On June 29, 2026 Replimune Group, Inc. (Nasdaq: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, reported financial results for the fiscal fourth quarter and year ended March 31, 2026 and provided a business update.

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The Company recently announced that the U.S. Food and Drug Administration (FDA) has accepted for review the resubmission of the Biologics License Application (BLA) for RP1 (vusolimogene oderparepvec) in combination with nivolumab for the treatment of advanced melanoma. The FDA considers this a complete, class 1 response with a goal date of August 2, 2026, and has notified the company to expect an advisory committee meeting in late July.

"The FDA’s acceptance of our RP1 BLA resubmission marks a pivotal milestone in our mission to bring this important therapy to patients facing advanced melanoma, where the need for durable, effective treatment options remains significant," said Sushil Patel, Ph.D., CEO of Replimune. "We are working hard to ensure we can provide access to RP1 as soon as possible pending an approval. We are equally pleased by the momentum across our clinical programs including continued strong enrollment in our IGNYTE-3 trial of RP1 in advanced melanoma and our REVEAL trial of RP2 in metastatic uveal melanoma."

Program Highlights & Milestones

RP1 (vusolimogene oderparepvec)

• IGNYTE Trial (RP1 + Nivolumab) – 3-Year Overall Survival Analysis: In an oral presentation at the ASCO (Free ASCO Whitepaper) 2026 annual meeting, RP1 plus nivolumab demonstrated exceptional durability in anti-PD-1-failed melanoma patients, with 47.8% of all treated patients alive at 3 years and a median overall survival of 32.9 months – including an 83.5% 3-year survival rate among responders – representing a rare and meaningful long-term benefit in a patient population with historically limited treatment options (Presentation).
• IGNYTE-3 Confirmatory Study: The global Phase 3 trial assessing RP1 in combination with nivolumab versus physician’s choice in patients with advanced melanoma who have progressed on anti-PD-1 and anti-CTLA-4 therapies or are ineligible for anti-CTLA-4 treatment is actively enrolling. The primary endpoint of this trial is overall survival, and key secondary endpoints are progression free survival and overall response rate.

RP2

• Phase 1 First-in-Human Trial (RP2) – Final Data: In an oral presentation at the ASCO (Free ASCO Whitepaper) 2026 annual meeting, RP2 monotherapy and in combination with nivolumab demonstrated promising efficacy across multiple advanced solid tumor types, achieving a 19% objective response rate in both arms with durable responses (median duration not reached for monotherapy), while translational analyses confirmed the intended mechanism of transforming immunologically "cold" tumors into immune-inflamed environments with systemic T-cell activation, supporting advancement to a randomized Phase 2/3 trial in metastatic uveal melanoma (Presentation).
• REVEAL Study: The registration-directed Phase 2/3 trial of RP2 in metastatic uveal melanoma is actively enrolling. The trial is evaluating RP2 in combination with nivolumab versus ipilimumab in combination with nivolumab in approximately 280 patients. The primary endpoints of the trial are overall survival and progression free survival, and key secondary endpoints are overall response rate and disease control rate. Phase 2/3 transition is expected in Q1 2027.

Financial Highlights

• Cash Position: As of March 31, 2026, cash, cash equivalents and short-term investments were $268.9 million, as compared to $483.8 million as of fiscal year ended March 31, 2025. The decrease in cash balance was a result of cash burn related to operating activities in advancing the company’s clinical development plans.

Based on the current operating plan, the Company believes that existing cash, cash equivalents and short-term investments will enable us to fund operations into the first quarter of calendar 2027, which includes scale up for the potential commercialization of RP1 in skin cancers and for working capital and general corporate purposes and excludes any potential revenue.

• R&D Expenses: Research and development expenses were $52.3 million for the fiscal fourth quarter and $221.2 million for the fiscal year ended March 31, 2026, as compared to $54.0 million for the fiscal fourth quarter and $189.4 million for the fiscal year ended March 31, 2025. This year over year increase was primarily due to an increase in personnel-related costs as we scaled operations in preparation for commercial launch of RP1, as well as consulting and facility-related costs. Research and development expenses included $4.1 million in stock-based compensation expenses for the fiscal fourth quarter and $16.7 million for the fiscal year ended March 31, 2026.

• S,G&A Expenses: Selling, general and administrative expenses were $21.0 million for the fiscal fourth quarter and $98.7 million for the fiscal year ended March 31, 2026, as compared to $25.4 million for the fiscal fourth quarter and $72.2 million for the fiscal year ended March 31, 2025. Selling, general and administrative expenses included $4.1 million in stock-based compensation expenses for the fiscal fourth quarter and $15.5 million for the fiscal year ended March 31, 2026.

• Net Loss: Net loss was $73.7 million for the fiscal fourth quarter and $313.9 million for the fiscal year ended March 31, 2026, as compared to a net loss of $74.1 million for the fiscal fourth quarter and $247.3 million for the fiscal year ended March 31, 2025.

About RP1

RP1 (vusolimogene oderparepvec) is Replimune’s lead product candidate and is based on a proprietary strain of herpes simplex virus engineered and genetically armed with a fusogenic protein (GALV-GP R-) and GM-CSF intended to maximize tumor killing potency, the immunogenicity of tumor cell death, and the activation of a systemic anti-tumor immune response.

About RP2

RP2 is based on a proprietary strain of herpes simplex virus engineered and genetically armed with a fusogenic protein (GALV-GP R-) and GM-CSF intended to maximize tumor killing potency, the immunogenicity of tumor cell death and the activation of a systemic anti-tumor immune response. RP2 additionally expresses an anti-CTLA-4 antibody-like molecule, as well as GALV-GP R- and GM-CSF. RP2 is intended to provide targeted and potent delivery of these proteins to the sites of immune response initiation in the tumor and draining lymph nodes, with the goal of focusing systemic-immune-based efficacy on tumors and limiting off-target toxicity.

(Press release, Replimune, JUN 29, 2026, View Source [SID1234668993])