Caladrius Update on Phase 2b Trial of XOWNA® in Coronary Microvascular Dysfunction

Interim analysis to be conducted following enrollment suspension in the double-blind, randomized, placebo-controlled clinical trial

Next development steps for XOWNA® to be announced by year-end 2022 following regulatory and business review

Caladrius Management will host a conference call tomorrow, May 24th at 8:15 a.m. EDT

As previously communicated, enrollment in the FREEDOM Trial initially proceeded as planned with the first patient treated in January 2021; however, the impact of the COVID-19 pandemic in the U.S., coupled with supply chain issues associated with the catheters used for diagnosis of CMD and/or administration of XOWNA® as well as with a contrast agent typically used in many catheter laboratories, have made and continue to make enrollment much slower than originally predicted and challenging to accelerate. Despite the multiple protocol amendments to address these obstacles, along with an increased number of sites in the study, the FREEDOM Trial has only enrolled approximately one third of the targeted 105 patients, and at this rate, more than four years would likely be required to reach the primary endpoint follow-up at 6 months post-treatment for all subjects. The Company believes that this revised timeline is not viable for financial and commercial reasons and an alternative development plan must be considered. As a result, the Company has suspended further enrollment activities and will conduct an interim analysis of the data to determine the next steps for the program.

Conference Call Details:

Date: Tuesday, May 24, 2022
Time: 8:15 a.m. Eastern time
Toll-free Dial-in Number: (866) 595-8403
International Dial-in Number: (706) 758-9979
Conference ID: 7729348

A live webcast will be available on the Events & Presentations page (https://ir.caladrius.com/news-events/events-presentations) under the Investors & News section of the Caladrius website.

A telephone replay will also be available through May 27, 2022. To access replay, please dial (855) 859-2056 (Domestic) or (404) 537-3406 (International). At the system prompt, please enter the code 7729348 followed by the # sign.

https://finance.yahoo.com/news/caladrius-biosciences-provides-phase-2b-200500636.html