Replimune Reports Fiscal Second Quarter 2026 Financial Results and Provides Corporate Update

Core Insights - Replimune Group, Inc. reported financial results for the fiscal second quarter ended September 30, 2025, and provided a business update, highlighting progress in clinical trials and financial status [1][2]. Business Updates - The FDA accepted the Biologics License Application (BLA) resubmission for RP1, targeting advanced melanoma, with a PDUFA action date set for April 10, 2026 [2]. - The ongoing global Phase 3 trial, IGNYTE-3, is evaluating RP1 in combination with nivolumab, with an expected enrollment of approximately 400 patients [5]. - Recent data presented at the ESMO Congress 2025 showed an objective response rate (ORR) of 44% for RP1 plus nivolumab in acral melanoma, with a median duration of response of 11.9 months [5]. - RP1 plus nivolumab demonstrated a 100% ORR in anti–PD-1 naïve Merkel cell carcinoma (MCC) patients, with varying ORRs in other non-melanoma skin cancers [5]. Financial Highlights - As of September 30, 2025, the company had cash, cash equivalents, and short-term investments of $323.6 million, down from $483.8 million as of March 31, 2025, due to cash burn from clinical development activities [8]. - Research and development expenses for the fiscal second quarter were $57.9 million, an increase from $43.4 million in the same quarter of the previous year, primarily due to costs associated with the IGNYTE-3 study [12]. - Selling, general and administrative expenses rose to $26.4 million from $15.5 million year-over-year [12]. - The net loss for the fiscal second quarter was $83.1 million, compared to $53.1 million in the same quarter of the previous year [12]. Upcoming Events - Replimune will present late-breaking oral presentations and posters at the Society for Immunotherapy of Cancer (SITC) 2025 Annual Meeting, showcasing updated clinical data for RP1 plus nivolumab [11].