Press Release Details

Caladrius Biosciences Sells Rights to Counter-Flow Centrifugation System to Hitachi Chemical Advanced Therapeutics Solutions

Sale of non-core asset brings $2.5 million in non-dilutive funding

BASKING RIDGE, N.J. (June 5, 2018) – Caladrius Biosciences, Inc. (Nasdaq: CLBS) (“Caladrius” or the “Company”), a clinical-stage biopharmaceutical company with multiple technology platforms targeting autoimmune and select cardiovascular indications, announces today that the Company has sold for $2.5 million its ownership interest in a development-stage, fully enclosed, automated, programmable counter-flow centrifugation (“CFC”) system for use in cell therapy manufacturing to Hitachi Chemical Advanced Therapeutics Solutions, LLC (“HCATS”), previously known as PCT Cell Therapy Services, LLC.

The CFC system enables cell therapy developers to wash and concentrate cells in an enclosed environment. It was designed for incorporation into Good Manufacturing Practice (“GMP”) equipment as a key element in commercial manufacture of cell therapies. The CFC system is designed for use in multiple stages of research and production for concentration/volume reduction, cell washing, media exchange, particle depletion and short-term incubation.  The goal of such innovation is to move closer to a cell processing environment where most, if not all, manufacturing is conducted in a fully-enclosed, automated fashion to reduce the requirement of both a highly skilled workforce and high specification cleanrooms, while providing a robust and reproducible process.

“We are particularly pleased to have sold our rights to the CFC system to the team we have worked so closely with at HCATS, knowing that it is in the hands of scientists, engineers and business people with the expertise to advance this technology, in partnership with Invetech Pty Ltd., and to bring it to market with the highest probability of success,” said David J. Mazzo, Ph.D., President and Chief Executive Officer of Caladrius Biosciences.  “Caladrius’ focus is solely on therapeutic product development, and the sale of this non-core asset provides non-dilutive funds to further support our key strategic interests.”

About Caladrius Biosciences

Caladrius Biosciences, Inc. is a clinical stage biopharmaceutical company with multiple technology platforms targeting select cardiovascular indications and autoimmune diseases. The Company is developing CLBS14, a CD34 cell therapy intended as a treatment for coronary microvascular dysfunction (CLBS14-CMD) and refractory angina (CLBS14-RfA).  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.  CLBS14-CMD is the subject of an ongoing Phase 2 proof-of-principal study being conducted in the USA at Cedars-Sinai (Los Angeles) and the Mayo Clinic (Minneapolis).  A companion product, CLBS12, is formulated specifically for intramuscular administration for the treatment of lower extremity ischemia. A Phase 2 study of CLBS12 as a treatment for critical limb ischemia is being conducted in Japan, a successful outcome of which will, based on discussions with the Japanese regulatory authorities, qualify the program for consideration of early conditional approval as provided for under Japan’s progressive regenerative medicine regulations.  CLBS12 has been granted SAKIGAKE designation in Japan for the CLI indication, a designation similar to “Breakthrough Therapy Designation” granted by FDA in the USA.  Additionally, the Company is investigating its CLBS03 product candidate, an ex vivo expanded polyclonal T regulatory cell therapy for the treatment of recent-onset type 1 diabetes, in an ongoing Phase 2 trial for which top-line data is expected in early 2019.  CLBS03 has been granted Fast Track and orphan drug designations from the U.S. Food and Drug Administration (“FDA”) as well as Advanced Therapeutic Medicinal Product (“ATMP”) classification from the European Medicines Agency (“EMA”).  For more information about Caladrius please visit www.caladrius.com.

Safe Harbor for 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 differ materially 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 22, 2018, as subsequently amended on April 2, 2018, 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. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date of this Press Release. Caladrius does not intend, and disclaims any obligation, to update or revise any forward-looking information contained in this Press Release or with respect to the matters described herein.

 Contacts:

Investors:
Caladrius Biosciences, Inc.
John Menditto
Executive Director, Investor Relations and Corporate Communications
Phone: 908-842-0084
Email: jmenditto@caladrius.com

LHA Investor Relations
Miriam Weber Miller
Senior Vice President
Phone: 212-838-3777
Email: MMiller@lhai.com

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Source: Caladrius Biosciences, Inc.