Cardiol Therapeutics Inc. Class A · TSX:CRDL
Cardiol Therapeutics Inc. Class A — Investor Presentation (September 2021)
31 slides from Cardiol Therapeutics Inc. Class A's investor presentation, September 2021
Slide 1: Clinical-stage Biotechnology Company Developing Anti-inflammatory Therapies for Cardiovascular Disease
NASDAQ: CRDL | TSX: CRDL Clinical-stage Biotechnology Company Focused on Developing Innovative Anti-inflammatory Therapies for the Treatment of Cardiovascular Disease SEPTEMBER 2021 Copyright © 2021 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 or any other entity contained in this presentation are intended only to illustrate past p
Slide 3: Cardiol Therapeutics Today
Cardiol Therapeutics Today SCIENTIFIC CLINICAL INTELLECTUAL LEADERSHIP PIPELINE RATIONAL PROGRAMS PROPERTY Strong scientific Innovative research Experienced leadership Phase II/III clinical Comprehensive rationale for pipeline focused on with extensive industry programs targeting intellectual proper
Slide 4: Evidence Supporting Cannabidiol Use For Inflammatory Heart Disease
2 - Cardiol Therapeutics Inc. Evidence Supporting Cannabidiol Use For Inflammatory Heart Disease • Attenuates cardiac dysfunction and reduces inflammation in a model of diabetic cardiomyopathy. • Significantly decreases cardiac fibrosis (scarring of the heart muscle) in a non-ischemic model of heart
Slide 5: Clinical Development Program
Clinical Development Program INDICATION Pre-clinical Phase I Phase II Phase III PATIENTS WITH, OR RISK FACTORS FOR, CARDIOVASCULAR DISEASE (CVD), HOSPITALIZED WITH COVID-19 ORAL FORMULATION ACUTE MYOCARDITIS CHRONIC SUBCUTANEOUS HEART FAILURE FORMULATION NASDAQ: CRDL | TSX: CRDL www.CardiolRx.com |
Slide 6: CardiolRx™ Oral Cannabidiol Formulation
2 - Cardiol Therapeutics Inc. CardiolRx™ • High-concentration cannabidiol formulation for acute inflammatory heart disease. Oral Cannabidiol Formulation • Manufactured under cGMP to meet the highest standards for product purity, consistency, and stability. • Lead drug candidate for Phase II/III tria
Slide 7: How Cannabidiol Protects the Heart in Models of Cardiovascular Disease
How Cannabidiol Protects the Heart in Models of Cardiovascular Disease Evidence Supporting Therapeutic Potential in High-risk COVID-19 Patients • Reduces inflammation and improves endothelial dysfunction • Reduces cardiac inflammatory cytokine levels in a model of myocarditis (inflammatory heart fai
Slide 8: Steering Committee for Phase II/III Clinical Development Programs
Steering Committee for Phase II/III Clinical Development Programs Dennis M. McNamara, MD Leslie T. Cooper, Jr., MD Barry Trachtenberg, MD Chair Co-Chair Cardiologist specializing in heart Professor of Medicine at the General cardiologist and the failure and cardiac transplantation. University of Pit
Slide 9: LANCER Study
LANCER Study Phase II/III Trial in High-risk Patients with Cardiovascular Disease or Risk Factors Hospitalized with COVID-19 N ASDAQ TSX:CRDL : C R D L | FSE:CT9 OTCQX:CRTPF TSX: CRDL www.CardiolRx.com | 9
Slide 10: 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 11: COVID-19 Clinical Development Program
COVID-19 Clinical Development Program IND Application Approved by FDA for Phase II/III Trial Multi-center, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of CardiolRxTM in Patients with COVID-19 and cardiovascular disease or risk factors Primary Efficacy Endpoint
Slide 12: Appointment of WorldWide Clinical Trials as CRO
2 - Cardiol Therapeutics Inc. Appointment of WorldWide Clinical Trials as CRO Worldwide Clinical Trials appointed as CRO for Cardiol’s Phase II/III Outcomes Trial in High-risk Patients Hospitalized With COVID-19 • Worldwide has been the CRO for several international COVID-19 clinical programs and ha
Slide 13: Acute Myocarditis
Acute Myocarditis Orphan Drug Program NASDAQ: CRDL | TSX: CRDL www.CardiolRx.com | 13
Slide 14: Acute Myocarditis – Orphan Drug Disease
2 - Cardiol Therapeutics Inc. Acute Myocarditis – Orphan Drug Disease Acute Myocarditis is eligible for U.S. MYOCARDITIS and European Orphan Drug Status • Inflammatory condition of the heart most often resulting from viral infection. • A major cause of sudden death in children and Inflammation of yo
Slide 15: Acute Myocarditis – Orphan Drug Opportunity
2 - Cardiol Therapeutics Inc. Acute Myocarditis – Orphan Drug Opportunity Higher Prevalence vs. Previously Approved FDA Orphan Drug Cannabidiol Product Paediatric Epilepsy (1)(2) Acute Myocarditis U.S. Patient Estimate (Prevalence) 37,250 73,000 Orphan Drug and Fast Track Eligibility – Market Exclus
Slide 16: Cannabidiol Downregulates Key Markers of Inflammation
Cannabidiol Downregulates Key Markers of Inflammation Effect of Cannabidiol on Heart Inflammation and 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
Slide 17: Acute Myocarditis Clinical Development Program: Phase I Completed
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 18: Acute Myocarditis Clinical Development Program: Phase II Trial
2 - Cardiol Therapeutics Inc. Acute Myocarditis Clinical Development Program IND application cleared by FDA for Phase II international trial Multi-center, double-blind, randomized, placebo-controlled trial designed to study the safety and tolerability of CardiolRxTM, as well as its impact on myocard
Slide 19: Heart Failure
Heart Failure Mass Market Potential NASDAQ: CRDL | TSX: CRDL www.CardiolRx.com | 19
Slide 20: 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 21: 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 22: International Research Collaborations
International Research Collaborations Developing Subcutaneous Cannabidiol Formulation for Heart Failure • TecSalud del Tecnológico de Monterrey and DeBakey Heart & Vascular Center • Research producing scientific and pre-clinical data to support clinical development • Cardioprotection demonstrated i
Slide 23: CardiolRx™ Subcutaneous Cannabidiol Formulation
2 - Cardiol Therapeutics Inc. CardiolRx™ • Subcutaneous formulation to achieve higher bioavailability than an oral formulation. Subcutaneous Cannabidiol Formulation • Anti-fibrotic activity of cannabidiol to prevent progressive fibrosis (scarring) in the heart muscle. • Anti-inflammatory activity of
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- BNP Groups treated with Cannabidiol mRNA BNP/GAPDH at 1 or 10 mg/kg show reduced BNP 4- (fold change) in animals with Angio
Slide 25: Cardioprotective Properties of Subcutaneous Cannabidiol Formulation (Fibrosis)
Cardioprotective Properties of Subcutaneous Cannabidiol Formulation Demonstrated in a Non-ischemic Model of Heart Failure Cardiol’s research shows cannabidiol reduces angiotensin-induced fibrosis: histopathologic analysis of heart tissue, representative slides Heart Sections Stained with Masson’s Tr
Slide 26: 2021 Milestones to Date
2021 Milestones to Date Q1 ü Received total proceeds of $11.1M on the exercise of warrants and stock options. ü Appointed Dr. Andrew Hamer as the new Chief Medical Officer. Q2 ü Enrolled 1st patient in Phase II/III LANCER Study. ü Topline results reported from a Phase I single and multiple ascending
Slide 27: Upcoming Milestones
Upcoming Milestones Complete enrollment of 422 patients in International Phase II/III COVID-19 trial examining the cardioprotective properties of CardiolRx™. Initiate enrollment in Phase II international trial of CardiolRx™ for acute myocarditis. Complete pre-clinical development of a subcutaneous f
Slide 28: Experienced Management Team
Experienced Management Team David Elsley, MBA Andrew Hamer, MB, ChB President and CEO Chief Medical Officer Founder and former President and CEO Thirty years of global life sciences industry, of Vasogen Inc. More than 25 years’ medical affairs, and cardiology practice experience. experience developi
Slide 29: Strong Board of Directors
Strong Board of Directors Guillermo Torre-Amione, MD, PhD David Elsley, MBA Chairman President and CEO 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 25 years’ experience Cornell
Slide 30: Capital Structure
Capital Structure NASDAQ: CRDL | TSX: CRDL Common Shares Outstanding 42.9 M Fully Diluted Common Shares(1), (2), (3), (4) 53.3 M Insider and Employee Ownership 16% Pharmaceutical Partners & Research Collaborators 6% Cash and Cash Equivalents as at June 30, 2021 $32.7 M Current Debt $0.0 M (1) Includ
Slide 31: Contact Information
NASDAQ: CRDL | TSX: CRDL Contact Information E: investor.relations@cardiolrx.com T: +1 (289) 910-0850 W: CardiolRx.com Copyright © 2021 Cardiol Therapeutics Inc.
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