{"schema_version":"secwatch.filing_event.v1","accession":"0000950170-23-063350","form_type":"8-K","ticker":"ITRMF","cik":"0001659323","company_name":"Iterum Therapeutics plc","filed_at":"2023-11-14T23:59:59+00:00","discovered_at":"2026-05-14T18:03:29.971065+00:00","generated_at":"2026-06-08T03:41:43.728520+00:00","sec_items":["2.02","9.01"],"event_type":"other_material","sentiment":"neutral","materiality_score":0.65,"calibrated_materiality_score":0.65,"confidence":"high","headline":"Iterum completes REASSURE enrollment; NDA resubmission for uUTI expected Q2 2024","bullets":["Enrolled 2,229 patients in pivotal Phase 3 REASSURE trial; top-line data expected early Q1 2024.","NDA resubmission for uncomplicated UTI planned Q2 2024; FDA action expected Q4 2024.","Cash and investments $35.9M as of Sept 30, 2023; expected to fund operations into Q3 2024.","GAAP net loss $3.9M in Q3 2023 vs $29.1M in Q3 2022; non-GAAP net loss $15.7M vs $5.3M.","New composition patents for oral sulopenem granted in Korea and Australia, expiring no earlier than 2039."],"urls":{"canonical":"https://secwatch.observer/filing/0000950170-23-063350","json":"https://secwatch.observer/filing/0000950170-23-063350.json","markdown":"https://secwatch.observer/filing/0000950170-23-063350.md","text":"https://secwatch.observer/filing/0000950170-23-063350.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1659323/000095017023063350/0000950170-23-063350-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1659323/000095017023063350/itrm-20231115.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-08T03:41:43.728520+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":"e2cf025c9fe6956ea0f40d9abf3df7daaf83b74d","claim":"Iterum Therapeutics plc reported the third quarter ended September 30, 2023 results: net income Net loss for the third quarter 2023 was $3.9 million.","evidence_excerpt":"Iterum Therapeutics Reports Third Quarter 2023 Financial Results","evidence_source":"SEC 8-K Item 2.02","evidence_url":"https://www.sec.gov/Archives/edgar/data/1659323/000095017023063350/0000950170-23-063350-index.htm","confidence":0.95,"family_label":"Earnings Releases","details":[{"label":"Period","value":"the third quarter ended September 30, 2023"},{"label":"Net income","value":"Net loss for the third quarter 2023 was $3.9 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"}