{"schema_version":"secwatch.filing_event.v1","accession":"0001493152-26-023065","form_type":"8-K","ticker":"CELC","cik":"0001603454","company_name":"Celcuity Inc.","filed_at":"2026-05-14T20:05:21+00:00","discovered_at":"2026-05-14T20:07:00.245507+00:00","generated_at":"2026-05-14T21:01:43.485406+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 Q1 net loss $52.8M; VIKTORIA-1 hits primary endpoint in PIK3CA mutant","bullets":["Net loss $52.8M ($0.97/share) vs $37.0M ($0.86/share) in Q1 2025; non-GAAP adjusted net loss $46.8M ($0.86).","VIKTORIA-1 PIK3CA mutant cohort: gedatolisib triplet and doublet both achieved statistically significant PFS improvement vs alpelisib+fulvestrant.","Detailed VIKTORIA-1 data to be presented at ASCO LBA oral session on June 2, 2026; sNDA submission planned for Q3 2026.","NDA for gedatolisib in PIK3CA wild-type accepted with Priority Review; PDUFA date July 17, 2026.","VIKTORIA-2 expanded: Study 2 (~740 patients) evaluating gedatolisib as first-line in endocrine-sensitive HR+/HER2- advanced breast cancer."],"urls":{"canonical":"https://secwatch.observer/filing/0001493152-26-023065","json":"https://secwatch.observer/filing/0001493152-26-023065.json","markdown":"https://secwatch.observer/filing/0001493152-26-023065.md","text":"https://secwatch.observer/filing/0001493152-26-023065.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1603454/000149315226023065/0001493152-26-023065-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1603454/000149315226023065/form8-k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-14T21:01:43.485406+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":[{"claim_id":"ef6158b536bf8620c6ecf0b14786a943d8c410bd","claim":"Celcuity Inc. reported first quarter ended March 31, 2026 results: net income Net loss for the first quarter of 2026 was $52.8 million, or $0.97 per share, EPS or $0.97 per share.","evidence_excerpt":"Net loss for the first quarter of 2026 was $52.8 million, or $0.97 per share, compared to a net loss of $37.0 million, or $0.86 per share, for the first quarter of 2025.","evidence_source":"SEC 8-K Item 2.02","evidence_url":"https://www.sec.gov/Archives/edgar/data/1603454/000149315226023065/0001493152-26-023065-index.htm","confidence":0.9,"family_label":"Earnings Releases","details":[{"label":"Period","value":"first quarter ended March 31, 2026"},{"label":"Net income","value":"Net loss for the first quarter of 2026 was $52.8 million, or $0.97 per share"},{"label":"EPS","value":"or $0.97 per share"},{"label":"Result","value":"reported results"}],"fact_type":"earnings_release"}],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}