Replimune Reports Fiscal Fourth Quarter and Year End 2025 Financial Results and Provides Corporate Update

Core Insights - Replimune Group, Inc. is preparing for the commercial launch of its lead product candidate RP1 for advanced melanoma, with a PDUFA date set for July 22, 2025 [2][6][7] - The company reported a net loss of $74.1 million for the fiscal fourth quarter and $247.3 million for the fiscal year ended March 31, 2025, compared to a net loss of $55.1 million and $215.8 million for the same periods in the previous year [9][19] - As of March 31, 2025, Replimune's cash position was $483.8 million, an increase from $420.7 million a year earlier, which is expected to fund operations into the fourth quarter of 2026 [8][20] Business Update - The commercial organization is fully hired and ready to execute the launch plan for RP1, which is designed for outpatient treatment of advanced melanoma patients [2][6] - Approximately 13,000 patients in the U.S. progress on or after PD-1 treatment annually, with around 80% eligible for RP1 treatment [2] - The company has established distribution channels and completed the build-out of its commercial infrastructure, including hiring and training customer-facing teams [7] Clinical Development - Enrollment is ongoing in the confirmatory Phase 3 trial IGNYTE-3, which aims to assess RP1 in combination with nivolumab in patients with advanced melanoma who have progressed on prior therapies [7] - The registration-directed REVEAL trial of RP2 in metastatic uveal melanoma is currently enrolling approximately 280 patients [7] - A Phase 2 clinical trial of RP2 combined with atezolizumab and bevacizumab in hepatocellular carcinoma (HCC) is also in progress, expected to enroll 30 patients [7] Financial Performance - Research and development expenses for the fiscal fourth quarter were $54.0 million, up from $42.6 million in the previous year, primarily due to increased personnel-related costs [14] - Selling, general and administrative expenses were $25.4 million for the fiscal fourth quarter, compared to $16.2 million for the same period last year [14] - Total operating expenses for the fiscal year ended March 31, 2025, were $261.6 million, compared to $234.8 million in the previous year [19]