ImmunityBio Earnings Call: ANKTIVA Surge Amid High Burn

Immunitybio Inc ((IBRX)) has held its Q4 earnings call. Read on for the main highlights of the call.

ImmunityBio’s latest earnings call painted a mixed but overall constructive picture, with management emphasizing explosive ANKTIVA revenue growth, expanding global approvals, and encouraging clinical data. At the same time, executives acknowledged heavy losses, significant liabilities, and execution risks as the company scales its oncology franchise internationally.

Transformational ANKTIVA Revenue Growth

Full‑year ANKTIVA net product revenue surged to $113.0 million in FY2025 from $14.1 million in FY2024, representing roughly 700% growth and underscoring rapid commercial traction. Unit volumes climbed about 750% year over year, while Q4 revenue of $38.3 million was up 20% sequentially from Q3, signaling accelerating adoption.

Rapid Global Regulatory and Commercial Expansion

Management highlighted a swift international rollout, with ANKTIVA now authorized in 33 countries across four major jurisdictions, including the U.S., U.K., Saudi Arabia, and the European Union. The European Commission’s conditional marketing authorization in February 2026 (covering EU27 plus Iceland, Norway, and Liechtenstein) marks a major foothold in the European bladder‑cancer market.

Strategic Regional Approvals and Partnerships

In Saudi Arabia, regulators approved ANKTIVA for BCG‑unresponsive NMIBC and granted a first‑in‑world conditional lung‑cancer approval in combination with checkpoint inhibitors for metastatic NSCLC. To monetize these wins, ImmunityBio is leaning on partners such as Accord Healthcare for EU and U.K. distribution and regional firms Biopharma and Cigalah for the Middle East and North Africa.

Robust Clinical Data from QUILT Programs

The company reported strong signals from its QUILT clinical portfolio, particularly in bladder cancer. BCG‑naive study QUILT‑2.005 fully enrolled 366 patients and showed markedly higher complete response rates with ANKTIVA plus BCG versus BCG alone at both six and nine months, while QUILT‑3.032 cohorts delivered durable responses and high bladder preservation.

Evidence of Physician Adoption in the U.S.

Commercial commentary pointed to growing comfort among urologists, with repeat prescribing, usage in both community practices and academic centers, and real‑world evidence backing routine use in BCG‑unresponsive NMIBC. Management noted that most FY2025 ANKTIVA revenue still comes from the U.S., underscoring the domestic market’s importance at this stage.

Manufacturing Scale‑Up and AI‑Driven Platforms

ImmunityBio is investing in manufacturing capacity and technology, including the NANT Leonardo robotic system in Dunkirk, N.Y., aimed at scalable NK and CAR‑NK production. The company also introduced askIB, an internal AI platform designed to integrate large‑language models and analytics across research, manufacturing, and operational workflows.

Expanded Access Amid Global BCG Shortage

To address a longstanding global shortage of BCG, the firm is running an FDA‑authorized expanded‑access program for its recombinant BCG candidate. Around 100 clinical sites are active or activating, roughly 580 patients have been dosed, and several thousand doses have been delivered, supporting both monotherapy use and combinations with ANKTIVA.

Narrowing Losses While Funding an Active Pipeline

Financially, the net loss attributable to common stockholders narrowed to $351.4 million in 2025 from $413.6 million a year earlier, a reduction of about 15%. Despite this improvement, the company maintained heavy R&D spending to advance ANKTIVA combinations, CAR‑NK programs, and DNA‑vaccine platforms, underscoring its growth‑first posture.

High Cash Burn and Leverage Weigh on the Story

The call underscored the capital‑intensive nature of the model, with $304.9 million in net cash used and only $242.8 million in cash, equivalents, and securities at year‑end. Major liabilities, including $505 million in related‑party convertible notes and about $325 million in revenue‑interest obligations, create a levered balance sheet that could constrain flexibility.

Regulatory Delays and Executional Costs

Not all regulatory news was positive, as the FDA initially refused to file a submission tied to the papillary Cohort B of QUILT‑3.032, prompting a subsequent Type B meeting and requests for additional data. R&D expenses rose to $218.6 million, partly due to a one‑time $14 million equipment write‑off, reflecting growing pains as manufacturing scales.

Geopolitical and Market‑Access Launch Risks

Management flagged geopolitical and operational challenges, particularly in the Middle East, that could disrupt logistics and delay launches despite Saudi approvals. Outside the U.S., ANKTIVA revenue will depend on country‑by‑country reimbursement and market‑access work in Europe and other regions, leading to uncertainty around the timing of international contributions.

Forward‑Looking Milestones Without Formal Guidance

While the company reiterated it will not provide formal financial guidance, it outlined key operational milestones investors should watch, including growing ANKTIVA sales, expansion of international launches, and progress toward a targeted regulatory filing for recombinant BCG. Management also emphasized ongoing readouts from bladder‑cancer QUILT studies, further development of CAR‑NK assets, and continued deployment of the askIB AI and NANT Leonardo platforms.

ImmunityBio’s earnings call showcased a company transitioning from clinical story to commercial player, with ANKTIVA delivering rapid revenue growth and a widening global footprint. Yet investors must balance this momentum against sizable losses, high cash burn, and regulatory and geopolitical uncertainties that could shape the next phase of the company’s evolution.