Form 8-K

8-K — Replimune Group, Inc.

Accession: 0001104659-26-119354

Filed: 2026-10-28

Period: 2026-10-28

CIK: 0001737953

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

Item: Results of Operations and Financial Condition

Item: Financial Statements and Exhibits

Documents

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EX-99.1 — EXHIBIT 99.1 (tm2628395d1_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): October 28, 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.

October 28, 2026, Replimune Group, Inc. issued a news release announcing its financial results for the second fiscal quarter ended

September 30, 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 October 28, 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: October 28, 2026

By:

/s/ Sushil Patel

Sushil Patel

Chief Executive Officer

EX-99.1 — EXHIBIT 99.1

EX-99.1

Filename: tm2628395d1_ex99-1.htm · Sequence: 2

Exhibit 99.1

Replimune Reports

Fiscal Second Quarter 2027 Financial Results and Provides Corporate Update

TUDRIQEV first

delivered to patients for advanced melanoma on October 6th

More than 15 institutions have prescribed TUDRIQEV

Management will

host a webcast today at 8:00 a.m. ET

Woburn, MA, October 28,

2026 – Replimune Group, Inc. (Nasdaq: REPL), a commercial stage biotechnology company pioneering the development of

novel oncolytic immunotherapies, today announced financial results for the fiscal second quarter ended September 30, 2026 and provided

a business update.

In early October, the Company announced

that TUDRIQEV (vusolimogene oderparepvec-wtpg), previously referred to as RP1, is now commercially available in the United States for

use in combination with nivolumab for the treatment of adults with advanced melanoma. Healthcare providers began ordering TUDRIQEV for

next day delivery immediately upon availability. The Company has more than a year of inventory on hand, produced at its in-house manufacturing

facility.

“Melanoma takes nearly 8,500 lives

in the U.S. every year, and for patients whose disease progresses after anti-PD-1 therapy, treatment options have been limited. TUDRIQEV

is now available to patients in urgent need,” said Sushil Patel, Ph.D., CEO of Replimune. “The response from physicians has

been enthusiastic and both oncologists and interventional radiologists are eager to bring TUDRIQEV into their practices. They value the

broad label that lets them treat patients immediately after progression on a PD-1 based therapy. We are focused on reaching as many of

these patients as possible.”

Program Highlights & Milestones

TUDRIQEV™ (vusolimogene oderparepvec-wtpg)

· Early launch off to a positive start. The Company has actively engaged with more than 70 percent of its initial 200 priority

accounts to establish workflows and enable TUDRIQEV adoption. Leading melanoma institutions have rapidly placed TUDRIQEV on formulary

and have started treating patients.

· Broad label supports use across a wide range of patients. TUDRIQEV is indicated in combination with nivolumab after progression

on a PD-1-blocking antibody-based regimen, with no requirement for prior BRAF treatment, and can be injected into superficial, deep and

visceral lesions, including lung and liver. Patients can be retreated if clinically appropriate.

· Rapid and broad payer coverage

facilitated by NCCN guideline inclusion. Multiple payer policies have been published

covering TUDRIQEV to label. TUDRIQEV has been listed in the NCCN Clinical Practice Guidelines

in Oncology as a category 2A recommendation.

· IGNYTE-3 confirmatory study

remains on track. The global Phase 3 trial assessing TUDRIQEV 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 is overall survival, and key secondary endpoints are progression free

survival and overall response rate.

RP2

· 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. 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.

Financial Highlights

· Cash Position: As of September 30,

2026, cash and cash equivalents were $307.8 million,

as compared to cash, cash equivalents and short-term investments of $268.9 million as of

fiscal year ended March 31, 2026. The increase in cash balance was a result of approximately net $141.0 million in

proceeds from the Company's offering of common stock and pre-funded warrants in August 2026, as well as $15.0 million in proceeds from

long-term debt from the initial draw down on tranche 4 in September 2026, partially offset by cash burn related to operating activities

in advancing the company’s clinical development plans.

We expect that our existing

cash and cash equivalents will enable us to fund operations for greater than twelve months from the issuance of the condensed consolidated

financial statements, which includes the commercialization of TUDRIQEV in advanced melanoma and for working capital and general corporate

purposes.

· R&D Expenses: Research

and development expenses were $34.4 million for the fiscal

second quarter ended September 30, 2026,

and $57.9 million for

the fiscal second quarter ended September 30, 2025. This decrease was primarily

due to a decrease in personnel related and other costs, as well as a decrease in direct research

costs relating to the IGNYTE, ARTACUS and CERPASS studies. Research and development

expenses included $4.9 million in stock-based

compensation expenses for the fiscal second quarter ended September 30, 2026.

· S,G&A

Expenses: Selling, general and administrative expenses were $21.9

million for the fiscal second quarter ended September 30,

2026, as compared to $26.4 million for the fiscal second quarter ended September 30,

2025. Selling, general and administrative expenses

included $5.7 million in stock-based compensation

expenses for the fiscal second quarter ended September 30, 2026.

· Net

Loss: Net loss was $57.1 million for

the fiscal second quarter ended September 30, 2026 and

$83.1 million for the fiscal second quarter ended

September 30, 2025.

About TUDRIQEVTM (vusolimogene

oderparepvec-wtpg)

TUDRIQEV is a genetically modified herpes

simplex virus type 1 (HSV-1) oncolytic viral therapy that encodes a fusogenic glycoprotein derived from gibbon ape leukemia virus with

the R sequence deleted (GALV-GP-R–) and human granulocyte macrophage colony-stimulating factor (GM-CSF). The genes encoding the

HSV-1 neurovirulence factor ICP34.5 and the ICP47 inhibitor of antigen presentation are deleted. TUDRIQEV preferentially replicates within

tumors, leading to tumor lysis and release of tumor and viral antigens. In combination with nivolumab, TUDRIQEV may promote an anti-tumor

immune response in the anti-PD-1-resistant setting. For more information, visit Tudriqev.com.

INDICATION

TUDRIQEV™ is indicated in combination

with nivolumab for the treatment of adult patients with unresectable advanced cutaneous melanoma who experienced disease progression

with a programmed death receptor-1 (PD-1)-blocking antibody-based regimen.

This indication is approved under accelerated

approval based on objective response rate (ORR) and duration of response. Continued approval for this indication may be contingent upon

verification of clinical benefit in a confirmatory trial(s).

IMPORTANT SAFETY INFORMATION

Warnings and Precautions

Accidental exposure of TUDRIQEV: Healthcare

providers, caregivers, close contacts, pregnant women, newborns, and patients should avoid direct contact with injected tumors, dressings,

or bodily fluids of patients.

Herpetic infection or reactivation:

Patients with suspected herpetic infections should contact their healthcare provider for assessment and antiviral treatment of the suspected

herpetic infection as clinically warranted.

Injection procedure complications: Complications

related to injection procedure have occurred, including hemorrhage, infection, and visceral injury. Patients should be monitored for

signs and symptoms of visceral injury (eg, pneumothorax) during and after TUDRIQEV administration and managed according to clinical practice.

Immune-mediated events: In clinical

studies, immune-mediated events, including colitis, hepatitis, myocarditis, neuropathy, capillary leak syndrome, dermatitis, and vitiligo

have been reported in patients treated with TUDRIQEV and nivolumab.

Adverse Reactions

Most common non-laboratory adverse reactions

reported in more than 10% of patients were fatigue, pyrexia, infections, chills, musculoskeletal pain, nausea, diarrhea, injection site

reaction, headache, cough, influenza like illness, rash, vomiting, pruritus, arthralgia, constipation, decreased appetite, dizziness,

dyspnea, hemorrhage, edema, and abdominal pain.

Serious adverse reactions occurring

in >1% patients include pleural effusion (n=3), acute kidney injury (n=2), arthralgia (n=2), atrial fibrillation (n=2), atrial flutter

(n=2), cancer pain (n=2), hypophysitis (n=2), immune-mediated enterocolitis (n=2), pyrexia (n=2), sepsis (n=2), urinary tract infection

(n=2), and myocardial infarction (n=2). Serious adverse reactions leading to death include myocardial infarction (n=1) and multiple organ

dysfunction (n=1).

Drug Interactions

Patients receiving systemic antiviral

treatment for herpetic infection should delay TUDRIQEV treatment for 72 hours after completion of antiviral therapy.

Special Populations

Advise females and males of reproductive

potential to use effective contraception during treatment with TUDRIQEV and for 90 days after the last dose.

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 clinical trials, clinical studies and other clinical work (including

the funding therefor, anticipated patient enrollment, safety data, study data, trial outcomes, timing or associated costs, sufficiency

of any resulting data), regulatory applications and related submission contents and timelines, the timelines or outcomes related to litigation,

including any rehearings or appeals of decisions in any such proceedings, and our expectations about our cash runway, our ability to

execute on our strategic or financial initiatives, our estimates regarding future expenses, capital requirements and needs for additional

financing, and potential commercial viability, and potential reimbursement and utilization of TUDRIQEV involve significant risks and

uncertainties and actual results could differ materially from those expressed or implied herein. Our ability to maintain TUDRIQEV’s

accelerated approval and to continue commercialization of TUDRIQEV may be contingent on verification of clinical benefit in a confirmatory

trial(s). Other forward looking statements may be 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 experience

in commercializing products for sale, our ability to successfully verify the clinical benefit of TUDRIQEV in our ongoing confirmatory

Phase 3 trial, IGNYTE-3, our ability to meet our product manufacturing goal, the timing and scope of future 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, the impact of political and global macro factors and military

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.

Condensed Consolidated

Statements of Operations

(Amounts in thousands,

except share and per share amounts)

(Unaudited)

Three Months Ended September 30,

Six Months Ended September 30,

2026

2025

2026

2025

Operating expenses:

Research and development

$ 34,365

$ 57,877

$ 83,644

$ 115,721

Selling, general and administrative

21,916

26,414

40,885

58,994

Total operating expenses

56,281

84,291

124,529

174,715

Loss from operations

(56,281 )

(84,291 )

(124,529 )

(174,715 )

Other income (expense):

Research and development incentives

238

377

534

797

Investment income

1,880

3,696

3,840

8,411

Interest expense on finance lease liability

(502 )

(518 )

(1,007 )

(1,039 )

Interest expense on debt obligations

(2,523 )

(1,488 )

(5,104 )

(2,963 )

Other income (expense), net

(876 )

(621 )

(284 )

Total other (expense) income, net

(840 )

1,191

(2,358 )

4,922

Net loss

$ (57,121 )

$ (83,100 )

$ (126,887 )

$ (169,793 )

Net loss per common share, basic and diluted

$ (0.54 )

$ (0.90 )

$ (1.26 )

$ (1.85 )

Weighted average common shares outstanding, basic and diluted

105,176,101

91,915,769

101,042,985

91,717,076

Replimune Group, Inc.

Condensed Consolidated

Balance Sheets

(Amounts In thousands,

except share and per share amounts)

(Unaudited)

September 30,

2026

March 31,

2026

(in thousands)

Consolidated Balance Sheet Data:

Cash, cash equivalents and short-term investments

$ 307,833

$ 268,889

Working capital

278,482

220,891

Total assets

373,940

332,388

Total stockholders' equity

204,778

166,160

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-Section 425

+ Details

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