Replimune Announces Q1 2025 Financials and Corporate Update

Replimune Group, Inc., a biotechnology company focused on the development of oncolytic immunotherapies, reported its fiscal first-quarter financial results for the period ending June 30, 2024. The company also provided significant updates on its ongoing clinical programs.

CEO Sushil Patel, Ph.D., highlighted the productive quarter, emphasizing preparations for the upcoming Pre-Biologics License Application (BLA) meeting with the U.S. Food and Drug Administration (FDA) scheduled for September. The company is also preparing to enroll the first patient in its Phase 3 confirmatory trial of RP1 in advanced melanoma, expected to commence in the third quarter of 2024.

Replimune's RP1 program, which combines RP1 with Opdivo® (nivolumab) for treating anti-PD1 failed melanoma, has shown promise. In June, the company shared positive topline primary analysis data from the IGNYTE clinical trial. The results revealed a 12-month overall response rate of 33.6% by modified RECIST 1.1 criteria, the primary endpoint, and 32.9% by RECIST 1.1 criteria, an additional analysis requested by the FDA. The responses were notably durable, with all lasting over six months and a median duration exceeding 35 months. The company plans to present full primary analysis data from this cohort at an upcoming medical congress.

The Phase 3 IGNYTE-3 trial design has been agreed upon with the FDA and will be a two-arm randomized trial. It will involve a comparator arm with a set list of physician’s choice treatment options for advanced melanoma patients who have not responded to anti-PD1 and anti-CTLA-4 therapies or are ineligible for anti-CTLA-4 treatment. Replimune aims to enroll its first patient in this trial in the third quarter of 2024, with the RP1 BLA submission planned for the second half of 2024.

In another significant development, Replimune has finalized the protocol for a registration-directed study of RP2 in uveal melanoma, based on FDA input. The company has commenced study initiation activities for this trial, which will be a randomized study comparing RP2 combined with nivolumab against ipilimumab and nivolumab, or nivolumab alone for those ineligible for ipilimumab.

In the field of hepatocellular carcinoma (HCC), Replimune is gearing up for a Phase 2 clinical trial of RP2 combined with atezolizumab and bevacizumab in anti-PD1/PD-L1 progressed HCC, with the first patient expected to be dosed in the second half of 2024.

Financially, the company completed a securities purchase agreement, raising $96.7 million through a private investment in public equity (PIPE). These funds will support the commercialization of RP1 and other corporate purposes. As of June 30, 2024, Replimune reported cash, cash equivalents, and short-term investments totaling $469.1 million, up from $420.7 million as of March 31, 2024. This increase was driven by the PIPE financing.

Research and development expenses for the quarter amounted to $43.0 million, up from $40.4 million in the previous year's first quarter. The rise was primarily due to increased personnel costs, including a $2.8 million increase in payroll and fringe benefits and a $0.9 million rise in stock-based compensation. Selling, general, and administrative expenses were $14.4 million, slightly down from $15.2 million in the same period last year. The net loss for the fiscal first quarter was $53.8 million, compared to $49.6 million in the previous year.

RP1 (vusolimogene oderparepvec) is Replimune’s lead product candidate, based on a proprietary strain of herpes simplex virus engineered to maximize tumor-killing potency and stimulate a systemic anti-tumor immune response. RP2, another product candidate, also leverages a proprietary herpes simplex virus strain and includes additional genetic modifications intended to enhance tumor targeting and immune response.

Replimune, founded in 2015 and headquartered in Woburn, Massachusetts, aims to revolutionize cancer treatment through its innovative oncolytic immunotherapy portfolio. The company's proprietary RPx platform is designed to elicit strong and durable systemic anti-tumor responses, potentially in combination with other cancer treatments.