Key Points. Pluristem issues shares to CHA at a price per share of $4.16. Development and Commercialization of PLX-PAD cells for the Treatment of Peripheral Artery Disease in South Korea
Haifa, Israel -- (SBWIRE) -- 12/20/2013 -- Pluristem Therapeutics Inc. today announced that pursuant to the previously announced exclusive out-license and strategic partnership agreement between Pluristem Ltd. and South Korea-based CHA Bio&Diostech, the details of which were announced on June 26, 2013. Pluristem and CHA entered into investment agreements pursuant to which Pluristem has issued to CHA 2,500,000 shares of its common stock in consideration for the issuance to Pluristem of 1,011,504 shares of CHA. This reflects a total consideration of $10.4 million, at a price of $4.16 per Pluristem common share, a premium of 26% over the closing price on December 16, 2013. The shares are subject to a lock up period of one year.
The previously announced agreement with CHA encompasses the use of Pluristem’s PLX-PAD cells in the treatment of two subsets of Peripheral Artery Disease (PAD) in South Korea: Intermittent Claudication (IC) and Critical Limb Ischemia (CLI).
Zami Aberman, Pluristem’s Chairman and CEO stated, “We are excited to finalize and move forward with this strategic agreement with CHA Bio. We believe that initiating clinical trials with CHA Bio for indications in the area of peripheral vascular disease opens significant opportunities for Pluristem in South Korea’s dynamic regenerative medicine industry. We also look forward to potentially expanding the use of our PLX cells for other indications with our partner, CHA Bio.”
The first clinical study to be performed as part of the agreement will be a Phase II trial in IC which will run in parallel to the Phase II trial being conducted in the USA, Germany and Israel. As previously announced, this study was approved in November 2013 by South Korea’s Ministry of Food and Drug Safety (MFDS). Pursuant to the previously announced agreement with CHA, upon the first regulatory approval for a PLX product in South Korea, Pluristem and CHA Bio will establish a joint venture (JV) co-owned by the parties. The purpose of the JV will be to commercialize PLX cell products in South Korea. Additionally, Pluristem will be able to use the data generated by CHA Bio to pursue the development of PLX product candidates outside of South Korea.
About CHA Bio&Diostech
CHA Bio&Diostech Co., Ltd. is a leading biopharmaceutical company headquartered in South Korea; its R&D focuses on stem cells, cell therapeutics, medical device, and new drug development. The company is a member of CHA Health Systems Group, which is composed of a medical university, medical centers and hospitals located in the US and Korea with in excess of two thousand beds under care, stem cell research centers, personal & preventive medicine, and bio venture divisions. CHA Bio&Diostech has multiple stem cell R&D pipelines in therapeutic areas including Stargardt’s disease, age-related macular disease, Parkinson’s disease, Alzheimer disease, Cerebral Palsy and glioblastoma in mid-to late-stages of development. With its extensive experience and research infrastructure, CHA Bio&Diostech has built up multiple strategic relations with major research institutions in the fields of stem cell research and infertility. For more information visit http://www.chabio.com, the content of which is not part of this press release.
About Pluristem Therapeutics
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapies. The Company's patented PLX (PLacental eXpanded) cells are a drug delivery platform that releases a cocktail of therapeutic proteins in response to a host of local and systemic inflammatory and ischemic diseases. PLX cells are grown using the company's proprietary 3D micro-environmental technology and are an "off-the-shelf" product that requires no tissue matching prior to administration.
Pluristem has a strong intellectual property position, company-owned GMP certified manufacturing and research facilities, strategic relationships with major research institutions and a seasoned management team. For more information visit http://www.pluristem.com, the content of which is not part of this press release.
Safe Harbor Statement
This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 and federal securities laws. For example, when we discuss the, we are using forward-looking statements. For example, we are using forward looking statement when we discuss our belief that initiating clinical trials with CHA Bio for indications in the area of peripheral vascular disease opens significant opportunities for us in South Korea’s medicine industry and that we look forward to potentially expanding the use of our PLX cells for other indications with CHA Bio, or when we discuss the Phase II trial in IC to be conducted as part of our agreement with CHA. These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; we may encounter delays or obstacles in launching and/or successfully completing our clinical trials; our products may not be approved by regulatory agencies, our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; our products may wind up being more expensive than we anticipate; results in the laboratory may not translate to equally good results in real surgical settings; results of preclinical studies may not correlate with the results of human clinical trials; our patents may not be sufficient; our products may harm recipients; changes in legislation; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem's reports filed from time to time with the Securities and Exchange Commission.
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