Full Press Release Details
Replimune Reports Fiscal Third Quarter 2025
Financial Results and Provides Corporate Update
Food and Drug Administration (FDA) recently accepted the Biologics License Application (BLA) for RP1 plus nivolumab in advanced melanoma
for priority review with a PDUFA date of July 22, 2025
confirmatory trial of RP1(vusolimogene oderparepvec) plus nivolumab in advanced melanoma is enrolling
first patients in trials evaluating RP2 for the treatment of metastatic uveal melanoma and hepatocellular carcinoma
MA, February 12, 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 third quarter ended December 31,
2024 and provided a business update.
"Over the past couple of months, we have achieved significant
regulatory milestones for RP1 in anti-PD-1 failed melanoma," said Sushil Patel, Ph.D., CEO of Replimune. "With Priority Review
and a PDUFA date set for July 22, 2025, by the FDA, our efforts are focused on ensuring a successful commercial launch of RP1 upon
approval. Our commercial strategy is built on a deep understanding of the patient population and prescriber landscape, coupled with a
launch model designed to effectively deliver intratumoral therapy. With over $500 million in cash, we are well-capitalized to execute
our plans and are excited to provide further updates as we transition to a commercial-stage company."
Program Highlights & Milestones
Financial Highlights
Based on the current operating plan, the Company believes
that existing cash, cash equivalents and short-term investments, as of December 31, 2024 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.
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
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 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
Replimune Group, Inc.
Condensed Consolidated Statements of Operations
(Amounts in thousands, except share and per
| Three Months Ended December 31, | Nine Months Ended December 31, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 48,004 | $ | 42,847 | $ | 135,472 | $ | 132,384 | ||||||||
| General and administrative | 18,015 | 13,693 | $ | 46,827 | 43,633 | |||||||||||
| Total operating expenses | 66,019 | 56,540 | 182,299 | 176,017 | ||||||||||||
| Loss from operations | (66,019 | ) | (56,540 | ) | (182,299 | ) | (176,017 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Research and development incentives | 376 | 415 | 1,222 | 1,251 | ||||||||||||
| Investment income | 5,137 | 5,686 | 15,243 | 17,922 | ||||||||||||
| Interest expense on finance lease liability | (528 | ) | (540 | ) | (1,594 | ) | (1,626 | ) | ||||||||
| Interest expense on debt obligations | (1,450 | ) | (1,012 | ) | (4,314 | ) | (3,083 | ) | ||||||||
| Other (expense) income | (3,281 | ) | 1,344 | (850 | ) | 1,307 | ||||||||||
| Total other income (expense), net | 254 | 5,893 | 9,707 | 15,771 | ||||||||||||
| Loss before income taxes | $ | (65,765 | ) | $ | (50,647 | ) | $ | (172,592 | ) | $ | (160,246 | ) | ||||
| Income tax provision | $ | 575 | $ | 473 | $ | 575 | $ | 473 | ||||||||
| Net loss | $ | (66,340 | ) | $ | (51,120 | ) | $ | (173,167 | ) | $ | (160,719 | ) | ||||
| Net loss per common share, basic and diluted | $ | (0.79 | ) | $ | (0.77 | ) | $ | (2.25 | ) | $ | (2.42 | ) | ||||
| Weighted average common shares outstanding, basic and diluted | 83,498,892 | 66,645,691 | 77,113,695 | 66,532,488 |
Replimune Group, Inc.
Condensed Consolidated Balance Sheets
(Amounts In thousands, except share and per
| December 31, 2024 | March 31, 2024 | |||||||
| (in thousands) | ||||||||
| Consolidated Balance Sheet Data: | ||||||||
| Cash, cash equivalents and short-term investments | $ | 536,539 | $ | 420,668 | ||||
| Working capital | 499,687 | 393,229 | ||||||
| Total assets | 603,628 | 487,722 | ||||||
| Total stockholders' equity | 482,374 | 374,508 |