Replimune Reports Fiscal Fourth Quarter and Year Ended 2024 Financial Results and Provides Corporate Update

Core Insights - Replimune Group, Inc. is advancing its lead product candidate RP1 (vusolimogene oderparepvec) for the treatment of anti-PD1 failed melanoma, with a 12-month primary analysis expected in Q2 2024 and a Biologics License Application (BLA) submission anticipated in the second half of 2024 [1][2][4] Clinical Development Updates - The company has successfully completed a Type C meeting with the FDA, confirming alignment on Chemistry, Manufacturing and Controls (CMC) plans for the BLA submission [3][4] - Enrollment of the first patients in the Phase 3 confirmatory trial (IGNYTE-3) for RP1 is expected to begin in the second half of 2024 [1][5] - Positive six-month follow-up data from the IGNYTE clinical trial indicated efficacy and safety of RP1 combined with nivolumab in patients with anti-PD-1 failed melanoma [4] Financial Performance - As of March 31, 2024, the company reported cash, cash equivalents, and short-term investments of $420.7 million, down from $583.4 million a year earlier, primarily due to cash utilized in operating activities [9] - Research and development expenses for the fourth quarter were $42.6 million, and $175.0 million for the fiscal year, compared to $37.9 million and $126.5 million, respectively, in the previous year [10] - The net loss for the fourth quarter was $55.1 million, with a total net loss of $215.8 million for the fiscal year, compared to $49.2 million and $174.3 million in the prior year [11] Upcoming Milestones - The company plans to present several abstracts at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, including data on RP1 and RP2 in various cancer types [3][4] - The Phase 2 clinical trial of RP2 in hepatocellular carcinoma is expected to initiate in the second half of 2024 [8]