BASKING RIDGE, N.J., May 26, 2016 – Caladrius Biosciences, Inc. (NASDAQ:CLBS) (“Caladrius” or the “Company”), a cell therapy company combining an industry-leading development and manufacturing services provider (PCT) with a select therapeutic development pipeline, announces that it has licensed to AiVita Biomedical, Inc. (“AiVita”) the exclusive global rights to its tumor cell/dendritic cell technology for the treatment of ovarian cancer. In return, Caladrius will receive certain development milestone payments as well as royalties on sales of any commercial product. This transaction supports the Company’s strategy to monetize non-core assets. Under the license agreement AiVita will assume responsibility for all costs to develop a product using the licensed intellectual property, including the maintenance costs of the associated intellectual property.
The license contributes to AiVita’s intellectual property protection for its next generation immunotherapy targeting cancer stem cells. AiVita intends to begin a Phase II clinical trial to evaluate the efficacy of its novel appoach for ovarian cancer in 2016. To facilitate these clinical objectives, AiVita has also assumed a sublease of the Company’s former Irvine, California facility. This sublease obligation will cover for the remainder of the lease term all cash obligations of Caladrius with respect to the rent and overhead of the Irvine facility.
“Licensing this technology to AiVita is another step forward in streamlining our strategic focus and reducing our operating expenses while monetizing non-core assets through royalty and other milestone-driven transactions,” said David J. Mazzo, Ph.D., Chief Executive Officer of Caladrius. “This agreement adds to the one signed in February 2016 whereby we licensed to AiVita exclusive global rights to our cell-derived dermatological technology for topical skin applications.”
About AiVita Biomedical
AiVita Biomedical is advancing commercial and clinical-stage programs utilizing curative and regenerative medicines. Built upon expertise in stem cell growth and directed, high- purity differentiation, AiVita Biomedical has engineered safe, efficient and economical manufacturing systems to support the development and commercialization of curative and regenerative medicines.
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 AiVita Biomedical’s future development of an ovarian cancer product candidate and launch of a Phase II trial, future royalty or milestone payments to Caladrius and anticipated future cost savings. 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.