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Replimune(REPL) - 2019 Q3 - Quarterly Report
2019-02-14 14:18
Table of Contents Commission file number 001-38596 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q REPLIMUNE GROUP, INC. (Exact name of registrant as specified in its charter) x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended December 31, 2018 OR o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to (State or other jurisdiction of (I. ...
Replimune Group (REPL) Presents At 37th Annual J.P. Morgan Healthcare Conference - Slideshow
2019-01-10 20:24
Company Overview - Replimune, founded in 2015 by the ex-BioVex management team, focuses on developing "armed" oncolytic immunotherapy [4] - The company's lead product candidate, RP1, is intended to enter a registration-directed Phase 2 clinical trial in cutaneous squamous cell carcinoma (CSCC) in H1 2019 with approximately 240 patients [44, 58, 60] - Replimune had a cash balance of $147.9 million as of September 30th, 2018 [4] Technology and Pipeline - The company's platform uses HSV (Herpes Simplex Virus) to selectively replicate in and kill tumors, activating both innate and adaptive immunity [12, 21] - RP1 is being studied in an ongoing Phase 1/2 clinical trial with approximately 150 patients in combination with nivolumab across four tumor types [4, 41, 60] - RP2 and RP3, designed for PD-1/L1 non-responsive tumors, are expected to enter clinical development in 2019 and 2020, respectively [53, 59, 60] Clinical Trials and Collaborations - A randomized, controlled Phase 2 clinical trial in CSCC with approximately 240 patients will compare RP1+ cemiplimab vs cemiplimab alone [42, 44, 60] - Replimune has a clinical trial collaboration with BMS for the supply of nivolumab in an ongoing ≈150 patient Phase 1/2 trial [4, 41, 60] - The company also has a collaboration with Regeneron, involving 50:50 cost sharing and cemiplimab supply, for a randomized controlled Phase 2 trial with approximately 240 patients starting in H1 2019 [4, 42, 44, 60]