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Cardiol to present comprehensive findings from Phase II ARCHER trial at ESC M&PD meeting

Cardiol Therapeutics (NASDAQ: CRDL; TSX: CRDL) has announced that the full data from ARCHER—a randomized double-blind, placebo-controlled, multi-center Phase II clinical trial of CardiolRx in patients with acute myocarditis—will be presented in an oral session at the Annual Meeting of the European Society of Cardiology (ESC) Working Group on Myocardial & Pericardial Disease (M&PD) in Trieste, Italy, on November 29, 2025.

The presentation will provide comprehensive findings from the ARCHER trial for the first time following Cardiol’s August 2025 reporting of topline results.

Dr. Leslie T. Cooper, Jr., the Elizabeth C. Lane, Ph.D., and M. Nadine Zimmerman, Ph.D. Professor of Internal Medicine at the Mayo Clinic in Jacksonville, Florida, and Co-Chair of the Steering Committee for the ARCHER trial will present on behalf of the ARCHER investigators. Dr. Cooper’s presentation is expected to provide comprehensive insights into CardiolRx’s effects on myocardial inflammation and remodeling, highlighting a reduction in left ventricular mass comparable to that achieved with blockbuster therapies in obesity, hypertension, and heart failure, and implications for future development to address chronic inflammation in the broader heart failure population.

In a statement, Dr. Andrew Hamer, CMO and Head of Research & Development of Cardiol, commented, “The ESC M&PD meeting is an important global forum that unites leading clinicians and scientists advancing the understanding and treatment of myocarditis, pericarditis, and other inflammatory heart diseases. This year’s program is timely given the growing interest in and recognition of inflammation as a central driver of cardiac injury and remodeling. We are honored to have Dr. Cooper, one of the world’s foremost authorities in myocarditis, present the ARCHER results at this prestigious meeting dedicated to myopericardial diseases.”

David Elsley, President and CEO of Cardiol, remarked, “The previously reported positive topline results from our Phase II ARCHER clinical trial provided compelling clinical proof of concept for CardiolRx, demonstrating notable improvements in cardiac structure after twelve weeks of blinded therapy in patients with acute myocarditis and preserved left ventricular function. These findings represent the first evidence of a drug’s efficacy on structural recovery and reverse remodeling in this patient population, underscoring the potential of CardiolRx to address the underlying inflammatory processes driving myocardial injury. The forthcoming presentation will further characterize the therapeutic profile of CardiolRx as a novel, anti-inflammatory strategy with the potential to significantly improve the treatment landscape not only for acute myocarditis, but also for the broader population of patients suffering from chronic heart failure, where inflammation is a fundamental mechanism leading to the development and progression of disease.”

ARCHER enrolled 109 patients from leading cardiovascular research centers in the United States, France, Brazil, and Israel, and investigated the safety, tolerability, and impact of CardiolRx™ on myocardial recovery in patients presenting with acute myocarditis. The design and rationale for ARCHER were published on June 27, 2024, in the journal ESC Heart Failure.

Cardiol will host a webcast conference call at 8:30 a.m. EST on December 1, 2025, following the presentation at the ESC M&PD meeting. Members of the company’s management team will discuss the clinical findings of the ARCHER trial, implications for future development, and next steps in advancing Cardiol’s programs in inflammatory heart disease.

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