Cardiol Therapeutics Inc. Class A · TSX:CRDL
Cardiol Therapeutics Inc. Class A — Investor Presentation (November 2024)
49 slides from Cardiol Therapeutics Inc. Class A's investor presentation, November 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 November 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 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 late-stage • Novel small molecule drug formulation in IND-enabling clinical developme
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 NOVEMBER 2
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 & 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 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 • Change in patient-reported pericarditis pain using safety, tolerability, and efficacy of CardiolRx™ in an NRS* from baseline to 8 weeks. patients with rec
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 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 18: 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 19: MAvERIC-Pilot Study Primary Endpoint
MAvERIC-Pilot Study 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 Range 4.0 –
Slide 20: Daily NRS Score
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 continuing CardiolRx™ 8 Daily NRS
Slide 21: C-Reactive Protein (mg/dL)
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 weeks of EP, background therapies
Slide 22: MAvERIC-Pilot Study CRP Subgroup
MAvERIC-Pilot Study CRP Subgroup 80% of symptomatic patients and a CRP ≥1.0 mg/dL at baseline achieved CRP Percentage of patients with CRP normalization* at 8 weeks (for patients normalization* by 8 weeks. with CRP ≥1.0 mg/dL at baseline). Number of Patients with CRP ≥1.0 mg/dL at Baseline 10 (of 27
Slide 23: CardiolRx Markedly Reduced Pericarditis Events per Year
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 Period was Maintained in 71% of P
Slide 24: MAvERIC-Pilot Study Data Presented at American Heart Association 2024
MAvERIC-Pilot Study Data • CardiolRx™ resulted in rapid reductions in pericarditis pain and inflammation in patients with recurrent pericarditis. Presented at o NRS score decreased by 3.7 points from 5.8 at baseline to 2.1 at week 8. the American o Median time to resolution or near resolution of per
Slide 25: MAVERIC-2 Trial
MAVERIC-2 Trial A Phase II/III Clinical Trial to Assess Impact of CardiolRx™ on Recurrent Pericarditis Following Cessation of Interleukin-1 Blocker Therapy NASDAQ: NASDAQ: CRDL CRDL ||TSX: TSX: CRDL CRDL NOVEMBER 2024 25
Slide 26: Executive Committee for the MAVERIC Program
Executive Committee for the MAVERIC Program Allan Klein, MD, CM Paul Cremer, MD Director, Center for the Diagnosis and Treatment of Departments of Medicine and Radiology, Pericardial Diseases, and Professor of Medicine, Northwestern University, and Multimodality Cardiac Heart, Vascular and Thoracic
Slide 27: MAVERIC-2 Trial
MAVERIC-2 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 following cessation of interleukin-1 epi
Slide 28: Rationale for MAVERIC-2 Trial
Rationale for MAVERIC-2 Trial To treat the chronic phase of this disease, alternative therapies are needed to overcome this clinical challenge. • CardiolRx™ may have therapeutic potential to prevent recurrences following discontinuation of IL-1 blocker therapy. Interleukin-1 (IL-1) blocker injection
Slide 29: 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 30: MAVERIC Clinical Development Program
MAVERIC Clinical Development Program CardiolRx™ for the treatment of recurrent pericarditis. 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 Line 1st Line
Slide 31: 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 32: 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 33: 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 34: 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 35: 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 36: 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 37: 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 38: 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 NOVEMBER 2024 38
Slide 39: 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 40: 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 41: Subcutaneous CRD-38 Administered 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 42: 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 43: 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 44: 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-2 Phase II/III • Report ARCHER Phase II topline • Complete IND-enabling studies. trial Q4 2024. data early 2025. • Initiate Phase I clinical prog
Slide 45: 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 46: 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 47: 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 48: 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 49: 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 NOVEMBER 2024 49
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