Cogent Biosciences Reports First Quarter 2024 Financial Results By Investing.com

SUMMIT, PEAK and APEX registration-directed clinical trial enrollment remains on track; topline results expected from all three studies in 2025

Ended 1Q 2024 with $435.7 million in cash, sufficient to fund operations into 2027

WALTHAM, Mass. and BOULDER, Colo., May 07, 2024 (GLOBE NEWSWIRE) — Cogent Biosciences, Inc.  (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today provided a business update and announced financial results for the first quarter ended  March 31, 2024.

Our team made important progress in the first quarter, said Andrew Robbins, the Company’s President and Chief Executive Officer. Based on the emerging clinical results demonstrating the potential of bezuclastinib in both systemic mastocytosis and GIST patients, we have experienced very strong interest in our ongoing clinical trials from patients and investigators. We remain on track to complete enrollment in APEX and PEAK by the end of this year, and to complete enrollment in SUMMIT during 2Q 2025. This should allow us to report topline results from all three registration-directed trials during 2025. Following our successful financing in February, we are well positioned with a cash runway into 2027, allowing us to complete our ongoing studies while continuing to broaden our portfolio with a robust research pipeline of novel compounds.

Recent Business Highlights

• Reported positive Part 1b data from the Company’s ongoing SUMMIT trial evaluating bezuclastinib in patients with nonadvanced systemic mastocytosis (NonAdvSM) at the 2024 American Academy of Allergy Asthma & Immunology Annual Meeting (AAAAI) meeting and initiated the registration-directed SUMMIT Part 2.
  • Selected the 100 mg once-daily recommended Phase 2 dose (RP2D) based on:
    • 51% week 12 mean improvement in Total Symptom Score (TSS), including 70% of patients achieving ‰¥50% reduction in TSS at week 12
    • 49% week 12 mean improvement in quality-of-life (MC-QoL)
    • Safety and tolerability profile generally similar to placebo with no grade 3/4 events, and no bleeding, edema or cognitive events, no dose reductions and no discontinuations
• Presented preclinical data from the company’s ErbB2 candidate at the American Association of Cancer Research (AACR) annual meeting.
  • The new preclinical data described CGT4255’s exceptional stability in human whole blood and liver cytosol fractions, high oral bioavailability and low clearance across preclinical species. CGT4255 also…