Cardiol Therapeutics Inc. Class A · TSX:CRDL
Cardiol Therapeutics Inc. Class A — Investor Presentation (March 2025)
32 slides from Cardiol Therapeutics Inc. Class A's investor presentation, March 2025
Slide 1: Corporate Presentation March 2025
CORPORATE PRESENTATION MARCH 2025 NASDAQ: CRDL | TSX: CRDL
Slide 2: Disclaimer
Disclaimer In this presentation, all amounts are in Canadian dollars, unless otherwise indicated. Any graphs, tables or other information in this presentation demonstrating the historical performance of Cardiol Therapeutics Inc. (“Cardiol”) or any other entity contained in this presentation are inte
Slide 3: Developing life-changing medicines for people living with heart disease
Developing life-changing medicines for people living with heart disease 3
Slide 4: Focused on Advancing Therapies that Target Inflammation in the Heart
Focused on Advancing Therapies that Target Inflammation in the Heart L ATE-STAGE INITIAL MARKET VALIDATED WORLD-CL ASS NEAR-TERM PIPELINE OPPORTUNIT Y TARGET COLL ABORATIONS VALUE DRIVERS Lead oral drug candidate, Current revenue for 3rd line Targeting inflammasome Established long-standing Commence
Slide 5: Late-stage Clinical Pipeline in Pericarditis and Myocarditis, with IND-Enabling Program in Heart Failure
Late-stage Clinical Pipeline in Pericarditis and Myocarditis, with IND-Enabling Program in Heart Failure PRODUCT INDICATION STATUS PRE-CLINICAL PHASE I PHASE II PHASE III EXCLUSIVIT Y FDA Orphan Drug Designation (ODD) Recurrent MAVERIC granted for the treatment of pericarditis, Pericarditis Phase II
Slide 6: CardiolRx and CRD-38: Small Molecule Drugs that Modulate Inflammasome Pathway Activation
CardiolRx™ and CRD-38: Small Molecule Drugs that Modulate Inflammasome Pathway Activation CANNABIDIOL Targets pathways associated with NF-κβ-mediated inflammasome priming and NLRP-3 inflammasome formation. • Stressors or injurious stimuli (e.g., viral infection; tissue damage) trigger activation of
Slide 7: MAVERIC Program
MAVERIC Program Late-stage Clinical Development of CardiolRx™ for the Treatment of Recurrent Pericarditis 7
Slide 8: Recurrent Pericarditis
Recurrent 38,000 Pericarditis Recurrent pericarditis patients in the United States Striking healthy adults in 18,000 Pericarditis hospitalizations per year in the United States the prime of their lives Inflammation of the membrane surrounding the heart characterized by severe chest pain, 4.7 – 6.2 y
Slide 9: Recurrent Pericarditis Treatment Challenges
Recurrent Pericarditis Treatment Challenges CURRENT 1 st LINE 2 nd LINE 3 rd LINE TREATMENTS NSAID + colchicine Corticosteroid Interleukin-1 blocker* Patients who fail first-line therapy typically require immunosuppressants (corticosteroids and IL-1 blockers). CHALLENGES Non-responsive; Intolerant T
Slide 10: MAvERIC-Pilot Phase II Study: 27 Patients Enrolled at 8 U.S Sites
MAvERIC-Pilot Phase II Study Results presented at the American Heart Association Scientific Sessions 2024 27 Patients Enrolled at 8 U.S Sites PRIMARY ENDPOINT • Change in pericarditis pain score (NRS*) at 8 weeks SECONDARY ENDPOINTS • Pain score at 26 weeks • Freedom from pericarditis recurrence • C
Slide 11: MAvERIC-Pilot Phase II Study Design
MAvERIC-Pilot Phase II Study Design 27 patients enrolled (met ESC criteria) → 24 progressed to Extension Period on CardiolRx™. CARDIOLRX™ titration over 8-Week initial 10 days Primary Endpoint CardiolRx™ + baseline medications Withdrawal of background medications† while continuing CardiolRx™ BASELIN
Slide 12: CardiolRx Resulted in Marked, Rapid, and Durable Reduction in Pericarditis Pain
CardiolRx™ Resulted in a Marked Relevant, Rapid, and Durable Reduction in Pericarditis Pain CHANGE IN NRS PAIN SCORE OVER 26 WEEKS 10 9 TREATMENT PERIOD (N=27) EXTENSION PERIOD (N=24) C a rdi o l R x ™ + ba s e l i n e me di ca ti o n s Wi thdra w a l o f ba ckg ro u n d me di ca ti o n s * w hi l e
Slide 13: CardiolRx Resulted in Rapid Reduction in Inflammation (CRP)
CardiolRx™ Resulted in a Clinically Meaningful and Rapid Reduction in Inflammation (CRP) CHANGE IN CRP LEVEL OVER 26 WEEKS 3.0 TREATMENT PERIOD (N=27) EXTENSION PERIOD (N=24) C-REACTIVE PROTEIN (mg/dL) C a rdi o l R x ™ + ba s e l i n e me di ca ti o n s Wi thdra w a l o f ba ckg ro u n d me di ca t
Slide 14: CardiolRx Substantially Reduced Pericarditis Events Per Year
CardiolRx™ Substantially Reduced Pericarditis Events Per Year 71% of patients (17/24) recurrence free during 5.8 Extension Period 0.9 PRIOR TO THE STUDY DURING THE STUDY 14
Slide 15: MAVERIC Phase III Trial: 110 Patients at ~20 Clinical Sites
MAVERIC Phase III Trial Multi-national, double-blind, randomized, placebo-controlled Trial designed to demonstrate the impact of CardiolRx™ on pericarditis recurrence in a high-risk patient population. PRIMARY EFFICACY ENDPOINT 110 Patients at ~20 Clinical Sites • Number of patients (percentage) fre
Slide 16: Advisors and Key Investigators for the MAVERIC Phase III Program
Advisors and Key Investigators for the MAVERIC Phase III Program ALLAN KLEIN, MD, CM PAUL CREMER, MD PROGRAM CHAIR Departments of Medicine and Radiology, Northwestern Director, Center for the Diagnosis and Treatment of University, and Multimodality Cardiac Imaging and Clinical Pericardial Diseases,
Slide 17: MAVERIC Phase III Recruiting Patients at High Risk for Recurrence
MAVERIC Phase III Recruiting Patients at High Risk for Recurrence PERICARDITIS RECURRENCE RISK FOLLOWING WITHDRAWAL OF IL-1 BLOCKER 100 90 75% of patients experience a PERICARDITIS RECURRANCE (%) 80 recurrence at a median time of 70 11.8 weeks following discontinuation FREEDOM FROM 60 50 40 30 20 10
Slide 18: MAVERIC Phase III Trial Design
MAVERIC Phase III Trial Design Multi-national, double-blind, randomized, placebo-controlled trial to assess the impact of CardiolRx™ on pericarditis recurrence in a high-risk patient population CardiolRx™ STUDY PARTICIPANTS • Male or female • ≥18 years RANDOMIZATION 1:1 • Stable disease SCREENING 10
Slide 19: CardiolRx Market Opportunity in Recurrent Pericarditis
CardiolRx™ Market Opportunity in Recurrent Pericarditis FDA Orphan Drug Designation granted to CardiolRx™ for treatment of pericarditis (includes recurrent pericarditis) Patient population = 38,000 * 1 ST LINE 2 ND LINE 3 RD LINE NSAID + colchicine Corticosteroid Interleukin-1 blocker CARDIOLRX™ Col
Slide 20: Acute Myocarditis
Acute 46,000 Myocarditis Patients in the United States A leading cause of sudden cardiac 32,400 Deaths worldwide due to myocarditis in 2019 death in people <35 years of age Inflammatory condition of the heart muscle characterized by chest pain, impaired heart 4 – 6% function, and arrythmias In-hospi
Slide 21: Cannabidiol Attenuates Myocarditis-induced Fibrosis
Cannabidiol Attenuates Myocarditis-induced Fibrosis SECTIONS OF HEART TISSUE HEALTHY TISSUE MYOCARDITIS MYOCARDITIS + CANNABIDIOL Representative images of Sirius red-stained LV myocardium sections. Magnification: 100x. Lee W-S et al. (2016). Mol. Med. 22, 136-146 21
Slide 22: Steering Committee for the ARCHER Trial
Steering Committee for the ARCHER Trial DENNIS M. MCNAMARA, MD LESLIE T. COOPER, JR., MD CHAIR CO-CHAIR Professor of Medicine at the University of Pittsburgh. He is also the Director of the General cardiologist and the Chair of the Mayo Clinic Enterprise Department of Heart Failure/Transplantation P
Slide 23: ARCHER Phase II Trial: 100 Patients at 34 Clinical Sites
ARCHER Phase II Trial Multi-national, double-blind, randomized, placebo-controlled Trial designed to study the impact of CardiolRx™ on PRIMARY EFFICACY ENDPOINTS * myocardial recovery in patients with acute myocarditis. • Extracellular volume (ECV) • Global longitudinal strain (GLS) 100 Patients at
Slide 24: Heart Failure
Heart $108 billion Failure Estimated global economic cost in 2012 Chronic, progressive syndrome 8 million Patients in the United States by 2030 in which the heart is unable to pump enough blood to meet the body’s needs 1.2 million Patients experience shortness of breath, rapid Hospitalizations annua
Slide 25: CRD-38
CRD-38 Small Molecule Subcutaneous Drug Being Developed For Heart Failure 25
Slide 26: CRD-38: Potential Treatment to Prevent Heart Failure Dysfunction & Remodeling
CRD-38: Potential Treatment to Prevent Heart Failure Dysfunction & Remodeling DOSE-DEPENDENT EFFECT IN PREVENTING PROTECTS AGAINST CARDIAC DYSFUNCTION CARDIAC REMODELLING AND INFL AMMATION García-Rivas, G, Lozano, O, Bernal-Ramírez, J. et al. J Am Coll Cardiol Basic Trans Science. Published online F
Slide 27: CRD-38: Potential Treatment For Heart Failure With Preserved Ejection Fraction
CRD-38: Potential Treatment For Heart Failure With Preserved Ejection Fraction REDUCES BODY WEIGHT GAIN REDUCED VISCERAL TO SUBCUTANEOUS FAT RATIO PREVENTS INFL AMMATION PREVENTS CARDIAC REMODELING Lozano O et al. Heart Failure Society of America Annual Scientific Meeting 2023: ePoster Viewing Sessi
Slide 28: Near-term Value Drivers
Near-term Value Drivers RECURRENT PERICARDITIS ACUTE MYOCARDITIS HEART FAILURE • Enroll first patient in MAVERIC • Report ARCHER Phase II topline • Complete IND-enabling studies Phase III study during Q1 2025 data Q2 2025 • File IND for Phase I and initiate • 50% enrollment H2 2025 • Presentation of
Slide 29: Management Team
Management Team DAVID ELSLEY, MBA ANDREW HAMER, MBChB PRESIDENT AND CHIEF EXECUTIVE OFFICER CHIEF MEDICAL OFFICER AND HEAD OF R&D Founder and former President and CEO of Vasogen Inc. More than 30 years’ Thirty years of global life sciences industry, medical affairs, and cardiology experience develop
Slide 30: Board of Directors
Board of Directors GUILLERMO TORRE-AMIONE, MD, PhD DAVID ELSLEY, MBA CHAIRMAN PRESIDENT AND CHIEF EXECUTIVE OFFICER Professor of Cardiology at the Methodist Hospital Research Institute, Professor of Founder and former President and CEO of Vasogen Inc. More than 30 years’ Medicine at the Weill Cornel
Slide 31: Scientific Advisory Board
Scientific Advisory Board DR. PAUL M. RIDKER, MD, MPH DR. BRUCE MCMANUS, PhD, MD DR. JOSEPH A. HILL, MD, PhD Director of the Center for Cardiovascular Disease Prevention, Professor Emeritus, Department of Pathology and Laboratory Professor of Internal Medicine and Molecular Biology, Chief a translat
Slide 32: Developing life-changing medicines for people living with heart disease
Developing life-changing medicines for people living with heart disease L ATE-STAGE TARGETING ADDRESSING UNMET COLL ABORATIONS MULTIPLE CLINICAL PROGRAM INFL AMMASOME PATIENT NEEDS IN WITH INTERNATIONAL NEAR-TERM IN HEART DISEASE ACTIVATION GROWING MARKETS CENTERS OF VALUE DRIVERS EXCELLENCE CARDIOL
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