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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 September 30, 2025 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 ...

FDA Designation and Trials - Bicara Therapeutics received FDA Breakthrough Therapy Designation for ficerafusp alfa in combination with pembrolizumab for first-line treatment of HPV-negative R/M HNSCC[2] - The pivotal Phase 2/3 FORTIFI-HN01 trial is ongoing, focusing on ficerafusp alfa in first-line HPV-negative R/M HNSCC[3] - Data from a Phase 1b expansion cohort evaluating 750mg of ficerafusp alfa weekly is expected to be presented at ESMO Asia 2025[9] - The company aims to present additional data for ficerafusp alfa across various dose cohorts to inform future studies[2] Financial Performance - As of September 30, 2025, Bicara had approximately $408 million in cash, cash equivalents, and investments, down from $489.7 million as of December 31, 2024[9] - Research and development expenses for Q3 2025 were $33.0 million, compared to $15.9 million in Q3 2024, reflecting increased costs associated with clinical trials[9] - General and administrative expenses for Q3 2025 were $7.7 million, up from $4.8 million in Q3 2024, primarily due to additional personnel costs[10] - Net loss for Q3 2025 totaled $36.3 million, compared to a net loss of $17.5 million in Q3 2024[10] - The company expects its existing cash resources to fund operations into the first half of 2029[9] Management Changes - Bicara expanded its management team with new appointments, including Chief Corporate Affairs Officer and Chief Development Officer[5]

Core Insights - The FDA granted Breakthrough Therapy Designation for ficerafusp alfa in combination with pembrolizumab for first-line treatment of HPV-negative recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) [2][6] - Bicara Therapeutics aims to advance its pivotal Phase 2/3 FORTIFI-HN01 trial and present additional data to characterize ficerafusp alfa's efficacy and tolerability [2][3] - The company reported a strong financial position with approximately $408 million in cash and investments as of September 30, 2025 [1][12] Clinical Development - Ficerafusp alfa is being evaluated in multiple clinical trials, including a Phase 1b expansion cohort for HPV-positive HNSCC patients and a Phase 1b cohort for metastatic colorectal cancer [6][12] - Data presented at recent conferences highlighted ficerafusp alfa's ability to improve anti-tumor effects and block transitions in tumor cells, supporting its potential in overcoming drug resistance [6][12] Financial Performance - For Q3 2025, research and development expenses increased to $33 million from $15.9 million in Q3 2024, primarily due to ongoing clinical trials [12][9] - General and administrative expenses rose to $7.7 million in Q3 2025 compared to $4.8 million in Q3 2024, reflecting increased personnel costs [12][9] - The net loss for Q3 2025 was $36.3 million, up from $17.5 million in the same quarter of the previous year [12][9] Upcoming Milestones - Bicara plans to present data from various Phase 1b expansion cohorts at upcoming conferences, including ESMO Asia 2025 and other events in 2026 [12][10] - The company is focused on executing enrollment for the FORTIFI-HN01 trial and further characterizing ficerafusp alfa's profile across different cohorts [2][12]

Core Insights - The U.S. FDA has granted Breakthrough Therapy Designation (BTD) to ficerafusp alfa in combination with pembrolizumab for the first-line treatment of patients with metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) expressing PD-L1 with CPS ≥1, specifically for HPV-negative cases [1][2][3] Company Overview - Bicara Therapeutics is a clinical-stage biopharmaceutical company focused on developing bifunctional therapies for solid tumors, with ficerafusp alfa as its lead program [10] - Ficerafusp alfa is a first-in-class bifunctional antibody designed to enhance tumor penetration by targeting both epidermal growth factor receptor (EGFR) and human transforming growth factor beta (TGF-β) [8][10] Clinical Trial Insights - The BTD was supported by results from multiple Phase 1/1b dose cohorts, showing a median duration of response of 21.7 months and a median overall survival of 21.3 months, alongside a favorable safety profile [3] - The ongoing pivotal trial, FORTIFI-HN01, aims to enroll approximately 650 patients with R/M HNSCC, focusing on overall response rate and overall survival as primary endpoints [5][9] Industry Context - HPV-negative HNSCC is recognized as a distinct clinical indication with poor outcomes and limited treatment options, representing a significant unmet need in oncology [2][7] - HNSCC is one of the most common cancers globally, with an anticipated rise to one million new cases annually by 2030, and approximately 80% of R/M HNSCC cases are HPV-negative [6][7]

Summary of Bicara Therapeutics FY Conference Call Company Overview - Bicara Therapeutics is a clinical-stage biotech company focused on targeted tumor modulation, developing bifunctional molecules that enhance efficacy and durability while eliciting an immunotherapy-like response [3][4] Lead Molecule: Ficerafusp Alfa - Ficerafusp alfa is a bifunctional EGFR-TGF-1/3 inhibitor that entered clinical trials in summer 2020 [3] - Recent data presented at ASCO showed that combining ficerafusp alfa with pembrolizumab in first-line HPV-negative recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) tripled response rates and doubled overall survival compared to pembrolizumab monotherapy [3][12] Unmet Medical Need - HPV-negative head and neck cancer has a poor prognosis, with a 19% overall response rate and a median overall survival of about nine months [7][12] - Ficerafusp alfa shows significantly better efficacy in HPV-negative patients, which are primarily driven by smoking and alcohol use [8][19] Mechanism of Action - Ficerafusp alfa targets TGF-1 and TGF-3, known cancer-associated isoforms, while avoiding cardiotoxicities associated with TGF-2 [4][5] - The molecule is designed to localize TGF- inhibition directly to the tumor microenvironment, enhancing its therapeutic effect [5] Clinical Development and Regulatory Path - The Phase 2/3 trial is designed to satisfy Project Optimus, allowing for accelerated approval based on interim analyses of overall response rates and survival [15][17] - The company anticipates full enrollment by 2027 and is actively engaging with the FDA to ensure compliance with regulatory requirements [14][17][36] Market Opportunity - The majority of recurrent and metastatic head and neck cancer patients are HPV-negative, with estimates of 80-85% in the U.S. and up to 99% in some regions of Europe and Asia [20][21] - The company is developing a companion diagnostic to harmonize HPV testing, which is crucial for patient stratification [21][22] Financial Position - Bicara Therapeutics has over $440 million in cash, sufficient to fund pivotal studies and support ongoing clinical trials [36] Competitive Landscape - The company believes that the market for head and neck cancer is large enough to accommodate multiple therapies, with ficerafusp alfa positioned favorably due to its unique mechanism of action [32][34] Future Directions - Bicara is exploring ficerafusp alfa in other solid tumor indications, including colorectal cancer and cutaneous squamous cell carcinoma, with data expected next year [28][29] - The company is also considering geographic-specific partnerships to enhance market access and commercialization strategies [44] Key Takeaways - Ficerafusp alfa demonstrates promising clinical efficacy in a high unmet need area, with a strong regulatory strategy and financial backing to support its development [3][12][36] - The company is well-positioned to navigate the competitive landscape of oncology therapeutics, particularly in head and neck cancer [32][34]

Financial Data and Key Metrics Changes - The company reported a median overall survival of over 21 months in head and neck cancer, showing a significant improvement over the current standard of care, which is approximately 12.3 months with pembro monotherapy [5][13]. - The confirmed response rate for the company's treatment was reported at 54%, indicating a tripling of the responder population compared to pembro monotherapy [12]. Business Line Data and Key Metrics Changes - The lead asset is an EGFR TGF beta bifunctional molecule, which has been in clinical development since 2020 across various tumor types [3]. - The company is currently enrolling patients in the FORTIFY HN-one trial, which is a pivotal trial for the treatment in head and neck cancer [6]. Market Data and Key Metrics Changes - HPV negative patients account for about 85% of overall head and neck cancer cases in the recurrent and metastatic setting, indicating a substantial target market for the company's treatment [35]. - The total annual incidence of head and neck cancer in the U.S. is around 57,000, with recurrent metastatic cases accounting for approximately 23,000 patients [42]. Company Strategy and Development Direction - The company aims to optimize dosing in its pivotal trial by evaluating two different doses (750 mg and 1500 mg) in combination with pembro, with plans to select the most effective dose based on initial patient data [17][34]. - There are ongoing plans to expand into the locally advanced setting, where the company believes its treatment could show differential effects due to the TGF beta component [40][41]. Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the treatment's ability to mitigate acquired resistance pathways associated with EGFR monoclonal antibodies by combining it with TGF beta [10]. - The company has sufficient cash reserves, with $437 million on hand, providing a runway to fund operations through 2029, allowing it to complete its pivotal trial [61]. Other Important Information - The company is developing a PCR HPV test as a companion diagnostic to improve sensitivity over traditional testing methods [38]. - The company is exploring the potential of its treatment in colorectal cancer, particularly in heavily pretreated populations, with preliminary data expected in 2026 [56]. Q&A Session Summary Question: What is the relative contribution of the two different targets in the mechanism? - The combination of EGFR and TGF beta is designed to mitigate acquired resistance and enhance efficacy in head and neck cancer treatment [10]. Question: What safety events are being observed? - The most common adverse events include acneiform rash and anemia, with manageable side effects and no treatment discontinuations reported [14][15]. Question: How is the pivotal study designed? - The pivotal study includes a dose optimization portion, where initial data from 10 to 20 patients per group will inform the selection of the most effective dose [17]. Question: What is the expected market opportunity for the treatment? - The recurrent metastatic head and neck cancer market is significant, with a large percentage of patients being HPV negative, which the company is targeting [35][42]. Question: What is the company's cash position and funding for future trials? - The company has raised $362 million at its IPO and has $437 million in cash, providing a runway to fund its current pivotal trial through 2029 [61].

Summary of Bicara Therapeutics Conference Call Company Overview - Bicara Therapeutics is a clinical-stage biotechnology company focused on targeted tumor modulation, specifically through its lead program, an EGFR TGF beta trap, which entered clinical trials in 2020 [2][4] Core Points and Arguments Market Opportunity - The recurrent and metastatic head and neck cancer market presents a significant unmet need, with approximately 30,000 patients annually in the US alone, and a larger global market due to high rates of smoking and chewing tobacco [4] - The majority of patients in this market are HPV negative, accounting for about 80% of the frontline opportunity in the US and 90-95% in Europe and Asia [5] Treatment Mechanism - Fisera, the company's lead drug, combines EGFR and TGF beta targeting, which is particularly relevant for the immunosuppressive HPV negative tumor microenvironment [6][7] - The drug has shown a greater than 50% response rate and a tripling of progression-free survival (PFS) compared to standard treatments [16] Clinical Data - At ASCO, data indicated a greater than 50% response rate in HPV negative patients, with a median overall survival (OS) exceeding 20 months, compared to 9 months with standard pembrolizumab [16][30] - The company has observed a 25% complete response rate, which is notable in head and neck cancer [23] Competitive Landscape - Bicara faces competition from Merus, which is developing a bispecific EGFR LGR5 molecule. However, Bicara argues that their mechanism as an immunotherapy leads to deeper and more durable responses [19][20] - The company emphasizes the importance of overall survival and durability over short-term response rates, which have historically not translated into long-term benefits [21] Future Clinical Trials - Bicara plans to expand its clinical trials to include 90 HPV negative patients and is exploring alternative dosing schedules [35][36] - The phase two-three design includes a seamless transition to a larger study, with an interim analysis expected in 2027 [44][56] Financial Position - As of Q2, Bicara reported over $440 million in cash, sufficient to fund its pivotal study and ongoing research [70] Additional Important Points - The company is developing its own HPV PCR test to improve diagnostic accuracy, which is expected to be part of the drug's label [13] - Bicara is also exploring treatment options in colorectal cancer, targeting TGF beta's role in resistance to existing therapies [68][69] - The CPS zero cohort is being enrolled to assess the drug's efficacy in patients who typically do not respond to pembrolizumab [65] This summary encapsulates the key points discussed during the conference call, highlighting Bicara Therapeutics' strategic focus, clinical advancements, and market positioning.

Group 1 - Bicara Therapeutics Inc. is a clinical-stage biopharmaceutical company focused on developing bifunctional therapies for patients with solid tumors [2] - The company's lead program, ficerafusp alfa, is a first-in-class bifunctional antibody that targets the tumor microenvironment to enhance treatment efficacy [2] - Ficerafusp alfa combines an EGFR-directed monoclonal antibody with a domain that binds to TGF-β, aiming to reverse the fibrotic and immune-excluded tumor microenvironment [2] Group 2 - Bicara Therapeutics will participate in multiple investor conferences, including the Cantor Global Healthcare Conference and the Wells Fargo Healthcare Conference [3] - The live webcasts of the investor presentations will be available on the company's Investor Relations website [1][3] - Replays of the webcasts will be archived for access after each event [1]

Core Viewpoint - Bicara Therapeutics Inc. (BCAX) has seen a 5% increase in share price over the past four weeks, closing at $11.33, with a mean price target of $32.6 indicating a potential upside of 187.7% [1] Price Targets - The average price target consists of five estimates ranging from a low of $8.00 to a high of $48.00, with a standard deviation of $15.26, suggesting variability in analyst predictions [2] - The lowest estimate indicates a potential decline of 29.4%, while the highest suggests a 323.7% upside [2] Analyst Consensus and Earnings Estimates - Analysts are optimistic about BCAX's earnings prospects, as indicated by a trend of upward revisions in earnings estimates, which historically correlates with stock price movements [4][11] - Over the past 30 days, one earnings estimate has increased, leading to a 3.6% rise in the Zacks Consensus Estimate for the current year [12] Zacks Rank - BCAX holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate factors, indicating strong potential for upside [13] Caution on Price Targets - While price targets are a common metric, they should not be the sole basis for investment decisions due to concerns about analysts' biases and the reliability of their estimates [3][10]