On November 12, 2024 Replimune Group, Inc. (Nasdaq: REPL), a clinical stage biotechnology company pioneering the development of a novel class of oncolytic immunotherapies, reported financial results for the fiscal second quarter ended September 30, 2024 and provided a business update (Press release, Replimune, NOV 12, 2024, View Source [SID1234648209]).

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"I am incredibly proud of our progress as we rapidly approach the submission of our BLA for RP1," said Sushil Patel, Ph.D., CEO of Replimune. "The IGNYTE data was presented at major medical meetings and was well received by the oncology community, who noted the importance of the systemic activity demonstrated and the continuing need for additional treatments for patients with advanced melanoma. As a team, we have been focused on our ongoing preparation for commercialization, including building our field teams, completing important market research and developing our market access teams, among many other activities to ensure we are well positioned to reach as many physicians and patients as possible."

Program Highlights & Milestones

RP1

RP1 combined with Opdivo (nivolumab) in anti-PD1 failed melanoma
In September, the Company completed a pre-BLA meeting with the FDA confirming plans to submit a BLA for RP1 for the treatment of anti-PD1 failed melanoma via the accelerated approval pathway before the end of the year.
The IGNYTE-3 confirmatory trial of RP1 in advanced melanoma is underway with first patient enrolled in August. This clinical trial is a 2-arm randomized Phase 3 trial with a defined list of physician’s choice treatment options as the comparator arm in advanced melanoma patients who progressed on anti-PD1 and anti-CTLA-4 therapy or are ineligible for anti-CTLA-4 treatment.
Late-breaking abstracts presented at ESMO (Free ESMO Whitepaper) and SITC (Free SITC Whitepaper) shared the primary analysis from the IGNYTE trial.
The primary analysis reiterated the positive top line results presented in June and confirmed the 12-month overall response rate was 33.6% by modified RECIST 1.1 criteria, the primary endpoint as defined in the protocol, and 32.9% by RECIST 1.1 criteria, an additional analysis requested by the FDA.
In addition, new data shared showed activity across all clinical subgroups, including patients who had prior anti-PD1 and anti-CTLA-4 (ORR 27.7%) and for those who had primary resistance to anti-PD1 (ORR 35.9%) by modified RECIST 1.1.
Median duration of response from response initiation was 21.6 months and median duration of response from treatment initiation was 27.6 months.
Initial biomarker data shows increased CD8+ T cell and PD-L1 expression post treatment in 50% of the tested biopsies. The increase in gene expression signature, associated CD8+ T cells and inflammatory cytokines further highlight the potential of RP1 plus nivolumab to generate a potent anti-tumor response.
RP2

RP2 in Uveal Melanoma
Study start-up activities are underway for a registration-directed study of RP2 in metastatic uveal melanoma in patients who are immune checkpoints inhibitor-naïve. The study plans to enroll the first patient in a randomized trial of RP2 in combination with nivolumab vs. ipilimumab and nivolumab, or nivolumab for those ineligible for ipilimumab in the first quarter of 2025.
RP2 in hepatocellular carcinoma (HCC)
A Phase 2 clinical trial with RP2 combined with atezolizumab and bevacizumab in anti-PD1/PD-L1 progressed HCC is actively screening patients.
Financial Highlights

Cash Position: As of September 30, 2024, cash, cash equivalents and short-term investments were $432.1 million, as compared to $420.7 million as of fiscal year ended March 31, 2024. The increase in cash balance was directly related to the PIPE financing in June, offset by cash utilized in operating activities in advancing the Company’s clinical development plans.
Based on the current operating plan, the Company believes that existing cash, cash equivalents and short-term investments, as of September 30, 2024 will enable the Company to fund operations into the second half of 2026 which includes scale up for the commercialization of RP1 in skin cancers and for working capital and general corporate purposes.

R&D Expenses: Research and development expenses were $43.4 million for the fiscal second quarter ended September 30, 2024, as compared to $49.1 million for the fiscal second quarter ended September 30, 2023. This decrease was primarily due to the wind down of the CERPASS and IGNYTE Phase II studies, as well as the deprioritization of development efforts on RP3. Research and development expenses included $4.1 million in stock-based compensation expenses for the fiscal second quarter ended September 30, 2024.
S,G&A Expenses: Selling, general and administrative expenses were $15.5 million for the fiscal second quarter ended September 30, 2024, as compared to $14.7 million for the fiscal second quarter ended September 30, 2023. Selling, general and administrative expenses included $4.6 million in stock-based compensation expenses for the fiscal second quarter ended September 30, 2024.
Net Loss: Net loss was $53.1 million for the fiscal second quarter ended September 30, 2024, as compared to a net loss of $60.0 million for the fiscal second quarter ended September 30, 2023.
About RP1

RP1 (vusolimogene oderparepvec) is Replimune’s lead product candidate and is based on a proprietary strain of herpes simplex virus engineered and genetically armed with a fusogenic protein (GALV-GP R-) and GM-CSF intended to maximize tumor killing potency, the immunogenicity of tumor cell death, and the activation of a systemic anti-tumor immune response.

About RP2

RP2 is based on a proprietary strain of herpes simplex virus engineered and genetically armed with a fusogenic protein (GALV-GP R-) and GM-CSF intended to maximize tumor killing potency, the immunogenicity of tumor cell death and the activation of a systemic anti-tumor immune response. RP2 additionally expresses an anti-CTLA-4 antibody-like molecule, as well as GALV-GP R- and GM-CSF. RP2 is intended to provide targeted and potent delivery of these proteins to the sites of immune response initiation in the tumor and draining lymph nodes, with the goal of focusing systemic-immune-based efficacy on tumors and limiting off-target toxicity.