ImmunityBio Inc
For the period ended Dec 31, 2024. Filed Mar 3, 2025.
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FY2024 · Filed Mar 3, 2025
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Table of Contents
IMMUNITYBIO, INC.
ANNUAL REPORT ON FORM 10-K
FOR THE YEAR ENDED DECEMBER 31, 2024
TABLE OF CONTENTS
| Page | ||
|---|---|---|
| PART I | ||
| Item 1. | Business. | 1 |
| Item 1A. | Risk Factors. | 54 |
| Item 1B. | Unresolved Staff Comments. | 122 |
| Item 1C. | Cybersecurity. | 123 |
| Item 2. | Properties. | 125 |
| Item 3. | Legal Proceedings. | 126 |
| Item 4. | Mine Safety Disclosures. | 128 |
| PART II | ||
| Item 5. | Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities. | 129 |
| Item 6. | Reserved. | 130 |
| Item 7. | Management’s Discussion and Analysis of Financial Condition and Results of Operations. | 131 |
| Item 7A. | Quantitative and Qualitative Disclosures About Market Risk. | 154 |
| Item 8. | Financial Statements and Supplementary Data. | 156 |
| Item 9. | Changes in and Disagreements with Accountants on Accounting and Financial Disclosure. | 230 |
| Item 9A. | Controls and Procedures. | 230 |
| Item 9B. | Other Information. | 233 |
| Item 9C. | Disclosure Regarding Foreign Jurisdictions that Prevent Inspections. | 233 |
| PART III | ||
| Item 10. | Directors, Executive Officers and Corporate Governance. | 234 |
| Item 11. | Executive Compensation. | 234 |
| Item 12. | Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters. | 234 |
| Item 13. | Certain Relationships and Related Transactions, and Director Independence. | 234 |
| Item 14. | Principal Accountant Fees and Services. | 234 |
| PART IV | ||
| Item 15. | Exhibits and Financial Statement Schedules. | 235 |
| Signatures | 241 | |
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 |
|---|---|
| 2014 Plan | NantKwest, Inc. 2014 Equity Incentive Plan |
| 2015 Plan | ImmunityBio, Inc. 2015 Equity Incentive Plan |
| 2015 Share Repurchase Program | Board of Directors-approved share repurchase program |
| 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 |
| ALC | absolute lymphocyte count |
| Altor | Altor BioScience, LLC |
| America Invents Act | Leahy-Smith America Invents Act |
| Amyris | Amyris, Inc. |
| ANC | absolute neutrophil count |
| aNK | activated NK cells |
| ANKTIVA® | Proprietary name for N-803 (formerly ALT-803), our novel IL-15 receptor superagonist complex (nogapendekin alfa inbakicept-pmln) currently approved for use in the United States with BCG for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ with or without papillary tumors, and currently in clinical development for other indications. |
| Approved product | ANKTIVA |
| ART | anti-retroviral therapy |
| ASC | Accounting Standards Codification |
| 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 |
| BCG | Bacillus Calmette-Guérin (TICE® BCG approved for use in the U.S.) |
| Beike | Shenzhen Beike Biotechnology Co. Ltd. |
| BLA | Biologics License Application |
| bNAbs | broadly-neutralizing antibodies |
| BPCIA | Biologics Price Competition and Innovation Act of 2009 |
| Brink | Brink Biologics, Inc. |
| Cambridge | Cambridge Equities, LP |
| CAR | chimeric antigen receptor |
| CCPA | California Consumer Privacy Act of 2018 |
| CEO | chief executive officer |
i
| Term | Definition |
|---|---|
| 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 |
| 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 |
| CMC | Chemistry, Manufacturing and Controls |
| 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 |
| CR | complete response |
| CRADA | Cooperative Research and Development Agreement |
| CRL | complete response letter |
| CRO | contract research organization |
| CVR | contingent value right |
| DAMPs | damage-associated molecular patterns |
| DGCL | Delaware General Corporation Law |
| DOD | U.S. Department of Defense |
| 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 |
| 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 |
| FDASIA | Food and Drug Administration Safety and Innovation Act of 2012 |
| FIFO | First In First Out inventory method |
ii
| Term | Definition |
|---|---|
| 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 multiforme |
| GCP | Good Clinical Practice |
| GDPR | General Data Protection Regulation |
| GlobeImmune | GlobeImmune, Inc. |
| GLP | Good Laboratory Practice |
| 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 |
| 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 |
| 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 |
| 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 |
| LDMC | low-dose metronomic chemotherapy |
| LMIC | low- and middle-income countries |
| M-ceNK | memory-like cytokine-enhanced NK |
| MAA | Marketing Authorization Application |
| mAbs | monoclonal antibodies |
| MCC | Merkel cell carcinoma |
| mCRCP | metastatic castration-resistant prostate cancer |
| MDSC | myeloid-derived suppressor cells |
| MHC | major histocompatability complex |
| MHC-I | major histocompatability complex class I |
| MHC-II | major histocompatability complex class II |
iii
| Term | Definition |
|---|---|
| MHRA | Medicines and Healthcare products Regulatory Agency |
| MTD | maximum tolerated dose |
| NAI | nogapendekin alfa inbakicept-pmln |
| NantBio | NantBio, Inc. |
| 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 |
| NantPharma | NantPharma, LLC |
| NantWorks | NantWorks, LLC, a related party |
| NC 2015 Plan | NantCell, Inc. 2015 Stock Incentive Plan |
| NCI | National Cancer Institute |
| NCV | Nant Cancer Vaccine |
| NEO | named executive officer |
| 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) |
| OFAC | U.S. Treasury Department’s Office of Foreign Assets Control |
| PCAOB | Public Company Accounting Oversight Board (United States) |
| PD-1 | programmed death receptor 1 |
| PD-L1 | programmed death receptor ligand |
| PDMA | U.S. Prescription Drug Marketing Act |
| PHI | Protected Health Information |
| PHSA | Public Health Service Act |
| PMA | premarket approval |
| PREA | Pediatric Research Equity Act |
| PRO | Patient Recorded Outcomes |
| Proxy Statement | Schedule 14A in connection with our 2025 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 |
| RAC | Recombinant DNA Advisory Committee |
iv
| Term | Definition |
|---|---|
| rBCG | recombinant BCG |
| RDO | registered direct offering |
| RBCs | red blood cells |
| RECIST | response evaluation criteria in solid tumors |
| REMS | Risk Evaluation and Mitigation Strategy |
| RIPA | Revenue Interest Purchase Agreement |
| Riptide | Riptide Bioscience, Inc. |
| RMAT | regenerative medicine advanced therapy |
| RSU | restricted stock unit |
| 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 |
| Sorrento | Sorrento Therapeutics, Inc. |
| SPOA | Stock Purchase and Option Agreement |
| SQ | subcutaneous |
| 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 |
| TF Platform | tissue factor-based fusion discovery platform |
| TGF-β | transforming growth factor beta |
| t-haNK | targeted high-affinity NK |
| TLR | toll-like receptor |
| TME | tumor microenvironment |
| TNBC | triple-negative breast cancer |
| T-reg | regulatory T cells |
| TriAd | Triple Antigen (CEA, MUC1, Brachyury) |
| UK | United Kingdom |
| UK GDPR | UK Data Protection Act of 2018 |
| U.S. GAAP | accounting principles generally accepted in the United States of America |
| USPTO | U.S. Patent and Trademark Office |
| VA | Veterans Affairs |
| 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 |
v
PART I
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.