Cardiol Therapeutics Inc. Class A · TSX:CRDL
Cardiol Therapeutics Inc. Class A — Investor Presentation (October 2024)
45 slides from Cardiol Therapeutics Inc. Class A's investor presentation, October 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 October 2024 TSX: CRDL NASDAQ: C
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 for Patients with Underserved Heart Diseases
Developing Novel Therapeutic Late-stage Programs in Rare Diseases Broad Exclusivity Protection Approaches for CardiolRx™, lead small molecule oral drug candidate, granted FDA orphan drug designation Comprehensive intellectual property portfolio. Focused on rare diseases eligible for FDA and Patients
Slide 4: Product Pipeline
Product Pipeline Drug Candidate Pre-Clinical Phase I Phase II Phase II/III Phase III Lead oral drug candidate, CardiolRx™, is being clinically CardiolRx™ Recurrent Pericarditis – MAVERIC-2 developed for use in rare heart diseases. CRD-38 is a novel subcutaneously administered Recurrent Pericarditis
Slide 5: CardiolRx and CRD-38
CardiolRx™ and CRD-38 Targeting intracellular inflammatory signalling pathways CardiolRx™ (cannabidiol) oral solution 100mg/mL CRD-38 (cannabidiol) for subcutaneous injection • Lead small molecule drug candidate in clinical • Novel small molecule drug formulation in IND-enabling development for use
Slide 6: 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 7: 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 8: 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: NASDAQ: CRDL CRDL ||TSX: TSX: CRDL CRDL OCTOBER 20
Slide 9: 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 wee
Slide 10: Recurrent Pericarditis – Clinical Need & Opportunity
Recurrent Pericarditis – Clinical Need & Opportunity Clinical Need CardiolRx™ Opportunity • A segment of pericarditis patients suffer from a high • Potential second-line use for patients with pericarditis recurrence burden and prolonged disease duration recurrences, inadequate response to current th
Slide 11: 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; Transcription Levels of pro-IL-1β & NLRP3 Reduced. IL-6 NLRP3 mRNA ***P<0.001 *P<0.05 ***P<0.001 Martinez-Naya N et al. Circ Res 2022;
Slide 12: Significant Reduction in Pericardial Effusion & Pericardial Thickness
Significant Reduction in Pericardial Pericardial Space Pericardial Space 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 2022; 1
Slide 13: 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 Director, Center for the Diagnosis and Treatment of University, and Multimodality Cardiac Imaging and Clinical Pericardial Diseases, and Prof
Slide 14: 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 safety and tolerability of CardiolRx™ during the • Change in patient-reported pericarditis pain using resolution of a pericarditis recurrence, evaluate an N
Slide 15: 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 16: Key Inclusion/Exclusion Criteria for the MAvERIC-Pilot Study
Key Inclusion/Exclusion Criteria for the MAvERIC-Pilot Study Inclusion: Exclusion: • Male or female patients aged ≥18 years. • Diagnosis of pericarditis secondary to the following • Diagnosis of at least 2 episodes of RP*. etiologies: tuberculosis; neoplastic, purulent or radiation etiology; post-th
Slide 17: 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 Endpoint Day 10 to End of Study 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 18: Previous Episodes of Pericarditis in MAvERIC-Pilot Patients at Baseline
Previous Episodes of Pericarditis in MAvERIC- # Previous Episodes CardiolRx™ Pilot Patients at Baseline of Pericarditis (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 19: MAvERIC-Pilot Study Topline Efficacy Data
MAvERIC-Pilot Study Primary Endpoint Topline Efficacy Data Change in patient-reported pericarditis pain using NRS* from baseline to CardiolRx™ resulted in a clinically meaningful 8 weeks. reduction in pericarditis pain in symptomatic Mean patients following 8 weeks of treatment. n=27 Baseline Week 8
Slide 20: MAvERIC-Pilot Study Topline Efficacy Data
MAvERIC-Pilot Study Topline Efficacy Data 80% of symptomatic patients and a CRP Secondary Endpoint ≥1.0 mg/dL at baseline achieved CRP normalization* by 8 weeks. Percentage of patients with CRP normalizationǂ at 8 weeks (for patients with CRP ≥1.0 mg/dL at baseline). Number of Patients with CRP ≥1.0
Slide 21: 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. Mean Baseline Week 8 Difference* rilonacept Difference Phase II -4.24 (EoTP
Slide 22: Summary: MAvERIC-Pilot Study Topline Efficacy Data
Summary: MAvERIC-Pilot Study Topline Efficacy Data • 89% (24/27) of patients enrolled in MAvERIC-Pilot have progressed Full data to be reported during an oral from the 8-week Treatment Period into the 18-week Extension Period; presentation at the American Heart strongly suggests CardiolRx™ has been
Slide 23: MAVERIC-2 Trial
MAVERIC-2 Trial Impact of CardiolRx™ on Recurrent Pericarditis A Phase II/III multi-national, double-blind, randomized, placebo-controlled trial to assess the impact of CardiolRx™ on pericarditis recurrence following cessation of interleukin-1 blocker therapy. NASDAQ: NASDAQ: CRDL CRDL ||TSX: TSX: C
Slide 24: MAVERIC-2 Trial
MAVERIC-2 Trial CardiolRx™ for Recurrent Pericarditis Primary Efficacy Endpoint Multi-national, double-blind, randomized, placebo- controlled trial to assess the impact of CardiolRx™ on • Number of patients (percentage) free from a new pericarditis recurrence following cessation of interleukin-1 epi
Slide 25: MAVERIC-2 Study Design
MAVERIC-2 Study Design Safety Screening Patients ≥ 18 years 24-week, double-blind, placebo-controlled Treatment Period (TP) Follow-up Period Visit Randomization 1:1 and start of either CardiolRx™ or placebo 10 – 14 days prior to the last scheduled dose of the IL-1 blocker Safety ≤ 7 days of follow-u
Slide 26: MAVERIC Clinical Development Program
MAVERIC Clinical Development Program CardiolRx™ for the Treatment of Pericarditis to Prevent Recurrences Orphan Drug Designation Population = 160K Initial Acute Pericarditis Episode = 122K Recurrent Pericarditis = 38K (includes 24K with 1st recurrence + 14K with multiple recurrences*) 1st Line 2nd L
Slide 27: 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 28: 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 29: Acute Myocarditis – Clinical Need & Opportunity
Acute Myocarditis – Clinical Need & Opportunity Clinical Need CardiolRx™ Opportunity • An FDA- and EMA-approved therapy indicated for the • Potential first-line use for uncomplicated low/intermediate treatment of acute myocarditis: risk profile patients with acute myocarditis: o Reduces the risk of
Slide 30: 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 31: 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 32: 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 acute • Extrace
Slide 33: ARCHER Trial Design
ARCHER Trial Design Trial has achieved 100% of the target patient enrollment of 100 patients. • Phase II multi-center, double-blind, placebo-controlled trial. • Participants screened within 10 days of a diagnostic cardiac magnetic resonance and randomized 1:1 to receive either CardiolRx™ or placebo.
Slide 34: Heart Failure
Heart Failure CRD-38 is a novel proprietary subcutaneously administered drug formulation of cannabidiol intended for use in heart failure. NASDAQ: NASDAQ: CRDL CRDL ||TSX: TSX: CRDL CRDL OCTOBER 2024 34
Slide 35: 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 36: 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 37: 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 Treatment For Prevents Inflammation Prevents Cardiac Remodeling Heart Failure With Preserved Ejection Fraction Lozano O et al. Heart Failure Society of America Annual Scien
Slide 38: 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 39: 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 40: Near-term Milestones
Near-term Milestones 1 MAVERIC Program in Recurrent Pericarditis 2 ARCHER Trial in Acute Myocarditis 3 Subcutaneous Administered CRD-38 • Full MAvERIC-Pilot Phase II • Report ARCHER Phase II topline • Complete IND-enabling studies. results Q4 2024. data early 2025. • Initiate Phase I clinical progra
Slide 41: 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 42: 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 43: 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 Prevention, Professor Emeritus, Department of Pathology and Laboratory Professor of Internal Med
Slide 44: Developing Novel Therapeutic Approaches for Patients with Underserved Heart Diseases
Developing Novel Therapeutic Late-stage Programs in Rare Diseases Broad Exclusivity Protection Approaches for CardiolRx™, lead small molecule oral drug candidate, granted FDA orphan drug designation Comprehensive intellectual property portfolio. Focused on rare diseases eligible for FDA and Patients
Slide 45: Cardiol Therapeutics Inc.
Cardiol Therapeutics Inc. +1 289.910.0850 NASDAQ: CRDL Toronto, Cardiolrx.com investor.relations@cardiolrx.com TSX: CRDL Ontario NASDAQ: CRDL | TSX: CRDL OCTOBER 2024 45
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