Form 8-K

8-K — Replimune Group, Inc.

Accession: 0001104659-26-088857

Filed: 2026-07-31

Period: 2026-07-30

CIK: 0001737953

SIC: 2836 (BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES))

Item: Other Events

Item: Financial Statements and Exhibits

Documents

8-K — tm2621708d1_8k.htm (Primary)

EX-99.1 — EXHIBIT 99.1 (tm2621708d1_ex99-1.htm)

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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): July 30, 2026

REPLIMUNE GROUP, INC.

(Exact name of registrant as specified in its charter)

Delaware

001-38596

82-2082553

(State or other jurisdiction

of incorporation)

(Commission

File Number)

(IRS Employer

Identification Number)

500

Unicorn Park Drive

Suite 303

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:

Title of each class

Trading

Symbol(s)

Name of each exchange on which registered

Common Stock, par value $0.001 per share

REPL

The Nasdaq Stock Market LLC

(Nasdaq Global Select Market)

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. ¨

Item 8.01 Other Events.

On July 30, 2026, Replimune

Group, Inc. (the “Company”) issued a press release announcing that the U.S. Food and Drug Administration's Cellular, Tissue, and Gene Therapies Advisory Committee (the “Advisory Committee”) met to discuss the Company’s Biologics License Application

(“BLA”) resubmission for RP1 (vusolimogene oderparepvec) in combination with nivolumab for the treatment of advanced melanoma.

The Advisory Commitee voted 10 to 3 that the efficacy results from the IGNYTE study are evaluable and clinically meaningful.

A copy of the press release announcing the results of the meeting is attached as Exhibit 99.1 hereto and is incorporated by reference

herein.

Item 9.01 Financial Statements and Exhibits.

Exhibit No.

Description

99.1

News

Release dated July 30, 2026

104

Cover

page interactive data file (formatted as Inline XBRL)

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.

REPLIMUNE GROUP, INC.

Date: July 30, 2026

By:

/s/ Sushil Patel

Sushil Patel

Chief Executive Officer

EX-99.1 — EXHIBIT 99.1

EX-99.1

Filename: tm2621708d1_ex99-1.htm · Sequence: 2

Exhibit 99.1

Replimune Announces Favorable Outcome of FDA's Cellular,

Tissue, and Gene Therapies Advisory Committee Meeting for RP1 in Advanced Melanoma

Advisory Committee voted 10 to 3 that the efficacy

results from the IGNYTE study are evaluable and clinically meaningful

WOBURN, Mass., July 30, 2026 (GLOBE NEWSWIRE) — Replimune

Group, Inc. (Nasdaq: REPL), a clinical-stage biotechnology company pioneering the development of novel oncolytic immunotherapies,

today announced the outcome of today's meeting of the U.S. Food and Drug Administration's (FDA) Cellular, Tissue, and Gene Therapies Advisory

Committee (CTGTAC), which discussed the Biologics License Application (BLA) resubmission for RP1 (vusolimogene oderparepvec) in combination

with nivolumab for the treatment of advanced melanoma in patients who have progressed on prior anti-PD-1 therapy.

The committee discussed two topics: (1) whether the single-arm

IGNYTE study, as designed and conducted, allows for a reliable determination of the expected response rate and durability of response

in the proposed population; and (2) the clinical meaningfulness of the response rate and duration of response reported in IGNYTE,

and whether the observed responses are indicative of systemic antitumor activity attributable to RP1. The committee then voted 10 to 3,

on the question: "Are the efficacy results from IGNYTE evaluable and clinically meaningful?"

"We are encouraged by today's outcome and would like to

thank the committee for its thoughtful discussion of the IGNYTE data," said Sushil Patel, Ph.D., CEO of Replimune. "We are

grateful to the patients and physicians who took the time to speak today and so clearly articulate the high unmet need in advanced

melanoma and importance of new treatment options such as RP1 for the community. This is an important step forward for patients with

advanced melanoma who have progressed on anti-PD-1 therapy. We look forward to continuing to work with the FDA as it completes its

review of the BLA ahead of the action date."

The FDA's target action date under the Class 1 resubmission is

August 2, 2026.

About RP1

RP1 (vusolimogene oderparepvec) is Replimune’s lead product candidate

and is based on a proprietary strain of herpes simplex virus engineered and genetically armed with a fusogenic protein (GALV-GP R-) and

GM-CSF intended to maximize tumor killing potency, the immunogenicity of tumor cell death, and the activation of a systemic anti-tumor

immune response.

About Replimune

Replimune Group, Inc., headquartered in Woburn, MA, was founded

in 2015 with the mission to transform cancer treatment by pioneering the development of novel oncolytic immunotherapies. Replimune’s

proprietary RPx platform is based on a potent HSV-1 backbone intended to maximize immunogenic cell death and the induction of a systemic

anti-tumor immune response. The RPx platform is intended to ignite local activity consisting of direct selective virus-mediated killing

of the tumor resulting in the release of tumor derived antigens and altering of the tumor microenvironment to then activate a strong and

durable systemic response. The RPx product candidates are expected to be synergistic with most established and experimental cancer treatment

modalities, leading to the versatility to be developed alone or combined with a variety of other treatment options. For more information,

please visit www.replimune.com.

Forward Looking Statements

This press release 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 expectations about the status of the advisory committee meeting being convened by the

FDA, the FDA review of our BLA for RP1 or potential approval of such BLA, the design and advancement of our clinical trials, the

timing and sufficiency of our clinical trial outcomes to support potential approval of any of our product candidates, the regulatory

review process and timing of potential product approval, our goals to develop and commercialize our product candidates, patient

enrollments in our existing and planned clinical trials and the timing thereof, 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 the outcome of FDA’s review process,

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, the availability of

combination therapies needed to conduct our clinical trials, 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 a

global pandemic and related public health issues and the ongoing political and military conflicts, including trade conflicts, 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.

Investor Inquiries

Chris Brinzey

ICR Healthcare

339.970.2843

chris.brinzey@icrhealthcare.com

Media Inquiries

Arleen Goldenberg

Replimune

917.548.1582

media@replimune.com

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