Form 8-K

8-K — Replimune Group, Inc.

Accession: 0001104659-26-078511

Filed: 2026-06-29

Period: 2026-06-29

CIK: 0001737953

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

Item: Results of Operations and Financial Condition

Item: Financial Statements and Exhibits

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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): June 29, 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 2.02 Results of Operations and Financial Condition.

On June 29, 2026, Replimune

Group, Inc. (the “Company”) issued a news release announcing its financial results for the fourth fiscal quarter and year

ended March 31, 2026 and certain corporate updates. A copy of the news release is furnished as Exhibit 99.1 to this Current Report

on Form 8-K.

In accordance with General

Instruction B.2 of Form 8-K, the information in Item 2.02 of this Current Report on Form 8-K, including Exhibit 99.1, shall

not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange

Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under

the Securities Act of 1933, as amended, or the Exchange Act, except as expressly stated by specific reference in such filing.

Item 9.01 Financial Statements and Exhibits.

Exhibit No.

Description

99.1

News Release dated June 29, 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: June 29, 2026

By:

/s/ Sushil Patel

Sushil Patel

Chief Executive Officer

EX-99.1 — EXHIBIT 99.1

EX-99.1

Filename: tm2619129d1_ex99-1.htm · Sequence: 2

Exhibit 99.1

Replimune Reports

Fiscal Fourth Quarter and Year End 2026 Financial Results and Provides Corporate Update

Woburn, MA, June 29, 2026 – Replimune Group, Inc.

(Nasdaq: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced

financial results for the fiscal fourth quarter and year ended March 31, 2026 and provided a business update.

The Company recently announced that the U.S. Food and Drug Administration

(FDA) has accepted for review the resubmission of the Biologics License Application (BLA) for RP1 (vusolimogene oderparepvec) in combination

with nivolumab for the treatment of advanced melanoma. The FDA considers this a complete, class 1 response with a goal date of August 2,

2026, and has notified the company to expect an advisory committee meeting in late July.

“The FDA’s acceptance of our RP1 BLA resubmission marks

a pivotal milestone in our mission to bring this important therapy to patients facing advanced melanoma, where the need for durable,

effective treatment options remains significant,” said Sushil Patel, Ph.D., CEO of Replimune. “We are working hard to ensure

we can provide access to RP1 as soon as possible pending an approval. We are equally pleased by the momentum across our clinical programs

including continued strong enrollment in our IGNYTE-3 trial of RP1 in advanced melanoma and our REVEAL trial of RP2 in metastatic uveal

melanoma.”

Program Highlights & Milestones

RP1 (vusolimogene oderparepvec)

• IGNYTE Trial (RP1 + Nivolumab)

- 3-Year Overall Survival Analysis: In an oral presentation at the ASCO 2026 annual meeting,

RP1 plus nivolumab demonstrated exceptional durability in anti-PD-1-failed melanoma patients,

with 47.8% of all treated patients alive at 3 years and a median overall survival of 32.9

months - including an 83.5% 3-year survival rate among responders - representing

a rare and meaningful long-term benefit in a patient population with historically limited

treatment options (Presentation).

• IGNYTE-3 Confirmatory Study:

The global Phase 3 trial assessing RP1 in combination with nivolumab versus physician's choice

in patients with advanced melanoma who have progressed on anti-PD-1 and anti-CTLA-4 therapies

or are ineligible for anti-CTLA-4 treatment is actively enrolling. The primary endpoint of

this trial is overall survival, and key secondary endpoints are progression free survival

and overall response rate.

RP2

• Phase 1 First-in-Human Trial

(RP2) - Final Data: In an oral presentation at the ASCO 2026 annual meeting, RP2 monotherapy

and in combination with nivolumab demonstrated promising efficacy across multiple advanced

solid tumor types, achieving a 19% objective response rate in both arms with durable responses

(median duration not reached for monotherapy), while translational analyses confirmed the

intended mechanism of transforming immunologically “cold” tumors into immune-inflamed

environments with systemic T-cell activation, supporting advancement to a randomized Phase

2/3 trial in metastatic uveal melanoma (Presentation).

• REVEAL Study: The registration-directed

Phase 2/3 trial of RP2 in metastatic uveal melanoma is actively enrolling. The trial is evaluating

RP2 in combination with nivolumab versus ipilimumab in combination with nivolumab in approximately

280 patients. The primary endpoints of the trial are overall survival and progression free

survival, and key secondary endpoints are overall response rate and disease control rate.

Phase 2/3 transition is expected in Q1 2027.

Financial Highlights

• Cash

Position: As

of March 31, 2026, cash, cash equivalents

and short-term investments were $268.9 million,

as compared to $483.8 million as of fiscal year

ended March 31, 2025. The decrease in cash balance was a result of cash burn

related to operating activities in advancing the company’s clinical development plans.

Based on the current operating plan, the Company believes

that existing cash, cash equivalents and short-term investments will enable us to fund operations into the first quarter of calendar

2027, which includes scale up for the potential commercialization of RP1 in skin cancers and for working capital and general corporate

purposes and excludes any potential revenue.

• R&D

Expenses: Research and development expenses were $52.3

million for the fiscal fourth quarter and $221.2

million for the fiscal year ended March 31,

2026, as compared to $54.0 million for

the fiscal fourth quarter and $189.4 million for the fiscal year ended

March 31, 2025. This year over year increase was primarily due to an increase

in personnel-related costs as we scaled operations in preparation for commercial launch of

RP1, as well as consulting and facility-related costs. Research

and development expenses included $4.1 million in

stock-based compensation expenses for the fiscal fourth quarter and $16.7 million

for the fiscal year ended March 31, 2026.

• S,G&A

Expenses: Selling, general and administrative expenses were $21.0

million for the fiscal fourth quarter and $98.7

million for the fiscal year ended March 31,

2026, as compared to $25.4 million for

the fiscal fourth quarter and $72.2 million for

the fiscal year ended March 31, 2025. Selling,

general and administrative expenses included $4.1 million in

stock-based compensation expenses for the fiscal fourth quarter and $15.5 million

for the fiscal year ended March 31, 2026.

• Net

Loss: Net loss was $73.7 million for

the fiscal fourth quarter and $313.9 million for the fiscal year ended

March 31, 2026, as compared to a net loss

of $74.1 million for the fiscal fourth quarter

and $247.3 million for the fiscal year ended March 31,

2025.

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 RP2

RP2 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. RP2 additionally expresses an anti-CTLA-4 antibody-like

molecule, as well as GALV-GP R- and GM-CSF. RP2 is intended to provide targeted and potent delivery of these proteins to the sites of

immune response initiation in the tumor and draining lymph nodes, with the goal of focusing systemic-immune-based efficacy on tumors

and limiting off-target toxicity.

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 our cash runway, the status of 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

Replimune Group, Inc.

Consolidated Statements of Operations

(Amounts in thousands, except share and per

share amounts)

(Unaudited)

Year Ended March 31,

2026

2025

Operating expenses:

Research and development

$ 221,184

$ 189,447

Selling, general and administrative

98,735

72,180

Total operating expenses

319,919

261,627

Loss from operations

(319,919 )

(261,627 )

Other income (expense):

Research and development incentives

1,604

1,773

Investment income

13,625

21,120

Interest expense on finance lease liability

(2,063 )

(2,118 )

Interest expense on debt obligations

(6,796 )

(5,775 )

Other expense

(942 )

(202 )

Total other income, net

5,428

14,798

Loss before income taxes

$ (314,491 )

$ (246,829 )

Income tax (benefit) provision

(551 )

468

Net loss

$ (313,940 )

$ (247,297 )

Net loss per common share, basic and diluted

$ (3.38 )

$ (3.07 )

Weighted average common shares outstanding, basic and diluted

92,803,711

80,564,147

Replimune Group, Inc.

Condensed Consolidated Balance Sheets

(Amounts in thousands, except share and per

share amounts)

(Unaudited)

March 31,

2026

March 31,

2025

(in thousands)

Consolidated Balance Sheet Data:

Cash, cash equivalents and short-term investments

$ 268,889

$ 483,804

Working capital

220,891

433,518

Total assets

332,388

551,328

Total stockholders' equity

166,160

415,843

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