ImmunityBio, Inc.
For the period ended Mar 31, 2025. Filed May 12, 2025.
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, 2025 · Filed May 12, 2025
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 2024-09-30; filed 2024-11-12.
0001326110-24-000111
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations—Future Funding RequirementsCurrent report: 10-Q
Period ended 2025-03-31; filed 2025-05-12.
0001326110-25-000071
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 248 previous paragraphs and 240 current paragraphs.
125 unchanged; 77 reworded; 35 added; 41 removed; 5 previous and 3 current paragraphs rearranged.
Tables are not compared: 5 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 (35)
Current report
•our ability to timely address the May 2025 RTF letter received from the FDA for the sBLA for the BCG-unresponsive NMIBC papillary indication;
Current report
Our Approved Product – ANKTIVA
Current 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.
Current report
ANKTIVA was approved by the FDA in 2024 for use in the United States 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.
Current 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 an sBLA in March 2025 and received an RTF letter from the FDA in May 2025, BCG-naïve CIS and BCG-naïve papillary), lung, colorectal, prostate and ovarian cancers, and GBM and NHL.
Current 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), and NHL (ANKTIVA in combination with rituximab). We are also exploring ANKTIVA in infectious diseases, including HIV and long COVID.
Current report
2025 Platforms and Indications
Current report
ImmunityBio Platforms – The Development of a Universal Therapeutic Cancer Vaccine
Current report
Based on the vision of activating the patient’s immune system, the company continues its efforts to demonstrate that a universal cancer vaccine 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.
Current report
•For the three months ended March 31, 2025—marking the first quarter with a permanent J-code that streamlined billing and reimbursement for prescribing providers—ImmunityBio achieved net product revenue of approximately $16.5 million, representing a 129% increase over $7.2 million in Q4 2024.
Current report
•ANKTIVA unit sales volume in Q1 2025 grew 150% over Q4 2024, with monthly volume in March up 69% over February.
Current report
•Nearly 200 urology practices across the United States are in the process of registering for ImmunityBio’s rBCG EAP, reflecting continued progress in ImmunityBio’s efforts to address the BCG shortage and broaden the market for ANKTIVA.
Current report
•The company completed a $75 million equity financing in April 2025 to support ongoing operations.
Current report
•In January 2025, an in-person meeting was held with leadership of CBER, CDER and OCE of the FDA, at which we provided the long-term cystectomy avoidance response rate results in papillary disease in patients with BCG-unresponsive NMIBC as well as a disease-specific overall survival rate of 99% at 12 months and 96% at 36 months. At this meeting, the leaders were asked, in light of these results, whether we should proceed with an sBLA based on our single-arm QUILT 3.032 clinical trial despite the FDA’s prior guidance that a randomized trial would be required. The FDA leaders present unanimously confirmed that ImmunityBio should expeditiously submit an sBLA for use of ANKTIVA plus BCG in BCG-unresponsive NMIBC for the indication of papillary disease. In March 2025, we submitted this sBLA based on data from the QUILT 3.032 clinical trial, consistent with the Agency’s recent guidance from the January 2025 meeting. On May 2, 2025, we received an RTF letter from the FDA for the sBLA stating that a randomized trial is required. This position is inconsistent with the guidance received at the January 2025 meeting. We are working to reconcile the inconsistency with the FDA as expeditiously as possible.
Current 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 significant revenue from our approved product 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.
Current report
NantWorks, LLC
Current report
Related-Party Leases
Current report
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 report
Related-Party Warrants
Current report
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, 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 report
Contingent Value Rights
Current 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 significant revenue from our approved product 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.
Current report
Our research and development expense primarily consists of:
Current report
Other Income (Expense), Net
Current report
Other Revenues
Current report
•a $0.3 million increase in equipment, depreciation, and facility costs, primarily due to increased facility expenses driven by building repairs and facility maintenance, partially offset by lower depreciation and amortization expenses and equipment expenses; and
Current report
•a $0.2 million increase in other research and development costs, primarily due to higher manufacturing costs and higher distribution costs driven by more production and clinical trial activities and higher license fees, partially offset by fewer sponsored research agreements.
Current report
Selling, general and administrative expense decreased $9.2 million during the three months ended March 31, 2025, as compared to the three months ended March 31, 2024. The decrease in selling, general and administrative expense was primarily driven by a$15.4 million decrease in legal expenses mainly due to lower costs related to litigation settlements, a$3.2 million decrease in commercial consulting activities, and a$0.4 million increase in net shared service costs charged out, partially offset by a $5.0 million increase in recruiting and training expenses, salaries, benefits and commissions, and travel expenses due to growing sales and marketing activities, a$2.6 million increase in stock-based compensation due to grants of 2025 equity incentive awards, and increased headcount, a$0.8 million increase in marketing and public relations expenses, a $0.5 million increase in facility costs, a $0.4 million increase in software license fees, a $0.3 million increase in distribution costs and a $0.2 million increase in research agreement costs.
Current report
Other Income (Expense), Net
Current report
Stock Purchase and Option Agreement
Current report
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, generating net proceeds of approximately $74.8 million, after deducting estimated offering costs. The warrants became immediately exercisable on April 9, 2025 and will expire five years after the issuance date on April 9, 2030.
Current report
RTF Letter from the FDA for sBLA for BCG-Unresponsive NMIBC Papillary Disease
Current report
In January 2025, an in-person meeting was held with leadership of CBER, CDER and OCE of the FDA, at which we provided the long-term cystectomy avoidance response rate results in papillary disease in patients with BCG-unresponsive NMIBC as well as a disease-specific overall survival rate of 99% at 12 months and 96% at 36 months. At this meeting, the leaders were asked, in light of these results, whether we should proceed with an sBLA based on our single-arm QUILT 3.032 clinical trial despite the FDA’s prior guidance that a randomized trial would be required. The FDA leaders present unanimously confirmed that ImmunityBio should expeditiously submit an sBLA for use of ANKTIVA plus BCG in BCG-unresponsive NMIBC for the indication of papillary disease. In March 2025, we submitted this sBLA based on data from the QUILT 3.032 clinical trial, consistent with the Agency’s recent guidance from the January 2025 meeting. On May 2, 2025, we received an RTF letter from the FDA for the sBLA stating that a randomized trial is required. This position is inconsistent with the guidance received at the January 2025 meeting. We are working to reconcile the inconsistency with the FDA as expeditiously as possible.
Removed paragraphs (41)
Previous report
•effectiveness of the J-code (HCPCS Level II Code) and timing thereof;
Previous report
Our lead biologic product ANKTIVA is a novel first-in-class IL-15 agonist antibody-cytokine fusion protein. On April 22, 2024, the FDA approved our product, ANKTIVA with BCG for the treatment of adult patients with BCG-unresponsive NMIBC with CIS, with or without papillary tumors. Based on ANKTIVA’s unique mechanism of action, we believe it has the potential to play a key role as a backbone for immunotherapy beyond T cells alone across multiple tumor types in the years to come. We began commercial distribution of our approved product in May 2024.
Previous report
Further late-stage efforts for ANKTIVA are in development within the broader bladder cancer space, including BCG-naïve NMIBC. In addition, data from multiple clinical trials suggest ANKTIVA has potential to enhance the activity of therapeutic mAbs, including checkpoint inhibitors (e.g., pembrolizumab/Keytruda), across a wide range of tumor types. 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. In addition to ANKTIVA, we have active clinical programs evaluating therapeutic candidates from our DNA and RNA vaccine technology platforms and our NK cell-based therapy platforms in oncology and infectious disease indications.
Previous report
•ANKTIVA received a J-code (HCPCS Level II Code) in October 2024, effective January 1, 2025.
Previous report
•ANKTIVA (FDA-approved and commercially available in the U.S. since May 2024) is now widely accessible to patients through commercial and government insurance programs (VA, DoD, Medicare). ImmunityBio has secured coverage for over 200 million medical lives through medical reimbursement policies.
Previous report
•ImmunityBio has extended the shelf life of ANKTIVA from two years to three years, with over 125,000 doses, providing ample product for the market and for clinical trials.
Previous report
•ImmunityBio submitted to the MHRA an MAA for ANKTIVA in the UK on November 1, 2024.
Previous report
•ImmunityBio intends to submit to the EMA an MAA for ANKTIVA in the EU in Q4 2024, covering 30 countries, including 27 in the EU and 3 in the EEA (Iceland, Norway, Liechtenstein).
Previous report
COVID-19 Pandemic
Previous report
The COVID-19 pandemic continues to present a public health and economic challenge around the world. Through the date of this Quarterly Report, we have not seen a material adverse impact to our business from the pandemic. However, given the continuously evolving nature of the pandemic, we cannot at this time predict the specific extent, duration, or full impact that this pandemic may have on our financial condition and results of operations, including ongoing and planned clinical trials. More specifically, the pandemic may result in prolonged impacts that we cannot predict at this time, and we expect that such uncertainties will continue to exist for the foreseeable future.
Previous report
We continue to monitor the impact of COVID-19 on our business, including our clinical trials, manufacturing facilities and capabilities, and ability to access necessary resources. For a discussion of the risks presented by the COVID-19 pandemic to our results of operations and financial condition, see Part II, Item 1A. “Risk Factors” of this Quarterly Report.
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 significant revenue from our approved product and we can provide no assurances 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
In 2021, we completed a review of alternative structures that could support our more complex clinical trial requirements and made a decision to explore a potential transition of clinical trials at the Clinic to a new structure (including contracting with a new, non-affiliated professional corporation) to be determined and agreed upon by all parties. While we have not yet finalized the potential transaction, we continue discussions with potential partners around alternative structures. During the nine months ended September 30, 2024 and 2023, we incurred $2.1 million and $1.9 million, respectively, inresearch and development expense, on the condensed consolidated statements of operations related to clinical trial and transition services provided by the Clinic.
Previous report
Revenue
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 significant revenue from our approved product and we can provide no assurances 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
Our research and development expenses primarily consist of:
Previous report
Research and development expense increased $2.0 million primarily attributable to the following:
Previous report
•a $2.2 million increase in other research and development costs, primarily due to a credit allocated to a joint venture in the prior period that is not expected to recur, a gain recognized from the termination of a lease used for R&D in the prior period, and higher lab supplies and distribution costs.
Previous report
We expect our research and development expenses 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
Selling, general and administrative expense increased $4.1 million during the three months ended September 30, 2024, as compared to the three months ended September 30, 2023. The increase in selling, general and administrative expense was primarily driven by a$5.3 million increase in salary and benefits expenses, primarily due to the reversal of accrued discretionary bonuses for 2022 not paid and a reduction in headcount during the three months ended September 30, 2023, an increase of$4.9 million in consulting costs, primarily associated with commercial activities, an increase of $0.6 million in equipment, depreciation and facility costs, an increase of $0.5 million in recruiting fees, an increase of$0.4 million in travel expenses, and an increase of$0.3 million in license fees. The increase in selling, general and administrative expense was partially offset by a$4.3 million decrease in legal expenses and a$3.6 million decrease in stock-based compensation expense.
Previous report
Comparison of the Nine Months Ended September 30, 2024 and 2023
Previous report
Product revenue, net increased $6.9 million during the nine months ended September 30, 2024, as compared to the nine months ended September 30, 2023. The increase was driven by sales of ANKTIVA after FDA approval in April 2024.
Previous report
Other revenues decreased $0.2 million during the nine months ended September 30, 2024, as compared to the nine months ended September 30, 2023 as a result of a decline in grant revenue.
Previous report
Research and Development Expense
Previous report
•a $30.8 million decrease in external research and development expenses that was primarily due to a reduction in CMO fees and drug materials purchased and used in manufacturing, a reduction in clinical trial costs, and a reduction in outside services costs; partially offset by
Previous report
•a $3.8 million increase in personnel-related costs that was primarily due to an increase in salary and benefits expense from the write off of accrued discretionary bonuses for 2022 not paid and a reduction in headcount during the nine months ended September 30, 2023, partially offset by a decrease in stock-based compensation costs due to decreases in headcount during the nine months ended September 30, 2024;
Previous report
•a $0.3 million decrease in equipment, depreciation, and facility costs that was primarily due to a decrease in lease expense due to the termination of a lease used for R&D in the prior period and a decrease in depreciation expense due to fully depreciated assets, partially offset by increased facility costs; and partially offset by
Previous report
•a $1.4 million increase in other research and development costs, primarily attributable to no costs allocated to a joint venture and higher research agreements cost due to new agreements, partially offset by lower manufacturing cost due to decreased production activities.
Previous report
Selling, General and Administrative Expense
Previous report
Selling, general and administrative expense increased $30.5 million during the nine months ended September 30, 2024, as compared to the nine months ended September 30, 2023. The increase in selling, general and administrative expense was primarily driven by an increase of$16.9 million in legal expenses, driven by higher defense costs and increased general legal services, an increase of$12.2 million in consulting costs, primarily associated with commercial readiness activities, a$7.0 million increase in salary and benefits expenses primarily due to the reversal of accrued discretionary bonuses for 2022 not paid and a reduction in headcount during the nine months ended September 30, 2023, a $0.9 million increase in license fees, and a $0.7 million increase in marketing expenses, partially offset by a$7.2 million reduction in stock-based compensation expense.
Previous report
Other expense, net increased $6.1 million during the nine months ended September 30, 2024, as compared to the nine months ended September 30, 2023. The increase in other expense, net was primarily driven by an increase of $28.2 million of interest expense related to the revenue interest liability, an increase of $21.6 million due to the change in fair value of warrant liabilities, and a $0.7 million decrease from a gainin the fair value of a related-party convertible note recorded during the prior period. These increases were partially offset by a decrease of$20.1 million due to the change in fair value of derivative liabilities, a decrease of$8.5 million in interest expense (including amounts with related parties), a decrease of $7.5 million due to loss on equity method investments recorded during the prior period, an increase of$6.1 million in interest and investment income, net, and a decrease of$2.2 million in other expense, net (including amounts with related parties).
Previous report
Open Market Sale Agreement
Previous report
In April 2024, we filed a shelf registration statement and associated prospectus that increased the amount available under the ATM to $300.8 million. As of September 30, 2024, we had $296.5 million available for future stock issuances under the ATM.
Previous report
Amounts available for use as of September 30, 2024 under these shelf registration statements are in addition to the amount available under the ATM described above.
Previous report
Exercise of Warrants
Previous report
During the nine months ended September 30, 2024, 22,242,740 of the February and July 2023 Warrants were exercised from which we received proceeds of $73.3 million. As of September 30, 2024, a total of 15,490,080 warrants remained outstanding at exercise prices ranging from $3.2946 per share to $6.60 per share.
Previous report
During the three months ended September 30, 2024, institutional holders exercised a total of 4,740,249 warrants pursuant to the February 2023 Warrant agreement at an exercise price of $3.2946 per share resulting in the issuance of 4,740,249 shares of the company’s common stock for proceeds totaling $15.6 million.
Previous report
◦Pursuant to the terms of the amended and restated promissory note, the amended $505.0 million December 2023 promissory note is comprised of the Tranche 1 principal amount of $125.0 million and the Tranche 2 principal amount of $380.0 million. All of the Tranche 2 principal amount of $380.0 million and any accrued and unpaid interest can be converted into shares of the company’s stock at $8.2690 per share at the option of the noteholder. The interest rates for the Tranche 1 principal amount and Tranche 2 principal amount of the $505.0 million December 2023 promissory note were Term SOFR plus 8.0% per annum and Term SOFR plus 7.5% per annum, respectively.
Previous report
◦The $200.0 million convertible promissory note bears interest at Term SOFR plus 8.0% per annum. The noteholder has the sole option to convert all of the outstanding principal amount and accrued but unpaid interest into shares of the company’s common stock at a conversion price of $1.9350 per share.
Previous report
◦The $30.0 million convertible promissory note bears interest at Term SOFR plus 8.0% per annum. The noteholder has the sole option to convert all of the outstanding principal amount and accrued but unpaid interest into shares of the company’s common stock at a conversion price of $2.28 per share.
Showing the first 40 of 41 passages. Open the source sections for the rest.
Reworded paragraphs (77)
Previous wording
•our ability to successfully commercialize our approved product or any future approved products;
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•our ability to successfully commercialize ANKTIVA or any future approved products;
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•our ability to obtain incremental approvals for ANKTIVA for new indications from the FDA or clearances or approvals from international regulatory agencies for the treatment of patients with NMIBC or other indications;
Current wording
•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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•potential futures uses and applications of ANKTIVA 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, and use in cancer vaccines and across multiple tumor types;
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•our ability to meet our payment obligations under the RIPA and to service the interest on our related-party promissory notes and repay such notes, to the extent required;
Current wording
•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;
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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 values;
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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;
Previous wording
•our expectations regarding our ability to utilize the Phase I/II aNK and haNK® clinical trials data to support the development of our product candidates, including our haNK, taNK, t‑haNK™, MSC, and M-ceNK™ product candidates;
Current wording
•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 the development, application, commercialization, marketing, prospects and use generally of our product candidates, including hAd5 and saRNA constructs, and PD-L1 t‑haNK and M-ceNK;
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•our expectations regarding the development, application, commercialization, marketing, prospects and use generally of our product candidates, including hAd5 constructs, and PD-L1 t‑haNK and M-ceNK;
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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 IND, BLA, NDA or MAA or similar filings or pursuit of accelerated regulatory approval pathways or orphan drug status and Breakthrough Therapy designations;
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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 ability and willingness of various third parties to engage in R&D 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 candidates, and our ability to leverage those activities;
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•our expectations regarding the timing of enrollment and submission of our clinical trials, and protocols related to such trials;
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•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;
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•our ability to produce an antibody-cytokine fusion protein, a DNA, RNA, or recombinant protein vaccine, or a cell therapy;
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•our ability to produce a cytokine fusion protein, a DNA or recombinant protein vaccine, or a cell therapy;
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•our belief in the potential of our antibody-cytokine fusion proteins, DNA, RNA, or recombinant protein vaccines, or cell therapies, and the fact that our business is based upon the success individually and collectively of these platforms;
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•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;
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•our belief regarding the magnitude or duration for additional clinical testing of our antibody-cytokine fusion proteins, DNA, RNA or recombinant protein vaccines, or cell therapies, along with other product candidate families;
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•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;
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•even if we successfully develop and commercialize other specific product candidates, our ability to develop and commercialize our other product candidates either alone or in combination with other therapeutic agents;
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•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;
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•the ability to 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;
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•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;
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•any government shutdown, which could adversely affect the U.S. and global economies, and materially and adversely affect our business and/or our future BLA submissions;
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•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;
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ImmunityBio, NantKwest, ANKTIVA, VesAnktiva, ThAnktiva, NK-92, ceNK, M-ceNK, haNK, taNK, t-haNK, GlobeImmune, Tarmogen, VivaBioCell, Nant001, NantXL, Nant Cancer Vaccine, QUILT, IPRT, Outsmart Your Disease, Smart Therapies for Difficult Diseases, and Nature’s First Responder are trademarks of ImmunityBio, Inc., its subsidiaries, or its affiliates.
Current wording
ImmunityBio, ImmunityBio Care, ANKTIVA, ThAnktiva, haNK, taNK, ceNK, NK-92, Nant Cancer Vaccine, 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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Our product candidates are investigational agents that are restricted by federal law to investigational use only. Safety and efficacy have not been established by any agency, including the FDA.
Current wording
ANKTIVA has been approved by the U.S. FDA 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 the FDA.
Previous wording
This Quarterly Report contains references to our trademarks 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 TM symbols, 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’ trade names or trademarks to imply a relationship with, or endorsement or sponsorship of us, by any other companies.
Current wording
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 TM symbols, 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.
Previous wording
ImmunityBio is a vertically-integrated biotechnology company developing next-generation therapies and vaccines 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. We are applying our 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.
Current wording
ImmunityBio is a vertically-integrated biotechnology company developing next-generation therapies and vaccines 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 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 natural killer cells, T cells, and memory T cells for a long duration response. The company is applying our 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 wording
Our proprietary platforms for the development of biologic product candidates include: (i) antibody-cytokine fusion proteins, (ii) DNA, RNA, and recombinant protein vaccines, and (iii) cell therapies. As of September 2024, our platforms have generated nine first-in-human therapeutic agents (including one FDA-approved agent) that are currently or planned to be studied in clinical trials in liquid and solid tumors. Specifically, our clinical focus includes bladder, lung, and colorectal cancers and GBM, which 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.
Current wording
Our proprietary platforms for the development of biologic products and product candidates include:
Previous wording
As of September 2024, our platforms have generated nine first-in-human therapeutic agents (including one FDA-approved agent) that are currently or planned to be studied in 24 clinical trials across 17 indications in liquid and solid tumors, including bladder, lung and colorectal cancers, and GBM. These indications are among the most frequent and lethal cancer types for which there are high failure rates for existing standards of care or, in some cases, 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.
Current wording
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 March 2025, our platforms have generated nine first-in-human therapeutic agents (including one agent approved by the FDA) 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 wording
Our platforms and their associated 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 checkpoint inhibitors, and/or reduce the need for standard high-dose chemotherapy in cancer by employing this coordinated approach to establish “immunological memory” that confers long-term benefit for the patient.
Current wording
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 wording
The following is a summary of selected significant developments affecting our business that occurred since the filing of our Quarterly Report dated June 30, 2024 with the SEC on August 12, 2024:
Current wording
The following is a summary of selected significant developments affecting our business that occurred since the filing of our Annual Report dated December 31, 2024 with the SEC on March 3, 2025:
Previous wording
We expect to continue to incur significant expenses as we seek to expand our business, including in connection with 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, seeking regulatory approvals, increasing our manufacturing capabilities and, upon successful receipt of FDA approval, commercializing our products. 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.
Current wording
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 wording
We have incurred net losses in each year since our inception and, as of September 30, 2024, we had an accumulated deficit of $3.3 billion. During the nine months ended September 30, 2024 and 2023, net losses attributable to ImmunityBio common stockholders were $354.4 million and $349.8 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.
Current wording
We have incurred net losses in each year since our inception and, as of March 31, 2025, we had an accumulated deficit of $3.5 billion. During the three months ended March 31, 2025 and 2024, net losses attributable to ImmunityBio common stockholders were $129.6 million and $134.1 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 wording
As of September 30, 2024, we had 672 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 12, 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.
Current wording
As of March 31, 2025, we had 671 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 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 technologies and 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 believe we are well positioned to become a leader in immunotherapy due to our broad and vertically-integrated platforms and through complementary strategic partnerships.
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 checkpoint inhibitors, across a wide range of tumor types. 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 19, 2024 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 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.
Previous wording
Our Executive Chairman and Global Chief Scientific and Medical Officer 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.
Current wording
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.
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.
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 Item 1. “Financial Statements” of this Quarterly Report for more information regarding our agreements with the Clinic.
Previous wording
Cost of product revenue consists primarily of third-party manufacturing costs, distribution, and overhead costs related to ANKTIVA sales. Cost of product revenue 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 product revenue.
Current wording
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 wording
We generally classify our operating expenses into cost of product revenue, 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.
Current wording
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.
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 product candidates. We recognize research and development expenses as they are incurred.
Current 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.
Previous 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.
Current 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.
Previous wording
We expect our research and development expenses 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.
Current wording
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.
Previous wording
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 indications for ANKTIVA. This is due to the numerous risks and uncertainties associated with the development of product candidates.
Current wording
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.
Previous wording
•the cost of comparative agents used in clinical trials;
Current wording
•the cost of comparative or combination agents used in clinical trials;
Previous wording
•potential additional safety monitoring or other studies requested by regulatory agencies;
Current wording
•potential additional safety monitoring or other studies or incremental cohorts requested by regulatory agencies;
Previous wording
We have only one approved product, ANKTIVA, for which we received approval from the FDA on April 22, 2024. We began commercial distribution of our approved product 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. We do not expect any of our other product candidates to be commercially available in the foreseeable future, if ever.
Current wording
We have only one approved product, ANKTIVA, for which we received approval from the FDA on April 22, 2024. We began commercial distribution of our approved product 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.
Showing the first 40 of 77 pairs. Open the source sections for the rest.
Rearranged current paragraphs (3)
Current report — wording carried from elsewhere
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 report — wording carried from elsewhere
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, 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 report — wording carried from 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.
Rearranged previous paragraphs (5)
Previous report — wording carried elsewhere
•our ability to successfully commercialize our approved product;
Previous report — wording carried elsewhere
See Note 12, 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 related-party agreements.
Previous report — wording carried elsewhere
We did not report cost of product revenue during the nine months ended September 30, 2024. Cost of product revenue 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 product revenue. As a result, our initial product gross margin is higher as our pre-launch inventory costs are not included in the cost of product revenue. We expect the cost of product revenue for ANKTIVA to increase in relation to product revenues as we deplete these inventories.
Previous report — wording carried elsewhere
Research and development expense decreased $25.9 million during the nine months ended September 30, 2024, as compared to the nine months ended September 30, 2023. The following table summarizes our research and development expenses during the nine months ended September 30, 2024 and 2023, together with the changes in those items (in thousands):
Previous report — wording carried elsewhere
On April 22, 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.