Cardiol Therapeutics Inc. Class A · TSX:CRDL
Cardiol Therapeutics Inc. Class A — Investor Presentation (December 2024)
44 slides from Cardiol Therapeutics Inc. Class A's investor presentation, December 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 December 2024 TSX: CRDL NASDAQ:
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 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 Lead oral drug candidate, Drug Candidate Pre-Clinical Phase I Phase II Phase III CardiolRx™, is being clinically developed for use in rare heart CardiolRx™ Recurrent Pericarditis diseases. CRD-38 is a novel subcutaneously administered drug formulation intended for Acute Myocarditis
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 Clinical Development Program
MAVERIC Clinical Development Program Impact of CardiolRx™ on Recurrent Pericarditis NASDAQ: NASDAQ: CRDL CRDL ||TSX: TSX: CRDL CRDL DECEMBER 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 wee
Slide 9: 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 10: Rationale for MAVERIC Clinical Development Program
Rationale for MAVERIC IL-1β Pro IL-1β mRNA Clinical Development *P<0.001 *P<0.05 ***P<0.001 Program Significant reduction of multiple in vitro 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.
Slide 11: Rationale for MAVERIC Clinical Development Program
Rationale for MAVERIC Clinical Pericardial Space Pericardial Thickness Zymosan A Development Program Significant reduction in pericardial effusion & pericardial thickness Zymosan A + Cannabidiol 10 mg/kg demonstrated in vivo pre-clinically. Pericardial thickness of heart sections stained with hemato
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 Director, Center for the Diagnosis and Treatment of University, and Multimodality Cardiac Imaging and Clinical Pericardial Diseases, and Prof
Slide 13: MAvERIC-Pilot Phase II Study
MAvERIC-Pilot Phase II Study CardiolRx™ for Recurrent Pericarditis Primary Efficacy Endpoint Multi-center, open-label pilot study assessed the • Change in patient-reported pericarditis pain using safety, tolerability, and efficacy of CardiolRx™ in an NRS* from baseline to 8 weeks. patients with recu
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: • 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 16: MAvERIC-Pilot Study Design
MAvERIC-Pilot Study Design 27 patients enrolled (met ESC criteria) → 24 progressed to EP on CardiolRx™. CardiolRx™ 8 Week Dose Titration Primary Endpoint to 10 mg/kg b.i.d. Dose Withdrawal of background medications† Titration* while continuing CardiolRx™ Baseline Treatment Period Extension Period 72
Slide 17: Patient Demographic and Clinical Characteristics at Baseline
Patient Demographic and Clinical Characteristics at Baseline Reflects a group with severe disease. Characteristic n=27 Age mean 52.7; median 54.0 (24.0-77.0) Sex female 18 (66.7%); male 9 (33.3%) Race / Ethnicity White 27 (100%) / non-Hispanic or Latino 27 (100%) Medications used to treat pericardit
Slide 18: MAvERIC-Pilot Study Results Primary Endpoint
MAvERIC-Pilot Study Results Primary Endpoint CardiolRx™ resulted in a marked reduction in Change in patient-reported pericarditis pain using NRS* from baseline pericarditis pain in symptomatic patients to 8 weeks. following 8 weeks of treatment. n=27 Baseline Week 8 Difference† Mean 5.8 2.1 -3.7 Ran
Slide 19: MAvERIC-Pilot Study Results: Daily NRS Score
MAvERIC-Pilot Study Results Clinically relevant, rapid and durable reductions in pericarditis pain. Mean Daily NRS Score Over Study Period Mean daily NRS score over the entire study period 10 Treatment Period (n=27) Extension Period (n=24) CardiolRx™ Withdrawal of background medications* while conti
Slide 20: MAvERIC-Pilot Study Results: C-Reactive Protein
MAvERIC-Pilot Study Results Clinically meaningful and rapid reductions in CRP. C-Reactive Protein (mg/dL) Treatment Period (n=27) Extension Period (n=24) CardiolRx™ Withdrawal of background medications* while continuing CardiolRx™ C-Reactive Protein (mg/dL) Mean (SE) Weeks * Within the first 10 week
Slide 21: MAvERIC-Pilot Study Results
MAvERIC-Pilot Study Results CardiolRx™ markedly reduced pericarditis events per year. CardiolRx™ (n=27) Events per Year of Pericarditis Prior to the Study Events per Year of Pericarditis During the Study 5.8 0.9 When Weaned to CardiolRx™ Monotherapy, Freedom From Recurrence During the Extension Peri
Slide 22: Summary of MAvERIC-Pilot Study Results
Summary of MAvERIC-Pilot • CardiolRx™ resulted in rapid reductions in pericarditis pain and inflammation in patients with recurrent pericarditis. Study Results o NRS score decreased by 3.7 points from 5.8 at baseline to 2.1 at week 8. Presented at o Median time to resolution or near resolution of pe
Slide 23: MAVERIC Phase III Clinical Trial
MAVERIC Phase III Clinical Trial A Late-stage Trial to Assess Impact of CardiolRx™ on Recurrent Pericarditis NASDAQ: NASDAQ: CRDL CRDL ||TSX: TSX: CRDL CRDL DECEMBER 2024 23
Slide 24: MAVERIC Phase III Trial
MAVERIC Phase III Trial CardiolRx™ for Recurrent Pericarditis Multi-national, double-blind, randomized, placebo- Primary Efficacy Endpoint controlled trial to assess the impact of CardiolRx™ on • Number of patients (percentage) free from a new pericarditis recurrence. episode of recurrent pericardit
Slide 25: MAVERIC Phase III Trial Design
MAVERIC Phase III Trial 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
Slide 26: MAVERIC Clinical Development Program
MAVERIC Clinical Development Program CardiolRx™ has been granted Orphan Drug Designation for the treatment of pericarditis, which includes recurrent pericarditis. Recurrent Pericarditis Patient Population =38,000 1st Line 2nd Line 3rd Line Pericardiectomy Aspirin or NSAID Low dose Interleukin-1 bloc
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 DECEMBER 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: 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 37: 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 38: 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 39: Near-term Milestones
Near-term Milestones 1 MAVERIC Program in Recurrent Pericarditis 2 ARCHER Trial in Acute Myocarditis 3 Subcutaneous Administered CRD-38 • Initiate MAVERIC Phase III • Report ARCHER Phase II topline • Complete IND-enabling studies. trial in Q1 2025. data early 2025. • Initiate Phase I clinical progra
Slide 40: 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 41: 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 42: 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 43: Developing Novel Therapeutic Approaches for 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 44: Cardiol Therapeutics Inc. Contact
Cardiol Therapeutics Inc. +1 289.910.0850 NASDAQ: CRDL Toronto, Cardiolrx.com investor.relations@cardiolrx.com TSX: CRDL Ontario NASDAQ: CRDL | TSX: CRDL DECEMBER 2024 44
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