secwatch.observer — SEC 8-K summary
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Issuer:     Celcuity Inc. (CELC)
CIK:        0001603454
Form:       8-K
Filed at:   2023-11-13T23:59:59+00:00
Accession:  0001493152-23-040317
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 $18.4M; raises $50M; advances gedatolisib in prostate cancer
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- Q3 net loss $18.4M ($0.83 loss per share) vs $10.9M ($0.75) YoY; non-GAAP adjusted loss $17.3M ($0.78).
- Closed $50M private placement equity in October 2023; cash runway extended into mid-2026.
- FDA cleared IND for gedatolisib + darolutamide in mCRPC; entered Bayer supply agreement for darolutamide.
- VIKTORIA-1 Phase 3 (HR+/HER2- breast cancer) on track: PIK3CA wt data H2 2024, PIK3CA mut data H1 2025.
- CELC-G-201 Phase 1b/2 (mCRPC) site activation Q1 2024; initial data expected H1 2025.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1603454/000149315223040317/0001493152-23-040317-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1603454/000149315223040317/form8-k.htm
  HTML page:      https://secwatch.observer/filing/0001493152-23-040317

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