Cogent Biosciences Reports Recent Business Highlights and Fourth Quarter and Full Year 2024 Financial Results

Core Insights - Cogent Biosciences is focused on developing precision therapies for genetically defined diseases, with a significant emphasis on bezuclastinib, a selective tyrosine kinase inhibitor targeting systemic mastocytosis and gastrointestinal stromal tumors [2][16] Business Highlights - The company plans to report data from three pivotal clinical trials for bezuclastinib in 2025, with a New Drug Application (NDA) submission expected by the end of 2025 [2][4] - As of December 31, 2024, Cogent had cash and cash equivalents of $287.1 million, which is projected to fund operations into late 2026 [10][19] - Research and development expenses for Q4 2024 were $62.0 million, up from $48.7 million in Q4 2023, driven by the development of bezuclastinib and other pipeline projects [11][18] Clinical Trial Updates - The SUMMIT trial for nonadvanced systemic mastocytosis (NonAdvSM) showed a 56% mean improvement in Total Symptom Score (TSS) at 24 weeks, with 76% of patients achieving over 50% reduction from baseline [5] - The APEX trial for advanced systemic mastocytosis (AdvSM) reported a 52% overall response rate (ORR) per mIWG criteria, with 83% ORR for patients receiving 100 mg BID [5] - The PEAK trial for gastrointestinal stromal tumors (GIST) is expected to report top-line results by the end of 2025 [7] Pipeline Developments - Cogent is advancing a potent and selective KRAS inhibitor, CGT6737, which demonstrated significant activity against KRAS mutations [5] - The company is also developing CGT6297, a potent allosteric inhibitor of PI3Kα, which showed high oral bioavailability and efficacy in animal models [5] Financial Performance - The net loss for Q4 2024 was $67.9 million, compared to a net loss of $54.4 million in Q4 2023, with total operating expenses for the year reaching $275.9 million [14][18] - General and administrative expenses increased to $11.7 million in Q4 2024 from $9.5 million in Q4 2023, reflecting organizational growth [12][18]