Replimune Releases Q4 and Year-End 2024 Financial Results and Corporate Update

Replimune Group, Inc., a clinical-stage biotechnology company specializing in oncolytic immunotherapies, announced its financial results for the fiscal fourth quarter and year ending March 31, 2024. The company, headquartered in Woburn, MA, has been making significant strides in the development of its lead product candidates, RP1 and RP2, which are derived from genetically modified herpes simplex virus strains.

CEO Sushil Patel, Ph.D., highlighted the company's upcoming milestones, including the release of the 12-month primary analysis results of the IGNYTE clinical trial for RP1 in anti-PD1 failed melanoma, expected in the second quarter of 2024. Replimune has also completed a Type C meeting with the FDA to align on its Chemistry, Manufacturing, and Controls (CMC) plans, paving the way for a Biologics License Application (BLA) submission in the second half of 2024. The Phase 3 confirmatory trial for RP1 in advanced melanoma is set to begin patient enrollment in the latter half of 2024. The company believes these steps are critical as it transitions towards becoming a commercial-stage entity, pending FDA approval, to offer its first oncolytic immunotherapy for advanced skin cancer.

Replimune will present several abstracts at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, including oral presentations on the efficacy and safety of RP1 in combination with nivolumab for anti-PD1 failed melanoma and the results of RP2 in uveal melanoma. Other presentations will cover ongoing clinical trials investigating RP2 in hepatocellular carcinoma and a phase 1/2 study of RP1 in primary melanoma to reduce the risk of sentinel lymph node metastasis.

The company completed a successful Type C meeting with the FDA to discuss its CMC plans, crucial for the BLA submission for the IGNYTE anti-PD1 failed melanoma. Replimune intends to kick off its Phase 3 IGNYTE-3 trial, a 2-arm randomized study comparing RP1 combined with nivolumab versus physician's choice treatments for advanced melanoma patients who have progressed on anti-PD1 and anti-CTLA-4 therapies.

In the ARTACUS clinical trial, RP1 monotherapy demonstrated an overall response rate (ORR) of 34.8% in solid organ transplant recipients with skin cancers, showing promising results without immune-mediated adverse events or allograft rejection. The trial continues to enroll patients.

The CERPASS trial aims to evaluate the long-term effectiveness of RP1 combined with Libtayo® (cemiplimab-rwlc) in cutaneous squamous cell carcinoma (CSCC). Meanwhile, the protocol for a registration-directed trial of RP2 with nivolumab in advanced uveal melanoma is nearing completion, and a Phase 2 trial of RP2 combined with atezolizumab and bevacizumab in hepatocellular carcinoma is expected to start in the second half of 2024.

Financially, Replimune reported a cash position of $420.7 million as of March 31, 2024, down from $583.4 million the previous year, primarily due to expenditures related to clinical development. The company expects its current funds to sustain operations into the second half of 2026. Debt increased to $44.8 million from $28.6 million, attributed to a $15 million drawdown in December 2023.

Research and development expenses rose to $42.6 million for the fourth quarter and $175.0 million for the fiscal year, driven by increased clinical and manufacturing activities. Selling, general, and administrative expenses were $16.2 million for the quarter and $59.8 million for the year, reflecting costs associated with personnel and commercial infrastructure development.

Overall, Replimune reported a net loss of $55.1 million for the fourth quarter and $215.8 million for the fiscal year, compared to $49.2 million and $174.3 million, respectively, in the previous year. Despite the financial losses, the company remains focused on advancing its clinical programs and preparing for potential commercial operations pending regulatory approvals.