On November 14, 2018 Replimune Group Inc. (NASDAQ: REPL), a biotechnology company developing oncolytic immunotherapies derived from its Immulytic platform, reported financial results for its second fiscal quarter ended September 30, 2018, and provided an update on its business (Press release, Replimune, NOV 14, 2018, View Source [SID1234531348]).

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"All of our programs are progressing to track within the timelines outlined to investors during our July 2018 initial public offering" said Robert Coffin, Ph.D., co-founder and CEO of Replimune. "We were pleased to receive FDA acceptance of our IND for RP1 this past quarter which allows us to expand enrollment of our Phase 1/2 trial beyond the U.K. and into the U.S. by year-end 2018. In addition, we continue to make progress developing both RP2 and RP3 which will expand the potential utility of our platform beyond the current indications and into most solid tumors."

Recent Business Highlights and Upcoming Events
Investigational New Drug (IND) application for RP1 accepted by the U.S. Food and Drug Administration (FDA). RP1 is Replimune’s first Immulytic product candidate to enter the clinic and is based on a proprietary new strain of herpes simplex virus engineered to maximize tumor killing potency intended to result in highly immunogenic cell death and activation of a systemic anti-tumor immune response. The accepted IND allows Replimune to start enrolling patients in the Company’s ongoing Phase 1/2 clinical trial in the U.S., which is expected to occur by year-end 2018.
Continued progress with the Phase 1/2 study of RP1 in multiple solid tumors. Replimune’s Phase 1/2 clinical trial with RP1 is currently ongoing in the U.K. In the first part of the clinical trial Replimune is initially testing RP1 alone and then in combination with nivolumab for safety and biological activity in patients with advanced, heavily pre-treated solid tumors. The combination phase of the first part of the clinical trial is expected to be underway in the U.S. and the U.K. by the year end. The second part of the Phase 1/2 clinical trial is on track to begin in the first half of 2019, and will study the safety and efficacy of RP1 in combination with nivolumab in approximately 120 patients with metastatic melanoma, metastatic bladder cancer, microsatellite instability high cancer, and non-melanoma skin cancers under Replimune’s collaboration agreement with Bristol-Myers Squibb.
Phase 2 clinical trial of RP1 in combination with cemiplimab remains on track to initiate in the first half of 2019. This Phase 2 trial is intended to be a randomized, controlled clinical trial of RP1 in combination with the anti-PD-1 antibody cemiplimab compared to cemiplimab alone, in approximately 240 patients with cutaneous squamous cell carcinoma (CSCC). CSCC is the highest mortality skin cancer after melanoma and accounts for 4,000 to 9,000 annual deaths in the U.S. The primary objective of the Phase 2

clinical trial is intended to assess the response rate of the combination therapy compared to treatment with anti-PD-1 therapy alone, with key secondary endpoints expected to include the rate of complete response and the duration of response. This clinical trial is the first to be conducted under our collaboration with Regeneron, and has been designed as a potentially registration-directed clinical trial.

Build out of Replimune’s own manufacturing facility to support late-stage development and commercialization is on track and expected to be operational first half of 2020. In July 2018, Replimune signed a lease for a 63,000-square-foot facility in Framingham, MA where the Company intends to establish world-class multi-product manufacturing capabilities for its Immulytic product candidates. The facility is currently being built out and expected to be operational in the first half of 2020.

IND filing for RP2 remains on track for the first half of 2019. The Company expects to file an IND during the first half of 2019 with the FDA in the U.S., and/or a Clinical Trial Authorisation (CTA) with the Medicine and Healthcare Products Regulatory Agency (MHRA) in the U.K., in order to initiate a Phase 1 trial of RP2 and RP2 in combination with anti-PD1 therapy in mixed solid tumors. RP2 is a version of RP1 that, in addition to expressing a fusogenic protein and GM-CSF, also expresses a genetically encoded anti-CTLA-4 antibody intended to block the inhibition of the immune response otherwise caused by CTLA-4.

·RP3 product candidate to be finalized by year-end 2018. RP3 is the Company’s third oncolytic immunotherapy and includes the properties of both RP1 and RP2 while also expressing ligands for the various immune co-stimulatory pathways responsible for T-cell proliferation and/or activation. The precise payload of immune-activating ligands for RP3 is expected to be finalized by the end of 2018, and initiation of the Phase 1 clinical trial with RP3 remains on track for the first half of 2020.

Financial Highlights

Replimune reported a net loss of $6.5 million for the quarter ended September 30, 2018 compared with $4.7 million for same period in the prior year. The increase in net loss for the year was due to increased research and development expenses as well as expenses related to Replimune’s initial public offering (IPO).

Research and development expenses for the quarter ended September 30, 2018 were $5.0 million compared with $3.1 million for same period in the prior year. The increase in research and development expenses was primarily driven by additional costs related to Replimune’s preclinical and clinical development activities for its pipeline, as well as increased salary and related benefits costs due to the increase in employee headcount from 28 on September 30, 2017 to 43 on September 30, 2018.

General and administrative expenses were $2.1 million for the quarter ended September 30, 2018 compared with $1.1 million for same period in the prior year. The increase in general and administrative expenses was primarily due to an increase in legal and accounting fees related to the Company’s IPO, the increase in employee headcount and the impact of stock-based compensation in 2018.

Replimune ended the quarter with $147.9 million in cash, cash equivalents and short-term investments, compared with $61.6 million as of March 31, 2018. The increase reflects net proceeds received of $103.3 million in connection with its IPO.

Based on its current operating plan, Replimune expects that its current cash, cash equivalents and short-term investments will enable it to fund its operating expenses and capital expenditure requirements into the second half of 2021.