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Mar 31, 2023
Replimune Q4 2023 Earnings Report
Replimune reported financial results for the fiscal fourth quarter and year ended March 31, 2023, and provided a business update.
Key Takeaways
Replimune Group, Inc. announced financial results for the fiscal fourth quarter and year ended March 31, 2023. The company is focused on topline data from the CERPASS clinical trial of RP1 combined with Libtayo® in CSCC, expected in the next quarter, and plans to provide an initial data snapshot from the full IGNYTE anti-PD1 failed melanoma cohort by year-end.
Topline data from the registration-directed CERPASS clinical trial of RP1 combined with Libtayo® in cutaneous squamous cell carcinoma (CSCC) is on track for Q3 2023, with Biologics License Application (BLA) submission on track for Q1 2024.
Enrollment was completed (n=141) for the IGNYTE registration-directed cohort of RP1 in anti-PD1 failed melanoma; updated data for the first 75 patients will be presented at ASCO, with data snapshot for all 141 patients expected in Q4 2023.
RP2 and RP3 Phase 2 programs are 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 is expected at year-end.
The company has a strong balance sheet with a cash runway into H2 2025.
Forward Guidance
Based on the current operating plan, the Company believes that existing cash, cash equivalents and short-term investments, as of March 31, 2023, will enable the Company to fund operations into the second half of calendar year 2025.
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