Cassava Sciences, Inc. announced the completion of another interim safety review of simufilam in on-going Phase 3 clinical trials in patients with Alzheimer's disease. A routine, scheduled meeting of a Data and Safety Monitoring Board (DSMB) recommended that both of Cassava Sciences' on-going Phase 3 studies continue as planned, without modification. The DSMB is composed of independent clinical research experts who periodically review interim patient safety data for Cassava Sciences?

on-going Phase 3 trials of simufilam in Alzheimer?s disease. This DSMB only reviews patient safety. It does not assess drug efficacy.

Cassava Sciences? simufilam is a novel, small molecule drug candidate for the proposed treatment of Alzheimer?s disease dementia. The drug is in late-stage clinical evaluation in a pair of pivotal Phase 3 trials.

These Phase 3 trials are fully enrolled. Over 1,900 patients with mild-to-moderate Alzheimer?s disease who also meet other study eligibility criteria are randomized into the trials. The first Phase 3 trial (NCT04994483) has a 52-week treatment period; 804 Alzheimer?s patients were randomized into this trial, as announced in October 2023.

Top-line results for the 52-week Phase 3 trial are currently expected approximately year-end 2024. The second Phase 3 trial (NCT05026177) has a 76-week treatment period; 1,125 Alzheimer?s patients were randomized into this trial, as announced in November 2023. Top-line results for the 76-week Phase 3 trial are currently expected approximately mid-year 2025.

Patients with mild-to-moderate Alzheimer?s disease dementia who met study eligibility criteria were recruited into the Phase 3 program from clinical sites in the U.S., Puerto Rico, Canada, Australia and South Korea. Cassava Sciences is conducting its on-going Phase 3 program in collaboration with Premier Research International, a global contract research organization (CRO). Simufilam is Cassava Sciences?

proprietary drug candidate. This investigational drug binds to altered filamin A protein in the brain and restores its normal shape and function. By targeting altered filamin A, simufilam may help patients with Alzheimer?s achieve better health outcomes.

Cassava Sciences owns exclusive, worldwide rights to its investigational product candidates and related technologies, without royalty obligations to any third party.