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Iovance Biotherapeutics Highlights Strong Fourth Quarter and Full Year 2025 Results, Business Achievements and Corporate Updates

Key Takeaway: Iovance Biotherapeutics reported strong financial results for Q4 and FY25, achieving $264M in revenue, driven by the demand for Amtagvi. The company also noted a significant increase in gross margin to 50% and received FDA Fast Track designation for Lifileucel in treating advanced non-small cell lung cancer. Management expressed confidence in future profitability and ongoing clinical trials.
Price reaction · baseline $2.89 (2026-02-23 close) · hit pre-market · 1 other IOVA headline(s) in the window, move may be shared
day 0 close
+30.8%
day 1
+32.5%
day 3 · peak
+33.6%

Market Sentiment Analysis

POSITIVE FACTORS

  • 30% quarterly revenue growth driven by Amtagvi demand.
  • Gross margin increased to 50%.
  • Achieved annual revenue guidance of $264M.
  • FDA Fast Track designation granted for Lifileucel.

CONCERNS & RISKS

  • Risks related to successful commercialization of products.
  • Potential challenges in manufacturing capacity at the facility.
  • Uncertainties regarding regulatory approvals for product candidates.

BiopharmaWatch Analysis

From our catalyst data and publicly available data · not financial advice
Best trade, last catalyst
+126%
120-day peak, hindsight
Typical move
6.2%
average across 3 past catalysts
Cash runway
~14 mo
Low dilution risk
Lead asset
LN-145
Phase 2 · Squamous Cell Carcinoma of the Head and Neck

Full Press Release Details

~30% Quarterly Revenue Growth Driven by Amtagvi Demand
Gross Margin Increased to 50%
FY25 Revenue of $264M Achieved Annual Guidance
U.S. FDA Fast Track Designation Granted for Lifileucel inSecond-Line Advanced Non-Small Cell Lung Cancer
SAN CARLOS, Calif., Feb. 24, 2026 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a commercial biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, today reported fourth quarter and full year 2025 financial results, business achievements and corporate updates.
Frederick Vogt, Ph.D., J.D., Interim President and Chief Executive Officer of Iovance, stated, “Iovance delivered approximately 30 percent quarterly revenue growth and achieved our 2025 guidance range in the first full calendar year of launch. Growth was driven by increasing demand for Amtagvi. After ongoing improvements in our operations and gross margin, we are well positioned for future profitability. Iovance is poised to create substantial value for patients and shareholders as we increase revenue while advancing our registrational trial in non-small cell lung cancer and best-in-class TIL pipeline in solid tumors.”

Fourth Quarter and Full Year 2025Financial HighlightsTopline Growth, Significant Margin Improvement, and Cost Optimization

Amtagvi Commercial LaunchStrong U.S. Commercial Growth and Execution with Approvals Pending in New Global Markets

Lifileucel in Previously Treated Advanced NSCLC: IOV-LUN-202 Registrational TrialClinical and Regulatory Momentum Building Towards Potential 2H27 Launch

Pipeline UpdatesNew Data Across Several Pipeline Programs Anticipated Throughout 2026

Webcast and Conference CallManagement will host a conference call and live audio webcast to discuss these results and provide a corporate update today at 8:30 a.m. ET. To listen to the live or archived audio webcast, please register athttps://edge.media-server.com/mmc/p/5rbo34au. The live and archived webcast can be accessed in the Investors section of the Company’s website, IR.Iovance.com, for one year.
1. Cash, cash equivalents, short-term investments, and restricted cash as of December 31, 20252. Ahn MJ et al. J Clin Onc 2024;43:260-272.

AboutIovance Biotherapeutics, Inc.

Iovance Biotherapeutics, Inc. aims to be the global leader in innovating, developing, and delivering tumor infiltrating lymphocyte (TIL) therapies for patients with cancer. We are pioneering a transformational approach to cure cancer by harnessing the human immune system’s ability to recognize and destroy diverse cancer cells in each patient. TheIovance TIL platformhas demonstrated promising clinical data across multiple solid tumors. Iovance’s Amtagvi®is the first FDA-approved T cell therapy for a solid tumor indication. We are committed to continuous innovation in cell therapy, including gene-edited cell therapy, that may extend and improve life for patients with cancer. For more information, please visitwww.iovance.com.
Amtagvi®and its accompanying design marks, Proleukin®, Iovance®, and IovanceCares™ are trademarks and registered trademarks of Iovance Biotherapeutics, Inc. or its subsidiaries. All other trademarks and registered trademarks are the property of their respective owners.
Information on Iovance’s broad, industry-leading patent portfolio is available on the Intellectual Property page onwww.iovance.com.

Forward-Looking Statements

Certain matters discussed in this press release are “forward-looking statements” of Iovance Biotherapeutics, Inc. (hereinafter referred to as the “Company,” “we,” “us,” or “our”) within the meaning of the Private Securities Litigation Reform Act of 1995 (the “PSLRA”). Without limiting the foregoing, we may, in some cases, use terms such as “predicts,” “believes,” “potential,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “forecast,” “guidance,” “outlook,” “may,” “can,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes and are intended to identify forward-looking statements. Forward-looking statements are based on assumptions and assessments made in light of management’s experience and perception of historical trends, current conditions, expected future developments, and other factors believed to be appropriate. Forward-looking statements in this press release are made as of the date of this press release, and we undertake no duty to update or revise any such statements, whether as a result of new information, future events or otherwise. Forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties, and other factors, many of which are outside of our control, that may cause actual results, levels of activity, performance, achievements, and developments to be materially different from those expressed in or implied by these forward-looking statements. Important factors that could cause actual results, developments, and business decisions to differ materially from forward-looking statements are described in the sections titled "Risk Factors" in our filings with the U.S. Securities and Exchange Commission, including our most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, and include, but are not limited to, the following substantial known and unknown risks and uncertainties inherent in our business: the risks related to our ability to successfully commercialize our products; the acceptance by the market of our products and product candidates, if approved, and their potential pricing and/or reimbursement by payors, and whether such acceptance is sufficient to support continued commercialization or development of our products or product candidates; the risk regarding our ability to manufacture our therapies at ouriCTC facility, including the risk that our ability to increase manufacturing capacity at our facility may adversely affect our commercial launch; the risk that the successful development or commercialization of our products may not generate sufficient revenue from product sales, and we may not become profitable in the near term, or at all; the risks related to the timing of and our ability to successfully develop, submit, obtain, or maintain regulatory authority approval of our product candidates; whether clinical trial results from our pivotal studies and cohorts, and meetings with regulatory authorities may support registrational studies and subsequent approvals by regulatory authorities, including the risk that the planned registrational trial in advanced sarcomas may not support approval; preliminary and interim clinical results, which may include efficacy and safety results, from ongoing clinical trials or cohorts may not be reflected in the final analyses of our ongoing clinical trials or subgroups within these trials or in other prior trials or cohorts; the risk that we may be required to conduct additional clinical trials or modify ongoing or future clinical trials based on feedback from regulatory authorities; the risk that our interpretation of the results of our clinical trials or communications with regulatory authorities may differ from the interpretation of such results or communications by such regulatory authorities; the risk that clinical data from ongoing clinical trials of Amtagvi will not continue or be repeated in ongoing or planned clinical trials or may not support regulatory approval or renewal of authorization; the risk that unanticipated expenses may decrease our estimated cash balances and forecasts and increase our estimated capital requirements; the risk that we may not be able to recognize revenue for our products; the risk that Proleukin revenues, and other factors such as the number of ATCs, may not serve as a leading indicator for Amtagvi revenues; the risks regarding our anticipated operating and financial performance, including our financial guidance and projections; the effects of global and domestic geopolitical factors or public health events; and other factors, including general economic conditions and regulatory developments, not within our control. Any financial guidance provided in this press release assumes the following: no material change in our ability to manufacture our products; no material change in payor coverage; no material change in revenue recognition policies; no new business development transactions not completed as of the period covered by this press release; and no material fluctuation in exchange rates.
IOVANCE BIOTHERAPEUTICS, INC.Selected Condensed Consolidated Balance Sheets(in thousands)
December 31, 2025 December 31, 2024
Cash, cash equivalents, and investments $ 296,980 $ 323,781
Restricted cash $ 5,980 $ 6,359
Total assets $ 913,170 $ 910,426
Stockholders' equity $ 698,583 $ 710,405
Condensed Consolidated Statements of Operations
(in thousands, except per share information)
For the Three Months EndedDecember 31, For the Twelve Months EndedDecember 31,
2025 2024 2025 2024
(unaudited) (unaudited)
Revenue
Product revenue, net $ 86,771 $ 73,694 $ 263,502 $ 164,070
Total revenue 86,711 73,694 263,502 164,070
Costs and expenses*
Cost of sales** $ 43,112 $ 37,789 $ 173,184 $ 93,248
Research and development** 71,202 71,007 300,270 276,228
Selling, general and administrative** 36,400 42,321 152,322 152,269
Depreciation and amortization 9,517 9,153 35,939 37,603
Restructuring charges 5,143
Total costs and expenses 160,231 160,270 666,858 559,348
Loss from operations (73,460 ) (86,576 ) (403,356 ) (395,278 )
Other income
Interest and other income, net 1,740 9,575 10,307 20,273
Net Loss before income taxes (71,720 ) (77,001 ) (393,049 ) (375,005 )
Income tax (expense) benefit (184 ) (1,558 ) 2,071 2,828
Net Loss $ (71,904 ) $ (78,559 ) $ (390,978 ) $ (372,177 )
Net Loss Per Share of Common Stock, Basic and Diluted $ (0.18 ) $ (0.26 ) $ (1.09 ) $ (1.28 )
Weighted-Average Shares of Common Stock Outstanding, Basic and Diluted 406,966 304,890 357,345 289,877
*Non-cash stock-based compensationincluded in cost of sales and operatingexpenses:
Cost of sales $ 1,309 $ 3,192 $ 7,286 $ 8,554
Research and development 5,672 13,445 26,959 49,270
Selling, general and administrative 4,836 14,336 27,330 51,799
Total stock-based compensation included in costs and expenses $ 11,817 $ 30,973 $ 61,575 $ 109,623
** Excludes depreciation and amortization

Frequently Asked Questions

What revenue growth did Iovance achieve in Q4 2025?

Iovance achieved approximately 30% revenue growth in Q4 2025.

What is the gross margin reported by Iovance?

Iovance reported a gross margin of 50%.

What designation did Lifileucel receive from the FDA?

Lifileucel received FDA Fast Track designation for advanced non-small cell lung cancer.

What was Iovance's total revenue for FY25?

Iovance achieved a total revenue of $264 million for FY25.

What are Iovance's future plans for their pipeline?

Iovance anticipates new data across several pipeline programs throughout 2026.

Last updated: Feb 24, 2026