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Jun 30, 2024
Cogent Biosciences Q2 2024 Earnings Report
Cogent Biosciences' financial results for Q2 2024 were reported, highlighting progress in clinical trials and financial stability.
Key Takeaways
Cogent Biosciences reported its Q2 2024 financial results, with key highlights including the ongoing progress of SUMMIT, PEAK, and APEX clinical trials, and a cash position of $390 million expected to fund operations into 2027. The company's net loss for the quarter was $59.0 million, with increased R&D expenses.
SUMMIT, PEAK, and APEX registration-directed clinical trial enrollment remains on track with topline results expected in 2025.
Ended 2Q 2024 with $390 million in cash, sufficient to fund operations into 2027.
Alignment with the FDA on the novel patient reported outcome measure, Mastocytosis Symptom Severity Daily Diary (MS2D2), for use in Part 2 of the registration-directed SUMMIT trial.
Initiated IND-enabling studies for the potent, selective CNS-penetrant ErbB2 program following presentation of new preclinical data at the American Association for Cancer Research (AACR) 2024 Annual Meeting.
Forward Guidance
Cogent Biosciences anticipates completing enrollment in the PEAK trial in Q3 2024, providing additional data from the SUMMIT trial by the end of 2024, completing enrollment in the APEX trial by the end of 2024, completing enrollment in SUMMIT Part 2 in Q2 2025, initiating a Phase 1 trial of the FGFR2 inhibitor in the second half of 2024, and selecting a lead candidate from the PI3Ka program.
Positive Outlook
- Complete enrollment in the global, Phase 3 PEAK trial in patients with GIST in Q3 2024.
- Provide additional safety, tolerability, and patient-reported outcomes data from the open label extension portion of SUMMIT Part 1 by the end of 2024.
- Complete enrollment in the registration-directed APEX Phase 2 trial in patients with Advanced Systemic Mastocytosis (AdvSM) by the end of 2024 and report top-line results by mid-2025.
- Complete enrollment in SUMMIT Part 2 in the second quarter of 2025 and deliver top-line results by the end of 2025.
- Initiate a Phase 1 trial of the first Cogent-discovered pipeline program, designed as a potent, selective, reversible FGFR2 inhibitor with best-in-class potential in the second half of 2024.
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