Unassociated Document
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): February 17, 2010
Brainstorm
Cell Therapeutics Inc.
(Exact
name of registrant as specified in its charter)
Delaware
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333-61610
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20-8133057
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(State
or other jurisdiction of
incorporation)
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(Commission
File No.)
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(IRS
Employer Identification No.)
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110
East 59 th
Street
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New
York, New York
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10022
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(Address
of principal executive offices)
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(Zip
Code)
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(212)
557-9000
(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:
¨ Written communications
pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
¨ Soliciting material
pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
¨ Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b))
¨ Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c))
Item
1.01 Entry into a Material Definitive Agreement.
On
February 17, 2010, a wholly owned Israeli subsidiary of BrainStorm Cell
Therapeutics Inc. (“Brainstorm”) entered into a series of agreements with
Hadasit Medical Research Services and Development Ltd., a subsidiary of the
Hadassah Medical Organization (“Hadassah”). Under the agreements, Hadassah and
BrainStorm personnel will conduct a clinical trial to evaluate the safety and
tolerability of BrainStorm's treatment using mesenchymal bone marrow stem cells
secreting neurotrophic factors (MSC-NTF) in patients with ALS, in accordance
with a protocol developed jointly by BrainStorm and Hadassah. The trial is
scheduled to include 26 patients.
Intellectual
property generated through the study will be owned by
BrainStorm. Hadassah will be entitled to use the intellectual
property generated through the study for non-commercial purposes. All existing
intellectual property of Brainstorm and Hadassah shall be retained by
them.
In
connection with the study, BrainStorm will pay Hadasit the following $38,190 per
patient totaling up to $992,880, as well as $31,250 per month for rental and
operation of clean room facilities according to GMP standards at Hadassah
facilities in Jerusalem in order to apply the cell growth and differentiation
process in accordance with Brainstorm's methods. The rental is for a period of
11 months (including one free month rent), which period may be extended for up
to an additional 5 months. In the event of a delay in receiving
approval for the study from the Israeli Ministry of Health, BrainStorm may
suspend the rental period for up to 4 months.
In
addition, BrainStorm will issue to Hadasit and Hadassah personnel warrants to
purchase up to 1,500,000 restricted shares of Common Stock of BrainStorm at an
exercise price of $0.001 per share, exercisable for a period of 5
years. The warrants shall vest over the course of the study as
follows: 500,000 upon enrolment of 1/3 of the patients; an additional 500,000
upon enrollment of all the patients and the final 500,000 upon completion of the
study.
The
agreements may be terminated by either party upon 60 days notice.
Item
3.02 Unregistered Sales of Equity Securities.
The
fourth paragraph of Item 1.01 is hereby incorporated by reference into this
item.
The
issuances of the securities described in this Item 3.02 were effected without
registration in reliance upon Regulation D promulgated under Securities Act of
1933, as amended. No underwriters were involved with the issuance of
such securities and no commissions were paid in connection with such
transaction.
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.
February
24, 2010
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Brainstorm
Cell Therapeutics Inc.
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By:
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/s/
Rami Efrati
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Rami
Efrati
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Chief
Executive Officer
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