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Sep 30, 2024
Cassava Sciences Q3 2024 Earnings Report
Reported financial results for the third quarter ended September 30, 2024.
Key Takeaways
Cassava Sciences reported their Q3 2024 financial results, with the anticipation of releasing top-line results from their first Phase 3 trial for simulfilam by the end of 2024.
Phase 3 program consists of two global, double-blind, randomized, placebo-controlled studies of simufilam for Alzheimer’s disease.
Both Phase 3 studies are fully enrolled with approximately 1,900 patients randomized.
The Last Patient/Last Visit occurred several weeks ago for the RETHINK-ALZ study, with approximately 635 patients completed.
The DSMB recommended that both Phase 3 studies continue as planned, without modification, following a third routine, scheduled meeting in September 2024.
Cassava Sciences
Cassava Sciences
Forward Guidance
Cassava Sciences is awaiting top-line data for RETHINK-ALZ before the end of 2024 and anticipates a top-line data readout for REFOCUS-ALZ approximately mid-year 2025.
Positive Outlook
- Open-label extension study provides no-cost access to oral simufilam to Alzheimer’s patients who have successfully completed a Phase 3 study.
- Approximately 88% of patients who have completed treatment in one of the two Phase 3 studies have opted to enter the open-label extension study.
- Cassava plans to add cognition and plasma biomarker monitoring to its OLE trial for patients who have completed either of the two Phase 3 trials.
- Gathering additional long-term data on the potential impact of simufilam treatment.
- DSMB recommended that both Phase 3 studies continue as planned, without modification.
Challenges Ahead
- All efficacy data from Phase 3 program remain blinded.
- No interim analyses on efficacy outcomes are planned.
- Clinical results from earlier-stage clinical trials may not be indicative of future results from later-stage or larger scale clinical trials and do not ensure regulatory approval.
- Research and development activities are long, complex, costly and involve a high degree of risk.
- Simufilam has not been approved for use in any medical indication by any regulatory authority in any jurisdiction.