ImmunityBio completed its NK2022 and NK2023 manufacturing engineering programs, establishing a scalable leukapheresis‑to‑manufacturing pathway for its autologous memory cytokine‑enhanced natural killer (M‑ceNK) cell therapy platform. The new process can produce up to five billion NK cells from a single apheresis collection, enabling eight to ten therapeutic doses within 12 days.
The milestone supports the company’s vision of a “World Bank of Natural Killer Cells,” a universal, off‑the‑shelf source that does not require HLA matching. “The ability to generate up to 5 billion highly pure NK cells from a single apheresis collection, yielding up to 8‑10 therapeutic doses within 12 days, opens the possibility of creating the ‘World Bank of Natural Killer Cells,’ with NK cells able to be universally donated to any patient without HLA matching,” said Patrick Soon‑Shiong, MD, Founder and Executive Chairman.
ImmunityBio’s Q4 2025 results reflected the impact of the new manufacturing capability. Revenue rose to $38.28 million, beating the consensus estimate of $35.99 million, while earnings per share of –$0.06 surpassed the forecast of –$0.11. The revenue gain was driven by a 700% increase in ANKTIVA sales, which reached $113 million in 2025, and by cost discipline that kept operating expenses in line with revenue growth.
ANKTIVA, the company’s IL‑15 superagonist approved in combination with BCG for BCG‑unresponsive non‑muscle invasive bladder cancer, is projected to generate $195 million in U.S. net revenues in 2026, up from $113 million in 2025. The sharp growth underscores the drug’s commercial traction and the company’s ability to scale its flagship product.
Regulatory momentum continued with the FDA’s acknowledgment of ImmunityBio’s resubmission of a supplemental Biologics License Application for ANKTIVA plus BCG. Analysts have upgraded coverage, citing the combined operational and commercial gains. The company’s ability to secure regulatory support while expanding its product portfolio signals a strengthening pipeline.
Despite the operational advances, the company faces financial headwinds. Negative operating margins and a distressed Altman Z‑Score highlight ongoing liquidity pressures. Management emphasized that the new manufacturing pathway will reduce reliance on costly contract manufacturing and improve cost of goods, positioning ImmunityBio to pursue broader indications beyond bladder cancer while addressing its financial challenges.
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