ImmunityBio, Inc. Q4 FY2025 earnings call

• ImmunityBio is a multi - platform, multi - indication immunotherapy company with ANKTIVA as the backbone. - 2025 was a transformative year with significant commercial and financial progress. - There has been strong commercial uptake of ANKTIVA. - Partnered with Accord Healthcare for the European market and with Biopharma and Cigalah for the Middle East. - It has 3 platform technologies: ANKTIVA, off - the - shelf CAR - NK cell therapy programs, and DNA vaccine vector technology. - Is dealing with the prolonged BCG shortage and has launched an expanded access program for recombinant BCG. - Introduced askIB, an internally developed AI solution. - Discussed the Immunotherapy 2.0 platform which combines cytokines, vaccines, and cell therapy platforms.

ANKTIVA is the key commercial asset. In 2025, full - year net product revenue for ANKTIVA was $113 million, a 700% year - on - year increase. Unit sales volume rose by 750% over the same period. ANKTIVA is authorized in 33 countries across 4 major regulatory jurisdictions: the United States, the United Kingdom, the Kingdom of Saudi Arabia, and the entire European Union. In the US, it's seeing strong adoption among urologists and oncologists treating BCG - unresponsive nonmuscle - invasive bladder cancer. In Europe, the European Commission granted conditional marketing authorization in February 2026. In Saudi Arabia, it received approvals for BCG - unresponsive nonmuscle - invasive bladder cancer and for combination with checkpoint inhibitors in metastatic nonsmall cell lung cancer.

The company will not provide forward financial guidance during this call. Intends to submit a biologics licensing application (BLA) for the BCG - naive indication in the fourth quarter of 2026. Has a 3 - year global clinical and commercial strategy with various platform technologies and ongoing trials.

Risks associated with forward - looking statements, including the possibility of actual results differing from described forward - looking statements. Risks related to clinical development, regulatory submissions and approvals, strategic collaborations, manufacturing capabilities, commercial launch planning and timing, market opportunities, and business strategy. For a detailed discussion of risk factors, refer to ImmunityBio's most recent filings with the SEC.

Q: Ted Tenthoff inquires about the new pathway of the plausible mechanism of action and why the FDA might consider accelerated approval of ANKTIVA plus CPI in lung cancer.

A: Patrick Soon - Shiong explains about the article in the New England Journal of Medicine regarding the plausible mechanism pathway where an appropriately designed study with a small sample size can support licensure if the pharmacological effect is in line with biological plausibility and consistent with observed clinical outcomes.

Q: Andres Maldonado asks about AI - driven robotic cellular manufacturing capabilities.

A: Patrick Soon - Shiong talks about the m - ceNK platform and the use of AI, machine vision, and robotics for scalable production of NK cells.

Q: Jeet Mukherjee asks about the number of patients treated in the QUILT - 3.055 study compared to pembrolizumab single - arm studies.

A: Patrick Soon - Shiong compares it to Merck's KEYTRUDA single - arm trials and states that the QUILT - 3.055 study had 147 patients with similar numbers in some single - arm trials.

Q: Clara Dong asks about the global commercial growth of ANKTIVA and market access.

A: Richard Adcock says they have distribution agreements, are working on a country - by - country basis in the EU and Middle East, and have product ready for delivery in some regions.

Q: Jason Kolbert asks about the mode of failure of checkpoint inhibitors and support for reconstitution of NK cells.

A: Patrick Soon - Shiong explains about tumor morphing and how ANKTIVA combines NK and T cells to outsmart cancer, supporting reconstitution of NK cells to reverse the failure of checkpoint inhibitors.