Caladrius Biosciences Inc

Company Profile

Caladrius Biosciences, Inc. is a clinical-stage biopharmaceutical company dedicated to the development of cellular therapies designed to reverse disease. It is developing first-in-class cell therapy products based on the finely tuned mechanisms for self-repair that exist in the human body. Its technology leverages and enables these mechanisms in the form of specific cells, using formulations and modes of delivery unique to each medical indication. The Company’s current product candidates include: HONEDRA® (formerly CLBS12), recipient of SAKIGAKE designation and eligible for early conditional approval in Japan for the treatment of critical limb ischemia (“CLI”) based on the results of an ongoing clinical trial; OLOGO™ (formerly CLBS14), a Regenerative Medicine Advanced Therapy (“RMAT”) designated therapy for which the Company has finalized with the U.S. Food and Drug Administration (the “FDA”) a protocol for a Phase 3 confirmatory trial in subjects with no-option refractory disabling angina (“NORDA”); CLBS16, the subject of both a recently completed positive Phase 2a study and a newly initiated Phase 2b study in the U.S. for the treatment of coronary microvascular dysfunction (“CMD”); CLBS119, an emergent CD34+ stem cell therapy responding to the COVID-19 pandemic and the potentially permanent damage the virus inflicts on the lungs of many patients; and CLBS201, designed to assess the safety and efficacy of CD34+ cell therapy as a treatment for chronic kidney disease (“CKD”).