Replimune completed a $150 million financing as the biotechnology company prepares to commercially launch TUDRIQEV following FDA accelerated approval and continues the Phase 3 confirmatory trial required to support the treatment’s longer-term regulatory position.
TUDRIQEV, previously known as RP1, received FDA accelerated approval on August 6 in combination with nivolumab for adults with unresectable advanced cutaneous melanoma whose disease progressed following a PD-1 antibody-based regimen. Replimune expects to have the product commercially available in the U.S. within 60 days of the approval.
The approval marks Replimune’s transition from a clinical-stage biotechnology company into a commercial-stage organization. The company is completing its commercial infrastructure buildout while preparing to bring TUDRIQEV to physicians and patients.
Replimune’s recently completed financing generated approximately $141 million of net proceeds from the issuance of common stock in August. The capital is expected to support the commercial launch, working capital, general corporate purposes, and the ongoing IGNYTE-3 confirmatory trial.
As of June 30, Replimune held $195.3 million of cash, cash equivalents and short-term investments, compared with $268.9 million at the end of March. The decline reflected cash used to advance the company’s clinical development programs.
Combined with the $141 million of net financing proceeds received after quarter-end, management expects existing resources to fund operations for greater than 12 months from issuance of the company’s financial statements. That runway includes the scale-up required for TUDRIQEV commercialization.
IGNYTE-3 is an actively enrolling global Phase 3 study evaluating RP1 in combination with nivolumab against physician’s choice in patients with advanced melanoma who progressed following anti-PD-1 and anti-CTLA-4 therapy or who are ineligible for anti-CTLA-4 treatment.
Overall survival is the primary endpoint, with the readout expected in 2030. Key secondary endpoints include progression-free survival and overall response rate. Confirmation of clinical benefit is important because continued approval of TUDRIQEV under the accelerated approval pathway may depend on results from a confirmatory trial.
Replimune is also advancing RP2 in metastatic uveal melanoma through its registration-directed REVEAL study. The Phase 2/3 trial is evaluating RP2 plus nivolumab against ipilimumab plus nivolumab in approximately 280 patients, with transition into the Phase 2/3 portion expected in the first quarter of 2027.
The company has added commercial leadership ahead of TUDRIQEV’s launch. Michelle DiNapoli was appointed Chief Commercial Officer effective August 18, bringing more than 25 years of biopharmaceutical experience, including commercial leadership roles at Deciphera Pharmaceuticals and Genentech.
Fiscal first-quarter R&D expenses declined to $49.3 million from $57.8 million a year earlier, while SG&A expenses decreased to $19 million from $32.6 million. Replimune reported a net loss of $69.8 million compared with $86.7 million in the prior-year period.
KEY QUOTES:
“The FDA’s approval of TUDRIQEV is a defining milestone for Replimune and, more importantly, for the patients facing advanced melanoma, where the need for safe and effective treatment options remains significant.”
“With this approval, we are now a fully integrated biotechnology company. We are completing the build out of our commercial infrastructure to enable a successful launch and bring TUDRIQEV to patients as quickly as possible.”
Dr. Sushil Patel, CEO of Replimune
