Replimune Group, Inc. (Nasdaq: REPL) announced financial results for the fiscal second quarter ended September 30, 2026, and provided a corporate update. The company reported that TUDRIQEV (vusolimogene oderparepvec-wtpg), previously referred to as RP1, is now commercially available in the United States for use in combination with nivolumab for the treatment of adults with advanced melanoma.
According to the filing, healthcare providers began ordering TUDRIQEV for next day delivery immediately upon availability. The company stated it has more than a year of inventory on hand, produced at its in-house manufacturing facility in Woburn, MA. As of the report date, more than 15 institutions have prescribed the therapy.
CEO Sushil Patel noted that the therapy is now available to patients in urgent need, as melanoma takes nearly 8,500 lives in the U.S. every year. He added that the response from physicians has been enthusiastic, with both oncologists and interventional radiologists eager to adopt the treatment.
Regarding the commercial launch, Replimune indicated that it has actively engaged with more than 70 percent of its initial 200 priority accounts to establish workflows. Leading melanoma institutions have rapidly placed TUDRIQEV on formulary and have started treating patients. The company highlighted that the broad label supports use across a wide range of patients, including those with superficial, deep, and visceral lesions, without a requirement for prior BRAF treatment. TUDRIQEV has been listed in the NCCN Clinical Practice Guidelines in Oncology as a category 2A recommendation.
Financially, as of September 30, 2026, cash and cash equivalents were $307.8 million. This represents an increase from $268.9 million as of March 31, 2026. The increase was driven by approximately $141.0 million in proceeds from the August 2026 offering of common stock and pre-funded warrants, as well as $15.0 million from the initial draw down on tranche 4 of long-term debt in September 2026. The company stated that its existing cash balance is expected to fund operations for greater than twelve months.
Research and development expenses for the fiscal second quarter ended September 30, 2026, were $34.4 million, a decrease compared to $57.9 million in the same period the previous year. Selling, general, and administrative expenses were $21.9 million for the quarter, compared to $26.4 million in the prior year. The company reported a net loss of $57.1 million for the quarter.
Replimune also provided updates on its clinical programs. The IGNYTE-3 confirmatory study remains on track and is actively enrolling patients with advanced melanoma who have progressed on anti-PD-1 and anti-CTLA-4 therapies. Additionally, the REVEAL study, a registration-directed Phase 2/3 trial of RP2 in metastatic uveal melanoma, is actively enrolling.
