Mr. David Elsley reports

CARDIOL THERAPEUTICS ANNOUNCES IT HAS EXCEEDED 50% ENROLLMENT IN ITS PHASE II ARCHER TRIAL IN ACUTE MYOCARDITIS

Cardiol Therapeutics Inc. has exceeded 50 per cent patient enrolment for Archer, the company's phase II, multicentre, international, double-blind, randomized, placebo-controlled trial investigating the safety, tolerability and impact of CardiolRx on myocardial recovery in patients presenting with acute myocarditis.

"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 clinical trial," said David Elsley, Cardiol Therapeutics' president and chief executive officer. "Acute myocarditis is an inflammatory heart disease that impairs heart function, is associated with symptoms that can seem like a heart attack, is an important cause of acute and fulminant heart failure, and is a leading cause of sudden cardiac death in people under 35 years of age. Results from the Archer trial will assist in further understanding the therapeutic potential of CardiolRx and will complement the important clinical data from our ongoing MAvERIC-pilot phase II study in patients presenting with recurrent pericarditis."

The Archer trial has been designed in collaboration with an independent steering committee comprising distinguished thought leaders in heart failure and myocarditis from international centres of excellence. The trial is expected to enroll 100 patients at pre-eminent cardiovascular research centres in North America, France, Brazil and Israel. The primary outcome measures of the trial, which will be evaluated following 12 weeks of double-blind therapy, consist of two cardiac magnetic resonance imaging measures: left ventricular function (longitudinal strain) and myocardial edema/fibrosis (extracellular volume), each of which has been shown to predict long-term prognosis of patients with acute myocarditis. Additional efficacy outcome measurements include survival, freedom from major cardiovascular events, resolution of clinical symptoms, and change in biomarkers associated with cardiac function and inflammation.

Myocarditis is an acute inflammatory condition of the heart muscle (myocardium) characterized by chest pain, shortness of breath at rest or during activity, fatigue, rapid or irregular heartbeat (arrhythmias), and light-headedness or feeling one might faint. Although the symptoms are often mild, many patients will also report flu-like symptoms such as headache, body aches, joint pain, fever or sore throat prior to disease onset. Viral infection is the most common cause of myocarditis; however, this disease can also result from bacterial infection and 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 Food and Drug Administration-approved therapies for acute myocarditis. Patients hospitalized with the condition experience an average seven-day length of stay and a 4-to-6-per-cent risk of in-hospital mortality, with average hospital charge per stay estimated at $110,000 in the United States. Cardiol believes there is a significant opportunity to develop an important new therapy for acute myocarditis that would also be eligible for designation as an orphan drug in the United States and the European Union. Orphan drug designation programs were established to provide life sciences companies with incentives to develop new therapies for rare diseases. These incentives include periods of prolonged marketing exclusivity and exemptions from certain fees. Products with orphan drug designation also frequently qualify for accelerated regulatory review.

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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