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| PART I | 4 | |
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| Item 1. | Business | 4 |
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| Item 1A. | Risk Factors | 29 |
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| Item 1B. | Unresolved Staff Comments | 85 |
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| Item 1C. | Cybersecurity | 85 |
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| Item 2. | Properties | 86 |
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| Item 3. | Legal Proceedings | 87 |
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| Item 4. | Mine Safety Disclosures | 87 |
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| PART II | 87 | |
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| Item 5. | Market for Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities | 87 |
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| Item 6. | [Reserved] | 89 |
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| Item 7. | Management’s Discussion and Analysis of Financial Condition and Results of Operations | 89 |
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| Item 7A. | Quantitative and Qualitative Disclosures About Market Risk | 106 |
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| Item 8. | Financial Statements and Supplementary Data | 106 |
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| Item 9. | Changes in and Disagreements with Accountants on Accounting and Financial Disclosure | 107 |
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| Item 9A. | Controls and Procedures | 107 |
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| Item 9B. | Other Information | 107 |
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| PART III | 108 | |
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| Item 10. | Directors, Executive Officers and Corporate Governance | 108 |
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| Item 11. | Executive Compensation | 108 |
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| Item 12. | Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters | 108 |
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| Item 13. | Certain Relationships and Related Transactions, and Director Independence | 108 |
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| Item 14. | Principal Accounting Fees and Services | 108 |
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| PART IV | 108 | |
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| Item 15. | Exhibits, Financial Statements Schedules | 108 |
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| Item 16. | 10-K Summary | 111 |
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| | Signatures | 112 |
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Forward-Looking Statements and Market Data
This Annual Report on Form 10-K contains forward-looking statements that are based on management’s beliefs and assumptions and on information currently available to management. All statements other than statements of historical facts contained in this report are forward-looking statements. In some cases, you can identify forward-looking statements by the following words: “may,” “will,” “might,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “aim,” “potential,” “continue,” “ongoing,” “goal,” “forecast,” “guidance,” “outlook,” or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words.
These statements involve risks, uncertainties, and other factors that may cause actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained in this report, we caution you that these statements are based on a combination of facts and factors currently known by us and our projections of the future, about which we cannot be certain. Forward-looking statements in this Annual Report on Form 10-K include, but are not limited to, statements about:
| ● | the success, cost, enrollment, design, and timing of our clinical trials; |
| ● | the success, cost, and timing of our product development activities; |
| ● | the ability of us or our third-party contract manufacturers to continue to manufacture tumor infiltrating lymphocytes, or TIL, in accordance with our selected process; |
| ● | our ability to design, construct, and staff our own manufacturing facility on a timely basis and within the estimated expenses; |
| ● | the success of competing therapies that are or may become available; |
| ● | regulatory developments in the United States of America, or U.S., and foreign countries; |
| ● | the timing of and our ability to obtain and maintain U.S. Food and Drug Administration, or the FDA, European Commission, or other regulatory authority approval of, or other action with respect to, our products and/or product candidates; |
| ● | our ability to attract and retain key scientific or management personnel; |
| ● | the timing, execution and expected benefits of our restructuring plan announced in August 2025; |
| ● | the accuracy of our estimates regarding expenses, future revenue, capital requirements, and needs for additional financing; |
| ● | our ability to obtain funding for our operations, including funding necessary to complete further development of our product candidates and commercialization of our products; |
| ● | our ability to successfully commercialize Amtagvi® (lifileucel) and Proleukin® (aldesleukin), and any other products and/or product candidates for which we obtain or have obtained FDA or other regulatory approvals, including by the European Commission in the European Union, or the EU; |
| ● | the ability and willingness of our third-party research institution collaborators to continue research and development activities relating to our product candidates; |
| ● | the potential of our other research and development and strategic collaborations; |
| ● | our expectations regarding our ability to obtain and maintain intellectual property protection for our manufacturing methods and products and/or product candidates; |
| ● | our plans to research, develop, and commercialize our products and/or product candidates; |
| ● | the size and growth potential of the markets for our products and/or product candidates, and our ability to serve those markets; |
| ● | our ability to contract with third-party suppliers and manufacturers and their ability to perform adequately; |
| ● | fluctuations in the trading price of our common stock; and |
| ● | our use of cash and other resources. |
Actual results may differ from those set forth in this Annual Report on Form 10-K due to the risks and uncertainties inherent in our business, including those provided in the foregoing list of forward-looking statements and also including, without limitation: the FDA may not agree with our interpretation of the results of our clinical trials; later developments with the FDA that may be inconsistent with already completed FDA meetings; the preliminary clinical results, including efficacy and safety results, from ongoing Phase 2 and Phase 3 clinical trials may not be reflected in the final analyses of these clinical trials including new cohorts within these clinical trials; the results obtained in our ongoing clinical trials, such as the studies and clinical trials referred to in this Annual Report on Form 10-K, may not be indicative of results obtained in future clinical trials or supportive of product approval; regulatory authorities may potentially delay the timing of FDA or other regulatory authority approval of, or other action with respect to, our product candidates, specifically, our description of FDA interactions are subject to the FDA’s interpretation, as well as the FDA’s authority to request new or additional information; we may not be able to obtain or maintain FDA or other regulatory authority approval of our product candidates; our ability to address FDA or other regulatory authority requirements relating to our clinical programs and registrational plans, such requirements including, but not limited to, clinical and safety requirements as well as manufacturing and control requirements; risks related to our accelerated FDA review designations; our ability to obtain and maintain intellectual property rights relating to our product pipeline; and the acceptance by the market of our product candidates and their potential reimbursement by payors, if approved.
We caution you that the risks, uncertainties, and other factors referenced above may not contain all the risks, uncertainties, and other factors that are important to you. In addition, we cannot guarantee future results, level of activity, performance, or achievements. Any forward-looking statement made by us in this Annual Report on Form 10-K speaks only as of the date of this Annual Report on Form 10-K or as of the date on which it is made. Except as required by law, we undertake no obligation to publicly update any forward-looking statements, whether because of new information, future events or otherwise, after the date of this Annual Report on Form 10-K.
Unless the context requires otherwise, in this report the terms “Iovance,” the “Company,” “we,” “us,” and “our” refer to Iovance Biotherapeutics, Inc.
