ImmunityBio (NASDAQ:IBRX) CEO Richard Adcock used a presentation at the Citizens Life Sciences Conference to outline the company’s commercial progress with its lead product ANKTIVA and to highlight multiple upcoming regulatory and clinical milestones across bladder cancer, lung cancer, and earlier-stage pipeline programs.
Company strategy and platform focus
Adcock said ImmunityBio’s work reflects founder Dr. Patrick Soon-Shiong’s long-standing view that combination therapy is required to “beat cancer,” a strategy he said the company began pursuing in 2010. Adcock described ImmunityBio’s development engine as three platform technologies:
- Fusion proteins, led by ANKTIVA
- DNA vaccine vectors, which he characterized as second-generation adenoviral vectors capable of delivering large payloads
- Cellular therapies, including off-the-shelf CAR-NK programs
ANKTIVA in bladder cancer: approvals, data, and commercial traction
Adcock said ANKTIVA is approved in 33 countries for non-muscle invasive bladder cancer and highlighted continued efforts to expand its use in BCG-unresponsive disease, including carcinoma in situ (CIS) with or without papillary tumors. He said the company submitted a filing for papillary disease to the U.S. Food and Drug Administration (FDA) “this week” at the agency’s invitation, and asserted that ANKTIVA has multi-year follow-up data in papillary patients.
On comparative durability, Adcock cited a 53-month duration referenced in Europe as “ongoing” with the median not yet determined, and contrasted that with other therapies he referenced during the talk, including median duration figures he quoted for other approved options. He emphasized that physicians, patients, and insurers focus on how long a response lasts, and he attributed ANKTIVA’s durability to activation and proliferation of natural killer cells and T cells, including memory T cells, which he noted are referenced in the product labeling.
He also cited bladder preservation outcomes, saying 84% of responders were able to keep their bladders at 36 months, and said 71% of participants had a complete response. Adcock said urologists are increasingly describing an “era of bladder preservation” enabled by immunotherapy.
Commercially, Adcock reported 700% year-over-year sales growth and 750% unit sales growth, describing steady quarter-over-quarter growth driven by repeat ordering and maintenance use. He also highlighted that the FDA label includes a recommendation allowing up to 36 doses over 37 months, which he described as unusual. Adcock said the company has not faced major payer issues and credited the commercial and market access teams as well as field medical representatives for facilitating adoption.
Adcock said ImmunityBio ended the year with about $250 million in cash.
Pipeline milestones: naïve NMIBC trial and BLA timing
Adcock said the company’s ANKTIVA + BCG trial in the BCG-naïve setting was fully enrolled and described it as a larger market opportunity. He said the randomized controlled trial includes 366 patients and will read out on a timeline of “last patient in + six months.” He added that ImmunityBio plans to submit an sBLA/BLA by the end of the year, describing the timeline as tight but achievable.
He also noted that after U.S. approval in the unresponsive setting, the naïve trial expanded globally with participants in Europe, Asia, and India. During the talk, Adcock described an FDA request made during the prior review process to see early patients from each arm of the naïve trial, which he said showed statistical significance at that interim stage.
BCG supply efforts and recombinant BCG access
Adcock addressed the prolonged BCG shortage and said ImmunityBio worked with the Serum Institute of India to bring recombinant BCG to the United States under expanded access. He said the company shipped thousands of doses in 2025 and relayed that physicians have been complimentary, describing it as a “friendly version” of BCG. He contrasted manufacturing approaches, describing recombinant BCG production in stainless steel tanks as a modernized alternative to traditional methods.
Lung cancer, lymphopenia focus, and early CAR-NK lymphoma readouts
In lung cancer, Adcock said ImmunityBio announced that Saudi Arabia approved its approach in non-small cell lung cancer and described that authorization as an accelerated approval. He said the company has two pivotal trials ongoing in frontline and second-line settings, and reported that other countries have reached out to discuss similar pathways. Adcock also said product shipments to Saudi Arabia were delayed by regional conflict but that the company had product ready and had received clearance related to airspace.
Adcock repeatedly returned to lymphopenia as a central theme, arguing that lymphocyte levels are underappreciated in cancer care and describing ANKTIVA as a lymphocyte-stimulating agent, which he said is recognized in U.S. and European labeling. He framed this as a potential pan-tumor opportunity.
Finally, Adcock highlighted early-stage work in non-Hodgkin lymphoma, specifically Waldenström’s, using CAR-NK CD19 plus ANKTIVA in a trial run in South Africa. He said investigators initially viewed it as a “bridge to transplant” but later reported that responses suggested it may reduce the need for transplant, while emphasizing the data remain early.
Looking ahead, Adcock pointed investors to near-term milestones including FDA acceptance of the papillary filing and potential NCCN guideline updates, which he said could expand practical access while the company pursues broader global approvals. He concluded that ImmunityBio aims to be increasingly global in 2026, with “substantive revenue” from international markets beginning to emerge in 2027.
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.
