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Replimune® Replimune Reports Third Fiscal Quarter Financial Results and Provides Corporate Update February 4 , 2021 RP1 : Initial data in new indications expected in 2021 in anti - PD1 failed NSCLC , anti - PD1 failed CSCC and CSCC solid organ transplant recipient patients ; further updates expected to be provided across all studies RP2 : Initial data to be reported in 2021 in combination with Opdivo in Phase 1 all comers study RP3 : First patient dosed ; initial single agent data expected to be reported in 2021 Commercial - scale facility operational ; GMP manufacturing underway WOBURN , Mass . , Feb. 04 , 2021 ( GLOBE NEWSWIRE ) -- Replimune Group Inc. ( NASDAQ : REPL ) , a biotechnology company developing oncolytic immuno - gene therapies derived from its Immulytic ™ platform , today announced financial results for the fiscal third quarter ended December 31 , 2020 and provided a business update . " It has been a productive start to 2021 , " said Philip Astley - Sparke , Chief Executive Officer of Replimune . " We started the current quarter with the news that dosing has commenced with our third product candidate , RP3 , which like RP2 is intended to treat tumor types that are not traditionally thought of as ‘ immune - responsive ' . The later stage clinical development pathway for these programs is currently being defined . We continue to enroll into our two registration - directed clinical trials with RP1 in cutaneous squamous cell carcinoma ( CSCC ) , the " CERPASS " study , and anti - PD1 failed melanoma , the " IGNYTE " study , and commercial planning activities are underway . We also expect to start dosing RP1 combined with OpdivoⓇ in anti - PD1 failed non - small cell lung cancer ( NSCLC ) patients and anti - PD1 failed CSCC patients at approximately the quarter end and look forward to releasing data on all our product candidates during the course of 2021. " Corporate Updates • Commenced GMP Manufacturing in completed state of the art facility . The Company has completed buildout of its 63,000 - square - foot state - of - the - art manufacturing facility in Framingham , MA , which will support late - stage development and full commercialization of all of its products . GMP production is underway with the first RP1 batch having been filled . RP2 tech - transfer is scheduled to commence this quarter . • Extended cash runway into the second half of 2024. In October , the company closed on an offering of common stock and pre - funded warrants raising approximately $ 287 million in gross proceeds and received aggregate net proceeds of approximately $ 270 million after deducting underwriting discounts , commissions , and other offering expenses . This includes the exercise in full by the underwriters of their option to purchase additional shares of common stock . Based on its current operating plan , Replimune expects that its cash , cash equivalents and short - term investments of $ 493.3 million as of December 31 , 2020 will fund its operating expenses and capital expenditure requirements into the second half of 2024 . • Potential impact of COVID - 19 on milestones : Enrollment into the Company's clinical trials , in particular the clinical trial of RP1 in solid organ transplant patients with CSCC , which represents a highly immune - compromised patient population , has been slower than expected , which the Company attributes to the global pandemic . While mitigation plans have been and are being implemented , as the clinical trial sites continue to evaluate their capacity to enroll patients into clinical trials , the Company could see additional impact on the pace of enrollment across its clinical trial programs . Program Highlights and Upcoming Milestones • RP1 in combination with LibtayoⓇ in CSCC : The Company is actively enrolling patients into its global registration- directed Phase 2 , randomized , controlled , clinical trial . The Company remains on track to report the primary data read out in 2022 . • RP1 in combination with Opdivo in anti - PD - 1 failed melanoma : The Company initiated recruitment into a new registration - directed 125 - patient cohort Phase 2 clinical trial of RP1 in combination with Opdivo in the first half of 2020 and continues to enroll patients . The Company remains on track to report the primary data readout in 2022 . • RP1 in combination with Opdivo in melanoma and non - melanoma skin cancers ( NMSC ) : In October 2020 , Replimune