Cogent Biosciences, Inc. · NASDAQ:COGT

Cogent Biosciences — Technical Presentation (July 2025)

18 slides from Cogent Biosciences's technical presentation, Jul 7, 2025

  1. Slide 1: SUMMIT Trial: Bezuclastinib in NonAdvSM Patients Top-Line Results

    SUMMIT Trial: Bezuclastinib in NonAdvSM Patients Top-Line Results Investor Webcast July 7, 2025

  2. Slide 2: Forward Looking Statements and Risk Factors

    Forward Looking Statements and Risk Factors This presentation and the accompanying oral commentary contain forward-looking statements that involve risks, uncertainties and assumptions. If the risks or uncertainties ever materialize or the assumptions prove incorrect, our results may differ materiall

  3. Slide 3: Agenda and Speakers

    Agenda and Speakers Andrew Robbins Nathan A. Boggs, MD, PhD Lindsay A.M. Rein, MD Jessica Sachs, MD President and Allergist Immunologist, Walter Reed Associate Professor of Medicine in the Chief Medical Officer Chief Executive Officer Allergy Division Director, Dept of Medicine Division of Hematolog

  4. Slide 4: Bezuclastinib Offers Potential Best-in-Class KIT Inhibitor Opportunity

    Bezuclastinib Offers Potential Best-in-Class KIT Inhibitor Opportunity 2024 2025 Registration-directed study in NonAdvSM Enrolled ~6 months early $2 billion+ US annual market bezuclastinib vs. placebo LPFV TLR opportunity; differentiated n=179, 24-week MS2D2 primary endpoint symptom improvement prov

  5. Slide 5: SUMMIT Part 2 Top-line Results

    SUMMIT Part 2 Top-line Results Full Results Expected to be Presented at an Upcoming Medical Meeting

  6. Slide 6: Systemic Mastocytosis (SM) is a Rare and Debilitating Disease

    Systemic Mastocytosis (SM) is a Rare and Debilitating Disease Characterized by Neoplastic Mast Cell Infiltration of Extracutaneous Tissues and Symptoms of Mast Cell Activation1 Figure 1. Symptoms of Nonadvanced Systemic Mastocytosis1 • Nonadvanced SM (NonAdvSM)2 includes indolent SM Neurocognitive D

  7. Slide 7: SUMMIT Part 2: Double-Blind, Placebo-Controlled Randomized Clinical Study

    SUMMIT Part 2: Double-Blind, Placebo-Controlled Randomized Clinical Study Evaluating Bezuclastinib in Non-Advanced Systemic Mastocytosis Patients Bezuclastinib 100mg QD + Best Supportive Care Open Label Extension n=119 Patients Bezuclastinib 2:1 C 24 weeks Treatment 100 mg QD Randomized + Best Suppo

  8. Slide 8: SUMMIT Part 2 Population Had Significant Disease Burden

    SUMMIT Part 2 Population Had Significant Disease Burden Representative of Moderate-to-Severe NonAdvSM Patients Patient Demographics Bezuclastinib Placebo Overall Systemic Mastocytosis Therapy Bezuclastinib Placebo Overall # Patients 119 60 179 Prior KIT Inhibitor1 17 (14.3) 5 (8.3) 22 (12.3) Female,

  9. Slide 9: SUMMIT Results Demonstrate Clinically Meaningful and Statistically Significant Effects

    SUMMIT Results Demonstrate Clinically Meaningful and Statistically Significant Effects Across All Primary and Secondary Endpoints Clinical Outcome Measures P-Value1 Primary Endpoint Mean Change in TSS at Week 24 0.0002 ≥ 50% Reduction in Serum Tryptase <0.0001 ≥ 50% Reduction in KIT D816V VAF <0.000

  10. Slide 10: Clinically Meaningful Decreases in Patient-Reported Symptoms and Objective Measures

    Treatment with Bezuclastinib Results in Clinically Meaningful Decreases in Patient-Reported Symptoms and Objective Measures of Disease Burden 0 Mean Change in TSS at Week 24 [95 % CI] Bezuclastinib Placebo P-Value LS Mean (SE) Change from Baseline -5 -24.32 -15.41 -10 (-27.56, -21.08) (-19.58, -11.2

  11. Slide 11: Bezuclastinib Demonstrated a Favorable and Manageable Safety Profile

    Bezuclastinib Demonstrated a Favorable and Manageable Safety Profile Bezuclastinib Placebo • Majority of TEAEs were of low grade (70% 100mg QD (N=60) Gr1) and reversible (N=118) TEAEs, n (%) 116 (98.3) 53 (88.3) • Variety of AEs occurred more often in SAEs, n (%) 5 (4.2) 3 (5.0) placebo group: Dizzi

  12. Slide 12: Case Study 1: 44 yo Woman with ISM Randomized to 100 mg Bezuclastinib

    Case Study 1: 44 yo Woman with ISM Randomized to 100 mg Bezuclastinib • Discontinued all BSC Medications in OLE • Patient remains on study more than 1 year with continued benefit Wk Wk Wk % Decrease BL 12 24 48 BL → Wk48 SM-Related Medical History MS2D2 TSS Percent Change Over Time Tryptase (ng/mL)

  13. Slide 13: Case Study 2: 63 yo Man with Long History of SM and High-Risk Features

    Case Study 2: 63 yo Man with Long History of SM and High-Risk Features Randomized to 100 mg Bezuclastinib • Discontinued 3 BSC medications in OLE: cetirizine, cromolyn and montelukast and cromolyn nasal • Patient remains on study for 32 weeks with continued benefit SM-Related Medical History Osteopo

  14. Slide 14: Highly Consistent Results Using Composite Items Included in Either MS2D2 or ISM-SAF TSS

    Highly Consistent Results Using Composite Items Included in Either MS2D2 or ISM-SAF TSS MS2D2: 11 Items ISM-SAF: 11 Items Total Symptom Score 0-110 Scale, Each Item 10 Points 0-110 Scale, Each Item 10 Points 0 Itching Itching Flushing Flushing Skin Mean (SE) Change from Baseline -5 Spots Spots Skin

  15. Slide 15: Bezuclastinib Systemic Mastocytosis Expanded Access Program Provides No-Cost Access

    Bezuclastinib Systemic Mastocytosis Expanded Access Program (NCT069157661) Provides No-Cost Access to Patients in Need AIM METHODS Designed to provide bezuclastinib outside of a Patients will receive oral bezuclastinib 100mg QD clinical trial to real-world patients with AdvSM or (NonAdvSM) or 150mg

  16. Slide 16: Topline Results from PEAK and APEX Pivotal Trials On Track 2H 2025

    Topline Results from PEAK and APEX Pivotal Trials On Track 2H 2025 Bezuclastinib 600 mg QD + Sunitinib 37.5 mg QD Single- R arm Bezuclastinib 150 mg QD 1:1 Sunitinib 37.5 mg QD n=58 n=413 Primary endpoint: Progression Free Survival Primary endpoint: ORR using mIWG-MRT-ECNM • PEAK enrollment Q4 2022

  17. Slide 17: SUMMIT Results are Transformative

    SUMMIT Results are Transformative - Bezuclastinib establishes new benchmarks for NonAdvSM symptomatic reduction - 24.3 point reduction from baseline at 24 weeks - 8.91 point placebo-adjusted effect size, representing 57% improvement over approved KIT therapy - Bezuclastinib associated with powerful

  18. Slide 18: Cogent Biosciences: Real Challenges. Real Solutions.

    BIOSCIENCES Real Challenges. Real Solutions. Precision therapies for genetically defined diseases

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