Cardiol Therapeutics Inc. Class A · TSX:CRDL
Cardiol Therapeutics Inc. Class A — Investor Presentation (March 2023)
32 slides from Cardiol Therapeutics Inc. Class A's investor presentation, March 2023
Slide 1: Cardiol Therapeutics Corporate Presentation March 2023
NASDAQ: CRDL | TSX: CRDL Clinical-stage Life Sciences Company Focused on the Research and Clinical Development of Anti-inflammatory and Anti-fibrotic Therapies for the Treatment of Heart Diseases MARCH 2023 Copyright © 2023 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™ Oral cannabidiol formulation in clinical development for underserved heart diseases Scientific Rationale Clinical Programs Compelling evidence demonstrating the Phase II clinical programs initiated in anti-inflammatory and anti-fibrotic recurrent pericarditis an
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 Indication IND-enabling Phase 1 Phase 2 Phase 3 Recurrent Pericarditis Eligible for Orphan Drug Designation** Oral Formulation* Acute Myocarditis Subcutaneous Formulation* Heart Failure *Active pharmaceutical ingredient = cannabidiol **The Company intends
Slide 6: Recurrent Pericarditis
Recurrent Pericarditis Phase II study to evaluate the tolerance and safety of CardiolRx™ in patients with recurrent pericarditis N ASDAQ TSX:CRDL : C R D L | FSE:CT9 OTCQX:CRTPF TSX: CRDL CardiolRx.com | 6
Slide 7: CardiolRx – Recurrent Pericarditis
CardiolRx™ – Recurrent Pericarditis • Pericarditis refers to inflammation of the pericardium – the membrane, or sac, that surrounds the heart. PERICARDITIS • Recurrent pericarditis is the reappearance of symptoms after a symptom-free period of at least 4 – 6 weeks following an episode of acute peric
Slide 8: Market Opportunity: Recurrent Pericarditis
Market Opportunity: Recurrent Pericarditis Current Pharmacotherapy • One FDA-approved therapy (2021): >$150,000 list price for 12-month course; primarily used for ≥3 recurrences. • First-line conventional treatment ® NSAIDs or aspirin with or without colchicine(1). • Second-line therapy in patients
Slide 9: Protective Effects of Pharmaceutically Manufactured Cannabidiol in a Model of Acute Pericarditis
Protective Effects of Pharmaceutically Manufactured Cannabidiol in a Model of Acute Pericarditis Presented at the American Heart Association Scientific Sessions on November 5, 2022 N ASDAQ TSX:CRDL : C R D L | FSE:CT9 OTCQX:CRTPF TSX: CRDL CardiolRx.com | 9
Slide 10: Cannabidiol Significantly Reduces Multiple in vitro Parameters
Cannabidiol Significantly Reduces Multiple in vitro Parameters IL-1β & IL-6 Secretion Inhibited; Transcription Levels of pro-IL-1β & NLRP3 Reduced IL-1ß Pro IL-1ß mRNA ✱✱✱ 600 ✱✱✱ ✱ 1600 ✱✱✱ ✱✱✱ 1400 Fold increase vs control ✱✱✱ ✱✱✱ 1200 * p<0.05 *** P<0.001 400 1000 *** P<0.001 pg/ml 800 600 200 40
Slide 11: Cannabidiol Significantly Reduces Pericardial Effusion & Pericardial Thickening in vivo
Cannabidiol Significantly Reduces Pericardial Effusion & Pericardial Thickening in vivo Pericardial space ✱✱✱ ✱✱✱ ✱✱✱ 0.25 0.20 *** P<0.001 * p<0.05 0.15 mm 0.10 0.05 0.00 10 h BD 1 h Ve ve D D C B + B + C + C e m + e in + in Zy m l Sa m l Zy Sa Zy Zymosan A + vehicle Zymosan A + cannabidiol Nadia M
Slide 12: CardiolRx Phase II Clinical Development Program
CardiolRx™ – Phase II Clinical Development Program IND authorized by FDA Multi-center, open-label pilot study to assess the safety and tolerability of CardiolRx™ during the resolution of a pericarditis recurrence, evaluate improvement in objective measures of disease, and assess the feasibility of w
Slide 13: Advisors and Key Investigators for Recurrent Pericarditis Phase II Study
Advisors and Key Investigators for Recurrent Pericarditis Phase II Study Allan Klein, MD, CM Antonio Abbate, MD, PhD Study Chair Ruth C. Heede Professor of Director, Center for the Diagnosis and Cardiology, School of Medicine, and Treatment of Pericardial Diseases, and Department of Medicine, Divisi
Slide 14: ARCHER Trial
ARCHER Trial Phase II trial of CardiolRx™ in patients with acute myocarditis NASDAQ: CRDL | TSX: CRDL CardiolRx.com | 14
Slide 15: CardiolRx – Acute Myocarditis
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. Inflammation of • Can progress to dilated cardiomyopathy and Heart Muscle heart failure. • Severe cases lead to ex
Slide 16: Market Opportunity: Acute Myocarditis
Market Opportunity: Acute Myocarditis Current Pharmacotherapy • No FDA-approved therapy for acute myocarditis. • Management ® guideline directed therapy for heart failure and arrythmia (e.g., β-blockers, ACE-i, ARBs, inotropes, diuretics). • Goal ® decrease cardiac workload, reduce congestion and im
Slide 17: 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 18: CardiolRx Phase II Clinical Development Program
CardiolRx™ – Phase II Clinical Development Program Multi-national, double-blind, randomized, placebo-controlled trial designed to study the safety and tolerability of CardiolRx™, as well as its impact on myocardial recovery in patients presenting with acute myocarditis 100 Patients will be randomize
Slide 19: Steering Committee for ARCHER Trial
Steering Committee for ARCHER Trial Dennis M. McNamara, MD Leslie T. Cooper, Jr., MD Arvind Bhimaraj, MD Chair Co-Chair Specialist in Heart Failure and Professor of Medicine at the University General cardiologist and the Chair of Transplantation Cardiology and of Pittsburgh. He is also the Director
Slide 20: Heart Failure
Heart Failure Developing a Proprietary Injectable (SC) Cannabidiol Formulation NASDAQ: CRDL | TSX: CRDL CardiolRx.com | 20
Slide 21: Overview of Heart Failure
Overview of Heart Failure Heart failure is a complex clinical syndrome with symptoms and signs that result from any structural or functional impairment of ventricular filling or ejection of blood • Risk factors for heart failure include hypertension (high blood pressure), obesity, diabetes, smoking,
Slide 22: Heart Failure – A Leading Cause of Morbidity and Mortality Globally
Heart Failure – A Leading Cause of Morbidity and Mortality Globally Total deaths attributed to heart failure annually in the United States have been reported in the range of 83,000 to >300,000, and hospitalizations range from 800,000 to 1.2 million • In the United States alone, 6 million people over
Slide 23: International Research Collaborations
International Research Collaborations Developing a novel subcutaneously administered drug for heart failure at DeBakey Heart & Vascular Center and TecSalud del Tecnológico de Monterrey • Research producing scientific and pre-clinical data to support clinical development. • Cardioprotection demonstr
Slide 24: 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 Heart Sections Stained expression in heart tissue With Masson’s Trichome 5- *** BNP CONTROL ANGIOTENSIN II mRNA BNP/GAPDH (fold change) 4- # 3- 2- 1- ANG
Slide 25: Cannabidiol Inhibits and Promotes Reversal of Mechanisms leading to Cardiac Fibrosis
Cannabidiol Inhibits and also Promotes Reversal of Mechanisms leading to Cardiac Fibrosis in a Dose Dependent Manner Protects cardiac function and exhibits an anti-fibrotic effect, possibly mediated by endothelial-to-mesenchymal transition (“EndoMT”) Immunoflourescence (IF) images of HUVEC cells Top
Slide 26: Major Milestones over next 12 – 24 Months
Major Milestones over next 12 – 24 Months 1 2 3 Complete patient Complete Advance enrollment in the Phase II U.S. study development of a global ARCHER in recurrent subcutaneously trial in acute pericarditis administered myocarditis with with CardiolRx™ formulation CardiolRx™ NASDAQ: CRDL | TSX: CRDL
Slide 27: Management Team
Management Team David Elsley, MBA Andrew Hamer, MBChB President and Chief Executive Officer Chief Medical Officer and Founder and former President and CEO of Vasogen Inc. More Head of Research & Development than 30 years’ experience developing, financing, and managing Thirty years of global life sci
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 Research Institute, Founder and former President and CEO of Vasogen Inc. More Professor of Medicine at the Weill Cornell Medical Colle
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 63.7 M Fully Diluted Common Shares 81.9 M Insider and Employee Ownership 10% Cash and Cash Equivalents as of September 30, 2022 C$65.5 M Current Debt C$0.0 M NASDAQ: CRDL | TSX: CRDL CardiolRx.com | 30
Slide 31: Cardiol Therapeutics Today
Cardiol Therapeutics Today CardiolRx™ Oral cannabidiol formulation in clinical development for underserved heart diseases Scientific Rationale Clinical Programs Compelling evidence demonstrating the Phase II clinical programs initiated in anti-inflammatory and anti-fibrotic recurrent pericarditis an
Slide 32: Contact Information
NASDAQ: CRDL | TSX: CRDL Contact Information E: Investor.relations@cardiolrx.com T: +1 289.910.0850 W: CardiolRx.com Copyright © 2023 Cardiol Therapeutics Inc.
Cardiol Therapeutics — Investor Presentation (March 2023) on 6ix