Cardiol Therapeutics (CRDL) investor relations material

Strategic focus and pipeline overview

• Focused on developing therapies targeting inflammation and fibrosis in heart disease, with late-stage programs for recurrent pericarditis, acute myocarditis, and heart failure.

• Lead asset CardiolRx™ is in Phase III for recurrent pericarditis (MAVERIC) and completed Phase II for acute myocarditis (ARCHER), both showing promising clinical results.

• CRD-38, a novel subcutaneous cannabidiol formulation, is in IND-enabling studies for heart failure, targeting a multi-billion-dollar market.

• CardiolRx™ has FDA Orphan Drug Designation for pericarditis and is positioned as a non-immunosuppressive, disease-modifying oral therapy.

Clinical trial highlights and results

• MAVERIC Phase II showed rapid, durable pain reduction and inflammation control in recurrent pericarditis, with 71% of patients experiencing no recurrence during the extension period.

• ARCHER Phase II demonstrated significant reductions in left ventricular mass and trends toward reduced extracellular and intracellular volumes in acute myocarditis, comparable to leading heart failure drugs.

• Both trials confirmed CardiolRx™ was safe and well tolerated, supporting advancement to pivotal Phase III and further development.

Market opportunity and positioning

• CardiolRx™ targets a U.S. recurrent pericarditis population of over 40,000, with a market opportunity exceeding $1 billion as a second-line therapy.

• Heart failure affects over 64 million globally, with no approved therapies targeting inflammation/fibrosis; CRD-38 aims to address this unmet need.

• Strategic partnerships and expanded indications are key to maximizing commercial potential.