Full Press Release Details
Replimune Reports Fiscal First Quarter 2025
Financial Results and Provides Corporate Update
Woburn, MA, August 8,
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 first quarter ended June 30, 2024 and provided
"We have had a highly productive quarter as we gear up for the
upcoming pre-BLA meeting with the FDA and prepare to enroll the first patient in our confirmatory trial of RP1 in anti-PD1 failed melanoma,"
said Sushil Patel, Ph.D., CEO of Replimune. "Our confidence in the RP1 program is reinforced by the IGNYTE primary analysis data
that we presented in June, which demonstrates the potential of RP1 to address unmet needs in anti-PD1 failed melanoma patients who have
not responded to prior existing therapies. We remain committed to advancing the clinical programs in our pipeline, including RP2, where
we are preparing to enroll patients in a registration-directed study in uveal melanoma."
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 June 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 corporate purposes.
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.
Group, Inc., headquartered in Woburn, MA, was founded in 2015 with the mission to transform cancer treatment by pioneering the development
of a novel portfolio of 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.
Replimune Group, Inc.
Condensed Consolidated Statements of Operations
(Amounts in thousands, except share and per
| Three Months Ended June 30, | ||||||||
| 2024 | 2023 | |||||||
| Operating expenses: | ||||||||
| Research and development | $ | 42,972 | $ | 40,437 | ||||
| Selling, general and administrative | 14,395 | 15,211 | ||||||
| Total operating expenses | 57,367 | 55,648 | ||||||
| Loss from operations | (57,367 | ) | (55,648 | ) | ||||
| Other income (expense): | ||||||||
| Research and development incentives | 438 | 393 | ||||||
| Investment income | 4,711 | 6,186 | ||||||
| Interest expense on finance lease liability | (534 | ) | (544 | ) | ||||
| Interest expense on debt obligations | (1,426 | ) | (1,115 | ) | ||||
| Other income | 406 | 1,374 | ||||||
| Total other income (expense), net | 3,595 | 6,294 | ||||||
| Loss before income taxes | $ | (53,772 | ) | $ | (49,354 | ) | ||
| Income tax provision | - | 201 | ||||||
| Net loss | $ | (53,772 | ) | $ | (49,555 | ) | ||
| Net loss per common share, basic and diluted | $ | (0.78 | ) | $ | (0.75 | ) | ||
| Weighted average common shares outstanding, basic and diluted | 69,185,885 | 66,367,702 |
Replimune Group, Inc.
Condensed Consolidated Balance Sheets
(Amounts In thousands, except share and per
| 30-Jun | March 31, | |||||||
| 2024 | 2024 | |||||||
| Consolidated Balance Sheet Data: | ||||||||
| Cash, cash equivalents and short-term investments | $ | 469,124 | $ | 420,668 | ||||
| Working capital | 444,640 | 393,229 | ||||||
| Total assets | 534,965 | 487,722 | ||||||
| Total stockholders' equity | 426,451 | 374,508 |