---
schema_version: "secwatch.filing_event.v1"
accession: "0001628280-23-028674"
form_type: "8-K"
ticker: "DCTH"
cik: "0000872912"
company_name: "DELCATH SYSTEMS, INC."
filed_at: "2023-08-09T23:59:59+00:00"
generated_at: "2026-06-11T23:55:44.469630+00:00"
event_type: "regulatory"
sentiment: "neutral"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

# Delcath reports Q2 results; PDUFA for HEPZATO KIT on Aug 14

## Summary
- 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.

## SEC filing metadata
- accession: 0001628280-23-028674
- form_type: 8-K
- ticker: DCTH
- cik: 0000872912
- company_name: DELCATH SYSTEMS, INC.
- filed_at: 2023-08-09T23:59:59+00:00
- event_type: regulatory
- sentiment: neutral
- materiality_score: 0.8
- calibrated_materiality_score: 0.8
- confidence: high
- sec_items: 2.02, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/872912/000162828023028674/0001628280-23-028674-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/872912/000162828023028674/dcth-20230809.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001628280-23-028674
- JSON: https://secwatch.observer/filing/0001628280-23-028674.json
- Plain text: https://secwatch.observer/filing/0001628280-23-028674.txt

## Key facts
- Earnings Releases
  DELCATH SYSTEMS, INC. reported the second quarter ended June 30, 2023 results: revenue approximately $0.5 million.
  - Period: the second quarter ended June 30, 2023
  - Revenue: approximately $0.5 million
  - Result: reported results
  source text: Total revenue for the three months ended June 30, 2023, was approximately $0.5 million, compared to $0.8 million for the prior year period, from our sales of CHEMOSAT in Europe.
  evidence_url: https://www.sec.gov/Archives/edgar/data/872912/000162828023028674/0001628280-23-028674-index.htm

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.