Cardiol's Archer data to be presented Nov. 29

Executive Summary

• Cardiol Therapeutics will present full data from its Phase II Archer trial, a randomized double-blind, placebo-controlled study of CardiolRx in patients with acute myocarditis, at the European Society of Cardiology (ESC) Scientific Meeting on Myocardial & Pericardial Diseases in Trieste, Italy.
• The presentation, led by Dr. Leslie T. Cooper Jr. and co-chairs of the steering committee, will provide comprehensive insights into CardiolRx's effects on myocardial inflammation and remodeling, highlighting a reduction in left ventricular mass comparable to blockbuster therapies for obesity, hypertension, and heart failure.
• The company will host a webcast conference call on December 1, 2025, to discuss the clinical findings, implications for future development, and next steps for CardiolRx and other programs in inflammatory heart disease.

Key Details

• Trial Name: Archer (Phase II, randomized, double-blind, placebo-controlled, multicentre).
• Indication: Acute myocarditis.
• Drug Candidate: CardiolRx (small molecule modulating inflammasome pathway activation).
• Presentation Date: November 29, 2025.
• Presentation Venue: Annual meeting of the European Society of Cardiology working group on myocardial and pericardial disease, Trieste, Italy.
• Presenters: Dr. Leslie T. Cooper Jr., Elizabeth C. Lane, PhD, and M. Nadine Zimmerman, PhD (Mayo Clinic, Jacksonville, Fla.), on behalf of the Archer investigators.
• Key Findings Highlighted:
  • Reduction in left ventricular mass comparable to blockbuster therapies in obesity, hypertension, and heart failure.
  • Evidence of structural recovery and reverse remodeling in patients with acute myocarditis and preserved left ventricular function.
  • Implications for addressing chronic inflammation in the broader heart failure population.
• Trial Design & Enrollment:
  • Enrolled 109 patients.
  • Sites included leading cardiovascular research centers in the United States, France, Brazil, and Israel.
  • Investigated safety, tolerability, and impact on myocardial recovery.
  • Design and rationale published in ESC Heart Failure on June 27, 2024.
• Upcoming Event: Webcast conference call scheduled for December 1, 2025, at 8:30 a.m. EST.
  • Dial-in (US/Canada): 877-346-6112.
  • Dial-in (International): 1-848-280-6350.
  • Live webcast with slides available on the Cardiol Therapeutics investor website.

Notable Quotes

• Dr. Andrew Hamer, Chief Medical Officer and Head of R&D: "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 remodelling."
• David Elsley, President and CEO: "The previously reported positive top-line results from our phase 2 Archer clinical trial provided compelling clinical proof of concept for CardiolRx, demonstrating notable improvements in cardiac structure after 12 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 remodelling in this patient population."