earnings
confidence high
sentiment neutral
materiality 0.70
Cellectar to pursue accelerated NDA for iopofosine I 131 in WM; Q2 net loss $5.4M
Cellectar Biosciences, Inc.
2025-Q2 EPS
reported -$7.66
vs consensus -$3.98
▼ miss
(-92.6%)
- Plans NDA submission for accelerated approval of iopofosine I 131 in WM, subject to sufficient funding and confirmatory trial initiation.
- FDA granted Breakthrough Therapy Designation for iopofosine I 131; EMA decision on conditional approval expected late Q3/early Q4 2025.
- Raised ~$9.5M in June/July financings; cash $11.0M at June 30, 2025, plus July net proceeds funds operations into Q2 2026.
- CLR 125 Phase 1 TNBC trial protocol submitted to FDA; plan to advance into clinic 4Q 2025/early 2026.
- Q2 2025 net loss $5.4M ($3.39 per share); R&D $2.4M, G&A $3.6M; both down YoY.
item 2.02item 9.01