Cognition Therapeutics Schedules a Type C Meeting with FDA to Align on Endpoints for Phase 3 Trial of Zervimesine (CT1812) in DLB

PURCHASE, N.Y., Sept. 29, 2026 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc., (the Company or Cognition) (NASDAQ: CGTX), a clinical-stage company developing product candidates that treat neurodegenerative disorders, (the “Company” or “Cognition”), announced that a Type C meeting with the U.S. Food and Drug Administration (FDA) Division of Neurology has been scheduled for October 20, 2026. The objective of this meeting is to align with the FDA on the analytical and statistical details pertaining to the proposed primary endpoint for the planned registrational study of zervimesine (CT1812) in people with dementia with Lewy bodies (DLB) who experience psychosis symptoms.  

"Hallucinations are a core feature of DLB and often occur early in the disease, sometimes before cognitive changes are observed," explained Anthony O. Caggiano, MD, PhD, CMO of Cognition. "Importantly, researchers have found that psychosis symptoms, such as hallucinations and delusions, typically worsen as DLB progresses. In previous meetings, FDA agreed that psychosis could be an approvable outcome and could represent a marker for DLB disease progression. We look forward to discussing this in more detail with our Agency colleagues in October and aligning on an approvable endpoint to deploy in our planned Phase 3 study."

Previous meeting minutes received in June 2026 provided alignment on key aspects of a pivotal trial design, including the measurement of psychosis as a primary outcome. Cognition currently expects the Phase 3 study will enroll people with DLB who experience psychosis symptoms of hallucinations and delusions. Participants are expected to be eligible whether they are on stable background medication or are untreated. Following screening, participants will be randomized to receive either 100 mg of once-daily oral zervimesine or placebo for nine months.

“We look forward to meeting with the agency to finalize details of our registrational trial of zervimesine in DLB,” said Lisa Ricciardi, Cognition’s president and CEO. “Our ultimate goal is to provide patients and their families with a disease-modifying treatment option that slows the progression of DLB, and by so doing, delays the onset or worsening of symptoms.”

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. 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.

About DLB
Dementia with Lewy bodies (DLB) is a progressive, fatal neurodegenerative disease characterized by neuropsychiatric, cognitive and motor deficits. There are no approved drugs to slow the decline of DLB or treat the symptoms associated with the disease. Up to 80% of people living with DLB experience psychosis, which manifests as debilitating hallucinations and delusions. Hallucinations are a core feature and are among the diagnostic criteria for DLB. Psychosis symptoms are frequently cited as the most challenging for patients and their care partners to manage. 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. In a Phase 2 trial, zervimesine slowed progression of hallucinations and delusions by 89% compared to placebo, as measured by the neuropsychiatric inventory (NPI). In studies to date, zervimesine has been generally well tolerated.

About Zervimesine (CT1812)
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. 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 registrational trial for people with DLB who experience 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.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. All statements contained in this press release, other than statements of historical facts or statements that relate to present facts or current conditions, including but not limited to, statements regarding our product candidates, including zervimesine (CT1812), and any expected or implied benefits or results, including that initial clinical results observed with respect to zervimesine will be replicated in later trials and our clinical development plans, including statements regarding our clinical studies of zervimesine, any analyses of the results therefrom, as well as statements regarding our regulatory plans, are forward-looking statements. These statements, including statements relating to the timing and expected results of our clinical trials involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance, or achievements to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “might,” “will,” “should,” “expect,” “plan,” “aim,” “seek,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “forecast,” “potential” or “continue” or the negative of these terms or other similar expressions. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition, and results of operations. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified and some of which are beyond our control. Factors that may cause actual results to differ materially from current expectations include, but are not limited to: competition; our ability to secure new (and retain existing) grant funding; our ability to grow and manage growth, maintain relationships with suppliers and retain our management and key employees; our ability to successfully advance our current and future product candidates through development activities, preclinical studies and clinical trials and costs related thereto; uncertainties inherent in the results of preliminary data, pre-clinical studies and earlier-stage clinical trials being predictive of the results of early or later-stage clinical trials; the timing, scope and likelihood of regulatory filings and approvals, including regulatory approval of our product candidates; changes in applicable laws or regulations; the possibility that we may be adversely affected by other economic, business or competitive factors, including ongoing economic uncertainty; our estimates of expenses and profitability; the evolution of the markets in which we compete; our ability to implement our strategic initiatives and continue to innovate our existing products; our ability to defend our intellectual property; the impacts of ongoing global and regional conflicts on our business, supply chain and labor force; our ability to maintain the listing of our common stock on the Nasdaq Capital Market; and the risks and uncertainties described more fully in the “Risk Factors” section of our annual and quarterly reports filed with the Securities & Exchange Commission and are available at www.sec.gov. These risks are not exhaustive and we face both known and unknown risks. You should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in our forward-looking statements may not be achieved or occur, and actual results could differ materially from those projected in the forward-looking statements. Moreover, we operate in a dynamic industry and economy. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties that we may face. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

Contact Information:    Cognition Therapeutics, Inc.     info@cogrx.com

Mike Moyer (investors) LifeSci Advisors mmoyer@lifesciadvisors.com

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