(RTTNews) - ImmunityBio, Inc. (IBRX) announced full-year 2025 financial and operational highlights, including net product revenue of $113 million for Anktiva, representing approximately 700% year-over-year growth. The company also reported a 750% increase in unit sale volume and expanded its regulatory footprint to 33 countries across four jurisdictions.
Anktiva, an IL-15 receptor super agonist antibody-cytokine fusion protein, is approved in combination with BCG for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors. In January 2026, Saudi Arabia's SFDA granted conditional accelerated approval for Anktiva in combination with checkpoint inhibitors for metastatic non-small cell lung cancer (NSCLC), marking the therapy's first approval outside bladder cancer.
The company has also established commercial partnerships to support global launches. In Europe, ImmunityBio partnered with Accord Healthcare, deploying a 100-person sales force across 30 countries, and set up a subsidiary in Dublin. In Saudi Arabia, partnerships with BioPharma and Cigalah will expand access to Anktiva, supported by a newly formed local subsidiary.
Upcoming Milestones
•QUILT-2.005 Trial (BCG-Naïve NMIBC): Enrolment ongoing; Biologics License Application (BLA) filing targeted by Q4 2026.
•QUILT-3.055 Trial (2L+NSCLC, Single-Arm): Anktiva + checkpoint inhibitor. Accelerated approval granted in Saudi Arabia in January 2026. Planned submissions to multiple ex- U.S. regulatory authorities in 2026, with U.S. FDA discussions also scheduled for accelerated approval pathway in 2026.
•Recombinant BCG Regulatory: Planned submission to SFDA; U.S. FDA meeting scheduled for March 2026.
The company ended December 31, 2025, with $242.8 million in cash, cash equivalents, and marketable securities.
For the quarter the net product revenue was $38.3 million in Q4 2025, compared to $7.2 million in Q4 2024- an increase in $31.1 million, driven by higher sales of Anktiva following its April 2024 approval.
Net loss attributable to ImmunityBio common stockholders was $61.9 million in Q4 2025, compared to $59.2 million in Q4 2024.
For Full year net product revenue was $113.2 million in 2025, compared to $14.7 million in 2024- reflecting strong year-over-year growth.
Net loss attributable to ImmunityBio common stockholders was $351.4 million in 2025, compared to $413.6 million in 2024.
IBRX has traded between $1.83 and $11.00 over the past year, touching a new 52-week high of $11.00 during the latest trading session. The stock is currently trading at $10.14 up 16.54%.
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