ImmunityBio Inc
For the period ended Dec 31, 2023. Filed Mar 19, 2024.
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A company's yearly report to the SEC, with audited financial statements. It is the fullest account a company gives of its business, its finances and the risks it sees.
FY2023 · Filed Mar 19, 2024
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Table of Contents
IMMUNITYBIO, INC.
ANNUAL REPORT ON FORM 10-K
FOR THE YEAR ENDED DECEMBER 31, 2023
TABLE OF CONTENTS
| Page | ||
|---|---|---|
| PART I | ||
| Item 1. | Business. | 1 |
| Item 1A. | Risk Factors. | 42 |
| Item 1B. | Unresolved Staff Comments. | 106 |
| Item 1C. | Cybersecurity. | 107 |
| Item 2. | Properties. | 109 |
| Item 3. | Legal Proceedings. | 109 |
| Item 4. | Mine Safety Disclosures. | 110 |
| PART II | ||
| Item 5. | Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities. | 111 |
| Item 6. | Reserved. | 112 |
| Item 7. | Management’s Discussion and Analysis of Financial Condition and Results of Operations. | 113 |
| Item 7A. | Quantitative and Qualitative Disclosures About Market Risk. | 135 |
| Item 8. | Financial Statements and Supplementary Data. | 137 |
| Item 9. | Changes in and Disagreements with Accountants on Accounting and Financial Disclosure. | 206 |
| Item 9A. | Controls and Procedures. | 206 |
| Item 9B. | Other Information. | 207 |
| Item 9C. | Disclosure Regarding Foreign Jurisdictions that Prevent Inspections. | 207 |
| PART III | ||
| Item 10. | Directors, Executive Officers and Corporate Governance. | 208 |
| Item 11. | Executive Compensation. | 208 |
| Item 12. | Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters. | 208 |
| Item 13. | Certain Relationships and Related Transactions, and Director Independence. | 208 |
| Item 14. | Principal Accountant Fees and Services. | 208 |
| PART IV | ||
| Item 15. | Exhibits and Financial Statement Schedules. | 209 |
| Signatures | 216 | |
Defined Terms
Unless expressly indicated or the context required otherwise, the terms “ImmunityBio,” “the company,” “the combined 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 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 |
| 401(k) Plan | 401(k) retirement and savings plan |
| AAHI | Access to Advanced Health Institute |
| ACA | Affordable Care Act |
| ADCC | antibody-dependent cellular cytotoxicity |
| Altor | Altor BioScience, LLC |
| America Invents Act | Leahy-Smith America Invents Act |
| AML | acute myeloid leukemia |
| Amyris | Amyris, Inc. |
| Anktiva® | Proposed proprietary name for N-803, our novel antibody-cytokine fusion protein (nogapendekin alfa inbakicept-pmln) in the non-muscle invasive bladder cancer indication. The FDA has not yet approved this proposed proprietary name for such use, and this proposed proprietary name will be approved at the time the BLA is approved, if at all. |
| 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 |
| BARDA | Biomedical Advanced Research and Development Authority |
| BCG | bacillus Calmette-Guérin |
| Beike | Shenzhen Beike Biotechnology Co. Ltd. |
| BICR | blinded independent central review |
| BLA | Biologics License Application |
| BPCIA | Biologics Price Competition and Innovation Act of 2009 |
| bNAbs | broadly-neutralizing antibodies |
| Brink | Brink Biologics, Inc. |
| Cambridge | Cambridge Equities, LP |
| 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 |
i
| Term | Definition |
|---|---|
| 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 |
| Company Common Stock | common stock, par value $0.0001 per share, of the company |
| CPRA | California Privacy Rights Act of 2020 |
| CR | complete response |
| CRADA | Cooperative Research and Development Agreement |
| CRL | complete response letter |
| CRO | contract research organization |
| CVR | contingent value right |
| Cynviloq™ | IG-101 (paclitaxel nanoparticle polymeric micelle) |
| 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 |
| EGFR | epidermal growth factor receptor |
| EMA | European Medicines Agency |
| ERM | Enterprise Risk Management |
| Etubics | Etubics Corporation |
| EU | European Union |
| EUA | emergency use authorization |
| Exchange Act | Securities Exchange Act of 1934, as amended |
| Exchange Ratio | a right to receive 0.8190 newly issued shares of Company Common Stock |
| 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 |
| 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 |
ii
| Term | Definition |
|---|---|
| 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 |
| Hatch-Waxman Act | Drug Price Competition and Patent Term Restoration Act of 1984 |
| 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 |
| ICB | immune checkpoint blockade |
| IDE | Investigational Device Exemption |
| IDRI | Infectious Disease Research Institute |
| 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 |
| IPR&D | In-process research and development |
| IRA | Inflation Reduction Act of 2022 |
| IRB | Institutional review boards |
| IRS | Internal Revenue Service |
| LadRx | LadRx Corporation |
| LMIC | low- and middle-income countries |
| Lung-MAP | Lung Cancer Master Protocol |
| M-ceNK | memory-like cytokine-enhanced NK cells |
| mAbs | monoclonal antibodies |
| MDSC | myeloid-derived suppressor cells |
| MHC | majors histocompatability |
| MNC | mononuclear cells |
| Nant Capital | Nant Capital, LLC |
| NantBio | NantBio, Inc. |
| 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 |
| NCSC | NantCancerStemCell, LLC |
| NCTN | National Clinical Trials Network |
iii
| Term | Definition |
|---|---|
| NDA | New Drug Application |
| NEO | named executive officer |
| NHP | non-human primate |
| NIAID | National Institute of Allergy and Infectious Diseases |
| NIDCD | National Institute on Deafness and Other Communication Disorders |
| NIH | National Institutes of Health |
| NIH Guidelines | NIH Guidelines for Research Involving Recombinant DNA Molecules |
| NK | natural killer |
| NLC | nanostructured lipid carrier |
| 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 |
| OSHA | Occupational Safety and Health Administration |
| OWS | Operation Warp Speed |
| PCAOB | Public Company Accounting Oversight Board (United States) |
| PDMA | U.S. Prescription Drug Marketing Act |
| PDUFA date | user fee goal date |
| PF | physical function |
| PHI | Protected Health Information |
| PHSA | Public Health Service Act |
| PIK | paid-in-kind |
| PMA | premarket approval |
| PREA | Pediatric Research Equity Act |
| PRO | Patient Recorded Outcomes |
| Proxy Statement | Schedule 14A in connection with our 2024 Annual Meeting of Stockholders |
| QMSR | Quality Management System Regulation |
| QSR | Quality System Regulation |
| R&D | research and development |
| R&E | research and experimental expenditures |
| RAC | Recombinant DNA Advisory Committee |
| RECIST | response evaluation criteria in solid tumors |
| REMS | Risk Evaluation and Mitigation Strategy |
| RIPA | Revenue Interest Purchase Agreement |
| Riptide | Riptide Bioscience, Inc. |
| RSU | restricted stock unit |
| Sarbanes-Oxley | Sarbanes-Oxley Act of 2002 |
| saRNA | self-amplifying RNA |
| SARS-CoV-2 | novel strain of the coronavirus (COVID-19) |
iv
| Term | Definition |
|---|---|
| SBRT | stereotactic body radiotherapy |
| 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 |
| SCLC | small cell lung cancer |
| Sorrento | Sorrento Therapeutics, Inc. |
| SPOA | Stock Purchase and Option Agreement |
| SRLY | separate return limitation year |
| SWOG | SWOG Cancer Research Network |
| 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 |
| TLR | toll-like receptor |
| Treg | Regulatory T cells |
| U.S. GAAP | accounting principles generally accepted in the United States of America |
| USPTO | U.S. Patent and Trademark Office |
| VBC Holdings | VBC Holdings, LLC, a subsidiary of the company |
| VIE | variable interest entity |
| Viracta | Viracta Therapeutics, Inc. |
| 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.