Cognition Therapeutics, Inc. · NASDAQ:CGTX
Cognition Therapeutics — Investor Presentation (January 2025)
33 slides from Cognition Therapeutics's investor presentation, Jan 13, 2025
Slide 1: Targeting Pathogenic Oligomers: A Disruptive Approach to the Treatment of Neurodegenerative Diseases
Targeting Pathogenic Oligomers: January 2025 A Disruptive Approach to the Treatment of Neurodegenerative Diseases
Slide 2: Forward-Looking Statements
2 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 to present facts or curren
Slide 3: Executive Summary
3 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
Slide 4: Zervimesine (CT1812) – Lead Product Candidate
4 • BBB-penetrant small molecule oligomer antagonist • Distinct MoA: ligand of TMEM97 (sigma-2) receptor • Oral, once-daily dosing, favorable safety data • Fast Track granted for Alzheimer’s disease • Phase 2 PoC efficacy across cognitive measures in mild-to-moderate Alzheimer’s disease • Phase 2 Po
Slide 5: AD and DLB: 2 Diseases with Overlapping Pathology
5 α-synuclein Amyloid beta (Aβ) • Aβ: closely associated with Alzheimer’s pathogenesis • α-synuclein: closely associated with Lewy body dementias • Co-pathology is common - Up to 80% of DLB patients have BOTH α-synuclein and Amyloid beta (Aβ)1 - Appx 50% of Alzheimer’s patients have BOTH Aβ and α-sy
Slide 6: Strong clinical signals across four major symptom domains in Phase 2 SHIMMER Study
Strong clinical signals across four major symptom domains in Phase 2 SHIMMER Study Dementia with Lewy Bodies (DLB)
Slide 7: Dementia with Lewy Bodies (DLB)
7 Dementia with Lewy Bodies (DLB) Core Symptoms of DLB Fluctuating cognition and alertness Neuropsychiatric symptoms such as visual hallucinations, anxiety, depression and delusions Decline in cognition, attention, executive function Spontaneous parkinsonism REM sleep behavior disorder More common i
Slide 8: SHIMMER Study in Dementia with Lewy Bodies
8 SHIMMER Study in Dementia with Lewy Bodies Conducted in collaboration with experts at LBDA and University of Miami SHIMMER COG1201 study (NCT05225415) partially funded by $30M NIA grant R01AG071643 Enrollment Criteria Treatment Period 6 months Assessments Program Objectives ‐ Age 50-85 ‐ DLB diagn
Slide 9: Summary of SHIMMER Safety and Tolerability findings
9 Summary of SHIMMER Safety and Tolerability findings Favorable safety profile vs placebo, AEs well balanced between arms * occurring in a zervimesine treatment group at a rate >10% and at a rate >2X the placebo rate † not considered treatment related Study Discontinuations due to AEs not related to
Slide 10: Four Symptom Domains Drive Lewy Body Disease Burden
10 Behavior Cognition Function Movement Four Symptom Domains Drive Lewy Body Disease Burden “A multifactorial disease with a buffet of symptoms” Cognitive Drug Research (CDR) System Montreal Cognitive Assessment (MoCA) Clinician Assessment of Fluctuation (CAF) Neuropsychiatric Inventory (NPI) Care P
Slide 11: Strong clinical signals across major DLB symptoms
11 Up to 91% Percent Slowing on Assessments Strong clinical signals across major DLB symptoms relative to placebo * Measure of the distress experienced by the care partners of SHIMMER participants Behavior Cognition Function Movement NPI (total) NPI (distress) CDR (episodic memory) MoCA CAF ADCS-ADL
Slide 12: Zervimesine Showed Dramatic 82% Impact on Neuropsychiatric Measures
12 Zervimesine Showed Dramatic 82% Impact on Neuropsychiatric Measures NPI captures a variety of patient disturbances, including hallucinations, anxiety, and delusions NPI: Neuropsychiatric inventory NPI favor Treatment with Zervimesine LS Mean Difference from Placebo 95% CI -3 -2 -1 0 1 2 Apathy El
Slide 13: Caregivers were Notably Better
13 Because Participants Improved in Hallucinations, Delusions & Anxiety, Caregivers were Notably Better New tool created to measure caregiver burden in DLB NPI Distress: Neuropsychiatric inventory (Care Partner Distress) NPI Distress favors Treatment with Zervimesine LS Mean Difference from Placebo
Slide 14: Up to 91% Slowing of Cognitive Decline Across Assessments
14 0.979 0.643 0.550 Up to 91% Slowing of Cognitive Decline Across Assessments Zervimesine improved patients’ attentiveness and problem solving CDR: Cognitive Drug Research (CDR) Battery; MoCA: Montreal Cognitive Assessment; CAF: Clinician Assessment of Fluctuation CDR - Episodic Memory (ITT) MoCA (
Slide 15: People on Zervimesine Maintained Self-care
15 People on Zervimesine Maintained Self-care 52% preservation in activities of daily living (ADL) measures ADCS-ADL: Activities of Daily Living -12.0 -10.0 -8.0 -6.0 -4.0 -2.0 0.0 2.0 ADCS-ADL CT1812 100 mg (n=44) CT1812 300 mg (n=44) Placebo (n=42) Worsening Components of ADL Score Bathing Toileti
Slide 16: People Treated with Zervimesine Maintained Motor Function
16 -4.0 -2.0 0.0 2.0 4.0 6.0 8.0 MDS-UPDRS3 CT1812 100 mg (n=44) CT1812 300 mg (n=44) Placebo (n=42) People Treated with Zervimesine Maintained Motor Function 62% preservation in measures of movement ADCS-ADL: Activities of Daily Living Worsening Components of UPDRS: Balance Speech Rigidity Tremor G
Slide 17: SHIMMER Met and Exceeded Objectives and Expectations
17 SHIMMER Met and Exceeded Objectives and Expectations Identified consistent signals of efficacy and a safe and tolerable dose range 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
Slide 18: Phase 2 PoC 'SHINE' trial in Alzheimer's Disease
Extensive preclinical and clinical testing culminating in positive results in Phase 2 PoC ‘SHINE’ trial Alzheimer’s Disease
Slide 19: SHINE: Phase 2 PoC in Mild-to-Moderate Alzheimer's Disease
19 Enrolled Population: • PET- or biomarker-confirmed AD • Majority of participants were female (60%), Caucasian (96%), ~ 72 yo • Mean MMSE score upon entry: 21.37 • ~60% of patients carry the ApoE4 gene • Characteristics well-balanced between all 3 arms SHINE: Phase 2 PoC in Mild-to-Moderate Alzhei
Slide 20: SHINE Cognitive Endpoints: ADAS-Cog and MMSE
20 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 in the pooled dose group vs placebo was the first of the ordered secondary efficacy endpoints ADAS-Cog 11* mITT population (n=150) MMSE mITT population (n=150)
Slide 21: SHINE Cognitive Endpoints: ADAS-Cog 13, Cognitive Composite
21 SHINE Cognitive Endpoints: ADAS-Cog 13, Cognitive Composite Consistent results across multiple cognitive endpoints ADAS-Cog 13 Cognitive Composite Note: n's are at Day 182
Slide 22: 95% slowing of cognitive decline in lower-p-tau217 SHINE participants
95% slowing of cognitive decline in lower-p-tau217 'SHINE' participants Amyloid positivity confirmed for all participants by CSF or PET Prespecified Subgroup Analysis from Phase 2
Slide 23: Tau Burden in Amyloid-related AD Clinical Trials
23 • 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, have greater response to amyloid-based therapies, eg: - Donanemab TRAILBLAZER 2* • iADRS: 36% slowing in low tau ter
Slide 24: Below Median p-tau217, Treated Participants Experienced Profound Cognitive Effect
24 Below Median p-tau217, Treated Participants Experienced Profound Cognitive Effect Preservation of ADAS-Cog 11 in participants below median plasma p-tau217† † Median plasma p-tau217 level is 1.0pg/mL at baseline mITT population (n=150) Below median p-tau217 (n=69)
Slide 25: Treatment Impact in Below Median p-tau217 Consistent Across Baseline MMSE
25 Treatment Impact in Below Median p-tau217 Consistent Across Baseline MMSE scores Cognitive Preservation Observed in Zervimesine-Treated Mild (MMSE 22-26) and Moderate (MMSE 18-21) Participants
Slide 26: Summary of SHINE Safety and Tolerability findings
26 • Zervimesine demonstrated a favorable safety and tolerability profile • Most TEAEs were mild or moderate in severity (following slide) • Similar percentages of adverse events in treated (76.5%) and placebo (78%) groups • No discontinuations due to AEs in the 100mg dose group • Most discontinuati
Slide 27: SHINE Study: Summary and Conclusions
27 Next steps: End-of-Phase 2 meeting with FDA to establish protocol for Phase 3 in mild-to-moderate Alzheimer’s disease in population defined by plasma p-tau217 • Zervimesine generally safe and well tolerated - Similar percentages of AEs in pooled treated and placebo groups • All cognitive and func
Slide 28: Ongoing Studies Expand into Related Patient Populations
28 Ongoing Studies Expand into Related Patient Populations COG0203 - START About Early AD: Current treatments require burdensome monitoring ARIA risk may limit adoption Combining MAbs with small molecules holds potential Enrolling ~540 with MCI / early Alzheimer’s disease Supported by appx $81M NIA
Slide 29: START - A 540-Person Study in Amyloid-positive Early AD
29 START - A 540-Person Study in Amyloid-positive Early AD First study to allow lecanemab as background therapy in combination with zervimesine START COG0203 study (NCT05531656) partially funded by $81M NIA grant R01AG065248 Enrollment Criteria Treatment Period 18 months Assessments Program Objectiv
Slide 30: MAGNIFY Trial in dAMD/GA
30 MAGNIFY Trial in dAMD/GA Potential first oral drug for geographic atrophy Enrollment Criteria Treatment Period 24 months Assessments Program Objectives ‐ Age: ≥ 50 ‐ Diagnosis of dry AMD ‐ BCVA ≥ 24 letters (ETDRS) ‐ GA lesion ≥ 2.5 and ≤17.5mm2 ‐ Change in GA lesion area (FAF) ‐ Ellipsoid zone a
Slide 31: Executive Summary
31 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
Slide 32: Current Financial Position
32 Current Financial Position 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 As of quarter ended September 30, 2024
Slide 33: Thank You
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