Full Press Release Details
Fiscal Third Quarter 2024 Financial Results and Provides Corporate Update
Woburn, MA, February 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 third quarter ended December 31, 2023, and provided
"The collective data for RP1 shows
that it has the potential to be a safe and effective treatment option for patients with a range of different skin cancers in various
treatment settings. We plan to submit a BLA for the treatment of patients with anti-PD1 failed melanoma in 2H 2024. Subsequently, we
will explore the potential for additional submissions based on the evolving data from our multiple non-melanoma skin cancer studies,"
said Philip Astley-Sparke, CEO of Replimune. "We are excited about the data we have seen to-date with RP2 including as monotherapy
in very difficult to treat tumors. Planning is underway for a clinical trial in advanced uveal melanoma as a foundational study for establishing
a rare cancer franchise. Following the decision to reprioritize our pipeline, we have extended our cash runway to fund operations into
2H 2026, leaving us well positioned to bring our lead product to market."
Program Highlights & Milestones
Financial Highlights
on the current operating plan, the Company believes that existing cash, cash equivalents and short-term investments, as of December 31,
2023, will enable the Company to fund operations into the second half of 2026.
RP1 is Replimune's lead product
candidate and is based on a proprietary new 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 is a derivative of RP1, Replimune's
lead product candidate that is based on a proprietary new strain of herpes simplex virus engineered and genetically armed with a fusogenic
protein (GALV-GP R-) and GM-CSF 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 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 share amounts)
| Three Months Ended December 31, | Nine Months Ended December 31, | |||||||||||||||
| 2023 | 2022 | 2023 | 2022 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 42,847 | $ | 30,261 | $ | 132,384 | $ | 88,573 | ||||||||
| Selling, general and administrative | 13,693 | 11,369 | 43,633 | 35,512 | ||||||||||||
| Total operating expenses | 56,540 | 41,630 | 176,017 | 124,085 | ||||||||||||
| Loss from operations | (56,540 | ) | (41,630 | ) | (176,017 | ) | (124,085 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Research and development incentives | 415 | 607 | 1,251 | 2,032 | ||||||||||||
| Investment income | 5,686 | 2,675 | 17,922 | 4,130 | ||||||||||||
| Interest expense on finance lease liability | (540 | ) | (548 | ) | (1,626 | ) | (1,650 | ) | ||||||||
| Interest expense on debt obligations | (1,012 | ) | (941 | ) | (3,083 | ) | (941 | ) | ||||||||
| Other income (expense) | 1,344 | 147 | 1,307 | (4,531 | ) | |||||||||||
| Total other income (expense), net | 5,893 | 1,940 | 15,771 | (960 | ) | |||||||||||
| Loss before income taxes | $ | (50,647 | ) | $ | (39,690 | ) | $ | (160,246 | ) | $ | (125,045 | ) | ||||
| Income tax provision | 473 | - | 473 | - | ||||||||||||
| Net loss | $ | (51,120 | ) | $ | (39,690 | ) | $ | (160,719 | ) | $ | (125,045 | ) | ||||
| Net loss per common share, basic and diluted | $ | (0.77 | ) | $ | (0.69 | ) | $ | (2.42 | ) | $ | (2.25 | ) | ||||
| Weighted average common shares outstanding, basic and diluted | 66,645,691 | 57,857,132 | 66,532,488 | 55,618,052 |
Replimune Group, Inc.
Condensed Consolidated
(Amounts In thousands,
except share and per share amounts)
| December 31, | March 31, | |||||||
| 2023 | 2023 | |||||||
| Consolidated Balance Sheet Data: | ||||||||
| Cash, cash equivalents and short-term investments | $ | 466,351 | $ | 583,386 | ||||
| Working capital | 440,514 | 558,778 | ||||||
| Total assets | 532,930 | 646,591 | ||||||
| Total stockholders' equity | 421,537 | 555,292 |