ImmunityBio (NASDAQ:IBRX) executives used the company’s full-year 2025 earnings call to highlight a sharp ramp in ANKTIVA commercial revenue following U.S. approval, outline recent international regulatory milestones, and reiterate a broader platform strategy that pairs ANKTIVA with cell therapy and vaccine technologies.
ANKTIVA revenue grew sharply in 2025
President and CEO Richard Adcock said 2025 was a “transformational year,” driven primarily by U.S. commercialization of ANKTIVA. The company reported full-year 2025 net product revenue of $113 million, compared with $14.1 million in 2024, which it described as a 700% year-over-year increase. Adcock attributed the change in part to the addition of a billing J-code in 2025.
In the U.S., Adcock said ANKTIVA uptake continued among urologists and oncologists treating BCG-unresponsive non-muscle invasive bladder cancer carcinoma in situ (CIS) with or without papillary disease. He cited physician feedback around tolerability and “durable response,” and said the company was seeing repeat prescribing behavior. ImmunityBio expanded its sales force and medical affairs infrastructure during 2025, while also building real-world evidence efforts, he said.
International authorizations and commercialization plans
Adcock said ANKTIVA is authorized across 33 countries spanning “four major regulatory jurisdictions”: the U.S., the U.K., the Kingdom of Saudi Arabia, and the European Union. He called the pace one of the most rapid international expansions for an immunotherapy in this bladder cancer indication.
In Europe, Adcock said the European Commission granted conditional marketing authorization in February 2026, covering all 27 EU member states plus Iceland, Norway, and Liechtenstein. ImmunityBio partnered with Accord Healthcare, which Adcock said will deploy over 100 dedicated sales, medical, and marketing professionals across 31 countries in the EU, U.K., and EFTA states. The company also established an Irish subsidiary in Dublin to support distribution and commercialization and said it is prioritizing Germany, France, Italy, Spain, and the U.K. for market access work, noting Germany could be first based on progress to date.
In Saudi Arabia, Adcock said ImmunityBio received two approvals from the Saudi FDA in January 2026: one for BCG-unresponsive non-muscle invasive bladder cancer CIS (with or without papillary disease) and a second conditional approval for ANKTIVA in combination with checkpoint inhibitors for metastatic non-small cell lung cancer. He described the lung cancer clearance as the first worldwide authorization for ANKTIVA in that indication. Adcock said product shipments were ready to commence and that the company would work with the Kingdom to manage imports “amid the current escalating circumstances.” He also cited partnerships with Biopharma and Cigalah to expand access across the Middle East and North Africa and said the company formed a subsidiary in Saudi Arabia to support launch operations.
2025 expenses, loss, and balance sheet items
For full-year 2025, Adcock reported:
- R&D expenses of $218.6 million, up from $190.2 million in 2024, driven by increased clinical trial expenses, manufacturing expansion costs for ANKTIVA, CAR-NK programs and DNA vaccine vectors, and a $14 million one-time fixed asset write-off related to manufacturing equipment.
- SG&A of $150 million, down from $168.8 million in 2024, which he attributed to lower consulting activities as the company expanded commercial teams internally.
- Net loss attributable to common stockholders of $351.4 million, compared with $413.6 million in 2024.
As of Dec. 31, 2025, ImmunityBio reported $242.8 million in consolidated cash, cash equivalents, and marketable securities. Adcock said net cash used in operating activities for the year was $304.9 million. He also referenced $505 million in related-party convertible notes and about $325 million in revenue interest liability on the balance sheet, directing investors to the company’s Form 10-K for additional detail.
Clinical update: bladder cancer, lung cancer, and BCG supply
Founder and Executive Chairman Dr. Patrick Soon-Shiong emphasized ANKTIVA as the “backbone” of a broader “BioShield” platform, describing it as an IL-15 superagonist and outlining combinations with standard of care therapies, cell therapies, and vaccine approaches. He also highlighted what he described as the National Cancer Institute’s 2007 workshop ranking IL-15 as the top molecule among more than 100 candidates to cure cancer.
In bladder cancer, Soon-Shiong discussed QUILT 2.005, a randomized trial in BCG-naïve non-muscle invasive bladder cancer comparing BCG alone versus BCG plus ANKTIVA. He said 366 patients are now fully enrolled and described an interim analysis the FDA requested earlier in the study showing complete response rates of 85% at six months for BCG plus ANKTIVA versus 57% for BCG alone, and 84% at nine months versus 52%, which he said reached statistical significance. He stated the company is targeting a BLA submission in Q4 2026 for the BCG-naïve indication, while noting the trial remains blinded for final analysis.
For BCG-unresponsive disease, Soon-Shiong reviewed the already approved CIS cohort from QUILT 3.032, citing a 71% complete response rate and duration of response “beyond 53 months,” which he said was reported at the AUA 2025 meeting. He also summarized results for the trial’s papillary-only cohort (cohort B), which he said was published in the Journal of Urology in 2026 and met its primary endpoint, reporting 58% disease-free at 12 months and 52% at 24 months, with 96% disease-specific survival at 36 months and approximately 82% bladder preservation at 36 months. He said the FDA refused to file a submission in May 2025 and requested additional data following a Type B meeting in January 2026.
Executives also discussed the long-running BCG shortage. Adcock said ImmunityBio launched an FDA-authorized expanded access program for recombinant BCG, with about 100 sites active or activating and more than 500 patients treated, along with “several thousand doses” delivered as monotherapy or in combination with ANKTIVA. Soon-Shiong said expanded access was authorized Feb. 19, 2025, first U.S. dosing occurred in March 2025, and 580 patients were enrolled as of February 2026. He added that the company requested an FDA meeting scheduled for the month of the call to discuss next steps.
In lung cancer, Soon-Shiong described QUILT 3.055, a single-arm study in which patients progressing on a checkpoint inhibitor continued that therapy with ANKTIVA added, without chemotherapy. He contrasted the approach with published docetaxel outcomes in later-line non-small cell lung cancer, which he said generally show median overall survival of 6–9 months, and stated the company was able to “double” that to 14 months in QUILT 3.055, which he said supported the Saudi FDA approval.
Regulatory pathway discussion and manufacturing initiatives
During Q&A, Soon-Shiong addressed the FDA’s “plausible mechanism of action” concept and read from a December 11, 2025 New England Journal of Medicine article describing how small studies could support licensure when pharmacologic effect aligns with biological plausibility and observed outcomes. He also compared ImmunityBio’s QUILT 3.055 enrollment to Merck’s MSI-high Keytruda label history, stating Keytruda’s tumor-agnostic MSI-high approval was based on 149 patients across five single-arm trials and that QUILT 3.055 enrolled 147 patients, including 86 in later-line non-small cell lung cancer.
Management also discussed efforts to automate cell therapy manufacturing, describing an AI-driven, robotic platform intended to produce natural killer cell products with reduced human handling. The call also included an introduction of “Ask IB,” an internally developed AI solution that Adcock said integrates with the company’s enterprise systems to support R&D, manufacturing, and operational analytics.
About ImmunityBio (NASDAQ:IBRX)
ImmunityBio, Inc is a clinical-stage biotechnology company specializing in the development of novel immunotherapies for cancer and infectious diseases. The company’s research platform centers on harnessing the power of the human immune system—through engineered T cells, natural killer (NK) cells, cytokine superagonists and viral-vectored vaccines—to target and eliminate diseased cells across a range of indications.
Among its lead assets is Anktiva (formerly known as N-803), an interleukin-15 superagonist designed to stimulate NK and T cell activity.
