ImmunityBio Achieves Manufacturing Milestone for Next-Generation Cell Therapy

ImmunityBio validates scalable NK cell manufacturing, supporting pipeline beyond ANKTIVA. Sales grew 700% to $113M in 2025, with promising early efficacy data in lung cancer models.

ImmunityBio shares surged 10.5% to $8.64 on Friday following a significant announcement regarding its cell therapy manufacturing capabilities. The company has successfully validated a scalable production process for its natural killer (NK) cell therapy platform, a technical achievement that lays the groundwork for an extensive pipeline extending well beyond its currently approved bladder cancer drug, ANKTIVA.

Commercial Momentum and Financial Standing

The technical progress builds upon a growing commercial foundation. In 2025, ANKTIVA generated net sales of $113 million, representing a staggering 700% increase year-over-year. This growth was fueled by a 750% rise in product volume, with $38.3 million in sales coming in the fourth quarter alone. The company ended the year with a solid financial position, holding $242.8 million in cash, cash equivalents, and marketable securities.

Despite this robust revenue growth, profitability remains a future target. The company's EBIT margin stands at -278.4%. While a gross margin of 99.3% highlights the high-value nature of its therapeutic product, substantial ongoing investments in research, scaling operations, and regulatory work continue to weigh heavily on the bottom line. Management has cautioned investors about potential challenges in automating production and meeting all regulatory requirements.

Details of the Production Breakthrough

At the heart of this advancement is ImmunityBio's M-ceNK platform, which stands for memory cytokine-enhanced natural killer cells. Completed manufacturing programs, designated NK2022 and NK2023, demonstrate that a single leukapheresis collection can yield up to five billion NK cells. From this starting material, the process can generate eight to ten therapeutic doses within approximately twelve days. This level of scalability is a critical prerequisite for any allogeneic "off-the-shelf" cell therapy aiming for widespread commercial adoption.

Accompanying the manufacturing update were initial in vivo efficacy data presented by the National Cancer Institute at the AACR IO Annual Meeting 2026. In two small cell lung cancer (SCLC) xenograft models, M-ceNK cells combined with ANKTIVA achieved a statistically significant reduction in tumor volume. Furthermore, the treatment increased MHC class I expression on remaining tumor cells. This suggests a potential dual mechanism: direct tumor destruction by the NK cells, followed by a potential increased susceptibility of the cancer to checkpoint inhibitor therapies.

This has direct clinical relevance. Tissue analyses indicate that 62% of neuroendocrine tumors lack MHC class I expression, rendering them largely inaccessible to T-cell-based treatments—precisely the gap the M-ceNK platform is designed to address.

Regulatory Progress and Competitive Landscape

Alongside its NK cell development, ImmunityBio is advancing the regulatory strategy for ANKTIVA. The QUILT 2.005 study, which enrolled 366 BCG-naïve NMIBC CIS patients, is now fully enrolled. An interim analysis requested by the U.S. Food and Drug Administration (FDA) showed an improved duration of response for ANKTIVA plus BCG, with a nine-month complete response rate of 84% compared to 52% (p=0.0455) and no new safety signals. The company plans to submit its Biologics License Application (BLA) in the fourth quarter of 2026.

The competitive environment is intensifying. Gilead Sciences aims to quadruple its cell therapy manufacturing capacity by 2026, and Johnson & Johnson received U.S. approval for its bladder cancer therapy TAR-200 (Inlexzo) last September. ImmunityBio is countering this with its newly validated, reproducible manufacturing process, arguing that its M-ceNK platform can be expanded to target multiple tumor types.

In Europe, the firm is pursuing a country-specific market access strategy. Germany is among the priority markets and is slated to be one of the first countries to see an ANKTIVA launch, potentially before the end of 2026.