Cognition Therapeutics, Inc. · NASDAQ:CGTX
Cognition Therapeutics — Investor Presentation (September 2024)
38 slides from Cognition Therapeutics's investor presentation, September 2024
Slide 1: Targeting Amyloid Beta Oligomers: A Disruptive Approach to the Treatment of CNS Disorders
Targeting Amyloid Beta Oligomers: A Disruptive Approach to the Treatment of CNS Disorders September 2024
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: Cognition Snapshot
Cognition Snapshot Successful Phase 2 AD Trial read out plus signal-finding studies ongoing in other indications Alzheimer’s Dementia with Lewy Geographic Atrophy Disease Bodies (DLB) Secondary to dry AMD • Pursuing 2 populations: mild-to- • Phase 2 signal-finding SHIMMER • Phase 2 signal-finding MA
Slide 4: Alzheimer's Disease
Alzheimer’s Disease SHINE Study in Mild-to-Moderate Alzheimer’s disease
Slide 5: Breaking News – SHINE Phase 2 Alzheimer's Disease Study
Breaking News – SHINE Phase 2 Alzheimer’s Disease Study CT1812 is Among Few Oral Candidates Showing Cognitive Impact in Moderate Patients • Pooled (100 and 300mg arms) CT1812 treatment slowed cognitive decline by 39% on ADAS-Cog 11 vs placebo • All key cognitive and functional outcome measures trend
Slide 6: SHINE Phase 2 Study in Adults with Mild-to-Moderate Alzheimer's Disease
SHINE Phase 2 Study in Adults with Mild-to-Moderate Alzheimer’s Disease Enrollment Treatment Period Program Assessments Criteria 6 months Objectives ‐ AD diagnosis ‐ Safety/tolerability ✓ Identify efficacy CT1812 300 mg signal(s) ‐ PET or CSF biomarker 153 ‐ Principal cognitive definition of AD part
Slide 7: SHINE Patient Population
SHINE Patient Population • PET- or biomarker-confirmed Alzheimer’s disease • Majority of participants were female (60%), Caucasian (96%), approximately 72 years of age • Mean MMSE score upon entry: 21.37 • ~60% of patients were carriers of the ApoE4 gene • Characteristics well-balanced between all 3
Slide 8: 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 MMSE Pooled vs. pbo: Pooled vs. pbo: 39% slowing 70% slowing 8 Note: n's are at Day 182
Slide 9: 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 Pooled vs. pbo: Pooled vs. pbo: 39% slowing 50% slowing 9 Note: n's are at Day 182
Slide 10: Summary of SHINE Safety and Tolerability findings
Summary of SHINE Safety and Tolerability findings Adverse Events • CT1812 demonstrated a favorable safety and tolerability profile CT1812 Placebo • Most TEAEs were mild or moderate in severity 76.5% 78% • Similar percentages of adverse events in treated (76.5%) and Serious AEs placebo (78%) groups C
Slide 11: SHINE Response at 6 Months Comparable to Approved MAbs
SHINE Response at 6 months Comparable to Approved MAbs Once-daily pill • no ARIA • 39% slowing at 6 months vs Leqembi’s 26% at 18 months 0 SHINE Results at 6 months Adjusted Mean Change from Baseline 1 1.4-point difference ~26% slowing with 2 lecanemab 1.1 pt difference btw pooled CT1812 vs. placebo
Slide 12: SHINE: Summary Exploratory Outcomes - Percent Slowing Day 182
SHINE: Summary Exploratory Outcomes - Percent Slowing Day 182 Effect as large or larger than approved MAbs ADAS-Cog 11 ADAS-Cog 13 MMSE Cognitive Composite CT1812 Pooled1 39% 39% 70% 50% Lecanemab2 26% 24% -- -- (at 18mo) (ADAS-Cog 14) (ADCOMS) Donanemab3 20% 16% 22% -- (at 18 mo) (ADAS-Cog 13) (MMS
Slide 13: SHINE: Corroborated by Experts
SHINE: Corroborated by Experts Results of a Commissioned Survey of 51 neurologists
Slide 14: CT1812 Market Opportunity
CT1812 Market Opportunity Insights from a Survey of Neurologists Current Options for Alzheimer’s Disease: • Two recently approved monoclonal antibodies: lecanemab and donanemab • Acetylcholinesterase (AChE) inhibitors: donepezil, galantamine, and rivastigmine • NMDA receptor antagonist: memantine Ma
Slide 15: SHINE Data Feedback from Neurologists
SHINE Data Feedback from Neurologists Surveyed diverse group of 51 neurologists who treat over 13,000 AD patients annually Cross Section of Practice Cross Section of Cross Section of Patients Setting Specialties (MMSE) Movement Memory disorder Severe Community disorder specialist VA hospital special
Slide 16: CT1812's Safety and Oral Delivery Appealed to Neurologists
CT1812’s Safety and Oral Delivery Appealed to Neurologists Most Appealing Features of CT1812’s Product Profile (10-pt scale) 10 “Ease of dosing as oral medication” “Oral medication without ARIA risks” 8 “Pill form is always welcome over an IV infusion” 6 “Does not require infusion or intensive monit
Slide 17: Neurologists Enthusiastic About SHINE Results
Neurologists Enthusiastic About SHINE Results Oral, once-daily treatment with cognitive benefit and no increased ARIA risk • The absence of symptomatic ARIA was seen as Overall Characterization of SHINE Results important (rated 8.4 out of 10) • 86.3% of respondents felt CT1812’s cognitive Neutral Ne
Slide 18: Efficacy Findings in Particular were Viewed as Significant
Efficacy Findings in Particular were Viewed as Significant Importance Neurologists Place on 8 SHINE’s Cognitive Outcomes • Importance on cognitive outcomes echoed in open (10-pt scale) discussion of the most attractive aspects of the 7.1 7 6.8 6.8 SHINE results - “Consistent improvement in all clini
Slide 19: Next Steps: Larger Studies with Longer Duration
Next Steps: Larger Studies with Longer Duration Neurologists surveyed see a path forward for CT1812 In discussion of next steps for CT1812, neurologists expressed interest in: • Treatment effect in combination with and/or head-to-head against anti amyloid drugs • Treatment effect in combination with
Slide 20: If Approved, Neurologists Would Consider CT1812
If Approved, Neurologists Would Consider CT1812 Monotherapy and combination uses appealed to clinicians 98% of Respondents Would Prescribe CT1812 • What percentage of your mild patients would you consider 62.8% candidates for CT1812? • What percent of your moderate patients would you consider candid
Slide 21: Alzheimer's Disease
Alzheimer’s Disease START Study in early Alzheimer’s disease
Slide 22: START - A 540-Person Study in Early AD
START - A 540-Person Study in Early AD First study to allow lecanemab as background therapy in combination with CT1812 Enrollment Treatment Period Program Assessments Criteria 6 months Objectives ‐ Ages 50-85 ‐ Safety ✓ Identify efficacy CT1812 200 mg signal(s) ‐ Diagnosis of MCI due Recruiting 540
Slide 23: CT1812 is Also Being Investigated in two Additional Indications
CT1812 is Also Being Investigated in two Additional Indications Alzheimer’s Dementia with Dry AMD Disease Lewy Bodies Geographic Atrophy 23
Slide 24: Dementia with Lewy Bodies
Dementia with Lewy Bodies “The most common dementia you’ve never heard of”
Slide 25: Lewy Body Dementias are Second only to AD in Prevalence
Lewy Body Dementias are Second only to AD in Prevalence • In the U.S. an estimated 1.4 million people1 Dementias Estimated US Population have dementia with Lewy bodies (DLB) • It is estimated that 50-80% of patients with DLB have Aβ as well as α-synuclein2 pathology DLB • Core symptoms of DLB includ
Slide 26: Evidence Supports CT1812 Potential in DLB
Evidence Supports CT1812 Potential in DLB Protection of neurons from Neurons rescued from α-synuclein α-synuclein oligomers oligomer-induced damage -synuclein oligomers -synuclein oligomers + CT1812 rescued damaged -Synuclein oligomers in red Limegrover CS, et al. J Neurosci Res. 2021. doi: 10.10
Slide 27: SHIMMER Study Brings Together Experts and New Tools to Explore Efficacy of CT1812
SHIMMER Study Brings Together Experts and New Tools to Explore Efficacy of CT1812 • Until recently, DLB could only be CORE CLINICAL FEATURES OF DLB confirmed upon autopsy, making clinical research difficult • SHIMMER was designed to have the best chance available to Skin biopsy detect signals of imp
Slide 28: SHIMMER Study in Dementia with Lewy Bodies
SHIMMER Study in Dementia with Lewy Bodies Topline YE 2024 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 CT1812 300 mg 130 ‐ Global CGIC signal
Slide 29: Geographic Atrophy
Geographic Atrophy Damage to the macula resulting from advanced dry age-related macular degeneration (dry AMD)
Slide 30: Rationale for CT1812 in Dry AMD/Geographic Atrophy
Rationale for CT1812 in Dry AMD/Geographic Atrophy Opportunity: crosses blood-retinal barrier to reach retina without an injection What is dAMD/GA Geographic atrophy (GA), the most advanced form of dry AMD, effects ~5M people WW and is associated with significant vision loss Unmet Need Complement in
Slide 31: Dry AMD and Geographic Atrophy
Dry AMD and Geographic Atrophy Leading cause of severe vision loss in people over 50 (AAO) • AMD is leading cause of blindness over 50 yr1 20 million people in North America have AMD3 • Dry AMD is a progressive condition accounting ~90% of all AMD cases Wet AMD, - Advanced dry AMD, or GA, affects ap
Slide 32: CT1812 Protects RPE Cells and the Photoreceptors they Support
CT1812 Protects RPE Cells and the Photoreceptors they Support • Photoreceptors – specialized neurons necessary for sight – require support from retinal pigment epithelial (RPE) cells that are damaged in dry AMD • CT1812 has been shown to rescue RPE cells in vitro • CT1812’s potential to preserve vis
Slide 33: Cellular and Molecular Pathogenesis of Dry AMD (dAMD)
Cellular and Molecular Pathogenesis of Dry AMD (dAMD) CT1812 restores trafficking and degradation of POS Receptor-bound POS Early Compartment (Rab 5) Rab 7 Lysosome (LAMP 1/2) Autophagy Body (LC3b) In dry AMD, RPE cells are unable to successfully recycle photoreceptor outer segments ( ) through the
Slide 34: MAGNIFY Trial in dAMD/GA
MAGNIFY Trial in dAMD/GA Potential first oral drug for geographic atrophy Enrollment Treatment Period Program Assessments Criteria 6 months Objectives ‐ Age: ≥ 50 ‐ Change in GA lesion area ✓ Identify efficacy (FAF) signal(s) ‐ Diagnosis of CT1812 200 mg dry AMD Recruiting 246 ‐ Ellipsoid zone area
Slide 35: Completed Studies Support Potential in Mild-to-Moderate AD
Completed Studies Support Potential in Mild-to-Moderate AD Ongoing Trials Expand CT1812 into New Indications SEQUEL1 • 16 participants • Normalization of brain waves COG0203 - START across EEG measures Early-to-mild Alzheimer's disease • Significant improvement in AEC-c and relative theta in Activel
Slide 36: The Promise of CT1812
The Promise of CT1812 • First-in-class Aβ oligomer antagonism via sigma-2 receptor • Consistent efficacy in Alzheimer’s disease studies - ARIA unlikely to occur based on MoA • Potential first-to-market for DLB • Potential first oral for dAMD/GA • Well tolerated safety profile anticipated • Oral admi
Slide 37: Current Financial Position
Current Financial Position As of June 30, 2024 Cash and cash equivalents $28.5 M Expected cash runway into 2Q 2025 Grant funding for CT1812 studies Preclinical through Phase 2 ~$171 M Approximate funding used ($113.7 M) Remaining grant funding $57.3M 37
Slide 38: Thank You
Thank You Lisa Ricciardi President & CEO lricciardi@cogrx.com Tony Caggiano, MD, PhD CMO and Head of R&D acaggiano@cogrx.com John Doyle Chief Financial Officer jdoyle@cogrx.com
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