Cognition Therapeutics, Inc. · NASDAQ:CGTX
Cognition Therapeutics — Investor Presentation (January 2025)
33 slides from Cognition Therapeutics's investor presentation, January 2025
Slide 1: Targeting Pathogenic Oligomers: A Disruptive Approach to the Treatment of Neurodegenerative Diseases
Targeting Pathogenic Oligomers: A Disruptive Approach to the Treatment of Neurodegenerative Diseases January 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: 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 6: Dementia with Lewy Bodies (DLB)
Dementia with Lewy Bodies (DLB) Strong clinical signals across four major symptom domains in Phase 2 SHIMMER Study
Slide 7: 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 8: 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 9: Summary of SHIMMER Safety and Tolerability findings
Summary of SHIMMER Safety and Tolerability findings Favorable safety profile vs placebo, AEs well balanced between arms Adverse Events Zervimesine 94.3% Total AE frequency was similar in Study Discontinuations due to AEs not Placebo 88.1% zervimesine and placebo related to LFTs: • Placebo – 4.8% • 1
Slide 10: 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 Neu
Slide 11: 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) 82% 114%* 85% 60% 91% 52% 62% 11 * Measure of th
Slide 12: Zervimesine Showed Dramatic 82% Impact on Neuropsychiatric Measures
Zervimesine Showed Dramatic 82% Impact on Neuropsychiatric Measures NPI captures a variety of patient disturbances, including hallucinations, anxiety, and delusions NPI A-L NPI favor Treatment with Zervimesine NPI Total Score (A-L) LS Mean Difference from Placebo 95% CI Anxiety -4.0 Delusions LS Mea
Slide 13: Participants Improved in Hallucinations, Delusions & Anxiety; Caregivers Notably Better
Because Participants Improved in Hallucinations, Delusions & Anxiety, Caregivers were Notably Better New tool created to measure caregiver burden in DLB NPI A-J Distress NPI Distress favors Treatment with Zervimesine NPI Total Score (A-J) Caregiver Distress LS Mean Difference from Placebo 95% CI Anx
Slide 14: 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 15: People on Zervimesine Maintained Self-care
People on Zervimesine Maintained Self-care 52% preservation in activities of daily living (ADL) measures ADCS-ADL 2.0 Components 0.0 of ADL Score LS Mean (SE) Change from Baseline -2.0 -4.0 Bathing Toileting Worsening -6.0 -8.0 Dressing Conversing CT1812 100 mg (n=44) -10.0 CT1812 300 mg (n=44) Plac
Slide 16: People Treated with Zervimesine Maintained Motor Function
People Treated with Zervimesine Maintained Motor Function 62% preservation in measures of movement Components MDS-UPDRS3 -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 (n=42) Rigi
Slide 17: 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 18: Alzheimer's Disease
Alzheimer’s Disease Extensive preclinical and clinical testing culminating in positive results in Phase 2 PoC ‘SHINE’ trial
Slide 19: 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 Treatment Period Exclusion 6 months • PET- or biomarker-confirmed AD • AD diagnosis • Majority of participants were female • PET o
Slide 20: 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 ◆ Pooled CT1812 (n=101) ADAS-Cog 11* mITT population (n=150) MMSE mITT population (n=150) Placebo (n=49) 20 * ADAS-Cog 11 mITT in the pooled dose group vs placebo was the first of
Slide 21: SHINE Cognitive Endpoints: ADAS-Cog 13, Cognitive Composite
SHINE Cognitive Endpoints: ADAS-Cog 13, Cognitive Composite Consistent results across multiple cognitive endpoints ◆ Pooled CT1812 (n=101) ADAS-Cog 13 Cognitive Composite Placebo (n=49) 21 Note: n's are at Day 182
Slide 22: 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 23: 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 24: 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) ◆ Pooled CT1812 (n=101) Placebo (n=49) 24 † Median plasma p-tau217 level is
Slide 25: 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 25
Slide 26: 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 27: 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 Presentation Full CTAD - Similar percentages of AEs in pooled treated and placebo groups • All cognitive and functional m
Slide 28: Ongoing Studies Expand into Related Patient Populations
Ongoing Studies Expand into Related Patient Populations Enrolling ~540 with MCI / early Supported by appx $81M Enrollment commenced COG0203 - START Alzheimer’s disease NIA award 2023 with ACTC About Early AD: Current treatments require ARIA risk may limit Combining MAbs with small burdensome monitor
Slide 29: 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 30: MAGNIFY Trial in dAMD/GA
MAGNIFY Trial in dAMD/GA Potential first oral drug for geographic atrophy Enrollment Treatment Period Program Assessments Criteria 24 months Objectives ‐ Age: ≥ 50 ‐ Change in GA lesion area ✓ Identify efficacy ‐ Diagnosis of (FAF) signal(s) Zervimesine 200 mg dry AMD Recruiting 246 ‐ Ellipsoid zone
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 September 30, 2024 Cash and cash equivalents $22.0 M Grant funding for zervimesine studies Preclinical through Phase 2 ~$171 M Approximate funding used ($117.4 M) Remaining grant funding $53.6M 32
Slide 33: Thank You
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