Replimune(REPL) - 2026 Q2 - Quarterly Results
ReplimuneReplimune(US:REPL)2025-11-06 13:20

Financial Performance - As of September 30, 2025, cash, cash equivalents, and short-term investments were $323.6 million, down from $483.8 million as of March 31, 2025, indicating a cash burn related to clinical development activities [7]. - Research and development expenses for the fiscal second quarter were $57.9 million, compared to $43.4 million for the same period in 2024, primarily due to increased costs associated with the RP1 and RP2 studies [11]. - Selling, general, and administrative expenses rose to $26.4 million for the fiscal second quarter, up from $15.5 million in the prior year, reflecting increased personnel-related costs [11]. - The net loss for the fiscal second quarter was $83.1 million, compared to a net loss of $53.1 million for the same period in 2024 [11]. - The company expects existing cash to fund operations into late Q4 2026, including potential commercialization of RP1 [7]. Clinical Trials and Developments - The ongoing global Phase 3 trial IGNYTE-3 is expected to enroll approximately 400 patients, evaluating RP1 in combination with nivolumab versus a control arm in advanced melanoma patients [5]. - RP1 plus nivolumab demonstrated an objective response rate (ORR) of 44% in acral melanoma patients, with a median duration of response of 11.9 months [5]. - The registration-directed Phase 2/3 REVEAL trial of RP2 in metastatic uveal melanoma is currently enrolling approximately 280 patients [5]. - The FDA has accepted the BLA resubmission of RP1 for advanced melanoma, with a target action date set for April 10, 2026 [2]. - The IGNYTE clinical trial cohort in non-melanoma skin cancer (NMSC) is ongoing, with promising response rates across multiple tumor types [5].

Replimune(REPL) - 2026 Q2 - Quarterly Results - Reportify