ImmunityBio, Inc.
For the period ended Mar 31, 2026. Filed May 7, 2026.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Mar 31, 2026 · Filed May 7, 2026
IBRX$8.64+7.8%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-09-30; filed 2025-11-05.
0001326110-25-000139
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations—Future Funding RequirementsCurrent report: 10-Q
Period ended 2026-03-31; filed 2026-05-07.
0001326110-26-000059
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations—Future Funding RequirementsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 262 previous paragraphs and 251 current paragraphs.
104 unchanged; 75 reworded; 72 added; 75 removed; 8 previous and 0 current paragraphs rearranged.
Tables are not compared: 6 previous and 4 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (72)
Current report
•our ability to successfully address any concerns the FDA may have associated with the sBLA for the BCG-unresponsive NMIBC with papillary tumors indication, and whether or not we will receive a CRL if there is a need for the initiation or design of a new RCT, which we could ultimately be required to complete;
Current report
•our ability to enter into and successfully execute on clinical, regulatory and commercial arrangements internationally to accelerate the development and commercialization of ANKTIVA and our other product candidates;
Current report
•our plans regarding manufacturing and distribution of our approved product and potential future products, including the enhancement of our in-house manufacturing capabilities;
Current report
•our expectations regarding the abilities of our international partners to drive commercialization of ANKTIVA in the EU and MENA regions;
Current report
•our global expansion efforts and the accuracy of our assumptions related to tariffs and government policy changes, including Most-Favored Nation Prescription Drug Pricing;
Current report
ImmunityBio, Inc. is a biotechnology company focused on innovating, developing, and commercializing next-generation immunotherapies designed to activate the patient’s immune system and deliver durable protection against cancer and infectious diseases. Our approach harnesses both the adaptive and innate immune systems with the goal of restoring immune function and generating lasting immunological memory in patients. At the core of our strategy is the Cancer BioShield platform, which is designed to stimulate critical lymphocytes, including natural killer (NK) cells, cytotoxic T cells, and memory T cells via our proprietary IL-15 superagonist, ANKTIVA. Our Cancer BioShield platform is anchored by this antibody-cytokine fusion protein and is complemented by a portfolio that includes adenovirus-vectored vaccines, allogeneic (off-the-shelf) and autologous NK-cell therapies, and additional immunomodulators intended to promote immunogenic cell death and support durable immune responses while potentially reducing reliance on high-dose chemo-radiation therapy.
Current report
ANKTIVA is our lead biological product and a first-in-class IL-15 receptor superagonist antibody-cytokine fusion protein. We are commercializing ANKTIVA for the treatment of BCG-unresponsive NMIBC with CIS, with or without papillary tumors. ANKTIVA has received FDABreakthrough Therapy designation for use in BCG-unresponsive NMIBC with CIS in adult patients, with or without papillary tumors.
Current report
ANKTIVA is now approved in the U.S., UK, and Saudi Arabia for BCG-unresponsive NMIBC with CIS, with or without papillary tumors. In February 2026, the European Commission granted conditional marketing authorization in the EU for ANKTIVA for the same indication. In addition, ANKTIVA is conditionally approved in Saudi Arabia, for use in combination with a CPI, for the treatment of adult patients with metastatic NSCLC whose disease has progressed following standard-of-care therapy. The approved labels highlight ANKTIVA’s ability to simultaneously activate NK cells, cytotoxic T cells, and memory T cells.
Current report
ANKTIVA in combination with our CAR-NK therapy (PD-L1 t-haNK) has received RMAT designation from the FDA for use in combination with standard-of-care chemotherapy/radiotherapy for the reversal of lymphopenia and treatment of multiply relapsed locally advanced or metastatic pancreatic cancer. Separately, the FDA has authorized an EAP for ANKTIVA to treat lymphopenia in adult patients with refractory or relapsed solid tumors, regardless of tumor type, who have progressed following first-line standard-of-care treatment, including chemotherapy, radiation, or immunotherapy. The EAP includes patients with solid tumors who have failed first-line therapy and have a low ALC (ALC <1,000/μL).
Current report
We are seeking to expand development of ANKTIVA in combination with current standard-of-care therapies across multiple solid and liquid tumor indications including:
Current report
•BCG-naïve NMIBC;
Current report
•BCG-unresponsive NMIBC with papillary tumors;
Current report
•Second-line NSCLC;
Current report
•First-line NSCLC;
Current report
•Glioblastoma;
Current report
•Indolent non-Hodgkin lymphoma, including Waldenström macroglobulinemia;
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•Pancreatic cancer;
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•Prostate cancer; and
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•Ovarian cancer.
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In addition, ANKTIVA has been selected by the NCI for evaluation in a cancer prevention study in patients with Lynch syndrome, and we are evaluating the combination of ANKTIVA with other agents in colorectal cancer. The company is also supporting an ongoing EAP for rBCG to help address U.S. supply constraints. We are also establishing or conducting trials in multiple myeloma, HCC, and TNBC.
Current report
•Q1 2026 Revenue Growth with Continued Strong Sales Momentum: $44.2 million, representing an ~168% year-over-year increase compared with Q1 2025 and up 15% from Q4 2025
Current report
•ANKTIVA Regulatory Update: ANKTIVA is now approved or authorized across five regulatory jurisdictions, representing approximately 34 countries, including first approval in Asia by the ISAF of the Macau Special Administrative Region of the People’s Republic of China. Commercial availability achieved within two months of announcing MENA partnership with Biopharma and Cigalah Healthcare.
Current report
•Pivotal BCG-Naïve CIS trial (QUILT-2.005): Fully enrolled, with the IDMC confirming no additional enrollment is required. An sBLA submission is on track for 2026.
Current report
•BCG-Unresponsive NMIBC with Papillary-Only Disease Category 2A NCCN Recommendation: NCCN Clinical Practice Guidelines in Oncology have been updated to include ANKTIVA plus BCG for patients with BCG-unresponsive NMIBC with papillary-only disease in addition to CIS, with or without papillary tumors. Both recommendations are Category 2A, representing uniform consensus.
Current report
Pipeline Summary
Current report
Cancer BioShield Platform Components Addressing the Immune System
Current report
As of March 31, 2026, our pipeline includes clinical-stage programs in the following indications:
Current report
•Bladder Cancer: BCG-unresponsive NMIBC with CIS, with or without papillary tumors (approved), BCG-unresponsive papillary, BCG-naïve NMIBC
Current report
•Lung Cancer: Progressing, metastatic NSCLC in combination with CPIs (accelerated conditional approval in Saudi Arabia)
Current report
•Lymphopenia: Tumor-agnostic treatment of chemotherapy/radiation-induced lymphopenia (EAP authorized)
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•Pancreatic Cancer: Advanced/metastatic disease (RMAT designation)
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•Glioblastoma: Recurrent GBM (registration trial)
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•Non-Hodgkin Lymphoma: Waldenström macroglobulinemia and other CD19+/CD20+ lymphomas
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•Colorectal Cancer/Lynch Syndrome: Cancer prevention in high-risk patients (NCI-sponsored)
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•Prostate Cancer: High-risk prostate cancer
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•Ovarian Cancer: Platinum-resistant ovarian cancer
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•Infectious Diseases: HIV, Long COVID, universal nucleocapsid vaccine
Current report
•Apheresis Platform: M-ceNK with cryopreservation and storage
Current report
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Removed paragraphs (75)
Previous report
•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;
Previous report
•details regarding our strategic vision and planned product candidate pipeline;
Previous report
•the timing of the development and commercialization of our other product candidates;
Previous report
•whether the NCCN will review and/or approve our submission for BCG-unresponsive NMIBC papillary on the anticipated timeline or at all;
Previous report
•our ability to successfully address the May 2025 RTF letter received from the FDA for thesBLA 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;
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•our ability to attract additional third-party collaborators;
Previous report
•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;
Previous report
•our plans regarding our manufacturing facilities and our belief that our manufacturing is capable of being conducted in‑house;
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•our global expansion efforts;
Previous report
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.
Previous report
Our Approved Product – ANKTIVA
Previous report
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.
Previous report
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.
Previous report
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.
Previous report
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 ansBLA 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.
Previous report
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.
Previous report
2025 Platforms and Indications
Previous report
Our proprietary platforms for the development of biologic products and product candidates include:
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Our Pipeline
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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.
Previous report
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.
Previous report
ImmunityBio Platforms – The Development of a Universal Therapeutic CancerBioShield
Previous report
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.
Previous report
•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.
Previous report
•Product Revenue: Up 434% in Q3 2025 versus Q3 2024, with year-to-date sales of $74.7 million.
Previous report
•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.
Previous report
•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.
Previous report
•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.
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•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.
Previous report
•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.
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Operating Results
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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.
Previous report
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.
Previous report
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 the nine months ended September 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.
Previous report
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.
Previous report
Components of our Results of Operations
Previous report
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.
Previous report
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.
Previous report
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 inresearch 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.
Previous report
Operating Expenses
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Previous wording
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:
Current wording
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 Part I, 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:
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•our ability to successfully commercialize ANKTIVA or any future approved products in the U.S. or internationally;
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•our ability to successfully commercialize ANKTIVA globally in NMIBC, NSCLC or other indications or any future approved products in the U.S. or internationally;
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•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;
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•our ability to obtain incremental approvals for ANKTIVA for new indications, including, without limitation, in BCG-unresponsive NMIBC with CIS, with papillary tumors and NSCLC from the FDA or clearances or approvals from international regulatory agencies for the treatment of patients with NMIBC, NSCLC or other indications;
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•potential future uses and applications of ANKTIVA, including as a lymphopenia rescue agent, and use in cancer vaccines and across multiple tumor types;
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•potential future uses and applications of ANKTIVA, including as a lymphopenia rescue agent in solid tumors or other indications, and use in cancer vaccines and across multiple tumor types;
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•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;
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•our ability to obtain additional financing to fund our operations and advance the commercialization of our approved product and the development and commercialization of our other product candidates;
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•our expectations regarding the potential benefits of our strategy and technology;
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•our expectations regarding the potential benefits of our Cancer BioShield platform (comprises multiple therapeutic modalities to activate immune response) and our strategy and technology;
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•our ability to forecast operating results and make period-to-period comparisons predictive of future performance due to fluctuations in warrant and derivative values;
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•our ability to forecast operating results and make period-to-period comparisons predictive of future performance, including due to the impact of fluctuations in warrant, derivative, and fair value accounting measurement values;
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•our expectations regarding the operation and effectiveness of our product candidates and related benefits;
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•our expectations regarding the operation and effectiveness of our approved product and product candidates and related benefits;
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•our ability to utilize multiple modes to induce cell death;
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•our ability to utilize multiple modes to induce cell death in cancers and infectious diseases;
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•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;
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•our beliefs regarding the success, cost and timing of our approved product and product candidate development activities and current and future clinical trials and studies, including study design, the enrollment of patients, and the timing of data readouts related thereto;
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•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;
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•our expectations regarding our ability to utilize the Phase 1/2 aNK, haNK®, taNK, and NK-CAR (t-haNK™) clinical trials data to support the development of our product candidates, including our NK-CAR (t-haNK), MSC, and M-ceNK™ product candidates;
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•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;
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•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 impact on BLA submission filing or approval timing and or approval probability;
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•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;
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•the ability and willingness of various third parties to engage in research and development activities involving our product or product candidates, and our ability to leverage those activities;
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•our expectations regarding the ease of administration associated with our product candidates;
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•our expectations regarding the ease of administration associated with our approved product and product candidates;
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•our expectations regarding patient compatibility associated with our product candidates;
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•our expectations regarding patient compatibility associated with our approved product and product candidates;
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•our beliefs regarding the potential markets for our product candidates and our ability to serve those markets;
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•our beliefs regarding the potential markets for our approved product and product candidates and our ability to serve those markets, including the rate and degree of market acceptance of any approved products;
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•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;
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•our beliefs regarding the potential manufacturing and distribution benefits associated with our approved product and product candidates, and our third-party CMOs’ abilities to follow cGMP standards to scale up the production of our approved product and product candidates;
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•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;
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•our ability to obtain, maintain, protect, and enforce patent protection and other proprietary rights for our approved product and our other product candidates, and other technologies in development;
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•shelf life of ANKTIVA drug substance and drug product and availability of product supply;
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•the expected shelf life of ANKTIVA drug substance and drug product and availability of product supply;
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•the impact on us, if any, if the CVRs held by former Altor stockholders become due and payable in accordance with their terms; and
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•the impact on us, if any, if the CVRs held by former Altor stockholders become due and payable; and
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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.
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ImmunityBio, ImmunityBio Care, ANKTIVA, ThAnktiva, haNK, taNK, ceNK, NK-92, Nant Cancer Vaccine, 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.
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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.
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ANKTIVA has been approved by the U.S. FDA, the UK MHRA, the SFDA, and the ISAF of the Macau Special Administrative Region of the People’s Republic of China and has been granted conditional marketing authorization from the EC (EMA) for the EU and Iceland, Liechtenstein, and Norway for use with BCG for the treatment of adult patients with BCG-unresponsive NMIBC with CIS, with or without papillary tumors. ANKTIVA has also received conditional approval from the SFDA in combination with checkpoint therapy for adult patients with metastatic NSCLC whose disease has progressed following standard-of-care therapy. 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.
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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:
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The following is a summary of selected significant developments affecting our business that occurred since the filing of our Annual Report dated December 31, 2025 with the SEC on February 23, 2026:
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•ANKTIVA Unit Growth: 467% unit sales volume growth in year-to-date 2025 compared to fiscal year 2024.
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•ANKTIVA Unit Growth: 168% increase in unit sales volume in Q1 2026 compared to Q1 2025
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•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.
Current wording
•Cash Position: $380.9 million in cash, cash equivalents and marketable securities as of March 31, 2026, up from $242.8 million as of December 31, 2025.
Previous wording
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.
Current wording
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 have initiated strategic commercial partnerships in Europe and the Middle East to expand access to our approved product and expect to continue to form additional commercial partnerships in other regions as our business grows.
Previous wording
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.
Current wording
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 monoclonal antibodies, 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 February 23, 2026 for a more detailed discussion regarding our collaboration and license agreements.
Previous wording
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.
Current wording
See Note 14 “Related-Party Debt” of the “Notes to Unaudited Condensed Consolidated Financial Statements” that appears in Part I, Item 1. “Financial Statements” of this Quarterly Report for information regarding our related-party debt.
Previous wording
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.
Current wording
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 Part I, Item 1. “Financial Statements” of this Quarterly Report for more information regarding our agreements with NantWorks.
Previous wording
We have entered into multiple agreements withthe Clinicto 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.
Current wording
We have entered into multiple agreements withthe Clinicto 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 Part I, Item 1. “Financial Statements” of this Quarterly Report for more information regarding our agreements with the Clinic.
Previous wording
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.
Current wording
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 Part I, Item 1. “Financial Statements” of this Quarterly Report for more information about our related-party leases.
Previous wording
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.
Current wording
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 March 31, 2026. See Note 18 “Stock-Based Compensation” of the “Notes to Unaudited Condensed Consolidated Financial Statements” that appears in Part I, Item 1. “Financial Statements” of this Quarterly Report for more information regarding the related-party warrants.
Previous wording
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.
Current wording
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 March 31, 2026, 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 Part I, Item 1. “Financial Statements” of this Quarterly Report for more information regarding the CVRs.
Previous wording
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.
Current wording
Product revenue, net increased $27.7 million during the three months ended March 31, 2026, as compared to the three months ended March 31, 2025, due to an increase in sales of ANKTIVA.
Previous wording
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.
Current wording
Other revenues increased during the three months ended March 31, 2026, as compared to the three months ended March 31, 2025, primarily due to increased bioreactor related consumable product sales, and increased license royalty income.
Previous wording
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 inresearch 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.
Current wording
Cost of sales increased $0.2 million during the three months ended March 31, 2026, as compared to the three months ended March 31, 2025. 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 inresearch 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.
Previous wording
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.
Current wording
Research and development expense consists of expenses incurred while performing research and development activities to expand the approved markets, label, and indications of our approved product ANKTIVA and 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.
Previous wording
•expenses incurred under agreements with investigative sites and consultants that conduct our clinical trials;
Current wording
•expenses incurred under agreements with investigative sites, CROs, and consultants that conduct our clinical trials;
Previous wording
•facility expenses dedicated to research and development.
Current wording
•facility and equipment expenses dedicated to research and development.
Previous wording
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.
Current wording
The company classifies its research and development expenses as either external or internal. The company’s external research and development expenses support its various preclinical and clinical programs. The company’s internal research and development expenses include payroll and benefits expenses, facilities and equipment expense, and other indirect research and development expenses 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.
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Previous report — wording carried elsewhere
•the rate and degree of market acceptance of any approved products;
Previous report — wording carried elsewhere
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.
Previous report — wording carried elsewhere
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.
Previous report — wording carried elsewhere
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):
Previous report — wording carried elsewhere
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.
Previous report — wording carried elsewhere
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.
Previous report — wording carried elsewhere
We anticipate that we will need substantial additional funding in connection with our continuing operations.
Previous report — wording carried elsewhere
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.