ImmunityBio, Inc.
For the period ended Dec 31, 2025. Filed Feb 23, 2026.
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FY2025 · Filed Feb 23, 2026
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Table of Contents
IMMUNITYBIO, INC.
ANNUAL REPORT ON FORM 10-K
FOR THE YEAR ENDED DECEMBER 31, 2025
TABLE OF CONTENTS
| Page | ||
|---|---|---|
| PART I | ||
| Item 1. | Business. | 1 |
| Item 1A. | Risk Factors. | 55 |
| Item 1B. | Unresolved Staff Comments. | 128 |
| Item 1C. | Cybersecurity. | 129 |
| Item 2. | Properties. | 131 |
| Item 3. | Legal Proceedings. | 131 |
| Item 4. | Mine Safety Disclosures. | 134 |
| PART II | ||
| Item 5. | Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities. | 135 |
| Item 6. | Reserved. | 136 |
| Item 7. | Management’s Discussion and Analysis of Financial Condition and Results of Operations. | 137 |
| Item 7A. | Quantitative and Qualitative Disclosures About Market Risk. | 158 |
| Item 8. | Financial Statements and Supplementary Data. | 160 |
| Item 9. | Changes in and Disagreements with Accountants on Accounting and Financial Disclosure. | 238 |
| Item 9A. | Controls and Procedures. | 238 |
| Item 9B. | Other Information. | 241 |
| Item 9C. | Disclosure Regarding Foreign Jurisdictions that Prevent Inspections. | 241 |
| PART III | ||
| Item 10. | Directors, Executive Officers and Corporate Governance. | 242 |
| Item 11. | Executive Compensation. | 242 |
| Item 12. | Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters. | 242 |
| Item 13. | Certain Relationships and Related Transactions, and Director Independence. | 242 |
| Item 14. | Principal Accountant Fees and Services. | 242 |
| PART IV | ||
| Item 15. | Exhibits and Financial Statement Schedules. | 243 |
| Signatures | 250 | |
Defined Terms
Unless expressly indicated or the context required otherwise, the terms “ImmunityBio,” “the company,” “we,” “us,” and “our” in this Annual Report refer to ImmunityBio, Inc., a Delaware corporation, and, where appropriate, its subsidiaries. We have also used several other terms in this Annual Report, the consolidated financial statements and accompanying notes included herein, most of which are defined below:
| Term | Definition |
|---|---|
| 2015 Plan | ImmunityBio, Inc. 2015 Equity Incentive Plan |
| 2015 Share Repurchase Program | Board of Directors-approved share repurchase program |
| 2025 Plan | ImmunityBio, Inc. 2025 Equity Incentive Plan |
| 3M IPC | 3M Innovative Properties Company |
| 3PL Agent | logistics agent |
| 401(k) Plan | 401(k) retirement and savings plan |
| AAHI | Access to Advanced Health Institute |
| ACA | Affordable Care Act |
| ADCC | antibody-dependent cellular cytotoxicity |
| AI | artificial intelligence |
| AKS | Anti-Kickback Statute |
| ALC | absolute lymphocyte count |
| Altor | Altor BioScience, LLC |
| America Invents Act | Leahy-Smith America Invents Act |
| Amyris | Amyris, Inc. |
| ANC | absolute neutrophil count |
| ANKTIVA® | Proprietary name for N-803 (formerly ALT-803), our novel IL-15 receptor superagonist complex (nogapendekin alfa inbakicept) |
| Approved product | ANKTIVA |
| ART | anti-retroviral therapy |
| ASC | Accounting Standards Codification |
| ASC 470-50 | FASB ASC Topic 470-50, Debt—Modifications and Extinguishments |
| ASC 480 | FASB ASC Topic 480, Distinguishing Liabilities from Equity |
| ASC 606 | FASB ASC Topic 606, Revenue from Contracts with Customers |
| ASC 718 | FASB ASC Topic 718, Compensation—Stock Compensation |
| ASC 808 | FASB ASC Topic 808, Collaborative Arrangements |
| ASC 815 | FASB ASC Topic 815, Derivatives and Hedging |
| ASC 825 | FASB ASC Topic 825, Financial Instruments |
| ASCO | American Society of Clinical Oncology |
| ASU | Accounting Standards Update |
| Athenex | Athenex, Inc. |
| ATM | “at-the-market” sales agreement |
| ATRA | American Taxpayer Relief Act of 2012 |
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| Term | Definition |
|---|---|
| BCG | Bacillus Calmette-Guérin (TICE® BCG approved for use in the U.S.) |
| Beike | Shenzhen Beike Biotechnology Co. Ltd. |
| BeOne | BeOne Medicines Ltd. (formerly BeiGene, Ltd.) |
| BIS | U.S. Department of Commerce, Bureau of Industry and Security |
| BLA | Biologics License Application |
| BPCIA | Biologics Price Competition and Innovation Act of 2009 |
| Brink | Brink Biologics, Inc. |
| Cambridge | Cambridge Equities, LP |
| Cancer BioShield™ platform | our first-in-class immunotherapy strategy designed to restore immune competence by reversing lymphopenia—the loss of functional immune cells caused by cancer itself and by conventional treatments such as chemotherapy, radiation and immunotherapy. |
| CAP | community-acquired pneumonia |
| CAR | chimeric antigen receptor |
| CCPA | California Consumer Privacy Act of 2018 |
| CEO | chief executive officer |
| CFO | chief financial officer |
| cGMP | current Good Manufacturing Practice |
| China | when used in connection with the RIPA, People’s Republic of China, Hong Kong and any territories controlled by the People’s Republic of China |
| CHMP | Committee for Medicinal Products for Human Use |
| CI | confidence interval |
| CIO | chief information officer |
| CIS | carcinoma in situ |
| Clinic | Immuno-Oncology Clinic, Inc. |
| Closing Date | when used in connection with the RIPA, December 29, 2023 |
| CMO | contract manufacturing organization |
| CMS | Centers for Medicare & Medicaid Services |
| Code | Internal Revenue Code of 1986, as amended |
| CODM | chief operating decision maker |
| CPI | checkpoint inhibitor |
| CPRA | California Privacy Rights Act |
| CRADA | Cooperative Research and Development Agreement |
| CRL | complete response letter |
| CRO | contract research organization |
| CVR | contingent value right |
| DGCL | Delaware General Corporation Law |
| DSCSA | Drug Supply Chain Security Act |
| Duley Road | Duley Road, LLC |
| Dunkirk Facility | a leasehold interest in a cGMP ISO Class 5 pharmaceutical manufacturing space in western New York |
| EAP | Expanded Access Program |
| EEA | European Economic Area |
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| Term | Definition |
|---|---|
| EGFR | epidermal growth factor receptor |
| EMA | European Medicines Agency |
| ERM | Enterprise Risk Management |
| EU | European Union |
| Exchange Act | Securities Exchange Act of 1934, as amended |
| Exyte | Exyte U.S., Inc. |
| FASB | Financial Accounting Standards Board |
| FCA | False Claims Act |
| FCPA | U.S. Foreign Corrupt Practices Act |
| FD&C Act | Federal Food, Drug, and Cosmetic Act |
| FDA | U.S. Food and Drug Administration (or the Agency) |
| FDASIA | Food and Drug Administration Safety and Innovation Act of 2012 |
| FIFO | First In First Out inventory method |
| FSMC | Fort Schuyler Management Corporation, a not-for-profit corporation affiliated with the State of New York |
| FTC | Federal Trade Commission |
| FTO | freedom-to-operate |
| FVO | fair value option |
| GBM | glioblastoma |
| GCP | Good Clinical Practice |
| GDPR | General Data Protection Regulation |
| GlobeImmune | GlobeImmune, Inc. |
| GMP | Good Manufacturing Practice |
| hAd5 | human adenovirus serotype 5 |
| haNK | high-affinity NK |
| Hatch-Waxman Act | Drug Price Competition and Patent Term Restoration Act of 1984 |
| HCC | hepatocellular carcinoma |
| HCPCS | Healthcare Common Procedure Coding System, a set of standardized codes used in the U.S. to describe specific medical procedures, services, equipment, medications, and supplies. |
| HCW | HCW Biologics, Inc. |
| HHS | U.S. Department of Health and Human Services |
| HIPAA | Health Insurance Portability and Accountability Act of 1996 |
| HITECH | Health Information Technology for Economic and Clinical Health Act |
| HIV | human immunodeficiency virus |
| HPV | human papillomavirus |
| IDE | Investigational Device Exemption |
| IgDraSol | IgDraSol, Inc., a subsidiary of the company |
| IL-15 | novel interleukin 15 |
| IND | investigational new drug |
| Infinity | Infinity SA LLC, as purchaser agent for affiliates of Oberland |
| iNHL | indolent non-Hodgkin lymphoma |
| IPR&D | In-process research and development |
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| Term | Definition |
|---|---|
| iPSP | initial Pediatric Study Plan |
| IRA | Inflation Reduction Act of 2022 |
| IRB | Institutional review boards |
| IRS | Internal Revenue Service |
| J-code | a part of the HCPCS used to designate non-oral medications and other medical devices |
| LMIC | low- and middle-income countries |
| M-ceNK | memory-like cytokine-enhanced NK |
| MAA | Marketing Authorization Application |
| mAbs | monoclonal antibodies |
| mCRCP | metastatic castration-resistant prostate cancer |
| MDSC | myeloid-derived suppressor cells |
| MENA | Middle East and North Africa |
| MFN | Most Favored Nation drug |
| MHC | major histocompatability complex |
| MHC-I | major histocompatability complex class I |
| MHC-II | major histocompatability complex class II |
| MHRA | UK Medicines and Healthcare products Regulatory Agency |
| Nant Capital | Nant Capital, LLC |
| NantCell | NantCell, Inc., a subsidiary of the company |
| NANTibody | Immunotherapy NANTibody, LLC, a subsidiary of the company |
| NantKwest | NantKwest, Inc. |
| NantMobile | NantMobile, LLC |
| NantWorks | NantWorks, LLC, a related party |
| NCCN | National Comprehensive Cancer Network |
| NC 2015 Plan | NantCell, Inc. 2015 Stock Incentive Plan |
| NCI | National Cancer Institute |
| NCSC | NantCancerStemCell, LLC |
| NDA | New Drug Application |
| NHL | non-Hodgkin lymphoma |
| NIAID | National Institute of Allergy and Infectious Diseases |
| NIH | National Institutes of Health |
| NIH Guidelines | NIH Guidelines for Research Involving Recombinant DNA Molecules |
| NK | natural killer |
| NMIBC | non-muscle invasive bladder cancer |
| NOL | net operating loss |
| NSCLC | non-small cell lung cancer |
| OBA | NIH Office of Biotechnology Activities |
| Oberland | Oberland Capital Management LLC and its affiliates (including Purchasers as defined in the RIPA) |
| OBBB Act | One Big Beautiful Bill Act |
| OECD | Organisation for Economic Co-operation and Development |
| PCAOB | Public Company Accounting Oversight Board (United States) |
| PD-1 | programmed death receptor 1 |
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| Term | Definition |
|---|---|
| PD-L1 | programmed death receptor ligand |
| PDMA | U.S. Prescription Drug Marketing Act |
| PHI | Protected Health Information |
| PHSA | Public Health Service Act |
| PMA | pre-market approval |
| PREA | Pediatric Research Equity Act |
| Proxy Statement | Schedule 14A in connection with our 2026 Annual Meeting of Stockholders |
| PSA | prostate-specific antigen |
| QMSR | Quality Management System Regulation |
| QSR | Quality System Regulation |
| QUILT | QUantum Integrative Lifelong Trial |
| R&E | research and experimental expenditures |
| r/r | relapsed/ refractory |
| RAC | Recombinant DNA Advisory Committee |
| rBCG | recombinant BCG |
| RCT | randomized controlled trial |
| RDO | registered direct offering |
| REMS | Risk Evaluation and Mitigation Strategy |
| Revenue Interest Payments | with respect to each calendar quarter during the revenue interest period, the amount payable by the company to Oberland equal to the net sales in the covered territory for such calendar quarter multiplied by the applicable percentage, subject to the terms and conditions set forth in the RIPA; provided that, with respect to any calendar quarter, that the total revenue interest payments will not exceed the cap amount applicable at such time |
| Revenue Interests | all of the company’s right, title and interest in and to that portion of the accounts and payment intangibles arising out of sales and licenses of the included products and the product assets equal to the Revenue Interest Payments for each calendar quarter (or portion thereof) during the revenue interest period |
| RIPA | Revenue Interest Purchase Agreement |
| Riptide | Riptide Bioscience, Inc. |
| RMAT | regenerative medicine advanced therapy |
| RSU | restricted stock unit |
| RTF | Refuse to File |
| SAFE | Simple Agreement for Future Equity |
| Sarbanes-Oxley | Sarbanes-Oxley Act of 2002 |
| SARS-CoV-2 | novel strain of the coronavirus (COVID-19) |
| sBLA | supplemental Biologics License Application |
| SEC | U.S. Securities and Exchange Commission |
| Section 404 | Section 404 of the Sarbanes-Oxley Act of 2002 |
| Securities Act | Securities Act of 1933, as amended |
| Serum Institute | Serum Institute of India Private Limited |
| SFDA | Saudi Food and Drug Authority |
| Sorrento | Sorrento Therapeutics, Inc. |
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| Term | Definition |
|---|---|
| SPOA | Stock Purchase and Option Agreement |
| SRLY | separate return limitation year |
| TAA | tumor-associated antigen |
| TCJA | Tax Cuts and Jobs Act of 2017 |
| Term SOFR | Term Secured Overnight Financing Rate |
| Test Date | when used in connection with the RIPA, December 31, 2029 |
| TGF-β | transforming growth factor beta |
| t-haNK | targeted high-affinity NK (CAR-NK) |
| TLR | toll-like receptor |
| TNBC | triple-negative breast cancer |
| Tregs | regulatory T cells |
| TriAd | Triple Antigen (CEA, MUC1, Brachyury) |
| TTFields | tumor treating fields |
| UK | United Kingdom |
| UK GDPR | UK Data Protection Act of 2018 |
| U.S. | United States of America |
| U.S. GAAP | accounting principles generally accepted in the U.S. |
| USMCA | United States-Mexico-Canada Agreement |
| USPTO | U.S. Patent and Trademark Office |
| VBC Holdings | VBC Holdings, LLC, a subsidiary of the company |
| VIE | variable interest entity |
| VivaBioCell | VivaBioCell, S.p.A., a wholly-owned subsidiary of VBC Holdings |
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The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.