Cassava Sciences Announces Publication Of Article Phase 3 Randomized Clinical Trials Of Simufilam In Mild-To-Moderate Alzheimer's Disease In Upcoming Issue Of JPAD

As previously disclosed, the studies did not meet pre-specified co-primary, secondary, or exploratory biomarker endpoints 

The paper provides a detailed analysis of the RETHINK-ALZ and REFOCUS-ALZ studies and confirms simufilam's favorable safety profile in these studies

Exploratory post-hoc analyses offer informative insights

AUSTIN, Texas, Jan. 13, 2026 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (NASDAQ:SAVA, "Cassava", the "Company"))), a biotechnology company focused on developing novel, investigational treatments for central nervous system (CNS) disorders such as Tuberous Sclerosis Complex (TSC)-related epilepsy, today announced publication of the article Phase 3 randomized clinical trials of simufilam in mild-to-moderate Alzheimer's disease in an upcoming issue of the Journal of Prevention of Alzheimer's Disease (JPAD). The paper provides a detailed analysis of data from two Phase 3 clinical trials, RETHINK-ALZ and REFOCUS-ALZ. While, as previously disclosed, the two studies did not meet their pre-specified co-primary, secondary, or exploratory biomarker endpoints, exploratory post-hoc analysis of the studies offers informative insights.

Topline results of RETHINK-ALZ (NCT04994483), which randomized 804 people with mild to moderate Alzheimer's disease, were originally reported in November 2024, and topline results from REFOCUS-ALZ (NCT05026177), which randomized 1,125 patients, were reported in March 2025. As previously disclosed, the Company has discontinued development of, and plans no further investment in, the Alzheimer's disease program.