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Cardiol Therapeutics Inc
Symbol CRDL
Shares Issued 111,680,087
Close 2026-02-10 C$ 1.45
Market Cap C$ 161,936,126
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Cardiol sees phase 2 Archer study results published

2026-02-10 17:15 ET - News Release

Mr. David Elsley reports

CARDIOL THERAPEUTICS' ARCHER PHASE II STUDY RESULTS PUBLISHED IN ESC HEART FAILURE

Cardiol Therapeutics Inc. has seen the publication of results from its phase 2 Archer study in ESC Heart Failure, a journal of the European Society of Cardiology.

The peer-reviewed article reports results from a randomized, double-blind, placebo-controlled trial evaluating CardiolRx, Cardiol's lead oral drug candidate, in 109 patients with acute myocarditis using advanced cardiac magnetic resonance imaging measures of myocardial inflammation and remodelling.

In the study, treatment with CardiolRx produced a significant reduction in left ventricular mass versus placebo, along with a decrease in left atrial remodelling, and favourable trends across multiple markers of myocardial inflammation. CardiolRx was also shown to be safe and well tolerated. Reduction in left ventricular mass is widely considered consistent with decreased myocardial edema and inflammatory burden in myocarditis and improved clinical outcomes.

The biological signals observed in Archer are directly relevant to Cardiol's continuing pivotal phase 3 Maveric trial in recurrent pericarditis. Myocarditis and pericarditis are inflammatory diseases of the myocardium and pericardium, respectively, and are recognized to fall within the spectrum of inflammatory myopericardial syndrome, an umbrella term describing the potential myocarditis-pericarditis overlap: similar causes, anatomical contiguous structures, and mixed forms with possible reciprocal involvement, such as myopericarditis and perimyocarditis.

"This publication marks an important moment in the broader dissemination of CardiolRx's therapeutic potential," said David Elsley, president and chief executive officer of Cardiol Therapeutics. "Archer provides additional compelling clinical evidence that CardiolRx impacts the underlying biology of inflammatory heart disease and reduces inflammation-driven structural damage in the heart, increasing our confidence in Maveric, which is focused on delivering meaningful outcomes for patients with recurrent pericarditis."

About Cardiol Therapeutics Inc.

Cardiol Therapeutics 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 is also studying 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.

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