---
schema_version: "secwatch.filing_event.v1"
accession: "0001628280-23-038607"
form_type: "8-K"
ticker: "DCTH"
cik: "0000872912"
company_name: "DELCATH SYSTEMS, INC."
filed_at: "2023-11-13T23:59:59+00:00"
generated_at: "2026-06-08T05:56:34.267447+00:00"
event_type: "earnings"
sentiment: "positive"
materiality_score: 1.0
calibrated_materiality_score: 1.0
confidence: "high"
source: SEC EDGAR
---

# Delcath reports Q3 results; FDA approved HEPZATO KIT, launch planned Jan 2024

## Summary
- FDA approved HEPZATO KIT for metastatic uveal melanoma with hepatic metastases; commercial launch planned for January 2024.
- Raised ~$35M from Tranche A warrant exercise; up to $25M more upon achieving $10M quarterly revenue.
- Q3 revenue $0.4M vs $0.9M YoY; R&D $4.7M, SG&A $6.2M.
- Retrospective study showed median overall survival 516 days for PHP vs 301 days for SIRT in metastatic uveal melanoma.
- CHOPIN trial enrolled 55 of 76 patients; interim futility analysis recommended continuing; full enrollment expected mid-2024.

## SEC filing metadata
- accession: 0001628280-23-038607
- form_type: 8-K
- ticker: DCTH
- cik: 0000872912
- company_name: DELCATH SYSTEMS, INC.
- filed_at: 2023-11-13T23:59:59+00:00
- event_type: earnings
- sentiment: positive
- materiality_score: 1.0
- calibrated_materiality_score: 1.0
- confidence: high
- sec_items: 2.02, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/872912/000162828023038607/0001628280-23-038607-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/872912/000162828023038607/dcth-20231113.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001628280-23-038607
- JSON: https://secwatch.observer/filing/0001628280-23-038607.json
- Plain text: https://secwatch.observer/filing/0001628280-23-038607.txt

## Key facts
- Earnings Releases
  DELCATH SYSTEMS, INC. reported third quarter ended September 30, 2023 results: revenue approximately $0.4 million.
  - Period: third quarter ended September 30, 2023
  - Revenue: approximately $0.4 million
  - Result: reported results
  source text: Total revenue for the three months ended September 30, 2023, was approximately $0.4 million, compared to $0.9 million for the prior year period
  evidence_url: https://www.sec.gov/Archives/edgar/data/872912/000162828023038607/0001628280-23-038607-index.htm

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