Replimune Group, Inc. - REPL STOCK NEWS

Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company, has announced the grant of inducement equity awards to 9 newly hired non-executive employees. The awards include:

- Non-qualified stock options to purchase 8,870 shares of common stock
- Restricted stock units representing 17,745 shares of common stock

The stock options have an exercise price of $11.33 per share, equal to the closing price on October 7, 2024. They have a 10-year term and will vest over four years. The restricted stock units vest in approximately four equal annual installments beginning on November 15, 2025.

These inducement awards were approved by the compensation committee under Nasdaq Listing Rule 5635(c)(4) and will have terms consistent with the Company's 2018 Equity Incentive Plan.

Replimune Group, Inc. (Nasdaq: REPL), a clinical stage biotechnology company focused on developing novel oncolytic immunotherapies, has announced its participation in two upcoming investor conferences. The company's management team will be presenting and hosting investor meetings at these events:

1. BMO 2024 Oncology Summit on Tuesday, October 8, 2024

2. 3rd Annual Roth Healthcare Opportunities Conference on Wednesday, October 9, 2024

These conferences provide Replimune with an opportunity to showcase its progress in the field of oncolytic immunotherapies and engage with investors. The company's presence at these events underscores its commitment to advancing its clinical-stage pipeline and maintaining open communication with the investment community.

Replimune Group (NASDAQ: REPL) presented primary analysis data from the IGNYTE clinical trial of RP1 combined with nivolumab in anti-PD1 failed melanoma at ESMO Congress 2024. The trial included 140 patients who received RP1 plus nivolumab after confirmed progression on anti-PD1 based therapy. Key results include:

- Overall response rate (ORR) of 33.6% by mRECIST and 32.9% by RECIST 1.1
- Complete response rate of 15% by mRECIST
- ORR of 27.7% in patients with prior anti-PD1 and anti-CTLA-4 treatment
- Median duration of response from treatment initiation was 27.6 months
- One-, two-, and three-year survival rates were 75.3%, 63.3%, and 54.8% respectively

The treatment was well-tolerated with mostly Grade 1-2 adverse events. Replimune plans to submit a BLA for RP1 in anti-PD1 failed melanoma in the second half of 2024.

Replimune Group, Inc. (NASDAQ: REPL) has successfully completed a pre-Biologics License Application (pre-BLA) meeting with the FDA, supporting their plans to submit a BLA for RP1 (vusolimogene oderparepvec) in the treatment of anti-PD1 failed melanoma via the accelerated approval pathway in 2H 2024. The company's CEO, Sushil Patel, confirmed that the accelerated approval path is available for RP1 in this indication. Topline results from the primary analysis of the IGNYTE clinical trial of RP1 plus nivolumab showed an overall response rate of 33%. Independently reviewed data from this trial, including key secondary endpoints and subgroup analyses, will be presented at the ESMO Annual Congress 2024 in Barcelona on September 15, 2024.

Replimune Group, Inc. (Nasdaq: REPL), a clinical stage biotechnology company, announced the election of Madhavan (Madhu) Balachandran to its Board of Directors at the annual stockholders meeting. Balachandran brings over 40 years of experience in manufacturing and operations to Replimune's board. He previously served as Executive Vice President of Operations at Amgen Inc., overseeing global operations. CEO Sushil Patel expressed enthusiasm about Balachandran's addition, citing his valuable experience in commercial development, manufacturing, and operations as assets for Replimune's commercialization preparations. Balachandran's background includes senior operations positions at Burroughs Wellcome Co. and an extensive educational background in chemical engineering and business administration.

Replimune Group (NASDAQ: REPL) announced that a late-breaking abstract presenting the primary analysis of the IGNYTE clinical trial has been selected for oral presentation at the European Society for Medical Oncology (ESMO) Congress 2024. The presentation, titled 'Primary efficacy, safety, and survival data from the registration-intended cohort of patients with anti-PD-1-failed melanoma from the IGNYTE clinical trial with RP1 combined with nivolumab,' will be delivered by Dr. Caroline Robert from Gustave Roussy Cancer Center on September 15, 2024. This presentation is part of the Mini Oral Session on Melanoma and other skin tumors, highlighting Replimune's progress in developing novel oncolytic immunotherapies.

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.