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Replimune Group Inc (REPL)
NASDAQ:REPL

Replimune Group (REPL) AI Stock Analysis

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REPL

Replimune Group

(NASDAQ:REPL)

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Neutral 48 (OpenAI - 5.2)
Rating:48Neutral
Price Target:
$8.00
▼(-0.50% Downside)
The score is held down primarily by weak financial performance (no revenue, widening losses, and heavy cash burn) and bearish technical momentum. Offsetting these, corporate events are a meaningful positive given the FDA acceptance and defined April 2026 decision date plus stated launch preparation, but valuation remains unfavorable due to ongoing losses and no dividend support.
Positive Factors
Regulatory Milestone (BLA Acceptance)
FDA acceptance with a defined PDUFA date provides a clear regulatory timeline that materially reduces uncertainty versus an open review. This enables prioritized resource allocation for potential launch, planning for commercialization, and clarity on the path to revenue for a clinical-stage biotech.
Clinical Efficacy in Resistant Subgroups
Durable objective responses and nearly 12-month median duration of response in a PD-1–failed population indicate the RP1 platform can deliver clinically meaningful outcomes in hard-to-treat subgroups. Sustained efficacy and tolerable safety support long-term product differentiation and commercial adoption if approved.
Commercial Readiness and Platform Experience
A pre-built commercial team and targeted account activation plans reduce time-to-market execution risk if approval is granted. Operational experience treating ~1,000 patients across the RPx platform demonstrates scalability of administration and clinical operations, aiding sustainable roll-out and uptake.
Negative Factors
Heavy and Accelerating Cash Burn
Large, accelerating negative operating and free cash flows deplete liquidity and force ongoing reliance on external financing. Over a multi-month horizon this raises dilution risk, constrains discretionary R&D or commercial spend, and creates execution risk if capital markets tighten.
Pre-Commercial, No Revenue Base
With no recurring product revenue and widening operating losses, the company cannot self-fund growth. This structural lack of internal cash generation increases dependency on financings and partners, elevating the probability of dilution or program prioritization decisions that could impair long-term pipeline development.
Program Viability Tied to Regulatory Pathway
Management has indicated RP1's advanced melanoma program may be non-viable without accelerated approval, concentrating business risk on a single regulatory outcome. This binary dependency increases the chance that unfavorable or delayed decisions materially impact future clinical development and commercial prospects.

Replimune Group (REPL) vs. SPDR S&P 500 ETF (SPY)

Replimune Group Business Overview & Revenue Model

Company DescriptionReplimune Group, Inc., a biotechnology company, develops oncolytic immuno-gene therapies to treat cancer. It uses its proprietary Immunotherapy platform to design and develop product candidates that are intended to activate the immune system against cancer. The company's lead product candidate is RP1, a selectively replicating version of herpes simplex virus 1, which is in Phase I/II clinical trials for a range of solid tumors; and that is in Phase II clinical trials for patients with cutaneous squamous cell carcinoma. It is also developing RP2, which is in Phase I clinical trials for an anti-CTLA-4 antibody-like protein in order to block the inhibition of the immune response otherwise caused by CTLA-4; and RP3 that is in Phase I clinical trials to express immune-activating proteins that stimulate T cells. Replimune Group, Inc. was founded in 2015 and is headquartered in Woburn, Massachusetts.
How the Company Makes MoneyReplimune Group generates revenue primarily through partnerships, collaborations, and licensing agreements with other pharmaceutical and biotechnology companies. These partnerships often involve upfront payments, milestone payments, and potential royalties based on the successful development and commercialization of their oncolytic immunotherapies. While Replimune is still in the clinical trial phase for many of its product candidates, such collaborations are crucial for funding ongoing research and development activities. Additionally, the company may also receive government grants or funding from cancer research organizations to support its innovative work in oncolytic virotherapy.

Replimune Group Key Performance Indicators (KPIs)

Any
Any
Revenue by Geography
Revenue by Geography
Breaks down revenue across different regions, revealing where the company is strongest and where it may face risk or growth potential due to local economic conditions or market share shifts.
Chart InsightsReplimune Group's revenue in the United States has surged significantly since late 2023, indicating strong market penetration and possibly successful product launches or strategic initiatives. In contrast, the United Kingdom has seen a sharp decline in revenue since 2024, suggesting potential market challenges or strategic shifts away from this region. The disparity highlights the company's focus on the U.S. market as a key growth driver, while the U.K. market may require reassessment or targeted strategies to regain momentum.
Data provided by:The Fly

Replimune Group Earnings Call Summary

Earnings Call Date:May 22, 2025
(Q4-2025)
|
% Change Since: |
Next Earnings Date:May 14, 2026
Earnings Call Sentiment Positive
The earnings call provided a positive outlook, highlighting significant regulatory achievements, strong commercial readiness, and financial stability. However, the increase in net loss and operational expenses presents challenges. The overall sentiment is optimistic about RP1's potential launch and market adoption.
Q4-2025 Updates
Positive Updates
Breakthrough Therapy Designation and Priority Review for RP1
RP1 has been recognized as a breakthrough therapy with priority review, with a PDUFA date set for July 22, 2025. The company has completed late-cycle meetings and manufacturing inspections with the FDA, indicating substantial regulatory progress.
Strong Commercial Readiness for RP1 Launch
Replimune has completed the build-out of its commercial infrastructure, including a customer-facing team of approximately 60 people, a patient support hub, and a distribution model ready for next-day delivery.
Financial Stability and Cash Position
The company ended the fiscal year with $483.8 million in cash and cash equivalents, providing a cash runway into the fourth quarter of 2026, supporting commercial launch plans and ongoing operations.
Potential for Broad and Rapid Adoption of RP1
Significant interest from medical oncologists and interventional radiologists, with over 90% willing to utilize RP1 routinely upon approval, suggests strong market potential for RP1 in advanced melanoma.
Negative Updates
Increased Net Loss
The company's net loss increased to $74.1 million for the fiscal fourth quarter and $247.3 million for the fiscal year ended March 31, 2025, compared to $55.1 million and $215.8 million, respectively, for the prior year.
Significant Increase in Operational Expenses
Research and development expenses increased to $54 million for the fiscal fourth quarter, and selling, general, and administrative expenses rose to $25.4 million, reflecting higher costs related to scaling operations and commercial preparations.
Company Guidance
During the Replimune Fiscal Year Fourth Quarter 2025 Financial Results and Corporate Update Conference Call, significant progress was highlighted across regulatory, clinical, and commercial fronts as the company approaches the potential approval and launch of RP1. The product has been recognized as a breakthrough therapy with a priority review and a PDUFA date set for July 22, 2025. The Ignite 3 confirmatory study is underway, with over 100 planned global sites, focusing on overall survival as the primary endpoint. Replimune estimates that approximately 13,000 patients progress on or after PD-1 treatment annually in the U.S., with 80% of these patients potentially eligible for RP1. The company ended the fiscal year with $483.8 million in cash and cash equivalents and anticipates a cash runway into the fourth quarter of 2026. Research and development expenses totaled $189.4 million for the fiscal year, with a net loss of $247.3 million. The company has completed its commercial infrastructure build-out, comprising approximately 60 people, and plans to provide critical services through the Replimune Connect Plus patient support hub.

Replimune Group Financial Statement Overview

Summary
Replimune Group is in an early growth stage, heavily investing in R&D, which impacts profitability and cash flow. While the company maintains a strong equity position, it experiences significant operational losses typical for its industry phase. Future financial performance will depend on successful product development and commercialization.
Income Statement
12
Very Negative
Replimune Group has shown minimal revenue with a TTM revenue of $4.04 million, indicating an initial phase of commercial operations. The company is experiencing significant negative EBIT and EBITDA margins due to high operating expenses, typical for biotechnology firms in research phases. Net profit margins are also deeply negative, reflecting ongoing losses as the company invests heavily in R&D.
Balance Sheet
62
Positive
The balance sheet shows a strong equity position relative to liabilities, with a debt-to-equity ratio of 0.06 in TTM. The equity ratio stands at 79.9%, indicating a low leverage. However, substantial net losses contribute to a low return on equity, typical for companies heavily investing in development before achieving commercial success.
Cash Flow
18
Very Negative
Operating cash flow remains negative, reflecting cash outflows associated with R&D activities. Despite this, the company has managed robust financing activities, maintaining liquidity with significant cash reserves. Free cash flow has shown a marginal decline, emphasizing the need for efficient cash management to support ongoing operations.
BreakdownTTMDec 2025Dec 2024Dec 2023Dec 2022Dec 2021
Income Statement
Total Revenue0.000.000.000.000.000.00
Gross Profit-848.00K0.000.000.00-4.58M-4.14M
EBITDA-308.37M-253.92M-227.77M-171.72M-114.41M-76.48M
Net Income-310.26M-247.30M-215.79M-174.28M-118.04M-80.87M
Balance Sheet
Total Assets389.45M551.33M487.72M646.59M461.19M543.10M
Cash, Cash Equivalents and Short-Term Investments323.64M483.80M420.67M583.39M395.65M476.30M
Total Debt76.32M76.17M75.87M60.76M32.84M33.28M
Total Liabilities126.11M135.49M113.21M91.30M49.96M44.37M
Stockholders Equity263.34M415.84M374.51M555.29M411.23M498.73M
Cash Flow
Free Cash Flow-269.69M-198.94M-191.13M-130.32M-84.52M-63.78M
Operating Cash Flow-262.67M-192.25M-185.47M-128.05M-82.18M-61.39M
Investing Cash Flow95.20M-23.80M97.20M-142.50M-1.81M-188.78M
Financing Cash Flow155.96M252.40M16.28M311.30M6.60M372.46M

Replimune Group Technical Analysis

Technical Analysis Sentiment
Negative
Last Price8.04
Price Trends
50DMA
9.34
Negative
100DMA
7.58
Positive
200DMA
7.89
Negative
Market Momentum
MACD
-0.43
Positive
RSI
31.16
Neutral
STOCH
7.23
Positive
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For REPL, the sentiment is Negative. The current price of 8.04 is below the 20-day moving average (MA) of 9.13, below the 50-day MA of 9.34, and above the 200-day MA of 7.89, indicating a bearish trend. The MACD of -0.43 indicates Positive momentum. The RSI at 31.16 is Neutral, neither overbought nor oversold. The STOCH value of 7.23 is Positive, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Negative sentiment for REPL.

Replimune Group Risk Analysis

Replimune Group disclosed 60 risk factors in its most recent earnings report. Replimune Group reported the most risks in the "Finance & Corporate" category.
Finance & Corporate - Financial and accounting risks. Risks related to the execution of corporate activity and strategy
Latest Risks Added 0 New Risks

Replimune Group Peers Comparison

Overall Rating
UnderperformOutperform
Sector (51)
Financial Indicators
Name
Overall Rating
Market Cap
P/E Ratio
ROE
Dividend Yield
Revenue Growth
EPS Growth
62
Neutral
$430.66M-8.86-43.11%-5.71%
55
Neutral
$3.04B-68.13%-8.75%-8.79%
54
Neutral
$1.10B-6.50-39.73%4.29%
54
Neutral
$1.93B-65.35%48.32%-1.91%
51
Neutral
$7.86B-0.30-43.30%2.27%22.53%-2.21%
51
Neutral
$1.26B-4.88-96.11%31.16%
48
Neutral
$604.80M-2.14-96.24%-15.77%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
REPL
Replimune Group
7.71
-2.65
-25.58%
AVXL
Anavex Life Sciences
4.82
-5.33
-52.51%
RCUS
Arcus Biosciences
24.56
10.44
73.94%
ORIC
Oric Pharmaceuticals
11.25
1.21
12.05%
NRIX
Nurix Therapeutics
19.04
-0.45
-2.31%
SANA
Sana Biotechnology
4.74
1.49
45.85%

Replimune Group Corporate Events

Business Operations and StrategyProduct-Related Announcements
Replimune Highlights RP1, RP2 Progress Ahead of JPM Conference
Positive
Jan 12, 2026

On January 12, 2026, Replimune released an updated corporate presentation highlighting recent strategic developments and clinical data for its RP1 and RP2 oncolytic immunotherapy programs ahead of its appearance at the J.P. Morgan Healthcare Conference on January 14, 2026. The company reported that it is preparing for a potential commercial launch in melanoma, with a near-term regulatory decision date of April 10, 2026, a “launch ready” commercial team, and roughly 150 treatment accounts expected to be activated on day one, reflecting significant operational build-out. Clinical data from the IGNYTE study in anti-PD-1–failed melanoma showed durable and clinically meaningful response rates across difficult, resistant patient subgroups, with approximately 1,000 patients treated across the RPx platform and successful administration into deep lesions such as liver and lung, underscoring the platform’s potential to address resistance to checkpoint inhibitors and support Replimune’s competitive positioning in the immuno-oncology field.

The most recent analyst rating on (REPL) stock is a Hold with a $10.00 price target. To see the full list of analyst forecasts on Replimune Group stock, see the REPL Stock Forecast page.

Product-Related AnnouncementsRegulatory Filings and Compliance
Replimune Group’s FDA Resubmission for RP1 Accepted
Positive
Oct 20, 2025

On October 20, 2025, Replimune Group announced that the FDA accepted their resubmission of the Biologics License Application for RP1 in combination with nivolumab for advanced melanoma treatment. The FDA set a PDUFA date of April 10, 2026, marking a significant step in providing new treatment options for patients who have progressed on PD-1 based therapies. This acceptance follows Replimune’s efforts to address FDA feedback, and the resubmission is considered a complete response to a previous letter from the FDA.

The most recent analyst rating on (REPL) stock is a Buy with a $18.00 price target. To see the full list of analyst forecasts on Replimune Group stock, see the REPL Stock Forecast page.

Glossary
BuyA stock rated as a "Buy" is expected to perform better than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock is likely to deliver higher returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
HoldA stock rated as a "Hold" is expected to perform in line with the overall market or a specific benchmark. This rating indicates that the stock is neither particularly compelling nor unfavorable for investment. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
SellA stock rated as a "Sell" is expected to perform worse than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock may deliver lower returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.

Disclaimer

This AI Analyst Stock Report is automatically generated by our AI systems using advanced algorithms and publicly available financial, technical, and market data. While the information provided aims to be accurate and insightful, it is intended for informational purposes only and should not be considered financial advice. Any content created by an AI (Artificial Intelligence) system may contain inaccuracies and/or contain errors. Investing in stocks carries inherent risks, and past performance is not indicative of future results. This report does not account for your personal financial circumstances, objectives, or risk tolerance. Always conduct your own research or consult with a qualified financial advisor before making investment decisions. The analysis and recommendations provided are based on historical and current data and may not fully reflect future market conditions or unexpected developments. Neither the creators of this report nor its affiliated entities guarantee the accuracy, completeness, or reliability of the information presented. Use this report at your own discretion and risk.Date of analysis: Jan 12, 2026