Highlights

  • Net loss was $57.1 million for the three months ended September 30, 2026, compared with $83.1 million a year earlier.
  • The FDA granted accelerated approval to TUDRIQEV with nivolumab for advanced cutaneous melanoma, announced August 6, 2026.
  • The August 2026 offering raised net proceeds of approximately $141.0 million, and cash and short-term investments were $307.8 million.
  • TUDRIQEV became commercially available in early October 2026; product revenue had not yet been generated as of September 30, 2026.

Replimune Group, Inc. (NASDAQ:REPL) shares were trading at USD 15.40 on October 28, 2026, up 18.01%, with a relative volume at time of 4.35. The oncolytic immunotherapy company announced FDA accelerated approval of TUDRIQEV on August 6, completed a stock offering on August 10 and filed its quarterly report for the period ended September 30, 2026 on October 28.

Replimune is incorporated in Delaware and has its principal executive offices in Woburn, Massachusetts. The company describes itself as a commercial-stage biotechnology company applying oncolytic immunotherapy to cancer. Its proprietary RPx platform is based on an engineered strain of herpes simplex virus 1. TUDRIQEV, previously referred to as RP1, is its only approved product, and RP2 and RP3 are product candidates. Its fiscal year ends March 31, so the quarter covered is the second quarter of fiscal 2027.

Results for the Quarter Ended September 30, 2026

Replimune reported a net loss of $57.1 million for the three months ended September 30, 2026, compared with $83.1 million for the same period of 2025. For the six months ended September 30, 2026, the net loss was $126.9 million, compared with $169.8 million. The accumulated deficit was $1,389.4 million at September 30, 2026.

Research and development expenses were $34.4 million, compared with $57.9 million. Selling, general and administrative expenses were $21.9 million, compared with $26.4 million. The company attributed lower costs in part to a restructuring announced in April 2026 that included a workforce reduction of approximately 55%, and said rehiring began to ramp up later in the second quarter after FDA approval.

Interest expense on debt obligations was $2,523 thousand, compared with $1,488 thousand. As of September 30, 2026, TUDRIQEV was the only approved product and the company had not generated revenue from product sales.

Liquidity and Capital

Cash and cash equivalents and short-term investments were $307.8 million at September 30, 2026. The company said it expects this amount to fund operations and capital expenditure requirements for greater than twelve months from the issuance of the financial statements, including commercialization of TUDRIQEV in advanced melanoma.

On August 10, 2026, the company completed an offering of 9,701,490 shares of common stock at $12.06 per share and pre-funded warrants to purchase 2,736,340 shares at $12.0599 per warrant. Net proceeds were approximately $141.0 million after fees and expenses of approximately $9.0 million. On September 29, 2026, it entered a fourth amendment to its Hercules loan agreement and drew $15.0 million.

For the six months, net cash used in operating activities was $123.4 million, and net cash provided by financing activities was $161.3 million.

TUDRIQEV and Pipeline

On August 6, 2026, the company announced the FDA granted accelerated approval to TUDRIQEV in combination with nivolumab for adults with unresectable advanced cutaneous melanoma who progressed on an anti-PD-1 regimen. The approval is based on objective response rate and duration of response, and continued approval may be contingent on verification of clinical benefit in confirmatory trials. In the efficacy-evaluable population, the objective response rate was 24.2%, with a median duration of response of 14.1 months.

The company said payer policies covering TUDRIQEV to label represent a majority of commercially covered lives and that it has submitted for a permanent J-code, anticipated in the first half of 2027. The IGNYTE-3 Phase 3 trial, an FDA postmarketing requirement, is expected to randomize approximately 400 patients.

Outlook

The 10-Q does not provide numerical guidance. The company said the Phase 2/3 transition of the REVEAL study of RP2 in metastatic uveal melanoma is expected in the first quarter of 2027, and that it expects to share preliminary findings from RP2 studies in hepatocellular carcinoma and biliary tract cancer in the first quarter of 2027. It also said it will be required to seek additional financing and that no assurance exists that such financing will be available.