Cassava Sciences Q3 2024 Earnings Report
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.