Replimune Group, Inc., a clinical-stage biotechnology company focused on oncolytic immunotherapy, reported a net loss of $247.3 million for the fiscal year ending March 31, 2025, compared to a loss of $215.8 million in the previous year, marking a 15% increase in losses. The company's total operating expenses rose to $261.6 million, an 11% increase from $234.8 million in the prior year. Research and development expenses accounted for $189.4 million, up from $175.0 million, driven by increased personnel costs and other operational expenses, while selling, general, and administrative expenses also increased by 21% to $72.2 million.
The company has not yet generated any revenue from product sales, as it awaits regulatory approval for its lead product candidate, RP1 (vusolimogene oderparepvec). The U.S. Food and Drug Administration (FDA) has accepted Replimune's Biologics License Application (BLA) for RP1 in combination with nivolumab for advanced melanoma, granting it priority review with a target decision date of July 22, 2025. This application follows promising results from the IGNYTE trial, which demonstrated a 33.6% overall response rate in patients with anti-PD-1 failed cutaneous melanoma.
In terms of operational developments, Replimune has expanded its clinical trials, including the IGNYTE-3 trial, which aims to enroll 400 patients globally. The company is also pursuing additional indications for RP1, including non-melanoma skin cancers and skin cancers in solid organ transplant recipients. As of March 31, 2025, Replimune employed 479 full-time staff, with a significant portion dedicated to research and development.
Looking ahead, Replimune anticipates continued significant operating losses as it advances its clinical programs and prepares for potential commercialization of RP1. The company reported cash and cash equivalents of $483.8 million as of March 31, 2025, which it believes will fund operations into the fourth quarter of 2026. However, the company acknowledges the need for additional financing to support its ongoing development efforts and potential commercialization activities, emphasizing the inherent risks and uncertainties in the biopharmaceutical industry.
About Replimune Group, Inc.
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