Core Insights - Cognition Therapeutics is advancing the clinical development of zervimesine for treating psychosis associated with dementia with Lewy bodies (DLB), with a meeting with the FDA Division of Psychiatry expected by mid-2026 [1][2] Clinical Development - The company has developed a clinical plan for zervimesine, targeting a patient population with no approved treatment options for DLB psychosis [2] - The 545-patient 'START' trial in early Alzheimer's disease has completed enrollment, with results expected in 2027 to inform future development [2][7] - The company plans to advance zervimesine into late-stage trials for DLB psychosis based on strong efficacy signals observed in previous studies [10] Financial Results - As of December 31, 2025, the company reported cash and cash equivalents of approximately $37.0 million, with total obligated grant funds remaining at $35.7 million, indicating sufficient cash to fund operations through Q2 2027 [4] - Research and development expenses decreased to $37.2 million in 2025 from $41.7 million in 2024, attributed to the completion of clinical trials [5] - General and administrative expenses also decreased to $10.6 million in 2025 from $12.3 million in 2024, primarily due to reduced stock-based compensation [6] - The net loss for 2025 was $23.5 million, or $(0.32) per share, an improvement from a net loss of $34.0 million, or $(0.86) per share, in 2024 [6][15] Operational Highlights - The company launched an expanded access program for DLB patients and appointed Dr. David Weinstein as VP of clinical development [7] - A meeting with the FDA is planned to discuss the path forward for zervimesine in treating DLB psychosis [7] - The company has conducted an end-of-Phase 2 meeting with the FDA and received alignment on the development plan for zervimesine in Alzheimer's disease [7]

Core Viewpoint - Cognition Therapeutics, Inc. is set to release its financial results for Q4 and the full year ended December 31, 2025, on March 26, 2026, before market opening, followed by a conference call to discuss these results and provide a business update [1]. Company Overview - Cognition Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing treatments for neurodegenerative diseases, aiming to provide effective therapies for conditions such as dementia with Lewy bodies, Alzheimer's disease, and Parkinson's disease [3]. - The company's lead candidate, zervimesine (CT1812), is an investigational oral therapy that has shown promise in Phase 2 clinical trials for DLB and mild-to-moderate Alzheimer's disease [3]. - The company has received nearly $200 million in grants from the National Institutes of Health and related foundations to support its clinical research efforts [3]. Conference Call Information - The conference call to discuss the financial results can be accessed by dialing (800) 445-7795 for U.S. participants or (785) 424-1699 for international participants, using conference ID number CGTXQ4 [2]. - A live webcast with Q&A will be available on the company's website, and an archive of the webcast will be accessible for 90 days starting from March 26, 2026 [2].

Core Insights - Cognition Therapeutics, Inc. presented findings from the Phase 2 COG1201 SHIMMER study on zervimesine (CT1812) for dementia with Lewy bodies (DLB) at the AD/PD™ 2026 Conference, highlighting its potential to treat neuropsychiatric symptoms associated with DLB [1][2] Group 1: Study Findings - The Phase 2 SHIMMER study demonstrated an 86% slowing of decline on the neuropsychiatric index (NPI-12) with zervimesine treatment compared to placebo, indicating its unique disease-modifying mechanism of action [2][5] - Zervimesine showed a robust impact on neuropsychiatric symptoms, cognitive fluctuations, memory, movement symptoms, and daily living activities, making it a potential alternative for DLB patients who cannot tolerate traditional antipsychotics [3][6] Group 2: Clinical Development - Based on the Phase 2 results and a recent meeting with the FDA, the company plans to advance zervimesine for treating DLB psychosis, which includes symptoms like hallucinations and agitation that worsen as the disease progresses [5][10] - Zervimesine has been generally well tolerated in clinical studies, and the company aims to move it into late-stage clinical trials for DLB psychosis [10][11] Group 3: Market Context - Approximately 75% of DLB patients experience psychosis, leading to significant burdens on patients and caregivers, and highlighting the need for effective treatments as traditional antipsychotics are often contraindicated [7][9] - Cognition Therapeutics is focused on developing novel therapies for neurodegenerative diseases, with zervimesine being a key candidate backed by nearly $200 million in grants [9][10]

Core Viewpoint - Cognition Therapeutics, Inc. has extended the duration of its expanded access program for dementia with Lewy bodies, allowing participants several more months of treatment beyond the initial twelve months [1]. Group 1: Expanded Access Program (EAP) - The EAP has been operational since June 2025 and aims to gather additional long-term safety data [2]. - Feedback from participants and their care partners has been favorable, highlighting the program's operational aspects that reduce travel for patients [2][3]. - A total of 32 individuals are enrolled across eight sites, each receiving 100 mg of oral zervimesine daily [2]. Group 2: Clinical Development and Regulatory Engagement - The EAP is part of a broader clinical development program for dementia with Lewy bodies, which includes the Phase 2 SHIMMER study [3]. - Cognition Therapeutics held a Type C meeting with the FDA on January 21, 2026, to discuss findings from the SHIMMER study, focusing on clinically meaningful endpoints for future studies [3]. Group 3: Company Overview - Cognition Therapeutics is a clinical-stage biopharmaceutical company focused on developing small molecule therapeutics for age-related neurodegenerative disorders [5]. - The company has completed Phase 2 studies for its lead candidate, zervimesine, in various conditions including dementia with Lewy bodies and mild-to-moderate Alzheimer's disease [5].

Core Insights - The after-hours market showed a generally positive tone with small- and mid-cap stocks experiencing modest gains, highlighted by a significant surge in DBV Technologies following major clinical news [1] Company Highlights - DBV Technologies S.A. (DBVT) experienced a dramatic increase of 61.29%, reaching $29.00, after announcing that its Phase 3 study for the VIASKIN Peanut patch met its primary endpoint, reigniting investor enthusiasm [2] - Modular Medical, Inc. (MODD) saw a slight increase of 3.53% to $0.3549, with no new news but possibly influenced by a recent public offering announcement [3] - Co-Diagnostics, Inc. (CODX) rose 1.58% to $0.25, indicating light-volume trading rather than a specific catalyst [4] - Elutia Inc. (ELUT) gained 1.38% to $0.5525, reflecting broader low-volume momentum without new announcements [4] - Treace Medical Concepts, Inc. (TMCI) increased by 3.70% to $2.80, suggesting gains were driven by light trading activity [5] - Amylyx Pharmaceuticals, Inc. (AMLX) advanced 4.83% to $12.90, potentially reflecting positive early trial data from a recent presentation [6] - Cognition Therapeutics, Inc. (CGTX) gained 3.95% to $1.58, with recent announcements regarding full enrollment in its expanded access program for zervimesine [7]

Core Insights - Cognition Therapeutics, Inc. has successfully completed enrollment in its expanded access program for zervimesine, with participants receiving 100 mg daily for up to one year [1][2] - The company has scheduled a Type C meeting with the U.S. FDA for the second half of January to discuss the proposed design of a Phase 3 program for zervimesine in dementia with Lewy bodies (DLB) [2][3] Expanded Access Program - The COG1202 expanded access program is open-label and includes eligible participants from the Phase 2 SHIMMER study and additional patients diagnosed with mild-to-moderate DLB [3] - Dr. James E. Galvin is the lead investigator for this multi-center program [3] Zervimesine (CT1812) - Zervimesine is an investigational oral medication aimed at treating CNS diseases, specifically Alzheimer's disease and DLB, by interrupting the toxic effects of Aβ and ɑ-synuclein [4] - The drug has shown a good safety profile in clinical studies to date [4][5] Company Overview - Cognition Therapeutics is a clinical-stage biopharmaceutical company focused on developing small molecule therapeutics for age-related degenerative disorders of the central nervous system [6] - The company has completed Phase 2 studies for zervimesine in DLB and mild-to-moderate Alzheimer's disease, with ongoing studies in early Alzheimer's disease [6]

Core Insights - Cognition Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing therapies for neurodegenerative disorders [3] - The company will participate in the 37th Annual Piper Sandler Healthcare Conference, with a discussion scheduled for December 3, 2025 [1][2] Company Overview - Cognition Therapeutics specializes in small molecule therapeutics targeting age-related degenerative disorders of the central nervous system [3] - The company has completed Phase 2 studies for its lead candidate, zervimesine (CT1812), in conditions such as dementia with Lewy bodies, mild-to-moderate Alzheimer's disease, and geographic atrophy secondary to dry AMD [3] - An ongoing Phase 2 START Study (NCT05531656) is focused on early Alzheimer's disease [3] - Zervimesine is believed to interact with the sigma-2 receptor, offering a distinct mechanism compared to other treatments for degenerative diseases [3]

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]