BrainStorm Issues Annual Letter to Shareholders
NEW YORK & PETACH TIKVAH, Israel -- February 4, 2014
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
-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
-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
-In addition, PRC Clinical, based in San Francisco, came on board as the
Contract Research Organization (CRO) for the US Phase II trial.
-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
-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
Thank you very much for your continued support.
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
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