Full Press Release Details
Replimune Reports Fiscal Second Quarter 2025
Financial Results and Provides Corporate Update
MA, November 12, 2024 - Replimune Group, Inc. (Nasdaq: REPL), a clinical stage biotechnology company pioneering
the development of a novel class of oncolytic immunotherapies, today announced financial results for the fiscal second quarter ended
September 30, 2024 and provided a business update.
"I am incredibly proud of our progress as we rapidly approach
the submission of our BLA for RP1," said Sushil Patel, Ph.D., CEO of Replimune. "The IGNYTE data was presented at major medical
meetings and was well received by the oncology community, who noted the importance of the systemic activity demonstrated and the continuing
need for additional treatments for patients with advanced melanoma. As a team, we have been focused on our ongoing preparation for commercialization,
including building our field teams, completing important market research and developing our market access teams, among many other activities
to ensure we are well positioned to reach as many physicians and patients as possible."
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 September 30, 2024 will enable the Company to fund operations
into the second half of 2026 which includes scale up for the commercialization of RP1 in skin cancers and for working capital and general
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 a 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, 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.
Westwicke, an ICR Company
Replimune Group, Inc.
Condensed Consolidated Statements of Operations
(Amounts in thousands, except share and per
| Three Months Ended September 30, | Six Months Ended September 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 43,448 | $ | 49,101 | $ | 86,420 | $ | 89,538 | ||||||||
| General and administrative | 15,468 | 14,730 | 29,863 | 29,941 | ||||||||||||
| Total operating expenses | 58,916 | 63,831 | 116,283 | 119,479 | ||||||||||||
| Loss from operations | (58,916 | ) | (63,831 | ) | (116,283 | ) | (119,479 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Research and development incentives | 408 | 443 | 846 | 836 | ||||||||||||
| Investment income | 5,394 | 6,049 | 10,106 | 12,235 | ||||||||||||
| Interest expense on finance lease liability | (531 | ) | (542 | ) | (1,065 | ) | (1,086 | ) | ||||||||
| Interest expense on debt obligations | (1,438 | ) | (955 | ) | (2,864 | ) | (2,070 | ) | ||||||||
| Other income (expense) | 2,028 | (1,409 | ) | 2,433 | (35 | ) | ||||||||||
| Total other income (expense), net | 5,861 | 3,586 | 9,456 | 9,880 | ||||||||||||
| Loss before income taxes | $ | (53,055 | ) | $ | (60,245 | ) | $ | (106,827 | ) | $ | (109,599 | ) | ||||
| Income tax provision | - | (201 | ) | - | - | |||||||||||
| Net loss | $ | (53,055 | ) | $ | (60,044 | ) | $ | (106,827 | ) | $ | (109,599 | ) | ||||
| Net loss per common share, basic and diluted | $ | (0.68 | ) | $ | (0.90 | ) | $ | (1.45 | ) | $ | (1.65 | ) | ||||
| Weighted average common shares outstanding, basic and diluted | 78,570,135 | 66,582,280 | 73,903,650 | 66,475,577 |
Replimune Group, Inc.
Condensed Consolidated Balance Sheets
(Amounts In thousands, except share and per
| September 30, | March 31, | |||||||
| 2024 | 2024 | |||||||
| (in thousands) | ||||||||
| Consolidated Balance Sheet Data: | ||||||||
| Cash, cash equivalents and short-term investments | $ | 432,059 | $ | 420,668 | ||||
| Working capital | 398,845 | 393,229 | ||||||
| Total assets | 498,202 | 487,722 | ||||||
| Total stockholders' equity | 381,459 | 374,508 |