On February 23, 2026 ImmunityBio, Inc. (NASDAQ: IBRX), a commercial-stage immunotherapy company, reported 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.
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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:
United States: FDA approval (April 2024)
United Kingdom: MHRA authorization (July 2025)
Kingdom of Saudi Arabia: SFDA accelerated approval for BCG-unresponsive NMIBC CIS (January 2026) and conditional accelerated approval for metastatic NSCLC in combination with checkpoint inhibitors (January 2026), the first jurisdiction globally to authorize ANKTIVA for lung cancer
European Union: European Commission conditional marketing authorization covering all 27 EU member states plus Iceland, Norway, and Liechtenstein (February 2026)
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:
European Union and United Kingdom: Partnered with Accord Healthcare to deploy over 100 sales, medical, and marketing professionals across 30 countries in the EU, UK, and European Free Trade Association (EFTA) member states. ImmunityBio also established an Irish subsidiary in Dublin to support European distribution and commercialization strategy.
Kingdom of Saudi Arabia: Partnering with BioPharma & Cigalah to expand access to ANKTIVA in Saudi Arabia and, over time, throughout the MENA region. ImmunityBio has formed a KSA subsidiary to support commercial launch operations in the Kingdom.
"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
QUILT-2.005 Randomized Trial (BCG-Naïve CIS): ANKTIVA + BCG; BLA filing targeted by Q4 2026
QUILT-3.032 Single Arm Trial (BCG-Unresponsive Papillary): Response submitted to U.S. FDA regarding additional data for BCG-unresponsive papillary-only NMIBC; awaiting Agency review
ResQ133A-NMIBC Single Arm Trial: Intravesical recombinant Mycobacterium (rBCG) in participants with NMIBC eligible to receive intravesical Tice BCG, addressing the global BCG shortage
ResQ132EX-NMIBC Expanded Access: Expanded access use of rBCG in NMIBC; over 570 patients dosed to date at 58 sites
ResQ132 Clinical Trial: Ablation therapy in participants with intermediate-risk non-muscle invasive papillary bladder cancer
Recombinant BCG Regulatory: Planned submission to SFDA and U.S. FDA meeting scheduled for March 2026
2. Non-Small Cell Lung Cancer (NSCLC): ANKTIVA + Chemotherapy + Checkpoint Inhibitor
QUILT-3.055 Single Arm Trial (2L+ NSCLC): ANKTIVA + checkpoint inhibitor. Accelerated approval by SFDA (January 2026). Planned submissions to multiple regulatory authorities (Ex-USA) for accelerated approval in 2026. Discussions planned with the U.S. FDA in 2026 for the accelerated approval pathway
QUILT-2.023 Randomized Trial (1L NSCLC): ANKTIVA + chemotherapy/checkpoint inhibitor versus chemotherapy/checkpoint inhibitor alone
ResQ201A Randomized Trial (2L NSCLC): ANKTIVA in combination with tislelizumab + 2 cycles of docetaxel versus docetaxel alone
3. Pancreatic Cancer: ANKTIVA + Chemo + CAR-NK
QUILT-88 Single Arm Trial (2L+ Metastatic): ANKTIVA + CAR-NK (PD-L1 t-haNK) + chemotherapy. Clinical trial completed. RMAT Designation granted
ResQ108B-PANC Single Arm Trial (Neoadjuvant Locally Advanced 1L): ANKTIVA + zabadinostat + sotevtamab
Planned Randomized Trial (1L Metastatic): ANKTIVA + CAR-NK (PD-L1 t-haNK) + Abraxane + gemcitabine versus Abraxane + gemcitabine, trial design pending finalization
4. Hepatocellular Carcinoma (HCC): ANKTIVA + Checkpoint Inhibitor
Planned 2L+ HCC Randomized Trial: ANKTIVA + zabadinostat + checkpoint inhibitor
5. Colorectal Cancer: ANKTIVA + Checkpoint
ResQ203D-CRC Randomized Phase 3: Colorectal patients undergoing resection/ablation of colorectal metastases: ANKTIVA + zabadinostat + tislelizumab versus standard of care
6. Multiple Tumor Types: ANKTIVA + Checkpoint Inhibitors
QUILT-3.055 Single Arm Trial (2L+ NSCLC and Multiple Tumor Types): Clinical trial completed. Accelerated approval for advanced NSCLC (SFDA, January 2026). Planned submissions for the expansion of the label in the Middle East, North Africa (MENA), for multiple tumor types
B. ANKTIVA + CAR-NK / M-ceNK-Designated Clinical Trials
1. Pancreatic Cancer: ANKTIVA + CAR-NK
QUILT-88 Pancreatic Cancer ANKTIVA + CAR-NK: 2L+ metastatic pancreatic cancer; ANKTIVA + CAR-NK (PD-L1 t-haNK) + chemotherapy. Clinical trial completed. RMAT Designation
2. Triple Negative Breast Cancer: ANKTIVA + CAR-NK
QUILT-3.067 Triple Negative Breast Cancer (TNBC) ANKTIVA + haNK: Single arm trial. Clinical trial completed
Planned Randomized Trial (2L+ TNBC): ANKTIVA + CAR-NK (PD-L1 t-haNK) + Trop2 Antibody: Trial design pending finalization
3. Glioblastoma: ANKTIVA + CAR-NK
QUILT-3.078 Glioblastoma Single Arm Trial (Recurrent) ANKTIVA + +CAR-NK: CAR-NK (PD-L1 t-haNK) + ANKTIVA + bevacizumab. Enrollment completed
Planned Randomized Trial (Neoadjuvant Glioblastoma) ANKTIVA + CAR-NK: ANKTIVA + CAR-NK (PD-L1 t-haNK) versus standard of care
Planned Randomized Trial (2L Recurrent Glioblastoma) ANKTIVA + CAR-NK: ANKTIVA + CAR-NK (PD-L1 t-haNK) + bevacizumab + TTF versus standard of care
4. Non-Hodgkin Lymphoma: ANKTIVA + CAR-NK
QUILT-106 Relapsed Refractory Non-Hodgkin’s Lymphoma (iNHL) Single Arm Trial CAR-NK (CD-19 t-haNK): No lymphodepletion. Relapsed/refractory NHL: CAR-NK (CD19 t-haNK) + rituximab. Enrolling
ResQ215A Relapsed Refractory NHL Single Arm Trial ANKTIVA + CAR-NK (CD19 t-haNK): Lymphodepletion. Flu/Cy + CAR-NK (CD19 t-haNK) + ANKTIVA + rituximab. Enrolling
ResQ215B Indolent Non-Hodgkin’s Lymphoma (Including Waldenstrom’s) Single Arm Trial: No lymphodepletion. CAR-NK (CD19 t-haNK) + ANKTIVA + rituximab
Planned Randomized Trial Relapsed/Refractory NHL: Lymphodepletion. Flu/Cy + CAR-NK (CD19 t-haNK) + ANKTIVA + rituximab versus Flu/Cy + CAR-NK (CD19 t-haNK) + rituximab
5. Multiple Tumor Types: M-ceNK (World Bank of Natural Killer Cells)
NK2022 & NK2023 (Cancer Patients & Healthy Donors): 64 subjects completed apheresis and M-ceNK manufacturing cell therapy process development for robotic training and future AI robot manufacturing. Cells cryopreserved and stored.
QUILT-3.076 Safety Phase 1 of Apheresis and M-ceNK + ANKTIVA Completed: Solid tumor: apheresis followed by M-ceNK + ANKTIVA. 10 patients treated with autologous M-ceNK infusion
ResQ209 Phase 2 Platinum Resistant Ovarian Cancer M-ceNK + ANKTIVA Single Arm Trial: Ovarian cancer: apheresis followed by M-ceNK + ANKTIVA + gemcitabine
LYMPHOPENIA STRATEGY
1. Sepsis: Community Acquired Pneumonia (CAP): ANKTIVA + iNKT
ResQ219-CAP Phase 2 Single Arm Trial (N=20): ANKTIVA + iNKT. Clinical trial protocol submitted to the FDA. USA trial sites
ResQ218-CAP Planned Phase 3 Randomized Trial: ANKTIVA + iNKT versus standard of care. To be initiated in Saudi Arabia, United States and planned UAE.
2. Radiation-Induced Lymphopenia: ANKTIVA
Real-World Evidence: Radiation-induced lymphopenia (Completed)
ResQ210 Randomized Trial Radiation-Induced Lymphopenia in Biochemical Recurrent and Localized Prostate Cancer: Radiation alone versus radiation + ANKTIVA. To be submitted.
3. Treatment Induced Infection: Multiple Myeloma: ANKTIVA
Planned Single Arm, Relapsed Multiple Myeloma: Bispecific antibody + 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.
(Press release, ImmunityBio, FEB 23, 2026, View Source [SID1234662852])