BOSTON, Dec. 15, 2025 (GLOBE NEWSWIRE) -- Bicara Therapeutics Inc. (Nasdaq: BCAX), a clinical-stage biopharmaceutical company committed to bringing transformative bifunctional therapies to patients with solid tumors, today announced that Claire Mazumdar, PhD, MBA, Chief Executive Officer, will present at the J.P. Morgan 2026 Healthcare Conference on Monday, January 12, 2026 at 11:15 a.m. PT. A live webcast of the presentation will be accessible through the Investor Relations section of Bicara’s website unde ...

Core Insights - Bicara Therapeutics presented preliminary data from a Phase 1b expansion cohort evaluating 750 mg of ficerafusp alfa in combination with pembrolizumab for treating HPV-negative recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) [2][3] - The data showed a 57% confirmed overall response rate with 10% of patients achieving a complete response and 29% demonstrating deep responses of at least 80% tumor shrinkage [3][4] - The company plans to declare the optimal biologic dose for the pivotal FORTIFI-HN01 study in the first quarter of 2026 [5] 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 [12] - Ficerafusp alfa is a first-in-class bifunctional antibody designed to enhance tumor penetration and drive durable responses by targeting both EGFR and TGF-β [10][12] - The FDA has granted Breakthrough Therapy Designation to ficerafusp alfa in combination with pembrolizumab for first-line treatment of R/M HNSCC [10] Clinical Data - The Phase 1b expansion cohort data indicated that 750 mg of ficerafusp alfa was well-tolerated, with a safety profile consistent with previous studies [3][4] - Higher doses of ficerafusp alfa (1500 mg) showed greater TGF-β inhibition and immune activation, leading to deeper clinical responses, with a median depth of response of 82% compared to 63% at the 750 mg dose [4][5] - The totality of data suggests that increased TGF-β inhibition correlates with more durable outcomes for patients [5]

Core Insights - Bicara Therapeutics Inc. presented preliminary data from a Phase 1b expansion cohort evaluating 750 mg of ficerafusp alfa in combination with pembrolizumab for treating HPV-negative recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) [2][3] - The data showed a 57% confirmed overall response rate with 10% of patients achieving a complete response and 29% of responders demonstrating deep responses of at least 80% tumor shrinkage [3][4] - The company plans to declare the optimal biologic dose for the pivotal FORTIFI-HN01 study in the first quarter of 2026 [5] Company Overview - Bicara Therapeutics is a clinical-stage biopharmaceutical company focused on developing bifunctional therapies for solid tumors, with ficerafusp alfa being its lead program [12] - Ficerafusp alfa is a first-in-class bifunctional antibody designed to enhance tumor penetration and drive durable responses by targeting both EGFR and TGF-β [10][12] - The FDA has granted Breakthrough Therapy Designation to ficerafusp alfa in combination with pembrolizumab for first-line treatment of R/M HNSCC [10] Clinical Data - The Phase 1b expansion cohort data indicated that 750 mg of ficerafusp alfa combined with pembrolizumab was well-tolerated, maintaining a safety profile consistent with previous studies [3][4] - Higher doses of ficerafusp alfa (1500 mg) showed greater TGF-β inhibition and immune activation, leading to deeper clinical responses, with a median depth of response of 82% compared to 63% at the 750 mg dose [4][5] - The totality of data suggests that increased TGF-β inhibition correlates with more durable outcomes for patients [5] Industry Context - HNSCC is one of the most common cancers globally, with an anticipated rise to one million new cases annually by 2030 [8] - Approximately 80% of patients with recurrent/metastatic HNSCC are HPV-negative, highlighting a significant unmet need for effective therapies [9]

Summary of Bicara Therapeutics FY Conference Call Company Overview - Bicara Therapeutics focuses on developing bifunctional, trifunctional, and multifunctional agents targeting solid tumors, with a primary emphasis on TGF- and EGFR [4][5][6] Key Clinical Developments - The lead program, ficerafusp alfa, is in a pivotal phase 2-3 trial for frontline recurrent metastatic head and neck cancer, initiated in February 2025 [5][6] - Clinical data presented at ASCO 2023 showed significant improvements in response rates, progression-free survival (PFS), duration of response, and overall survival [6][9] - The response rate in the trial has nearly tripled compared to standard treatments, with a median duration of response exceeding 20 months [10][11] Mechanism of Action Insights - TGF- is believed to enhance the depth and durability of responses, while EGFR primarily drives response rates [14][15] - The trial has demonstrated a 55% confirmed response rate at the 750 mg dose, comparable to the 1500 mg dose, indicating effective saturation of the EGFR target [14][15] - The data suggests that TGF- contributes significantly to the clinical benefits observed, particularly in terms of duration of response [12][34] Safety Profile - The safety profile at the 1500 mg dose includes transient, low-grade bleeding events, primarily epistaxis and gingival bleeding, which are common in head and neck cancer patients [21][22] - Anemia rates are higher at the 1500 mg dose, but this has not led to treatment discontinuations [22] Trial Design and Regulatory Strategy - The phase 2 component of the trial aims to determine the optimal dose between 750 mg and 1500 mg, with a seamless design allowing for accelerated approval based on overall response rate [25][27] - The FDA has guided that approximately 350 events will be sufficient for a data cut to facilitate potential accelerated approval [25] Competitive Landscape - Bicara's approach is differentiated by its focus on TGF- in combination with EGFR, which has shown superior duration of response compared to other treatments [33][34] - The company has excluded HPV-positive patients from its pivotal study to focus on a population with a higher likelihood of response [36][37] Future Outlook - Bicara plans to provide updates on the 2000 mg Q2W expansion cohort in early 2026, which may allow for less frequent dosing and better synchronization with pembrolizumab [28][30] - The company is expanding its clinical trial sites globally, including North America, Europe, Asia, and South America, to enhance patient recruitment [40]

Core Insights - Bicara Therapeutics announced early data from a Phase 1b expansion cohort evaluating 750mg of ficerafusp alfa in combination with pembrolizumab for first-line HPV-negative recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) [1][2] - The results indicate a high overall response rate and a safety profile consistent with the 1500mg dose, supporting ongoing pivotal trials [1][2] 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 [11] - Ficerafusp alfa is a first-in-class bifunctional antibody designed to enhance tumor penetration by targeting both epidermal growth factor receptor (EGFR) and transforming growth factor beta (TGF-β) [9][11] Clinical Trial Data - In the efficacy evaluable population of 30 patients, the objective response rate was 57%, with 50% achieving partial responses and 7% achieving complete responses [6] - The disease control rate was reported at 83%, and complete neutralization of TGF-β1 was observed [6] - Safety findings were consistent with the known safety profile of ficerafusp alfa plus pembrolizumab in R/M HNSCC [6] Upcoming Events - Bicara Therapeutics will present the findings at the European Society for Medical Oncology (ESMO) Asia Congress on December 6, 2025, and will host a conference call and webcast on the same day [1][5][3]

Core Insights - The article emphasizes the importance of staying updated on stocks within the biotech, pharma, and healthcare sectors, highlighting key trends and catalysts that influence market valuations [1]. Group 1: Industry Overview - The biotech, pharma, and healthcare industries are experiencing significant movements, necessitating investors to track developments closely [1]. - The Haggerston BioHealth investing group provides insights into catalysts for investment decisions, including buy and sell ratings, product sales forecasts, and integrated financial analyses [1]. Group 2: Analyst Background - Edmund Ingham, a biotech consultant with over five years of experience, has compiled detailed reports on more than 1,000 companies in the sector [1]. - The investing group led by Ingham caters to both novice and experienced investors, offering comprehensive market analyses and forecasts [1].

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]