Cogent Biosciences Inc (COGT) 2025 Earnings Call Presentation

Clinical Programs & Catalysts - Cogent Biosciences has multiple clinical and preclinical programs with upcoming catalysts, including top-line results for Bezuclastinib in AdvSM expected in July 2025, NonAdvSM in 2H 2025, and GIST by EOY 2025 [7, 8, 11] - The company is conducting a registration-directed study of Bezuclastinib in NonAdvSM with 179 patients, using a 24-week MS2D2 primary endpoint [11] - A registration-directed study of Bezuclastinib monotherapy is underway in AdvSM with 58 patients, using ORR as the primary endpoint [11] - PEAK Part 2 is a global Phase 3 trial of Bezuclastinib in 2nd-line GIST, with top-line results expected by the end of 2025 [8] Financial Position - As of Q1 2025, Cogent Biosciences has $245.7 million, expected to fund operations into late 2026 [9] Market Opportunity - The aggregate US annual sales opportunity for Bezuclastinib across AdvSM, NonAdvSM, and GIST is greater than $3 billion with limited competition [12] - The US annual market opportunity for NonAdvSM is estimated at $2 billion, with differentiated symptom improvement potentially leading to market leadership [11] - The US annual market opportunity for 2nd-line GIST is estimated at over $1 billion, with limited competition [11] - The US annual market opportunity for AdvSM is estimated at $300 million, with differentiated safety/tolerability results potentially leading to market leadership [11] Competitive Landscape - Cogent believes Bezuclastinib offers a best-in-class KIT inhibitor opportunity with minimal late-stage competitive activity [10, 13, 30] Safety and Efficacy - In ISM patients, only 25% of Ayvakit patients achieved clinically meaningful improvement [18] - In PIONEER Part 2, low-dose Ayvakit (25 mg once daily) was associated with an improved safety profile, with 13% experiencing eye edema and dizziness [19]