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Caladrius Subsidiary, PCT, to Manufacture Phase 3 Cell Therapy Product for Kiadis Pharma

BASKING RIDGE, N.J., June 21, 2016 (GLOBE NEWSWIRE) -- Caladrius Biosciences, Inc. (NASDAQ:CLBS) (“Caladrius” or the “Company”), a cell therapy company combining an industry-leading development and manufacturing services provider (PCT, LLC, A Caladrius Company or “PCT”) with a select therapeutic development pipeline, today announces that PCT has expanded its relationship with Kiadis Pharma (Euronext Amsterdam:KDS) (Euronext Brussels:KDS) (“Kiadis”), by entering into an agreement for the manufacturing of cell therapy product for United States and Canada clinical trial sites for a Phase 3 trial of Kiadis’ lead product, ATIR101™, for the treatment of blood cancers.

To date, PCT has provided engineering and process development services for Kiadis which included optimizing its manufacturing process to incorporate functionally closed processing. Work is currently underway at PCT’s Allendale, New Jersey facility to expand its clean room capacity by 60% and to develop and implement cell therapy specific pharmaceutical grade quality systems.

“We are pleased to select PCT as our contract manufacturing organization in the United States,” said Manfred Rüdiger, PhD, Chief Executive Officer of Kiadis. “The manufacture and supply of study medication for our Phase 3 clinical trial with ATIR101™ in the United States and Canada is a critical component to the successful and smooth running of our clinical study and having a partner who is well established and highly experienced, like PCT, is very important. PCT has been an excellent advisor and provider of process development to Kiadis in the past and we look forward to leveraging those efforts as we begin to broaden the activities of Kiadis in the United States.”

“We are pleased to expand our relationship with Kiadis to help bring new cell therapies to patients in need. Our Kiadis partnership is an excellent example of PCT’s growth strategy in motion – initiation of process and manufacturing development partnerships that subsequently expand to clinical manufacturing projects. Our strategy is for our partnerships to culminate, upon regulatory approval of client products, with commercial-scale manufacturing and advancement towards the cell therapy factory of the future,” said Robert A. Preti, PhD, President of PCT, and Senior Vice President, Manufacturing and Technical Operations and Chief Technology Officer of Caladrius Biosciences. “A growing number of cell therapy developers are partnering with PCT to take advantage of our quality, scalable, innovative, reliable, and cost-efficient manufacturing platforms and services to advance commercialization of cellular therapies.”

About Kiadis Pharma

Kiadis Pharma is focused on cell-based immunotherapy products for the treatment of blood cancers and inherited blood disorders. The Company’s products have the potential to address the risks and limitations connected with allogeneic hematopoietic stem cell transplantation (HSCT), namely Graft-versus-Host-Disease (GVHD), cancer relapse, opportunistic infections and limited matched donor availability. The Company believes that HSCT could become a first-choice treatment for blood cancers, inherited blood disorders and possibly autoimmune diseases and solid organ transplantations.

In April 2016, the Company reported positive Phase II results with its lead product ATIR101™ in patients with blood cancer. The data showed that ATIR101™ significantly reduced Transplant Related Mortality and significantly improved Overall Survival. In addition, ATIR101™ did not elicit grade III-IV GVHD in any patient. ATIR101™ has been granted Orphan Drug Designations both in the US and Europe. The Company’s second product candidate, ATIR201™, addresses inherited blood disorders with an initial focus on thalassemia, a disease which results in destruction of red blood cells in patients. ATIR201™ is expected to enter Phase I/II clinical development in the second half of 2016.

Kiadis Pharma, based in Amsterdam, The Netherlands, was granted an Advanced Therapy Medicinal Product (ATMP) certificate for manufacturing quality and non-clinical data by the European Medicines Agency (EMA). The Company’s shares are listed on Euronext Amsterdam and Euronext Brussels. For more information visit www.kiadis.com.

About Caladrius Biosciences

Caladrius Biosciences, Inc., through its subsidiary, PCT, is a leading development and manufacturing partner to the cell therapy industry. PCT works with its clients to overcome the fundamental challenges of cell therapy manufacturing by providing a wide range of innovative services including product and process development, GMP manufacturing, engineering and automation, cell and tissue processing, logistics, storage and distribution, as well as expert consulting and regulatory support. PCT and Hitachi Chemical Co., Ltd. have entered into a strategic global collaboration to accelerate the creation of a global commercial cell therapy development and manufacturing enterprise with deep engineering expertise. Around the core expertise of PCT, Caladrius strategically develops select product candidates, which currently includes an innovative therapy for type 1 diabetes based on a proprietary platform technology for immunomodulation. For more information, 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, including statements regarding Kiadis Pharma’s launch of a Phase 3 trial of ATIR101™, regulatory approval of ATIR101™, the potential commercial manufacture of ATIR101™ by PCT, the expansion of PCT”s Allendale, New Jersey facility and the development and implementation of cell therapy specific pharmaceutical grade quality systems to support commercial manufacturing for the United States and Europe, and PCT’s growth in partnerships with cell therapy developers. 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 15, 2016, and in the Company’s other periodic filings with the SEC, including: risks related to: (i) our expected continued losses and negative cash flows; (ii) our anticipated need for substantial additional financing; (iii) the significant costs and management resources required to comply with the requirements of being a public company; (iv) the possibility that a significant market for cell therapy may not emerge; (v) the potential variability in PCT’s revenues; (vi) PCT’s limited manufacturing capacity; (vii) the need to improve manufacturing efficiency at PCT; (viii) the limited marketing staff and budget at PCT; (ix) the logistics associated with the distribution of materials produced by PCT; (x) government regulation; (xi) our intellectual property; (xii) cybersecurity; (xiii) the development, approval and commercialization of our products; (xiv) enrolling patients in and completing, clinical trials; (xv) the variability of autologous cell therapy; (xvi) our access to reagents we use in the clinical development of our cell therapy product candidates; (xvii) the validation and establishment of manufacturing controls; (xviii) the failure to obtain regulatory approvals outside the United States; (xix) our failure to realize benefits relating to “fast track” and “orphan drug” designations; (xx) the failure of our clinical trials to demonstrate the safety and efficacy of our product candidates; (xxi) our current lack of sufficient manufacturing capabilities to produce our product candidates at commercial scale; (xxii) our lack of revenue from product sales; (xxiii) the commercial potential and profitability of our products; (xxiv) our failure to realize benefits from collaborations, strategic alliances or licensing arrangements; (xxv) the novelty and expense of the technology used in our cell therapy business; (xxvi) the possibility that our competitors will develop and market more effective, safer or less expensive products than our product candidates; (xxvii) product liability claims and litigation, including exposure from the use of our products; (xxviii) our potential inability to retain or hire key employees; and (xxix) risks related to our capital stock. 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.

CONTACTS: Investors: LHA Anne Marie Fields Senior Vice President Phone: +1-212-838-3777 Email: afields@lhai.com Media: Caladrius Biosciences, Inc. Eric Powers Director, Communications and Marketing Phone: +1-212-584-4173 Email: epowers@caladrius.com

Source:Caladrius Biosciences, Inc.