements Marketable Securities Marketable securities consist of obligations of, and issues guaranteed by the U.S. Treasury, U.S. Agencies and U.S. Government Sponsored Enterprises. The Company's marketable securities are classified as available-for-sale and are carried at fair value. The Company classifies all available-for-sale securities as current assets. Marketable securities are classified as current assets because they are available to fund current operations. Any unrealized holding gains or losses on debt securities, including their tax effect, are reported as components of Other comprehensive loss in the condensed consolidated statement of operations and comprehensive loss. Realized gains and losses, included in Interest and other income, net in the condensed consolidated statement of operations and comprehensive loss, are determined using the specific identification method for determining the cost of securities sold. Declines in fair value below amortized cost related to credit losses (i.e., impairment due to credit losses) are included in the condensed consolidated statement of operations and comprehensive loss, with a corresponding allowance established. If the estimate of expected credit losses decreases in subsequent periods, the Company will reverse the credit losses through current period earnings and adjust the allowance accordingly. Research and Development Expense Research and development costs are expensed as incurred in accordance with ASC 730, Research and Development (“ASC 730”). Research and development expenses include costs directly attributable to the conduct of research and development programs, including compensation costs, which includes salaries and benefits, stock-based compensation expense and the cost of services provided by outside contractors. The Company capitalizes advance payments for goods or services that will be used or rendered for future research and development activities and recognizes expense as the related goods are delivered or services are performed. The Company also records expenses and accruals for estimated costs of research and development activities, including third party contract services for clinical research and contract manufacturing. The Company bases its estimates on the best information available at the time. Costs for certain research and development activities are recognized based on the pattern of performance of the individual arrangements, which may differ from the pattern of billings incurred, and are reflected in the condensed consolidated financial statements as prepaid expenses or as accrued research and development expenses. The financial terms of these agreements are subject to negotiation, vary from contract to contract, and may result in uneven payment flows to the Company’s vendors. Billing terms and payments are reviewed by management to ensure estimates of outstanding obligations are appropriate as of period end. Tracking the progress of completion for clinical trial and contract manufacturing activities performed by third parties allows the Company to record the appropriate expense and accruals under the terms of the agreements. General and Administrative Expense General and administrative expenses consist primarily of salaries and related benefits, including share-based compensation expense, related to the Company's executive, finance and other support functions. Other general and administrative expenses include professional fees for legal, auditing, tax, consulting services, investor relations, IT and office expenses, rent and insurance. Stock-Based Compensation The Company accounts for stock-based employee and nonemployee compensation awards in accordance with provisions of ASC 718, Compensation—Stock Compensation (“ASC 718”) . ASC 718 requires the recognition of stock-based compensation expense, using a fair-value based method, for costs related to all stock-based compensation awards. We use the Black-Scholes option-pricing model to determine the fair value of options. The Black-Scholes option-pricing model requires the use of judgment to develop input assumptions, some of which are highly subjective, including: (i) the fair value of our common stock on the date of grant; (ii) the expected term of the award; (iii) the expected volatility; (iv) the risk-free interest rate; and (v) expected dividends. In applying these assumptions, we consider the following factors: Fair Value of Common Stock : The Company’s common stock is listed on the Nasdaq Global Market and its value is determined by the market price on the Nasdaq Global Market as of the date of the grant. 16 Notes to Unaudited Condensed Consolidated Financial Statements Expected Term: The expected term represents the period that the options granted are expected to be outstanding and is determined using the simplified method (based on the mid-point between the vesting date and the end of the contractual term). The expected life is applied to the stock option grant group as a whole as we do not expect substantially different exercise or post-vesting termination behavior among our employee population. Expected Volatility: We used an average historical stock price volatility of comparable public companies within the biotechnology and pharmaceutical industry that were deemed to be representative of future stock price trends due to absence of an active market for the Company’s common stock. Risk-Free Interest Rate: We based the risk-free interest rate over the expected term of the options based on the constant maturity rate of U.S. Treasury securities with similar maturities as of the date of the grant. Expected Dividend: We have not paid and do not anticipate paying any dividends in the near future. Therefore, the expected dividend yield was zero. For awards that vest based solely on achievement of a service condition, the Company recognizes expense on a straight-line basis over the period during which the award holder provides such services. The Company recognizes forfeitures as they occur and reverses any previously recognized compensation cost associated with forfeited awards. The Company accounts for share-based compensation for awards granted to non-employees in a similar fashion to the way it accounts for share-based compensation awards to employees. Warrants Management assesses warrants to determine whether they should be classified as equity or liability. If the classification is determined to be equity, proceeds received for the warrants are recorded as an increase to additional paid-in capital in the condensed consolidated balance sheets. If classified as a liability, the Company records the warrant as a liability on its consolidated balance sheet and remeasures this liability to fair value at each reporting date and recognizes changes in the fair value of the warrant in earnings. Net Loss Per Common Share Basic net loss per common share is determined by dividing the net loss applicable to common shareholders by the weighted average common shares outstanding during the period. The pre-funded warrants to purchase 2,200,000 shares of common stock issued in February 2026 and outstanding as of June 30, 2026 (see Note 8) were included in computing the weighted average common shares outstanding used in calculating basic and diluted loss per share. Outstanding common stock options are e xcluded from the calculation of diluted net loss per share when their effect would be anti-dilutive. For the three and six months ended June 30, 2026 and 2025, the 11,737,518 and 8,797,689 options outstanding, respectively, have been excluded from the computations of diluted weighted average shares outstanding as they would be anti-dilutive. Segments The Company has one operating segment. The Company’s chief operating decision maker, its Chief Executive Officer, manages the Company’s operations on a consolidated basis for the purpose of allocating resources. Recent Accounting Pronouncements The Company reviews new accounting standards as they are issued by the FASB or other standard-setting bodies. The Company did not identify any new standards during the quarter ended June 30, 2026 that it believes will have a material impact on the Company’s financial statements. Accounting Pronouncements Issued and Not Adopted Accounting Standards Update 2024-03— Disaggregation of Income Statement Expenses (DISE) . This new guidance requires all public entities to incorporate disclosures about specific types of expenses included in the expense captions presented on the face of the income statement as well as disclosures about selling expenses. The standard is effective prospectively for fiscal years beginning after December 15, 2026, and interim reporting periods beginning after December 15, 2027. Early adoption and retrospective application are permitted. We are currently evaluating the impact that ASU 2024-03 will have on our condensed consolidated financial statements. 17 Notes to Unaudited Condensed Consolidated Financial Statements The Company reviewed additional recent accounting pronouncements and concluded they are either not applicable or that the Company does not expect adoption to have a material effect on the unaudited condensed consolidated financial statements. 3. Fair Value Measurements The following tables present information about the Company’s financial assets that have been measured at fair value as of June 30, 2026 and December 31, 2025 (in thousands): Description Level 1 Level 2 Level 3 June 30, 2026 Assets: U.S. Treasury Bills $ — $ 400,660 $ — $ 400,660 Money market funds included within cash and cash equivalents 87,832 — — 87,832 Total $ 87,832 $ 400,660 $ — $ 488,492 Description Level 1 Level 2 Level 3 December 31, 2025 Assets: U.S. Treasury Bills $ — $ 318,116 $ — $ 318,116 Money market funds included within cash and cash equivalents 93,595 — — 93,595 Total $ 93,595 $ 318,116 $ — $ 411,711 As of June 30, 2026 and December 31, 2025, the Company’s cash equivalents consisted of money market funds. During the three and six months ended June 30, 2026 and the year ended December 31, 2025, there were no transfers between Level 1, Level 2 and Level 3. 4. Marketable Securities The fair value of available-for-sale marketable securities by type of security was as follows (in thousands): June 30, 2026 Amortized Cost Unrealized Gains Unrealized Losses Fair Value Marketable Securities: U.S. Treasury Bills with original maturity of one year or less $ 134,091 $ — $ ( 40 ) $ 134,051 U. S. Treasury Bills with original maturity of one to two years 267,135 — ( 526 ) 266,609 Total marketable securities $ 401,226 $ — $ ( 566 ) $ 400,660 18 Notes to Unaudited Condensed Consolidated Financial Statements December 31, 2025 Amortized Cost Unrealized Gains Unrealized Losses Fair Value Marketable Securities: U.S. Treasury Bills with original maturity of one year or less $ 233,672 $ 146 $ — $ 233,818 U.S. Treasury Bills with original maturity of one to two years 84,201 97 — 84,298 Total marketable securities $ 317,873 $ 243 $ — $ 318,116 The following table summarizes the Company's available-for-sale securities in an unrealized loss position, aggregated by type and length of time in a continuous unrealized position (in thousands): June 30, 2026 Less than 12 Months 12 Months or Longer Total Fair Value Unrealized Losses Fair Value Unrealized Losses Fair Value Unrealized Losses Marketable Securities: U.S. Treasury Bills $ 400,660 $ ( 566 ) $ — $ — $ 400,660 $ ( 566 ) Total $ 400,660 $ ( 566 ) $ — $ — $ 400,660 $ ( 566 ) As summarized in the tables immediately above, the Company held nineteen debt securities that were in an unrealized loss position as of June 30, 2026. The unrealized losses at June 30, 2026 were attributable to changes in interest rates and do not represent credit losses. The Company does not intend to sell these securities, and it is not more likely than not that it will be required to sell them before recovery of their amortized cost basis. The Company held no debt securities that were in an unrealized loss position as of December 31, 2025. 5. Leases On August 16, 2023, the Company entered into a 2.5 year lease for 4,617 square feet of office space in Boston, Massachusetts (the “Lease Agreement”). In October 2024, the Company amended its Lease Agreement to lease an additional 4,744 square feet of office space in order to expand the Company’s headquarters to 9,361 square feet of office space. The lease required a security deposit totaling $ 0.1 million, which the Company has met with cash on deposit. On June 2, 2025, the Company entered into a Sublease Agreement (the “Sublease”) with J.W. Childs Associates, L.P., as sublandlord, effective on June 4, 2025. Under the Sublease, the Company leased approximately 9,682 square feet of additional office space as part of its corporate headquarters, through June 30, 2027. The base rent of the Sublease is approximately $ 0.5 million per year. The Sublease required an immaterial security deposit, which the Company has satisfied with cash on deposit. On June 3, 2025, the Company entered into a second amendment to the Lease Agreement (the Lease Agreement, together with all amendments, the “Amended Lease”) to extend the term for the 9,361 square feet of office space leased under the Amended Lease through June 30, 2027. The modification of the Lease Agreement required the Company to remeasure the value of the asset and liability in accordance with ASC 842, Leases . The base rent under the Amended Lease continues to be approximately $ 0.6 million per year. The remeasurement did not have a material impact on the Company's right-of-use assets. 19 Notes to Unaudited Condensed Consolidated Financial Statements 6. Accrued Expenses and Other Current Liabilities Accrued expenses and other current liabilities consisted of the following (in thousands): June 30, 2026 December 31, 2025 Accrued research and development expenses $ 28,179 $ 13,085 Accrued bonus and payroll related expenses 4,052 5,041 Accrued professional fees 1,315 591 Accrued other 120 181 Total $ 33,666 $ 18,898 7. Commitments and Contingencies Legal Matters From time to time, the Company is involved in lawsuits, arbitrations, claims, investigations and proceedings, consisting of intellectual property, commercial, employment and other matters, which arise in the ordinary course of business. The Company makes provisions for liabilities when it is both probable that a liability has been incurred and the amount of the loss can be reasonably estimated. On October 22, 2024, a complaint was filed in federal district court in the District of Massachusetts by Y-Trap, Inc. ("Y-Trap"), naming as defendants the Company and Biocon Ltd ("Biocon"), captioned Y-Trap, Inc. v. Biocon Ltd and Bicara Therapeutics Inc., No. 24-cv-12678 (D. Mass.). On January 31, 2025, Y-Trap filed its operative amended complaint. The operative complaint alleges a claim against defendants for correction of inventorship of a number of patents based on a license from The Johns Hopkins University, including patents licensed to the Company relating to ficerafusp alfa. The complaint also alleges claims against defendants for unfair trade practices pursuant to Chapter 93A of the Massachusetts General Laws, unjust enrichment, and civil conspiracy. The operative complaint seeks, among other things, damages (including compensatory, enhanced, and punitive damages), an order correcting the inventorship of the patents at issue, costs and attorney’s fees, and other equitable and injunctive relief. On February 28, 2025, Biocon and Bicara moved to dismiss all of Y-Trap’s claims. On September 30, 2025, the court denied Bicara's motion. On October 30, 2025, Bicara answered the operative complaint, and discovery is ongoing. The Company will continue to vigorously defend against this litigation. On July 15, 2026, the Patent Trial and Appeal Board (“PTAB”) of the United States Patent and Trademark Office instituted a post-grant review petition brought by the Company against The John Hopkins University, No. PGR2026-00025, concerning a patent in a family alleged to be licensed to Y-Trap, U.S. Patent 12,295,968 (“the ’968 patent”). The Company challenges all claims of the ’968 patent under 35 U.S.C. § 112. It is anticipated that the PTAB will issue a final written decision on or before July 14, 2027. The Company does not have contingency reserves established for any litigation liabilities as of June 30, 2026 and December 31, 2025. 8. Stockholder's Equity Preferred Stock The Company has 10,000,000 shares of preferred stock authorized for issuance, par value $ 0.0001 per share. As of June 30, 2026 and December 31, 2025, no shares of preferred stock were issued or outstanding. Common Stock The Company has 500,000,000 shares of Common Stock authorized for issuance, par value $ 0.0001 per share. As of June 30, 2026 and December 31, 2025, 65,931,128 and 56,600,724 sha res were issued and outstanding, respectively. February 2026 Offering 20 Notes to Unaudited Condensed Consolidated Financial Statements In February 2026, the Company issued and sold 8,581,250 shares of its common stock, including 1,406,250 shares pursuant to the exercise of the underwriters’ option to purchase additional shares, at a price to the public of $ 16.00 per share, and pre-funded warrants to purchase 2,200,000 shares of common stock (the "pre-funded warrants"), at a public offering price of $ 15.9999 per pre-funded warrant, which represents the per share public offering price of each share of common stock in the offering, less the $ 0.0001 per share exercise price for each pre-funded warrant. Pre-funded Warrants Subject to certain requirements, the pre-funded warrants, sold in the Company's February 2026 offering, can be exercised by the holder at anytime. As of June 30, 2026, there have not been any exercises of the pre-funded warrants. The pre-funded warrants meet the criteria to be classified as an equity instrument under ASC 815-40, Derivatives and Hedging — Contracts in Entity’s Own Equity , and funds received were recorded as an increase in additional paid-in capital in the condensed consolidated balance sheets. Funds received upon exercise of warrants will be recorded as common stock in the condensed consolidated balance sheets as the exercise price represents the par value of the underlying common stock. At-The-Market Program On October 3, 2025, the Company filed a shelf registration statement on Form S-3 (the “Registration Statement”), with the SEC covering the offering of up to $ 400.0 million of common stock, preferred stock, debt securities, warrants and/or units. The Registration Statement was declared effective by the SEC on November 26, 2025. Concurrent with the filing of the Registration Statement, the Company entered into a sales agreement, dated October 3, 2025, by and between the Company and TD Securities (USA) LLC, acting as sales agent, to establish the ATM Program, pursuant to which the Company may offer and sell shares of its common stock from time to time. In connection with the ATM Program, the Company filed a prospectus with the Registration Statement for the offer and sale of up to $ 150.0 million of shares of common stock from time to time through the sales agent. The Company will pay the agent a commission rate up to 3 % of the gross proceeds of any shares sold and has agreed to provide the sales agent with customary indemnification and contributions against certain liabilities. As of June 30, 2026, the Company had remaining available capacity for share issuances of up to $ 120.0 million under the ATM Program. During the three and six months ended June 30, 2026, there were no sales under the ATM Program. 9. Stock-Based Compensation 2024 Stock Option and Grant Plan In 2024, in connection with the Company’s IPO, the board of directors adopted, and the Company’s shareholders approved the 2024 Stock Option and Grant Plan (the “2024 Plan”) under which the Company may grant equity-based incentive awards to the Company’s employees, officers, directors, consultants and other key persons of the Company and its affiliates upon whose judgment, initiative, and efforts the Company largely depends for the successful conduct of its business. Following the effectiveness of the 2024 Plan, no shares remained available for future issuance under the 2019 Stock Option and Grant Plan (as amended, the “2019 Plan”). Any other options or awards outstanding under the 2019 Plan remain outstanding and effective. The 2024 Plan, initially allowed the Company to grant awards up to 2,453,616 shares of Common Stock, plus shares of common stock subject to awards outstanding under the 2019 Plan that are forfeited, canceled, held back upon exercise of an option or settlement of an award to cover the exercise price or tax withholding, reacquired by the Company prior to vesting, satisfied without the issuance of stock or otherwise terminated (other than by exercise). Each year starting on January 1, 2025 and on each January 1 thereafter, the number of shares of stock reserved and available for issuance under the 2024 Plan shall automatically be cumulatively increased by 5 % of the outstanding shares on the immediately preceding December 31 or such lesser number of shares as approved by the Company. Through June 30, 2026, the Company registered 5,552,037 shares of Common Stock for issuance. The terms of equity award agreements, including vesting requirements, were determined by the board of directors and are subject to the provisions of the 2024 Plan. Equity awards granted to employees and non-employees generally vest over one to four-year period but may be granted with different vesting terms. 21 Notes to Unaudited Condensed Consolidated Financial Statements Stock options granted to employees and non-employees expire no more than 10 years from the date of grant and are generally service based. The 2024 Plan allows for awards to contain performance-based vesting criteria and for such awards that are deemed probable of vesting, the Company records expense in the period in which such determination is made through any estimated remaining vesting period. No awards with performance-based vesting criteria have been granted. 2026 Inducement Plan In January 2026, the Company’s board of directors adopted the Bicara Therapeutics Inc. 2026 Inducement Plan (the “Inducement Plan”) and reserved 1,000,000 shares of common stock for future issuance under the Inducement Plan. In June 2026, the Company amended the Inducement Plan and reserved an additional 700,000 shares of common stock for future issuance under the Inducement Plan. The Inducement Plan, as amended, has not been approved by the stockholders of the Company and provides for the grant of non-qualified stock options, stock appreciation rights, RSAs, RSUs, unrestricted stock awards and dividend equivalent rights to newly hired employees as a material inducement to accept employment with the Company in accordance with Nasdaq Listing Rule 5635(c)(4). Stock-Based Compensation Expense The Company recognized total stock-based compensation expense for non-employees and employees in its statements of operations and comprehensive loss as follows (in thousands): Three Months Ended June 30, Six Months Ended June 30, 2026 2025 2026 2025 Research and development $ 4,226 $ 1,159 $ 6,451 $ 2,300 General and administrative 4,012 2,333 7,645 4,643 Total $ 8,238 $ 3,492 $ 14,096 $ 6,943 Stock Options Stock-based compensation, measured at the grant date based on the fair value of the award, is typically recognized ratably over the requisite service period, using the straight-line method of expense attribution. When utilizing the Black-Scholes option-pricing model to determine the grant date fair value of stock options granted to employees or non-employees, we used the following weighted average assumptions: Three Months Ended June 30, Six Months Ended June 30, 2026 2025 2026 2025 Risk-free interest rate 4.0 %- 4.2 % 3.9 %- 4.1 % 3.7 %- 4.2 % 3.9 %- 4.4 % Expected life (in years) 6.1 5.5 - 6.1 6.1 5.5 - 6.1 Volatility 93.4 %- 94.7 % 90.8 %- 95.4 % 93.4 %- 94.7 % 90.6 %- 95.4 % Expected dividend rate — % — % — % — % Fair value of common stock $ 20.50 -$ 22.58 $ 9.90 -$ 14.71 $ 16.11 -$ 22.58 $ 9.90 -$ 14.71 22 Notes to Unaudited Condensed Consolidated Financial Statements A summary of options award activity for non-employees and employees of the Company is as follows: Shares Weighted- Average Exercise Price Weighted Average – Remaining Contractual Life (years) Aggregate Intrinsic Value (1) (in thousands) Outstanding as of December 31, 2025 9,850,977 $ 9.03 Granted 3,071,020 17.89 Exercised ( 749,154 ) 5.22 Canceled ( 435,325 ) 11.55 Outstanding as of June 30, 2026 11,737,518 11.50 8.56 $ 213,544 Exercisable as of June 30, 2026 3,823,103 $ 8.03 7.84 $ 82,818 Exercisable and expected to vest as of June 30, 2026 11,737,518 $ 11.50 8.56 (1) The aggregate intrinsic value is calculated as the difference between the exercise price of the underlying options and the fair value of the Company’s common stock on June 30, 2026 for the options that were in the money. The weighted-average fair value of options granted during the six months ended June 30, 2026 and 2025, was $ 13.98 and $ 12.16 , respectively. The aggregate intrinsic value of options exercised for the six months ended June 30, 2026 and 2025 was $ 11.5 million and $ 0.8 million, respectively. The Company had 7,914,415 unvested stock options outstanding as of June 30, 2026. As of June 30, 2026, total unrecognized compensation costs of $ 71.1 million related to unvested stock options are expected to be recognized as expense over a weighted average period of 3.0 years. 2024 Employee Stock Purchase Plan On September 5, 2024, the Company’s board of directors adopted, and its stockholders approved, the 2024 Employee Stock Purchase Plan (the "ESPP"), which became effective September 5, 2024. The ESPP initially reserves and authorizes the issuance of up to 507,383 shares of our common stock to participating employees. The ESPP provides that the number of shares reserved and available for issuance will automatically increase on January 1, 2025 and each January 1 thereafter through January 1, 2034, by the least of (i) 1,014,766 shares of common stock, (ii) 1 % of the sum of (A) the number of shares of our common stock issued and outstanding on the immediately preceding December 31, and (B) the number of shares of common stock issuable pursuant to the exercise of any outstanding, pre-funded warrants to acquire such common stock for a nominal exercise price on the immediately preceding December 31, or (iii) such number of shares of common stock as determined by the administrator of the ESPP. The number of shares reserved under the ESPP is subject to adjustment in the event of a stock split, stock dividend, or other change in our capitalization. There has been no activity on this plan to date, and no stock-based compensation expense was recognized during the three and six months ended June 30, 2026. 23 Notes to Unaudited Condensed Consolidated Financial Statements 10. Income Taxes Deferred tax assets and deferred tax liabilities are recognized based on temporary differences between the financial reporting and tax basis of assets and liabilities using statutory rates. A valuation allowance is recorded against deferred tax assets if it is more likely than not that some or all of the deferred tax assets will not be realized. Due to losses incurred since inception and the uncertainty surrounding the realization of the favorable tax attributes in future tax returns, the Company has recorded a full valuation allowance against the Company’s otherwise recognizable net deferred tax assets. 11. Significant Agreements – Related Parties The Company entered into a master services agreement on December 15, 2020 (the “Master Services Agreement”) with Biocon. Pursuant to the terms of the master service agreement, Biocon provided services related to research and development, clinical trials, regulatory interactions and manufacturing. The Company incurred $ 0.1 million and $ 0.0 million expenses under the Master Services Agreement during the three and six months ended June 30, 2026 and 2025, respectively. On July 23, 2019, the Company entered into a contract manufacturing agreement with a wholly-owned subsidiary of Biocon, Biocon Biologics Limited (“BBL”) formerly Biocon Biologics India Limited, which was amended on November 6, 2024 to extend the term of the contract manufacturing agreement until July 23, 2026. Additionally, the Company entered into a material transfer agreement on August 17, 2023, a quality agreement on October 12, 2023, a service agreement on October 18, 2023, and a manufacturing service agreement on December 15, 2023 (collectively, the “BBL Agreements”). Pursuant to the terms of the BBL Agreements, BBL manufactures and supplies specified quantities of products to Bicara to be utilized in research and development and manufacturing as per purchase orders executed from time to time between the two parties. For the three months ended June 30, 2026 and 2025, the Company incurred $ 0.1 million and $ 0.0 million of research and development expenses, respectively, under the BBL Agreements. For the six months ended June 30, 2026 and 2025, the Company incurred $ 0.2 million and $ 0.0 million of research and development expenses, respectively, under the BBL Agreements. As of June 30, 2026 and December 31, 2025, the Company owed $ 0.1 million and $ 0.0 million, respectively. The Company additionally entered into a contract manufacturing agreement with a wholly-owned subsidiary of Biocon, Syngene International Limited (“Syngene”), on July 17, 2019, which was amended and restated on April 1, 2020 with the amended and restated manufacturing service agreement, as amended (the “Syngene Manufacturing Services Agreement”), and a master contract services agreement on July 24, 2020, as amended (the “Syngene Master Contract Services Agreement” and together with the Syngene Manufacturing Services Agreement, the “Syngene Agreements”). Pursuant to the terms of the Syngene Agreements, Syngene manufactures and supplies specified quantities of products to Bicara to be used in research and development as per purchase orders executed from time to time between the two parties and performs additional contract research services under the master contract services agreement. The Syngene Manufacturing Services Agreement expires on the later of October 31, 2027 or the completion of services under all work orders under the agreement. The Syngene Master Contract Services Agreement expires on the later of November 1, 2031 or the completion of all services under the statements of work under the agreement. On December 16, 2024, the Company entered into an additional master contract services agreement with Syngene, whereby Syngene agreed to provide the Company with dedicated research laboratories and personnel (“Dedicated Center Agreement”). The Dedicated Center Agreement expires on the later of December 16, 2028 or the completion of all services under all statements of work under the agreement. For the three months ended June 30, 2026 and 2025, the Company incurred $ 0.9 million and $ 2.9 million of manufacturing and research and development expenses, respectively, under the Syngene Agreements. For the six months ended June 30, 2026 and 2025, the Company incurred $ 2.7 million and $ 9.5 million of manufacturing and research and development expenses, respectively, under the Syngene Agreements. As of June 30, 2026, and December 31, 2025, the Company owed Syngene $ 1.0 million and $ 3.4 million, respectively, relating to these incurred costs, of which $ 0.9 million and $ 2.3 million, respectively, were classified in accounts payable-related party and $ 0.1 million and $ 1.1 million, respectively, were classified as accrued expenses-related party on the balance sheets. 24 Notes to Unaudited Condensed Consolidated Financial Statements 12. Significant Agreements IQVIA On October 15, 2019, the Company entered into a master clinical contract services agreement with IQVIA RDS Inc. (“IQVIA”), which was amended in December 2023 to include global clinical trials. Pursuant to the terms of the agreement, as amended, IQVIA will provide the Company with certain global clinical-development related services and laboratory services under separately executed statements of work (“SOWs”). In June 2021, the Company entered into an SOW with IQVIA for lab and clinical development services, to be invoiced on a monthly basis based on work performed by IQVIA. Under this SOW, Bicara agreed to provide IQVIA with an initial upfront payment of $ 1.8 million, of which $ 1.0 million was a refundable deposit and $ 0.8 million for investigator grant payment in advance. In December 2022, Bicara entered into an authorized to proceed agreement (“ATP”) with IQVIA. Under the ATP, Bicara agreed to provide IQVIA with an additional refundable deposit of $ 0.9 million, which was paid in March 2023. Both the initial deposit and the ATP deposit will be held on account and reconciled against final invoices. As of June 30, 2026 and December 31, 2025, the refundable deposit balance was $ 1.9 million, which is included within other assets on the balance sheets. On December 18, 2024, the Company entered into a second SOW, as amended in April 2026 (the “second SOW”), for lab and clinical development services with IQVIA, which was incorporated into the master clinical contract services agreement and part of the Company’s FORTIFI-HN01 Phase 2/3 clinical trial. Services will be invoiced on a monthly basis based on work performed by IQVIA. Under the second SOW, Bicara agreed to provide IQVIA with an initial upfront payment of $ 12.8 million, of which $ 7.3 million was for investigator grant payments made in advance, $ 4.5 million was a deposit for IQVIA direct services and $ 1.0 million was a deposit for pass through costs. The deposits will be held on account with an incremental return starting the month after 75 % of the budgeted costs has been paid by the Company. Under the second SOW, IQVIA is eligible to receive potential additional payments and it is subject to potential penalties based on certain milestone targets. For the three months ended June 30, 2026 and 2025, the Company incurred $ 17.3 million and $ 8.8 million in expenses, respectively and paid $ 9.2 million and $ 5.2 million, respectively, to IQVIA. For the six months ended June 30, 2026 and 2025 the Company incurred $ 27.1 million and $ 16.8 million in expenses, respectively and paid $ 16.9 million and $ 17.5 million, respectively, to IQVIA. As of June 30, 2026 and December 31, 2025, the Company had $ 1.3 million and $ 0.4 million classified in accounts payable, respectively, and $ 20.0 million and $ 8.6 million classified in accrued expenses and other current liabilities on the balance sheets. Clinical Trial Collaboration and Supply Agreement with MSD On May 19, 2022, we entered into a Clinical Trial Collaboration and Supply Agreement (the "MSD Agreement") with MSD International GmbH ("MSDIG"), and MSD International Business GmbH ("MSDIB" and collectively with MSDIG, "MSD"). Pursuant to the MSD Agreement, we provide ficerafusp alfa and MSD provides pembrolizumab to be used in combination in a clinical trial sponsored by us. The clinical trial is a First-in-Human, Phase 1/1b, Open-label, Multicenter Study intended to characterize the safety, tolerability and recommended dose of single agent ficerafusp alfa and combination ficerafusp alfa plus pembrolizumab. To facilitate such collaboration activities and information exchange and pursuant to the MSD Agreement, we and MSD created a joint development committee with an equal number of representatives from each party. Pursuant to the MSD Agreement, all clinical data resulting from the portion of the clinical trial involving the combination of ficerafusp alfa and pembrolizumab is jointly owned by both us and MSD. We own all clinical data resulting from the part of the clinical trial involving ficerafusp alfa alone or in combination with other treatments that are not pembrolizumab, and MSD owns all clinical data resulting from the part of the clinical trial involving pembrolizumab alone or in combination with other treatments that are not ficerafusp alfa. There are no accounting considerations for this agreement. 25 Notes to Unaudited Condensed Consolidated Financial Statements 13. Defined Contribution Plan The Company currently maintains a tax-qualified 401(k) retirement savings plan for our employees. All eligible employees are able to participate in the plan beginning one month after their first day of employment. Under our defined contribution plan, employees may elect to defer a percentage of their compensation per year, subject to a maximum limit prescribed by tax law, and the Company match a portion of their eligible contributions. The Company provided matching discretionary contributions under the 401(k) plan of $ 0.2 million and $ 0.1 million for the three months ended June 30, 2026 and June 30, 2025, respectively. The Company provided matching discretionary contributions under the 401(k) plan of $ 0.4 million and $ 0.2 million for the six months ended June 30, 2026 and June 30, 2025, respectively. 14. Segment Reporting The Company has one reportable segment relating to research and development of its product. The segment does not currently generate revenues as it is currently conducting clinical trials and has not commercialized any products. The Company’s Chief Operating Decision Maker (the “CODM”), its Chief Executive Officer, manages the Company’s operations on an integrated basis for the purposes of allocating resources. When evaluating the Company’s financial performance, the CODM regularly reviews total expenses and expenses by function and the CODM makes decisions using this information on a global basis. The CODM monitors performance at the consolidated level such that the measure of segment loss is consolidated net loss and the measure of reportable segment assets is reported on the balance sheet as total assets. The table below is a summary of the segment profit or loss, including significant segment expenses (in thousands): Three Months Ended June 30, Six Months Ended June 30, 2026 2025 2026 2025 Expenses Manufacturing and process development $ 11,484 $ 8,266 $ 34,277 $ 26,921 Clinical operations and development 21,384 10,461 36,311 20,487 Research and development personnel cost and other (including stock-based compensation) 12,469 5,528 21,588 10,624 Research 436 543 1,061 1,099 Total research and development 45,773 24,798 93,237 59,131 General and administrative personnel costs (including stock-based compensation) 8,871 4,854 16,834 9,686 Professional fees 4,677 1,392 8,960 2,896 Facility costs, IT, office expense and other 630 974 1,160 2,093 Total general and administrative expenses 14,178 7,220 26,954 14,675 Total operating expenses 59,951 32,018 120,191 73,806 Operating loss ( 59,951 ) ( 32,018 ) ( 120,191 ) ( 73,806 ) Interest income 4,576 4,682 8,659 9,696 Total other income 4,576 4,682 8,659 9,696 Net income before losses ( 55,375 ) ( 27,336 ) ( 111,532 ) ( 64,110 ) Income tax expense ( 61 ) ( 52 ) ( 115 ) ( 124 ) Segment and consolidated net loss $ ( 55,436 ) $ ( 27,388 ) $ ( 111,647 ) $ ( 64,234 ) Included within facility costs, IT, office expense and other are depreciation expense, which is disclosed on the Statement of Cash Flows 26 Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations. The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our unaudited financial statements and related notes appearing elsewhere in this Quarterly Report on Form 10-Q. Some of the information contained in this discussion and analysis or set forth elsewhere in this Quarterly Report on Form 10-Q, including information with respect to our future results of operations or financial condition, business strategy and plans and objectives of management for future operations, includes forward-looking statements that involve risks and uncertainties and should be read together with the “Risk Factors” section of this Quarterly Report on Form 10-Q for a discussion of important factors that could cause our actual results to differ materially from those described in or implied by these forward-looking statements contained in the following discussion and analysis. Please also see the section titled “Special Note Regarding Forward-Looking Statements.” Overview We are a clinical-stage biopharmaceutical company committed to bringing transformative bifunctional therapies to patients with solid tumors. We have built a platform designed to facilitate the development of bifunctional therapies that precisely target the tumor and deliver a tumor-modulating payload to the tumor site. This dual-targeting approach both enhances drug exposure within the tumor microenvironment, or TME, and limits systemic toxicity. This approach was deployed in the development of our lead program ficerafusp alfa, formerly BCA101, a bifunctional epidermal growth factor receptor-, or EGFR, directed monoclonal antibody bound to a human transforming growth factor beta, or TGF-β, ligand trap. By combining these two clinically validated targets, ficerafusp alfa has the potential to exert potent anti-tumor activity by simultaneously blocking both cancer cell-intrinsic EGFR survival and proliferation, as well as the immunosuppressive TGF-β signaling within the TME. Ficerafusp alfa directs the TGF-β inhibitor into the immediate TME through the binding of EGFR on tumor cells, which we believe will drive the tumor penetration of immune cells that lead to deep and durable responses and an increase in overall survival. We believe ficerafusp alfa has the potential to provide meaningful clinical benefit in solid tumors that are challenged by inadequate tumor penetration and where there is a strong biologic rationale for the dual inhibition of both EGFR and TGF-β, such as head and neck cancers and other squamous cell carcinomas which typically overexpress EGFR and TGF-β pathways. We are focusing our efforts and resources on the continued development of ficerafusp alfa in those tumor types for which there is strong biologic rationale and remaining unmet need for enhanced tumor penetration. Our Pipeline Our current development plan for ficerafusp alfa is summarized in the following pipeline chart: 27 Corporate Highlights, Recent Progress and Key Upcoming Milestones • FORTIFI-HN01 Phase 2/3 pivotal trial : We are currently conducting a global, randomized, double-blind, Phase 2/3 FORTIFI-HN01 pivotal trial evaluating 1500mg dosed once weekly, or QW, of ficerafusp alfa in combination with pembrolizumab in first-line, or 1L, recurrent/metastatic, or R/M, human papillomavirus infection, or HPV, -negative head and neck squamous cell carcinoma, or HNSCC, whose tumors express programmed death-ligand 1 with combined positive score, or CPS, of ≥1. In January 2026, we announced that 1500mg QW of ficerafusp alfa was selected as the optimal dose to bring forward in the Phase 3 portion of the FORTIFI-HN01 trial. In February 2026, the transition to the Phase 3 portion of the FORTIFI-HN01 trial was completed. The dose determination was informed by the open-label data sets from our Phase 1/1b trial, as well as data from the treatment arms of the Phase 2 portion of the FORTIFI-HN01 trial. The FORTIFI-HN01 will enroll approximately 650 patients, which we believe is sufficiently designed to achieve results to support potential approval by the U.S. Food and Drug Association, or the FDA. We enrolled the first patients in the FORTIFI-HN01 trial in February 2025. We expect to achieve substantial enrollment by the end of 2026 to enable an interim analysis in mid-2027 to support potential accelerated approval and U.S. launch in 2028. • Alternate dose study to evaluate loading and every-three-week maintenance regimen : In August 2026, we announced the initiation of FORTIFI-FLEX, a randomized clinical study that will evaluate ficerafusp alfa in combination with pembrolizumab, administered as a 12-week loading dose of 1500mg QW followed by maintenance dosing of 2250mg every three weeks. We expect to have results from this study by the time of potential U.S. accelerated approval in 1L R/M HPV-negative HNSCC. This builds on positive data we presented in February 2026 from the Phase 1b expansion cohort evaluating 2000mg of ficerafusp alfa every-other-week in combination with pembrolizumab in 1L R/M HPV-negative HNSCC at the 2026 Multidisciplinary Head and Neck Cancers Symposium, which supported our plans to develop an alternate dosing regimen to expand optionality for patients and providers. • Phase 1b expansion cohorts ◦ 1500mg QW, 750mg QW and 2000mg Q2W plus pembrolizumab in 1L R/M HPV-negative HNSCC : In May 2026, we presented extended follow-up data out to three years from the Phase 1b study of ficerafusp alfa in combination with pembrolizumab in 1L R/M HPV-negative HNSCC at the 2026 American Society of Clinical Oncology Annual Meeting. As of the March 31, 2026 data snapshot, the data, which included the 750mg QW, 1500mg QW, and 2000mg every-other-week, or Q2W, expansion cohorts, showed deep, durable responses observed to be driven by TGF-β inhibition. All three dose cohorts demonstrated clinically meaningful duration of response, or DOR, progression-free survival, or PFS, and overall survival, or OS, representing substantial improvements over standard of care treatment, as well as a generally well-tolerated safety profile. Specifically, three-year follow-up from the 1500mg QW dose cohort showed an estimated overall survival rate of 31%, approximately doubling the survival rate observed in retrospective analysis with standard of care pembrolizumab in HPV-negative patients. Additionally, biomarker analyses across all three dose cohorts demonstrated sustained TGF-β inhibition and immune activation with ficerafusp alfa, reinforcing the mechanistic link between intra-tumoral TGF-β inhibition, immune activation, and the deep, durable responses. Across a pooled cohort analysis, two-thirds of responders achieved deep responses of greater than 80% tumor shrinkage and experienced more durable disease control, with meaningfully longer DOR, PFS, and OS compared to patients with partial responses of less than 80% tumor shrinkage, further reinforcing depth of response as a driver of long-term outcomes in patients with 1L R/M HPV-negative HNSCC. ◦ 1500mg QW plus pembrolizumab in 1L R/M HPV-negative HNSCC with CPS<1 : We are continuing to enroll a Phase 1b expansion cohort evaluating 1500mg QW of ficerafusp alfa in combination with pembrolizumab in patients with 1L R/M HPV-negative HNSCC with a CPS<1. ◦ 1500mg QW plus pembrolizumab in 1L R/M HPV-positive smokers HNSCC : We are continuing to enroll an additional Phase 1b expansion cohort evaluating 1500mg QW of ficerafusp alfa in combination with pembrolizumab in patients with HPV-positive R/M HNSCC and a history of heavy smoking. ◦ 1500mg QW in other solid tumors : We are continuing to enroll Phase 1b expansion cohorts evaluating 1500mg QW of ficerafusp alfa both as monotherapy and in combination with pembrolizumab in patients with third-line metastatic colorectal cancer with microsatellite stable RAS/BRAF wild-type. We expect to present data from these cohorts in the second half of 2026. In 2025, we presented data from additional Phase 1b cohorts evaluating ficerafusp alfa monotherapy in patients with second-line or later cutaneous 28 squamous cell carcinoma, as well as ficerafusp alfa in combination with pembrolizumab in patients with second-line or later squamous cancer of the anal canal. These data demonstrated proof-of-concept in both indications and reinforced our conviction in ficerafusp alfa's broad applicability across TGF-β-driven tumors. Since our inception in December 2018, we have not generated any revenue from product sales or other sources and have incurred significant operating losses and negative cash flows from our operations. Our primary uses of cash to date have been conducting research and development, advancing development of ficerafusp alfa, raising capital, building infrastructure, developing intellectual property, hiring personnel and providing general and administrative support for these operations. To date, we have funded our operations primarily through sale of common stock in connection with our initial public offering, or IPO, ATM Program (as defined below), our February 2026 Offering (as defined below), exercise of stock options, private placements of our redeemable convertible preferred stock, and through debt financing. As of June 30, 2026, we had raised aggregate net proceeds of $885.3 million an d had cash, cash equivalents and marketable securities of $497.3 million . The February 2026 Offering closed on February 26, 2026 and resulted in net proceeds to us of approximate ly $161.8 million. We have incurred operating losses in each year since our inception. Our net losses were $55.4 million and $27.4 million for the three months ended June 30, 2026 and 2025, respectively and $111.6 million and $64.2 million for the six months ended June 30, 2026 and 2025, respectively. As of June 30, 2026, we had an accumulated deficit of $470.6 million. We expect our expenses and operating losses will increase substantially as we: • conduct our current and future clinical trials; • continue our research and development activities; • utilize third parties to manufacture our product candidate and related raw materials or, should we decide to do so, build and maintain a commercial-scale current good manufacturing practice, or cGMP, manufacturing facility; • hire additional research and development, clinical and commercial, and operational personnel; • add quality control, quality assurance, legal, compliance, and other groups to support our operations; • maintain, expand, enforce, defend and protect our intellectual property portfolio (including intellectual property obtained through license agreements) and provide reimbursement of third-party expenses related to our patent portfolio; • seek regulatory approvals for ficerafusp alfa or any future product candidates for which we successfully complete clinical trials; • ultimately establish a sales, marketing and distribution infrastructure to commercialize ficerafusp alfa or any future product candidates for which we may obtain marketing approval; • make any payments due under potential license agreements and any potential milestones, royalties or other payments due under any future in-license or collaboration agreements; and • incur additional costs associated with being a public company. Our net losses may fluctuate significantly from quarter-to-quarter and year-to-year, depending on the timing of our planned clinical trials , manufacturing and research and development activities. Based upon our current operating plans, we believe that our existing cash, cash equivalents and marketable securities, will be sufficient to fund our operations and capital expenditure requirements into the first half of 2029. Without additional funding, we believe that we will have sufficient funds to meet our obligations within the next twelve months from the date of issuance of our condensed consolidated financial statements. We do not expect to generate any revenue from product sales unless and until we successfully complete development and obtain regulatory approval for ficerafusp alfa or future product candidates, which will not be for at least the next several years, if ever. If we obtain regulatory approval for ficerafusp alfa or any of our future product candidates, we expect to incur significant commercialization expenses related to product sales, marketing, manufacturing and distribution. Accordingly, until such time as we can generate significant revenue from sales of our product candidate, if ever, we expect to finance our cash needs through equity offerings, debt financings or other capital sources, including potential collaborations, licenses and other similar arrangements. See the section titled “Liquidity and Capital Resources” below. However, we may be unable to raise 29 additional funds or enter into such other arrangements when needed on favorable terms or at all. Our failure to raise capital or enter into such other arrangements when needed would have a negative impact on our financial condition and could force us to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market product candidate that we would otherwise prefer to develop and market ourselves. Components of Results of Operations Revenue We currently have no products approved for sale, and we have not generated any revenue to date. In the future, we may generate revenue from collaboration or license agreements we may enter into with respect to our product candidate, as well as product sales from any approved product, which approval we do not expect to occur for at least the next several years, if ever. Our ability to generate product revenue will depend on the successful development and eventual commercialization of ficerafusp alfa and any future product candidates we pursue. If we fail to complete clinical development of or to obtain regulatory approval for ficerafusp alfa or any future product candidates, our ability to generate future revenues, and our results of operations and financial position would be adversely affected. Operating Expenses Research and Development (including Research and Development—Related Party) Research and development expenses (including related party research and development) have primarily consisted of external and internal costs associated with our research and development activities, including the development of our bifunctional ficerafusp alfa antibody therapies to treat solid tumors, and the clinical development of our product candidate. Our research and development expenses include: • external expenses, including expenses incurred under arrangements with third parties, such as sponsored research agreements, consultants and our scientific advisors; • the cost to obtain licenses to intellectual property; • personnel-related costs, including salaries, bonuses, benefits, and stock-based compensation for employees engaged in research and development functions; • costs for laboratory supplies, research materials and reagents; and • the cost of developing and validating our manufacturing process for use in our future clinical trials. Most of our research and development expenses have been related to the development of ficerafusp alf a . We use our personnel and infrastructure resources across the breadth of our research and development activities, which are directed toward identifying and developing our product candidate. We expense all research and development costs in the periods in which they are incurred. Costs for certain research and development activities are recognized based on an evaluation of the progress to completion of specific tasks using information and data provided to us by our vendors, related parties and third-party service providers. We plan to substantially increase our research and development expenses for the foreseeable future as we continue with the development of ficerafusp alfa and any other product candidates we may determine to pursue. Due to the inherently unpredictable nature of pre-clinical and clinical development, we cannot determine with certainty the timing of the initiation, duration or costs of future clinical trials and pre-clinical studies of product candidates. The timelines and costs associated with research and development activities are uncertain and can vary significantly for any product candidate we pursue, and development programs are inherently unpredictable due to the nature of clinical development. We anticipate we will make determinations as to which programs to pursue and how much funding to direct to each current program on an ongoing basis in response to clinical results, regulatory developments, and ongoing assessments as to each program’s commercial potential. Research and development activities are central to our business model. Therapeutic candidates in later stages of clinical development generally have higher development costs than those in earlier stages, primarily due to the increased size and duration of later-stage clinical trials. As a result, we expect that our research and development expenses will increase substantially over the next several years as we expect to (i) advance ficerafusp alfa into late-stage clinical trials, (ii) develop ficerafusp alfa for other potential indications and (iii) expand our manufacturing efforts. 30 Our future development costs may vary significantly based on various factors such as timely and successful completion of clinical trials, positive results from our future clinical trials, receipt of marketing approvals from applicable regulatory authorities, establishment of arrangements with third parties, intellectual property updates, and continued acceptable safety, tolerability and efficacy profile of any product candidates that we may develop following approval. Any changes in the outcome of any of these variables with respect to the development of our therapeutic candidates in preclinical and clinical development could mean a significant change in the costs and timing associated with the development of these therapeutic candidates. For example, if the FDA or another regulatory authority were to delay our planned start of clinical trials or require us to conduct clinical trials or other testing beyond those that we currently expect, or if we experience significant delays in enrollment in any of our planned clinical trials, we could be required to expend significant additional financial resources and time to complete clinical development of that therapeutic candidate. We may never obtain regulatory approval for any of our therapeutic candidates, and, even if we do, drug commercialization takes several years and millions of dollars in development costs. General and Administrative General and administrative expenses consist primarily of personnel-related costs, including salaries, bonuses, benefits, and stock-based compensation charges for those individuals in executive, legal, finance, human resources, facility operations, and other administrative functions. Other significant costs include legal fees relating to intellectual property, litigation and corporate matters, professional fees for auditing, accounting, tax and consulting services, office and information technology costs, insurance costs, and facilities, depreciation and other general and administrative expenses, which include rent and maintenance of facilities and utilities. We anticipate that our general and administrative expenses will increase for the foreseeable future to support our increased research and development activities. We also anticipate increased expenses related to audit, accounting, legal, regulatory, and tax-related services associated with maintaining compliance with our Nasdaq and Securities and Exchange Commission, or SEC, requirements, director and officer insurance premiums, and investor relations costs associated with operating as a public company. Other (Expenses) Income Interest I ncome Interest income consists primarily of interest income earned on cash, cash equivalents and marketable securities. Income Taxes The Company’s provision for income taxes is not material for the three and six months ended June 30, 2026 and 2025. Since our inception, we have not recorded any U.S. federal or state income tax benefits for the net losses we have incurred in each year or our earned research and development tax credits, due to our uncertainty of realizing a benefit from those items. Other Comprehensive Loss During the three and six months ended June 30, 2026, the Company held marketable securities in U.S. Treasury Bills. The unrealized loss on these instruments was recorded in Other Comprehensive Loss. 31 Results of Operations Comparison of the three months ended June 30, 2026 and 2025 The following table summarizes our results of operations for the three months ended June 30, 2026 and 2025 (in thousands): Three Months Ended June 30, 2026 2025 Change Operating Expenses: Research and development—related party $ 911 $ 2,932 $ (2,021) Research and development 44,862 21,866 22,996 General and administrative 14,178 7,220 6,958 Total operating expenses 59,951 32,018 27,933 Loss from operations (59,951) (32,018) (27,933) Other income Interest income 4,576 4,682 (106) Total other income 4,576 4,682 (106) Net loss before income taxes (55,375) (27,336) (28,039) Income tax expense (61) (52) (9) Net loss $ (55,436) $ (27,388) $ (28,048) Research and Development Expenses (including Research and Development—Related Party) Research and development expenses increased by $21.0 million from $24.8 million for the three months ended June 30, 2025 to $45.8 million for the three months ended June 30, 2026. The following table summarizes our research and development expenses for the three months ended June 30, 2026 and 2025 (in thousands): Three Months Ended June 30, 2026 2025 Change Manufacturing and process development $ 11,484 $ 8,266 $ 3,218 Clinical operations and development 21,384 10,461 10,923 Research and development personnel cost and other (including stock-based compensation) 12,469 5,528 6,941 Research 436 543 (107) Total research and development expenses $ 45,773 $ 24,798 $ 20,975 The increase in research and development expenses for the three months ended June 30, 2026, compared to the three months ended June 30, 2025 was primarily due to: • approximately $3.2 million in increased manufacturing and process development cost, driven by cost to purchase pembrolizumab in connection with our Phase 2/3 FORTIFI-HN01 pivotal trial; • approximately $10.9 million in increased clinical operation and development cost, driven by costs associated with our Phase 2/3 FORTIFI-HN01 pivotal trial and continued patient enrollment in our ongoing Phase 1/1b trials; and • approximately $6.9 million in increased personnel related costs, including stock-based compensation, driven by higher number and value of stock options granted and an increase in the size of our workforce to support clinical development, manufacturing and research and increased professional service expenses as we continue to build out our clinical operations and development functions. 32 General and Administrative Expenses General and administrative expenses increased by $7.0 million from $7.2 million for the three months ended June 30, 2025 to $14.2 million for the three months ended June 30, 2026. The following table summarizes our general and administrative expenses for the six months ended June 30, 2026 and 2025 (in thousands): Three Months Ended June 30, 2026 2025 Change General and administrative personnel costs (including stock-based compensation) $ 8,871 $ 4,854 $ 4,017 Professional fees 4,677 1,392 3,285 Facility costs, insurance, IT, office expense and other 630 974 (344) Total general and administrative expenses $ 14,178 $ 7,220 $ 6,958 The increase in general and administrative expenses for the three months ended June 30, 2026, compared to the three months ended June 30, 2025 was primarily due to: • approximately $4.0 million in increased personnel related costs, including stock-based compensation, driven by an increase in the size of our workforce and by a higher number and value of stock options granted; and • approximately $3.3 million in increased professional service expenses associated with higher legal, accounting, commercial and other expenses as we continue to build out our general and administrative functions to support advancement of our clinical trials and prepare for potential commercial launch. Other Income Interest income Interest income for the three months ended June 30, 2026 and 2025 was $4.6 million and $4.7 million, respectively. The decrease was primarily due to lower interest rates. Comparison of the six months ended June 30, 2026 and 2025 The following table summarizes our results of operations for the six months ended June 30, 2026 and 2025 (in thousands): Six Months Ended June 30, 2026 2025 Change Operating Expenses: Research and development—related party $ 2,892 $ 9,507 $ (6,615) Research and development 90,345 49,624 40,721 General and administrative 26,954 14,675 12,279 Total operating expenses 120,191 73,806 46,385 Loss from operations (120,191) (73,806) (46,385) Other income Interest income 8,659 9,696 (1,037) Total other income 8,659 9,696 (1,037) Net loss before income taxes (111,532) (64,110) (47,422) Income tax expense (115) (124) 9 Net loss $ (111,647) $ (64,234) $ (47,413) Research and Development Expenses (including Research and Development—Related Party) Research and development expenses increased by $34.1 million from $59.1 million for the six months ended June 30, 2025 to $93.2 million for the six months ended June 30, 2026. 33 The following table summarizes our research and development expenses for the six months ended June 30, 2026 and 2025 (in thousands): Six Months Ended June 30, 2026 2025 Change Manufacturing and process development $ 34,277 $ 26,921 $ 7,356 Clinical operations and development 36,311 20,487 15,824 Research and development personnel cost and other (including stock-based compensation) 21,588 10,624 10,964 Research 1,061 1,099 (38) Total research and development expenses $ 93,237 $ 59,131 $ 34,106 The increase in research and development expenses for the six months ended June 30, 2026, compared to the six months ended June 30, 2025 was primarily due to: • approximately $7.4 million in increased manufacturing and process development cost, driven by additional batch manufacturing of drug substance in connection with our Phase 2/3 FORTIFI-HN01 pivotal trial and Phase 1/1b clinical trial and cost to purchase pembrolizumab in connection with our Phase 2/3 FORTIFI-HN01 pivotal trial: • approximately $15.8 million in increased clinical operation and development cost, driven by costs associated with our Phase 2/3 FORTIFI-HN01 pivotal trial and continued patient enrollment in our ongoing Phase 1/1b trials; and • approximately $11.0 million in increased personnel related costs, including stock-based compensation, driven by higher number and value of stock options granted and an increase in the size of our workforce to support clinical development, manufacturing and research and increased professional service expenses as we continue to build out our clinical operations and development functions. General and Administrative Expenses General and administrative expenses increased by $12.3 million from $14.7 million for the six months ended June 30, 2025 to $27.0 million for the six months ended June 30, 2026. The following table summarizes our general and administrative expenses for the six months ended June 30, 2026 and 2025 (in thousands): Six Months Ended June 30, 2026 2025 Change General and administrative personnel costs (including stock-based compensation) $ 16,834 $ 9,686 $ 7,148 Professional fees 8,960 2,896 6,064 Facility costs, insurance, IT, office expense and other 1,160 2,093 (933) Total general and administrative expenses $ 26,954 $ 14,675 $ 12,279 The increase in general and administrative expenses for the six months ended June 30, 2026, compared to the six months ended June 30, 2025 was primarily due to: • approximately $7.1 million in increased personnel related costs, including stock-based compensation, driven by an increase in the size of our workforce and by a higher number and value of stock options granted; and • approximately $6.1 million in increased professional service expenses associated with higher legal, accounting, commercial and other expenses as we continue to build out our general and administrative functions to support advancement of our clinical trials and prepare for potential commercial launch. 34 Other Income Interest income Interest income for the six months ended June 30, 2026 and 2025 was $8.7 million and $9.7 million, respectively. The decrease was primarily due to lower interest rates. Liquidity and Capital Resources Sources of Liquidity Since our inception in December 2018, we have not generated any revenue from any sources and have incurred significant operating losses and negative cash flows from operations. We expect to incur significant expenses and operating losses for the foreseeable future as we advance the clinical development of ficerafusp alfa or any future product candidates we elect to pursue. Further, we expect to incur additional costs associated with operating as a public company. From our inception in December 2018 through June 30 , 2026 , we have received aggregate net proceeds of $885.3 million fr om the sale of our common stock in the IPO, ATM Program and the February 2026 Offering, the exercise of stock options, and sale of redeemable convertible preferred stock in private placements and debt financing. “At-the-Market” Offering On October 3, 2025, we filed a Registration Statement on Form S-3 with the SEC covering the offering of up to $400.0 million of common stock, preferred stock, debt securities, warrants and/or units. The Registration Statement was declared effective by the SEC on November 26, 2025. Concurrent with the filing of the Registration Statement, we entered into a sales agreement, dated October 3, 2025, by and between the Company and TD Securities (USA) LLC, acting as sales agent, to establish an at-the-market offering program pursuant to which we may offer and sell shares of our common stock from time to time, or the ATM Program. In connection with the ATM Program, we filed a prospectus with the Registration Statement for the offer and sale of up to $150.0 million of shares of common stock from time to time through the sales agent. As market conditions permit, we may offer and sell securities under the Registration Statement, including through the ATM Program, in order to fund our operations or provide additional liquidity. During the three and six months ended June 30, 2026, there were no sales of our common stock through the ATM Program. As of June 30, 2026, a total of 1,604,000 shares of our common stock had been sold through the ATM Program, resulting in net proceeds to us of $29.5 million. February 2026 Offering In February 2026, we issued and sold 8,581,250 shares of its common stock, including 1,406,250 shares pursuant to the exercise of the underwriters’ option to purchase additional shares, at a price to the public of $16.00 per share, and in lieu of common stock to certain investors, we sold pre-funded warrants to purchase 2,200,000 shares of common stock at a public offering price of $15.9999 per pre-funded warrant, which represents the per share public offering price of each share of common stock less the $0.0001 per share exercise price for each pre-funded warrant, or the February 2026 Offering. The February 2026 Offering closed on February 26, 2026 and resulted in net proceeds to us of approximately $161.8 million. Future Funding Requirements As of June 30, 2026, we had cash, cash equivalents and marketable securities of $497.3 million . Based upon our current operating plans, we believe that our existing cash, cash equivalents and marketable securities will be sufficient to fund our operations and capital expenditure requirements into the first half of 2029. However, our forecast of the period of time through which our financial resources will be adequate to support our operations is a forward-looking statement that involves risks and uncertainties, and actual results could vary materially. Additionally, the process of testing our product candidate in clinical trials is costly, and the timing of progress and expenses in these trials is uncertain. We will need to raise substantial additional capital in the future. Our future capital requirements will depend on many factors, including but not limited to: • the type, number, scope, progress, expansions, results, costs, and timing of clinical trials of ficerafusp alfa and future product candidates; 35 • the costs and timing of manufacturing for ficerafusp alfa and any future product candidates and commercial manufacturing thereof; • the costs, timing, and outcome of regulatory review of ficerafusp alfa and any future product candidates; • the terms and timing of establishing and maintaining licenses and other similar arrangements; • the legal costs of obtaining, maintaining, and enforcing our patents and other intellectual property rights (including intellectual property obtained through license agreements); • our efforts to enhance operational systems and hire additional personnel to satisfy our obligations as a public company; • the costs associated with hiring additional personnel and consultants as our clinical activities increase; • the costs and timing of establishing or securing sales and marketing capabilities if ficerafusp alfa or any future product candidate is approved; • our ability to achieve sufficient market acceptance, coverage and adequate reimbursement from third-party payors and adequate market share and revenue for any approved products; and • costs associated with any products or technologies that we may in-license or acquire. Until such time, if ever, as we can generate substantial product revenue to support our cost structure, we expect to finance our cash needs through equity offerings, debt financings, or other capital sources, potentially including collaborations, licenses and other similar arrangements. However, we may be unable to raise additional funds or enter into such other arrangements when needed on favorable terms or at all. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interest of our stockholders will be or could be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our common stockholders. Debt financing and equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures, or declaring dividends. If we raise funds through collaborations, or other similar arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or current or future product candidates or grant licenses on terms that may not be favorable to us and/or may reduce the value of our common stock. Our failure to raise capital or enter into such other arrangements when needed could have a negative impact on our financial condition and on our ability to pursue our business plans and strategies. If we are unable to raise additional funds through equity or debt financings when needed, we may be required to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market our current or future product candidates even if we would otherwise prefer to develop and market such product candidates ourselves. Cash Flows Comparison of the Six Months Ended June 30, 2026 and 2025 The following table sets forth a summary of the net cash flow activity for the six months ended June 30, 2026 and 2025 (in thousands): Six Months Ended June 30, 2026 2025 Net cash used in operating activities $ (81,714) $ (53,700) Net cash used in investing activities (84,049) — Net cash provided by financing activities 165,677 595 Net decrease in cash and cash equivalents $ (86) $ (53,105) Operating Activities For the six months ended June 30, 2026, net cash used in operating activities was $81.7 million resulting from our net loss of $111.6 million, partially offset by net increases in our operating assets and liabilities o f $14.6 million and by non-cash charges of $15.3 million, consisting of stock-based compensation expense, depreciation and non-cash lease e xpense. 36 For the six months ended June 30, 2025, net cash used in operating activities was $53.7 million resulting from our net loss of $64.2 million, partially offset by net increase in our operating assets and liabilities of $3.2 million and non-cash charges of $7.3 million. Non-cash charges consisted of stock-based compensation expense, depreciation and non-cash lease charges. Investing Activities Net cash used in investing activities was $84.0 million for the six months ended June 30, 2026, resulting from cash used to purchase $244.9 million marketable securities, partially offset by proceeds from maturity of marketable securities in 2026 totaling $161.0 million, which were purchased in the third quarter of 2025. Financing Activities Net cash provided by financing activities was $165.7 million for the six months ended June 30, 2026, consisting primarily of proceeds from the offering of common stock and pre-funded warrants in February 2026 and proceeds from the exercise of stock options. Net cash provided by financing activities was $0.6 million for the six months ended June 30, 2025, consisting primarily of proceeds from the exercise of common stock options. Critical Accounting Policies and Estimates This discussion and analysis of our financial condition and results of operations is based on our condensed consolidated financial statements, which we have prepared in accordance with GAAP. The preparation of our financial statements and related disclosures requires us to make estimates, assumptions and judgments that affect the reported amount of assets, liabilities, costs and expenses, and related disclosures. During the three months ended June 30, 2026, there were no material changes to our critical accounting policies and significant judgments described under Management’s Discussion and Analysis of Critical Accounting Policies and Significant Judgments which are included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2025. Emerging Growth Company and Smaller Reporting Company Status The Jumpstart Our Business Startups Act of 2012, or JOBS, permits an “emerging growth company” such as us to take advantage of an extended transition to comply with new or revised accounting standards applicable to public companies until those standards would otherwise apply to private companies. We have elected not to “opt out” of such extended transition period, which means that when a standard is issued or revised and it has different application dates for public or private companies, we will adopt the new or revised standard at the time private companies adopt the new or revised standard and will do so until such time that we either (i) irrevocably elect to “opt out” of such extended transition period or (ii) no longer qualify as an emerging growth company. We may choose to early adopt any new or revised accounting standards whenever such early adoption is permitted for private companies. There are other exemptions and reduced reporting requirements provided by the JOBS Act that we are currently evaluating. For example, as an “emerging growth company,” we are exempt from Sections 14A(a) and (b) of the Securities Exchange Act of 1934, as amended, which would otherwise require us to (1) submit certain executive compensation matters to shareholder advisory votes, such as “say-on-pay,” “say-on-frequency,” and “golden parachutes;” and (2) disclose certain executive compensation related items such as the correlation between executive compensation and performance and comparisons of our chief executive officer’s compensation to our median employee compensation. We also intend to rely on an exemption from the rule requiring us to provide an auditor’s attestation report on our internal controls over financial reporting pursuant to Section 404(b) of the Sarbanes-Oxley Act. We will continue to remain an “emerging growth company” until the earliest of the following: (1) the last day of the fiscal year following the fifth anniversary of the date of the completion of our IPO; (2) the last day of the fiscal year in which our total annual gross revenue is equal to or more than $1.235 billion; (3) the date on which we have issued more than $1 billion in nonconvertible debt during the previous three years; or (4) the date on which we are deemed to be a large accelerated filer under the rules of the SEC. We are also a “smaller reporting company” as defined in the Exchange Act. We may continue to be a smaller reporting company even after we are no longer an emerging growth company. We may take advantage of certain of the scaled disclosures available to smaller reporting companies for so long as either (i) our voting and non-voting common stock held by non-affiliates is less than $250.0 million measured on the last business day of our second fiscal quarter, or (ii) our annual revenue is less than $100.0 million during the most recently completed fiscal year and our voting and non-voting common stock held by non-affiliates is less than $700.0 million measured on the last business day of our second fiscal quarter. 37 Recent Accounting Pronouncements A description of recently issued accounting pronouncements that may potentially impact our financial position and results of operations is disclosed in Note 2 titled “ Summary of Significant Accounting Policie s ” to our condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q . Item 3. Quantitative and Qualitative Disclosures About Market Risk Information required by this Item is not applicable as we are electing scaled disclosure requirements available to Smaller Reporting Companies with respect to this Item. Item 4. Controls and Procedures Evaluation of Disclosure Controls and Procedures We maintain disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended, or the Exchange Act) designed to ensure that information required to be disclosed in the reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms and is accumulated and communicated to management, including the principal executive officer (our Chief Executive Officer) and principal financial officer (our Chief Financial Officer), to allow timely decisions regarding required disclosure. In designing and evaluating our disclosure controls and procedures, management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives, and management necessarily applies judgment in evaluating the benefits of possible controls and procedures relative to their costs. Our management, with the participation of our Chief Executive Officer and Chief Financial Officer, has evaluated the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended) as of June 30, 2026. Based on such evaluation, our Chief Executive Officer and Chief Financial Officer have concluded that our disclosure controls and procedures were effective at the reasonable assurance level as of June 30, 2026. Changes in Internal Control over Financial Reporting There were no changes in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) that occurred during the quarter ended June 30, 2026 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting. 38 PART II—OTHER INFORMATION Item 1. Legal Proceedings. We are subject to various litigation, claims and other proceedings that arise from time to time in the ordinary course of business. On October 22, 2024, a complaint was filed in federal district court in the District of Massachusetts by Y-Trap, Inc., or Y-Trap, naming as defendants us and Biocon Ltd, or Biocon, captioned Y-Trap, Inc. v. Biocon Ltd and Bicara Therapeutics Inc., No. 24-cv-12678 (D. Mass.). On January 31, 2025, Y-Trap filed its operative amended complaint. The operative complaint alleges a claim against the defendants for correction of inventorship of a number of patents based on a license from The Johns Hopkins University, including patents licensed to us relating to ficerafusp alfa. The complaint also alleges claims against defendants for unfair trade practices pursuant to Chapter 93A of the Massachusetts General Laws, unjust enrichment, and civil conspiracy. The operative complaint seeks, among other things, damages (including compensatory, enhanced, and punitive damages), an order correcting the inventorship of the patents at issue, costs and attorney’s fees, and other equitable and injunctive relief. On February 28, 2025, we and Biocon moved to dismiss all of Y-Trap’s claims. On September 30, 2025, the court denied our motion. On October 30, 2025, we answered the operative complaint, and discovery is ongoing. We will continue to vigorously defend against this litigation. On July 15, 2026, the Patent Trial and Appeal Board (“PTAB”) of the United States Patent and Trademark Office instituted a post-grant review petition brought by us against The John Hopkins University, No. PGR2026-00025, concerning a patent in a family alleged to be licensed to Y-Trap, U.S. Patent 12,295,968 (“the ’968 patent”). We challenge all claims of the ’968 patent under 35 U.S.C. § 112. It is anticipated that the PTAB will issue a final written decision on or before July 14, 2027. 39 Item 1A. Risk Factors. Investing in our common stock involves a high degree of risk. You should consider and read carefully all of the risks and uncertainties described below, as well as the other information in this Quarterly Report on Form 10-Q, including our condensed consolidated financial statements and the related notes appearing elsewhere in this Quarterly Report on Form 10-Q and the section titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations” before deciding whether to invest in our common stock. The risks described below are not the only ones facing us. The following risks or additional risks and uncertainties not presently known to us or that we currently believe to be immaterial could materially and adversely affect our business, financial condition, results of operations and growth prospects. In such an event, the trading price of our common stock could decline, and you may lose all or part of your investment. This Quarterly Report on Form 10-Q also contains forward-looking statements and estimates that involve risks and uncertainties not presently known to us or that we currently deem immaterial that also may impair our business operations. Our actual results could differ materially from those anticipated in our forward-looking statements as a result of specific factors, including the risks and uncertainties described below. Risks Related to Our Limited Operating History, Financial Condition and Need for Additional Capital We are a clinical-stage biopharmaceutical company with a limited operating history, which may make it difficult to evaluate our current business and predict our future success and viability. We have incurred significant financial losses since our inception and anticipate that we will continue to incur significant financial losses for the foreseeable future. We are a clinical-stage biopharmaceutical company with a limited operating history. We were formed in December 2018, and our operations to date have been limited to pre-commercial activities. We have not yet demonstrated an ability to generate revenue, obtain regulatory approval, manufacture any product on a commercial scale or arrange for a third party to do so on our behalf or conduct sales and marketing activities necessary for successful product commercialization. Our limited operating history as a company makes any assessment of our future success and viability subject to significant uncertainty. We will encounter risks and difficulties frequently experienced by early-stage biopharmaceutical companies in rapidly evolving fields, and we have not yet demonstrated an ability to successfully overcome such risks and difficulties. If we do not address these risks and difficulties successfully, our business will suffer. We have no products approved for commercial sale and have not generated any revenue from product sales to date. We will continue to incur significant research and development and other expenses related to clinical development and ongoing operations. As a result, we are not profitable and have incurred losses in each period since our inception. Net losses and negative cash flows have had, and will continue to have, an adverse effect on our stockholders’ equity and working capital. Our net losses totale d $55.4 million a nd $27.4 million f or the three months ended June 30, 2026 and 2025, respectively and $111.6 million and $64.2 million for the six months ended June 30, 2026 and 2025, respectively. As of June 30, 2026, we have not yet generated revenues. We expect to continue to incur significant losses for the foreseeable future, and we expect these losses to increase as we continue our research and development of, and seek regulatory approvals for, ficerafusp alfa. We anticipate that our expenses will increase substantially if, and as, we: • advance ficerafusp alfa through clinical development; • seek regulatory approvals for ficerafusp alfa and any of our future product candidates that successfully complete clinical trials; • hire additional clinical, quality control, medical, scientific and other technical personnel to support the clinical development of ficerafusp alfa and any future product candidate; • experience an increase in headcount as we expand our market development and pre-commercial planning activities; • undertake any pre-commercial or commercial activities to establish sales, marketing and distribution capabilities; • advance any future product candidates into clinical development; • seek to identify, acquire and develop additional product candidates, including through business development efforts to invest in or in-license other technologies or product candidates; • maintain, expand and protect our intellectual property portfolio; • make any payments due under our license agreements and any potential milestones, royalties or other payments due under any future in-license or collaboration agreements; and • make milestone, royalty, interest or other payments due under any future financing or other arrangements with third parties. 40 Biopharmaceutical product development entails substantial upfront capital expenditures and significant risk that any potential product candidate will fail to demonstrate adequate efficacy or an acceptable safety profile, gain regulatory approval, secure market access and reimbursement and become commercially viable, and therefore any investment in us is highly speculative. Accordingly, before making an investment in us, you should consider our prospects, factoring in the costs, uncertainties, delays and difficulties frequently encountered by companies in clinical development, especially clinical-stage biopharmaceutical companies such as ours. Any predictions you make about our future success or viability may not be as accurate as they would otherwise be if we had a longer operating history or a history of successfully developing and commercializing pharmaceutical products. We may encounter unforeseen expenses, difficulties, complications, delays and other known or unknown factors in achieving our business objectives. Additionally, our expenses could increase beyond our expectations if we are required by the U.S. Food and Drug Administration, or the FDA, Health Canada, the European Medicines Agency, or the EMA, or other comparable regulatory authorities to perform clinical trials in addition to those that we currently expect, or if there are any delays in establishing appropriate manufacturing arrangements for or in completing our clinical trials or the development of any of our product candidates. If we are unable to raise capital when needed, or on acceptable terms, we may be unable to complete the development and commercialization of ficerafusp alfa or any future product candidates. Developing biopharmaceutical products, including conducting preclinical studies and clinical trials, is a very time-consuming, expensive and uncertain process that takes years to complete. We expect our expenses to continue to increase in connection with our ongoing activities, particularly as we conduct clinical trials of, and seek regulatory and marketing approval for, ficerafusp alfa. Even if ficerafusp alfa or any future product candidates are approved for commercial sale, we anticipate incurring significant costs associated with commercializing any approved product candidate. To date, we have funded our operations principally through our initial public offering, or our IPO, our ATM Program (as defined below), the February 2026 Offering (as defined below), and private financings and may in the future fund operations through additional sales of our securities, including under our ATM Program. We expect our expenses to increase in connection with our ongoing activities, particularly as we continue the clinical development of ficerafusp alfa, continue to develop and deploy our bifunctional approach, commence additional preclinical studies and clinical trials, and continue to identify and develop additional product candidates either through internal development or through acquisitions or in-licensing product candidates. As of June 30, 2026, we had $497.3 million of cash, cash equivalents and marketable securities. Based upon our current operating plan, we believe that our existing cash, cash equivalents and marketable securities will enable us to fund our operating expenses and capital expenditure requirements into the first half of 2029. We have based this estimate on assumptions that may prove to be wrong, and we could utilize our available capital resources sooner than we expect. We may also raise additional financing on an opportunistic basis in the future. For example, we may seek additional capital due to favorable market conditions or strategic considerations even if we believe we have sufficient funds for our current or future operating plans. Attempting to secure additional financing may divert our management from our day-to-day activities, which may adversely affect our ability to develop ficerafusp alfa. Our future capital requirements will depend on many factors, including but not limited to: • the scope, timing, progress, costs and results of clinical trials for ficerafusp alfa or the discovery and preclinical development of any future product candidates; • the number of clinical trials required for regulatory approval of ficerafusp alfa or future product candidates; • the costs, timing and outcome of regulatory review of ficerafusp alfa or any future product candidates; • the costs associated with acquiring or licensing additional product candidates, technologies or assets, including the timing and amount of any milestones, royalties or other payments due in connection with our acquisitions and licenses; • the cost of manufacturing clinical and commercial supplies of ficerafusp alfa or any future product candidates; • the costs and timing of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending any intellectual property-related claims, including any claims by third parties that we are infringing upon their intellectual property rights; • the effectiveness of our approach at identifying target patient populations and utilizing our approach to enrich our patient population in our clinical trials; • our ability to maintain existing, and establish new, strategic collaborations or other arrangements and the financial terms of any such agreements, including the timing and amount of any future milestone, royalty or other payments due under any such agreement; • the costs and timing of future commercialization activities, including manufacturing, marketing, sales and distribution, for any of our product candidates for which we receive marketing approval; 41 • the revenue, if any, received from commercial sales of our product candidates for which we receive marketing approval; • expenses to attract, hire and retain skilled personnel; • the costs of operating as a public company; • our ability to establish a commercially viable pricing structure and obtain approval for coverage and adequate reimbursement from third-party and government payors; • the effect of macroeconomic trends including inflation and rising interest rates; • addressing any potential supply chain interruptions or delays; • the effect of competing technological and market developments; and • the extent to which we acquire or invest in business, products and technologies. Because of the numerous risks and uncertainties associated with research and development of product candidates, we may not be able to accurately predict the timing or amount of our working capital requirements. In addition, if we obtain regulatory approval for ficerafusp alfa, we expect to incur significant commercialization expenses related to product manufacturing, marketing, sales and distribution which make it difficult to predict when or if we will be able to achieve or maintain profitability. Furthermore, we expect to continue to incur increased costs associated with operating as a public company. Accordingly, we will need to obtain substantial additional funding in order to support our continuing operations. Our ability to raise additional funds will depend on financial, economic, political and market conditions and other factors, over which we may have no or limited control. Additional funds may not be available when we need them, on terms that are acceptable to us, or at all. If we fail to obtain necessary capital when needed on acceptable terms, or at all, it could force us to delay, limit, reduce or terminate our product development programs, future commercialization efforts or other operations. Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to ficerafusp alfa. Until such time, if ever, as we can generate substantial product revenue, we expect to finance our operations with our existing cash, cash equivalents and marketable securities, the net proceeds from our IPO, sales of our common stock under our ATM Program, marketable securities, equity financings, or any future equity or debt financings and upfront and milestone and royalties payments, if any, received under any future licenses or collaborations. In the future, if we raise additional capital through the sale of equity or convertible debt securities or issue any equity or convertible debt securities in connection with a collaboration agreement or other contractual arrangement, your ownership interest will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect your rights as a holder of our common stock. In addition, the possibility of such issuance may cause the market price of our common stock to decline. In October 2025, we filed a Registration Statement pursuant to which we may issue up to $400.0 million in shares of our common stock, preferred stock, debt securities, warrants and/or units. Concurrent with the filing of the Registration Statement, we entered into a common stock sales agreement, dated October 3, 2025, by and between the Company and TD Securities (USA) LLC, acting as the sales agent, to establish an at-the-market offering program pursuant to which we may offer and sell shares of our common stock from time to time, or the ATM Program. In connection with the ATM Program, we filed a prospectus with the Registration Statement for the offer and sale of up to $150.0 million of shares of common stock from time to time through the sales agents, or the ATM Prospectus. As of June 30, 2026, we have sold 1,604,000 shares of common stock under our ATM Program for aggregate net proceeds to us of $29.5 million. In February 2026, we entered into an underwriting agreement with Morgan Stanley & Co. LLC, TD Securities (USA) LLC and BofA Securities, Inc., as representatives of the underwriters named therein, pursuant to which we issued and sold an aggregate of 8,581,250 shares of our common stock at a price to the public of $16.00 per share, which included full exercise of the underwriters’ option to purchase 1,406,250 additional shares, and pre-funded warrants to purchase up to 2,200,000 shares of common stock to the underwriters at a public offering price of $15.9999 per pre-funded warrant, or the February 2026 Offering. The February 2026 Offering resulted in net proceeds to us of approximately $161.8 million. As market conditions permit, we may offer and sell securities under the Registration Statement, including through the ATM Program or additional equity financings, which may cause dilution to our stockholders or impact the market price of our common stock. Debt financing, if available, may result in increased fixed payment obligations and involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures, declaring dividends or acquiring, selling or licensing intellectual property rights or assets, which could adversely impact our ability to conduct our business. If we raise additional funds through collaborations, strategic alliances or marketing, distribution or licensing arrangements with third parties in the future, we may have to relinquish valuable rights to our intellectual property, technologies, future 42 revenue streams or product candidates or grant licenses on terms that may not be favorable to us. We could also be required to seek funds through arrangements with collaborators or others at an earlier stage than otherwise would be desirable. Any of these occurrences may have a material adverse effect on our business, operating results and prospects. We maintain the majority of our cash, cash equivalents and marketable securities in accounts with major U.S. and multi-national financial institutions, and our deposits at certain of these institutions exceed insured limits. Market conditions and changes in financial regulations and policies can impact the viability of these institutions. In the event of failure of any of the financial institutions where we maintain our cash, cash equivalents and marketable securities, there can be no assurance that we would be able to access uninsured funds in a timely manner or at all. Any inability to access or delay in accessing these funds could adversely affect our business and financial position. In addition, changes in regulations governing financial institutions are beyond our control and difficult to predict; consequently, the impact of such changes on our business and results of operations is difficult to predict and may have an adverse effect on us. Risks Related to Our Business Operations and Industry Our business is highly dependent on the success of ficerafusp alfa. If we are unable to successfully complete clinical development, obtain regulatory approval for or commercialize ficerafusp alfa, or if we experience delays in doing so, our business will be materially harmed. To date, as an organization, we have not completed the development of any product candidates, and ficerafusp alfa remains in clinical development. Our future success and ability to generate revenue from ficerafusp alfa is dependent on our ability to successfully develop and commercialize ficerafusp alfa or any of our future product candidates. If any of our product candidates encounters safety or efficacy problems, development delays or regulatory issues or other problems, our development plans and business would be materially harmed. We may not have the financial resources to continue development of ficerafusp alfa if we experience any issues that delay or prevent regulatory approval of, or our ability to commercialize, ficerafusp alfa, including: • our inability to demonstrate to the satisfaction of the FDA, Health Canada, the EMA or other comparable regulatory authorities that ficerafusp alfa is safe and effective; • delays or failure in obtaining the necessary approvals from regulators to commence a clinical trial or a suspension, termination, or hold, of a clinical trial once commenced; • conditions imposed by the FDA, Health Canada, the EMA or other comparable regulatory authorities regarding the scope or design of our clinical trials; • delays or failures in reaching agreement on acceptable terms with clinical trial sites or contract research organizations, or CROs; • poor effectiveness of ficerafusp alfa during clinical trials; • better than expected performance of control arms, such as placebo groups, which could lead to negative or inconclusive results from our clinical trials; • higher than anticipated clinical trial or manufacturing costs; • unfavorable FDA, Health Canada, the EMA or other comparable regulatory authority inspection and review of our clinical trial sites; • failure of our CROs, clinical trial sites, or investigators to comply with regulatory requirements or the clinical trial protocol or otherwise meet their contractual obligations in a timely manner, or at all; • delays and changes in regulatory requirements, policies and guidelines, including the imposition of additional regulatory oversight around clinical testing generally or with respect to our therapies in particular; or • varying interpretations of data by the FDA, Health Canada, the EMA and other comparable regulatory authorities. We face significant competition from other biotechnology and pharmaceutical companies, and our operating results will suffer if we fail to compete effectively. The biotechnology industry is intensely competitive and subject to rapid and significant technological change. ficerafusp alfa or any future product candidates may face competition from major pharmaceutical companies, specialty pharmaceutical companies, universities and other research institutions and from products and therapies that currently exist or are being developed, some of which products and therapies we may not currently know about. Many of our competitors have significantly greater financial, manufacturing, marketing, product development, technical and human resources than we do. Large pharmaceutical companies, in particular, have extensive experience in clinical testing, obtaining marketing approvals, recruiting patients and manufacturing pharmaceutical products, and they may also have products that have been approved or are in late stages of development, and collaborative arrangements in our target markets with leading companies and research institutions. Established pharmaceutical companies may also invest heavily to accelerate discovery and development of novel compounds or to in-license novel compounds that could make the product candidates that we develop obsolete. Mergers and acquisitions in the pharmaceutical and biotechnology industries may result in even more 43 resources being concentrated among a smaller number of our competitors. As a result of all of these factors, our competitors may succeed in obtaining patent protection and/or FDA, Health Canada, the EMA or other regulatory approval or discovering, developing and commercializing products in our field before we do, which could result in our competitors establishing a strong market position before we are able to enter the market. Our competitors may obtain FDA, Health Canada, the EMA or other regulatory approval of their product candidates more rapidly than we may or may obtain patent protection or other intellectual property rights that limit our ability to develop or commercialize ficerafusp alfa. Our competitors may also develop drugs or discovery platforms that are more effective, more convenient, more widely used or less costly than ficerafusp alfa or, in the case of drugs, have a better safety profile than ficerafusp alfa. These competitors may also be more successful than us in manufacturing and marketing their products and have significantly greater financial resources and expertise in research and development. There are a large number of companies developing or marketing treatments for cancer, including many major pharmaceutical and biotechnology companies. In addition, numerous compounds are in clinical development for cancer treatment. Many of these companies are well-capitalized and have significant clinical experience. More specifically, we expect to compete with commercially available therapies for the treatment of head and neck squamous cell carcinoma, or HNSCC, including pembrolizumab (marketed as Keytruda by Merck & Co); the combination of pembrolizumab, platinum chemotherapy and 5-fluorouracil; and the combination of cetuximab (marketed as Erbitux by Eli Lilly & Company in the U.S. and by Merck KGaA outside of the U.S.), platinum chemotherapy and 5-fluorouracil. In addition, there are numerous companies that are developing new treatments for HNSCC, including but not limited to Akeso, Inc., AstraZeneca PLC, AVEO Pharmaceuticals, Inc., BioAtla Inc., BioNTech SE, Corbus Pharmaceuticals Holdings Inc., GSK plc, InhibRx Biosciences, Inc., Johnson & Johnson, Merus N.V. (a Genmab A/S company), PDS Biotechnology Corp, Pyxis Oncology, Inc., and Rakuten Medical, Inc. Smaller and other early-stage companies may also prove to be significant competitors. These third parties compete with us in recruiting and retaining qualified scientific and management personnel, establishing clinical trial sites and patient registration for clinical trials, as well as in acquiring technologies complementary to, or necessary for, ficerafusp alfa and any future product candidates. In addition, the biopharmaceutical industry is characterized by rapid technological change. If we fail to stay at the forefront of technological change, we may be unable to compete effectively. Technological advances or products developed by our competitors may render ficerafusp alfa obsolete, less competitive or uneconomical. Our commercial opportunity could be reduced or eliminated if our competitors develop and commercialize products that are safer, more effective, have fewer or less severe side effects, are more convenient, have a broader label, are marketed more effectively, are reimbursed or are less expensive than any products that we may develop. Our competitors may also obtain patent protection or other intellectual property rights that limit our ability to develop or commercialize ficerafusp alfa. Even if ficerafusp alfa achieves marketing approval, it may be priced at a significant premium over competitive products if any have been approved by then, resulting in reduced competitiveness. If we do not compete successfully, we may not generate or derive sufficient revenue from any product candidate for which we obtain marketing approval and may not become or remain profitable. Due to the significant resources required for the development of our pipeline, and depending on our ability to access capital, we must prioritize the development of certain product candidates over others. Moreover, we may fail to expend our limited resources on product candidates or indications that may have been more profitable or for which there is a greater likelihood of success. Our initial focus is the development of ficerafusp alfa in HNSCC and, more generally, we seek to bring transformative bifunctional therapies to patients with solid tumors. We are currently conducting our Phase 2/3 FORTIFI-HN01 pivotal trial of ficerafusp alfa in combination with pembrolizumab in first-line, or 1L, recurrent/metastatic, or R/M, human papillomavirus, or HPV, -negative HNSCC, as well as evaluating ficerafusp alfa in multiple Phase 1b expansion cohorts. In addition, we have initiated an alternate dose study to evaluate ficerafusp alfa with a loading and every-three-week maintenance regimen. Due to the significant resources required for the development of our product candidates, we must decide which product candidates and indications to pursue and advance and the amount of resources to allocate to each. Our decisions concerning the allocation of research, development, collaboration, management and financial resources toward particular product candidates, therapeutic areas or indications may not lead to the development of viable commercial products and may divert resources away from better opportunities. If we make incorrect determinations regarding the viability or market potential of any of our product candidates or misread trends in the pharmaceutical industry, in particular for disorders of the brain and nervous system, our business, financial condition and results of operations could be materially and adversely affected. As a result, we may fail to capitalize on viable commercial products or profitable market oppor