Cardiol Therapeutics (CRDL) H.C. Wainwright 28th Annual Global Investment Conference summary

Strategic focus and pipeline overview

• Focused on anti-inflammatory therapies for cardiovascular diseases, with a lead program in recurrent pericarditis and ambitions to expand into broader heart failure indications.

• Lead program nearing completion of pivotal phase III enrollment, targeting a growing market with significant unmet need.

• Plans to read out pivotal phase III data, advance a next-stage heart failure asset, and pursue a New Drug Application with Orphan Drug Designation for pericarditis within 12-24 months.

• Second-stage asset (CRD-38) expected to enter first-in-human trials within the next year, aiming for mass-market chronic conditions.

MAVERIC trial design and expectations

• MAVERIC phase III trial targets 110 patients across up to 24 specialized centers, with 75% enrollment already achieved.

• Trial is powered for 90% probability to detect a 40% relative risk reduction in recurrence, with a well-established 75% placebo event rate.

• Overlap period with rilonacept withdrawal is designed to ensure robust exposure to the investigational drug, minimizing risk of early recurrence.

• Phase II data showed a reduction in annualized event rate from 5.8 to 0.9 events per year, supporting strong expectations for phase III.

• Clinically meaningful results are expected with even a 35% reduction in event rates, which would drive rapid adoption in practice.

Regulatory and commercial outlook

• Trial design and enrichment strategy are aligned with FDA guidance, mirroring successful precedent set by rilonacept's approval.

• Orphan Drug Designation secured for pericarditis, with potential for a broad label across the disease spectrum.

• Commercial strategy options include partnerships, licensing, or building a specialized sales force, with flexibility to adapt based on trial outcomes.

• Drug positioned as an accessible, oral, and potentially disease-modifying therapy, with pricing expected to be more attractive and convenient than current immune-suppressing options.