{"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","discovered_at":"2026-05-14T18:03:36.831779+00:00","generated_at":"2026-06-11T23:55:44.469630+00:00","sec_items":["2.02","9.01"],"event_type":"regulatory","sentiment":"neutral","materiality_score":0.8,"calibrated_materiality_score":0.8,"confidence":"high","headline":"Delcath reports Q2 results; PDUFA for HEPZATO KIT on Aug 14","bullets":["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."],"urls":{"canonical":"https://secwatch.observer/filing/0001628280-23-028674","json":"https://secwatch.observer/filing/0001628280-23-028674.json","markdown":"https://secwatch.observer/filing/0001628280-23-028674.md","text":"https://secwatch.observer/filing/0001628280-23-028674.txt","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"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-11T23:55:44.469630+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":[{"claim_id":"d5a7217709c24078462332675bb39751db074063","claim":"DELCATH SYSTEMS, INC. reported the second quarter ended June 30, 2023 results: revenue approximately $0.5 million.","evidence_excerpt":"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_source":"SEC 8-K Item 2.02","evidence_url":"https://www.sec.gov/Archives/edgar/data/872912/000162828023028674/0001628280-23-028674-index.htm","confidence":0.9,"family_label":"Earnings Releases","details":[{"label":"Period","value":"the second quarter ended June 30, 2023"},{"label":"Revenue","value":"approximately $0.5 million"},{"label":"Result","value":"reported results"}],"fact_type":"earnings_release"}],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}