Cardiol Therapeutics Inc. Class A · TSX:CRDL
Cardiol Therapeutics Inc. Class A — Investor Presentation (April 2022)
32 slides from Cardiol Therapeutics Inc. Class A's investor presentation, April 2022
Slide 1: Cardiol Therapeutics Corporate Presentation April 2022
NASDAQ: CRDL | TSX: CRDL Clinical-stage Life Sciences Company Focused on the Research and Clinical Development of Cannabidiol as an Anti-fibrotic and Anti-inflammatory Therapy for the Treatment of Cardiovascular Disease APRIL 2022 Copyright © 2022 Cardiol Therapeutics Inc.
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: Cardiol Therapeutics Today
Cardiol Therapeutics Today CardiolRx™ Leader in developing cannabidiol as a therapy for the treatment of cardiovascular disease Advance Clinical Programs Scientific Rationale Phase II and Phase II/III trials of Compelling evidence supporting CardiolRx™ for acute myocarditis and cannabidiol’s anti-fi
Slide 4: Evidence Supporting Cannabidiol Use For Inflammatory Heart Disease
Evidence Supporting Cannabidiol Use For Inflammatory Heart Disease • Reduces inflammation and protects heart function in a model of diabetic cardiomyopathy(1). • Significantly decreases cardiac fibrosis (scarring of the heart muscle) in a non-ischemic model of heart failure(2). • Reduces cardiac inf
Slide 5: Clinical Development Programs
Clinical Development Programs DRUG CANDIDATE TRIAL DESIGN INDICATION Pre-clinical Phase 1 Phase 2 Phase 3 Reduce Evaluate the efficacy and safety of Cardiorespiratory CardiolRx in Patients with COVID-19 complications in and Cardiovascular Disease or Risk Oral Cannabidiol hospitalized Factors. A doub
Slide 6: LANCER Trial
LANCER Trial Phase II/III Trial designed to investigate the cardiorespiratory protective properties of CardiolRx™ in patients hospitalized with COVID-19 who have a prior history of, or risk factors for, cardiovascular disease N A S D AOTCQX:CRTPF TSX:CRDL Q : C R D LFSE:CT9 | TSX: CRDL CardiolRx.com
Slide 7: Rationale for the LANCER Trial
Rationale for the LANCER Trial • Up to 70% of people admitted to hospital COVID-19 and the Cardiovascular System for COVID-19 have underlying CVD. • The impact of SARS-CoV-2 infection COVID-19 is not limited to the pulmonary system. • Hospitalized COVID-19 patients with Risks Complications pre-exist
Slide 8: COVID-19 Patients with CVD Complications Have Lower Survival Rates
COVID-19 Patients with CVD Complications Have Lower Survival Rates Journal of the American Medical Association Mortality During Hospitalization Between Patients With vs. Without Cardiac Injury Time from symptom onset 100 - • COVID-19 patients with cardiac injury had WITHOUT CARDIAC INJURY a higher m
Slide 9: CardiolRx Phase II/III Clinical Development Program
CardiolRx™ – Phase II/III Clinical Development Program Multi-national, double-blind, placebo-controlled trial to investigate the cardiorespiratory protective properties of CardiolRx™ in patients hospitalized with COVID-19 who have a prior history of, or risk factors for, cardiovascular disease 422 P
Slide 10: Phase II/III LANCER Study Design
Phase II/III LANCER Study Design Hospitalized COVID-19 Patients with Cardiovascular Disease or Risk Factors RANDOMIZED 1:1 DOUBLE BLIND PLACEBO 2.5 mg/kg to 7.5 mg/kg b.i.d Primary endpoint after 28 days’ treatment: ICU admission, ventilation, CV complications and death 60-day follow up NASDAQ: CRDL
Slide 11: Steering Committee for LANCER Trial
Steering Committee for LANCER 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 General cardiologist and the Chair of the Mayo Clinic Enterprise Department of of the Heart Failure/ Transplantation Prog
Slide 12: Acute Myocarditis
Acute Myocarditis Orphan Drug Indication* Investigational New Drug (IND) application cleared for Phase II clinical trial of CardiolRx™ for treatment in acute myocarditis *The Company has not yet received Orphan Drug Designation from the FDA. NASDAQ: CRDL | TSX: CRDL CardiolRx.com | 12
Slide 13: CardiolRx – Acute Myocarditis
2 - Cardiol Therapeutics Inc. CardiolRx™ – Acute Myocarditis • Inflammatory condition of the heart most often resulting from viral infection. MYOCARDITIS • A major cause of sudden death in children and young adults. • Can progress to dilated cardiomyopathy and heart failure. Inflammation of Heart Mu
Slide 14: Acute Myocarditis – Potential for Orphan Drug Designation
2 - Cardiol Therapeutics Inc. Acute Myocarditis – Potential for Orphan Drug Designation Acute Myocarditis U.S. Patient Estimate (Prevalence) 73,000 Orphan Drugs in the United States • Fewer than 200,000 cases required to qualify as Orphan Drug • Potential for Fast Track regulatory development and ap
Slide 15: Cannabidiol Attenuates Myocarditis-induced Fibrosis
Cannabidiol Attenuates Myocarditis-induced Fibrosis Effect of Cannabidiol on Heart Fibrosis Experimental Model of Autoimmune Myocarditis (EAM) Sections of Heart Tissue - Fibrosis HEALTHY TISSUE MYOCARDITIS MYOCARDITIS + CBD Representative images of Sirius red-stained LV myocardium sections. Magnific
Slide 16: Acute Myocarditis Clinical Development Program
2 - Cardiol Therapeutics Inc. Acute Myocarditis Clinical Development Program Phase I Clinical Trial Completed A single center, double-blind, placebo-controlled, randomized 8-week trial in 52 healthy adult subjects Safety and tolerability of CardiolRx up to 30 mg/kg/day for up to 6 days was assessed
Slide 17: CardiolRx Acute Myocarditis Phase II Clinical Development Program
2 - Cardiol Therapeutics Inc. CardiolRx™ – Acute Myocarditis Phase II Clinical Development Program IND authorized by FDA Multi-center, double-blind, randomized, placebo-controlled trial designed to study the safety and tolerability of CardiolRx™, as well as its impact on myocardial recovery in patie
Slide 18: Acute Myocarditis Study Design
2 - Cardiol Therapeutics Inc. Acute Myocarditis Study Design Clinical diagnosis of acute myocarditis within the previous 90 days Confirmed by: Cardiac Magnetic Resonance (CMR) OR Endomyocardial biopsy RANDOMIZED 1:1 DOUBLE BLIND PLACEBO 2.5 mg/kg to 10 mg/kg b.i.d Primary Endpoint: improvement in CM
Slide 19: Steering Committee for Acute Myocarditis Clinical Development Program
Steering Committee for Acute Myocarditis Clinical Development Program 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 General cardiologist and the Chair of the Mayo Clinic Enterprise Department of of the H
Slide 20: Heart Failure
Heart Failure Developing a Proprietary Subcutaneous Cannabidiol Formulation of CardiolRx™ for Chronic Heart Failure NASDAQ: CRDL | TSX: CRDL CardiolRx.com | 20
Slide 21: Heart Failure – A Leading Cause of Death and Disability
2 - Cardiol Therapeutics Inc. Heart Failure – A Leading Cause of Death and Disability Developing a Proprietary Subcutaneous Cannabidiol Formulation to Target Inflammation in the Heart • Over 6 million adults in Canada and the U.S. suffer from heart failure(1). • About half of all heart failure patie
Slide 22: The Issue: Overview of Diastolic Heart Failure
2 - Cardiol Therapeutics Inc. The Issue: Overview of Diastolic Heart Failure Occurs when the heart fails to relax normally and fill with blood which is required to oxygenate tissues of the body HEALTHY HEART DIASTOLIC HEART FAILURE Left atrium Right atrium Thickened Left ventricular Right ventricle
Slide 23: International Research Collaborations
International Research Collaborations Developing Subcutaneous Cannabidiol Formulation for Heart Failure at TecSalud del Tecnológico de Monterrey and DeBakey Heart & Vascular Center • Research producing scientific and pre-clinical data to support clinical development. • Cardioprotection demonstrated
Slide 24: Cardioprotective Properties of Subcutaneous Cannabidiol Formulation (BNP)
Cardioprotective Properties of Subcutaneous Cannabidiol Formulation Demonstrated in a Non-ischemic Model of Heart Failure Measurements of BNP mRNA expression in heart tissue 5- Groups of animals with Angiotensin *** BNP mRNA BNP/GAPDH II-induced Heart Failure treated with 4- (fold change) Cannabidio
Slide 25: Cardioprotective Properties of Subcutaneous Cannabidiol Formulation (Fibrosis)
Cardioprotective Properties of Subcutaneous Cannabidiol Formulation Demonstrated in a Non-ischemic Model of Heart Failure As seen in histopathologic analyses of heart tissue, Cardiol’s research shows cannabidiol reduces the development of angiotensin-induced fibrosis Heart Sections Stained with Mass
Slide 26: Upcoming Milestones
Upcoming Milestones 1 2 3 4 Complete patient enrollment and report Advance Initiate Conduct further top line results development of a patient enrollment discovery research in the Phase II/III subcutaneous in a Phase II focused on international formulation of international trial additional LANCER tri
Slide 27: Management Team
Management Team David Elsley, MBA Andrew Hamer, MB, ChB President and Chief Executive Officer Chief Medical Officer Founder and former President and CEO Thirty years of global life sciences industry, of Vasogen Inc. More than 30 years’ medical affairs, and cardiology practice experience. experience
Slide 28: 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 Founder and former President and CEO of Research Institute, Professor of Medicine at the Weill Vasogen Inc. More than 30 years’ experi
Slide 29: Scientific Advisory Board
Scientific Advisory Board Dr. Paul M. Ridker, MD, MPH Director of the Center for Cardiovascular Disease Prevention, a translational research unit at Brigham and Women’s Hospital (BWH), he is also the Eugene Braunwald Professor of Medicine at Harvard School of Medicine (HMS). Dr. Ridker's clinical in
Slide 30: Capital Structure
Capital Structure NASDAQ: CRDL | TSX: CRDL Common Shares Outstanding 61.9 M Fully Diluted Common Shares 81.6 M Insider and Employee Ownership 11% Pharmaceutical Partners & Research Collaborators 4% Cash and Cash Equivalents as of December 31, 2021 $83.9 M Current Debt $0.0 M NASDAQ: CRDL | TSX: CRDL
Slide 31: Cardiol Therapeutics Today
Cardiol Therapeutics Today CardiolRx™ Leader in developing cannabidiol as a therapy for the treatment of cardiovascular disease Advance Clinical Programs Scientific Rationale Phase II and Phase II/III trials of Compelling evidence supporting CardiolRx™ for acute myocarditis and cannabidiol’s anti-fi
Slide 32: Contact Information
NASDAQ: CRDL | TSX: CRDL Contact Information E: [email protected] T: +1 289.910.0850 W: CardiolRx.com Copyright © 2022 Cardiol Therapeutics Inc.
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