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Replimune Reports Fiscal Fourth Quarter and Year Ended 2023 Financial Results and Provides Corporate Update
Topline data disclosure from the registration-directed CERPASS clinical trial of RP1 combined with Libtayo® (cemiplimab-rwlc) in cutaneous squamous cell
About this update from Replimune Group, Inc.
[{"type":"text","content":"Topline data disclosure from the registration-directed CERPASS clinical trial of RP1 combined with Libtayo® (cemiplimab-rwlc) in cutaneous squamous cell carcinoma (CSCC) on track for Q3 2023 and Biologics License Application (BLA) submission on track for Q1 2024 Completed enrollment (n=141) of the IGNYTE registration directed cohort of RP1 in anti-PD1 failed melanoma; updated data for the first 75 patients to be presented at ASCO, with data snapshot for all 141 patients expected Q4 2023 RP2 and RP3 Phase 2 programs expected to initiate around mid-year 2023 in third-line (3L) colorectal cancer (CRC), first- and second-line (1L & 2L) hepatocellular carcinoma (HCC) and squamous cell carcinoma of the head and neck (SCCHN); Phase 1 study update expected at year end Strong balance sheet with cash runway into H2 2025 WOBURN, Mass., May 18, 2023 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of a novel portfolio of tumor-directed oncolytic immunotherapies, today announced financial results for the fiscal fourth quarter and year ended March 31, 2023 and provided a business update. “We have multiple value-driving catalysts across our pipeline ahead of us, with a focus on the topline data from our registration-directed CERPASS clinical trial of RP1 combined with Libtayo® in CSCC expected in the next quarter and plan to provide an initial data snapshot from the full IGNYTE anti-PD1 failed melanoma cohort by the year end, by which point all patients will have been followed for at least 6 months,” said Philip Astley-Sparke, CEO of Replimune. “As we prepare for the upcoming data readouts, and intended BLA submission, we continue to ramp up our commercial efforts for a potential launch in late 2024 as we seek to establish a major skin cancer franchise with RP1. We are also looking forward to launching our Phase 2 program with RP2 and RP3 in CRC, HCC and SCCHN in the next few months.” Program Highlights & Milestones: RP1 CERPASS clinical trial of RP1 combined with Libtayo® in cutaneous squamous cell carcinoma (CSCC) The Company remains on track to announce top line data from its registration-directed CERPASS clinical trial in Q3 2023, and assuming positive primary analysis data demonstrating overall clinical benefit, the Company plans to submit a BLA for RP1 in Q1 2024....