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Replimune Group, Inc. reports clinical, regulatory and financial developments for a clinical-stage biotechnology business developing oncolytic immunotherapies for cancer. The company’s proprietary RPx platform uses an engineered HSV-1 backbone intended to promote tumor cell killing, immunogenic cell death and systemic anti-tumor immune responses.
Recurring Replimune news centers on RP1, or vusolimogene oderparepvec, including data from the IGNYTE clinical trial, combination use with nivolumab in advanced melanoma, Biologics License Application activity and FDA complete response letters. Updates also cover RP2 clinical data in advanced solid tumors, scientific presentations at oncology meetings, quarterly financial results, research and development spending, cash runway commentary and management presentations at healthcare conferences.
Replimune Group, Inc. (NASDAQ: REPL) announced the appointment of Tanya Lewis to its Board of Directors, effective November 2, 2020. With over 20 years in global drug development, particularly in oncology, her expertise enhances Replimune's regulatory strategies. Previously, she held significant roles at Karyopharm Therapeutics, Tesaro, and Millennium, where she drove successful drug approval processes. This appointment aims to strengthen Replimune's efforts to bring their oncolytic immunotherapies to market amid a growing pipeline.
Replimune Group Inc. (NASDAQ: REPL) announced the initial safety and efficacy data of its oncolytic immuno-gene therapy candidates, RP1 and RP2, during the Society for Immunotherapy of Cancer (SITC) virtual meeting. The Phase 1 trial of RP2 indicated promising results with 50% of patients showing ongoing partial responses. The RP1 trial also demonstrated positive outcomes, including a response rate of 87.5% in non-melanoma skin cancers. Both therapies exhibited manageable safety profiles, supporting further clinical study.
Replimune Group Inc. (Nasdaq: REPL) announces that CEO Philip Astley-Sparke will present at the BMO Capital Markets 2020 Prescriptions for Success Healthcare Conference on June 23, 2020, at 9:30 a.m. ET. Replimune is a biotechnology company based in Woburn, MA, specializing in developing oncolytic immuno-gene therapies through its Immulytic™ platform. This innovative approach aims to enhance the immune response to tumors and improve cancer treatment efficacy, particularly in conjunction with immune checkpoint blockade therapies.
Replimune Group, a biotechnology firm, announced a public offering of 2,826,088 shares of common stock at $23.00 per share, along with pre-funded warrants for 1,521,738 shares at $22.9999 each. The total gross proceeds are estimated at $100 million, excluding underwriting discounts. The offering is set to close on June 11, 2020, pending customary conditions. J.P. Morgan, SVB Leerink, and BMO Capital act as joint managers. This offering aims to fund ongoing development of Replimune's oncolytic immuno-gene therapies derived from its Immulytic platform.
Replimune Group, Inc. (Nasdaq: REPL) announced a proposed public offering of $80 million in common stock, alongside pre-funded warrants for certain investors. The offering includes a 30-day option for underwriters to purchase an additional $12 million in shares. The offering is subject to market conditions and customary closing criteria. J.P. Morgan Securities LLC, SVB Leerink LLC, and BMO Capital Markets Corp. are the joint book-running managers. All sales will be conducted under a previously filed shelf registration statement.
Replimune Group, Inc. (NASDAQ: REPL) reported fiscal Q4 and year-end financial results as of March 31, 2020. The net loss was $15.8 million for Q4 and $52.6 million for the fiscal year, an increase from $6.7 million and $30.8 million in the prior year. Cash and equivalents increased to $168.6 million from $134.8 million. Clinical updates revealed promising data for RP1 in treating cutaneous squamous cell carcinoma and melanoma. The firm is set to expand its clinical development into non-small cell lung cancer (NSCLC) and has completed a new manufacturing facility.
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