Cognition Therapeutics Requests EOP2 Meeting With FDA To Review Results From SHINE Study In Alzheimer's Disease

- End-of-Phase 2 meeting with FDA requested for Alzheimer's disease -

- Phase 2 results in dementia with Lewy bodies accepted for oral presentation at AAIC -

- Two posters at ARVO describe zervimesine's role supporting retinal cell health -

PURCHASE, N.Y., May 07, 2025 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc. (the "Company" or "Cognition") (NASDAQ:CGTX), a clinical-stage company developing drugs that treat neurodegenerative disorders, today reported financial results for the first quarter ended March 31, 2025, and provided a business update.

"During our first quarter of 2025 and in recent weeks, we continued to advance our Alzheimer's disease and dementia with Lewy bodies (DLB) programs," stated Lisa Ricciardi, Cognition's president and CEO. "A request was made with the U.S. Food and Drug Administration to schedule an end-of-Phase 2 (EOP2) meeting to review the results from the SHINE study in Alzheimer's disease and discuss plans for a registrational study. In order to request separate EOP2 meetings for each indication, both need to have a unique FDA program number. For that reason, we recently initiated the process of securing a commercial investigational new drug (IND) application for zervimesine (CT1812) in DLB. Once that process is complete, we will request an EOP2 for DLB."

Business and Corporate Highlights

• Requested an EOP2 meeting with FDA to review the results from the SHINE study in Alzheimer's disease.
• Phase 2 ‘SHIMMER' study results in DLB were accepted for a podium presentation at the Alzheimer's Association International Congress (AAIC), to be held July 27-31, 2025 in Toronto, Canada.
• Presenting two posters at the Association for Research in Vision and Ophthalmology (ARVO) meeting describing zervimesine's role in regulating lipid metabolism and its ability to protect retinal cells from oxidized lipids, a component of drusen.
• In January 2025 results from the Company's Phase 2 ‘SHIMMER' study were presented at the International Lewy Body Dementia Conference (ILBDC) by James E. Galvin, MD, MPH. (Director, Comprehensive Center for Brain Health at the University of Miami Miller School of Medicine; study director and principal investigator on the SHIMMER study grant from the National Institute of Aging).