Full Press Release Details
Replimune Reports Fiscal Fourth Quarter and
Year End 2025 Financial Results and Provides Corporate Update
priority review of RP1 plus nivolumab in advanced melanoma proceeding on schedule; manufacturing inspections and late cycle review meeting
commercial infrastructure for launch in place ahead of July 22nd PDUFA date
call today at 8:00 AM ET
MA, May 22, 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 fourth quarter and year ended March 31,
2025 and provided a business update.
"As we near our PDUFA date, our commercial organization is now
fully hired and ready to execute our first launch in advanced melanoma," said Sushil Patel, Ph.D., CEO of Replimune. "We have
a deep understanding of the market landscape, prescriber adoption and referral patterns, and a launch plan optimized for intra-tumoral
delivery across all customer segments. We believe the opportunity for RP1 to help improve the lives of patients with advanced melanoma
is significant. We estimate approximately 13,000 patients progress on or after PD-1 treatment annually in the U.S. with approximately
80% of these patients eligible for treatment with RP1. Importantly, these treatments will take place in the outpatient setting and not
require hospitalization. We look forward to further discussing our commercial plans for RP1 and pipeline development for RP1 and RP2 at
an investor day on June 24th."
Program Highlights & Milestones
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 March 31, 2025 will enable the Company to fund operations
into the fourth quarter of 2026 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.
In connection with this announcement, the Company will host a conference
call and webcast at 8:00 AM ET today. Listeners can register for the webcast via this link. Analysts wishing to participate in
the question and answer session should use this link. A replay of the webcast will be available via the Company's investor
website approximately two hours after the call's conclusion. Those who plan on participating are advised to join 15 minutes prior
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 designed to have a unique dual local and systemic 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 ignite
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
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 in advance of our scheduled PDUFA date, 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 the coronavirus as a global pandemic and related public
health issues and the Russian-Ukrainian and Israel-Hamas political 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.
Replimune Group, Inc.
Condensed Consolidated Statements of Operations
(Amounts in thousands, except share and per
| March 31, | ||||||||
| 2025 | 2024 | |||||||
| Operating expenses: | ||||||||
| Research and development | $ | 189,447 | $ | 174,963 | ||||
| General and administrative | $ | 72,180 | 59,810 | |||||
| Total operating expenses | 261,627 | 234,773 | ||||||
| Loss from operations | (261,627 | ) | (234,773 | ) | ||||
| Other income (expense): | ||||||||
| Research and development incentives | 1,773 | 1,920 | ||||||
| Investment income | 21,120 | 23,356 | ||||||
| Interest expense on finance lease liability | (2,118 | ) | (2,163 | ) | ||||
| Interest expense on debt obligations | (5,775 | ) | (4,497 | ) | ||||
| Other (expense) income | (202 | ) | 771 | |||||
| Total other income (expense), net | 14,798 | 19,387 | ||||||
| Loss before income taxes | $ | (246,829 | ) | $ | (215,386 | ) | ||
| Income tax provision | $ | 468 | $ | 408 | ||||
| Net loss | $ | (247,297 | ) | $ | (215,794 | ) | ||
| Net loss per common share, basic and diluted | $ | (3.07 | ) | $ | (3.24 | ) | ||
| Weighted average common shares outstanding, basic and diluted | 80,564,147 | 66,569,894 |
Replimune Group, Inc.
Condensed Consolidated Balance Sheets
(Amounts In thousands, except share and per
| March 31, 2025 | March 31, 2024 | |||||||
| (in thousands) | ||||||||
| Consolidated Balance Sheet Data: | ||||||||
| Cash, cash equivalents and short-term investments | $ | 483,804 | $ | 420,668 | ||||
| Working capital | 433,518 | 393,229 | ||||||
| Total assets | 551,328 | 487,722 | ||||||
| Total stockholders' equity | 415,843 | 374,508 |