Financial Position - Bicara Therapeutics reported a cash position of approximately 489.7 million at the end of 2024, with expectations to fund operations into the first half of 2029[11]. - Research and development expenses for Q1 2025 were 12.0 million in Q1 2024, primarily due to costs associated with the initiation of the FORTIFI-HN01 trial[11]. - General and administrative expenses rose to 3.3 million in Q1 2024, driven by increased personnel costs and professional fees[11]. - The net loss for Q1 2025 was 12.5 million in Q1 2024[11]. Clinical Trials - The ongoing FORTIFI-HN01 trial is a pivotal Phase 2/3 study evaluating ficerafusp alfa in combination with pembrolizumab for HPV-negative recurrent/metastatic head and neck squamous cell carcinoma[4]. - An oral presentation at the 2025 ASCO Annual Meeting will highlight updated data from the ongoing Phase 1/1b trial of ficerafusp alfa, scheduled for June 1, 2025[8]. - Preliminary findings from the Phase 1/1b trial indicated an overall response rate of 30.4% in patients with second line or later cutaneous squamous cell carcinoma, with a median progression-free survival of 7.0 months[8]. - Bicara is developing ficerafusp alfa as a first-in-class dual-action bifunctional antibody targeting EGFR and TGF-β for various solid tumor types[3]. - Additional Phase 1b expansion cohorts for ficerafusp alfa are ongoing, including evaluations in HPV-negative patients and those with metastatic colorectal cancer[8]. - The company plans to initiate a cohort evaluating ficerafusp alfa in combination with pembrolizumab for HPV-positive patients with a history of heavy smoking in 2025[8].
Bicara Therapeutics Inc.(BCAX) - 2025 Q1 - Quarterly Results