Replimune Group Stock Price, News & Analysis

Replimune Group (NASDAQ: REPL) has announced the enrollment of first patients in two clinical trials evaluating RP2: one for checkpoint naïve metastatic uveal melanoma and another for second-line recurrent or metastatic hepatocellular carcinoma (HCC).

The RP2-202 trial for uveal melanoma is a randomized, phase 2/3 study that will enroll approximately 280 patients, evaluating RP2 with nivolumab versus ipilimumab with nivolumab. Previous Phase 2 results showed a 29.4% overall response rate and 58.8% disease control rate.

The RP2-003 trial for HCC will enroll 30 patients to evaluate RP2 combined with atezolizumab and bevacizumab in advanced cases. This study is being conducted in collaboration with Roche. HCC represents 75-85% of primary liver cancer cases and is the third leading cause of cancer-related deaths globally.

Replimune Group (Nasdaq: REPL), a clinical stage biotechnology company focused on developing novel oncolytic immunotherapies, has announced its participation in the 43rd Annual J.P. Morgan Healthcare Conference. The company's management team will deliver a presentation on Monday, January 13, 2025, at 2:15 PM PT.

The presentation will be accessible through a simultaneous webcast in the Investors section of Replimune's website at replimune.com. For those unable to attend live, a replay option will remain available for 30 days after the conference.

Replimune Group (Nasdaq: REPL) has announced the pricing of an upsized public offering, consisting of 6,923,000 shares of common stock at $13.00 per share and pre-funded warrants to purchase 3,846,184 shares at $12.9999 per warrant. The offering is expected to generate approximately $140 million in gross proceeds. The company has granted the underwriter a 30-day option to purchase up to an additional 1,615,377 shares. The offering, managed by Leerink Partners as sole bookrunner, is expected to close on November 27, 2024.

Replimune Group (Nasdaq: REPL) announced a proposed public offering of $125 million in common stock and pre-funded warrants. The company plans to grant underwriters a 30-day option to purchase up to an additional $18.75 million of securities at the public offering price, less underwriting discounts. Leerink Partners is acting as sole bookrunning manager. The offering will be made through a preliminary prospectus supplement and accompanying prospectus, subject to market and customary closing conditions.

Replimune Group (NASDAQ: REPL) has submitted a biologics license application (BLA) to the FDA for RP1 in combination with nivolumab to treat advanced melanoma patients who previously received anti-PD1 treatment. The FDA has granted Breakthrough Therapy designation for this combination therapy, potentially expediting its development and review process. The submission was made under the Accelerated Approval pathway, based on safety and clinical activity data from the IGNYTE clinical trial. A confirmatory Phase 3 IGNYTE-3 trial is currently enrolling patients.

Replimune Group (NASDAQ: REPL) announced financial results for Q2 2024 and provided corporate updates. The company completed a pre-BLA meeting with FDA and plans to submit BLA for RP1 plus nivolumab in anti-PD1 failed melanoma via accelerated approval pathway by year-end. The IGNYTE-3 confirmatory trial enrolled its first patient in August.

Key financial metrics: Cash position of $432.1 million as of September 30, 2024, R&D expenses decreased to $43.4 million from $49.1 million YoY, and net loss improved to $53.1 million from $60.0 million YoY. The company expects current cash to fund operations into second half of 2026.

Replimune presented primary analysis data from the IGNYTE clinical trial evaluating RP1 combined with nivolumab in anti-PD1 failed melanoma patients at SITC 2024. The trial included 140 patients with a median follow-up of 15.4 months. Key results showed an overall response rate of 33.6% by mRECIST criteria, with a 15% complete response rate. The median duration of response was 21.6 months, with one-, two-, and three-year survival rates of 75.3%, 63.3%, and 54.8%, respectively. Biomarker data demonstrated increased CD8+ T cell and PD-L1 expression, indicating potential for generating anti-tumor immune responses. The treatment was well-tolerated with mostly Grade 1-2 adverse events.

Replimune Group announced inducement equity awards to 12 newly hired non-executive employees. The awards include non-qualified stock options to purchase 19,390 shares at $12.02 per share and restricted stock units representing 38,810 shares. The options have a 10-year term with 25% vesting after one year and the remainder monthly over three years. The restricted stock units vest in four annual installments starting November 15, 2025. These awards were approved under Nasdaq Listing Rule 5635(c)(4) and align with the Company's 2018 Equity Incentive Plan terms.

Replimune Group (NASDAQ: REPL) announced two key presentations at the 39th Annual Meeting of the Society for Immunotherapy of Cancer (SITC 2024) in Houston, Texas. The first is a late-breaking oral presentation featuring primary analysis data from the IGNYTE clinical trial, including subgroup and initial biomarker analyses of RP1 plus nivolumab in anti-PD1 failed melanoma patients. Dr. Michael K. Wong from MD Anderson Cancer Center will present this on November 9, 2024.

Additionally, Dr. Diwakar Davar from UPMC Hillman Cancer Center will present an encore poster on November 8, 2024, sharing data from the ARTACUS clinical trial, which studied RP1 monotherapy in solid organ transplant patients with advanced cutaneous malignancies.