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

Core Insights - Cogent Biosciences reported positive top-line results from the SUMMIT trial for bezuclastinib in patients with NonAdvanced Systemic Mastocytosis, achieving statistical significance across all primary and key secondary endpoints [1][5] - The company is on track to share pivotal trial results from PEAK in GIST and APEX in AdvSM in the second half of 2025 [1][12] - Cogent has $453 million in pro-forma cash, sufficient to fund operations through the anticipated launch and into 2027, including proceeds from a $230 million public offering in July 2025 [1][6] Recent Business Highlights - The SUMMIT trial demonstrated a highly statistically significant difference in the mean change in Total Symptom Score (TSS) at 24 weeks (p=0.0002), with a mean reduction of 24.3 points in the bezuclastinib arm compared to 15.4 points in the placebo arm [5] - 87.4% of bezuclastinib-treated patients had a ≥50% reduction in serum tryptase, compared to no patients in the control arm (p<0.0001) [5] - The majority of treatment-emergent adverse events (TEAEs) were of low grade, with serious AEs occurring in 4.2% of patients treated with bezuclastinib [5] Financial Overview - As of June 30, 2025, Cogent had cash, cash equivalents, and marketable securities of $237.8 million, which, along with net proceeds from the public offering, is expected to fund operations into 2027 [6][15] - Research and development expenses for Q2 2025 were $62.2 million, up from $54.3 million in Q2 2024, primarily due to ongoing clinical trials [7] - General and administrative expenses increased to $13.4 million in Q2 2025 from $10.1 million in Q2 2024, attributed to organizational growth [8] Net Loss - The net loss for Q2 2025 was $73.5 million, compared to a net loss of $59.0 million for the same period in 2024 [9][14] Upcoming Milestones - The company anticipates reporting top-line results from the PEAK and APEX trials in the second half of 2025 and plans to submit its first New Drug Application (NDA) by the end of 2025 [12][13] - The anticipated commercial launch of bezuclastinib is expected in 2026 [13] Inducement Grants - On July 30, 2025, the Compensation Committee approved equity awards to six new employees under the company's 2020 Inducement Plan, totaling nonqualified options to purchase 172,450 shares of common stock [10] Company Overview - Cogent Biosciences focuses on developing precision therapies for genetically defined diseases, with bezuclastinib being the most advanced clinical program targeting the KIT D816V mutation [11]