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Dec 31, 2022
Cogent Biosciences Q4 2022 Earnings Report
Cogent Biosciences reported financial results for the fourth quarter and full year of 2022 and provided a business update.
Key Takeaways
Cogent Biosciences reported a net loss of $39.6 million for the fourth quarter of 2022 and ended the year with $259.3 million in cash, sufficient to fund operations into 2025. The company highlighted progress with bezuclastinib in systemic mastocytosis and GIST and the initiation of the Phase 3 PEAK trial.
Initiation of APEX Part 2 is planned for mid-2023.
Updated clinical data from Phase 3 PEAK lead-in in GIST patients is expected in the first half of 2023.
Initial clinical data from Phase 2 SUMMIT trial in NonAdvSM is on-track for the second half of 2023.
Ended 2022 with $259.3 million in cash, sufficient to fund operations into 2025.
Cogent Biosciences
Cogent Biosciences
Forward Guidance
Cogent Biosciences anticipates several milestones including presenting updated clinical data from the Phase 3 PEAK lead-in study, providing a mid-year update on APEX Part 2 initiation, presenting initial clinical data from SUMMIT, and presenting updated preclinical data from research programs.
Positive Outlook
- Present updated clinical data from refractory GIST patients in the lead-in cohort of the Phase 3 PEAK trial of bezuclastinib plus sunitinib during the first half of 2023.
- Provide a mid-year update on the planned initiation of APEX Part 2 based on clinical data from approximately 25-30 patients in APEX Part 1.
- Present initial clinical data from SUMMIT, a randomized, double-blind, placebo-controlled, global, multicenter, Phase 2 clinical trial of bezuclastinib in patients with NonAdvSM in the second half of 2023. Clinical data is expected to include safety/tolerability, pharmacokinetics and measures of clinical activity.
- Present updated preclinical data from Cogent’s selective FGFR2 and ErbB2 research programs at the American Association for Cancer Research annual meeting taking place April 14-19, 2023 in Orlando, Florida.