secwatch.observer — SEC 8-K summary
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Issuer:     Celcuity Inc. (CELC)
CIK:        0001603454
Form:       8-K
Filed at:   2022-11-10T23:59:59+00:00
Accession:  0001493152-22-031332
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 $10.9M ($0.75/sh); Phase 3 VIKTORIA-1 site activation underway
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- Net loss $10.9M ($0.75/sh) vs $6.0M ($0.41/sh) in Q3 2021; adjusted net loss $9.5M ($0.63/sh).
- R&D expenses $9.6M, up $4.7M YoY, mainly from VIKTORIA-1 trial initiation and existing trials.
- Completed selection of 200 clinical sites for Phase 3 VIKTORIA-1; first site activated; first dosing expected by end of 2022.
- FDA granted Breakthrough Therapy designation for gedatolisib in July; $100M private placement to close after first patient dose.
- Appointed Polly Murphy to Board; Phase 1b update accepted for December 2022 San Antonio Breast Cancer Symposium.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1603454/000149315222031332/0001493152-22-031332-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1603454/000149315222031332/form8-k.htm
  HTML page:      https://secwatch.observer/filing/0001493152-22-031332

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