NEW YORK & PETACH TIKVAH, Israel --(BUSINESS WIRE)-- BrainStorm Cell Therapeutics (OTC.QB: BCLI), a leading developer of adult stem cell technologies for neurodegenerative diseases, today issued a Letter to Shareholders from its President, Mr. Chaim Lebovits , summarizing the company’s major developments in 2013. Dear BrainStorm Shareholders, This past year has been an exciting one for BrainStorm, as we have made steady progress preparing the groundwork for our Phase II clinical trial in the United States . Our 2013 activities on many fronts have enabled us to recently submit our IND application to the FDA , sign a definitive agreement with Mayo Clinic , and approach completion of the technology transfer process to Dana Farber's cleanroom manufacturing facility. 2013 was a year during which we achieved a number of milestones I am proud to summarize below. Clinical Trials: Israel -In late 2012 we completed a Phase I/II clinical trial in 12 ALS patients at Hadassah Medical Center in Jerusalem . The results of this study were presented by Principal Investigator Dimitrios Karussis , M.D., Ph.D., in an oral and poster presentation at the 2013 annual meeting of the American Academy of Neurology (AAN). -According to the final Clinical Study Report recently released by BRD Medical, BrainStorm's Contract Research Organization (CRO) at Hadassah, the study successfully met its primary and secondary endpoints. Moreover, there were "encouraging signals of efficacy in single individuals of both study groups, in which a dramatic improvement, was observed during more than two consecutive visits following MSC-NTF cells treatment in one or more of their secondary efficacy endpoints (ALSFRS-R score, total neurological examination score, FVC, and CMAP).” -In Q1 we launched a Phase IIa clinical trial at Hadassah with another 12 ALS patients, who are now undergoing six months follow-up. Due to medical and technical considerations, we recently enrolled two additional patients in the trial, in order to preserve the originally planned protocol design. These two patients will be treated by the end of Q1 2014. The final data from this trial will be analyzed and reported in the coming months. Clinical Trials: USA -In Q1 Mayo Clinic became the third US center to sign an MOU for participating in our multi-center Phase II trial, with a definitive agreement recently signed. -In parallel, we signed an agreement with Dana Farber Cancer Institute (DFCI) for manufacturing of NurOwn in its cGMP-compliant clean room facilities at the Connell and O'Reilly Cell Manipulation Core Facility (CMCF) for the MGH and UMass Hospital clinical sites. -In Q3 we initiated the NurOwn technology transfer process at CMCF, with on-site training currently ongoing by BrainStorm team members at their facility. -In addition, PRC Clinical, based in San Francisco , came on board as the Contract Research Organization (CRO) for the US Phase II trial. Financing: -In Q2 the Company completed an underwritten public offering, raising gross proceeds of approximately $4 million . Maxim Group LLC and Roth Capital Partners LLC acted as joint book-running managers for the offering. -In Q4 we were awarded our seventh annual non-dilutive grant from Israel’s Office of the Chief Scientist (OCS) in the amount of $800,000 for the company’s R&D and clinical program for NurOwn in ALS patients. The OCS has supported us since 2007, providing grants of a total of approximately $3 million until today. Regulatory, IP, Product Development: -In Q3 NurOwn was granted Orphan Drug Status by the European Commission (EC). This was previously granted by the US FDA in 2011. -The Letters of Allowance we recently received for our technologies from both the US and European Patent Offices represent a strong vote of confidence in our technology. -In Q4 we received approval for an animal study in Multiple Sclerosis (MS) at the Hebrew University Hadassah Medical Center’s SPF-grade animal laboratory in Jerusalem , which was subsequently initiated. -Throughout 2013 we made significant progress in our bioreactor development collaboration with Octane Biotech of Kingston, Ontario , and we believe that our first prototype will be up and running very soon. We are confident that, with G-d's help, during 2014 we will continue to achieve additional milestones in both clinical and product development, expand our activities internationally, continue to build company value, and most importantly, witness medical breakthroughs with our stem cells for ALS patients worldwide. Thank you very much for your continued support. Chaim Lebovits President and Principal Executive Officer About BrainStorm Cell Therapeutics, Inc. BrainStorm Cell Therapeutics Inc. is a biotechnology company engaged in the development of first-of-its-kind adult stem cell therapies derived from autologous bone marrow cells for the treatment of neurodegenerative diseases. The Company holds the rights to develop and commercialize its NurOwn technology through an exclusive, worldwide licensing agreement with Ramot, the technology transfer company of Tel Aviv University . For more information, visit the company’s website at www.brainstorm-cell.com . Safe Harbor Statement Statements in this announcement other than historical data and information constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as “may,” “should,” “would,” “could,” “will,” “expect,” “likely,” “believe,” “plan,” “estimate,” “predict,” “potential,” and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, risks associated with BrainStorm's limited operating history, history of losses; minimal working capital, dependence on its license to Ramot's technology; ability to adequately protect the technology; dependence on key executives and on its scientific consultants; ability to obtain required regulatory approvals; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov . These factors should be considered carefully, and readers should not place undue reliance on BrainStorm’s forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management’s beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements. BrainStorm Cell Therapeutics Inc. (OTC.QB: BCLI) Mr. Chaim Lebovits, President +972-3-9236384 email@example.com www.brainstorm-cell.com Source: BrainStorm Cell Therapeutics, Inc.
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