Cardiol Therapeutics (CRDL) investor relations material

Strategic focus and pipeline highlights

• Targeting inflammation as a key mechanism in heart disease, with late-stage and early-stage programs addressing orphan and broader indications.

• MAVERIC, the lead program, is in phase III for recurrent pericarditis, with enrollment accelerating and top-line data expected in late 2024.

• ARCHER trial in myocarditis demonstrated the first biological impact by any medicine, supporting the MAVERIC program and opening new opportunities.

• All current developments are fully funded, supporting strategic alliances for commercialization.

• CRD-38, a next-generation once-monthly subQ formulation, is being advanced for heart failure and attracting strategic partner interest.

Clinical trial results and data

• Phase II MAVERIC trial showed rapid, durable pain reduction and significant decrease in pericarditis recurrence, with 71% of patients recurrence-free.

• CardiolRx demonstrated normalization of C-reactive protein and sustained efficacy as monotherapy.

• ARCHER trial in myocarditis showed a significant reduction in left ventricular mass in just 12 weeks, comparable to leading therapies over longer periods.

• CMR improvements in ARCHER align with myocardial recovery and de-risk the MAVERIC phase III program.

• Phase III MAVERIC trial design is conservatively powered, aiming for at least 35-40% reduction in recurrence, with phase II having achieved 70%.

Market opportunity and positioning

• Immunosuppressants for pericarditis are generating nearly $700 million annually, forecasted to reach $1 billion by 2028, but leave many patients without good options.

• CardiolRx aims to be a more accessible, oral, non-immunosuppressive alternative, potentially displacing steroids and preceding IL-1 blockers in treatment algorithms.

• Physicians express strong interest in a non-immunosuppressive, oral therapy that could become second-line after NSAIDs and colchicine.

• Strategic alliances are being pursued for commercialization and broader market reach.