Mr. David Elsley reports

CARDIOL THERAPEUTICS EXPANDS U.S. MAVERIC PHASE III TRIAL NETWORK TO ADDRESS GROWING INTEREST IN THE PIVOTAL PROGRAM

Cardiol Therapeutics Inc. has continued the expansion of its pivotal phase 3 Maveric trial in the United States, with the planned activation of up to seven additional clinical centres. Patient enrolment in Maveric surpassed the 50-per-cent threshold in early January and has reached 75 per cent. Target recruitment is anticipated by the end of second quarter 2026, with the potential to extend into third quarter to accommodate patient enrolment from additional clinical sites.

"Broadening the Maveric clinical site network reflects the strong interest we have received from leading clinical centres across the United States and underscores the level of investigator conviction in both the therapeutic rationale and the unmet need in recurrent pericarditis," said David Elsley, president and chief executive officer of Cardiol Therapeutics. "The participation of multiple premier cardiovascular research institutions gives us confidence that Maveric will generate a robust data set to define the clinical profile of CardiolRx and support its potential as a non-immunosuppressive oral, more accessible therapy earlier in the treatment pathway."

Maveric phase 3 trial

Maveric is a randomized, double-blind, placebo-controlled pivotal phase 3 trial evaluating CardiolRx for the prevention of disease recurrence in patients with recurrent pericarditis. The study is designed to enroll approximately 110 patients. Maveric was designed with input from the U.S. Food and Drug Administration, with alignment on trial design achieved at an end-of-phase-2 meeting in April, 2025. The first patient was randomized at Northwestern University in April, 2025.

Phase 2 foundation

Maveric builds on the clinical evidence established in the phase 2 Maveric study, which demonstrated that CardiolRx produced rapid and sustained reductions in pericarditis pain and inflammation, along with a substantial decrease in recurrent episodes per year. These findings, presented at the American Heart Association Scientific Sessions 2024, provide a compelling clinical and mechanistic foundation for the continuing pivotal phase 3 program and support the potential for CardiolRx to address a significant unmet need in recurrent pericarditis.

About pericarditis

Pericarditis refers to inflammation of the pericardium (the membrane or sac that surrounds the heart), which frequently results from a viral infection. Patients may have multiple recurrences following that initial episode, and the primary goal of treatment is recurrence prevention. 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. On an annual basis, the number of patients in the United States experiencing at least one recurrence is estimated at 40,000. Approximately 60 per cent of patients with more than one recurrence suffer for more than two years, and one-third remain impacted at five years. Hospitalization due to recurrent pericarditis is typically associated with a six- to eight-day stay, and the cost per stay is estimated to range between $20,000 and $30,000 in the United States.

About Cardiol Therapeutics Inc.

Cardiol is a late-stage life science company focused on advancing the development of anti-inflammatory and anti-fibrotic therapies for heart disease. The company's lead small-molecule drug candidate, CardiolRx, modulates inflammasome pathway activation, an intracellular process known to play an important role in the development and progression of inflammation and fibrosis associated with pericarditis, myocarditis and heart failure.

The Maveric program is evaluating CardiolRx for the treatment of recurrent pericarditis, an inflammatory disease of the pericardium associated with symptoms including debilitating chest pain, shortness of breath and fatigue, which can lead to physical limitations, reduced quality of life, emergency department visits and hospitalizations. The program comprises the completed phase 2 Maveric pilot study (NCT05494788) and the continuing pivotal phase 3 Maveric trial (NCT06708299). The U.S. Food and Drug Administration has granted orphan drug designation to CardiolRx for the treatment of pericarditis, including recurrent pericarditis.

The Archer program also studied CardiolRx, specifically in acute myocarditis -- an important cause of acute and fulminant heart failure in young adults and a leading cause of sudden cardiac death in individuals under 35 years of age. The program comprises the completed phase 2 Archer study (NCT05180240), which evaluated the safety, tolerability and efficacy of CardiolRx in this patient population.

The company is also developing CRD-38, a novel, subcutaneously administered drug formulation intended for the treatment of inflammatory heart disease, including heart failure -- a leading cause of death and hospitalization in the developed world, with associated health care costs in the United States exceeding $30-billion (U.S.) per year.

We seek Safe Harbor.