Replimune Group, Inc. - REPL STOCK NEWS

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.

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.