**Cassava Sciences Faces Setback with Simufilam after Disappointing Phase 3 Trial Results**

Cassava Sciences Inc. experienced a significant downturn after revealing topline data from its Phase 3 ReThink-ALZ study of simufilam, a treatment for mild-to-moderate Alzheimer's disease. The recent trial results have led to a major impact on the company’s second Phase 3 trial, ReFocus-ALZ, causing the firm to discontinue this study. As of Monday, Cassava's stock (SAVA) dropped dramatically, plummeting 84.2% to $4.19 in the premarket session.

The trial failed to achieve the pre-specified co-primary, secondary, and exploratory biomarker endpoints. Specifically, the co-primary endpoints included changes in cognition and function from baseline to the conclusion of the double-blind treatment period at week 52, which were measured using the ADAS-COG12 and ADCS-ADL scales. Comparing simufilam to a placebo, the results did not demonstrate significant improvements.

Rick Barry, the CEO, expressed his disappointment by stating, "The loss of cognition in the placebo group was less pronounced than was previously reported in other placebo-controlled studies in Alzheimer’s Disease, despite our careful measures to enroll patients with mild-to-moderate AD." Barry had previously communicated to shareholders and employees about the high stakes involved in simufilam's testing phases.

The complete dataset from the 52-week study and a substantial portion of the 76-week data will soon be released for further review. Cassava plans to present detailed results at a forthcoming medical meeting and will continue to assess the data to determine its next steps.

This setback comes on the heels of a substantial controversy for Cassava Sciences. In September, the company agreed to pay more than $40 million to settle SEC charges over misleading statements related to a Phase 2 trial of simufilam. The SEC’s investigation uncovered that Cassava had manipulated data in 2020, reporting falsely promising results in Alzheimer's biomarkers, such as total tau and phosphorylated tau. Hoau-Yan Wang, a consultant and the drug's co-developer, was also charged for his role in manipulating trial results.

The decision to halt ReFocus-ALZ and the Open Label Extension study reflects the broader impact of these unfavorable trial outcomes, raising significant concerns about the future of simufilam in Alzheimer’s treatment.