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

LISATA THERAPEUTICS, INC.

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.

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