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

Core Insights - Replimune Group, Inc. announced financial results for the fiscal third quarter ended December 31, 2025, and provided a business update, highlighting the upcoming FDA action date for RP1 in advanced melanoma on April 10, 2026 [1][2]. Financial Performance - As of December 31, 2025, the company's cash, cash equivalents, and short-term investments totaled $269.1 million, down from $483.8 million as of March 31, 2025, primarily due to cash burn related to clinical development activities [8][19]. - Research and development expenses for the fiscal third quarter were $53.1 million, an increase from $48.0 million in the same quarter of 2024, driven by costs associated with the RP1 and RP2 studies [12]. - Selling, general and administrative expenses were $18.7 million for the fiscal third quarter, compared to $18.0 million in the prior year [12]. - The net loss for the fiscal third quarter was $70.9 million, compared to a net loss of $66.3 million for the same period in 2024 [12]. Product Development and Clinical Trials - The FDA accepted the resubmission of the Biologics License Application (BLA) for RP1 in October 2025, with a target action date set for April 10, 2026, and commercial readiness activities are in progress [2][4]. - The REVEAL Study for RP2 in metastatic uveal melanoma is actively enrolling approximately 280 patients, evaluating RP2 in combination with nivolumab versus ipilimumab [5]. - The IGNYTE-3 Confirmatory Study is assessing RP1 in combination with nivolumab in advanced melanoma patients who have progressed on prior therapies, with a primary endpoint of overall survival [6]. - Recent data presented at ESMO Congress 2025 showed an objective response rate (ORR) of 44% for RP1 plus nivolumab in acral melanoma patients [6]. - The ARTACUS Study demonstrated RP1 monotherapy's robust anti-tumor activity in cutaneous squamous cell carcinoma patients, with an ORR of 34.6% [6]. Strategic Financial Moves - The company amended its loan agreement with Hercules Capital, Inc., allowing for a drawdown of $35 million and the potential for an additional $120 million upon achieving post-approval milestones, while delaying debt repayment from 2026 to 2027 [3].