Cogent Biosciences Announces Q2 2024 Results and Business Highlights

Cogent Biosciences, Inc., a biotechnology firm dedicated to developing precision therapies for genetically defined diseases, has disclosed its financial results for the second quarter ending June 30, 2024. The company, based in Waltham, Massachusetts, and Boulder, Colorado, has reported significant progress across its clinical and research endeavors, alongside notable financial and operational updates.

In the first half of 2024, Cogent Biosciences has advanced its three registration-directed clinical trials for bezuclastinib, a selective tyrosine kinase inhibitor aimed at targeting the KIT D816V mutation implicated in systemic mastocytosis, and mutations in KIT exon 17 associated with advanced gastrointestinal stromal tumors (GIST). These trials, named SUMMIT, PEAK, and APEX, are proceeding as planned, with full enrollment expected soon. The company anticipates the completion of the PEAK Phase 3 trial enrollment for GIST patients this quarter and plans to announce topline results from all three studies in 2025.

Recent business developments include a new alignment with the U.S. Food and Drug Administration (FDA) concerning the use of a novel patient-reported outcome measure, the Mastocytosis Symptom Severity Daily Diary (MS2D2), in the SUMMIT trial. Additionally, Cogent shared promising clinical data from SUMMIT Part 1 at the European Hematology Association (EHA) Congress, highlighting significant reductions in mast cell burden and symptom severity in patients receiving a 100 mg dose of bezuclastinib.

Further, Cogent Biosciences presented strong lead-in data from the ongoing Phase 3 PEAK trial at the American Society of Clinical Oncology (ASCO) annual meeting, revealing that treatment with bezuclastinib and sunitinib led to a median progression-free survival (mPFS) of 10.2 months across all patients, with a higher mPFS of 19.4 months in a subset of second-line GIST patients who had only prior imatinib treatment. The combination therapy also showed a disease control rate of 80% overall and 100% in patients solely treated with imatinib previously.

In another strategic move, Cogent announced a Phase 2 clinical trial of bezuclastinib and sunitinib for later-line GIST patients. This trial, sponsored by the Sarcoma Alliance for Research through Collaboration (SARC) and in partnership with The Life Raft Group and Dana-Farber Cancer Institute, aims to test the safety and efficacy of the combination treatment in 40 patients who have previously progressed on sunitinib.

Leadership changes include the appointment of Cole Pinnow as Chief Commercial Officer. Pinnow brings extensive experience from Pfizer, where he held senior roles, including President and Managing Director of Pfizer Canada and Global Franchise Lead for Genitourinary and Breast Cancer Business.

Cogent also initiated IND-enabling studies for their CNS-penetrant ErbB2 program, following new preclinical data presented at the American Association for Cancer Research (AACR) 2024 Annual Meeting. These studies highlighted CGT4255’s stability and high oral bioavailability, suggesting its potential as a best-in-class therapeutic candidate.

Looking ahead, Cogent Biosciences has outlined several upcoming milestones, including completing enrollment for their PEAK, SUMMIT, and APEX trials, initiating a Phase 1 trial for a new FGFR2 inhibitor, and selecting a lead candidate from their PI3Kα program.

Financially, the company closed the second quarter of 2024 with $389.9 million in cash, cash equivalents, and marketable securities, sufficient to fund operations into 2027. Research and development expenses for the quarter were $54.3 million, reflecting increased costs to accelerate trial enrollments and pipeline development. General and administrative expenses rose to $10.1 million, driven by organizational growth. The net loss for the quarter was $59.0 million.

Overall, Cogent Biosciences continues to make significant strides in its clinical programs and research initiatives, with a robust financial position supporting its long-term strategic goals.

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