Core Insights - Bicara Therapeutics has initiated dosing in the pivotal Phase 2/3 trial, FORTIFI-HN01, for ficerafusp alfa in first-line recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) [1][4] - The company reported a strong financial position with approximately $490 million in cash and cash equivalents, expected to fund operations into the first half of 2029 [1][12] - The year 2024 was significant for Bicara, marked by its transition to a public company and advancements in its lead asset, ficerafusp alfa [2] Pipeline Highlights - Ficerafusp alfa is a first-in-class bifunctional antibody targeting both epidermal growth factor receptor (EGFR) and transforming growth factor beta (TGF-β) for various solid tumors [3][10] - The ongoing Phase 1/1b trial data will be presented at the 2025 ASCO Annual Meeting, showcasing the potential of ficerafusp alfa in HNSCC [5] Clinical Trials - The FORTIFI-HN01 trial is a global, randomized, double-blind, placebo-controlled study combining ficerafusp alfa with pembrolizumab in first-line R/M HNSCC, excluding HPV-positive oropharyngeal cases [4] - Additional expansion cohorts for ficerafusp alfa are planned in various cancer types, including cutaneous squamous cell carcinoma and colorectal cancer [8] Financial Results - For the fourth quarter of 2024, research and development expenses were $19.9 million, up from $10.6 million in the same period of 2023, primarily due to costs associated with the FORTIFI-HN01 trial [12] - General and administrative expenses increased to $6.8 million for Q4 2024, compared to $3.1 million in Q4 2023, reflecting costs related to operating as a public company [12] - The net loss for the fourth quarter of 2024 was $21.0 million, compared to $12.4 million in Q4 2023 [12][15] Cash Position - As of December 31, 2024, Bicara had cash and cash equivalents of $489.7 million, significantly up from $230.4 million at the end of 2023 [12][17] - The company expects its cash resources to sustain operations through the first half of 2029, supporting ongoing clinical trials and development efforts [12][13]
Bicara Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Update