SECURITIES AND EXCHANGE COMMISSION
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|Item 7.01||Regulation FD Disclosure.|
In its Quarterly Report on Form 10-Q for the quarter ended December 31, 2022, Replimune Group, Inc. (“Replimune” or “we”) disclosed that we had recently received a response from the U.S. Food and Drug Administration (the “FDA”) following submission in September 2022 of our draft statistical analysis plan (the “SAP”) for the CERPASS clinical trial. In its response, the FDA raised a number of points and recommendations requiring further discussion, including relating to the study endpoints. We have since met with the FDA to discuss its response. During the meeting and as a result of our discussion, the FDA agreed that no changes would be made to the clinical trial protocol and that no material changes would be made to the data analysis plan (minor changes to the SAP were agreed unrelated to the dual independent primary endpoints of overall response rate and complete response rate). Assuming positive primary analysis data is generated, including demonstrating overall clinical benefit, we continue to expect to make a Biologics License Application submission for RP1 in early 2024.
This report contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including statements regarding our interactions with the FDA, our expectations about the design, conduct and analysis of the CERPASS clinical trial, the timing and sufficiency of our clinical trial outcomes to support potential approval of any of our product candidates, and other statements identified by words such as “could,” “expects,” “intends,” “may,” “plans,” “potential,” “should,” “will,” “would,” or similar expressions and the negatives of those terms. Forward-looking statements are not promises or guarantees of future performance, and are subject to a variety of risks and uncertainties, many of which are beyond our control, and which could cause actual results to differ materially from those contemplated in such forward-looking statements. These factors include risks related to our limited operating history, our ability to generate positive clinical trial results for our product candidates, the costs and timing of operating our in-house manufacturing facility, the timing and scope of regulatory approvals, changes in laws and regulations to which we are subject, competitive pressures, our ability to identify additional product candidates, political and global macro factors including the impact of the coronavirus as a global pandemic and related public health issues, the ongoing military conflict between Russia and Ukraine and the impact on the global economy and related governmental imposed sanctions, and other risks as may be detailed from time to time in our Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q and other reports we file with the Securities and Exchange Commission. Our actual results could differ materially from the results described in or implied by such forward-looking statements. Forward-looking statements speak only as of the date hereof, and, except as required by law, we undertake no obligation to update or revise these forward-looking statements.
|Item 9.01||Financial Statements and Exhibits.|
|104||Cover page interactive data file (formatted as Inline XBRL)|
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|REPLIMUNE GROUP, INC.|
|Date: February 27, 2023||By:||/s/ Philip Astley-Sparke|
|Chief Executive Officer|