On May 16, 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 fourth quarter and year ended March 31, 2024 and provided a business update (Press release, Replimune, MAY 16, 2024, View Source [SID1234643403]).
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"We have exciting milestones in the coming months, including sharing the investigator-assessed 12-month IGNYTE data at ASCO (Free ASCO Whitepaper) and then the official primary analysis by independent central review later in the second quarter," said Sushil Patel, Ph.D., CEO of Replimune. "Importantly, the design of our Phase 3 confirmatory IGNYTE-3 clinical trial has been agreed with the FDA, with patient enrollment planned to initiate in the second half of the year prior to the submission of our BLA for RP1. We also completed a successful Type C meeting with the FDA to align on our CMC plans ahead of the intended BLA. These are all critical steps as we plan for our next phase as a commercial stage company and, pending FDA approval, prepare to bring our first oncolytic immunotherapy to patients with advanced skin cancer."
Corporate Updates
The following abstracts, including two oral presentations, will be presented at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, May 31-June 4:
Abstract #9517 (Rapid Oral Abstract Session): Efficacy and safety of RP1 combined with nivolumab in patients with anti-PD-1 failed melanoma from the IGNYTE clinical trial.
Abstract #9511 (Rapid Oral Abstract Session): Safety, efficacy, and biomarker results from an open-label, multicenter, phase 1 study of RP2 alone or combined with nivolumab in a cohort of patients with uveal melanoma.
Abstract #TPS9604 (Poster Session): A randomized, controlled, multicenter, phase 3 study of vusolimogene oderparepvec (VO) combined with nivolumab vs treatment of physician’s choice in patients with advanced melanoma that has progressed on anti–PD-1 and anti–CTLA-4 therapy (IGNYTE-3).
Abstract #TPS4191 (Poster Session): An open-label, multicenter study investigating RP2 oncolytic immunotherapy in combination with second-line systemic atezolizumab combined with bevacizumab in patients with locally advanced unresectable or metastatic hepatocellular carcinoma.
Abstract #TPS9614 (Poster Session): Trial in progress: A phase 1/2 study of Vusolimogene oderparepvec in primary melanoma (mel) to reduce the risk of sentinel lymph node (SLN) metastasis.
Manufacturing progress. The Company completed a successful Type C meeting with the FDA that confirmed alignment on our Chemistry, Manufacturing and Controls (CMC) plans to support our IGNYTE anti-PD1 failed melanoma BLA submission in the 2H 2024.
Program Highlights & Milestones
RP1
RP1 combined with Opdivo (nivolumab) in anti-PD1 failed melanoma
The Company presented positive six-month follow up data by investigator assessment (N=140) from the anti-PD1 failed melanoma cohort of the IGNYTE clinical trial late last year. The Company is on track to present the 12-month primary analysis by independent central review in Q2 2024.
The Company plans to enroll its first patient in the Phase 3 confirmatory IGNYTE-3 trial prior to submitting the RP1 BLA. The Phase 3 trial design has been agreed to with the FDA and will be a 2-arm randomized 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.
RP1 in solid organ transplant recipients with skin cancers
The Company presented data from the ARTACUS clinical trial of RP1 monotherapy in solid organ transplant recipients with skin cancers at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) 2024 Annual Meeting in April 2024. The data included 23 evaluable patients with CSCC (n=20) and MCC (n=3).
The data demonstrated an overall response rate (ORR) of 34.8% (8 of 23 evaluable patients, including 5 complete responses and 3 partial responses).
RP1 monotherapy was well tolerated, and the safety profile was similar to non-immunocompromised patients with advanced skin cancers (i.e. from the IGNYTE study). No immune-mediated adverse events or evidence of allograft rejection were observed.
The ARTACUS clinical trial continues to enroll patients.
RP1 in combination with Libtayo (cemiplimab-rwlc) in CSCC
The CERPASS trial continues as planned to assess the time-based endpoints of duration of response, progression free survival and overall survival with greater maturity.
RP2
RP2 in Uveal Melanoma
The protocol for the registration-directed clinical trial of RP2 combined with nivolumab in advanced uveal melanoma is near final following input from the FDA.
RP2 in Hepatocellular Carcinoma (HCC)
The Phase 2 clinical trial with RP2 in anti-PD1/PD-L1 progressed HCC of RP2 combined with atezolizumab and bevacizumab is expected to initiate in 2H 2024.
Financial Highlights
Cash Position: As of March 31, 2024, cash, cash equivalents and short-term investments were $420.7 million, as compared to $583.4 million as of fiscal year March 31, 2023. The decrease was primarily related to 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 March 31, 2024 will enable the Company to fund operations into the second half of 2026.
Debt: As of March 31, 2024, the debt (net of discount) balance was $44.8 million, as compared to $28.6 million as of March 31, 2023. The increase was primarily related to the draw down of $15 million in December 2023, at the time of the closing of the second amendment to the loan and security agreement with Hercules.
R&D Expenses: Research and development expenses were $42.6 million for the fourth quarter and $175.0 million for the fiscal year ended March 31, 2024, as compared to $37.9 million for the fourth quarter and $126.5 million for the fiscal year ended March 31, 2023. This increase was primarily due to increased clinical and manufacturing expenses driven by the Company’s lead programs and increased personnel expenses. Research and development expenses included $3.2 million in stock-based compensation expenses for the fourth quarter and $14.7 million in stock-based compensation expenses for the fiscal year ended March 31, 2024.
S,G&A Expenses: Selling, general and administrative expenses were $16.2 million for the fourth quarter and $59.8 million for the fiscal year ended March 31, 2024, as compared to $15.0 million for the fourth quarter and $50.6 million for the year ended March 31, 2023. The increase was primarily driven by personnel related costs, including sales and marketing personnel associated with pre-launch planning and build of the Company’s commercial infrastructure. Selling, general and administrative expenses included $4.7 million in stock-based compensation expenses for the fourth quarter and $19.4 million in stock-based compensation expenses for the fiscal year ended March 31, 2024.
Net Loss: Net loss was $55.1 million for the fourth quarter and $215.8 million for the fiscal year ended March 31, 2024, as compared to a net loss of $49.2 million for the fourth quarter and $174.3 million for the fiscal year ended March 31, 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 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.