Replimune Group reported a net loss of $313.9 million for the fiscal year ended March 31, 2026, and held $268.9 million in cash, cash equivalents and short-term investments at period end. Research and development expense was $221.2 million for the year while selling, general and administrative expense totaled $98.7 million. The company said the FDA accepted the resubmission of the RP1 BLA with a goal date of August 2, 2026 and expects an advisory committee meeting in late July.

Financial Highlights

  • Net loss: $313.9 million for year ended March 31, 2026 (comparative net loss $247.3 million for FY2025).
  • Research and development expense: $221.2 million for the year (FY2025: $189.4 million).
  • Selling, general and administrative expense: $98.7 million for the year (FY2025: $72.2 million).
  • Cash, cash equivalents and short-term investments: $268.9 million as of March 31, 2026 (March 31, 2025: $483.8 million).
  • Total operating expenses: $319.9 million for the year (FY2025: $261.6 million); loss from operations: $(319.9) million.

Business Highlights

  • Regulatory milestone: FDA accepted the resubmission of the Biologics License Application for RP1 (vusolimogene oderparepvec) in combination with nivolumab for advanced melanoma, with a PDUFA goal date of August 2, 2026 and an advisory committee meeting expected in late July.
  • IGNYTE program: ASCO 2026 oral presentation reported 3-year overall survival of 47.8% for all treated patients and median overall survival of 32.9 months for RP1 plus nivolumab in anti-PD-1-failed melanoma; responders showed 83.5% 3-year survival. The global Phase 3 IGNYTE-3 confirmatory trial is actively enrolling with overall survival as the primary endpoint.
  • RP2 development: ASCO 2026 presentation reported a 19% objective response rate for RP2 monotherapy and RP2 plus nivolumab across advanced solid tumors with durable responses and translational data supporting immune conversion of cold tumors; advancement to a randomized Phase 2/3 trial in metastatic uveal melanoma is planned.
  • REVEAL study: Registration-directed Phase 2/3 trial of RP2 in metastatic uveal melanoma is actively enrolling ~280 patients evaluating RP2 plus nivolumab versus ipilimumab plus nivolumab; Phase 2/3 transition expected in Q1 2027.
  • Operational posture: Company states existing cash resources are expected to fund operations into Q1 2027, including scaling for potential commercialization of RP1 in skin cancers and working capital needs, excluding any potential product revenue.

Original SEC Filing:

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