secwatch.observer — SEC 8-K summary
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Issuer:     Celcuity Inc. (CELC)
CIK:        0001603454
Form:       8-K
Filed at:   2023-05-15T23:59:59+00:00
Accession:  0001493152-23-017289
Event type: earnings
Sentiment:  neutral
Materiality: 0.60
Item codes: 2.02, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Celcuity Q1 2023 net loss $11.9M; Phase 1b gedatolisib shows median PFS 48.6 months
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- Net loss of $11.9M ($0.55 loss per share) vs $7.9M ($0.53 loss per share) in Q1 2022.
- R&D expenses $11.3M, up from $6.7M, driven by VIKTORIA-1 Phase 3 trial costs.
- Cash and short-term investments $157.5M at March 31, 2023.
- Phase 1b gedatolisib data: median PFS 48.6 months in treatment-naïve HR+/HER2- advanced breast cancer.
- VIKTORIA-1 Phase 3 enrollment on track for primary analysis of PIK3CA WT subgroup in H2 2024.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1603454/000149315223017289/0001493152-23-017289-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1603454/000149315223017289/form8-k.htm
  HTML page:      https://secwatch.observer/filing/0001493152-23-017289

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