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Replimune Reports Fiscal First Quarter 2026 Financial Results and Provides Corporate Update Woburn, MA

Key Takeaway: Replimune Group, Inc. reported its fiscal first quarter 2026 financial results, detailing a net loss of $86.7 million. The announcement included a business update indicating that the FDA issued a Complete Response Letter for its lead product candidate RP1 in advanced melanoma. Despite the challenges, the CEO emphasized the strong belief within the melanoma community that RP1 should be made available to patients soon. The company anticipates its current financial resources will support operations into the fourth quarter of 2026, allowing for potential commercialization efforts.

Market Sentiment Analysis

POSITIVE FACTORS

  • Replimune's RP1 shows compelling clinical data and safety profile.
  • The company believes existing cash reserves will fund operations through 2026.

CONCERNS & RISKS

  • Received a Complete Response Letter (CRL) from the FDA for RP1 in advanced melanoma.
  • There is a significant net loss reported for the quarter, indicating financial challenges.

Full Press Release Details

Replimune Reports Fiscal First Quarter 2026
Financial Results and Provides Corporate Update
Woburn, MA, August 7, 2025 - Replimune Group,
Inc. (Nasdaq: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced
financial results for the fiscal first quarter ended June 30, 2025 and provided a business update.
The Company announced on July 22, 2025 that the U.S. Food and Drug
Administration (FDA) had issued a Complete Response Letter (CRL) for the RP1 BLA in advanced melanoma.
"Based on the compelling clinical data and safety profile generated
to date with RP1 in the IGNYTE study, the melanoma community, including clinical experts and patients, strongly believe RP1 should be
made available to patients that have few remaining treatment options as soon as possible. We are committed to finding an expeditious path
forward with the FDA," said Sushil Patel, Ph.D., CEO of Replimune.
Program Highlights & Milestones
RP1 (vusolimogene oderparepvec)
RP1 (vusolimogene oderparepvec)
Financial Highlights
Based on the current operating plan, the Company believes
that existing cash, cash equivalents and short-term investments, as of June 30, 2025 will enable the Company to fund operations into
the fourth quarter of 2026 which includes the potential commercialization of RP1 in skin cancers and for working capital and general corporate
purposes and excludes any potential revenue.
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
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.
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 or interactions following the complete response
letter, 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 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.
Replimune Group, Inc.
Condensed Consolidated Statements of Operations
(Amounts in thousands, except share and per
Three Months Ended June 30,
2025 2024
Operating expenses:
Research and development $ 57,843 $ 42,972
General and administrative $ 32,579 14,395
Total operating expenses 90,422 57,367
Loss from operations (90,422 ) (57,367 )
Other income (expense):
Research and development incentives 420 438
Investment income 4,714 4,711
Interest expense on finance lease liability (521 ) (534 )
Interest expense on debt obligations (1,475 ) (1,426 )
Other (expense) income 591 406
Total other income (expense), net 3,729 3,595
Net loss $ (86,693 ) $ (53,772 )
Net loss per common share, basic and diluted $ (0.95 ) $ (0.78 )
Weighted average common shares outstanding, basic and diluted 91,516,199 69,185,885
Replimune Group, Inc.
Condensed Consolidated Balance Sheets
(Amounts In thousands, except share and per
June 30, 2025 March 31, 2025
(in thousands)
Consolidated Balance Sheet Data:
Cash, cash equivalents and short-term investments $ 403,340 $ 483,804
Working capital 353,807 433,518
Total assets 469,507 551,328
Total stockholders' equity 336,715 415,843

Frequently Asked Questions

What is Replimune's main product candidate?

Replimune's lead product candidate is RP1, a novel oncolytic immunotherapy.

What happened with RP1's BLA for advanced melanoma?

The FDA issued a Complete Response Letter for RP1's BLA in advanced melanoma.

How long will Replimune's cash reserves last?

Replimune expects its cash reserves to fund operations into the fourth quarter of 2026.

What is the aim of the RPx platform?

The RPx platform aims to maximize immunogenic cell death and systemic anti-tumor responses.

When did Replimune announce its financial results?

Replimune announced its financial results for the first quarter on August 7, 2025.

Last updated: Aug 7, 2025