PURCHASE, N.Y., Nov. 20, 2025 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc. (Nasdaq: CGTX), a clinical stage company developing product candidates designed to treat neurodegenerative disorders, announced that the Company’s president and CEO, Lisa Ricciardi will participate in an “unplugged” fireside discussion at the annual Piper Sandler Healthcare Conference. The conference will take place December 2-4, 2025 at The Lotte New York Palace hotel. Details of Cognition’s fireside discussion are as follows: E ...

Core Insights - Cognition Therapeutics, Inc. has achieved target enrollment of 540 participants in the Phase 2 'START' Study, which evaluates the safety and efficacy of zervimesine (CT1812) in patients with mild cognitive impairment or early Alzheimer's disease [1][2] - The study is supported by an $81 million grant from the National Institute of Aging and is conducted in collaboration with the Alzheimer's Clinical Trials Consortium [5] Enrollment and Study Design - The START study has seen strong enrollment, with approximately 50% of participants enrolled in the last six months, driven by interest from patients and investigators [2] - The study involves a randomized, placebo-controlled design, assessing once-daily oral zervimesine over 18 months, measuring cognition and executive function using validated tools [4] Drug Mechanism and Potential - Zervimesine is an investigational oral drug targeting neurodegenerative disorders, with a unique mechanism distinct from currently approved therapies, potentially benefiting a broader range of Alzheimer's patients [3][6] - The drug aims to interrupt the toxic effects of protein buildup in the brain, which is associated with Alzheimer's and dementia with Lewy bodies, potentially slowing disease progression [7] Clinical Context - The START study was initiated following the accelerated approval of Leqembi in the US, allowing participants on stable background therapy with approved monoclonal antibodies to enroll [2] - Approximately 15% of participants in the START study are also receiving infusions of Leqembi or Kisunla [2] Company Overview - Cognition Therapeutics is focused on developing small molecule therapeutics for age-related degenerative disorders of the central nervous system, with ongoing Phase 2 studies for zervimesine in various conditions [8]

Core Insights - Cognition Therapeutics, Inc. has completed a $30 million registered direct offering to support the next stage of development for its drug zervimesine (CT1812) [2][8] - The company has aligned with the U.S. FDA on a registrational path for zervimesine in Alzheimer's disease, which is seen as a significant achievement [2][8] - An ongoing expanded access program for zervimesine in dementia with Lewy bodies is in place [8] Financial Highlights - As of September 30, 2025, the company reported cash, cash equivalents, and restricted cash equivalents of approximately $39.8 million, with total obligated grant funds remaining from the National Institute of Aging at $36.3 million [4] - Research and development expenses for Q3 2025 were $3.8 million, a decrease from $11.4 million in Q3 2024, attributed to the completion of clinical trials [5] - General and administrative expenses were $2.6 million for Q3 2025, down from $3.1 million in Q3 2024, primarily due to reduced stock-based compensation [6] - The net loss for Q3 2025 was $4.9 million, or $(0.06) per share, compared to a net loss of $9.9 million, or $(0.25) per share, for the same period in 2024 [6][11] Business Developments - The company has surpassed 75% enrollment in the Phase 2 'START' study of zervimesine in early Alzheimer's disease, which is being conducted in collaboration with the Alzheimer's Clinical Trials Consortium [8] - Clinical pharmacology and bioavailability studies are being executed to prepare zervimesine for the next stage of development across various indications [8] - The proposed registrational study design for Alzheimer's disease has been accepted for presentation at the Clinical Trials in Alzheimer's Disease (CTAD) Conference scheduled for December 1-4, 2025 [8]

Core Insights - Several biotech companies experienced significant after-hours stock gains due to clinical trial updates, funding announcements, and upcoming product showcases Group 1: Prime Medicine Inc. (PRME) - Shares rose 8.14% in after-hours trading, reaching $5.05 after a regular session close of $4.67, which was up 16.46% [2] - The company reported a narrowed net loss of $52.6 million or $0.41 per share on revenue of $1.12 million, highlighting early clinical data from its CGD program [3] - Upcoming catalysts include planned IND filings for Wilson's Disease and Alpha-1 Antitrypsin Deficiency in 2026, with initial clinical data expected in 2027 [4] Group 2: Meihua International Medical Technologies Co. Ltd. (MHUA) - Shares increased by 7.55% in after-hours trading, reaching $0.4444 after a regular session close of $0.4132, which was down 2.62% [4] - The company is set to report its quarterly earnings on September 18, 2025 [5] Group 3: Elutia Inc. (ELUT) - Shares rose 10.17% in after-hours trading, reaching $1.30 after closing at $1.18, which was down 3.28% [5] - Elutia announced clinical data showing its biologic envelopes significantly ease reoperations for cardiac implantable electronic devices, reducing procedural difficulty by over 40% [6] - The company will exhibit its EluPro antibiotic-eluting BioEnvelope at the Vizient Innovative Technology Exchange on September 17, 2025 [6] Group 4: Aligos Therapeutics Inc. (ALGS) - Shares increased by 2.79% in after-hours trading, reaching $9.20 after closing at $8.95, which was down 4.48% [7] - Aligos presented six preclinical studies at the 2025 International HBV Meeting, including new data on its capsid assembly modulator and a novel ASO strategy targeting hepatitis delta virus [8] - Upcoming catalysts include continued enrollment and data updates from the B-SUPREME study and a scheduled earnings report on November 5, 2025 [9] Group 5: Bionano Genomics Inc. (BNGO) - Shares fell 35.74% to $1.78 before rebounding 6.74% in after-hours trading to $1.90 [10] - The decline followed a $10 million public offering priced at $2.00 per share, expected to close around September 17, 2025 [11] - Bionano plans to use the funds for working capital and general corporate purposes, with recent publications highlighting the utility of its Optical Genome Mapping in cancer biomarker analysis [11] Group 6: Cognition Therapeutics Inc. (CGTX) - Shares climbed 6.21% in after-hours trading, reaching $1.71 after closing at $1.61, which was up 4.55% [12] - The company’s lead candidate, zervimesine, reached 75% enrollment in its Phase 2 START study for early Alzheimer's disease, backed by the National Institute on Aging [13] - Cognition recently closed a $30 million registered direct offering to support Phase 3 development [13]

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]

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].

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]

Core Insights - Cognition Therapeutics received FDA confirmation on the design of its Phase 3 program for zervimesine (CT1812) as a treatment for Alzheimer's disease, which may support a New Drug Application (NDA) filing [1][4] - The Phase 3 program will focus on enrolling adults with mild-to-moderate Alzheimer's disease who have lower levels of p-tau217, a biomarker indicating potential treatment efficacy [2][3] - Zervimesine has demonstrated a 95% reduction in cognitive deterioration compared to placebo in previous studies, supporting its potential effectiveness in the targeted population [2][4] Company Overview - Cognition Therapeutics is a clinical-stage biopharmaceutical company focused on developing small molecule therapeutics for neurodegenerative disorders [9] - The company has completed Phase 2 studies for zervimesine in conditions such as dementia with Lewy bodies and mild-to-moderate Alzheimer's disease, with ongoing studies supported by significant grant funding [9][8] - Zervimesine is designed to interrupt the toxic effects of proteins associated with neurodegenerative diseases, potentially improving patient outcomes [5][9] Study Design and Strategy - The Phase 3 study will randomize participants to receive either 100mg of zervimesine or a placebo daily for six months, with efficacy and safety endpoints confirmed by the FDA [3][4] - The study will incorporate biomarker and imaging assessments to further support clinical outcomes, enhancing the robustness of the trial [3] - The FDA's agreement on the study design allows for faster and more cost-effective enrollment, expediting the regulatory filing process [4]

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]

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]