UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): June 6, 2014
Brainstorm Cell Therapeutics Inc.
(Exact name of registrant as specified in its charter)
| Delaware | 000-54365 | 20-8133057 | ||||
| (State or other jurisdiction of incorporation) |
(Commission File No.) | (IRS Employer Identification No.) |
| 605 Third Avenue, 34th Floor | |
| New York, NY | 10158 |
| (Address of principal executive offices) | (Zip Code) |
(646) 666-3188
(Registrant’s telephone number, including area code)
N/A
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Item 8.01 Other Events.
On June 6, 2014, BrainStorm Cell Therapeutics Inc. (“Brainstorm”) issued a press release announcing that its Phase II ALS clinical trial has now commenced with the enrollment of the first patient at Massachusetts General Hospital (MGH) in Boston, Massachusetts. BrainStorm’s Phase II trial is a randomized, double-blind, placebo controlled multi-center study designed to evaluate the safety and efficacy of transplantation of Autologous Mesenchymal Stem Cells Secreting Neurotrophic Factors ("MSC-NTF" or NurOwn™) in 48 ALS patients. The trial is also being conducted at the University of Massachusetts Memorial (UMass) Hospital in Worcester, Massachusetts and the Mayo Clinic in Rochester, Minnesota.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
The exhibit listed in the Exhibit Index below is filed with this report.
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| June 6, 2014 | Brainstorm Cell Therapeutics Inc. | |
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| By: |
/s/ Chaim Lebovits Chaim Lebovits | |
| President | ||
EXHIBIT INDEX
| Exhibit No. | Description | |||
| 99.1 | Press Release dated June 6, 2014 | |||
First Patient Enrolled in BrainStorm's Phase II ALS Trial at Massachusetts General Hospital
NEW YORK, NY and PETACH TIKVAH, ISRAEL--(Marketwired - Jun 6, 2014) - BrainStorm Cell Therapeutics (OTCQB: BCLI), a leading developer of adult stem cell technologies for neurodegenerative diseases, announced today that the first patient was enrolled in its Phase II ALS trial at Massachusetts General Hospital (MGH) in Boston.
BrainStorm's Phase II trial is a randomized, double-blind, placebo controlled multi-center study designed to evaluate the safety and efficacy of transplantation of Autologous Mesenchymal Stem Cells Secreting Neurotrophic Factors ("MSC-NTF" or NurOwn™) in 48 ALS patients. The trial is also being conducted at the University of Massachusetts Memorial (UMass) Hospital in Worcester, MA and the Mayo Clinic in Rochester, Minnesota.
About NurOwn™
NurOwn is an autologous, adult stem cell therapy technology that differentiates bone marrow-derived mesenchymal stem cells (MSC)
into "MSC-NTF" cells. These neuron-supporting cells secrete elevated levels of neurotrophic, or nerve-growth, factors
for PROTECTION of existing motor neurons, PROMOTION of motor neuron growth, and RE-ESTABLISHMENT of nerve-muscle interaction. The
ability to differentiate mesenchymal stem cells into MSC-NTF cells, and confirmation of their activity and potency before transplantation,
makes NurOwn a first-of-its-kind approach for treating neurodegenerative diseases. More information about NurOwn™ can
be found at http://brainstorm-cell.com/index.php/science-a-technology/-nurown.
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.
Contact:
Contact
BrainStorm Cell Therapeutics Inc. (OTCQB: BCLI)
Mr. Chaim Lebovits
President
Phone: +972-3-9236384
info@brainstorm-cell.com
US Investor Contact
LifeSci Advisors, LLC
Michael Rice
Phone: 646-597-6979
mrice@lifesciadvisors.com