earnings
confidence high
sentiment neutral
materiality 0.70
Cellectar Biosciences FY2024 net loss $44.6M; FDA agrees on accelerated approval path for iopofosine I 131
Cellectar Biosciences, Inc.
- Net loss of $44.6M ($1.22 basic EPS) vs $42.8M in 2023; cash $23.3M as of Dec 31, 2024.
- FDA aligned on regulatory path for accelerated approval of iopofosine I 131 in WM; confirmatory study (100/arm) expected to cost $40M-$45M.
- Phase 2 CLOVER-WaM data: ORR 83.6%, MRR 58.2% (exceeded FDA 20% endpoint).
- G&A expenses surged to $25.6M from $11.7M due to commercialization infrastructure; R&D $26.1M slightly down.
- IND cleared for Auger-emitting radioconjugate; alpha-emitting IND planned H1 2025.