Cytori Completes Acquisition of Azaya Therapeutics Assets, Initiates Nanomedicine Program

"This acquisition is a very important step in the development of Cytori," said Dr. Marc Hedrick, President and Chief Executive Officer of Cytori. "The Acquisition provides Cytori both a near term opportunity to seek regulatory approval in Europe for the acquired ATI-0918 drug candidate, a generic form of nanoparticle encapsulated doxorubicin, with the goal of launching it in Europe as early as 2019, and bolsters Cytori's early and intermediate stage pipeline with new drug candidates in regenerative medicine and oncology".  

Cytori plans to develop nanoparticle-based therapeutics under the name Cytori Nanomedicine™ in the areas of oncology and regenerative medicine. In addition to ATI-0918, the generic nanoparticle encapsulated doxorubicin, Cytori has added the clinical stage ATI-1123 drug candidate, a protein-stabilized nanoparticle formulation of docetaxel and a preclinical stage regenerative medicine drug candidate for scleroderma.

About Cytori Therapeutics, Inc.

Cytori is a therapeutics company developing regenerative and oncologic therapies from its proprietary cell therapy and nanoparticle platforms for a variety of medical conditions. Data from preclinical studies and clinical trials suggest that Cytori Cell Therapy™ acts principally by improving blood flow, modulating the immune system, and facilitating wound repair. As a result, Cytori Cell Therapy™ may provide benefits across multiple disease states and can be made available to the physician and patient at the point-of-care through Cytori's proprietary technologies and products. Cytori Nanomedicine™ is developing encapsulated therapies for regenerative medicine and oncologic indications using technology that allows Cytori to use the benefits of its encapsulation platform to develop novel therapeutic strategies and reformulate other drugs to optimize their clinical properties.

Cautionary Statement Regarding Forward-Looking Statements

This communication includes forward-looking statements regarding events, trends and business prospects, which may affect our future operating results and financial position. Such statements, including, but not limited to, statements regarding: potential regulatory approval of the ATI-0918 drug candidate in Europe; potential commercial launch of ATI-0918 as early as 2019 and; plans to develop nanoparticle-based therapeutics under the name Cytori Nanomedicine in the areas of oncology and regenerative medicine, are subject to risks and uncertainties that could cause our actual results and financial position to differ materially. Some of these risks and uncertainties include, but are not limited to: unanticipated clinical, regulatory, commercial or other hurdles or uncertainties in developing, manufacturing and commercializing the acquired assets, including ATI-0918 and ATI-1123; any inability to identify and realize potential synergies between Cytori's and Azaya's technologies; inability to access capital to develop the acquired assets on terms acceptable to; potential negative market reaction to the Acquisition; unforeseen costs and expenses relating to the acquired assets that may exert significant pressure on Cytori's human, technical and financial resources, including its ability to fund development and commercialization of its clinical pipeline, including ATI-0918 and ATI-1123; failure to find suitable financing to operate Cytori's business as currently contemplated after consummation of the Acquisition; risk regarding identification of suitable partnering candidates for ATI-0918 or ATI-1123; technical capabilities risks, including the ability to successfully obtain and maintain sufficient drug development and manufacturing expertise; risks relating to review by the European Medicines Agency (EMA) of the ATI-0918 marketing authorization dossier and related EMA application requirements;  inherent risk and uncertainty in the conduct of clinical trials and clinical trial results (including Azaya's previously conducted bioequivalence trial for ATI-0918); risks in the collection of clinical data, final clinical outcomes risks; risks regarding protection of intellectual property rights, including protection of know-how and other trade secrets relating to manufacture of ATI-0918 and ATI-1123; competitive risks, including risk associated with commercializing a generic drug (ATI-0918) competitive with drugs offered by potentially much larger companies with greater technical, financial and human resources;  risks regarding dependence on third-party performance, and performance and acceptance of Cytori's products in the marketplace; risks regarding Cytori's and Azaya's compliance with the terms and provisions the Purchase Agreement; and other risks and uncertainties described under the "Risk Factors" section in Cytori's Securities and Exchange Commission Filings on Form 10-K and Form 10-Q. Cytori assumes no responsibility to update or revise any forward-looking statements contained in this press release to reflect events, trends or circumstances after the date of this communication.