{"schema_version":"secwatch.filing_event.v1","accession":"0002023658-25-000112","form_type":"8-K","ticker":"BCAX","cik":"0002023658","company_name":"Bicara Therapeutics Inc.","filed_at":"2025-12-08T23:59:59+00:00","discovered_at":"2026-05-14T18:02:41.351086+00:00","generated_at":"2026-05-16T14:07:26.501986+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.65,"calibrated_materiality_score":0.65,"confidence":"high","headline":"Bicara reports 57% ORR in Phase 1b expansion; deeper responses at 1500mg dose; dose declaration on track for Q1 2026","bullets":["750mg ficerafusp alfa + pembrolizumab showed 57% confirmed ORR (17/30) with 10% complete response.","At 1500mg, median depth of response was 82% vs 63% at 750mg at 24 weeks.","Deep response rate (≥80% shrinkage) was 64% at 1500mg vs 27% at 750mg.","Safety profile consistent with known safety; no new tolerability concerns.","Company on track to declare optimal biologic dose for pivotal FORTIFI-HN01 study in Q1 2026."],"urls":{"canonical":"https://secwatch.observer/filing/0002023658-25-000112","json":"https://secwatch.observer/filing/0002023658-25-000112.json","markdown":"https://secwatch.observer/filing/0002023658-25-000112.md","text":"https://secwatch.observer/filing/0002023658-25-000112.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/2023658/000202365825000112/0002023658-25-000112-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/2023658/000202365825000112/bcax-20251206.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-16T14:07:26.501986+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"}