On February 13, 2020 Replimune Group Inc. (Nasdaq: REPL), a biotechnology company developing oncolytic immuno-gene therapies derived from its Immulytic platform, reported a corporate update, highlighting the progress of its key programs (Press release, Replimune, FEB 13, 2020, View Source [SID1234554262]).
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"Based on the early data in our lead indication of CSCC, we believe there is a high probability of success in our ongoing randomized registration-directed clinical trial of RP1 in combination with Libtayo compared to Libtayo alone, and we are also looking forward to starting an additional trial to test RP1 as a monotherapy in solid organ transplant recipients with CSCC. This is a patient population for whom immune checkpoint blockade is contraindicated due to the substantial risk of rejection of the transplanted organ and for whom the incidence of CSCC is particularly high," said Philip Astley-Sparke, Chief Executive Officer of Replimune. "Deaths from CSCC in the US approach the levels of those from melanoma, suggesting a significant initial commercial opportunity. In addition to reporting further data from our lead indications and initial clinical data with RP2 during 2020, we look forward to announcing the expansion of the clinical development plan for RP1 into additional indications as we continue to execute upon our mission to make our oncolytic immuno-gene therapies a cornerstone of cancer treatment."
Program Highlights
Replimune is currently developing three oncolytic immuno-gene therapies derived from its Immulytic platform. RP1 is Replimune’s first clinical product candidate and is based on a proprietary new strain of herpes simplex virus armed with a gene encoding a potent fusogenic protein (GALV-GP-R), 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. 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. RP3 is a further armed oncolytic immuno-gene therapy which expresses two immune co-stimulatory activating ligands – CD40L and 4-1BBL – together with anti-CTLA-4 and GALV-GP-R-. CD40L activates CD40, with the goal of achieving broad activation of both innate and adaptive immunity, and 4-1BBL activates 4-1BB (CD137), intended to promote the expansion of cellular and memory immune responses.
RP1 in combination with Libtayo in CSCC: Enrollment in the 240-patient registration-directed Phase 2, randomized, controlled clinical trial is ongoing and is expected to take approximately 18 to 24 months with enrollment intended in the US, Australia, Canada, United Kingdom and European Union.
RP1 in combination with Opdivo in melanoma, non-melanoma skin cancers, metastatic bladder cancer, and MSI-H/dMMR tumors: The Phase 2 part of the Phase 1/2 clinical trial of RP1 in combination with Opdivo remains on track with initial data from completely enrolled or ongoing skin cancer cohorts expected in mid-2020 with further data from all four cohorts expected to be available by year-end.
RP1 in combination with Opdivo in anti-PD-1 refractory melanoma patients: The Company has initiated recruitment in a new registration-directed 125-patient cohort in the Phase 2 clinical trial of RP1 in combination with Opdivo in anti-PD-1 refractory melanoma patients.
RP1 as monotherapy in solid organ transplant recipients with CSCC: The Company remains on track to initiate a 30 patient Phase 1/2 clinical trial to assess the safety and efficacy of RP1 in liver and kidney transplant recipients with recurrent CSCC in the first half of 2020.
RP2 alone and in combination with Opdivo: The ongoing Phase 1 clinical trial evaluating the safety, tolerability, and optimal dose for further development of RP2 alone and in combination with Opdivo remains on track with initial data from this all-comers clinical trial expected by the end of 2020.
RP3 alone and in combination with anti-PD-1 therapy: The Phase 1 clinical trial of RP3 alone and in combination with anti-PD-1 therapy remains on track to initiate in 2020.
Corporate Highlights
Organization transitioning into a late-stage clinical development company and preparing for commercialization. Replimune continues to grow and evolve its leadership team as it transitions into a late-stage clinical development company with the recent appointment of Jean Franchi as Chief Financial Officer and the transition of Robert Coffin, Ph.D. from Chief Executive Officer into the newly created role of President and Chief Research & Development Officer. As previously announced, Philip Astley-Sparke has moved from part-time Executive Chairman to now full-time Chief Executive Officer, and together with Robert Coffin will co-lead the company going forward.
Completed building manufacturing facility to support late-stage development and commercialization. The 63,000-square-foot facility in Framingham, MA is intended to provide multi-product manufacturing capabilities for Replimune’s product candidates with sufficient capacity to support full commercialization. The facility is now fully operational and technology transfer activities are underway.
Financial Highlights
Replimune strengthened the balance sheet in the quarter closing with $180.9 million in cash, cash equivalents and short-term investments, compared with $134.8 million as of March 31, 2019, an increase of $46.1 million. Our increased cash operating expenses were offset by $99.7 million of net proceeds from financing activities.
Based on our current operating plan, we expect our current cash, cash equivalents, and short-term investments will be sufficient to fund operating expenses and capital expenditure requirements into the second half of calendar year 2022.
Research and development expenses for the quarter ended December 31, 2019 were $11.9 million compared with $7.9 million for the same period in the prior year. The increase was driven by increased headcount and services supporting advancement of our lead program RP1 into phase II trials, additional trials, and initiating work in RP2 and RP3.
General and administrative expenses were $4.7 million for the quarter ended December 31, 2019 compared with $2.3 million for the same period in the prior year. The increase was primarily driven by increased headcount and related expense, professional fees, and facility expansion.
Replimune reported a net loss of $16.2 million for the quarter ended December 31, 2019 compared with $7.7 million for the same period in the prior year.