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Replimune Reports Fiscal Third Quarter 2025 Financial Results and Provides Corporate Update
REPLReplimune(REPL) Newsfilter·2025-02-12 13:00

Core Insights - Replimune Group, Inc. has achieved significant regulatory milestones for its lead product candidate RP1, with a Priority Review granted by the FDA and a PDUFA date set for July 22, 2025 [2][6][7] - The company is well-capitalized with over 500millionincashtosupportitstransitiontoacommercial−stageentityandthelaunchofRP1uponapproval[2][12]−Thecompanyreportedanetlossof500 million in cash to support its transition to a commercial-stage entity and the launch of RP1 upon approval [2][12] - The company reported a net loss of 66.3 million for the fiscal third quarter ended December 31, 2024, an increase from a net loss of 51.1millioninthesameperiodthepreviousyear[12][14]RegulatoryandClinicalDevelopments−TheFDAacceptedtheBiologicsLicenseApplication(BLA)forRP1incombinationwithnivolumabforadvancedmelanoma,supportedbydatafromtheIGNYTEtrial[6][7]−TheIGNYTE−3confirmatorytrialisenrollingpatientsgloballytoassessRP1incombinationwithnivolumabforthosewhohaveprogressedonpriortherapies[6][7]−ThefirstpatientshavebeenenrolledintrialsevaluatingRP2formetastaticuvealmelanomaandhepatocellularcarcinoma[6][7]FinancialHighlights−Thecompanycompletedapublicofferingraisingapproximately51.1 million in the same period the previous year [12][14] Regulatory and Clinical Developments - The FDA accepted the Biologics License Application (BLA) for RP1 in combination with nivolumab for advanced melanoma, supported by data from the IGNYTE trial [6][7] - The IGNYTE-3 confirmatory trial is enrolling patients globally to assess RP1 in combination with nivolumab for those who have progressed on prior therapies [6][7] - The first patients have been enrolled in trials evaluating RP2 for metastatic uveal melanoma and hepatocellular carcinoma [6][7] Financial Highlights - The company completed a public offering raising approximately 156 million net of issuance costs, which will fund the development of the RPx platform and general corporate purposes [5][12] - As of December 31, 2024, cash, cash equivalents, and short-term investments were 536.5million,upfrom536.5 million, up from 420.7 million as of March 31, 2024 [12][15] - Research and development expenses increased to 48millionforthefiscalthirdquarter,comparedto48 million for the fiscal third quarter, compared to 42.8 million in the same quarter the previous year [12][14] Product Candidates - RP1 is designed to maximize tumor killing potency and activate a systemic anti-tumor immune response through a proprietary strain of herpes simplex virus [8][10] - RP2, similar to RP1, is engineered to enhance tumor killing and immune response, additionally expressing an anti-CTLA-4 antibody-like molecule [9][10] Company Overview - Replimune Group, Inc. was founded in 2015 and focuses on developing novel oncolytic immunotherapies to transform cancer treatment [10] - The company's proprietary RPx platform aims to induce a strong systemic anti-tumor immune response while selectively targeting tumors [10]