Delcath Systems receives FDA approval for HEPZATO KIT for metastatic uveal melanoma

DELCATH SYSTEMS, INC.

FDA approved HEPZATO KIT (melphalan/HDS) for unresectable hepatic-dominant metastatic uveal melanoma patients.
Phase 3 FOCUS study showed ORR 36.3%, median DoR 14 months, DCR 73.6%.
Approval triggers Tranche A warrants for up to $34.9M additional PIPE financing within 21 days.
Tranche B warrants for up to $24.9M exercisable upon $10M quarterly US revenue from HEPZATO.
Commercial product expected to be available in Q4 2023.

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