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Caladrius Biosciences Reports Second Quarter 2021 Financial Results and Provides Business Update August 5, 2021 Conference call begins today at 4:30 p.m. Eastern Time BASKING RIDGE, N.J., Aug. 05, 2021 (GLOBE NEWSWIRE) -- Caladrius Biosciences, Inc. (Nasdaq: CLBS) (“Caladrius” or
Caladrius Biosciences Reports Second Quarter 2021 Financial Results and Provides Business
Conference call begins today at 4:30 p.m. Eastern Time
BASKING RIDGE, N.J., Aug. 05, 2021 (GLOBE NEWSWIRE) -- Caladrius Biosciences, Inc. (Nasdaq: CLBS) (“Caladrius” or the “Company”), a
clinical-stage biopharmaceutical company dedicated to the development of cellular therapies designed to reverse disease, provides a corporate
update and reports financial results for the three and six months ended June 30, 2021.
“The second quarter and first six months of 2021 have proven to be operationally and financially positive for Caladrius. Despite the continuing
challenges presented by the COVID-19 pandemic, we continued to advance and expand our clinical pipeline while also adding a large amount of
additional capital to our balance sheet,” stated David J. Mazzo, Ph.D., President and Chief Executive Officer of Caladrius. “Most notably, we are
seeing steady progress with site activation for our Phase 2b FREEDOM Trial of CLBS16 for the treatment of coronary microvascular dysfunction, as
we continue to increase outreach activities to potential subjects in order to accelerate enrollment. In addition, a Phase 2 proof-of-concept clinical trial of
CLBS201, designed to assess the safety and efficacy of CD34+ cell therapy as a treatment for patients with pre-dialysis diabetic kidney disease, is on
track for a planned initiation in the second half of 2021. Lastly, even though our registration-eligible study of HONEDRA® in critical limb ischemia and
Buerger’s disease continues to be greatly impacted by the Japanese government-issued states of emergency tied to the COVID-19 pandemic, we
have managed to treat patients and remain optimistic that the few remaining patients needed to complete enrollment will be treated by year end.”
Product Development and Financing Highlights
CLBS16 for the treatment of coronary microvascular dysfunction
Caladrius reported in May 2020 the compelling results of its ESCaPE-CMD Phase 2a study of CLBS16 for the treatment of coronary microvascular
dysfunction (“CMD”), a disease that continues to be underdiagnosed and potentially afflicts millions annually - a vast majority of whom are female -
with no current treatment options. The Company is committed to raising awareness of this growing women’s health crisis and finding an effective
treatment. To this end, we have partnered with the American Heart Association on a number of activities designed to educate people about CMD and
to encourage them to discuss the condition with their physician. Caladrius recently initiated, and is currently treating patients in, a rigorous 105-subject
Phase 2b clinical trial (the FREEDOM Trial) which, to our knowledge, is the first controlled regenerative medicine trial in CMD.
Investigator and subject response to the FREEDOM Trial has been favorable and early enrollment proceeded according to plan. However, the
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