Cardiol Therapeutics Announces Year-End 2025 Update on Operations

Executive Summary

• Initiated pivotal Phase III MAVERIC trial for CardiolRx™ in recurrent pericarditis and surpassed 50% patient enrollment; full enrollment expected Q2 2026.
• Reported positive Phase II ARCHER data showing a statistically significant reduction in left‑ventricular mass (−9.2 g, p=0.0117) in acute myocarditis patients; results published in ESC Heart Failure.
• Completed $31 million of financing (private placement $16 M + bought‑deal financing $14.85 M) extending cash runway into Q4 2027.

Key Details

• Phase III MAVERIC Trial
• Randomized, double‑blind, placebo‑controlled; target ≈110 patients at 25 U.S. sites.

• 50% of enrollment achieved as of April 2026; full enrollment projected Q2 2026.

• Designed to support a New Drug Application (NDA) for CardiolRx™ in recurrent pericarditis.

• Phase II ARCHER Trial

• Conducted in 109 acute myocarditis patients across 34 sites in five countries.
• Top‑line results (Aug 2025): LV mass reduced by 9.2 g (p=0.0117); multiple CMR endpoints improved after 12 weeks of treatment.

• Full data presented at ESC Scientific Meeting (Nov 2025) and published in ESC Heart Failure (Feb 2026).

• CRD‑38 Program

• Advanced IND‑enabling studies; formulation optimization, PK & toxicology completed.

• Preparing IND submission and initiation of Phase I clinical development for inflammatory heart diseases, including heart failure.

• Intellectual Property

• U.S. patent allowance (Nov 2025) broadly covering CardiolRx™ and CRD‑38 for treatment/prevention of a wide range of cardiac conditions through Oct 2040.

• Board Appointment

• Dr. Timothy J. Garnett, former CMO of Eli Lilly, elected to Board of Directors (May 2025).

• Financing

• Private placement: $16 M (Oct 2025).
• Bought‑deal financing: $14.85 M gross proceeds (Jan 2026), with full over‑allotment exercised.

• Total cash raised: ~$31 M, providing runway to Q4 2027.

• Outlook

• Complete MAVERIC enrollment and generate pivotal data for potential NDA submission.
• Launch Phase I trial of CRD‑38 as a second value driver.
• Pursue strategic partnerships and expand KOL collaborations based on ARCHER results.

Notable Quotes

“2025 was a pivotal year of clinical execution and strategic advancement… We are now fully funded through completion of the MAVERIC trial…” – David Elsley, President & CEO

“The pace of enrollment in MAVERIC reflects strong investigator confidence… an oral, accessible, non‑immunosuppressive therapy that could be used prior to corticosteroids and biologics.” – Dr. Andrew Hamer, Chief Medical Officer

“The results of ARCHER are the first … demonstrating improvements in key measures of cardiac structure and remodeling in patients with myocarditis.” – Dr. Dennis M. McNamara, Professor of Medicine, University of Pittsburgh