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Dec 31, 2024
Replimune Q3 2025 Earnings Report
Replimune announced financial results for the fiscal third quarter ended December 31, 2024 and provided a business update.
Key Takeaways
Replimune reported significant regulatory milestones for RP1 in anti-PD-1 failed melanoma, with the FDA accepting the BLA for RP1 plus nivolumab in advanced melanoma for priority review and setting a PDUFA date of July 22, 2025. The company is focused on ensuring a successful commercial launch of RP1 upon approval and is well-capitalized with over $500 million in cash to execute its plans.
FDA accepted the Biologics License Application (BLA) for RP1 plus nivolumab in advanced melanoma for priority review with a PDUFA date of July 22, 2025.
IGNYTE-3 confirmatory trial of RP1 plus nivolumab in advanced melanoma is enrolling.
Enrolled first patients in trials evaluating RP2 for the treatment of metastatic uveal melanoma and hepatocellular carcinoma
Company believes that existing cash, cash equivalents and short-term investments, as of December 31, 2024 will enable the Company to fund operations into the fourth quarter of 2026
Replimune
Replimune
Forward Guidance
Based on the current operating plan, the Company believes that existing cash, cash equivalents and short-term investments, as of December 31, 2024 will enable the Company to fund operations into the fourth quarter of 2026 which includes scale up for the potential commercialization of RP1 in skin cancers and for working capital and general corporate purposes and excludes any potential revenue.