Replimune(REPL)2025-05-22 12:05Financial Performance - As of March 31, 2025, cash, cash equivalents, and short-term investments were $483.8 million, up from $420.7 million as of March 31, 2024, primarily due to a public offering in November 2024[9] - Research and development expenses for the fiscal fourth quarter were $54.0 million, compared to $42.6 million for the same period in 2024, and $189.4 million for the fiscal year, up from $175.0 million in 2024[14] - Selling, general and administrative expenses were $25.4 million for the fiscal fourth quarter, compared to $16.2 million in the same quarter of 2024, and $72.2 million for the fiscal year, up from $59.8 million in 2024[14] - The net loss for the fiscal fourth quarter was $74.1 million, compared to a net loss of $55.1 million for the same period in 2024, and the total net loss for the fiscal year was $247.3 million, up from $215.8 million in 2024[14] - The company believes existing cash will fund operations into the fourth quarter of 2026, excluding any potential revenue[9] Clinical Trials and Research - The company estimates approximately 13,000 patients progress on or after PD-1 treatment annually in the U.S., with about 80% eligible for treatment with RP1[3] - The confirmatory Phase 3 trial, IGNYTE-3, is expected to enroll 400 patients globally, assessing RP1 in combination with nivolumab in patients with advanced melanoma[7] - The registration-directed REVEAL trial of RP2 in metastatic uveal melanoma is currently enrolling approximately 280 patients[5] - The Phase 2 clinical trial of RP2 combined with atezolizumab and bevacizumab in hepatocellular carcinoma is expected to enroll 30 patients[6] Regulatory Updates - The FDA has indicated no advisory committee is planned for the biologics license application, which remains on schedule ahead of the July 22, 2025 PDUFA date[7]