WOBURN, Mass., Aug. 08, 2024 (GLOBE NEWSWIRE) -- 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 a business update.
"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
RP1
RP2
Financial Highlights
About RP1
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 immune response.
About RP2
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.
About Replimune
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.
Investor Inquiries
Chris Brinzey
ICR Westwicke
339.970.2843
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Media Inquiries
Arleen Goldenberg
Replimune
917.548.1582
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Replimune Group, Inc. Condensed Consolidated Statements of Operations (Amounts in thousands, except share and per share amounts) (Unaudited) | |||||||
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 share amounts) (Unaudited) | |||||||
June 30, | 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 | |||||
Last Trade: | US$11.90 |
Daily Change: | -0.21 -1.73 |
Daily Volume: | 629,711 |
Market Cap: | US$813.010M |
October 30, 2024 October 01, 2024 September 09, 2024 |
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