Elayta (zervimesine) / Cognition Therap - LARVOL DELTA

Cognition Therapeutics Reaches Full Enrollment in Expanded Access Program for Zervimesine (CT1812) in Dementia with Lewy Bodies (GlobeNewswire) - "Each of the individuals enrolled in the program are being treated with 100 mg of oral zervimesine daily for up to one year. The program was made possible through a generous donation from the family of a participant in the Phase 2 SHIMMER study of zervimesine (CT1812) in dementia with Lewy bodies (DLB)....The Company's request for a Type C meeting has been accepted by the U.S. Food and Drug Administration (FDA) and the meeting scheduled for the second half of January. The Type C meeting will focus on the proposed design of a Phase 3 program for zervimesine in this patient population. Meeting minutes are expected to follow the Type C meeting."

Enrollment closed • FDA event • New P3 trial • Dementia • Lewy Body Disease

Cognition Therapeutics Presents Phase 3 Plan for Zervimesine (CT1812) in Alzheimer’s Disease at Clinical Trials on Alzheimer’s Disease (CTAD) Conference (GlobeNewswire) - "Seeking Alignment with European Medicines Agency (EMA) at February 2026 Meeting...The Phase 3 program is expected to enroll adults with mild-to-moderate Alzheimer's disease who have lower levels of plasma p-tau217 at screening...'Results from the Phase 2 ‘SHINE’ study showed that participants treated with zervimesine who had lower plasma p-tau217 levels experienced a 95% slowing of cognitive decline (by ADAS-Cog11) compared with placebo.'....FDA meeting minutes stated that two six-month Phase 3 studies with participants randomized 1:1 to receive either 100 mg of oral zervimesine or placebo daily may be sufficient. Efficacy may be measured using the iADRS, a composite of the ADAS-Cog 13 and ADCS-ADL, validated scales measuring cognition and function. Participants who complete either study will be eligible to enroll in an open-label extension."

European regulatory • New P3 trial • P2 data • Alzheimer's Disease

Cognition Therapeutics…announced that the company has reached target enrollment of 540 participants in the randomized, placebo-controlled Phase 2 ‘START’ Study (GlobeNewswire) - "A number of additional patients are in the final stages of screening and will be randomized if they meet all eligibility requirements....Topline results are expected after all participants have completed 18 months of treatment."

P2 data • Trial status • Alzheimer's Disease

Cognition Therapeutics Reports Financial Results for the Third Quarter 2025 and Highlights Progress Across Clinical Programs (GlobeNewswire) - "Proposed registrational Alzheimer’s disease study design accepted for presentation at Clinical Trials in Alzheimer’s Disease (CTAD) Conference, being held December 1-4, 2025."

Clinical protocol • Alzheimer's Disease

START: A Study to Evaluate the Safety and Efficacy of CT1812 in Early Alzheimer's Disease (clinicaltrials.gov) - P2 | N=540 | Active, not recruiting | Sponsor: Cognition Therapeutics | Recruiting ➔ Active, not recruiting

Enrollment closed • Alzheimer's Disease • CNS Disorders

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)

Financing • Alzheimer's Disease

Cognition Therapeutics Study of Zervimesine (CT1812) in Early Alzheimer’s Disease Reaches 75% Enrollment Target (PRNewswire) - "The START Study is enrolling approximately 540 individuals with mild cognitive impairment (MCI) and early Alzheimer’s disease who will be treated with zervimesine (CT1812) or placebo for 18 months."

Enrollment status • Alzheimer's Disease

Cognition Therapeutics Presents Data at AAIC Highlighting Broad Neurological Impact of Zervimesine (CT1812) in...Alzheimer’s Disease (GlobeNewswire) - P2 | N=153 | SHINE (NCT03507790) | Sponsor: Cognition Therapeutics | "Results from the Phase 2 COG0201 ‘SHINE’ study (NCT03507790) of zervimesine in Alzheimer’s disease were also presented at AAIC. The SHINE study met its primary endpoint of safety and tolerability. An analysis was conducted on a subgroup of participants whose Alzheimer’s disease brain pathology was less pronounced, as determined by lower levels of a protein called p-tau217 in their blood. Approximately half of this subgroup was identified as having mild Alzheimer’s disease and half with moderate Alzheimer’s disease by the mini mental state exam (MMSE)...SHINE participants with lower p-tau217 had a more robust response to zervimesine compared to those with higher p-tau217 levels regardless of their MMSE scores. Zervimesine was shown to arrest further cognitive deterioration in people with mild or moderate Alzheimer’s disease by 129% and 91%, respectively."

P2 data • Alzheimer's Disease

Cognition Therapeutics Completes End-of-Phase 2 Meeting with FDA for Zervimesine (CT1812) in Alzheimer’s Disease (GlobeNewswire) - "Cognition Therapeutics, Inc...conducted an end-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) on July 9, 2025. The objective of this meeting was to review results from the Phase 2 study of zervimesine (CT1812) and to discuss plans for a Phase 3 program that would support a new drug application (NDA) for zervimesine as a treatment for Alzheimer’s disease...'We discussed the results from the Phase 2 ‘SHINE’ Study in Alzheimer’s disease and our proposed Phase 3 plan with the FDA and believe we have a path forward for the development of zervimesine in the treatment of Alzheimer’s disease. We look forward to reviewing the FDA’s formal minutes in August to confirm our path forward.'"

FDA event • Alzheimer's Disease

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) - "FDA confirmed the proposed design of the Phase 3 program may support a New Drug Application (NDA) filing for zervimesine (CT1812)....The Phase 3 program is expected to enroll adults with a diagnosis of mild-to-moderate Alzheimer's disease who have lower levels of p-tau217 at screening....Cognition also plans to include biomarker and imaging assessments in the Phase 3 program..."

FDA event • New P3 trial • Alzheimer's Disease

Cognition Therapeutics' Positive Clinical Data from Zervimesine (CT1812) Phase 2 Study in Dementia with Lewy Bodies (DLB) will be Presented in a Podium Presentation at AAIC (GlobeNewswire) - "Cognition Therapeutics...announced that James E. Galvin, MD, MPH will present results from the Phase 2 ‘SHIMMER’ study of zervimesine (CT1812) in dementia with Lewy bodies (DLB) during an oral presentation at the Alzheimer’s Association International Conference (AAIC). Dr. Galvin is director of the Comprehensive Center for Brain Health at the University of Miami Miller School of Medicine and was the COG1201 SHIMMER study (NCT05225415) director. The presentation will take place on July 29, 2025....Results from the Phase 2 ‘SHINE’ study in people with Alzheimer’s disease add further evidence to zervimesine’s neuroprotective properties. We look forward to presenting results from both studies at AAIC....Cognition will present clinical efficacy results and new proteomic findings from this Alzheimer’s study at AAIC."

P2 data • Alzheimer's Disease • Dementia • Lewy Body Disease

Cognition Therapeutics Publishes Proteomic Analysis Elucidating Zervimesine’s Protection of Neurons and Synapses in Alzheimer’s Disease (GlobeNewswire) - P2 | N=16 | SEQUEL (NCT04735536) | Sponsor: Cognition Therapeutics | "Cognition Therapeutics...published results of a proteomics analysis from the Phase 2 ‘SEQUEL’ COG0202 Study of zervimesine (CT1812) in adults with mild-to-moderate Alzheimer's disease. The manuscript...was published in the peer-reviewed journal Alzheimer's & Dementia: Translational Research & Clinical Interventions....In the SEQUEL study (NCT04735536), zervimesine treatment resulted in consistent trends of improvement across all prespecified EEG parameters, including the prominence of certain EEG frequencies associated with Alzheimer’s disease. Slower frequencies termed 'theta' waves were reduced after 29 days of zervimesine treatment compared to placebo. This suggests zervimesine may normalize the function of neurons and synapses....In vitro experiments showing protection of neurons under disease conditions support proteomics biomarker analysis from phase 2 SEQUEL study."

Biomarker • P2 data • Alzheimer's Disease

Cognition Therapeutics Presents Data at AAIC Highlighting Broad Neurological Impact of Zervimesine (CT1812) in Dementia with Lewy Bodies... (GlobeNewswire) - P2 | N=130 | SHIMMER (NCT05225415) | Sponsor: Cognition Therapeutics | "Cognition...presented results from the Phase 2 COG1201 SHIMMER study (NCT05225415) of zervimesine (CT1812) in dementia with Lewy bodies (DLB) at the Alzheimer’s Association International Conference (AAIC 2025)...As previously reported, the SHIMMER study met its primary endpoint of safety and tolerability. Results showed that zervimesine treatment had a positive impact across neuropsychiatric, cognitive, motor, and functional scales. After six months of treatment, DLB patients treated with zervimesine scored an average of 86% better than placebo-treated patients on the neuropsychiatric inventory (NPI-12). This tool measures 12 separate behavioral symptoms, including hallucinations, delusions, and anxiety, which are hallmarks of DLB. The findings were presented by James E. Galvin, MD, MPH during a Featured Research Session on July 29, 2025."

P2 data • Dementia • Lewy Body Disease

Cognition Therapeutics Reports Financial Results for the Second Quarter 2025 and Highlights Progress Across Clinical Programs (GlobeNewswire) - "...'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 these will confirm our understanding of the Agency's expectations for a clinical program in Alzheimer’s disease....In addition, we expect FDA will have a decision on breakthrough designation for zervimesine in DLB in the third quarter 2025'."

FDA event • Alzheimer's Disease • Dementia • Lewy Body Disease

Cognition Therapeutics Study of Zervimesine (CT1812) in Early Alzheimer’s Disease Surpasses 50% Enrollment Target (GlobeNewswire) - "Cognition Therapeutics...announced that the Phase 2 ‘START’ Study surpasses 50% enrollment....The START Study (NCT05531656) is designed to enroll up to 540 individuals with mild Alzheimer’s disease who will be treated with zervimesine (CT1812) or placebo for 18 months. Participants are being enrolled at approximately 50 sites in the United States, including premier institutions in the ACTC network."

Enrollment status • Alzheimer's Disease

Cognition Therapeutics Provides Regulatory Update on Zervimesine (CT1812) in Alzheimer’s Disease and Dementia with Lewy Bodies (DLB) (GlobeNewswire) - "Cognition Therapeutics, Inc...announced that the company will conduct an end-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) on July 9, 2025. During the meeting, the Cognition team will review results of the Phase 2 'SHINE’ study (NCT03507790) of zervimesine (CT1812) in mild-to-moderate Alzheimer’s disease. In addition, proposed plans for a Phase 3 program designed to support regulatory approval of zervimesine in this patient population will be discussed with the FDA."

Clinical protocol • FDA event • P2 data • Alzheimer's Disease • Dementia • Lewy Body Disease

Identification of cerebrospinal fluid pharmacodynamic biomarkers and molecular correlates of brain activity in a Phase 2 clinical trial of the Alzheimer's disease drug candidate CT1812. (PubMed, Alzheimers Dement (N Y)) - P2 | "After 1 month of treatment, the identification of biomarkers supporting pathway engagement, the replication of biomarker findings from prior trials, and the discovery of molecular correlates of improved functional connectivity with CT1812 treatment bolster support for and expound upon the mechanism of action for CT1812 in displacing Aβ oligomers at neuronal synapses, as well as underscores the CT1812 relevance to AD."

Biomarker • Journal • P2 data • PK/PD data • Alzheimer's Disease • CNS Disorders

A Review of the Clinical Progress of CT1812, a Novel Sigma-2 Receptor Antagonist for the Treatment of Alzheimer's Disease. (PubMed, Pharmaceuticals (Basel)) - "Preclinical studies and early clinical trials of CT1812 show promising results and provide evidence for its potential to slow AD progression. This review outlines the role of Aβ oligomers in AD, CT1812's mechanism of action, and the effectiveness and limitations of CT1812 based on preclinical and clinical studies."

Journal • Review • Alzheimer's Disease • CNS Disorders

Cognition Therapeutics Presented Data at Association for Research in Vision and Ophthalmology Showing Impact on Retinal Cell Health (GlobeNewswire) - "Cognition Therapeutics, Inc...reported preclinical data this week at the Association for Research in Vision and Ophthalmology (ARVO) showing the potential for zervimesine (CT1812) to protect retinal pigment epithelial (RPE) cells from damage in dry age-related macular degeneration (dry AMD)....A poster presented by research scientist, Britney Lizama, PhD, shows that this receptor regulates the ability of retinal cells to take in low-density lipoprotein (LDL), a major fuel source for cells....A second poster presented by Drs. Hamby and Lizama, shows zervimesine may protect retinal cells from the onslaught of oxidized lipids. In dry AMD, oxidized lipids build up in the retina."

Preclinical • Dry Age-related Macular Degeneration

Cognition Therapeutics Reports Topline Results Showing Oral Zervimesine (CT1812) Reduced Lesion Growth in Phase 2 Study in Geographic Atrophy (GlobeNewswire) - P2 | N=100 | MAGNIFY (NCT05893537) | Sponsor: Cognition Therapeutics | "Cognition Therapeutics... reported topline results today from the Phase 2 COG2201 ‘MAGNIFY’ trial of zervimesine (CT1812) in adults with geographic atrophy (GA) secondary to dry age-related macular degeneration (dry AMD). The results show zervimesine-treated participants had 28.6% slower GA lesion growth on average and at 18 months, their lesions were 28.2% smaller compared to placebo. The MAGNIFY study (NCT05893537) was concluded, after approximately 100 of the planned 246 participants were enrolled....Growth rate: in MAGNIFY, a slope analysis showed that the trajectory of GA had slowed by 28.6% in participants treated with zervimesine."

P2 data • Dry Age-related Macular Degeneration • Ophthalmology

Expanded Access Program for CT1812 (Zervimesine) (clinicaltrials.gov) - P=N/A | N=0 | Available | Sponsor: Cognition Therapeutics

New trial • Alzheimer's Disease • CNS Disorders • Dementia • Lewy Body Disease

Cognition Therapeutics Reports Financial Results for the First Quarter 2025 and Provides Business Update (GlobeNewswire) - "Requested an EOP2 meeting with FDA to review the results from the SHINE study in Alzheimer’s disease. Phase 2 ‘SHIMMER’ study results in DLB were accepted for a podium presentation at the Alzheimer’s Association International Congress (AAIC), to be held July 27-31, 2025 in Toronto, Canada."

FDA event • P2 data • Alzheimer's Disease • Dementia • Lewy Body Disease

MAGNIFY: Study to Evaluate the Efficacy and Safety of Oral CT1812 in Participants With Geographic Atrophy (GA) Secondary to Dry Age-Related Macular Degeneration (AMD). (clinicaltrials.gov) - P2 | N=100 | Terminated | Sponsor: Cognition Therapeutics | Active, not recruiting ➔ Terminated; The trial was closed as part of a strategic business decision.

Trial termination • Age-related Macular Degeneration • Dry Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders

IDENTIFICATION OF MOLECULAR CORRELATES WITH CT1812 TREATMENT -RELATED DECREASE IN NFL CSF LEVELS CONNECTED TO SIGMA -2 2RECEPTOR (ADPD 2025) - "Molecular correlates relevant to neurodegeneration were identified with CSF NfL levels after treatment with CT1812. Of note NEFL can interact with prion protein (PRNP), which is a component of the S2R complex. This analysis enabled additional learnings on what other changes may occur in tandem with the decrease in NfL."

Alzheimer's Disease • CNS Disorders • CSF NfL • FABP3 • NEFL • PRNP • S100B

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 (ADPD 2025) - P2 | "CT1812 PD biomarkers that correlated with favorable ADAS -Cog11 change were identified. Correlation analysis results were consistent with the impact of CT1812 on synaptic protection and mechanisms in amyloid biology. These exploratory biomarker analyses, to gether with CT1812 -associated trends in slowing cognitive decline, particularly in a pre -specified p -Tau217 subgroup, support the clinical developme nt of CT1812 for AD."

Clinical • P2 data • Alzheimer's Disease • CNS Disorders • APOE • PRNP