Business
Bicara Therapeutics Reports Second Quarter 2025 Financial Results and Provides Business Update
Updated data from Phase 1/1b trial presented at 2025 ASCO Annual Meeting demonstrated deep and durable responses in 1L HPV-negative R/M HNSCC Data from
About this update from Bicara Therapeutics Inc.
[{"type":"text","content":"Updated data from Phase 1/1b trial presented at 2025 ASCO Annual Meeting demonstrated deep and durable responses in 1L HPV-negative R/M HNSCC Data from additional Phase 1/1b expansion cohorts evaluating alternate dose regimens in HPV-negative patients expected by Q1 2026 Strong financial position with approximately $437 million in cash and cash equivalents as of June 30, 2025 expected to fund operations into the first half of 2029 BOSTON, Aug. 12, 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 financial results for the second quarter ended June 30, 2025 and provided a business update. “We continue to make excellent progress with the development of ficerafusp alfa,” said Claire Mazumdar, PhD, MBA, Chief Executive Officer of Bicara Therapeutics. “Updated Phase 1/1b data recently presented at ASCO 2025 from the 1500mg weekly cohort underscore the differentiated ability of ficerafusp alfa to remodel the tumor stroma and drive tumor penetration, with deep, durable anti-tumor responses observed in HPV-negative recurrent/metastatic head and neck squamous cell carcinoma patients. These data provide a strong foundation for the continued advancement of our pivotal Phase 2/3 FORTIFI-HN01 trial, and reinforce our confidence in the study design. We also look forward to presenting data from two additional Phase 1/1b expansion cohorts evaluating alternate dose regimens in patients with HPV-negative disease, which are expected to further characterize the safety and efficacy profile of ficerafusp alfa in this population with high unmet need.” Pipeline Highlights Bicara is developing ficerafusp alfa, a first-in-class, dual-action bifunctional epidermal growth factor receptor (EGFR)/transforming growth factor beta (TGF-β) antibody designed to enhance tumor penetration by breaking barriers in the tumor microenvironment that have challenged the treatment of multiple solid tumor cancers. FORTIFI-HN01: Pivotal Phase 2/3 Clinical Trial in 1L R/M HNSCC Enrollment is ongoing in FORTIFI-HN01, a global, randomized, double-blind, placebo-controlled, pivotal Phase 2/3 trial of ficerafusp alfa in combination with pembrolizumab in first line (1L) recurrent/metastatic (R/M) head and neck squamou...