ImmunityBio's ANKTIVA Drives Record Revenue and Expands Global Reach

ImmunityBio reports 2025 revenue of $113.3M, driven by 700% growth for ANKTIVA. Key clinical trial recruitment complete, with EU approval secured.

ImmunityBio is poised to discuss its full-year 2025 results and pipeline updates in a conference call tomorrow. The spotlight remains firmly on its commercial immunotherapy, ANKTIVA, which is demonstrating explosive sales growth, delivering new clinical data, and achieving significant regulatory expansion. However, with multiple pivotal regulatory and clinical milestones scheduled for 2026, questions remain about the sustainability of its next growth phase.

Financial Performance: A Year of Exponential Growth

The company's 2025 financial results were overwhelmingly driven by its flagship product. Net product revenue for ANKTIVA reached approximately $113 million, representing a staggering increase of roughly 700% year-over-year. Sales volume saw a corresponding surge of about 750%. Furthermore, net product revenue for the most recent quarter showed a sequential increase of 20%.

For that final quarter, ImmunityBio reported a loss per share of -$0.06, which was $0.02 better than the consensus analyst estimate of -$0.08. Quarterly revenue totaled $38.29 million.

As of December 31, 2025, the company held an estimated $242.8 million in cash, cash equivalents, and marketable securities. Its full-year 2025 revenue was $113.29 million, a substantial jump from $14.75 million in the prior year. The annual net loss was -$351.40 million, an improvement of approximately 15% from the previous year.

Clinical Progress: Key Trial Recruitment Completed

On the operational front, ImmunityBio has completed patient recruitment for its Phase 2 study, QUILT 2.005. This trial is evaluating ANKTIVA plus BCG versus BCG alone in BCG-naïve patients with non-muscle invasive bladder cancer (Carcinoma in situ). The study successfully randomized 366 participants ahead of schedule.

An interim analysis requested by the U.S. Food and Drug Administration (FDA) demonstrated advantages for the ANKTIVA-BCG combination in terms of duration of complete response. At the six-month mark, the complete response rate was 85% for the combination therapy, compared to 57% for BCG alone. By nine months, the rates were 84% versus 52%, with the difference at nine months being statistically significant.

The company anticipates reporting further results from this study in the fourth quarter of 2026. Based on that data, ImmunityBio plans to submit a Biologics License Application (BLA) to the FDA in the same quarter.

Global Expansion: Regulatory Footprint Grows

ImmunityBio has significantly broadened its international regulatory presence, now covering 33 countries across four jurisdictions. A key development was the first regulatory approval for ANKTIVA in combination with checkpoint inhibitors for lung cancer.

In February, ANKTIVA received conditional marketing authorization in the European Union, covering all 27 member states plus Iceland, Norway, and Liechtenstein. The company built this reach in less than two years following the initial FDA approval in 2024.

To commercialize the therapy in Europe, ImmunityBio has partnered with Accord Healthcare, which will distribute ANKTIVA in 30 European countries. Additional partnerships are in place with Biopharma and Cigalah Healthcare for Saudi Arabia and the broader MENA (Middle East and North Africa) region.

In a landmark decision, the Saudi Food and Drug Authority (SFDA) granted a conditional accelerated approval in January for ANKTIVA combined with checkpoint inhibitors to treat metastatic non-small cell lung cancer (NSCLC). This made Saudi Arabia the first jurisdiction worldwide to approve ANKTIVA for an indication outside of bladder cancer. The company plans further submissions to non-U.S. regulators for accelerated approvals in 2026 and intends to engage the U.S. FDA on a potential accelerated pathway that same year.

Pipeline Developments Beyond Bladder Cancer

Beyond its core programs, ImmunityBio provided updated Phase 2 data from the QUILT-3.078 trial in recurrent or progressive glioblastoma. Of 23 enrolled patients, 19 remain alive, and median overall survival has not yet been reached. The longest survival time from relapse in the evaluable cohort is ongoing at 12 months.

The company has also initiated the ResQ215B study (Phase 2), an outpatient regimen that requires no chemotherapy or lymphodepletion. This trial is testing "off-the-shelf" CD19 t-haNK CAR-NK cells in combination with ANKTIVA and Rituximab for indolent B-cell Non-Hodgkin Lymphoma.

Corporate and Insider Activity

A recent transaction saw Director Barry J. Simon sell 75,000 shares on February 24 at a volume-weighted average price of $12.0105. The total transaction value was $900,787.

ImmunityBio will host its conference call tomorrow at 1:30 p.m. Pacific Time to discuss the business development and present the 2025 results. The market expects more details on ANKTIVA's commercial trajectory and updates on upcoming regulatory and clinical milestones, including the targeted BLA submission timeline for late 2026.