Cognition Therapeutics Aligns on Key Aspects of Pivotal Study for Zervimesine (CT1812) in DLB Psychosis Following Receipt of FDA Meeting Minutes (Form 8-K)

Cognition Therapeutics Aligns on Key Aspects of Pivotal Study for Zervimesine (CT1812) in DLB Psychosis Following Receipt of FDA Meeting Minutes

- Zervimesine Would be the First Long-term, Durable Treatment Option with an Impact on Underlying Disease -

- Company Developing NPI as a Measure of DLB Psychosis -

PURCHASE, NY - June 24, 2026 - Cognition Therapeutics, Inc., (the "Company" or "Cognition") (NASDAQ: CGTX), a clinical-stage company developing product candidates that treat neurodegenerative disorders, today announced that it received written feedback from the U.S. Food and Drug Administration (FDA) following its recent meeting. The FDA agreed that psychosis associated with dementia with Lewy bodies (DLB) could be an approvable outcome and reached alignment with the Company on key aspects of a pivotal trial to support a New Drug Application (NDA). The registrational program is expected to begin in mid-2027.

As discussed with the FDA, Cognition expects the Phase 3 study will enroll people with DLB who experience psychosis symptoms of hallucinations and delusions. Patients receiving stable background treatment with off-label antipsychotic medications will be eligible. Following screening, participants will be randomized to receive either 100 mg of once-daily oral zervimesine or placebo for nine months. The company will work with the FDA on the analytical and statistical details for the use of the neuropsychiatric inventory (NPI) as a novel primary endpoint for a pivotal trial in DLB psychosis.

"We reached an important agreement with the FDA that DLB psychosis is an approvable outcome and that key aspects of our registrational trial design are appropriate and supportive of an NDA," explained Anthony O. Caggiano, MD, PhD, chief medical officer of Cognition. "To date, few drugs have been researched for DLB and none have been approved. The only recourse for DLB patients experiencing psychosis is the off-label use of potentially dangerous antipsychotics."

The proposed Phase 3 study builds on findings from Cognition's Phase 2 COG1201 'SHIMMER' trial in mild-to-moderate DLB, which demonstrated improvements in psychosis symptoms with zervimesine versus placebo as measured by the NPI. In a recent analysis of results from the Phase 2 study, zervimesine slowed progression of hallucinations and delusions by 89%. In July, the Company will present additional analyses from the Phase 2 study showing zervimesine's impact on the hallucination and delusion components of the NPI at the Alzheimer's Association's International Conference (AAIC).

"Working with the FDA, we intend to find a path forward for a patient population that has waited too long," said Lisa Ricciardi, president and CEO. "Our ultimate goal is to provide patients and their families with a durable treatment option for DLB psychosis that actually slows the progression of hallucinations and delusions."

About Cognition Therapeutics

Cognition Therapeutics, Inc. is a clinical-stage biopharmaceutical company dedicated to helping millions of families seeking effective treatments for devastating neurodegenerative diseases through the development of novel, accessible therapies. The company has led pioneering research into the underlying mechanisms of degenerative nerve disorders. Our scientific approach builds on well-established biological pathways and translates across indications in which toxic oligomers drive disease progression, offering potential in dementia with Lewy bodies (DLB), Alzheimer's disease, geographic atrophy, Parkinson's, among others. The company's lead candidate, zervimesine (CT1812), is an investigational once-daily oral therapy that has demonstrated promise in Phase 2 clinical trials in DLB and mild-to-moderate Alzheimer's disease. Backed by nearly $200 million in National Institutes of Health and related foundation grants, Cognition Therapeutics continues to advance clinical research in its efforts to bring forth solutions that meet patients where they are and reduce caregiver burden. Learn more at cogrx.com.

Cognition Therapeutics, Inc.

www.cogrx.com

About DLB Psychosis

Dementia with Lewy bodies (DLB) is a progressive, fatal neurodegenerative disease characterized by neuropsychiatric, cognitive and motor deficits. Up to 80% of people living with DLB experience psychosis, which manifests primarily as debilitating hallucinations and delusions. These symptoms are frequently cited as the most challenging for patients and their care partners to manage. There are no FDA-approved drugs for DLB, and the off-label use of traditional antipsychotics is often avoided due to the risk of severe and potentially life-threatening adverse reactions, underscoring a critical unmet need.

About Zervimesine (CT1812)

Zervimesine (CT1812) is currently being studied in the Phase 2 START Study (NCT05531656) in patients with MCI and early Alzheimer's disease. Phase 2 clinical studies have concluded in dementia with Lewy bodies (DLB), mild-to-moderate Alzheimer's disease, and geographic atrophy secondary to dry AMD. Based in part on the strong efficacy signals observed in the Phase 2 SHIMMER study in DLB (NCT05225415), the company plans to advance zervimesine into a late-stage clinical trial for people with DLB psychosis. Zervimesine has been generally well tolerated in clinical studies to date.

The USAN Council has adopted zervimesine as the United States Adopted Name (USAN) for CT1812.