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Jun 30, 2021
Replimune Q1 2022 Earnings Report
Replimune's financial results for the fiscal first quarter were announced and a business update was provided.
Key Takeaways
Replimune reported its fiscal first quarter financial results, highlighting the continued demonstration of depth and durability of responses observed with RP1 and RP2. The company expects to complete accrual in its registration directed CERPASS study in CSCC and in its registration directed cohort of patients with anti-PD-1 failed melanoma mid next year. They are designing a comprehensive development plan with the goal of establishing their product candidates as a cornerstone of cancer treatment regimens, including in patients with liver metastases.
Updated complete and durable response data in RP1 skin cancer cohorts support the ongoing registration directed development programs in CSCC and anti-PD-1 failed melanoma.
Full accrual for both programs is expected in mid-2022.
Initial data with RP2 as monotherapy and in combination with Opdivo® (nivolumab) supports expanding the Phase 1 clinical trial to focus on patients whose tumors have metastasized to the liver.
A broad Phase 2 program with RP2 and/or RP3 is being designed with a detailed development plan expected in the first quarter of 2022.
Forward Guidance
Replimune believes that existing cash and cash equivalents and short-term investments will fund operating expenses and capital expenditure requirements into the second half of 2024, excluding any confirmatory trial required by the FDA or other regulatory body.
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