{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-25-242909","form_type":"8-K","ticker":"DCTH","cik":"0000872912","company_name":"DELCATH SYSTEMS, INC.","filed_at":"2025-10-20T23:59:59+00:00","discovered_at":"2026-05-14T18:02:42.416264+00:00","generated_at":"2026-05-17T03:19:39.120913+00:00","sec_items":["2.02","7.01","8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"Delcath: Q3 prelim rev $20.5M, net income $0.8M; CHOPIN trial meets endpoint","bullets":["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."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-25-242909","json":"https://secwatch.observer/filing/0001193125-25-242909.json","markdown":"https://secwatch.observer/filing/0001193125-25-242909.md","text":"https://secwatch.observer/filing/0001193125-25-242909.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/872912/000119312525242909/0001193125-25-242909-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/872912/000119312525242909/d51469d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-17T03:19:39.120913+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}