secwatch.observer — SEC 8-K summary
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Issuer:     Celcuity Inc. (CELC)
CIK:        0001603454
Form:       8-K
Filed at:   2023-08-10T23:59:59+00:00
Accession:  0001493152-23-027544
Event type: earnings
Sentiment:  positive
Materiality: 0.75
Item codes: 2.02, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Celcuity Q2 net loss $14.6M; Phase 1b gedatolisib data shows 48.6-month median PFS
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- Net loss $14.6M ($0.66/share) vs $10.0M ($0.67) Q2 2022; non-GAAP adjusted net loss $12.8M.
- Cash, equivalents and short-term investments $146.2M at June 30; R&D $13.7M, up $5.4M on VIKTORIA-1.
- Phase 3 VIKTORIA-1 on track; recruiting at ~200 sites in 20 countries; PIK3CA wild-type data H2 2024, mutant H1 2025.
- Updated Phase 1b gedatolisib combo: median PFS 48.6 months, ORR 79% in 41 treatment-naïve HR+/HER2- advanced breast cancer patients.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1603454/000149315223027544/0001493152-23-027544-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1603454/000149315223027544/form8-k.htm
  HTML page:      https://secwatch.observer/filing/0001493152-23-027544

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