{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-25-003026","form_type":"8-K","ticker":"BCYC","cik":"0001761612","company_name":"BICYCLE THERAPEUTICS PLC","filed_at":"2025-01-13T23:59:59+00:00","discovered_at":"2026-05-14T18:03:04.772885+00:00","generated_at":"2026-05-28T03:41:11.509179+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"Bicycle Therapeutics reports 65% ORR in Ph1 combo zelenectide plus pembro in 1L mUC; outlines 2025 milestones","bullets":["Updated Phase 1 Duravelo-1 data: 65% ORR (13/20 evaluable) in 1L cisplatin-ineligible mUC; 50% confirmed ORR.","Median duration of response not yet mature; 12 patients remain on treatment at data cut-off (Jan 3, 2025).","No Grade 4/5 TRAEs of clinical interest; no patients withdrew due to zelenectide TRAEs; low-grade peripheral neuropathy, skin/eye events.","Cash and equivalents $890.9M as of Sept 30, 2024; financial runway into 2H 2027.","2025 milestones: Phase 2/3 Duravelo-2 dose selection data in 2H; initiate Phase 1 trials in NECTIN4-amplified breast, lung, and multi-tumor cancers."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-25-003026","json":"https://secwatch.observer/filing/0001104659-25-003026.json","markdown":"https://secwatch.observer/filing/0001104659-25-003026.md","text":"https://secwatch.observer/filing/0001104659-25-003026.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1761612/000110465925003026/0001104659-25-003026-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1761612/000110465925003026/tm253122d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-28T03:41:11.509179+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"}