Business
Bicara Therapeutics Reports First Quarter 2025 Financial Results and Provides Business Update
Updated data from ongoing Phase 1/1b trial in 1L R/M HNSCC to be presented at 2025 ASCO Annual Meeting Enrollment ongoing in FORTIFI-HN01, a pivotal Phase 2/3
About this update from Bicara Therapeutics Inc.
[{"type":"text","content":"Updated data from ongoing Phase 1/1b trial in 1L R/M HNSCC to be presented at 2025 ASCO Annual Meeting Enrollment ongoing in FORTIFI-HN01, a pivotal Phase 2/3 trial of ficerafusp alfa in 1L R/M HNSCC Strong financial position with approximately $462 million in cash and cash equivalents expected to fund operations into the first half of 2029 BOSTON, May 13, 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 first quarter ended March 31, 2025 and provided a business update. \"We continued to execute across our clinical programs in the first quarter, maintaining strong momentum as we advance FORTIFI-HN01, the pivotal Phase 2/3 trial of ficerafusp alfa in HPV-negative recurrent/metastatic head and neck squamous cell carcinoma,\" said Claire Mazumdar, PhD, MBA, Chief Executive Officer of Bicara Therapeutics. \"Near term, we look forward to presenting updated data from our ongoing Phase 1/1b clinical trial in this patient population as part of an oral presentation at the 2025 ASCO Annual Meeting. We believe the data have the potential to demonstrate differentiated depth and durability of response driven by the TGF-β arm of ficerafusp alfa. Additionally, we recently presented several datasets at AACR highlighting the broad therapeutic potential of ficerafusp alfa, including translational data that support its potential to prevent resistance mechanisms and potentially prolong durability in HPV-negative patients.\" 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 for multiple different solid tumor cancer types. 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 1L (first line) recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC), excluding patients with oropharyngeal squamous cell carcinoma associated with human papillomavirus infection (HPV-positive). Ongoing Phase 1/1b Clinical Trial in 1L R/M HNSCC Updated...