Mr. David Elsley reports

CARDIOL THERAPEUTICS ANNOUNCES IT HAS EXCEEDED 50% ENROLLMENT IN ITS PHASE II MAVERIC-PILOT STUDY IN RECURRENT PERICARDITIS

Cardiol Therapeutics Inc. has exceeded 50 per cent of the patient enrolment target for its phase II open-label pilot study (MAvERIC-pilot), investigating the safety, tolerability and efficacy of CardiolRx in patients with recurrent pericarditis. In addition to standard safety assessments, the study is designed to evaluate improvement in objective measures of this rare disease, and during an extension period, assess the feasibility of weaning concomitant background therapy, including corticosteroids, while taking CardiolRx.

"Achieving this milestone reflects the commitment and interest demonstrated by our clinical collaborators and participating patients, and we thank them for their contribution to the progress being made in this important study," said David Elsley, Cardiol Therapeutics' president and chief executive officer. "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."

MAvERIC-pilot is enrolling 25 patients at medical research centres in the United States that specialize in pericarditis care. The study chairman is Dr. Allan L. Klein, MD, director of the Center of Pericardial Diseases and professor of medicine, Heart and Vascular Institute, at the Cleveland Clinic. The primary efficacy end point is the change, from baseline to eight weeks, in patient-reported pericarditis pain using an 11-point numeric rating scale (NRS). The NRS is a validated clinical tool employed across multiple conditions with acute and chronic pain, including previous studies of recurrent pericarditis. Secondary end points include the NRS score after 26 weeks of treatment, and changes in circulating levels of C-reactive protein, a commonly used clinical marker of inflammation. Importantly, the study will assess freedom from pericarditis recurrence.

Preclinical data adding to the strong scientific basis for investigating CardiolRx clinically in recurrent pericarditis were presented at the American Heart Association Scientific Sessions 2022. Cardiol's research collaborators from Virginia Commonwealth University presented results demonstrating the protective effects of CardiolRx in a model of pericarditis, which included a significant reduction in imaging signs of pericardial effusion and thickening, and significant suppression of key pro inflammatory markers interleukin-1beta (IL-1beta) and interleukin-6 (IL-6). The release of these cytokines IL-1beta and IL-6 is responsible for the cycle of inflammation in recurrent pericarditis leading to the pericardial effusion and thickening, and associated chest pain, characteristic of the disease.

About Cardiol Therapeutics Inc.

Cardiol Therapeutics is 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. 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 inhibits 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.

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