Cardiol Therapeutics Inc. Class A · TSX:CRDL
Cardiol Therapeutics Inc. Class A — Investor Presentation (February 2025)
35 slides from Cardiol Therapeutics Inc. Class A's investor presentation, February 2025
Slide 1: Developing life-changing medicines for people living with heart disease
Developing life-changing medicines for people living with heart disease CORPORATE PRESENTATION FEBRUARY 2025 CARDIOLRX.COM NASDAQ: CRDL TSX: CRDL NASDAQ: CRDL | TSX: CRDL FEBRUARY 2025 1
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: Our mission: innovative therapies for inflammatory heart conditions
Our mission is to introduce innovative therapies that modify disease progression, alleviate symptoms, and restore quality of life for patients with inflammatory heart conditions NASDAQ: CRDL | TSX: CRDL FEBRUARY 2025 3
Slide 4: Executing a Strategy to Advance Transformative Medicines That Target Inflammation in Heart Disease
Executing a Strategy to Advance Transformative Medicines That Target Inflammation in Heart Disease L ATE-STAGE COMPELLING VALIDATED MARKET NEAR-TERM CLINICAL PIPELINE PHASE II RESULTS TARGET OPPORTUNITY VALUE DRIVERS • Lead oral drug • CardiolRx™ showed • Mechanism of action • Valued at >$500M and •
Slide 5: Global Research and Clinical Collaborations with Centers of Excellence
Global Research and Clinical Collaborations with Centers of Excellence Established long-standing working relationships with leading researchers and clinicians at renowned international centers of excellence. We leverage their expertise in drug development, inflammation and fibrosis, cardiovascular d
Slide 6: Late-stage Clinical Pipeline in Inflammatory Cardiac Diseases and Heart Failure
Late-stage Clinical Pipeline in Inflammatory Cardiac Diseases and 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 III ongoing which includes
Slide 7: CardiolRx and CRD-38 Target Inflammasome Activation in Cardiac Diseases
CardiolRx™ and CRD-38 Target Inflammasome Activation in Cardiac Diseases • Inflammasome activation, triggered by stress CARDIOLRX™ / CRD-38 Targeting pathways signals such as infection or tissue damage, leads associated with NF-κβ- mediated inflammasome to the release of pro-inflammatory cytokines p
Slide 8: MAVERIC Clinical Program
MAVERIC Clinical Program Focused on Developing CardiolRx™ for the Treatment of Recurrent Pericarditis NASDAQ: NASDAQ: CRDL CRDL ||TSX: TSX: CRDL CRDL FEBRUARY 2025 8
Slide 9: Recurrent Pericarditis
Recurrent Pericarditis Pericarditis is inflammation of the membrane surrounding the heart resulting in severe chest pain, shortness of breath, and depression. Recurrent episodes, returning after a 4-to-6-week symptom-free period, significantly impact quality of life and may require emergency care or
Slide 10: Advisors and Key Investigators for the MAVERIC Program
Advisors and Key Investigators for the MAVERIC Program Allan Klein, MD, CM Paul Cremer, MD Study Chair Departments of Medicine and Radiology, Northwestern Director, Center for the Diagnosis and Treatment of University, and Multimodality Cardiac Imaging and Clinical Pericardial Diseases, and Professo
Slide 11: MAvERIC-Pilot Phase II Study
MAvERIC-Pilot Phase II Study CardiolRx™ for Recurrent Pericarditis Primary Efficacy Endpoint Multi-center, open-label pilot study assessed the • Change in patient-reported pericarditis pain using safety, tolerability, and efficacy of CardiolRx™ in an NRS* from baseline to 8 weeks patients with recur
Slide 12: MAvERIC-Pilot Phase II Study Design
MAvERIC-Pilot Phase II Study Design 27 patients enrolled (met ESC criteria) → 24 progressed to EP on CardiolRx™. CardiolRx™ 8-Week Dose Titration Primary Endpoint to 10 mg/kg b.i.d. Dose Withdrawal of background medications† Titration* while continuing CardiolRx™ Baseline Treatment Period Extension
Slide 13: Rapid, Durable Reduction in Pericarditis Pain
CardiolRx™ Resulted in a Clinically Relevant, Rapid, and Durable Reduction in Pericarditis Pain Mean Daily NRS Score Over Study Period Mean daily NRS score over the entire study period 10 Treatment Period (n=27) Extension Period (n=24) CardiolRx™ Withdrawal of background medications* while continuin
Slide 14: Rapid Reduction in Inflammation (CRP)
CardiolRx™ Resulted in a Clinically Meaningful and Rapid Reduction in Inflammation (CRP) C-Reactive Protein (mg/dL) Treatment Period (n=27) Extension Period (n=24) CardiolRx™ Withdrawal of background medications* while continuing CardiolRx™ C-Reactive Protein (mg/dL) Mean (SE) Weeks * Within the fir
Slide 15: CardiolRx Substantially Reduced Pericarditis Events Per Year
CardiolRx™ Substantially Reduced Pericarditis Events Per Year CardiolRx™ (n=27) Events per Year of Pericarditis Prior to the Study Events per Year of Pericarditis During the Study 5.8 0.9 When Weaned to CardiolRx™ Monotherapy, Freedom From Recurrence During the Extension Period was Maintained in 71%
Slide 16: Summary of MAvERIC-Pilot Phase II Study
Summary of MAvERIC-Pilot • CardiolRx™ resulted in rapid and sustained reductions in pericarditis Phase II Study pain and inflammation in patients with recurrent pericarditis. Presented at the o 71% of patients remained recurrence free during the Extension Period. 2024 American o Pericarditis events
Slide 17: MAVERIC Phase III Trial
MAVERIC Phase III Trial CardiolRx™ for Recurrent Pericarditis Multi-national, double-blind, randomized, placebo- Primary Efficacy Endpoint controlled trial to assess the impact of CardiolRx™ on • Number of patients (percentage) free from a new pericarditis recurrence in a high-risk patient populatio
Slide 18: Phase III Designed for High-Risk Recurrence Population
MAVERIC Phase III Trial Designed to Demonstrate the Impact of CardiolRx™ in a Patient Population at High Risk for Recurrence RECURRENCE RISK FOLLOWING • Immunosuppressive therapy to treat recurrent CESSATION OF IL-1 BLOCKER pericarditis includes IL-1 blockers (rilonacept; 100 anakinra) and corticost
Slide 19: 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 Study Participants CardiolRx™ • Male or female • ≥18 years • Stable disease RANDOMIZATION 1:1 Freedom from
Slide 20: Recurrent Pericarditis Market Opportunity
Recurrent Pericarditis Market Opportunity • Patients who fail first-line therapy have no options other than immunosuppressants (steroids and IL-1 blockers). • CardiolRx™ offers the potential for a disease-modifying and non-immunosuppressive approach. Recurrent Pericarditis Patient Population = 38,00
Slide 21: ARCHER Trial
ARCHER Trial Impact of CardiolRx™ on Acute Myocarditis A Phase II multi-national, double-blind, randomized, placebo-controlled trial. NASDAQ: NASDAQ: CRDL CRDL ||TSX: TSX: CRDL CRDL FEBRUARY 2025 21
Slide 22: Acute Myocarditis
Acute Myocarditis Inflammatory condition of the heart muscle (myocardium) often resulting from viral infection, and characterized by chest pain, impaired heart function, arrythmias, and conduction disturbances. • An important cause of acute and fulminant heart failure in young adults and a leading c
Slide 23: Cannabidiol Attenuates Myocarditis-induced Fibrosis
Cannabidiol Attenuates Myocarditis-induced Fibrosis Effect of Cannabidiol on Heart Fibrosis SECTIONS OF HEART TISSUE – FIBROSIS Healthy Tissue Myocarditis Myocarditis + Cannabidiol Representative images of Sirius red-stained LV myocardium sections. Magnification: 100x. Lee W-S et al. (2016). Mol. Me
Slide 24: 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 25: Phase II ARCHER Trial
Phase II ARCHER Trial CardiolRx™ for Acute Myocarditis Multi-national, double-blind, randomized, placebo- controlled trial designed to study the safety and tolerability of CardiolRx™, as well as its impact on Primary Efficacy Endpoints* myocardial recovery in patients presenting with acute • Extrace
Slide 26: ARCHER Trial Design
ARCHER Trial Design Trial has achieved 100% of the target patient enrollment of 100 patients. • Phase II multi-center, double-blind, placebo-controlled trial • Participants screened within 10 days of a diagnostic cardiac magnetic resonance and randomized 1:1 to receive either CardiolRx™ or placebo •
Slide 27: Heart Failure
Heart Failure CRD-38 is a novel proprietary subcutaneously administered drug formulation of cannabidiol intended for use in heart failure. NASDAQ: NASDAQ: CRDL CRDL ||TSX: TSX: CRDL CRDL FEBRUARY 2025 27
Slide 28: Heart Failure
Heart Failure A chronic, progressive syndrome caused by a structural and/or functional cardiac abnormality in which the heart is unable to pump enough blood to meet the body’s needs. • Patients experience shortness of breath, rapid heart rate, and edema, resulting in reduced exercise capacity, limit
Slide 29: Subcutaneous CRD-38 Administered Cannabidiol as a Potential Treatment for HFpEF
Subcutaneous REDUCES BODY WEIGHT GAIN REDUCED VISCERAL TO SUBCUTANEOUS FAT RATIO CRD-38 Administered Cannabidiol as a Potential Treatment For PREVENTS INFL AMMATION PREVENTS CARDIAC REMODELING Heart Failure With Preserved Ejection Fraction Lozano O et al. Heart Failure Society of America Annual Scie
Slide 30: Cardioprotective Properties of Subcutaneous Cannabidiol Formulation
Cardioprotective Properties of Subcutaneous Cannabidiol Formulation Demonstrated in a Non-ischemic Model of Heart Failure Measurements of BNP mRNA expression in heart tissue Heart Sections Stained with Masson’s Trichome CONTROL ANGIOTENSIN II 5 *** BNP mRNA BNP/GAPDH 4 (fold change) 3 # 2 ANGII + Ca
Slide 31: Near-term Value Drivers
Near-term Value Drivers 1 MAVERIC Phase III in Recurrent Pericarditis 2 ARCHER Phase II in Acute Myocarditis 3 CRD-38 for Heart Failure • Enroll first patient during Q1 2025 • Report ARCHER Phase II topline • Complete IND-enabling studies • 50% enrollment H2 2025 data Q2 2025 • Enter Phase I clinica
Slide 32: Management Team
Management Team David Elsley, MBA Andrew Hamer, MBChB President and Chief Executive Officer Chief Medical Officer and Head of Research & Development Founder and former President and CEO of Vasogen Inc. More than 30 years’ Thirty years of global life sciences industry, medical affairs, and cardiology
Slide 33: 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 34: Scientific Advisory Board
Scientific Advisory Board Dr. Paul M. Ridker, MD, MPH Dr. Bruce McManus, PhD, MD Dr. Joseph A. Hill, MD, PhD Senior Advisor Senior Advisor Senior Advisor Director of the Center for Cardiovascular Disease Prevention, Professor Emeritus, Department of Pathology and Laboratory Professor of Internal Med
Slide 35: Developing life-changing medicines for people living with heart disease
Developing life-changing medicines for people living with heart disease CARDIOL THERAPEUTICS INC. + 1 2 8 9. 9 1 0.0 8 5 0 N A S DAQ : C R D L TO R O N TO, CARDIOLRX.COM INVES TO R . R E NASDAQ: L AT|I TSX: CRDL O N SCRDL @CARDIOLRX.COM TSX: CR FEBRUARY DL 2025 O N TA R I O 35
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