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Mar 31, 2025
Replimune Q4 2025 Earnings Report
Replimune reported its fiscal fourth quarter and year-end 2025 financial results, highlighting progress in clinical trials and commercial readiness for RP1.
Key Takeaways
Replimune reported a net loss of $74.1 million for the fiscal fourth quarter of 2025, compared to a net loss of $55.1 million in the same period last year. The company's cash position increased to $483.8 million, driven by a public offering. Research and development expenses rose due to scaling operations for the commercial launch of RP1.
BLA priority review of RP1 plus nivolumab in advanced melanoma is on schedule, with manufacturing inspections and late cycle review complete.
Full commercial infrastructure for RP1 launch is in place ahead of the July 22nd PDUFA date.
Cash, cash equivalents, and short-term investments totaled $483.8 million as of March 31, 2025, an increase from $420.7 million in the prior year.
Net loss for the fiscal fourth quarter was $74.1 million, compared to $55.1 million in the same period last year.
Forward Guidance
Replimune anticipates that existing cash, cash equivalents, and short-term investments will fund operations into the fourth quarter of 2026, supporting the potential commercialization of RP1 in skin cancers and general corporate purposes, excluding any potential revenue.
Positive Outlook
- BLA priority review of RP1 plus nivolumab in advanced melanoma is proceeding on schedule.
- Manufacturing inspections and late cycle review meeting for RP1 are complete.
- Full commercial infrastructure for RP1 launch is in place ahead of the July 22nd PDUFA date.
- The Company believes existing cash will fund operations into Q4 2026.
- Enrollment is ongoing in the confirmatory Phase 3 trial, IGNYTE-3, for RP1.
Challenges Ahead
- The company's ability to generate positive clinical trial results for product candidates is a risk.
- The costs and timing of operating the in-house manufacturing facility pose a risk.
- Regulatory approvals and their timing are subject to uncertainty.
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