Replimune Group (REPL) 43rd Annual J.P. Morgan Healthcare Conference 2025 summary

Key clinical and regulatory updates

• RP1 achieved a 30–34% durable response rate in anti-PD-1 failed melanoma, with median response duration of 21.6 months and strong systemic activity, including visceral lesions.

• RP1 received FDA Breakthrough Designation and BLA submission, with acceptance expected soon and a commercial launch targeted for the second half of 2025.

• Confirmatory phase III IGNYTE-3 trial is enrolling globally with a primary overall survival endpoint, expected to take two to three years.

• Expanded access program initiated for advanced melanoma patients outside traditional trial sites.

• RP2 showed a 29–30% response rate and 60% disease control in uveal melanoma, with pivotal and confirmatory studies underway.

Commercial strategy and market opportunity

• Targeting approximately 13,000 patients progressed on PD-1 regimens, with 80% estimated to be injectable in outpatient settings and strong interventional radiology partnerships.

• Commercial model leverages concentrated treatment centers, supporting co-management in academic and large community networks.

• Field force to include about 30 sales reps and a total of 65 field-facing staff, including nurse educators and interventional radiology coordinators.

• Off-the-shelf therapy, favorable economics, and in-house manufacturing support rapid and broad uptake, with a 63,000 ft² US facility for global supply.

• Ongoing market education and profiling of 200 key accounts to ensure seamless launch and patient access.

Differentiation and product attributes

• RP1 demonstrates systemic benefit, especially in visceral uninjected lesions, with nearly two-thirds achieving significant response.

• Safety profile is favorable, with mostly mild immune-related symptoms, most adverse events grade 1 or 2, and no grade five toxicities.

• Product attributes include outpatient administration, immediate availability, and compatibility with standard buy-and-bill reimbursement codes.

• Interventional radiologists report the injection procedure is simple and low-risk, supporting broad adoption.

• RP1 and RP2 are being evaluated in additional indications, including non-melanoma skin cancers and hepatocellular carcinoma.