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

Key clinical data and pipeline progress

• RP1 achieved breakthrough designation in anti-PD-1 failed melanoma, showing a 34% response rate, median duration of 21.6 months, and 55% three-year survival, with systemic activity in visceral lesions and favorable safety profile.

• RP2 advanced into registration studies for uveal melanoma and hepatocellular carcinoma, with a 29–30% response rate and 60% disease control in uveal melanoma; first patients enrolled in pivotal studies.

• Confirmatory phase III IGNITE-3/IGNYTE-3 trial for RP1 is enrolling globally, expected to take two to three years, supporting global pricing and reimbursement.

• Expanded access program launched to broaden patient reach outside traditional clinical trial sites for advanced melanoma.

• RP1 and RP2 are being evaluated in additional indications, including non-melanoma skin cancers, solid organ transplant patients, and liver metastases, with response rates around 30–35%.

Commercial strategy and market preparation

• Priority U.S. launch for RP1 planned for the second half of 2025, supported by over $500 million in cash and in-house manufacturing.

• Market opportunity estimated at 13,000 patients progressed on PD-1 regimens, with 80% injectable by RP1, mostly in outpatient settings and supported by established reimbursement codes.

• Commercial model leverages concentrated treatment centers, with 80% of patients in academic or large community networks, and strong collaboration with interventional radiology.

• Field force to include about 30 sales reps and a total field-facing team of 65, plus medical affairs and interventional radiology coordinators.

• Ongoing market education, account profiling, and patient support hub development to ensure seamless launch and uptake.

Regulatory milestones and timelines

• BLA for RP1 submitted in late November, with FDA decision expected late January or early February and priority review anticipated.

• Manufacturing inspections and PDUFA date to follow, with approval targeted by end of summer 2025.

• IGNITE-3/IGNYTE-3 confirmatory trial enrollment aligns with FDA guidance, with global expansion underway and over 100 sites planned.

• R&D day planned for first half of 2025 to provide further pipeline and strategy updates.

• 2025 milestones include RP1 BLA acceptance, commercial launch, and continued enrollment in pivotal trials for RP2.