ImmunityBio, Inc.
For the period ended Sep 30, 2025. Filed Nov 5, 2025.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2025 · Filed Nov 5, 2025
IBRX$7.11-17.7%Stored close · as of Nov 9, 2026
Extracted filing text, with the paragraph anchors used by the comparison.
See the whole filing, with its images and exhibitsContents
Table of Contents
| Page | ||
|---|---|---|
| PART I—FINANCIAL INFORMATION | ||
| Item 1. · Financial Statements | ||
| Condensed Consolidated Balance Sheets – As of September 30, 2025 and December 31, 2024 | 1 | |
| Condensed Consolidated Statements of Operations – For the three and nine months ended September 30, 2025 and 2024 | 3 | |
| Condensed Consolidated Statements of Comprehensive Loss – For the three and nine months ended September 30, 2025 and 2024 | 4 | |
| Condensed Consolidated Statements of Stockholders’ Deficit – For the three and nine months ended September 30, 2025 and 2024 | 5 | |
| Condensed Consolidated Statements of Cash Flows – For the nine months ended September 30, 2025 and 2024 | 9 | |
| Notes to Unaudited Condensed Consolidated Financial Statements | 12 | |
| Item 2. | Management’s Discussion and Analysis of Financial Condition and Results of Operations | 64 |
| Item 3. | Quantitative and Qualitative Disclosures about Market Risk | 91 |
| Item 4. | Controls and Procedures | 91 |
| PART II—OTHER INFORMATION | ||
| Item 1. | Legal Proceedings | 92 |
| Item 1A. | Risk Factors | 95 |
| Item 2. | Unregistered Sales of Equity Securities and Use of Proceeds | 169 |
| Item 3. | Defaults Upon Senior Securities | 169 |
| Item 4. | Mine Safety Disclosures | 169 |
| Item 5. | Other Information | 169 |
| Item 6. | Exhibits | 170 |
| Signatures | 171 | |
i
Defined Terms
Unless expressly indicated or the context required otherwise, the terms “ImmunityBio,” “the company,” “we,” “us,” and “our” in this Quarterly Report refer to ImmunityBio, Inc., a Delaware corporation, and, where appropriate, its subsidiaries. We have also used several other terms in this Quarterly Report, the unaudited condensed consolidated financial statements and accompanying notes included herein, most of which are defined below:
| Term | Definition |
|---|---|
| 2015 Plan | ImmunityBio, Inc. 2015 Equity Incentive Plan |
| 2025 Plan | ImmunityBio, Inc. 2025 Equity Incentive Plan |
| 3M IPC | 3M Innovative Properties Company |
| 3PL Agent | logistics agent |
| AAHI | Access to Advanced Health Institute |
| ACA | Affordable Care Act |
| AI | artificial intelligence |
| Altor | Altor BioScience, LLC |
| America Invents Act | Leahy-Smith America Invents Act |
| Amyris | Amyris, Inc. |
| 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 |
| ASC | Accounting Standards Codification |
| ASU | Accounting Standards Update |
| Athenex | Athenex, Inc. |
| ATM | “at-the-market” sales agreement |
| BCG | Bacillus Calmette-Guérin (TICE® BCG approved for use in the U.S.) |
| Beike | Shenzhen Beike Biotechnology Co. 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 |
| CancerBioShield™ | a 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. At its core is ANKTIVA, which activates and proliferates NK cells and T cells, restoring lymphocyte levels critical for immunosurveillance, immunogenic cell death, and long-term tumor control. |
| CAR | chimeric antigen receptor |
| CCPA | California Consumer Privacy Act of 2018 |
| CEO | chief executive officer |
| CFO | chief financial officer |
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| Term | Definition |
|---|---|
| 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 |
| 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 |
| CRL | complete response letter |
| CRO | contract research organization |
| CVR | contingent value right |
| DGCL | Delaware General Corporation Law |
| 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 |
| EMA | European Medicines Agency |
| 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 |
| FDA | U.S. Food and Drug Administration (or the Agency) |
| FIFO | First In First Out inventory method |
| FSMC | Fort Schuyler Management Corporation, a not-for-profit corporation affiliated with the State of New York |
| 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 |
| 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. |
iii
| Term | Definition |
|---|---|
| HCW | HCW Biologics, Inc. |
| HHS | U.S. Department of Health and Human Services |
| HIPAA | Health Insurance Portability and Accountability Act of 1996 |
| HIV | human immunodeficiency virus |
| 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 |
| iPSP | initial Pediatric Study Plan |
| IRA | Inflation Reduction Act of 2022 |
| J-code | a part of the HCPCS used to designate non-oral medications and other medical devices |
| M-ceNK | memory-like cytokine-enhanced NK |
| MAA | Marketing Authorization Application |
| mAbs | monoclonal antibodies |
| MHC | major histocompatability complex |
| MHRA | UK Medicines and Healthcare products Regulatory Agency |
| 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 |
| NantWorks | NantWorks, LLC, a related-party |
| NCCN | National Comprehensive Cancer Network |
| NCSC | NantCancerStemCell, LLC |
| NDA | New Drug Application |
| NHL | non-Hodgkin lymphoma |
| NK | natural killer |
| NMIBC | non-muscle invasive bladder cancer |
| NOL | net operating loss |
| NSCLC | non-small cell lung cancer |
| 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 |
| PD-L1 | programmed death receptor ligand |
| PHI | Protected Health Information |
| PMA | premarket approval |
iv
| Term | Definition |
|---|---|
| QSR | Quality System Regulation |
| Quarterly Report | Quarterly Report on Form 10-Q for the three and nine months ended September 30, 2025 |
| QUILT | QUantum Integrative Lifelong Trial |
| 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 |
| Sorrento | Sorrento Therapeutics, Inc. |
| SPOA | Stock Purchase and Option Agreement |
| 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 (CAR-NK) |
| TLR | toll-like receptor |
| TriAd | Triple Antigen (CEA, MUC1, Brachyury) |
| TURBT | transurethral resection of bladder tumor |
| UK | United Kingdom |
| UK GDPR | UK Data Protection Act of 2018 |
| U.S. | United States of America |
v
| Term | Definition |
|---|---|
| U.S. GAAP | accounting principles generally accepted in the U.S. |
| USMCA | U.S.-Mexico-Canada trade 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.