Transformational Revenue Growth for ANKTIVA
Full-year net product revenue for ANKTIVA was $113.0M in FY2025 versus $14.1M in FY2024, a 700% year-over-year increase; unit sales volume increased ~750% year-over-year, and Q4 revenue of $38.3M represented a 20% sequential increase vs Q3, indicating accelerating commercial adoption.
Rapid Global Regulatory and Commercial Expansion
ANKTIVA authorized in 33 countries and 4 major jurisdictions (U.S., U.K., Saudi Arabia, European Union) within ~2 years of initial FDA approval; European Commission granted conditional marketing authorization in Feb 2026 (EU27 + Iceland, Norway, Liechtenstein).
Key Regional Approvals and Partnerships
Saudi FDA granted approvals for ANKTIVA in BCG-unresponsive NMIBC and conditional approval in combination with checkpoint inhibitors for metastatic NSCLC (first worldwide lung cancer authorization); commercial partnerships: Accord Healthcare for EU/U.K. distribution (deploying 100+ personnel), Biopharma and Cigalah for Middle East/North Africa, Irish and Saudi subsidiaries established.
Strong Clinical Program Readouts and Enrollment Milestones
QUILT-2.005 (BCG-naive NMIBC) fully enrolled 366 patients; interim results showed 6-month complete response (CR) 85% (ANKTIVA+BCG) vs 57% (BCG alone) and 9-month CR 84% vs 52% (statistically significant at interim). QUILT-3.032 Cohort A (BCG-unresponsive CIS ± papillary) reported 71% CR with duration extending beyond 53 months; Cohort B (papillary) met endpoints: 12‑month disease-free 58%, 24‑month 52%, 36‑month disease-specific survival 96% and ~82% bladder preservation.
Commercial Evidence of Physician Adoption
Company reported repeat prescribing behavior, uptake across community urology practices and academic centers, and generation of real-world evidence supporting routine use in BCG-unresponsive NMIBC; majority of FY2025 ANKTIVA revenue driven by U.S. commercial performance.
Progress on Manufacturing and Novel Platforms
Advancing NANT Leonardo AI-driven robotic cellular manufacturing (Dunkirk, NY) for scalable NK/CAR-NK and m-ceNK production; introduced askIB, an internal AI platform to integrate LLMs and analytics across R&D, manufacturing, and operations.
Expanded Access and Supply Response for BCG Shortage
FDA-authorized expanded access program for recombinant BCG to address longstanding global shortage: ~100 clinical sites active/activating, ~580 patients dosed as of Feb 2026 and several thousand doses delivered, supporting both monotherapy and combination use with ANKTIVA.
Narrowing Net Loss and Active Pipeline Investment
Full-year net loss attributable to common stockholders narrowed to $351.4M in 2025 from $413.6M in 2024 (improvement of ~$62.2M, ~15% reduction) while continuing aggressive R&D investment across multiple platforms (ANKTIVA combos, CAR-NK, DNA vaccine).