On August 8, 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 first quarter ended June 30, 2024 and provided a business update (Press release, Replimune, AUG 8, 2024, View Source [SID1234645622]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"We have had a highly productive quarter as we gear up for the upcoming pre-BLA meeting with the FDA and prepare to enroll the first patient in our confirmatory trial of RP1 in anti-PD1 failed melanoma," said Sushil Patel, Ph.D., CEO of Replimune. "Our confidence in the RP1 program is reinforced by the IGNYTE primary analysis data that we presented in June, which demonstrates the potential of RP1 to address unmet needs in anti-PD1 failed melanoma patients who have not responded to prior existing therapies. We remain committed to advancing the clinical programs in our pipeline, including RP2, where we are preparing to enroll patients in a registration-directed study in uveal melanoma."
Program Highlights & Milestones
RP1
RP1 combined with Opdivo (nivolumab) in anti-PD1 failed melanoma
In June, the Company announced positive topline primary analysis data by independent central review from the IGNYTE clinical trial of RP1 plus nivolumab in anti-PD1 failed melanoma. Topline results showed 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. Responses from baseline were highly durable, with all responses lasting more than 6 months and median duration of response exceeding 35 months.
The Company plans to present the full primary analysis data from the anti-PD1 failed melanoma cohort including key secondary endpoint data and subgroups for presentation at an upcoming medical congress.
The Company expects to enroll its first patient in the Phase 3 confirmatory IGNYTE-3 trial in Q3 2024, prior to submitting the RP1 BLA expected in 2H 2024. 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.
A pre-BLA meeting with the FDA is scheduled for September and a BLA submission is planned for 2H 2024.
RP2
RP2 in Uveal Melanoma
In June during ASCO (Free ASCO Whitepaper) 2024, the Company presented 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. RP2 administered as monotherapy or in combination with nivolumab demonstrated an ORR of 29.4%, with a disease control rate (DCR) of 58.8%.
Replimune has finalized the protocol based on FDA input and begun trial initiation activities for a registration-directed study of RP2 in metastatic uveal melanoma in patients who are immune checkpoints inhibitor-naïve. The study is a randomized trial of RP2 in combination with nivolumab vs. ipilimumab and nivolumab, or nivolumab for those ineligible for ipilimumab.
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 expected to dose its first patient in 2H 2024.
Financial Highlights
Financing: Completed a securities purchase agreement for a private investment in public equity ("PIPE") raising $96.7 million net of issuance costs. Proceeds from the financing will be used to scale up for the commercialization of RP1 and for working capital and general corporate purposes.
Cash Position: As of June 30, 2024, cash, cash equivalents and short-term investments were $469.1 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, 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 June 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 $43.0 million for the fiscal first quarter ended June 30, 2024, as compared to $40.4 million for the fiscal first quarter ended June 30, 2023. This increase was primarily due to increased personnel expenses, including a $2.8 million increase in payroll and fringe benefits, and a stock-based compensation increase of $0.9 million. Research and development expenses included $4.2 million in stock-based compensation expenses for the fiscal first quarter ended June 30, 2024.
S,G&A Expenses: Selling, general and administrative expenses were $14.4 million for the fiscal first quarter ended June 30, 2024, as compared to $15.2 million for the fiscal first quarter ended June 30, 2023. Selling, general and administrative expenses included $5.2 million in stock-based compensation expenses for the fiscal first quarter ended June 30, 2024.
Net Loss: Net loss was $53.8 million for the fiscal first quarter ended June 30, 2024, as compared to a net loss of $49.6 million for the fiscal first quarter ended June 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.