Cognition Therapeutics, Inc. · NASDAQ:CGTX
Cognition Therapeutics — Investor Presentation (May 2025)
33 slides from Cognition Therapeutics's investor presentation, May 2025
Slide 1: Targeting Pathogenic Oligomers: A Disruptive Approach to Neurodegenerative Diseases
Targeting Pathogenic Oligomers: A Disruptive Approach to the Treatment of Neurodegenerative Diseases May 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 First-in-class oligomer antagonist with compelling efficacy data • Consistent efficacy in Alzheimer’s disease and DLB studies - One of few compounds effective in both mild & moderate Alzheimer’s disease • Well tolerated safety profile - ARIA unexpected based on MoA - Modest side ef
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 • Oral, once-daily
Slide 5: Ongoing programs
Ongoing programs Program Preclinical Phase 1 Phase 2 Phase 3 Alzheimer’s disease Phase 2 COG0203 • START Early-to-mild Alzheimer’s disease Completed Studies Phase 2 COG1201 • SHIMMER Mild-to-moderate DLB Mild-to-moderate Alzheimer’s disease Phase 2 COG0201 • SHINE Dry age-related macular degeneratio
Slide 6: 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 7: Dementia with Lewy Bodies (DLB)
Dementia with Lewy Bodies (DLB) Strong clinical signals across four major symptom domains in Phase 2 SHIMMER Study
Slide 8: 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 9: 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 10: 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 11: 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 12: 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% 12 * Measure of the
Slide 13: 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 14: Participants Improved in Hallucinations, Delusions & Anxiety; Caregivers 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 15: Up to 91% Slowing of Cognitive Decline Across Assessments
Up to 91% Slowing of Cognitive CT1812 100mg (n=44) Decline Across Assessments 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 16: 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 17: 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 18: 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 19: Alzheimer's Disease
Alzheimer’s Disease Extensive preclinical and clinical testing culminating in positive results in Phase 2 PoC ‘SHINE’ trial
Slide 20: 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 21: SHINE Cognitive Endpoints: ADAS-Cog 11 and MMSE
SHINE Cognitive Endpoints: ADAS-Cog 11 and MMSE Magnitude of ADAS-Cog 11 decline at 6 months similar to approved MAbs ADAS-Cog 11* mITT population (n=150) MMSE mITT population (n=150) 22 * ADAS-Cog 11 mITT in the pooled dose group vs placebo was the first of the ordered secondary efficacy endpoints
Slide 22: SHINE Cognitive Endpoints: ADAS-Cog 13, Cognitive Composite
SHINE Cognitive Endpoints: ADAS-Cog 13, Cognitive Composite Consistent results across multiple cognitive endpoints ADAS-Cog 13 Cognitive Composite 23 Note: n's are at Day 182
Slide 23: Prespecified Subgroup Analysis from Phase 2
Prespecified Subgroup Analysis from Phase 2 95% slowing of cognitive decline in lower-p-tau217 'SHINE' participants Amyloid positivity confirmed for all participants by CSF or PET
Slide 24: 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 25: 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 26: 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) 27 † Median plasma p-tau217 level is 1.0pg/mL at baseline
Slide 27: Treatment Impact in Below Median p-tau217 Consistent Across Baseline MMSE
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 28
Slide 28: 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 29: Zervimesine SHINE Study: Summary and Conclusions
Zervimesine SHINE Study: Summary and Conclusions Plasma p-tau217 biomarker identifies strong zervimesine-treatment responder group • Zervimesine generally safe and well tolerated - Similar percentages of AEs in pooled treated and placebo groups • All cognitive and functional measures trended in favo
Slide 30: 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 31: Executive Summary
Executive Summary First-in-class oligomer antagonist with compelling efficacy data • Consistent efficacy in Alzheimer’s disease and DLB studies - One of few compounds effective in both mild & moderate Alzheimer’s disease • Well tolerated safety profile - ARIA unexpected based on MoA - Modest side ef
Slide 32: Current Financial Position
Current Financial Position As of quarter ended March 31, 2025 Cash and cash equivalents $16.4 M Grant funding for zervimesine studies Preclinical through Phase 2 ~$171 M Approximate funding used ($124 M) Remaining grant funding $47M 33
Slide 33: Thank You
Thank You Lisa Ricciardi President & CEO info@cogrx.com
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