BOSTON, Feb. 26, 2026 (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 the closing of its underwritten public offering of 8,581,250 shares of its common stock, and to certain investors that so choose, pre-funded warrants to purchase 2,200,000 shares of its common stock at an exercise price of $0.0001 per share. The shares of common stock sold inclu ...

BOSTON, Feb. 24, 2026 (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 it has commenced an underwritten public offering of $150 million of shares of its common stock. Bicara intends to grant the underwriters a 30-day option to purchase up to an additional $22,500,000 of shares of common stock offered in the public offering, at the public offer ...

Core Insights - Bicara Therapeutics presented preliminary data from a Phase 1b expansion cohort evaluating ficerafusp alfa in combination with pembrolizumab for treating first-line HPV-negative recurrent/metastatic head and neck squamous cell carcinoma (HNSCC), showing rapid, deep, and durable responses with a well-tolerated safety profile [1][3][4] 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][13] - Ficerafusp alfa is a first-in-class bifunctional antibody designed to enhance tumor penetration and improve survival outcomes by combining an EGFR-directed antibody with a TGF-β ligand trap [2][10] Clinical Data - The Phase 1b expansion cohort data indicated a 48% confirmed overall response rate (ORR) for the 2000mg every other week (Q2W) dosing regimen, with 26% of patients achieving a complete response (CR) and 77% of responders showing at least 80% tumor shrinkage [3][4] - The safety profile of the 2000mg Q2W regimen was consistent with previous findings for ficerafusp alfa combined with pembrolizumab [3][4] - Updated biomarker results confirmed that the 2000mg Q2W regimen maintains TGF-β inhibition and immune activation while delivering deep responses [5] Future Development Plans - The company plans to develop a loading and every-three-week maintenance regimen for ficerafusp alfa, pending regulatory alignment [1][6] - Ongoing enrollment in the pivotal FORTIFI-HN01 study continues to evaluate ficerafusp alfa at 1500mg weekly in combination with pembrolizumab [6][11] Industry Context - HNSCC is one of the most common cancers globally, with a rising incidence expected to reach one million new cases annually by 2030, highlighting a significant unmet need for effective therapies [8][9]

Core Insights - Bicara Therapeutics Inc. is a clinical-stage biopharmaceutical company focused on developing bifunctional therapies for patients with solid tumors [4] Group 1: Employee Inducement Grants - Bicara awarded inducement grants to two new employees on February 2, 2026, under its 2026 Inducement Plan [1] - The employees received non-qualified stock options to purchase a total of 158,900 shares at an exercise price of $16.76 per share, which is the closing price on the grant date [2] - The stock options vest one-fourth on the first anniversary of the employees' start date, with the remaining options vesting in 12 equal quarterly installments, contingent on continued service [2][3] Group 2: Company Overview - Bicara's lead program, ficerafusp alfa, is a first-in-class bifunctional antibody aimed at enhancing tumor penetration by addressing barriers in the tumor microenvironment [4] - Ficerafusp alfa targets two clinically validated components: an epidermal growth factor receptor (EGFR) directed monoclonal antibody and a domain that binds to human transforming growth factor beta (TGF-β) [4] - The therapy is being developed for head and neck squamous cell carcinoma and other solid tumor types, addressing significant unmet medical needs [4]

Company Overview - Bicara Therapeutics Inc. is a clinical-stage biopharmaceutical company focused on developing transformative bifunctional therapies for patients with solid tumors [3] - The company's lead program, ficerafusp alfa, is a first-in-class bifunctional antibody aimed at enhancing tumor penetration by addressing challenges in the tumor microenvironment [3] Product Details - Ficerafusp alfa combines an epidermal growth factor receptor (EGFR) directed monoclonal antibody with a domain that binds to human transforming growth factor beta (TGF-β) [3] - This targeted mechanism aims to reverse the fibrotic and immune-excluded tumor microenvironment driven by TGF-β signaling, facilitating deeper and more durable responses in treatment [3] - Ficerafusp alfa is currently being developed for head and neck squamous cell carcinoma and other solid tumor types, addressing significant unmet medical needs [3] Upcoming Events - Claire Mazumdar, PhD, MBA, the CEO of Bicara Therapeutics, will present at the J.P. Morgan 2026 Healthcare Conference on January 12, 2026, at 11:15 a.m. PT [1] - A live webcast of the presentation will be available on the Investor Relations section of Bicara's website, with a replay accessible after the event [2]

Core Insights - Bicara Therapeutics Inc. is a clinical-stage biopharmaceutical company focused on developing bifunctional therapies for patients with solid tumors [3] - The company will participate in the Goldman Sachs 46th Annual Global Healthcare Conference on June 10, 2025 [1] Company Overview - Bicara Therapeutics is dedicated to creating transformative bifunctional therapies, with its lead program being ficerafusp alfa, a first-in-class bifunctional antibody [3] - Ficerafusp alfa targets the tumor microenvironment by combining an epidermal growth factor receptor (EGFR) directed monoclonal antibody with a domain that binds to human transforming growth factor beta (TGF-β) [3] - The therapy aims to reverse the fibrotic and immune-excluded tumor microenvironment, facilitating deeper tumor penetration and promoting durable responses [3] - Ficerafusp alfa is currently being developed for head and neck squamous cell carcinoma and other solid tumor types, addressing significant unmet medical needs [3]

Core Insights - Bicara Therapeutics presented updated data from its Phase 1/1b clinical trial of ficerafusp alfa combined with pembrolizumab for treating first-line recurrent/metastatic head and neck squamous cell carcinoma (HNSCC), showing promising efficacy and overall survival rates [1][2][4] Efficacy Data - The median duration of response (DOR) was reported at 21.7 months, with 80% of responders achieving a deep response defined as ≥80% tumor shrinkage [1][4] - The median overall survival (OS) was 21.3 months, with a 2-year OS rate of 46% in HPV-negative patients [2][4] - The objective response rate (ORR) was 54% (15 out of 28 patients), with a complete response rate of 21% (6 out of 28 patients) [4] Clinical Significance - The results indicate a significant improvement over historical controls for HPV-negative recurrent/metastatic HNSCC, addressing a critical unmet need in this patient population [3][4] - The combination therapy demonstrated a median progression-free survival of 9.9 months and a disease control rate of 89% [4] Mechanism of Action - Ficerafusp alfa is a first-in-class bifunctional antibody designed to enhance tumor penetration by targeting both the epidermal growth factor receptor (EGFR) and human transforming growth factor beta (TGF-β), which helps remodel the tumor microenvironment [8][10] Company Overview - Bicara Therapeutics is a clinical-stage biopharmaceutical company focused on developing transformative bifunctional therapies for solid tumors, with ficerafusp alfa being its lead program [10]

Core Insights - Bicara Therapeutics is advancing its clinical programs, particularly the pivotal Phase 2/3 trial of ficerafusp alfa in HPV-negative recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) [2][4] - The company has a strong financial position with approximately $462 million in cash and cash equivalents, expected to fund operations into the first half of 2029 [1][11] - Updated data from ongoing clinical trials will be presented at the 2025 ASCO Annual Meeting, showcasing the potential of ficerafusp alfa to demonstrate differentiated depth and durability of response [2][7] Clinical Development - Enrollment is ongoing in the FORTIFI-HN01 trial, which is a global, randomized, double-blind, placebo-controlled study of ficerafusp alfa in combination with pembrolizumab for first-line treatment of R/M HNSCC [4] - The ongoing Phase 1/1b trial is expected to provide insights into the drug's efficacy and mechanisms of action, with preliminary findings indicating effective TGF-β signaling blockade [11][6] - Several expansion cohorts are evaluating different dosing regimens of ficerafusp alfa in combination with pembrolizumab for various patient populations, including those with HPV-negative and HPV-positive cancers [7][6] Financial Performance - For the first quarter of 2025, research and development expenses increased to $34.3 million from $12.0 million in the same period of 2024, primarily due to costs associated with the initiation of clinical trials [11][9] - General and administrative expenses rose to $7.5 million in Q1 2025 from $3.3 million in Q1 2024, reflecting increased personnel costs and professional fees [11][9] - The net loss for the first quarter of 2025 was $36.8 million, compared to a net loss of $12.5 million in the first quarter of 2024 [11][9]