MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.
Forward-Looking Statements
The following discussion and analysis of our financial condition and results of operations should be read together with the description of our business and the condensed consolidated financial statements and related notes thereto Item 1. "Financial Statements" in this Quarterly Report. This Quarterly Report contains forward-looking statements within the meaning of Section 27A of the Securities Act and Section 21E of the Exchange Act that are based on our management's beliefs and assumptions and on information currently available to our management. Actual results could differ materially from those discussed in or implied by such forward-looking statements. Factors that could cause or contribute to these differences include those discussed below and elsewhere in this Quarterly Report, particularly in Part II, Item 1A. "Risk Factors." Except as required by law, we do not undertake any responsibility to update any of these factors or to announce publicly any revisions to any of the forward-looking statements contained in this or any document, whether as a result of new information, future events, or otherwise. Forward-looking statements include, but are not limited to:
•our ability to successfully commercialize ANKTIVA or any future approved products in the U.S. or internationally;
•our ability to obtain incremental approvals for ANKTIVA for new indications, including, without limitation, in BCG-unresponsive NMIBC papillary, from the FDA or clearances or approvals from international regulatory agencies for the treatment of patients with NMIBC or other indications;
•potential future uses and applications of ANKTIVA, including as a lymphopenia rescue agent, and use in cancer vaccines and across multiple tumor types;
•our ability to develop next-generation therapies and vaccines that complement, harness, and amplify the immune system to defeat cancers and infectious diseases;
•our ability to obtain additional financing to fund our operations and complete the commercialization of our approved product and the development and commercialization of our other product candidates;
•our ability to meet our payment obligations under the RIPA and to service the interest on our related-party promissory note and repay such note, to the extent required;
•our ability to comply with the terms, conditions, covenants, restrictions, and obligations set forth in the RIPA and related transaction documents;
•our expectations regarding the potential benefits of our strategy and technology;
•our ability to forecast operating results and make period-to-period comparisons predictive of future performance due to fluctuations in warrant and derivative values;
•our expectations regarding the operation and effectiveness of our product candidates and related benefits;
•our ability to utilize multiple modes to induce cell death;
•our beliefs regarding the benefits and perceived limitations of competing approaches, and the future of competing technologies and our industry;
•details regarding our strategic vision and planned product candidate pipeline;
•our beliefs regarding the success, cost and timing of our product candidate development activities and current and future clinical trials and studies, including study design and the enrollment of patients;
•the timing of the development and commercialization of our other product candidates;
•whether the NCCN will review and/or approve our submission for BCG-unresponsive NMIBC papillary on the anticipated timeline or at all;
ImmunityBio, Inc. and Subsidiaries
Management's Discussion and Analysis of Financial Condition and Results of Operations (Continued)
•our expectations regarding our ability to utilize the Phase 1/2 aNK and haNK®clinical trials data to support the development of our product candidates, including our taNK, t-haNK™, MSC, and M-ceNK™product candidates;
•our expectations regarding the development, clinical trials timeline, application, commercialization, marketing, prospects and use generally of our product candidates, including hAd5 constructs, and PD-L1 t-haNK and M-ceNK;
•the timing or likelihood of regulatory filings or other actions and related regulatory authority responses in the U.S. and jurisdictions outside of the U.S., including any planned meetings, IND, BLA, NDA or MAA or similar filings or pursuit of accelerated regulatory approval pathways or orphan drug status and Breakthrough Therapy, Fast Track or RMAT designations and any designation's eventual impact on BLA submission, filing or approval timing and or approval probability;
•our ability to successfully address the May 2025 RTF letter received from the FDA for the sBLA for the BCG-unresponsive NMIBC papillary indication and related FDA meeting stating that an RCT against chemotherapy is required, the approach to which we are continuing to evaluate;
•our ability to implement an integrated discovery ecosystem and the operation of that planned ecosystem, including being able to regularly add neoepitopes and subsequently formulate new product candidates;
•the ability and willingness of strategic collaborators to share our vision and effectively work with us to achieve our goals;
•the ability and willingness of various third parties to engage in research and development activities involving our product candidates, and our ability to leverage those activities;
•our ability to attract additional third-party collaborators;
•our expectations regarding the ease of administration associated with our product candidates;
•our expectations regarding patient compatibility associated with our product candidates;
•our beliefs regarding the potential markets for our product candidates and our ability to serve those markets;
•our expectations regarding the timing of enrollment and submission of our clinical trials, and protocols and timing of data read-outs related to such trials;
•our ability to produce a cytokine fusion protein, a DNA or recombinant protein vaccine, or a cell therapy;
•our beliefs regarding the potential manufacturing and distribution benefits associated with our product candidates, and our third-party CMOs' abilities to follow cGMP standards to scale up the production of our product candidates;
•our plans regarding our manufacturing facilities and our belief that our manufacturing is capable of being conducted in-house;
•our belief in the potential of our cytokine fusion proteins, DNA or recombinant protein vaccines, or cell therapies, and the fact that our business is based upon the success individually and collectively of these platforms;
•our belief regarding the magnitude or duration for additional clinical testing of our cytokine fusion proteins, DNA or recombinant protein vaccines, or cell therapies, along with other product candidate families;
•even if we successfully develop and commercialize specific product candidates, our ability to develop and commercialize our other product candidates either alone or in combination with other therapeutic agents;
•the ability to obtain and maintain regulatory approval of our approved product and to obtain and maintain regulatory approval of any of our other product candidates, and any related restrictions, limitations and/or warnings in the label of any approved product candidate;
ImmunityBio, Inc. and Subsidiaries
Management's Discussion and Analysis of Financial Condition and Results of Operations (Continued)
•the rate and degree of market acceptance of any approved products;
•our ability to attract and retain key personnel;
•the accuracy of our estimates regarding our future revenue, as well as our future operating expenses, capital requirements and needs for additional financing;
•our ability to obtain, maintain, protect, and enforce patent protection and other proprietary rights for our approved product, other product candidates, and other technologies in development;
•the terms and conditions of licenses granted to us and our ability to license additional intellectual property relating to our product, product candidates and technology;
•our expectations regarding the results of market access initiatives and coverage under medical reimbursement policies;
•shelf life of ANKTIVA drug substance and drug product and availability of product supply;
•our global expansion efforts;
•any government shutdown or budget disruption, which could adversely affect the U.S. and global economies, and materially and adversely affect our business and/or our future BLA submissions;
•the impact on us, if any, if the CVRs held by former Altor stockholders become due and payable in accordance with their terms; and
•regulatory developments in the U.S. and foreign countries.
Forward-looking statements include statements that are not historical facts and can be identified by terms such as "anticipates," "believes," "continues," "goal," "could," "estimates," "scheduled," "expects," "intends," "may," "plans," "potential," "predicts," "indicate," "projects," "seeks," "should," "will," "would," "strategy," and variations of such words or similar expressions. and the negatives of those terms. In addition, statements that "we believe" and similar statements reflect our beliefs and opinions on the relevant subject. Statements of past performance, efforts, or results of our preclinical and clinical trials, about which inferences or assumptions may be made, can also be forward-looking statements and are not indicative of future performance or results. These statements are based upon information available to us as of the date of this Quarterly Report, and although we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted a thorough inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain, and investors are cautioned not to unduly rely upon these statements.
Forward-looking statements involve known and unknown risks, uncertainties, and other factors that may cause our actual results, performance, or achievements to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. We discuss these risks in greater detail in Part II, Item 1A. "Risk Factors" of this Quarterly Report. Given these uncertainties, you should not place undue reliance on these forward-looking statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame. Also, forward-looking statements represent our management's beliefs and assumptions only as of the date of this Quarterly Report.
Except as required by law, we assume no obligation to update these forward-looking statements, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. You should read this Quarterly Report completely and with the understanding that our actual future results may be materially different from what we expect.
ImmunityBio, Inc. and Subsidiaries
Management's Discussion and Analysis of Financial Condition and Results of Operations (Continued)
ImmunityBio, ImmunityBio Care, ANKTIVA, ThAnktiva, haNK, taNK, ceNK, NK-92, Nant Cancer Vaccine, CancerBioShield, BioShield (and other BioShield-related trademarks), NANT 001, NANT XL, NANT 001 and Design, QUILT, Outsmart Your Disease, Smart Therapies for Difficult Diseases, NantKwest, VivaBioCell, and Infacell are trademarks or registered trademarks of ImmunityBio, Inc., its subsidiaries and affiliates.
ANKTIVA has been approved by the U.S. FDA and the MHRA for use with BCG for the treatment of adult patients with BCG-unresponsive NMIBC with CIS with or without papillary tumors. Other than as set forth in such specific approved label, our product candidates, including N-803, are investigational agents that are restricted by federal law to investigational use only, and safety and efficacy have not been established by any agency, including, without limitation, the FDA.
This Quarterly Report contains references to our products and trademarks and products and trademarks belonging to other entities. Solely for convenience, trademarks and trade names referred to in this Quarterly Report, including logos, artwork, and other visual displays, may appear without the ®or TMsymbols, but such references are not intended to indicate, in any way, that we will not assert, to the fullest extent under applicable law, our rights or the rights of the applicable licensor to these trademarks and trade names. We do not intend our use or display of other companies' products or trade names or trademarks to imply a relationship with, or endorsement or sponsorship of us, by any other companies.
In this Quarterly Report, the terms "ImmunityBio," "the company," "we," "us," and "our" refer to ImmunityBio, Inc. and its subsidiaries.
Our Business
ImmunityBio is a vertically-integrated commercial-stage biotechnology company developing next-generation therapies that bolster the natural immune system to defeat cancers and infectious diseases. The company's range of immunotherapy and cell therapy platforms, alone and together, act to drive and sustain an immune response with the goal of creating durable and safe protection against disease. Designated an FDA Breakthrough Therapy, ANKTIVA is the first FDA-approved immunotherapy for non-muscle invasive bladder cancer CIS that activates NK cells, T cells, and memory T cells for a long-duration response. The company is applying its science and platforms to treating cancers, including the development of potential cancer vaccines, as well as developing immunotherapies and cell therapies that we believe sharply reduce or eliminate the need for standard high-dose chemotherapy. These platforms and their associated product candidates are designed to be more effective, accessible, and easily administered than current standards of care in oncology and infectious diseases.
Our Approved Product - ANKTIVA
ANKTIVA is a first-in-class IL-15 receptor superagonist IgG1 fusion complex, consisting of an IL-15 mutant (IL-15N72D) fused with an IL-15 receptor alpha, which binds with high affinity to IL-15 receptors on NK, CD4+, and CD8+ T cells. This fusion complex of ANKTIVA mimics the natural biological properties of the membrane-bound IL-15 receptor alpha, delivering IL-15 by dendritic cells and drives the activation and proliferation of NK cells with the generation of memory killer T cells that have retained immune memory against these tumor clones. The proliferation of the trifecta of these immune killing cells and the activation of trained immune memory results in immunogenic cell death, inducing a state of equilibrium with durable complete responses. ANKTIVA has improved pharmacokinetic properties, longer persistence in lymphoid tissues, and enhanced anti-tumor activity compared to native, non-complexed IL-15 in-vivo.
ANKTIVA was approved by the FDA in 2024 for use in the U.S. with BCG for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer with CIS with or without papillary tumors. We began commercial distribution of our approved product in May 2024.
In July 2025, the MHRA granted marketing authorization in the UK for ANKTIVA in combination with BCG for the treatment of adult patients with BCG-unresponsive NMIBC with CIS with or without papillary tumors. This is the first marketing approval outside the U.S. for ANKTIVA.
ImmunityBio, Inc. and Subsidiaries
Management's Discussion and Analysis of Financial Condition and Results of Operations (Continued)
We believe there is potential for ANKTIVA to become a therapeutic foundation across all phases of treatment, including in adjunctive therapy, to amplify, reactivate or extend the efficacy of standard of care. ANKTIVA is being clinically evaluated in multiple oncology indications. We believe that other oncology indications with registration potential for ANKTIVA include other types of NMIBC (BCG-unresponsive papillary, for which we submitted an sBLA in March 2025 and received an RTF letter from the FDA in May 2025, which we are continuing to evaluate, BCG-naïve CIS and BCG-naïve papillary), lung, colorectal, prostate and ovarian cancers, and GBM and NHL.
Data from multiple clinical trials suggest ANKTIVA has potential to enhance the activity of therapeutic mAbs, including CPIs (e.g., pembrolizumab/Keytruda), across a wide range of tumor types, including lung cancer. Further, ANKTIVA has been observed to increase lymphocyte count in healthy adults, making it a potential therapy to rescue lymphopenia. We are also exploring or pursuing several other studies of ANKTIVA in combination with our other product candidates, including in prostate cancer (ANKTIVA in combination with hAd5 PSA), colon cancer (ANKTIVA in combination with hAd5 TriAd), GBM (ANKTIVA in combination with PD-L1 CAR-NK (PD-L1 t-haNK)), and NHL (ANKTIVA in combination with rituximab). We are also exploring ANKTIVA in infectious diseases, including HIV and Long COVID.
ImmunityBio, Inc. and Subsidiaries
Management's Discussion and Analysis of Financial Condition and Results of Operations (Continued)
2025 Platforms and Indications
Our proprietary platforms for the development of biologic products and product candidates include:
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Our Next-Generation Platforms
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i.
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Cytokine Fusion Proteins
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(a)ANKTIVA
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ii.
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DNA and Vaccine Vectors
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(a)hAd5 (PSA, Brachyury, CEA, MUC1, HPV [E6/E7], neoantigens, nucleocapsid)
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iii.
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Cell Therapies
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(a)CD19 CAR-NK (CD19 t-haNK)
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(b)PD-L1 CAR-NK (PD-L1 t-haNK)
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(c)M-ceNK (autologous, allogeneic)
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Indications (Current Prioritized Studies)
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i.
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BCG-Unresponsive NMIBC with CIS (approved)
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ii.
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BCG-Unresponsive NMIBC Papillary (sBLA submitted in March 2025 with an RTF letter received
in May 2025, which we are continuing to evaluate)
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iii.
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BCG-Naïve NMIBC with CIS
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iv.
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rBCG in NMIBC
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Non-Small Cell Lung Cancer
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Pancreatic Cancer
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Chemotherapy, Radiotherapy, and Immunotherapy-induced Lymphopenia
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viii.
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Lynch Syndrome
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Hematological Malignancies (Liquid Tumors)
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Colon Cancer
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Glioblastoma Multiforme
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xii.
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Non-Hodgkin Lymphoma
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xiii.
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Ovarian Cancer
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xiv.
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Prostate Cancer
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xv.
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HIV
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xvi.
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Universal Nucleocapsid Vaccine
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xvii.
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Long COVID
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ImmunityBio, Inc. and Subsidiaries
Management's Discussion and Analysis of Financial Condition and Results of Operations (Continued)
Our Pipeline
Our proprietary platforms for the development of biologic products and product candidates include: (i) cytokine fusion proteins, (ii) vaccine vectors, and (iii) cell therapies. As of September 2025, our platforms have generated nine first-in-human therapeutic agents (including one agent approved by the FDA and the MHRA in a specific indication) that are currently or planned to be studied in clinical trials in liquid and solid tumors. The indications in the table above are among the most frequent and lethal cancer types and where there are high failure rates for existing standards of care or no available effective treatment. We are constantly monitoring and prioritizing clinical development based upon the availability of our resources and the efficacy and market developments of our competitors' products and product candidates, among other factors.
Our platforms and their associated approved product and product candidates are designed to attack cancer and infectious pathogens by activating both the innate immune system, including NK cells, dendritic cells, and macrophages, as well as the adaptive immune system comprising B and T cells, in an orchestrated manner. The goal of this potentially best-in-class approach is to generate immunogenic cell death thereby eliminating rogue cells from the body whether they are cancerous or virally-infected. Our ultimate goal is to overcome the limitations of current treatments, such as CPIs, by turning immunologically cold, MHC-deficient tumors into hot tumors, and/or reducing the need for standard high-dose chemotherapy in cancer by employing a coordinated approach to establish "immunological memory" that confers long-term benefit for the patient.
ImmunityBio Platforms - The Development of a Universal Therapeutic CancerBioShield
Based on the vision of activating the patient's immune system, the company continues its efforts to demonstrate that a universal therapeutic CancerBioShield that leverages the power of its platforms - backbone ANKTIVA, off-the-shelf and autologous NK-cell-based therapies, adenovirus-vectored delivered vaccines, and other technologies - provide benefit and hope not only for patients with cancer but also for those with a high risk of developing cancer.
ImmunityBio, Inc. and Subsidiaries
Management's Discussion and Analysis of Financial Condition and Results of Operations (Continued)
Significant Developments
The following is a summary of selected significant developments affecting our business that occurred since the filing of our Quarterly Report dated June 30, 2025 with the SEC on August 5, 2025:
•Q3 2025 Revenue and Other Income Growth with Continued Strong Sales Momentum:$33.7 million of total revenue and other income, up from $26.4 million in Q2 2025.
•Product Revenue:Up 434% in Q3 2025 versus Q3 2024, with year-to-date sales of $74.7 million.
•ANKTIVA Unit Growth:467% unit sales volume growth in year-to-date 2025 compared to fiscal year 2024.
•Cash Position:$257.8 million in cash, cash equivalents, and marketable securities as of September 30, 2025, up from $153.7 million as of June 30, 2025.
•Glioblastoma:Early results from the first five recurrent glioblastoma patients treated with ANKTIVA plus the Optune Gio®device in combination with PD-L1 CAR-NK showed 100% disease control, including three responses (two near complete) and two cases of stable disease. Lymphocyte counts increased in all five patients. Based on these findings, ImmunityBio is initiating a randomized registration trial for second line GBM patients.
•Non-Small Cell Lung Cancer:ImmunityBio has initiated enrollment in ResQ201A, a global, randomized Phase 3 study evaluating ANKTIVA in combination with TEVIMBRA®(BeOne) and docetaxel versus docetaxel alone in patients with checkpoint inhibitor-resistant NSCLC.
•Non-Hodgkin Lymphoma: Early results from the company's QUILT.106 trial showed promising complete responses in the first two patients with late-stage Waldenstrom macroglobulinemia treated to date using its CD19 CAR-NK natural killer cell therapy.
•Papillary NMIBC:The company shared updated QUILT-3.032 trial data showing durable 36-month progression-free survival and bladder-sparing benefits of ANKTIVA plus BCG. We continue to evaluate our submission path in this indication and have a meeting scheduled with the FDA in December 2025 to discuss potential regulatory paths. In addition, ImmunityBio has applied to the NCCN to seek expansion of the BCG-unresponsive NMIBC guidelines to include papillary-only disease in addition to CIS with or without papillary tumors. The NCCN reviewed the submission at its August 2025 meeting, and the company is awaiting their decision.
•ANKTIVA Access Update:ANKTIVA selected as preferred drug of choice for NMIBC patients with CIS, with or without papillary tumors by a large medication contracting organization with ~80 million lives under management. The company remains committed to patients through the expansion of the rBCG EAP and its copay assistance program with as low as $25 copay payments for qualifying patients.
Operating Results
Until April 2024, we had no clinical products approved for commercial sale and thus had not generated any revenue from therapeutic and vaccine product candidates that are or were under development. Now that we have received FDA approval for ANKTIVA, we have begun to generate revenue, although we expect it to take some time to generate sufficient revenue from our approved product to offset our expenses, and we can provide no assurance when, or if, this will occur. We began commercial distribution of our approved product in May 2024; however, we can provide no assurance with respect to our future revenues, market acceptance, reimbursement from third-party payors, or the profitability of our approved product or any other product candidate for which we may obtain approval. We do not expect additional revenue from our other product candidates unless and until we obtain regulatory approval of and commercialize any of our other product candidates, and we do not know when, or if, this will occur.
ImmunityBio, Inc. and Subsidiaries
Management's Discussion and Analysis of Financial Condition and Results of Operations (Continued)
We expect to continue to incur significant expenses as we seek to expand our business, including commercializing our approved product, seeking regulatory approvals, conducting research and development across multiple therapeutic areas, participating in clinical trial activities, continuing to acquire or in-license technologies, maintaining, protecting and expanding our intellectual property, and increasing our manufacturing capabilities. Furthermore, the timing and magnitude of our approved product sales and revenue remain uncertain and may take a significant amount of time to materialize, if ever.
We have incurred net losses in each year since our inception and, as of September 30, 2025, we had an accumulated deficit of $3.7 billion. During thenine months endedSeptember 30, 2025 and 2024, net losses attributable to ImmunityBio common stockholders were $289.5 million and $354.4 million, respectively. Substantially all of our net losses resulted principally from costs incurred in connection with our ongoing clinical trials and operations, our research and development programs, and from selling, general and administrative costs associated with our operations, including stock-based compensation expense.
As of September 30, 2025, we had 673 employees. Personnel of related companies who provide corporate, general and administrative, certain research and development, and other support services under our shared services agreement with NantWorks are not included in this number. See Note 15"Related-Party Agreements"of the "Notes to Unaudited Condensed Consolidated Financial Statements" that appears in Item 1. "Financial Statements" of this Quarterly Report for more information. In anticipation of the ongoing commercialization of our approved product, we expect to continue to incur significant expenses and increasing operating expenses for the foreseeable future, which may fluctuate significantly from quarter-to-quarter and year-to-year. See "-Future Funding Requirements" below for a discussion of our anticipated expenditures and sources of capital we expect to access to fund these expenditures.
Collaboration Agreements
We anticipate that strategic collaborations will continue to be an integral part of our operations, providing opportunities to leverage our partners' expertise and capabilities to gain access to new markets for our approved product and acquire new technologies or further expand the potential of our technologies, approved product and product candidates across relevant platforms. We believe we are well positioned to become a leader in immunotherapy due to our broad and vertically-integrated platforms and through complementary strategic partnerships.
We believe that our innovative approach to orchestrate and combine therapies for optimal immune system response will become a therapeutic foundation across multiple indications. Additionally, we believe that data from multiple clinical trials indicates ANKTIVA has broad potential to enhance the activity of therapeutic mAbs, including CPIs, across a wide range of tumor types and potentially rescue lymphopenia by proliferation and activation of NK and T cells. We may also enter into supply arrangements for various investigational agents to be used in our clinical trials. See Part I, Item 1. "Business-Collaboration and License Agreements" of our Annual Report filed with the SEC on March 3, 2025 for a more detailed discussion regarding our collaboration and license agreements.
Agreements with Related Parties
Our Executive Chairman and Global Chief Scientific and Medical Officer also founded and has a controlling interest in NantWorks, which is a collection of companies in the healthcare and technology space. We have entered into arrangements with NantWorks, and certain affiliates of NantWorks. Affiliates of NantWorks are also affiliates of the company due to the common control by and/or common ownership interest of our Founder, Executive Chairman and Global Chief Scientific and Medical Officer.
Related-Party Debt
See Note 14"Related-Party Debt"of the "Notes to Unaudited Condensed Consolidated Financial Statements" that appears in Item 1. "Financial Statements" of this Quarterly Report for information regarding our related-party debt.
ImmunityBio, Inc. and Subsidiaries
Management's Discussion and Analysis of Financial Condition and Results of Operations (Continued)
NantWorks, LLC
Our Founder, Executive Chairman and Global Chief Scientific and Medical Officer also founded and has a controlling interest in NantWorks, which is a collection of companies in the healthcare and technology space. We have entered into arrangements with NantWorks, and certain affiliates of NantWorks. Affiliates of NantWorks are also affiliates of the company due to the common control by and/or common ownership interest of our Founder, Executive Chairman and Global Chief Scientific and Medical Officer. See Note 15 "Related-Party Agreements"of the "Notes to Unaudited Condensed Consolidated Financial Statements" that appears in Item 1. "Financial Statements" of this Quarterly Report for more information regarding our agreements with NantWorks.
Immuno-Oncology Clinic, Inc.
We have entered into multiple agreements with the Clinic to conduct clinical trials related to certain of our product candidates. The Clinic is a related party as it is owned by an officer of the company and NantWorks manages the administrative operations of the Clinic. See Note 15"Related-Party Agreements"of the "Notes to Unaudited Condensed Consolidated Financial Statements" that appears in Item 1. "Financial Statements" of this Quarterly Report for more information regarding our agreements with the Clinic.
Related-Party Leases
We lease property in multiple facilities across the U.S. and Italy, including facilities located in El Segundo and Culver City, CA that are leased from related parties. See Note 15 "Related-Party Agreements"of the "Notes to Unaudited Condensed Consolidated Financial Statements" that appears in Item 1. "Financial Statements" of this Quarterly Report for more information about our related-party leases.
Related-Party Warrants
A total of 1,638,000 warrants issued to an affiliate of Dr. Soon-Shiong with an exercise price of $3.24 per share were outstanding as of September 30, 2025. See Note 18 "Stock-Based Compensation"of the "Notes to Unaudited Condensed Consolidated Financial Statements" that appears in Item 1. "Financial Statements" of this Quarterly Report for more information regarding the related-party warrants.
Contingent Value Rights
In connection with our 2017 acquisition of Altor, we issued CVRs under which we agreed to pay the prior stockholders of Altor approximately $304.0 million of contingent consideration upon calendar-year worldwide net sales of ANKTIVA exceeding $1.0 billion prior to December 31, 2026, with amounts payable in cash or shares of our common stock or a combination thereof. As of September 30, 2025, Dr. Soon-Shiong, our Founder, Executive Chairman and Global Chief Scientific and Medical Officer, and his related party hold approximately $139.8 million of net sales CVRs. See Note 11 "Commitments and Contingencies"of the "Notes to Unaudited Condensed Consolidated Financial Statements" that appears in Item 1. "Financial Statements" of this Quarterly Report for more information regarding the CVRs.
Components of our Results of Operations
Product Revenue, Net
Prior to the approval of ANKTIVA for commercial sale, we primarily generated revenues from non-exclusive license agreements related to our cell lines, the sale of our bioreactors and related consumables, and grant programs. The company expects to continue to generate revenue from these programs.
ImmunityBio, Inc. and Subsidiaries
Management's Discussion and Analysis of Financial Condition and Results of Operations (Continued)
Until April 2024, we had no clinical products approved for commercial sale and thus had not generated any revenue from therapeutic and vaccine product candidates that are or were under development. Now that we have received FDA approval for ANKTIVA, we have begun to generate revenue, although we expect it to take some time to generate sufficient revenue from our approved product to offset our expenses, and we can provide no assurance when, or if, this will occur. We began commercial distribution of our approved product in May 2024; however, we can provide no assurance with respect to our future revenues, market acceptance, reimbursement from third-party payors, or the profitability of our approved product or any other product candidate for which we may obtain approval. We do not expect additional revenue from our other product candidates unless and until we obtain regulatory approval of and commercialize any of our other product candidates, and we do not know when, or if, this will occur.
Cost of Sales
Cost of sales consists primarily of third-party manufacturing costs, distribution, and overhead costs related to ANKTIVA sales. Cost of sales may also include costs related to excess or obsolete inventory adjustment charges, abnormal costs, unabsorbed manufacturing and overhead costs, and manufacturing variances. All costs associated with the production of ANKTIVA prior to receiving regulatory approval were expensed in research and development expense, on the condensed consolidated statement of operations in the period incurred and therefore are not reflected in cost of sales. We expect the cost of sales for ANKTIVA to increase in relation to product revenues as we deplete these inventories.
Operating Expenses
We generally classify our operating expenses into research and development, and selling, general and administrative expenses. Personnel costs, including salaries, benefits, bonuses, and stock-based compensation expense comprise a significant component of our research and development, and selling, general and administrative expense categories. We allocate expenses associated with our facilities and information technology costs between these two categories, primarily based on the nature of each cost.
Research and Development
Research and development expense consists of expenses incurred while performing research and development activities to discover and develop our technology and product candidates. This includes conducting preclinical studies and clinical trials, manufacturing development efforts and activities related to regulatory submissions for our approved product and product candidates. We expense research and development costs as they are incurred.
Our research and development expense primarily consists of:
•clinical trial and regulatory-related costs;
•expenses incurred under agreements with investigative sites and consultants that conduct our clinical trials;
•expenses incurred under collaborative agreements;
•manufacturing and testing costs and related supplies and materials;
•employee-related expenses, including salaries, benefits, travel and stock-based compensation; and
•facility expenses dedicated to research and development.
ImmunityBio, Inc. and Subsidiaries
Management's Discussion and Analysis of Financial Condition and Results of Operations (Continued)
The company classifies its research and development expense as either external or internal. The company's external research and development expense supports its various preclinical and clinical programs. The company's internal research and development expense includes payroll and benefits expense, facilities and equipment expense, and other indirect research and development expense incurred in support of its research and development activities. The company's external and internal resources are not directly tied to any one research or drug discovery program and are typically deployed across multiple programs and are not allocated to specific product candidates or development programs.
We expect our research and development expense to increase significantly for the foreseeable future as we continue to invest in research and development activities related to expanding our product into new indications and markets, developing our other product candidates, and conducting our ongoing and planned clinical trials.
The process of conducting clinical trials necessary to obtain regulatory approval is costly and time consuming. The successful development of product candidates is highly uncertain. At this time, we cannot reasonably estimate the nature, timing or costs required to complete the remaining development of our other product candidates or to expand potential approved markets and indications for ANKTIVA. This is due to the numerous risks and uncertainties associated with the development of product candidates.
The costs of clinical trials may vary significantly over the life of a project owing to, but not limited to, the following:
•per patient trial costs;
•the number of sites included in the clinical trials;
•the countries in which the clinical trials are conducted;
•the length of time required to enroll eligible patients;
•the number of patients that participate in the clinical trials;
•the number of doses that patients receive;
•the cost of comparative or combination agents used in clinical trials;
•the drop-out or discontinuation rates of patients;
•potential additional safety monitoring or other studies or incremental cohorts requested by regulatory agencies;
•the duration of patient follow-up; and
•the safety profile and efficacy of the product candidate.
We have only one approved product, ANKTIVA, for which we received approval from the FDA in April 2024 and the MHRA in July 2025. We began commercial distribution of our approved product in the U.S. in May 2024. There can be no assurance that our other product candidates will be approved for commercial sale by the FDA in the near term, if ever.
Selling, General and Administrative
Selling, general and administrative expense consists primarily of salaries and personnel-related costs, including employee benefits and any stock-based compensation, for employees performing functions other than research and development. This includes personnel in executive, finance, human resources, information technology, legal, sales and administrative support functions. Other selling, general and administrative expenses include sales and marketing costs, facility-related costs not otherwise allocated to research and development expense, professional fees for auditing, tax and legal services, advertising costs, expenses associated with strategic business transactions and business development efforts, obtaining and maintaining patents, consulting costs, royalties and licensing costs, and costs of our information systems.
ImmunityBio, Inc. and Subsidiaries
Management's Discussion and Analysis of Financial Condition and Results of Operations (Continued)
We expect that our selling, general and administrative expense will increase for the foreseeable future as we commercialize our approved product and expand operations, build out information systems and increase our headcount to support continued research activities and the development of our clinical programs. We have incurred and expect that we will continue to incur in the future, additional costs associated with operating as a public company, including costs to comply with stock exchange listing and SEC requirements, future funding efforts, corporate governance, internal controls, investor relations, disclosure and similar requirements applicable to public companies. Additionally, if and when we believe that a regulatory approval of one of our other product candidates appears likely, we expect to incur significant increases in our selling, general and administrative expense relating to the sales and marketing of any additional approved product candidate.
Other Income (Expense), Net
Other income (expense), net consists primarily of interest and investment income, interest expense (including amortization of debt discounts), unrealized gains and losses from investments in equity securities and equity-method investments, changes in fair value of warrant liabilities, derivative liabilities, and convertible notes, realized gains and losses on debt and equity securities, warrants issuance costs, gain from recovery of damaged goods, and gains and losses on foreign currency transactions.
Income Taxes
We are subject to U.S. federal income tax, as well as income tax in California, other states and other certain foreign jurisdictions. From inception through September 30, 2025, we have not been required to pay significant U.S. federal and state income taxes because of current and accumulated NOLs.
ImmunityBio, Inc. and Subsidiaries
Management's Discussion and Analysis of Financial Condition and Results of Operations (Continued)
Discussion of Condensed Consolidated Results of Operations
Comparison of the Three Months Ended September 30, 2025 and 2024
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
September 30,
|
|
$ Change
|
|
% Change
|
|
|
2025
|
|
2024
|
|
|
|
|
($ in thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue
|
|
|
|
|
|
|
|
|
Product revenue, net
|
$
|
31,780
|
|
|
$
|
5,954
|
|
|
$
|
25,826
|
|
|
434
|
%
|
|
Other revenues
|
281
|
|
|
152
|
|
|
129
|
|
|
85
|
%
|
|
Total revenue
|
32,061
|
|
|
6,106
|
|
|
25,955
|
|
|
425
|
%
|
|
Operating costs and expenses:
|
|
|
|
|
|
|
|
|
Cost of sales
|
177
|
|
|
-
|
|
|
177
|
|
|
100%
|
Research and development (including amounts
with related parties)
|
51,232
|
|
|
50,443
|
|
|
789
|
|
|
2
|
%
|
Selling, general and administrative (including amounts
with related parties)
|
36,282
|
|
|
35,916
|
|
|
366
|
|
|
1
|
%
|
|
Total operating costs and expenses
|
87,691
|
|
|
86,359
|
|
|
1,332
|
|
|
2
|
%
|
|
Loss from operations
|
(55,630)
|
|
|
(80,253)
|
|
|
24,623
|
|
|
(31)
|
%
|
|
Other income (expense), net
|
|
|
|
|
|
|
|
|
Interest and investment income, net
|
2,067
|
|
|
1,798
|
|
|
269
|
|
|
15
|
%
|
Interest expense (including amounts
with related party)
|
(15,282)
|
|
|
(29,322)
|
|
|
14,040
|
|
|
(48)
|
%
|
|
Change in fair value of warrant liabilities
|
14,905
|
|
|
31,324
|
|
|
(16,419)
|
|
|
(52)
|
%
|
|
Interest expense related to revenue interest liability
|
(12,302)
|
|
|
(10,925)
|
|
|
(1,377)
|
|
|
13
|
%
|
|
Change in fair value of related-party convertible note
|
(1,169)
|
|
|
-
|
|
|
(1,169)
|
|
|
100%
|
|
Change in fair value of derivative liabilities
|
289
|
|
|
1,614
|
|
|
(1,325)
|
|
|
(82)
|
%
|
|
Other (expense) income, net
|
(187)
|
|
|
12
|
|
|
(199)
|
|
|
(1658)
|
%
|
|
Total other expense, net
|
(11,679)
|
|
|
(5,499)
|
|
|
(6,180)
|
|
|
112
|
%
|
|
Loss before income taxes and noncontrolling interests
|
(67,309)
|
|
|
(85,752)
|
|
|
18,443
|
|
|
(22)
|
%
|
|
Income tax benefit
|
35
|
|
|
-
|
|
|
35
|
|
|
100%
|
|
Net loss
|
$
|
(67,274)
|
|
|
$
|
(85,752)
|
|
|
$
|
18,478
|
|
|
(22)
|
%
|
Product Revenue, Net
Product revenue, net increased $25.8 million during the three months ended September 30, 2025, as compared to the three months ended September 30, 2024, due to an increase in sales of ANKTIVA, which was approved in April 2024.
Other Revenues
Other revenues increased during the three months ended September 30, 2025, as compared to the three months ended September 30, 2024, primarily due to increased bioreactor and related consumable product sales.
ImmunityBio, Inc. and Subsidiaries
Management's Discussion and Analysis of Financial Condition and Results of Operations (Continued)
Cost of Sales
Cost of sales increased $0.2 million during the three months ended September 30, 2025, as compared to the three months ended September 30, 2024. We did not report cost of sales during the three months ended September 30, 2024. Cost of sales consists primarily of third-party manufacturing, distribution, and overhead costs. All costs associated with the production of ANKTIVA prior to receiving regulatory approval were expensed in research and development expense, on the condensed consolidated statement of operations in the period incurred and therefore are not reflected in cost of sales. As a result, our initial product gross margin is higher as our pre-launch inventory costs are not included in the cost of sales. We expect the cost of sales for ANKTIVA to increase in relation to product revenues as we deplete these inventories.
Research and Development Expense
Research and development expense increased $0.8 million during the three months ended September 30, 2025, as compared to the three months ended September 30, 2024. The following table summarizes our research and development expense during the three months ended September 30, 2025 and 2024, together with the changes in those items (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
September 30,
|
|
|
|
|
|
2025
|
|
2024
|
|
$ Change
|
|
|
|
|
|
|
|
|
|
External research and development expense
|
|
$
|
7,322
|
|
|
$
|
8,114
|
|
|
$
|
(792)
|
|
|
Internal research and development expense:
|
|
|
|
|
|
|
|
Personnel-related costs
|
|
23,397
|
|
|
22,712
|
|
|
685
|
|
|
Equipment, depreciation, and facility costs
|
|
12,843
|
|
|
13,223
|
|
|
(380)
|
|
|
Other research and development costs
|
|
7,670
|
|
|
6,394
|
|
|
1,276
|
|
|
Total internal research and development expense
|
|
43,910
|
|
|
42,329
|
|
|
1,581
|
|
|
Total research and development expense
|
|
$
|
51,232
|
|
|
$
|
50,443
|
|
|
$
|
789
|
|
Research and development expense increased $0.8 million primarily attributable to the following:
•an $0.8 million decrease in external research and development expense, primarily due to a reduction in consulting costs and regulatory expenses, partially offset by higher clinical trial related costs; partially offset by
•a $0.7 million increase in personnel-related costs, primarily due to an increase in stock based compensation expenses due to 2025 new grants, and a decrease in shared service costs charged out, partially offset by a decrease in salaries and benefits due to lower headcount;
•a $0.4 million decrease in equipment, depreciation, and facility costs, primarily due to lower depreciation and amortization expenses, lower common area maintenance expenses, and lower software purchase expenses, partially offset by increased facility expenses driven by building repairs; and
•a $1.3 million increase in other research and development costs, primarily due to higher manufacturing costs, higher license fees, and higher distribution costs driven by more production and clinical trial activities, partially offset by fewer sponsored research agreements and fewer supplies and materials purchases.
We expect our research and development expense to increase for the foreseeable future as we continue to invest in research and development activities related to developing our product candidates and conducting our ongoing and planned clinical trials.
ImmunityBio, Inc. and Subsidiaries
Management's Discussion and Analysis of Financial Condition and Results of Operations (Continued)
Selling, General and Administrative Expense
Selling, general and administrative expense increased $0.4 million during the three months ended September 30, 2025, as compared to the three months ended September 30, 2024. The increasein selling, general and administrative expense was primarily driven by a $4.4 million increase in headcount-related costs, including salaries, benefits and commissions, and travel expenses mainly due to growing sales and marketing activities, a $0.7 million increase in marketing expenses, a $0.6 million increase in software license fees, a $0.5 million increase in stock-based compensation due to new grants, a $0.4 million increase in audit and tax fees, a $0.3 million increase in distribution costs, a $0.3 million increase in facility costs, and a $0.2 million increase in other operating expenses, partially offset by a $4.0 million decrease in commercial consulting activities, primarily due to insourced related functions, and a $3.0 million decreasein legal expenses mainly due to lower litigation settlement costs.
Other Income (Expense), Net
Total other expense, net increased $6.2 million during the three months ended September 30, 2025, as compared to the three months ended September 30, 2024. The increasein total other expense, net was primarily driven by a $16.4 million decline in the change in fair value of warrant liabilities compared to the prior period, an increase of $1.4 million in interest expense related to the revenue interest liability, a $1.3 million decline in the change in fair value of derivative liabilities compared to the prior period, a $1.2 million increase in fair value of a related-party convertible note, and an increase of $0.2 million in other income (expense), net, partially offset by a decrease of $14.0 million in interest expense mainly due to the lower outstanding balance of related-party debt and no amortization of related-party notes discounts as a result of December 2024 debt extinguishment, and a $0.3 million increase in interest and investment income.
ImmunityBio, Inc. and Subsidiaries
Management's Discussion and Analysis of Financial Condition and Results of Operations (Continued)
Comparison of the Nine Months Ended September 30, 2025 and 2024
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended
September 30,
|
|
$ Change
|
|
% Change
|
|
|
2025
|
|
2024
|
|
|
|
|
($ in thousands)
|
|
|
|
Revenue
|
|
|
|
|
|
|
|
|
Product revenue, net
|
$
|
74,710
|
|
|
$
|
6,944
|
|
|
$
|
67,766
|
|
|
976
|
%
|
|
Other revenues
|
293
|
|
|
249
|
|
|
44
|
|
|
18
|
%
|
|
Total revenue
|
75,003
|
|
|
7,193
|
|
|
67,810
|
|
|
943
|
%
|
|
Operating costs and expenses
|
|
|
|
|
|
|
|
|
Cost of sales
|
371
|
|
|
-
|
|
|
371
|
|
|
100%
|
Research and development (including amounts
with related parties)
|
154,702
|
|
|
154,923
|
|
|
(221)
|
|
|
(0)
|
%
|
Selling, general and administrative (including amounts
with related parties)
|
111,274
|
|
|
127,052
|
|
|
(15,778)
|
|
|
(12)
|
%
|
|
Total operating costs and expenses
|
266,347
|
|
|
281,975
|
|
|
(15,628)
|
|
|
(6)
|
%
|
|
Loss from operations
|
(191,344)
|
|
|
(274,782)
|
|
|
83,438
|
|
|
(30)
|
%
|
|
Other income (expense), net
|
|
|
|
|
|
|
|
|
Interest and investment income, net
|
4,107
|
|
|
6,788
|
|
|
(2,681)
|
|
|
(39)
|
%
|
|
Interest expense (including amounts with related parties)
|
(46,092)
|
|
|
(88,599)
|
|
|
42,507
|
|
|
(48)
|
%
|
|
Change in fair value of related-party convertible note
|
(42,582)
|
|
|
-
|
|
|
(42,582)
|
|
|
100%
|
|
Interest expense related to revenue interest liability
|
(39,241)
|
|
|
(28,154)
|
|
|
(11,087)
|
|
|
39
|
%
|
|
Change in fair value of warrant liabilities
|
18,346
|
|
|
10,222
|
|
|
8,124
|
|
|
79
|
%
|
|
Change in fair value of derivative liabilities
|
7,798
|
|
|
20,084
|
|
|
(12,286)
|
|
|
(61)
|
%
|
|
Other expense, net
|
(506)
|
|
|
(25)
|
|
|
(481)
|
|
|
1924
|
%
|
|
Total other expense, net
|
(98,170)
|
|
|
(79,684)
|
|
|
(18,486)
|
|
|
23
|
%
|
|
Loss before income taxes and noncontrolling interests
|
(289,514)
|
|
|
(354,466)
|
|
|
64,952
|
|
|
(18)
|
%
|
|
Income tax benefit
|
-
|
|
|
-
|
|
|
-
|
|
|
100%
|
|
Net loss
|
$
|
(289,514)
|
|
|
$
|
(354,466)
|
|
|
$
|
64,952
|
|
|
(18)
|
%
|
Product Revenue, Net
Product revenue, net increased $67.8 million during the nine months ended September 30, 2025, as compared to the nine months ended September 30, 2024, due to an increase in sales of ANKTIVA, which was approved in April 2024.
Other Revenues
Other revenues increased slightly during the nine months ended September 30, 2025, as compared to the nine months ended September 30, 2024 primarily due to increased bioreactor and related consumable product sales, and increased license royalty income.
ImmunityBio, Inc. and Subsidiaries
Management's Discussion and Analysis of Financial Condition and Results of Operations (Continued)
Cost of Sales
Cost of sales increased $0.4 million during the nine months ended September 30, 2025, as compared to the nine months ended September 30, 2024. We did not report cost of sales during the nine months ended September 30, 2024. Cost of sales consists primarily of third-party manufacturing, distribution, and overhead costs. All costs associated with the production of ANKTIVA prior to receiving regulatory approval were expensed in research and development expense, on the condensed consolidated statement of operations in the period incurred and therefore are not reflected in cost of sales. As a result, our initial product gross margin is higher as our pre-launch inventory costs are not included in the cost of sales. We expect the cost of sales for ANKTIVA to increase in relation to product revenues as we deplete these inventories.
Research and Development Expense
Research and development expense decreased $0.2 million during the nine months ended September 30, 2025, as compared to the nine months ended September 30, 2024. The following table summarizes our research and development expense during the nine months ended September 30, 2025 and 2024, together with the changes in those items (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended
September 30,
|
|
|
|
|
|
2025
|
|
2024
|
|
$ Change
|
|
|
|
|
|
|
|
|
|
External research and development expense
|
|
$
|
21,385
|
|
|
$
|
27,575
|
|
|
$
|
(6,190)
|
|
|
Internal research and development expense:
|
|
|
|
|
|
|
|
Personnel-related costs
|
|
70,094
|
|
|
69,765
|
|
|
329
|
|
|
Equipment, depreciation, and facility costs
|
|
39,146
|
|
|
39,279
|
|
|
(133)
|
|
|
Other research and development costs
|
|
24,077
|
|
|
18,304
|
|
|
5,773
|
|
|
Total internal research and development expense
|
|
133,317
|
|
|
127,348
|
|
|
5,969
|
|
|
Total research and development expense
|
|
$
|
154,702
|
|
|
$
|
154,923
|
|
|
$
|
(221)
|
|
Research and development expense decreased $0.2 million primarily attributable to the following:
•a $6.2 million decrease in external research and development expense that was primarily due to a reduction in outside service costs, and a reduction in CMO fees and drug materials purchased and used in manufacturing, partially offset by an increase in investigator fees and CRO fees; partially offset by
•a $0.3 million increase in personnel-related costs that was primarily due to a decrease in shared service costs charged out, partially offset by a decrease in stock based compensation;
•a $0.1 million decrease in equipment, depreciation, and facility costs that was primarily due to decreased depreciation expenses due to fully depreciated fixed assets, and decreased software subscription expenses, partially offset by an increase in facility costs mainly driven by building repairs; partially offset by
•a $5.8 million increase in other research and development costs, primarily attributable to higher manufacturing costs due to increased production activities, increased license fees due to new subscriptions, and increased distribution costs due to higher clinical trial activities, partially offset by decreased sponsored research agreements and lower inventory materials costs.
We expect our research and development expense to increase significantly for the foreseeable future as we continue to invest in research and development activities related to developing our product candidates and conducting our ongoing and planned clinical trials.
ImmunityBio, Inc. and Subsidiaries
Management's Discussion and Analysis of Financial Condition and Results of Operations (Continued)
Selling, General and Administrative Expense
Selling, general and administrative expense decreased $15.8 million during the nine months ended September 30, 2025, as compared to the nine months ended September 30, 2024. The decrease in selling, general and administrative expense was primarily due to a decreaseof $31.2 millionin legal expenses, driven by lower defense costs and litigation settlements, a decreaseof $11.4 millionin consulting costs, primarily driven by insourced related functions, and an increaseof $0.5 million in net benefit from shared service costs, partially offset by a $15.8 million increase in recruiting and training expenses, salaries, benefits and commissions, and travel expenses due to growing sales and marketing activities, a $3.8 million increase in stock-based compensation expense primarily due to new grants, a $3.8 millionincrease in marketing and public relations expenses, a $1.3 million increasein software license fees, a $1.1 million increase in facility costs, a $0.9 million increase in distribution costs, a $0.4 million increase in depreciation expenses, and a $0.2 million increase in other miscellaneous operating expenses.
Other Income (Expense), Net
Other expense, net increased $18.5 million during the nine months ended September 30, 2025, as compared to the nine months ended September 30, 2024. The increase in other expense, net was primarily driven by a $42.6 million increase in fair value of a related-party convertible note, a $12.3 milliondecline in the change in fair value of derivative liabilities compared to the prior period, an increase of $11.1 million in interest expense related to the revenue interest liability, a decrease of $2.7 million in interest and investment income, and an increase of $0.4 millionin other expense, net, partially offset by a decrease of $42.5 millionin interest expense due to the lower outstanding balance of related-party debt and no amortization of related-party notes discounts as a result of December 2024 debt extinguishment, and an $8.1 million increase in the change in fair value of warrant liabilities compared to the prior period.
Financial Condition, Liquidity and Capital Resources
Sources of Liquidity
From inception through September 30, 2025, we have funded our operations primarily through proceeds from the issuance of related-party promissory notes, sales of common stock under our shelf registration statements, through RDOs and the ATM, and a RIPA financing.
Cash and Marketable Securities on Hand
As of September 30, 2025, we had cash and cash equivalents, and marketable securities of $257.8 million compared to $149.8 million as of December 31, 2024. We have typically invested our cash in a variety of financial instruments and classified these investments as available-for-sale. However, after our entry into the RIPA we can no longer invest our excess funds in corporate or European bonds. Certain of our investments are subject to credit, liquidity, market, and interest-rate risks. The general condition of the financial markets and the economy may increase those risks and may affect the value and liquidity of investments and restrict our ability to access the capital markets.
Shelf Registration Statements
During 2023, we filed a $750.0 million shelf registration statement with the SEC on Form S-3 for the offering and sale of equity and equity-linked securities, including common stock, preferred stock, debt securities, depositary shares, warrants to purchase common stock, preferred stock or debt securities, subscription rights, purchase contracts, and units. As of September 30, 2025, we had $565.6 million available for use under this shelf.
In April 2024, we filed a shelf registration statement with the SEC on Form S-3ASR pursuant to which we may, from time to time, sell an indeterminate amount of our common stock, preferred stock, debt securities, depositary shares, warrants, subscription rights, purchase contracts, or units, and an associated prospectus related to the ATM. As of September 30, 2025, we had $95.3 million available for future stock issuances under the ATM.
ImmunityBio, Inc. and Subsidiaries
Management's Discussion and Analysis of Financial Condition and Results of Operations (Continued)
At-the-Market Offering
In April 2021, we entered into the ATM under which we may offer and sell, from time to time at our sole discretion, shares of our common stock through our sales agent. During the three and nine months ended September 30, 2025, we received net proceeds totaling $98.2 million and $196.4 million, respectively, from the issuance of shares under the ATM. As of September 30, 2025, we had $95.3 million available for future stock issuances under the ATM.
Registered Direct Offerings
On April 7, 2025, we entered into a securities purchase agreement with an institutional investor for the purchase and sale of 29,024,768 shares of our common stock, as well as warrants that allows such investor to purchase an additional 29,024,768 shares of common stock at an exercise price of $3.101 per share, for a purchase price of $2.584 per share and accompanying warrant. This transaction generated net proceeds of approximately $74.8 million, after deducting offering costs of $0.2 million. The warrants became immediately exercisable on April 9, 2025 and expire on April 9, 2030.
On July 28, 2025, we entered into a securities purchase agreement with institutional investors for the purchase and sale of 29,629,632 shares of our common stock, as well as warrants that allows such investors to purchase an additional 29,629,632 shares of common stock at an exercise price of $3.240 per share, for a purchase price of $2.700 per share and accompanying warrant. This transaction generated net proceeds of approximately $75.4 million, after deducting placement agent fees and offering costs totaling $4.6 million. The warrants became immediately exercisable on July 28, 2025 and expire on July 28, 2030.
Revenue Interest Purchase Agreement
On December 29, 2023, we entered into the RIPA with Infinity and Oberland. Pursuant to the RIPA, Oberland had the option to purchase additional Revenue Interests from us in exchange for a $100.0 million Second Payment upon satisfaction of certain conditions in the RIPA, including receipt of approval from the FDA of our BLA for ANKTIVA on or before June 30, 2024. In April 2024, the FDA approved our product ANKTIVA and as a result, on May 13, 2024 Oberland purchased additional Revenue Interests from us for a gross purchase price of $100.0 million, less certain issuance costs.
As consideration for the aforementioned payments, Oberland has the right to receive quarterly Revenue Interest Payments from us based on, among other things, a certain percentage of our net sales during such quarter, which are tiered payments ranging from 4.5% to 10.0% (before funding of the Second Payment, 3.0% to 7.0%) of the company's worldwide net sales, excluding those in China. See Note 13"Revenue Interest Purchase Agreement"of the "Notes to Unaudited Condensed Consolidated Financial Statements" that appears in Item 1. "Financial Statements" of this Quarterly Report for more information.
Stock Purchase and Option Agreement
On December 29, 2023 and in connection with the RIPA, we entered into a SPOA with Oberland. Under this agreement, Oberland had an option to purchase up to $10.0 million of our common stock, at a price per share to be determined by reference to the 30-day trailing volume weighted-average price of our common stock, calculated from the date of exercise. The option is exercisable by Oberland at any time until the earliest of (i) December 29, 2028, (ii) a change of control of the company, or (iii) a sale of substantially all of the company's assets. Among other limitations, the option may only be exercised to the extent that the common stock issuable pursuant to such exercise would not exceed 19.9% of the common stock outstanding immediately after giving effect to such exercise.
Pursuant to the SPOA, in April 2024 Oberland exercised its option to purchase 858,990 shares of our common stock at an exercise price of $5.8208 per share generating net proceeds of approximately $4.9 million. Following such exercise, approximately $5.0 million remains available for future exercise under the SPOA as of September 30, 2025.
ImmunityBio, Inc. and Subsidiaries
Management's Discussion and Analysis of Financial Condition and Results of Operations (Continued)
Uses of Liquidity
In addition to the cash used to fund our operating activities discussed in "-Future Funding Requirements" below, we will require cash to settle the following obligations:
•As of September 30, 2025, the aggregate amount of our indebtedness payable was $505.0 million in the form of a convertible promissory note due December 31, 2027. This convertible promissory note is held by Nant Capital, an entity affiliated with Dr. Soon-Shiong. In connection with the RIPA, our related-party promissory note is a general unsecured obligation of the company that is subordinated in right of payment to indebtedness, obligations, and other liabilities under the RIPA, the Revenue Interests issued pursuant to such agreement, and refinancing of the foregoing.
There can be no assurance that the company can refinance this promissory note or what terms will be available in the market at the time of refinancing. Furthermore, if prevailing interest rates or other factors at the time of refinancing result in higher interest rates upon refinancing, then the interest expense relating to the refinanced indebtedness would increase. These risks could materially adversely affect the company's financial condition, cash flows and results of operations.
•On December 29, 2023, we entered into the RIPA with Infinity and Oberland. Oberland has the right to receive quarterly Revenue Interest Payments from us based on, among other things, our worldwide net sales, excluding those in China, which will be tiered payments initially ranging from 4.5% to 10.0% (before funding of the Second Payment, 3.0% to 7.0%), subject to increase or decrease, following December 31, 2029(the Test Date) depending on whether our aggregate payments made to Oberland as of the Test Date have met or exceeded the Cumulative Purchaser Payments. In addition, if our aggregate payments made as of the Test Date to Oberland do not equal or exceed the amount of the Cumulative Purchaser Payments as of such date, then we are obligated to make a one-time True-Up Payment to Oberland in an amount equal to 100% of the Cumulative Purchaser Payments as of the Test Date, less the aggregate amount of our previous payments to Oberland as of the Test Date. See Note 13 "Revenue Interest Purchase Agreement"of the "Notes to Unaudited Condensed Consolidated Financial Statements" that appears in Item 1. "Financial Statements" of this Quarterly Report for more information regarding the RIPA.
•In connection with our 2017 acquisition of Altor, we issued CVRs under which we agreed to pay the prior stockholders of Altor approximately $304.0 million of contingent consideration upon calendar-year worldwide net sales of ANKTIVA exceeding $1.0 billion prior to December 31, 2026, with amounts payable in cash or shares of our common stock or a combination thereof. As of September 30, 2025, Dr. Soon-Shiong and his related party hold approximately $139.8 million of net sales CVRs and they have both irrevocably agreed to receive shares of the company's common stock in satisfaction of their CVRs. We may be required to pay the other prior Altor stockholders up to $164.2 million for their net sales CVRs should they choose to have their CVRs paid in cash instead of common stock. We may need to seek additional sources of capital to satisfy the CVR obligations if they are achieved.
•In connection with our acquisition of VivaBioCell, we are obligated to pay the former owners approximately $2.3 million of contingent consideration upon the achievement of a regulatory milestone relating to the GMP-in-a-Box technology.
ImmunityBio, Inc. and Subsidiaries
Management's Discussion and Analysis of Financial Condition and Results of Operations (Continued)
Discussion of Condensed Consolidated Cash Flows
The following discussion of ImmunityBio's cash flows is based on the condensed consolidated statements of cash flows in Item 1. "Financial Statements" and is not meant to be an all-inclusive discussion of the changes in its cash flows for the periods presented below.
The following table sets forth our primary sources and uses of cash for periods indicated (in thousands):
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Nine Months Ended
September 30,
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2025
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2024
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Cash (used in) provided by:
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Operating activities
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$
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(234,558)
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$
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(306,092)
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Investing activities
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(193,374)
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(22,080)
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Financing activities
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345,347
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174,701
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Effect of exchange rate changes on cash and cash equivalents, and restricted cash
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10
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(16)
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Net change in cash and cash equivalents, and restricted cash
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$
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(82,575)
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$
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(153,487)
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Operating Activities
During the nine months ended September 30, 2025, net cash used in operating activities of $234.6 million consisted of a net loss of $289.5 million and $40.0 million of cash used in net working capital, partially offset by $94.9 million in adjustments for non-cash items. The changes in net working capital consisted primarily of an increase of $29.7 million in accounts receivable, net, an increase of $7.9 million in prepaid expenses and other current assets, a decrease of $5.4 million in operating lease liabilities, and a decrease of $1.2 million in accounts payable, partially offset by a decrease of $1.6 million in inventories, an increase of $1.3 million in accrued expenses and other liabilities, a decrease of $0.8 million in other assets, and an increase of $0.5 million with related parties. Adjustments for non-cash items primarily consisted of a $42.6 million change in the fair value of a related-party convertible note, $32.6 million of non-cash interest expense related to the revenue interest liability, $28.1 million in stock-based compensation expense, $11.7 million in depreciation and amortization expense, $4.7 million in non-cash lease expense related to operating lease right-of-use assets, $2.2 million of transaction costs allocable to warrant liabilities, and $0.3 million in other items, reduced by an $18.3 million change in fair value of warrant liabilities, a $7.8 million change in the fair value of derivative liabilities, $1.0 million of accretion of discounts on marketable debt securities, and $0.2 million in non-cash interest.
During the nine months ended September 30, 2024, net cash used in operating activities of $306.1 million consisted of a net loss of $354.5 million and $8.5 million of cash used in net working capital, partially offset by $56.9 million in adjustments for non-cash items. The changes in net working capital consisted primarily of an increase of $4.2 million in accounts receivable, net, a decrease of $3.9 million in operating lease liabilities, an increase of $2.0 million in inventories and an increase of $0.1 million in other assets, partially offset by an increase of $0.7 million in accounts payable and accrued expenses and other liabilities, an increase of $0.6 million with related parties, and a decrease of $0.4 million in prepaid expenses and other current assets. Adjustments for non-cash items primarily consisted of $27.7 million of non-cash interest expense related to the revenue interest liability, $25.4 million in stock-based compensation expense, $17.6 million in amortization of related-party note discounts, $13.4 million in depreciation and amortization expense, $4.1 million in non-cash lease expense related to operating lease right-of-use assets, and $0.5 million in unrealized losses on equity securities driven by a decrease in the value of our investments, reduced by a $20.1 million change in the fair value of derivative liabilities, a $10.2 million change in the fair value of warrant liabilities, and $1.5 million of accretion of discounts on marketable debt securities.
We have historically experienced negative cash flows from operating activities, with such negative cash flows likely to continue for the foreseeable future.
ImmunityBio, Inc. and Subsidiaries
Management's Discussion and Analysis of Financial Condition and Results of Operations (Continued)
Investing Activities
During the nine months ended September 30, 2025, net cash used in investing activities was $193.4 million, which included cash outflows of $195.8 million for purchases of marketable debt securities and $3.0 million for purchases of property, plant and equipment, partially offset by proceeds of $5.4 million from maturities of marketable debt securities.
During the nine months ended September 30, 2024, net cash used in investing activities was $22.1 million, which included cash outflows of $134.1 million of purchases of marketable debt securities, $4.8 million of purchases of property, plant and equipment, $1.0 million used for the acquisition of a business, net of transaction costs, and $0.7 million cash paid for other investments, partially offset by proceeds of $118.5 million from maturities and sales of marketable debt securities.
Our investments in property, plant and equipment are primarily related to acquisitions of equipment that will be used for the manufacturing of our approved product and product candidates and expenditures related to the build out of our manufacturing facilities. We expect to accelerate our capital spending as we scale our GMP manufacturing capabilities, which will require significant capital for the foreseeable future.
Financing Activities
During the nine months ended September 30, 2025, net cash provided by financing activities was $345.3 million, which consisted of $346.8 million in net proceeds from equity offerings and $0.2 million in proceeds from the exercise of stock options, partially offset by $1.7 million related to net share settlement of vested RSUs for payment of payroll tax withholding.
During the nine months ended September 30, 2024, net cash provided by financing activities was $174.7 million, which consisted of $97.0 million in net proceeds from payments received pursuant to the RIPA, $73.3 million of proceeds from the exercise of warrants, $4.9 million in net proceeds from the partial exercise of the Oberland stock option, $3.6 million in net proceeds from equity offerings, and $0.7 million in proceeds from the exercise of stock options, partially offset by $4.7 million related to net share settlement of vested RSUs for payment of payroll tax withholding and $0.1 million in principal payments of finance leases.
Future Funding Requirements
Prior to the approval of ANKTIVA for commercial sale, we primarily generated revenues from non-exclusive license agreements related to our cell lines, the sale of our bioreactors and related consumables, and grant programs. The company expects to continue to generate revenue from these programs.
Until April 2024, we had no clinical products approved for commercial sale and thus had not generated any revenue from therapeutic and vaccine product candidates that are or were under development. Now that we have received FDA approval for ANKTIVA, we have begun to generate revenue, although we expect it to take some time to generate sufficient revenue from our approved product to offset our expenses, and we can provide no assurance when, or if, this will occur. We began commercial distribution of our approved product in May 2024 and our permanent J-code became effective in January 2025; however, we can provide no assurance with respect to our future revenues, market acceptance, reimbursement from third-party payors, or the profitability of our approved product or any other product candidate for which we may obtain approval. We do not expect additional revenue from our other product candidates unless and until we obtain regulatory approval of and commercialize any of our other product candidates, and we do not know when, or if, this will occur. In addition, we expect our operating expenses to significantly increase in connection with our ongoing development activities, particularly as we continue the research, development and clinical trials of, and seek regulatory approval for, our other product candidates. We have also incurred and expect that we will continue to incur in the future additional costs associated with operating as a public company as well as costs related to future fundraising efforts. In addition, subject to obtaining regulatory approval of our other product candidates, we expect to incur significant incremental commercialization expenses for product sales, marketing, manufacturing and distribution.
ImmunityBio, Inc. and Subsidiaries
Management's Discussion and Analysis of Financial Condition and Results of Operations (Continued)
We anticipate that we will need substantial additional funding in connection with our continuing operations.
We expect that our operating expenses will increase substantially if and as we:
•commercialize our approved product;
•continue research and development, including preclinical and clinical development of our other existing product candidates;
•seek regulatory approval of our approved product in incremental markets and indications and potentially seek regulatory approval for our other product candidates;
•seek to discover and develop additional product candidates;
•establish a commercialization infrastructure and scale up our manufacturing and distribution capabilities to commercialize any of our other product candidates for which we may obtain regulatory approval;
•seek to comply with regulatory standards and laws;
•maintain, leverage and expand our intellectual property portfolio;
•hire clinical, manufacturing, scientific and other personnel to support our product candidates' development and future commercialization efforts;
•add operational, financial and management information systems and personnel; and
•incur additional legal, accounting and other expenses in operating as a public company.
As a result of continuing anticipated operating cash outflows as we commercialize our approved product and accelerate our development efforts, we believe that substantial doubt exists regarding our ability to continue as a going concern without additional funding or financial support. However, we believe our existing cash and cash equivalents, and investments in marketable securities; sales of our approved product; capital to be raised through equity offerings, including but not limited to, the offering, issuance and sale by us of our common stock under our shelf registration statement; and our potential ability to borrow from affiliated entities will be sufficient to fund our operations through at least the next 12 months following the issuance date of the condensed consolidated financial statements based primarily upon our Founder, Executive Chairman and Global Chief Scientific and Medical Officer's intent and ability to support our operations with additional funds, including loans from affiliated entities, as required, which we believe alleviates such doubt. In addition to funds from the future sales of our approved product, which we expect to take time to establish, we may also seek to sell additional equity, through one or more follow-on public offerings, or in separate financings, or obtain a credit facility, issue other debt in compliance with the terms of the RIPA, or engage in strategic partnership transactions. However, we may not be able to secure such external financing in a timely manner or on favorable terms, if at all. Without additional funds, we may choose to delay or reduce our operating or investment expenditures. Further, because of the numerous risks and uncertainties associated with the development and commercialization of our product candidates, we may need additional funds to meet our needs sooner than planned.
We will need to obtain additional financing to fund our future operations, including completing the commercialization of our approved product and the development and commercialization of our other product candidates. Changing circumstances may cause us to increase our spending significantly faster than we currently anticipate and we may need to raise additional funds sooner than we presently anticipate. Moreover, research and development and our operating costs and fixed expenses such as rent and other contractual commitments, including those for our research collaborations, are substantial and are expected to increase in the future.
ImmunityBio, Inc. and Subsidiaries
Management's Discussion and Analysis of Financial Condition and Results of Operations (Continued)
Our future funding requirements will depend on many factors, including, but not limited to:
•our ability to successfully commercialize ANKTIVA or any future approved products in the U.S. or internationally;
•progress, timing, number, scope and costs of researching and developing our product candidates and our ongoing, planned and potential clinical trials;
•time and cost of regulatory approvals;
•our ability to successfully commercialize any of our other product candidates, if approved and the costs of such commercialization activities;
•revenue from product candidates that we may commercialize, if any, including the selling prices for such potential products and the availability of adequate third-party coverage and reimbursement for patients;
•interest and principal payments on our related-party promissory note, and repayment of Revenue Interests and Test Date payments due under the RIPA;
•cost of building, staffing and validating our own manufacturing facilities in the U.S., including having a product candidate successfully manufactured consistent with FDA and EMA regulations;
•terms, timing and costs of our current and any potential future collaborations, business or product acquisitions, CVRs, milestones, royalties, licensing or other arrangements that we have established or may establish;
•time and cost necessary to respond to technological, regulatory, political and market developments; and
•costs of filing, prosecuting, maintaining, defending and enforcing any patent claims and other intellectual property rights.
Unless and until we can generate a sufficient amount of revenues, we may finance future cash needs through public or private equity offerings, license agreements, debt financings, collaborations, strategic alliances and marketing or distribution arrangements. However, we may be unable to raise additional funds or enter into such other arrangements when needed on favorable terms, or at all.
To the extent that we raise additional capital through the sale of equity or equity-linked securities (including warrants), convertible debt, our shelf registration statements, or other offerings, or if any of our current debt is converted into equity or if our existing warrants are exercised, your ownership interest will be diluted, and the terms may include liquidation or other preferences that adversely affect your rights as a stockholder. The incurrence of additional indebtedness would result in increased fixed payment obligations and could involve certain restrictive covenants, such as limitations on our ability to incur additional debt, limitations on our ability to acquire or license intellectual property rights and other operating restrictions that could adversely impact our ability to conduct our business. If we raise additional funds through strategic partnerships and alliances and licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies or product candidates, or grant licenses on terms unfavorable to us and our revenue interest liability may come due. We have no committed source of additional capital and if we are unable to raise additional capital in sufficient amounts or on terms acceptable to us, we may be required to delay or reduce the scope of or eliminate one or more of our research or development programs or our commercialization efforts. Our current license and collaboration agreements may also be terminated if we are unable to meet the payment obligations under those agreements. As a result, we may seek to access the public or private capital markets whenever conditions are favorable, even if we do not have an immediate need for additional capital at that time.
ImmunityBio, Inc. and Subsidiaries
Management's Discussion and Analysis of Financial Condition and Results of Operations (Continued)
Contractual Obligations
We have material cash requirements to pay related-party affiliates and third parties under various contractual obligations discussed below:
•We are obligated to make payments to several related-party affiliates under written agreements and other informal arrangements. We are also obligated to pay interest and to repay principal under our related-party promissory notes. See Note 14"Related-Party Debt"of the "Notes to Unaudited Condensed Consolidated Financial Statements" that appears in Item 1. "Financial Statements" of this Quarterly Report for information regarding our financing obligations.
•We are obligated to make payments to Oberland associated with our revenue interest liability, which do not have a fixed repayment schedule. Oberland's right to receive payments under the RIPA shall terminate when Oberland has received maximum payments (including any True-Up Payment) equal to 195.0% of the then Cumulative Purchaser Payments unless the RIPA is terminated prior to such date.
Under the terms of the agreement, prior to the Test Date, every $100.0 million of worldwide net sales, excluding those in China, of less than or equal to $600.0 million in a calendar year will result in a tiered Revenue Interest Payment of approximately $10.0 million or 10.0% (after funding of the Second Payment). Worldwide net sales, excluding those in China, for a calendar year exceeding $600.0 million will result in a tiered Revenue Interest Payment of approximately $4.5 million or 4.5% (after funding of the Second Payment) for every $100.0 million of worldwide net sales, excluding those in China, above the threshold.
In the future, cumulative worldwide net sales, excluding those in China, levels up to the Test Date will determine whether or not we are required to make a True-Up Payment and implement modified payment rates. The amount of the obligation and timing of payment is likely to change. See Note 13"Revenue Interest Purchase Agreement"of the "Notes to Unaudited Condensed Consolidated Financial Statements" that appears in Item 1. "Financial Statements" of this Quarterly Report for more information regarding the RIPA.
•We are obligated to make payments under our operating leases, which primarily consist of facility leases. See Note 12"Lease Arrangements"and Note 15"Related-Party Agreements"of the "Notes to Unaudited Condensed Consolidated Financial Statements" that appear in Item 1. "Financial Statements" of this Quarterly Report for information regarding our lease obligations.
•In connection with the acquisitions of Altor and VivaBioCell, we are obligated to pay contingent consideration upon the achievement of certain milestones. See Note 11"Commitments and Contingencies-Contingent Consideration Related to Business Combinations"of the "Notes to Unaudited Condensed Consolidated Financial Statements" that appears in Item 1. "Financial Statements" of this Quarterly Report for information regarding our contingent consideration obligations.
•We have contractual obligations to make payments to related-party affiliates and third parties under unconditional purchase arrangements. See Note 9 "Commitments and Contingencies-Unconditional Purchase Obligations"of the "Notes to Consolidated Financial Statements" that appears in Part II, Item 8. "Financial Statements and Supplementary Data" of our Annual Report filed with the SEC on March 3, 2025 for information on these unconditional purchase obligations.
•We have certain unconditional contractual commitments that are expected to be paid depending on the actual progress of build outs, completion of services, or in accordance with the terms of the respective third-party agreements as the payments become due. These are primarily related to capital expenditures and open purchase orders as of September 30, 2025 for the acquisition of goods and services in the ordinary course of business. As of September 30, 2025, the amounts of the contractual commitments that are expected to be paid are $43.1 million within one year and $8.6 million for fiscal year 2026 and beyond.
ImmunityBio, Inc. and Subsidiaries
Management's Discussion and Analysis of Financial Condition and Results of Operations (Continued)
•In addition, we have conditional contractual commitments that are expected to be paid in fiscal year 2026 and beyond based on the achievement of various development, regulatory and commercial milestones for agreements with third parties. These payments may not be realized or may be modified and are contingent upon the occurrence of various future events, substantially all of which have a high degree of uncertainty of occurring. As of September 30, 2025, the maximum amount that may be payable related to these commitments is $88.2 million.
•In connection with our leasehold interest in the Dunkirk Facility, we committed to spend an aggregate of $1.52 billion on operational expenses during the initial 10-year term, and an additional $1.50 billion on operational expenses if we elect to renew the lease for the additional 10-year term. These amounts are not included in the discussion above. See Note 10"Collaboration and License Agreements and Acquisition-Acquisition"of the "Notes to Unaudited Condensed Consolidated Financial Statements" that appears in Item 1. "Financial Statements" of this Quarterly Report for more information on these obligations.
Critical Accounting Policies and Estimates
Our discussion and analysis of our financial condition and results of operations is based on our condensed consolidated financial statements, which have been prepared in accordance with U.S. GAAP. The preparation of condensed consolidated financial statements requires management to make certain estimates and assumptions that affect the reported amounts of assets, liabilities and expenses and the disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements and the reported amounts of revenues and expenses during the reporting period. Those estimates can be complex and actual results could differ materially from those estimates. Estimates are assessed each period and updated to reflect current information.
See Note 2 "Summary of Significant Accounting Policies"of the "Notes to Consolidated Financial Statements" that appears in Part II, Item 8. "Financial Statements and Supplementary Data" of our Annual Report filed with the SEC on March 3, 2025 for information on our significant accounting policies.
Recent Accounting Pronouncements
See Note 2"Summary of Significant Accounting Policies"of the "Notes to Unaudited Condensed Consolidated Financial Statements" that appears in Item 1. "Financial Statements" of this Quarterly Report for a discussion of recent accounting pronouncements or changes in accounting pronouncements that are of significance, or potential significance, to us.
Subsequent Event
Increase in Shares of Common Stock Authorized for Issuance
On October 20, 2025, ImmunityBio, Inc. filed a DEF 14C with the SEC to inform its stockholders of an action taken by its Board of Directors and by the written consent of stockholders representing a majority of the voting power of its common stock to amend its Amended and Restated Certificate of Incorporation to increase the number of authorized shares of common stock from 1.350 billion shares of common stock, $0.0001 par value per share, to 1.650 billion shares of common stock, $0.0001 par value per share. The number of shares of preferred stock, $0.0001 par value per share, that the company is authorized to issue remains unchanged at 20.0 million shares. We expect the amendment to take effect in November 2025.