Replimune Group (REPL) Q3 2026 earnings summary

Executive summary

• Clinical-stage biotech focused on oncolytic immunotherapies, with lead candidate RP1 in advanced melanoma and other skin cancers, and additional candidates RP2 and RP3 in development.

• RP1 BLA for advanced melanoma received a Complete Response Letter (CRL) from the FDA in July 2025; BLA was resubmitted and accepted with a new PDUFA date of April 10, 2026; commercial readiness underway.

• Ongoing clinical trials include confirmatory phase 3 (IGNYTE-3) for RP1, phase 1b/2 ARTACUS for transplant recipients, and REVEAL phase 2/3 for RP2 in metastatic uveal melanoma and liver-focused studies.

• Loan agreement amended with Hercules Capital, drawing $35M and potential for $120M more post-approval; debt repayment delayed to 2027, extending cash runway into Q1 2027.

Financial highlights

• Net loss for the quarter ended December 31, 2025 was $70.9 million, compared to $66.3 million in the prior year quarter; net loss per share was $0.77 versus $0.79 year-over-year.

• Net loss for the nine months ended December 31, 2025 was $240.7 million, up from $173.2 million year-over-year.

• Cash, cash equivalents, and short-term investments totaled $269.1 million as of December 31, 2025, down from $483.8 million at March 31, 2025.

• Research and development expenses for the quarter were $53.1 million, up from $48.0 million year-over-year; for the nine months, $168.9 million, up from $135.5 million.

• Selling, general and administrative expenses for the quarter were $18.7 million, up from $18.0 million; for the nine months, $77.7 million, up from $46.8 million.

Outlook and guidance

• Cash runway expected to fund operations late into Q1 2027, including potential commercialization of RP1, assuming successful regulatory approval.

• If RP1 is not approved, company may need to restructure and reprioritize its pipeline.

• Ongoing engagement with FDA regarding RP1 BLA; interim analysis for IGNYTE-3 phase 3 trial planned for H2 2027.

• REVEAL Phase 2/3 trial for RP2 in metastatic uveal melanoma actively enrolling; Phase 2/3 transition expected Q1 2027.