Cassava Sciences, Inc. reported a net loss of $24.3 million for the year ended December 31, 2024, compared to a net loss of $97.2 million in 2023. Research and development expenses decreased by 22% to $69.6 million in 2024, primarily due to the completion of enrollment in its Phase 3 clinical program for simufilam in Alzheimer's disease. General and administrative expenses, however, increased by 334% to $71.8 million, largely due to a $40 million SEC settlement and increased stock-based compensation. The company's cash and cash equivalents totaled $128.6 million as of December 31, 2024.
Significant changes occurred during the year. On November 25, 2024, Cassava announced that its Phase 3 RETHINK-ALZ study of simufilam did not meet its pre-specified endpoints. Consequently, the company discontinued its Phase 3 REFOCUS-ALZ study and all open-label extension studies for simufilam in Alzheimer's disease. The company also entered into a license agreement with Yale University on February 26, 2025, granting Cassava exclusive worldwide rights to develop and commercialize simufilam for the treatment of TSC-related epilepsy. A workforce reduction of 33%, impacting 10 employees, was announced on January 7, 2025, to align resources with strategic goals.
Operational developments included the completion of patient enrollment in both Phase 3 studies (RETHINK-ALZ and REFOCUS-ALZ) in November 2023, totaling approximately 1,900 patients. The company is analyzing the complete 52-week dataset from REFOCUS-ALZ, along with a portion of 76-week data, with top-line results expected in late Q1/early Q2 2025. As of December 31, 2024, Cassava had 30 full-time employees. The company also settled an SEC investigation in September 2024, paying a $40 million civil monetary penalty.
The company's outlook remains focused on evaluating the REFOCUS-ALZ results to determine next steps for its Alzheimer's program. It also plans to conduct exploratory preclinical studies for simufilam in TSC-related epilepsy. The company anticipates a significant decrease in research and development expenses in 2025 due to the discontinuation of its Alzheimer's clinical trials, although this will be partially offset by higher stock-based compensation. Cassava expects its existing cash resources to fund operations for at least the next 12 months but may seek additional funding in the future. The company's financial performance is subject to various risks and uncertainties, including those related to drug development, regulatory approvals, and market competition, as detailed in the 10-K filing.
About CASSAVA SCIENCES INC
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