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Cognition Therapeutics Study of Zervimesine (CT1812) in Early Alzheimer’s Disease Reaches 75% Enrollment Target
Globenewswire· 2025-09-03 11:30
Core Insights - Cognition Therapeutics, Inc. has announced that the Phase 2 'START' Study has reached 75% enrollment, targeting approximately 540 individuals with mild cognitive impairment (MCI) and early Alzheimer's disease [1][2] - The study is evaluating the efficacy of zervimesine (CT1812) over 18 months, in collaboration with the Alzheimer's Clinical Trials Consortium and funded by the National Institute of Aging [1][4] Study Details - The START Study (NCT05531656) aims to assess the efficacy and tolerability of once-daily oral zervimesine in individuals with MCI or early Alzheimer's disease who have elevated Aβ levels [3] - Participants are randomized to receive either zervimesine or placebo, with cognitive and executive function measured using validated tools such as the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) and ADAS-Cog rating scales [3] Funding and Support - The START Study is supported by an $81 million grant from the National Institute of Aging [4] - The study is conducted in collaboration with the Alzheimer's Clinical Trials Consortium, which includes 35 leading academic sites specializing in Alzheimer's clinical trials [4] Previous Studies - The SHINE Study, a Phase 2 trial, enrolled 153 adults with mild-to-moderate Alzheimer's disease and met its primary endpoints of safety and tolerability [5][6] - The SHINE Study demonstrated that zervimesine slows cognitive deterioration in patients with lower levels of p-tau217 [2] Product Information - Zervimesine (CT1812) is an investigational oral medication aimed at treating CNS diseases like Alzheimer's and dementia with Lewy bodies [7] - The drug targets the toxic effects of protein buildup in the brain, potentially slowing disease progression and improving patient quality of life [7]
Cognition Therapeutics Closes $30 Million Registered Direct Offering to Two New Fundamental Institutional Investors, Including a Preeminent Global Investment Firm to Support Phase 3 Development of Zervimesine (CT1812)
Globenewswire· 2025-09-02 20:00
PURCHASE, N.Y., Sept. 02, 2025 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc., (the “Company” or “Cognition”) (NASDAQ: CGTX), a clinical-stage company developing drugs that treat neurodegenerative disorders, closed its previously announced registered direct offering of 14,700,000 shares of common stock at a purchase price of $2.05 per share. Gross proceeds from the offering were approximately $30 million, before deducting placement agent fees and other offering expenses. Titan Partners Group, a division o ...
Cognition Therapeutics Announces $30 Million Registered Direct Offering of Common Stock
Globenewswire· 2025-08-28 00:53
Core Viewpoint - Cognition Therapeutics, Inc. has announced a registered direct offering of 14,700,000 shares of common stock, expected to generate approximately $30 million in gross proceeds to fund Phase 3 programs of zervimesine for neurodegenerative disorders and for general corporate purposes [1][2]. Group 1: Offering Details - The offering is made to two new fundamental institutional investors, including a prominent global investment manager [2]. - The closing of the offering is anticipated to occur on or about August 29, 2025, pending customary closing conditions [1]. Group 2: Use of Proceeds - The net proceeds from the offering will be utilized for the preparation of Phase 3 programs of zervimesine in neurodegenerative disorders, as well as for working capital and general corporate purposes [2]. Group 3: Company Background - Cognition Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing small molecule therapeutics for age-related degenerative disorders of the central nervous system [5]. - The company has completed Phase 2 studies of zervimesine in conditions such as dementia with Lewy bodies, mild-to-moderate Alzheimer's disease, and geographic atrophy secondary to dry AMD [5]. - The ongoing Phase 2 START study in early Alzheimer's disease is supported by $81 million in grant funding from the National Institute of Aging [5].
Cognition Therapeutics Regains Compliance with Nasdaq Minimum Bid Price Requirement
Globenewswire· 2025-08-26 20:00
Core Points - Cognition Therapeutics, Inc. has regained compliance with Nasdaq's minimum share price requirement under Rule 5550(a)(2) [1][2] - The company achieved a minimum closing bid price of $1.00 or more for at least 10 consecutive business days, with the requirement fulfilled on August 25, 2025 [2] - Cognition Therapeutics is a clinical-stage biopharmaceutical company focused on developing small molecule therapeutics for neurodegenerative disorders [3] Company Overview - Cognition Therapeutics is currently developing zervimesine (CT1812), targeting dementia with Lewy bodies, mild-to-moderate Alzheimer's disease, and geographic atrophy secondary to dry AMD [3] - The Phase 2 START study in early Alzheimer's disease is ongoing, supported by $81 million in grants from the National Institute of Aging [3] - The mechanism of zervimesine involves interaction with the sigma-2 receptor, which is distinct from other treatment approaches for degenerative diseases [3]
Cognition: Zervimesine AD Treatment Program FDA Alignment Means "Strong Buy" Rating
Seeking Alpha· 2025-08-26 14:08
Company Overview - Cognition Therapeutics (NASDAQ: CGTX) is advancing several clinical drug candidates, with a focus on zervimesine [CT1812] for treating patients [2]. Product Pipeline - The lead program under development is zervimesine [CT1812], which is being evaluated for its efficacy in treating specific patient populations [2]. Investment Insights - The Biotech Analysis Central service offers a comprehensive analysis of various pharmaceutical companies, including a library of over 600 biotech investing articles and a model portfolio of more than 10 small and mid-cap stocks [2].
Cognition Therapeutics Receives End-of-Phase 2 Meeting Minutes Confirming Alignment with U.S. FDA on Registrational Path for Zervimesine (CT1812) in Alzheimer's Disease
Globenewswire· 2025-08-12 20:00
PURCHASE, N.Y., Aug. 12, 2025 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc., (the Company or Cognition) (NASDAQ: CGTX), a clinical-stage company developing drugs that treat neurodegenerative disorders, received final minutes from the U.S. Food and Drug Administration (FDA) pertaining to the end-of- Phase 2 meeting that was conducted on July 9, 2025. FDA confirmed the proposed design of the Phase 3 program may support a New Drug Application (NDA) filing for zervimesine (CT1812) as a treatment for Alzheime ...
Cognition Therapeutics(CGTX) - 2025 Q2 - Quarterly Results
2025-08-07 21:16
Exhibit 99.1 Cognition Therapeutics Reports Financial Results for the Second Quarter 2025 and Highlights Progress Across Clinical Programs - Discussed plans to support a pivotal Alzheimer's disease program with FDA at end-of-phase 2 meeting - - Initiated expanded access program (EAP) for people with dementia with Lewy bodies (DLB) - "Later this month we anticipate receiving the FDA's minutes from our end-of-Phase 2 meeting regarding registrational plans for zervimesine in Alzheimer's disease. We expect thes ...
Cognition Therapeutics(CGTX) - 2025 Q2 - Quarterly Report
2025-08-07 20:17
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-40886 Cognition Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 13-4365359 ...
Cognition Therapeutics Presents Data at AAIC Highlighting Broad Neurological Impact of Zervimesine (CT1812) in Dementia with Lewy Bodies and Alzheimer’s Disease
Globenewswire· 2025-07-29 11:30
Core Insights - Cognition Therapeutics, Inc. presented positive results from the Phase 2 COG1201 SHIMMER study of zervimesine in dementia with Lewy bodies (DLB) at the Alzheimer's Association International Conference 2025 [1][2] - The SHIMMER study demonstrated zervimesine's significant impact on neuropsychiatric symptoms, with DLB patients showing an average of 86% improvement compared to placebo [2][3] - Zervimesine's efficacy in Alzheimer's disease was also highlighted in the Phase 2 SHINE study, where it was found to halt cognitive decline in patients with lower plasma p-tau217 levels by 129% and 91% for mild and moderate cases, respectively [4] Study Details - The SHIMMER study enrolled 130 adults with mild-to-moderate DLB, randomized to receive either zervimesine or placebo for six months [6][7] - The SHINE study included 153 adults with mild-to-moderate Alzheimer's disease, also randomized to receive zervimesine or placebo for six months [9][10] - Both studies met their primary endpoint of safety and tolerability, supported by approximately $30 million in grants from the National Institute on Aging [8][10] Biomarker Findings - Plasma p-tau217 levels were identified as a potential biomarker to predict which Alzheimer's patients would benefit most from zervimesine treatment [1][4] - Significant reductions in plasma glial fibrillary acidic protein (GFAP) were observed in SHINE participants with lower p-tau217 levels, indicating a potential impact on neuroinflammation [5][4] - The studies also showed trends towards normalization of neurofilament light (NfL) and amyloid beta species, suggesting zervimesine's influence on Alzheimer's disease biology [5][4] Company Overview - Cognition Therapeutics, Inc. focuses on developing innovative therapeutics for neurodegenerative disorders, with zervimesine as its lead candidate [13] - Zervimesine is an investigational oral medication aimed at treating Alzheimer's disease and DLB, targeting the toxic effects of protein buildup in the brain [11][13] - The company has received FDA Fast Track designation for zervimesine in Alzheimer's disease, indicating its potential significance in addressing unmet medical needs [11]
Cognition Therapeutics Presents Data at AAIC Highlighting Broad Neurological Impact of Zervimesine (CT1812) in Dementia with Lewy Bodies and Alzheimer's Disease
GlobeNewswire News Room· 2025-07-29 11:30
Core Insights - Cognition Therapeutics, Inc. presented positive results from the Phase 2 COG1201 SHIMMER study of zervimesine in dementia with Lewy bodies (DLB) at the Alzheimer's Association International Conference 2025 [1][2] - Zervimesine treatment showed an 86% improvement in neuropsychiatric symptoms compared to placebo after six months [2] - The SHINE study results indicated that lower plasma p-tau217 levels can identify Alzheimer's patients more likely to benefit from zervimesine treatment [3][4] Study Results - The SHIMMER study met its primary endpoint of safety and tolerability, with zervimesine showing a positive impact across various scales [2][6] - DLB patients treated with zervimesine scored significantly better on the neuropsychiatric inventory, particularly in symptoms like hallucinations and anxiety [2][3] - The SHINE study also met its primary endpoint, with zervimesine arresting cognitive deterioration by 129% in mild Alzheimer's and 91% in moderate Alzheimer's patients [4][9] Biomarker Analysis - Plasma p-tau217 levels were used to identify patients likely to benefit from zervimesine, with significant reductions in neuroinflammation markers observed [4][5] - The study found trends towards normalization of neurofilament light (NfL) and amyloid beta species in patients with lower p-tau217 levels [5][4] - Zervimesine's impact on neuroinflammation and neurodegeneration was supported by biomarker evidence presented at the conference [5][4] Company Overview - Cognition Therapeutics is focused on developing innovative therapeutics for neurodegenerative disorders, with zervimesine as a lead candidate [11][13] - The company has received significant funding from the National Institute on Aging, totaling approximately $30 million for both the SHIMMER and SHINE studies [8][10] - Zervimesine has been granted FDA Fast Track designation for Alzheimer's disease, indicating its potential significance in treatment [11]