Toronto, Ontario — November 13, 2025 — Leads & Copy — Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) has received a Notice of Allowance from the United States Patent and Trademark Office for its U.S. patent application entitled “Cannabidiol Compositions for Use in Treating Heart Conditions.” The clinical-stage life sciences company is developing anti-inflammatory and anti-fibrotic therapies for heart disease.
The new patent, once issued, will provide broad intellectual property protection for the use of CardiolRx™ and CRD-38 in the treatment or prevention of a wide range of cardiac conditions. These include heart failure, myocarditis, acute pericarditis, inflammatory cardiomyopathy, cardiac toxicity from anti-cancer therapies, and atherosclerosis. The protection extends to October 2040.
According to David Elsley, President and Chief Executive Officer of Cardiol Therapeutics, this milestone extends the company’s I.P. protection to the world’s largest pharmaceutical market. He added that the new patent allowance, combined with the U.S. Orphan Drug Designation for pericarditis, strengthens Cardiol’s market position and I.P. portfolio. This provides broad protection across a diverse range of heart diseases characterized by inflammation and fibrosis, reinforcing the long-term value of the company’s pipeline.
The company is advancing late-stage clinical programs in recurrent pericarditis and acute myocarditis, addressing inflammatory heart diseases with significant unmet medical needs. Cardiol is also preparing to initiate the first-in-human clinical evaluation of CRD-38, a novel subcutaneously administered therapy for inflammatory heart disease, including heart failure.
Dr. Andrew Hamer, Chief Medical Officer and Head of Research & Development of Cardiol Therapeutics, noted that the patent allowance comes at an opportune time, adding extensive intellectual property protection in new areas of heart disease. These areas have been identified for potential research expansion based on the recently reported topline ARCHER findings.
Comprehensive data from ARCHER, a randomized, double-blind, placebo-controlled Phase II trial of CardiolRx™ in acute myocarditis, will be presented at the upcoming European Society of Cardiology Annual Meeting in Trieste, Italy, on November 29. Insights into potential new development opportunities in myocarditis, as well as the positive implications for the CRD-38 program in heart failure, will also be provided.
An update on the pivotal Phase III MAVERIC trial in recurrent pericarditis will also be provided, as patient enrollment continues to accelerate across leading cardiovascular research centers in the U.S.
Cardiol Therapeutics Inc. is focused on advancing late-stage, anti-inflammatory, and anti-fibrotic therapies for heart disease. Its 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. The program includes the completed Phase II MAvERIC-Pilot study (NCT05494788) and the ongoing pivotal Phase III MAVERIC trial (NCT06708299). The U.S. FDA has granted Orphan Drug Designation to CardiolRx™ for the treatment of pericarditis, including recurrent pericarditis.
The ARCHER Program is studying CardiolRx™ 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 includes the completed Phase II 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, with associated healthcare costs in the United States exceeding US$30 billion per year.
Investor.relations@cardiolrx.com
Source: Cardiol Therapeutics Inc.
