Form 8-K

8-K — Replimune Group, Inc.

Accession: 0001104659-26-096483

Filed: 2026-08-14

Period: 2026-08-14

CIK: 0001737953

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

Item: Results of Operations and Financial Condition

Item: Financial Statements and Exhibits

Documents

8-K — tm2623208d1_8k.htm (Primary)

EX-99.1 — EXHIBIT 99.1 (tm2623208d1_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): August 14, 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 August 14, 2026, Replimune Group, Inc. issued

a news release announcing its financial results for the first fiscal quarter ended June 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 August 14, 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: August 14, 2026

By:

/s/ Sushil Patel

Sushil Patel

Chief Executive Officer

EX-99.1 — EXHIBIT 99.1

EX-99.1

Filename: tm2623208d1_ex99-1.htm · Sequence: 2

Exhibit

99.1

Replimune

Reports Fiscal First Quarter 2027 Financial Results and Provides

Corporate

Update

TUDRIQEV™

in combination with nivolumab receives FDA accelerated approval and will launch within 60 days

Michelle

DiNapoli appointed as Chief Commercial Officer

Recently

completed financing extends cash runway to support commercial launch and confirmatory trial

Woburn,

MA, August 14, 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 first quarter ended June 30, 2026 and provided a

business update.

August 6, 2026, the Company announced the U.S. Food and Drug Administration (FDA) has approved TUDRIQEV (vusolimogene oderparepvec-wtpg),

previously referred to as RP1, in combination with nivolumab for the treatment of adults with unresectable advanced cutaneous melanoma

who experienced disease progression with a PD-1 antibody-based regimen. The Company has begun launch preparations in the U.S. and anticipates

having product in the market within 60 days. Replimune also recently completed a $150 million financing to support commercial launch

and the ongoing IGNYTE-3 confirmatory trial.

The

Company also announced today the appointment of Michelle DiNapoli as Chief Commercial Officer, effective August 18, 2026. Ms. DiNapoli

brings more than 25 years of biopharmaceutical experience commercializing innovative oncology therapies and building high-performing

commercial organizations. She joins Replimune after a seven-year tenure at Deciphera Pharmaceuticals. At Deciphera, she built the U.S.

sales force, led the U.S. Commercial organization, and scaled infrastructure to drive launch execution as the company grew from a single

product to a multi-product organization. Prior to Deciphera, Ms. DiNapoli spent 16 years at Genentech in commercial leadership roles

spanning breast, lung, and colorectal cancer franchises as well as cancer immunotherapy, developing deep expertise in market access,

lifecycle management, and cross-functional execution.

“The

FDA’s approval of TUDRIQEV is a defining milestone for Replimune and, more importantly, for the patients facing advanced melanoma,

where the need for safe and effective treatment options remains significant,” said Sushil Patel, Ph.D., CEO of Replimune. “With

this approval, we are now a fully integrated biotechnology company. We are completing the build out of our commercial infrastructure

to enable a successful launch and bring TUDRIQEV to patients as quickly as possible.”

Program

Highlights & Milestones

RP1

(vusolimogene oderparepvec)

· 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, expected to readout in 2030, 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 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 June 30, 2026, cash, cash equivalents and short-term investments were

$195.3 million, as compared to $268.9 million as of fiscal year ended March 31, 2026. 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 our current operating plan, we expect that our existing cash and cash equivalents and short-term investments, as of June 30, 2026,

in addition to the $141.0 million of net proceeds from the issuance of our common stock in August 2026, will enable us to fund operations

for greater than twelve months from the issuance of the condensed consolidated financial statements, which includes scale up for the

commercialization of TUDRIQEV in advanced melanoma and for working capital and general corporate purposes.

· R&D

Expenses: Research and development expenses were $49.3 million for the fiscal first quarter

and $57.8 million for the fiscal first quarter ended June 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 $3.6 million in stock-based compensation expenses for the fiscal first quarter ended

June 30, 2026.

· S,G&A

Expenses: Selling, general and administrative expenses were $19.0 million for the fiscal

first quarter ended June 30, 2026, as compared to $32.6 million for the fiscal first quarter

ended June 30, 2025. Selling, general and administrative expenses included $4.1 million in

stock-based compensation expenses for the fiscal first quarter ended June 30, 2026.

· Net

Loss: Net loss was $69.8 million for the fiscal first quarter ended June 30, 2026 and

$86.7 million for the fiscal first quarter ended June 30, 2025.

About

TUDRIQEVTM (vusolimogene oderparepvec-wtpg)

TUDRIQEV

(vusolimogene oderparepvec-wtpg) 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 transporter associated

with antigen presentation inhibitor ICP47 are deleted from TUDRIQEV. TUDRIQEV preferentially replicates within the tumor leading to tumor

lysis, release of tumor and viral antigens, proinflammatory molecules, and infiltration of T cells. The GALV-GP-R– expressed by

TUDRIQEV increases direct tumor killing and the GM-CSF expressed by TUDRIQEV is intended to activate and mature dendritic cells and monocytes.

In the anti-PD-1 resistant setting, TUDRIQEV and nivolumab in combination may promote anti-tumor immune response.

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

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

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

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, 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 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 June 30,

2026

2025

Operating expenses:

Research and development

$ 49,277

$ 57,843

Selling, general and administrative

18,970

32,579

Total operating expenses

68,247

90,422

Loss from operations

(68,247 )

(90,422 )

Other income (expense):

Research and development incentives

296

420

Investment income

1,960

4,714

Interest expense on finance lease liability

(506 )

(521 )

Interest expense on debt obligations

(2,581 )

(1,475 )

Other (expense) income, net

(688 )

591

Total other (expense) income, net

(1,519 )

3,729

Net loss

$ (69,766 )

$ (86,693 )

Net loss per common share, basic

and diluted

$ (0.72 )

$ (0.95 )

Weighted average common shares

outstanding, basic and diluted

96,864,452

91,516,199

Replimune

Group, Inc.

Condensed

Consolidated Balance Sheets

(Amounts

In thousands, except share and per share amounts)

(Unaudited)

June 30,

March 31,

2026

(in thousands)

Consolidated Balance Sheet Data:

Cash, cash equivalents and short-term investments

$ 195,328

$ 268,889

Working capital

162,395

220,891

Total assets

252,447

332,388

Total stockholders' equity

105,645

166,160

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dei_WrittenCommunications

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dei_

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xbrli:booleanItemType

Balance Type:

Period Type:

duration