---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-23-142792"
form_type: "8-K"
ticker: "DCTH"
cik: "0000872912"
company_name: "DELCATH SYSTEMS, INC."
filed_at: "2023-05-12T23:59:59+00:00"
generated_at: "2026-06-15T03:11:17.737829+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Delcath provides Q1 preliminary results; PDUFA date Aug 14, closes $25M financing

## Summary
- FDA set PDUFA goal date of August 14, 2023 for Hepzato Kit NDA resubmission.
- Closed initial $25M of up to $85M private placement led by Vivo Capital.
- Amended loan with Avenue Venture to defer $4.3M in principal payments through September 2023.
- Appointed John R. Sylvester as Chairman of the Board.
- CHOPIN trial: 7 uveal melanoma patients had median PFS of 29.1 months at 29.1-month follow-up.

## SEC filing metadata
- accession: 0001193125-23-142792
- form_type: 8-K
- ticker: DCTH
- cik: 0000872912
- company_name: DELCATH SYSTEMS, INC.
- filed_at: 2023-05-12T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 2.02, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/872912/000119312523142792/0001193125-23-142792-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/872912/000119312523142792/d495520d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-23-142792
- JSON: https://secwatch.observer/filing/0001193125-23-142792.json
- Plain text: https://secwatch.observer/filing/0001193125-23-142792.txt

## Key facts
- Earnings Releases
  DELCATH SYSTEMS, INC. reported preliminary financial results for first quarter ended March 31, 2023.
  - Period: first quarter ended March 31, 2023
  - Result: preliminary results
  source text: Delcath Systems, Inc. (Nasdaq: DCTH) (Delcath or the “Company”), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, today reported business highlights and certain preliminary financial results for the first quarter ended March 31, 2023.
  evidence_url: https://www.sec.gov/Archives/edgar/data/872912/000119312523142792/0001193125-23-142792-index.htm

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