Replimune Group Stock Price, News & Analysis

Replimune Group, Inc. (NASDAQ: REPL) has initiated the IGNYTE-3 study, a global Phase 3 clinical trial evaluating RP1 (vusolimogene oderparepvec) plus nivolumab in advanced melanoma patients who have progressed on anti-PD1 and anti-CTLA-4 therapies or are ineligible for anti-CTLA-4 treatment. The trial, which has dosed its first patient, aims to support global regulatory interactions and confirm clinical benefits reported in the Phase 2 IGNYTE cohort. With 400 patients enrolled, the study will compare RP1 plus nivolumab against physician's choice treatments, focusing on overall survival as the primary endpoint. Secondary endpoints include progression-free survival and objective response rate. This trial is important for Replimune's planned BLA submission for RP1 in advanced melanoma later this year.

Replimune Group (NASDAQ: REPL) reported fiscal Q1 2025 results and provided a corporate update. Key highlights include:

• Pre-BLA meeting with FDA scheduled for September, BLA submission planned for 2H 2024
• First patient enrollment in Phase 3 confirmatory trial of RP1 in advanced melanoma expected in Q3 2024
• Protocol finalized for registration-directed study of RP2 in uveal melanoma
• Completed PIPE financing raising $96.7 million net
• Cash position of $469.1 million as of June 30, 2024
• R&D expenses increased to $43.0 million for Q1 2025
• Net loss of $53.8 million for Q1 2025

The company believes its current cash position will fund operations into the second half of 2026, including RP1 commercialization scale-up.

Replimune Group, a clinical stage biotech company developing novel oncolytic immunotherapies, has announced its participation in two upcoming investor conferences. The company's management team will host investor meetings at the BTIG Virtual Biotechnology Conference on August 5-6, 2024, and the 2024 Wedbush PacGrow Healthcare Conference on Tuesday, August 13, 2024.

These conferences provide Replimune with opportunities to engage with investors and showcase their progress in developing innovative cancer treatments. As a Nasdaq-listed company (REPL), Replimune's participation in these events may be of interest to current and potential investors in the biotechnology sector.

Replimune Group announced a $100 million private placement financing led by a life-sciences focused institutional investor, with participation from Redmile Group, RTW Investments, Boxer Capital, and other institutional investors. This financing follows the strong primary analysis data from the RP1 IGNYTE clinical trial in anti-PD1 failed melanoma, with a Biologics License Application (BLA) filing expected in the second half of 2024. Proceeds will be used to fully scale up for the commercialization of RP1 in skin cancers, aiming for a potential launch in the second half of 2025, alongside general corporate purposes. The closing of the financing is anticipated on or about June 14, 2024, subject to customary closing conditions.

Replimune Group, a clinical stage biotech firm specializing in oncolytic immunotherapies, announced that its CEO, Sushil Patel, will speak at the Goldman Sachs 45th Annual Global Healthcare Conference.

The event is scheduled for June 11, 2024, at 2:00 PM ET. A live webcast will be accessible via the Investors section on Replimune's website, with a replay available for 30 days post-conference.

Replimune announced positive results from the IGNYTE clinical trial, showing an overall response rate (ORR) of 33.6% for RP1 plus nivolumab in anti-PD1 failed melanoma patients. The results, independently reviewed, reveal a median duration of response exceeding 35 months, with all responses lasting over 6 months. The company plans to submit a biologics license application (BLA) in the second half of 2024, with first patient enrollment in the IGNYTE-3 trial expected by Q3 2024. The treatment exhibited predominantly mild side effects, with few severe adverse events reported. A conference call to discuss these findings will be held today at 8:00 a.m. ET.

Replimune presented positive data from its RP1 and RP2 clinical programs at the 2024 ASCO Annual Meeting. The IGNYTE trial showed a 32.7% overall response rate (ORR) for RP1 plus nivolumab in anti-PD-1 failed melanoma, with responses lasting over six months and a median duration exceeding 36 months. RP2, both as monotherapy and in combination with nivolumab, achieved an ORR of nearly 30% in uveal melanoma. The company plans a registration-directed trial for RP2 and will submit a Biologics License Application for RP1 in the second half of 2024. These results indicate a promising risk-benefit profile, particularly in hard-to-treat cancers.

Replimune Group, a clinical-stage biotech firm, is set to present at the 2024 ASCO Annual Meeting from May 31-June 4 in Chicago. The company will showcase data from two significant trials: the IGNYTE trial of RP1 combined with nivolumab in anti-PD-1 failed melanoma, and a Phase 1 trial of RP2 combined with nivolumab in advanced uveal melanoma. Additional highlights include three trial-in-progress posters for RP1 and RP2. Oral presentations will feature updated 12-month data and new biomarker results, with key sessions scheduled on June 3.

Replimune has reported its fiscal fourth quarter and year-end 2024 financial results while providing a corporate update. The company highlighted significant progress in its clinical trials, including the IGNYTE trial for RP1 in advanced melanoma. They plan to present 12-month primary analysis results in Q2 2024 and expect to submit a Biologics License Application (BLA) in 2H 2024. Financially, the company reported cash and equivalents of $420.7M, with a net loss of $215.8M for the fiscal year. Operationally, their cash runway extends into 2H 2026.

Key corporate milestones include a successful Type C meeting with the FDA and the expected enrollment of patients in Phase 3 trials in 2H 2024. Replimune also presented new data from various trials at the ASCO Annual Meeting, showing promising outcomes in melanoma and other cancers.