Advancing Zervimesine (CT1812) towards late-stage trials for 
dementia with Lewy bodies (DLB) psychosis

Fully funded $80 million Phase 2 START trial readout expected in the second half of 2027

PURCHASE, N.Y., March 31, 2026 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc. (Nasdaq: CGTX), a clinical-stage neuroscience company developing drugs that treat neurodegenerative disorders, has published CEO Lisa Ricciardi’s Letter to Shareholders. The full text of the letter follows.

A MESSAGE FROM OUR CHIEF EXECUTIVE OFFICER

To my fellow Shareholders,

We made significant progress in 2025 towards our goal of developing transformative treatments for neurodegenerative diseases. As discussed on our financial results conference call last week, we are advancing zervimesine (CT1812) in late-stage trials for the treatment of the DLB psychosis. And in parallel we are making good progress in our START trial in mild cognitive impairment (MCI) and early Alzheimer’s disease.

Compelling SHIMMER Results Support Advancing Zervimesine in DLB Psychosis

Last year, we presented strong results from our Phase 2 SHIMMER trial in mild-to-moderate DLB at the International Lewy Body Dementia Conference. In the SHIMMER trial, we assessed the impact of zervimesine using standardized CNS measurements. While zervimesine showed a favorable impact across diverse symptom domains, some of the most compelling results were in the neuropsychiatric inventory (NPI), which assesses behavior and psychosis.

Based on these results, an analysis of the DLB-psychosis market, conversations with advisors and regulators, including a Type C meeting with the FDA, and feedback from individuals in the expanded access program, we announced our decision to advance zervimesine for the treatment of DLB psychosis. In the second quarter of 2026, we expect to meet with the FDA’s Division of Psychiatry to discuss next steps in our registrational plan for DLB psychosis.

Commitment to Alzheimer’s Disease

Our Phase 2 SHINE study in mild-to-moderate Alzheimer’s disease showed a reduction in cognition decline on par with the approved monoclonal antibodies. In addition, it was clear that participants with less disease burden were experiencing a more robust response to zervimesine. These individuals, who had lower levels of the protein p-tau217 in their blood, had a 95% reduction in decline compared to placebo – a near stabilization of their cognitive function in the six-month study.

As reflected in our end-of Phase 2 meeting minutes, the FDA aligned with our Phase 3 program design for six-months studies that screen for low p-tau217 levels to advance zervimesine for the treatment of Alzheimer's disease.

START Study Progressing to Data Readout in the Second Half of 2027

The fully enrolled START study is our Phase 2 study in 545 participants with MCI and early Alzheimer’s disease. Since these participants are earlier in the course of the disease, we expect that the majority will have lower levels of p-tau217. We showed at CTAD 2025 very compelling efficacy results in patients with low p-tau 217 – in fact, up to 95% slowing of disease progression. In addition, over 15% of participants in the START trial are on stable regimens of Kisunla or Leqembi. The data on concomitant use with currently available agents will be very informative for us. As a reminder, the START trial has been fully funded by an NIH grant and costs are covered through the completion of the study in 2027. Once we see the final results from this trial in the second half of 2027, we will assess next steps for the treatment of Alzheimer’s disease.

Looking Ahead

Thank you for your continued support as we pursue this mission together. With the momentum of 2025’s achievements, I am confident that 2026 will bring zervimesine one step closer to the patients who need safe and effective treatment options.

Sincerely,
Lisa Ricciardi
Chief Executive Officer, Cognition Therapeutics

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.

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 on the strong efficacy signals observed in the Phase 2 SHIMMER study in DLB (NCT05225415), the size of the market and the unmet need, 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.

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 or made during the conference, 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, the timing and expected results of our clinical 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 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.

This press release was published by a CLEAR® Verified individual.