{"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","discovered_at":"2026-05-14T18:03:32.201446+00:00","generated_at":"2026-06-08T05:56:34.267447+00:00","sec_items":["2.02","9.01"],"event_type":"earnings","sentiment":"positive","materiality_score":1.0,"calibrated_materiality_score":1.0,"confidence":"high","headline":"Delcath reports Q3 results; FDA approved HEPZATO KIT, launch planned Jan 2024","bullets":["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."],"urls":{"canonical":"https://secwatch.observer/filing/0001628280-23-038607","json":"https://secwatch.observer/filing/0001628280-23-038607.json","markdown":"https://secwatch.observer/filing/0001628280-23-038607.md","text":"https://secwatch.observer/filing/0001628280-23-038607.txt","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"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-08T05:56:34.267447+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":"5780c81c611a8b694fd95b8e4317d2cefb461114","claim":"DELCATH SYSTEMS, INC. reported third quarter ended September 30, 2023 results: revenue approximately $0.4 million.","evidence_excerpt":"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_source":"SEC 8-K Item 2.02","evidence_url":"https://www.sec.gov/Archives/edgar/data/872912/000162828023038607/0001628280-23-038607-index.htm","confidence":0.95,"family_label":"Earnings Releases","details":[{"label":"Period","value":"third quarter ended September 30, 2023"},{"label":"Revenue","value":"approximately $0.4 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"}