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Cognition Therapeutics Presents Results at AD/PD 2025 Showing Impact of Zervimesine (CT1812) on Alzheimer's Disease Processes

1. Cognition presented zervimesine Phase 2 SHINE study results at AD/PD 2025. 2. Significant biomarker reductions were noted in Alzheimer's patients treated with zervimesine. 3. Lower p-Tau217 subgroup showed pronounced biomarker improvement compared to placebo. 4. Zervimesine's mechanism plausibly correlates biomarker changes to cognitive effects. 5. Cognition targets neurodegenerative disorders, including Alzheimer's and Lewy body dementia.

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Why Bullish?

The presentation of positive biomarker results from a Phase 2 trial generally boosts investor confidence. Past instances, such as successful clinical trial announcements leading to stock price surges, support this sentiment.

How important is it?

The findings from the SHINE study directly relate to CGTX's main drug candidate, making it highly relevant to investors and stakeholders. Market reactions to clinical trial results are often significant, influencing price movements.

Why Long Term?

The ongoing clinical developments and potential future trials can lead to sustained interest and investment. Historical examples, like other biotech firms advancing to successful FDA approvals, can drive long-term stock value increases.

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Presentation Shows Pronounced Reduction in Key Plasma Biomarkers Among Prespecified Study Population April 01, 2025 07:30 ET  | Source: Cognition Therapeutics, Inc. PURCHASE, N.Y., April 01, 2025 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc., (the “Company” or “Cognition”) (NASDAQ: CGTX), a clinical-stage company developing drugs that treat neurodegenerative disorders, presented biomarker results from the Phase 2 SHINE (COG0201) study of zervimesine (CT1812) in mild-to-moderate Alzheimer’s disease at the AD/PD™ 2025 Alzheimer's & Parkinson's Diseases Conference taking place April 1-5, 2025 in Vienna, Austria. In her presentation, Mary Hamby, Ph.D., VP of research at Cognition, compared changes in key proteins, called biomarkers, in the entire study population with changes observed in participants who began the study with lower levels of a protein called p-Tau217 in their blood. This protein, which can be measured with a blood test, has emerged as an indicator of Alzheimer’s disease pathology. Analysis of this low-p-Tau217 subgroup was defined in the SHINE study design in order to examine the impact of zervimesine in people with less neurodegeneration. In the overall study population, compared to participants treated with placebo, those who received zervimesine for six months had reductions in plasma biomarkers associated with Alzheimer’s disease processes. Further analysis showed that the SHINE low-p-Tau217 subgroup experienced a pronounced reduction in these key plasma biomarkers compared to placebo. Most notably, significant reductions were observed in the level of glial fibrillary acidic protein (GFAP), a protein associated with neuroinflammation. Neurofilament light (NfL), a protein associated with neurodegeneration was also reduced in participants treated with zervimesine compared to placebo. Similarly, amyloid beta (Aβ) and tau species (p-Tau217), which are proteins that build up in patients with Alzheimer’s disease, were lower in participants treated with zervimesine for six months compared to placebo-treated individuals. “The data that we are presenting at AD/PD this week show that changes in certain proteins correlate to the cognitive effect of zervimesine that we saw in the overall study population,” explained Dr. Hamby. “Just as the cognitive effects were more pronounced in the SHINE low-p-Tau217 subgroup, the impact on biomarkers such as GFAP and NfL was also more pronounced in this patient population. Taken as a whole, these analyses support our understanding of zervimesine’s mechanism of action in impacting disease and point to key biological underpinnings by which zervimesine may elicit its effect.” Details of Cognition’s presentation are as follows:Title: Positive Impact of CT1812 Treatment on Plasma Biomarkers in Lower p-tau217 Subgroup Aligns with Clinical Benefits in Mild-to-Moderate AD Patients (ID 3184)Authors: Hamby ME, Kavanagh S, Di Caro V, Zetterberg H, Blennow K, Teunissen CE, Grundman M, Caggiano AODate/time: 01 April 2025 at 2:45pm CETLocation: Hall A   Title: CSF Proteomic Biomarker Analysis from Phase 2 Study Shine Identified Effects of S2R Modulator CT1812 in Alzheimer’s Disease (ID 2921)Authors: Lizama B, Pandey K, Duong D, Seyfried NT, Cho E, Grundman M, Di Caro V, Caggiano AO, Hamby MELocation: Poster Hall   Title: Identification of CSF Proteins That Correlate with Cognitive Outcomes in Participants of Phase 2 Study Shine Evaluating Effects of CT1812 in Patients with Alzheimer's Disease (ID 3119)Authors: Lizama B, Pandey K, Duong D, Seyfried NT, Grundman M, Caggiano AO, Hamby MELocation: Poster Hall   Title: Identification of Molecular Correlates with CT1812 Treatment-related Decrease in NfL CSF Levels Connected to Sigma-2 ReceptorAuthors: Di Caro V, Cho E, Lizama B, Pandey K, Duong D, Seyfried NT, Blennow K, Zetterberg H, Grundman M, Caggiano AO, Hamby MELocation: Poster Hall    About Cognition Therapeutics, Inc.Cognition Therapeutics, Inc., is a clinical-stage biopharmaceutical company discovering and developing innovative, small molecule therapeutics targeting age-related degenerative disorders of the central nervous system. We are currently investigating our lead candidate, zervimesine (CT1812), in clinical programs in dementia with Lewy bodies (DLB) and Alzheimer’s disease, including the ongoing START study (NCT05531656) in early Alzheimer’s disease. We believe zervimesine can regulate pathways that are impaired in these diseases though its interaction with the sigma-2 receptor, a mechanism that is functionally distinct from other approaches for the treatment of degenerative diseases. More about Cognition Therapeutics and our pipeline can be found at https://cogrx.com. 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 and our clinical development plans, including statements regarding our clinical studies of zervimesine and any analyses of the results therefrom, 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. This press release was published by a CLEAR® Verified individual.

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