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:
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.
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.
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.
On
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
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, 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 | | |
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 | |
