secwatch.observer — SEC 8-K summary
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Issuer:     BRAINSTORM CELL THERAPEUTICS INC. (BCLI)
CIK:        0001137883
Form:       8-K
Filed at:   2022-11-14T23:59:59+00:00
Accession:  0001104659-22-117689
Event type: regulatory
Sentiment:  negative
Materiality: 0.85
Item codes: 2.02, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

BrainStorm Q3 net loss $6.9M; FDA refuses to file NurOwn BLA for ALS
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- Cash & short-term deposits $7.4M as of Sep 30, down from $12.2M on Jun 30.
- Net loss $6.9M in Q3 2022 vs $5.3M in Q3 2021; EPS -$0.19 vs -$0.15.
- FDA refused to file new BLA for NurOwn in ALS; company plans to request Type A meeting.
- Phase 3 ALS post-hoc analyses at NEALS meeting addressed ALSFRS-R floor effect.
- Phase 2 progressive MS trial results published showing safety and preliminary efficacy.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1137883/000110465922117689/0001104659-22-117689-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1137883/000110465922117689/tm2230408d1_8-k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-22-117689

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