---
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"
generated_at: "2026-05-17T13:12:02.914366+00:00"
event_type: "earnings"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

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

## Summary
- 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.

## SEC filing metadata
- 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
- event_type: earnings
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 2.02, 9.01
- 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

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001641172-25-024007
- JSON: https://secwatch.observer/filing/0001641172-25-024007.json
- Plain text: https://secwatch.observer/filing/0001641172-25-024007.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.