On August 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 first fiscal quarter, ended June 30, 2019, and provided an update on its business (Press release, Replimune, AUG 14, 2019, View Source [SID1234538717]).

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"All programs are on track and progressing as expected," said Robert Coffin, Ph.D., co-founder, President and CEO of Replimune. "The second half of this year will be important for Replimune, with the release of the initial Phase 1 data from our ongoing Phase 1/2 clinical trial of RP1 alone and in combination with nivolumab in the fourth quarter, the initiation of a registration-directed randomized controlled Phase 2 clinical trial in cutaneous squamous carcinoma (CSCC), and the initiation of clinical development with our second product candidate, RP2. In particular, we look forward to sharing the initial Phase 1 results with RP1 in patients with advanced solid tumors later in the year."

Recent Business Highlights and Upcoming Events

RP1 – Data from the Phase 1 part of the Phase 1/2 clinical trial of RP1 alone and in combination with nivolumab expected to be reported at a medical conference in the fourth quarter of 2019. The Phase 1 part of the clinical trial enrolled patients with advanced heavily pre-treated cancers, who have failed available therapy. Initially, single-agent RP1 was administered into a single tumor up to five times at a range of dose levels by direct injection into superficial tumors or by imaging-guided injection into deeper, including visceral, tumors. Following determination of the recommended Phase 2 dose, an expansion group of advanced cancer patients then received RP1 in combination with nivolumab. The main goals of the Phase 1 part of the clinical trial were to assess safety, to determine the optimal dose to administer in combination with nivolumab in the Phase 2 portion of the study, and to gather evidence of clinical activity in line with the expected profile of RP1. This clinical trial is being conducted under a clinical trial collaboration and supply agreement with Bristol Myers Squibb (BMS) for the supply of nivolumab.

RP1 – Enrollment is ongoing in the Phase 2 part of the Phase 1/2 trial of RP1 in combination with nivolumab. The Phase 2 part of the clinical trial is currently enrolling 30-patient cohorts of patients with melanoma, non-melanoma skin cancers and metastatic bladder cancer. Enrollment in a fourth, microsatellite instability high (MSI-H) tumor cohort, is expected to open once a protocol-required MSI-H patient is evaluable for safety from Phase 1 (expected in September). The patients enrolled into the melanoma cohort will either be treatment naïve or have received prior systemic therapy, including anti-PD1 and/or anti-CTLA-4 therapy, and the patients enrolled into the other three cohorts will all be naïve to anti-PD1 therapy. Efficacy and biomarker data will be evaluated within each tumor-type cohort.

RP1 – Phase 2 clinical trial of RP1 in combination with cemiplimab remains on track to open in August 2019. This registration-directed randomized controlled Phase 2 clinical trial is planned to enroll approximately 240 patients with CSCC, comparing treatment with cemiplimab alone to treatment with cemiplimab in combination with RP1, under the Company’s collaboration with Regeneron. Cemiplimab is Regeneron’s anti-PD1 therapy which was approved by the U.S. Food and Drug Administration (FDA) for the treatment of locally recurrent or metastatic CSCC in 2018.

RP2 – Phase 1 clinical trial of RP2 as a single agent and in combination with nivolumab remains on track to initiate in the current quarter.RP2 is a further armed oncolytic immuno-gene therapy 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. As with the clinical trial with RP1 in combination with nivolumab, this clinical trial will be conducted under a clinical trial collaboration and supply agreement with BMS for the supply of nivolumab.

RP3 – Phase 1 clinical trial of RP3 as a single agent and in combination with anti-PD1 therapy to initiate in 2020.RP3 is a further armed oncolytic immuno-gene therapy which expresses two immune co-stimulatory activating ligands (CD40L and 4-1BBL) in addition to the GALV-GP R- fusogenic protein and anti-CTLA-4. The Phase 1 trial of RP3 as a single agent and in combination with anti-PD1 therapy remains on track to be initiated in 2020.

Paper describing the development of Replimune’s Imylytic platform published in the Journal for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (JITC). A paper describing the design, underlying characteristics and pre-clinical data for the Company’s enhanced potency oncolytic immuno-gene therapy product platform and entitled "Development of a new fusion-enhanced oncolytic immunotherapy platform based on herpes simplex virus type 1" was recently published in JITC.

Build-out of Replimune’s manufacturing facility to support late-stage development and commercialization is on track. The 63,000-square-foot facility in Framingham, MA is intended to provide multi-product manufacturing capabilities for Replimune’s Immulytic product candidates. The capacity of this facility will be sufficient to support full commercialization of the Company’s product candidates and is expected to be operational in the first half of 2020.
Financial Highlights

Replimune reported a net loss of $9.5 million for the quarter ended June 30, 2019 compared with $10.0 million for the same period in the prior year.

Research and development expenses for the quarter ended June 30, 2019 were $7.5 million compared with $3.9 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 an increase in employee headcount.

General and administrative expenses were $3.5 million for the quarter ended June 30, 2019 compared with $1.9 million for the same period in the prior year. The increase in general and administrative expenses was primarily due to an increase in employee headcount and the impact of stock-based compensation in 2019.

Replimune ended the quarter with $120.8 million in cash and cash equivalents and short-term investments, compared with $134.8 million as of March 31, 2019.

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 calendar 2021.