Cogent Biosciences (COGT) investor relations material

Transformative clinical milestones and market opportunity

• Three pivotal trials for bezuclastinib in GIST, NonAdvSM, and AdvSM showed positive results, positioning it as a best-in-class KIT inhibitor with over $8 billion global market potential.

• Bezuclastinib achieved a 50% reduction in risk of progression or death and a 16.5-month median PFS in 2L GIST, the first such advance in over 20 years.

• NonAdvSM trial demonstrated rapid, durable symptom improvement, with 86% of patients achieving clinically meaningful benefit and robust biomarker reductions at 48 weeks.

• AdvSM trial showed 57% ORR and significant reductions in disease markers, with a favorable safety profile and no treatment-related discontinuations.

• NDA submissions are underway or planned for all three indications, with anticipated US launches in 2026 and patent protection expected through 2046.

Financial position and pipeline expansion

• End-of-2025 cash balance projected at $901 million, supporting operations through 2028 and enabling commercial launch preparations.

• Structured debt facility retired in Q4 2025, further strengthening the balance sheet.

• Pipeline includes next-generation oncology and hematology assets, with pan-KRAS and JAK2 V617F inhibitors on track for IND submissions in 2026.

• Additional programs targeting ErbB2 and PI3Ka mutations are advancing, with early clinical and preclinical data supporting best-in-class potential.

Competitive landscape and strategic positioning

• Bezuclastinib’s broad activity against KIT mutations and favorable safety profile differentiate it from existing therapies, addressing significant unmet needs in GIST and SM.

• Limited late-stage competition in systemic mastocytosis, with bezuclastinib poised for market leadership.

• Expanded access programs and experienced commercial leadership are in place to support rapid adoption upon approval.

• Intellectual property portfolio provides exclusivity through 2046, including compound, formulation, and method patents.