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Replimune Replimune Reports Fiscal Second Quarter Financial Results and Provides Corporate Update November 4 , 2021 RP1 ; Full patient accrual in CERPASS registration - directed clinical trial continues to be expected in mid - year 2022 with the primary data trigger expected in late 2022. Interim data in the IGNYTE anti - PD1 failed registration directed melanoma cohort continues to be expected in late 2022 RP2 ; Updated monotherapy and combination data with Opdivo ( nivolumab ) to be presented at SITC this month ; Phase 1 protocol amendment expansion to add additional patients with liver metastases filed RP2 / 3 ; Detailed Phase 2 clinical development program including patients with liver metastases to be presented in Q1 2022 along with initial RP3 Phase 1 monotherapy data Cash at 30 September of - $ 436m with runway into second half of 2024 WOBURN , Mass . , Nov. 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 second quarter ended September 30 , 2021 and provided a business update . " Replimune continues to build towards a data rich 2022 where we are expecting to reach multiple inflection points culminating in the primary data analysis trigger for our registration - directed randomized controlled clinical trial with RP1 in cutaneous squamous cell carcinoma ( CSCC ) and the presentation of interim data from our registration directed cohort in anti - PD1 failed melanoma from the IGNYTE clinical trial , " said Philip Astley - Sparke , CEO of Replimune . “ In the first quarter of 2022 we will be presenting initial data in anti - PD1 failed non - melanoma skin cancers ( NMSC ) and in NMSC transplant patients with single agent RP1 , both including CSCC . Our objective is to establish a broad skin cancer franchise with RP1 . In addition to an update on RP2 at SITC 2021 , we look forward to presenting data during 2022 from the expansion of our Phase 1 studies with RP2 and RP3 with a focus on patients with liver metastases from prevalent tumor types . We also look forward to presenting a comprehensive Phase 2 development plan with RP2 and / or 3 in the first quarter of 2022 , with study initiation intended around midyear , as we continue to make progress towards positioning our programs as a cornerstone of cancer treatment . " Recent Events and Corporate Updates • Replimune to present three ' Trial - In - Progress ' posters and a poster including new data with RP2 at the 2021 Society for Immunotherapy of Cancer's ( SITC ) 36th Annual Meeting . The Company is scheduled to present four posters at SITC being held November 10-14 , 2021. Included in these posters will be a data update from its 30 - patient Phase 1 clinical trial evaluating RP2 alone and combined with Opdivo in difficult - to - treat cancers . Program Highlights * CERPASS - Registration directed Phase 2 clinical trial in CSCC • RP1 in combination with LibtayoⓇ ( cemiplimab ) in CSCC : The Company is actively enrolling patients in CERPASS , its registration directed , global , randomized controlled Phase 2 clinical trial of RP1 in combination with Libtayo vs. Libtayo alone in 180 patients with advanced CSCC . The Company expects to complete enrollment such that the primary data analysis is expected to be triggered in late 2022 . IGNYTE - multi cohort Phase 2 clinical trial of RP1 combined with Opdivo • Anti - PD - 1 failed melanoma cohort : The Company continues to enroll patients in the 125 - patient cohort of the IGNYTE Phase 2 clinical trial in patients with anti - PD1 failed melanoma . The company continues to expect to release interim data from this cohort in late 2022 but , as previously disclosed , in order to document sufficient durability of response , an important secondary endpoint of the study , the primary analysis is expected to be triggered in mid - year 2023 . • Non - melanoma skin cancer ( NMSC ) cohort : The Company has completed enrollment of 30 - patients with anti - PD - 1 naïve NMSC and continues to enroll patients with anti - PD - 1 failed NMSC . The Company remains on track to provide updated data from the anti - PD1 naïve patients and initial data from the anti - PD - 1 failed patients in the first quarter of 2022 . • Anti - PD ( L ) -1 failed non - small cell lung cancer ( NSCLC ) cohort : Dosing is underway in a 30 - patient cohort of RP1 in combination with Opdivo in anti - PD ( L ) -1 failed NSCLC . A recently filed amendment to the IGNYTE protocol includes modifications to the patient eligibility criteria which are expected to enhance enrollment into this cohort of the clinical trial .