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Iovance Biotherapeutics (IOVA)
NASDAQ:IOVA

Iovance Biotherapeutics (IOVA) AI Stock Analysis

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IOVA

Iovance Biotherapeutics

(NASDAQ:IOVA)

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Neutral 52 (OpenAI - 5.2)
Rating:52Neutral
Price Target:
$3.00
▲(14.07% Upside)
The score is held back primarily by weak financial performance (large losses and negative cash flows). This is partially offset by constructive technical trends and a relatively upbeat earnings outlook featuring revenue growth, reiterated guidance, and margin-improvement initiatives; valuation provides limited support due to negative earnings and no dividend.
Positive Factors
TIL leadership and clinical efficacy
Iovance's position as a leader in tumor-infiltrating lymphocyte (TIL) therapy and reported ~50% real-world response rates give it a durable clinical differentiation. This platform advantage supports long-term adoption across solid tumors and underpins sustained commercial opportunity if regulatory and manufacturing scale succeed.
Manufacturing centralization to improve margins
Moving production in-house and centralizing manufacturing is structural: it reduces per-dose costs, tightens quality control, and creates operating leverage as volumes scale. If executed on schedule, the change should sustainably raise gross margins and reduce dependency on contract CMO capacity over multiple years.
Strong cash position and low leverage
About $307M in cash and a conservative debt profile (D/E ~0.08, high equity ratio) provide a multiquarter runway, allowing the company to fund commercialization, trials, and the manufacturing transition without immediate refinancing. This balance sheet conservatism supports strategic optionality through 2026.
Negative Factors
Deep negative profitability
The company is operating with very large losses; a net margin near -161% signals that revenue growth has not translated into profitability. Persistently negative margins erode equity returns and require sustained margin improvement or structural cost reductions to reach self-sustaining commercial economics over the medium term.
Negative operating and free cash flow
Operating and free cash flow remain negative, indicating ongoing burn despite modest FCF improvement. This structural cash-consumption pattern increases reliance on existing cash, potential capital markets access, or partnerships to fund the commercialization and late-stage trials beyond the stated runway, pressuring strategic flexibility.
Commercial scaling and regulatory timing risk
Iovance's commercial upside depends on international approvals and broad adoption at academic and community ATCs. Regulatory lag and the multi-step ramp of community centers are structural timing risks that delay access to larger patient pools and postpone peak sales, extending the timeline to durable revenue scale.

Iovance Biotherapeutics (IOVA) vs. SPDR S&P 500 ETF (SPY)

Iovance Biotherapeutics Business Overview & Revenue Model

Company DescriptionIovance Biotherapeutics, Inc., a clinical-stage biotechnology company, focuses on developing and commercializing cancer immunotherapy products to harness the power of a patient's immune system to eradicate cancer cells. It has six ongoing phase 2 clinical studies, including C-144-01, of its lead product candidate, lifileucel, for the treatment of metastatic melanoma; C-145-04, of its product candidate lifileucel for recurrent, metastatic, or persistent cervical cancer; and C-145-03, of its product candidate LN-145, for recurrent and/or metastatic head and neck squamous cell carcinoma. Iovance Biotherapeutics, Inc. has collaborations and licensing agreements with H. Lee Moffitt Cancer Center; M.D. Anderson Cancer Center; Ohio State University; Centre hospitalier de l'Université de Montreal; Cellectis S.A.; and Novartis Pharma AG. The company was formerly known as Lion Biotechnologies, Inc. and changed its name to Iovance Biotherapeutics, Inc. in June 2017. Iovance Biotherapeutics, Inc. was incorporated in 2007 and is headquartered in San Carlos, California.
How the Company Makes MoneyIovance Biotherapeutics generates revenue primarily through the commercialization of its cell therapy products, including lifileucel, once approved by regulatory authorities. The company also engages in partnerships and collaborations with larger pharmaceutical companies for research and development support, which can include upfront payments, milestone payments, and royalties on future sales. Additionally, Iovance may receive funding through grants or other financial support aimed at advancing its clinical programs. The successful transition of its products from clinical trials to market approval is crucial for its revenue generation.

Iovance Biotherapeutics Earnings Call Summary

Earnings Call Date:Nov 06, 2025
(Q3-2025)
|
% Change Since: |
Next Earnings Date:Mar 03, 2026
Earnings Call Sentiment Positive
The earnings call was largely positive, highlighting significant revenue growth, successful strategic restructuring, and promising clinical data in lung cancer. However, challenges remain in expense management, global market expansion, and community ATC adoption.
Q3-2025 Updates
Positive Updates
Revenue Growth and Improved Margins
Third quarter revenue grew 13% over the prior quarter, reaching approximately $68 million. Gross margin improved to 43% following strategic restructuring and cost optimization.
Expansion of Academic and Community ATCs
Iovance expanded its network to include new academic and multiple community ATCs, with initial patients being treated and earlier patient referrals driving growth.
Positive Clinical Data in Lung Cancer
Interim clinical data for previously treated non-squamous non-small cell lung cancer showed a 26% objective response rate and median duration of response not reached at over 25 months.
Successful Manufacturing Transition Plans
Iovance is centralizing manufacturing at its internal facility, expecting significant cost savings and improved gross margin as operations transition in early 2026.
Strong Cash Position
The cash position was approximately $307 million as of September 30, expected to fund operations into the second quarter of 2027.
Negative Updates
Need for Continued Expense Management
Ongoing efforts are required to manage expenses and profitability, including further manufacturing cost reductions and resource allocation adjustments.
Challenges in Global Market Expansion
While Canada approved Amtagvi, approvals in other markets such as the UK and Australia are pending, with significant revenue from these markets not expected until 2027.
Complexity in Community ATC Adoption
While new community ATCs are coming online, the ramp-up to treating patients and achieving full capacity will take time.
Company Guidance
During the third quarter of 2025, Iovance Biotherapeutics reported a 13% increase in revenue compared to the previous quarter, reaching approximately $68 million, with $58 million from Amtagvi sales and $10 million from global Proleukin revenue. The company achieved a gross margin of 43%, an improvement attributed to strategic restructuring efforts and cost optimization initiatives. Iovance reiterated its full-year revenue guidance range of $250 million to $300 million and projected peak sales of over $1 billion for Amtagvi in the U.S. for melanoma, with additional opportunities in international markets. The company also highlighted a significant market opportunity in non-squamous non-small cell lung cancer, aiming for a supplemental biologics license application by 2027. Iovance is focusing on expanding its network of academic and community authorized treatment centers (ATCs) to drive Amtagvi adoption, with real-world data showing a 60% response rate in the second-line melanoma treatment setting. The company is also centralizing manufacturing at its internal facility, which is expected to further improve margins.

Iovance Biotherapeutics Financial Statement Overview

Summary
Financials remain pressured by very weak profitability and cash flow (net margin -161% and negative operating/free cash flow). Offsetting factors include low leverage (debt-to-equity 0.08) and a strong equity ratio (77.6%), but overall execution still needs to translate revenue growth into sustainable margins.
Income Statement
25
Negative
Iovance Biotherapeutics shows a modest revenue growth rate of 3.69% in the TTM, but the company is struggling with profitability. The net profit margin is significantly negative at -161.44%, indicating substantial losses relative to revenue. The EBIT and EBITDA margins are also deeply negative, reflecting high operational costs and challenges in achieving profitability.
Balance Sheet
40
Negative
The company's debt-to-equity ratio is relatively low at 0.08, suggesting conservative leverage. However, the return on equity is negative at -52.87%, indicating that the company is not generating profits from its equity base. The equity ratio stands at 77.57%, showing a strong equity position relative to total assets, which is a positive aspect.
Cash Flow
30
Negative
Iovance Biotherapeutics has a negative operating cash flow and free cash flow, although there is a slight improvement in free cash flow growth at 8.74% in the TTM. The operating cash flow to net income ratio is negative, indicating cash flow challenges. The free cash flow to net income ratio is slightly above 1, suggesting that free cash flow is slightly better than net income, but still negative.
BreakdownTTMDec 2024Dec 2023Dec 2022Dec 2021Dec 2020
Income Statement
Total Revenue250.43M164.07M1.19M0.000.000.00
Gross Profit97.07M40.08M-9.57M0.000.000.00
EBITDA-368.31M-351.67M-427.43M-377.74M-328.72M-260.80M
Net Income-397.63M-372.18M-444.04M-395.89M-342.25M-259.58M
Balance Sheet
Total Assets904.95M910.43M780.35M663.98M777.33M768.46M
Cash, Cash Equivalents and Short-Term Investments300.80M323.78M279.87M471.85M504.41M629.44M
Total Debt52.49M58.26M75.86M85.45M71.53M51.66M
Total Liabilities202.66M200.02M195.74M164.34M155.67M111.96M
Stockholders Equity702.29M710.40M584.61M499.64M621.66M656.50M
Cash Flow
Free Cash Flow-351.82M-364.05M-384.11M-313.18M-265.51M-251.93M
Operating Cash Flow-323.14M-352.98M-361.82M-292.76M-227.94M-205.13M
Investing Cash Flow70.40M-96.41M-155.24M256.45M132.00K-317.85M
Financing Cash Flow246.91M390.66M462.96M190.15M239.27M576.42M

Iovance Biotherapeutics Technical Analysis

Technical Analysis Sentiment
Positive
Last Price2.63
Price Trends
50DMA
2.48
Positive
100DMA
2.34
Positive
200DMA
2.37
Positive
Market Momentum
MACD
0.07
Negative
RSI
51.83
Neutral
STOCH
70.80
Neutral
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For IOVA, the sentiment is Positive. The current price of 2.63 is above the 20-day moving average (MA) of 2.57, above the 50-day MA of 2.48, and above the 200-day MA of 2.37, indicating a bullish trend. The MACD of 0.07 indicates Negative momentum. The RSI at 51.83 is Neutral, neither overbought nor oversold. The STOCH value of 70.80 is Neutral, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Positive sentiment for IOVA.

Iovance Biotherapeutics Risk Analysis

Iovance Biotherapeutics disclosed 82 risk factors in its most recent earnings report. Iovance Biotherapeutics reported the most risks in the "Tech & Innovation" category.
Finance & Corporate - Financial and accounting risks. Risks related to the execution of corporate activity and strategy
Latest Risks Added 0 New Risks

Iovance Biotherapeutics Peers Comparison

Overall Rating
UnderperformOutperform
Sector (51)
Financial Indicators
Name
Overall Rating
Market Cap
P/E Ratio
ROE
Dividend Yield
Revenue Growth
EPS Growth
59
Neutral
$1.82B-8.34-52.49%1137.19%70.51%
57
Neutral
$765.27M-3.91-13.14%
56
Neutral
$1.30B-8.58-29.01%-27.61%-69.49%
56
Neutral
$1.59B-8.25-56.52%-100.34%52.85%
55
Neutral
$1.05B-2.15-49.06%-78.55%7.74%
52
Neutral
$1.09B-53.89%175.62%19.63%
51
Neutral
$7.86B-0.30-43.30%2.27%22.53%-2.21%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
IOVA
Iovance Biotherapeutics
2.63
-3.22
-55.04%
KALV
KalVista Pharmaceuticals
15.65
6.74
75.65%
VIR
Vir Biotechnology
7.78
-2.62
-25.19%
IMTX
Immatics
9.38
3.91
71.48%
NUVB
Nuvation Bio
5.34
3.03
131.17%
AMLX
Amylyx Pharmaceuticals Inc
14.85
11.20
306.85%

Iovance Biotherapeutics Corporate Events

Business Operations and StrategyFinancial Disclosures
Iovance Highlights Amtagvi Momentum and Confirms 2025 Guidance
Positive
Jan 9, 2026

On January 9, 2026, Iovance Biotherapeutics updated its corporate presentation, indicating that it expected to meet its previously disclosed full-year 2025 revenue guidance of $250 million to $300 million in the first full calendar year of Amtagvi sales. The presentation highlighted that total revenue since the first quarter of 2024 had reached about $340 million as of September 30, 2025, with approximately $307 million in cash on hand, more than 85 treatment centers in the U.S. and Canada and multiple global markets engaged, and improving gross margins following organizational streamlining. Iovance emphasized its leadership in TIL-based cell therapy, the commercial momentum of Amtagvi in advanced melanoma with real-world response rates around 50%, and the potential for substantial future growth driven by ongoing registration-directed trials in metastatic non-small cell lung cancer and other solid tumors, positioning the company as a key player in next-generation oncology cell therapies.

The most recent analyst rating on (IOVA) stock is a Buy with a $14.00 price target. To see the full list of analyst forecasts on Iovance Biotherapeutics stock, see the IOVA 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 09, 2026