Enhanced Investments - Financial Portal

Replimune Reports Fiscal Fourth Quarter and Year Ended 2023 Financial Results and Provides Corporate Update

Published: 2023-05-18 12:00:00 ET

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.

Completed enrollment in the IGNYTE anti-PD1 failed melanoma cohort
- The Company enrolled its last patient (n=141) in the registration directed cohort of patients evaluating RP1 combined with Opdivo® (nivolumab) in anti-PD1 failed melanoma in March 2023. In addition to presenting updated data from the first 75 patients at ASCO in June, the Company expects to announce snapshot data for all patients in Q4 2023 by which point all patients will have had at least 6 months follow up, prior to the per protocol primary analysis at 12 months post the last patient enrolled.

RP1 combined with Opdivo®in anti-PD1 failed non-melanoma skin cancers
- Recruitment remains ongoing into the cohort of patients with anti-PD1 failed non-melanoma skin cancers, including CSCC, with a data update expected in Q3 2023.

RP1 in solid organ transplant recipients with skin cancers
- The Company continues to enroll patients into its ARTACUS clinical trial of RP1 monotherapy in solid organ transplant recipients with skin cancers and expects to provide a data update at the American Transplant Congress in June.

RP2 and RP3

Phase 2 program

RP2 and RP3 in combination with atezolizumab and bevacizumab in 3L CRC
- Two signal finding cohorts of 30 patients each will be enrolled in collaboration with Roche. The first cohort will enroll patients to be treated with atezolizumab combined with bevacizumab and RP2 and the second cohort with atezolizumab and bevacizumab and RP3. The Company believes that data with both RP2 and RP3 in CRC will allow the comparative efficacy of RP2 and RP3 to be evaluated in a particularly difficult to treat patient population.

RP3 in combination with standard of care therapy in SCCHN
- A two-cohort clinical trial will be conducted, with the first cohort of 100 patients with locally advanced disease being randomized to receive either standard of care (SOC) chemotherapy combined with radiation or RP3 combined with chemotherapy and radiation followed by adjuvant nivolumab therapy. The second, signal finding cohort, will enroll 30 patients with recurrent or metastatic SCCHN with low PDL1 levels (CPS

Enhanced Investments, Inc.
329 South Oyster Bay Road #2085
Plainview, NY 11803
team@eninvs.com

Important disclosures

Performance results were prepared by Enhanced Investments, and have not been compiled, reviewed or audited by an independent accountant. Performance estimates are subject to future adjustment and revision. Investors should be aware that a loss of investment is possible. Account holdings are for illustrative purposes only and are not investment recommendations. Additional information, including (i) the calculation methodology; and (ii) a list showing the contribution of each holding to the portfolio’s performance during the time period will be provided upon request.
All statements made via social media sites sponsored or maintained by Enhanced Investments and its affiliates are for informational purposes only and do not constitute a comprehensive description of Enhanced Investments' investment advisory services.
Certain investments are not suitable for all investors. Before investing, consider your investment objectives and applicable fees. The rate of return on investments can vary widely over time, especially for long term investments. Investment losses are possible, including the potential loss of all amounts invested. Information provided by Enhanced Investments is for informational and general educational purposes only and is not investment or financial advice.

Nothing on this website should be considered an offer, solicitation of an offer, or advice to buy or sell securities.
Past performance is no guarantee of future results. Any historical returns, expected returns [or probability projections] are hypothetical in nature and may not reflect actual future performance.
All the strategies assume investments in equity invstrumenta only and are more relevant for "agressive investment profile". Eastern European flagship strategy assumes using up to 20% leverage of total portfolio. GlobalCommodities and US Growth strategy currently assume no leverage.
Results for the Enhanced Investments strategies as compared to the performance of Illustrative Benchmarks is for informational purposes only. Our investment program does not mirror that of the Illustrative Benchmarks and the volatility may be materially different from the volatility of Illustrative Benchmarks. Reference or comparison to an Illustrative Benchmark does not imply that strategies of Enhanced Investments will be constructed in the same way as the Illustrative Benchmark or achieve returns, volatility, or other results similar to those of the Illustrative Benchmark. The S&P 500 is an unmanaged market capitalization-weighted index of 500 common stocks chosen for market size, liquidity, and industry group representation to represent U.S. equity performance.
Performance results were prepared by Enhanced Investments, and have not been compiled, reviewed or audited by an independent accountant. Performance estimates are subject to future adjustment and revision. Investors should be aware that a loss of investment is possible. Account holdings are for illustrative purposes only and are not investment recommendations. Additional information, including (i) the calculation methodology; and (ii) a list showing the contribution of each holding to the portfolio’s performance during the time period will be provided upon request.
All statements made via social media sites sponsored or maintained by Enhanced Investments and its affiliates are for informational purposes only and do not constitute a comprehensive description of Enhanced Investments' investment advisory services.
Certain investments are not suitable for all investors. Before investing, consider your investment objectives and applicable fees. The rate of return on investments can vary widely over time, especially for long term investments. Investment losses are possible, including the potential loss of all amounts invested. Information provided by Enhanced Investments is for informational and general educational purposes only and is not investment or financial advice.