ImmunityBio revenue surges 668% as Anktiva drives bladder cancer expansion

ImmunityBio Inc. posted $44.2 million in net product revenue for the first quarter of 2026, a 168% increase from a year earlier, as its bladder cancer immunotherapy Anktiva gained traction among US urologists and expanded into international markets. The company's full-year 2025 revenue reached $113.3 million, up 668% from $14.8 million in 2024, according to financial statements filed with the Securities and Exchange Commission.

"ANKTIVA's continued momentum reflects growing physician adoption and disciplined commercial execution," Chief Executive Officer Richard Adcock said in a statement. The company reported a 168% increase in unit sales volume in the first quarter compared with the same period last year.

The Culver City, California-based biotechnology company ended March with $380.9 million in cash and marketable securities, up from $242.8 million at the end of 2025. The GAAP net loss widened to $632.8 million in the first quarter from $129.6 million a year earlier, driven primarily by $530.9 million in non-cash fair value changes on warrant and derivative liabilities tied to the company's rising stock price. On an adjusted basis, the net loss was $86.2 million compared with $82.7 million.

Anktiva, an IL-15 superagonist designed to activate natural killer cells and T cells, received its first US approval in 2024 for BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ. The drug is now approved or authorized across five regulatory jurisdictions covering approximately 34 countries, including a first approval in Asia through Macau. The Saudi Food and Drug Authority also approved Anktiva in combination with immune checkpoint inhibitors for metastatic non-small cell lung cancer, marking the first global approval for that indication and the first authorization for subcutaneous administration.

Pipeline Milestones and Regulatory Progress

The company's pivotal BCG-naive NMIBC trial, QUILT-2.005, has fully enrolled, with the Independent Data Monitoring Committee confirming adequate statistical power. ImmunityBio expects to submit a supplemental Biologics License Application for that indication in 2026. In March, the National Comprehensive Cancer Network updated its clinical practice guidelines to include Anktiva plus BCG for patients with BCG-unresponsive papillary-only disease, a Category 2A recommendation representing uniform consensus among panel members.

The US Food and Drug Administration accepted a separate supplemental BLA for Anktiva plus BCG in BCG-unresponsive NMIBC with papillary disease, setting a Prescription Drug User Fee Act action date of Jan. 6, 2027. The company also secured comprehensive US patents covering the combination of Anktiva with BCG for cancer treatment, with terms extending through 2035.

Competitive Positioning and Market Opportunity

Anktiva competes in the NMIBC treatment market against therapies including Johnson & Johnson's TAR-200 and Ferring Pharmaceuticals' nadofaragene firadenovec. ImmunityBio has presented health economic data showing Anktiva plus BCG delivers a lower cost per sustained complete response versus TAR-200 in BCG-unresponsive NMIBC with CIS. The company is also advancing its pipeline beyond bladder cancer, including a randomized trial in non-small cell lung cancer for patients who progressed after checkpoint inhibitor therapy, and cell therapy programs targeting CD19 in non-Hodgkin lymphoma and PD-L1 t-haNK in glioblastoma.

Research and development spending rose to $68 million in the first quarter from $48.2 million a year earlier, driven by increased clinical trial costs and external manufacturing. Selling, general and administrative expenses increased to $45.8 million from $32.7 million, reflecting higher commercial-related costs and professional services as the company scales its sales organization.

ImmunityBio shares trade on the Nasdaq under the ticker IBRX. The company's market capitalization stood at approximately $8.1 billion as of late May, reflecting investor optimism about Anktiva's commercial trajectory and pipeline optionality. With $380.9 million in cash and growing product revenue, the company has funding to support its clinical programs through multiple regulatory milestones, though the adjusted net loss of $86.2 million per quarter indicates the path to profitability remains dependent on continued revenue acceleration.

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