Cognition Therapeutics, Inc. · NASDAQ:CGTX
Cognition Therapeutics — Investor Presentation (June 2025)
39 slides from Cognition Therapeutics's investor presentation, Jun 2, 2025
Slide 1: Targeting Pathogenic Oligomers: A Disruptive Approach to Neurodegenerative Diseases
Targeting Pathogenic Oligomers: June 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 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
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 in three indications Zervimesine (CT1812) – Lead Product Candidate Extensive comp of ma
Slide 5: Findings from Completed Studies Support Phase Plans
5 Findings from Completed Studies Support Phase 3 Plans Program Preclin Phase 1 Phase 2 Phase 3 Alzheimer’s disease Early-to-mild Alzheimer’s disease Completed Studies Dry age-related macular degeneration GA secondary to dry AMD Mild-to-moderate DLB Mild-to-moderate Alzheimer’s disease Phase 2 COG02
Slide 6: GA lesion growth slower with zervimesine treatment
GA lesion growth slower with zervimesine treatment Topline results reported May 8, 2025 MAGNIFY Topline Results
Slide 7: MAGNIFY Trial in Dry AMD/GA
7 MAGNIFY Trial in Dry AMD/GA Zervimesine: oral drug development candidate 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 (FA
Slide 8: Zervimesine Treatment Slowed GA Lesion Growth
8 • 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% (p=0.0074) • Effect size increases with longer study duration Effect size increas
Slide 9: Zervimesine Slowed GA Lesion Growth Rate and Area
9 Zervimesine Slowed GA Lesion Growth Rate (slope) and Area (observed) 1) Data on file: Cognition Therapeutics FAF: Fundus Autofluorescence Slope Analysis1 Mean Area by Time1 Zervimesine Placebo Diff Growth rate (mm2 / month) 0.10 ± 0.015 0.14 ± 0.014 - 0.04 Annualized Growth rate (mm2 / year) 1.23
Slide 10: Zervimesine Effect Size Comparable to SoC IVT with Oral Once-Daily Dosing
10 12% 16% 28% 0% 5% 10% 15% 20% 25% 30% 35% 6 12 18 Percent Difference from Placebo Months Zervimesine Effect Size Comparable to SoC IVT with Oral Once-Daily Dosing 1) Izervay package insert, Page 15 Table 2: https://tinyurl.com/294dwnxe 2) Goldberg et al. 18-month results presented at ARVO 2022: h
Slide 11: COG2201 (MAGNIFY): Safety Summary
11 COG2201 (MAGNIFY): Safety Summary Favorable safety and tolerability profile ULN: upper limit of normal; AST: aspartate aminotransferase; ALT: alanine transaminase Total (N=100) Placebo (N=51) Zervimesine (n=49) Subjects with: At least one TEAE, n (%) 38 (77.6%) 36 (70.6%) 74 (74.0%) At least one
Slide 12: Strong clinical signals in the two primary causes of dementia
Strong clinical signals in the two primary causes of dementia: Dementia with Lewy Bodies (DLB) Mild-to-Moderate Alzheimer’s Disease Dementia Programs:
Slide 13: AD and DLB: 2 Diseases with Overlapping Pathology
13 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-s
Slide 14: Strong clinical signals across four 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 15: Dementia with Lewy Bodies (DLB)
15 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
Slide 16: SHIMMER Study in Dementia with Lewy Bodies
16 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 diag
Slide 17: Four Symptom Domains Drive Lewy Body Disease Burden
17 Behavior Cognition Function Movement Four Symptom Domains Drive Lewy Body Disease Burden “A multifactorial disease with a buffet of symptoms” Patient symptom Hallucinations, anxiety, delusions Memory and problem solving Bathing, toileting, shopping, meal preparation Standing, maintaining balance
Slide 18: Strong clinical signals across major DLB symptoms
18 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 19: Zervimesine Showed 86% Impact on Neuropsychiatric Measures
19 Zervimesine Showed Dramatic 86% 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 P-val
Slide 20: Caregivers were Notably Better
20 -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 21: Up to 91% Slowing of Cognitive Decline Across Assessments
21 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 22: People on Zervimesine Maintained Self-care
22 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 23: People Treated with Zervimesine Maintained Motor Function
23 -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 24: SHIMMER Met and Exceeded Objectives and Expectations
24 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 25: Summary of SHIMMER Safety and Tolerability findings
25 Summary of SHIMMER Safety and Tolerability findings * occurring in a CT1812 treatment group at a rate >10% and at a rate >2X the placebo rate † not considered treatment related Favorable safety profile vs placebo, AEs well balanced between arms Adverse Events Serious AEs Deaths† CT1812 94.3% 10.3
Slide 26: 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 Alzheimer’s Disease
Slide 27: SHINE: Phase 2 PoC in Mild-to-Moderate Alzheimer's Disease
27 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 28: Up to 108% Percent Slowing on Assessments
28 ADAS-Cog 11 ADAS-Cog 13 MMSE ADCS-ADL ADCS-CGIC median p-tau217 95% 103% 108% 68% 61% mITT 38% 39% 70% 26% 28% Up to 108% Percent Slowing on Assessments Strong, consistent efficacy signals across measures Cognition Function Zervimesine Pooled (100/300mg)
Slide 29: Tau Burden in Amyloid-related AD Clinical Trials
29 • 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 30: Below Median p-tau217, Treated Participants Experienced Profound Cognitive Effect
30 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) -3.0 -2.0 -1.0 0.0 1
Slide 31: Treatment Impact in Below Median p-tau217 Consistent Across Baseline MMSE
31 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 -3.0 -2.0 -1.0 0.0 1.0 2.0 3.0 4.0 Pooled Zervimesine
Slide 32: Participants Evenly Distributed by Median p-tau217 and MMSE Severity
32 Participants Evenly Distributed by Median p-tau217 and MMSE Severity Baseline Plasma p-tau217 MMSE at Screening Below Median Above Median Total Mild (22-26) 35 32 67 Moderate (18-21) 34 37 71 Total 69 69 138 MMSE at Screening vs p-tau217 at Baseline in SHINE Median MMSE Median plasma p-tau217 Mil
Slide 33: Summary of SHINE Safety and Tolerability findings
33 • 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 34: SHINE Study: Summary and Conclusions and Next Steps
34 Next steps: Requested End-of-Phase 2 meeting with FDA to establish protocol for Phase 3 in population defined by plasma p-tau217 • Zervimesine has favorable safety and tolerability profile - Similar percentages of AEs in pooled treated and placebo groups • All cognitive and functional measures tr
Slide 35: START - A 540-Person Study in Amyloid-positive Early AD
35 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 36: Major Diseases Addressed with Once-Daily Oral Pill
36 3 Major Diseases Addressed with Once-Daily Oral Pill Collective Phase 2 Results Supports Advancing Zervimesine (CT1812) to Registrational Studies Dementia with Lewy Bodies Marked slowing of progression across multiple domains Geographic Atrophy Slowing of GA growth rate and area Alzheimer’s Disea
Slide 37: Executive Summary
37 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 tole
Slide 38: Current Financial Position
38 Current Financial Position 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 As of quarter ended March 31, 2025
Slide 39: Thank You
Thank You Lisa Ricciardi President & CEO info@cogrx.com
Cognition Therapeutics — Investor Presentation (June 2025) on 6ix