Cognition Therapeutics, Inc. · NASDAQ:CGTX
Cognition Therapeutics — Investor Presentation (January 2025)
32 slides from Cognition Therapeutics's investor presentation, Jan 28, 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: Ongoing programs
5 Ongoing programs Program Preclinical Phase 1 Phase 2 Phase 3 Alzheimer’s disease Early-to-mild Alzheimer’s disease Dry age-related macular degeneration GA secondary to dry AMD * Completed Studies Mild-to-moderate DLB Mild-to-moderate Alzheimer’s disease Phase 2 COG0203 • START Phase 2 COG2201 • MA
Slide 6: AD and DLB: 2 Diseases with Overlapping Pathology
6 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 7: 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 8: Dementia with Lewy Bodies (DLB)
8 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 9: SHIMMER Study in Dementia with Lewy Bodies
9 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 10: Summary of SHIMMER Safety and Tolerability findings
10 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 t
Slide 11: Four Symptom Domains Drive Lewy Body Disease Burden
11 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 12: Strong clinical signals across major DLB symptoms
12 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 Zervimesine Pooled (100/300mg) NPI (total) NPI (distress) CDR (episodic memory) MoCA CAF ADCS-ADL UPDRS
Slide 13: Zervimesine Showed 82% Impact on Neuropsychiatric Measures
13 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 Favors zervimesine -4.0
Slide 14: Caregivers Were Notably Better
14 -1.5 -1 -0.5 0 0.5 1 1.5 Apathy Elation/Euphoria Aberrant Motor Disinhibitions Irritability Appetite Sleep Behaviour Depression Agitation/Aggresssion Hallucinations Delusions Anxiety Favors zervimesine Because Participants Improved in Hallucinations, Delusions & Anxiety, Caregivers were Notably B
Slide 15: Up to 91% Slowing of Cognitive Decline Across Assessments
15 0 Week 4 Week 14 Week 26 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 - Epi
Slide 16: People on Zervimesine Maintained Self-care
16 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 CT1812 100 mg (n=44) CT1812 300 mg (n=44) Placebo (n=42) Worsening Components of ADL Score Bathing Toileting Dressi
Slide 17: People Treated with Zervimesine Maintained Motor Function
17 -4.0 -2.0 0.0 2.0 4.0 6.0 8.0 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 Gait Facial
Slide 18: SHIMMER Met and Exceeded Objectives and Expectations
18 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 profil
Slide 19: 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 20: SHINE: Phase 2 PoC in Mild-to-Moderate Alzheimer's Disease
20 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 21: SHINE Cognitive Endpoints: ADAS-Cog and MMSE
22 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 22: SHINE Cognitive Endpoints: ADAS-Cog 13, Cognitive Composite
23 SHINE Cognitive Endpoints: ADAS-Cog 13, Cognitive Composite Consistent results across multiple cognitive endpoints Note: n's are at Day 182 ADAS-Cog 13 Cognitive Composite Pooled CT1812 (n=101) Placebo (n=49) 39% slowing 50% slowing
Slide 23: 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 24: Tau Burden in Amyloid-related AD Clinical Trials
25 • 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 25: Below Median p-tau217, Treated Participants Experienced Profound Cognitive Effect
26 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 ADAS-Cog 11* mITT population (n=150) Below median p-tau217 (n=69) Pooled CT1812 (n=101
Slide 26: Treatment Impact Consistent Across Baseline MMSE Scores
27 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 129% slowing 91% slowing
Slide 27: Summary of SHINE Safety and Tolerability findings
28 • Zervimesine demonstrated a favorable safety and tolerability profile • Most TEAEs were mild or moderate in severity • Similar percentages of adverse events in treated (76.5%) and placebo (78%) groups • No discontinuations due to AEs in the 100mg dose group • Most discontinuations were in 300mg
Slide 28: SHINE Study: Summary and Conclusions, Next Steps
29 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 29: START - A 540-Person Study in Amyloid-positive Early AD
30 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: 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 31: 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 32: Thank You
Thank You XCOGNITION
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