Cognition Therapeutics, Inc. · NASDAQ:CGTX
Cognition Therapeutics — Investor Presentation (September 2023)
23 slides from Cognition Therapeutics's investor presentation, Sep 12, 2023
Slide 1: Disease-modifying medicines for neurodegenerative disorders
Disease - modifying medicines for neurodegenerative disorders September 9, 2023
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 prese nt that rela
Slide 3: Alzheimer's Disease impacts every one of us
3 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 one
Slide 4: AD: Finally breakthroughs and the realities of constraints
4 • 2 approved mAbs , 1 additional drug filed for approval - Annual cost for therapy = $26K - $28K/ patient - Estimated $5B cost to Medicare for 216K patients on Leqembi • Diagnostics & treatment considerations - 3,600 Infusion centers in the US - 2,500 PET scanners in the US performing 2M scans/yea
Slide 5: Cognition Therapeutics - Our Company
5 • Why we do what we do : Neurodegenerative diseases, particularly Alzheimer’s disease, impacts every one of us. • How we address neurodegenerative diseases: We identify neurodegeneration targets and treatments. NIH and Advocacy groups help us cost - effectively develop clinical candidates. • What
Slide 6: CGTX Near-term Catalysts
6 CGTX Near - term Catalysts Alzheimer's Development DLB Development GA / Dry AMD Development 2021 2022 2023 2024 2025 Ph2 SHINE (COG0201) Mild - Mod AD Ph2 START (COG0203) Early AD Ph2 SEQUEL (COG0202) qEEG Ph2 SHIMMER (COG1201) DLB Ph2 MAGNIFY (COG2201) GA Topline SHINE Topline SHIMMER Topline IND
Slide 7: Our approach to neurodegenerative diseases
Our approach to neurodegenerative diseases
Slide 8: Innovative mechanism of action within the established amyloid cascade
8 • Oral, small molecule ligand of sigma - 2 ( σ - 2) receptor - High degree of blood brain barrier penetration, reaches therapeutic target • Targets oligomers, a pathogenic form of amyloid plaques produced early in AD • Blocks toxic oligomer binding, displaces bound oligomers - protecting synapses
Slide 9: CT1812: A Novel Approach Within the Established Amyloid Cascade
9 Anti - oligomer Mab A β monomer CT1812: A Novel Approach Within the Established Amyloid Cascade Anti - protofibril Mab Anti - plaque Mab CT1812: Protect Synapses • Small molecule ligand to the σ - 2 receptor • Displaces A β oligomers and prevents their binding to synapses mABs : Lower A β plaque •
Slide 10: σ-2 is a druggable receptor target
10 • Robust scientific research has demonstrated target engagement and biological effects of σ - 2 modulation • Backed by in vitro studies, behavioral data from in vivo animal models and strong preclinical program • Now in multiple Phase 2 trials • Science vetted through peer - reviewed publications
Slide 11: Our MoA Video
11 Our MoA Video: https://vimeo.com/800999561
Slide 12: Our Trials and Target Product Profile
Our Trials and Target Product Profile
Slide 13: What We Have Learned From Clinical Trials to Date
13 What We Have Learned From Clinical Trials to Date Target engagement Anatomical effect Preliminary cognitive improvement Neurophysiology SEQUEL 3 SHINE - A SPARC 2 SNAP 1 1 1. AD/PD Π2022 & LaBarbera, et al. Transl Neurodegener 2023 2. SPARC results submitted for publication 3. Abstract of SEQUEL
Slide 14: Clinical Evidence of Cognitive Benefit
14 • SHINE interim analysis (n=24) yields promising evidence: - 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 Clinic
Slide 15: SHIMMER Phase 2 Study in Dementia with Lewy Bodies
15 Phase 2 Study Adults with Mild - to - Moderate DLB -- " The most common dementia you have never heard of " Conducted in collaboration with Lewy Body Dementia Association & U Miami Principal investigator: James E. Galvin, MD, MPH, professor of neurology and director of the Comprehensive Center for
Slide 16: START Phase 2 Study in Early Alzheimer's Disease
16 Phase 2 Efficacy Study in 540 Adults with Early Alzheimer’s Disease Conducted in collaboration with Alzheimer’s Clinical Trials Consortium Screening Treatment Period (18 mo ) Assessments - Labs - MRI - Brain amyloid via PET - Cognitive testing - Biomarkers (CSF/Plasma) 1:1:1 CT1812 100 mg (n=180)
Slide 17: CT1812 Target Profile
17 CT1812 – Target profile • Once - daily oral therapy • Slows cognitive and functional decline in early/MCI and mild - to - moderate AD including Dementia with Lewy Bodies • Well tolerated, modest side effect profile for use in aging population - Limited potential for ARIA • Minimal caregiver burde
Slide 18: Successful drugs will address gaps in the market
18 Gaps in development - stage candidates • Breadth of Indication: AD spectrum including early, MCI, mild and moderate AD and DLB • Limited diagnostic exclusions • Comparable efficacy as measured by ADAS - COG or CDR - SB • No requirement for PET surveillance • No ARIA or infusion safety considerati
Slide 19: Phase 2 Program Informs Phase 3 & Regulatory Strategy
19 • Enrollment appx 700 - 1,500 / study • Global enrollment - Randomized 2:1 to CT1812 or placebo - Phase 2 results inform duration • Stratification with concomitant therapy • Initiate heath economics and outcomes research, pricing research and IRA considerations • Baseline - unbiased analyses of p
Slide 20: Grant Funding Has Provided Substantial Support
20 $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
Slide 21: Financial Position
Financial Position Financials as of June 30, 2023 • Cash and Cash Equivalents: $37.2 million • Expected cash runway through third quarter of 2024 Grant funding for CT1812 studies as of June 30, 2023 • Preclinical through Phase 2: appx $171.0 million − Approximate funding used: ($89.2 million) − Rema
Slide 22: Next Steps: Preparations for Phase 3 & Commercialization
22 • Complete dementia trials: mild - moderate Alzheimer’s and DLB • Progress START study in early Alzheimer’s disease • Conduct KOL panels on dementia product profile for Phase 3 development • Advance MAGNIFY study in dry AMD • Initiate research on IRA & pricing impact • Continue pharma engagement
Slide 23: Thank You
Thank You Tony Caggiano, MD, PhD CMO and Head of R&D 914 - 221 - 6730 acaggiano@cogrx.com Lisa Ricciardi President & CEO 917 - 658 - 5789 lricciardi@cogrx.com John Doyle Chief Financial Officer 914 - 556 - 3347 jdoyle @cogrx.com
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