secwatch.observer — SEC 8-K summary
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Issuer:     Celcuity Inc. (CELC)
CIK:        0001603454
Form:       8-K
Filed at:   2025-08-14T23:59:59+00:00
Accession:  0001641172-25-024007
Event type: earnings
Sentiment:  positive
Materiality: 0.85
Item codes: 2.02, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Celcuity reports Phase 3 gedatolisib milestone; NDA filing on track for Q4 2025
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- 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.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1603454/000164117225024007/0001641172-25-024007-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1603454/000164117225024007/form8-k.htm
  HTML page:      https://secwatch.observer/filing/0001641172-25-024007

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer