secwatch.observer — SEC 8-K summary
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Issuer:     Celcuity Inc. (CELC)
CIK:        0001603454
Form:       8-K
Filed at:   2025-11-12T23:59:59+00:00
Accession:  0001493152-25-021903
Event type: earnings
Sentiment:  neutral
Materiality: 0.65
Item codes: 2.02, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1603454/000149315225021903/0001493152-25-021903-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1603454/000149315225021903/form8-k.htm
  HTML page:      https://secwatch.observer/filing/0001493152-25-021903

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