secwatch.observer — SEC 8-K summary
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Issuer:     Celcuity Inc. (CELC)
CIK:        0001603454
Form:       8-K
Filed at:   2024-05-15T23:59:59+00:00
Accession:  0001493152-24-019852
Event type: earnings
Sentiment:  neutral
Materiality: 0.60
Item codes: 2.02, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Celcuity Q1 net loss $21.6M; Phase 3 VIKTORIA-1 on track for H2 2024 data
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- Net loss $21.6M ($0.64/sh) vs $11.9M ($0.55/sh) in Q1 2023; cash $177.7M expected runway into H1 2026.
- Phase 3 VIKTORIA-1 on track: topline PIK3CA wild-type data H2 2024; mutant sub-group H1 2025.
- First patient dosed in Phase 1b/2 trial of gedatolisib + darolutamide for mCRPC; prelim data expected H1 2025.
- Appointed Eldon Mayer as CCO in Feb 2024 to prepare for potential gedatolisib launch.
- R&D expenses $20.7M (up $9.4M YoY) driven by VIKTORIA-1 and new trial initiation.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1603454/000149315224019852/0001493152-24-019852-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1603454/000149315224019852/form8-k.htm
  HTML page:      https://secwatch.observer/filing/0001493152-24-019852

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