regulatory
confidence high
sentiment neutral
materiality 0.80
Delcath reports Q2 results; PDUFA for HEPZATO KIT on Aug 14
DELCATH SYSTEMS, INC.
- PDUFA date August 14, 2023 for HEPZATO KIT NDA resubmission; FDA review ongoing.
- Financing: $25M closed; up to $35M additional upon NDA approval; up to $25M on $10M quarterly revenue.
- Q2 revenue $0.5M (down from $0.8M); R&D $3.6M (down from $5.6M); SG&A $4.8M (up from $4.5M).
- Hired new CMO, SVP Finance, Director of Sales; treating patients at 3 Expanded Access sites.