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Dec 31, 2020
Replimune Q3 2021 Earnings Report
Replimune reported financial results for the third fiscal quarter and provided a business update.
Key Takeaways
Replimune Group Inc. announced financial results for the fiscal third quarter ended December 31, 2020, and provided a business update, highlighting the commencement of dosing with RP3 and continued enrollment in registration-directed clinical trials with RP1.
Dosing commenced with RP3, the company's third product candidate.
Continued enrollment into two registration-directed clinical trials with RP1 in CSCC and anti-PD1 failed melanoma.
Commercial planning activities are underway.
Expect to start dosing RP1 combined with Opdivo in anti-PD1 failed NSCLC and anti-PD1 failed CSCC patients at approximately the quarter end.
Replimune
Replimune
Forward Guidance
Replimune expects to release data on all product candidates during the course of 2021 and is focused on advancing its clinical trials and commercial planning activities.
Positive Outlook
- 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
- Initial data to be reported in 2021 in combination with Opdivo in Phase 1 all comers study
- First patient dosed; initial single agent data expected to be reported in 2021
- Commercial-scale facility operational; GMP manufacturing underway