# EDGAR Filing Document

**Accession Number:** 0001737953
**File Stem:** 0001104659-23-025680
**Filing Date:** 2023-2
**Character Count:** 7250
**Document Hash:** 645dd8618cf9545f1ab393d1bb4ef95b
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001104659-23-025680.hdr.sgml**: 20230227

**ACCESSION NUMBER**: 0001104659-23-025680

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 12

**CONFORMED PERIOD OF REPORT**: 20230227

**ITEM INFORMATION**: Regulation FD Disclosure

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20230227

**DATE AS OF CHANGE**: 20230227

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** Replimune Group, Inc.
- **CENTRAL INDEX KEY:** 0001737953
- **STANDARD INDUSTRIAL CLASSIFICATION:** BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836]
- **IRS NUMBER:** 822082553
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 0331

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-38596
- **FILM NUMBER:** 23670219

**BUSINESS ADDRESS:**
- **STREET 1:** 500 UNICORN PARK
- **CITY:** WOBURN
- **STATE:** MA
- **ZIP:** 01801
- **BUSINESS PHONE:** (781) 222-9600

**MAIL ADDRESS:**
- **STREET 1:** 500 UNICORN PARK
- **CITY:** WOBURN
- **STATE:** MA
- **ZIP:** 01801

?xml version="1.0" encoding="utf-8"?

**UNITED STATES**

**SECURITIES AND EXCHANGE COMMISSION**

**Washington, D.C. 20549**

**FORM 8-K**

**CURRENT REPORT**

**Pursuant to Section 13 or 15(d)**

**of the Securities Exchange Act of 1934**

Date of Report (Date of earliest event reported): **February 27, 2023**

**REPLIMUNE GROUP, INC.**

(Exact name of registrant as specified in its charter)

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| | | |
|:---|:---|:---|
| **Delaware** | **001-38596** | **82-2082553** |
| (State or other jurisdiction<br> of incorporation) | (Commission<br> File Number) | (IRS Employer<br> Identification Number) |

---

**500 Unicorn Park**

**Woburn** **, MA 01801**

(Address of principal executive offices, including Zip Code)

Registrant's telephone number, including area code: **(781) 222-9600**

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

◻ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

◻ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

◻ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

◻ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

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| | | |
|:---|:---|:---|
| Title of each class | Trading<br> Symbol(s) | Name of each exchange on which registered |
| Common Stock, par value $0.001 per share | REPL | The Nasdaq Stock Market LLC<br> (Nasdaq Global Select Market) |

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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter). Emerging growth company ⌧

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ⌧

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| | |
|:---|:---|
| **Item 7.01** | **Regulation FD Disclosure.** |

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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.

**Forward-Looking Statements**

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.

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| | |
|:---|:---|
| **Item 9.01** | **Financial Statements and Exhibits.** |

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| | |
|:---|:---|
| **Exhibit No.** | **Description** |
| 104 | Cover page interactive data file (formatted as Inline XBRL) |

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**SIGNATURES**

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.

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| | | |
|:---|:---|:---|
|  | **REPLIMUNE GROUP, INC.** | **REPLIMUNE GROUP, INC.** |
| Date: February 27, 2023 | By: | /s/ Philip Astley-Sparke |
|  |  | Philip Astley-Sparke |
|  |  | Chief Executive Officer |

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