---
schema_version: "secwatch.filing_event.v1"
accession: "0001493152-25-021903"
form_type: "8-K"
ticker: "CELC"
cik: "0001603454"
company_name: "Celcuity Inc."
filed_at: "2025-11-12T23:59:59+00:00"
generated_at: "2026-05-16T21:13:05.562705+00:00"
event_type: "earnings"
sentiment: "neutral"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# Celcuity Q3 net loss $43.8M; gedatolisib NDA on track for Q4 2025

## Summary
- Q3 net loss $43.8M ($0.92 loss per share) vs $29.8M ($0.70 loss) in prior year.
- Operating expenses $42.8M (R&D $34.9M, G&A $7.9M), up from $30.1M.
- PIK3CA WT cohort: gedatolisib triplet reduced risk of progression/death by 76% (HR 0.24); median PFS 9.3 vs 2.0 months.
- FDA accepted NDA under RTOR program; submission for gedatolisib on track for Q4 2025.
- PIK3CA mutant cohort fully enrolled; topline data expected late Q1 2026 or Q2 2026.

## SEC filing metadata
- accession: 0001493152-25-021903
- form_type: 8-K
- ticker: CELC
- cik: 0001603454
- company_name: Celcuity Inc.
- filed_at: 2025-11-12T23:59:59+00:00
- event_type: earnings
- sentiment: neutral
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 2.02, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1603454/000149315225021903/0001493152-25-021903-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1603454/000149315225021903/form8-k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001493152-25-021903
- JSON: https://secwatch.observer/filing/0001493152-25-021903.json
- Plain text: https://secwatch.observer/filing/0001493152-25-021903.txt

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