---
schema_version: "secwatch.filing_event.v1"
accession: "0000320017-22-000046"
form_type: "8-K"
ticker: "LSTA"
cik: "0000320017"
company_name: "LISATA THERAPEUTICS, INC."
filed_at: "2022-05-23T23:59:59+00:00"
generated_at: "2026-06-25T08:24:18.353091+00:00"
event_type: "other_material"
sentiment: "negative"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# Caladrius suspends enrollment in Phase 2b FREEDOM Trial of XOWNA; interim analysis expected Aug 2022

## Summary
- 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.

## SEC filing metadata
- accession: 0000320017-22-000046
- form_type: 8-K
- ticker: LSTA
- cik: 0000320017
- company_name: LISATA THERAPEUTICS, INC.
- filed_at: 2022-05-23T23:59:59+00:00
- event_type: other_material
- sentiment: negative
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/320017/000032001722000046/0000320017-22-000046-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/320017/000032001722000046/clbs-20220523.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0000320017-22-000046
- JSON: https://secwatch.observer/filing/0000320017-22-000046.json
- Plain text: https://secwatch.observer/filing/0000320017-22-000046.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.