Replimune Narrows Fiscal Second-Quarter Net Loss to $57.1 Million

The Tip Desk · November 9, 2026 · 4 min read

Replimune's net loss narrowed to $57.1 million for the fiscal second quarter ended September 30, 2026. Its balance-sheet table showed $307.8 million in cash, cash equivalents and short-term investments as of that date, after an August equity raise and a September debt drawdown.

Replimune Group, Inc. (REPL) reported a net loss of $57.1 million, or $0.54 a share, for the fiscal second quarter ended September 30, 2026, as it moved TUDRIQEV from FDA accelerated approval into U.S. commercial availability for advanced melanoma.

The commercial-stage biotechnology company said TUDRIQEV (vusolimogene oderparepvec-wtpg), previously RP1, became commercially available in the United States in combination with nivolumab for adults with advanced melanoma. First patient deliveries occurred on October 6, and more than 15 institutions had prescribed the product. Healthcare providers began ordering for next-day delivery immediately upon availability. The company said it had more than a year of inventory on hand, produced at its in-house manufacturing facility.

Chief Executive Officer Sushil Patel said melanoma takes nearly 8,500 lives in the U.S. every year and that treatment options have been limited for patients whose disease progresses after anti-PD-1 therapy. He said the response from physicians has been enthusiastic and that both oncologists and interventional radiologists are eager to bring TUDRIQEV into their practices.

The company said it has actively engaged with more than 70 percent of its initial 200 priority accounts to establish workflows and enable TUDRIQEV adoption. Leading melanoma institutions have placed the product on formulary and started treating patients. TUDRIQEV is indicated in combination with nivolumab for the treatment of adult patients with unresectable advanced cutaneous melanoma who experienced disease progression with a PD-1-blocking antibody-based regimen, with no requirement for prior BRAF treatment, and can be injected into superficial, deep and visceral lesions, including lung and liver. The company said multiple payer policies have been published covering TUDRIQEV to label and that the product has been listed in the NCCN Clinical Practice Guidelines in Oncology as a category 2A recommendation. Continued approval of the accelerated indication may be contingent upon verification of clinical benefit in a confirmatory trial.

Cash, cash equivalents and short-term investments totaled $307.8 million as of September 30, 2026, according to the balance-sheet table. The company attributed the increase to approximately $141.0 million of net proceeds from an August 2026 offering of common stock and pre-funded warrants and $15.0 million from a September 2026 initial drawdown on tranche 4 of long-term debt, partially offset by cash burn related to operating activities. The company said existing cash and cash equivalents will enable it to fund operations for greater than twelve months from the issuance of the condensed consolidated financial statements, including commercialization of TUDRIQEV in advanced melanoma.

Research and development expenses were $34.4 million for the fiscal second quarter ended September 30, 2026, down from $57.9 million a year earlier. The company said the decrease was primarily due to lower personnel-related and other costs and lower direct research costs relating to the IGNYTE, ARTACUS and CERPASS studies. The quarter included $4.9 million of stock-based compensation. Selling, general and administrative expenses were $21.9 million, compared with $26.4 million a year earlier, including $5.7 million of stock-based compensation.

Interest expense on debt obligations was $2.5 million in the three months ended September 30, 2026, versus $1.5 million a year earlier. Investment income was $1.9 million. Weighted-average common shares outstanding were 105.2 million, versus 91.9 million a year earlier.

The IGNYTE-3 global Phase 3 confirmatory trial assessing TUDRIQEV 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 remained actively enrolling. The primary endpoint is overall survival, with key secondary endpoints of progression-free survival and overall response rate. The prior quarter had said the primary endpoint was expected to read out in 2030.

The REVEAL registration-directed Phase 2/3 trial of RP2 in metastatic uveal melanoma remained actively enrolling. The trial is evaluating RP2 in combination with nivolumab versus ipilimumab in combination with nivolumab. The prior quarter had said Phase 2/3 transition was expected in the first quarter of 2027.