Cogent Biosciences, Inc. · NASDAQ:COGT
Cogent Biosciences — Jefferies Global Healthcare Conference 2025
15 slides from Cogent Biosciences's conference presentation, Jun 5, 2025
Slide 1: Jefferies Global Healthcare Conference
Exhibit 99.1 Jefferies Global Healthcare Conference June 5, 2025
Slide 2: Forward-Looking Statements and Risk Factors
Forward-Looking Statements and Risk Factors The information contained in this presentation has been prepared by Cogent Biosciences, Inc. (“Cogent” or the “Company”) and contains information pertaining to the business and operations of the Company. The information contained in this presentation: (a)
Slide 3: Multiple Clinical and Preclinical Programs with Upcoming Catalysts
Multiple Clinical and Preclinical Programs with Upcoming Catalysts EARLY-STAGE LATE-STAGE REGULATORY APPROVAL DEVELOPMENT DEVELOPMENT SUBMISSION SUMMIT Part 2 (Registration-Directed) Bezuclastinib Nonadvanced Systemic Mastocytosis (NonAdvSM) Top-line results expected July 2025 PEAK Part 2 (Global Ph
Slide 4: Bezuclastinib Offers Best-in-Class KIT Inhibitor Opportunity
Bezuclastinib Offers Best-in-Class KIT Inhibitor Opportunity 2024 2025 $2 billion US annual market Enrolled ~6 months early Registration-directed study in NonAdvSM bezuclastinib vs. placebo opportunity; differentiated LPFV TLR symptom improvement would n=179, 24-week MS2D2 primary endpoint July prov
Slide 5: Minimal Late-Stage Competitive Activity with Clear Path to Best-in-Class Position
KIT MUTANT COMPETITIVE LANDSCAPE Minimal Late-Stage Competitive Activity with Clear Path to Best-in-Class Position Gastrointestinal Stromal Tumors (GIST) Systemic Mastocytosis bezuclastinib avapritinib elenestinib bezuclastinib sunitinib ripretinib + sunitinib D816V potent: Exon 13/14 potent: CNS se
Slide 6: Ayvakit Demonstrated POC for KITm Inhibitors in ISM Patients
Ayvakit Demonstrated POC for KITm Inhibitors in ISM Patients 5.7 point placebo-adjusted benefit on primary endpoint at 24 weeks Source: Ayvakit USPI Section 13 7
Slide 7: Ayvakit Demonstrated POC for KITm Inhibitors in ISM Patients
Ayvakit Demonstrated POC for KITm Inhibitors in ISM Patients Only 25% of Ayvakit patients achieved clinically meaningful improvement Source: Ayvakit USPI Section 13 7
Slide 8: Low-Dose Ayvakit (25 mg) Associated with Improved Safety Profile
Low-Dose Ayvakit (25 mg) Associated with Improved Safety Profile Among Patients Treated with 25 mg Avapritinib on PIONEER Part 2: • 21.3% Grade 3+ AE • 9.9% Dose Modification due to AE • 5% Serious Adverse Events (SAE) Source: Ayvakit USPI Section 6 including Table 9; Gotlib, J. et al “Avapritinib v
Slide 9: Low-Dose Investigated in ISM Patients to Avoid Safety Concerns
Low-Dose Investigated in ISM Patients in Order to Avoid Safety Concerns Reported at Clinically Effective Dose in AdvSM Patients • Serious adverse reactions occurred in 34% of patients receiving the recommended starting dose of 200 mg once daily and in 50% of patients receiving AYVAKIT at all doses •
Slide 10: Scoring System Comparison: SUMMIT Part 1 TSS Results Nearly Identical
Scoring System Comparison: Summit Part 1 TSS Results Nearly Identical Using Composite Items From Either MS2D2 or ISM-SAF Weeks on Active Treatment MS2D2: 11 Items ISM-SAF: 11 Items 0 4 8 12 16 20 24 0-110 Scale, Each Item 10 Points 0-110 Scale, Each Item 10 Points 0 Itching Itching Flushing Flushing
Slide 11: Preparing for SUMMIT Part 2 TLR – Defining Success
Preparing for SUMMIT Part 2 TLR – Defining Success Summit Part 2 Primary Endpoint <5.7 points 5.7 points 8.5 points 11.4 points (placebo-adjusted mean 24 week TSS) Competitive Positioning vs. >50% >100% Worse than Equivalency Standard of Care (SOC) “Home Run” “Grand Slam” SOC w/SOC Summit Part 2 Saf
Slide 12: Cogent: Real Challenges. Real Solutions.
cogent PEAK Pending Real Challenges. Real Solutions. Precision therapies for genetically defined diseases
Slide 13: Minimal Late-Stage Competitive Activity with Clear Path to Best-in-Class Position
KIT MUTANT COMPETITIVE LANDSCAPE Minimal Late-Stage Competitive Activity with Clear Path to Best-in-Class Position Gastrointestinal Stromal Tumors (GIST) Systemic Mastocytosis bezuclastinib avapritinib elenestinib bezuclastinib sunitinib ripretinib + sunitinib D816V potent: Exon 13/14 potent: CNS se
Slide 14: PEAK: Global Phase 3 Pivotal Trial in 2nd-Line GIST Patients
nd PEAK: Global Phase 3 Pivotal Trial in 2 -line GIST Patients KEY ENTRY CRITERIA n=413 Patients • Histologically confirmed Gastrointestinal Stromal Bezuclastinib 600 mg QD + Tumors (GIST) w/at least 1 measurable lesion per Sunitinib 37.5 mg QD mRECIST v1.1 R • Locally advanced, unresectable or meta
Slide 15: Bezuclastinib + Sunitinib POC in 2nd-Line GIST Patients
nd Bezuclastinib + Sunitinib POC in 2 -Line GIST Patients 19.4 mPFS EAP > 16 cycles PR EOT 05/2021 EAP > 38 cycles PR EOT 11/2022 SD SD SD SD PR PR SD Ω SD Ω NE 0 5 10 15 20 25 30 Treatment Cycles (28 days) 8.3 nd sunitinib INTRIGUE (2 -line) 8.0 PEAK result of ~3 month advantage over sunitinib nd r
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