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Dec 31, 2023
Cassava Sciences Q4 2023 Earnings Report
Reported full year 2023 financial results and corporate updates.
Key Takeaways
Cassava Sciences reported a net loss for the full year 2023 of $97.2 million, or $2.32 per share. The company completed patient enrollment in both Phase 3 studies of simufilam and anticipates top-line data readout for the 52-week study approximately year-end 2024.
Completed patient enrollment in both Phase 3 studies of simufilam with approximately 1,900 patients randomized.
Over 555 patients have completed either the 52-week or 76-week Phase 3 studies.
Initiated discussion with the FDA to finalize a statistical analysis plan (SAP) for Phase 3 trials.
The investigation found no evidence to substantiate allegations that the Company or its employees engaged in or were aware of research misconduct.
Cassava Sciences
Cassava Sciences
Forward Guidance
Cassava Sciences expects research and development expenses to decrease modestly in 2024 due to decreased spending for the Phase 3 program. Cash use for operations for the first half of 2024 is expected to be $35 to $45 million.
Positive Outlook
- Patient screening and enrollment are now complete for the Phase 3 clinical studies.
- Expect our research and development expenses to decrease modestly in 2024 as a result of decreased spending for our Phase 3 program.
- Increased enrollment in the open-label study.
- Top-line data readout for our 52-week study (RETHINK-ALZ) approximately year-end 2024.
- Raised gross proceeds of approximately $21.8 million from the exercise of common stock warrants through February 26, 2024.
Challenges Ahead
- Net loss for full year 2023 was $97.2 million.
- Net cash used in operations full-year 2023 was $82.0 million.
- Cash use for operations for the first half of 2024 is expected to be $35 to $45 million.
- Open-label study patient enrollment began in November 2022.
- Development activity related to SavaDx accounts for less than 1% of our research budget.