Business
Replimune Reports Fiscal Fourth Quarter and Year-Ended 2022 Financial Results and Provides Corporate Update
Enrollment in the CERPASS clinical trial with RP1 in cutaneous squamous cell carcinoma (CSCC) expected to be completed in mid-year 2022; top line data
About this update from Replimune Group, Inc.
[{"type":"text","content":"Enrollment in the CERPASS clinical trial with RP1 in cutaneous squamous cell carcinoma (CSCC) expected to be completed in mid-year 2022; top line data expected Q1 2023 Directional data from the first 75 patents with 6 months follow up from the IGNYTE clinical trial with RP1 in anti-PD1 failed melanoma expected in late 2022 Phase 2 development plan for RP2/RP3 in HCC, CRC and SCCHN announced WOBURN, Mass., May 19, 2022 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of a novel class of tumor-directed oncolytic immunotherapies, today announced financial results for the fiscal fourth quarter and year ended March 31, 2022 and provided a business update. “We have ended the fiscal year in a very strong position from which to execute on our vision to establish our products as a cornerstone of immuno-oncology regimens and we look forward with these firm foundations in place to a potentially transformative 12-month period ahead,” said Philip Astley-Sparke CEO of Replimune. “Updated data in anti-PD1 naïve cutaneous squamous cell carcinoma (CSCC) and anti-PD1 failed melanoma continue to support our two registration-directed clinical trials in these settings. We are maintaining guidance that we expect to complete enrollment into our registration directed CERPASS clinical trial in CSCC mid-year and to release top line data in early 2023. Further, we expect to release initial directional data from our registration directed IGNYTE clinical trial in anti-PD1 failed melanoma in late 2022. Launch scale manufacturing has been established and commercial planning to establish a major skin cancer franchise is advancing. With RP2/3 we have announced an exciting mid stage program in colorectal cancer (CRC), hepatocellular carcinoma (HCC) and head and neck cancer (SCCHN) where an expedited path to potential approval in some settings may be feasible. Finally, we have a strong cash position to drive value through multiple major data catalysts.” Corporate Updates Provided data update for RP1 in its skin cancer programs at a virtual investor event in March 2022. IGNYTE anti-PD1 naïve NMSC cohort of patients treated with RP1 combined with Opdivo® (nivolumab) (n=32; recruitment complete): The overall response rate (ORR) in CSCC increased to 65%, compared to 60% at the June 2021 update...