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Dec 31, 2023
Cogent Biosciences Q4 2023 Earnings Report
Cogent Biosciences reported financial results for the fourth quarter and full year of 2023 and provided a business update.
Key Takeaways
Cogent Biosciences reported its Q4 and full-year 2023 financial results, highlighting the ongoing clinical trials of bezuclastinib and a strong cash position to fund operations into 2027.
SUMMIT Part 2 registration-directed study of bezuclastinib in NonAdvSM patients initiated and actively enrolling.
PEAK Phase 3 study of bezuclastinib + sunitinib in 2nd-line GIST patients on track to complete enrollment by end of 2024.
APEX Part 2 registration-directed study of bezuclastinib in AdvSM patients on track to complete enrollment by end of 2024.
$487 million in pro-forma cash sufficient to fund operations into 2027, including net proceeds from oversubscribed $225 million February 2024 PIPE.
Forward Guidance
Cogent Biosciences provided forward-looking statements regarding the expected completion of enrollment and top-line results for its SUMMIT, PEAK, and APEX trials, as well as its cash runway and plans for additional clinical data and pipeline development.
Positive Outlook
- SUMMIT to complete enrollment in the second quarter of 2025 and deliver top-line results by the end of 2025
- PEAK to complete enrollment by the end of 2024 and to deliver top-line results by the end of 2025
- APEX to complete enrollment by the end of 2024 and to deliver top-line results by mid-2025
- Company’s anticipated cash runway into 2027
- Plans to initiate a Phase 1 trial of the first internally-discovered pipeline program, designed as a potent, selective, reversible FGFR2 inhibitor with best-in-class potential, in the second half of 2024
Challenges Ahead
- The expectation for SUMMIT to complete enrollment in the second quarter of 2025 and deliver top-line results by the end of 2025 is a forward-looking statement and is subject to a number of material risks and uncertainties
- The expectation for PEAK to complete enrollment by the end of 2024 and to deliver top-line results by the end of 2025 is a forward-looking statement and is subject to a number of material risks and uncertainties
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