Replimune Group, Inc. reported a fiscal second‑quarter 2025 net loss of $83.1 million, or $0.90 per share, compared with a $53.1 million loss ($0.57 per share) in the same quarter last year. The widening loss reflects a $57.9 million increase in research and development expenses and a $26.4 million rise in selling, general and administrative costs, underscoring the company’s continued investment in its oncolytic immunotherapy pipeline.
Revenue for the quarter was $0.50 million, a modest figure that reflects the company’s status as a clinical‑stage biopharma with no commercial product sales. The figure is unchanged from the prior quarter, indicating flat revenue growth, but the company’s cash position remains robust, with $323.6 million in cash, cash equivalents and short‑term investments as of September 30, 2025. Management believes this runway will support operations through late Q4 2026, providing a cushion for upcoming regulatory milestones.
A key regulatory development announced in the earnings release is the U.S. Food and Drug Administration’s acceptance of the resubmitted Biologics License Application for RP1 in advanced melanoma. The agency set a PDUFA date of April 10, 2026, following a complete response letter issued in July 2025. CEO Sushil Patel highlighted the significance of this acceptance, noting that the feedback from the melanoma community underscores the unmet need and the compelling risk‑benefit profile observed in the IGNYTE‑3 trial. The acceptance positions RP1 for a potential approval that could transform Replimune’s commercial prospects.
Analysts had expected a net loss of $0.83 per share for the quarter, so the reported loss of $0.90 per share represents a miss of $0.07 per share. The miss is largely attributable to the higher R&D and SG&A spend, which were driven by intensified clinical development activities and expanded operational support for the RP1 program. The company did not provide a revised guidance range for the remainder of the fiscal year, but the cash runway and regulatory progress suggest management remains cautiously optimistic about future milestones.
The earnings announcement was met with mixed analyst reactions. Some analysts upgraded their outlooks, citing the regulatory milestone and the company’s strong cash position, while others expressed concern over the widening net loss and the lack of revenue growth. The overall sentiment reflects a balance between confidence in the pipeline’s potential and caution about the company’s current financial trajectory.
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