aibioCassava Sciences (now Filana Therapeutics) cuts workforce by about 33%, reports $128.6 million cash
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The Alzheimer's drug developer expects about $0.4 million in one-time costs. The release gives no efficacy numbers for the two Phase 3 studies, and it still plans to report topline results from the one it is discontinuing.
Key facts
- Company
- Filana Therapeutics, Inc. (NASDAQ: FLNA)
- News type
- Distress
- Primary source
- Filana Therapeutics, Inc. 8-K (2025-01-07)
The cuts
Cassava Sciences, Inc. (NASDAQ: SAVA) said on January 7, 2025 that it will reduce its workforce by 10 employees, or about 33%, in the first quarter of 2025. It also said it will keep up strategic expense management, and it is halting a planned biomarker analysis of additional plasma samples from earlier Phase 2 studies.
The company estimates one-time costs of approximately $0.4 million in the first quarter for the reduction. It reported unaudited cash and cash equivalents of approximately $128.6 million at December 31, 2024. Chief Executive Officer Rick Barry said the company believes it is "prudent to implement additional cost saving measures, including a reduction in force," after the results of one study and the planned end of another.
The two Phase 3 studies
The cuts follow the November 2024 topline results from RETHINK-ALZ, a Phase 3 study of simufilam in patients with mild-to-moderate Alzheimer's disease. The release says the study did not meet its prespecified co-primary endpoints, which were change in cognition and function at week 52, measured by the ADAS-COG12 and ADCS-ADL scales. RETHINK-ALZ randomized 804 people across more than 75 sites in the U.S., Canada and Australia. It was run under a Special Protocol Assessment with the U.S. Food and Drug Administration. A pharmacokinetic and plasma biomarker sub-study of about 100 subjects was also included.
The company planned to discontinue REFOCUS-ALZ, a second Phase 3 study, and an open label extension study. REFOCUS-ALZ randomized approximately 1,125 people 1:1:1 to simufilam in 50 mg or 100 mg tablets, taken orally twice daily, or to a matched placebo. Treatment ran for 76 weeks, and the co-primary endpoints were measured at week 76 with the same two scales. The study also tracked plasma and cerebrospinal fluid biomarkers, including P-tau181, P-tau217 and neurofilament light chain, along with brain volumes on MRI and amyloid and tau deposition on PET scans. Its sites were completely distinct from those used in RETHINK-ALZ.
The release gives no efficacy figures for either study. It does not say how far RETHINK-ALZ missed its endpoints, and it does not report any result from REFOCUS-ALZ.
What the company still plans
Cassava plans to analyze the complete 52-week dataset from REFOCUS-ALZ, along with a large portion of the 76-week data, and to release topline results in late first quarter or early second quarter 2025. The company is therefore reporting results from a study it is ending. It says it will fold those results into its evaluation of next steps for Cassava, but it does not describe what those steps are. The release does not say whether simufilam will move into another trial.
The company also plans to share detailed results from both studies at a future medical meeting. It describes simufilam as a proprietary oral small molecule that targets the filamin A protein, and it says all of its pharmaceutical assets are investigational.
The money
The $128.6 million figure is unaudited, and the release gives no net loss, cash use or runway estimate for 2024. The $0.4 million estimate is tied to the workforce reduction. The release does not say whether the company expects more restructuring costs beyond the first quarter. Cassava is based in Austin, Texas, and calls itself a clinical-stage biotechnology company focused on central nervous system diseases, including Alzheimer's disease dementia.