<div id="readability-page-1"><div>Replimune Group, Inc., a biotechnology company focused on developing oncolytic immunotherapies, has released its Form 10-Q report for the third quarter of 2025. The report provides a comprehensive overview of the company's financial performance and key business developments, reflecting its ongoing efforts in clinical trials and regulatory submissions. Financial Highlights <ul><li>Loss from operations: $(71.9) million, reflecting increased operating expenses primarily due to higher research and development costs.</li><li>Net loss: $(70.9) million, compared to $(66.3) million in the prior year period, driven by increased operating expenses.</li><li>Net loss per common share, basic and diluted: $(0.77), compared to $(0.79) in the prior year period, reflecting the impact of increased net loss.</li></ul> Business Highlights <ul><li>RP1 Clinical Trials: The IGNYTE trial, a multi-cohort clinical trial in collaboration with Bristol Myers Squibb, is a key focus. The trial includes a Phase 2 expansion cohort in anti-PD-1 failed cutaneous melanoma, showing a confirmed ORR of 32.9% with a median duration of response of 33.7 months. The trial continues to be well-tolerated with mainly Grade 1-2 side effects.</li><li>BLA Resubmission for RP1: Following a complete response letter from the FDA, the company resubmitted its Biologics License Application for RP1 in combination with nivolumab for advanced melanoma. The FDA has set a PDUFA date of April 10, 2026, for this resubmission.</li><li>IGNYTE-3 Trial: The IGNYTE-3 trial is a confirmatory Phase 3 clinical trial for RP1 in anti-PD-1 failed melanoma patients. The trial plans to enroll 400 patients globally and will assess RP1 in combination with nivolumab.</li><li>ARTACUS Trial: The ARTACUS trial is a Phase 1b/2 clinical trial of single-agent RP1 in solid organ transplant recipients with skin cancers. Initial data shows an ORR of 34.5% with a complete response rate of 21%.</li><li>RP2 and RP3 Development: RP2 and RP3 are being developed to enhance anti-tumor immune responses. RP2 has shown durable responses in difficult-to-treat tumors, and RP3 is engineered to stimulate immune co-stimulatory pathways.</li><li>Geographical Performance: The company operates in the United States and the United Kingdom, with long-lived assets of $12.9 million and $0.9 million, respectively, as of December 31, 2025.</li><li>Future Outlook: The company is focused on the potential commercialization of RP1 in advanced melanoma and expects its cash and cash equivalents to fund operations through at least 12 months from the issuance of the financial statements.</li></ul>SEC Filing: Replimune Group, Inc. [ REPL ] - 10-Q - Feb. 03, 2026</div></div>

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Replimune Group, Inc. has released its Form 10-Q report for Q3 2025, highlighting a net loss of $(70.9) million, up from $(66.3) million year-over-year. Key business developments include ongoing clinical trials for RP1, with promising results in the IGNYTE trial and a resubmission of the Biologics License Application to the FDA. The company anticipates cash reserves will support operations for at least 12 months. The report reflects the company's focus on advancing its oncolytic immunotherapies in the U.S. and U.K.

Replimune Group, Inc. SEC 10-Q Report