Cognition Therapeutics, Inc. · NASDAQ:CGTX
Cognition Therapeutics — Investor Presentation (August 2025)
39 slides from Cognition Therapeutics's investor presentation, August 2025
Slide 1: Targeting Pathogenic Oligomers: A Disruptive Approach to Neurodegenerative Diseases
Targeting Pathogenic Oligomers: A Disruptive Approach to the Treatment of Neurodegenerative Diseases August 2025
Slide 2: Forward-looking Statements
Forward-looking Statements FORWARD-LOOKING STATEMENTS This presentation contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. All statements contained in this presentation, other than statements of historical facts or statements that relate t
Slide 3: Executive Summary
Executive Summary Compelling data with first-in-class candidate supports registrational plan • Consistent efficacy signals in Alzheimer’s, DLB and dry AMD - One of few compounds effective in both mild & moderate Alzheimer’s disease - GA lesion growth reduced with zervimesine treatment • Generally we
Slide 4: Zervimesine (CT1812) – Lead Product Candidate
Zervimesine (CT1812) – Lead Product Candidate Extensive comp of matter IP on zervimesine and other candidates developed from foundational platform Zervimesine • BBB-penetrant small molecule oligomer antagonist PrPc • Distinct MoA: ligand of TMEM97 (sigma-2) receptor lilrb2 TMEM97 PGRMC1 • Oral, once
Slide 5: Findings from Completed Studies Support Phase 3 Plans
Findings from Completed Studies Support Phase 3 Plans Program Preclin Phase 1 Phase 2 Phase 3 Takeaways from completed studies • Phase 2 MAGNIFY Study: slower lesion Alzheimer’s disease Phase 2 COG0203 • START Early-to-mild Alzheimer’s disease growth in geographic atrophy secondary to dry AMD Comple
Slide 6: MAGNIFY Topline Results
MAGNIFY Topline Results GA lesion growth slower with zervimesine treatment Topline results reported May 8, 2025
Slide 7: MAGNIFY Trial in Dry AMD/GA
MAGNIFY Trial in Dry AMD/GA Zervimesine: oral drug development candidate for geographic atrophy Enrollment Treatment Period Program Assessments Criteria 24 months Objectives ‐ Age: ≥ 50 ‐ Change in GA lesion ‐ Identify efficacy ‐ Diagnosis of dry AMD area (FAF) signal(s) Zervimesine 200 mg Adults wi
Slide 8: Zervimesine Treatment Slowed GA Lesion Growth
Zervimesine Treatment Slowed GA Lesion Growth Effect size increases with exposure • 29% mean rate of change (slope) in GA lesion area vs placebo (p=0.0538) • Change in GA progression rate favored zervimesine vs placebo at each timepoint - 6-months: -11.79% - 12-months: -15.83% - 18-months: -28.19% (
Slide 9: Zervimesine Slowed GA Lesion Growth Rate (slope) and Area (observed)
Zervimesine Slowed GA Lesion Growth Rate (slope) and Area (observed) Slope Analysis1 Mean Area by Time1 3 P = 0.0074 2.5 Zervimesine Placebo Diff LS Mean Change from Baseline in zervimesine GA lesion size (mm2 ) by FAF placebo 2 Growth rate 0.10 0.14 - 0.04 1.5 (mm2 / month) ± 0.015 ± 0.014 1 Annual
Slide 10: Zervimesine Effect Size Comparable to SoC IVT with Oral Once-Daily Dosing
Zervimesine Effect Size Comparable to SoC IVT with Oral Once-Daily Dosing Topline MAGNIFY Results3 Compared to Published Results1,2: Percent Reduction in GA Lesion Growth Over Time 35% IZERVAY Avacincaptad pegol (2mg)1 30% 28% Percent Difference from Placebo • Gather1 at 18 months – 35% • Gather2 at
Slide 11: COG2201 (MAGNIFY): Safety Summary
Zervimesine Placebo Total Subjects with: (n=49) (N=51) (N=100) At least one TEAE, n (%) 38 (77.6%) 36 (70.6%) 74 (74.0%) At least one TEAE possibly/probably related to treatment 12 (24.4%) 5 (9.8%) 17 (17.0%) At least one TEAE leading to treatment discontinuation 4 (8.2%) 3 (5.9%) 7 (7.0%) At least
Slide 12: Dementia Programs
Dementia Programs: Strong clinical signals in the two primary causes of dementia: Dementia with Lewy Bodies (DLB) Mild-to-Moderate Alzheimer’s Disease
Slide 13: AD and DLB: Diseases with Overlapping Pathology
AD and DLB: 2 Diseases with Overlapping Pathology Primary treatment goal – slow the progression of cognitive decline • Aβ: closely associated with Alzheimer’s pathogenesis Amyloid • α-synuclein: closely associated with Lewy body dementias beta (Aβ) • Co-pathology is common - Up to 80% of DLB patient
Slide 14: Dementia with Lewy Bodies (DLB)
Dementia with Lewy Bodies (DLB) Strong clinical signals across four major symptom domains in Phase 2 SHIMMER Study
Slide 15: Dementia with Lewy Bodies (DLB)
Dementia with Core Lewy Bodies (DLB) Symptoms of DLB 2nd most common cause Patients may have Fluctuating cognition and alertness of dementia after faster decline than Alzheimer’s disease Alzheimer’s Neuropsychiatric symptoms such as visual hallucinations, anxiety, depression and delusions Characteri
Slide 16: SHIMMER Study in Dementia with Lewy Bodies
SHIMMER Study in Dementia with Lewy Bodies Conducted in collaboration with experts at LBDA and University of Miami Enrollment Treatment Period Program Assessments Criteria 6 months Objectives ‐ Age 50-85 ‐ Safety/tolerability Identify efficacy Zervimesine 300 mg 130 ‐ Global CGIC signal(s) ‐ DLB d
Slide 17: Four Symptom Domains Drive Lewy Body Disease Burden
Four Symptom Domains Drive Lewy Body Disease Burden “A multifactorial disease with a buffet of symptoms” Behavior Cognition Function Movement Patient Hallucinations, Memory and Bathing, toileting, shopping, Standing, symptom anxiety, delusions problem solving meal preparation maintaining balance M
Slide 18: Up to 91% Percent Slowing on Assessments
Up to 91% Percent Slowing on Assessments Strong clinical signals across major DLB symptoms relative to placebo Behavior Cognition Function Movement CDR NPI NPI (episodic MoCA CAF ADCS-ADL UPDRS (total) (distress) memory) Zervimesine Pooled (100/300mg) 86% 114% 85% 60% 91% 52% 62% 18 * Measure of the
Slide 19: Zervimesine Showed Dramatic 86% Impact on Neuropsychiatric Measures
Zervimesine Showed Dramatic 86% Impact on Neuropsychiatric Measures NPI captures a variety of patient disturbances, including hallucinations, anxiety, and delusions NPI NPI favor Treatment with Zervimesine NPI Total Score (A-L) 86% Slowing LS Mean Difference from Placebo 95% CI Anxiety Delusions Hal
Slide 20: Caregivers were Notably Better
Because Participants Improved in Hallucinations, Delusions & Anxiety, Caregivers were Notably Better New tool created to measure caregiver burden in DLB NPI Distress NPI Distress favors Treatment with Zervimesine NPI Total Score (A-L) Caregiver Distress 114% Slowing LS Mean Difference from Placebo 9
Slide 21: Up to 91% Slowing of Cognitive Decline Across Assessments
Up to 91% Slowing of Cognitive Decline Across Assessments CT1812 100mg (n=44) CT1812 300mg (n=44) Zervimesine improved patients’ attentiveness and problem solving Placebo (n=42) CDR - Episodic Memory (ITT) MoCA (ITT) CAF (Fluctuations) (ITT) 10.0 2.0 -2.0 5.0 -1.5 1.0 LS Mean (SE) Change from Baseli
Slide 22: People on Zervimesine Maintained Self-care
People on Zervimesine Maintained Self-care 52% preservation in activities of daily living (ADL) measures ADCS-ADL 52% slowing 2.0 Components 0.0 of ADL Score LS Mean (SE) Change from Baseline -2.0 -4.0 Bathing Toileting Worsening -6.0 Dressing Conversing -8.0 CT1812 100 mg (n=44) -10.0 CT1812 300 mg
Slide 23: People Treated with Zervimesine Maintained Motor Function
People Treated with Zervimesine Maintained Motor Function 62% preservation in measures of movement MDS-UPDRS3 62% slowing Components -4.0 of UPDRS: -2.0 LS Mean (SE) Change from Baseline 0.0 Balance Gait Worsening 2.0 4.0 Speech Facial expression CT1812 100 mg (n=44) 6.0 CT1812 300 mg (n=44) Placebo
Slide 24: SHIMMER Met and Exceeded Objectives and Expectations
SHIMMER Met and Exceeded Objectives and Expectations Identified consistent signals of efficacy with a favorable tolerability profile COG1201 SHIMMER was a phase 2a safety and tolerability study seeking signals of efficacy in people with dementia with Lewy bodies The safety and tolerability profile w
Slide 25: Summary of SHIMMER Safety and Tolerability findings
Summary of SHIMMER Safety and Tolerability findings Favorable safety profile vs placebo, AEs well balanced between arms Total AE frequency was similar There were no deaths related Participants with LFT elevations in CT1812 and placebo to study drug ≥ 3x ULN • 100mg CT1812 – 3 • 300mg CT1812 –
Slide 26: Alzheimer's Disease
Alzheimer’s Disease 95% slowing of cognitive decline in lower-p-tau217 'SHINE' participants Amyloid positivity confirmed for all participants by CSF or PET
Slide 27: SHINE: Phase 2 PoC in Mild-to-Moderate Alzheimer's Disease
SHINE: Phase 2 PoC in Mild-to-Moderate Alzheimer’s Disease Well-executed, over-enrolled study, supports advancing clinical development Enrolled Population: Inclusion and Exclusion Treatment Period 6 months • PET- or biomarker-confirmed AD • AD diagnosis • Majority of participants were female • PET o
Slide 28: Up to 108% Percent Slowing on Assessments
Up to 108% Percent Slowing on Assessments Strong, consistent efficacy signals across measures Cognition Function ADAS-Cog 11 ADAS-Cog 13 MMSE ADCS-ADL ADCS-CGIC Zervimesine median Pooled p-tau217 95% 103% 108% 68% 61% (100/300mg) mITT 38% 39% 70% 26% 28% 28
Slide 29: Tau Burden in Amyloid-related AD Clinical Trials
Tau Burden in Amyloid-related AD Clinical Trials Baseline plasma p-tau217: a predictive biomarker of response to therapy • Plasma p-tau217 reflects brain amyloid and tau burden • Prior data indicate that individuals with lower AD pathology at baseline, as reflected by lower levels of plasma p-tau217
Slide 30: Below Median p-tau217, Treated Participants Experienced Profound Cognitive Effect
Below Median p-tau217, Treated Participants Experienced Profound Cognitive Effect Preservation of ADAS-Cog 11 in participants below median plasma p-tau217† ADAS-Cog 11* mITT population (n=150) Below median p-tau217 (n=69) -2.0 -3.0 38% slowing 95% slowing -2.0 -1.0 LS Mean (SE) Change from Baseline
Slide 31: Treatment Impact in Below Median p-tau217 Consistent Across Baseline MMSE scores
Treatment Impact in Below Median p-tau217 Consistent Across Baseline MMSE scores Cognitive preservation (ADAS-Cog 11) observed across MMSE range Zervimesine-Treated Mild (MMSE 22-26) Zervimesine-Treated Moderate (MMSE 18-21) Participants -4.0 -5.0 129% slowing -4.0 91% slowing -3.0 -3.0 LS Mean (SE)
Slide 32: Participants Evenly Distributed by Median p-tau217 and MMSE Severity
Participants Evenly Distributed by Median p-tau217 and MMSE Severity MMSE at Screening vs p-tau217 at Baseline in SHINE Mild MMSE Moderate MMSE Median MMSE Plasma pTau-217 at Baseline 3- Median plasma p-tau217 Baseline Plasma p-tau217 2- MMSE at Below Above Total Screening Median Median Mild (22-26)
Slide 33: Summary of SHINE Safety and Tolerability findings
Summary of SHINE Safety and Tolerability findings Favorable safety profile vs placebo, Adverse Events AEs well balanced between arms, no ARIA Zervimesine 76.5% • Zervimesine demonstrated a favorable safety and Placebo 78.0% tolerability profile • Most TEAEs were mild or moderate in severity Serious
Slide 34: Zervimesine SHINE Study: Summary and Conclusions
Zervimesine SHINE Study: Summary and Conclusions Plasma p-tau217 biomarker identifies strong zervimesine-treatment responder group • Zervimesine has favorable safety and tolerability profile - Similar percentages of AEs in pooled treated and placebo groups • All cognitive and functional measures tre
Slide 35: START - A 540-Person Study in Amyloid-positive Early AD
START - A 540-Person Study in Amyloid-positive Early AD First study to allow lecanemab as background therapy in combination with zervimesine Enrollment Treatment Period Program Assessments Criteria 18 months Objectives ‐ Ages 50-85 ‐ Safety Identify efficacy Zervimesine 200 mg signal(s) ‐ Diagnosi
Slide 36: 3 Major Diseases Addressed with Once-Daily Oral Pill
3 Major Diseases Addressed with Once-Daily Oral Pill Collective Phase 2 Results Supports Advancing Zervimesine (CT1812) to Registrational Studies Dementia with Alzheimer’s Disease Geographic Atrophy Lewy Bodies Marked slowing of progression Slowing of progression; robust Slowing of GA growth across
Slide 37: Executive Summary
Executive Summary First-in-class oligomer antagonist with compelling efficacy data • Consistent efficacy signals in Alzheimer’s, DLB and dry AMD - One of few compounds effective in both mild & moderate Alzheimer’s disease - GA lesion growth reduced with zervimesine treatment • Generally well tolerat
Slide 38: Current Financial Position
Current Financial Position As of quarter ended June 30, 2025 Cash and cash equivalents $11.6 M Grant funding for zervimesine studies Preclinical through Phase 2 ~$171 M Approximate funding used ($129 M) Remaining grant funding $42 M 38
Slide 39: Thank You
Thank You Lisa Ricciardi President & CEO info@cogrx.com
Cognition Therapeutics — Investor Presentation (August 2025) on 6ix