Cardiol Therapeutics Inc. Class A · TSX:CRDL
Cardiol Therapeutics Inc. Class A — Investor Presentation (January 2021)
33 slides from Cardiol Therapeutics Inc. Class A's investor presentation, January 2021
Slide 1: Clinical-stage Biotechnology Company Focused on Developing Innovative Therapies for Inflammatory Heart Disease
Clinical-stage Biotechnology Company Focused on Developing Innovative Therapies for Inflammatory Heart Disease TSX: CRDL | OTCQX: CRTPF January 2021
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 Lead clinical Proprietary Strong scientific Commercial Strong leadership programs cannabidiol oral rational for cannabidiol with extensive targeting large formulation developing product industry opportunities in entering cannabidiol addressing experience and inflammatory P
Slide 4: Evidence Supporting Cannabidiol Use for Inflammatory Heart Disease
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 failure • Reduces cardiac infl
Slide 5: Clinical Development Program
Clinical Development Program PRE-CLINICAL PHASE 1 PHASE 2 PHASE 3 Indication Formulation COVID-19 with prior history Oral Solution of Cardiovascular Disease (CVD) Acute Myocarditis and other Oral Solution inflammatory heart disease Diastolic Heart Failure Subcutaneous TSX: CRDL OTCQX: CRTPF 5
Slide 6: CardiolRx™ Oral Cannabidiol Formulation
CardiolRx™ Oral Cannabidiol Formulation • High concentration cannabidiol formulation for acute inflammatory heart disease • Manufactured under cGMP to meet the highest standards for product purity, consistency, and stability • IND approval received from the FDA for a phase II/III clinical program in
Slide 7: COVID-19
COVID-19 Phase II/III Trial in Patients with Prior History of, or Risk Factors for, Cardiovascular Disease 7
Slide 8: COVID-19 Patients with CV Complications Have Lower Survival Rates
COVID-19 Patients with CV Complications Have Lower Survival Rates Journal of the American Medical Association • COVID-19 patients with cardiac injury had a higher mortality rate than those without cardiac injury • Patients with cardiac injury were more likely to require mechanical ventilation • Comp
Slide 9: 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 10: 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 11: Appointment of Worldwide Clinical Trials as CRO
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 has extensive experience in cond
Slide 12: Steering Committee for COVID-19 and Acute Myocarditis
Steering Committee for COVID-19 and Acute Myocarditis Dennis M. McNamara, MD Peter Liu, MD Chair Chief Scientific Officer and Vice President, Research, of the Professor of Medicine at the University of Pittsburgh. He University of Ottawa Heart Institute, and Professor of Medicine and is also the Dir
Slide 13: Acute Myocarditis
Acute Myocarditis Orphan Drug Program 13
Slide 14: Acute Myocarditis is eligible for U.S. and European Orphan Drug status
Acute Myocarditis Myocarditis • Inflammatory condition of the heart most often resulting from viral infection • A major cause of sudden death in children and young adults Inflammation of Heart • Can progress to dilated cardiomyopathy and heart failure Muscle • Severe cases lead to extensive ICU hosp
Slide 15: Acute Myocarditis – Orphan Drug Opportunity
Acute Myocarditis – Orphan Drug Opportunity High Prevalence vs. Previously Approved FDA Orphan Drug Cannabidiol Product Paediatric Epilepsy (1)(2) Acute Myocarditis U.S. Patient 37,250 73,000 Estimate (Prevalence) Orphan Drug and Fast Track Eligibility – Market Exclusivity and Expedited Review • Pot
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 Ref: Adapted from Lee W-S et al. (2016). Mol. Med. 22, 13
Slide 17: Acute Myocarditis Clinical Development Program
Acute Myocarditis Clinical Development Program IND Filing for Phase II Trial Planned Q1 2021* Multi-center, double-blind, randomized, placebo-controlled, parallel group design: Designed to study impact of CardiolRx™ on Myocardial Recovery Three co-primary endpoints: • Left ventricular ejection fract
Slide 18: Heart Failure
Heart Failure Mass Market Potential 18
Slide 19: Heart Failure – a Leading Cause of Death and Disability
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 patients suffer from Diastolic Heart
Slide 20: The Issue: Overview of Diastolic Heart Failure
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 Thickened Left ventricular Right atrium muscle atrium Left Right ventricle ventricle TSX: CRDL OTC
Slide 21: 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 in
Slide 22: CardiolRx™ Subcutaneous Cannabidiol Formulation
CardiolRx™ Subcutaneous Cannabidiol Formulation • Subcutaneous formulation to achieve higher bioavailability than an oral formulation • Anti-inflammatory activity of cannabidiol to treat inflamed heart tissue • Anti-fibrotic activity of cannabidiol to prevent progressive fibrosis (scarring) in heart
Slide 23: 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 BNP is a stress marker released as pressure in the heart increases and the muscle is stretched. Raised BNP levels reflect card
Slide 24: Cardioprotective Properties of Subcutaneous Cannabidiol Formulation
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 25: Unique Commercial Opportunity
Unique Commercial Opportunity 25
Slide 26: Pharmaceutical Cannabidiol
Pharmaceutical Cannabidiol Setting a Higher Product Standard for Patients and Doctors • Pharmaceutically produced to ensure purity and consistency • Manufactured under cGMP • High concentration 100mg/ml • THC free* *<10 ppm TSX: CRDL OTCQX: CRTPF 26
Slide 27: The Market Opportunity in Canada
The Market Opportunity in Canada Medical Cannabidiol For Patients Who Should Not Be Exposed to THC • Total medical cannabinoid market exceeds $600 million annually in Canada(1) • Growing demand from paediatricians and family physicians for a CBD formulation that does not contain THC (for patients <2
Slide 28: National Supply Agreement with Shoppers Drug Mart Now Available
National Supply Agreement with Shoppers Drug Mart Providing Access Across Canada for Medical Patients Now Available • Online platform for the sale of medicinal cannabinoids • HelloMD telemedicine program available to patients • Largest national pharmacy chain in Canada - >1,300 stores • National sup
Slide 29: 12-month Milestones
12-month Milestones Initiate and complete enrollment of 422 patients in International Phase II/III COVID-19 trial examining the cardioprotective properties of CardiolRxTM Submit IND application to the FDA and commence an international Phase II acute myocarditis trial led by highly distinguished Stee
Slide 30: Capital Structure
Capital Structure TSX: CRDL OTCQX: CRTPF Common Shares Outstanding 33.0 M Fully Diluted Common Shares (1), (2), (3), (4) 41.8 M Insider and Employee Ownership 20% Pharmaceutical Partners & Research Collaborators 8% Cash and Cash Equivalents as at September 30, 2020 $16.5 M Working Capital as at Sept
Slide 31: Experienced Executive Team
Experienced Executive Team David Elsley, MBA Thomas Moffatt, BBA President and CEO Chief Commercial Officer Founder and former President and CEO of Vasogen Inc. More Senior operations and retailing executive with an extensive background in than 25 years’ experience developing, financing, and managin
Slide 32: Strong Board of Directors
Strong Board of Directors Eldon R. Smith, OC, LLD (Hon), MD, FCAHS, FCCS, FRCPC David Elsley, MBA Chairman and Chief Medical Officer President and CEO Cardiologist. Former Head of Cardiology, former Chairman of Founder and former President and CEO of Vasogen Inc., with more than Medicine, former Dea
Slide 33: Clinical-stage Biotechnology Company Focused on Developing Innovative Therapies for Inflammatory Heart Disease
Clinical-stage Biotechnology Company Focused on Developing Innovative Therapies for Inflammatory Heart Disease TSX: CRDL | OTCQX: CRTPF CONTACT INFORMATION E: investor.relations@cardiolrx.com T: +1 (289) 910-0850 W: cardiolrx.com January 2021
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