BRAINSTORM CELL THERAPEUTICS INC. - Annual Report: 2009 (Form 10-K)
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
D.C. 20549
FORM
10-K
x ANNUAL REPORT
UNDER SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT
OF
1934
FOR
THE FISCAL YEAR ENDED DECEMBER 31, 2009
¨ TRANSITION REPORT
UNDER SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE
ACT
OF 1934
FOR
THE TRANSITION PERIOD FROM __________ TO __________
COMMISSION
FILE NUMBER 333-61610
BRAINSTORM
CELL
THERAPEUTICS
INC.
(Exact
Name of Registrant as specified in its charter)
Delaware
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20-8133057
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(State or other jurisdiction of
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(I.R.S. Employer
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incorporation or organization)
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Identification No.)
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110 East 59th Street
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New York, NY
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10022
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(Address of principal executive
offices)
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(Zip Code)
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Registrant’s
telephone number, including area code: 212-557-9000
Securities
registered under Section 12(b) of the Act: None
Securities
registered under Section 12(g) of the Act:
Title of each class
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Name of each exchange on which registered
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Common Stock, $0.00005 par value
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Over-the-Counter Bulletin Board
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Indicate
by check mark if the registrant is a well-known seasoned issuer, as defined in
Rule 405 of the Securities Act. Yes¨
No x
Indicate
by check mark if the registrant is not required to file reports pursuant to
Section 13 or 15(d) of the Act. Yes¨ No x
Indicate
by check mark whether the registrant (1) has filed all reports required to be
filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the
preceding 12 months (or for such shorter period that the registrant was
required to file such reports), and (2) has been subject to such filing
requirements for the past 90 days. Yes x No¨
Indicate
by check mark whether the registrant has submitted electronically and posted on
its corporate Web site, if any, every Interactive Data File required to be
submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this
chapter) during the preceding 12 months (or for such shorter period that the
registrant was required to submit and post such files).
Yes ¨ No ¨
Indicate
by check mark if disclosure of delinquent filers pursuant to Item 405 of
Regulation S-K is not contained herein, and will not be contained, to the best
of the registrant’s knowledge, in definitive proxy or information statements
incorporated by reference in Part III of this Form 10-K or any amendment to this
Form 10-K.¨
Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, a non-accelerated filer, or a smaller reporting company. See
the definitions of “large accelerated filer,” “accelerated filer” and “smaller
reporting company” in Rule 12b-2 of the Exchange Act. (Check one):
Large accelerated
filer ¨
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Accelerated
filer ¨
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Non-accelerated
filer ¨
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Smaller reporting company x
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(Do not check if a
smaller reporting
company)
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Indicate
by check mark whether the registrant is a shell company (as defined in Rule
12b-2 of the Act). Yes¨ No x
The
approximate aggregate market value of the voting and non-voting common equity
held by non-affiliates of the issuer as of June 30, 2009 (the last business
day of the registrant’s most recently completed second fiscal quarter), was
$2,607,465.
As of
March 24, 2010, the number of shares outstanding of the registrant's common
stock, $0.00005 par value per share, was 87,707,647.
DOCUMENTS
INCORPORATED BY REFERENCE
Portions
of the definitive proxy statement (the “Definitive Proxy Statement”) to be filed
with the Securities and Exchange Commission relative to the registrant’s 2010
Annual Meeting of Stockholders are incorporated by reference into Part III of
this annual report.
BRAINSTORM
CELL THERAPEUTICS, INC.
ANNUAL
REPORT ON FORM 10-K
YEAR
ENDED DECEMBER 31, 2009
TABLE
OF CONTENTS
ITEM
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Page
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PART
I
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1.
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Business
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3
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1A.
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Risk
Factors
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14
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1B.
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Unresolved
Staff Comments
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19
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2.
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Properties
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19
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3.
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Legal
Proceedings
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19
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4.
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Removed
and Reserved
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19
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PART
II
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5.
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Market
for Registrant’s Common Equity, Related Stockholder Matters and Issuer
Purchases of Equity Securities
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20
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6.
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Selected
Financial Data
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21
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7.
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Management’s
Discussion and Analysis of Financial Condition and Results of
Operations
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21
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7A.
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Quantitative
and Qualitative Disclosures About Market Risk
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25
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8.
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Financial
Statements and Supplementary Data
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25
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9.
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Changes
in and Disagreements with Accountants on Accounting and Financial
Disclosure
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64
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9A(T).
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Controls
and Procedures
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64
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9B.
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Other
Information
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66
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PART
III
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10.
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Directors,
Executive Officers and Corporate Governance
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66
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11.
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Executive
Compensation
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66
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12.
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Security
Ownership of Certain Beneficial Owners and Management and Related
Stockholder Matters
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67
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13.
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Certain
Relationships and Related Transactions, and Director
Independence
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67
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14.
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Principal
Accounting Fees and Services
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67
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PART
IV
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15.
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Exhibits,
Financial Statement Schedules
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68
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SPECIAL
NOTE
Unless
otherwise specified in this annual report on Form 10-K, all references to
currency, monetary values and dollars set forth herein shall mean United States
(U.S.) dollars.
SPECIAL
NOTE REGARDING FORWARD-LOOKING STATEMENTS
This annual report contains numerous
statements, descriptions, forecasts and projections, regarding Brainstorm Cell
Therapeutics Inc. and its potential future business operations and performance.
These statements, descriptions, forecasts and projections constitute
“forward-looking statements,” and as such involve known and unknown risks,
uncertainties, and other factors that may cause our actual results, levels of
activity, performance and achievements to be materially different from any
results, levels of activity, performance and achievements expressed or implied
by any such “forward-looking statements.” Some of these are described under
“Risk Factors” in this annual report. In some cases you can identify such
“forward-looking statements” by the use of words like “may,” “will,” “should,”
“could,” “expects,” “hopes,” “anticipates,” “believes,” “intends,” “plans,”
“estimates,” “predicts,” “likely,” “potential,” or “continue” or the negative of
any of these terms or similar words. These “forward-looking statements” are
based on certain assumptions that we have made as of the date hereof. To the
extent these assumptions are not valid, the associated “forward-looking
statements” and projections will not be correct. Although we believe that the
expectations reflected in these “forward-looking statements” are reasonable, we
cannot guarantee any future results, levels of activity, performance or
achievements. It
is routine for our internal projections and expectations to change as the year
or each quarter in the year progresses, and therefore it should be clearly
understood that the internal projections and beliefs upon which we base our
expectations may change prior to the end of each quarter or the year. Although
these expectations may change, we may not inform you if they do and we undertake
no obligation to do so. We caution investors that our business and financial
performance are subject to substantial risks and uncertainties. In evaluating
our business, prospective investors should carefully consider the information
set forth under the caption “Risk Factors” in addition to the other information
set forth herein and elsewhere in our other public filings with the Securities
and Exchange Commission.
Company
Overview
Brainstorm
Cell Therapeutics Inc. (“Brainstorm” or the “Company”) is a leading company
developing stem cell therapeutic products based on breakthrough technologies
enabling the in-vitro
differentiation of bone marrow stem cells to neural-like cells. We aim to become
a leader in adult stem cell transplantation for neurodegenerative diseases. Our
focus is on utilizing the patient’s own bone marrow stem cells to generate
neuron-like cells that may provide an effective treatment initially for ALS, PD
and Multiple Sclerosis.
Our core
technology was developed in collaboration with prominent neurologist, Prof.
Eldad Melamed, the former head of Neurology of the Rabin Medical Center and
member of the Scientific Committee of the Michael J. Fox Foundation for
Parkinson's Research, and expert cell biologist Prof. Daniel Offen, of the
Felsenstein Medical Research Center of Tel Aviv University.
The
Company’s team is among the first to demonstrate creation of neurotrophic-factor
secreting cells (glial cells) from in-vitro differentiated bone
marrow cells that produce neurotrophic factors (“NTF”) including GDNF, BDNF, NGF
and IGF-1.
The team
is also among the first to have successfully demonstrated release of
neurotrophic factors from in-vitro differentiated bone
marrow cells. Moreover, in research conducted by this team, implantation of
these differentiated cells into brains of animal models that had been induced to
Parkinsonian behavior markedly improved their symptoms.
3
Our aim
is to provide neural stem cell transplants that maintain, preserve and restore
the damaged and remaining dopaminergic cells in the patient’s brain, protecting
them from further degeneration.
The Company holds exclusive worldwide
rights to commercialize the technology, through a licensing agreement with
Ramot, the technology transfer company of Tel Aviv
University.
We are
currently in the developmental stage of our technology and products and we
intend to begin the process of seeking regulatory approval from regulatory
agencies in the U.S and Europe.
In
Israel, we have obtained Institutional Review Board (IRB) approval for a Phase
I/II clinical study in ALS patients at the Hadassah Medical Center, and are
currently awaiting final approval of the Israeli Ministry of
Health.
In
parallel, our efforts are directed at:
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Finalizing a GMP compliant
production process;
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Demonstrating safety and efficacy
in animals and in human ALS patients;
and
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Setting up centralized facilities
to provide the therapeutic products and services for transplantation in
patients.
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As a result of limited cash resources
and the desire to take a faster path to clinical trials, in the fourth quarter
of 2008 the Company determined to focus all of its efforts on ALS, and we are
currently not allocating resources towards PD or other neurodegenerative
diseases.
Our
Approach
Our
research team led by Prof. Melamed and Dr. Offen has shown that human bone
marrow mesenchymal stem cells can be expanded and induced to differentiate into
two types of brain cells, neurons-like and astrocyte-like, each having different
therapeutic potential, as follows:
NurOwn program
1 - Dopaminergic neuron-like cells - human bone marrow derived dopamine
producing neural cells for restorative treatment in PD. Human bone marrow
mesenchymal stem cells were isolated and expanded. Subsequent differentiation of
the cell cultures in a proprietary differentiation medium generated cells with
neuronal-like morphology and showing protein markers specific to neuronal cells.
Moreover, the in-vitro differentiated cells were shown to express enzymes and
proteins required for dopamine metabolism, particularly the enzyme tyrosine
hydroxylase. Most importantly, the cells produce and release dopamine in-vitro.
Further research consisting of implanting these cells in an animal model of PD
(6-OHDA induced lesions), showed the differentiated cells exhibit long-term
engraftment, survival and function in vivo. Most importantly, such implantation
resulted in marked attenuation of their symptoms, essentially reversing their
Parkinsonian movements.
NurOwn
program 2 - Neurotrophic-factors (“NTF”) secreting cells - human bone marrow
derived NTF secreting cells for treatment of PD, ALS and Multiple Sclerosis.
In-vitro differentiation of the expanded human bone marrow derived mesenchymal
stem cells in a proprietary medium leads to the generation of
neurotrophic-factors secreting cells. The in-vitro differentiated cells were
shown to express and secrete GDNF, as well as other NTFs, into the growth
medium. GDNF is a neurotrophic-factor, previously shown to protect, preserve and
even restore neuronal function, particularly dopaminergic cells in PD, but also
neuron function in other neurodegenerative pathologies such as ALS and
Huntington’s disease. Unfortunately, therapeutic application of GDNF is hampered
by its poor brain penetration and stability. Attempting to infuse the protein
directly to the brain is impractical and the alternative, using GDNF gene
therapy, suffers from the limitations and risks of using viral vectors. Our
preliminary results show that our NTF secreting cells, when transplanted into a
6-OHDA lesion PD rat model, show significant efficacy. Within weeks of the
transplantation, there was an improvement of more than 50% in the animals’
characteristic disease symptoms.
4
We
already optimized the proprietary processes for induction of differentiation of
human bone marrow derived mesenchymal stem cells into differentiated cells that
produce dopamine and/or NTFs for transplantation into PD and ALS
patients. The optimization and process development will be conducted
in Good Manufacturing Practice (“GMP”). Once the optimization of the
process is completed, we intend to evaluate the safety and efficacy of our
various cell transplants in animal models. Based on the results in
animals, we intend to use the differentiated cell products for conducting
clinical trials to assess the efficacy of the cell therapies in ALS and PD
patients.
Our
technology is based on the NurOwn products - an autologous cell therapeutic
modality, comprising the extraction of the patient bone marrow, processed into
the appropriate neuronal-like cells and re-implanted into the patient’s muscles
or brain. This approach is taken in order to increase patient safety and
minimize any chance of immune reaction or cell rejection.
We
believe that the therapeutic modality will comprise the following:
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Bone marrow aspiration from
patient;
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Isolation and expansion of the
mesenchymal stem cells;
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Differentiation of the expanded
stem cells into neuronal-like dopamine producing cells and/or
neurotrophic-factor secreting cells;
and
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Autologous transplantation into
the patient.
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History
The
Company was incorporated under the laws of the State of Washington on September
22, 2000, under the name Wizbang Technologies, Inc. and acquired the right to
market and sell a digital data recorder product line in certain states in the
U.S. Subsequently, the Company changed its name to Golden Hand Resources Inc. On
July 8, 2004, the Company entered into the licensing agreement with Ramot to
acquire certain stem cell technology and decided to discontinue all activities
related to the sales of digital data recorder product. On November 22, 2004, the
Company changed its name from Golden Hand Resources Inc. to Brainstorm Cell
Therapeutics Inc. to better reflect its new line of business in development of
novel cell therapies for neurodegenerative diseases. On October 25, 2004, the
Company opened its wholly-owned subsidiary, Brainstorm Cell Therapeutics Ltd. in
Israel. On December 18, 2006, the stockholders of the Company approved a
proposal to change the state of incorporation of the Company from the State of
Washington to the State of Delaware. The reincorporation was completed on
December 21, 2006 through the merger of the Company into a newly formed,
wholly-owned Delaware subsidiary of Brainstorm, also named Brainstorm Cell
Therapeutics Inc.
Recent
Developments
Hadassah
On
February 17, 2010, a wholly owned Israeli subsidiary of the Company 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.
5
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.
Investment of
$1,500,000
On
February 17, 2010, the Company entered into Securities Purchase Agreements with
three individual investors (collectively, the “Investors”), pursuant to which
the Company agreed to issue to the Investors an aggregate of 6,000,000
shares of common stock and two-year warrants to purchase 3,000,000 shares of
common stock with an exercise price of $0.50 in exchange for
$1,500,000.
On March
2, 2010, the transaction involving the sale of the shares of common stock and
warrants was completed, and the 6,000,000 shares of common stock and warrants or
purchase 3,000,000 shares of common stock were issued in exchange for the
investment of $1,500,000 in the Company.
Stem
Cell Therapy
Our
activities are within the stem cell therapy field. Stem cells are
non-specialized cells with a potential for both self-renewal and differentiation
into cell types with a specialized function, such as muscle, blood or brain
cells. The cells have the ability to undergo asymmetric division such that one
of the two daughter cells retains the properties of the stem cell, while the
other begins to differentiate into a more specialized cell type. Stem
cells are therefore central to normal human growth and development, and also are
a potential source of new cells for the regeneration of diseased and damaged
tissue. Stem cell therapy aims to restore diseased tissue function by the
replacement and/or addition of healthy cells by stem cell
transplants.
Currently,
two principal platforms for cell therapy products are being explored: (i)
embryonic stem cells (“ESC”), isolated from the inner mass of a few days old
embryo; and (ii) adult stem cells, sourced from bone marrow, cord blood and
various organs. Although ESCs are the easiest to grow and differentiate, their
use in human therapy is limited by safety concerns associated with their
tendency to develop Teratomas (a form of tumor) and their potential to elicit an
immune reaction. In addition, ESC has generated much political and ethical
debate due to their origin in early human embryos.
Cell
therapy using adult stem cells does not suffer from the same concerns. Bone
marrow is the tissue where differentiation of stem cells into blood cells
(haematopoiesis) occurs. In addition, it harbors stem cells capable of
differentiation into mesenchymal (muscle, bone, fat and other) tissues. Such
mesenchymal stem cells have also been shown capable of differentiating into
nerve, skin and other cells. In fact, bone marrow transplants have been safely
and successfully performed for many years, primarily for treating leukemia,
immune deficiency diseases, severe blood cell diseases, lymphoma and multiple
myeloma. Moreover, bone marrow may be obtained through a simple procedure of
aspiration, from the patient himself, enabling autologous cell therapy, thus
obviating the need for donor matching, circumventing immune rejection and other
immunological mismatch risks, as well as avoiding the need for immunosuppressive
therapy. We believe bone marrow, in particular autologous bone marrow, capable
of in-vitro growth and
multipotential differentiation, presents a preferable source of therapeutic stem
cells.
Neurodegenerative
Diseases
Studies
of neurodegenerative diseases suggest that symptoms that arise in afflicted
individuals are secondary to defects in neuron cell function and neural
circuitry and, to date, cannot be treated effectively with systemic drug
delivery. Consequently, alternative approaches for treating neurodegenerative
diseases have been attempted, such as transplantation of cells capable of
replacing or supplementing the function of damaged neurons. For such cell
replacement therapy to work, implanted cells must survive and integrate, both
functionally and structurally, within the damaged tissue.
6
Amyotrophic
Lateral Sclerosis
ALS,
often referred to as “Lou Gehrig's disease,” is a progressive neurodegenerative
disease that affects nerve cells in the brain and the spinal cord. Motor neurons
reach from the brain to the spinal cord and from the spinal cord to the muscles
throughout the body. The progressive degeneration of the motor neurons in ALS
eventually leads to death. As motor neurons degenerate, they can no longer send
impulses to the muscle fibers that normally result in muscle movement. With
voluntary muscle action progressively affected, patients in the later stages of
the disease may become completely paralyzed. However, in most cases, mental
faculties are not affected.
Approximately
6,000 people in the U.S. are diagnosed with ALS each year. It is estimated that
as many as 30,000 Americans and 100,000 people across the western world may have
the disease at any given time. Consequently, the total estimated cost of
treating ALS patients is approximately $1.25 billion per year in the U.S. and $3
billion per year in the western world.
Description
Early
symptoms of ALS often include increasing muscle weakness or stiffness,
especially involving the arms and legs, speech, swallowing or
breathing.
ALS is
most often found in the 40 to 70 year age group with the same incidence as
Multiple Sclerosis (“MS”). There appear to be more MS sufferers because MS
patients tend to live much longer, some for 30 years or more. The life
expectancy of an ALS patient averages about two to five years from the time of
diagnosis. However, up to 10% of ALS patients will survive more than ten
years.
Current
Treatments
The
physician bases medication decisions on the patient's symptoms and the stage of
the disease. Some medications used for ALS patients include:
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·
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Riluzole - the only medication
approved by the FDA to slow the progress of ALS. While it does not reverse
ALS, Riluzole has been shown to reduce nerve damage. Riluzole may extend
the time before a patient needs a ventilator (a machine to help breathe)
and may prolong the patient's life by several months;
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·
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Baclofen or Diazepam - these
medications may be used to control muscle spasms, stiffness or tightening
(spasticity) that interfere with daily activities;
and
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·
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Trihexyphenidyl or Amitriptyline
- these medications may help patients who have excess saliva or
secretions, and emotional
changes.
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Other
medications may be prescribed to help reduce such symptoms as fatigue, pain,
sleep disturbances, constipation, and excess saliva and phlegm.
Parkinson’s
Disease
Background
PD is a
chronic, progressive disorder, affecting certain nerve cells, which reside in
the Substantia Nigra of the brain and which produce dopamine, a neurotransmitter
that directs and controls movement. In PD, these dopamine-producing nerve cells
break down, causing dopamine levels to drop below the threshold levels and
resulting in brain signals directing movement to become abnormal. The cause of
the disease is unknown.
7
Over four
million people suffer from PD in the western world, of whom about 1.5 million
are in the United States. In over 85% of cases, PD occurs in people over the age
of 65. Prevalence of PD is increasing in line with the general aging of the
population. We believe the markets for pharmaceutical treatments for PD have a
combined value of approximately $4 billion per year. However, these costs are
dwarfed when compared to the total economic burden of the disease, which has
been estimated by the National Institute of Neurological Disease (“NINDS”) to
exceed $26 billion annually in the U.S. alone, including costs of medical
treatment, caring, facilities and other services, as well as loss of
productivity of both patients and caregivers.
Description
The
classic symptoms of PD are shaking (tremor), stiff muscles (rigidity) and slow
movement (bradykinesia). A person with fully developed PD may also have a
stooped posture, a blank stare or fixed facial expression, speech problems and
difficulties with balance or walking. Although highly debilitating, the disease
is not life threatening and an average patient’s life span is approximately 15
years.
Current
Treatments
Current
drug therapy for PD primarily comprises dopamine replacement, either directly
(levodopa), with dopamine mimetics or by inhibition of its breakdown. Thus, the
current drugs focus on treating the symptoms of the disease and do not presume
to provide a cure.
Levodopa,
which remains the standard and most potent PD medication available, has a
propensity to cause serious motor response complications (“MRCs”) with long-term
use. Moreover, effective drug dosage often requires gradual increase, leading to
more adverse side effects and eventual resistance to their therapeutic action.
This greatly limits patient benefit. Therefore, physicians and researchers are
continuously seeking levodopa-sparing strategies in patients with early-stage
disease to delay the need for levodopa, as well as in patients with late stage
disease who no longer respond to therapy.
Prescription
drugs to treat PD currently generate sales of over $1 billion and the market is
expected to grow to approximately $2.3 billion by 2010, driven by the increase
in size of the elderly population and the introduction of new PD therapies that
carry a higher price tag than the generic levodopa.
Another
method for treating PD is Deep Brain Stimulation (“DBS”), which consists of
transplanting electrodes deep into the brain to provide permanent electrical
stimulation to specific areas of the brain and to cause a delay in the activity
in those areas. However, DBS is problematic as it often causes uncontrollable
and severe side effects such as bleeding in the brain, infection and depression.
In addition, like drug therapy, DBS focuses on treating the symptoms of PD and
does not provide a cure.
There is
a greatly unsatisfied need for novel approaches towards management of PD. These
include development of neurotrophic agents for neuroprotection and/or
neurorestoration, controlling levodopa-induced adverse side effects, developing
compounds targeting nondopaminergic systems (e.g., glutamate antagonists)
controlling the motor dysfunction such as gait, freezing, and postural
imbalance, treating and delaying the onset of disease-related dementia and
providing simplified dosing regimens.
In
addition to the symptomatic drug development approaches, there is an intense
effort to develop cell and gene therapeutic “curative” approaches to restore the
neural function in patients with PD, by (i) replacing the dysfunctional cells
with dopamine producing cell transplant, or by (ii) providing growth factors and
proteins, such as glial derived neurotrophic factor (“GDNF”), that can maintain
or preserve the patient’s remaining dopaminergic cells, protecting them from
further degeneration. Preclinical evaluation of cell therapeutic approaches
based on transplantation of dopaminergic neurons differentiated in-vitro from ESC, have been
successful in ameliorating the parkinsonian behavior of animal models, as has
direct gene therapy with vectors harboring the GDNF gene. However, these
approaches are limited, in the first case, by the safety and ethical
considerations associated with use of ESC, and, in the second case, by the
safety risks inherent to gene therapy.
8
In fact,
PD is the first neurodegenerative disease for which cell transplantation has
been attempted in humans, first with adrenal medullary cells and, later, with
tissue grafts from fetal brains. About 300 such fetal transplants have already
been performed and some benefits have been observed, mainly in younger patients.
However, this approach is not only impractical but greatly limited by the
ethical issues influencing the availability of human fetuses. The above
considerations have led to intensive efforts to define and develop appropriate
cells from adult stem cells.
Business
Strategy
Our
efforts are currently focused on the development of the technology to convert
the process from the lab stage to the clinical stage, with the following main
objectives:
|
·
|
Developing the cell
differentiation process according to health regulation
guidelines;
|
|
·
|
Demonstrating safety and
efficacy, first in animals and then in patients;
and
|
|
·
|
Setting up centralized facilities
to provide NurOwn therapeutic products and services for transplantation in
patients.
|
We intend
to enter into strategic partnerships as we progress towards advanced clinical
development and commercialization with companies responsible for advanced
clinical development and commercialization. This approach is intended to
generate an early inflow of up-front and milestone payments and to enhance our
capacities in regulatory and clinical infrastructure while minimizing
expenditure and risk.
Business
Model
Our
objective is to have the proprietary procedure adopted by many medical centers,
throughout the U.S., Europe, Israel and East Asia for the treatment of ALS, PD,
and other neurodegenerative diseases. Our intended procedure for the replacement
of the degenerated neurons with healthy functional cells derived by
differentiation of bone marrow, may be among the earliest successes of stem cell
technologies and could be the starting point for a massive market potential in
the area of autologous transplantation. A central laboratory would be
responsible for processing bone marrow extracted from patients, enabling the
production of the cells required for the transplantation. Transplantation would
be carried out by the medical centers, with revenues shared with us on an agreed
basis.
We will
consider seeking cooperation with a major strategic marketing partner, having
established distribution channels and the ability to gain relatively fast access
to the target markets.
Our
approach will be optimized by working with a major partner. We believe there is
a substantial market opportunity and cooperation with strategic partners would
facilitate a more rapid and broad market penetration, by leveraging the
partner’s market credibility and the proven ability to provide service and
support across a large and geographically spread target market.
Potential
strategic partners include:
|
·
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Private Medical Center Chains -
interested in expanding their service offerings and being associated with
an innovative technology, thereby enhancing their professional standing
and revenue potential; and
|
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·
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Major Pharmaceutical and/or
Medical Device Companies - seeking new product opportunities and/or
wishing to maintain interest in the market, which may shift away from
drugs towards surgical
treatment.
|
9
We cannot
assure you that we will succeed in finding strategic partners that are willing
to enter into collaborations for our potential products at the appropriate stage
of development, on economic terms that are attractive to us or at
all.
Our
business model calls for significant investments in research and
development. Our research and development expenditures (i) in 2009
(before Ramot reserve accrual and participation by the Israeli Office of Chief
Scientist) were $1,069,000, which included $289,000 in stock-based compensation
and (ii) in 2008 were $2,097,000, which included $219,000 in stock-based
compensation.
Intellectual
Property
We have
filed the following patent applications:
WO2004/046348
METHODS, NUCLEIC ACID CONSTRUCTS AND CELLS FOR TREATING NEURODEGENERATIVE
DISORDERS. National phase filings in Europe and the United States. Substantive
examinations have been initiated in the U.S. and Europe. A patent was granted in
Singapore.
WO2006/134602
ISOLATED CELLS AND POPULATIONS COMPRISING SAME FOR THE TREATMENT OF CNS
DISEASES. National phase filings in the U.S., Australia, Europe, Israel and
China. Substantive examinations have been initiated in some
jurisdictions, including Israel and Europe. A patent was granted in South
Africa.
A joint
Brainstorm-Ramot patent application as PCT:
WO2009/144718MESENCHYMAL
STEM CELLS FOR THE TREATMENT OF CNS DISEASES
The
patent applications, as well as relevant know-how and research results are
licensed from Ramot. We intend to work with Ramot to protect and enhance our
mutual intellectual property rights by filing continuations and new patent
applications on any improvements and any new discoveries arising in the course
of research and development.
Research
and License Agreement with Ramot
On July
8, 2004, we entered into a Research and License Agreement (the “Original Ramot
Agreement”) with Ramot, the technology licensing company of Tel Aviv University,
which agreement was amended on March 30, 2006 by the Amended Research and
License Agreement (described below). Under the terms of the Original Ramot
Agreement, Ramot granted to us an exclusive license to (i) the know-how and
patent applications on the above-mentioned stem cell technology developed by the
team led by Prof. Melamed and Dr. Offen, and (ii) the results of further
research to be performed by the same team on the development of the stem cell
technology. Simultaneously with the execution of the Original Ramot Agreement,
we entered into individual consulting agreements with Prof. Melamed and Dr.
Offen pursuant to which all intellectual property developed by Prof. Melamed or
Dr. Offen in the performance of services thereunder will be owned by Ramot and
licensed to us under the Original Ramot Agreement.
Under the
Original Ramot Agreement, we agreed to fund further research relating to the
licensed technology in an amount of $570,000 per year for an initial period of
two years, and for an additional two-year period if certain research milestones
were met.
In
consideration for the license, we originally agreed to pay
Ramot:
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An up-front license fee payment
of $100,000;
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An amount equal to 5% of all net
sales of products; and
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An amount equal to 30% of all
sublicense receipts.
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On March
30, 2006, we entered into an Amended Research and License Agreement (the
“Amended Research and License Agreement”) with Ramot. Under the Amended Research
and License Agreement, the funding of further research relating to the licensed
technology in an amount of $570,000 per year was reduced to $380,000 per year.
Moreover, under the Amended Research and License Agreement, the initial period
of time that we agreed to fund the research was extended from an initial period
of two (2) years to an initial period of three (3) years. The Amended Research
and License Agreement also extended the additional two-year period in the
Original Ramot Agreement to an additional three-year period, if certain research
milestones were met. In addition, the Amended Research and License Agreement
reduced (i) certain royalties payments from five percent (5%) to three percent
(3%) of all net sales in cases of third party royalties and (ii) potential
payments concerning sublicenses from 30% to 20-25% of sublicense receipts.
We
entered into a Second Amended and Restated Research and License Agreement with
Ramot on July 26, 2007. Like the Original Ramot Agreement, the amended license
agreement imposed on us development and commercialization obligations, milestone
and royalty payment obligations and other obligations. As of June 30, 2007, we
owed Ramot an aggregate of $513,249 in overdue payments and patent fees
under the Amended Research and License Agreement. On August 1, 2007, we
obtained a waiver and release from Ramot pursuant to which Ramot agreed to an
amended payment schedule regarding our payment obligations under the amended
license agreement and waived all claims against us resulting from our previous
breaches, defaults and non-payment under the Amended Research and License
Agreement.
In
addition, in the event that the “research period”, as defined in the amended
license agreement, was extended for an additional three year period in
accordance with the terms of the amended license agreement, then we had to make
payments to Ramot during the first year of the extended research period in an
aggregate amount of $380,000.
On
December 24, 2009, we entered into a Letter Agreement (the “Letter Agreement”)
with Ramot, pursuant to which, among other things, Ramot agreed to: (i) release
the Company from it’s obligation to fund three years of additional research
(which would have totaled $1,140,000); (ii) accept shares of common stock of the
Company in lieu of $272,000 is past-due amounts. Pursuant to the
Letter Agreement, the Company agreed, among other things, to: (i) reimburse
Ramot for outstanding patent-related expenses; (ii) abandon its rights in
certain patents of Ramot.
Government
Regulations and Supervision
Once
fully developed, we intend to market our bone marrow derived differentiated
neurothrophic-factor secreting cell products, NurOwnTM, for
autologous transplantation in patients by neurosurgeons in medical facilities in
the U.S., Europe, Japan and the Pacific Rim. Accordingly, we believe our
research and development activities and the manufacturing and marketing of our
technology are subject to the laws and regulations of governmental authorities
in the United States and other countries in which our technology and products
will be marketed. Specifically, in the U.S., the FDA, among other agencies,
regulates new biological product approvals (“BLA”) to establish safety and
efficacy, as well as appropriate production of these products. Governments in
other countries have similar requirements for testing and
marketing.
As we are
currently in the research and development stage of our technology and
NurOwnTM cell
product, we have initiated the process of seeking regulatory approval from the
FDA and other regulatory agencies. We have retained/recruited expert regulatory
consultants and employees to assist us in our approaches to the FDA. In our
efforts to obtain regulatory approval, we have had a pre Investigational New
Drug (“IND”) meeting with the FDA and we are planning to retain such expert
regulatory consultants to assist the Company in its approach to the EMEA in
order to get regulatory approval in Europe. We have also engaged a
regulatory consultant to assist us with the regulatory authorities in
Israel.
11
Regulatory
Process in the United States
Regulatory
approval of new biological products is a lengthy procedure leading from
development of a new product through pre-clinical animal testing and clinical
studies in humans. This process takes a number of years, is regulated by the FDA
and requires the expenditure of significant resources. There can be no assurance
that our technology will ultimately receive regulatory approval. We summarize
below our understanding of the regulatory approval requirements that may be
applicable to us if we pursue the process of seeking an approval from the
FDA.
The
Federal Food, Drug, and Cosmetic Act and other federal statutes and regulations
govern or influence the research, testing, manufacture, safety, labeling,
storage, record-keeping, approval, distribution, use, reporting, advertising and
promotion of our future products. Non-compliance with applicable requirements
can result in civil penalties, recall, injunction or seizure of products,
refusal of the government to approve or clear product approval applications or
to allow us to enter into government supply contracts, withdrawal of previously
approved applications and criminal prosecution.
The FDA
has developed and is continuously updating the requirements with respect to cell
and gene therapy products and has issued documents concerning the regulation of
cellular and tissue-based products, as new biological products. In order to file
for a BLA, we will be required to develop our stem cell product in accordance
with the regulatory guidelines for cell therapy and manufacture the cell
products under GMP. GMP, or Good Manufacturing Practice, is a standard set of
guidelines for pharmaceutical and bio-pharmaceutical production operations and
facilities by the FDA and other health regulatory authorities, which apply
caution in allowing any biologically active material to be administered into the
human body.
Although
there can be no assurance that the FDA will not choose to change its
regulations, current regulation proposes that cell products which are
manipulated, allogeneic, or as in our case, autologous but intended for a
different purpose than the natural source cells (NurOwn are bone marrow derived
and are intended for transplantation into the brain or into the muscles) must be
regulated through a "tiered approach intended to regulate human cellular and
tissue based products only to the extent necessary to protect public health".
Thus the FDA requires: (i) preclinical laboratory and animal testing; (ii)
submission of an IND exemption which must be effective prior to the initiation
of human clinical studies; (iii) adequate and well-controlled clinical trials to
establish the safety and efficacy of the product for its intended use; (iv)
submission to the FDA of a BLA; and (v) review and approval of the BLA as well
as inspections of the manufacturing facility for GMP compliance, prior to
commercial marketing of the product.
Generally,
in seeking an approval from the FDA for sale of a new medical product, an
applicant must submit proof of safety and efficacy. Such proof entails extensive
pre-clinical studies in the lab and in animals and, if approved by the agency,
in humans. The testing, preparation of necessary applications and processing of
those applications by the FDA is expensive and may take several years to
complete. There can be no assurance that the FDA will act favorably or in a
timely manner in reviewing submitted applications, and an applicant may
encounter significant difficulties or costs in its efforts to obtain FDA
approvals. This, in turn, could delay or preclude the applicant from marketing
any products it may develop. The FDA may also require post-marketing testing and
surveillance of approved products, or place other conditions on the approvals.
These requirements could cause it to be more difficult or expensive to sell the
products, and could therefore restrict the commercial applications of such
products. Product approvals may be withdrawn if compliance with regulatory
standards is not maintained or if problems occur following initial marketing.
For patented technologies, delays imposed by the governmental approval process
may materially reduce the period during which an applicant will have the
exclusive right to exploit such technologies.
12
In order
to conduct clinical trials of the proposed product, the manufacturer or
distributor of the product will have to file an IND submission with the FDA for
its approval to commence human clinical trials. The submission must be supported
by data, typically including the results of pre-clinical and laboratory testing.
Following submission of the IND, the FDA has 30 days to review the application
and raise safety and other clinical trial issues. If an applicant is not
notified of objections within that period, clinical trials may be initiated at a
specified number of investigational sites with the number of patients, as
applied. Clinical trials which are to be conducted in accordance with good
clinical practice (“GCP”) guidelines are typically conducted in three sequential
phases. Phase I represents the initial administration of the drug or biologic to
a small group of humans, either healthy volunteers or patients, to test for
safety and other relevant factors. Phase II involves studies in a small number
of patients to explore the efficacy of the product, to ascertain dose tolerance
and the optimal dose range and to gather additional data relating to safety and
potential adverse affects. Once an investigational drug is found to have some
efficacy and an acceptable safety profile in the targeted patient population,
multi-center Phase III studies are initiated to establish safety and efficacy in
an expanded patient population and multiple clinical study sites. The FDA
reviews both the clinical plans and the results of the trials and may request an
applicant to discontinue the trials at any time if there are significant safety
issues.
In
addition, the manufacturer of our cell therapy product, whether it is performed
in-house or by a contract manufacturer, should be registered as a biologic
product manufacturer with the FDA product approval process. The FDA may inspect
the production facilities on a routine basis for compliance with the GMP and GTP
guidelines for cell therapy products. The regulations of the FDA require that
we, and/or any contract manufacturer, design, manufacture and service products
and maintain documents in the prescribed manner with respect to manufacturing,
testing, distribution, storage, design control and service activities. The FDA
may prohibit a company from promoting an approved product for unapproved
applications and reviews product labeling for accuracy.
Competition
We face
significant competition in our efforts to develop our products and services,
including: (i) cell therapies competing with NurOwnTM and its
applications and (ii) other treatments or procedures to cure or slow the effects
of PD and other neurodegenerative diseases. There are a number of companies
developing cell therapies. Among them are companies that are involved in the
controversial fetal cell transplant or ESC-derived cell therapy, as well as
companies developing adult stem cells. Other companies are developing
traditional chemical compounds, new biological drugs, cloned human proteins and
other treatments, which are likely to impact the markets, which we intend to
target. We believe that as an autologous bone marrow derived product that has
shown proof of concept in-vitro and in animal
studies, NurOwnTM has a
first mover advantage in the adult stem cell space and such space has
competitive advantages over the fetal cell or ESC-derived cell space as it has a
long safety record and does not have the same ethical limitations.
Employees
We
currently have eight scientific and administrative employees, six of whom are
full-time. None of our employees is represented by a labor union and
we believe that we have good relations with our employees.
WHERE
YOU CAN FIND MORE INFORMATION
We
maintain a website at www.brainstorm-cell.com. We make available through our
website, free of charge, our Annual Report on Form 10-K, Quarterly Reports on
Form 10-Q, Current Reports on Form 8-K, and amendments to those reports
filed or furnished pursuant to Section 13(a) or 15(d) of the Securities
Exchange Act of 1934, as amended (the Exchange Act), as soon as reasonably
practicable after we electronically file those reports with, or furnish them to,
the Securities and Exchange Commission. We also similarly make available, free
of charge through our website, the reports filed with the SEC by our executive
officers, directors and 10% stockholders pursuant to Section 16 under the
Exchange Act. We are not including the information contained at
www.stockeryale.com or at any other Internet address as part of, or
incorporating it by reference into, this Annual Report on Form
10-K.
13
Item
1A. RISK FACTORS
We
operate in a rapidly changing environment that involves a number of risks, some
of which are beyond our control. Forward looking statements in this report and
those made from time to time by us through our senior management are made under
the safe harbor provisions of the Private Securities Litigation Reform Act of
1995. Forward looking statements concerning the expected future revenues,
earnings or financial results or concerning project plans, performance, or
development of products and services, as well as other estimates related to
future operations are necessarily only estimates of future results and there can
be no assurance that actual results will not materially differ from
expectations. Forward-looking statements represent management’s current
expectations and are inherently uncertain. We do not undertake any obligation to
update forward-looking statements. If any of the following risks actually
occurs, our financial condition and operating results could be materially
adversely affected.
We need to raise
additional capital. If we are unable to raise additional capital on favorable
terms and in a timely manner, we will not be able to execute our business plan
and we could be forced to restrict or cease our operations. We will need
to raise additional funds to meet our anticipated expenses so that we can
execute our business plan. We expect to incur substantial and increasing net
losses for the foreseeable future as we increase our spending to execute our
development programs. Our auditors have expressed in their audit report that
there is substantial doubt regarding our ability to continue as a going
concern.
Pursuant
to a subscription agreement, as amended, we have with ACCBT Corp., we expected
to issue and sell additional shares and warrants to ACCBT for aggregate
consideration of up to $5,000,000. As of December 31, 2009, ACCBT had invested
up to $4,509,000 in the Company pursuant to the subscription agreement, as
amended.
In recent
months, we have entered into subscription agreements and/or securities purchase
agreements with various investors and have raised an aggregate of
$1,750,000. However, we will still need to secure additional funds to
effect our plan of operations.
We may
not be able to raise additional funds on favorable terms, or at all. If we are
unable to obtain additional funds on favorable terms and in a timely fashion, we
will be unable to execute our business plan and we will be forced to restrict or
cease our operations.
Assuming
we raise additional funds through the issuance of equity, equity-related or debt
securities, these securities may have rights, preferences or privileges
(including registrations rights) senior to those of the rights of our common
stock and our stockholders will experience additional dilution.
Our
business in the foreseeable future will be based on technology licensed from
Ramot and if this license were to be terminated for any reason, including
failure to make required payments, we would need to change our business strategy
and we may be forced to cease our operations. Agreements we have with Ramot impose
on us development and commercialization obligations, milestone and royalty
payment obligations and other obligations. Under these agreements, we
are obligated to pay certain fees to Ramot. If we fail to comply with
these obligations, Ramot may have the right to terminate the
license. If Ramot elects to terminate our license, we would need to
change our business strategy and we may be forced to cease our
operations. We currently do not owe Ramot any overdue
payments.
14
Disruption in
financial and currency markets could have a negative effect on our
business. As has
been widely reported, financial markets in the U.S., Europe, Asia and elsewhere
have been experiencing extreme disruption in recent months, including, among
other things, extreme volatility in security prices, severely diminished
liquidity and credit availability, rating downgrades of certain investments and
declining valuations of others. Governments have taken unprecedented actions
intended to address extreme market conditions that include severely restricted
credit and declines in real estate values. While currently these conditions have
not impaired our ability to operate our business, there can be no assurance that
there will not be a further deterioration in financial markets and confidence in
major economies, which can then lead to challenges in the operation of our
business. These economic developments affect businesses such as ours in a number
of ways, including our ability to obtain the financing that is necessary to
continue operating our business. We are unable to predict the likely duration
and severity of the current disruption in financial markets and adverse economic
conditions and the effects they will have on our business and financial
condition.
Our company has a
history of losses and we expect to incur losses for the foreseeable
future. We had no revenues for the fiscal years ended December 31, 2009
or December 31, 2008. As a development stage company, we are in the early stages
of executing our business plan. Our ability to operate successfully is
materially uncertain and our operations are subject to significant risks
inherent in a developing business enterprise. Most notably, we do not expect
that any therapies resulting from our or our collaborators’ research and
development efforts will be commercially available for a significant number of
years, if at all. We also do not expect to generate revenues from strategic
partnerships or otherwise for at least the next 12 months, and likely longer.
Furthermore, we expect to incur substantial and increasing operating losses for
the next several years as we increase our spending to execute our development
programs. These losses are expected to have an adverse impact on our working
capital, total assets and stockholders’ equity, and we may never achieve
profitability.
The field of stem
cell therapy is new and our development efforts may not yield an effective
treatment of human diseases. Except for bone marrow transplants for
neoplastic disease, the field of stem cell therapy remains largely untested in
the clinical setting. Our intended cell therapeutic treatment methods for ALS
and PD involve a new approach that has never been proven to work in human
testing. We are still conducting experimental testing in animals for our
treatment and are going to conduct clinical trials, which, together with other
stem cell therapies, may ultimately prove ineffective in treatment of human
diseases. If we cannot successfully implement our stem cell therapy in human
testing, we would need to change our business strategy and we may be forced to
cease our operations.
Our
ability to commercialize the products we intend to develop will depend upon our
ability to prove the efficacy and safety of these products according to
government regulations.
Our present and proposed activities are subject to extensive and rigorous
regulation by governmental authorities in the U.S. and other countries. To
clinically test, produce and market our proposed future products for human use,
we must satisfy mandatory procedural and safety and efficacy requirements
established by the FDA and comparable state and foreign regulatory agencies.
Typically, such rules require that products be approved by the government agency
as safe and effective for their intended use prior to being marketed. The
approval process is expensive, time consuming and subject to unanticipated
delays. It takes years to complete the testing of a product, and failure can occur at
any stage of testing. Our product candidates may not be approved. In addition,
our product approvals could be withdrawn for failure to comply with regulatory
standards or due to unforeseen problems after the product's marketing
approval.
We may
not be able to obtain regulatory approval of potential products, or may
experience delays in obtaining such approvals, and we may consequently never
generate revenues from product sales because of any of the following risks
inherent in the regulation of our business:
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We may not be successful in
obtaining the approval to perform clinical studies, including the approval
the Israeli Ministry of Health to conduct clinical trials on ALS patients,
an investigational new drug application, or IND, with respect to a
proposed product;
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Preclinical or clinical trials
may not demonstrate the safety and efficacy of proposed products
satisfactory to the FDA or foreign regulatory authorities;
or
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Completion of clinical trials may
be delayed, or costs of clinical trials may exceed anticipated amounts
(for example, negative or inconclusive results from a preclinical test or
clinical trial or adverse medical events during a clinical trial could
cause a preclinical study or clinical trial to be repeated, additional
tests to be conducted or a program to be terminated, even if other studies
or trials relating to the program are
successful).
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We may not be
able to succeed in our business model of seeking to enter into collaborations at
appropriate stages of development. We intend to enter into
strategic partnerships as we progress towards advanced clinical development and
commercialization with companies responsible for such activities. We intend to
provide strategic partners with services required to process the NurOwn products
for the clinical trials. It may be difficult for us to find third parties that
are willing to enter into collaborations for our potential products at the
appropriate stage of development, on economic terms that are attractive to us or
at all. If we are not able to continue to enter into acceptable collaborations,
we could fail in our strategy of generating an early inflow of up-front and
milestone payments and to enhance our capacities in regulatory and clinical
infrastructure while minimizing expenditure and risk and we could be required to
undertake and fund further development, clinical trials, manufacturing and
marketing activities solely at our own expense.
We may be
dependent upon a company with which we enter into collaborations to conduct
clinical trials and to commercialize our potential products. If we are
ultimately successful in executing our strategy of securing collaborations with
companies that would undertake advanced clinical development and
commercialization of our products, we may not have day-to-day control over their
activities. Any such collaborator may adhere to criteria for determining whether
to proceed with a clinical development program under circumstances where we
might have continued such a program. Potential collaborators may have
significant discretion in determining the efforts and amount of resources that
they dedicate to our collaborations or may be unwilling or unable to fulfill
their obligations to us, including their development and commercialization.
Potential collaborators may underfund or not commit sufficient resources to the
testing, marketing, distribution or other development of our products. They may
also not properly maintain or defend our intellectual property rights or they
may utilize our proprietary information in such a way as to invite litigation
that could jeopardize or potentially invalidate our proprietary information or
expose us to potential liability. Potential collaboration partners may have the
right to terminate the collaboration on relatively short notice and if they do
so or if they fail to perform or satisfy their obligations to us, the
development or commercialization of products would be delayed and our ability to
realize any potential milestone payments and royalty revenue would be adversely
affected.
We face
significant competition in our efforts to develop cell therapies for ALS, PD and
other neurodegenerative diseases. We face significant competition in our
efforts to develop cell therapies and other treatment or procedures to cure or
slow the effects of ALS, PD and other neurodegenerative diseases. Among our
competitors are companies that are involved in the fetal cell transplant or
embryonic stem cell derived cell therapy and companies developing adult stem
cells. Other companies are developing traditional chemical compounds, new
biological drugs, cloned human proteins and other treatments, which are likely
to impact the markets that we intend to target. Many of our competitors possess
longer operating histories and greater financial, managerial, scientific and
technical resources than we do and some possess greater name recognition and
established customer bases. Many also have significantly more experience in
preclinical testing, human clinical trials, product manufacturing, the
regulatory approval process and marketing and distribution than we
do.
If Ramot is
unable to obtain patents on the patent applications and technology exclusively
licensed to us or if patents are obtained but do not provide meaningful
protection, we may not be able to successfully market our proposed
products. We rely upon the patent application as filed by Ramot and the
license granted to us by Ramot under the Original Ramot Agreement. We agreed
under the Original Ramot Agreement to seek comprehensive patent protection for
all inventions licensed to us under the Original Ramot Agreement. However, we
cannot be sure that any patents will be issued to Ramot as a result of its
domestic or future foreign patent applications or that any issued patents will
withstand challenges by others.
16
We also rely upon unpatented
proprietary technology, know-how and trade secrets and seek to protect them
through confidentiality agreements with employees, consultants and advisors. If
these confidentiality agreements are breached, we may not have adequate remedies
for the breach. In addition, others may independently develop or otherwise
acquire substantially the same proprietary technology as our technology and
trade secrets.
As a result of
our reliance on consultants, we may not be able to protect the confidentiality
of our technology, which, if disseminated, could negatively impact our plan of
operations. We currently have relationships with two academic consultants
who are not employed by us, and we may enter into additional relationships of
such nature in the future. We have limited control over the activities of these
consultants and can expect only limited amounts of their time to be dedicated to
our activities. These persons may have consulting, employment or advisory
arrangements with other entities that may conflict with or compete with their
obligations to us. Our consultants typically sign agreements that provide for
confidentiality of our proprietary information and results of studies. However,
in connection with every relationship, we may not be able to maintain the
confidentiality of our technology, the dissemination of which could hurt our
competitive position and results of operations. To the extent that our
scientific consultants develop inventions or processes independently that may be
applicable to our proposed products, disputes may arise as to the ownership of
the proprietary rights to such information, we may expend significant resources
in such disputes and we may not win those disputes.
The price of our
stock is expected to be volatile. The market price of our common stock
has fluctuated significantly, and is likely to continue to be highly volatile.
To date, the trading volume in our stock has been relatively low and significant
price fluctuations can occur as a result. An active public market for our common
stock may not continue to develop or be sustained. If the low trading volumes
experienced to date continue, such price fluctuations could occur in the future
and the sale price of our common stock could decline significantly. Investors
may therefore have difficulty selling their shares.
Your percentage
ownership will be diluted by future offerings of our securities, upon the
conversion of outstanding convertible promissory notes into shares of common
stock and by options, warrants or shares we grant to management, employees,
directors and consultants. If we issue all of the shares and warrants to
ACCBT Corp. as provided for in the subscription agreement, it will have a
significant dilutive effect on your percentage ownership in the Company. In
addition, in order to meet our financing needs described above, we may issue
additional significant amounts of our common stock and warrants to purchase
shares of our common stock. The precise terms of any future financings will be
determined by us and potential investors and such future financings may also
significantly dilute your percentage ownership in the Company.
In
November 2004 and February 2005, the Company’s Board of Directors adopted and
ratified the Global Plan and the U.S. Plan (the “Global Plan” and “U.S. Plan”
respectively and the “Plans” together), and further approved the reservation of
9,143,462 shares of our common stock for issuance under the Plans (the
“Shares”). Our shareholders approved the Plans and the issuance of the Shares in
a special meeting of shareholders that was held on March 28, 2005.
On April
28, 2008, the Board approved the amendment and restatement of the Plans to
increase the number of shares available for issuance under the Plans by an
additional 5,000,000 shares. Our shareholders approved the amendment
and restatement of the Plans on June 5, 2008. We have made and intend
to make further option grants under the Plans or otherwise issue warrants or
shares of our common stock to individuals under the Plans. For example, as of
March 16, 2010:
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under our Global Plan we have
granted and not canceled a total of 9,546,778 options with various
exercise prices and expiration dates, to officers, directors, services
providers, consultants and
employees.
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under our U.S. Plan we have
issued an additional 830,000 shares of restricted stock and options for
grants to Scientific Advisory Board members, service providers,
consultants and directors.
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Such
issuances will, if and when made (and if options or warrants are subsequently
exercised), dilute your percentage ownership in the Company.
As of
March 16, 2010, all of our outstanding convertible notes had been converted or
repaid.
ACCBT Corp. holds
equity participation rights that could affect our ability to raise funds.
Pursuant to the subscription agreement with ACCBT Corp., a company under
the control of Mr. Chaim Lebovits, our President, we granted ACCBT Corp. the
right to acquire additional shares of our common stock whenever we issue
additional shares of common stock or other securities of the Company, or options
or rights to purchase shares of the Company or other securities directly or
indirectly convertible into or exercisable for shares of the Company (including
shares of any newly created class or series). This participation right could
limit our ability to enter into equity financings and to raise funds from third
parties.
You may
experience difficulties in attempting to enforce liabilities based upon U.S.
federal securities laws against us and our non-U.S. resident directors and
officers. Our principal operations are located through our subsidiary in
Israel and our principal assets are located outside the U.S. Our President,
Chief Executive Officer, Chief Financial Officer, and some of our directors are
foreign citizens and do not reside in the U.S. It may be difficult for courts in
the U.S. to obtain jurisdiction over our foreign assets or these persons and as
a result, it may be difficult or impossible for you to enforce judgments
rendered against us or our directors or executive officers in U.S. courts. Thus,
should any situation arise in the future in which you have a cause of action
against these persons or entities, you are at greater risk in investing in our
company rather than a domestic company because of greater potential difficulties
in bringing lawsuits or, if successful, collecting judgments against these
persons or entities as opposed to domestic persons or entities.
Political,
economic and military instability in Israel may impede our ability to execute
our plan of operations.
Our principal operations and the research and development facilities of the
scientific team funded by us under the Original Ramot Agreement are located in
Israel. Accordingly, political, economic and military conditions in Israel may
affect our business. Since the establishment of the State of Israel in 1948, a
number of armed conflicts have occurred between Israel and its Arab neighbors.
Since October 2000, terrorist violence in Israel increased significantly and
until they were recently revived, negotiations between Israel and Palestinian
representatives had effectively ceased. Ongoing or revived hostilities or other
factors related to Israel could harm our operations and research and development
process and could impede our ability to execute our plan of
operations.
Investors may
face significant restrictions on the resale of our stock due to the way in which
stock trades are handled by broker-dealers. Brokers may be less willing
to execute transactions in securities subject to “penny stock” rules. This may
make it more difficult for investors to dispose of shares of our common stock
and cause a decline in the market value of our stock. Because of large
broker-dealer spreads, investors may be unable to sell the stock immediately
back to the broker-dealer at the same price the broker-dealer sold the stock to
the investor. In some cases, the stock may fall quickly in value. Investors may
be unable to reap any profit from any sale of the stock, if they can sell it at
all. The market among broker-dealers may not be active. Investors in penny
stocks often are unable to sell stock back to the dealer that sold them the
stock. The mark-ups or commissions charged by the broker-dealers may be greater
than any profit a seller may make.
18
The trading price
of our common stock entails additional regulatory requirements, which may
negatively affect such trading price. Our common stock is
currently listed on the OTC Bulletin Board, an over-the-counter electronic
quotation service, which stock currently trades below $5.00 per share. We
anticipate the trading price of our common stock will continue to be below $5.00
per share. As a result of this price level, trading in our common stock would be
subject to the requirements of certain rules promulgated under the Securities
Exchange Act of 1934, as amended. These rules require additional disclosure by
broker-dealers in connection with any trades generally involving any non-NASDAQ
equity security that has a market price of less than $5.00 per share, subject to
certain exceptions. Such rules require the delivery, before any penny stock
transaction, of a disclosure schedule explaining the penny stock market and the
risks associated therewith, and impose various sales practice requirements on
broker-dealers who sell penny stocks to persons other than established customers
and accredited investors (generally institutions). For these types of
transactions, the broker-dealer must determine the suitability of the penny
stock for the purchaser and receive the purchaser's written consent to the
transaction before sale. The additional burdens imposed upon broker-dealers by
such requirements may discourage broker-dealers from effecting transactions in
our common stock. As a consequence, the market liquidity of our common stock
could be severely affected or limited by these regulatory
requirements.
Item 1B.
|
UNRESOLVED STAFF
COMMENTS
|
None.
Item 2.
|
PROPERTIES
|
The
address of our principal executive offices is 110 East 59 th Street,
New York, NY 10022, where we have a license to use office space and receive
general office services. We have paid rent in the past, but are currently not
required to do so.
On
December 1, 2004, our Israeli subsidiary, Brainstorm Cell Therapeutics Ltd. (the
“Subsidiary”) entered into a lease agreement for the lease of premises in 12
Basel Street, Petach Tikva, Israel, which include approximately 600 square
meters of office and laboratory space. The original term of the lease was 36
months, with two options to extend: one for an additional 24 months (the “First
Option”); and one for an additional 36 months (the “Second Option”). We are
currently in the Second Option period and rent is paid on a quarterly basis in
the amount of NIS 31,035 (approximately $8,200) per month.
We
expanded our Petach Tikva facility in 2008 to include an animal research
facility.
LEGAL
PROCEEDINGS
|
On April
17, 2008, Chapman, Spira & Carson, LLC (“CSC”) filed a breach of contract
complaint in the Supreme Court of the State of New York (the “Court”) against
the Company. The complaint alleges that CSC performed its obligations to the
Company under a consulting agreement entered into between the parties and that
the Company failed to provide CSC with the compensation outlined in the
consulting agreement. The complaint seeks compensatory damages in an amount up
to approximately $896,667, as well as costs and attorneys’ fees. On June 5,
2008, the Company filed an answer with the Court. The Company believes CSC’s
claims are without merit. We intend to vigorously defend our actions.
We cannot predict the scope, timing or outcome of this matter. We cannot predict
what impact, if any, this matter may have on our business, financial condition,
results of operations and cash flow.
From time
to time, we may become involved in litigation relating to claims arising out of
operations in the normal course of business, which we consider routine and
incidental to our business. We currently are not a party to any legal
proceedings other than as described above, the adverse outcome of which, in
management’s opinion, would have a material adverse effect on our business,
results of operation or financial condition.
REMOVED AND
RESERVED
|
19
Market
Information
Our
common stock is currently traded on the OTC Bulletin Board operated by the NASD
(OTC BB) under the symbol “BCLI”. The following table sets forth for
the periods indicated the high and low sales prices for our common stock as
reported on the OTC BB.
Quarter Ended
|
High
|
Low
|
||||||
December
31, 2009
|
$ | 0.44 | $ | 0.18 | ||||
September
30, 2009
|
$ | 0.49 | $ | 0.05 | ||||
June
30, 2009
|
$ | 0.10 | $ | 0.06 | ||||
March
31, 2009
|
$ | 0.22 | $ | 0.05 | ||||
December
31, 2008
|
$ | 0.19 | $ | 0.06 | ||||
September
30, 2008
|
$ | 0.32 | $ | 0.15 | ||||
June
30, 2008
|
$ | 0.51 | $ | 0.24 | ||||
March
31, 2008
|
$ | 0.73 | $ | 0.32 |
We
believe that a number of factors may cause the market price of our common stock
to fluctuate significantly. These factors are described in Item 7
below.
Dividends
We have
not paid or declared any cash or other dividends on our common stock within the
last two years. Any future determination as to the payment of dividends will
depend upon our results of operations, and on our capital requirements,
financial condition and other factors relevant at the time.
Record
Holders
As of
March 16, 2010, there were approximately 84 holders of record of our common
stock.
Equity
Compensation Plans
Information
regarding our equity compensation plans and the securities authorized under the
plans is included in Item 12 below.
Recent
Sales of Unregistered Securities
On
October 1, 2009, the Company issued 150,000 shares of the Company’s common stock
to ERS Associates Ltd. for public relations and investor relations work
performed by ERS Associates Ltd. for the Company.
On
January 6, 2010, the Company issued 60,000 shares of the Company’s common stock
to Landoy Risk Management Ltd. in full satisfaction of the $15,000 owed by the
Company to Landoy Risk Management Ltd. The amount payable by the
Company to Landoy Risk Management Ltd. was converted into our common stock at a
conversion price of $0.25.
20
On
January 27, 2010, upon conversion of a $150,000 8% Convertible Promissory Note,
dated as of March 5, 2007, issued by the Company to Eliyahu Weinstein, the
Company issued 1,016,109 shares of the Company’s common stock to Tayside Trading
Ltd. (“Tayside”), Mr. Weinstein’s assignee, upon receipt of Tayside’s written
notice of his election to convert all of the outstanding principal and interest
amount of the note into shares of the Company’s common stock. The
conversion price was $0.1875.
On
February 19, 2010, upon conversion of a $135,000 4% Convertible Promissory Note,
dated as of December 13, 2009, issued by the Company to Thomas B. Rosedale, the
Company issued 402,385 shares of the Company’s common stock to Thomas B.
Rosedale upon receipt of written notice of his election to convert all of the
outstanding principal and interest amount of the note into shares of the
Company’s common stock. The conversion price was $0.338.
On
January 5, 2010, the Company issued 50,000 shares of common stock to its public
relations advisors for six months of services performed for the
Company. The issuance of such shares was in accordance with an
agreement with the public relations advisors that entitles them to a monthly
grant of 8,333 shares of the Company’s common stock.
The
issuances of the securities described in this Item 5 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.
SELECTED FINANCIAL
DATA
|
Not
required.
Item 7.
|
MANAGEMENT’S DISCUSSION AND
ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF
OPERATIONS
|
Company
Overview
The
Company is a leading company developing stem cell therapeutic products based on
breakthrough technologies enabling the in-vitro differentiation of
bone marrow stem cells to neural-like cells. We aim to become a leader in adult
stem cell transplantation for neurodegenerative diseases. Our technology is
based on the use of the patient’s own bone marrow stem cells to generate
astrocyte-like cells secreting Neurotrophic factors that may provide an
effective treatment initially for ALS, PD and Multiple Sclerosis.
Our core
technology was developed in collaboration with prominent neurologist, Prof.
Eldad Melamed, the former head of Neurology of the Rabin Medical Center and
member of the Scientific Committee of the Michael J. Fox Foundation for
Parkinson's Research, and expert cell biologist Prof. Daniel Offen, of the
Felsenstein Medical Research Center of Tel Aviv University.
The
Company’s team is among the first to demonstrate the in-vitro differentiation of
bone marrow cells into glial-like cells secreting neurotrophic-factor (“NTF”)
including GDNF, BDNF, NGF and IGF-1.
The team
is also among the first to have successfully demonstrated release of
neurotrophic factors from in-vitro differentiated bone
marrow cells. Moreover, in research conducted by this team, implantation of
these differentiated cells into the brains of animal models that had been
induced to Parkinsonian behavior markedly improved their Parkinsonian
symptoms.
Our aim
is to provide neural stem cell transplants that maintain, preserve and restore
the damaged and remaining dopaminergic cells in the patient’s brain, protecting
them from further degeneration.
21
The
Company holds exclusive worldwide rights to commercialize the technology,
through a licensing agreement with Ramot, the technology transfer company of Tel
Aviv University.
On
February 17, 2010, the Company entered into an agreement with Hadasit Medical
Research Services and Development Ltd., a subsidiary of the Hadassah Medical
Organization (“Hadassah”) to conduct clinical trials to evaluate the safety and
tolerability of the Company’s treatment using mesenchymal bone marrow stem cells
secreting neurotrophic factors in up to 26 ALS patients at the Hadassah Medical
Center.
Hadassah’s
Institutional Review approved the commencement of such clinical trials, pending
approval by the Israel’s Ministry of Health Review Board.
We are
going to begin the process of seeking regulatory approval from regulatory
agencies in the U.S and Europe. Our efforts are directed at the development of
the technology from the lab to the clinic with the following main
objectives:
|
·
|
Developing the cell
differentiation process according to Food and Drug Administration (“FDA”)
and the European agency for evaluation of medical product (“EMEA”)
guidelines;
|
|
·
|
Demonstrating safety and efficacy
in animals and in human patients;
and
|
|
·
|
Setting up centralized
facilities to provide the therapeutic products and services for
transplantation in patients.
|
As a
result of limited cash resources and the desire to take a faster path to
clinical trials, in the fourth quarter of 2008 the Company determined to focus
all of its efforts on ALS, and we are currently not allocating resources towards
PD or other neurodegenerative diseases.
Results
of Operations
The
Company has been a development stage company since its inception. For the period
from inception (September 22, 2000) until December 31, 2009, the Company did not
earn any revenues from operations. The Company does not expect to earn revenues
from operations until 2013. In addition, the Company incurred operating costs
and expenses of approximately $1,750,000 during the year ending December 31,
2009, and approximately $34,939,000 for the period from inception (September 22,
2000) through December 31, 2009. Operating expenses incurred since inception
were approximately $13,254,000 for general and administrative expenses and
$21,685,000 for research and development costs.
Research
and Development, net:
Research
and development expenses, net for the year ended December 31, 2009 and 2008 were
$181,000 and $1,639,000, respectively. In addition, the Company grant
from The Office of the Chief Scientist decreased by $330,000 to $128,000 for the
year ended December 31, 2009 from $458,000 for the year ended December 31,
2008.
The
decrease in research and development expenses, net for the year ended December
31, 2009 is primarily due to: (i) the Settlement Agreement with Ramot, under
which Ramot released the Company from it’s obligation to fund the extended
research period; the Company reversed an amount equal to $760,000 that
accumulated in the past years for the extended research period; (ii)
the decrease in salary expenses due to the downsizing of the employee base in
connection with the Company's financial condition; and (iii) the reduction in
development activities as the Company decided to delay development activities in
PD and other neurodegenerative diseases and focus solely on
ALS.
22
General
and Administrative
General
and administrative expenses for the years ended December 31, 2009 and 2008 were
$1,569,000 and $1,629,000, respectively. General and administrative expenses for
the year ended December 31, 2009 consisted of $895,000 in stock-based
compensation expenses and $674,000 in salary, legal, audit, public and investor
relations and other expenses. General and administrative expenses for the year
ended December 31, 2008 consisted of $509,000 in stock-based compensation
expenses and $1,120,000 in salary, legal, audit, public and investor relations
and other expenses.
The
decrease in general and administrative expenses, excluding stock-based
compensation expenses, for the year ended December 31, 2009 is
primarily due to a reduction in Company activities in fiscal 2009 due to the
Company’s financial condition.
Financial
Expenses
Financial
expenses decreased by $173,000 to $31,000 for the year ended December 31, 2009
from $204,000 for the year ended December 31, 2008.
The
decrease in financial expenses for the year ended December 31, 2009 is primarily
to a decrease in amortization of the discount on short-term convertible loans
that were recognized in the first half of 2008 and the exchange differentials
derived from the changes in the exchange rate between the New Israeli Shekel to
U.S. dollar.
Net
Loss
Net loss
for the year ended December 31, 2009 was $1,781,000, as compared to a net loss
of $3,472,000 for the year ended December 31, 2008. Net loss per share for the
year ended December 31, 2009 was $0.03, as compared to a net loss per share of
$0.07 for the year ended December 31, 2008.
The
decrease in the net loss for the year ended December 31, 2009 is due to a (i)
reduction in Company activities, (ii) downsizing of employees and (iii)
amortization of discount on short-term convertible loans.
The
weighted average number of shares of common stock used in computing basic and
diluted net loss per share for the year ended December 31, 2009 was 61,151,011,
compared to 49,040,500 for the year ended December 31, 2008.
The
increase in the weighted average number of shares of common stock used in
computing basic and diluted net loss per share for the year ended December 31,
2009 was due to (i) the issuance of shares in a private placement, (ii) the
conversion of convertible loans, (iii) the exercise of warrants and (iv) the
issuance of shares to service providers.
Liquidity
and Capital Resources
The
Company has financed its operations since inception primarily through private
sales of its common stock and warrants and the issuance of convertible
promissory notes. At December 31, 2009, we had $87,000 in total current assets
and $2,388,000 in total current liabilities.
Net cash
used in operating activities was $744,000 for the year ended December 31, 2009.
Cash used for operating activities in the year ended December 31, 2009 was
primarily for (i) payment of salaries and fees to our employees, consultants,
subcontractors and services providers, (ii) purchase of laboratory materials and
(iii) Company operations.
Net cash
used in investing activities was $39,000 for the year ended December 31, 2009.
Cash used for investing activities in the year ended December 31, 2009 was
primarily for cancellation of restricted cash.
23
Net cash
provided by financing activities was $704,000 for the year ended December 31,
2009 and is primarily attributable to funds received from ACCBT under the
Subscription Agreement and the amendment of the Subscription
Agreement.
Our
material cash needs for the next 12 months include the payments due under the
following:
|
1.
|
An
agreement with a lender under which we must pay approximately $120,000
over the next year; and
|
|
2.
|
An
agreement with Hadassah to conduct clinical trials in ALS patients, under
which we must pay to Hadassah an amount of (i) up to $38,190
per patient (up to $992,880 in the aggregate) and (ii) $31,250
per month for rent and operations.
|
Our other
material cash needs for the next 12 months will include payments of/to (i)
employee salaries, (ii) lease of clean room for cell differentiation for
Hadassah's clinical trials (iii) conduct clinical trials in the Hadassah Medical
Center, (iv) patents, (v) construction fees for facilities to be used in our
research and development and (vi) fees to our consultants and legal
advisors.
On July
2, 2007, we entered into a subscription agreement with ACCBT Corp., pursuant to
which we agreed to sell and issue (i) up to 27,500,000 shares of our common
stock for an aggregate subscription price of up to $5.0 million, and (ii) for no
additional consideration, warrants to purchase up to 30,250,000 shares of our
common stock. Subject to certain closing conditions, separate closings of the
purchase and sale of the shares and the warrants were scheduled to take place
from August 30, 2007 through November 15, 2008.
On August
18, 2009, we entered into an amendment to the subscription agreement with ACCBT
Corp. (the “Amendment”). Pursuant to the Amendment: (i) ACCBT Corp. agreed to
invest the remaining amount (approximately $1,000,000) under the subscription
agreement at a price per share of $0.12 (instead of a price per share of
$0.1818) in monthly installments of not less than $50,000 beginning in August
2009; (ii) the exercise price of the final 10,083,334 warrants decreased from
$0.36 to $0.29; (iii) the expiration date of all warrants extended from November
5, 2011 to November 5, 2013; and (iv) the purchase price per share of all
27,500,000 shares purchased pursuant to the subscription agreement decreased
from $0.1818 to $0.12, which repricing applied retroactively to all shares
purchased by ACCBT Corp. prior to the Amendment.
On
January 25, 2010, we entered into a Subscription Agreement with Reytalon Ltd,
pursuant to which the Company issued 1,250,000 shares of common stock of the
Company to Reytalon Ltd at a purchase price of $0.20 per share for total gross
proceeds of $250,000 paid to the Company and a warrant to purchase up to an
additional 1,250,000 shares of the Company’s common stock at an exercise price
of $0.50 per share and which is exercisable until January 24, 2012.
On
February 17, 2010, we entered into Securities Purchase Agreements with three
individual investors, pursuant to which the Company agreed to issue to the
Investors an aggregate of 6,000,000 shares of common stock and two-year warrants
to purchase 3,000,000 shares of common stock with an exercise price of $0.50 in
exchange for $1,500,000. On March 2, 2010, the transaction was completed
and the Company received the $1,500,000 investment.
We will
need to raise additional capital in order to meet our anticipated expenses. If
we are not able to raise substantial additional capital, we may not be able to
continue to function as a going concern and we may have to cease operations.
Even if we obtain funding sufficient to continue functioning as a going concern,
we will be required to raise a substantial amount of capital in the future in
order to reach profitability and to complete the commercialization of our
products. Our ability to fund these future capital requirements will depend on
many factors, including the following:
24
|
·
|
our
ability to obtain funding from third parties, including any future
collaborative partners;
|
|
·
|
the
scope, rate of progress and cost of our clinical trials and other research
and development programs;
|
|
·
|
the
time and costs required to gain regulatory
approvals;
|
|
·
|
the
terms and timing of any collaborative, licensing and other arrangements
that we may establish;
|
|
·
|
the
costs of filing, prosecuting, defending and enforcing patents, patent
applications, patent claims, trademarks and other intellectual property
rights;
|
|
·
|
the
effect of competition and market
developments;
|
|
·
|
Pre-clinical
and clinical trial results,.
|
Off
Balance Sheet Arrangements
We have
no off balance sheet arrangements that have or are reasonably likely to have a
current or future material effect on our financial condition, changes in
financial condition, revenues or expenses, results of operations, liquidity,
capital expenditures, or capital resources.
QUANTITATIVE AND QUALITATIVE
DISCLOSURE ABOUT MARKET RISK
|
Not
required.
Item 8.
|
FINANCIAL STATEMENTS AND
SUPPLEMENTARY DATA
|
BRAINSTORM
CELL THERAPEUTICS INC. AND SUBSIDIARY
(A
development stage company)
CONSOLIDATED
FINANCIAL STATEMENTS
AS
OF DECEMBER 31, 2009
U.S.
DOLLARS IN THOUSANDS
(Except
share data)
25
BRAINSTORM
CELL THERAPEUTICS INC. AND SUBSIDIARY
(A
development stage company)
CONSOLIDATED
FINANCIAL STATEMENTS
AS
OF DECEMBER 31, 2009
U.S.
DOLLARS IN THOUSANDS
(Except
share data)
INDEX
Page
|
||
Report
of Independent Registered Public Accounting Firm
|
27
|
|
Consolidated
Balance Sheets
|
29
|
|
Consolidated
Statements of Operations
|
30
|
|
Statements
of Changes in Stockholders' Equity (Deficiency)
|
31 - 34
|
|
Consolidated
Statements of Cash Flows
|
35
|
|
Notes
to Consolidated Financial Statements
|
36 - 63
|
26
Brightman
Almagor
1
Azrieli Center
Tel
Aviv 67021
P.O.B.
16593, Tel Aviv 61164
Israel
Tel: +972
(3) 608 5555
Fax: +972
(3) 609 4022
info@deloitte.co.il
www.deloitte.com/il
|
|
REPORT
OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING
FIRM
To
the Board of Directors and Stockholders of
BRAINSTORM
CELL THERAPEUTICS Inc. (A Development Stage Company)
We have
audited the accompanying consolidated balance sheet of BRAINSTORM CELL
THERAPEUTICS Inc. and subsidiary (a development stage company) (the “Company”)
as of December 31, 2009 and 2008, and the related consolidated statement of
income, stockholders' deficiency, and cash flows for each of the
two years in the period ended December 2009 and
for the period from September 22, 2000 (date of inception) to December 31, 2009.
These financial statements are the responsibility of the Company’s Board of
Directors and management. Our responsibility is to express an opinion on the
financial statements based on our audits.
The
financial statements for the period from September 22, 2000 (inception)
through December 31, 2007, were audited by other auditors. The consolidated
financial statements for the period from September 22, 2000 (inception)
through December 31, 2007 included a net loss of $32,488,000. Our opinion
on the consolidated statements of operations, changes in stockholders'
deficiency and cash flows for the period from September 22, 2000
(inception) through December 31, 2009, insofar as it relates to amounts for
prior periods through December 31, 2007, is based solely on the report of
other auditors. The other auditors report dated April 13, 2008 expressed an
unqualified opinion, and included
an explanatory paragraph concerning an uncertainty about the Company's
ability to continue as a going concern, and regarding the status of the Company research and development
license agreement with Ramot.
We
conducted our audits in accordance with the standards of the Public Company
Accounting Oversight Board (United States). Those standards require
that we plan and perform the audit to obtain reasonable assurance about whether
the financial statements are free of material misstatement. The Company is not
required to have, nor were we engaged to perform, an audit of its internal
control over financial reporting. Our audits included consideration
of internal control over financial reporting as a basis for designing audit
procedures that are appropriate in the circumstances, but not for the purpose of
expressing an opinion on the effectiveness of the Company’s internal control
over financial reporting. Accordingly, we express no such
opinion. An audit also includes examining, on a test basis, evidence
supporting the amounts and disclosures in the financial statements, assessing
the accounting principles used and significant estimates made by management, as
well as evaluating the overall financial statement presentation. We
believe that our audits provide a reasonable basis for our opinion.
In our
opinion, based on our audits and the report of other auditor, such consolidated
financial statements present fairly, in all material respects, the financial
position of BRAINSTORM CELL THERAPEUTICS Inc. and subsidiary as of December 31,
2009 and 2008, and the results of their operations and their cash flows for each
of the two years in the period ended December 2009 and for the period
from September 22, 2000 (date of inception) to December 31, 2009, in conformity
with accounting principles generally accepted in the United States of
America.
27
The
accompanying financial statements have been prepared assuming that the Company
will continue as a going concern. The Company is a development stage enterprise
engaged in development of novel cell therapies for neurodegenerative diseases,
particularly Parkinson's disease, based on the acquired technology and research
to be conducted and funded by the Company as discussed in Note 1 to the
financial statements. The
Company's working capital deficiency and operating losses since inception
through December 31, 2009 raise substantial doubts about its ability to continue
as a going concern. Management's plans concerning these matters are also
described in Note 1 to the financial statements. The financial
statements do not include any adjustments that might result from the outcome of
these uncertainties.
/s/
Brightman Almagor Zohar & Co.
Brightman
Almagor Zohar & Co.
Certified
Public Accountants
A
Member Firm of Deloitte Touche Tohmatsu
Tel
Aviv, Israel
March
25, 2010
28
BRAINSTORM
CELL THERAPEUTICS INC. AND SUBSIDIARY
(A
development stage company)
CONSOLIDATED
BALANCE SHEETS
U.S.
dollars in thousands (except share data)
December
31
|
||||||||
2009
|
2008
|
|||||||
ASSETS
|
||||||||
CURRENT
ASSETS:
|
||||||||
Cash
and cash equivalents
|
1 | 2 | ||||||
Restricted
cash (Note 10b)
|
- | 36 | ||||||
Accounts
receivable and prepaid expenses (Note 5)
|
86 | 21 | ||||||
Total
current assets
|
87 | 59 | ||||||
LONG-TERM
INVESTMENTS:
|
||||||||
Prepaid
expenses
|
7 | 11 | ||||||
Severance
pay fund
|
88 | 62 | ||||||
Total
long-term investments
|
95 | 73 | ||||||
PROPERTY
AND EQUIPMENT, NET (Note 6)
|
575 | 743 | ||||||
Total
assets
|
757 | 875 | ||||||
LIABILITIES
AND STOCKHOLDERS' DEFICIENCY
|
||||||||
CURRENT
LIABILITIES:
|
||||||||
Short
term Credit from bank
|
46 | 72 | ||||||
Trade
payables
|
600 | 744 | ||||||
Other
accounts payable and accrued expenses (Note 7)
|
1,418 | 1,672 | ||||||
Short-
term convertible note (Note 8 and 15g)
|
135 | - | ||||||
Short-term
convertible loans (Note 9b and 15b)
|
189 | 172 | ||||||
Short-term
loans (Note 9h)
|
- | 199 | ||||||
Total
current liabilities
|
2,388 | 2,859 | ||||||
ACCRUED
SEVERANCE PAY
|
112 | 92 | ||||||
Total
liabilities
|
2,500 | 2,951 | ||||||
COMMITMENTS
AND CONTINGENCIES (Note 10)
|
- | - | ||||||
STOCKHOLDERS'
DEFICIENCY:
|
||||||||
Stock
capital: (Note 11)
|
4 | 3 | ||||||
Common
stock of $ 0.00005 par value - Authorized: 800,000,000 shares at
December 31, 2009 and 2008; Issued and outstanding: 76,309,152 and
55,241,418 shares at December 31, 2009 and 2008,
respectively
|
||||||||
Additional
paid-in-capital
|
35,994 | 33,881 | ||||||
Deficit
accumulated during the development stage
|
(37,741 | ) | (35,960 | ) | ||||
Total
stockholders' deficiency
|
(1,743 | ) | (2,076 | ) | ||||
Total
liabilities and stockholders' deficiency
|
757 | 875 |
The
accompanying notes are an integral part of the consolidated financial
statements.
29
BRAINSTORM
CELL THERAPEUTICS INC. AND SUBSIDIARY
(A
development stage company)
CONSOLIDATED
STATEMENTS OF OPERATIONS
U.S. dollars in thousands (except share data)
Year
ended
December
31,
|
Period
from
September
22,
2000
(inception
date)
through
December
31,
|
|||||||||||
2009
|
2008
|
2009
|
||||||||||
Operating
costs and expenses:
|
||||||||||||
Research
and development, net (Note 12)
|
181 | 1,639 | 21,685 | |||||||||
General
and administrative
|
1,569 | 1,629 | 13,254 | |||||||||
Total operating
costs and expenses
|
1,750 | 3,268 | 34,939 | |||||||||
Financial
expenses, net
|
31 | 204 | 2,585 | |||||||||
1,781 | 3,472 | 37,524 | ||||||||||
Taxes
on income (Note 13)
|
- | - | 53 | |||||||||
Loss
from continuing operations
|
1,781 | 3,472 | 37,577 | |||||||||
Net
loss from discontinued operations
|
- | - | 164 | |||||||||
Net
loss
|
1,781 | 3,472 | 37,741 | |||||||||
Basic
and diluted net loss per share from continuing operations
|
0.03 | 0.07 | ||||||||||
Weighted
average number of shares outstanding used in computing basic and diluted
net loss per share
|
61,151,011 | 49,040,500 |
The
accompanying notes are an integral part of the consolidated financial
statements.
30
BRAINSTORM
CELL THERAPEUTICS INC. AND SUBSIDIARY
(A
development stage company)
STATEMENTS
OF CHANGES IN STOCKHOLDERS' EQUITY (DEFICIENCY)
U.S.
dollars in thousands (except share data)
Deficit
accumulated
|
Total
|
|||||||||||||||||||||||
Additional
|
Deferred
|
during
the
|
stockholders'
|
|||||||||||||||||||||
Common
stock
|
paid-in
|
stock-based
|
development
|
Equity
|
||||||||||||||||||||
Number
|
Amount
|
capital
|
compensation
|
stage
|
(deficiency)
|
|||||||||||||||||||
Balance
as of September 22, 2000 (date of inception)
|
- | - | - | - | - | - | ||||||||||||||||||
Stock
issued on September 22, 2000 for cash at $0.00188 per
share
|
8,500,000 | $ | 1 | $ | 16 | $ | - | $ | - | $ | 17 | |||||||||||||
Stock
issued on March 31, 2001 for cash at $0.0375 per share
|
1,600,000 |
(*) -
|
60 | - | - | 60 | ||||||||||||||||||
Contribution
of capital
|
- | - | 8 | - | - | 8 | ||||||||||||||||||
Net
loss
|
- | - | - | - | (17 | ) | (17 | ) | ||||||||||||||||
Balance
as of March 31, 2001
|
10,100,000 | 1 | 84 | - | (17 | ) | 68 | |||||||||||||||||
Contribution
of capital
|
- | - | 11 | - | - | 11 | ||||||||||||||||||
Net
loss
|
- | - | - | - | (26 | ) | (26 | ) | ||||||||||||||||
Balance
as of March 31, 2002
|
10,100,000 | 1 | 95 | - | (43 | ) | 53 | |||||||||||||||||
Contribution
of capital
|
- | - | 15 | - | - | 15 | ||||||||||||||||||
Net
loss
|
- | - | - | - | (47 | ) | (47 | ) | ||||||||||||||||
Balance
as of March 31, 2003
|
10,100,000 | 1 | 110 | - | (90 | ) | 21 | |||||||||||||||||
2-for-1
stock split
|
10,100,000 |
(*) -
|
- | - | - | - | ||||||||||||||||||
Stock
issued on August 31, 2003 to purchase mineral option at $0.065 per
share
|
100,000 |
(*) -
|
6 | - | - | 6 | ||||||||||||||||||
Cancellation
of shares granted to Company's Former President
|
(10,062,000 | ) |
(*) -
|
(*) -
|
- | - | - | |||||||||||||||||
Contribution
of capital
|
- | - | 15 | - | - | 15 | ||||||||||||||||||
Net
loss
|
- | - | - | - | (73 | ) | (73 | ) | ||||||||||||||||
Balance
as of March 31, 2004
|
10,238,000 | 1 | 131 | - | (163 | ) | (31 | ) | ||||||||||||||||
Stock
issued on June 24, 2004 for private placement at $0.01 per share, net of
$25,000 issuance expenses
|
8,510,000 |
(*) -
|
60 | - | - | 60 | ||||||||||||||||||
Contribution
capital
|
- | - | 7 | - | - | 7 | ||||||||||||||||||
Stock
issued in 2004 for private placement at $0.75 per unit
|
1,894,808 |
(*) -
|
1,418 | - | - | 1,418 | ||||||||||||||||||
Cancellation
of shares granted to service providers
|
(1,800,000 | ) |
(*) -
|
- | - | - | ||||||||||||||||||
Deferred
stock-based compensation related to options granted to
employees
|
- | - | 5,979 | (5,979 | ) | - | - | |||||||||||||||||
Amortization
of deferred stock-based compensation related to shares and options granted
to employees
|
- | - | - | 584 | - | 584 | ||||||||||||||||||
Compensation
related to shares and options granted to service providers
|
2,025,000 |
(*) -
|
17,506 | - | - | 17,506 | ||||||||||||||||||
Net
loss
|
- | - | - | - | (18,840 | ) | (18,840 | ) | ||||||||||||||||
Balance
as of March 31, 2005
|
20,867,808 | $ | 1 | $ | 25,101 | $ | (5,395 | ) | $ | (19,003 | ) | $ | 704 |
(*) Represents
an amount less than $1.
The accompanying notes are an integral
part of the consolidated financial statements.
31
BRAINSTORM
CELL THERAPEUTICS INC. AND SUBSIDIARY
(A
development stage company)
STATEMENTS
OF CHANGES IN STOCKHOLDERS' EQUITY (DEFICIENCY)
U.S.
dollars in thousands (except share data)
Deficit
accumulated
|
Total
|
|||||||||||||||||||||||
Additional
|
Deferred
|
during
the
|
stockholders'
|
|||||||||||||||||||||
Common
stock
|
paid-in
|
stock-based
|
development
|
equity
|
||||||||||||||||||||
Number
|
capital
|
compensation
|
stage
|
(deficiency)
|
(deficiency)
|
|||||||||||||||||||
Balance
as of March 31, 2005
|
20,867,808 | $ | 1 | $ | 25,101 | $ | (5,395 | ) | $ | (19,003 | ) | $ | 704 | |||||||||||
Stock
issued on May 12, 2005 for private placement at $0.8 per
share
|
186,875 |
(*) -
|
149 | - | - | 149 | ||||||||||||||||||
Stock
issued on July 27, 2005 for private placement at $0.6 per
share
|
165,000 |
(*) -
|
99 | - | - | 99 | ||||||||||||||||||
Stock
issued on September 30, 2005 for private placement at $0.8 per
share
|
312,500 |
(*) -
|
225 | - | - | 225 | ||||||||||||||||||
Stock
issued on December 7, 2005 for private placement at $0.8 per
share
|
187,500 |
(*) -
|
135 | - | - | 135 | ||||||||||||||||||
Forfeiture
of options granted to employees
|
- | - | (3,363 | ) | 3,363 | - | - | |||||||||||||||||
Deferred
stock-based compensation related to shares and options granted to
directors and employees
|
200,000 |
(*) -
|
486 | (486 | ) | - | - | |||||||||||||||||
Amortization
of deferred stock-based compensation related to options and shares granted
to employees and directors
|
- | - | 51 | 1,123 | - | 1,174 | ||||||||||||||||||
Stock-based
compensation related to options and shares granted to service
providers
|
934,904 |
(*) -
|
662 | - | - | 662 | ||||||||||||||||||
Reclassification
due to application of ASC 815-40-25 (formerly EITF 00-19)
|
- | - | (7,906 | ) | - | - | (7,906 | ) | ||||||||||||||||
Beneficial
conversion feature related to a convertible bridge loan
|
- | - | 164 | - | - | 164 | ||||||||||||||||||
Net
loss
|
- | - | - | - | (3,317 | ) | (3,317 | ) | ||||||||||||||||
Balance
as of March 31, 2006
|
22,854,587 | 1 | 15,803 | (1,395 | ) | (22,320 | ) | (7,911 | ) | |||||||||||||||
Elimination
of deferred stock compensation due to implementation of ASC 718-10
(formerly SFAS 123(R))
|
- | - | (1,395 | ) | 1,395 | - | - | |||||||||||||||||
Stock-based
compensation related to shares and options granted to directors and
employees
|
200,000 | - | 1,168 | - | - | 1,168 | ||||||||||||||||||
Reclassification
due to application of ASC 815-40-25 (formerly EITF 00-19)
|
- | - | 7,191 | - | - | 7,191 | ||||||||||||||||||
Stock-based
compensation related to options and shares granted to service
providers
|
1,147,225 |
(*) -
|
453 | - | - | 453 | ||||||||||||||||||
Warrants
issued to convertible note holder
|
- | - | 11 | - | - | 11 | ||||||||||||||||||
Warrants
issued to loan holder
|
- | - | 110 | - | - | 110 | ||||||||||||||||||
Beneficial
conversion feature related to convertible bridge loans
|
- | - | 1,086 | - | - | 1,086 | ||||||||||||||||||
Net
loss
|
- | - | - | - | (3,924 | ) | (3,924 | ) | ||||||||||||||||
Balance
as of December 31, 2006
|
24,201,812 | $ | 1 | $ | 24,427 | $ | - | $ | (26,244 | ) | $ | (1,816 | ) |
(*) Represents
an amount less than $1.
The
accompanying notes are an integral part of the consolidated financial
statements.
32
BRAINSTORM
CELL THERAPEUTICS INC. AND SUBSIDIARY
(A
development stage company)
STATEMENTS
OF CHANGES IN STOCKHOLDERS' EQUITY (DEFICIENCY)
U.S.
dollars in thousands (except share data)
Additional
|
Deficit
|
|||||||||||||||||||||||
paid-in
|
Deferred
|
accumulated
|
Total
|
|||||||||||||||||||||
Capital
and
|
stock-
|
during
the
|
stockholders'
|
|||||||||||||||||||||
Common
stock
|
subscription
|
based
|
development
|
equity
|
||||||||||||||||||||
Number
|
Amount
|
of
shares
|
compensation
|
stage
|
(deficiency)
|
|||||||||||||||||||
Balance
as of December 31, 2006
|
24,201,812 | $ | 1 | $ | 24,427 | $ | - | $ | (26,244 | ) | $ | (1,816 | ) | |||||||||||
Stock-based
compensation related to options and shares granted to service
providers
|
544,095 |
(*) -
|
1,446 | - | - | 1,446 | ||||||||||||||||||
Warrants
issued to convertible note holder
|
- | - | 109 | - | - | 109 | ||||||||||||||||||
Stock-based
compensation related to shares and options granted to directors and
employees
|
200,000 |
(*) -
|
1,232 | - | - | 1,232 | ||||||||||||||||||
Beneficial
conversion feature related to convertible loans
|
- | - | 407 | - | - | 407 | ||||||||||||||||||
Conversion
of convertible loans
|
725,881 |
(*) -
|
224 | - | - | 224 | ||||||||||||||||||
Exercise
of warrants
|
3,832,621 |
(*) -
|
214 | - | - | 214 | ||||||||||||||||||
Stock
issued for private placement at $0.1818 per unit, net of finder's
fee
|
11,500,000 | 1 | 1,999 | - | - | 2,000 | ||||||||||||||||||
Net
loss
|
- | - | - | - | (6,244 | ) | (6,244 | ) | ||||||||||||||||
Balance
as of December 31, 2007
|
41,004,409 | 2 | 30,058 | - | (32,488 | ) | (2,428 | ) | ||||||||||||||||
Stock-based
compensation related to options and stock granted to service
providers
|
90,000 | - | 33 | - | - | 33 | ||||||||||||||||||
Stock-based
compensation related to stock and options granted to directors and
employees
|
- | 731 | - | - | 731 | |||||||||||||||||||
Conversion
of convertible loans
|
3,644,610 |
(*) -
|
1,276 | - | - | 1,276 | ||||||||||||||||||
Exercise
of warrants
|
1,860,000 |
(*) -
|
- | - | - | - | ||||||||||||||||||
Exercise
of options
|
17,399 |
(*) -
|
3 | - | - | 3 | ||||||||||||||||||
Stock
issued for private placement at $0.1818 per unit, net of finder's
fee
|
8,625,000 | 1 | 1,499 | - | - | 1,500 | ||||||||||||||||||
Subscription
of shares
|
- | - | 281 | - | - | 281 | ||||||||||||||||||
Net
loss
|
- | - | - | - | (3,472 | ) | (3,472 | ) | ||||||||||||||||
Balance
as of December 31, 2008
|
55,241,418 | $ | 3 | $ | 33,881 | $ | - | $ | (35,960 | ) | $ | (2,076 | ) | |||||||||||
(*) Represents
an amount less than $1.
The
accompanying notes are an integral part of the consolidated financial
statements.
33
BRAINSTORM
CELL THERAPEUTICS INC. AND SUBSIDIARY
(A
development stage company)
STATEMENTS
OF CHANGES IN STOCKHOLDERS' EQUITY (DEFICIENCY)
U.S.
dollars in thousands (except share data)
Additional
|
Deficit
|
|||||||||||||||||||||||
paid-in
|
Deferred
|
accumulated
|
Total
|
|||||||||||||||||||||
Capital
and
|
stock-
|
during
the
|
stockholders'
|
|||||||||||||||||||||
Common
stock
|
subscription
|
based
|
development
|
equity
|
||||||||||||||||||||
Number
|
Amount
|
of
shares
|
compensation
|
stage
|
(deficiency)
|
|||||||||||||||||||
Balance
as of December 31, 2008
|
55,241,418 | $ | 3 | $ | 33,881 | $ | - | $ | (35,960 | ) | $ | (2,076 | ) | |||||||||||
Stock-based
compensation related to options and stock granted to service
providers
|
5,284,284 | ( | *) | 775 | - | 775 | ||||||||||||||||||
Stock-based
compensation related to stock and options granted to directors and
employees
|
- | - | 409 | - | 409 | |||||||||||||||||||
Conversion
of convertible loans
|
2,500,000 | ( | *) | 200 | - | 200 | ||||||||||||||||||
Exercise
of warrants
|
3,366,783 | ( | *) | - | - | - | ||||||||||||||||||
Stock
issued for amendment of private placement (Note
11(b)(1)(f))
|
9,916,667 | 1 | - | - | 1- | |||||||||||||||||||
Subscription
of shares
|
- | - | 729 | - | 729 | |||||||||||||||||||
Net
loss
|
- | - | - | - | $ | (1,781 | ) | (1,781 | ) | |||||||||||||||
Balance
as of December 31, 2009
|
76,309,152 | $ | 4 | $ | 35,994 | $ | - | $ | (37,741 | ) | $ | (1,743 | ) |
(*) Represents
an amount less than $1.
The
accompanying notes are an integral part of the consolidated financial
statements.
34
BRAINSTORM
CELL THERAPEUTICS INC. AND SUBSIDIARY
(A
development stage company)
CONSOLIDATED
STATEMENTS OF CASH FLOWS
U.S. dollars in thousands
Year ended
December 31,
|
Period from
September 22,
2000 (inception
date) through
December 31,
|
|||||||||||
2009
|
2008
|
2009
|
||||||||||
Cash flows from operating
activities:
|
||||||||||||
Net
loss
|
(1,781 | ) | (3,472 | ) | (37,741 | ) | ||||||
Less
- loss for the period from discontinued operations
|
- | - | 164 | |||||||||
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
||||||||||||
Depreciation
|
168 | 151 | 536 | |||||||||
Amortization
of deferred charges
|
- | 2 | 150 | |||||||||
Severance
pay, net
|
(6 | ) | 23 | 24 | ||||||||
Accrued
interest on loans
|
19 | 113 | 448 | |||||||||
Amortization
of discount on short-term loans
|
- | 41 | 1,864 | |||||||||
Change
in fair value of options and warrants
|
- | - | (795 | ) | ||||||||
Expenses
related to shares and options granted to service providers
|
775 | 33 | 20,941 | |||||||||
Amortization
of deferred stock-based compensation related to option and stocks granted
to employees and directors
|
409 | 731 | 5,298 | |||||||||
Decrease
(increase) in accounts receivable and prepaid expenses
|
(65 | ) | 116 | (86 | ) | |||||||
Increase
(decrease) in trade payables and convertible note
|
(9 | ) | (94 | ) | 735 | |||||||
Increase
in other accounts payable and accrued expenses
|
(254 | ) | 623 | 1,413 | ||||||||
Erosion
of restricted cash
|
- | (1 | ) | (6 | ) | |||||||
Net
cash used in continuing operating activities
|
(744 | ) | (1,734 | ) | (7,055 | ) | ||||||
Net
cash used in discontinued operating activities
|
- | - | (23 | ) | ||||||||
Total
net cash used in operating activities
|
(744 | ) | (1,734 | ) | (7,078 | ) | ||||||
Cash flows from investing
activities:
|
||||||||||||
Purchase
of property and equipment
|
- | (154 | ) | (1,080 | ) | |||||||
Restricted
cash
|
35 | - | 6 | |||||||||
Investment
in lease deposit
|
4 | (2 | ) | (7 | ) | |||||||
Net
cash used in continuing investing activities
|
39 | (156 | ) | (1,081 | ) | |||||||
Net
cash used in discontinued investing activities
|
- | - | (16 | ) | ||||||||
Total
net cash used in investing activities
|
39 | (156 | ) | (1,097 | ) | |||||||
Cash flows from financing
activities:
|
||||||||||||
Proceeds
from issuance of Common stock and warrants, net
|
730 | 1,781 | 6,599 | |||||||||
Proceeds
from loans, notes and issuance of warrants, net
|
- | - | 2,061 | |||||||||
Credit
from bank
|
(26 | ) | 72 | 46 | ||||||||
Proceeds
from exercise of warrants and options
|
- | 3 | 28 | |||||||||
Repayment
of short-term loans
|
- | (50 | ) | (601 | ) | |||||||
Net
cash provided by continuing financing activities
|
704 | 1,806 | 8,133 | |||||||||
Net
cash provided by discontinued financing activities
|
- | - | 43 | |||||||||
Total
net cash provided by financing activities
|
704 | 1,806 | 8,176 | |||||||||
Increase
(decrease) in cash and cash equivalents
|
(1 | ) | (84 | ) | 1 | |||||||
Cash
and cash equivalents at the beginning of the period
|
2 | 86 | - | |||||||||
Cash
and cash equivalents at end of the period
|
1 | 2 | 1 | |||||||||
Non-cash financing
activities:
|
||||||||||||
Conversion
of convertible loans to shares
|
200 | 1,276 | 1,476 |
The
accompanying notes are an integral part of the consolidated financial
statements.
35
BRAINSTORM
CELL THERAPEUTICS INC. AND SUBSIDIARY
(A
development stage company)
Notes
to the financial statements
U.S. dollars in thousands (except share data)
NOTE 1
|
-
GENERAL
|
|
A.
|
Brainstorm
Cell Therapeutics Inc. (formerly: Golden Hand Resources Inc.) (the
"Company") was incorporated in the State of Washington on September 22,
2000.
|
B.
|
On
May 21, 2004, the former major stockholders of the Company entered into a
purchase agreement with a group of private investors, who purchased from
the former major stockholders 6,880,000 shares of the then issued and
outstanding 10,238,000 shares of Common
Stock.
|
C.
|
On
July 8, 2004, the Company entered into a licensing agreement with Ramot of
Tel Aviv University Ltd. ("Ramot"), an Israeli corporation, to acquire
certain stem cell technology (see Note 3). Subsequent to this agreement,
the Company decided to focus on the development of novel cell therapies
for neurodegenerative diseases based on the acquired technology and
research to be conducted and funded by the
Company.
|
Following
the licensing agreement dated July 8, 2004, the management of the Company
decided to abandon all old activities related to the sale of the digital data
recorder product. The discontinuation of this activity was accounted for under
the provision of Statement of Financial Accounting Standard ASC 360-10 (formerly
"SFAS" 144), "Accounting for the Impairment or Disposal of Long-Lived
Assets".
D.
|
On
November 22, 2004, the Company changed its name from Golden Hand Resources
Inc. to Brainstorm Cell Therapeutics Inc. to better reflect its new line
of business in the development of novel cell therapies for
neurodegenerative diseases. BCT owns all operational property and
equipment.
|
E.
|
On
October 25, 2004, the Company formed a wholly-owned subsidiary in Israel,
Brainstorm Cell Therapeutics Ltd.
("BCT").
|
F.
|
In
December 2006, the Company changed its state of incorporation from
Washington to Delaware.
|
G.
|
On
September 17, 2006, the Company's changed the Company's fiscal year-end
from March 31 to December 31.
|
H.
|
Since
its inception, the Company has devoted substantially most of its efforts
to research and development, recruiting management and technical staff,
acquiring assets and raising capital. In addition, the Company has not
generated revenues. Accordingly, the Company is considered to be in the
development stage, as defined in Statement of Financial Accounting
Standards No. 7, "Accounting and reporting by development Stage
Enterprises" ASC 915-10 (formerly "SFAS
No. 7").
|
36
BRAINSTORM
CELL THERAPEUTICS INC. AND SUBSIDIARY
(A
development stage company)
Notes
to the financial statements
U.S. dollars in thousands (except share data)
NOTE 1
|
-
GENERAL (Cont.)
|
GOING
CONCERN
As
reflected in the accompanying financial statements, the Company’s operations for
the year ended on December 31, 2009, resulted in a net loss of $ 1,781 and the
Company’s balance sheet reflects a net stockholders’ deficiency of $ 1,743,
accumulated deficit of $37,741 and working capital deficiency of $2,301. These
conditions raise substantial doubt about the Company's ability to continue to
operate as a going concern. The Company’s ability to continue operating as a
“going concern” is dependent on several factors, among them is its ability to
raise sufficient additional working capital. Management’s plans in this regard
include, among others, raising additional cash from current and potential
stockholders and lenders.
Accordingly,
as a result of the current economic situation and the difficulty to raise
immediate fund to support all of the Company’s projects, including Parkinson
disease and spinal cord injury, the Company decided to reduce its activity and
focus only on the effort to reach clinical trials in ALS in 2010. Recently, the
Company entered into an agreement with Hadassah Medical Centre to conduct
clinical trails in up to 26 ALS patients in 2010 and raised approximately [$2
million] from investors.
The
Company also reduced its general and administrative expenses and ceased and
delayed some development projects until it is able to obtain sufficient
financing. There can be no assurance that sufficient revenues will be generated
and that additional funds will be available on terms acceptable to the Company,
or at all.
These
financial statements do not include any adjustments relating to the
recoverability and classification of assets carrying amounts or the amount and
classification of liabilities that may be required should the Company be unable
to continue as a going concern.
NOTE 2
|
-
SIGNIFICANT ACCOUNTING POLICIES
|
A.
|
Basis
of presentation:
|
The
consolidated financial statements have been prepared in accordance with United
States generally accepted accounting principles applied on a consistent
basis.
B.
|
Use
of estimates:
|
The
preparation of financial statements in conformity with generally accepted
accounting principles requires management to make estimates and assumptions that
affect the amounts reported in the financial statements and accompanying notes.
Actual results could differ from those estimates.
C.
|
Financial
statement in U.S. dollars:
|
The
functional currency of the Company is the U.S dollar ("dollar") since the dollar
is the currency of the primary economic environment in which the Company has
operated and expects to continue to operate in the foreseeable future. Part of
the transactions of the subsidiary, are recorded in new Israeli shekels ("NIS");
however, a substantial portion of the subsidiary's costs is incurred in dollars
or linked to the dollar. Accordingly, management has designated the dollar as
the currency of its subsidiary's primary economic environment and thus it is
their functional and reporting currency.
Transactions
and balances denominated in dollars are presented at their original amounts.
Non-dollar transactions and balances have been remeasured to dollars in
accordance with the provisions of ASC 830-10 (formerly Statement of Financial
Accounting Standard 52), "Foreign Currency Translation". All transaction gains
and losses from remeasurement of monetary balance sheet items denominated in
non-dollar currencies are reflected in the statement of operations as financial
income or expenses, as appropriate.
37
BRAINSTORM
CELL THERAPEUTICS INC. AND SUBSIDIARY
(A
development stage company)
Notes
to the financial statements
U.S.
dollars in thousands (except
share data)
NOTE 2
|
-
SIGNIFICANT ACCOUNTING POLICIES
(Cont.)
|
D.
|
Principles
of consolidation:
|
The
consolidated financial statements include the accounts of the Company and its
wholly-owned subsidiary. Intercompany balances and transactions have been
eliminated upon consolidation.
E.
|
Cash
equivalents:
|
Cash
equivalents are short-term highly liquid investments that are readily
convertible to cash with maturities of three months or less as of the date
acquired.
F.
|
Property
and equipment:
|
Property
and equipment are stated at cost, less accumulated depreciation. Depreciation is
calculated by the straight-line method over the estimated useful lives of the
assets.
The
annual depreciation rates are as follows:
%
|
||
Office
furniture and equipment
|
7
|
|
Computer
software and electronic equipment
|
33
|
|
Laboratory
equipment
|
15
|
|
Leasehold
improvements
|
|
Over
the shorter of the lease term (including the option) or useful
life
|
|
G.
|
Impairment
of long-lived assets:
|
The
Company’s and its subsidiary’s long-lived assets are reviewed for impairment in
accordance with ASC 360-10 (formerly Statement of Financial Accounting Standard
144), "Accounting for the Impairment or Disposal of Long-Lived Assets". Whenever
events or changes in circumstances indicate that the carrying amount of an asset
may not be recoverable. Recoverability of assets to be held and used is measured
by a comparison of the carrying amount of the assets to the future undiscounted
cash flows expected to be generated by the assets. If such assets are considered
to be impaired, the impairment to be recognized is measured by the amount by
which the carrying amount of the assets exceeds their fair value. During 2008
and 2009, no impairment losses were identified.
|
H.
|
Research
and development expenses, net:
|
Research
and development expenses, are charged to the statement of operations as
incurred.
Royalty-bearing
grants from the Government of Israel for funding approved research and
development projects are recognized at the time the Company is entitled to such
grants, on the basis of the costs incurred and applied as a deduction from
research and development expenses. Such grants are included as a deduction of
research and development costs since at the time received it is not probable the
Company will generate sales from these projects and pay the royalties resulting
from such sales.
38
BRAINSTORM
CELL THERAPEUTICS INC. AND SUBSIDIARY
(A
development stage company)
Notes
to the financial statements
U.S.
dollars in thousands (except
share data)
NOTE 2
|
-
SIGNIFICANT ACCOUNTING POLICIES
(Cont.)
|
I.
|
Severance
pay:
|
The
liability of the subsidiary for severance pay is calculated pursuant to the
Severance Pay Law in Israel, based on the most recent salary of the employees
multiplied by the number of years of employment as of the balance sheet date and
is presented on an undiscounted basis.
The
subsidiary's employees are entitled to one month's salary for each year of
employment or a portion thereof. The subsidiary's liability for all of its
employees is fully provided by monthly deposits with insurance policies and by
an accrual. The value of these policies is recorded as an asset in the Company's
balance sheet.
The
deposited funds may be withdrawn only upon the fulfillment of the obligation
pursuant to Severance Pay Law in Israel or labor agreements. The value of the
deposited funds is based on the cash surrendered value of these
policies.
Severance
expenses for the year ended December 31, 2009 were $14.
J.
|
Accounting
for stock-based compensation:
|
The
Company applied ASC 718-10 (formerly Statement of Financial Accounting
Standards 123 (Revised 2004))"Share-Based Payment,".which requires the
measurement and recognition of compensation expense for all share-based payment
awards made to employees and directors including employee stock options under
the Company's stock plans based on estimated fair values. ASC 718-10 supersedes
the Company's previous accounting under Accounting Principles Board
Opinion 25, "Accounting for Stock Issued to Employees" ("APB 25"). In March
2005, the Securities and Exchange Commission issued Staff Accounting
Bulletin 107 ("SAB 107") relating to ASC 718-10. The Company has applied
the provisions of SAB 107 in its adoption of ASC 718-10.
ASC
718-10 requires companies to estimate the fair value of equity-based payment
awards on the date of grant using an option-pricing model. The value of the
portion of the award that is ultimately expected to vest is recognized as
expense over the requisite service periods in the Company's consolidated
statement of operations.
The
Company recognizes compensation expense for the value of non-employee awards,
which have graded vesting, based on the accelerated attribution method over the
requisite service period of each award, net of estimated
forfeitures.
The
Company recognizes compensation expense for the value of employee awards that
have graded vesting, based on the straight-line method over the requisite
service period of each of the awards, net of estimated forfeitures.
The
Company estimates the fair value of restricted shares based on the market price
of the shares at the grant date and estimates the fair value of stock options
granted using a Black-Scholes options pricing model. The option-pricing model
requires a number of assumptions, of which the most significant are, expected
stock price volatility and the expected option term (the time from the grant
date until the options are exercised or expire). Expected volatility was
calculated based upon actual historical stock price movements over the period,
equal to the expected option term. The expected option term was calculated for
options granted to employees and directors in accordance with SAB-107 and SAB
110, using the "simplified" method. Grants to non-employees are based on the
contractual term. The Company has historically not paid dividends and has no
foreseeable plans to issue dividends. The risk-free interest rate is based on
the yield from U.S. Treasury zero-coupon bonds with an equivalent
term.
39
BRAINSTORM
CELL THERAPEUTICS INC. AND SUBSIDIARY
(A
development stage company)
Notes
to the financial statements
U.S. dollars in thousands (except share data)
NOTE 2
|
-
SIGNIFICANT ACCOUNTING POLICIES
(Cont.)
|
K.
|
Basic
and diluted net loss per
share:
|
Basic net
loss per share is computed based on the weighted average number of shares
outstanding during each year. Diluted net loss per share is computed based on
the weighted average number of shares outstanding during each year, plus the
dilutive potential of the Common Stock considered outstanding during the year,
in accordance with ASC 260-10 (formerly Statement of Financial Accounting
Standard 128), "Earnings per Share."
All
outstanding stock options and warrants have been excluded from the calculation
of the diluted loss per share for the year ended December 31, 2009 and December
31, 2008, since all such securities have an anti-dilutive effect.
L.
|
Income
taxes:
|
The
Company and its subsidiary account for income taxes in accordance with ASC 740
(formerly Statement of Financial Accounting Standard 109), "Accounting for
Income Taxes." This Statement requires the use of the liability method of
accounting for income taxes, whereby deferred tax asset and liability account
balances are determined based on the differences between financial reporting and
tax bases of assets and liabilities and are measured using the enacted tax rates
and laws that will be in effect when the differences are expected to reverse.
The Company and its subsidiary provide a valuation allowance, if necessary, to
reduce deferred tax assets to their estimated realizable value.
In
September 2006, the Financial Accounting Standards Board ("FASB") issued ASC
740-10 (formerly FASB interpretation ("FIN") 48), "Accounting for
Uncertainty in Income Taxes - an Interpretation of FASB Statement 109". ASC
740-10 establishes a single model to address accounting for uncertain tax
positions. ASC 740-10 clarified the accounting for income taxes by prescribing
the minimum recognition threshold a tax position is required to meet before
being recognized in the financial statements. ASC 740-10 also provides guidance
on recognition, measurement, classification, interest and penalties, accounting
in interim periods, disclosure and transition. The adoption of the provisions of
ASC 740-10 did not have an impact on the Company's consolidated financial
position and results of operations.
M.
|
Fair
value of financial
instruments:
|
The
carrying values of cash and cash equivalents, accounts receivable and prepaid
expenses, trade payables and other accounts payable approximate their fair value
due to the short-term maturity of these instruments.
N.
|
Impact
of recently issued accounting
standards:
|
ASC
105-10-65-1 establishes the Financial Accounting Standards Board
Accounting Standards Codification (Codification) as the source of
authoritative U.S. generally accepted accounting principles (GAAP) recognized by
the Financial Accounting Standards Board (“FASB”) to be applied by
nongovernmental entities. Rules and interpretive releases of the Securities and
Exchange Commission (SEC) under authority of federal securities laws are also
sources of authoritative GAAP for SEC registrants. This Codification supersede
all then-existing non-SEC accounting and reporting standards. All other
non-grandfathered non-SEC accounting literature not included in the Codification
will become non-authoritative. The Codification is effective for
financial statements issued for interim and annual periods ending after
September 15, 2009.
40
BRAINSTORM
CELL THERAPEUTICS INC. AND SUBSIDIARY
(A
development stage company)
Notes
to the financial statements
U.S.
dollars in thousands (except
share data)
On July
8, 2004, the Company entered into a research and license agreement (the
"Original Agreement") with Ramot. The license agreement grants the Company an
exclusive, worldwide, royalty-bearing license to develop, use and sell certain
stem cell technology. In consideration of the license, the Company was required
to remit an upfront license fee payment of $100; royalties at a rate of 5% of
all net sales of products and 30% of all sublicense receipts. In addition, the
Company granted Ramot and certain of its designees fully vested warrants to
purchase 10,606,415 shares of Common Stock at an exercise price of $0.01 per
share. The Company will also fund, through Ramot, further research in
consideration of $570 per year for an initial two-year period (“initial research
period”). The Company will also fund for a further two-year period if certain
research milestones are met additional $1,140 (“extended research period”).
Ramot may terminate the agreement if the Company fails to reach certain
development milestones or materially breaches the agreement.
The
warrants issued pursuant to the agreement were issued to Ramot and its designees
effective as of November 4, 2004. Each of the warrants is exercisable for a
seven-year period beginning on November 4, 2005.
Ramot has
instructed the Company that the warrants will be issued as follows: Ramot shall
be issued 60% of the warrants, the two consultants, or trustees for their
benefit, shall each be issued, in addition to the Consultants' warrants
described in Note 4, 15% of the Ramot warrants, Mr. Yosef Levy, a member of the
research team, shall be issued 8% of the Ramot warrants and Mrs. Pnina Green, a
member of the research team, shall be issued 2% of the Ramot
warrants.
On March
30, 2006, the Company entered into an Amended Research and License Agreement
with Ramot, for the purpose of amending and restating the Original Agreement.
According to the agreement, the initial period was amended to an initial
research period of three years. The Amended Research and License Agreement also
extends the additional two-year research period in the Original Agreement to an
additional three-year research period if certain research milestones are met.
The Amended Research and License Agreement retroactively amends the
consideration to $380 per year, instead of $570 per year. As a consequence, an
amount of $300 was charged to the statement of operations as research and
development expenses in the year ended in March 31, 2006. In addition, the
Amended Research and License Agreement reduces royalties that the Company may
have to pay Ramot, in certain cases, from 5% to 3% of net sales and also reduces
the sublicenses receipt from 30% to 20%-25% of sublicense receipts.
On July
26, 2007, the Company entered into a Second Amended and Restated Research and
License Agreement with Ramot. On August 1, 2007, the Company obtained a waiver
and release from Ramot pursuant to which Ramot agreed to an amended payment
schedule regarding the Company's payment obligations under the Amended Research
and License Agreement, dated March 30, 2006, and waived all claims against the
Company resulting from the Company's previous defaults and non-payment under the
Original Agreement and the Amended Research and License Agreement. The payments
described in the waiver and release covered all payment obligations that were
past due and not yet due pursuant to the Original Agreement. The waiver and
release amended and restated the remaining unpaid balance of $640 of
the original payment schedule for the initial research period under
the Original Agreement as follows:
Payment
date
|
Amount
|
|||
September
5, 2007
|
100 | |||
November
20, 2007
|
150 | |||
February
20, 2008
|
150 | |||
May
20, 2008
|
150 | |||
August
4, 2008
|
90 |
41
BRAINSTORM
CELL THERAPEUTICS INC. AND SUBSIDIARY
(A
development stage company)
Notes
to the financial statements
U.S. dollars in thousands (except share data)
NOTE 3
|
-
RESEARCH AND LICENSE AGREEMENT
(Cont.)
|
As of
December 24, 2009, the Company paid to Ramot the first three payments out of the
remaining balance total of $400 but has not made the last two payments total of
$240 and for the extended research period.
On
December 24, 2009, the Company and Ramot entered into a settlement agreement
which also amended the Research and License Agreement in July 8, 2004 and the
first and second amendments to the agreement pursuant to which, among others,
the following matters were agreed upon:
a)
|
Ramot
released the Company from its obligation to fund the extended research
period in the total amount of $1,140.Therefore the company deleted amount
of $ 760 from it research and development expenses that were accumulated
in the past.
|
b)
|
Past
due amount of $240 for the initial research period plus interest of $32
owed by the Company to Ramot was converted into 1,120,000 shares of common
stock on December 30,2010. Ramot shall deposit the shares with a broker
and shall sell the shares in the free market after 185 days from the
issuance day.
|
In the
event that the total proceeds generated by sales of the shares are less than
$120 on or prior to September 30, 2010 ("September Payment"), then on such date
the Company shall pay to Ramot the difference between the aggregate proceeds
that have been received by Ramot up to such date, and $120. In the
event that the total proceeds generated by sales of the shares on December
31,2010, together with the September 30, 2010 payment, are less than $240 on or
prior to December 31, 2010, then on such date the Company shall pay to Ramot the
difference between the proceeds that Ramot has received from sales of the shares
up to such date together with the September Payment (if any) that has been
transferred to Ramot up to such date, and $240.
Related
compensation in the amount of $51 was recorded as research and development
expenses.
NOTE 4
|
-
CONSULTING AGREEMENTS
|
A.
|
On
July 8, 2004, the Company entered into two consulting agreements with
Prof. Eldad Melamed and Prof. Daniel Offen (together, the "Consultants"),
upon which the Consultants shall provide the Company scientific and
medical consulting services in consideration for a monthly payment of $6
each. In addition, the Company granted each of the Consultants, a fully
vested warrant to purchase 1,097,215 shares of Common Stock at an exercise
price of $0.01 per share. The warrants issued pursuant to the agreement
were issued to the Consultants effective as of November 4, 2004. Each of
the warrants is exercisable for a seven-year period beginning on November
4, 2005.
|
B.
|
As
of December 31, 2009, the Company has a total obligation of $370 for
services rendered by the
Consultants.
|
NOTE 5
|
-
ACCOUNTS RECEIVABLE AND PREPAID
EXPENSES
|
December
31,
|
||||||||
2009
|
2008
|
|||||||
Government
authorities
|
14 | 12 | ||||||
Prepaid
expenses
|
72 | 9 | ||||||
86 | 21 |
42
BRAINSTORM
CELL THERAPEUTICS INC. AND SUBSIDIARY
(A
development stage company)
Notes
to the financial statements
U.S.
dollars in thousands (except
share data)
NOTE 6
|
-
PROPERTY AND EQUIPMENT
|
December
31,
|
||||||||
2009
|
2008
|
|||||||
Cost:
|
||||||||
Office
furniture and equipment
|
9 | 9 | ||||||
Computer
software and electronic equipment
|
101 | 101 | ||||||
Laboratory
equipment
|
347 | 347 | ||||||
Leasehold
improvements
|
655 | 655 | ||||||
1,112 | 1,112 | |||||||
Accumulated
depreciation:
|
||||||||
Office
furniture and equipment
|
3 | 2 | ||||||
Computer
software and electronic equipment
|
84 | 64 | ||||||
Laboratory
equipment
|
128 | 95 | ||||||
Leasehold
improvements
|
322 | 208 | ||||||
537 | 369 | |||||||
Depreciated
cost
|
575 | 743 |
Depreciation
expenses for the year ended December 31, 2009 and December 31, 2008 were $168,
and $151 respectively.
NOTE 7
|
-
OTHER ACCOUNTS PAYABLE AND ACCRUED
EXPENSES
|
December
31,
|
||||||||
2009
|
2008
|
|||||||
Employee
and payroll accruals
|
404 | 176 | ||||||
Ramot
accrued expenses
|
- | 475 | ||||||
Accrued
expenses
|
992 | 1,021 | ||||||
Other
|
22 | - | ||||||
1,418 | 1,672 |
NOTE 8
|
-
SHORT-TERM CONVERTIBLE NOTE
|
On
December 13, 2009, the Company issued a $135 Convertible Promissory Note to it
legal advisor for $217 legal fee accrued through October 31, 2009. Interest on
the note accrues at the rate of 4%. The legal advisor has
the right at any time to convert all or part of the outstanding principal and
interest amount of the note into shares of Common Stock based on the five day
average closing stock price prior to conversion election.
The gap
between the amount the company owed to legal advisor and the principal of the
convertible Promissory Note in amount of $82 deducted from general and
administrative expenses.
On
February 19, 2010, the legal advisor elected to convert the entire accrued
principal and interest into shares of Common Stock (See note15
g.)
43
BRAINSTORM
CELL THERAPEUTICS INC. AND SUBSIDIARY
(A
development stage company)
Notes
to the financial statements
U.S.
dollars in thousands (except
share data)
NOTE 9
|
-
SHORT-TERM CONVERTIBLE LOANS
|
A.
|
On
December 12, 2006, the Company issued a $200 Convertible Promissory Note
to a third party. Interest on the note accrues at the rate of 8% per annum
and was due and payable in full on December 31, 2007. The note could
become immediately due and payable upon the occurrence of certain events
of default, as defined in the note. The third party had the right at any
time prior to the close of business on the maturity date to convert all or
part of the outstanding principal and interest amount of the note into
shares of Common Stock. The conversion price, as defined in the note, was
75% (60% upon the occurrence of an event of default) of the average of the
last bid and ask price of the Common Stock as quoted on the
Over-the-Counter Bulletin Board for the five trading days prior to the
Company's receipt of the third party written notice of election to
convert, but in no event will the conversion price be greater than $0.35
or more than 4,000,000 shares of Common Stock be issued. The conversion
price will be adjusted in the event of a stock dividend, subdivision,
combination or stock split of the outstanding
shares.
|
In
addition, the Company granted to the third party warrants to purchase 200,000
shares of Common Stock at an exercise price of $0.45 per share. The warrants are
fully vested and exercisable at any time after December 2006 until the second
anniversary of the issue date. The fair value of the warrants amounts to
$23.
The
Company agreed to pay a finder's fee of 10% of the loan. The finder’s fee
totaling $20 was charged to deferred charges and is amortized as financial
expense over the note period.
In
accordance with ASC 470-20 (formerly APB 14), the Company allocated the proceeds
of the convertible note issued with detachable warrants based on the relative
fair values of the two securities at the time of issuance. As a result, the
Company recorded in its statement of changes in stockholders' equity an amount
of $12 with respect to the warrants and the convertible note was recorded in the
amount of $188.
On
February 21, 2008, the third party converted the entire accrued principal and
interest into 619,523 shares of Common Stock.
B.
|
On
March 5, 2007, the Company issued a $150 Convertible Promissory Note to a
third party. Interest on the note accrues at the rate of 8% per annum for
the first year and 10% per annum afterward .The note will become
immediately due and payable upon the occurrence of certain events of
default, as defined in the note. The third party has the right at any time
prior to the close of business on the maturity date to convert all or part
of the outstanding principal and interest amount of the note into shares
of Common Stock. The conversion price, as defined in the note, will be 75%
(60% upon the occurrence of an event of default) of the average of the
last bid and ask price of the Common Stock as quoted on the
Over-the-Counter Bulletin Board for the five trading days prior to the
Company's receipt of the third party written notice of election to
convert, but in no event shall the conversion price be greater than $0.35
or more than 3,000,000 shares of Common Stock be issued. The conversion
price will be adjusted in the event of a stock dividend, subdivision,
combination or stock split of the outstanding
shares.
|
In
addition, the Company granted to the third party warrants to purchase 150,000
shares of Common Stock at an exercise price of $0.45 per share. The warrants are
fully vested and are exercisable at any time after March 5, 2007 until the
second anniversary of the issue date. The fair value of the warrants is
$43.
In
accordance with ASC
470-20, the Company allocated the proceeds of the convertible note issued with
detachable warrants based on the relative fair values of the two securities at
the time of issuance. As a result, the Company recorded in its statement of
changes in stockholders' equity for 2007 an amount of $22 with respect to the
warrants and the convertible note was recorded in the amount of
$128.
The
Company agreed to pay a finder's fee of $15; $13 was allocated to deferred
charges and is amortized as financial expense over the note period and $2 was
allocated to stockholder's equity.
The BCF,
in the amount of $122, embedded in the note was calculated based on a conversion
rate of 60%, as defined upon the occurrence of an event of default and according
to the notes’ effective conversion price. The amount was recorded as discount on
the note against additional paid-in capital and is amortized to financial
expense over the note period.
The
company has not paid the loan on the original maturity date, and is negotiating
with the third party for payment terms.
44
BRAINSTORM
CELL THERAPEUTICS INC. AND SUBSIDIARY
(A
development stage company)
Notes
to the financial statements
U.S.
dollars in thousands (except
share data)
NOTE 9
|
-
SHORT-TERM CONVERTIBLE LOANS
(Cont.)
|
B.
|
(Cont.)
|
The
balance of the convertible loan is comprised as follows:
December
31,
|
||||||||
2009
|
2008
|
|||||||
Note
|
150 | 150 | ||||||
Accrued
interest
|
39 | 22 | ||||||
189 | 172 |
On
January 27, 2010, the third party converted the entire accrued principal and
interest into Shares of Common Stock. (See note 15b)
C.
|
On
April 10, 2007, the Company issued a $25 Convertible Promissory Note to a
third party. Interest on the note accrues at the rate of 8% per annum and
is due and payable in full on April 10, 2008. The note became immediately
due and payable upon the occurrence of certain events of default, as
defined in the note. The third party has the right at any time prior to
the close of business on the maturity date to convert all or part of the
outstanding principal and interest amount of the note into shares of
Common Stock. The conversion price, as defined in the note, will be 75%
(60% upon the occurrence of an event of default) of the average of the
last bid and ask price of the Common Stock as quoted on the
Over-the-Counter Bulletin Board for the five trading days prior to the
Company's receipt of the third party written notice of election to
convert, but in no event shall the conversion price be greater than $0.35
or more than 1,000,000 shares of Common Stock be issued. The conversion
price will be adjusted in the event of a stock dividend, subdivision,
combination or stock split of the outstanding
shares.
|
In
addition, the Company granted to the third party warrants to purchase 25,000 of
Common Stock at an exercise price of $0.45 per share. The warrants are fully
vested and are exercisable at any time after April 10, 2007, until the second
anniversary of the issue date. The fair value of the warrants is
$6.
In
accordance with ASC
470-20, the Company allocated the proceeds of the convertible note issued with
detachable warrants based on the relative fair values of the two securities at
the time of issuance. As a result, the Company recorded in its statement of
changes in stockholders' equity an amount of $4 with respect to the warrants and
the convertible note was recorded in the amount of $21.
The BCF,
in the amount of $12, embedded in the note was calculated based on a conversion
rate of 75% and according to the notes’ effective conversion price. The amount
was recorded as discount on the note against additional paid-in capital and is
amortized to financial expense over the note period.
On
February 18, 2008, the third party converted the entire accrued principal and
interest amount of $27 into 75,937 shares of Common Stock.
D.
|
On
July 3, 2007, the Company issued a $30 Convertible Promissory Note to a
third party. Interest on the note accrues at the rate of 8% per annum and
is due and payable in full on July 3, 2008. The note became
immediately due and payable upon the occurrence of certain events of
default, as defined in the note. The third party had the right at any time
prior to the close of business on July 3, 2008 to convert all or part of
the outstanding principal and interest amount of the note into shares of
Common Stock. The conversion price, as defined in the note, will be 75%
(60% upon the occurrence of an event of default) of the average of the
last bid and ask price of the Common Stock as quoted on the
Over-the-Counter Bulletin Board for the five trading days prior to the
Company's receipt of the third party written notice of election to
convert, but in no event shall the conversion price be greater than $0.35
or more than 1,000,000 shares of Common Stock be issued. The conversion
price will be adjusted in the event of a stock dividend, subdivision,
combination or stock split of the outstanding
shares.
|
45
BRAINSTORM
CELL THERAPEUTICS INC. AND SUBSIDIARY
(A
development stage company)
Notes
to the financial statements
U.S.
dollars in thousands (except
share data)
NOTE
9
|
-
|
SHORT-TERM
CONVERTIBLE LOANS (Cont.)
|
D.
|
(Cont.)
|
In
addition, the Company granted to the third party warrants to purchase 30,000
shares of Common Stock at an exercise price of $0.45 per share. The warrants are
fully vested and are exercisable at any time after July 3, 2007 until the second
anniversary of the issue date. The fair value of the warrants is
$12.
In
accordance with ASC
470-20, the Company allocated the proceeds of the convertible note issued with
detachable warrants based on the relative fair values of the two securities at
the time of issuance. As a result, the Company recorded in its statement of
changes in stockholders' equity an amount of $5 with respect to the warrants and
the convertible note was recorded in the amount of $25.
The BCF,
in the amount of $15, embedded in the note was calculated based on a conversion
rate of 75% and according to the notes’ effective conversion price. The amount
was recorded as discount on the note against additional paid-in capital and is
amortized to financial expense over the note period.
On June
5, 2008, the third party converted the entire accrued principal and interest
amount of $32 into 92,008 shares of Common Stock.
E.
|
On
September 10, 2007, the Company entered into a payment agreement with the
lender with respect to the Convertible Promissory Notes issued during
2006.
|
Pursuant
to the agreement, the Company agreed to pay the outstanding amount due under the
Convertible Promissory Notes, plus any accrued interest and penalties, in
accordance with the following schedule:
Payment date
|
Amount ($)
|
|||
August
16, 2007
|
100 | |||
November
30, 2007
|
100 | |||
January
15, 2008
|
175 | |||
February
28, 2008
|
175 | |||
April
30, 2008
|
175 | |||
June
30, 2008
|
175 | |||
August
31, 2008
|
175 | |||
November
30, 2008
|
175 | |||
January
31, 2009
|
200 | |||
The
lender, then, agreed that upon payment of the foregoing amounts in accordance
with the foregoing schedule, all of the Company's outstanding obligations owed
to the lender under the Convertible Promissory Notes will be satisfied in full.
The lender also waived any breach or default that may have arisen prior to the
date of the agreement from the failure of the Company to make payments under any
of the Convertible Promissory Notes. In addition, the lender waived his
conversion rights.
According
to the provisions of ASC 470-60-55 (formerly EITF 02-4), the modification of
terms of the convertible loans payments is in the scope of ASC 310-40-15
(formerly FASB No. 15 "Accounting by Debtors and Creditors for Troubled Debt
Restructurings"). According to the payment agreement, the carrying amount of the
loan is not in excess of total future payments and, therefore, in accordance
with ASC 310-40-15, no gain or loss is recognized.
46
BRAINSTORM
CELL THERAPEUTICS INC. AND SUBSIDIARY
(A
development stage company)
Notes
to the financial statements
U.S.
dollars in thousands (except
share data)
NOTE
9
|
-
|
SHORT-TERM
CONVERTIBLE LOANS (Cont.)
|
E.
|
(Cont.)
|
On April
13, 2008, the Company entered into a new agreement with a lender which the
lender agreed to partially defer and partially convert to the Company’s Common
Stock the payment of $1,250 owed by the Company to the lender, in that day,
based on the above payment agreement between the two
parties..
Pursuant
to the new agreement, the Company agreed to pay $250 of the Debt in accordance
with the following schedule:
Payment Date
|
Amount ($)
|
|||
May
30, 2008
|
50 | |||
July
31, 2008
|
50 | |||
September
30, 2008
|
50 | |||
December
31, 2008
|
50 | |||
February
28, 2009
|
50 |
In
addition, the Company issued 2,857,142 shares of common stock to the lender in
lieu of the repayment of $1,000 of the Debt.
The
lender agreed that upon payment of the foregoing amounts in accordance with the
foregoing schedule and the receipt of the stock grant, all of the Company’s
,then , outstanding obligations owed to the lender under the notes will be
satisfied in full. The lender also waived any breach or default that may have
arisen prior to the date of the new agreement from the failure of the Company to
make payments to the lender under any of past agreements.
The
Company paid to the lender the first payment of $50 and on April 6, 2009 the
Company and the lender agreed to convert the entire remaining debt of $200 to
2,500,000 restricted shares of common stock.
Since the
outcome of the issuance of the shares was to relieve the debtor from its
obligation, based on guidance in ASC 860-10 (formerly FASB No 140) “Accounting
for Transfer and Servicing of Financial Assets and Extinguishment of
Liabilities“ the Company derecognized the liability with the
difference recognized in earning.
NOTE
10
|
-
|
COMMITMENTS
AND CONTINGENCIES
|
A.
|
On
December 1, 2004, the Israeli subsidiary entered into a lease agreement
for the lease of its facilities. The term of the lease is 36 months, with
two options to extend: one for an additional 24 months (the "First
Option"); and one for an additional 36 months (the "Second Option"). Rent
is to be paid on a quarterly basis in the following amounts: (i) NIS
17,965 (approximately $5) per month during the first 12 months of the
lease; (ii) NIS 19,527 (approximately $5) per month during the following
24 months of the lease; (iii) NIS 22,317 (approximately $6) per month
during the First Option period; and (iv) NIS 23,712 (approximately
$6) per month during the Second Option period. As of December 31, 2009,
the lease agreement and the first option has expired and the Israeli
subsidiary has entered into the “second
option”.
|
On July
25, 2006 the Company entered into a lease agreement for the lease of
it's office in the US at a monthly rate of $2.5.On February 6, 2008 the lessor
agreed to waive any amount owed by the Company to the lessor and let the Company
continue to occupy the office for no additional consideration. Therefore amount
of $35 was deducted from expenses in the general and administrative expenses for
the year ended December 31, 2008.
47
BRAINSTORM
CELL THERAPEUTICS INC. AND SUBSIDIARY
(A
development stage company)
Notes
to the financial statements
U.S.
dollars in thousands (except
share data)
NOTE
10
|
-
|
COMMITMENTS
AND CONTINGENCIES (Cont.)
|
A.
|
(Cont.)
|
The
facilities and vehicles of the Company and its subsidiary are rented under
operating leases that expire on various dates. Aggregate minimum rental
commitments under non-cancelable leases as of December 31, 2009 are as
follows:
Period
ending December 31,
|
Facilities
|
Vehicles
|
Total
|
|||||||||
2010
|
100 | 27 | 127 | |||||||||
2011
|
100 | 2 | 102 | |||||||||
2012
|
100 | - | 100 | |||||||||
300 | 29 | 329 |
Total
rent expenses for the year ended December 31, 2009 and 2008 were $94 and $70
respectively.
B.
|
The
Company's subsidiary gave a bank guarantee in the amount of $36 to secure
its obligation under the facilities lease agreement. Accordingly, an
amount of $ 36 was classified in the balance sheet for the year ended
December 31,2008 as restricted
cash.
|
In July
29, 2009 the lessor exercised his right and withdraw the amount under the bank
guarantee from the bank.
C.
|
On
March 20, 2006, the Company entered into a Termination Agreement and
General Release (the "Termination Agreement") with Dr. Yaffa Beck, the
Company's former President and Chief Executive Officer who resigned her
position as an officer and director of the Company on November 10,
2005.
|
Under the
Termination Agreement, the Company and Dr. Beck agreed to terminate their
employment relationship effective February 9, 2006. Pursuant to the Termination
Agreement, the Company paid in 10 monthly installments beginning March 1, 2006 a
total of $47 to Dr. Beck. In addition, as per the original terms of the
grant, options previously granted to Dr. Beck to acquire 800,000 shares of
Common Stock at an exercise price of $0.15 per share, which are fully vested,
will be exercisable until February 9, 2010. All compensation expense related to
such vested options was previously recorded in the statement of operations. All
other options previously granted to Dr. Beck were forfeited. As a consequence,
in the year ended March 31, 2006, of deferred stock compensation in the amount
of $3,363, was eliminated against additional paid-in capital and compensation
expense in the amount of $104 was reversed.
Such
Termination Agreement settles all of Dr. Beck's claims against the Company. No
further claims can be raised by either party following the signing of the
Termination Agreement.
As of
December 31, 2009, there is still an unpaid balance of $17 to Dr. Beck regarding
this Termination Agreement.
D.
|
Commitments
to pay royalties to the Chief Scientist:
|
The
Subsidiary obtained from the Chief Scientist of the State of Israel grants for
participation in research and development for the years 2007, 2008 and 2009 and,
in return, the Subsidiary is obligated to pay royalties amounting to 3% of its
future sales up to the amount of the grant. The grant is linked to the exchange
rate of the dollar and bears interest of Libor per annum.
Through
December 31, 2009, total grants obtained amounted to $926.
48
BRAINSTORM
CELL THERAPEUTICS INC. AND SUBSIDIARY
(A
development stage company)
Notes
to the financial statements
U.S.
dollars in thousands (except
share data)
NOTE
11
|
-
|
STOCK
CAPITAL
|
A.
|
The
rights of Common Stock are as
follows:
|
Holders
of Common Stock have the right to receive notice to participate and vote in
general meetings of the Company, the right to a share in the excess of assets
upon liquidation of the Company and the right to receive dividends, if
declared.
The
Common Stock is registered and publicly traded on the Over-the-Counter Bulletin
Board service of the National Association of Securities Dealers, Inc. under the
symbol BCLI.
B.
|
Issuance
of shares, warrants and
options:
|
1.
|
Private
placements:
|
a)
|
On
June 24, 2004, the Company issued to investors 8,510,000 shares of Common
Stock for total proceeds of $60 (net of $25 issuance
expenses).
|
b)
|
On
February 23, 2005, the Company completed a private placement for sale of
1,894,808 units for total proceeds of $1,418. Each unit consists of one
share of Common Stock and a three-year warrant to purchase one share of
Common Stock at $2.50 per share. This private placement was consummated in
three tranches which closed in October 2004, November 2004 and February
2005.
|
c)
|
On
May 12, 2005, the Company issued to an investor 186,875 shares of Common
Stock for total proceeds of $149 at a price of $0.8 per
share.
|
d)
|
On
July 27, 2005, the Company issued to investors 165,000 shares of Common
Stock for total proceeds of $99 at a price of $0.6 per
share.
|
e)
|
On
August 11, 2005, the Company signed a private placement agreement with
investors for the sale of up to 1,250,000 units at a price of $0.8 per
unit. Each unit consists of one share of Common Stock and one warrant to
purchase one share of Common Stock at $1.00 per share. The warrants are
exercisable for a period of three years from issuance. On September 30,
2005, the Company sold 312,500 units for total net proceeds of $225. On
December 7, 2005, the Company sold 187,500 units for total net proceeds of
$135.
|
f)
|
On
July 2, 2007, the Company entered into an investment agreement, pursuant
to which the Company agreed to sell up to 27,500,000 shares of Common
Stock, for an aggregate subscription price of up to $5 million and
warrants to purchase up to 30,250,000 shares of Common Stock. Separate
closings of the purchase and sale of the shares and the warrants shall
take place as follows:
|
Purchase date
|
Purchase
price
|
Number of
subscription
shares
|
Number of
warrant
shares
|
|||||||||
August
30, 2007
|
$ | 1,250 | 6,875,000 | 7,562,500 | ||||||||
November
15, 2007
|
$ | 750 | 4,125,000 | 4,537,500 | ||||||||
February
15, 2008
|
$ | 750 | 4,125,000 | 4,537,500 | ||||||||
May
15, 2008
|
$ | 750 | 4,125,000 | 4,537,500 | ||||||||
July
30, 2008
|
$ | 750 | 4,125,000 | 4,537,500 | ||||||||
November
15, 2008
|
$ | 750 | 4,125,000 | 4,537,500 |
49
BRAINSTORM
CELL THERAPEUTICS INC. AND SUBSIDIARY
(A
development stage company)
Notes
to the financial statements
U.S.
dollars in thousands (except
share data)
NOTE
11
|
-
|
STOCK
CAPITAL (Cont.)
|
B.
|
Issuance
of shares, warrants and options:
(Cont.)
|
1.
|
Private
placements: (Cont.)
|
f)
|
(Cont.)
|
At each closing date, the Company
shall deliver to the investor the number of shares and warrants, subject to
customary closing conditions and the delivery of funds, described above. The
warrants shall have the following exercise prices: (i) the first 10,083,333
warrants have an exercise price of $0.20 per share; (ii) the next 10,083,333
warrants will have an exercise price of $0.29 per share; and (iii) the final
10,083,334 warrants issued will have an exercise price of $0.36 per share. All
warrants will expire on November 5, 2011.
On August
18, 2009, the Company entered into an amendment to the investment agreement with
the investor as follows:
(a)
|
The
investor shall invest the remaining amount of the original investment
agreement at price per share of $0.12 in monthly installments of not less
then $50 starting August 1,
2009.
|
(b)
|
The
exercise price of the last 10,083,334 warrants will decrease from an
exercise price of $0.36 per share to $0.29 per
share.
|
(c)
|
All
warrants will expire on November 5, 2013 instead of November 5,
2011.
|
(d)
|
The
price per share of the investment agreement shall decreased from $0.1818
to $0.12, Therefore the Company shall adjust the number of Shares of
Common Stock issuable pursuant the investment agreement retroactively and
shall issue to the investor additional 9,916,667 Shares of Common Stock
for past investment. On October 28, 2009, the 9,916,667 Shares of Common
Stock were issued.
|
(e)
|
The
investor shall have the right to cease payments in the event that the
price per share as of the closing on five consecutive trading days shall
decrease to $0.05.
|
As of
December 31, 2009, the investor completed payment of the first five installments
and $259 of the sixth installment and the Company issued to the investor and its
designees an aggregate of 29,166,667 shares of common stock and a warrant to
purchase 10,083,333 shares of the Company's common stock at an exercise price of
$0.20 per share and a warrant to purchase 15,629,167 shares of common stock at
an exercise price of $0.29 per share. The warrants may be exercised at any time
and expire on November 5, 2013.The Company shall issue to the investor
additional 6,250,000 shares of common stock for the fifth installment that had
already been paid.
In
addition, the Company agreed to issue an aggregate of 1,250,000 shares of Common
Stock to a related party as an introduction fee for the investment. The shares
shall be issued pro rata to the funds received from the investor.
As of
December 31, 2009, 875,000 shares of Common Stock had been issued as an
introduction fee.
50
BRAINSTORM
CELL THERAPEUTICS INC. AND SUBSIDIARY
(A
development stage company)
Notes
to the financial statements
U.S.
dollars in thousands (except
share data)
NOTE
11
|
-
|
STOCK
CAPITAL (Cont.)
|
B.
|
Issuance
of shares, warrants and options:
(Cont.)
|
2.
|
Share-based
compensation to employees and to
directors:
|
a)
|
Options
to employees and directors:
|
On
November 25, 2004, the Company's stockholders approved the 2004 Global Stock
Option Plan and the Israeli Appendix thereto (which applies solely to
participants who are residents of Israel) and on March 28, 2005, the Company's
stockholders approved the 2005 U.S. Stock Option and Incentive Plan, and the
reservation of 9,143,462 shares of Common Stock for issuance in the aggregate
under these stock option plans.
On June
5, 2008, the Company's stockholders approved to amend and restate the
Company’s 2004 Global Share Option Plan and 2005 U.S. Stock Option and Incentive
Plan to increase the number of shares of common stock available for issuance
under these stock option plans in the aggregate by 5,000,000
shares.
Each
option granted under the plans is exercisable until the earlier of ten years
from the date of grant of the option or the expiration dates of the respective
option plans. The 2004 and 2005 options plans will expire on November 25, 2014
and March 28, 2015, respectively. The exercise price of the options granted
under the plans may not be less than the nominal value of the shares into which
such options are exercised. The options vest primarily over three or four years.
Any options that are canceled or forfeited before expiration become available
for future grants.
As of
December 31, 2009, 3,766,684 options are available for future
grants.
On May
27, 2005, the Company granted one of its directors an option to purchase 100,000
shares of Common Stock at an exercise price of $0.75 per share. The options are
fully vested and expire after 10 years.
On
February 6, 2006, the Company entered into an amendment to the Company's option
agreement with the Company's Chief Financial Officer. The amendment changes the
exercise price of the 400,000 options granted to him on February 13, 2005 from
$0.75 to $0.15 per share.
On May 2,
2006, the Company granted to one of its directors an option to purchase 100,000
shares of Common Stock at an exercise price of $0.15 per share. The options are
fully vested and expire after 10 years. The compensation related to the options,
in the amount of $48, was recorded as general and administrative
expense.
On June
22, 2006, the Company entered into an amendment to the Company's option
agreement with two of its employees. The amendment changes the exercise price of
270,000 options granted to them from $0.75 to $0.15 per share. The excess of the
fair value resulting from the modification, in the amount of $2, was recorded as
general and administration expense over the remaining vesting period of the
option.
On
September 17, 2006, the Company entered into an amendment to the Company's
option agreement with one of its directors. The amendment changes the exercise
price of 100,000 options granted to the director from $0.75 to $0.15 per
share.
51
BRAINSTORM
CELL THERAPEUTICS INC. AND SUBSIDIARY
(A
development stage company)
Notes
to the financial statements
U.S.
dollars in thousands (except
share data)
NOTE
11
|
-
|
STOCK
CAPITAL (Cont.)
|
B.
|
Issuance
of shares, warrants and options:
(Cont.)
|
2.
|
Share-based
compensation to employees and to directors:
(Cont.)
|
a)
|
Options
to employees and directors:
(cont.)
|
On March
21, 2007, the Company granted to one of its directors an option to purchase
100,000 shares of Common Stock at an exercise price of $0.15 per share. The
option is fully vested and is exercisable for a period of 10 years. The
compensation related to the option, in the amount of $43, was recorded as
general and administrative expense.
On July
1, 2007, the Company granted to one of its directors an option to purchase
100,000 shares of Common Stock at an exercise price of $0.15 per share. The
option is fully vested and is exercisable for a period of 10 years. The
compensation related to the option, in the amount of $38, was recorded as
general and administrative expense. On October 22, 2007, the Company and the
director agreed to cancel and relinquish all the options which were granted on
July 1, 2007.
On July
16, 2007, the Company granted to one of its directors an option to purchase
100,000 shares of Common Stock at an exercise price of $0.15 per share. The
option is fully vested and is exercisable for a period of 10 years. The
compensation related to the option, in the amount of $75, was recorded as
general and administrative expense.
On August
27, 2007, the Company granted to one of its directors an option to purchase
100,000 shares of Common Stock at an exercise price of $0.15 per share. The
option is fully vested and is exercisable for a period of 10 years. The
compensation related to the option, in the amount of $84, was recorded as
general and administrative expense.
On
October 23, 2007, the Company granted to its CEO an option to purchase 1,000,000
shares of Common Stock at an exercise price of $0.87 per share. The option vests
with respect to 1/6 of the option on each six month anniversary and expires
after 10 years. The total compensation related to the option is $733, which is
amortized over the vesting period as general and administrative
expense.
On
November 5, 2008, the Company entered into an amendment to the Company's option
to purchase 1,000,000 shares of common stock agreement with the Company's CEO.
The amendment changes the exercise price of the option from $0.87 to $0.15 per
share. The compensation related the modification of the purchase price in the
amount of $4 was recorded as general and administrative expense.
On June
29, 2009, the Company granted to its CEO and director an option to purchase
1,000,000 shares of Common Stock at an exercise price of $0.067 per share. The
option vests with respect to 1/3 of the option on each year anniversary and
expires after 10 years. The total compensation related to the option is $68,
which is amortized over the vesting period as general and administrative
expense.
On June
29, 2009, the Company granted to its CFO an option to purchase 200,000 shares of
Common Stock at an exercise price of $0.067 per share. The option vests with
respect to 1/3 of the option on each year anniversary and expires after 10
years. The total compensation related to the option is $8, which is amortized
over the vesting period as general and administrative expense.
52
BRAINSTORM
CELL THERAPEUTICS INC. AND SUBSIDIARY
(A
development stage company)
Notes
to the financial statements
U.S.
dollars in thousands (except
share data)
NOTE
11
|
-
|
STOCK
CAPITAL (Cont.)
|
B.
|
Issuance
of shares, warrants and options:
(Cont.)
|
2.
|
Share-based
compensation to employees and to directors:
(Cont.)
|
a)
|
Options
to employees and directors:
(cont.)
|
On August
31, 2009, the Company granted to two of its directors an option to purchase
100,000 shares of Common Stock for each of them at an exercise price of $0.15
per share. The option vests with respect to 1/3 of the option on each year
anniversary and expires after 10 years. The total compensation related to the
option is $32, which is amortized over the vesting period as general and
administrative expense.
On
December 13, 2009, the Company granted to one of its directors an option to
purchase 100,000 shares of Common Stock at an exercise price of $0.15 per share.
The option is fully vested and is exercisable for a period of 10 years. The
compensation related to the option, in the amount of $21, was recorded as
general and administrative expense.
A summary
of the Company's option activity related to options to employees and directors,
and related information is as follows:
Year ended December 31, 2009
|
||||||||||||
Amount of
options
|
Weighted
average
exercise
price
|
Aggregate
intrinsic
value
|
||||||||||
$ | $ | |||||||||||
Outstanding
at beginning of period
|
5,433,361 | 0.244 | - | |||||||||
Granted
|
1,650,000 | 0.082 | ||||||||||
Exercised
|
- | - | ||||||||||
Cancelled
|
(595,000 | ) | 0.419 | |||||||||
Outstanding
at end of period
|
6,488,361 | 0.187 | 704,770 | |||||||||
Vested
and expected-to-vest at end of period
|
4,501,417 | 0.222 | 385,553 |
Year ended December 31, 2008
|
||||||||||||
Amount of
options
|
Weighted
average
exercise
price
|
Aggregate
intrinsic
value
|
||||||||||
$ | $ | |||||||||||
Outstanding
at beginning of period
|
5,280,760 | 0.372 | - | |||||||||
Granted
|
170,000 | 0.49 | ||||||||||
Exercised
|
(17,399 | ) | 0.15 | |||||||||
Cancelled
|
- | - | ||||||||||
Outstanding
at end of period
|
5,433,361 | *0.244 | - | |||||||||
Vested
and expected-to-vest at end of period
|
4,324,437 | 0.238 | - |
53
BRAINSTORM
CELL THERAPEUTICS INC. AND SUBSIDIARY
(A
development stage company)
Notes
to the financial statements
U.S.
dollars in thousands (except
share data)
NOTE
11
|
-
|
STOCK
CAPITAL (Cont.)
|
B.
|
Issuance
of shares, warrants and options:
(Cont.)
|
2.
|
Share-based
compensation to employees and to directors:
(Cont.)
|
a)
|
Options
to employees and directors:
(cont.)
|
*)
|
During
2008, the Company extended the exercise period for some of it employees
that were terminated. The extension was accounted for as modification in
accordance with ASC
718-10. According to ASC
718-10, modifications are treated as an exchange of the original award,
resulting in additional compensation expense based on the difference
between the fair value of the new award and the original award immediately
before modification. Applying modification accounting resulted in
additional compensation expense for the year ended December 31, 2008,
amounted to $6
|
The
aggregate intrinsic value in the table above represents the total intrinsic
value (the difference between the fair market value of the Company’s shares on
December 31, 2009 and 2008 and the exercise price, multiplied by the number of
in-the-money options) that would have been received by the option holders had
all option holders exercised their options on December 31, 2009 and
2008.
The
options outstanding as of December 31, 2008, have been separated into exercise
prices, as follows:
Options
outstanding as of
|
Weighted
average
remaining
|
Options
exercisable as of
|
||||||||||
December 31,
|
contractual
|
December 31,
|
||||||||||
Exercise price
|
2009
|
life
|
2009
|
|||||||||
$
|
Years
|
|||||||||||
0.15
|
4,038,361 | 4.88 | 3,505,028 | |||||||||
0.75
|
80,000 | 5.18 | 80,000 | |||||||||
0.4
|
140,000 | 6.03 | 123,750 | |||||||||
0.47
|
720,000 | 4.69 | 660,833 | |||||||||
0.39
|
160,000 | 6.81 | 131,806 | |||||||||
0.067
|
1,350,000 | 9.50 | 0 | |||||||||
6,488,361 | 5.90 | 4,501,417 |
Compensation
expense recorded by the Company in respect of its stock-based employee
compensation award in accordance with ASC 718-10 for the year ended December 31,
2009 and 2008 amounted to $402 and $731, respectively.
The fair
value of the options is estimated at the date of grant using a Black-Scholes
options pricing model with the following assumptions used in the
calculation:
Year ended December 31,
|
||||
2009
|
2008
|
|||
Expected
volatility
|
140%-143%
|
112%-165%
|
||
Risk-free
interest
|
0.47%-3.85%
|
0.37%-3.73%
|
||
Dividend
yield
|
0%
|
0%
|
||
Expected
life of up to (years)
|
0.2-10
|
1-10
|
||
Forfeiture
rate
|
0
|
54
BRAINSTORM
CELL THERAPEUTICS INC. AND SUBSIDIARY
(A
development stage company)
Notes
to the financial statements
U.S.
dollars in thousands (except
share data)
NOTE
11
|
-
|
STOCK
CAPITAL (Cont.)
|
B.
|
Issuance
of shares, warrants and options:
(Cont.)
|
2.
|
Share-based
compensation to employees and to directors:
(Cont.)
|
b)
|
Restricted
shares to directors:
|
On May 2,
2006, the Company issued to two of its directors 200,000 restricted shares of
common stock (100,000 each). The restricted shares are subject to the Company's
right to repurchase them at a purchase price of par value ($0.00005). The
restrictions of the shares shall lapse in three annual and equal portions
commencing with the grant date. The compensation related to the stocks issued
amounted to $104, which will be amortized over the vesting period as general and
administrative expenses.
On April 20, 2007, based on a board
resolution dated March 21, 2007, the Company issued to its director 100,000
restricted shares of common stock. The restricted shares are subject to the
Company's right to repurchase them at a purchase price of par value ($0.00005).
The restrictions of the shares shall lapse in three annual and equal portions
commencing with the grant date. The compensation related to the shares issued
amounted to $47, which will be amortized over the vesting period as general and
administrative expenses.
In addition, on April 20, 2007, based
on a board resolution dated March 21, 2007, the Company issued to another
director 100,000 restricted shares of common stock. The restricted shares are
not subject to any right to repurchase, and the compensation related to the
shares issued amounted to $47 was recorded as prepaid general and administrative
expenses in the three months ended March 31, 2007.
On August
27, 2008 the Company issued to its director 960,000 shares of common stock upon
a cashless exercise by a shareholder of a warrant to purchase 1,000,000 shares
of Common Stock at an exercise price of $.01 per share that was acquired by the
shareholder from Ramot. The shares were allocated to the director by the
shareholder.
3.
|
Shares
and warrants to service
providers:
|
The
Company accounts for shares and warrant grants issued to non-employees using the
guidance of ASC
718-10, "Accounting for Stock-Based Compensation" and EITTF 96-18, "Accounting
for Equity Instruments that are Issued to Other than Employees for Acquiring, or
in Conjunction with Selling, Goods or Services," whereby the fair value of such
option and warrant grants is determined using a Black-Scholes options pricing
model at the earlier of the date at which the non-employee's performance is
completed or a performance commitment is reached.
55
BRAINSTORM
CELL THERAPEUTICS INC. AND SUBSIDIARY
(A
development stage company)
Notes
to the financial statements
U.S.
dollars in thousands (except
share data)
NOTE
11
|
-
|
STOCK
CAPITAL (Cont.)
|
B.
|
Issuance
of shares, warrants and options:
(Cont.)
|
|
3.
|
Shares
and warrants to service providers:
(Cont.)
|
a) Warrants:
Issuance date
|
Number of
warrants
issued
|
Exercised
|
Forfeited
|
Outstanding
|
Exercise
Price $
|
Warrants
exercisable
|
Exercisable through
|
||||||||||||||||||
November
2004
|
12,800,845 | 6,508,708 | 144,724 | 6,147,413 | 0.01 | 6,147,413 |
November
2012
|
||||||||||||||||||
December
2004
|
1,800,000 | 1,800,000 | - | 0.00005 | — |
-
|
|||||||||||||||||||
February
2005
|
1,894,808 | 1,894,808 | - | 2.5 | - | ||||||||||||||||||||
May
2005
|
47,500 | 47,500 | 1.62 | 47,500 |
May
2010
|
||||||||||||||||||||
June
2005
|
30,000 | 30,000 | 0.75 | 30,000 |
June
2010
|
||||||||||||||||||||
August
2005
|
70,000 | 70,000 | - | 0.15 | - |
-
|
|||||||||||||||||||
September
2005
|
3,000 | 3,000 | - | 0.15 | - |
-
|
|||||||||||||||||||
September
2005
|
36,000 | 36,000 | 0.75 | 36,000 |
September
2010
|
||||||||||||||||||||
September-December
2005
|
500,000 | 500,000 | - | 1 | - |
-
|
|||||||||||||||||||
December
2005
|
20,000 | 20,000 | - | 0.15 | - |
-
|
|||||||||||||||||||
December
2005
|
457,163 | 457,163 | 0.15 | 457,163 |
July
2010
|
||||||||||||||||||||
February
2006
|
230,000 | 230,000 | 0.65 | 230,000 |
February
2016
|
||||||||||||||||||||
February
2006
|
40,000 | 40,000 | 1.5 | 40,000 |
February
2011
|
||||||||||||||||||||
February
2006
|
8,000 | 8,000 | 0.15 | 8,000 |
February
2011
|
||||||||||||||||||||
February
2006
|
189,000 | 97,696 | 91,304 | - | 0. 5 | - |
-
|
||||||||||||||||||
May
2006
|
50,000 | 50,000 | 0.0005 | 50,000 |
May
2016
|
||||||||||||||||||||
May
-December 2006
|
48,000 | 48,000 | 0.35 | 48,000 |
May
- December 2011
|
||||||||||||||||||||
May
-December 2006
|
48,000 | 48,000 | 0.75 | 48,000 |
May
- December 2011
|
||||||||||||||||||||
May
2006
|
200,000 | 200,000 | 1 | 200,000 |
May
2011
|
||||||||||||||||||||
June
2006
|
24,000 | 24,000 | 0.15 | 24,000 |
June
2011
|
||||||||||||||||||||
May
2006
|
19,355 | 19,355 | 0.15 | 19,355 |
May
2011
|
||||||||||||||||||||
October
2006
|
630,000 | 630,000 | - | 0.3 | - |
-
|
|||||||||||||||||||
December
2006
|
200,000 | 200,000 | - | 0.45 | - |
-
|
|||||||||||||||||||
March
2007
|
200,000 | 200,000 | 0.47 | 200,000 |
March
2012
|
||||||||||||||||||||
March
2007
|
500,000 | 500,000 | 0.47 | 458,333 |
March
2017
|
||||||||||||||||||||
March
2007
|
50,000 | 50,000 | 0.15 | 50,000 |
March
2010
|
||||||||||||||||||||
March
2007
|
15,000 | 15,000 | 0.15 | 15,000 |
February
2012
|
||||||||||||||||||||
February
2007
|
50,000 | 50,000 | - | 0.45 | - |
-
|
|||||||||||||||||||
March
2007
|
225,000 | 225,000 | - | 0.45 | - |
-
|
|||||||||||||||||||
March
2007
|
50,000 | 50,000 | 0.45 | 50,000 |
March
2010
|
||||||||||||||||||||
April
2007
|
33,300 | 25,000 | 8,300 | 0.45 | 8,300 |
April
2010
|
|||||||||||||||||||
May
2007
|
250,000 | 250,000 | - | 0.45 | - |
-
|
|||||||||||||||||||
July
2007
|
500,000 | 500,000 | 0.39 | 402,778 |
July
2017
|
||||||||||||||||||||
September
2007
|
500,000 | 500,000 | 0.15 | 500,000 |
August
2017
|
||||||||||||||||||||
August
2007
|
7,562,500 | 7,562,500 | 0.2 | 7,562,500 |
November
2013
|
||||||||||||||||||||
July
2007
|
30,000 | 30,000 | - | 0.45 | - |
-
|
|||||||||||||||||||
July
2007
|
100,000 | 100,000 | 0.45 | 100,000 |
July
2010
|
||||||||||||||||||||
October
2007
|
200,000 | 200,000 | 0.15 | 200,000 |
August-October
2017
|
||||||||||||||||||||
November
2007
|
2,520,833 | 2,520,833 | 0.20 | 2,520,833 |
November
2013
|
||||||||||||||||||||
November
2007
|
2,016,667 | 2,016,667 | 0.29 | 2,016,667 |
November
2013
|
||||||||||||||||||||
April
2008
|
4,537,500 | 4,537,500 | 0.29 | 4,537,500 |
November
2013
|
||||||||||||||||||||
August
2008
|
3,529,166 | 3,529,166 | 0.29 | 3,529,166 |
November
2013
|
||||||||||||||||||||
August
2008
|
1,008,333 | 1,008,333 | 0.36 | 1,008,333 |
November
2013
|
||||||||||||||||||||
November
2008
|
100,000 | 100,000 | 0.15 | 100,000 |
September
2018
|
||||||||||||||||||||
April 2009
|
200,000 | 200,000 | 0.1 | - |
April
2019
|
||||||||||||||||||||
October
2009
|
200,000 | 200,000 | 0.067 | - |
October
2019
|
||||||||||||||||||||
October
2009
|
4,537,500 | 4,537,500 | 0.29 | 4,537,500 |
November
2013
|
||||||||||||||||||||
48,261,470 | 9,059,404 | 3,480,836 | 35,721,230 | 35,182,342 |
The fair
value for the warrants to service providers was estimated on the date of grant
using a Black-Scholes option pricing model, with the following weighted-average
assumptions for the year ended December 31, 2009 and December 31, 2008; weighted
average volatility of 126%-165% and 108%, 93%-115%, respectively, risk free
interest rates of 0.37%-2.12% and 3.3%-4.5%, respectively dividend yields of 0%
and a weighted average life of the options of 1-9 and 6-.7 years,
respectively.
56
BRAINSTORM
CELL THERAPEUTICS INC. AND SUBSIDIARY
(A
development stage company)
Notes
to the financial statements
U.S.
dollars in thousands (except
share data)
NOTE
11
|
-
|
STOCK
CAPITAL (Cont.)
|
B.
|
Issuance
of shares, warrants and options:
(Cont.)
|
3.
|
Shares
and warrants to service providers:
(Cont.)
|
b)
|
Shares:
|
On June 1
and June 4, 2004, the Company issued 40,000 and 150,000 shares of Common Stock
for 12 months of filing services and legal and due-diligence services,
respectively, with respect to a private placement. Compensation expense related
to filing services, totaling $26, is amortized over a 12-month period.
Compensation related to legal services, totaling $105 was recorded as equity
issuance cost and had no effect on the statement of operations.
On July 1
and September 22, 2004, the Company issued 20,000 and 15,000 shares to a former
director for financial services for the first and second quarters of 2004,
respectively. Related compensation in the amount of $39 was recorded as general
and administrative expense.
On
February 10, 2005, the Company signed an agreement with one of its service
providers according to which the Company issued the service provider 100,000
restricted shares at a purchase price of $0.00005 par value under the U.S Stock
Option and Incentive Plan of the Company. The restricted shares are subject to
the Company's right to repurchase them within one year of the grant date as
follows: (i) in the event that the service provider breaches his obligations
under the agreement, the Company shall have the right to repurchase the
restricted shares at a purchase price equal to par value; and (ii) in the event
that the service provider has not breached his obligations under the agreement,
the Company shall have the right to repurchase the restricted shares at a
purchase price equal to the then fair market value of the restricted
shares.
In March
and April 2005, the Company signed an agreement with four members of its
Scientific Advisory Board according to which the Company issued to the members
of the Scientific Advisory Board 400,000 restricted shares at a purchase price
of $0.00005 par value under the U.S Stock Option and Incentive Plan (100,000
each). The restricted shares will be subject to the Company's right to
repurchase them if the grantees cease to be members of the Company's Advisory
Board for any reason. The restrictions of the shares shall lapse in three annual
and equal portions commencing with the grant date.
In July
2005, the Company issued to its legal advisors 50,000 shares for legal services
for 12 months. The compensation related to the shares in the amount of $37.5 was
recorded as general and administrative expense.
In
January 2006, the Company issued to two service providers 350,000 restricted
shares at a purchase price of $0.00005 par value under the U.S Stock Option and
Incentive Plan of the Company. The restricted shares are subject to the
Company's right to repurchase them within 12 months from the grant date as
follows: (i) in the event that the service providers breach their obligations
under the agreement, the Company shall have the right to repurchase the
restricted shares at a purchase price equal to the par value; and (ii) in the
event that the service providers have not breached their obligations under the
service agreements, the Company shall have the right to repurchase the
restricted shares at a purchase price equal to the fair market value of the
restricted shares. Related compensation in the amount of $23 was recorded as
general and administrative expense.
57
BRAINSTORM
CELL THERAPEUTICS INC. AND SUBSIDIARY
(A
development stage company)
Notes
to the financial statements
U.S.
dollars in thousands (except
share data)
NOTE
11
|
-
|
STOCK
CAPITAL (Cont.)
|
B.
|
Issuance
of shares, warrants and options:
(Cont.)
|
3.
|
Shares
and warrants to service providers:
(Cont.)
|
b)
|
Shares:
(Cont.)
|
On March
6, 2006, the Company issued to its legal advisor 34,904 shares of Common Stock.
The shares are in lieu of $18.5 payable to the legal advisor. Related
compensation in the amount of $18.5 was recorded as general and administrative
expense.
On April
13, 2006, the Company issued to service providers 60,000 shares at a purchase
price of $0.00005 par value under the U.S Stock Option and Incentive Plan of the
Company. Related compensation in the amount of $25.8 was recorded as general and
administrative expense.
On May 9,
2006, the Company issued to its legal advisor 65,374 shares of Common Stock in
lieu of payment for legal services. Related compensation in the amount of $33
was recorded as general and administrative expense.
On June
7, 2006, the Company issued 50,000 shares of Common Stock for filing services
for 12 months. Related compensation in the amount of $24.5 was recorded as
general and administrative expense.
On May 5,
2006, the Company issued 200,000 shares to a finance consultant for his
services. Related compensation in the amount of $102 was recorded as general and
administrative expense.
On August
14, 2006, the Company issued 200,000 shares to a service provider. Related
compensation in the amount of $68 was recorded as general and administrative
expense.
On August
17, 2006, the Company issued 100,000 shares to a service provider. Related
compensation in the amount of $35 was recorded as general and administrative
expense.
On
September 17, 2006, the Company issued to its legal advisor 231,851 shares of
Common Stock. The shares are in lieu of $63 payable to the legal
advisor.
During
April 1 and September 30, 2006, the Company issued to its business development
advisor, based on an agreement, 240,000 shares of Common Stock. Related
compensation in the amount of $74 was recorded as general and administrative
expense.
On
January 3, 2007, the Company issued to its legal advisor 176,327 shares of
Common Stock. The shares are for the $45 payable to the legal advisor. Related
compensation in the amount of $49 was recorded as general and administrative
expense.
58
BRAINSTORM
CELL THERAPEUTICS INC. AND SUBSIDIARY
(A
development stage company)
Notes
to the financial statements
U.S.
dollars in thousands (except
share data)
NOTE
11
|
-
|
STOCK
CAPITAL (Cont.)
|
B.
|
Issuance
of shares, warrants and options:
(Cont.)
|
3.
|
Shares
and warrants to service providers:
(Cont.)
|
b)
|
Shares:
(Cont.)
|
On April
12, 2007, the Company issued to its filing and printing service providers 80,000
shares of Common Stock. The shares issued are for the $15 payable to the service
provider. Related compensation in the amount of $30 was recorded as general and
administrative expense. In addition, the Company is obligated to issue the
filing and printing service providers additional shares, in the event that the
total value of the shares previously issued (as quoted on the Over-the-Counter
Bulletin Board or such other exchange where the Common Stock is quoted or
listed) is less than $0.20, on March 20, 2008. In no event shall the Company
issue more than 30,000 additional shares to the service providers. As a result,
the Company recorded a liability in the amount of $20.
On April
12, 2007, the Company issued to its legal advisor 108,511 shares of Common
Stock. The shares are for $29 payable to the legal advisor. Related compensation
in the amount of $40 was recorded as general and administrative
expense.
On May
18, 2007, the Company issued to its legal advisor 99,257 shares of Common Stock.
The shares are for $33, payable to the legal advisor. Related compensation in
the amount of $33 was recorded as general and administrative
expense.
On
October 29, 2007, the Company issued to a scientific advisory board member
80,000 shares of the Company’s Common Stock for scientific services.
Compensation of $67 was recorded as research and development
expense.
On May
20, 2008, the Company issued to its finance advisor 90,000 shares of the
Company's common stock. The shares are for $35 payable to the finance advisor
for introduction fee of past convertible loans. Related compensation in the
amount of $36 is recorded as finance expenses.
On April
5, 2009, the Company issued to its Chief Technology Advisor 1,800,000
shares of Common Stock. The shares are for $180 payable to the advisor. Related
compensation in the amount of $144 was recorded as research and development
expense.
On June
24, 2009, the Company issued to its public relation advisor 250,000 shares of
Common Stock. The shares are for $25 payable to the advisor. Related
compensation in the amount of $18 was recorded as general and administrative
expense.
On July
8, 2009, the Company issued to its finance consultant 285,714 shares of the
Company's Common Stock. The shares are for $20 payable to the finance consultant
for valuation of options and warrants. Related compensation in the amount of $20
is recorded as general and administrative expense.
On July
15, 2009, the Company issued to its service provider 357,142 shares of the
Company's common stock. The shares are for $25 payable to the service provider
for filing services. Related compensation in the amount of $21 is recorded as
general and administrative expense.
59
BRAINSTORM
CELL THERAPEUTICS INC. AND SUBSIDIARY
(A
development stage company)
Notes
to the financial statements
U.S.
dollars in thousands (except
share data)
NOTE
11
|
-
|
STOCK
CAPITAL (Cont.)
|
B.
|
Issuance
of shares, warrants and options:
(Cont.)
|
3.
|
Shares
and warrants to service providers:
(Cont.)
|
b)
|
Shares:
(Cont.)
|
On August
10, 2009, the Company issued to its service provider 71,428 shares of the
Company's Common Stock. The shares are for $5 payable to the service provider
for IT services. Related compensation in the amount of $4 is recorded as general
and administrative expense.
On
October 1, 2009, the Company issued to its service provider 150,000 shares of
the Company's Common Stock. The shares are for financial and investor relation
services done by the provider. Related compensation in the amount of $51 is
recorded as general and administrative expense.
On
October 2, 2009, the Company issued to its service provider 1,250,000 shares of
the Company's Common Stock. The shares are for investor and public relation
services. Related compensation in the amount of $400 is recorded as general and
administrative expense.
On
December 30, 2009, the Company issued to Ramot 1,120,000 shares of the Company's
Common Stock (see note 3).
A summary
of the Company's stock awards activity related to shares issued to service
providers and related information is as follows:
Year ended December
31,
|
Year ended December
31,
|
|||||||||||||||
2009
|
2008
|
|||||||||||||||
Amount of
shares
|
Weighted
average
issue price
|
Amount of
shares
|
Weighted
average
issue price
|
|||||||||||||
|
$
|
$
|
||||||||||||||
Outstanding
at beginning of period
|
2,941,224 | 0.85 | 2,851,224 | 0.86 | ||||||||||||
Issued
|
5,284,284 | 0.18 | 90,000 | 0.40 | ||||||||||||
Outstanding
at end of period
|
8,225,508 | 0.26 | 2,941,224 | 0.85 |
c)
|
Stock-based
compensation recorded by the Company in respect of shares and warrants
granted to service providers amounted to $776 and $13 for the year ended
December 31, 2009 and 2008,
respectively.
|
The total
stock-based compensation expense, related to shares, options and warrants
granted to employees and service providers, was comprised, at each period, as
follows:
Year ended
December 31,
|
Period from
September 22,
2000 (inception
date) through
December 31,
|
|||||||||||
2009
|
2008
|
2009
|
||||||||||
Research
and development
|
289 | 219 | 16,914 | |||||||||
General
and administrative
|
895 | 509 | 8,483 | |||||||||
Financial
expenses, net
|
- | 36 | 56 | |||||||||
Total
stock-based compensation expense
|
1,184 | 764 | 25,453 |
60
BRAINSTORM
CELL THERAPEUTICS INC. AND SUBSIDIARY
(A
development stage company)
Notes
to the financial statements
U.S.
dollars in thousands (except
share data)
NOTE
12
|
-
|
RESEARCH
AND DEVELOPMENT ,NET
|
December 31,
|
Period from
September 22,
2000 (inception
date) through
December 31,
|
|||||||||||
2009
|
2008
|
2009
|
||||||||||
Research
and development
|
1,069 | 2,097 | 23,371 | |||||||||
Less
: Ramot reverse accruals ( See Note 3)
|
(760 | ) | - | (760 | ) | |||||||
Less
: Participation by the Israeli Office of the Chief
Scientist
|
(128 | ) | (458 | ) | (926 | ) | ||||||
181 | 1,639 | 21,685 |
NOTE
13
|
-
|
TAXES
ON INCOME
|
A.
|
Tax
rates applicable to the income of the
subsidiary:
|
In June
2004, an amendment to the Income Tax Ordinance (No. 140 and Temporary
Provision), 2004 was passed by the "Knesset" (Israeli parliament) and on July
25, 2005, another law was passed, the amendment to the Income Tax Ordinance (No.
147) 2005, according to which the corporate tax rate is to be progressively
reduced to the following tax rates: 2004 - 35%, 2005 - 34%, 2006 - 31%, 2007 -
29%, 2008 - 27%, 2009 - 26%, 2010 and thereafter - 25%.
B.
|
Tax
laws applicable to the income of the
Subsidiary:
|
The Law for the
Encouragement of Capital Investments, 1959 ("the Law"):
According
to the Law, BCT is entitled to various tax benefits by virtue of "beneficiary
enterprise" status granted, as defined by this Law.
In March
2005, the Israeli Parliament passed the Arrangements Law for fiscal year 2005,
which includes a broad and comprehensive amendment to the provisions of the
above Law ("Amendment No. 60 to the Law").
The
principal benefits by virtue of the Law are:
Tax
benefits and reduced tax rates under the Alternative Track of
Benefits:
The
Company is tax exempt for a benefit period of two years and in the five/eight
subsequent years of the benefit period is subject to a reduced tax rate of
10%-25%.
C.
|
Changes
in the tax laws applicable to the income of the
Subsidiary:
|
In
February 2008, the "Knesset" (Israeli parliament) passed an amendment to the
Income Tax (Inflationary Adjustments) Law, 1985, which limits the scope of the
law beginning in 2008 and thereafter. Beginning in 2008, the results for tax
purposes will be measured in nominal values, excluding certain adjustments for
changes in the Consumer Price Index carried out in the period up to December 31,
2007. The amended law includes, inter alia, the elimination of the inflationary
additions and deductions and the additional deduction for depreciation starting
in 2008.
61
BRAINSTORM
CELL THERAPEUTICS INC. AND SUBSIDIARY
(A
development stage company)
Notes
to the financial statements
U.S.
dollars in thousands (except
share data)
NOTE
13
|
-
|
TAXES
ON INCOME (Cont.)
|
D.
|
Deferred
income taxes:
|
Deferred
income taxes reflect the net tax effects of temporary differences between the
carrying amounts of assets and liabilities for financial reporting purposes and
the amounts used for income tax purposes. Significant components of the
Company's deferred tax assets are as follows:
December 31,
|
||||||||
2009
|
2008
|
|||||||
Operating
loss carryforward
|
30,206 | 29,316 | ||||||
Net
deferred tax asset before valuation allowance
|
12,858 | 13,192 | ||||||
Valuation
allowance
|
(12,858 | ) | (13,192 | ) | ||||
Net
deferred tax asset
|
- | - |
As of
December 31, 2009, the Company has provided valuation allowances of $12,858 in
respect of deferred tax assets resulting from tax loss carryforward and other
temporary differences. Management currently believes that because the Company
has a history of losses, it is more likely than not that the deferred tax
regarding the loss carryforward and other temporary differences will not be
realized in the foreseeable future.
E.
|
Available
carryforward tax losses:
|
As of
December 31, 2009, the Company has an accumulated tax loss carryforward of
approximately $11,426. Carryforward tax losses in the U.S. can be carried
forward and offset against taxable income in the future for a period of 20
years. Utilization of U.S. net operating losses may be subject to substantial
annual limitations due to the "change in ownership" provisions of the Internal
Revenue Code of 1986 and similar state provisions. The annual limitation may
result in the expiration of net operating losses before
utilization.
F.
|
Loss
from continuing operations, before taxes on income, consists of the
following:
|
Year ended December 31,
|
||||||||
2009
|
2008
|
|||||||
United
States
|
(890 | ) | (1,776 | ) | ||||
Israel
|
(891 | ) | (1,696 | ) | ||||
(1,781 | ) | (3,472 | ) |
G.
|
Due
to the company cumulative losses the effect of ASC 740 as codified from
ASC 740-10 (formerly FIN 48) are
not material
|
H.
|
BCT
has not received final tax assessments since its
incorporation.
|
62
BRAINSTORM
CELL THERAPEUTICS INC. AND SUBSIDIARY
(A
development stage company)
Notes
to the financial statements
U.S.
dollars in thousands (except
share data)
NOTE
14
|
-
|
TRANSACTIONS
WITH RELATED PARTIES
|
Year ended December 31,
|
|||||||||
2009
|
2008
|
||||||||
A.
|
Fees
and related benefits and compensation expenses in respect of options
granted to a member of the Board who is a related party
|
27 | 23 | ||||||
B.
|
Salary
to the Company president which controls the company's main
shareholder
|
- | 59 |
C.
|
As
for transactions with Ramot, see Note
3.
|
NOTE
15
|
-
|
SUBSEQUENT
EVENTS
|
|
A.
|
On
January 25, 2010, the Company issued 1,250,000 units for total proceeds of
$250 from private investor. Each unit consists of one share of Common
Stock and a two-year warrant to purchase one share of Common Stock at
$0.50 per share.
|
|
B.
|
On
January 27, 2010, a third party converted the entire accrued
principle and interest of $150 Convertible Promissory Note
granted on March 5, 2007 ( See Note 9b) into 1,016,109
shares of Common Stock
|
|
C.
|
On
February 17, 2010 the Company entered into a private investment agreement
with three investors. The Company agreed to issue to the investors an
aggregate of 6,000,000 shares of Common Stock ( 2,000,000 for each
investor) and two years warrants to purchase an aggregate of 3,000,000
shares of Common Stock with an exercise price of $0.5 for an aggregate
amount of $1,500.
|
|
D.
|
On
January 6, 2010, the Company issued to its service provider 60,000 shares
of the Company's common stock. The shares are for $15 payable to the
service provider for insurance and risk management consulting and agency
services for three years.
|
|
E.
|
On
January 5 2010 the Company issued to its public relation
advisors 50,000 shares of the Company's common stock for six months
service. The issuance of the shares is part of the agreement with the
public relation advisors that entitle to get a monthly grant
of 8,333 shares of the Company's common stock
.
|
|
F.
|
On
February 17,2010 BCT entered into agreement with Hadasit Medical Research
Services and Development Ltd ("Hadasit") to conduct clinical trials in ALS
patients. In connection with the trials BCT will pay Hadasit $38,190 per
patient totaling up to $992,880 as well as $31,250 per month for rental
and operation of clean room for a period of 11 months (including one free
month rent)
|
In
addition, the Company will issue to Hadasit warrants to purchase up to 1,500,000
restricted shares of Company's Common Stock 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 trials 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.
|
G.
|
On
February 19, 2010, the Company's legal advisor converted the entire
accrued principal and interest of $135 Convertible Promissory
Note granted on December 13, 2009 ( See Note 8) into 402,385
shares of Common Stock.
|
63
Item 9.
|
CHANGES IN AND DISAGREEMENTS WITH
ACCOUNTANTS ON ACCOUNTING AND FINANCIAL
DISCLOSURE
|
None.
CONTROLS
AND PROCEDURES.
|
Evaluation of Disclosure Controls
and Procedures
As of the
end of the period covered by this annual report, we carried out an evaluation,
under the supervision and with the participation of our Chief Executive Officer
and Chief Financial Officer, of the effectiveness of our disclosure controls and
procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Securities
Exchange Act of 1934, as amended (the “Exchange Act”)). Based on this
evaluation, our Chief Executive Officer and Chief Financial Officer concluded
that, as a result of the material weakness in our internal control over
financial reporting described below, our disclosure controls and procedures were
not effective, as of the end of the period covered by this report, to ensure
that information required to be disclosed by us in the reports we file under the
Exchange Act is recorded, processed, summarized and reported within the time
periods specified in the Securities and Exchange Commission's rules and forms,
and that the information required to be disclosed by us in such reports is
accumulated and communicated to our management, including our Chief Executive
Officer and Chief Financial Officer, as appropriate to allow timely decisions
regarding required disclosure.
64
Management's
Report on Internal Control Over Financial Reporting
Our
management is responsible for establishing and maintaining adequate internal
control over financial reporting, as such term is defined in Exchange Act
Rule 13a-15(f). Under the supervision and with the participation of our
management, including our Chief Executive Officer and Chief Financial Officer,
we conducted an evaluation of the effectiveness of our internal control over
financial reporting as of December 31, 2009 based on the criteria set forth
in Internal Control—Integrated
Framework issued by the Committee of Sponsoring Organizations of the
Treadway Commission. Based on the evaluation, our management
concluded that, as of December 31, 2009, our internal control over financial
reporting was not effective.
A
material weakness is a control deficiency, or combination of control
deficiencies in internal control over financial reporting, that results in more
than a remote likelihood that a material misstatement of the Company’s annual or
interim financial statements will not be prevented or detected. Management
identified the following material weakness in its assessment of the
effectiveness of internal control over financial reporting as of December 31,
2009:
|
·
|
The Company did not maintain
effective controls over certain aspects of the financial reporting process
because we lacked a sufficient complement of personnel with a level of
accounting expertise and an adequate supervisory review structure that is
commensurate with the Company’s financial reporting requirements.
Specifically, our Chief Financial Officer handles all the accounting
issues of the Company alone as we terminated the Company’s accountant as
part of the downsizing of the Company’s employee
base.
|
|
·
|
Due
to the decrease in the Company’s activities and limited cash resources,
the Company manually inputs all purchase and order activities and
confirmation process instead of via an ERP
system.
|
Nevertheless,
based on a number of factors, including the performance of additional procedures
performed by management designed to ensure the reliability of our financial
reporting, our Chief Executive Officer and Chief Financial Officer believe that
the consolidated financial statements included with this annual report fairly
present, in all material respects, our financial position, results of
operations, and cash flows as of the dates, and for the periods, presented, in
conformity with U.S. GAAP.
This
annual report does not include an attestation report of our independent
registered public accounting firm regarding internal control over financial
reporting. Management’s report was not subject to attestation by the Company’s
registered public accounting firm pursuant to temporary rules of the Securities
and Exchange Commission that permit the Company to provide only management’s
report in this annual report.
Management’s
Remediation Initiatives
Based on
our financial condition and if we are able to raise sufficient funds, we plan to
recruit new staff and develop policies and procedures for training of personnel
or external advisers to verify that we have a sufficient number of personnel
with knowledge, experience and training in the application of generally accepted
accounting principles commensurate with our financial reporting and U.S. GAAP
requirements. Where necessary, we will supplement personnel with qualified
external advisors. Additionally, where appropriate and if we have the resources,
we plan to identify training on accounting principles and procedures that would
benefit our accounting and finance personnel.
65
Internal
Control Enhancements Implemented During the Fiscal Year Ended December 31,
2009
During
the fiscal year ended December 31, 2009, we were unable to implement any
enhancements to our internal control over financial reporting due to
insufficient funds.
Inherent
Limitations on Internal Control
A
control system, no matter how well conceived and operated, can provide only
reasonable, not absolute, assurance that the objectives of the control system
are met. Further, the benefits of controls must be considered relative to their
costs. Because of the inherent limitations in all control systems, no evaluation
of controls can provide absolute assurance that all control issues and instances
of fraud, if any, have been detected. These inherent limitations include the
realities that judgments in decision making can be faulty, and that breakdowns
can occur because of simple errors. Additionally, controls can be circumvented
by the individual acts of some persons, by collusion of two or more people, or
by management override of the control. The design of any system of controls is
also based in part upon certain assumptions about the likelihood of future
events, and there can be no assurance that any design will succeed in achieving
its stated goals under all potential future conditions. Because of the inherent
limitations in a cost-effective control system, misstatements due to error or
fraud may occur and not be detected.
Changes in Internal
Control Over
Financial Reporting
Other
than as described above, there were no changes in our internal control over
financial reporting that occurred during the last fiscal quarter that have
materially affected, or are reasonably likely to materially affect, our internal
control over financial reporting.
On March
21, 2010, David Stolick, Chief Financial Officer of the Company, tendered his
resignation to the Company in order to pursue other
opportunities. Mr. Stolick and the Company agreed that Mr. Stolick’s
resignation will be effective as of April 6, 2010. The Company is
currently searching for a successor to Mr. Stolick.
PART
III
Except as
set forth below, for information required by Item 10 see the Definitive Proxy
Statement which will be filed with the Securities and Exchange Commission and is
incorporated herein by reference.
Code
of Ethics
On May
27, 2005, our Board of Directors adopted a Code of Business Conduct and Ethics
that applies to, among other persons, members of our Board of Directors,
officers, employees, contractors, consultants and advisors. A copy of the
Company’s Code of Business Conduct and Ethics is posted on the Company’s website
at www.brainstorm-cell.com. We
intend to satisfy the disclosure requirement regarding any amendment to, or
waiver of, a provision of the Code of Business Conduct and Ethics applicable to
the Company’s principal executive officer or its senior financial officers
(principal financial officer and controller or principal accounting officer, or
persons performing similar functions) by posting such information on our
website.
For
information required by Item 11 see the Definitive Proxy Statement which will be
filed with the Securities and Exchange Commission and is incorporated herein by
reference.
66
Except as
set forth below, for information required by Item 12 see the Definitive Proxy
Statement which will be filed with the Securities and Exchange Commission and is
incorporated herein by reference.
Equity
Compensation Plan Information
The
following table summarizes certain information regarding our equity compensation
plans as of December 31, 2009:
Plan Category
|
Number of
securities to be
issued upon
exercise of
outstanding
options,
warrants and
rights
|
Weighted-
average exercise
price of
outstanding
options,
warrants and
rights
|
Number of
securities
remaining
available for
future issuance
under equity
compensation
plans
|
|||||||||
Equity
compensation plans approved by security holders
|
9,776,778 | (1) | $ | 0.244 | 3,766,684 | (2) | ||||||
Equity
compensation plans not approved by security holders
|
0 | 0 | 0 | |||||||||
Total
|
5,151,684 | (1) | 3,766,684 | (2) |
(1)
|
Does not include 600,000 shares
of restricted stock that the Company has issued pursuant to the 2005 U.S.
Stock Option and Incentive Plan to scientific advisory board members,
directors, service providers, and
consultants.
|
(2)
|
A total of 14,143,462 shares of
our common stock was reserved for issuance in aggregate under the 2004
Global Share Option Plan and the 2005 U.S. Stock Option and Incentive Plan
and the amendment in June 2008. Any awards granted under the 2004 Global
Share Option Plan or the 2005 U.S. Stock Option and Incentive Plan will
reduce the total number of shares available for future issuance under the
other plan.
|
CERTAIN RELATIONSHIPS AND RELATED
TRANSACTIONS, AND DIRECTOR
INDEPENDENCE.
|
For
information required by Item 13 see the Definitive Proxy Statement which will be
filed with the Securities and Exchange Commission and is incorporated herein by
reference.
Item 14.
|
PRINCIPAL ACCOUNTING FEES AND
SERVICES
|
For
information required by Item 14 see the Definitive Proxy Statement which will be
filed with the Securities and Exchange Commission and is incorporated herein by
reference.
67
PART
IV
EXHIBITS, FINANCIAL STATEMENT
SCHEDULES
|
Financial
Statements.
The
financial statements listed in the Index to Consolidated Financial Statements
are filed as part of this report.
Financial
Statement Schedules.
All
financial statement schedules have been omitted as they are either not required,
not applicable, or the information is otherwise included.
Exhibits.
The
exhibits listed in the Exhibit Index are filed with or incorporated by reference
in this report.
68
SIGNATURES
In
accordance with Section 13 or 15(d) of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf by the
undersigned, thereunto duly authorized.
BRAINSTORM
CELL THERAPEUTICS INC.
|
||
Date:
March 25, 2010
|
By:
|
/s/ Rami Efrati
|
Name:
Rami Efrati
|
||
Title: Chief
Executive Officer and
director
|
In
accordance with the Securities Exchange Act of 1934, this report has been signed
below by the following persons on behalf of the registrant and in the capacities
and on the dates indicated.
Signature
|
Title
|
Date
|
||
/s/ Rami
Efrati
|
Chief
Executive Officer and director
|
March
25, 2010
|
||
Rami
Efrati
|
(Principal
Executive Officer)
|
|||
/s/ David
Stolick
|
Chief
Financial Officer
|
March
25, 2010
|
||
David
Stolick
|
(Principal
Financial and Accounting Officer)
|
|||
/s/ Irit Arbel
|
Director |
March
25, 2010
|
||
Irit
Arbel
|
|
|||
|
Director
|
March
__, 2010
|
||
Jonathan
C. Javitt
|
||||
/s/ Moshe Lion
|
Director
|
March
25, 2010
|
||
Moshe
Lion
|
||||
/s/ Robert Shorr
|
Director
|
March
24, 2010
|
||
Robert
Shorr
|
||||
/s/ Malcolm
Taub
|
Director
|
March
24, 2010
|
||
Malcolm
Taub
|
69
EXHIBIT
INDEX
Exhibit
No.
|
Description
|
|
2.1
|
Agreement
and Plan of Merger, dated as of November 28, 2006, by and between
Brainstorm Cell Therapeutics Inc., a Washington corporation, and
Brainstorm Cell Therapeutics Inc., a Delaware corporation, is incorporated
herein by reference to Appendix A of the Company’s Definitive Schedule 14A
dated November 20, 2006 (File No. 333-61610).
|
|
3.1
|
Certificate
of Incorporation of Brainstorm Cell Therapeutics Inc., a Delaware
corporation, is incorporated herein by reference to Appendix B of the
Company’s Definitive Schedule 14A dated November 20, 2006 (File No.
333-61610).
|
|
3.2
|
ByLaws
of Brainstorm Cell Therapeutics Inc., a Delaware corporation, is
incorporated herein by reference to Appendix C of the Company’s Definitive
Schedule 14A dated November 20, 2006 (File No.
333-61610).
|
|
3.3
|
Amendment
No. 1 to ByLaws of Brainstorm Cell Therapeutics Inc., dated as of March
21, 2007, is incorporated herein by reference to Exhibit 3.1 of the
Company’s Current Report on Form 8-K dated March 27, 2007 (File No.
333-61610).
|
|
10.1
|
Restricted
Stock Purchase Agreement, dated as of April 28, 2003, by and between Irit
Arbel and Michael Frankenberger is incorporated herein by reference to
Exhibit 10.1 of the Company’s Current Report on Form 8- K dated May 21,
2004 (File No. 333-61610).
|
|
10.2
|
Letter
of Intent, dated as of April 30, 2004, by and between the Company and
Ramot at Tel Aviv University Ltd. is incorporated herein by reference to
Exhibit 10.2 of the Company’s Current Report on Form 8-K dated May 21,
2004 (File No. 333-61610).
|
|
10.3
|
Research
and License Agreement, dated as of July 8, 2004, by and between the
Company and Ramot at Tel Aviv University Ltd. is incorporated herein by
reference to Exhibit 10.1 of the Company’s Current Report on Form 8-K
dated July 8, 2004 (File No. 333-61610).
|
|
10.4
|
Research
and License Agreement, dated as of March 30, 2006, by and between the
Company and Ramot at Tel Aviv University Ltd. is incorporated herein by
reference to Exhibit 10.1 of the Company’s Current Report on Form 8-K
dated March 30, 2006 (File No. 333-61610).
|
|
10.5
|
Amendment
Agreement, dated as of May 23, 2006, to Research and License Agreement, by
and between the Company and Ramot at Tel Aviv University Ltd. is
incorporated herein by reference to Exhibit 10.1 of the Company’s Current
Report on Form 8-K/A dated March 30, 2006 (File No.
333-61610).
|
|
10.6
|
Form
of Common Stock Purchase Warrant, dated as of November 4, 2004, issued
pursuant to Research and License Agreement with Ramot at Tel Aviv
University Ltd. is incorporated herein by reference to Exhibit 4.07 of the
Company’s Current Report on Form 8-K/A dated November 4, 2004 (File No.
333-61610).
|
|
10.7
|
Amendment
Agreement, dated as of March 31, 2006, among the Company, Ramot at Tel
Aviv University Ltd. and certain warrantholders is incorporated herein by
reference to Exhibit 10.2 of the Company’s Current Report on Form 8-K
dated March 30, 2006 (File No.
333-61610).
|
70
10.8
|
Form
of Common Stock Purchase Warrant, dated as of November 4, 2004, issued as
a replacement warrant under the Amendment Agreement to Ramot at Tel Aviv
University Ltd., is incorporated herein by reference to Exhibit 10.4 of
the Company’s Current Report on Form 8-K dated March 30, 2006 (File No.
333-61610).
|
|
10.9
|
Second
Amended and Restated Research and License Agreement, dated July 31, 2007,
by and between the Company and Ramot at Tel Aviv University Ltd. is
incorporated herein by reference to Exhibit 10.4 of the Company’s
Quarterly Report on Form 10-QSB dated June 30, 2007 (File No.
333-61610).
|
|
10.10
|
Second
Amended and Restated Registration Rights Agreement, dated August 1, 2007,
by and between the Company and Ramot at Tel Aviv University Ltd. is
incorporated herein by reference to Exhibit 10.5 of the Company’s
Quarterly Report on Form 10-QSB dated June 30, 2007 (File No.
333-61610).
|
|
10.11
|
Waiver
and Release, dated August 1, 2007, executed by Ramot at Tel Aviv
University Ltd. in favor of the Company is incorporated herein by
reference to Exhibit 10.6 of the Company’s Quarterly Report on Form 10-QSB
dated June 30, 2007 (File No. 333-61610).
|
|
10.12
|
Letter
Agreement, dated December 24, 2009, by and between the Company and Ramot
at Tel Aviv University Ltd. is incorporated herein by reference to Exhibit
10.1 of the Company’s Current Report on Form 8-K filed December 31, 2009
(File No. 333-61610).
|
|
10.13
|
Amendment
No. 1 to Second Amended and Restated Research and License Agreement, by
and between the Company and Ramot at Tel Aviv University Ltd. is
incorporated herein by reference to Exhibit 10.2 of the Company’s Current
Report on Form 8-K filed Decembed 31, 2009 (File No.
333-61610).
|
|
10.14
|
Amended
and Restated Registration Rights Agreement, dated as of March 31, 2006, by
and between the Company and certain warrant holders is incorporated herein
by reference to Exhibit 10.3 of the Company’s Current Report on Form 8-K
dated March 30, 2006 (File No. 333-61610).
|
|
10.15
|
Consulting
Agreement, dated as of July 8, 2004, by and between the Company and Prof.
Eldad Melamed is incorporated herein by reference to Exhibit 10.2 of the
Company’s Current Report on Form 8-K dated July 8, 2004 (File No.
333-61610).
|
|
10.16
|
Consulting
Agreement, dated as of July 8, 2004, by and between the Company and Dr.
Daniel Offen is incorporated herein by reference to Exhibit 10.3 of the
Company’s Current Report on Form 8-K dated July 8, 2004 (File No.
333-61610).
|
|
10.17
|
Form
of Warrant to purchase common stock dated as of November 4, 2004 issued
pursuant to consulting agreements with Prof. Eldad Melamed and Dr. Daniel
Offen is incorporated herein by reference to Exhibit 4.08 of the Company’s
Current Report on Form 8-K/A dated November 4, 2004 (File No.
333-61610).
|
|
10.18
|
Common
Stock Purchase Agreement, dated as of October 22, 2004, by and between the
Company and certain buyers is incorporated herein by reference to Exhibit
10.03 of the Company’s Current Report on Form 8-K dated October 22, 2004
(File No. 333-61610).
|
|
10.19
|
Subscription
Agreement, dated as of October 22, 2004, by and between the Company and
certain buyers is incorporated herein by reference to Exhibit 10.04 of the
Company’s Current Report on Form 8-K dated October 22, 2004 (File No.
333-61610).
|
71
10.20
|
Form
of Class A Common Stock Purchase Warrant to purchase common stock for
$1.50 per share, dated as of October 2004, issued to certain buyers
pursuant to Common Stock Purchase Agreement with certain buyers is
incorporated herein by reference to Exhibit 4.03 of the Company’s Current
Report on Form 8-K dated October 22, 2004 (File No.
333-61610).
|
|
10.21
|
Form
of Class B Common Stock Purchase Warrant to purchase common stock for
$2.50 per share, dated as of October 2004, issued to certain buyers
pursuant to Common Stock Purchase Agreement with certain buyers is
incorporated herein by reference to Exhibit 4.04 of the Company’s Current
Report on Form 8-K dated October 22, 2004 (File No.
333-61610).
|
|
10.22*
|
Employment
Agreement, dated as of November 8, 2004, by and between the Company and
Dr. Yaffa Beck is incorporated herein by reference to Exhibit 10.5 of the
Company’s Current Report on Form 8-K dated November 4, 2004 (File No.
333-61610).
|
|
10.23*
|
Termination
Agreement and General Release, dated as of March 20, 2006, by and between
the Company and Dr. Yaffa Beck is incorporated herein by reference to
Exhibit 10.1 of the Company’s Current Report on Form 8-K dated March 20,
2006 (File No. 333-61610).
|
|
10.24*
|
Employment
Agreement, dated as of November 16, 2004, by and between the Company and
Yoram Drucker is incorporated herein by reference to Exhibit 10.6 of the
Company’s Current Report on Form 8-K dated November 16, 2004 (File No.
333-61610).
|
|
10.25*
|
Termination
Agreement, dated December 17, 2007, between the Registrant, Brainstorm
Cell Therapeutics Ltd. and Yoram Drucker is incorporated herein by
reference to Exhibit 10.1 of the Company’s Current Report on Form 8-K
dated December 17, 2007 (File No. 333-61610).
|
|
10.26
|
Consulting
Agreement, dated as of December 23, 2004, by and between the Company and
Malcolm E. Taub is incorporated herein by reference to Exhibit 10.7 of the
Company’s Current Report on Form 8-K dated December 23, 2004 (File No.
333-61610).
|
|
10.27
|
Common
Stock Purchase Warrant, dated as of December 23, 2004, issued to Malcolm
E. Taub is incorporated herein by reference to Exhibit 4.5 of the
Company’s Current Report on Form 8-K dated December 23, 2004 (File No.
333-61610).
|
|
10.28
|
Consulting
Agreement, dated as of December 23, 2004, by and between the Company and
Ernest Muller is incorporated herein by reference to Exhibit 10.8 of the
Company’s Current Report on Form 8-K dated December 23, 2004 (File No.
333-61610).
|
|
10.29
|
Common
Stock Purchase Warrant, dated as of December 23, 2004, issued to Ernest
Muller is incorporated herein by reference to Exhibit 4.6 of the Company’s
Current Report on Form 8-K dated December 23, 2004 (File No.
333-61610).
|
|
10.30*
|
Employment
Agreement, dated as of January 16, 2005, by and between the Company and
David Stolick is incorporated herein by reference to Exhibit 10.9 of the
Company’s Current Report on Form 8-K dated January 16, 2005 (File No.
333-61610).
|
|
10.31*
|
Employment
Agreement, dated as of October 7, 2007, by and among Brainstorm Cell
Therapeutics Ltd., the Company and Abraham Efrati is incorporated herein
by reference to Exhibit 10.1 of the Company’s Current Report on Form 8-K/A
dated October 15, 2007 (File No.
333-61610).
|
72
10.32
|
Lease
Agreement, dated as of December 1, 2004, among the Company, Petah Tikvah
Science and Technology District ‘A’ Ltd., Petah Tikvah Science and
Technology District ‘B’ Ltd. and Atzma and Partners Maccabim Investments
Ltd. is incorporated herein by reference to Exhibit 10.10 of the Company’s
Quarterly Report on Form 10-QSB dated December 31, 2004 (File No.
333-61610).
|
|
10.33
|
Form
of Lock-up Agreement, dated as of March 21, 2005, by and between the
Company and certain shareholders of the Company is incorporated herein by
reference to Exhibit 10.10 of the Company’s Current Report on Form 8-K
dated March 21, 2005 (File No. 333-61610).
|
|
10.34
|
Form
of Lock-up Agreement, dated as of March 26, 2006, by and between the
Company and certain shareholders of the Company is incorporated herein by
reference to Exhibit 10.1 of the Company’s Current Report on Form 8-K
dated March 26, 2006 (File No. 333-61610).
|
|
10.35*
|
Amended
and Restated 2004 Global Share Option Plan is incorporated herein by
reference to Exhibit A of the Company’s Definitive Proxy Statement on
Schedule 14A filed April 29, 2008 (File No. 333-61610).
|
|
10.36*
|
Amended
and Restated 2005 U.S. Stock Option and Incentive Plan is incorporated
herein by reference to Exhibit B of the Company’s Definitive Proxy
Statement on Schedule 14A filed on April 29, 2008 (File No.
333-61610).
|
|
10.37*
|
Option
Agreement, dated as of December 31, 2004, by and between the Company and
Yaffa Beck is incorporated herein by reference to Exhibit 10.13 of the
Company’s Current Report on Form 8-K dated March 28, 2005 (File No.
333-61610).
|
|
10.38*
|
Option
Agreement, dated as of December 31, 2004, by and between the Company and
Yoram Drucker is incorporated herein by reference to Exhibit 10.14 of the
Company’s Current Report on Form 8-K dated March 28, 2005 (File No.
333-61610).
|
|
10.39*
|
Option
Agreement, dated as of December 31, 2004, by and between the Company and
David Stolick is incorporated herein by reference to Exhibit 10.15 of the
Company’s Current Report on Form 8-K dated March 28, 2005 (File No.
333-61610).
|
|
10.40*
|
Amendment
to Option Agreement, dated as of February 6, 2006, by and between the
Company and David Stolick is incorporated herein by reference to Exhibit
10.2 of the Company’s Current Report on Form 8-K dated February 6, 2006
(File No. 333-61610).
|
|
10.41
|
Common
Stock Purchase Warrant, dated as of May 16, 2005, issued to Trout Capital
LLC is incorporated herein by reference to Exhibit 10.19 of the Company’s
Quarterly Report on Form 10-QSB dated June 30, 2005 (File No.
333-61610).
|
|
10.42
|
Restricted
Stock Award Agreement under 2005 U.S. Stock Option and Incentive Plan
issued by the Company to Scientific Advisory Board Members in April, 2005
is incorporated herein by reference to Exhibit 10.18 of the Company’s
Quarterly Report on Form 10-QSB dated June 30, 2005 (File No.
333-61610).
|
|
10.43
|
Form
of Investor Questionnaire and Subscription Agreement, dated October 2005,
by and between the Company and certain investors is incorporated herein by
reference to Exhibit 10.20 of the Company’s Current Report on Form 8-K
dated September 30, 2005 (File No. 333-61610).
|
|
10.44
|
Form
of Common Stock Purchase Warrant to purchase common stock for $1.00 per
share, dated as of September 2005, issued to certain investors pursuant to
a private placement with certain investors is incorporated herein by
reference to Exhibit 4.09 of the Company’s Current Report on Form 8-K
dated September 30, 2005 (File No.
333-61610).
|
73
10.45
|
Form
of Investor Questionnaire and Subscription Agreement, dated December 2005,
by and between the Company and certain investors is incorporated herein by
reference to Exhibit 10.21 of the Company’s Current Report on Form 8-K
dated December 7, 2005 (File No. 333-61610).
|
|
10.46
|
Form
of Common Stock Purchase Warrant to purchase common stock for $1.00 per
share, dated as of December 2005, issued to certain investors pursuant to
a private placement with certain investors is incorporated herein by
reference to Exhibit 4.10 of the Company’s Current Report on Form 8-K
dated December 7, 2005 (File No. 333-61610).
|
|
10.47
|
Convertible
Promissory Note, dated as of February 7, 2006, issued by the Company to
Vivian Shaltiel is incorporated herein by reference to Exhibit 10.1 of the
Company’s Current Report on Form 8-K dated February 6, 2006 (File No.
333-61610).
|
|
10.48
|
Convertible
Promissory Note, dated as of June 5, 2006, issued by the Company to Vivian
Shaltiel is incorporated herein by reference to Exhibit 10.1 of the
Company’s Current Report on Form 8-K dated June 5, 2006 (File No.
333-61610).
|
|
10.49
|
Amendment
to Convertible Promissory Notes, dated as of June 13, 2006, by and between
the Company and Vivian Shaltiel is incorporated herein by reference to
Exhibit 10.42 of the Company’s Annual Report on Form 10-KSB dated June 29,
2006 (File No. 333-61610).
|
|
10.50
|
Convertible
Promissory Note, dated as of September 14, 2006, issued by the Company to
Vivian Shaltiel is incorporated herein by reference to Exhibit 10.1 of the
Company’s Current Report on Form 8-K dated September 18, 2006 (File No.
333-61610).
|
|
10.51
|
Agreement,
dated September 10, 2007, by and between the Company and Vivian Shaltiel
is incorporated herein by reference to Exhibit 10.1 of the Company’s
Current Report on Form 8-K filed on September 14, 2007 (File No.
333-61610).
|
|
10.52
|
Agreement,
dated April 13, 2008, by and between the Company and Vivian Shaltiel is
incorporated herein by reference to Exhibit 10.50 of the Company’s Annual
Report on Form 10-KSB filed on April 14, 2008 (File No.
333-61610).
|
|
10.53
|
Common
Stock Purchase Warrant, dated as of October 3, 2006, issued by the Company
to Double U Master Fund L.P. is incorporated herein by reference to
Exhibit 10.2 of the Company’s Quarterly Report on Form 10-QSB dated
November 14, 2006 (File No. 333-61610).
|
|
10.54
|
Convertible
Promissory Note, dated as of December 13, 2006, issued by the Company to
Eli Weinstein is incorporated herein by reference to Exhibit 10.1 of the
Company’s Current Report on Form 8-K dated December 19, 2006 (File No.
333-61610).
|
|
10.55
|
Common
Stock Purchase Warrant, dated as of December 13, 2006, issued by the
Company to Eli Weinstein is incorporated herein by reference to Exhibit
10.2 of the Company’s Current Report on Form 8-K dated December 19, 2006
(File No. 333-61610).
|
|
10.56
|
Collaboration
Agreement, dated as of December 26, 2006, by and between the Company and
Fundacion para la Investigacion Medica Aplicada is incorporated herein by
reference to Exhibit 10.1 of the Company’s Current Report on Form 8-K
dated January 23, 2007. (File No. 333-61610).
|
|
10.57
|
Convertible
Promissory Note, dated as of March 5, 2007, issued by the Company to Eli
Weinstein is incorporated herein by reference to Exhibit 10.1 of the
Company’s Current Report on Form 8-K dated March 12, 2007 (File No.
333-61610).
|
74
10.58
|
Common
Stock Purchase Warrant, dated as of March 5, 2007, issued by the Company
to Eli Weinstein is incorporated herein by reference to Exhibit 10.2 of
the Company’s Current Report on Form 8-K dated March 12, 2007 (File No.
333-61610).
|
|
10.59
|
8%
Convertible Promissory Note, dated May 6, 2007, issued by the Company to
ACCBT Corp. is incorporated herein by reference to Exhibit 10.1 of the
Company’s Current Report on Form 8-K dated May 10, 2007 (File No.
333-61610).
|
|
10.60
|
Common
Stock Purchase Warrant, dated May 6, 2007, issued by the Company to ACCBT
Corp. is incorporated herein by reference to Exhibit 10.2 of the Company’s
Current Report on Form 8-K dated May 10, 2007 (File No.
333-61610).
|
|
10.61
|
Subscription
Agreement, dated July 2, 2007, by and between the Company and ACCBT Corp.
is incorporated herein by reference to Exhibit 10.1 of the Company’s
Current Report on Form 8-K filed on July 5, 2007 (File No.
333-61610).
|
|
10.62
|
Amendment
to Subscription Agreement, dated as of July 31, 2009, by and between the
Company and ACCBT Corp. is incorporated herein by reference to Exhibit
10.1 of the Company’s Current Report on Form 8-K filed on August 24, 2009
(File No. 333-61610).
|
|
10.63
|
Form
of Common Stock Purchase Warrant issued by the Company to ACCBT Corp. is
incorporated herein by reference to Exhibit 10.2 of the Company’s Current
Report on Form 8-K filed on July 5, 2007 (File No.
333-61610).
|
|
10.64
|
Form
of Registration Rights Agreement by and between the Company and ACCBT
Corp. is incorporated herein by reference to Exhibit 10.3 of the Company’s
Current Report on Form 8-K filed on July 5, 2007 (File No.
333-61610).
|
|
10.65
|
Form
of Security Holders Agreement, by and between ACCBT Corp. and certain
security holders of the Registrant is incorporated herein by reference to
Exhibit 10.4 of the Company’s Current Report on Form 8-K filed on July 5,
2007 (File No. 333-61610).
|
|
10.66
|
Finder’s
Fee Agreement, dated as of October 29, 2007, by and between the Company
and Tayside Trading Ltd. is incorporated herein by reference to Exhibit
10.63 of the Company’s Annual Report on Form 10-KSB filed on April 14,
2008 (File No. 333-61610).
|
|
10.67
|
Subscription
Agreement, dated January 24, 2010, by and between the Company and Reytalon
Ltd. is incorporated herein by reference to Exhibit 10.1 of the Company’s
Current Report on Form 8-K filed on February 1, 2010 (File No.
333-61610).
|
|
10.68
|
Common
Stock Purchase Warrant, dated January 24, 2010, issued by the Company to
Reytalon Ltd. is incorporated herein by reference to Exhibit 10.2 of the
Company’s Current Report on Form 8-K filed on February 1, 2010 (File No.
333-61610).
|
|
10.69
|
Securities
Purchase Agreement, dated as of February 17, 2010, by and between the
Company and Abraham Suisse.
|
|
10.70
|
Securities
Purchase Agreement, dated as of February 17, 2010, by and between the
Company and Yaakov Ben Zaken.
|
|
10.71
|
Securities
Purchase Agreement, dated as of February 17, 2010, by and between the
Company and Abram
Nanikashvili.
|
75
16.1
|
Letter
from Kost Forer Gabbay & Kasierer to the Securities and Exchange
Commission dated April 30, 2008 regarding change in certifying accountant
of the Registrant is incorporated herein by reference to Exhibit 16.1 of
the Company’s Current Report on Form 8-K filed on April 30, 2008 (File No.
333-61610).
|
|
21
|
Subsidiaries
of the Company is incorporated herein by reference to Exhibit 21 of the
Company’s Transition Report on Form 10-KSB filed on March 30, 2007 (File
No. 333-61610).
|
|
23
|
Consent
of Brightman Almagor & Co., a member of Deloitte Touche
Tohmatsu.
|
|
31.1
|
Certification
by the Principal Executive Officer pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002.
|
|
31.2
|
Certification
by the Principal Financial Officer pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002.
|
|
32.1
|
Certification
of Principal Executive Officer pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002.
|
|
32.2
|
Certification
of Principal Financial Officer pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002.
|
|
*
|
Management contract or
compensatory plan or arrangement filed in response to Item 15(a)(3) of
Form 10-K.
|
76