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Cogent Biosciences Reports Recent Business Highlights and Third Quarter 2024 Financial Results

Cogent Biosciences has reported significant progress in its clinical trials, including the completion of enrollment in the Phase 3 PEAK trial and the initiation of a Phase 1 trial for CGT-4859. The company also announced a strong cash position of $346 million, sufficient to fund operations into late 2026. Upcoming milestones include the delivery of top-line results from SUMMIT, PEAK, and APEX trials in 2025.

Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, has reported recent business highlights and financial results for the third quarter ended September 30, 2024. The company has made significant progress across its pipeline, including completing enrollment in its Phase 3 PEAK trial in Gastrointestinal Stromal Tumor (GIST) patients, accelerating enrollment in SUMMIT, its registration-directed trial with bezuclastinib in Nonadvanced Systemic Mastocytosis (NonAdvSM), and initiating its first Phase 1 trial with its FGFR2 inhibitor, CGT-4859.
Business Highlights & Milestones
  • Completed enrollment in PEAK, a randomized, open-label, global Phase 3 trial evaluating bezuclastinib in combination with sunitinib vs sunitinib alone in patients with imatinib-resistant gastrointestinal stromal tumors (GIST). A total of 413 patients were enrolled in the trial.
  • Cogent completed a pre-planned interim futility analysis for the PEAK study, with the Independent Data Monitoring Committee (IDMC) recommending continuing the study without modification.
  • Cogent will present updated clinical data from both SUMMIT and APEX clinical trials at the upcoming ASH annual meeting in December.
  • Initiated a Phase 1 study of CGT4859, a reversible, selective FGFR2 inhibitor in patients with FGFR2 mutations, including advanced cholangiocarcinoma. Preliminary results from this trial are expected in 2025.
  • Announced the addition of a potent and selective KRAS inhibitor to the pipeline, with preclinical data presented at the 2024 EORTC-NCI-AACR International Symposium on Molecular Targets and Cancer Therapeutics.
Anticipated Upcoming Milestones
  • Complete enrollment in SUMMIT Part 2 in the first quarter of 2025 and deliver top-line results in the second half of 2025.
  • Deliver top-line results from APEX in mid-2025.
  • Deliver top-line results from PEAK by the end of 2025.
Third Quarter 2024 Financial Results
  • Cash Position: As of September 30, 2024, cash, cash equivalents and marketable securities were $345.5 million.
  • R&D Expenses: Research and development expenses were $63.6 million for the third quarter of 2024.
  • G&A Expenses: General and administrative expenses were $11.8 million for the third quarter of 2024.
  • Net Loss: Net loss was $70.6 million for the third quarter of 2024.
Cogent Biosciences continues to focus on developing precision therapies for genetically defined diseases, with a strong pipeline of novel targeted therapies aimed at helping patients with serious, genetically driven diseases.
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Reference News

[1]
Cogent Biosciences Reports Recent Business Highlights
globenewswire.com · Nov 12, 2024

Cogent Biosciences reported Q3 2024 highlights, including Phase 3 PEAK trial enrollment completion, Phase 1 CGT-4859 tri...

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