Cassava Sciences Provides a Business Update
SAVA 01.07.2025
Drug:simufilam-unknown simufilam
Diseases:Alzheimer's Disease
About Gravity Analytica
Topline data from Phase 3 REFOCUS-ALZ study of simufilam in patients with mild-to-moderate Alzheimer’s disease expected late first-quarter/early second-quarter 2025
Implementing cost curtailment including a workforce reduction of approximately 33%
Approximately
In
The Company today announced that it is reducing its workforce by 10 employees, or approximately 33%, in the first quarter of 2025, as well as continuing strategic expense management efforts. Expense reductions include halting the planned biomarker analysis of additional plasma samples from prior Phase 2 studies. The Company estimates that it will incur approximately
The Company’s unaudited cash and cash equivalents balance as of
“Cassava continues to be dedicated to its mission of developing novel medicines for central nervous system disorders and enhancing shareholder value. We are in the final stages of discontinuing the REFOCUS-ALZ study and expect to report topline results late first-quarter/early second-quarter 2025. In addition, we continue to carefully review the data from the RETHINK-ALZ study and plan to incorporate the results of the REFOCUS-ALZ study into our evaluation of next steps for Cassava. With that in mind, following the announcement that the RETHINK-ALZ study did not meet its primary endpoints and that the REFOCUS-ALZ and Open Label Extension studies will be discontinued, we believe it is prudent to implement additional cost saving measures, including a reduction in force,” said
About RETHINK-ALZ
RETHINK-ALZ(NCT04994483) is a Phase 3 trial designed to evaluate the safety and efficacy of simufilam compared to a placebo in a multi-center, double-blinded, placebo-controlled, randomized parallel group study involving over 75 clinical trial sites in the
The co-primary endpoints for this study included the change in cognition and function from baseline to the end of the double-blind treatment period at week 52, assessed by the ADAS-COG12 and ADCS-ADL scales, comparing simufilam to placebo. Secondary endpoints included several well validated measures of neuropsychiatric symptoms and caregiver burden. Safety was evaluated by adverse event monitoring, as well as standard laboratory and ECG assessments. The study also included a pharmacokinetic and plasma biomarker sub-study comprised of approximately 100 subjects, evaluated at three timepoints. RETHINK-ALZ was conducted under a Special Protocol Assessment (“SPA”) with the
REFOCUS-ALZ(NCT05026177) is a Phase 3 trial designed as a multi-center, double-blinded, placebo-controlled, randomized parallel group study to evaluate the safety and efficacy of two doses of simufilam compared to a placebo in a study involving over 75 clinical trial sites in the
The co-primary endpoints for this study included the change in cognition and function from baseline to the end of the double-blind treatment period at week 76, assessed by the ADAS-COG12 and ADCS-ADL scales, comparing each dose of simufilam to placebo. Secondary endpoints included several well validated measures of neuropsychiatric symptoms and caregiver burden. Safety was evaluated by adverse event monitoring, as well as standard laboratory and ECG assessments. The study also included an evaluation of changes in plasma and cerebrospinal fluid biomarkers from baseline to week 76, including P-tau181, P-tau217 and neurofilament light chain, as well as an evaluation of various brain volumes using magnetic resonance imaging (MRI) and amyloid and tau deposition using positron emission tomography (PET) scans from baseline to week 76. REFOCUS-ALZ was also conducted under an SPA with the FDA.
About Simufilam
Simufilam is a proprietary, investigational oral small molecule that targets the filamin A protein.
About
For more information, please visit:https://www.CassavaSciences.com
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Mediamedia@cassavasciences.com
Company
Cautionary Note Regarding Forward-Looking Statements:This news release contains forward-looking statements that include but are not limited to statements regarding:the planned discontinuation of the REFOCUS-ALZ and open-label extension studies and the status of their ongoing wind-down; our intent to share topline data from REFOCUS-ALZ; our intent to share detailed study results from RETHINK-ALZ and REFOCUS-ALZ at a future medical meeting; the timing of anticipated milestones; the reduction in force of employees at the Company; and the anticipated costs associated with the reduction in force. These statements may be identified by words such as “anticipate”, “before,” “believe”, “could”, “expect”, “forecast”, “intend”, “may”, “pending,” “plan”, “possible”, “potential”, “prepares for,” “will”, and other words and terms of similar meaning.
Such statements are based on our current expectations and projections about future events. Such statements speak only as of the date of this news release and are subject to a number of risks, uncertainties and assumptions, including, but not limited to, those risks relating to the ability to conduct or complete clinical studies on expected timelines; the clinical results related to studies of simufilam in Alzheimer’s disease, results of the RETHINK-ALZ study reported on
All of our pharmaceutical assets under development are investigational product candidates. These have not been approved for use in any medical indication by any regulatory authority in any jurisdiction and their safety, efficacy or other desirable attributes, if any, have not been established in any patient population. Consequently, none of our product candidates is approved or available for sale anywhere in the world.
Source: Cassava Sciences, Inc.