Company Overview - Cassava Sciences (SAVA) recently faced a significant setback as its phase III study REFOCUS-ALZ for simufilam in mild-to-moderate Alzheimer's disease failed to meet the prespecified co-primary endpoints [1][4] - The study enrolled 1,125 Alzheimer's disease patients who received either simufilam or placebo for 76 weeks, but the drug did not show a significant reduction in cognitive and functional decline compared to placebo [2][3] Study Results - Treatment with simufilam did not achieve significant results on the ADAS-COG12 and ADCS-ADL scales over the 76-week period, nor did it meet any secondary or exploratory biomarker endpoints [2] - Despite the lack of efficacy, simufilam maintained an acceptable safety profile throughout the study [3][4] Program Termination - Following the failure of the REFOCUS-ALZ study, Cassava decided to discontinue the study and will phase out the development of simufilam for Alzheimer's disease by the end of the second quarter [4] - With the termination of this program, Cassava no longer has any late-stage candidates in its pipeline [4] Financial Position - As of December 2024, Cassava reported having $128.6 million in cash and equivalents, raising concerns about its ability to fund future operations [5] Industry Context - The Alzheimer's disease market is characterized by significant challenges in drug development, with many pharmaceutical and biotech companies experiencing setbacks [6] - Currently, there are two FDA-approved drugs for Alzheimer's disease: Leqembi and Kisunla, which target the reduction of amyloid beta plaques in the brain [7][8]