BRAINSTORM CELL THERAPEUTICS INC. - Annual Report: 2008 (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, 2008
o 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
|
|
(State
or other jurisdiction of
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(I.R.S.
Employer
|
|
incorporation
or organization)
|
Identification
No.)
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110
East 59th
Street
|
||
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
|
Name
of each exchange on which registered
|
|
Common
Stock, $0.00005 par value
|
Over-the-Counter
Bulletin Board
|
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 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
¨
|
Accelerated
filer
¨
|
Non-accelerated
filer ¨
|
Smaller
reporting company x
|
(Do
not check if a
smaller
reporting
company)
|
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, 2008 (the last business
day of the registrant’s most recently completed second fiscal quarter), was
$8,669,955.
As of
April 1, 2009, the number of shares outstanding of the registrant's common
stock, $0.00005 par value per share, was 55,241,418.
DOCUMENTS
INCORPORATED BY REFERENCE
None.
BRAINSTORM
CELL THERAPEUTICS, INC.
ANNUAL
REPORT ON FORM 10-K
YEAR
ENDED DECEMBER 31, 2008
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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16
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1B.
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Unresolved
Staff Comments
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21
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2.
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Properties
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21
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3.
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Legal
Proceedings
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22
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4.
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Submission
of Matters to a Vote of Security Holders
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22
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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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22
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6.
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Selected
Financial Data
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23
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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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23
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7A.
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Quantitative
and Qualitative Disclosures About Market Risk
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26
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8.
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Financial
Statements and Supplementary Data
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27
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9.
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Changes
in and Disagreements with Accountants on Accounting and Financial
Disclosure
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77
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9A.
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Controls
and Procedures
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77
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9B.
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Other
Information
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78
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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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79
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11.
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Executive
Compensation
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82
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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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86
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13.
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Certain
Relationships and Related Transactions, and Director
Independence
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90
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14.
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Principal
Accounting Fees and Services
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92
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PART
IV
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15.
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Exhibits,
Financial Statement Schedules
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93
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PART
I
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.
Item
1. Description of Business.
Company
Overview
Brainstorm
Cell Therapeutics Inc. (“Brainstorm” or the “Company”) is an emerging 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 NTF cells that may provide an effective treatment
for Amyotrophic Lateral Sclerosis (“ALS”), Parkinson’s Disease (“PD”) and spinal
cord injury.
Our core
technology, NurOwn™, was developed through collaboration between prominent
neurologist, Prof. Eldad Melamed, 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 Dr. Daniel Offen, of the
Felsenstein Medical Research Center of Tel Aviv University.
The
Company’s team is among the first to have successfully demonstrated release of
dopamine from differentiated bone marrow cells. Moreover, in research conducted
by this team, implantation of these differentiated cells into the brain of
animal models that had been induced to Parkinsonian behavior markedly improved
their symptoms.
Our aim
is to provide neural stem cell transplants that “restore” damaged dopaminergic
nerve cells and diseased tissue by augmentation with healthy neurotrophic factor
producing cells;
3
The team
is also among the first to demonstrate creation of glial-like cells from
differentiated bone marrow cells that produce and secrete neurotrophic factors
(NTF) including GDNF, BDNF, NGF and IGF-1. Transplantation of these cells into
rats model of PD, reduced the motor dysfunction by 50%, inhibited the induced
dopamine depletion and restored the dopaminergic cells’ terminals. Moreover,
in-vivo imaging revealed that the engrafted cells migrated toward the lesion,
indicating their survival and integration in the brain tissues. Therefore,
Brainstorm’s aim is to use this technology to maintain, preserve and restore the
damaged and remaining dopaminergic cells in the patient’s brain, protecting them
from further degeneration.
Further
studies indicated that the Brainstorm's NTF cells protect motor-neuron cells
against various toxins and stress that are relevant in the pathophysiology of
ALS. Therefore, the Company decided to focus on ALS and one of the first
applications that will be tested in clinical studies will be intra muscular
injection of the NTF cells in ALS patients.
Brainstorm
holds exclusive worldwide rights to commercialize the NurOwn™ technology,
through a licensing agreement with Ramot at Tel Aviv University Ltd. (“Ramot”),
the technology transfer company of the Tel Aviv University. The agreement also
provides for further research, funded by Brainstorm, to be performed by Prof.
Melamed, Dr. Offen and members of their research team at the Felsenstein Medical
Research Center. The results of this research are licensed to us under the terms
of the license agreement. We have access to the research results of an R&D
team comprised of approximately 10 experts in the technology field, including
molecular and cell biologists, pharmacologists and animal model
experts
Our
Approach
Our
research team led by Prof. Melamed and Dr. Offen has achieved expansion of human
bone marrow mesenchymal stem cells and their differentiation into both 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 spinal cord injury.
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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·
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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.
|
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
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.
5
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.
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.
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.
6
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.
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.
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.
7
Approximately
5,600 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:
·
|
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;
|
·
|
Baclofen or Diazepam - these
medications may be used to control muscle spasms, stiffness or tightening
(spasticity) that interfere with daily activities;
and
|
·
|
Trihexyphenidyl or Amitriptyline
- these medications may help patients who have excess saliva or
secretions, and emotional
changes.
|
Other
medications may be prescribed to help reduce such symptoms as fatigue, pain,
sleep disturbances, constipation, and excess saliva and phlegm.
Spinal
Cord Injury
Background
A Spinal
Cord Injury (“SCI”) is damage or trauma to the spinal cord that results in a
loss or impaired function causing reduced mobility or feeling. Common causes of
damage are trauma (car accident, gunshot, falls, sports injuries, etc.) or
disease (Transverse Myelitis, Polio, Spina Bifida, Friedreich's Ataxia, etc.).
The spinal cord does not have to be severed in order for a loss of functioning
to occur. In most people with SCI, the spinal cord is intact, but the cellular
damage to it results in loss of functioning.
Description
A spinal
cord injury usually begins with a sudden, traumatic blow to the spine that
fractures or dislocates vertebrae. The damage begins at the moment of injury
when displaced bone fragments, disc material, or ligaments bruise or tear into
spinal cord tissue. Most injuries to the spinal cord do not completely sever it.
Instead, an injury is more likely to cause fractures and compression of the
vertebrae, which then crush and destroy the axons, extensions of nerve
cells that carry signals up and down the spinal cord between the brain and the
rest of the body. An injury to the spinal cord can
damage a few, many, or almost all of these axons. Some injuries will allow
almost complete recovery. Others will result in complete paralysis. There are an
estimated 10,000 to 12,000 spinal cord injuries every year in the United States,
and a quarter of a million Americans are currently living with spinal cord
injuries. Additionally, 55 percent of spinal cord injury victims are between 16
and 30 years old. The cost of managing the care of spinal cord injury
patients approaches $4 billion each year.
8
Current
Treatments
Improved
emergency care for people with spinal cord injuries and aggressive treatment and
rehabilitation can minimize damage to the nervous system and even restore
limited abilities. Respiratory complications are often an indication of
the severity of spinal cord injury. About one-third of those with injury to the
neck area will need help with breathing and require respiratory support.
Treatment for acute traumatic spinal cord injuries consisting of giving a high
dose of methylprednisolone appears to reduce the damage to nerve cells if it is
given within the first 8 hours after injury. Rehabilitation programs
combine physical therapies with skill-building activities and counseling to
provide social and emotional support.
Our
Approach
We intend
to focus our efforts to develop cell therapeutic treatments for PD based on the
expansion of human mesenchymal stem cells from adult bone marrow and their
differentiation into neuron like cells, such as neurons that produce dopamine
and astrocytes (glial cells) that produce neurotrophic factors (“NTF”) including
GDNF, BDNF, NGF and IGF-1. Our aim is to provide neural stem cell transplants
that (i) "replace" damaged dopaminergic nerve cells and diseased tissue by
augmentation with healthy dopamine producing cells; and (ii) maintain, preserve
and restore the damaged and remaining dopaminergic cells in the patient’s brain,
protecting them from further degeneration.
The
research team led by Prof. Melamed and Dr. Offen has achieved expansion of human
bone marrow mesenchymal stem cells and their differentiation into both types of
brain cells, neurons and astrocytes, each having therapeutic potential, as
follows:
NurOwnTM program 1 - DA 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.
NurOwnTM program 2 - Neurotrophic-factors
(“NTF") secreting cells - human bone marrow derived NTF secreting cells
for treatment of PD, ALS and spinal cord injury. In-vitro differentiation of
the expanded human bone marrow derived mesenchymal stem cells in a special
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.
9
We intend
to optimize 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 compliance with
FDA guidelines for Good Tissue Practice (“GTP”) and 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 PD and ALS patients.
Our
technology is based on the NurOwn TM
products - an autologous cell therapeutic modality, comprising the extraction of
the patient bone marrow, processed into the appropriate neuronal cells and
re-implanted into the patient’s 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:
·
|
Bone marrow aspiration from
patient;
|
·
|
Isolating and expanding the
mesenchymal stem cells;
|
·
|
Differentiating the expanded stem
cells into neuronal-like dopamine producing cells and/or
neurotrophic-factor secreting cells;
and
|
·
|
Implantation of the
differentiated cells into the patient from whom the bone marrow was
extracted.
|
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 NurOwnTM 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. and Europe, for the treatment of PD, ALS, spinal cord injury
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.
10
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 a strategic partner 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:
·
|
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
|
·
|
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.
|
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 2008 were $2,097,000, which
included $219,000 in stock-based compensation and (ii) in 2007 were $2,265,000,
which included $783,000 in stock-based compensation.
Intellectual
Property
We have
filed the following patent and trademark applications:
WO2004/046348 METHODS,
NUCLEIC ACID CONSTRUCTS AND CELLS FOR TREATING NEURODEGENERATIVE
DISORDERS. National phase filings in Israel, Canada, Japan, Europe, and
the United States. Substantive examinations have been initiated
in some jurisdictions, including 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, India,
Israel, New Zealand,
Singapore, Japan and China. Substantive examinations have been
initiated in some jurisdictions, including Israel and Europe. A patent was
allowed in South Africa.
WO2007/066338
ISOLATED OLIGODENDROCYTE-LIKE CELLS AND POPULATIONS COMPRISING SAME FOR THE
TREATMENT OF CNS DISEASES.
Two new
provisional applications were submitted in the U.S. in 2008:
61/071,054:
INDUCTION OF HUMAN MESENCHYMAL STEM CELLS INTO DOPAMINE-PRODUCING CELLS WITH
DIFFERENT DIFFERENTIATION PROTOCOLS
A joint
Brainstorm-Ramot provisional patent application:
61/071,970:
MESENCHYMAL STEM CELLS FOR THE TREATMENT OF CNS DISEASES
11
In
addition, the Company has a trademark on NurOwn™, the technologies for inducing
the differentiation of mesenchymal stromal stem cells into neuronal-like
cells.
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 our 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.
As of
November 4, 2004, we entered into three-year consulting agreements with Prof.
Melamed and Dr. Offen, under which we paid each of them an annual consulting fee
of $72,000 and we issued each of them warrants to purchase 1,097,215 shares of
our Common Stock (each grant equaling 3% of our issued and outstanding shares at
such time). Each of the warrants is exercisable for a five-year period beginning
on November 4, 2005. The consulting agreements expired in November 2007 and we
are currently in the final stage of negotiations with Prof. Melamed and Dr.
Offen to renew the agreements.
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
are met.
In
consideration for the license, we originally agreed to pay Ramot:
·
|
An up-front license fee payment
of $100,000;
|
·
|
An amount equal to 5% of all Net
Sales of Products (as those terms are defined in the Original Ramot
Agreement); and
|
·
|
An amount equal to 30% of all
Sublicense Receipts (as such term is defined in the Original Ramot
Agreement).
|
In
addition, under the Original Ramot Agreement, we issued to Ramot and its
designees, warrants to purchase an aggregate of 10,606,415 shares of our Common
Stock (29% of our issued and outstanding shares as of November 4, 2004). Each of
the warrants is exercisable for a five-year period beginning on November 4,
2005.
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 has been reduced to $380,000 per
year. Moreover, under the Amended Research and License Agreement, the initial
period of time that we have agreed to fund the research has been extended from
an initial period of two (2) years to an initial period of three (3) years. The
Amended Research and License Agreement also extends the additional two-year
period in the Original Ramot Agreement to an additional three-year period, if
certain research milestones are met. In addition, the Amended Research and
License Agreement reduces certain royalties payments that we may have to pay
from five percent (5%) to three percent (3%) of all Net Sales (as defined
therein) in cases of third party royalties. The Amended Research and License
Agreement also reduces potential payments concerning sublicenses from 30% to
20-25% of Sublicense Receipts (as defined in the agreement).
12
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 imposes 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 original license agreement with Ramot. 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 original license agreement. The
payments described in the waiver and release cover all of our payment
obligations (including interest) that were past due and not yet due pursuant to
the Original Ramot Agreement. The waiver and release amended and restated the
original payment schedule under the Original Ramot Agreement as
follows:
Payment Date
|
Amount
|
|||
September
5, 2007
|
$
|
100,000
|
||
November
20, 2007
|
$
|
150,000
|
||
February
20, 2008
|
$
|
150,000
|
||
May
20, 2008
|
$
|
150,000
|
||
August
4, 2008
|
$
|
90,000
|
In
addition, in the event that the “research period”, as defined in the license
agreement, is extended for an additional three year period in accordance with
the terms of the license agreement, then we must make the following payments to
Ramot during the first year of the extended research period:
Payment Date
|
Amount
|
|||
August
4, 2008
|
$
|
60,000
|
||
November
20, 2008
|
$
|
150,000
|
||
February
20, 2009
|
$
|
170,000
|
If we
fail to make a payment to Ramot on any required payment date, and we do not cure
the default within seven business days of notice of the default, all claims of
Ramot against us which were waived and released by the waiver and release will
be reinstated. As of the date hereof, the May 20, 2008 payment of $150,000 and
the August 4, 2008 payment of $90,000 have not been paid and the Company is
currently negotiating a postponement of such payments with Ramot.
In
addition, on August 1, 2007, we entered into the Second Amended and Restated
Registration Rights Agreement with Ramot. The amended Registration Rights
Agreement provides Ramot with demand and piggyback registration rights whereby
if we propose to register any of our Common Stock under the Securities Act of
1933, as amended, for sale for our own account including for the account of any
of our shareholders or for ACCBT’s account in connection with the public
offering of such Common Stock, then Ramot may request that we file, or include
within a registration statement to be filed, the shares of Common Stock
underlying the warrants held by Ramot.
13
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.
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 (NurOwnTM 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.
14
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.
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 six scientific and administrative employees, four 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.
15
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.
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.
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 pay the
required research funding or royalties, we would need to change our business
strategy and we may be forced to cease our operations. We entered into a
Second Amended and Restated Research and License Agreement with Ramot on July
31, 2007 (the “Amended Agreement”). The Amended Agreement imposes on us
development and commercialization obligations, milestone and royalty payment
obligations and other obligations.
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 Agreement and waived all claims against us resulting from our
previous breaches and non-payment under the original license agreement. The
payments described in the waiver and release cover all of our payment
obligations (including interest) that were past due and not yet due pursuant to
the original license agreement. To date, we have not yet made the May 2008
payment of $150,000, the August 2008 payment of $90,000 or some payments for
patents to Ramot. In March 2009, we received a
written breach warning from Ramot and we are currently negotiating a new
agreement with Ramot to postpone such payments. If we fail to
negotiate an agreement with Ramot, Ramot will have the right to terminate the
license and all claims waived by Ramot pursuant to the August 2007 waiver and
release may be reinstated. 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 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.
16
Pursuant
to the subscription agreement with ACCBT, we expected to issue and sell
additional shares and warrants to ACCBT through November 2008 for aggregate
consideration of up to $5,000,000. As of December 31, 2008, ACCBT had invested
up to $3.8 million in the Company pursuant to the subscription
agreement. Even if ACCBT purchases all of the shares and warrants
under the subscription agreement, we will still need to secure additional funds
to effect our plan of operations. Recent funding installments from ACCBT have
not been made when expected and we continue to be in need of raising additional
cash.
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.
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, 2008
or December 31, 2007. 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 PD and
ALS 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,
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.
17
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:
·
|
We may not be successful in
obtaining the approval to perform clinical studies, an investigational new
drug application, or IND, with respect to a proposed
product;
|
·
|
Preclinical or clinical trials
may not demonstrate the safety and efficacy of proposed products
satisfactory to the FDA or foreign regulatory authorities;
or
|
·
|
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).
|
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 NurOwnTM
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.
18
We face
significant competition in our efforts to develop cell therapies for PD, ALS 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 PD, ALS 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. All of
these factors put us at a competitive disadvantage.
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.
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.
19
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
April 1, 2009:
·
|
under our Global Plan we have
granted and not canceled a total of 8,161,778 options with various
exercise prices and expiration dates, to officers, directors, services
providers, consultants and
employees.
|
·
|
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.
|
Such
issuances will, if and when made (and if options or warrants are subsequently
exercised), dilute your percentage ownership in the Company.
As of
April 1, 2009, we have issued convertible notes that have not yet been converted
or repaid in an aggregate principal amount of $150,000 to an investor. The
holder of a convertible note may choose to convert all or part of the
outstanding principal and interest amount of such holder’s note into shares of
our common stock on or prior to the maturity date of the respective note. The
maximum number of shares that are issuable pursuant to outstanding convertible
notes is 3,000,000.
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.
20
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.
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 (the "Exchange Act"). 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 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 $5,200)
per month during the first 12 months of the lease; (ii) NIS 19,527
(approximately $5,700) per month during the following 24 months of the lease;
(iii) NIS 22,317 (approximately $6,500) per month during the First Option
period; and (iv) NIS 23,712 (approximately $6,900) per month during the Second
Option period.
21
We have
recently expanded our Petach Tikva facility to include an animal research
facility. The new animal research facility began operations the week of
April 7, 2008.
Item 3.
|
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.
Item 4.
|
SUBMISSION OF MATTERS TO A VOTE
OF SECURITY HOLDERS
|
There
were no matters submitted to a vote of security holders during the quarter ended
December 31, 2008.
PART
II
Item
5. Market for Common Equity and Related Stockholder Matters and Small Business
Issuer Purchases of Equity Securities.
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 OTB BB.
Quarter Ended
|
High
|
Low
|
||||||
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 | ||||
December
31, 2007
|
$ | 1.13 | $ | 0.40 | ||||
September
30, 2007
|
$ | 1.15 | $ | 0.40 | ||||
June
30, 2007
|
$ | 0.39 | $ | 0.26 | ||||
March
31, 2007
|
$ | 0.49 | $ | 0.23 |
22
We
believe that a number of factors may cause the market price of our common stock
to fluctuate significantly. These factors are described in Management’s
Discussion and Analysis 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
April 7, 2009, there were approximately 78 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 April
13, 2009, the Company agreed to issue 250,000 shares of its common stock to
Rasheda Ali in full satisfaction of $25,000 owed by the Company to Ms. Ali for
services rendered to the Company.
On April
13, 2009, the Company, in consideration for certain legal services, agreed to
issue to Sagiv Rotenberg, an option to purchase 200,000 shares of its common
stock at an exercise price of $0.10 per share, with such option to vest and
become exercisable on the first anniversary of the grant date.
These
transactions did not involve any underwriters, underwriting discounts or
commissions and we believe that such transactions were exempt from the
registration requirements of the Securities Exchange Act of 1933 pursuant to
Section 4(2) thereof and Regulation D promulgated thereunder.
Item 6.
|
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 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 spinal cord
injury.
Our core
technology was developed through a collaboration between prominent neurologist,
Prof. Eldad Melamed, 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 Dr. 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 dopamine
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.
Our aim
is to provide neural stem cell transplants that (i) “replace” damaged
dopaminergic nerve cells and diseased tissue by augmentation with healthy
dopamine producing cells; and (ii) maintain, preserve and restore the damaged
and remaining dopaminergic cells in the patient’s brain, protecting them from
further degeneration.
23
Brainstorm
holds exclusive worldwide rights to commercialize the NurOwn™ technology,
through a licensing agreement with Ramot, the technology transfer company of Tel
Aviv University. The agreement also provides for further research, funded by
Brainstorm, to be performed by Prof. Melamed, Dr. Offen and members of their
research team at the Felsenstein Medical Research Center. The results of this
research are licensed to us under the terms of the license
agreement.
On
December 21, 2007, we entered into a Cooperative Research Agreement with Rutgers
University. Pursuant to the Cooperative Research Agreement, our subsidiary and
Rutgers University will work jointly in researching the use of differentiated
stem cells for the treatment of spinal cord injury. This research project began
in January 2008 and is expected to conclude during 2009.
On April
1, 2008, we started to operate our new animal house and we are conducting new
experiments following our work plan.
We are
currently in the developmental stage of our technology and products and we are
going to begin the process of seeking regulatory approval from regulatory
agencies in the U.S., Israel 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
first in animals and then in human patients;
and
|
·
|
Setting up centralized facilities
to provide NurOwn™ therapeutic products and services for transplantation
in patients.
|
As a
result of limited cash resources at this time and the faster path through
necessary clinical trials, the Company recently determined to focus all of its
efforts on ALS, and for now will not allocate resources towards
PD. As a result of this new focus and the Company’s limited cash
resources, the Company recently significantly downsized its employee
base.
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, 2008, the Company has not
earned any revenues from operations. The Company does not expect to earn
revenues from operations until 2013. In addition, the Company has incurred
operating costs and expenses of approximately $3,472,000 during the year ending
December 31, 2008, and approximately $35,960,000 for the period from inception
(September 22, 2000) until December 31, 2008. Operating expenses incurred since
inception were approximately $11,689,000 for general and administrative expenses
and $21,504,000 for research and development costs.
Research
and Development, net:
Research
and development expenses, net for the year ended December 31, 2008 and 2007 were
$1,639,000 and $1,925,000, respectively, which includes stock-based compensation
expense in each of the years. Stock-based compensation decreased by $564,000 to
$219,000 for the year ended December 31, 2008 from $783,000 for the year ended
December 31, 2007. In addition, the Company grant from The Office of the Chief
Scientist increased by $118,000 to $458,000 for the year ended December 31, 2008
from $340,000 for the year ended December 31, 2007.
24
Therefore,
although there was a decrease in research and development, net expenses for the
year ended December 31, 2008 from the research and development expenses, net for
the year ended December 31, 2007, research and development expenses, excluding
stock-based compensation expenses, and participation from The Office of the
Chief Scientist have increased by $396,000 to $1,878,000 for the year ended
December 31, 2008 from $1,482,000 for the year ended December 31, 2007. The
increase in research and development expenses, excluding stock-based
compensation, is primarily due to an increase in salary expenses as we had a
greater number of (i) employees until the recent downsize of the employee base
due to the Company's current financial condition and (ii) subcontractors due in
part to the Cooperative Research Agreement with Rutgers University. The increase
was also due in part on an expansion of our research activities, including
operating our new animal house.
General
and Administrative
General
and administrative expenses for the years ended December 31, 2008 and 2007 were
$1,629,000 and $2,990,000, respectively. 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. General and administrative expenses for
the year ended December 31, 2007 consisted of $1,895,000 in stock-based
compensation expenses and $1,095,000 in other expenses.
General
and administrative expenses, excluding stock-based compensation expenses, have
increased primarily due an increase in salary expenses as we have a greater
number of employees and consultants.
Financial
Expenses
Financial
expenses decreased by $1,125,000 to $204,000 for the year ended December 31,
2008 from $1,329,000 for the year ended December 31, 2007.
The
decrease in financial expenses for the year ended December 31, 2008 is primarily
attributable to a decrease in amortization of the discount on short-term
convertible loans.
Net
Loss
Net loss
for the year ended December 31, 2008 was $3,472,000, as compared to a net loss
of $6,244,000 for the year ended December 31, 2007. Net loss per share for the
year ended December 31, 2008 was $0.07, as compared to a net loss per share of
$0.21 for the year ended December 31, 2007. The decrease in the net loss is
mainly due to a decrease in stock-based compensation expenses and a decrease in
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, 2008 was 49,040,500, compared to
29,278,452 year ended December 31, 2007. This increase 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 the issuance of convertible promissory notes. At
December 31, 2008, we had $59,000 in total current assets and $2,859,000 in
total current liabilities.
Net cash
used in operating activities was $1,734,000 for the year ended December 31,
2008. Cash used for operating activities in the year ended December 31, 2008 was
primarily for payment of salaries and fees to our employees, consultants,
subcontractors and services providers and purchase of laboratory
materials.
Net cash
used in investing activities was $156,000 for the year ended December 31, 2008.
Cash used for investing activities in the year ended December 31, 2008 was
primarily for building the animal house.
25
Net cash
provided by financing activities was $1,806,000 for the year ended December 31,
2008 and is primarily attributable to funds received from ACCBT under the
Subscription Agreement.
We have a
licensing agreement with Ramot under which we owe approximately $95,000 per
quarter. In addition, we have an agreement with a lender under which we must pay
approximately $30,000 over the next three months.
Our other
material cash needs for the next 12 months will include payment of employee
salaries, payments for pre clinical and clinical trials in ALS and animal
experiments, lease payments, payments to Ramot, payments with respect to
patents, payment of construction fees for facilities to be used in our research
and development, payment of fees to our consultants and legal advisors and
capital equipment expenses.
On July
2, 2007, we entered into the Subscription Agreement with ACCBT, 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. To date, we have received an
aggregate of approximately $4 million from ACCBT and we do not have an estimated
date by when we expect the future payment of up to $1.0 million.
We will
need to raise substantial 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:
·
|
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;
and
|
·
|
Future
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.
Item 7A.
|
QUANTITATIVE AND QUALITATIVE
DISCLOSURE ABOUT MARKET RISK
|
Not
required.
26
Item 8.
|
FINANCIAL STATEMENTS AND
SUPPLEMENTARY DATA
|
BRAINSTORM
CELL THERAPEUTICS INC. AND SUBSIDIARY
(A
development stage company)
CONSOLIDATED
FINANCIAL STATEMENTS
AS
OF DECEMBER 31, 2008
U.S.
DOLLARS IN THOUSANDS
INDEX
Page
|
|
|
|
Report
of Independent Registered Public Accounting Firm
|
28
|
Consolidated
Balance Sheets
|
29
|
Consolidated
Statements of Operations
|
30
|
Statements
of Changes in Stockholders' Equity (Deficiency)
|
31
|
Consolidated
Statements of Cash Flows
|
34
|
Notes
to Consolidated Financial Statements
|
35
|
27
Deloitte
|
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
into@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, 2008, and the related consolidated statement of income,
stockholders' deficiency, and cash flows for the year then ended and for the
period from September 22, 2000 (date of inception) to December 31, 2008. 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, 2008,
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, such consolidated financial statements present fairly, in all material
respects, the financial position of BRAINSTORM CELL THERAPEUTICS Inc. and
subsidiary as of December 31, 2008, and the results of their operations and
their cash flows for the year then ended and for the period from September 22,
2000 (date of inception) to December 31, 2008, in conformity with accounting
principles generally accepted in the United States of America.
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 operating losses since inception through
December 31, 2008 and the Company research and development license breach of
agreement with Ramot, (see Note 3) 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
April
13, 2009
Audit.Tax.Consulting.Financial
Advisory.
|
Member
of
Deloitte Touche
Tohmatsu
|
28
|
BRAINSTORM
CELL THERAPEUTICS INC. AND
SUBSIDIARY
|
|
(A
development stage company)
|
CONSOLIDATED
BALANCE SHEETS
|
U.S.
dollars in thousands (except share
data)
|
December
31,
|
||||||||
2008
|
2007
|
|||||||
ASSETS
|
||||||||
CURRENT
ASSETS:
|
||||||||
Cash
and cash equivalents
|
2 | 86 | ||||||
Restricted
cash (Note 10b)
|
36 | 35 | ||||||
Accounts
receivable and other current asset (Note 5)
|
21 | 137 | ||||||
Total current
assets
|
59 | 258 | ||||||
LONG-TERM
INVESTMENTS:
|
||||||||
Prepaid
expenses
|
11 | 9 | ||||||
Severance
pay fund
|
62 | 75 | ||||||
Total long-term
investments
|
73 | 84 | ||||||
PROPERTY
AND EQUIPMENT, NET (Note 6)
|
743 | 739 | ||||||
DEFERRED
CHARGES (Note 8)
|
- | 2 | ||||||
Total
assets
|
875 | 1,083 | ||||||
LIABILITIES
AND STOCKHOLDERS' DEFICIENCY
|
||||||||
CURRENT
LIABILITIES:
|
||||||||
Short
term credit from bank
|
72 | - | ||||||
Trade
payables
|
744 | 838 | ||||||
Other
accounts payable and accrued expenses (Note 7)
|
1,672 | 1,049 | ||||||
Short-term
convertible loans (Note 8)
|
172 | 396 | ||||||
Short-term
loans (Notes 8a and 9)
|
199 | 945 | ||||||
Total current
liabilities
|
2,859 | 3,228 | ||||||
LONG-TERM
LOAN (Note 8a)
|
- | 200 | ||||||
ACCRUED
SEVERANCE PAY
|
92 | 83 | ||||||
Total
liabilities
|
2,951 | 3,511 | ||||||
COMMITMENTS
AND CONTINGENCIES (Note 10)
|
||||||||
STOCKHOLDERS'
DEFICIENCY:
|
||||||||
Stock
capital: (Note 11)
|
||||||||
Common
stock of $ 0.00005 par value - Authorized: 800,000,000 shares at
December 31, 2008 and 2007; Issued and outstanding: 55,241,418 and
41,004,409 shares at December 31, 2008 and 2007,
respectively
|
3 | 2 | ||||||
Additional
paid-in-capital
|
33,881 | 30,058 | ||||||
Deficit
accumulated during the development stage
|
(35,960 | ) | (32,488 | ) | ||||
Total
stockholders' deficiency
|
(2,076 | ) | (2,428 | ) | ||||
Total
liabilities and stockholders' deficiency
|
875 | 1,083 |
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,
|
|||||||||||
2008
|
2007
|
2008
|
||||||||||
Operating
costs and expenses:
|
||||||||||||
Research
and development
|
2,097 | 2,265 | 22,302 | |||||||||
Less
- participation by the Israeli Office of the Chief
Scientist
|
(458 | ) | (340 | ) | (798 | ) | ||||||
Research
and development, net
|
1,639 | 1,925 | 21,504 | |||||||||
General
and administrative
|
1,629 | 2,990 | 11,689 | |||||||||
Total operating
costs and expenses
|
3,268 | 4,915 | 33,193 | |||||||||
Financial
expenses, net
|
204 | 1,329 | 2,550 | |||||||||
3,472 | 6,244 | 35,743 | ||||||||||
Taxes
on income (Note 12)
|
- | - | 53 | |||||||||
Loss
from continuing operations
|
3,472 | 6,244 | 35,796 | |||||||||
Net
loss from discontinued operations
|
- | - | 164 | |||||||||
Net
loss
|
3,472 | 6,244 | 35,960 | |||||||||
Basic
and diluted net loss per share from continuing operations
|
0.07 | 0.21 | ||||||||||
Weighted
average number of shares outstanding used in computing basic and diluted
net loss per share
|
49,040,500 | 29,278,452 |
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 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 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 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
|
accumulated
|
Total
|
||||||||||||||||||||||
Capital and
|
Deferred
|
during the
|
stockholders'
|
|||||||||||||||||||||
Common stock
|
subscription of
|
stock-based
|
development
|
equity
|
||||||||||||||||||||
Number
|
Amount
|
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)
|
CONSOLIDATED STATEMENTS OF CASH FLOWS |
U.S.
dollars
in thousands
|
Year ended
December 31,
|
Period from
September 22,
2000 (inception
date) through
December 31,
|
|||||||||||
2008
|
2007
|
2008
|
||||||||||
Cash flows from operating
activities:
|
||||||||||||
Net
loss
|
(3,472 | ) | (6,244 | ) | (35,960 | ) | ||||||
Less
– loss for the period from discontinued operations
|
- | - | 164 | |||||||||
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
||||||||||||
Depreciation
|
151 | 99 | 368 | |||||||||
Amortization
of deferred charges
|
2 | 62 | 150 | |||||||||
Severance
pay, net
|
23 | 5 | 31 | |||||||||
Accrued
interest on loans
|
113 | 237 | 430 | |||||||||
Amortization
of discount on short-term loans
|
41 | 972 | 1,865 | |||||||||
Change
in fair value of options and warrants
|
- | - | (795 | ) | ||||||||
Expenses
related to shares and options granted to service providers
|
33 | 1,446 | 20,166 | |||||||||
Amortization
of deferred stock-based compensation related to options granted to
employees
|
731 | 1,232 | 4,888 | |||||||||
Decrease
(increase) in accounts receivable and prepaid expenses
|
116 | (95 | ) | (21 | ) | |||||||
Increase
(decrease) in trade payables
|
(94 | ) | 117 | 744 | ||||||||
Increase
in other accounts payable and accrued expenses
|
623 | 398 | 1,666 | |||||||||
Erosion
of restricted cash
|
(1 | ) | (3 | ) | (6 | ) | ||||||
Net
cash used in continuing operating activities
|
(1,734 | ) | (1,774 | ) | (6,310 | ) | ||||||
Net
cash used in discontinued operating activities
|
- | - | (23 | ) | ||||||||
Total
net cash used in operating activities
|
(1,734 | ) | (1,774 | ) | (6,333 | ) | ||||||
Cash flows from investing
activities:
|
||||||||||||
Purchase
of property and equipment
|
(154 | ) | (347 | ) | (1,080 | ) | ||||||
Restricted
cash
|
- | (29 | ) | |||||||||
Investment
in lease deposit
|
(2 | ) | - | (11 | ) | |||||||
Net
cash used in continuing investing activities
|
(156 | ) | (347 | ) | (1,120 | ) | ||||||
Net
cash used in discontinued investing activities
|
- | - | (16 | ) | ||||||||
Total
net cash used in investing activities
|
(156 | ) | (347 | ) | (1,136 | ) | ||||||
Cash flows from financing
activities:
|
||||||||||||
Proceeds
from issuance of Common stock and warrants, net
|
1,781 | 1,750 | 5,868 | |||||||||
Proceeds
from loans, notes and issuance of warrants, net
|
- | 673 | 2,061 | |||||||||
Credit
from bank
|
72 | - | 72 | |||||||||
Proceeds
from exercise of warrants and options
|
3 | 214 | 28 | |||||||||
Repayment
of short-term loans
|
(50 | ) | (490 | ) | (601 | ) | ||||||
Net
cash provided by continuing financing activities
|
1,806 | 2,147 | 7,428 | |||||||||
Net
cash provided by discontinued financing activities
|
- | - | 43 | |||||||||
Total
net cash provided by financing activities
|
1,806 | 2,147 | 7,471 | |||||||||
Increase
(decrease) in cash and cash equivalents
|
(84 | ) | 26 | 2 | ||||||||
Cash
and cash equivalents at the beginning of the period
|
86 | 60 | - | |||||||||
Cash
and cash equivalents at end of the period
|
2 | 86 | 2 | |||||||||
Non-cash financing
activities:
|
||||||||||||
Non-cash
proceeds from issuance of Common stock and warrants, net
|
- | 250 | - | |||||||||
Conversion
of debt to shares
|
1,276 | - | - | |||||||||
Non-cash
repayment of short-term loans
|
- | (250 | ) | |||||||||
Interest
paid
|
- | 17 | - |
The
accompanying notes are an integral part of the consolidated financial
statements.
34
|
BRAINSTORM
CELL THERAPEUTICS INC. AND
SUBSIDIARY
|
|
(A
development stage company)
|
NOTES TO CONSOLIDATED 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, particularly Parkinson's disease, 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
("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.
|
On
December 2006, the Company changed its state of incorporation from
Washington to Delaware.
|
G.
|
On
September 17, 2006, the Company's Board determined to change 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" ("SFAS No. 7").
|
35
|
BRAINSTORM
CELL THERAPEUTICS INC. AND
SUBSIDIARY
|
|
(A
development stage company)
|
NOTES TO CONSOLIDATED 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, 2008, resulted in a net loss of $3,472 and the
Company’s balance sheet reflects a net stockholders’ deficiency of $2,076,
accumulated deficit of $35,960 and working capital deficiency of $2,800. 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, the Company decided to
reduce its activity and focus only on the effort to reach clinical trials in ALS
in 2009.
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.
The
Company depends on Ramot to conduct its research and development activities. As
discussed in Note 3, the Company didn't make a certain payment in 2008 to Ramot.
As a result, the Company did not meet the payment schedule according to the
agreement with Ramot and Ramot is entitled to terminate the research and license
agreement.
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:
|
36
|
BRAINSTORM
CELL THERAPEUTICS INC. AND
SUBSIDIARY
|
|
(A
development stage company)
|
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS |
U.S.
dollars in thousands (except share
data)
|
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 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.
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.
37
|
BRAINSTORM
CELL THERAPEUTICS INC. AND
SUBSIDIARY
|
|
(A
development stage company)
|
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS |
U.S.
dollars in thousands (except share
data)
|
NOTE
2 -
|
SIGNIFICANT
ACCOUNTING POLICIES (Cont.)
|
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 Statement of Financial Accounting Standard 144, "Accounting for
the Impairment or Disposal of Long-Lived Assets" ("SFAS 144") 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 2007 and
2008, 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 CONSOLIDATED 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, 2008, year ended December 31, 2007
were $83, $41, respectively.
J.
|
Accounting
for stock-based compensation:
|
Effective
April 1, 2006, the Company adopted Statement of Financial Accounting
Standards 123 (Revised 2004), "Share-Based Payment," ("SFAS 123(R)") 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.
SFAS 123(R) 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 SFAS 123(R). The Company
has applied the provisions of SAB 107 in its adoption of SFAS
123(R).
SFAS
123(R) 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.
39
BRAINSTORM
CELL THERAPEUTICS INC. AND SUBSIDIARY
(A
development stage company)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS |
U.S.
dollars in thousands (except share
data)
|
NOTE
2 -
|
SIGNIFICANT
ACCOUNTING POLICIES (Cont.)
|
J.
|
Accounting
for stock-based compensation:
(Cont.)
|
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.
40
|
BRAINSTORM
CELL THERAPEUTICS INC. AND
SUBSIDIARY
|
|
(A
development stage company)
|
NOTES
TO CONSOLIDATED 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 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, 2008 and December
31, 2007, since all such securities have an anti-dilutive effect.
|
L.
|
Income
taxes:
|
The
Company and its subsidiary account for income taxes in accordance with 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 FASB
interpretation ("FIN") 48, "Accounting for Uncertainty in Income Taxes - an
Interpretation of FASB Statement 109". FIN 48 establishes a single model to
address accounting for uncertain tax positions. FIN 48 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. FIN 48
also provides guidance on recognition, measurement, classification, interest and
penalties, accounting in interim periods, disclosure and transition. The
adoption of the provisions of FIN 48 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.
41
|
BRAINSTORM
CELL THERAPEUTICS INC. AND
SUBSIDIARY
|
|
(A
development stage company)
|
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
U.S.
dollars in thousands (except share data)
NOTE
2 -
|
SIGNIFICANT
ACCOUNTING POLICIES (Cont.)
|
|
N.
|
Impact
of recently issued accounting
standards:
|
In May
2008, the FASB issued Statement of Financial Accounting Standards (SFAS) No.
162, The Hierarchy of Generally Accepted Accounting Principles. SFAS No. 162
identifies the sources of accounting principles and provides entities with a
framework for selecting the principles used in preparation of financial
statements that are presented in conformity with GAAP. The current GAAP
hierarchy has been criticized because it is directed to the auditor rather than
the entity, it is complex, and it ranks FASB Statements of Financial Accounting
Concepts, which are subject to the same level of due process as FASB Statements
of Financial Accounting Standards, below industry practices that are widely
recognized as generally accepted but that are not subject to due process. The
FASB believes the GAAP hierarchy should be directed to entities because it is
the entity (not its auditors) that is responsible for selecting accounting
principles for financial statements that are presented in conformity with GAAP.
The adoption of FASB 162 is not expected to have a material impact on the
Company's financial position.
42
|
BRAINSTORM
CELL THERAPEUTICS INC. AND
SUBSIDIARY
|
|
(A
development stage company)
|
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
U.S.
dollars in thousands (except share data)
NOTE
2 -
|
SIGNIFICANT
ACCOUNTING POLICIES (Cont.)
|
|
N.
|
Impact
of recently issued accounting standards
(cont.):
|
In May
2008, the FASB issued FASB Staff Position (FSP) APB 14-1, “Accounting for
Convertible Debt Instruments That May Be Settled in Cash upon Conversion
(Including Partial Cash Settlement)” (“APB 14-1”). APB 14-1 requires the issuer
to separately account for the liability and equity components of convertible
debt instruments in a manner that reflects the issuer’s nonconvertible debt
borrowing rate. The guidance will result in companies recognizing higher
interest expense in the statement of operations due to amortization of the
discount that results from separating the liability and equity components. APB
14-1 will be effective for financial statements issued for fiscal years
beginning after December 15, 2008, and interim periods within those fiscal
years. The Company is currently assessing the impact of APB 14-1 on its
consolidated financial statements.
In June
2008, the FASB issued FASB Staff Position No. EITF 03-6-1, “Determining Whether
Instruments Granted in Share-Based Payment Transactions Are Participating
Securities” (“FSP EITF 03-6-1”). FSP EITF 03-6-1 establishes that unvested
share-based payment awards that contain nonforfeitable rights to dividends or
dividend equivalents (whether paid or unpaid) are participating securities as
defined in Emerging Issues Task Force (“EITF”) Issue No. 03-6, “Participating
Securities and the Two-Class Method under FASB Statement No. 128”, and should be
included in the computation of earnings per share pursuant to the two-class
method as described in Statement of Financial Accounting Standards No. 128,
“Earnings per Share”. FSP EITF 03-6-1 is effective for financial statements
issued for fiscal years beginning after December 15, 2008, and interim periods
within those years. All prior-period earnings per share data presented shall be
adjusted retrospectively to conform to the provisions of FSP EITF 03-6-1. Early
application is not permitted. The adoption of FSP EITF 03-6-1is not expected to
have an impact on the Company's financial position.
EITF
Issue No. 07-5
In June
2008, the FASB Emerging Items Task Force reached a consensus on EITF Issue No.
07-5, “Determining Whether an Instrument (or an Embedded Feature) Is Indexed to
an Entity’s Own Stock". The Consensus was reached on the following three
issues:
|
1.
|
The way an entity
should evaluate whether an instrument (or embedded feature) is indexed to
its own stock.
|
|
2.
|
The way the currency
in which the strike price of an equity-linked financial instrument (or
embedded equity-linked feature) is denominated affects the determination
of whether the instrument is indexed to an entity’s own
stock.
|
|
3.
|
The way an issuer
should account for market-based employee stock option valuation
instruments.
|
43
|
BRAINSTORM
CELL THERAPEUTICS INC. AND
SUBSIDIARY
|
|
(A
development stage company)
|
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
U.S.
dollars in thousands (except share data)
NOTE
2 -
|
SIGNIFICANT
ACCOUNTING POLICIES
(Cont.)
|
|
N.
|
Impact
of recently issued accounting standards:
(Cont.)
|
This
consensus will affect entities with (1) options or warrants on their own shares
(not within the scope of Statement 150), including market-based employee stock
option valuation instruments; (2) forward contracts on their own shares,
including forward contracts entered into as part of an accelerated share
repurchase program; and (3) convertible debt instruments and convertible
preferred stock. Also affected are entities that issue equity-linked financial
instruments (or financial instruments that contain embedded equity-linked
features) with a strike price that is denominated in a foreign
currency.
The
consensus is effective for fiscal years (and interim periods) beginning after
December 15, 2008. The consensus must be applied to outstanding instruments as
of the beginning of the fiscal year in which the issue is adopted as a
cumulative-effect adjustment to the opening balance of retained earnings for
that fiscal year. Early application is not permitted.
The
Company is currently evaluating the effect of EITF 07-5 and has not yet
determined the impact of the consensus on its financial position or results of
operations.
NOTE
3 -
|
RESEARCH
AND LICENSE AGREEMENT
|
|
A.
|
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 and for a further two-year period if
certain research milestones are met. Ramot may terminate the agreement if
the Company fails to reach certain development milestones or materially
breaches the agreement.
|
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.
44
|
BRAINSTORM
CELL THERAPEUTICS INC. AND
SUBSIDIARY
|
|
(A
development stage company)
|
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
U.S.
dollars in thousands (except share data)
NOTE
3 -
|
RESEARCH
AND LICENSE AGREEMENT (Cont.)
|
|
A.
|
Cont.
|
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 amends and restates the original payment schedule 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 |
In
addition, in the event that the "research period," as defined in the Amended
Research and License Agreement, is extended for an additional three year period
in accordance with the terms of the Amended Research and License Agreement, then
the Company is obligated to the following payments to Ramot during the first
year of the extended research period:
Payment
date
|
Amount
|
|||
August
4, 2008
|
60 | |||
November
20, 2008
|
150 | |||
February
20, 2009
|
170 |
If the
Company fails to make a payment to Ramot on any required payment date, and the
Company does not cure the default within seven business days of notice of the
default, all claims of Ramot against the Company, which were waived and released
by the waiver and release, may be reinstated.
In March
2009, the Company received a breach warning from Ramot and the parties are
currently negotiating an updated agreement to postpone the
payments. The Company verbally agreed with Ramot on the principles of
such agreement but no agreement has been signed yet.
As of
April 13, 2009, the Company has paid to Ramot the first three payments, a total
of $400, but has not made yet the last two payments totaling $240 nor
paid for the extended research period. As a result, the Company is in
breach of the new agreement with Ramot and Ramot may terminate the research and
license agreement. The Company is negotiating with Ramot to postpone the
payments.
In
addition, on August 1, 2007, the Company entered into the Second Amended and
Restated Registration Rights Agreement with Ramot. According to the Second
Amended and Restated Registration Rights Agreement, Ramot waived their demand
for registration rights, according to the amended registration rights agreement
dated March 31, 2006, and instead agreed to piggyback registration rights in the
event that the Company files a registration statement.
45
|
BRAINSTORM
CELL THERAPEUTICS INC. AND
SUBSIDIARY
|
|
(A
development stage company)
|
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
U.S.
dollars in thousands (except share data)
NOTE
3 -
|
RESEARCH
AND LICENSE AGREEMENT (Cont.)
|
|
A.
|
Cont.
|
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.
|
B.
|
The
Company's total current obligation to Ramot as of December 31, 2008, is in
the amount of $772. The amount includes $475 for the extended research
period.
|
NOTE
4 -
|
CONSULTING
AGREEMENTS
|
|
A.
|
On
July 8, 2004, the Company entered into two consulting agreements with
Prof. Eldad Melamed and Dr. 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, 2008, the Company has a total obligation of $226 for
services rendered by the
Consultants.
|
NOTE
5 -
|
ACCOUNTS
RECEIVABLE AND PREPAID EXPENSES
|
December
31,
|
||||||||
2008
|
2007
|
|||||||
Government
authorities
|
12 | 102 | ||||||
Prepaid
expenses and other current asset
|
9 | 35 | ||||||
21 | 137 |
46
|
BRAINSTORM
CELL THERAPEUTICS INC. AND
SUBSIDIARY
|
|
(A
development stage company)
|
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
U.S.
dollars in thousands (except share data)
NOTE
6 -
|
PROPERTY
AND EQUIPMENT
|
December
31,
|
||||||||
2008
|
2007
|
|||||||
Cost:
|
||||||||
Office
furniture and equipment
|
9 | 9 | ||||||
Computer
software and electronic equipment
|
101 | 86 | ||||||
Laboratory
equipment
|
347 | 237 | ||||||
Leasehold
improvements
|
655 | 625 | ||||||
1,112 | 957 | |||||||
Accumulated
depreciation:
|
||||||||
Office
furniture and equipment
|
2 | 1 | ||||||
Computer
software and electronic equipment
|
64 | 40 | ||||||
Laboratory
equipment
|
95 | 54 | ||||||
Leasehold
improvements
|
208 | 123 | ||||||
369 | 218 | |||||||
Depreciated
cost
|
743 | 739 |
Depreciation
expenses for the year ended December 31, 2008 and December 31, 2007 were $151
and $99, respectively.
NOTE
7 -
|
OTHER
ACCOUNTS PAYABLE AND ACCRUED
EXPENSES
|
December
31,
|
||||||||
2008
|
2007
|
|||||||
Employee
and payroll accruals
|
176 | 193 | ||||||
Ramot
accrued expenses
|
475 | 95 | ||||||
Accrued
expenses
|
1,021 | 761 | ||||||
1,672 | 1,049 |
47
|
BRAINSTORM
CELL THERAPEUTICS INC. AND
SUBSIDIARY
|
|
(A
development stage company)
|
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
U.S.
dollars in thousands (except share data)
NOTE
8 -
|
SHORT-TERM
CONVERTIBLE LOANS
|
|
A.
|
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 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 EITF 02-4, the modification of terms of the convertible
loans payments is in the scope of 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 FASB No. 15, no gain or loss is recognized. As a
result of this agreement, an amount of $200 was included in long-term loan on
the balance sheet for the year ended December 31, 2007.
On April
13, 2008 the Company reached a new agreement with the lender, see
Note 9b.
|
B.
|
On
November 14, 2006, the Company issued a $50 Convertible Promissory Note to
a stockholder. Interest on the original note accrues at the rate of 12%
per annum and was due and payable in full on February 12,
2007.
|
On August
20, 2007, the stockholder waived all the interest accrued through August 20,
2007 and afterwards. On November 12, 2007, the Company repaid the $50 loan to
the stockholder.
48
|
BRAINSTORM
CELL THERAPEUTICS INC. AND
SUBSIDIARY
|
|
(A
development stage company)
|
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
U.S.
dollars in thousands (except share data)
NOTE
8 -
|
SHORT-TERM
CONVERTIBLE LOANS (Cont.)
|
|
C.
|
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 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.
The
beneficial conversion feature ("BCF"), in the amount of $133, embedded in the
note was calculated based on a conversion rate of 60%, as defined upon the
occurrence of an event of default. The amount was recorded as discount on the
note against additional paid-in capital and is amortized to financial expenses
over the note period.
The
balance as of December 31, 2007 was comprised as follows:
Note
|
200 | |||
Accrued
interest
|
16 | |||
216 |
On
February 21, 2008, the third party converted the entire accrued principal and
interest into 619,523 shares of Common Stock.
49
|
BRAINSTORM
CELL THERAPEUTICS INC. AND
SUBSIDIARY
|
|
(A
development stage company)
|
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
U.S.
dollars in thousands (except share data)
NOTE
8 -
|
SHORT-TERM
CONVERTIBLE LOANS (Cont.)
|
|
D.
|
On
January 26, 2007, the Company issued a $25 Convertible Promissory Note to
a stockholder. Interest on the original note accrued at the rate of 12%
per annum and was due and payable in full on February 28, 2007. The BCF,
in the amount of $8, embedded in the note was recorded as discount on the
note against additional paid-in capital and was amortized to financial
expenses over the note
period.
|
The
Company did not pay the loan on the original maturity date. On May 1, 2007, the
Company and the creditor agreed that the payment of the $25 for the above
Convertible Promissory Note and payment of $50 of the Convertible Promissory
Note from the stockholder dated November 14, 2006 would be deferred to May 31,
2007.
For the
deferral of the maturity dates, the Company granted on March 25, 2007 to the
stockholder, warrants to purchase 75,000 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 25, 2007 until the second anniversary of the issue date.
The fair value of the warrants in the amount of $20 was recorded as financial
expense for the year end December 31, 2007.
On August
13, 2007, the Company repaid the $25 loan to the stockholder. On August 20,
2007, the stockholder waived all the interest accrued through August 20, 2007
and afterwards. On November 12, 2007, the Company repaid the $50 loan to the
stockholder.
|
E.
|
On
February 5, 2007, the Company issued a $50 Convertible Promissory Note to
a stockholder. Interest on the note accrues at the rate of 8% per annum
and was due and payable in full on February 5, 2008. The stockholder 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 2,000,000 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 stockholder warrants to purchase 50,000
shares of Common Stock at an exercise price of $0.45 per share. The warrants are
fully vested and exercisable at any time after February 5, 2007 until the second
anniversary of the issue date. The fair value of the warrants is
$8.
In
accordance with 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 $4 with respect to the
warrants and the convertible note was recorded in the amount of
$46.
50
|
BRAINSTORM
CELL THERAPEUTICS INC. AND
SUBSIDIARY
|
|
(A
development stage company)
|
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
U.S.
dollars in thousands (except share data)
NOTE
8 -
|
SHORT-TERM
CONVERTIBLE LOANS (Cont.)
|
|
E.
|
Cont.
|
The BCF,
in the amount of $37, 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 in full to
financial expense due to converting the loan into shares.
On May
28, 2007, the stockholder converted the entire accrued principal and interest
amount of $51 into 210,812 shares of Common Stock.
|
F.
|
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 and
was due and payable in full on March 5, 2008. 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 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 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 did not pay the loan on the original maturity date, and is negotiating
with the third party for new payment terms.
51
BRAINSTORM
CELL THERAPEUTICS INC. AND SUBSIDIARY
(A
development stage company)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
U.S.
dollars in thousands (except share data)
NOTE
8 -
|
SHORT-TERM
CONVERTIBLE LOANS (Cont.)
|
The
balance of the convertible loan, is comprised as follows:
December 31,
|
||||||||
2008
|
2007
|
|||||||
Note
|
150 | 150 | ||||||
Discount
|
- | (24 | ) | |||||
Accrued
interest
|
22 | 10 | ||||||
172 | 136 |
|
G.
|
On
March 14, 2007, the Company issued a $50 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 March 14, 2008. 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%
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 2,000,000 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 50,000
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 14, 2007 until the
third anniversary of the issue date. The fair value of the warrants is
$16.
In
accordance with 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 $9 with respect to the
warrants and the convertible note was recorded in the amount of
$41.
The BCF,
in the amount of $26, 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 in full to financial expense due to converting the loan into
shares.
On June
27, 2007, the third party converted the entire accrued principal and interest
amount of $51 into 225,347 shares of Common Stock.
52
BRAINSTORM
CELL THERAPEUTICS INC. AND SUBSIDIARY
(A
development stage company)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
U.S.
dollars in thousands (except share data)
NOTE
8 -
|
SHORT-TERM
CONVERTIBLE LOANS (Cont.)
|
|
H.
|
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 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 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 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 $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.
The
balance as of December 31, 2007, is comprised as follows:
Note
|
25 | |||
Discount
|
(4 | ) | ||
Accrued
interest
|
1 | |||
22 |
On
February 18, 2008, the third party converted the entire accrued principal and
interest amount of $27 into 75,937 shares of Common Stock.
53
BRAINSTORM
CELL THERAPEUTICS INC. AND SUBSIDIARY
(A
development stage company)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
U.S.
dollars in thousands (except share data)
NOTE
8 -
|
SHORT-TERM
CONVERTIBLE LOANS (Cont.)
|
|
I.
|
On
May 6, 2007, the Company issued a $250 Convertible Promissory Note to a
stockholder. Interest on the note accrues at the rate of 8% per annum and
is due and payable in full on May 6, 2008. The note will become
immediately due and payable upon the occurrence of certain events of
default, as defined in the note. The stockholder 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 5,000,000 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 stockholder warrants to purchase 250,000
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 May 6, 2007 until May 31,
2010. The fair value of the warrants is $82.
In
accordance with 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 for 2007 an amount of $46 with
respect to the warrants and the convertible note was recorded in the amount of
$204.
The BCF,
in the amount of $129, 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 August
30, 2007, as part of a private placement with the stockholder (Note 11b(1)(f)),
the stockholder surrendered to the Company the $250 Promissory Note and the
250,000 warrants issued to the stockholder. The amount of $250 paid
by the investor on May 6, 2007 was considered as part of the private placement
payment.
|
J.
|
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 will 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 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.
|
54
BRAINSTORM
CELL THERAPEUTICS INC. AND SUBSIDIARY
(A
development stage company)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
U.S.
dollars in thousands (except share data)
NOTE
8 -
|
SHORT-TERM
CONVERTIBLE LOANS (Cont.)
|
|
J.
|
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 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 $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.
The
balance as of December 31, 2007 was comprised as follows:
Note
|
30 | |||
Discount
|
(10 | ) | ||
Accrued
interest
|
1 | |||
21 |
On June
5, 2008, the third party converted the entire accrued principal and interest
amount of $32 into 92,008 shares of Common Stock.
|
K.
|
On
July 3, 2007, the Company issued a $100 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 becomes
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, will be 75%
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 2,000,000 shares of Common Stock be
issued.
|
In
addition, the Company granted to the third party warrants to purchase 100,000
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 third
anniversary of the issue date. The fair value of the warrants is
$44.
In
accordance with 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 $19 with respect to
the warrants and the convertible note was recorded in the amount of
$81.
55
BRAINSTORM
CELL THERAPEUTICS INC. AND SUBSIDIARY
(A
development stage company)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
U.S.
dollars in thousands (except share data)
NOTE
8:-
|
SHORT-TERM
CONVERTIBLE LOANS (Cont.)
|
|
K.
|
Cont.
|
The BCF,
in the amount of $82, 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 in full to financial expense due to converting the loan into
shares.
On
September 5, 2007, the third party converted the entire accrued principal and
interest amount of $101 into 289,722 shares of Common Stock.
|
L.
|
According
to EITF 00-19 "Accounting for Derivative Financial Instruments Indexed to,
and Potentially Settled in a Company's Own Stock", in order to classify
warrants and options (other than employee stock options) as equity and not
as liabilities, the Company must have sufficient authorized and unissued
shares of Common Stock to provide for settlement of those instruments that
may require share settlement.
|
All notes
issued during the year ended December 31, 2007, include a provision that limits
the maximum number of shares to be issued upon conversion. EITF 00-19 was
analyzed for all warrants issued during 2007 and it was determined that equity
classification is appropriate.
NOTE
9 -
|
SHORT-TERM
LOANS
|
|
A.
|
On
February 8, 2006, the Company issued a $189 Promissory Note due June 8,
2006, with interest of 8% to a third party (the "Lender"). In addition,
the Company granted to the Lender warrants to purchase 189,000 shares of
Common Stock at an exercise price of $0.50 per share. The warrants are
fully vested and are exercisable at any time after February 8, 2006 until
the third anniversary of the issue
date.
|
The
Company agreed to pay $22 for due diligence and legal fees. The fees were
amortized over a four-month period ended June 8, 2006.
The fair
value of the warrants amounted to approximately $79. The Company estimated the
fair value of the warrants using a Black-Scholes options pricing model, with the
following assumptions: volatility of 119%, risk free interest rate of 4.66%,
dividend yield of 0% and an expected life of 36 months.
In
accordance with EITF 00-19 (see Note 8(L) above for further discussion), the
warrants were recorded as a liability at their entire fair value and the
residual amount (the difference between the amounts invested and the fair value
of the warrants at the date of issuance) was allocated to the
note.
56
BRAINSTORM
CELL THERAPEUTICS INC. AND SUBSIDIARY
(A
development stage company)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
U.S.
dollars in thousands (except share data)
NOTE
9 -
|
SHORT-TERM
LOANS (Cont.)
|
|
A.
|
Cont.
|
As a
result, an amount equal to the fair value allocated to the warrants was recorded
as discount on the note, and was amortized to financial expense over a
four-month period ended June 8, 2006.
On
October 3, 2006, the Company issued a warrant to purchase 630,000 shares of
Common Stock at a purchase price of $0.3 per share to the Lender under the
Lender's agreement to extend the maturity date of the note to December 31, 2006
and to waive any and all interest or fees. The warrants are fully exercisable
and expire after three years.
The fair
value of the warrants is $110. The Company estimated the fair value of the
warrants using a Black-Scholes options pricing model, with the following
assumptions: volatility of 101.7%, risk free interest rate of 4.5%, dividend
yield of 0% and an expected life of 36 months. The amount of $110 was recorded
as financial expense. In accordance with FASB 15 "Accounting by Debtors and
Creditors for Troubled Debt Restructuring" and in accordance with EITF 02-4
"Determining whether a Debtor's Modifications or Exchange of Debt Instruments
are Within the Scope of FASB 15", the Company recorded the fair value of the
warrants as a discount on the note with a corresponding credit to equity. The
discount was amortized as financial expense over a three-month period ended
December 31, 2006.
On July
30, 2007, the third party and the Company agreed on loan termination under the
terms as follows:
|
1.
|
The
third party shall exercise the 630,000 warrants issued on October 3,
2006.
|
|
2.
|
The
exercise price shall be used to pay the principal of the
loan.
|
|
3.
|
The
Company shall pay $17 for the accrued
interest.
|
|
B.
|
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 after payment of $100 owed by
the Company to the lender based on the payment agreement between the two
parties (see Note 8a).
|
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 |
57
BRAINSTORM
CELL THERAPEUTICS INC. AND SUBSIDIARY
(A
development stage company)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
U.S.
dollars in thousands (except share data)
NOTE
9 -
|
SHORT-TERM
LOANS (Cont.)
|
|
B.
|
Cont.
|
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
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.
As of
December 31, 2008 the Company paid the first payment to the lender and the last
four installments have not been paid yet. On April 2, 2009, the Company and the
lender agreed to convert the entire debt to shares (see note 14a).
Since the
outcome of the issuance of the shares was to relieve the debtor from its
obligation, based on paragraph 16a of 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.
58
BRAINSTORM
CELL THERAPEUTICS INC. AND SUBSIDIARY
(A
development stage company)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
U.S.
dollars in thousands (except share data)
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. On December 1, 2007, the
lease agreement has expired and the Israeli subsidiary has entered into
the First Option.
|
On July
25, 2006 the Company entered into a lease agreement for it's office in the US at
a monthly rate of $2.5. On February 6, 2008 the landlord agreed to waive any
amount owed by the Company to the landlord 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.
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, 2008 are as
follows:
Period ending December 31,
|
Facilities
|
Vehicles
|
Total
|
|||||||||
2009
|
81 | 42 | 123 | |||||||||
2010
|
86 | 34 | 120 | |||||||||
2011
|
86 | 1 | 87 | |||||||||
253 | 77 | 330 | ||||||||||
Total
rent expenses for the year ended December 31, 2008 and 2007 were $70 and $90
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 is represented in the balance sheet as restricted
cash.
|
|
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.
59
BRAINSTORM
CELL THERAPEUTICS INC. AND SUBSIDIARY
(A
development stage company)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
U.S.
dollars in thousands (except share data)
NOTE
10 -
|
COMMITMENTS
AND CONTINGENCIES (Cont.)
|
|
C.
|
Cont.
|
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, 2008, 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
Company’s subsidiary obtained from the Chief Scientist of the State of Israel
grants for participation in research and development for the years 2007 and 2008
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, 2008, total grants obtained amounted to $798.
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.
|
60
BRAINSTORM
CELL THERAPEUTICS INC. AND SUBSIDIARY
(A
development stage company)
NOTES
TO CONSOLIDATED 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.)
|
|
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
(includes $250
paid
as a convertible
loan
(Note 8i))
|
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 |
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.
61
BRAINSTORM
CELL THERAPEUTICS INC. AND SUBSIDIARY
(A
development stage company)
NOTES
TO CONSOLIDATED 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.
|
As of
December 31, 2008, the investor completed payment of the first four installments
and $281 of
the fifth installment and the Company issued to the investor and its
designee an aggregate of 19,250,000 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 , a warrant to purchase 10,083,333 shares of
common stock at an exercise price of $0.29 per share and a warrant to purchase
1,008,334 shares of common stock at an exercise price of $0.36 per
share. The warrants may be exercised at any time and expire on November 5,
2011.
The
investor did not complete his obligation based on the investment agreement
above. The Company is negotiating with the investor on continuance of payments.
The investor continued to invest in the company during 2009.
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, 2008, 875,000 shares of Common Stock had been issued as an
introduction fee.
|
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.
62
BRAINSTORM
CELL THERAPEUTICS INC. AND SUBSIDIARY
(A
development stage company)
NOTES
TO CONSOLIDATED 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:
|
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.
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.
As of
December 31, 2008, 5,151,684 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.
63
BRAINSTORM
CELL THERAPEUTICS INC. AND SUBSIDIARY
(A
development stage company)
NOTES
TO CONSOLIDATED 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.)
|
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.
A summary
of the Company's option activity related to options to employees and directors,
and related information is as follows:
64
BRAINSTORM
CELL THERAPEUTICS INC. AND SUBSIDIARY
(A
development stage company)
NOTES
TO CONSOLIDATED 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.)
|
Year ended
December 31,
|
Year ended
December 31,
|
|||||||||||||||||||||||
2008
|
2007
|
|||||||||||||||||||||||
Amount of
options
|
Weighted
average
exercise
price
|
Aggregate
intrinsic
value
|
Amount of
options
|
Weighted
average
exercise
price
|
Aggregate
intrinsic
value
|
|||||||||||||||||||
$
|
$ |
|
$ | $ | ||||||||||||||||||||
Outstanding
at beginning of period
|
5.280.760 | 0.372 | - | 2,850,760 | 0.188 | $ | 332 | |||||||||||||||||
Granted
|
170,000 | 0.49 | 2,540,000 | 0.57 | ||||||||||||||||||||
Exercised
|
(17,399 | ) | 0.15 | - | - | |||||||||||||||||||
Cancelled
|
- | - | (110,000 | ) | 0.179 | |||||||||||||||||||
Outstanding
at end of period
|
5,433,361 | *0.244 | - | 5,280,760 | 0.372 | $ | 1,663 | |||||||||||||||||
Vested
and expected-to-vest at end of period
|
4,324,437 | 0.238 | - | 3,158,354 | 0.195 | $ | 1,427 |
|
*)
|
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 SFAS 123(R). According to SFAS 123(R),
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, 2008 and 2007 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, 2008 and
2007.
65
BRAINSTORM
CELL THERAPEUTICS INC. AND SUBSIDIARY
(A
development stage company)
NOTES
TO CONSOLIDATED 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.)
|
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
|
2008
|
life
|
2008
|
|||||||||
$ |
Years
|
|||||||||||
0.15
|
2,838,361 | 4.15 | 2,838,361 | |||||||||
0.49
|
170,000 | 0.83 | 170,000 | |||||||||
0.75
|
105,000 | 4.94 | 99,688 | |||||||||
0.28
|
10,000 | 0.83 | 10,000 | |||||||||
0.4
|
180,000 | 6.01 | 127,500 | |||||||||
0.47
|
780,000 | 5.41 | 480,000 | |||||||||
0.39
|
250,000 | 5.75 | 165,556 | |||||||||
0.5
|
100,000 | 0.67 | 100,000 | |||||||||
0.15
|
1,000,000 | 8.81 | 333,333 | |||||||||
5,280,760 | 5.17 | 4,324,438 |
Compensation
expense recorded by the Company in respect of its stock-based employee
compensation award in accordance with SFAS 123(R) for the year ended
December 31, 2008 and 2007 amounted to $731 and $1,232,
respectively.
66
BRAINSTORM
CELL THERAPEUTICS INC. AND SUBSIDIARY
(A
development stage company)
NOTES
TO CONSOLIDATED 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.)
|
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,
|
||||||
2008
|
2007
|
|||||
Expected
volatility
|
112%-165%
|
93% - 115%
|
||||
Risk-free
interest
|
0.37%-3.73%
|
3.34% - 4.51%
|
||||
Dividend
yield
|
0%
|
0%
|
||||
Expected
life of up to (years)
|
1-10
|
|
5 - 6
|
|||
Forfeiture
rate
|
0
|
0%
|
|
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 SFAS 123(R), "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.
67
BRAINSTORM
CELL THERAPEUTICS INC. AND SUBSIDIARY
(A
development stage company)
NOTES
TO CONSOLIDATED 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 | 3,141,925 | 40,000 | 9,618,920 | 0.01 | 9,618,920 |
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 | 153,333 |
February
2008
|
|||||||||||||||||||||||
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 | 291,667 |
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 | 50,000 |
February
2009
|
|||||||||||||||||||||||
March
2007
|
225,000 | 225,000 | 0.45 | 225,000 |
March
2009
|
|||||||||||||||||||||||
March
2007
|
50,000 | 50,000 | 0.45 | 50,000 |
March
2010
|
|||||||||||||||||||||||
April
2007
|
33,300 | 33,300 | 0.45 | 33,300 |
April
2009
|
|||||||||||||||||||||||
May
2007
|
250,000 | *250,000 | - | 0.45 | - | - | ||||||||||||||||||||||
July
2007
|
500,000 | 500,000 | 0.39 | 236,111 |
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
2011
|
|||||||||||||||||||||||
July
2007
|
30,000 | 30,000 | 0.45 | 30,000 |
July
2009
|
|||||||||||||||||||||||
July
2007
|
100,000 | 100,000 | 0.45 | 100,000 |
July
2010
|
|||||||||||||||||||||||
October
2007
|
200,000 | 200,000 | 0.15 | 150,000 |
August
- October 2017
|
|||||||||||||||||||||||
November
2007
|
2,520,833 | 2,520,833 | 0.20 | 2,520,833 |
November
2011
|
|||||||||||||||||||||||
November
2007
|
2,016,667 | 2,016,667 | 0.29 | 2,016,667 |
November
2011
|
|||||||||||||||||||||||
April
2008
|
4,537,500 | 4,537,500 | 0.29 | 4,537,500 |
November
2011
|
|||||||||||||||||||||||
August
2008
|
3,529,166 | 3,529,166 | 0.29 | 3,529,166 |
November
2011
|
|||||||||||||||||||||||
August
2008
|
1,083,333 | 1,083,333 | 0.36 | 1,008,333 |
November
2011
|
|||||||||||||||||||||||
November
2008
|
100,000 | 100,000 | 0.15 | 100,000 | ||||||||||||||||||||||||
43,323,970 | 5,692,621 | 3,046,112 | 34,585,237 | 33,986,349 |
|
*)
|
See
Note 8i.
|
68
BRAINSTORM
CELL THERAPEUTICS INC. AND SUBSIDIARY
(A
development stage company)
NOTES
TO CONSOLIDATED 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:
|
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, 2008 and December 31, 2007; 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.
|
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.
69
BRAINSTORM
CELL THERAPEUTICS INC. AND SUBSIDIARY
(A
development stage company)
NOTES
TO CONSOLIDATED 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:
|
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.
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.
70
BRAINSTORM
CELL THERAPEUTICS INC. AND SUBSIDIARY
(A
development stage company)
NOTES
TO CONSOLIDATED 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
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.
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.
71
BRAINSTORM
CELL THERAPEUTICS INC. AND SUBSIDIARY
(A
development stage company)
NOTES
TO CONSOLIDATED 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
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 was recorded as finance expenses.
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,
|
|||||||||||||||
2008
|
2007
|
|||||||||||||||
Amount of
shares
|
Weighted
average
issue price
|
Amount of
shares
|
Weighted
average
issue price
|
|||||||||||||
$
|
|
$ | ||||||||||||||
Outstanding
at beginning of period
|
2,851,224 | 0.86 | 2,307,129 | 0.97 | ||||||||||||
Issued
|
90,000 | 0.40 | 544,095 | 0.40 | ||||||||||||
Outstanding
at end of period
|
2,941,224 | 0.85 | 2,851,224 | 0.86 |
|
c)
|
Stock-based
compensation recorded by the Company in respect of shares and warrants
granted to service providers amounted to $13 and $1,466 for the year ended
December 31, 2008 and 2007,
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,
|
|||||||||||
2008
|
2007
|
2008
|
||||||||||
Research
and development
|
219 | 783 | 16,625 | |||||||||
General
and administrative
|
509 | 1,895 | 7,583 | |||||||||
Financial
expenses, net
|
36 | 20 | 56 | |||||||||
Total
stock-based compensation expense
|
764 | 2,698 | 24,264 |
72
BRAINSTORM
CELL THERAPEUTICS INC. AND SUBSIDIARY
(A
development stage company)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
U.S.
dollars in thousands (except share data)
NOTE
12 -
|
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:
|
Income Tax (Inflationary
Adjustments) Law, 1985:
According
to the law, the results for tax purposes are measured based on the changes in
the Israeli Consumer Price Index ("CPI").
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;
and
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.
73
BRAINSTORM
CELL THERAPEUTICS INC. AND SUBSIDIARY
(A
development stage company)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
U.S.
dollars in thousands (except share data)
NOTE
12 -
|
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,
|
||||||||
2008
|
2007
|
|||||||
Operating
loss carryforward
|
29,316 | 27,540 | ||||||
Net
deferred tax asset before valuation allowance
|
13,192 | 12,215 | ||||||
Valuation
allowance
|
(13,192 | ) | (12,215 | ) | ||||
Net
deferred tax asset
|
- | - |
As of
December 31, 2008, the Company has provided valuation allowances of $13,192 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, 2008, the Company has an accumulated tax loss carryforward of
approximately $10,200. 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,
|
||||||||
2008
|
2007
|
|||||||
United
States
|
(1,776 | ) | (5,007 | ) | ||||
Israel
|
(1,696 | ) | (1,237 | ) | ||||
(3,472 | ) | (6,244 | ) |
74
BRAINSTORM
CELL THERAPEUTICS INC. AND SUBSIDIARY
(A
development stage company)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
U.S.
dollars in thousands (except share data)
NOTE
12 -
|
TAXES
ON INCOME (Cont.)
|
|
G.
|
The
Company files income tax returns in the U.S. federal jurisdiction and
various states and foreign jurisdictions. The Company is not currently
subject to any IRS or state tax examinations but years 2001-2007 remain
open for examination.
|
The
Company adopted the provisions of FIN 48 on January 1, 2007. The Company has
accumulated tax loss carryforwards of approximately $11,000 and has taken a full
valuation allowance against deferred tax assets. As a result, there are no tax
benefits existing subject to adjustment under FIN 48.
|
H.
|
BCT
has not received final tax assessments since its
incorporation.
|
75
BRAINSTORM
CELL THERAPEUTICS INC. AND SUBSIDIARY
(A
development stage company)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
U.S.
dollars in thousands (except share data)
NOTE
13 -
|
TRANSACTIONS
WITH RELATED PARTIES
|
Year ended December 31,
|
|||||||||
2008
|
2007
|
||||||||
A.
|
Fees
and related benefits and compensation expenses in respect of options
granted to a member of the Board who is a related party
|
23 | 128 | ||||||
B
|
Salary
to the Company president which controls the company's main
shareholder
|
59 | - | ||||||
C.
|
Financial
expenses (income) connected to convertible loan from related party (Note
8b)
|
- | (3 | ) | |||||
D. |
As
for transactions with Ramot, see Note 3.
|
NOTE
14 -
|
SUBSEQUENT
EVENTS (Cont.)
|
|
A.
|
On
March 29, 2009, the Company's Board passed the following
resolutions:
|
|
1.
|
Issuance
of 2,500,000 restricted shares of common stock to a lender. The shares are
for the $200 unpaid loan to the lender (see note
9b).
|
|
2.
|
Issuance
of 1,800,000 restricted shares to the Company's chief technology advisor.
The shares are for the $180 unpaid debt to the
advisor.
|
|
3.
|
Allocation
of 1,000,000 shares of common stock for a frame program for conversion
suppliers and consultants debt to shares of the Company common
stock.
|
|
B.
|
On
April 13, 2009, the Company’s Board passed the following
resolutions:
|
|
1.
|
Issuance
of 250,000 restricted shares to a Company advisor. The shares
are for $25 unpaid debt to the
advisor.
|
|
2.
|
Grant
option to purchase 200,000 shares of Common Stock at an exercise price of
$0.10 per share to the Company’s legal advisor for legal
services. The option vests and becomes exercisable on the first
anniversary of the grant
date.
|
|
3.
|
Elect
Abraham (Rami) Efrati, the Company’s CEO, to the Board of
Directors.
|
76
Item 9.
|
CHANGES IN AND DISAGREEMENTS WITH
ACCOUNTANTS ON ACCOUNTING AND FINANCIAL
DISCLOSURE
|
None.
Item
9A.
|
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.
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, 2008 based on the criteria set forth
in Internal Control—Integrated
Framework issued by the Committee of Sponsoring Organizations of the
Treadway Commission.
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,
2008:
·
|
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 because we recently
terminated the Company’s accountant as part of the downsizing of the
Company’s staff.
|
77
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
We plan
to 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.
Internal
Control Enhancements Implemented During the Fiscal Year Ended December 31,
2008
We
implemented a new ERP software system that strengthens our internal control over
financial reporting. The Company started to work with the new ERP system on
January 1, 2008. In November 2008, we terminated some employees who
operated the ERP system. Therefore, the ERP system currently operates
only as bookkeeping software.
Also,
during the fiscal year ended December 31, 2007, we hired a full-time bookkeeper
and salary controller with relevant accounting experience, skills and knowledge,
thereby increasing internal accounting expertise. On October 31, 2008, we
terminated the bookkeeper due to the Company’s financial situation.
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.
Item
9B. OTHER INFORMATION.
On April
13, 2009, the Board of Directors elected Abraham (Rami) Efrati to the Board of
Directors, provided that Mr. Efrati will tender his resignation from the Board
of Directors at such time as his employment with the Company
terminates. Mr. Efrati joined the Company in October 2007 as our
Chief Executive Officer. Mr. Efrati has not been named to any
committees of the Board of Directors, nor does the Company expect that he will
be named to any committees of the Board of Directors. There are no
arrangements or understandings between Mr. Efrati and any other persons pursuant
to which Mr. Efrati was selected as a director.
78
PART
III
Item
10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE.
Set forth
below is a summary description of the principal occupation and business
experience of each of the Company's directors and executive
officers:
Name
|
Age
|
Position
|
||
Abraham
Efrati
|
59
|
Chief
Executive Officer and Director
|
||
Chaim
Lebovits
|
38
|
President
|
||
David
Stolick
|
43
|
Chief
Financial Officer
|
||
Irit
Arbel
|
49
|
Director
|
||
Jonathan
C. Javitt
|
52
|
Director
|
||
Moshe
Lion
|
47
|
Director
|
||
Robert
Shorr
|
55
|
Director
|
||
Malcolm
Taub
|
63
|
Director
|
Abraham (Rami) Efrati joined
the Company in October 2007 as our Chief Executive Officer. On April
13, 2009, Mr. Efrati was elected to the Board of Directors. In 2004,
Mr. Efrati founded, and is currently the Chief Executive Officer of, Pro-Int
Ltd., a private company. In 2005, Mr. Efrati co-founded, and is currently the
Chief Executive Officer of, TeleFlight Technologies Ltd., a technology company
specializing in research and development of micro electronics solutions mainly
oriented for unmanned systems. From 1997 until 2004, Mr. Efrati
served as the Vice President, Sales, Business Development and Marketing for the
government project division of NICE-Systems Ltd., a leading provider of
solutions that capture, manage and analyze unstructured multimedia content and
transactional data enabling companies and public organizations to enhance
business and operational performance, address security threats and behave
proactively.
Chaim Lebovits joined the
Company in July 2007 as our President. Mr. Lebovits controls ACC Holdings, a
holding company which controls three subsidiaries: (i) C&L Natural
Resources; (ii) ACC Resources; and (iii) ACCBT. C&L Natural Resources
focuses on oil production in West Africa and operates an oil and gas field with
proven reserves of 20 million barrels of oil and an option to discover up to an
additional 100 million barrels of oil. ACC Resources holds 10 permits
for gold exploration in Burkina Faso. ACCBT focuses on new and emerging
biotechnologies. Mr. Lebovits has been at the forefront of mining and natural
resource management in the African region for close to a decade. Mr.
Lebovits serves as the President and as a director of Dominion Minerals Corp., a
company that trades on the OTC BB.
David Stolick joined the
Company in February 2005 as our Chief Financial Officer. From January 1995 to
April 2005, Mr. Stolick was Corporate Controller of M-Systems Flash Disk
Pioneers Ltd., a NASDAQ listed company. In 1994, he served as Deputy Controller
of Electronics Line Ltd., an Israeli publicly traded company, and from 1991
until 1994 he was Audit Manager at Goldstein, Sabbo, and Tebet Accountants. Mr.
Stolick holds a B.A. in Economics and Accounting from Ben-Gurion University. He
has been qualified as a certified accountant in Israel since 1993.
Dr. Irit Arbel joined the
Company in May 2004 as a director and as our President. She served as President
until she resigned in November 2004. Dr. Arbel was President and CEO of
Pluristem Life Systems, Inc. from 2002 to June 2004, and was Israeli Sales
Manager of Merck, Sharp & Dohme from 1998 to 2002. From 1995 to 1997, Dr.
Arbel served as the head of research for Hadassa-Ein Karem Hospital in
Jerusalem. Dr. Arbel specialized in the use of pharmaceuticals for neurology,
ophthalmology and dermatology treatments. Dr. Arbel earned her Post Doctorate
degree in 1997 in Neurobiology, after performing research in the area of
Multiple Sclerosis. Dr. Arbel also holds a Chemical Engineering degree from the
Technion, Israel's Institute of Technology.
Dr. Jonathan C. Javitt joined
the Company as a director in August 2007. Dr. Javitt is a physician with a
background in information technology, health economics, and public health. Since
2001, Dr. Javitt has served as a Senior Fellow of the Potomac Institute for
Policy Studies, and since 1998 has also served as Chairman and CEO of Health
Directions, LLC, an investment and consulting group that focuses on healthcare
information technology and biotechnology. Dr. Javitt has been a founder of
health information technology companies that have become part of Siemens, Inc.,
United Health Group, Inc., and Aetna, Inc. Currently, he serves as Managing
Director for Health Care and Life Sciences of BTI, Inc. and is a Director of
Flexscan, Inc. Since 1988, Dr. Javitt has also served as a Professor of
Ophthalmology (adjunct) at the Johns Hopkins University. Dr. Javitt has
considerable expertise and experience in the development of new drugs, having
worked extensively over the past twenty years with Merck, Inc., Pfizer, Inc.,
Allergan, Inc., Alcon, Inc., OSI, Inc., and others in bringing new drugs and
medical devices to the marketplace.
79
Mr. Moshe Lion joined the
Company as a director in July 2007. Since 1999, Mr. Lion has been a senior
partner of Lion, Orlitzki and Partners, a member of Moore Stephens international
partnership. Mr. Lion also serves as a director for Elbit Medical Imaging Ltd.
Previously, Mr. Lion was Chairman of Israel Railways, Director of the Israel
Council for Higher Education and the Wingate Institute for Physical Education,
Director of Elscint Ltd., Director of Massad Bank and Director of Bank Tefahot.
Prior to that, Mr. Lion served as Director General of the Israeli Prime
Minister's Office as well as an economic advisor to the Israeli Prime Minister.
He also served as the Head of the Bureau of the Israeli Prime Minister's Office.
Mr. Lion holds a Bachelor of Arts degree in accounting and economics and a
Master's Degree in Law (LL.M.) from Bar Ilan University.
Dr. Robert Shorr joined the
Company as a director in March 2005. Since 2000, Dr. Shorr has served as
President and CEO of Cornerstone Pharmaceuticals, a bio technology company.
Since 1998, he has also served as Director of Business Development at the State
University of New York at the Stony Brook Center for Advanced Technology. From
1998 until 2002, Dr. Shorr was Vice-President of Science and Technology (CSO) of
United Therapeutics, a NASDAQ listed company. He has served as trustee at the
Tissue Engineering Charities, Imperial College, London since 1999. Prior to 1998
he held management positions at Enzon Inc., a NASDAQ listed company, and AT
Biochem of which he was also founder. Dr. Shorr also served on the Board of
Directors of Biological Delivery Systems Inc., a NASDAQ listed company. Dr.
Shorr holds both a Ph.D. and a D.I.C. from the University of London, Imperial
College of Science and Technology as well as a B.Sc. from the State University
of New York.
Malcolm Taub joined the
Company as a director in March 2009. Since 1995, Mr. Taub has been
the Managing Member of Malcom S. Taub LLP, a law firm which practices in
the area of commercial litigation, among other practice areas. Mr. Taub
also works on art transactions, in the capacity of an attorney and
consultant. My Taub has also served as a principal of a firm that
provides consulting services to private companies going public in the United
States. Mr. Taub
has acted as a consultant to the New York Stock Exchange in its Market
Surveillance Department. Mr. Taub acts as a Trustee of The Gateway
Schools of New York and The Devereux Glenholme School in Washington,
Connecticut. Mr. Taub has served as an adjunct professor at Long
Island University, Manhattan Marymount College and New York University Real
Estate Institute. Mr. Taub holds a B.A. degree from Brooklyn College
and a J.D. degree from Brooklyn Law School. Mr. Taub
serves on the Board of Directors of Safer Shot, Inc. (formerly known as
Monumental Marketing Inc.), a company which trades on the Pink
Sheets.
Certain
Arrangements
Under the
Security Holders Agreement (described in detail under the heading “Change in
Control” in Item 12 below), ACCBT is entitled to nominate 50.1% of our Board of
Directors. Dr. Jonathan C. Javitt and Moshe Lion were nominated pursuant to this
provision.
Family
Relationships
No
director or executive officer is related by blood, marriage or adoption to any
other director or executive officer.
Involvement
in Certain Legal Proceedings
None.
80
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.
Audit
Committee
On
February 7, 2008, the Board of Directors established a standing Audit Committee
in accordance with Section 3(a)(58)(A) of the Securities Exchange Act of 1934,
which assists the Board of Directors in fulfilling its responsibilities to
stockholders concerning the Company’s financial reporting and internal controls,
and facilitates open communication among the Audit Committee, Board of
Directors, outside auditors and management. The Audit Committee discusses with
management and the Company’s outside auditors the financial information
developed by the Company, the Company’s systems of internal controls and the
Company’s audit process. The Audit Committee is solely and directly responsible
for appointing, evaluating, retaining and, when necessary, terminating the
engagement of the independent auditor. The independent auditors meet with the
Audit Committee (both with and without the presence of the Company’s management)
to review and discuss various matters pertaining to the audit, including the
Company’s financial statements, the report of the independent auditors on the
results, scope and terms of their work, and their recommendations concerning the
financial practices, controls, procedures and policies employed by the Company.
The Audit Committee preapproves all audit services to be provided to the
Company, whether provided by the principal auditor or other firms, and all other
services (review, attest and non-audit) to be provided to the Company by the
independent auditor. The Audit Committee coordinates the Board of Directors’
oversight of the Company’s internal control over financial reporting, disclosure
controls and procedures and code of conduct. The Audit Committee is charged with
establishing procedures for (i) the receipt, retention and treatment of
complaints received by the Company regarding accounting, internal accounting
controls or auditing matters; and (ii) the confidential, anonymous
submission by employees of the Company of concerns regarding questionable
accounting or auditing matters. The Audit Committee reviews all related party
transactions on an ongoing basis, and all such transactions must be approved by
the Audit Committee. The Audit Committee is authorized, without further action
by the Board of Directors, to engage such independent legal, accounting and
other advisors as it deems necessary or appropriate to carry out its
responsibilities. The Board of Directors has adopted a written charter for the
Audit Committee, which is available in the corporate governance section of the
Company’s website at www.brainstorm-cell.com. The
Audit Committee currently consists of Mr. Lion (Chairman), Dr. Arbel and Mr.
Taub, each of whom is independent as defined under applicable Nasdaq listing
standards.
The Board
of Directors does not have a standing nominating committee, instead each member
of the Board of Directors participates in the consideration of director
nominees. Due to the size of the Company, the Board of Directors does not
currently have a policy regarding stockholder recommendations of director
nominees. The Board of Directors does not have any specific, minimum
qualifications for director nominees, but considers a variety of factors in
selecting director nominees, including, but not limited to the following:
integrity, education, business acumen, knowledge of the Company's business and
industry, age, experience, diligence, conflicts of interest and the ability to
act in the interests of all stockholders.
Audit
Committee Financial Expert
The Board
of Directors has determined that Moshe Lion is an “audit committee financial
expert” as defined in Item 407(d)(5) of Regulation S-K. Mr. Lion is
independent as defined under applicable Nasdaq listing standards.
Section
16(a) Beneficial Ownership Reporting Compliance
Section 16(a) of the Securities
Exchange Act requires our executive officers and directors, and persons who own
more than 10% of our Common Stock (collectively, the "Reporting Persons"), to
file reports regarding ownership of, and transactions in, our securities with
the Securities and Exchange Commission and to provide us with copies of those
filings. Based solely on our review of the copies of such forms received by us,
or written representations from the Reporting Persons, we believe that during
the fiscal year ended December 31, 2008, all Reporting Persons complied with the
applicable requirements of Section 16(a) of the Exchange Act, except for the
following:
81
·
|
ACCBT Corp. filed one late Form
4, reporting a total of four transactions
late.
|
There are no known failures to file a
required Form 3, Form 4 or Form 5.
Item
11. EXECUTIVE COMPENSATION
Summary
Compensation
The
following table sets forth certain summary information with respect to the
compensation paid during the fiscal years ended December 31, 2008 and December
31, 2007 earned by each of the following individuals: (i) the Chief Executive
Officer, (ii) the President, and (iii) the Chief Financial Officer (together,
the “Named Executive Officers”). In the table below, columns required by the
regulations of the SEC have been omitted where no information was required to be
disclosed under those columns.
SUMMARY
COMPENSATION TABLE (*)
Name and Principal Position
|
Year
|
Salary
($)
|
Option
Awards
($) (1)
|
All Other
Compensation
($)(2)
|
Total ($)
|
|||||||||
Abraham
(Rami) Efrati
|
2008
|
179,889
|
246,153
|
61,255
|
487,297
|
(3)
|
||||||||
Chief
Executive Officer and Director
|
2007
|
39,565
|
46,130
|
11,468
|
97,163
|
|||||||||
Chaim
Lebovits
|
2008
|
56,405
|
-
|
2,937
|
59,342
|
(4)
|
||||||||
President
|
2007
|
-
|
-
|
-
|
-
|
|||||||||
David
Stolick
|
2008
|
104,784
|
80,230
|
40,173
|
225,187
|
(5)
|
||||||||
Chief
Financial Officer
|
2007
|
86,931
|
299,365
|
34,057
|
420,353
|
(*)Each
of the Named Executive Officers is paid in New Israeli Shekel (NIS); the amounts
above are the U.S. dollar equivalent. The conversion rate used was the average
of the end of month’s rate between the U.S. dollar and the New Israeli Shekels
(NIS) as published by the Bank of Israel, the central bank of
Israel.
(1) The
value of the option awards are determined in accordance with SFAS 123(R) as
disclosed in Footnote 2(j) to the Consolidated Financial Statements
included in Item 8 of this Annual Report on Form 10-K for the fiscal year ended
December 31, 2008. There can be no assurance that the amounts calculated under
SFAS 123(R) will be realized and amounts realized could ultimately exceed the
amounts calculated under SFAS 123(R).
(2)
Includes management insurance (which includes pension, disability insurance and
severance pay), payments towards such employee’s education fund, amounts paid
for use of a Company car and Israeli social security.
(3) In
2008, Mr. Efrati earned a salary of $179,889 and other compensation in the
amount of $61,255, totaling $241,144, but only $165,780 was paid to Mr.
Efrati in 2008 due to the Company’s lack of funds. The Total reflects
total compensation earned in 2008.
82
(4) In
2008, Mr. Lebovits earned a salary of $56,405, and other
compensation in the amount of $2,937, totaling $59,342, but only $27,489 was
paid to Mr. Lebovits in 2008 due to the Company’s lack of
funds. The Total reflects total compensation earned in
2008.
(5) In
2008, Mr. Stolick earned a salary of $104,784 and other compensation in the
amount of $40,173, totaling $144,956, but only $120,156 was paid to
Mr. Stolick in 2008 due to the Company’s lack of funds. The Total
reflects total compensation earned in 2008.
Executive
Employment Agreement and Termination of Employment and Change-in-Control
Arrangements
Abraham Efrati. Pursuant to
his employment agreement dated October 7, 2007, Mr. Efrati is entitled to an
initial base salary of 50,000 NIS per month (approximately
$14,285).
Mr.
Efrati is entitled to coverage under our Manager’s Insurance Policy. Mr. Efrati
is also entitled to an education fund and the use of a Company car.
Mr.
Efrati’s employment under his employment agreement is “at will”. It may be
terminated by him upon giving notice of ninety (90) days prior to his departure
until the first anniversary of his employment and upon notice of one hundred and
eighty (180) days notice after the first anniversary. The Company may terminate
Mr. Efrati’s employment with the same amount of notice, however the Company may
also terminate Mr. Efrati by giving payment for the notice period in lieu of
prior notice and may terminate Mr. Efrati without any notice or any compensation
whatsoever if such termination is for cause (as “cause” is defined in Mr.
Efrati’s employment agreement).
Mr.
Efrati has also agreed not to compete with the Company or solicit the Company’s
customers or employees during the term of his employment and for a period of
twelve (12) months following the termination of his employment for any
reason.
Chaim Lebovits. On February
11, 2008, the Company agreed that it would provide Mr. Lebovits with a salary of
37,450 NIS per month (approximately $10,400) starting February 15, 2008. The
Company and Mr. Lebovits have not yet entered into a written
agreement.
David Stolick. Pursuant to
his employment agreement effective as of February 13, 2005 (the “Stolick
Effective Date”), Mr. Stolick was entitled to an initial base salary of 20,000
NIS per month (approximately $4,470), which was increased six (6) months
subsequent to the Stolick Effective Date, to 28,000 NIS per month. Mr. Stolick
was granted, pursuant to the Company’s Global Plan, an option to purchase
400,000 shares of the Company’s Common Stock at a price per share of $0.75 each,
which options will vest and become exercisable in thirty-six (36) equal monthly
installments from the Stolick Effective Date. This option shall be exercisable
by Mr. Stolick for a ten (10) year period following the Stolick Effective Date,
but in any case not later than two (2) years after termination of the agreement.
On February 6, 2006, the Company’s Board of Directors approved the repricing of
this option, such that said option now has an exercise price of $0.15 per share
as opposed to $0.75 per share. Mr. Stolick is entitled to coverage
under the Company’s Directors’ and Officers’ liability insurance policy and to a
written undertaking from the Company and its subsidiary to indemnify and release
him to the full extent possible in accordance with the Israeli Companies Law
5759-1999 and the applicable laws of the State of Delaware.
Mr.
Stolick’s employment agreement has no stated term and is terminable by either
party upon 90 days prior notice or by the Company without prior notice in the
event of a termination for cause. In the event that Mr. Stolick resigns as a
result of constructive discharge, or in the event of termination of employment
by reason of Mr. Stolick’s disability or death, 67% of the remaining unvested
options granted to Mr. Stolick shall vest immediately as of the date of the
notice of termination, and Mr. Stolick or his successor shall be entitled to
exercise the vested options from the date of such termination until the earlier
of two (2) years thereafter or their expiration date. Mr. Stolick is prohibited,
during the term of his employment and for a period of 12 months thereafter, from
competing with the Company or its subsidiary or soliciting any of the Company’s
or its subsidiary’s customers or employees.
83
Terms
of Option Awards
Mr. Stolick was
granted, pursuant to the Company’s Global Plan, an option to purchase 100,000
shares of the Company’s Common Stock at a price per share of $0.15 each, which
options were fully vested and exercisable on the date of grant, May 2,
2006. In addition, on March 21, 2007, Mr. Stolick was granted,
pursuant to the Company’s Global Plan, an option to purchase 350,000 shares of
the Company’s Common Stock at a price per share of $0.47 each, which options
will vest and become exercisable in 36 equal monthly installments from the date
of grant, provided Mr. Stolick is employed by or providing services to the
Company on each applicable vesting date. These options shall be
exercisable by Mr. Stolick for a ten (10) year period following the date of
grant, but in any case not later than two (2) years after termination of his
employment agreement.
On
October 23, 2007, Mr. Efrati was granted, pursuant to the Company’s Global Plan,
an option to purchase 1,000,000 shares of the Company’s Common Stock at a price
per share of $0.87 each, which options will vest and become exercisable with
respect to 1/6 of the shares subject to the option on each six-month anniversary
of the date of grant, provided Mr. Efrati is employed by or providing services
to the Company on each applicable vesting date. This option shall be
exercisable by Mr. Efrati for a ten (10) year period following the date of
grant. On November 5, 2008, the Company’s Board of Directors approved the
repricing of this option, such that said option now has an exercise price of
$0.15 per share as opposed to $0.87 per share.
Outstanding
Equity Awards
The
following table sets forth information regarding equity awards granted to any
Named Executive Officer that are outstanding as of December 31, 2008. In the
table below, columns required by the regulations of the SEC have been omitted
where no information was required to be disclosed under those
columns.
OUTSTANDING
EQUITY AWARDS AT DECEMBER 31, 2008
Option Awards
|
||||||||||||||||
Name
|
Number of
Securities
Underlying
Unexercised
Options
(#)
Exercisable
|
Number of
Securities
Underlying
Unexercised
Options
(#)
Unexercisable
|
Option
Exercise
Price
($)
|
Option Expiration Date
|
||||||||||||
Abraham
(Rami) Efrati
|
333,333 | 666,667 | (1) | 0.15 |
10/22/17
|
|||||||||||
|
||||||||||||||||
Chaim
Lebovits
|
— | — | — | — | ||||||||||||
David
Stolick
|
400,000 | — | 0.15 |
2/13/15
|
||||||||||||
100,000 | — | 0.15 |
5/1/16
|
|||||||||||||
204,167 | 145,833 | (2) | 0.47 |
3/20/17
|
(1)
Options for the purchase of approximately 166,666 shares vest and become
exercisable on April 15, 2009, October 15, 2009, April 15, 2010 and October 15,
2010. On November 5, 2008, the Company approved the repricing of Mr. Efrati’s
option to purchase 1,000,000 shares of Common Stock, such that said option shall
have an exercise price of $0.15 per share instead of $0.87 per
share.
84
(2)
Options for the purchase of approximately 9,722 shares vest and become
exercisable each month until they are fully vested and exercisable on March 20,
2010.
Stock
Incentive Plans
In
November 2004 and February 2005, the Company’s Board of Directors adopted and
ratified the Global Plan and the U.S. Plan, respectively, and further approved
the reservation of 9,143,462 shares of the Company’s Common Stock for issuance
thereunder. The Company’s stockholders approved the Plans and the shares
reserved for issuance thereunder at a special meeting of stockholders 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. The Company’s stockholders approved the
amendment and restatement of the Plans on June 5, 2008.
Under the
Global Plan, the Company granted a total of 8,161,778 options with various
exercise prices (a weighted average exercise price of $0.376) and expiration
dates, to service providers, subcontractors, directors, officers, and employees.
Under the U.S. Plan, the Company issued an additional 830,000 shares of
restricted stock and options to Scientific Advisory Board members, consultants,
and directors. As of March 31, 2009, there were 5,151,384 shares available for
issuance under the Plans.
Director
Compensation
The
following table sets forth certain summary information with respect to the
compensation paid during the fiscal year ended December 31, 2008 earned by each
of the directors of the Company. In the table below, columns required by the
regulations of the SEC have been omitted where no information was required to be
disclosed under those columns.
DIRECTOR
COMPENSATION TABLE FOR FISCAL 2008
Name
|
Fees Earned
or
Paid in
Cash
($)
|
Stock
Awards
($) (1)
|
Option
Awards
($) (1)
|
Total
($)
|
|||||||
Dr.
Irit Arbel (*)
|
10,000
|
—
|
12,611
|
(2)
|
22,611
|
||||||
Dr.
Robert Shorr
|
10,000
|
53,829
|
(3)
|
—
|
63,829
|
||||||
Mr.
Moshe Lion
|
—
|
—
|
—
|
(4)
|
—
|
||||||
Dr.
Jonathan Javitt
|
—
|
—
|
—
|
(5)
|
—
|
||||||
Mr.
Malcolm Taub(6)
|
—
|
—
|
—
|
—
|
(*) Dr.
Irit Arbel is paid in New Israeli Shekel (NIS); the amounts above are the U.S.
dollar equivalent. The conversion rate used was the average of the end of
month’s rate between the U.S. dollar and the New Israeli Shekels (NIS) as
published by the Bank of Israel, the central bank of Israel.
(1) The
value of the stock awards and the option awards are determined in accordance
with SFAS 123(R) as disclosed in Footnote 2(j) to the Consolidated
Financial Statements included in Item 8 of this Annual Report on Form 10-K for
the fiscal year ended December 31, 2008. There can be no assurance that the
amounts calculated under SFAS 123(R) will be realized and amounts realized could
ultimately exceed the amounts calculated under SFAS 123(R).
(2) At
December 31, 2008, options to purchase 300,000 shares of Common Stock granted to
Dr. Arbel were outstanding.
(3) At
December 31, 2008, Dr. Shorr held an aggregate of 100,000 restricted
shares.
85
(4) At
December 31, 2008, options to purchase 100,000 shares of Common Stock granted to
Mr. Lion were outstanding.
(5) At
December 31, 2008, options to purchase 100,000 shares of Common Stock granted to
Dr. Javitt were outstanding.
(6) Mr.
Taub was not a director during the fiscal year ended December 31,
2008. Mr. Taub was elected a director on March 16, 2009.
We
reimburse our non-employee directors for reasonable travel and other
out-of-pocket expenses incurred in connection with attending board meetings. On
May 27, 2005, we approved the following compensation for non-employee directors
beginning with the fiscal year ended March 31, 2006: (i) annual retainer of
$10,000; (ii) meeting participation fees of $1,000 for each board meeting or
duly constituted committee thereof attended in person; and (iii) $500 for each
meeting attended by telephone. Dr. Arbel and Dr. Shorr earn
compensation in accordance with the above described plan.
Since
October 14, 2007, the Company has implemented a new compensation plan for
non-employee directors appointed in 2007 and thereafter. Under
this new compensation plan, each director is entitled to receive an option to
purchase 100,000 shares of the Company’s common stock or 100,000 restricted
shares of common stock. Dr. Javitt, Mr. Lion and Mr. Taub earn
compensation in accordance with the new compensation plan. In 2008, the Company
did not issue any options or restricted shares to any of its
directors.
Item
12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED
STOCKHOLDER MATTERS.
Security
Ownership of Certain Beneficial Owners and Management
The
following table sets forth certain information as of March 26, 2009 with respect
to the beneficial ownership of Common Stock of the Company by the following: (i)
each of the Company's current directors; (ii) each of the Named Executive
Officers; (iii) all of the current executive officers and directors as a group;
and (iv) each person known by the Company to own beneficially more than five
percent (5%) of the outstanding shares of the Company's Common
Stock.
For
purposes of the following table, beneficial ownership is determined in
accordance with the rules of the Securities and Exchange Commission (the “SEC”)
and the information is not necessarily indicative of beneficial ownership for
any other purpose. Except as otherwise noted in the footnotes to the table, the
Company believes that each person or entity named in the table has sole voting
and investment power with respect to all shares of the Company’s Common Stock
shown as beneficially owned by that person or entity (or shares such power with
his or her spouse). Under the SEC’s rules, shares of the Company’s Common Stock
issuable under options that are exercisable on or within 60 days after March 26,
2009 (“Presently Exercisable Options”) or under warrants that are exercisable on
or within 60 days after March 26, 2009 (“Presently Exercisable Warrants”) are
deemed outstanding and therefore included in the number of shares reported as
beneficially owned by a person or entity named in the table and are used to
compute the percentage of the Common Stock beneficially owned by that person or
entity. These shares are not, however, deemed outstanding for computing the
percentage of the Common Stock beneficially owned by any other person or entity.
Unless otherwise indicated, the address of each person listed in the table is
c/o Brainstorm Cell Therapeutics Inc., 110 East 59th Street,
New York, New York 10022.
The
percentage of the Common Stock beneficially owned by each person or entity named
in the following table is based on 55,241,418 shares of Common Stock outstanding
as of March 26, 2009 plus any shares issuable upon exercise of Presently
Exercisable Options and Presently Exercisable Warrants held by such person or
entity.
86
Shares Beneficially Owned
|
||||||
Name of Beneficial Owner
|
Number of
Shares
|
Percentage of
Class
|
||||
Directors,
Nominees and Named Executive Officers
|
|
|
||||
Abraham
Efrati
|
500,000
|
(1)
|
*
|
|||
Chaim
Lebovits
|
39,481,925
|
(2)
|
51.7
|
%
|
||
David
Stolick
|
752,778
|
(3)
|
1.3
|
%
|
||
Irit
Arbel
|
2,600,000
|
(4)
|
4.7
|
%
|
||
Jonathan Javitt | 1,060,000 | (5) | 1.9 | % | ||
Moshe
Lion
|
100,000
|
(6)
|
*
|
|||
Robert
Shorr
|
300,000
|
(7)
|
*
|
|||
Malcolm
Taub
|
1,350,000
|
(8)
|
2.4
|
%
|
||
All
directors and Named Executive Officers as
a group (8 persons)
|
46,144,703
|
(9) |
59.0
|
%
|
||
5%
Shareholders
|
||||||
ACCBT
Corp.
Morgan
& Morgan Building
Pasea
Estate, Road Town
Tortola
British
Virgin Islands
|
39,481,925
|
(10)
|
51.7
|
%
|
||
Ramot
at Tel Aviv University Ltd.
32
Haim Levanon St.
Tel
Aviv University, Ramat Aviv
Tel
Aviv, L3 61392
|
3,181,924 | (11) | 5.4 | % | ||
Eldad
Melamed
c/o
Rabin Medical Center
Beilinson
Campus
Sackler
School of Medicine, Tel Aviv University
Petah-Tikva,
L3 49100
|
2,840,956
|
(12)
|
5.1
|
%
|
||
Daniel
Offen
c/o
Felsenstein Medical Research Center
Rabin
Medical Center, Tel Aviv University
Petah-Tikva,
L3 49100
|
2,840,955
|
(13)
|
5.1
|
%
|
||
Vivian
Shaltiel
|
2,857,142
|
5.2
|
%
|
*
|
Less than
1%.
|
(1)
|
Consists of 500,000 shares of
Common Stock issuable upon the exercise of Presently Exercisable
Options.
|
(2)
|
Consists of (i) 18,306,925 shares
of Common Stock owed by ACCBT Corp. and (ii) 21,175,000 shares of Common
Stock issuable upon the exercise of Presently Exercisable
Warrants. ACCBT Corp. and ACC International Holdings Ltd. may
each be deemed the beneficial owners of these shares. Based
solely on information provided in Amendment No. 4 to Schedule 13D filed
with the SEC by ACCBT Corp. on April 28,
2008.
|
(3)
|
Consists of 752,778 shares of
Common Stock issuable upon the exercise of Presently Exercisable
Options.
|
87
(4)
|
Includes 300,000 shares of Common
Stock issuable upon the exercise of Presently Exercisable Options. Dr.
Arbel’s address is 6 Hadishon Street, Jerusalem,
Israel.
|
(5)
|
Includes 100,000 shares of Common
Stock issuable upon the exercise of Presently Exercisable
Options.
|
(6)
|
Consists of 100,000 shares of
Common Stock issuable upon the exercise of Presently Exercisable
Options.
|
(7)
|
Consists of 300,000 shares of
restricted stock, which shares are subject to the Company’s right to
repurchase.
|
(8)
|
Includes
100,000 shares of Common Stock issuable upon the exercise of Presently
Exercisable Options.
|
(9)
|
Includes 1,852,778 shares of Common Stock issuable upon the exercise of Presently Exercisable Options and 21,175,000 shares of Common Stock issuable upon the exercise of Presently Exercisable Warrants. |
(10)
|
Consists of (i) 18,306,925 shares
of Common Stock owed by ACCBT Corp. and (ii) 21,175,000 shares of Common
Stock issuable upon the exercise of Presently Exercisable
Warrants. ACC International Holdings Ltd. and Chaim Lebovits
may each be deemed the beneficial owners of these shares. Based
solely on information provided in Amendment No. 4 to Schedule 13D filed
with the SEC by ACCBT Corp. on April 28,
2008.
|
(11)
|
Consists of shares of Common
Stock issuable upon the exercise of Presently Exercisable Warrants.
Tel-Aviv University and Tel Aviv University Economic Corporation Ltd. may
each be deemed the beneficial owners of these shares. Based solely on
information provided in an Amendment to Schedule 13D filed with the SEC by
Ramot at Tel-Aviv University Ltd. on September 17,
2007.
|
(12)
|
Consists
of (i) 2,688,178 shares of Common Stock issuable upon the exercise of
Presently Exercisable Warrants and (ii) 152,778 shares of Common Stock
issuable upon exercise of Presently Exercisable Options. Based
solely on information provided in Schedule 13D filed with the SEC by Prof.
Eldad Melamed on September 26,
2005.
|
(13)
|
Consists
of (i) 2,688,177 shares of Common Stock issuable upon the exercise of
Presently Exercisable Warrants and (ii) 152,778 shares of Common Stock
issuable upon the exercise of Presently Exercisable
Options. Based solely on information provided in Schedule 13D
filed with the SEC by Daniel Offen on September 26,
2005.
|
Equity
Compensation Plan Information
The
following table summarizes certain information regarding our equity compensation
plans as of December 31, 2008:
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
|
8,391,778 | (1) | $ | 0.281 | 5,151,694 | (2) | ||||||
Equity
compensation plans not approved by security holders
|
0 | 0 | 0 | |||||||||
Total
|
5,151,684 | (1) | 5,151,684 | (2) |
88
(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.
|
Change
in Control
Subscription
Agreement
On July
2, 2007, we entered into a subscription agreement (the “Subscription Agreement”)
with ACCBT Corp. (“ACCBT”), 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 are scheduled to take place from August 30, 2007 through November 15,
2008. If ACCBT purchases all of the shares that it is entitled to under the
Subscription Agreement and converts all of the warrants that it is entitled to
receive, it will own approximately 66.9% of the Common Stock of the Company. A
change in control of the Company will occur upon ACCBT’s purchase and/or
conversion of more than 50% of our Common Stock. To date, ACCBT has purchased
17,125,000 and assigned to its designee 2,125,000 shares of the Company’s Common
Stock under the Subscription Agreement. ACCBT also purchased warrants
to purchase 1,181,925 shares of the Company’s Common Stock from Ramot and
converted the warrants to shares.
Security
Holders Agreement
Pursuant
to the Subscription Agreement, ACCBT and certain other security holders of
the Company holding at least 31% of the issued and outstanding shares of our
Common Stock entered into a Security Holders Agreement (the “Security Holders
Agreement”). The security holders party to the Security Holders Agreement
agreed, upon the payment by ACCBT of its first $1.0 million under the
Subscription Agreement, to vote all of their shares such that ACCBT’s nominees
to our Board of Directors will constitute a minimum of 40% of the Board of
Directors, and, upon the payment by ACCBT of its second $1.0 million, to vote
all of their shares such that ACCBT’s nominees will constitute a minimum of
50.1% of the Board of Directors. To date, ACCBT has paid $3.98 million
pursuant to the Subscription Agreement and therefore has the right to nominate
50.1% of the Board of Directors under the Security Holders
Agreement.
The
security holders who are parties to the Security Holders Agreement also agreed,
for so long as ACCBT holds at least 5% of the issued and outstanding shares of
our Common Stock, not to vote any of their shares to approve the following
matters, without the written consent of ACCBT: (i) any change in our certificate
of incorporation or bylaws, or alteration of our capital structure; (ii) the
declaration or payment of a dividend or the making of any distributions; (iii)
the taking of any steps to liquidate, dissolve, wind-up or otherwise terminate
our corporate existence; or (iv) the entering into any transaction the effect of
which would place control of our business in the hands of an arm’s length third
party.
89
Item 13.
|
CERTAIN RELATIONSHIPS AND RELATED
TRANSACTIONS, AND DIRECTOR
INDEPENDENCE.
|
The Audit Committee approves all
related party transactions to which the Company is a party.
Research
and License Agreement with Ramot
See “Item
1. Business” for a complete description of the Research and License Agreement
with Ramot.
Investment
Agreement with ACCBT Corp.
On July
2, 2007, we entered into a Subscription Agreement with ACCBT, a company under
the control of Mr. Chaim Lebovits, our newly appointed President, pursuant to
which we agreed to sell (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 are scheduled to take place from August 30,
2007 through November 15, 2008. The warrants will have the following exercise
prices: (i) warrants for the first 10,083,333 shares of our Common Stock will
have an exercise price of $0.20; (ii) warrants for the next 10,083,333 shares of
our Common Stock will have an exercise price of $0.29; and (iii) warrants for
the final 10,083,334 shares of our Common Stock will have an exercise price of
$0.36. Because of our recent resolution and restructuring of the amounts owed by
us to Ramot under the Ramot license agreement, ACCBT elected to accelerate the
date of the first closing under the Subscription Agreement from August 30, 2007
to August 10, 2007. Therefore, on August 20, 2007, we received an aggregate of
$1,000,000 from ACCBT, and, in connection therewith, ACCBT agreed to apply the
principal amounts outstanding under the $250,000 convertible promissory note,
dated as of May 6, 2007, issued to ACCBT by the Company towards the $5 million
aggregate subscription price under the subscription agreement in exchange for
shares of Common Stock (at which point the promissory note was cancelled).
Accordingly, we issued to ACCBT an aggregate of 6,875,000 shares of Common Stock
and a warrant to purchase an aggregate of 7,562,500 shares of Common Stock. In
November 2007, we received an aggregate of $750,000 from ACCBT, and we issued to
ACCBT an aggregate of 4,125,000 shares of Common Stock and a warrant to purchase
an aggregate of 4,537,500 shares of Common Stock. On April 3, 2008, we closed a
transaction where we received an aggregate of $750,000 from ACCBT and a
permitted assignee, and we issued 2,125,000 shares of Common Stock to the
permitted assignee, 2,000,000 shares of Common Stock to ACCBT and a warrant to
purchase an aggregate of 4,537,500 shares of Common Stock to ACCBT.
As a
condition to each closing under the Subscription Agreement, the market price per
share of our Common Stock may not be 10% less than the bid price per share under
the subscription agreement on any trading day between 30 and 10 days prior to
any given closing date. If at any time prior to the first closing date we issue
shares of Common Stock or others securities convertible into, exercisable or
exchangeable for Common Stock, then the number of shares to be issued to ACCBT
under the Subscription Agreement and the price per share will be adjusted so
that ACCBT will have the right to purchase up to 52.35% of our equity on a fully
diluted as converted basis (assuming ACCBT purchases all of the shares and
exercises in full all of the warrants subject to the Subscription Agreement) and
50.02% of the issued and outstanding shares of our Common Stock (assuming ACCBT
invests the full $5.0 million).
Pursuant
to the Subscription Agreement, ACCBT and certain other security holders of
the Company holding at least 31% of the issued and outstanding shares of our
Common Stock entered into a Security Holders Agreement. The security holders
party to the Security Holders Agreement agreed, upon the payment by ACCBT of its
first $1.0 million under the Subscription Agreement, to vote all of their shares
such that ACCBT’s nominees to our Board of Directors will constitute a minimum
of 40% of the Board of Directors, and, upon the payment by ACCBT of its second
$1.0 million, to vote all of their shares such that ACCBT’s nominees will
constitute a minimum of 50.1% of the Board of Directors. To date, ACCBT
has paid $3.98 million pursuant to the Subscription Agreement and therefore has
the right to nominate 50.1% of the Board of Directors under the Security Holders
Agreement. ACCBT has previously designated Dr. Jonathan C. Javitt and Moshe Lion
as its nominees for election to the Company’s Board of Directors.
90
The
security holders who are parties to the Security Holders Agreement also agreed,
for so long as ACCBT holds at least 5% of the issued and outstanding shares of
our Common Stock, not to vote any of their shares to approve the following
matters, without the written consent of ACCBT: (i) any change in our certificate
of incorporation or bylaws, or alteration of our capital structure; (ii) the
declaration or payment of a dividend or the making of any distributions; (iii)
the taking of any steps to liquidate, dissolve, wind-up or otherwise terminate
our corporate existence; or (iv) the entering into any transaction the effect of
which would place control of our business in the hands of an arm’s length third
party.
In
connection with the Subscription Agreement, we agreed to issue, as a finder’s
fee, an aggregate of 1,250,000 shares of our Common Stock to Tayside Trading
Ltd. or its assigns. The shares will be issued pro rata to the funds received
from ACCBT on each closing date under the subscription agreement. As of April 1,
2009, 875,000 shares have been issued to the assignee of Tayside Trading
Ltd.
Transfer
of Warrant from Ramot at Tel Aviv University Ltd. to ACCBT
Corp.
Pursuant
to the terms of a Warrant Purchase Agreement, dated August 2, 2007, between
Ramot at Tel Aviv University Ltd. and ACCBT, Ramot agreed to transfer and sell
to ACCBT (or to certain parties that may be designated by ACCBT), a warrant to
purchase an aggregate of 3,181,925 shares of our Common Stock for an aggregate
purchase price of $636,385. The warrant is exercisable at any time for an
exercise price per share equal to $0.01. The warrant will expire on November 4,
2012. On September 6, 2007, ACCBT acquired a warrant from Ramot to purchase an
aggregate of 1,181,925 shares of our Common Stock for an aggregate purchase
price of $236,385. ACCBT designated other purchasers to acquire the remaining
warrants to purchase 1,000,000 shares of our Common Stock. On September 10,
2007, ACCBT exercised the warrant for the entire 1,181,925 shares of our Common
Stock for an aggregate exercise price of $11,819.
On August
27, 2008, ACCBT received 960,000 shares of Common Stock upon a cashless exercise
of a warrant to purchase 1,000,000 shares of Common Stock. The shares
were sold to Jonathan Javitt, a company director
Agreement
with Vivian Shaltiel
On April
13, 2008, we entered into an agreement with Vivian Shaltiel, a 5% stockholder of
the Company, pursuant to which Ms. Shaltiel agreed to partially defer
and partially convert to equity the payment of $1,250,000 (the “Debt”) owed by
the Company to Ms. Shaltiel pursuant to: (i) a Convertible Promissory Note,
dated February 7, 2006, in the original principal amount of $500,000, (ii) a
Convertible Promissory Note, dated June 5, 2006, in the original principal
amount of $500,000, (iii) a Convertible Promissory Note, dated September 14,
2006, in the original principal amount of $100,000 and (iv) an agreement by and
between Ms. Shaltiel and the Company, dated as of September 10, 2007, and
amended as of November 1, 2007, scheduling repayment of the above Convertible
Promissory Notes on a deferred schedule (the “Deferral
Agreement”). The Company issued 2,857,142 shares of common stock to
Ms. Shaltiel in lieu of the repayment of $1,000,000 of the Debt.
Pursuant
to the Deferral, the Company agreed to pay $250,000 of the Debt in accordance
with the following schedule:
91
Payment
Date
|
Amount
|
|||
May
30, 2008
|
$
|
50,000
|
||
July
31, 2008
|
$
|
50,000
|
||
September
30, 2008
|
$
|
50,000
|
||
December
31, 2008
|
$
|
50,000
|
||
February
28, 2009
|
$
|
50,000
|
Ms.
Shaltiel 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
outstanding obligations owed to Ms. Shaltiel under the notes will be satisfied
in full. Ms. Shaltiel 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 to Ms. Shaltiel under any of the notes or the Deferral
Agreement.
On April
2, 2009, we entered into an agreement with Ms. Shaltiel pursuant to which Ms.
Shaltiel agreed to convert to equity the payment of $200,000 of the Debt (the
“Second Deferral Agreement”). The Company shall issue 2,500,000
shares of common stock to Ms. Shaltiel in lieu of the repayment of $200,000 of
the Debt. The remainder of the Debt owed to Ms. Shaltiel ($50,000)
was paid to her in July 2008.
Independence
of Members of Board of Directors
The Board
of Directors has determined that each of Dr. Arbel, Dr. Javitt, Mr. Lion, Dr.
Shorr and Mr. Taub satisfies the criteria for being an “independent
director” under the standards of the Nasdaq Stock Market, Inc. (“Nasdaq”) and
has no material relationship with the Company other than by virtue of service on
the Board of Directors.
Item 14.
|
PRINCIPAL
ACCOUNTING FEES AND SERVICES
|
The
following table presents fees for professional audit services rendered by
Brightman Almagor Zohar & Co., a member of Deloitte Touche Tohmatsu
(“Brightman”) for the audit of the Company’s financial statements for the fiscal
year ended December 31, 2008 and by Kost Forer Gabbay & Kasierer (“Kost”)
for the audit of the Company’s financial statements for the fiscal year ended
December 31, 2007 and fees billed for other services rendered by Brightman and
Kost during those periods.
December 31,
|
December 31,
|
|||||||
2008
|
2007
|
|||||||
Audit
Fees (1)
|
$ | 45,000 | $ | 72,000 | ||||
Audit-Related
Fees
|
— | — | ||||||
Tax
Fees
|
— | $ | 5,000 | |||||
All
Other Fees (2)
|
$ | — | $ | 1,500 | ||||
Total
Fees
|
$ | 45,000 | $ | 78,500 |
|
(1)
|
Audit fees are comprised of fees
for professional services performed by Brightman or Kost, as applicable,
for the audit of the Company’s annual financial statements and the review
of the Company’s quarterly financial statements, as well as other services
provided by Brightman or Kost, as applicable, in connection with statutory
and regulatory filings or
engagements.
|
|
(2)
|
In 2007, all other fees consisted
of an audit by Kost of the annual report for the Israeli Office of Chief
Scientist.
|
92
We did
not use Brightman or Kost for financial information system design and
implementation. These services, which include designing or implementing a system
that aggregates source data underlying the financial statements and generates
information that is significant to our financial statements, are provided
internally or by other service providers. We did not engage Brightman or Kost to
provide compliance outsourcing services.
Pre-approval
Policies
Prior to
the establishment of our Audit Committee, the Board of Directors pre-approved
all services provided by our independent auditors. All of the above services and
fees were reviewed and approved by the Board before the services were rendered.
Our Audit Committee is now responsible for pre-approving all services provided
by our independent auditors.
The Board
of Directors has considered the nature and amount of fees billed by Brightman
and believes that the provision of services for activities unrelated to the
audit is compatible with maintaining Brightman’s independence.
PART
IV
Item
15.
|
EXHIBITS, FINANCIAL
STATEMENT SCHEDULES
|
The
Exhibits listed in the Exhibit Index immediately preceding such Exhibits are
filed with, or incorporated by reference, in this report.
93
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:
April 15, 2009
|
By:
|
/s/ Rami Efrati
|
|
Name:
Rami Efrati
|
|||
Title:
Chief Executive
Officer
|
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
|
April 13,
2009
|
||
Rami
Efrati
|
(Principal
Executive Officer)
|
|||
/s/ David
Stolick
|
Chief
Financial Officer
|
April 13,
2009
|
||
David
Stolick
|
(Principal
Financial and Accounting Officer)
|
|||
|
Director
|
April __,
2009
|
||
Irit
Arbel
|
||||
/s/ Jonathan C.
Javitt
|
Director
|
April 13,
2009
|
||
Jonathan
C. Javitt
|
||||
|
Director
|
April __,
2009
|
||
Moshe
Lion
|
||||
/s/ Robert
Shorr
|
Director
|
April 13,
2009
|
||
Robert
Shorr
|
||||
/s/ Malcolm
Taub
|
Director
|
April 13,
2009
|
||
Malcolm
Taub
|
94
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).
|
|
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).
|
95
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
|
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).
|
|
10.13
|
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).
|
|
10.14
|
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).
|
|
10.15
|
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).
|
|
10.16
|
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).
|
|
10.17
|
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).
|
|
10.18
|
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).
|
|
10.19
|
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).
|
96
10.20*
|
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).
|
|
10.21*
|
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).
|
|
10.22*
|
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).
|
|
10.23*
|
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).
|
|
10.24
|
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).
|
|
10.25
|
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).
|
|
10.26
|
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).
|
|
10.27
|
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).
|
|
10.28*
|
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).
|
|
10.29*
|
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).
|
|
10.30
|
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).
|
|
10.31
|
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).
|
|
10.32
|
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).
|
97
10.33*
|
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).
|
|
10.34*
|
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).
|
|
10.35*
|
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).
|
|
10.36*
|
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).
|
|
10.37*
|
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).
|
|
10.38*
|
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).
|
|
10.39
|
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).
|
|
10.40
|
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).
|
|
10.41
|
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).
|
|
10.42
|
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).
|
|
10.43
|
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).
|
|
10.44
|
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).
|
98
10.45
|
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).
|
|
10.46
|
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).
|
|
10.47
|
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).
|
|
10.48
|
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).
|
|
10.49
|
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).
|
|
10.50
|
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).
|
|
10.51
|
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).
|
|
10.52
|
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).
|
|
10.53
|
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).
|
|
10.54
|
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).
|
|
10.55
|
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).
|
|
10.56
|
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).
|
|
10.57
|
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).
|
99
10.58
|
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).
|
|
10.59
|
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).
|
|
10.60
|
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).
|
|
10.61
|
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).
|
|
10.62
|
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).
|
|
10.63
|
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).
|
|
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 Zohar & 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.
|
100