{"schema_version":"secwatch.filing_event.v1","accession":"0001178913-25-002701","form_type":"8-K","ticker":"ENTXW","cik":"0001638097","company_name":"Entera Bio Ltd.","filed_at":"2025-08-08T23:59:59+00:00","discovered_at":"2026-05-14T18:02:44.538992+00:00","generated_at":"2026-05-17T16:37:40.532423+00:00","sec_items":["2.02","7.01","9.01"],"event_type":"earnings","sentiment":"positive","materiality_score":0.8,"calibrated_materiality_score":0.8,"confidence":"high","headline":"Entera Bio Q2 net loss $2.7M; FDA agrees on EB613 Phase 3 design with BMD endpoint","bullets":["FDA provided written concurrence on Phase 3 study for EB613, using total hip BMD as primary endpoint for NDA via 505(b)(2) pathway.","FDA waived dedicated oral carcinogenicity and DART studies for EB613, reducing regulatory burden.","Next-generation EB613 enters Phase 1 in November 2025; OPKO collaboration GLP-1/glucagon candidate OPK-88006 IND expected H1 2026.","Cash $18.9M including $8M restricted for OPKO; runway through mid-Q3 2026.","Q2 net loss $2.7M ($0.06 per share) vs $2.1M ($0.06 per share) a year ago; R&D up to $1.5M from $1.1M."],"urls":{"canonical":"https://secwatch.observer/filing/0001178913-25-002701","json":"https://secwatch.observer/filing/0001178913-25-002701.json","markdown":"https://secwatch.observer/filing/0001178913-25-002701.md","text":"https://secwatch.observer/filing/0001178913-25-002701.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1638097/000117891325002701/0001178913-25-002701-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1638097/000117891325002701/zk2533576.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-17T16:37:40.532423+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"}