---
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"
generated_at: "2026-05-14T21:01:43.485406+00:00"
event_type: "earnings"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# Celcuity reports Q1 net loss $52.8M; VIKTORIA-1 hits primary endpoint in PIK3CA mutant

## Summary
- 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.

## SEC filing metadata
- 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
- 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/1603454/000149315226023065/0001493152-26-023065-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1603454/000149315226023065/form8-k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001493152-26-023065
- JSON: https://secwatch.observer/filing/0001493152-26-023065.json
- Plain text: https://secwatch.observer/filing/0001493152-26-023065.txt

## Key facts
- Earnings Releases
  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.
  - Period: first quarter ended March 31, 2026
  - 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
  - Result: reported results
  source text: 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_url: https://www.sec.gov/Archives/edgar/data/1603454/000149315226023065/0001493152-26-023065-index.htm

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