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]

Core Insights - Cognition Therapeutics, Inc. published results from the Phase 2 SEQUEL study of zervimesine (CT1812) for treating mild-to-moderate Alzheimer's disease, indicating potential neuroprotective effects and improvements in neuronal function [1][2][3] Study Findings - The SEQUEL study demonstrated that zervimesine treatment led to consistent improvements in EEG parameters, particularly a reduction in theta wave frequencies associated with Alzheimer's disease after 29 days [2][11] - Zervimesine was linked to enhanced global alpha AEC-c, indicating improved functional connectivity between brain regions, with significant protein alterations related to vesicle formation and cellular transport functions [3][4] - In vitro experiments showed that zervimesine preserved neuronal health under oxidative stress conditions, maintaining cell viability and structural integrity in the presence of 4-Hydroxynonenal (4-HNE), a known inducer of oxidative stress [5][6][7] Company Overview - Cognition Therapeutics is a clinical-stage biopharmaceutical company focused on developing small molecule therapeutics for age-related neurodegenerative disorders, with zervimesine being a lead candidate currently in multiple Phase 2 studies [8][9] - Zervimesine has received FDA Fast Track designation for Alzheimer's disease, highlighting its potential therapeutic benefits [9][10] SEQUEL Study Details - The SEQUEL study enrolled 16 adults with mild-to-moderate Alzheimer's disease, randomized to receive either 300mg of zervimesine or placebo for 29 days, followed by a crossover to the alternate treatment [11][12]

Core Insights - Cognition Therapeutics, Inc. conducted a positive end-of-Phase 2 meeting with the FDA regarding zervimesine (CT1812) for Alzheimer's disease treatment [1][2] - The SHINE Study demonstrated safety and tolerability, meeting its primary endpoints with 153 participants [4] - Zervimesine has been adopted as the United States Adopted Name (USAN) for CT1812 [3] Company Overview - Cognition Therapeutics is a clinical-stage biopharmaceutical company focused on developing small molecule therapeutics for age-related neurodegenerative disorders [6] - The company is advancing zervimesine through various clinical studies, including ongoing trials for dementia with Lewy bodies and early Alzheimer's disease [6] Study Details - The SHINE Study was a double-blind, placebo-controlled Phase 2 trial that enrolled 153 adults with mild-to-moderate Alzheimer's disease, assessing cognitive and functional changes [4] - The study received approximately $30 million in grant support from the National Institute on Aging [5] Drug Mechanism - Zervimesine is an investigational oral medication that targets the toxic effects of Aβ and ɑ-synuclein proteins associated with neurodegenerative diseases [2][6] - The drug aims to slow disease progression and improve the quality of life for patients suffering from Alzheimer's and dementia with Lewy bodies [2]

Company Overview - Cognition Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing innovative small molecule therapeutics for age-related degenerative disorders of the central nervous system [7] - The company is currently investigating its lead candidate, zervimesine (CT1812), in clinical programs for dementia with Lewy bodies (DLB) and Alzheimer's disease [7] Expanded Access Program (EAP) - Cognition has received an anonymous philanthropic donation to fund an expanded access program for individuals with dementia with Lewy bodies [2] - The EAP will provide participants with 100 mg of oral zervimesine daily for approximately one year, starting with around 30 individuals [4] - The first site activated for the EAP is the Banner Sun Health Research Institute in Arizona, with Dr. David Shprecher as the primary investigator [2][5] Clinical Study and Collaboration - The EAP is based on the Phase 2 SHIMMER study, where zervimesine was administered to DLB patients [2] - Dr. James E. Galvin will serve as the lead investigator for the EAP, bringing his experience from the SHIMMER study [3][4] - The program aims to onboard additional participating sites rapidly to begin treatment for eligible patients [3] Future Prospects - Cognition aims to expand the EAP to accommodate more patients as funding and drug supply allow [4] - The company believes zervimesine can regulate impaired pathways in neurodegenerative diseases through its interaction with the sigma-2 receptor [7]