Replimune(US:REPL)2026-02-03 13:05Financial 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, reflecting cash burn related to clinical development activities [7]. - The net loss for the fiscal third quarter ended December 31, 2025, was $70.9 million, compared to a net loss of $66.3 million for the same period in 2024 [11]. - Selling, general and administrative expenses for the fiscal third quarter were $18.7 million, compared to $18.0 million in the same quarter of 2024 [11]. - The total operating expenses for the fiscal third quarter were $71.9 million, up from $66.0 million in the same quarter of 2024 [11]. - The company expects its existing cash resources to fund operations into the first quarter of calendar 2027, including potential commercialization of RP1 [7]. Research and Development - 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, primarily due to costs associated with the RP1 confirmatory study [11]. - The ongoing IGNYTE-3 Phase 3 trial is expected to enroll approximately 400 patients, assessing RP1 in combination with nivolumab versus physician's choice [5]. - RP1 combined with nivolumab showed an objective response rate (ORR) of 44% in patients with acral melanoma, with a median duration of response of 11.9 months [5]. Regulatory and Funding - The company has a Prescription Drug User Fee Act (PDUFA) target action date of April 10, 2026, for the resubmission of the Biologics License Application (BLA) for RP1 in advanced melanoma [3]. - The company amended its loan agreement with Hercules Capital, allowing for an initial drawdown of $35 million and potential additional funding of $120 million upon post-approval milestones [4].