Replimune Group (REPL) investor relations material

Company overview and pipeline

• Focused on next-generation oncolytic immunotherapies using an HSV platform with transgenes to stimulate the immune system.

• Lead asset RP1 targets advanced melanoma, with a PDUFA date set for April 10th and launch readiness underway.

• RP2, encoding CTLA-4, is in a registrational trial for uveal melanoma, enrolling well globally.

• Additional trials in HCC and BTC are progressing, aiming to expand into more prevalent tumor types.

Regulatory and clinical progress

• RP1 received Breakthrough Therapy designation and priority review after IGNYTE-2 data; initial BLA received a complete response letter due to FDA leadership changes.

• BLA was resubmitted and accepted, with ongoing information requests addressed ahead of the April 10th PDUFA.

• IGNYTE-3 confirmatory study is enrolling well, expanding internationally, and is considered sufficient for regulatory purposes.

Efficacy, safety, and clinical positioning

• RP1 plus nivolumab showed a 33% response rate in anti-PD-1 failed melanoma, with a favorable safety profile and durable responses over two years.

• Strong support from physicians and patient advocacy groups highlights the high unmet need in this space.

• RP1 is positioned as the next treatment after PD-1 failure, suitable for a broad range of patient types.