Replimune Reports Fiscal Third Quarter 2025 Financial Results and Provides Corporate Update

Rhea-AI Summary

Replimune Group (NASDAQ: REPL) announced key developments in its fiscal Q3 2025 report. The FDA accepted their BLA for RP1 plus nivolumab in advanced melanoma with priority review, setting a PDUFA date of July 22, 2025. The company enrolled first patients in trials for RP2 in metastatic uveal melanoma and hepatocellular carcinoma.

Financial highlights include a successful public offering raising $156.0 million net, bringing total cash position to $536.5 million as of December 31, 2024. Q3 showed increased expenses with R&D at $48.0 million (up from $42.8 million YoY) and SG&A at $18.0 million (up from $13.7 million YoY). Net loss widened to $66.3 million compared to $51.1 million in the previous year. Current cash runway extends into Q4 2026.

Positive

• FDA granted Priority Review for RP1 plus nivolumab BLA with July 2025 PDUFA date
• Strong cash position of $536.5 million, up from $420.7 million in March 2024
• Successful public offering raised $156.0 million net
• Cash runway extended into Q4 2026

Negative

• Net loss increased to $66.3 million from $51.1 million YoY
• R&D expenses increased to $48.0 million from $42.8 million YoY
• SG&A expenses rose to $18.0 million from $13.7 million YoY

Insights

Biotechnology Financial Analyst

The Q3 FY2025 results showcase Replimune's strategic positioning at a critical inflection point, with the FDA's Priority Review acceptance for RP1 in advanced melanoma marking a potential transformation from clinical to commercial stage. The PDUFA date of July 22, 2025, represents a significant near-term catalyst that could establish Replimune in the $4.5 billion melanoma market.

The company's robust financial position, with $536.5 million in cash and equivalents, provides approximately 20 months of runway. This timeline strategically accommodates both the potential RP1 launch and advancement of the broader pipeline, including the promising RP2 programs in uveal melanoma and HCC. The collaboration with Roche for the HCC program adds credibility and reduces development risk.

The 29.7% increase in net loss to $66.3 million reflects strategic investments in commercial infrastructure and pipeline expansion. While the elevated spending may concern some investors, it's appropriately timed given the proximity to potential commercialization. The ongoing IGNYTE-3 confirmatory trial enrollment and expansion of RP2 programs demonstrate a well-structured pipeline strategy that could deliver multiple value-creating catalysts.

The company's commercial preparation, backed by a "deep understanding of the patient population and prescriber landscape," indicates thoughtful planning for the intratumoral therapy launch. This is particularly important as success will depend not just on efficacy but also on healthcare provider adoption and reimbursement infrastructure.

• U.S. Food and Drug Administration (FDA) recently accepted the Biologics License Application (BLA) for RP1 plus nivolumab in advanced melanoma for priority review with a PDUFA date of July 22, 2025

• IGNYTE-3 confirmatory trial of RP1(vusolimogene oderparepvec) plus nivolumab in advanced melanoma is enrolling

• Enrolled first patients in trials evaluating RP2 for the treatment of metastatic uveal melanoma and hepatocellular carcinoma

WOBURN, Mass., Feb. 12, 2025 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (Nasdaq: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced financial results for the fiscal third quarter ended December 31, 2024 and provided a business update.

“Over the past couple of months, we have achieved significant regulatory milestones for RP1 in anti-PD-1 failed melanoma,” said Sushil Patel, Ph.D., CEO of Replimune. “With Priority Review and a PDUFA date set for July 22, 2025, by the FDA, our efforts are focused on ensuring a successful commercial launch of RP1 upon approval. Our commercial strategy is built on a deep understanding of the patient population and prescriber landscape, coupled with a launch model designed to effectively deliver intratumoral therapy. With over $500 million in cash, we are well-capitalized to execute our plans and are excited to provide further updates as we transition to a commercial-stage company.”

Program Highlights & Milestones

RP1

• RP1 combined with Opdivo^® (nivolumab) in anti-PD1 failed melanoma
  • In January, the FDA accepted the BLA for RP1 in combination with nivolumab for patients with advanced melanoma. The BLA was granted Priority Review by the FDA with a PDUFA action date of July 22, 2025.
  • The BLA is supported by the primary analysis data of the IGNYTE trial, evaluating RP1 combined with nivolumab in patients with anti-PD-1 failed melanoma.
  • Enrolling into the confirmatory Phase 3 trial, IGNYTE-3, with over 100 sites planned globally. This trial will assess RP1 in combination with nivolumab in patients with advanced melanoma who have progressed on anti-PD-1 and anti-CTLA-4 therapies or are ineligible for anti-CTLA-4 treatment.

RP2

• RP2 in uveal melanoma
  • Enrolled the first patient in a registration-directed study of RP2 in metastatic uveal melanoma in patients who are immune checkpoint inhibitor-naïve. The study will enroll approximately 280 patients and evaluate RP2 in combination with nivolumab versus ipilimumab in combination with nivolumab. The primary endpoints of the study are overall survival and progression free survival and key secondary endpoints are overall response rate and disease control rate.

• RP2 in hepatocellular carcinoma (HCC)
  • Enrolled the first patient in a Phase 2 clinical trial with RP2 combined with atezolizumab and bevacizumab in anti-PD1/PD-L1 progressed HCC. The trial is an open label trial that will enroll 30 patients and evaluate RP2 combined with the second-line therapy of atezolizumab and bevacizumab. The study is being conducted under a collaboration and supply agreement with Roche.

Financial Highlights

• Financing: Completed a public offering of shares of the Company’s common stock and pre-funded warrants, raising approximately $156.0 million net of issuance costs. Proceeds from the financing will be used to fund the continued development of our RPx platform, including expanding our ongoing studies within RP1 and broadening clinical development plans for RP2, as well as for working capital and general corporate purposes.

• Cash Position: As of December 31, 2024, cash, cash equivalents and short-term investments were $536.5 million, as compared to $420.7 million as of fiscal year ended March 31, 2024. The increase in cash balance was directly related to the public offering in November, somewhat offset by cash utilized in operating activities in advancing the Company’s clinical development plans.
  
  Based on the current operating plan, the Company believes that existing cash, cash equivalents and short-term investments, as of December 31, 2024 will enable the Company to fund operations into the fourth quarter of 2026 which includes scale up for the potential commercialization of RP1 in skin cancers and for working capital and general corporate purposes and excludes any potential revenue.

• R&D Expenses: Research and development expenses were $48.0 million for the fiscal third quarter ended December 31, 2024, as compared to $42.8 million for the fiscal third quarter ended December 31, 2023. This increase was primarily due to an increase in personnel-related costs, as well as consulting and facility-related costs. Research and development expenses included $4.6 million in stock-based compensation expenses for the fiscal third quarter ended December 31, 2024.

• S,G&A Expenses: Selling, general and administrative expenses were $18.0 million for the fiscal third quarter ended December 31, 2024, as compared to $13.7 million for the fiscal third quarter ended December 31, 2023. Selling, general and administrative expenses included $4.1 million in stock-based compensation expenses for the fiscal third quarter ended December 31, 2024.
• Net Loss: Net loss was $66.3 million for the fiscal third quarter ended December 31, 2024, as compared to a net loss of $51.1 million for the fiscal third quarter ended December 31, 2023.

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 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, the regulatory review process and timing of potential product approval, 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 Healthcare
339.970.2843
chris.brinzey@icrhealthcare.com

Media Inquiries
Arleen Goldenberg
Replimune
917.548.1582
media@replimune.com

Replimune Group, Inc. Condensed Consolidated Statements of Operations (Amounts in thousands, except share and per share amounts) (Unaudited)
	Three Months Ended December 31,								Nine Months Ended December 31,
		2024				2023				2024				2023
Operating expenses:
Research and development	$	48,004			$	42,847			$	135,472			$	132,384
General and administrative		18,015				13,693			$	46,827				43,633
Total operating expenses		66,019				56,540				182,299				176,017
Loss from operations		(66,019	)			(56,540	)			(182,299	)			(176,017	)
Other income (expense):
Research and development incentives		376				415				1,222				1,251
Investment income		5,137				5,686				15,243				17,922
Interest expense on finance lease liability		(528	)			(540	)			(1,594	)			(1,626	)
Interest expense on debt obligations		(1,450	)			(1,012	)			(4,314	)			(3,083	)
Other (expense) income		(3,281	)			1,344				(850	)			1,307
Total other income (expense), net		254				5,893				9,707				15,771
Loss before income taxes	$	(65,765	)		$	(50,647	)		$	(172,592	)		$	(160,246	)
Income tax provision	$	575			$	473			$	575			$	473
Net loss	$	(66,340	)		$	(51,120	)		$	(173,167	)		$	(160,719	)
Net loss per common share, basic and diluted	$	(0.79	)		$	(0.77	)		$	(2.25	)		$	(2.42	)
Weighted average common shares outstanding, basic and diluted		83,498,892				66,645,691				77,113,695				66,532,488

Replimune Group, Inc. Condensed Consolidated Balance Sheets (Amounts In thousands, except share and per share amounts) (Unaudited)
	December 31, 2024			March 31, 2024
	(in thousands)
Consolidated Balance Sheet Data:
Cash, cash equivalents and short-term investments	$	536,539		$	420,668
Working capital		499,687			393,229
Total assets		603,628			487,722
Total stockholders' equity		482,374			374,508

FAQ

When is the PDUFA date for Replimune's (REPL) RP1 melanoma treatment?

The FDA set a PDUFA date of July 22, 2025, for Replimune's RP1 plus nivolumab treatment for advanced melanoma.

What was Replimune's (REPL) cash position as of December 31, 2024?

Replimune reported $536.5 million in cash, cash equivalents and short-term investments as of December 31, 2024.

How much did Replimune (REPL) raise in their recent public offering?

Replimune raised approximately $156.0 million net through a public offering of common stock and pre-funded warrants.

What was Replimune's (REPL) net loss for Q3 fiscal 2025?

Replimune reported a net loss of $66.3 million for the fiscal third quarter ended December 31, 2024.

How long will Replimune's (REPL) current cash runway last?

Based on the current operating plan, Replimune's cash runway extends into the fourth quarter of 2026.