Replimune Group (REPL) Goldman Sachs 45th Annual Global Healthcare Conference summary

Clinical development highlights

• Two clinical assets, RP1 and RP2, are advancing, with RP1 targeting skin cancers and RP2 focusing on rare and hard-to-treat cancers.

• RP1 is on track for a BLA filing in the second half of 2024, with a confirmatory phase III trial (IGNITE-3) enrolling in Q3.

• RP2 is moving toward a registrational study in uveal melanoma, with promising early data in other rare tumors.

• Both assets demonstrate systemic and visceral activity, with robust safety profiles.

• Manufacturing capabilities are established for global supply, with commercial inventory underway.

RP1 efficacy and safety in melanoma

• In anti-PD-1 failed melanoma, RP1 plus nivolumab showed a 32.7% response rate in a real-world, high unmet need population.

• Durable responses observed, with a median duration exceeding 36 months and favorable safety (mostly grade 1/2 side effects).

• Central review confirmed consistent efficacy (33.6% response rate) and robust safety.

• FDA feedback incorporated, including RECIST 1.1 analysis and real-world population criteria.

• Confirmatory phase III trial will use overall survival as the primary endpoint.

RP1 in organ transplant and non-melanoma skin cancers

• Monotherapy RP1 in organ transplant patients with cutaneous squamous cell carcinoma showed a 35% response rate and 22% complete response, with no organ rejection.

• Opportunity for a registrational path in this high unmet need population, with a growing patient base.

• In the CERPASS trial, RP1 plus cemiplimab doubled the complete response rate in locally advanced CSCC compared to cemiplimab alone.

• RP1 shows potential for broad adoption in the U.S. across various skin cancer settings, including community practices.