On February 14, 2019 Replimune Group Inc. (NASDAQ: REPL), a biotechnology company developing oncolytic immuno-gene therapies derived from its Immulytic platform, reported financial results for its third fiscal quarter ended December 31, 2018, and provided an update on its business (Press release, Replimune, FEB 14, 2019, View Source [SID1234533346]).

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"Replimune continues to make significant progress with all of our development programs," said Robert Coffin, Ph.D., co-founder, President and CEO of Replimune. "We anticipate a number of key events in the first half of 2019, including the initiation of the Phase 2 portion of the Phase 1/2 clinical trial of RP1 in combination with nivolumab in four solid tumor types, initiation of a Phase 1 clinical trial of RP2 alone and in combination with anti-PD1 therapy and, of particular note, the initiation of enrollment of our potentially pivotal randomized controlled Phase 2 clinical trial of RP1 in combination with cemiplimab in cutaneous squamous cell carcinoma."

Recent Business Highlights and Upcoming Events

RP1 – Completed enrollment of RP1 as single agent and opened enrollment of patients to be treated with RP1 in combination with nivolumab in the Phase 1 portion of the Phase 1/2 clinical trial. RP1 is Replimune’s first product candidate to enter the clinic and is based on a proprietary strain of herpes simplex virus armed with a gene encoding a potent fusogenic protein, intended to enhance tumor killing potency, immunogenic cell death and the activation of systemic anti-tumor immune responses, and with a gene encoding the cytokine GM-CSF. Replimune is currently testing RP1 in a two-part Phase 1/2 clinical trial of RP1 alone and in combination with nivolumab in approximately 150 patients. In the Phase 1 portion of the Phase 1/2 clinical trial, Replimune is assessing the safety and tolerability of RP1 administered alone in patients with advanced solid tumors followed by dosing in combination with nivolumab anti-PD1 therapy. In part 2 of the Phase 1/2 clinical trial, Replimune intends to study the safety and efficacy of RP1 in combination with nivolumab in four cohorts of patients with melanoma, bladder cancer, microsatellite instability high cancers, and non-melanoma skin cancers. The Phase 2 portion of the clinical trial is on track to initiate in the first half of 2019. Data from the Phase 1 portion of the clinical trial (RP1 alone and RP1 combined with nivolumab) is expected to be presented at a medical conference in the second half of 2019.

RP1 – Phase 2 clinical trial of RP1 in combination with cemiplimab remains on-track to initiate in the first half of 2019. The registration directed randomized controlled Phase 2 clinical trial is intended to enroll approximately 240 patients with cutaneous squamous cell carcinoma (CSCC) comparing treatment with cemiplimab alone to treatment in combination with RP1, under the Company’s collaboration with Regeneron. Cemiplimab is Regeneron’s anti-PD1 drug which was approved by the U.S. Food and Drug Administration (FDA) for the treatment of locally recurrent and metastatic CSCC in 2018.

RP2 – Phase 1 clinical trial of RP2 as single agent and in combination with anti-PD1 therapy remains on-track to initiate in first half of 2019. RP2 is a version of RP1 that, in addition to expressing GALV-GP-R- and GM-CSF, also expresses a genetically encoded anti-CTLA-4 antibody intended to block the inhibition of the initiation of immune response caused by CTLA-4. RP2 is intended to be used primarily in combination with anti-PD1 or anti-PD-L1 therapy.

RP3 – Phase 1 clinical trial of RP3 as single agent and in combination with anti-PD1 therapy remains on-track to initiate in the first half of 2020. RP3 is a further armed oncolytic immuno-gene therapy which expresses two immune co-stimulatory activating ligands. Following the assessment of a number of co-stimulatory pathways, which like anti-CTLA-4 are expected to be primarily active at the site and time of anti-tumor immune response initiation, the selected RP3 product candidate expresses CD40L and 4-1BBL, together with anti-CTLA-4 and GALV-GP-R-. CD40L activates CD40, resulting in the broad activation of both innate and adaptive immunity, and 4-1BBL activates 4-1BB (CD137) to promote the expansion of cellular and memory immune responses.

Poster to be presented at AACR (Free AACR Whitepaper). A poster describing pre-clinical data relating to Replimune’s Immulytic platform and entitled "Development & characterization of a new oncolytic immunotherapy platform based on herpes simplex virus type 1" is to be presented at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) annual meeting in Atlanta, Georgia, March 29th-April 1st 2019 (Abstract # 3136). The poster will be made available on the Company’s website at the time of presentation.

Build out of Replimune’s manufacturing facility to support late-stage development and commercialization is on track and expected to be operational in the 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 capacity of this facility is expected to be sufficient to support full commercialization of the Company’s product candidates. The facility is expected to be operational in the first half of 2020.

Financial Highlights

Replimune reported a net loss of $7.7 million for the quarter ended December 31, 2018 compared with $4.4 million for the same period in the prior year. The increase in the net loss was primarily due to an increase in research and development expenses and administrative costs associated with our operations.

Research and development expenses for the quarter ended December 31, 2018 were $7.9 million compared with $3.6 million for the 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 33 on December 31, 2017 to 48 on December 31, 2018.

General and administrative expenses were $2.3 million for the quarter ended December 31, 2018 compared with $1.2 million for the same period in the prior year. The increase in general and administrative expenses was primarily due to the increase in employee headcount and the impact of stock-based compensation in 2018.

Replimune ended the quarter with $141.8 million in cash and 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 and cash equivalents and short-term investments will enable it to fund its operating expenses and capital expenditure requirements into the second half of 2021.