{"schema_version":"secwatch.filing_event.v1","accession":"0001641172-25-024007","form_type":"8-K","ticker":"CELC","cik":"0001603454","company_name":"Celcuity Inc.","filed_at":"2025-08-14T23:59:59+00:00","discovered_at":"2026-05-14T18:02:44.467582+00:00","generated_at":"2026-05-17T13:12:02.914366+00:00","sec_items":["2.02","9.01"],"event_type":"earnings","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"Celcuity reports Phase 3 gedatolisib milestone; NDA filing on track for Q4 2025","bullets":["Phase 3 VIKTORIA-1: gedatolisib triplet reduced risk of progression/death by 76% (HR=0.24); median PFS 9.3 mo vs 2.0 mo.","NDA for gedatolisib based on PIK3CA wild-type cohort expected Q4 2025; PIK3CA mutant topline data also in Q4 2025.","Q2 2025 net loss $45.3M ($1.04/sh) vs $23.7M ($0.62/sh) in Q2 2024; operating expenses $44.0M.","Completed concurrent offerings of notes, stock, warrants with net proceeds $286.5M; proforma cash $455M funding through 2027.","New patent extends gedatolisib dosing regimen exclusivity into 2042; first patient dosed in Phase 3 VIKTORIA-2 first-line trial."],"urls":{"canonical":"https://secwatch.observer/filing/0001641172-25-024007","json":"https://secwatch.observer/filing/0001641172-25-024007.json","markdown":"https://secwatch.observer/filing/0001641172-25-024007.md","text":"https://secwatch.observer/filing/0001641172-25-024007.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1603454/000164117225024007/0001641172-25-024007-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1603454/000164117225024007/form8-k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-17T13:12:02.914366+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"}