secwatch.observer — SEC 8-K summary
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Issuer:     DELCATH SYSTEMS, INC. (DCTH)
CIK:        0000872912
Form:       8-K
Filed at:   2025-10-20T23:59:59+00:00
Accession:  0001193125-25-242909
Event type: other_material
Sentiment:  positive
Materiality: 0.85
Item codes: 2.02, 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Delcath: Q3 prelim rev $20.5M, net income $0.8M; CHOPIN trial meets endpoint
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- Prelim Q3 rev $20.5M ($19.2M HEPZATO, $1.3M CHEMOSAT); net income $0.8M; adj EBITDA $5.3M; cash $88.9M, no debt.
- FY2025 rev guidance raised to $83-85M, reflecting ~150% treatment volume increase over 2024.
- CHOPIN trial met primary endpoint: 1-yr PFS 54.7% (combo) vs 15.8% (PHP alone); HR 0.34, p<0.001.
- Secondary endpoints: 2-yr OS 49.6% vs 22.1% (HR 0.39, p=0.006); ORR 76.3% vs 39.5% (p<0.001).
- Grade 3+ AEs higher in combo (81.6% vs 40.5%) but manageable; no new safety signals.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/872912/000119312525242909/0001193125-25-242909-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/872912/000119312525242909/d51469d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-25-242909

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer