ImmunityBio, Inc.

What they do

ImmunityBio commercializes ANKTIVA, an IL-15 receptor agonist, for BCG-unresponsive NMIBC and other indications, and develops a pipeline of natural killer cell therapies, cancer vaccines, and next-generation constructs. The company operates primarily in the U.S. and has authorized or approved ANKTIVA in five regulatory jurisdictions, reaching 34 countries.

Revenue drivers

• ANKTIVA net product revenue — Sole commercial product; net trade sales of ANKTIVA drove Q2 2026 revenue to $50.7 million, up 92% year-over-year.
• U.S. urologist adoption — Eighth consecutive quarter of sequential revenue growth, driven by continued adoption among U.S. urologists and strong market access.
• International partnerships — Expanding global footprint through international partners, including a new authorization in the UAE covering NMIBC and metastatic NSCLC.

Recent performance

Q2 2026 net product revenue was $50.7 million, up 92% year-over-year and 15% sequentially, contributing to first-half 2026 revenue of $94.8 million, up 121% versus the prior year. Full-year 2025 revenue was $113.3 million, up from $14.7 million in 2024, while net loss narrowed to $351.5 million from $413.6 million. R&D expense rose to $60.8 million in Q2 2026 from $55.2 million a year earlier. As of June 30, 2026, the company reported $357.4 million in cash, cash equivalents, and marketable securities.

Strategy

Management is focused on expanding ANKTIVA's approved indications, including a pending sBLA for BCG-unresponsive NMIBC with papillary disease (PDUFA date January 6, 2027) and a planned sBLA for BCG-naive NMIBC CIS. They are building long-term supply through an exclusive agreement with Japan BCG Laboratory for U.S. rights to Tokyo-172 BCG. The company is investing in commercial execution, international partnerships, and a late-stage pipeline spanning bladder cancer, NSCLC, and hematologic malignancies.

Risks

• Regulatory setbacks — The FDA issued a Refusal to File letter in May 2025 for the papillary NMIBC sBLA, and the company may be required to run a new randomized controlled trial.
• Dependence on a single product — ANKTIVA is the only approved product, so any commercial or manufacturing disruption would materially impact revenue.
• Negative equity and financial leverage — Shareholder equity was negative $1.05 billion with $1.67 billion in liabilities, raising going-concern and financing risks.
• Future financing needs — Continued operating losses and cash burn require additional financing to fund operations and commercial scale-up.

Outlook

Management expects continued sequential revenue growth from ANKTIVA and anticipates a PDUFA decision for the papillary NMIBC sBLA on January 6, 2027. A sBLA for BCG-naive NMIBC is planned for 2026, and multiple regulatory and clinical milestones are expected over the next 12 months. The company also plans to expand global approvals and commercial partnerships.