U.S. Food and Drug Administration ("FDA") denied a Citizen Petition that was filed in August 2021 by an attorney on behalf of short-selling clients. FDA also denied four supplements to the August 2021 Citizen Petition. FDA also denied a September 2021 Citizen Petition, and a supplement, that were also filed by the same attorney on behalf of short-selling clients.

“The news is very welcome but not surprising,” said Remi Barbier, President & CEO. “We said from the outset that the allegations are false. I think the message may be that the FDA’s citizen petition privilege is not to be trifled with by stock market participants.”

A full copy of FDA’s response letter can be found at the following link: https://www.regulations.gov/document/FDA-2021-P-0967-0017

In Fall 2021, Cassava Sciences advanced its lead drug candidate, simufilam, into a Phase 3 pivotal program in patients with mild-to-moderate Alzheimer’s disease. This Phase 3 program is being conducted under Special Protocol Assessments (SPA) from FDA. An SPA agreement indicates concurrence by the FDA with the adequacy and acceptability of specific critical elements of overall protocol design (e.g., entry criteria, dose selection, endpoints, etc.).

The first clinical study protocol is titled “A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 52-Week Study Evaluating the Safety and Efficacy of Simufilam 100mg Tablets in Subjects with Mild-to Moderate Alzheimer's Disease.”

The second clinical study is titled “A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 76-Week Study Evaluating the Safety and Efficacy of Two Doses of Simufilam in Subjects with Mild-to-Moderate Alzheimer’s Disease.”

Both Phase 3 clinical studies continue to enroll patients.