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Replimune Reports Fiscal Fourth Quarter and Year Ended 2024 Financial Results and Provides Corporate Update Twelve-month primary analysis results by independent central review from the IGNYTE clinical trial of RP1 (vusol

Key Takeaway: Replimune Group, Inc. announced its fiscal fourth quarter and year-end 2024 financial results, highlighting significant corporate updates. The company is poised to share primary analysis results from its IGNYTE clinical trial and plans to initiate patient enrollment for its Phase 3 IGNYTE-3 trial in the second half of the year. With secured funding expected to last into late 2026, Replimune aims to bring its first oncolytic immunotherapy to market, pending FDA approval. However, the reported net loss and increased operating expenses raise concerns regarding financial stability.

Market Sentiment Analysis

POSITIVE FACTORS

  • Replimune is set to release key trial data at ASCO.
  • FDA has agreed on the design for the Phase 3 IGNYTE-3 clinical trial.
  • The company has sufficient cash runway to support operations into late 2026.
  • Plans are in place to launch their first oncolytic immunotherapy pending approval.

CONCERNS & RISKS

  • Replimune reported a significant net loss of $215.8 million for the year.
  • Operating expenses have increased compared to the prior year.
  • The company's financial results indicate a loss before income taxes.
  • Regulatory uncertainty persists regarding the timing and scope of approvals.

Full Press Release Details

Fiscal Fourth Quarter and Year Ended 2024 Financial Results and Provides Corporate Update
Woburn, MA, May 16, 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 fourth quarter and year ended March 31, 2024 and
provided a business update.
"We have exciting milestones in
the coming months, including sharing the investigator-assessed 12-month IGNYTE data at ASCO and then the official primary analysis by
independent central review later in the second quarter," said Sushil Patel, Ph.D., CEO of Replimune. "Importantly, the design
of our Phase 3 confirmatory IGNYTE-3 clinical trial has been agreed with the FDA, with patient enrollment planned to initiate in the
second half of the year prior to the submission of our BLA for RP1. We also completed a successful Type C meeting with the FDA to align
on our CMC plans ahead of the intended BLA. These are all critical steps as we plan for our next phase as a commercial stage company
and, pending FDA approval, prepare to bring our first oncolytic immunotherapy to patients with advanced skin cancer."
Program Highlights & Milestones
Financial Highlights
on the current operating plan, the Company believes that existing cash, cash equivalents and short-term investments, as of March 31,
2024 will enable the Company to fund operations into the second half of 2026.
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.
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 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 share amounts)
Year Ended March 31,
2024 2023
Operating expenses:
Research and development $ 174,963 $ 126,527
Selling, general and administrative 59,810 50,553
Total operating expenses 234,773 177,080
Loss from operations (234,773 ) (177,080 )
Other income (expense):
Research and development incentives 1,920 2,914
Investment income 23,356 10,006
Interest expense on finance lease liability (2,163 ) (2,197 )
Interest expense on debt obligations (4,497 ) (1,963 )
Other income (expense) 771 (5,676 )
Total other income (expense), net 19,387 3,084
Loss before income taxes $ (215,386 ) $ (173,996 )
Income tax provision 408 288
Net loss $ (215,794 ) $ (174,284 )
Net loss per common share, basic and diluted $ (3.24 ) $ (2.99 )
Weighted average common shares outstanding, basic and
diluted 66,569,894 58,213,010
Replimune Group, Inc.
Condensed Consolidated
(Amounts In thousands,
except share and per share amounts)
March 31, March 31,
2024 2023
Consolidated Balance Sheet Data:
Cash, cash equivalents and short-term investments $ 420,668 $ 583,386
Working capital 393,229 558,778
Total assets 487,722 646,591
Total stockholders' equity 374,508 555,292

Frequently Asked Questions

What are Replimune's key financial figures for 2024?

In 2024, Replimune reported a net loss of $215.8 million and total operating expenses of $234.8 million.

What is the main focus of Replimune's research?

Replimune focuses on developing oncolytic immunotherapies, particularly its lead candidate RP1.

What are the upcoming milestones for Replimune?

Replimune plans to share 12-month IGNYTE data at ASCO and begin patient enrollment for IGNYTE-3.

How long can Replimune fund its operations?

Replimune's current cash and investments can fund operations into the second half of 2026.

What technology underpins Replimune's product candidates?

Replimune's candidates are based on a proprietary HSV-1 backbone designed for tumor targeting.

Last updated: May 16, 2024