Cardiol Therapeutics (CRDL) Canaccord Genuity's 46th Annual Growth Conference summary

Clinical program overview

• Lead program is a fully synthetic, pharmaceutically manufactured cannabidiol formulation targeting recurrent pericarditis, currently in a pivotal phase III trial (MAVERIC).

• The trial focuses on patients coming off long-term rilonacept, addressing a high unmet need for non-immunosuppressive therapies.

• CardiolRx demonstrated a reduction in recurrence rates from 5.8 to 0.9 events per year in phase II, with 71% of patients recurrence-free during the extension phase.

• Phase III is powered for a 40% relative risk reduction, targeting a clinically meaningful decrease in recurrence rates.

• The trial design closely mirrors the RHAPSODY trial for rilonacept, ensuring robust and interpretable results.

Regulatory and market positioning

• Anticipates a label for prevention of recurrence, similar to IL-1 blockers, based on regulatory discussions and trial design.

• Oral, non-immunosuppressive profile positions CardiolRx as a potential replacement for steroids and an option for patients intolerant to NSAIDs or colchicine.

• KOLs see potential for CardiolRx to move up in the treatment paradigm, possibly even as first-line therapy for those intolerant to standard options.

• Recent negative results from IL-6 inhibitor trials in atherosclerosis do not impact the approach to pericarditis, as IL-1 remains the key target.

• Non-immunosuppressive mechanism is highlighted as a major advantage, especially given infection risks with immunosuppressive therapies.

Commercial strategy and pricing

• Pricing studies suggest CardiolRx could be priced up to 60% of rilonacept, supporting profitability and payer acceptance.

• Commercial infrastructure will leverage specialty pharmacies and targeted sales, focusing on major pericardial practices.

• Plans include intensifying discussions with commercial partners ahead of phase III data, with flexibility for direct or partnered commercialization.

• Payer assist programs are seen as central, with the potential for CardiolRx to serve as a bridge off long-term biologic therapy, increasing market penetration.

• The growing market for IL-1 blockers and high demand for oral options reinforce the commercial opportunity.