BASKING RIDGE, N.J., Jan. 11, 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 with a therapeutic development pipeline, announces today that it has entered into an agreement with SPS Cardio, LLC (“SPS”) to out-license the patent and commercialization rights to the Company’s CD34 ischemic repair technology (CD34 cell therapy or CLBS10) for the indications of acute myocardial infarction (AMI) and chronic heart failure (CHF) in select territories outside of the U.S. SPS is a venture capital firm that will fund this technology’s further development in these indications and designated countries. SPS intends to conduct a Phase 2 proof-of-concept clinical trial in India to evaluate CD34 cell therapy for the prevention of adverse events in patients with heart failure. This trial will be conducted under internationally accepted cGMP processes and protocols, such that the data will be acceptable for use as part of regulatory submissions to the U.S. Food and Drug Administration and other international regulatory authorities. Caladrius will be eligible to receive royalties together with a milestone upon the successful development and commercialization of any product eventually sold in the selected territories.
Under the agreement, SPS will receive an exclusive license to the CD34 cell therapy technology for use in AMI and CHF in India and in other territories outside the U.S., including selected countries in Asia-Pacific and Latin America. The license does not include the U.S., Europe, Japan, China or South Korea. SPS will cover all costs associated with the further development of the technology in the assigned regions as well as the costs of related intellectual property maintenance and advancement. Caladrius retains the rights to unfettered, cost-free access to and use of any and all clinical and non-clinical data generated in India.
“We are pleased to out-license our CD34 technology in AMI and CHF to SPS as it is in keeping with our strategic focus to build on our core competency in cell therapy process development and manufacturing. Our goal in licensing our various product candidates is to allow us to build on our core, revenue-generating PCT business, while deriving value from the continued development of our clinical assets through royalty and other milestone based payments. This agreement allows us to preserve capital, while retaining our ability to enter into separate development and commercialization partnerships for other indications and in other territories, such as for critical limb ischemia in Japan,” said David J. Mazzo, Ph.D., Chief Executive Officer of Caladrius. “We echo SPS’s enthusiasm for the technology and its development in India and look forward to sharing in their success.”
About CD34 Cell Technology
Caladrius’ technology is designed to utilize CD34 cells to regenerate tissue damaged by ischemic conditions. Ischemia occurs when the supply of oxygenated blood in the body is restricted, causing local tissue distress and death. Ischemia can lead to conditions such as chronic heart failure and critical limb ischemia, conditions for which improving oxygen delivery to affected tissues through the development and formation of new blood vessels initiated or enhanced by CD34 cells could prove therapeutic. Caladrius believes that the positive suggestion of safety and therapeutic activity seen to date in the PreSERVE-AMI Phase 2 study of CLBS10 for ST segment elevation myocardial infarction supports the underlying platform technology.
About Caladrius Biosciences
Caladrius Biosciences, Inc., through its wholly-owned subsidiary, PCT, is a leading development and manufacturing partner to the cell therapy industry. Caladrius works with its clients to overcome the fundamental challenges presented by 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. Around this core expertise, Caladrius strategically develops product candidates, which currently include an innovative therapy for type 1 diabetes based on a proprietary platform technology for immunomodulation, and holds intellectual property around other cell therapy platform technologies. 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 our expected revenues and capital expenditures, personnel reductions, as well as the potential of CLBS03 in the treatment of recent-onset type 1 diabetes and the expected cost savings associated with the termination of the CLBS20 study. 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 2, 2015, 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; (xx) our current lack of sufficient manufacturing capabilities to produce our product candidates at commercial scale; (xxi) our lack of revenue from product sales; (xxii) the commercial potential and profitability of our products; (xxiii) our failure to realize benefits from collaborations, strategic alliances or licensing arrangements; (xxiv) the novelty and expense of the technology used in our cell therapy business; (xxv) the possibility that our competitors will develop and market more effective, safer or less expensive products than our product candidates; (xxvi) product liability claims and litigation, including exposure from the use of our products; (xxvii) our potential inability to retain or hire key employees; and (xxviii) 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.