Cogent Biosciences Reports Recent Business Highlights and Third Quarter 2025 Financial Results

Core Insights - Cogent Biosciences is approaching significant milestones with the upcoming top-line results from the Phase 3 PEAK trial in November 2025 and the APEX trial in December 2025 [1][4][13] - The company has received Breakthrough Therapy Designation for bezuclastinib, which is on track for a New Drug Application (NDA) submission for NonAdvanced Systemic Mastocytosis (NonAdvSM) by the end of 2025 [1][5][12] - Cogent has a strong cash position of $430 million, expected to fund operations through the anticipated launch of bezuclastinib and into 2027 [1][6] Recent Business Highlights - The company reported positive top-line results from the SUMMIT trial, achieving statistical significance across all primary and key secondary endpoints for NonAdvSM patients [5] - Cogent plans to present multiple abstracts at the 67th Annual Meeting of the American Society of Hematology (ASH) in December 2025, including two oral presentations on SUMMIT data [1][5][2] - The company has received FDA clearance for its Investigational New Drug (IND) submission for CGT4255, a novel ErbB2 inhibitor, with a Phase 1 trial set to begin in November [5] Financial Overview - As of September 30, 2025, cash, cash equivalents, and marketable securities totaled $390.9 million, an increase from $345.5 million as of June 30, 2025 [6] - Research and development expenses for Q3 2025 were $69.0 million, up from $63.6 million in Q3 2024, primarily due to ongoing clinical trials [7] - General and administrative expenses rose to $14.4 million in Q3 2025 from $11.8 million in Q3 2024, reflecting organizational growth [8] - The net loss for Q3 2025 was $80.9 million, compared to a net loss of $70.6 million for the same period in 2024 [9]