Caladrius Biosciences Awarded Approximately $2 Million NIH Grant to Support Clinical Study of CLBS14 in Patients with Coronary Microvascular Dysfunction

BASKING RIDGE, N.J., Oct. 02, 2017 -- Caladrius Biosciences, Inc. (NASDAQ:CLBS) (“Caladrius” or the “Company”), a development-stage biopharmaceutical company with multiple technology platforms targeting autoimmune and select cardiology indications, announces the award of a $1,941,000 Small Business Innovative Research (“SBIR”) grant from the National Heart, Lung and Blood Institute of the National Institutes of Health (“NIH”) to support a clinical study with CLBS14 in patients with Coronary Microvascular Dysfunction (“CMD”).  CLBS14 is Caladrius’ propriety CD34+ cell therapy and CMD is a disease manifested by reduced blood flow to the heart muscle, resulting in pain and dysfunction.  Under the terms of the grant, the Company expects to receive approximately $750,000 in 2017 with the balance to be received in 2018 and 2019 in conjunction with the advancement of the study. 

“One of the body’s natural responses to ischemia is the recruitment of CD34 cells with these cells being pre-programmed to repair damage to the small blood vessels, or microcirculation,” said Douglas W. Losordo, M.D., FACC, FAHA, and Chief Medical Officer of Caladrius Biosciences.  “We are excited to advance the clinical development of our CD34+ cells in CMD as there are currently no therapies to address defects in the small blood vessels that contribute to the impairment of patients with acute and chronic ischemia, such as in CMD.”

“Our enthusiasm for this program is underscored by a strong body of preclinical and human clinical data that support CD34 cell therapy as having a beneficial effect in many cardiovascular and peripheral vascular diseases.  We look forward to initiating a 20-patient Phase 2 proof-of-concept study of CLBS14 in patients with CMD in early 2018 with the vast majority of the necessary funding being provided by this grant award,” said David J. Mazzo, Ph.D., President and Chief Executive Officer of Caladrius Biosciences. “We are particularly pleased to be awarded this SBIR grant as it highlights the NIH’s strong interest in the development of therapies to treat CMD, while also supporting our strategy to advance our clinical pipeline and generate more opportunities within our product portfolio through non-dilutive grants and collaborations.”

About Caladrius Biosciences

Caladrius Biosciences, Inc. is a development stage biopharmaceutical company with multiple technology platforms targeting autoimmune and select cardiology indications. The Company is investigating its lead product candidate, CLBS03, an ex vivo expanded polyclonal T regulatory cell therapy for the treatment of recent-onset type 1 diabetes, in a currently enrolling Phase 2 trial.  CLBS14 is Caladrius’ proprietary and patent protected formulation of CD34 cells designed specifically to enhance the potency of the CD34 cells for repair and regeneration of cardiovascular tissue. Its companion product, CLBS12, is specifically formulated for intramuscular administration for the treatment of lower extremity ischemia. For more information about Caladrius please visit www.caladrius.com.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements reflect management’s current expectations, as of the date of this press release, and involve certain risks and uncertainties. All statements other than statements of historical fact contained in this press release are forward-looking statements. The Company’s actual results could differ materially from those anticipated in these forward-looking statements as a result of various factors. Factors that could cause future results to materially differ from the recent results or those projected in forward-looking statements include the “Risk Factors” described in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (“SEC”) on March 17, 2017, and in the Company’s other periodic filings with the SEC. The Company’s further development is highly dependent on, among other things, future medical and research developments and market acceptance, which are outside of its control.

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