Bicara Therapeutics Inc.(BCAX) - 2025 Q2 - Quarterly Results

Company Overview & Q2 2025 Highlights Bicara Therapeutics reported Q2 2025 financial results and business updates, showcasing positive Phase 1/1b trial data for ficerafusp alfa and a strong financial position Key Highlights Bicara Therapeutics reported Q2 2025 results, highlighting updated Phase 1/1b ficerafusp alfa data and a strong $437 million cash position - Updated data from Phase 1/1b trial of ficerafusp alfa presented at 2025 ASCO Annual Meeting showed deep and durable responses in 1L HPV-negative R/M HNSCC[1] - Data from additional Phase 1/1b expansion cohorts evaluating alternate dose regimens in HPV-negative patients are expected by Q1 2026[1] Cash Position | Metric | Value (million USD) | | :-------------------------------- | :------------------- | | Cash and Cash Equivalents (June 30, 2025) | $437 | | Expected Funding Runway | Into the first half of 2029 | CEO Commentary CEO Claire Mazumdar highlighted ficerafusp alfa's progress, with ASCO 2025 data supporting its differentiated mechanism and pivotal trial design - CEO highlighted excellent progress with ficerafusp alfa development, noting updated Phase 1/1b data presented at ASCO 2025[2] - The data from the 1500mg weekly cohort demonstrated ficerafusp alfa's ability to remodel tumor stroma and drive tumor penetration, resulting in deep, durable anti-tumor responses in HPV-negative R/M HNSCC patients[2] - The ASCO data provides a strong foundation for the pivotal Phase 2/3 FORTIFI-HN01 trial and reinforces confidence in its design, with additional Phase 1/1b expansion cohort data expected to further characterize the safety and efficacy profile[2] Business Update: Pipeline Highlights This section details the development of ficerafusp alfa, including its mechanism, pivotal trial progress, and data from Phase 1/1b studies Ficerafusp Alfa Overview Ficerafusp alfa is a first-in-class, dual-action bifunctional antibody targeting EGFR and TGF-β, designed to enhance tumor penetration - Ficerafusp alfa is a first-in-class, dual-action bifunctional epidermal growth factor receptor (EGFR)/transforming growth factor beta (TGF-β) antibody[3] - It is designed to enhance tumor penetration by breaking barriers in the tumor microenvironment that have challenged the treatment of multiple solid tumor cancers[3] FORTIFI-HN01: Pivotal Phase 2/3 Clinical Trial Enrollment is ongoing for FORTIFI-HN01, a pivotal Phase 2/3 trial evaluating ficerafusp alfa plus pembrolizumab in 1L R/M HNSCC (HPV-negative) - Enrollment is ongoing in FORTIFI-HN01, a global, randomized, double-blind, placebo-controlled, pivotal Phase 2/3 trial[4] - The trial evaluates ficerafusp alfa in combination with pembrolizumab in first-line (1L) recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC)[4] - Patients with oropharyngeal squamous cell carcinoma associated with human papillomavirus infection (HPV-positive) are excluded[4] Phase 1/1b Clinical Trial Data in 1L R/M HNSCC Updated Phase 1/1b trial data for ficerafusp alfa in 1L R/M HNSCC (HPV-negative) showed promising efficacy and safety, with further data expected 1500mg Weekly Cohort (ASCO 2025 Data) ASCO 2025 data for the 1500mg weekly ficerafusp alfa cohort in 1L R/M HNSCC (HPV-negative) demonstrated significant efficacy and a manageable safety profile - Updated data with extended follow-up from a Phase 1/1b trial evaluating 1500mg ficerafusp alfa weekly in patients with 1L R/M HNSCC was highlighted at the 2025 ASCO Annual Meeting[8] Efficacy in HPV-negative population (n=28) | Metric | Value | | :-------------------------------- | :------------------- | | Median Duration of Response (DOR) | 21.7 months (among responders, n=15) | | Median Overall Survival (OS) | 21.3 months | | 2-year OS rate | 46% | | Confirmed Objective Response Rate (ORR) | 54% (15/28) | | Total ORR (including unconfirmed) | 64% (18/28) | | Complete Response Rate (CRR) | 21% (6/28) | | Responders achieving deep response (≥80% tumor shrinkage) | 80% (12/15) | | Disease Control Rate (DCR) | 89% (25/28) | | Median Progression-Free Survival (PFS) | 9.9 months | | Safety Profile | Manageable, consistent with previously reported adverse events | Additional Phase 1b Expansion Cohorts Data from additional Phase 1b expansion cohorts evaluating alternate ficerafusp alfa dose regimens and patient populations are anticipated in late 2025 and 2026 - Data from a cohort evaluating 750mg of ficerafusp alfa weekly in combination with pembrolizumab in HPV-negative patients are expected to be presented at a medical meeting in Q4 2025 or Q1 2026[8] - Data from a cohort evaluating 2000mg of ficerafusp alfa every other week in combination with pembrolizumab in HPV-negative patients are expected to be presented at a medical meeting in Q1 2026[8] - A cohort evaluating 1500mg weekly of ficerafusp alfa in combination with pembrolizumab in HPV-negative patients with combined positive scores (CPS) of 0 continues to enroll, with data expected in 2026[8] Development Across Other Solid Tumor Types Bicara is expanding ficerafusp alfa's development into other solid tumor types, including an ongoing Phase 1b expansion cohort in metastatic colorectal cancer - A Phase 1b expansion cohort evaluating ficerafusp alfa as monotherapy and in combination with pembrolizumab in patients with 3L+ metastatic colorectal cancer (RAS/BRAF wild type) is currently enrolling[6] Second Quarter 2025 Financial Results This section details Bicara's Q2 2025 financial performance, including cash position, operating expenses, and net loss Financial Highlights Bicara Therapeutics reported decreased cash, increased R&D and G&A expenses, and a higher net loss for Q2 2025 year-over-year Cash Position | Date | Cash and Cash Equivalents (million USD) | | :---------------- | :------------------------ | | June 30, 2025 | $436.6 | | December 31, 2024 | $489.7 | * Change: Decrease of $53.1 million (-10.8%) QoQ * Funding Runway: Expected to fund operations into the first half of 2029 Research and Development Expenses (Q2 YoY) | Period | Amount (million USD) | | :---------------- | :------------------- | | Q2 2025 | $24.8 | | Q2 2024 | $15.8 | * Change: Increase of $9.0 million (+57.0%) YoY * Primary Reason: Additional costs for FORTIFI-HN01 initiation, ongoing Phase 1/1b trials, and increased personnel costs General and Administrative Expenses (Q2 YoY) | Period | Amount (million USD) | | :---------------- | :------------------- | | Q2 2025 | $7.2 | | Q2 2024 | $3.9 | * Change: Increase of $3.3 million (+84.6%) YoY * Primary Reason: Additional personnel costs and professional fees to support clinical trials and public company operations Net Loss (Q2 YoY) | Period | Amount (million USD) | | :---------------- | :------------------- | | Q2 2025 | $27.4 | | Q2 2024 | $17.0 | * Change: Increase of $10.4 million (+61.2%) YoY Condensed Consolidated Statements of Operations The statements of operations show increased operating expenses and net loss for Q2 and H1 2025, driven by higher R&D and G&A costs Condensed Consolidated Statements of Operations (in thousands USD) | | Three Months Ended June 30, | | Six Months Ended June 30, | | :------------------------------------------------- | :--- | :--- | :--- | :--- | | | 2025 | 2024 | 2025 | 2024 | | Operating expenses | | | | | | Research and development - related party | $ 2,932 | $ 1,510 | $ 9,507 | $ 5,091 | | Research and development | 21,866 | 14,331 | 49,624 | 22,782 | | General and administrative | 7,220 | 3,909 | 14,675 | 7,251 | | Total operating expenses | 32,018 | 19,750 | 73,806 | 35,124 | | Loss from operations | (32,018) | (19,750) | (73,806) | (35,124) | | Other income | | | | | | Interest income | 4,682 | 2,701 | 9,696 | 5,568 | | Total other income | 4,682 | 2,701 | 9,696 | 5,568 | | Net loss before income taxes | (27,336) | (17,049) | (64,110) | (29,556) | | Income tax expense | (52) | – | (124) | (1) | | Net loss | $ (27,388) | $ (46,606) | $ (64,234) | $ (29,557) | | Net Loss per share, basic and diluted | $ (0.50) | $ (19.01) | $ (1.18) | $ (38.19) | | Weighted-average number common shares outstanding, basic and diluted | 54,539,230 | 896,744 | 54,496,862 | 774,012 | | Expenses include the following non-cash stock-based compensation expense | | | | | | Research & Development | $ 1,159 | $ 251 | $ 2,300 | $ 481 | | General and administrative | 2,333 | 787 | 4,643 | 1,704 | | Total stock-based compensation expense | $ 3,492 | $ 1,038 | $ 6,943 | $ 2,185 | Condensed Consolidated Balance Sheets Bicara's balance sheet as of June 30, 2025, reflects decreased cash and total assets, stable liabilities, and reduced stockholders' equity Condensed Consolidated Balance Sheets (in thousands USD) | | June 30, 2025 | December 31, 2024 | | :------------------------------------ | :------------ | :---------------- | | Assets | | | | Cash and cash equivalents | $ 436,606 | $ 489,711 | | Prepaid expenses and other assets | 7,785 | 12,822 | | Total current assets | 444,391 | 502,533 | | Property and equipment, net | 117 | 155 | | Right of use asset – operating lease | 2,237 | 690 | | Other assets | 6,842 | 6,618 | | Total assets | $ 453,587 | $ 509,996 | | Liabilities and stockholders' equity | | | | Accounts payable | $ 2,041 | $ 3,893 | | Accounts payable – related party | 870 | 615 | | Accrued expenses and other current liabilities | 12,000 | 12,875 | | Accrued expenses and other current liabilities – related party | 1,242 | — | | Operating lease liability – current portion | 1,074 | 607 | | Total current liabilities | 17,227 | 17,990 | | Operating lease liability – net of current portion | 1,164 | 131 | | Total liabilities | 18,391 | 18,121 | | Total stockholders' equity | 435,196 | 491,875 | | Total liabilities and stockholders' equity | $ 453,587 | $ 509,996 | About Bicara Therapeutics Bicara Therapeutics is a clinical-stage biopharmaceutical company developing transformative bifunctional therapies for solid tumors, with ficerafusp alfa as its lead program - Bicara Therapeutics is a clinical-stage biopharmaceutical company committed to bringing transformative bifunctional therapies to patients with solid tumors[10] - Ficerafusp alfa, the lead program, is a first-in-class bifunctional antibody designed to drive tumor penetration by breaking barriers in the tumor microenvironment[10] - It combines two clinically validated targets: an epidermal growth factor receptor (EGFR) directed monoclonal antibody with a domain that binds to human transforming growth factor beta (TGF-β), reversing the fibrotic and immune-excluded tumor microenvironment[10] Forward-Looking Statements This section outlines standard forward-looking statements regarding Bicara's strategy, clinical development, and financial outlook, subject to inherent risks and uncertainties - The press release contains forward-looking statements regarding Bicara's strategy, business plans, clinical development of ficerafusp alfa (including enrollment, progress, and anticipated data readouts), expected therapeutic potential, and cash runway[11] - These statements are based on management's current expectations and beliefs and are subject to risks and uncertainties, including those related to product candidate development, clinical trial results, regulatory developments, and sufficiency of cash resources[11] - Bicara explicitly disclaims any obligation to update forward-looking statements and advises against relying on them as representing views as of any subsequent date[11] Investor Relations Bicara Therapeutics uses its Investor Relations website as a primary channel for disclosing material nonpublic information and fulfilling Regulation FD obligations - Bicara intends to use its Investor Relations website for disclosing material nonpublic information and complying with Regulation FD[12] - Investors should monitor the Company's Investor Relations website in addition to press releases, SEC filings, public conference calls, presentations, and webcasts[12] Contacts This section provides essential contact information for investor and media inquiries - Contact information for investors (Rachel Frank, IR@bicara.com) and media (Amanda Lazaro, 1AB, Amanda@1abmedia.com) is provided[17]