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CULVER CITY, Calif.--(BUSINESS WIRE)-- ImmunityBio, Inc. (NASDAQ: IBRX), a commercial-stage immunotherapy company, today announced full-year 2025 financial and operational highlights, including approximately $113 million in net product revenue for ANKTIVA, representing an approximately 700% increase year-over-year. The Company also reported a 750% increase in unit sales volume and a 20% quarter-over-quarter increase in net product revenue, demonstrating sustained commercial momentum. In parallel, ImmunityBio expanded its global regulatory footprint to 33 countries across four jurisdictions and secured the first approval for ANKTIVA in combination with checkpoint inhibitors for lung cancer.
Global Regulatory Approvals
ANKTIVA in combination with BCG for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) carcinoma in situ (CIS), with or without papillary tumors, is now authorized across four major regulatory jurisdictions encompassing 33 countries:
This global regulatory footprint of 33 countries was established in under two years from initial 2024 FDA approval, representing the most rapid international expansion for an immunotherapy in this indication.
First Approval for Lung Cancer and Label Expansion Plans
In January 2026, the SFDA granted conditional accelerated approval for ANKTIVA® in combination with checkpoint inhibitors for the treatment of metastatic NSCLC, making Saudi Arabia the first jurisdiction globally to authorize ANKTIVA outside of bladder cancer. The commercial launch in Saudi Arabia is planned within 60 days of approval. Submissions to multiple additional regulatory authorities (Ex-USA) for accelerated approval are planned for 2026, with discussions with the U.S. FDA regarding an accelerated approval pathway also planned for 2026. The Company is pursuing further label expansion across multiple tumor types and for the treatment of chemotherapy-induced lymphopenia, supported by ongoing clinical trial programs.
Long-Term Patent Protection
Multiple issued patents, including U.S. Patent Nos, protect the combination of ANKTIVA plus checkpoint inhibitor therapy. 9,925,247 and 11,071,774, with patent terms extending beyond 2035. These patents cover the combination of IL-15 receptor agonist therapy with anti-PD-1 and anti-PD-L1 checkpoint inhibitors across multiple tumor types, providing long-term exclusivity protection for ANKTIVA’s expanding combination indications.
“In under two years from initial FDA approval, ImmunityBio has built a global commercial footprint spanning 33 countries across four regulatory jurisdictions, with $113 million in full-year net product revenue representing 700% year-over-year growth,” said Dr. Patrick Soon-Shiong, Founder, Executive Chairman, and Global Chief Scientific and Medical Officer of ImmunityBio. “The SFDA’s accelerated approval of ANKTIVA in combination with checkpoint inhibitors for metastatic NSCLC marks a defining moment for the Company, the first authorization of ANKTIVA beyond bladder cancer and the first validation of its role as a lymphocyte-stimulating agent in solid tumors. We are now pursuing accelerated approvals in multiple additional jurisdictions and engaging with the U.S. FDA on a regulatory pathway for this indication. In parallel, our pipeline spans over 30 active and planned clinical trials across 10 tumor types, including randomized trials in BCG-naïve bladder cancer, first-line NSCLC, glioblastoma, and pancreatic cancer. ANKTIVA’s mechanism activating NK cells, CD8+ T cells, and memory T cells without expanding regulatory T cells positions it as a backbone immunotherapy across the oncology landscape, and our expanding patent portfolio protecting these combinations through 2035 and beyond ensures long-term commercial exclusivity.”
Commercial Partnerships and Global Infrastructure
ImmunityBio has established strategic partnerships and infrastructure to support the global commercial launch of ANKTIVA:
“Our 2025 financial results reflect the growing clinical adoption of ANKTIVA as a foundational backbone of immunotherapy for bladder cancer,” said Richard Adcock, President and CEO of ImmunityBio. “Our partnership with Accord Healthcare deploys over 100 commercial professionals across 30 European countries, and our collaboration with BioPharma & Cigalah positions us for rapid commercial execution in Saudi Arabia and the broader MENA region. With subsidiaries now established in Dublin and the Kingdom of Saudi Arabia, we have the infrastructure to support sustained commercial growth across all 33 countries where ANKTIVA is authorized. As we advance toward initial international commercial activities, we remain focused on disciplined execution: completing enrollment in our BCG-naïve randomized trial with a BLA filing targeted by Q4 2026, expanding the ANKTIVA label into lung cancer and lymphopenia, and converting our 700% revenue growth trajectory into durable, long-term value for shareholders.”
3 Year Global Strategy: ANKTIVA as a Backbone to the Cancer BioShield Platform
ImmunityBio is advancing enrollment in ongoing and planned key randomized clinical trials across multiple therapeutic areas, with anticipated submissions of completed single-arm trials as summarized below to implement the 3-year global strategy of ANKTIVA as the backbone in the following protocols:
A. ANKTIVA + Standard of Care
B. ANKTIVA + CAR-NK / M-ceNK
C. ANKTIVA in the Treatment of Lymphopenia
A. ANKTIVA + STANDARD OF CARE
1. Non-Muscle Invasive Bladder Cancer (NMIBC): ANKTIVA + BCG
2. Non-Small Cell Lung Cancer (NSCLC): ANKTIVA + Chemotherapy + Checkpoint Inhibitor
3. Pancreatic Cancer: ANKTIVA + Chemo + CAR-NK
4. Hepatocellular Carcinoma (HCC): ANKTIVA + Checkpoint Inhibitor
5. Colorectal Cancer: ANKTIVA + Checkpoint
6. Multiple Tumor Types: ANKTIVA + Checkpoint Inhibitors
B. ANKTIVA + CAR-NK / M-ceNK-Designated Clinical Trials
1. Pancreatic Cancer: ANKTIVA + CAR-NK
2. Triple Negative Breast Cancer: ANKTIVA + CAR-NK
3. Glioblastoma: ANKTIVA + CAR-NK
4. Non-Hodgkin Lymphoma: ANKTIVA + CAR-NK
5. Multiple Tumor Types: M-ceNK (World Bank of Natural Killer Cells)
LYMPHOPENIA STRATEGY
1. Sepsis: Community Acquired Pneumonia (CAP): ANKTIVA + iNKT
2. Radiation-Induced Lymphopenia: ANKTIVA
3. Treatment Induced Infection: Multiple Myeloma: ANKTIVA
2025 Financial Highlights
Metric |
2025 |
YoY Change |
Full-Year Net Product Revenue |
$113M |
~700% |
Unit Sales Volume |
3,745 |
~750% |
Q4 2025 Net Product Revenue |
$38.3M |
431% |
Cash and Marketable Securities Position
As of December 31, 2025, the Company had consolidated cash, cash equivalents, and marketable securities of $242.8 million.
Fourth-Quarter 2025 Financial Summary
Product Revenue, Net
Product revenue, net increased $31.1 million during the three months ended December 31, 2025, as compared to the three months ended December 31, 2024, due to an increase in sales of ANKTIVA, which was approved in April 2024.
Research and Development Expense
Research and development (R&D) expense increased $28.7 million to $63.9 million during the three months ended December 31, 2025, as compared to $35.2 million during the three months ended December 31, 2024. The increase was due to a $14.0 million one-time write-off of fixed assets, higher manufacturing and distribution costs driven by increased production and clinical trial activities, higher license fees, and higher salaries and benefits, partially offset by lower stock based compensation.
Selling, General and Administrative Expense
Selling, general and administrative (SG&A) expense decreased $3.0 million to $38.7 million during the three months ended December 31, 2025, as compared to $41.7 million during the three months ended December 31, 2024. The decrease was due to lower litigation settlement and commercial consulting costs, partially offset by higher headcount costs driven by growing sales and marketing activities.
Net Loss Attributable to ImmunityBio Common Stockholders
Net loss attributable to ImmunityBio common stockholders was $61.9 million during the three months ended December 31, 2025, as compared to $59.2 million during the three months ended December 31, 2024. The increase in loss was primarily driven by higher R&D expense described above, changes in the fair value of a related-party convertible note, and fixed asset write-offs, partially offset by higher product revenue, lower SG&A expense, lower related-party interest expense, and changes in the fair value of warrant liabilities.
Full-Year 2025 Financial Summary
Product Revenue, Net
Product revenue, net increased $98.8 million during the year ended December 31, 2025, as compared to the year ended December 31, 2024, due to an increase in sales of ANKTIVA, which was approved in April 2024.
Research and Development Expense
R&D expense increased $28.4 million to $218.6 million during the year ended December 31, 2025, as compared to $190.2 million during the year ended December 31, 2024. The increase was mainly due to a $14.0 million one-time write-off of fixed assets, higher clinical trial costs, salaries and benefits, and manufacturing costs driven by increased production activities.
Selling, General and Administrative Expense
SG&A expense decreased $18.8 million to $150.0 million during the year ended December 31, 2025, as compared to $168.8 million during the year ended December 31, 2024. The decrease was primarily driven by lower costs related to litigation settlements and commercial consulting activities, partially offset by higher stock-based compensation expense, recruiting and training expenses, salaries, benefits and commissions, and travel expenses due to growing sales and marketing activities.
Net Loss Attributable to ImmunityBio Common Stockholders
Net loss attributable to ImmunityBio common stockholders was $351.4 million during the year ended December 31, 2025, compared to $413.6 million during the year ended December 31, 2024. This reduction of loss was primarily driven by increased product revenue, lower SG&A expense described above, lower related-party interest expense, and changes in the fair value of warrant liabilities, partially offset by higher R&D expense described above, changes in the fair value of derivative liabilities and a related-party convertible note, an increase in interest expense related to the revenue interest liability, and lower interest and investment income.
ImmunityBio, Inc. Condensed Consolidated Statements of Operations |
|||||||||||||||
|
Three Months Ended December 31, |
|
Year Ended December 31, |
||||||||||||
(Unaudited; in thousands, except per share amounts) |
|
2025 |
|
|
|
2024 |
|
|
|
2025 |
|
|
|
2024 |
|
|
|
|
|
|
|
|
|
||||||||
Revenue |
|
|
|
|
|
|
|
||||||||
Product revenue, net |
$ |
38,272 |
|
|
$ |
7,206 |
|
|
$ |
112,982 |
|
|
$ |
14,150 |
|
Other revenues |
|
13 |
|
|
|
346 |
|
|
|
306 |
|
|
|
595 |
|
Total revenue |
|
38,285 |
|
|
|
7,552 |
|
|
|
113,288 |
|
|
|
14,745 |
|
Operating costs and expenses |
|
|
|
|
|
|
|
||||||||
Cost of sales |
|
382 |
|
|
|
— |
|
|
|
753 |
|
|
|
— |
|
Research and development |
|
60,808 |
|
|
|
33,657 |
|
|
|
207,875 |
|
|
|
182,230 |
|
Research and development – related parties |
|
3,049 |
|
|
|
1,564 |
|
|
|
10,684 |
|
|
|
7,914 |
|
Selling, general and administrative |
|
37,833 |
|
|
|
40,680 |
|
|
|
147,180 |
|
|
|
165,801 |
|
Selling, general and administrative – related parties |
|
896 |
|
|
|
1,051 |
|
|
|
2,823 |
|
|
|
2,982 |
|
Total operating costs and expenses |
|
102,968 |
|
|
|
76,952 |
|
|
|
369,315 |
|
|
|
358,927 |
|
Loss from operations |
|
(64,683 |
) |
|
|
(69,400 |
) |
|
|
(256,027 |
) |
|
|
(344,182 |
) |
Other income (expense), net: |
|
|
|
|
|
|
|
||||||||
Interest and investment income, net |
|
2,298 |
|
|
|
1,187 |
|
|
|
6,405 |
|
|
|
7,975 |
|
Change in fair value of warrant and derivative liabilities, and related-party convertible note |
|
29,152 |
|
|
|
46,598 |
|
|
|
12,714 |
|
|
|
76,904 |
|
Interest expense – related party |
|
(14,843 |
) |
|
|
(26,020 |
) |
|
|
(60,886 |
) |
|
|
(114,588 |
) |
Interest expense related to revenue interest liability |
|
(12,299 |
) |
|
|
(11,503 |
) |
|
|
(51,540 |
) |
|
|
(39,657 |
) |
Interest expense |
|
(50 |
) |
|
|
(51 |
) |
|
|
(99 |
) |
|
|
(82 |
) |
Other (expense) income, net |
|
(1,668 |
) |
|
|
10 |
|
|
|
(2,174 |
) |
|
|
(15 |
) |
Total other expense, net |
|
2,590 |
|
|
|
10,221 |
|
|
|
(95,580 |
) |
|
|
(69,463 |
) |
Loss before income taxes and noncontrolling interests |
|
(62,093 |
) |
|
|
(59,179 |
) |
|
|
(351,607 |
) |
|
|
(413,645 |
) |
Income tax benefit |
|
135 |
|
|
|
— |
|
|
|
135 |
|
|
|
— |
|
Net loss |
|
(61,958 |
) |
|
|
(59,179 |
) |
|
|
(351,472 |
) |
|
|
(413,645 |
) |
Net loss attributable to noncontrolling interests, net of tax |
|
(14 |
) |
|
|
(17 |
) |
|
|
(74 |
) |
|
|
(81 |
) |
Net loss attributable to ImmunityBio common stockholders |
$ |
(61,944 |
) |
|
$ |
(59,162 |
) |
|
$ |
(351,398 |
) |
|
$ |
(413,564 |
) |
|
|
|
|
|
|
|
|
||||||||
Net loss per ImmunityBio common share – basic |
$ |
(0.06 |
) |
|
$ |
(0.08 |
) |
|
$ |
(0.38 |
) |
|
$ |
(0.59 |
) |
Net loss per ImmunityBio common share – diluted |
$ |
(0.06 |
) |
|
$ |
(0.09 |
) |
|
$ |
(0.38 |
) |
|
$ |
(0.62 |
) |
Weighted-average number of common shares used in computing net loss per share – basic |
|
989,679 |
|
|
|
733,204 |
|
|
|
919,863 |
|
|
|
697,312 |
|
Weighted-average number of common shares used in computing net loss per share – diluted |
|
989,679 |
|
|
|
734,542 |
|
|
|
919,863 |
|
|
|
700,443 |
|
ImmunityBio, Inc. Selected Balance Sheet Data |
||||||
|
As of December 31, |
|||||
(Unaudited; in thousands) |
|
2025 |
|
|
2024 |
|
|
|
|
||||
Cash and cash equivalents, and marketable securities |
$ |
242,818 |
|
$ |
149,809 |
|
Total assets |
|
501,898 |
|
|
382,933 |
|
Related-party convertible note payable, at fair value |
|
477,093 |
|
|
461,877 |
|
Revenue interest liability |
|
324,615 |
|
|
284,404 |
|
Total liabilities |
|
1,001,472 |
|
|
871,062 |
|
Total ImmunityBio stockholders’ deficit |
|
(500,469 |
) |
|
(489,098 |
) |
Total liabilities and stockholders’ deficit |
|
501,898 |
|
|
382,933 |
|
ImmunityBio, Inc. Summary Reconciliations of Cash Flows |
|||||||||||||||
|
Three Months Ended December 31, |
|
Year Ended December 31, |
||||||||||||
(Unaudited; in thousands) |
|
2025 |
|
|
|
2024 |
|
|
|
2025 |
|
|
|
2024 |
|
|
|
|
|
|
|
|
|
||||||||
Cash (used in) provided by: |
|
|
|
|
|
|
|
||||||||
Net cash used in operating activities |
$ |
(70,378 |
) |
|
$ |
(85,144 |
) |
|
$ |
(304,936 |
) |
|
$ |
(391,236 |
) |
Net cash provided by (used in) investing activities |
|
43,573 |
|
|
|
9,834 |
|
|
|
(149,801 |
) |
|
|
(12,246 |
) |
Net cash provided by financing activities |
|
54,894 |
|
|
|
106,929 |
|
|
|
400,241 |
|
|
|
281,630 |
|
Effect of exchange rate changes on cash and cash equivalents, and restricted cash |
|
5 |
|
|
|
(7 |
) |
|
|
15 |
|
|
|
(23 |
) |
Net change in cash and cash equivalents, and restricted cash |
|
28,094 |
|
|
|
31,612 |
|
|
|
(54,481 |
) |
|
|
(121,875 |
) |
Cash and cash equivalents, and restricted cash, beginning of period |
|
61,337 |
|
|
|
112,300 |
|
|
|
143,912 |
|
|
|
265,787 |
|
Cash and cash equivalents, and restricted cash, end of period |
$ |
89,431 |
|
|
$ |
143,912 |
|
|
$ |
89,431 |
|
|
$ |
143,912 |
|
About ImmunityBio
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® (nogapendekin alfa inbakicept). 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.
About ANKTIVA
ANKTIVA (nogapendekin alfa inbakicept) is our lead biologic 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 U.S. Food and Drug Administration (FDA) Breakthrough Therapy designation for use in BCG-unresponsive NMIBC with CIS in adult patients with or without papillary tumors.
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.
ANKTIVA in combination with our CAR-NK therapy (PD-L1 t-haNK) has received RMAT designation from the FDA for use in combination with chemotherapy/radiotherapy for reversal of lymphopenia and treatment of 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
