Mr. Trevor Burns reports

CARDIOL THERAPEUTICS ANNOUNCES COMPLETION OF THE MAVERIC PHASE II STUDY IN RECURRENT PERICARDITIS WITH RESULTS TO BE PRESENTED AT THE AMERICAN HEART ASSOCIATION SCIENTIFIC SESSIONS 2024

Cardiol Therapeutics Inc. today presented data from its phase II open-label MAvERIC-Pilot study investigating the impact of CardiolRx administered to patients with symptomatic recurrent pericarditis will be reported in an oral presentation as part of the Laennec Clinician-Educator Award & Lecture that runs from 9:45 a.m. to 11 a.m. Central Time, on Monday, Nov. 18, 2024, at the American Heart Association Scientific Sessions 2024. Dr. S. Allen Luis, co-director, Pericardial Diseases Clinic and associate professor of medicine, Department of Cardiovascular Medicine at the Mayo Clinic, will present on behalf of the MAvERIC-Pilot investigators.

"Having recently reported the positive primary end point data from the MAvERIC-Pilot study demonstrating that oral administration of our small molecule CardiolRx led to marked reductions in pericarditis pain and inflammation at eight weeks, we are delighted that the data has been accepted for oral presentation in such a prestigious session of the American Heart Association Scientific Sessions 2024, the premier global event for advancements in cardiovascular science and medicine," said David Elsley, Cardiol Therapeutics' president and chief executive officer. "We extend our thanks and gratitude to the patients and our clinical research collaborators whose participation in this important study have served to support our objective of developing a more accessible and non-immunosuppressive therapeutic option for thousands of patients suffering from this chronic inflammatory heart disease."

"The MAvERIC-Pilot study was designed to investigate the impact of our novel therapy CardiolRx in patients with the debilitating symptoms of recurrent pericarditis," said Andrew Hamer, Cardiol Therapeutics' chief medical officer and head of research and development. "Having reached the important milestone of concluding the study, we now look forward to reporting the full clinical results from MAvERIC-Pilot that will include additional end points including freedom from pericarditis recurrence during the 18-week extension period, 26-week pericarditis pain score and inflammatory marker levels, and safety and tolerability outcomes. We anticipate the totality of the results will support and further inform our plans to advance to a phase III trial of CardiolRx in this inflammatory heart disease that is associated with symptoms that adversely affect quality of life, mental health and physical activity."

MAvERIC-Pilot study design

The MAvERIC-Pilot study evaluated CardiolRx in 27 adult participants (greater than or equal to 18 years) with symptomatic recurrent pericarditis (greater than or equal to two recurrences), with or without a raised level of C-reactive protein (CRP), at eight clinical sites across the United States. The study chairman is Allan L. Klein, MD, director of the Center of Pericardial Diseases and professor of medicine, heart and vascular institute, at the Cleveland Clinic. The study design consisted of an eight-week treatment period (TP) followed by an 18-week extension period (EP). Patients with pericarditis chest pain with a numerical rating scale (NRS) pain score greater than or equal to four together with either an elevated level of CRP (greater than or equal to one milligram/decilitre) or evidence of pericardial inflammation assessed by cardiac imaging were enrolled. CardiolRx was added to stable doses of baseline therapy for recurrent pericarditis (non-steroidal anti-inflammatory drugs, colchicine and/or corticosteroids, in any combination). In the first 10 days of the TP, CardiolRx was uptitrated to 10 milligrams/kilogram twice daily, or the maximum tolerated dose. Throughout the TP, patients continued receiving baseline therapy for recurrent pericarditis but were weaned off this during the EP to assess pericarditis recurrence. The primary efficacy end point is the change, from baseline to eight weeks, in patient-reported pericarditis pain using the NRS. Secondary end points include NRS pain score at 26 weeks, and freedom from pericarditis recurrence during the EP. Secondary CRP end points of interest include change from baseline to 26 weeks, and for patients with CRP greater than or equal to one mg/dL at baseline, the time to CRP normalization, as well as the percentage of patients with normalized CRP at both eight and 26 weeks.

Recurrent pericarditis

Recurrent pericarditis refers to inflammation of the pericardium (the membrane or sac that surrounds the heart) that follows an initial episode (frequently resulting from a viral infection). Patients may have multiple recurrences. Symptoms include debilitating chest pain, shortness of breath and fatigue, resulting in physical limitations, reduced quality of life, emergency department visits and hospitalizations. Significant accumulation of pericardial fluid and scarring can progress to life-threatening constriction of the heart. The only Food and Drug Administration-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 per cent of patients with multiple recurrences (greater than one) 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 six-to-eight-day length of stay and cost per stay is estimated to range between $20,000 and $30,000 in the United States.

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, the 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.

Cardiol Therapeutics has received investigational new drug application authorization from the United States Food and Drug Administration (FDA) to conduct clinical studies to evaluate the efficacy and safety of CardiolRx in two diseases affecting the heart: (i) a phase II multicentre open-label pilot study in recurrent pericarditis (the MAvERIC-pilot study; NCT05494788), 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; and (ii) a phase II multinational, randomized, double-blind, placebo-controlled trial (the Archer trial; NCT05180240) 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 U.S. FDA has granted orphan drug designation to CardiolRx for the treatment of pericarditis, which includes recurrent pericarditis.

Cardiol Therapeutics 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.

We seek Safe Harbor.