ImmunityBio (26CA) Q4 2025 Earnings Report

The call highlighted strong commercial traction for ANKTIVA with very large year-over-year revenue and unit growth, multiple regulatory milestones (including EU conditional authorization and Saudi first-in-world lung cancer approval), robust enrollment and promising clinical signals across randomized and single-arm QUILT programs, and strategic commercial partnerships and manufacturing initiatives. Offsetting these positives are substantial operating losses and cash burn, significant balance sheet liabilities, continued high R&D investment (including a one-time $14M equipment write-off), and some regulatory delays and market-access complexity in certain cohorts and geographies. Overall, the company is demonstrating clear commercial momentum and clinical progress but remains capital-intensive and faces execution and regulatory risks as it scales internationally.

The company did not provide forward financial guidance on the call but gave extensive 2025 metrics and near‑term milestones: ANKTIVA net product revenue was $113.0M in FY2025 (up 700% vs $14.1M in FY2024) with unit volumes +750% YoY and Q4 revenue $38.3M versus Q3 $31.1M (+20% sequential); ANKTIVA is authorized in 33 countries across four major jurisdictions (US, U.K., EU, KSA) with an EU conditional marketing authorization in Feb‑2026 and two Saudi approvals (bladder and conditional NSCLC combo) in Jan‑2026; cash, cash equivalents and marketable securities were $242.8M at 12/31/2025 and net cash used in operations was $304.9M for the year; FY R&D expense was $218.6M (vs $190.2M in 2024), SG&A was $150M (down from $168.8M), and FY net loss attributable to common stockholders was $351.4M (improved from $413.6M); key liabilities include $505M related‑party convertible notes and ~ $325M revenue‑interest liability. Clinical/regulatory metrics highlighted: QUILT‑2.005 fully enrolled 366 patients (interim 6‑month CR 85% vs 57%; 9‑month 84% vs 52%), QUILT‑3.032 Cohort A CR 71% (n≈100) with duration >53 months and Cohort B 12‑month DFS 58% / 24‑month DFS 52% with 36‑month disease‑specific survival 96% and ~82% bladder preservation; recombinant BCG expanded access spans ~100 sites and ~580 patients with several thousand doses delivered, BCG‑naive enrollment reported at 100% with a targeted BLA in Q4‑2026, QUILT‑3.055 treated ~147 patients, and the company introduced its askIB AI platform and NANT Leonardo automated cell‑manufacturing plans.