Overview
Cardiol Therapeutics (NASDAQ:CRDL,TSX:CRDL) is a clinical-stage life sciences company focused on developing anti-inflammatory and anti-fibrotic therapies for the treatment of heart disease. The Company’s lead small molecule drug candidate, CardiolRx™ (cannabidiol) oral solution, is pharmaceutically manufactured and in clinical development for use in the treatment of heart disease. It is recognized that cannabidiol modulates activation of the inflammasome pathway, an intracellular process known to play an important role in the development and progression of inflammation and fibrosis associated with myocarditis, pericarditis, and heart failure.
Cardiol has received Investigational New Drug Application authorization from the United States Food and Drug Administration (US FDA) to conduct clinical studies to evaluate the efficacy and safety of CardiolRx™ in two diseases affecting the heart: recurrent pericarditis and acute myocarditis. The MAVERIC Program in recurrent pericarditis, an inflammatory disease of the pericardium which is associated with symptoms including debilitating chest pain, shortness of breath, and fatigue, and results in physical limitations, reduced quality of life, emergency department visits, and hospitalizations, comprises the completed Phase II MAvERIC-Pilot study (NCT05494788) and the ongoing Phase III MAVERIC trial (NCT06708299). The ongoing ARCHER trial (NCT05180240) is a Phase II study in acute myocarditis, an important cause of acute and fulminant heart failure in young adults and a leading cause of sudden cardiac death in people less than 35 years of age. The US FDA has granted Orphan Drug Designation to CardiolRx™ for the treatment of pericarditis, which includes recurrent pericarditis.
Cardiol is also developing CRD-38, a novel subcutaneously administered drug formulation intended for use in heart failure – a leading cause of death and hospitalization in the developed world, with associated healthcare costs in the United States exceeding $30 billion annually.
Company Highlights
- Late-stage Pipeline: Lead oral drug candidate, CardiolRx™, in Phase III MAVERIC trial for recurrent pericarditis (RP).
- Initial Market Opportunity: Current revenue for 3rd line RP therapy in the US is approximately $500M and forecast to grow to $1B by 2028.*
- *Based on current revenue guidance for IL-1 blocker in the U.S; analysts’ forecast >$1Bn by 2028.
- Validated Target: Targeting inflammasome activation – central to the development and progression of several cardiac diseases.
- World-class Collaborations: Established long-standing working relationships with leading researchers and clinicians at renowned international centers of excellence.
- Near-term Value Drivers: Commence patient enrollment in MAVERIC trial; report top-line results from ARCHER Phase II trial; advance CRD-38 for heart failure into clinical development.
Key Projects
MAVERIC Program for Recurrent Pericarditis
The MAVERIC Program in recurrent pericarditis comprises the completed Phase II MAvERIC-Pilot study and the ongoing Phase III MAVERIC trial. Pericarditis is an inflammatory disease of the pericardium (the membrane or sac that surrounds the heart) that is associated with symptoms that include debilitating chest pain, shortness of breath and fatigue, and results in physical limitations, reduced quality of life, emergency department visits, and hospitalizations.
Pericarditis frequently results from a viral infection. Following an initial episode, patients may have multiple recurrences, and the primary goal of treatment is recurrence prevention. Significant accumulation of pericardial fluid and scarring can progress to life-threatening constriction of the heart. The only FDA-approved therapy for recurrent pericarditis, launched in 2021, is costly and is primarily used as a third-line intervention. On an annual basis, the number of patients in the United States having experienced at least one recurrence is estimated at 38,000. Approximately 60 percent of patients with multiple recurrences (>1) still suffer for longer than two years, and one third are still impacted at five years. Hospitalization due to recurrent pericarditis is often associated with a 6-8-day length of stay and cost per stay is estimated to range between $20,000 and $30,000 in the United States. The US FDA has granted Orphan Drug Designation to CardiolRx™ for the treatment of pericarditis, which includes recurrent pericarditis.
In November 2024, Cardiol reported clinical results from its Phase II open-label MAvERIC-Pilot study investigating the impact of CardiolRx™ administered to patients with symptomatic recurrent pericarditis. The data showed that the marked, rapid and clinically meaningful improvements in both pericarditis pain and inflammation reported at the 8-week primary endpoint, were maintained throughout the extension period of the 26-week study. In addition, patients’ episodes of pericarditis per year were substantially reduced while on CardiolRx™ as compared to episodes per year prior to the study. The data were included in an oral presentation as part of the Laennec Clinician-Educator Award & Lecture at the American Heart Association Scientific Sessions 2024. Dr. S. Allen Luis, Co-Director of the Pericardial Diseases Clinic and Associate Professor of Medicine in the Department of Cardiovascular Medicine at the Mayo Clinic, presented on behalf of the MAvERIC-Pilot investigators. These findings support the initiation of the MAVERIC Phase III trial, designed to assess CardiolRx™ for the treatment of pericarditis patients to prevent recurrence.
Cardiol is advancing their lead oral drug candidate, CardiolRx™, into the MAVERIC Phase III trial to demonstrate the impact of CardiolRx™ on pericarditis recurrence in a high-risk patient population. The MAVERIC Phase III trial is expected to enroll 110 patients at approximately 20 clinical centers in the United States and Europe that specialize in pericarditis care. The protocol has been designed in collaboration with thought leaders in pericardial disease. The study chairman is Dr. Allan L. Klein, director of the Center of Pericardial Diseases and professor of medicine, at the Heart and Vascular Institute at the Cleveland Clinic. The primary efficacy endpoint is the number of patients (percentage) free from a new episode of recurrent pericarditis at 24 weeks change. Other endpoints include time to new recurrence episode, change in NRS pain score – a validated clinical tool used across multiple conditions including previous studies of recurrent pericarditis – and change in C-reactive protein, a marker of inflammation.
Six highly distinguished thought leaders in cardiology of from the Cleveland Clinic, the Mayo Clinic, the University of Udine, the Monash Victoria Heart Institute, the University of Virginia, and Northwestern University comprise a committee of independent advisors established to design, oversee, and guide Cardiol’s MAVERIC Phase III trial.
“Recurrent pericarditis is a debilitating inflammatory heart disease associated with symptoms that adversely affect quality of life and physical activity. Results of the MAvERIC-Pilot study will assist in further understanding the therapeutic profile of our lead investigational drug in this condition and inform the design of a pivotal Phase III clinical trial to underpin the potential regulatory approval of CardiolRx, which is also being evaluated in the global ARCHER Phase II trial in patients presenting with acute myocarditis,” said David Elsley, Cardiol Therapeutics’ President and Chief Executive Officer.
ARCHER Trial for Acute Myocarditis
Cardiol’s ongoing ARCHER trial is a Phase II study in acute myocarditis, an important cause of acute and fulminant heart failure in young adults and a leading cause of sudden cardiac death in people less than 35 years of age. Myocarditis is an acute inflammatory condition of the heart muscle (myocardium) characterized by chest pain, impaired cardiac function, atrial and ventricular arrhythmias, and conduction disturbances. Although viral infection is the most common cause of myocarditis, the condition can also result from bacterial infection, commonly used drugs and mRNA vaccines, as well as therapies used to treat several common cancers, including chemo-therapeutic agents and immune checkpoint inhibitors.
There are no FDA-approved therapies for acute myocarditis. Patients hospitalized with the condition experience an average 7-day length of stay and a 4 – 6 percent risk of in-hospital mortality, with average hospital charge per stay estimated at $110,000 in the United States.
ARCHER is a Phase II, multi-center, international, double-blind, randomized, placebo-controlled trial is designed to study the impact of CardiolRx™ on myocardial recovery in patients with acute myocarditis. The primary efficacy endpoints of the ARCHER trial consist of extracellular volume (ECV) and global longitudinal strain (GLS). The secondary efficacy endpoint is left ventricular ejection fraction. Since people with acute myocarditis have impaired heart function, current treatment is based on standard-of-care recommendations for heart failure. This includes diuretics, ACE inhibitors, angiotensin receptors blockers, beta-blockers, and aldosterone inhibitors. For those with a severe and sudden onset presentation, intensive care is often required, with the use of inotropic medications (to increase the force of the heart muscle contraction) and occasionally, heart-lung bypass or ventricular assist devices. There is otherwise no specific treatment for acute myocarditis although some patients have responded to immuno-suppressive therapy in combination with steroids, but the data are not conclusive enough for this to be the recommended therapy.
An independent clinical steering committee, comprising 10 highly distinguished thought leaders in cardiology from the Cleveland Clinic, the Mayo Clinic, the Houston Methodist DeBakey Heart and Vascular Center, the University of Ottawa Heart Institute, McGill University Health Centre, the University of Pittsburgh Medical Center, University Medicine Berlin, Tel Aviv “Sourasky” Medical Center, São Paulo University Medical School, and Pitié Salpêtrière Hospital (Sorbonne University), has been established to design, oversee, and guide the ARCHER trial.
Cardiol Therapeutics’ Heart Failure Program
Heart failure affects more than 64 million people globally and associated healthcare costs exceed $30 billion annually in the US alone. Heart failure is a chronic, progressive syndrome in which the heart muscle is unable to pump enough blood to meet the body’s needs for blood and oxygen. People with heart failure suffer from shortness of breath, rapid heart rate, edema, reduced exercise capacity, often struggle with simple daily activities and are frequently hospitalized. For many, these symptoms significantly reduce their quality of life. Known causes of heart failure include ischemic heart disease and myocardial infarction (heart attack), hypertension, valvular heart disease, inflammatory diseases of the heart such as myocarditis and cardiomyopathies, anti-cancer therapies, and inherited metabolic diseases.
Heart failure remains a leading cause of morbidity and mortality worldwide and persists as a growing health and economic burden. In the United States alone, 6 million people over the age of 20 are living with heart failure, and this number is projected to increase to more than 8 million by 2030. The total annual cost attributed to heart failure is projected to increase to $69.8 billion by 2030.
Total deaths attributed to heart failure annually in the United States have been reported in the range of 86,000 to more than 300,000, and hospitalizations range from 800,000 to 1.3 million. The five-year mortality rate for those with heart failure has been reported at 52.6 percent overall.
Cardiol is developing CRD-38, a novel subcutaneously administered drug formulation intended for use in heart failure. The Company are undertaking IND-enabling activities to support clinical evaluation of CRD-38 as a therapeutic strategy in heart failure care – a leading cause of death and hospitalization in the developed world, with associated healthcare costs in the United States exceeding $30 billion annually.
In 2025, Cardiol announced the publication of research in the Journal of the American College of Cardiology: Basic to Translational Science (“JACBTS”), titled “Cannabidiol Prevents Heart Failure Dysfunction and Remodeling Through Preservation of Mitochondrial Function and Calcium Handling”. This research was conducted by scientists from Tecnológico de Monterrey who, together with researchers from the DeBakey Heart and Vascular Center in Houston, TX, are collaborating with Cardiol on the development of the Company’s proprietary subcutaneous formulation of cannabidiol, CRD-38, to treat heart failure with preserved ejection fraction. This common form of heart failure remains a leading cause of hospitalization worldwide and is associated with a five-year mortality that exceeds 75% in hospitalized patients.
Dr. Andrew Hamer, Cardiol Therapeutics’ Chief Medical Officer and Head of Research & Development stated: “Heart failure progression is characterized by fibrosis, inflammation, and decreased contractile function of the myocardium, in part driven by mitochondrial dysfunction. The JACBTS publication provides fascinating new data that suggest a key mode of action of CRD-38 to potentially treat heart failure is through its ability to sustain cardiomyocytes, the muscle cells of the heart, and preserve mitochondrial function, the energy producing structures in cardiac cells. We look forward to incorporating this new information into our CRD-38 development program as we complete the IND-enabling work necessary to support advancing this novel drug candidate into clinical development.”
These newly published data demonstrate that pharmaceutically manufactured cannabidiol, administered subcutaneously, provides cardioprotection in a pre-clinical model of heart failure by improving cardiac function and reducing cardiac hypertrophy, remodeling, inflammation, and cell death, and provides additional important rationale for the development of CRD-38 as a new approach to the treatment of heart failure.
Management Team
David Elsley – President, Chief Executive Officer, and Director
David Elsley is the founder and CEO of Vasogen and has an MBA degree. Elsley has over 30 years of experience developing, financing, and managing all aspects of corporate development in biotechnology and high-growth organizations. Elsley founded Vasogen, a biotechnology company focused on the research and commercial development of novel therapeutics for the treatment of heart failure and other inflammatory conditions. Elsley assembled a team of management, directors and scientific advisors comprising industry professionals and thought leaders from North America and Europe.
Dr. Andrew Hamer – Chief Medical Officer and Head of Research and Development
Dr. Andrew Hamer has an MBChB degree. Hamer is the former executive director at Amgen, responsible for leading global development of Repatha®. Hamer is the former chief cardiologist at Nelson Hospital, New Zealand. He has over 19 years of experience practicing cardiology and internal medicine.
Chris Waddick – Chief Financial Officer and Director
Chris Waddick has an MBA degree, is a chartered professional accountant, and is a certified management accountant. Waddick has over 30 years of experience in financial and executive roles in the biotechnology and energy industries. Waddick is the former chief financial officer and chief operating officer of Vasogen Inc.
Bernard Lim – Chief Operating Officer
Bernard Lim has over 30 years of experience in the life sciences industry, spanning biotechnology, diagnostics, medical devices, and high-technology companies. Lim is the founder and CEO of a highly successful drug delivery company that he led from research and development through to commercialization, and facilitated its eventual acquisition by Eli Lily. Lim is a chartered engineer per UK standards and is a member of the Institution of Engineering and Technology.
Andrea B. Parker – Senior Director of Clinical Operations
Dr. Andrea Parker is the former chief scientific officer at Peter Munk Cardiac Center, University Health Network. Parker is a clinical epidemiologist with more than 30 years’ experience in clinical trials design, management, and execution in industry and academic settings.
John A. Geddes – Vice-President, Corporate Development
John Geddes has over 25 years of experience in the healthcare industry, comprising roles within pharmaceutical, biotechnology, clinical diagnostics, and life science research technology companies. Geddes has an MBA degree and is the former corporate senior director of business development at Luminex Corporation, a DiaSorin Company.
Anne Tomalin – Director of Regulatory and Quality
Anne Tomalin is the founder of CanReg and TPIreg, regulatory firms previously sold to Optum Insight and Innomar Strategies, respectively. Tomalin is an expert in regulatory affairs in Canada, the United States, and Europe.
Board of Directors
Guillermo Torre-Amione – Chairman
Guillermo Torre-Amione is the president of TecSalud academic medical center and school of the Instituto Tecnológico y de Estudios Superiores de Monterrey (ITESM), Mexico. Torre-Amione is the former director of Cardiac Transplantation at the Houston Methodist DeBakey Heart & Vascular Center.
Jennifer M. Chao – Director
Jennifer M. Chao has over 25 years of experience in the biotech and life sciences industries focused primarily on finance and corporate strategy. Chao is managing partner of CoreStrategies Management, a company she founded in 2008 to provide transformational corporate and financial strategies to biotech/life science companies for maximizing core valuation.
Peter Pekos – Director
Founder of Dalton Pharma, Peter Pekos has broad experience in research, development, and commercialization of pharmaceuticals, products, and services.
Colin Stott – Director
Colin Stott has over 30 years of experience in pre-clinical and clinical development, with specific expertise in the development of cannabinoid-based medicines. Stott is the chief operating officer of Alterola Biotech Inc. and the former scientific affairs director, international, and research and development operations director for GW Pharmaceuticals, a world leader in the development of cannabinoid therapeutics.
Teri Loxam – Director
Teri Loxam has over 25 years of experience in the pharmaceutical, life sciences and TMT industries with diverse roles spanning strategy, investor relations, finance and communications. Loxam is chief financial officer of Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health.
Michael Willner – Director
Michael Willner has practiced as an attorney and a certified public accountant. He graduated from Emory University Law School as a member of the Emory Law Review. Subsequently, Willner practiced real estate and corporate law with New York City-based Milbank, Tweed, Hadley & McCloy, one of the nation’s most prominent international law firms. Before his legal career, Willner was employed by the former Arthur Andersen & Company, a national accounting firm, where he practiced in the tax department.
Scientific Advisory Board
Dr. Paul Ridker
Dr. Paul Ridker is director of the Center for Cardiovascular Disease Prevention, a translational research unit at Brigham and Women’s Hospital in Boston (BWH). A cardiovascular medicine specialist, he is also the Eugene Braunwald Professor of Medicine at Harvard School of Medicine (HSM). Ridker received his medical degree from HSM and then completed an internal medicine residency and a cardiology fellowship at BWH. He is board certified in internal medicine. Ridker’s clinical interests include coronary artery disease and the underlying causes and prevention of atherosclerotic disease. He is the author of over 900 peer-reviewed publications and reviews, 64 book chapters, and six textbooks related to cardiovascular medicine.
Dr. Bruce McManus
Dr. Bruce McManus is a professor emeritus of the Department of Pathology and Laboratory Medicine at the University of British Columbia. He has served as CEO of the Center of Excellence for Prevention of Organ Failure (PROOF Center), director of the UBC Center for Heart and Lung Innovation, and scientific director of the Institute of Circulatory and Respiratory Health, CIHR. McManus received BA and MD degrees from the University of Saskatchewan, an MSc from Pennsylvania State University, and a PhD from the University of Toledo. McManus pursued post-doctoral fellowships at the University of California, Santa Barbara in environmental physiology and at the National Heart, Lung, and Blood Institute in Bethesda. McManus served as MD in cardiovascular and pulmonary pathology, and completed residency training at the Peter Bent Brigham Hospital, Harvard University, in Internal Medicine and Pathology.
Dr. Joseph Hill
Dr. Joseph Hill is a professor of internal medicine and molecular biology, chief of cardiology at UT Southwestern Medical Center, in Dallas, and is the director of the Harry S. Moss Heart Center. Hill holds both the James T. Willerson, MD, distinguished chair in cardiovascular diseases, and the Frank M. Ryburn Jr. Chair in Heart Research. He graduated from Duke University with an MD and a PhD in 1987. Hill’s PhD dissertation research was in the field of cardiac ion channel biophysics. He then worked for five years as a postdoctoral fellow at the Institut Pasteur in Paris, studying central and peripheral nicotinic receptors. He next completed an internal medicine internship and residency, as well as a clinical cardiology fellowship, at the Brigham and Women’s Hospital, Harvard Medical School.
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