{"schema_version":"secwatch.filing_event.v1","accession":"0001178913-26-003946","form_type":"8-K","ticker":"ENTXW","cik":"0001638097","company_name":"Entera Bio Ltd.","filed_at":"2026-08-07T20:06:22+00:00","discovered_at":"2026-08-07T20:08:00.347361+00:00","generated_at":"2026-08-07T20:08:17.832117+00:00","sec_items":["2.02","7.01","9.01"],"event_type":"earnings","sentiment":"positive","materiality_score":0.9,"calibrated_materiality_score":0.9,"confidence":"high","headline":"Entera Bio reports Q2 2026 results; FDA agrees to 12-month Phase 3 for EB613, $275M PIPE led by BVF","bullets":["FDA accepted plan for single Phase 3 trial in ~750 postmenopausal women with osteoporosis, primary endpoint total hip BMD at Month 12; topline expected 2H 2028.","Oversubscribed $275M private placement led by BVF with participation from Longitude, Vivo, RA Capital, etc.; funds EB613 through NDA submission and extends cash runway into 2030.","Q2 2026 net loss $7.3M ($0.14/share) vs $2.7M ($0.06) in Q2 2025; R&D expenses $3.2M vs $1.5M.","Cash and equivalents $11.3M plus restricted cash $7.1M as of June 30, 2026; pro forma with $275M proceeds expected to fund operations into 2030.","EB612 IND filing planned 1H 2027 with OPKO; EB618 preclinical data presented at ENDO 2026."],"urls":{"canonical":"https://secwatch.observer/filing/0001178913-26-003946","json":"https://secwatch.observer/filing/0001178913-26-003946.json","markdown":"https://secwatch.observer/filing/0001178913-26-003946.md","text":"https://secwatch.observer/filing/0001178913-26-003946.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1638097/000117891326003946/0001178913-26-003946-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1638097/000117891326003946/zk2635891.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-08-07T20:08:17.832117+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"}