Replimune is a clinical-stage biotechnology company that develops oncolytic immunotherapies for cancer. The company uses its RPx platform to engineer strains of herpes simplex virus 1 that selectively replicate inside tumor cells to trigger a systemic immune response. This platform produces "off-the-shelf" products that do not require patient-specific personalization. Replimune's lead product candidate, RP1, is being developed in combination with nivolumab to treat advanced melanoma in patients who have failed prior anti-PD-1 therapy. The company has submitted a BLA for RP1 to the FDA and is awaiting a regulatory decision expected in August 2026. Beyond RP1, Replimune is developing RP2 for metastatic uveal melanoma and hepatocellular carcinoma, though it has paused development of its RP3 program to prioritize other candidates. Replimune currently generates no revenue and funds its clinical trials through capital markets. The company owns a 63,000-square-foot manufacturing facility in Massachusetts and plans to commercialize RP1 independently in the U.S. upon potential approval. Management acknowledges that the company's ability to continue as a going concern depends on the successful regulatory clearance and commercialization of RP1, noting that failure to secure accelerated approval could necessitate further corporate restructuring.