Cardiol Therapeutics Inc. Class A · TSX:CRDL
Cardiol Therapeutics Inc. Class A — Investor Presentation (September 2024)
40 slides from Cardiol Therapeutics Inc. Class A's investor presentation, September 2024
Slide 1: Heal the heart with innovative science
Corporate Presentation Heal the heart with innovative science We are a clinical-stage life sciences company focused on the research and clinical development of anti-inflammatory and anti-fibrotic therapies for the treatment of heart disease Cardiolrx.com NASDAQ: CRDL September 2024 TSX: CRDL
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: Developing Novel Therapeutic Approaches
Developing Novel Phase II Programs in Rare Diseases Broad Exclusivity Protection Therapeutic CardiolRx™, lead small molecule oral drug candidate, granted FDA orphan drug designation Comprehensive intellectual property portfolio. Focused on rare diseases eligible for FDA and Approaches for (ODD) for
Slide 4: Product Pipeline
Product Pipeline Drug Candidate Pre-Clinical Phase I Phase II Phase III CardiolRx™ Lead oral drug candidate, Recurrent Pericarditis CardiolRx™, is being clinically developed for use in rare Acute Myocarditis heart diseases. CRD-38 is a novel subcutaneously administered drug formulation intended for
Slide 5: Mechanism of Action
Mechanism of Action CardiolRx™ and CRD-38 [⬤] attenuate multiple intracellular inflammatory signaling pathways, including inhibiting activation of the NLRP3 inflammasome, known to play an important role in the development and progression of the inflammation associated with pericarditis, myocarditis,
Slide 6: Key Global Research and Clinical Collaborators
Key Global Research and Clinical Collaborators Working together with world-class researchers and clinicians at international centers of excellence and leveraging their expertise in drug development, experimental execution, inflammation and fibrosis, the treatment of cardiovascular diseases, and clin
Slide 7: MAvERIC-Pilot Study
MAvERIC-Pilot Study Impact of CardiolRx™ on Recurrent Pericarditis A Phase II multi-center, open-label study assessing the tolerability, safety, and efficacy of CardiolRx™ on recurrent pericarditis. ClinicalTrials.gov Identifier: NCT05494788 NASDAQ: CRDL | TSX: CRDL September 2024 7
Slide 8: Recurrent Pericarditis
Recurrent Pericarditis Pericarditis refers to inflammation of the pericardium (the membrane, or sac, surrounding the heart) that leads to fluid accumulation (effusion) and pericardial thickening. • Recurrent pericarditis is the reappearance of symptoms after a symptom-free period of at least 4 – 6 w
Slide 9: Recurrent Pericarditis – Clinical Need & Opportunity
Recurrent Pericarditis – Clinical Need & Opportunity Clinical Need CardiolRx™ Opportunity • A segment of pericarditis patients suffer from a • Potential second-line use for patients with high recurrence burden and prolonged disease pericarditis recurrences, inadequate response to duration with disea
Slide 10: Significant Reduction of Multiple in vitro Parameters
Significant Reduction IL-1β Pro IL-1β mRNA of Multiple in vitro ***P<0.001 *P<0.05 ***P<0.001 Parameters Demonstrated Pre-clinically IL-1β & IL-6 Secretion Inhibited; IL-6 NLRP3 mRNA Transcription Levels of pro-IL-1β & *P<0.05 NLRP3 Reduced. ***P<0.001 ***P<0.001 Martinez-Naya N et al. Circ Res 2022
Slide 11: Significant Reduction in Pericardial Effusion & Thickness
Significant Reduction in Pericardial Pericardial Space Pericardial Thickness Zymosan A Effusion & Pericardial Thickness Demonstrated Zymosan A + Cannabidiol 10 mg/kg in vivo Pre-clinically Pericardial thickness of heart sections stained with hematoxylin and eosin. Martinez-Naya N et al. Circ Res 202
Slide 12: Advisors and Key Investigators for the MAvERIC-Pilot Study
Advisors and Key Investigators for the MAvERIC-Pilot Study Allan Klein, MD, CM Paul Cremer, MD Study Chair Departments of Medicine and Radiology, Northwestern University, and Multimodality Cardiac Imaging and Clinical Trials Unit, Bluhm Director, Center for the Diagnosis and Treatment of Pericardial
Slide 13: Phase II MAvERIC-Pilot Study
Phase II MAvERIC-Pilot Study CardiolRx™ for Recurrent Pericarditis Primary Efficacy Endpoint Multi-center, open-label pilot study to assess the • Change in patient-reported pericarditis pain using an safety and tolerability of CardiolRx™ during the resolution of a pericarditis recurrence, evaluate N
Slide 14: MAvERIC-Pilot Study Sites (Principal Investigators)
MAvERIC-Pilot Study Sites (Principal Investigators) • Cleveland Clinic (Allan Klein, MD) • Mayo Clinic (S. Allen Luis, MD) • University of Vermont Medical Center (Tracey Haggerty, MD) • Minneapolis Heart Institute Foundation (David Lin, MD) • Pima Heart and Vascular Clinical Research (Thomas Waggone
Slide 15: Key Inclusion/Exclusion Criteria for the MAvERIC-Pilot Study
Key Inclusion/Exclusion Criteria for the MAvERIC-Pilot Study Inclusion Exclusion • Diagnosis of pericarditis secondary to the following • Male or female patients aged ≥18 years. etiologies: tuberculosis; neoplastic, purulent or • Diagnosis of at least 2 episodes of RP*. radiation etiology; post-thor
Slide 16: MAvERIC-Pilot Study Design
MAvERIC-Pilot Study Design Phase II open-label pilot study at 8 US centers. 25 Patient enrollment target → 27 enrolled → 24 progressed to EP on CardiolRx™. 8 Week Primary Day 10 to End of Study Endpoint Days 3-10 10mg/kg of body weight, BID Days 1-3 7.5mg/kg of body weight, BID 24 of 27 patients enr
Slide 17: Previous Episodes of Pericarditis in MAvERIC-Pilot Patients at Baseline
Previous Episodes of Pericarditis in MAvERIC- Pilot Patients at Baseline # Previous Episodes of Pericarditis CardiolRx™ (N = 27) Prior to the qualifying episode for entry into 2 episodes 9 (33%) the study. 3 episodes 9 (33%) 4 episodes 4 (15%) >4 episodes 5 (19%) Prior recurrences is a strong predic
Slide 18: MAvERIC-Pilot Study Topline Efficacy Data
MAvERIC-Pilot Study Topline Efficacy Data Primary Endpoint Change in patient-reported pericarditis pain using NRS* from baseline CardiolRx™ resulted in a clinically meaningful to 8 weeks. reduction in pericarditis pain in symptomatic n=27 Baseline Week 8 Difference† rilonacept Mean Difference† patie
Slide 19: MAvERIC-Pilot Study Topline Efficacy Data
MAvERIC-Pilot Study Topline Efficacy Data Secondary Endpoint 80% of symptomatic patients and a CRP ≥1.0 Percentage of patients with CRP normalization ǂ at 8 weeks (for patients mg/dL at baseline achieved CRP normalization* with CRP ≥1.0 mg/dL at baseline). by 8 weeks. Number of Patients with CRP ≥1.
Slide 20: MAvERIC-Pilot Study Topline Efficacy Data
MAvERIC-Pilot Study Topline Efficacy Data C-reactive Protein (CRP) CardiolRx™ resulted in a clinically meaningful Change in CRP for those patients with ≥1 mg/dL at BL. reduction in CRP (-5.39) following 8 weeks of treatment. rilonacept Mean Difference Baseline Week 8 Difference* Phase II -4.24 (EoTP
Slide 21: Summary: MAvERIC-Pilot Study Topline Efficacy Data
Summary: MAvERIC- Pilot Study • 89% (24/27) of patients enrolled in MAvERIC-Pilot have progressed from the 8-week Topline Treatment Period into the 18-week Extension Period; strongly suggests CardiolRx™ has Efficacy Data been well tolerated. • CardiolRx™ resulted in a clinically meaningful reduction
Slide 22: ARCHER Trial
ARCHER Trial Impact of CardiolRx™ on Acute Myocarditis A Phase II 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. ClinicalTrials
Slide 23: 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 24: Acute Myocarditis – Clinical Need & Opportunity
Acute Myocarditis – Clinical Need & Opportunity Clinical Need CardiolRx™ Opportunity • An FDA- and EMA-approved therapy indicated for • Potential first-line use for uncomplicated the treatment of acute myocarditis: low/intermediate risk profile patients with acute o Reduces the risk of progression.
Slide 25: 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 26: 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 27: 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 • Extracellular
Slide 28: ARCHER Trial Design
ARCHER Trial Design Trial has exceeded 85% of target enrollment. • Phase II multi-center, double-blind, placebo-controlled trial. • 100-patient enrollment target. • Participants screened within 10 days of a diagnostic cardiac magnetic resonance and randomized 1:1 to receive either CardiolRx™ or plac
Slide 29: Heart Failure
Heart Failure CRD-38 is a novel proprietary subcutaneously administered drug formulation of cannabidiol intended for use in heart failure. NASDAQ: CRDL | TSX: CRDL September 2024 29
Slide 30: 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 31: Types of Heart Failure
Types of Heart Failure • Systolic heart failure, also referred to as heart failure with reduced ejection fraction (HFrEF), occurs when the heart loses its ability to contract normally and is unable to pump with sufficient force to push enough blood into circulation. • Diastolic heart failure, also r
Slide 32: 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 Prevents Inflammation Prevents Cardiac Remodeling Treatment For Heart Failure With Preserved Ejection Fraction Lozano O et al. Heart Failure Society of America Annual Scien
Slide 33: 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 34: 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…
Slide 35: Upcoming Major Milestones
Upcoming Major Milestones 1 Phase II Recurrent Pericarditis Study 2 Phase II Acute Myocarditis Study 3 Subcutaneous Administered CRD-38 • Full results Q4 2024. • Complete 100% enrollment. • Complete IND-enabling studies. • Initiate Phase III program*. • Report topline data. • Initiate Phase I clinic
Slide 36: 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 37: 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 38: 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 Professor Emeritus, Department of Pathology and Professor of Internal Medicine and Molecular Bio
Slide 39: Developing Novel Therapeutic Approaches
Developing Novel Phase II Programs in Rare Diseases Broad Exclusivity Protection Therapeutic CardiolRx™, lead small molecule oral drug candidate, granted FDA orphan drug designation Comprehensive intellectual property portfolio. Focused on rare diseases eligible for FDA and Approaches for (ODD) for
Slide 40: Cardiol Therapeutics Inc.
Cardiol Therapeutics Inc. +1 289.910.0850 NASDAQ: CRDL Toronto, Cardiolrx.com Investor.relations@cardiolrx.com TSX: CRDL Ontario
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