Cognition Therapeutics, Inc. · NASDAQ:CGTX
Cognition Therapeutics — Investor Presentation (January 2024)
37 slides from Cognition Therapeutics's investor presentation, Jan 4, 2024
Slide 1: Disease-modifying medicines for neurodegenerative disorders
Disease-modifying medicines for neurodegenerative disorders January 2024
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: Our Mission
3 Our Mission: Develop oral therapies to protect neurons and restore normal cellular damage responses in age-related disorders of the CNS and retina
Slide 4: Cognition Therapeutics – Our Value Proposition
4 Cognition Therapeutics – Our Value Proposition Advancing mid-to-late-stage clinical trials in multiple indications including pre-Phase 3 programs in mild-to-moderate Alzheimer’s disease and DLB Strong Clinical Pipeline Executive team with pharma experience; R&D staff with depth of neuroscience dru
Slide 5: CT1812 lead product for multiple diseases
5 Alzheimer’s Disease Dementia with Lewy Bodies GA / Dry AMD Cognition’s lead product, CT1812, is an orally delivered, first-in-class, small molecule designed to restore key cellular functions that are impaired in diseases including:
Slide 6: CT1812 – Lead Product Candidate
6 CT1812 – Lead Product Candidate First-in-class, orally dosed and highly brain penetrant small molecule Powerful scientific validation of σ-2 science The Right Target ✓ Targeting toxic stressors: Aβ and α-synuclein oligomers and ROS in neurodegenerative diseases Oral, Once-daily Pill ✓ Oral, small
Slide 7: Sigma-2 complex and neuronal protection from toxic stressors
7 • Robust scientific research has demonstrated target engagement and biological effects of σ-2 modulation • Backed by in vitro studies, in vivo animal models and strong preclinical program • Science vetted through peer-reviewed publications and NIA grant process Sigma-2 (σ-2) complex regulates cell
Slide 8: CT1812 – Multiple Catalysts
8 CT1812 – Multiple Catalysts PROGRAM PRECLINICAL PHASE 1 PHASE 2 PHASE 3 MILESTONE ALZHEIMER’S DISEASE SHINE Topline data mid 2024 SEQUEL Data reported at CTAD 2023 START Complete patient enrollment DLB SHIMMER Topline data 2H 2024 DRY AMD MAGNIFY Complete patient enrollment MILD TO MODERATE MILD T
Slide 9: Alzheimer's Disease
S V ALZHEIMER DISEASE wn e) o = 0) Q 4 2 j= FA O E z 0) G x
Slide 10: Alzheimer's Disease – It Impacts Every One Of Us
10 The People • 2021 ~ 6.5M Americans • 2060 ~ 12.7M Americans The Cost • 2020 – Estimated 11M family members/unpaid caregivers provided 15.3B hours of care at a value of ~$257B* • 2050 – Anticipated caregiving costs ~ $1.1 trillion (in 2019 dollars) ** Alzheimer's Disease (AD) – It Impacts Every On
Slide 11: AD – Finally Breakthroughs & the Realities of Constraints
11 • Two approved mAbs, one additional drug filed for approval - Annual cost for therapy = $26K - $28K/ patient - Estimated $5B cost to Medicare • Constrained delivery systems for infused medications - 3,600 Infusion centers in the US - 2,500 PET scanners in the US performing 2M scans/year - 11,900
Slide 12: CT1812: A Novel Approach Within the Established Amyloid Cascade
12 CT1812: A Novel Approach Within the Established Amyloid Cascade CT1812: Protects Synapses • Small molecule ligand to the sigma-2 receptor • Displaces Aβ oligomers and prevents their binding to synapses mABs: Lower Aβ plaque • Monoclonal antibodies bind to Aβ proteins • Immunotherapeutic vaccines
Slide 13: CT1812 – Unique Mechanism of Action for Treating AD
13 CT1812 – Unique Mechanism of Action for Treating AD Age-related build-up of stressors including Aβ oligomers drive Alzheimer's disease Aβ oligomers bind to synapses and interfere with cellular functions such as autophagy, leading to neuronal loss CT1812 binds at σ-2, resulting in displacement of
Slide 14: What We Have Learned From Clinical Trials to Date
14 What We Have Learned From Clinical Trials to Date Target engagement Anatomical effect Neurophysiology SEQUEL4 SPARC3 SNAP1 Demonstrated displacement of amyloid oligomers from synapses Demonstrated effect on slowing brain atrophy Preliminary cognitive improvement SHINE-A2 Demonstrated 3+ point dif
Slide 15: Preliminary Clinical Evidence of Cognitive Benefit
15 • 3-point difference (ADAS-COG 11) between treated and untreated participants at Day 185 • Clinically meaningful magnitude of change • Trend towards slower cognitive decline in CT1812-treated vs placebo-treated participants Preliminary Clinical Evidence of Cognitive Benefit Cognitive Outcome SHIN
Slide 16: Enrollment Complete; Topline Expected mid 2024
16 • A total of 153 adults with mild-to-moderate Alzheimer's disease were enrolled - Exceeded target of 144 • Randomized to receive placebo or CT1812 (100mg or 300mg) for 6 months • Last-patient / last-visit therefore expected in May 2024 Enrollment Complete; Topline Expected mid 2024
Slide 17: Evidence of Target Engagement
17 Evidence of Target Engagement SNAP (n=3) mirrored preclinical Oligomer Displacement in Mice Replicates in Alzheimer’s Patients NOTE: Microimmunoelectrodes coated with oligomer-specific antibody detect soluble Aβ in transgenic hAPP/PS1 mice Izzo et al. Preclinical and clinical biomarker studies of
Slide 18: CT1812 Treatment Associated with Reduced Brain Atrophy
18 CT1812 Treatment Associated with Reduced Brain Atrophy LS Mean Change from Baseline in vMRI (composite) over Time by Treatment PIs Christopher H. van Dyck, M.D. at the Yale Alzheimer's Disease Research Unit and Richard E. Carson, Ph.D. at the Yale PET Center SPARC COG0105 study partially funded b
Slide 19: CT1812 Normalizes qEEG Measures of Synaptic Function and Connectivity
19 CT1812 Normalizes qEEG Measures of Synaptic Function and Connectivity Positive trends in first three ranked outcomes measures -0.0400 -0.0300 -0.0200 -0.0100 0.0000 0.0100 0.0200 0.0300 Global Relative Theta Power CT1812 Placebo normalizing p=0.123 * Nominally significant -0.02 -0.015 -0.01 -0.00
Slide 20: Expanding CT1812 Experience into Early Disease
20 • Early / mild Alzheimer disease • Recruitment ongoing - 540 target enrollment - Permitting participants to be enrolled who are receiving lecanemab infusions - Placebo or CT1812 (100mg or 200mg) 50+ sites expected to be activated • Treatment period: 18 month • Conducted in collaboration with ACTC
Slide 21: Dementia with Lewy Bodies
Dementia with Lewy Bodies COGNITION Therapeutics
Slide 22: Phase 2 Mild-to-Moderate DLB Trial Ongoing
22 • Mild-to-moderate DLB (including patients with Alzheimer’s co-pathology) • Enrollment ongoing - Target n=120 - Oral QD placebo or CT1812 (100mg or 300mg) • Treatment period: 6 months - Topline expected 2H 2024 • Conducted in collaboration with LBDA & University of Miami - Principal investigator:
Slide 23: CT1812 Potential Single Oral Medication for Alzheimer's Disease and DLB
23 CT1812 has the Potential to be a Single Oral Medication to Treat Alzheimer’s Disease and DLB Only therapeutic that targets Aβ oligomers and α-synuclein oligomers Appx 50% of DLB patients have both Aβ and α-synuclein oligomers present By regulating cellular damage response functions through the σ-
Slide 24: Geographic Atrophy Secondary to Dry AMD
Geographic Atrophy Secondary to Dry AMD
Slide 25: Large projected market with no FDA-approved therapies
25 • Total AMD drug market: $9B1 (approximately $6B for dry form2 ) • Dry AMD Phase 2 planned (subject to discussion with FDA) - Genetic link in dry AMD to σ-2 receptor - Novel mechanism of action - Proof-of-concept preclinical support - Proteomics from Alzheimer’s disease clinical trial patient dat
Slide 26: Why Dry AMD?
26 • Significant unmet medical need: - AMD is a leading cause of blindness - Approximately 11.2 M people are afflicted in U.S. alone • Patients suffer a loss of central vision due to deterioration of the macula, causing blurry vision making daily activities (reading, driving, watching TV, walking up
Slide 27: Cellular and Molecular Pathogenesis of Dry AMD
27 • In early dry AMD, drusen (i.e., deposits of lipids and some proteins) accumulates and causes a thickening of the Bruch’s membrane, disrupting the cytoarchitecture of the retinal pigment epithelium (RPE) • Subsequently and progressively, this impacts the health and functions of RPE cells and pho
Slide 28: Reasons to Believe CT1812 – Oral Agent for Dry AMD
28 • Genetic Mutation (SNP) in TMEM97-VTN locus confers decreased risk of dry AMD - Further study will determine if and how SNP affects TMEM97 expression or function • Knocking down TMEM97 rescues retinal pigment epithelial (RPE) cells from death by oxidative stress - Supports role of TMEM97 in dry
Slide 29: Human Genetics Points to a Role for TMEM97 in dry AMD
29 Human Genetics Points to a Role for TMEM97 in dry AMD GWAS identified a SNP in TMEM97-VTN locus that confers decreased risk of dry AMD Locus identified in several independent and large-scale GWAS Yan et al. Human Molecular Genetics, 2018 Further study will be needed to determine if and how this s
Slide 30: Phase 2 CT1812 in GA Secondary to Dry AMD
30 Screening Treatment Period (24 mo) Safety (4 wk) Assessments ‐ 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 area (SD-OCT) ‐ Drusen volume (SD-OCT) ‐ Safety Randomized 1:1 Placebo (n=123) CT1812 (n=123
Slide 31: Summary
31 Evidence supports targeting σ-2 receptor for dry AMD as a promising therapeutic approach The ability to target the σ-2 receptor with an oral small molecule approach would enable a competitive advantage by providing a non-invasive therapy for dry AMD to patients Plans to advance CT1812 into a Phas
Slide 32: Clinical, Market & Financial Outlook
Clinical, Market & Financial Outlook
Slide 33: Successful drugs will address gaps in the market
33 • Breadth of Indications: multiple stages of Alzheimer’s (early, MCI, mild, moderate) as well as DLB • Limited diagnostic exclusions • Comparable efficacy as measured by ADAS-COG or CDR-SB • No requirement for PET surveillance • No ARIA or infusion safety considerations • Convenience QD dosing, l
Slide 34: Grant Funding Has Provided Substantial Support
34 $0 $10 $20 $30 $40 $50 $60 $70 $80 $90 $100 2016 2017 2018 2019 2020 2021 2022 $15 $7 $17 $3 $81 $45 $2 $3 $5 $55 $42 FY Ending Cash Balance Grant Funding Full Grant Awards by year of Award, significantly support operations Grant Funding Has Provided Substantial Support *$10M+ grant funding 2010-
Slide 35: Near-Term Catalysts, Phase 3 Prep & Commercialization
35 • SHINE (Mild-to-Moderate AD) - Report topline data in mid 2024 • START (Early AD) - Next milestone: complete enrollment • SHIMMER (DLB) - Next milestone: complete enrollment - Report topline data in 2H 2024 • MAGNIFY (Dry AMD) - Next milestone: complete enrollment • Advance discussions with FDA
Slide 36: Financial Position
Financial Position Financials as of September 30, 2023 • Cash and Cash Equivalents: $33 million • Expected cash runway through November 2024 Grant funding for CT1812 studies as of Sep 30, 2023 • Preclinical through Phase 2: appx $171.0 million − Approximate funding used: ($96.7 million) − Remaining
Slide 37: 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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