Cardiol Therapeutics' Phase II ARCHER Trial Results to be Presented at the European Society of Cardiology Scientific Meeting on Myocardial & Pericardial Diseases

Executive Summary

• Cardiol Therapeutics will present full Phase II ARCHER trial data for CardiolRx™ at the ESC Myocardial & Pericardial Disease meeting (Nov 29, 2025) and host a webcast investor call on Dec 1, 2025.
• The topline results previously disclosed showed significant reductions in extracellular volume and left‑ventricular mass after 12 weeks of therapy in acute myocarditis patients, representing the first structural recovery proof‑of‑concept for this indication.
• ARCHER enrolled 109 patients across the U.S., France, Brazil and Israel; the upcoming presentation will provide comprehensive safety, tolerability, and efficacy details, underscoring CardiolRx™’s potential to expand into broader heart‑failure populations.

Key Details

• Trial Overview: ARCHER – randomized, double‑blind, placebo‑controlled Phase II study of CardiolRx™ in acute myocarditis with preserved LV function.
• Enrollment: 109 patients from leading cardiovascular centers in the United States, France, Brazil, and Israel.
• Topline Findings (previously released):
• Notable improvement in cardiac extracellular volume.
• Significant reduction in left‑ventricular mass comparable to effects seen with major obesity, hypertension, and heart‑failure therapies.
• Presentation Details:
• Oral session at the European Society of Cardiology Working Group on Myocardial & Pericardial Disease (ESC M&PD) meeting, Trieste, Italy – November 29, 2025.
• Presenter: Dr. Leslie T. Cooper, Jr., Mayo Clinic (Steering Committee Co‑Chair).
• Webcast Investor Call:
• Date/Time: December 1, 2025 at 8:30 a.m. EST.
• Access: Telephone dial‑in (877‑346‑6112 US/Canada; +1‑848‑280‑6350 International) and live listen‑only webcast on Cardiol’s investor website (archived ~90 days).
• Management Comments:
• Dr. Andrew Hamer (CMO & Head of R&D) highlighted the importance of the ESC forum for advancing inflammatory heart disease therapies.
• David Elsley (President & CEO) emphasized that ARCHER provides the first evidence of structural recovery and reverse remodeling in acute myocarditis, supporting broader development for chronic heart‑failure indications.
• Future Development Implications:
• Data will inform ongoing Phase III MAVERIC trial (recurrent pericarditis) and upcoming programs such as CRD‑38 (subcutaneous formulation for heart failure).
• U.S. FDA has granted Orphan Drug Designation to CardiolRx™ for pericarditis.

Notable Quotes

• Dr. Andrew Hamer: “The ESC M&PD meeting is an important global forum… We are honored to have Dr. Cooper present the ARCHAR results at this prestigious meeting.”
• David Elsley (CEO): “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 underlying inflammatory processes driving myocardial injury.”