secwatch.observer — SEC 8-K summary
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Issuer:     LISATA THERAPEUTICS, INC. (LSTA)
CIK:        0000320017
Form:       8-K
Filed at:   2022-05-23T23:59:59+00:00
Accession:  0000320017-22-000046
Event type: other_material
Sentiment:  negative
Materiality: 0.85
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Caladrius suspends enrollment in Phase 2b FREEDOM Trial of XOWNA; interim analysis expected Aug 2022
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- Enrollment paused in 105-patient double-blind placebo-controlled FREEDOM Trial; only ~35 patients enrolled to date.
- Interim analysis of first 20+ patients with 6-month follow-up data to evaluate efficacy/safety and effect size.
- Results due August 2022; next development steps for XOWNA to be announced by year-end 2022.
- Causes: COVID-19, supply shortages of catheters/contrast agent, and discontinuation of specified diagnostic equipment.
- CEO cites alternative development plan needed; prior timeline of >4 years to complete deemed not viable.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/320017/000032001722000046/0000320017-22-000046-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/320017/000032001722000046/clbs-20220523.htm
  HTML page:      https://secwatch.observer/filing/0000320017-22-000046

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