Replimune(REPL)2025-02-12 13:06Regulatory Approvals - The FDA accepted the Biologics License Application (BLA) for RP1 plus nivolumab in advanced melanoma with a PDUFA date of July 22, 2025[1]. Financial Performance - Cash, cash equivalents, and short-term investments as of December 31, 2024, were 420.7 million as of March 31, 2024[11]. - Research and development expenses for the fiscal third quarter ended December 31, 2024, were 42.8 million for the same period in 2023, reflecting a 5.4% increase[11]. - Selling, general and administrative expenses for the fiscal third quarter ended December 31, 2024, were 13.7 million in the prior year, representing a 31.3% increase[11]. - The net loss for the fiscal third quarter ended December 31, 2024, was 51.1 million for the same period in 2023, indicating a 29.6% increase in losses[11]. - The total operating expenses for the fiscal third quarter ended December 31, 2024, were 56.5 million for the same period in 2023, reflecting a 16.1% increase[11]. - The company completed a public offering raising approximately $156.0 million net of issuance costs to fund the continued development of its RPx platform[11]. - The company believes existing cash will fund operations into the fourth quarter of 2026, excluding any potential revenue[8]. Clinical Trials - The company enrolled the first patient in a registration-directed study of RP2 in metastatic uveal melanoma, targeting approximately 280 patients[4]. - The company also enrolled the first patient in a Phase 2 clinical trial of RP2 combined with atezolizumab and bevacizumab in hepatocellular carcinoma, with a total enrollment of 30 patients[5].