Successful first full year commercial launch of AUCATZYL
Net product revenue of $74.3M for full year 2025; Q4 2025 net product revenue $23.3M and total Q4 revenue $24.3M (includes $1M license milestone). Company reiterated 2026 net revenue guidance of $120M to $135M (implies ~61.5% to ~81.7% growth vs 2025).
Real-world ROCCA outcomes validate clinical profile
ROCCA Consortium: 96 patients apheresed, 91 infused (94.8% infusion rate), 84 evaluable at day 28 (92.3% of infused). Day-28 overall complete remission ~92% in real-world setting, aligning with FELIX clinical data; median follow-up 137 days.
Favorable safety profile replicated in real-world use
CRS predominantly low grade: 59% Grade 1–2 and no Grade ≥3 CRS; ICANS 17% Grade 1–2 and 3% Grade 3 in ROCCA. These rates compare favorably to FELIX (FELIX had some high-grade CRS ~2% and ICANS 23% overall with ~7% high-grade).
Regulatory and market access progress
Regulatory approvals achieved in the EU and U.K.; market access initiated in the U.K. (no material EU revenue expected in 2026 but approvals provide future expansion pathway).
Commercial footprint expansion targets
67 treatment centers activated by end of 2025; targeting >80 activated centers by end of 2026 (target implies ~19.4% increase vs 67).
Pipeline advancement with multiple pivotal/important studies
Pediatric ALL (CATULUS) expanding to Phase 2 (+30 patients) after Phase 1 data (CR/CRi ~95%, CR ~91%); expected pivotal data by end of 2027. CARLYSLE (advanced SLE) showed 5/6 DORIS responses and 3/6 complete renal remissions at 50M dose with 11.4 months follow-up; LUMINA (lupus nephritis) enrolling (pivotal readout expected 2028). BOBCAT (progressive MS) enrolling — early data expected later in 2026 and fuller data in 2027; AUTO8 (AL amyloidosis) early data expected in 2026 (ALARIC).
Operational plan to achieve positive gross margin in 2026
Company expects shift to positive gross margins in 2026 driven by higher patient volume, improved plant utilization and operating model efficiencies.
Cash runway and accounting refinement
Cash, cash equivalents and marketable securities of $300.7M at Dec 31, 2025; company expects funds sufficient to operate into Q4 2027. Accounting policy refined to recognize product revenue and COGS upon confirmation of second dose administration (aligns timing of revenue and cost recognition).