Unassociated Document
FILED PURSUANT TO RULE
424(b)(1)
Registration
Statement No. 333-179331
PROSPECTUS
BRAINSTORM CELL THERAPEUTICS INC.
19,818,972 Shares of Common
Stock
Warrants
to Purchase 14,864,229 Shares of Common Stock
and
14,864,229 Shares of Common
Stock Underlying Warrants
We are offering 19,818,972 shares of our common stock
and warrants to purchase up 14,864,229 shares of our common stock. For each share of our common stock purchased by an investor
in this offering, the investor will receive a warrant to purchase 0.75 shares of our common stock with an exercise price of $0.29
per share and a term of exercise of 30 months. We are not required to sell any specific dollar amount or number of shares of common
stock or warrants, but will use our best efforts to sell all of the shares of common stock and warrants being offered.
Our common stock is traded on the OTCQB Bulletin Board under
the symbol “BCLI”. On July 9, 2012, the last reported sales price for our common stock was $0.29 per share.
Investing in our common stock involves a high degree of risk. You should review carefully the risks and uncertainties described under the heading “Risk Factors” beginning on page 4 of this prospectus, and under similar headings in any amendments or supplements to this prospectus.
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Per Share
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Total
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Public
Offering Price
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$ |
0.29 |
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$ |
5,747,502 |
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Placement
Agent fees (1)
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$ |
0.0174 |
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$ |
344,850 |
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Offering
Proceeds before expenses (2)
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$ |
0.2726 |
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$ |
5,402,652 |
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| (1) | For the purpose of estimating the placement agent’s
fees, we have assumed that the placement agent will receive
its maximum commission on all sales made in the offering. Does
not include a corporate finance fee in the amount of 1.0%,
or $0.0029 per share and $57,475 in the aggregate, of the gross proceeds of the offering payable
to the placement agent. We have also agreed to issue warrants
to the placement agent and to reimburse the placement agent
for expenses incurred by them up to an aggregate of the lesser
of (i) $100,000 or (ii) 3% of the gross proceeds of the offering. |
| (2) | We estimate the total expenses of this offering will be
approximately $835,825.14 See “Plan of Distribution” beginning
on page 18 of this prospectus for more information on this offering. |
Because there is no minimum offering amount required as a condition to closing
in this offering, the actual public offering amount and proceeds to us, if any, are not presently determinable and may be substantially
less than the total maximum offering set forth above. Maxim Group LLC has agreed to act as our placement agent in connection with
this offering. The placement agent is not purchasing the securities offered by us, and is not required to sell any specific number
or dollar amount of securities, but will use their best efforts to arrange for the sale of the securities offered by us. We have
agreed to pay the placement agent a cash fee equal to 6% and a corporate finance fee equal to 1% of the gross proceeds of the
offering, as well as an expense allowance equal to the lesser of (i) $100,000 and (ii) 3% of the gross proceeds raised in the
offering.
This
offering will terminate on September 30, 2012, unless the offering is fully subscribed before that date or we decide to
terminate the offering prior to that date. In either event, the offering may be closed without further notice to you. All costs
associated with the registration will be borne by us. As there is no minimum purchase requirement, no funds are
required to be escrowed and all net proceeds will be available to us at closing for use as set forth in “Use
of Proceeds” beginning on page 16.
Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or passed upon the adequacy or accuracy of this prospectus. Any representation to the contrary is a criminal offense.
Maxim Group LLC
The
date of this prospectus is July 19, 2012.
TABLE OF CONTENTS
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Page
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PROSPECTUS SUMMARY
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1
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RISK FACTORS
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4 |
DISCLOSURE REGARDING FORWARD-LOOKING STATEMENTS
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15 |
EXCHANGE RATE INFORMATION
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16 |
USE OF PROCEEDS
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16 |
DIVIDEND POLICY
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17 |
DILUTION
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17 |
PLAN OF DISTRIBUTION
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18 |
DESCRIPTION OF SECURITIES
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19 |
OUR BUSINESS
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21 |
PROPERTIES
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31 |
LEGAL PROCEEDINGS
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31 |
MARKET FOR OUR COMMON EQUITY
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32 |
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
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34 |
CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE
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37 |
MANAGEMENT
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38 |
EXECUTIVE COMPENSATION
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44 |
SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT
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49 |
RELATED PARTY TRANSACTIONS
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50 |
LEGAL MATTERS
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54 |
EXPERTS
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54 |
INDEMNIFICATION UNDER OUR CERTIFICATE OF INCORPORATION AND BYLAWS
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54 |
WHERE YOU CAN FIND MORE INFORMATION
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55 |
ABOUT THIS PROSPECTUS
You should rely only on the information contained in or incorporated by reference in this prospectus and any applicable prospectus supplement. We have not authorized anyone to provide you with different or additional information. If anyone provides you with different or inconsistent information, you should not rely on it. The information contained in this prospectus is accurate only as of the date of this prospectus, regardless of the time of delivery of this prospectus or any sale of securities described in this prospectus. This prospectus is not an offer to sell these securities and it is not soliciting an offer to buy these securities in any jurisdiction where the offer or sale is not permitted. You should assume that the information appearing in this prospectus or any prospectus supplement, as well as information we have previously filed with the Securities and Exchange Commission (“SEC”) and incorporated by reference, is accurate as of the date on the front of those documents only. Our business, financial condition, results of operations and prospects may have changed since those dates.
As used herein, “we,” “us,” “our” or the “Company” refers to Brainstorm Cell Therapeutics Inc.
PROSPECTUS SUMMARY
This summary may not contain all of the information that may be important to you. You should read the entire prospectus, including the financial data and related notes, and risk factors.
Company Overview
We are a biotechnology company developing innovative stem cell therapeutic products based on technologies enabling the in-vitro differentiation of bone marrow stem cells into neural-like cells. We aim to become a leader in adult stem cell transplantation for neurodegenerative diseases. Our technology entails exploiting the patient’s own bone marrow stem cells to generate glial-like cells that may provide an effective treatment for Amyotrophic Lateral Sclerosis (“ALS”), Parkinson’s Disease (“PD”), Multiple Sclerosis (“MS”) and Spinal Cord Injury.
Our core technology was developed in collaboration with 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 Prof. Daniel Offen, of the Felsenstein Medical Research Center of Tel Aviv University.
Our team demonstrated formation of neurotrophic-factor secreting cells (glial-like cells) from in-vitro differentiated bone marrow cells that produce neurotrophic factors (“NTF”) including Glial Derived Neurotrophic factor (“GDNF”), Brain Derived Neurotrophic factor (“BDNF”) and additional factors. Moreover, in research conducted by our team, implantation of these differentiated cells into brains of animal models that had been induced to Parkinsonian behavior markedly improved their condition.
Our aim is to provide neural-supporting stem cell transplants that are expected to maintain, preserve and possibly restore the damaged neurons, protecting them from further degeneration.
Our wholly-owned Israeli subsidiary, Brainstorm Cell Therapeutics Ltd. (the "Israeli Subsidiary") holds exclusive worldwide rights to commercialize the technology, through a licensing agreement with Ramot at Tel Aviv University Ltd. (“Ramot”), the technology transfer company of Tel Aviv University, Israel.
As a result of limited cash resources and the desire to take a faster path to clinical trials, since the fourth quarter of 2008 we have focused all of our efforts on ALS, and are currently not allocating resources towards PD, MS or other neurodegenerative diseases. Other indications are currently being evaluated.
We
are currently in the clinical stage of development of our technology and we intend to begin the process of seeking regulatory
approval from regulatory agencies in the U.S.
In
June 2011, we initiated a Phase I/II clinical study for ALS patients using our autologous NurOwn™ stem cell
therapy, after receiving final approval from the Israel Ministry of Health (“MOH”). In June 2012,
the Company completed a study of twelve patients and an interim report is expected to be submitted to the Israel MOH in the
third quarter of fiscal 2012.
Three ALS
patients have been treated on a compassionate use basis in Israel and no adverse events were reported in the six-month
post-transplant follow-up.
In February 2011, the U.S. Food and Drug Administration (“FDA”) granted Orphan Drug designation to our NurOwn™ autologous adult stem cell product candidate for the treatment of ALS. Orphan Drug status entitles us to seven years of marketing exclusivity for NurOwn™ upon regulatory approval, as well as the opportunity to apply for grant funding from the FDA of up to $400,000 per year for four years to defray costs of clinical trial expenses, tax credits for clinical research expenses and potential exemption from the FDA's application user fee.
Our efforts are directed at:
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Operating a Good Manufacturing Practice (“GMP”) compliant production process;
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Demonstrating Safety Tolerability and Therapeutic effect of transplantation of Autologous cultured Bone Marrow Stromal Cells secreting Neurothrophic factors (MSC-NTF) in a Phase I/II Clinical trial in human ALS patients;
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Setting up a centralized facility to provide the therapeutic products
and services for transplantation in patients in the US, as part of the clinical development program; and
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Submitting an Investigational New Drug application (“IND”) to the FDA.
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Our Approach
Our research team led by Prof. Melamed and Prof. Offen has shown that human bone marrow mesenchymal stem cells can be expanded and induced to differentiate into two types of brain cells, neuron-like and astrocyte-like cells, each having different therapeutic potential, as follows:
NurOwn™ program one - Neurotrophic-factors (“NTF”) secreting cells (MSC-NTF) - human bone marrow derived NTF secreting cells for treatment of, ALS, PD and MS. In-vitro differentiation of the expanded human bone marrow derived mesenchymal stem cells in a proprietary medium led 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.
We
have optimized the proprietary processes for induction of differentiation of human bone marrow derived mesenchymal stem cells
into differentiated cells that produce NTF (MSC-NTF). The
optimization and process development is conducted in GMP compliance.
NurOwn™ program two - 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.
Our technology is based on the NurOwn™ products - an autologous cell therapeutic modality, comprising the extraction of the patient bone marrow, which is then processed into the appropriate neuronal-like cells and re-implanted into the patient’s muscles, spinal cord or brain. This approach is taken in order to increase patient safety and minimize any chance of immune reaction or cell rejection.
The therapeutic modality will comprise the following:
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Bone marrow aspiration from patient;
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Isolation and expansion of the mesenchymal stem cells;
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Differentiation of the expanded stem cells into neurotrophic-factor secreting cells; and
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Autologous transplantation into the patient into the site of damage.
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Corporate Information
We are incorporated under the laws of the State of Delaware. Our principal executive offices are located at 605 Third Avenue, 34th Floor, New York, New York 10158, and our telephone number is (646) 666-3188. We maintain an Internet website at http://www.brainstorm-cell.com. The information on our website is not incorporated into this prospectus.
The Offering
Securities
Offered
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19,818,972 shares
of common stock
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Warrants
to purchase 14,864,229 shares of common stock
14,864,229 shares of common stock
issuable upon exercise of the warrants
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Common
stock outstanding as of June 15, 2012
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128,586,644
shares
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Common stock to be outstanding after the offering assuming the sale of all shares covered hereby and assuming no exercise of the warrants for the shares covered by this prospectus
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148,405,616 shares
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Common stock to be outstanding after the offering assuming the sale of all shares covered hereby and assuming the exercise of all warrants for the shares covered by this prospectus
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163,269,845 shares
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Use
of proceeds
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We
estimate that we will receive up to $4,911,676.86 in net proceeds from the sale of the securities
in this offering, based on a per share purchase price of $0.29 and after deducting
placement agent fees and commissions and estimated offering expenses payable by us. We
will use the proceeds from the sale of the securities for clinical trials
in the United States and Israel, research and development, working capital needs, capital expenditures
and other general corporate purposes. See “Use of Proceeds” for more information.
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Risk factors
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The shares of common stock offered hereby involve a high degree of risk. See “Risk Factors” beginning on page 4.
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Dividend policy
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We currently intend to retain any future earnings to fund the development and growth of our business. Therefore, we do not currently anticipate paying cash dividends on our common stock.
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Trading Symbol
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Our common stock currently trades on the OTCQB Bulletin Board under the symbol “BCLI.”
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RISK FACTORS
You should carefully consider and evaluate all of the information in this prospectus, including the risk factors listed below. Risks and uncertainties in addition to those we describe below, that may not be presently known to us, or that we currently believe are immaterial, may also harm our business and operations. If any of these risks occur, our business, results of operations and financial condition could be harmed, the price of our common stock could decline, and future events and circumstances could differ significantly from those anticipated in the forward-looking statements contained in this prospectus.
Risks related to our business
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.
The amount of financing required will depend on many factors including our financial requirements to fund our research and clinical trials, and our ability to secure partnerships and achieve partnership milestones as well as to fund other working capital requirements. Our ability to access the capital markets or to enlist partners is mainly dependent on the progress of our research and development and regulatory approval of our products.
Assuming we raise additional funds through the issuance of equity, equity-related or debt securities, these securities may have rights, preferences or privileges (including registrations rights) senior to those of the rights of our common stock and our stockholders will experience additional dilution.
Our business in the foreseeable future will be based on technology licensed from Ramot and if this license were to be terminated upon failure to make required royalty payments in the future, we would need to change our business strategy and we may be forced to cease our operations.
Agreements we and our Israeli Subsidiary have with Ramot impose on us royalty payment obligations. If we fail to comply with these obligations, Ramot may have the right to terminate the license. If Ramot elects to terminate our license, we would need to change our business strategy and we may be forced to cease our operations. We currently do not owe Ramot any overdue payments.
Our
company has a history of losses and we expect to incur losses for the foreseeable future.
As
a development stage company, we are in the early stages of executing our business plan. We had no revenues for the fiscal years
ended December 31, 2011 or December 31, 2010 nor through June 30, 2012. Our ability to operate successfully is materially uncertain
and our operations are subject to significant risks inherent in a developing business enterprise. We are currently in the process
of introducing the Company to strategic partners. In the upcoming three years, the Company will focus on clinical trials. We are
unable at this time to foresee when we will generate revenues from strategic partnerships or otherwise. 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.
Our product development programs are based on novel technologies and are inherently risky.
We are subject to the risks of failure inherent in the development of products based on new technologies. The novel nature of our stem cell therapy creates significant challenges with regard to product development and optimization, manufacturing, government regulations, and market acceptance. For example, the FDA has relatively limited experience with stem cell therapies. None have been approved by them for commercial sale, and the pathway to regulatory approval for our cell therapy product candidates may accordingly be more complex and lengthy. As a result, the development and commercialization pathway for our therapies may be subject to increased uncertainty, as compared to the pathway for new conventional drugs.
We are faced with uncertainties related to our research.
Our research programs are based on scientific hypotheses and experimental approaches that may not lead to desired results. In addition, the timeframe for obtaining proof of principle and other results may be considerably longer than originally anticipated, or may not be possible given time, resource, financial, strategic and collaborator scientific constraints. Success in one stage of testing is not necessarily an indication that the particular program will succeed in later stages of testing and development. It is not possible to predict, based upon studies in in-vitro models and in animals, whether any of the therapies designed for these programs will prove to be safe, effective, and suitable for human use. Each therapy will require additional research and development, scale-up, formulation and extensive clinical testing in humans. Unsatisfactory results obtained from a particular study relating to a program may cause the Company to abandon its commitment to that program or to the lead therapy or product candidate being tested. The discovery of unexpected toxicities, lack of sufficient efficacy, unacceptable pharmacology, inability to increase scale of manufacture, market attractiveness, regulatory hurdles, competition, as well as other factors, may make our targets, lead therapies or product candidates unattractive or unsuitable for human use, and we may abandon our commitment to that program, target, lead therapy or product candidate. In addition, preliminary results seen in animal and/or limited human testing may not be substantiated in larger controlled clinical trials.
The field of stem cell therapy is relatively new and our development efforts may not yield an effective treatment of human diseases.
Except for bone marrow transplants for neoplastic disease, the field of stem cell therapy remains largely untested in the clinical setting. Our intended cell therapeutic treatment methods for ALS involve a new approach that has not yet been proven to work in humans. We are currently conducting Phase I/II clinical trials for ALS, which, together with other stem cell therapies, may ultimately prove ineffective in treatment of human diseases. If we cannot successfully implement our NurOwnTM stem cell therapy in human testing, we would need to change our business strategy and we may be forced to change our operations.
A significant global market for our services has yet to emerge.
Very few companies have been successful in their efforts to develop and commercialize a stem cell product. We believe that there will be many different applications for products successfully derived from our technologies and that the anticipated market for products under development will continue to expand. No assurance, however, can be given that these beliefs will prove to be correct due to competition from existing or new products and the yet to be established commercial viability of our products. Stem cell products in general may be susceptible to various risks, including undesirable and unintended side effects, unintended immune system responses, inadequate therapeutic efficacy, or other characteristics that may prevent or limit their approval or commercial use. The demand for stem cell processing and the number of people who may use cell or tissue-based therapies is difficult to forecast. As there are no real experts who can forecast this market with accuracy, there is limited data from which the future use of our services may be forecasted. Physicians, patients, formularies, third party payers or the medical community in general may not accept or utilize any products that the Company or its collaborative partners may develop. Our success is dependent on the establishment of a large global market for our products and services and our ability to capture a share of this market.
We have limited experience in conducting and managing clinical trials and the application process necessary to obtain regulatory approvals.
Our limited experience in conducting and managing clinical trials and the application process necessary to obtain regulatory approvals might prevent us from successfully designing or implementing a preclinical study or clinical trial. Cell-based therapy products, in general, may be susceptible to various risks, including undesirable and unintended side effects, unintended immune system responses, inadequate therapeutic efficacy or other characteristics that may prevent or limit their approval by regulators or commercial use. Many companies in the industry have suffered significant setbacks in advanced clinical trials, despite promising results in earlier trials. If our clinical trials are unsuccessful, or if we do not complete our clinical trials, we may not receive regulatory approval for or be able to commercialize our product candidates.
If we do not succeed in conducting and managing our preclinical development activities or clinical trials, or in obtaining regulatory approvals, we might not be able to commercialize our product candidates, or might be significantly delayed in doing so, which will materially harm our business.
Our ability to generate revenues from any of our product candidates will depend on a number of factors, including our ability to successfully complete clinical trials, obtain necessary regulatory approvals and implement our commercialization strategy. We may, and anticipate that we will need to, transition from a company with a research and development focus to a company capable of supporting commercial activities and we may not succeed in such a transition.
We may not be able to secure and maintain research institutions to conduct our clinical trials.
We rely on research institutions to conduct our clinical trials. Specifically, the limited number of centers experienced with cell therapy product candidates heightens our dependence on such research institutions. Our reliance upon research institutions, including hospitals and clinics, provides us with less control over the timing and cost of clinical trials and the ability to recruit subjects. If we are unable to reach agreements with suitable research institutions on acceptable terms, or if any resulting agreement is terminated, we may be unable to quickly replace the research institution with another qualified institution on acceptable terms. Furthermore, we may not be able to secure and maintain suitable research institutions to conduct our clinical trials.
We are subject to a strict regulatory environment. If we fail to obtain and maintain required regulatory approvals for our potential cell therapy products, our ability to commercialize our potential cell therapy products will be severely limited.
None of our product candidates have received regulatory approval for commercial sale.
Numerous statutes and regulations govern human testing and the manufacture and sale of human therapeutic products in the United States and other countries where we intend to market our products. Such legislation and regulation bears upon, among other things, the approval of protocols and human testing, the approval of manufacturing facilities, testing procedures and controlled research, review and approval of manufacturing, preclinical and clinical data prior to marketing approval including adherence to GMP during production and storage as well as regulation of marketing activities including advertising and labeling.
The completion of the clinical testing of our product candidates and the obtaining of required approvals are expected to take several years and require the expenditure of substantial resources. We may experience numerous unforeseen events during, or as a result of, the clinical trial process that could delay or prevent regulatory approval and/or commercialization of our product candidates, including the following:
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The FDA or similar foreign regulatory authorities may find that our product candidates are not sufficiently safe or
effective or may find our processes or facilities unsatisfactory; |
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Officials at the MOH, the FDA or similar foreign regulatory authorities may interpret data from preclinical studies
and clinical trials differently than we do; |
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Our clinical trials may produce negative or inconclusive results or may not meet the level of statistical significance
required by the MOH, the FDA or other regulatory authorities, and we may decide, or regulators may require us, to conduct
additional preclinical studies and/or clinical trials or to abandon one or more of our development programs; |
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The MOH, the FDA or similar foreign regulatory authorities may change their approval policies or adopt new regulations; |
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There may be delays or failure in obtaining approval of our clinical trial protocols from the MOH, the FDA or other
regulatory authorities or obtaining institutional review board approvals or government approvals to conduct clinical trials
at prospective sites; |
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We, or regulators, may suspend or terminate our clinical trials because the participating patients are being exposed
to unacceptable health risks or undesirable side effects; |
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We may experience difficulties in managing multiple clinical sites; |
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Enrollment in our clinical trials for our product candidates may occur more slowly than we anticipate, or we may experience
high drop-out rates of subjects in our clinical trials, resulting in significant delays; and |
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We may be unable to manufacture or obtain from third party manufacturers sufficient quantities of our product candidates
for use in clinical trials. |
Investors should be aware of the risks, problems, delays, expenses and difficulties which may be encountered by us in light of the extensive regulatory environment in which our business operates. In particular, our development costs will increase if we have material delays in our clinical trials, or if we are required to modify, suspend, terminate or repeat a clinical trial. If we are unable to conduct our clinical trials properly and on schedule, marketing approval may be delayed or denied by the MOH or the FDA.
Even if a product candidate is approved by the MOH, the FDA or any other regulatory authority, we may not obtain approval for an indication whose market is large enough to recoup our investment in that product candidate. We may never obtain the required regulatory approvals for any of our product candidates. Later discovery of previously unknown problems with a product, manufacturer or facility may result in restrictions on the product or manufacturer, including a withdrawal of the product from the market.
Even if regulatory approvals are obtained for our product candidates, we will be subject to ongoing government regulation. If we or one or more of our partners or collaborators fail to comply with applicable current and future laws and government regulations, our business and financial results could be adversely affected.
The healthcare industry is one of the most highly regulated industries in the United States. The federal government, individual state and local governments and private accreditation organizations all oversee and monitor the activities of individuals and businesses engaged in the delivery of health care products and services. Even if regulatory authorities approve any of our human therapeutic product candidates, current laws, rules and regulations that could directly or indirectly affect our ability and the ability of our strategic partners and customers to operate each of their businesses could include, without limitation, the following:
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State and local licensing, registration and regulation of laboratories, the collection, processing and storage of human cells and tissue, and the development and manufacture of pharmaceuticals and biologics;
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The federal Clinical Laboratory Improvement Act and amendments of 1988;
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Laws and regulations administered by the FDA, including the Federal Food Drug and Cosmetic Act and related laws and regulations;
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The Public Health Service Act and related laws and regulations;
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Laws and regulations administered by the United States Department of Health and Human Services, including the Office for Human Research Protections;
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State laws and regulations governing human subject research;
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Occupational Safety and Health requirements; and
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State and local laws and regulations dealing with the handling and disposal of medical waste.
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Compliance with such regulation may be expensive and consume substantial financial and management resources. If we, or any future marketing collaborators or contract manufacturers, fail to comply with applicable regulatory requirements, we may be subject to sanctions including fines, product recalls or seizures, injunctions, total or partial suspension of production, civil penalties, withdrawal of regulatory approvals and criminal prosecution. Any of these sanctions could delay or prevent the promotion, marketing or sale of our products.
We are subject to environmental, health and safety laws.
We are subject to various laws and regulations relating to safe working conditions, laboratory and manufacturing practices, the experimental use of animals and humans, emissions and wastewater discharges, and the use and disposal of hazardous or potentially hazardous substances used in connection with our research. We also cannot accurately predict the extent of regulations that might result from any future legislative or administrative action. Any of these laws or regulations could cause us to incur additional expense or restrict our operations.
Compliance with environmental laws and regulations may be expensive, and current or future environmental regulations may impair our research, development or production efforts.
Our success will depend in part on establishing and maintaining effective strategic partnerships and collaborations, which may impose restrictions on our business and subject us to additional regulation.
A key aspect of our business strategy is to establish strategic relationships in order, to expand or complement our research and development or commercialization capabilities, and to reduce the cost of research and development. There can be no assurance that we will enter into such relationships, that the arrangements will be on favorable terms or that such relationships will be successful. If we are ultimately successful in executing our strategy of securing collaborations with companies that would undertake advanced clinical development and commercialization of our products, we may not have day-to-day control over their activities. Any such collaborator may adhere to criteria for determining whether to proceed with a clinical development program under circumstances where we might have continued such a program. Potential collaborators may have significant discretion in determining the efforts and amount of resources that they dedicate to our collaborations or may be unwilling or unable to fulfill their obligations to us, including their development and commercialization. Potential collaborators may underfund or not commit sufficient resources to the testing, marketing, distribution or other development of our products. They may also not properly maintain or defend our intellectual property rights or they may utilize our proprietary information in such a way as to invite litigation that could jeopardize or potentially invalidate our proprietary information or expose us to potential liability. Potential collaboration partners may have the right to terminate the collaboration on relatively short notice and if they do so or if they fail to perform or satisfy their obligations to us, the development or commercialization of products would be delayed and our ability to realize any potential milestone payments and royalty revenue would be adversely affected.
We face competition in our efforts to develop cell therapies for ALS and other neurodegenerative diseases.
We face competition in our efforts to develop cell therapies and other treatment or procedures to cure or slow the effects of 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. Some 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. Some also have significantly more experience in preclinical testing, human clinical trials, product manufacturing, the regulatory approval process and marketing and distribution than we do.
The trend towards consolidation in the pharmaceutical and biotechnology industries may adversely affect us.
There is a trend towards consolidation in the pharmaceutical and biotechnology industries. This consolidation trend may result in the remaining companies having greater financial resources and discovery technological capabilities, thus intensifying competition in these industries. This trend may also result in fewer potential collaborators or licensees for our therapeutic product candidates. Also, if a consolidating company is already doing business with our competitors, we may lose existing licensees or collaborators as a result of such consolidation.
There is a scarcity of experienced professionals in the field of cell therapy and we may not be able to retain key personnel or hire new key personnel needed to implement our business strategy and develop our products and businesses. If we are unable to retain or hire key personnel, we may be unable to continue to grow our business or to implement our business strategy, and our business may be materially and adversely affected.
Given the specialized nature of cell therapy and the fact that it is a young field, there is an inherent scarcity of experienced personnel in the field. Our success depends on a significant extent to the continued services of certain highly qualified scientific and management personnel. We face competition for qualified personnel from numerous industry sources, and there can be no assurance that we will be able to attract and retain qualified personnel on acceptable terms. The loss of service of any of our key personnel could have a material adverse effect on our operations or financial condition. In the event of the loss of services of such personnel, no assurance can be given that we will be able to obtain the services of adequate replacement personnel. We do not have key person life insurance on all of our key personnel. The future success of the Company also depends upon our ability to attract and retain additional qualified personnel (including medical, scientific, technical, commercial, business and administrative personnel) necessary to support our anticipated growth, develop our business, and maintain appropriate licensure, on acceptable terms. There can be no assurance that we will be successful in attracting or retaining personnel required by us to continue and grow our operations. The loss of a key employee, the failure of a key employee to perform in his or her current position or our inability to attract and retain skilled employees, as needed, could result in our inability to continue to grow our business or to implement our business strategy, or may have a material adverse effect on our business, financial condition and results of operations.
Technological and medical developments or improvements in conventional therapies could render the use of stem cells and our services and planned products obsolete.
The pharmaceutical industry is characterized by rapidly changing markets, technology, emerging industry standards and frequent introduction of new products. The introduction of new products embodying new technologies, including new manufacturing processes, and the emergence of new industry standards may render our technologies obsolete, less competitive or less marketable. Advances in other treatment methods or in disease prevention techniques could significantly reduce or entirely eliminate the need for our stem cell services, planned products and therapeutic efforts. Additionally, technological or medical developments may materially alter the commercial viability of our technology or services, and require us to incur significant costs to replace or modify equipment in which we have a substantial investment. In either event, we may experience a material adverse effect on our business, results of operations and financial condition.
If
Ramot is unable to obtain patents on the patent applications and technology exclusively licensed to our Israeli Subsidiary 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 filed by Ramot and the license granted to us and our Israeli Subsidiary by
Ramot under the Research and License Agreement (the “Original Ramot Agreement”), dated as of July 8, 2004, with Ramot,
the technology licensing company of Tel Aviv University. We agreed under the Original Ramot Agreement that Ramot, in consultation
with us, is responsible for obtaining patent protection for technology owned by Ramot and licensed to us. No assurance can be
given that any of our pending or future patent applications will be approved, that the scope of any patent protection granted
will exclude competitors or provide us with competitive advantages, that any of the patents that may be issued to us will be held
valid if subsequently challenged, or that other parties will not claim rights to or ownership of our patents or other proprietary
rights that we hold. Furthermore, there can be no assurance that others have not developed or will not develop similar
products, duplicate any of our technology or products or design around any patents that have been or may be issued to us or any
future licensors. Since patent applications in the United States and in Europe are not disclosed until applications
are published, there can be no assurance that others did not first file applications for products covered by our pending patent
applications, nor can we be certain that we will not infringe any patents that may be issued to 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.
We may be unable to protect our intellectual property from infringement by third parties.
Despite our efforts to protect our intellectual property, third parties may infringe or misappropriate our intellectual property. Our competitors may also independently develop similar technology, duplicate our processes or services or design around our intellectual property rights. We may have to litigate to enforce and protect our intellectual property rights to determine their scope, validity or enforceability. Intellectual property litigation is costly, time-consuming, diverts the attention of management and technical personnel and could result in substantial uncertainty regarding our future viability. The loss of intellectual property protection or the inability to secure or enforce intellectual property protection would limit our ability to develop or market our services in the future. This would also likely have an adverse effect on the revenues generated by any sale or license of such intellectual property. Furthermore, any public announcements related to such litigation or regulatory proceedings could adversely affect the price of our common stock.
Third parties may claim that we infringe on their intellectual property.
We may be subject to costly litigation in the event our technology is claimed to infringe upon the proprietary rights of others. Third parties may have, or may eventually be issued, patents that would be infringed by our technology. Any of these third parties could make a claim of infringement against us with respect to our technology. We may also be subject to claims by third parties for breach of copyright, trademark or license usage rights. Litigation and patent interference proceedings could result in substantial expense to us and significant diversion of efforts by our technical and management personnel. An adverse determination in any such proceeding or in patent litigation could subject us to significant liabilities to third parties or require us to seek licenses from third parties. Such licenses may not be available on acceptable terms or at all. Adverse determinations in a judicial or administrative proceeding or failure to obtain necessary licenses could prevent us from commercializing our products, which would have a material adverse effect on our business, results of operations and financial condition.
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.
It is uncertain to what extent the government, private health insurers and third-party payers will approve coverage or provide reimbursement for the therapies and products to which our services relate. Availability for such reimbursement may be further limited by an increasing uninsured population and reductions in Medicare and Medicaid funding in the United States.
Our ability to successfully commercialize our human therapeutic products will depend significantly on our ability to obtain acceptable prices and the availability of reimbursement to the patient from third-party payers, such as government and private insurance plans. While we have not commenced discussions with any such parties, these third-party payers frequently require companies to provide predetermined discounts from list prices, and they are increasingly challenging the prices charged for pharmaceuticals and other medical products. Our human therapeutic products may not be considered cost-effective, and reimbursement to the patient may not be available or sufficient to allow us to sell our products on a competitive basis. Further, as cost containment pressures are increasing in the health care industry, government and private payers adopt strategies designed to limit the amount of reimbursement paid to health care providers. Such cost containment measures may include:
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Reducing reimbursement rates;
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Challenging the prices charged for medical products and services;
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Limiting services covered;
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Decreasing utilization of services;
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Negotiating prospective or discounted contract pricing;
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Adopting capitation strategies; and
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Seeking competitive bids.
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Similarly, the trend toward managed health care and bundled pricing for health care services in the United States could significantly influence the purchase of healthcare services and products, resulting in lower prices and reduced demand for our therapies.
We may not be able to negotiate favorable reimbursement rates for our human therapeutic products. If we fail to obtain acceptable prices or an adequate level of reimbursement for our products, the sales of our products would be adversely affected or there may be no commercially viable market for our products.
Unintended consequences of recently adopted health reform legislation in the U.S. may adversely affect our business.
The healthcare industry is undergoing fundamental changes resulting from political, economic and regulatory influences. In the U.S., comprehensive programs are under consideration that seek to, among other things, increase access to healthcare for the uninsured and control the escalation of healthcare expenditures within the economy. On March 23, 2010, health reform legislation was approved by Congress and has been signed into law. While we do not believe this legislation will have a direct impact on our business, the legislation has only recently been enacted and requires the adoption of implementing regulations, which may have unintended consequences or indirectly impact our business. For instance, the scope and implications of the recent amendments pursuant to the Fraud Enforcement and Recovery Act of 2009 have yet to be fully determined or adjudicated and as a result it is difficult to predict how future enforcement initiatives may impact our business. Also, in some instances our clients may be health insurers that will be subject to limitations on their administrative expenses and new federal review of “unreasonable” rate increases which could impact the prices they pay for our services. If the legislation causes such unintended consequences or indirect impact, it could have a material adverse effect on our business, financial condition and results of operations.
Ethical and other concerns surrounding the use of stem cell therapy may negatively impact the public perception of our stem cell services, thereby suppressing demand for our services.
Although our stem cell business pertains to adult stem cells only, and does not involve the more controversial use of embryonic stem cells, the use of adult human stem cells for therapy could give rise to similar ethical, legal and social issues as those associated with embryonic stem cells, which could adversely affect its acceptance by consumers and medical practitioners. Additionally, it is possible that our business could be negatively impacted by any stigma associated with the use of embryonic stem cells if the public fails to appreciate the distinction between adult and embryonic stem cells. Delays in achieving public acceptance may materially and adversely affect the results of our operations and profitability.
We are exposed to fluctuations in currency exchange rates.
A significant portion of our business, particularly our research and development, is conducted outside the United States. Therefore, we are exposed to currency exchange fluctuations in other currencies such as the New Israeli Shekels (“NIS”) and the Euro. Moreover, a portion of our expenses in Israel and Europe are paid in NIS and Euros, respectively, which subjects us to the risks of foreign currency fluctuations. Our primary expenses paid in NIS are employee salaries, fees for consultants and subcontractors and lease payments on our Israeli facilities.
The dollar cost of our operations in Israel will increase to the extent increases in the rate of inflation in Israel are not offset by a devaluation of the NIS in relation to the dollar, which would harm our results of operations.
Since a considerable portion of our expenses such as employees' salaries are linked to an extent to the rate of inflation in Israel, the dollar cost of our operations is influenced by the extent to which any increase in the rate of inflation in Israel is or is not offset by the devaluation of the NIS inrelation to the dollar. As a result, we are exposed to the risk that the NIS, after adjustment for inflation in Israel, will appreciate in relation to the dollar. In that event, the dollar cost of our operations in Israel will increase and our dollar-measured results of operations will be adversely affected. During the past few years inflation-adjusted NIS appreciated against the dollar, which raised the dollar cost of our Israeli operations. We cannot predict whether the NIS will appreciate against the dollar or vice versa in the future. Any increase in the rate of inflation in Israel, unless the increase is offset on a timely basis by a devaluation of the NIS in relation to the dollar, will increase labor and other costs, which will increase the dollar cost of our operations in Israel and harm our results of operations.
We may be subject to significant product liability claims and litigation which could adversely affect our future earnings and financial condition.
Our business exposes us to potential product liability risks inherent in the testing, processing and marketing of stem cell therapy products. Specifically, the conduct of clinical trials in humans involves the potential risk that the use of our stem cell therapy products will result in adverse effects. Such liability claims may be expensive to defend and result in large judgments against us. We currently maintain liability insurance for our clinical trials; however such liability insurance may not be adequate to fully cover any liabilities that arise from clinical trials of our stem cell therapy products. We also maintain errors and omissions, directors and officers, workers’ compensation and other insurance appropriate to our business activities. If we were to be subject to a claim in excess of this coverage or to a claim not covered by our insurance and the claim succeeded, we would be required to pay the claim from our own limited resources, which could have a material adverse effect on our financial condition, results of operations and business. Additionally, liability or alleged liability could harm our business by diverting the attention and resources of our management and damaging our reputation and that of our subsidiaries.
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. Acts of random terrorism periodically occur which could affect our operations or personnel. 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.
In addition, Israeli-based companies and companies doing business with Israel have been the subject of an economic boycott by members of the Arab League and certain other predominantly Muslim countries since Israel's establishment. Although Israel has entered into various agreements with certain Arab countries and the Palestinian Authority, and various declarations have been signed in connection with efforts to resolve some of the economic and political problems in the Middle East, we cannot predict whether or in what manner these problems will be resolved. Wars and acts of terrorism have resulted in damage to the Israeli economy, including reducing the level of foreign and local investment.
Furthermore, certain of our officers and employees may be obligated to perform annual reserve duty in the Israel Defense Forces and are subject to being called up for active military duty at any time. Israeli citizens who have served in the army may be subject to an obligation to perform reserve duty until they are between 40 and 49 years old, depending upon the nature of their military service.
Risks related to our common stock
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 issuances of our securities.
In order to meet our financing needs, 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.
ACCBT
Corp. holds equity participation rights and other 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.
ACCBT Corp. is entitled to purchase its pro rata share of any additional securities we offer, so that its percentage
ownership of the Company remains the same after any such issuance of additional securities. Such additional securities will
be offered to ACCBT Corp. at the same price and on the same terms as the other investors in the transaction. ACCBT Corp. will
have 30 days from the date of our notice to ACCBT Corp. of any intended transaction, to decide whether it wishes to exercise
its participation rights in the transaction. We also are prohibited from taking certain corporate actions without the consent
of ACCBT Corp., including issuing shares, acquiring or divesting assets and making payment of cash compensation over $60,000
per year. Further, ACCBT Corp. also has the right to appoint a majority of our Board of Directors. In connection
with the subscription agreement, we entered into a registration rights agreement with ACCBT Corp. pursuant to which we
granted piggyback registration rights to ACCBT Corp. In addition, we issued ACCBT warrants to purchase up to 30,250,000
shares of common stock, of which 30,250,000 warrants are presently outstanding. The outstanding warrants contain full-ratchet
anti-dilution provisions and cashless exercise provisions, which permit the cashless exercise of up to 50% of the underlying
shares of common stock, and 10,083,333 of such Warrants have an exercise price of $0.20 and the remainder have an exercise
price of $0.29. ACCBT has waived its participation rights, registration rights and anti-dilution rights solely in connection
with this offering and with respect to issuances that were made prior to the date hereof.
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 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.
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 Markets Group, 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 may 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 “penny stock” rules promulgated under the Securities Exchange Act of 1934, as amended. These rules require additional disclosure by broker-dealers in connection with any trades generally involving any equity security not listed on either a securities exchange or NASDAQ 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.
A
large number of shares issued in this offering may be sold in the market following this offering, which may depress the
market price of our common stock.
A
large number of shares issued in this offering may be sold in the market following this offering, which may depress the market
price of our common stock. Sales of a substantial number of shares of our common stock in the public market following
this offering could cause the market price of our common stock to decline. If there are more shares of common stock
offered for sale than buyers are willing to purchase, then the market price of our common stock may decline to a market price
at which buyers are willing to purchase the offered shares of common stock and sellers remain willing to sell the shares. All
of the securities issued in the offering will be freely tradable without restriction or further registration under the Securities
Act of 1933, as amended (the “Securities Act”).
If we fail to implement and maintain an effective
system of internal controls, we may be unable to accurately report our results of operations or prevent fraud, and investor confidence
and the market price of our Common Stock may be materially and adversely affected.
As a public company in the United States, we are subject
to the reporting obligations under the U.S. securities laws. The Securities and Exchange Commission, or the SEC, as required under
Section 404 of the Sarbanes-Oxley Act of 2002, has adopted rules requiring every public company to include a report of management
on the effectiveness of such company’s internal control over financial reporting in its annual report. Our consolidated
financial statements for the year ended December 31, 2011 and for the quarter ended March 31, 2012, provided that our management
has performed an evaluation of the effectiveness of our disclosure controls and internal control over financial reporting for
the periods covered by Forms 10-K and 10-Q, and concluded that our disclosure controls and procedures were not effective
as of March 31, 2012 as a result of the material weaknesses in our internal control over financial reporting. The material weaknesses
identified in our internal control over financial reporting are related to both the inadequate supervisory review structure and
insufficient personnel with appropriate levels of accounting knowledge and experience to address the high volume of U.S. GAAP
accounting issues and to prepare and review financial statements and related disclosures under U.S. GAAP. In response to
the material weaknesses described above, we plan to develop and take several measures designed to remediate the material weaknesses
in our internal control over financial reporting. The measures we intend to take in the future may not be sufficient to remediate
the material weaknesses noted by our management and our independent registered public accounting firm and to avoid potential future
material weaknesses. We may require more resources and incur more costs than currently expected to remediate our identified
material weaknesses or any additional significant deficiencies or material weaknesses that may be identified, which may adversely
affect our results of operations. If either of the material weaknesses is not remedied or recurs, or if we identify additional
weaknesses or fail to timely and successfully implement new or improved controls, our ability to assure timely and accurate financial
reporting may be adversely affected, and we could suffer a loss of investor confidence in the reliability of our financial statements,
which in turn could negatively impact the trading price of our shares of common stock, result in lawsuits being filed against
us by our shareholders, or otherwise harm our reputation. In addition, our auditor is not required to attest to the effectiveness
of our internal controls over financial reporting due to our status of qualifying as a small reporting company. As a result, current
and potential investors could lose confidence in our financial reporting, which could harm our business and have an adverse effect
on our share price.
Delaware law could discourage a change in control, or an acquisition of us by a third party, even if the acquisition would be favorable to you, and thereby adversely affect existing stockholders.
The Delaware General Corporation Law contain provisions that may have the effect of making more difficult or delaying attempts by others to obtain control of our Company, even when these attempts may be in the best interests of stockholders. Delaware law imposes conditions on certain business combination transactions with “interested stockholders.” These provisions and others that could be adopted in the future could deter unsolicited takeovers or delay or prevent changes in our control or management, including transactions in which stockholders might otherwise receive a premium for their shares over then current market prices. These provisions may also limit the ability of stockholders to approve transactions that they may deem to be in their best interests.
We do not expect to pay dividends in the foreseeable future, and accordingly you must rely on stock appreciation for any return on your investment.
We have paid no cash dividends on our common stock to date, and we currently intend to retain our future earnings, if any, to fund the continued development and growth of our business. As a result, we do not expect to pay any cash dividends in the foreseeable future. Further, any payment of cash dividends will also depend on our financial condition, results of operations, capital requirements and other factors, including contractual restrictions to which we may be subject, and will be at the discretion of our Board of Directors.
We may use these proceeds in ways with which you may not agree.
We have considerable discretion in the application of the proceeds of this offering. You will not have the opportunity, as part of your investment decision, to assess whether the proceeds are being used in a manner agreeable to you. You must rely on our judgment regarding the application of the net proceeds of this offering. The net proceeds may be used for corporate purposes that do not improve our profitability or increase the price of our shares. The net proceeds may also be placed in investments that do not produce income or that lose value.
DISCLOSURE REGARDING FORWARD-LOOKING STATEMENTS
This prospectus contains or incorporates forward-looking statements within the meaning of the federal securities laws. These forward-looking statements are management’s beliefs and assumptions. In addition, other written or oral statements that constitute forward-looking statements are based on current expectations, estimates and projections about the industry and markets in which we operate and statements may be made by or on our behalf. Words such as “should,” “could,” “may,” “expect,” “anticipate,” “intend,” “plan,” “believe,” “seek,” “estimate,” variations of such words and similar expressions are intended to identify such forward-looking statements. These statements are not guarantees of future performance and involve certain risks, uncertainties and assumptions that are difficult to predict. There are a number of important factors that could cause our actual results to differ materially from those indicated by such forward-looking statements.
We describe material risks, uncertainties and assumptions that could affect our business, including our financial condition and results of operations, under “Risk Factors” and may update our descriptions of such risks, uncertainties and assumptions in any prospectus supplement. We base our forward-looking statements on our management’s beliefs and assumptions based on information available to our management at the time the statements are made. We caution you that actual outcomes and results may differ materially from what is expressed, implied or forecast by our forward-looking statements. Accordingly, you should be careful about relying on any forward-looking statements. Forward looking statements include, but are not limited to, statements about:
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Statements as to the anticipated timing of clinical studies and other business developments;
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Statements as to the development of new products;
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Our expectations regarding federal, state and foreign regulatory requirements;
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Our expectations regarding grants from federal resources; and
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Statements regarding growth strategies, financial results, product development, competitive strengths, intellectual property rights, litigation, mergers and acquisitions, market acceptance or continued acceptance of our products, accounting estimates, financing activities and ongoing contractual obligations.
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Except as required under the federal securities laws and the rules and regulations of the SEC, we do not have any intention or obligation to update publicly any forward-looking statements after the distribution of this prospectus, whether as a result of new information, future events, changes in assumptions, or otherwise.
EXCHANGE RATE INFORMATION
In this prospectus, references to “$” are to U.S. dollars, and references to “NIS” are to New Israeli Shekels. The exchange rate between the NIS and the U.S. dollar used in this prospectus varies depending on the date and context of the information contained herein.
The following table sets forth for each period indicated: (1) the low and high exchange
rates during such period; (2) the exchange rates in effect at the end of the period; and (3) the average exchange rates for such
period, for one U.S. dollar, expressed in NIS, as quoted by the Bank of Israel. The average exchange rate is calculated on the
last business day of each month for the applicable period.
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Year ended
December 31, | | |
Quarter
ended March 31, |
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Quarter ended June 30,
| |
| |
2008 | | |
2009 | | |
2010 | | |
2011 | | |
2012 |
|
|
2012 | |
Low | |
| 3.230 | | |
| 3.690 | | |
| 3.549 | | |
| 3.363 | | |
| 3.700 |
|
|
3.715 | |
High | |
| 4.022 | | |
| 4.256 | | |
| 3.894 | | |
| 3.821 | | |
| 3.854 |
|
|
3.947 | |
Period End | |
| 3.802 | | |
| 3.775 | | |
| 3.549 | | |
| 3.821 | | |
| 3.715 |
|
|
3.923 | |
Average | |
| 3.588 | | |
| 3.933 | | |
| 3.733 | | |
| 3.578 | | |
| 3.771 |
|
|
3.8928 | |
As
of July 9, 2012, the daily representative
rate of exchange between the NIS and the U.S. dollar
as published by the Bank of Israel was NIS 3.9640
to $1.00.
USE OF PROCEEDS
We
estimate that we will receive up to $4,911,676.86
in net proceeds from the sale of the securities in this offering, based on a per share purchase price of $0.29 and after deducting
placement agent fees and commissions and estimated offering expenses payable by us. We will use the proceeds from the
sale of the securities for initiation of clinical trials in the United States, research and development, working capital needs,
capital expenditures and other general corporate purposes.
If a warrant holder exercises his warrants, we will also receive proceeds from the exercise of warrants. We cannot predict when, or if, the warrants will be exercised. It is possible that the warrants may expire and may never be exercised.
DIVIDEND POLICY
We have never declared or paid any cash dividends on our common stock. We currently intend to retain any future earnings to finance the growth and development of our business. Therefore, we do not anticipate that we will declare or pay any cash dividends on our common stock in the foreseeable future. Any future determination to pay cash dividends will be at the discretion of our Board of Directors and will be dependent upon our financial condition, results of operations, capital requirements, restrictions under any existing indebtedness and other factors the Board of Directors deems relevant.
DILUTION
Dilution represents the difference between the offering price and the net tangible book value per share immediately after completion of this offering. Net tangible book value is the amount that results from subtracting total liabilities and intangible assets from total assets. Dilution of the value of the shares you purchase is a result of the lower book value of the shares held by our existing stockholders.
At
March 31, 2012, the net tangible book value of our shares of common stock was $817,000 or approximately $0.006 per share
based upon 126,737,158 shares outstanding. After giving effect to our sale of 19,818,972 shares of common stock at
a public offering price of $0.29 per share, and after deducting placement agent fees and commissions and estimated offering
expenses, our pro forma net tangible book value as of March 31, 2012 would have been $5,728,777, or $0.039 per
share. This represents an immediate increase in net tangible book value of $0.033 per share to existing
stockholders and an immediate dilution in net tangible book value of $0.257 per share to purchasers of securities in this
offering, as illustrated in the following table:
Assumed
public offering price per share
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$ |
0.29 |
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Pro
forma net tangible book value per share as of March 31, 2012
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$ |
0.006 |
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Increase
per share attributable to new investors
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$ |
0.033 |
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Pro
forma as adjusted net tangible book value per share after this offering
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$ |
0.039 |
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Dilution
per share to new investors in this offering
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$ |
0.257 |
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The above discussion does not include the following:
3,225,103 shares of
common stock reserved for future issuance under our equity incentive plans as of June 6, 2012, and also does not include the
increase of 9,000,000 shares of common stock available for issuance under such plans approved on June 12, 2012. As
of June 6, 2012, there were 3,936,665 options outstanding under such plans with a weighted average exercise price of $0.1766
per share;
47,582,162 shares of common
stock issuable upon exercise of outstanding warrants as of June 6, 2012, with exercise prices ranging from $0.00005 per
share to $1.00 per share;
1,349,486 shares of
common stock issued between March 31, 2012 and July 17, 2012 upon exercise of options and warrants.
14,864,229 shares of common
stock issuable upon exercise of warrants at an exercise price of $0.29 per share sold as part of this offering.
PLAN OF DISTRIBUTION
Maxim Group LLC, which we refer to herein as the Placement
Agent, has agreed to act as placement agent in connection with this offering subject to the terms and conditions of the placement
agent agreement dated July 17, 2012. The Placement Agent is not purchasing or selling any securities offered by this prospectus,
nor is it required to arrange the purchase or sale of any specific number or dollar amount of securities, but has agreed to use
its best efforts to arrange for the sale of all of the securities offered hereby. The Placement Agent may retain other brokers
or dealers to act as sub-agents or selected-dealers on its behalf in connection with the offering. Therefore, we will enter into
a purchase agreement directly with investors in connection with this offering and we may not sell the entire amount of securities
offered pursuant to this prospectus.
We have agreed to pay the Placement Agent a placement agent’s
fee equal to six percent (6%) and a corporate finance fee equal to one percent (1%) of the aggregate purchase price of the
shares sold in this offering.
In addition, we
have agreed to issue to the Placement Agent, or its designees, warrants exercisable for a number of shares of common stock equal
to 3% of the aggregate number of shares of common stock sold in this offering (excluding any shares of common stock issuable upon
exercise of the warrants). The placement agent warrants will have the substantially same terms as the warrants offered hereunder,
except that the placement agent warrants will have an exercise price of 120% of the public offering price per share, or $0.348 per
share, and the expiration date shall be two years from the closing of this offering. Pursuant to FINRA Rule 5110(g)(1), neither
the placement agent warrants nor any shares of common stock issued upon exercise of the placement agent warrants may be sold,
transferred, assigned, pledged, or hypothecated, or be subject to any hedging, short sale, derivative, put, or call transaction
that would result in the effective economic disposition of such securities by any person for a period of 180 days immediately
following the date of effectiveness or commencement of sales of the public offering, except the transfer of any security:
| § | by operation
of law or by reason
of our reorganization; |
| § | to any
FINRA member firm
participating
in the offering
and the officers
and partners thereof,
if all securities
so transferred
remain subject
to the lock-up
restriction described
above for the
remainder of the
time period; |
| § | if the
aggregate amount
of our securities
held by the Placement
Agent or related
person does not
exceed 1% of the
securities being
offered; |
| § | that is
beneficially owned
on a pro-rata
basis by all equity
owners of an investment
fund, provided
that no participating
member manages
or otherwise directs
investments by
the fund, and
participating
members in the
aggregate do not
own more than
10% of the equity
in the fund; or |
| § | the exercise
or conversion
of any security,
if all securities
received remain
subject to the
lock-up restriction
set forth above
for the remainder
of the time period. |
Subject to compliance
with FINRA Rule 5110(f)(2)(D), we have also agreed to pay the Placement Agent a non-accountable expense reimbursement equal to
the lesser of (i) $100,000 and (ii) 3% of the gross proceeds raised in the offering. Based on the gross proceeds in the offering,
the Placement Agreement will receive a non-accountable expense reimbursement of 100,000. We have also agreed to reimburse the
Placement Agent for its actual “roadshow” expenses; provided, however, that such expenses shall not exceed $2,000.
We have reimbursed the Placement Agent for its actual road show expenses of $2000. In addition, subject to FINRA Rule 5110(f)(2)(D),
we have granted to the Placement Agent a right of first refusal with respect to additional raises of funds by means of a public
offering or a private placement of equity or debt securities using an underwriter or placement agent during the 12 months following
this offering.
The following table shows the per share and total placement
agent’s fees that we will pay to the Placement Agent in connection with the sale of the shares and warrants offered pursuant
to this prospectus assuming the purchase of all of the shares offered hereby.
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Per
share placement agent’s fees (1) | |
$ | 0.02 |
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Maximum
offering total | |
$ | 344,850 |
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(1) Does not include a corporate finance fee in the amount
of 1%, or $0.0029 per share and $57,475 in the aggregate, of the gross proceeds of the offering payable to the placement agent.
Because there is no minimum amount required as a condition
to the closing in this offering, the actual total offering commissions, if any, are not presently determinable and may be substantially
less than the maximum amount set forth above.
Our obligations to issue and sell securities to the purchasers
is subject to the conditions set forth in the securities purchase agreement attached as Annex A hereto, which may be waived
by us at our discretion. A purchaser’s obligation to purchase securities is subject to the conditions set forth in the securities
purchase agreement as well, which may also be waived.
We estimate the total offering expenses in this offering
that will be payable by us, excluding the placement agent’s fees, will be approximately $4,911,676.86 which include legal,
accounting and printing costs, various other fees and reimbursement of the placement agent’s expenses.
The foregoing does not purport to be a complete
statement of the terms and conditions of the placement agent agreement and the securities purchase agreement. A form of the
placement agent agreement and the form of securities purchase agreement with investors are included as exhibits to the
registration statement of which this prospectus forms a part.
We have agreed to indemnify the Placement Agent against
certain liabilities under the Securities Act of 1933, as amended. The Placement Agent may be deemed to be an underwriter within
the meaning of Section 2(a)(11) of the Securities Act, and any commissions received by it and any profit realized on the
resale of the securities sold by it while acting as principal might be deemed to be underwriting discounts or commissions under
the Securities Act.
As an underwriter, the Placement Agent would be required
to comply with the Securities Act and the Securities Exchange Act of 1934, as amended, including without limitation, Rule 10b-5
and Regulation M under the Exchange Act. These rules and regulations may limit the timing of purchases and sales of shares of
common stock and warrants by the Placement Agent acting as principal. Under these rules and regulations, the Placement Agent:
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|
may not engage in any stabilization activity in connection with our securities;
and |
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• |
|
may not bid for or purchase any of our securities or attempt to induce
any person to purchase any of our securities, other than as permitted under the Exchange Act, until it has completed its participation
in the distribution. |
The securities
registered under the registration statement of which this prospectus forms a part may be offered and sold to investors in
Israel. The offering of securities in Israel, if any, will be pursuant to an exemption from the registration requirements in
Israel and will be considered a private placement in Israel under Israeli Law.
Leader Underwriters (1993) Ltd (“Leader”),
an underwriter registered under the laws of Israel, acted as a sub-agent of the Placement Agent for the sole purpose
of arranging for the sale of securities registered under the registration statement of which this prospectus forms a part to
investors in Israel. The offering of securities in Israel will be pursuant to an exemption from the registration requirements
in Israel and will be considered a private placement in Israel under Israeli law. Pursuant to the terms of a Selected
Dealer Agreement, dated July 17, 2012, between the Placement Agent and Leader, Leader shall receive from the Placement Agent
a cash payment equal to 5% of gross proceeds of securities placed by Leader, or $48,625, and warrants to purchase 3% of the
shares of common stock placed by Leader, or warrants to purchase 100,603 shares of common stock.
Furthermore,
all of our directors, executive officers, key consultants and affiliates, including ACCBT, have entered into lock-up agreements
with Maxim Group LLC. Under those lock-up agreements, subject to certain exceptions, those holders of such stock may not, directly
or indirectly, offer, sell, contract to sell (including short-selling), pledge or otherwise dispose of or hedge any common stock
or securities convertible into or exchangeable for shares of common stock, without the prior written consent of Maxim Group LLC,
for a period of 180 days from the closing date of this offering. In addition, we have agreed not to issue, enter into any agreement
to issue or announce the issuance or proposed issuance of any shares of common stock or securities exchangeable, convertible or
exercisable into common stock for a period of 90 days following the closing date of this offering, subject to
certain exceptions.
DESCRIPTION OF SECURITIES
The descriptions of the securities contained in this prospectus summarizes all the material terms and provisions of the various types of securities that we may offer.
Common stock
We
are authorized to issue 800,000,000 shares of common stock, $0.00005 par value. As of June 15, 2012, there were
128,586,644 shares of our common stock issued and outstanding, held by approximately 66 record holders.
The holders of common stock are entitled to one vote per share on all matters to be voted upon by stockholders, including the election of directors. The holders of common stock do not have any cumulative voting, conversion, redemption or preemptive rights. The holders of common stock are entitled to receive ratably dividends as may be declared from time to time by our Board of Directors out of funds legally available for that purpose. In the event of our liquidation, dissolution, or winding up, the holders of common stock are entitled to share ratably in our assets available for distribution to such holders. All issued and outstanding shares of common stock are fully paid and non-assessable.
Anti-Takeover Provisions of Delaware Law
We are subject to Section 203 of the Delaware General Corporation Law, which prohibits a publicly-held Delaware corporation from engaging in a “business combination,” except under certain circumstances, with an “interested stockholder” for a period of three years following the date such person became an “interested stockholder” unless:
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before such person became an interested stockholder, the board of directors of the corporation approved either the business combination or the transaction that resulted in the interested stockholder becoming an interested stockholder;
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upon the consummation of the transaction that resulted in the interested stockholder becoming an interested stockholder, the interested stockholder owned at least 85% of the voting stock of the corporation outstanding at the time the transaction commenced, excluding shares held by directors who also are officers of the corporation and shares held by employee stock plans; or
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at or following the time such person became an interested stockholder, the business combination is approved by the board of directors of the corporation and authorized at a meeting of stockholders by the affirmative vote of the holders of 66 2/3% of the outstanding voting stock of the corporation which is not owned by the interested stockholder.
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The term “interested stockholder” generally is defined as a person who, together with affiliates and associates, owns, or, within the three years prior to the determination of interested stockholder status, owned, 15% or more of a corporation’s outstanding voting stock. The term “business combination” includes mergers, asset or stock sales and other similar transactions resulting in a financial benefit to an interested stockholder. Section 203 makes it more difficult for an “interested stockholder” to effect various business combinations with a corporation for a three-year period. The existence of this provision would be expected to have an anti-takeover effect with respect to transactions not approved in advance by our board of directors, including discouraging attempts that might result in a premium over the market price for the shares of common stock held by stockholders.
The Warrants offered in this offering will be issued in the
form attached as Annex B hereto. You should review a copy of the form of warrant for a complete description of the terms
and conditions applicable to the Warrants. The following is a brief summary of the Warrants and is subject in all respects to
the provisions contained in the form of warrant.
In
connection with this offering, we will issue a warrant to purchase 0.75 shares of common stock for each share of common stock
purchased or issued. Each warrant entitles the holder to purchase 0.75 shares of common stock at an exercise price
of $0.29 per share and has a term of exercise equal to 30 months. If an effective registration statement is not available
for the issuance of the underlying shares of a warrant to a warrant holder, the warrant holder may choose “cashless exercise.”
After the expiration of the 30-month exercise period, warrant holders will
have no further rights to exercise such warrants.
The
warrants may be exercised at any time in whole or in part at the applicable exercise price until expiration of the
warrants. We will not issue fractional shares of common stock and we will, at our election, either pay cash in
lieu of fractional shares of common stock or round up to the next whole share. Warrant holders do not have any
voting, dividend or other rights as a stockholder of our Company. The exercise price and the number of shares of
common stock purchasable upon the exercise of each warrant are subject to adjustment upon the happening of certain events,
such as stock dividends, splits, combinations or similar events affecting our common stock.
Subject to certain exceptions, in the event of a fundamental transaction, as defined
in the Form of Warrant attached as Annex B hereto, a warrant holder shall have the right to receive, at the warrant holder’s
option, for each share of common stock that would have been issuable upon exercise immediately prior to the occurrence of a fundamental
transaction, the number of shares of common stock of the successor or acquiring corporation or of the Company, if it is the surviving
corporation, and any additional consideration receivable as a result of such fundamental transaction by a holder of the number
of shares of common stock for which the warrant was exercisable immediately prior to such fundamental transaction. In the event
of certain fundamental transactions, the holders of the warrants may require us to redeem the warrants for a purchase price payable
in cash at the Black-Scholes value of the warrants, as calculated pursuant to the terms of the warrants.
Transfer Agent and Registrar
The transfer agent and registrar for our common stock is American Stock Transfer & Trust Company LLC.
OTC Bulletin Board Listing
Our common stock is currently traded on the OTCQB operated by the OTC Markets Group (“OTCQB”) under the trading symbol “BCLI.”
OUR BUSINESS
Company Overview
We are a biotechnology company developing innovative stem cell therapeutic products based on technologies enabling the in-vitro differentiation of bone marrow stem cells into neural-like cells. We aim to become a leader in adult stem cell transplantation for neurodegenerative diseases. Our technology entails exploiting the patient’s own bone marrow stem cells to generate glial-like cells that may provide an effective treatment for ALS, PD, MS and Spinal Cord Injury.
Our core technology was developed in collaboration with 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 Prof. Daniel Offen, of the Felsenstein Medical Research Center of Tel Aviv University.
Our team demonstrated formation of neurotrophic-factor secreting cells (glial-like cells) from in-vitro differentiated bone marrow cells that produce NTF including GDNF, BDNF and additional factors. Moreover, in research conducted by our team, implantation of these differentiated cells into brains of animal models that had been induced to Parkinsonian behavior markedly improved their condition.
Our aim is to provide neural-supporting stem cell transplants that are expected to maintain, preserve and possibly restore the damaged neurons, protecting them from further degeneration.
Our Israeli Subsidiary holds exclusive worldwide rights to commercialize the technology, through a licensing agreement with Ramot, the technology transfer company of Tel Aviv University, Israel.
As a result of limited cash resources and the desire to take a faster path to clinical trials, since the fourth quarter of 2008 we have focused all of our efforts on ALS, and are currently not allocating resources towards PD, MS or other neurodegenerative diseases. Other indications are currently being evaluated.
We
are currently in the clinical stage of development of our technology and we intend to begin the process of seeking regulatory
approval from regulatory agencies in the U.S.
In
June 2011, we initiated a Phase I/II clinical study for ALS patients using our autologous NurOwn™ stem cell
therapy, after receiving final approval from the Israel MOH. In June 2012, the Company completed a study of
twelve patients and an interim report is expected to be submitted to the Israel MOH in the third quarter of fiscal
2012.
Three ALS
patients have been treated on a compassionate use basis in Israel and no adverse events were reported in the six-month
post-transplant follow-up.
In
February 2011, the FDA granted Orphan Drug designation to our NurOwn™ autologous adult stem cell product candidate for the
treatment of ALS. Orphan Drug status entitles us to seven years of marketing exclusivity for NurOwn™ upon regulatory approval,
as well as the opportunity to apply for grant funding from the FDA of up to $400,000 per year for four years to defray costs of
clinical trial expenses, tax credits for clinical research expenses and potential exemption from the FDA's application user fee.
Our efforts are directed at:
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Operating a GMP compliant production process;
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Demonstrating Safety Tolerability and Therapeutic effect of transplantation of Autologous cultured Bone Marrow Stromal Cells secreting Neurothrophic factors (MSC-NTF) in a Phase I/II Clinical trial in human ALS patients;
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Setting up a centralized facility to provide the therapeutic products
and services for transplantation in patients in the US, as part of the clinical development program; and
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Submitting an IND to the FDA.
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Our research team led by Prof. Melamed and Prof. Offen has shown that human bone marrow mesenchymal stem cells can be expanded and induced to differentiate into two types of brain cells, neuron-like and astrocyte-like cells, each having different therapeutic potential, as follows:
NurOwn™ program one - NTF secreting cells (MSC-NTF) - human bone marrow derived NTF secreting cells for treatment of, ALS, PD and MS. In-vitro differentiation of the expanded human bone marrow derived mesenchymal stem cells in a proprietary medium led 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.
We have optimized the proprietary processes for induction of differentiation of human bone marrow derived mesenchymal stem cells into differentiated cells that produce NTF (MSC-NTF). The optimization and process development is conducted in GMP compliance.
NurOwn™
program two - 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.
Our technology is based on the NurOwn™ products - an autologous cell therapeutic modality, comprising the extraction of the patient bone marrow, which is then processed into the appropriate neuronal-like cells and re-implanted into the patient’s muscles, spinal cord or brain. This approach is taken in order to increase patient safety and minimize any chance of immune reaction or cell rejection.
The therapeutic modality will comprise the following:
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Bone marrow aspiration from patient;
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Isolation and expansion of the mesenchymal stem cells;
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Differentiation of the expanded stem cells into neurotrophic-factor secreting cells; and
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Autologous transplantation into the patient into the site of damage.
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History
The Company was incorporated under the laws of the State of Washington on September 22, 2000, under the name Wizbang Technologies, Inc. and acquired the right to market and sell a digital data recorder product line in certain states in the U.S. Subsequently, the Company changed its name to Golden Hand Resources Inc. On July 8, 2004, the Company entered into the licensing agreement with Ramot to acquire certain stem cell technology and decided to discontinue all activities related to the sales of the digital data recorder product. In November 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 formed 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
In February 2011, the FDA’s Office of Orphan Products Developments granted Orphan Drug designation for the Company’s NurOwn™ autologous adult stem cell product candidate for the treatment of ALS. In July 2011, we entered into a Memorandum of Understanding with Massachusetts General Hospital and the University of Massachusetts Medical School in anticipation of applying for FDA approval to begin ALS human clinical trials in the United States.
Between
February 22, 2011 and March 1, 2011, we entered into Securities Purchase Agreements with institutional and individual investors
pursuant to which we issued and sold 12,815,000 units comprised of shares of common stock and warrants for the purchase of common
stock in exchange for $3,588,200 ($0.28 per unit). Each unit includes (i) one share of common stock, (ii) a warrant to purchase
one-half of one share of our common stock until the first anniversary of the closing date at a purchase price of $0.28 per share
(as of March 1, 2012, 5,460,666 were cancelled as they were not exercised before the expiration date) and (iii) a warrant to purchase
one share of our common stock until the second anniversary of the closing date at a purchase price of $0.50 per share. The
warrants may only be exercised by the payment of the exercise price in cash. Upon exercise of any outstanding warrants,
the Company will receive additional cash proceeds from the exercise price paid by such warrant holders.
In June 2011, we initiated a Phase I/II clinical study for ALS patients using our autologous NurOwn™ stem cell therapy, after receiving final approval from the Israel MOH.
On February 17, 2010, our wholly owned Israeli subsidiary entered into a series of agreements with Hadasit Medical Research Services and Development Ltd., a subsidiary of the Hadassah Medical Organization (“Hadassah”) and Professor Dimitrios Karousis (the “Clinical Trial Agreement”). Under the Clinical Trial Agreement, Hadassah and our personnel will conduct a clinical trial to evaluate the safety and tolerability of our treatment using mesenchymal bone marrow stem cells secreting neurotrophic factors (MSC-NTF) in patients with ALS, in accordance with a protocol developed jointly by us and Hadassah. The trial is expected to include between 24 and 26 patients.
Intellectual property generated through the study will be owned by us. Hadassah will be entitled to use the intellectual property generated through the study for non-commercial purposes. All existing intellectual property of the Company and Hadassah shall be retained by each respective party.
In connection with the study, we agreed to pay Hadassah $38,190 per patient totaling up to $992,880, as well as $31,250 per month for rental and operation of clean room facilities according to GMP standards at Hadassah facilities in Jerusalem in order to apply the cell growth and differentiation process in accordance with our methods.
On June 27, 2011, our wholly owned Israeli subsidiary entered into the Amendment (the “Amendment”) to the Clinical Trial Agreement. The Amendment amended the Clinical Trial Agreement to, among other things: (i) decrease the total payment due to Hadassah from $992,880 to $773,400 and (ii) change the termination provisions so only we may terminate the agreement upon 60 days’ notice.
On September 22, 2011, our wholly owned Israeli subsidiary entered into an additional Amendment to the Clinical Trial Agreement (“Amendment 2”) to rent an additional clean room starting December 1, 2011.
In
September 2011, we received notice from the Israeli Office of the Chief Scientist (“OCS”) of its commitment to grant
the Company approximately $1.1 million in accordance with OCS guidelines. As of June 25, 2012, approximately $350,000 has been
received. We are obligated to pay royalties to the OCS, amounting to 3% to 5% of revenues derived from sales of the products funded
with the OCS grant, up to an amount equal to 100% of the grant received.
On March 12, 2012, we announced plans to initiate
a preclinical study assessing the efficiency of our NurOwn™ stem cell technology in patients with MS. Positive proof-of-concept
results for MS have been confirmed in a set of in-vitro and in-vivo experiments, and we are working to advance MS
into preclinical development in our second quarter in 2012.
Stem Cell Therapy
Our activities are within the stem cell therapy field. Stem cells are non-specialized cells with a potential for both self-renewal and differentiation into cell types with a specialized function, such as muscle, blood or brain cells. The cells have the ability to undergo asymmetric division such that one of the two daughter cells retains the properties of the stem cell, while the other begins to differentiate into a more specialized cell type. Stem cells are therefore central to normal human growth and development, and also are a potential source of new cells for the regeneration of diseased and damaged tissue. Stem cell therapy aims to restore diseased tissue function by the replacement and/or addition of healthy cells by stem cell transplants.
Currently, two principal platforms for cell therapy products are being explored: (i) embryonic stem cells (“ESC”), isolated from the inner mass of a few days old embryo; and (ii) adult stem cells, sourced from bone marrow, cord blood and various organs. Although ESCs are the easiest to grow and differentiate, their use in human therapy is limited by safety concerns associated with their tendency to develop Teratomas (a form of tumor) and their potential to elicit an immune reaction. In addition, ESC has generated much political and ethical debate due to their origin in early human embryos.
Cell therapy using adult stem cells does not suffer from the same concerns. Bone marrow is the tissue where differentiation of stem cells into blood cells (haematopoiesis) occurs. In addition, it harbors stem cells capable of differentiation into mesenchymal (muscle, bone, fat and other) tissues. Such mesenchymal stem cells have also been shown capable of differentiating into nerve, skin and other cells. In fact, bone marrow transplants have been safely and successfully performed for many years, primarily for treating leukemia, immune deficiency diseases, severe blood cell diseases, lymphoma and multiple myeloma. Moreover, bone marrow may be obtained through a simple procedure of aspiration, from the patient himself, enabling autologous cell therapy, thus obviating the need for donor matching, circumventing immune rejection and other immunological mismatch risks, as well as avoiding the need for immunosuppressive therapy. We believe bone marrow, in particular autologous bone marrow, capable of in-vitro growth and multipotential differentiation, presents a preferable source of therapeutic stem cells.
Neurodegenerative Diseases
Studies of neurodegenerative diseases suggest that symptoms that arise in afflicted individuals are secondary to defects in neuron cell function and neural circuitry and, to date, cannot be treated effectively with systemic drug delivery. Consequently, alternative approaches for treating neurodegenerative diseases have been attempted, such as transplantation of cells capable of replacing or supplementing the function of damaged neurons. For such cell replacement therapy to work, implanted cells must survive and integrate, both functionally and structurally, within the damaged tissue.
Amyotrophic Lateral Sclerosis (ALS)
ALS, often referred to as “Lou Gehrig's disease,” is a progressive neurodegenerative disease that affects nerve cells in the brain and the spinal cord. Motor neurons reach from the brain to the spinal cord and from the spinal cord to the muscles throughout the body. The progressive degeneration of the motor neurons in ALS eventually leads to death. As motor neurons degenerate, they can no longer send impulses to the muscle fibers that normally result in muscle movement. With voluntary muscle action progressively affected, patients in the later stages of the disease may become completely paralyzed. However, in most cases, mental faculties are not affected.
Approximately 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 MS. There appear to be more MS sufferers because MS patients tend to live much longer, some for 30 years or more. The life expectancy of an ALS patient averages about two to five years from the time of diagnosis. However, up to 10% of ALS patients will survive more than ten years.
Current Treatments
The physician bases medication decisions on the patient's symptoms and the stage of the disease. Some medications used for ALS patients include:
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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 assist breathing) and may prolong the patient's life by several months;
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Baclofen or Diazepam - these medications may be used to control muscle spasms, stiffness or tightening (spasticity) that interfere with daily activities; and
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Trihexyphenidyl or Amitriptyline - these medications may help patients who have excess saliva or secretions, and emotional changes.
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Other medications may be prescribed to help reduce such symptoms as fatigue, pain, sleep disturbances, constipation, and excess saliva and phlegm.
Parkinson’s Disease (PD)
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
6.3 million people worldwide suffer from PD, of whom about one 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 $3.754 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 $6 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
20 years.
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 $3.351 billion worldwide and the market is expected to grow to approximately
$3.754 billion by 2015, 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.
Company Business Strategy
Our efforts are currently focused on the development of the technology to upscale the process from the lab stage to the clinical stage, with the following main objectives:
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Operating a GMP compliant production process;
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Demonstrating Safety Tolerability and Therapeutic effect of transplantation of Autologous cultured Bone Marrow Stromal Cells secreting Neurothrophic factors (MSC-NTF) in a Phase I/II Clinical trial in human ALS patients;
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Setting up a centralized facility to provide the therapeutic products
and services for transplantation in patients in the US, as part of the clinical development program; and
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Submitting an IND to the FDA
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We intend to develop the NurOwn™ therapeutic technology to reach clinical proof of concept and proceed to commercialization with companies experienced in 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.
We have received
interim safety data for the first ALS patients in our Phase I/II clinical study at the Hadassah Medical
Center, in the first quarter of 2012. This clinical study is expected to be completed within an additional 12 to 15 months. Initial
steps have been made for conducting FDA approved clinical trials in the US. The study is intended to evaluate safety and efficacy
of our' cell therapy. We are currently considering developing our autologous cell therapy for the treatment of an additional Central
Nervous System indication. Our clinical development timeline is subject to a number of risks as described in the section entitled
“Risk Factors.”
Company Business Model
Our
objective is to have the proprietary procedure adopted by many medical centers, throughout the U.S., Europe, Israel and East Asia
for the treatment of ALS, MS, PD, and other neurodegenerative diseases. Our intended procedure for supporting the degenerated
neurons with healthy cells secreting Neurotrophic factors derived by differentiation of bone marrow cells, 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 transplantation. Transplantation would be carried out by the medical centers, with revenues shared with us on an
agreed basis.
We will consider seeking cooperation with a major strategic marketing partner, having established distribution channels and the ability to gain relatively fast access to the target markets.
Our approach will be optimized by working with a major partner. We believe there is a substantial market opportunity and cooperation with strategic partners would facilitate a more rapid and broad market penetration, by leveraging the partner’s market credibility and the proven ability to provide service and support across a large and geographically spread target market.
Potential strategic partners include:
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Private Medical Center Chains - interested in expanding their service offerings and being associated with an innovative technology, thereby enhancing their professional standing and revenue potential; and
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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.
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We cannot guarantee 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. We have entered into a Memorandum of Understanding with the Massachusetts General Hospital and the University of Massachusetts Medical School in anticipation of applying for FDA approval to begin ALS human clinical trials in the United States.
Our
business model calls for significant investments in research and development. Our research and development expenditures
(i) in 2011 (before participation by the Israeli OCS) were $2,077,000, which included $316,000 in stock-based
compensation and (ii) in 2010 (before participation by the Israeli OCS) were $1,385,000, which included
$325,000 in stock-based compensation.
Patents:
We have filed for patents in (1) the United States; (2)
Europe; (3) Israel; and (4) Hong Kong, resulting in the following:
In the United States, we co-own, with
Ramot at Tel-Aviv University Ltd., pending patent application no. 12/994,761, filed on November 25, 2010, entitled “Mesenchymal
Stem Cells for the Treatment of CNS Diseases.”
In Europe, we co-own, with Ramot at
Tel-Aviv University Ltd., pending patent application no. 09754337.5, filed on May 26, 2009, entitled “Mesenchymal Stem Cells
for the Treatment of CNS Diseases.”
In Israel, we co-own, with Ramot at
Tel-Aviv University Ltd., pending patent application no. 209604, filed on May 26, 2009, entitled “Mesenchymal Stem Cells
for the Treatment of CNS Diseases.”
In Hong Kong, we co-own, with Ramot
at Tel-Aviv University Ltd., pending patent application no. 11107062.5, filed on May 26, 2009, entitled “Mesenchymal Stem
Cells for the Treatment of CNS Diseases.”
We have also taken a license to several
patents and patent applications from Ramot at Tel-Aviv University Ltd., resulting in the following:
We are a licensee of United States patent
application no. 11/130,197, filed May 17, 2005, entitled “Methods, nucleic acid constructs and cells for treating neurodegenerative
disorders.”
We are a licensee of European patent
application no. 06766101.7, filed on June 18, 2006, entitled “Isolated Cells and Populations Comprising Same for the Treatment
of CNS Diseases.”
We are a licensee of European patent
application no. 11000994.1, filed on June 18, 2006, entitled “Isolated Cells and Populations Comprising Same for the Treatment
of CNS Diseases.”
We are a licensee of United States patent
application no. 11/727,583, filed on March 27, 2007, entitled “Isolated Cells and Populations Comprising Same for the Treatment
of CNS Diseases.”
Trademarks:
We own a pending United States application to register the trademark NUROWN (application no. 85154891,
filed October 18, 2010) for use in connection with “compositions of cells derived from stem cells for medical purposes;
stem cells for medical purposes.” The application was filed based on an intent-to-use the mark, but has not matured to registration
yet.
The patent applications, as well as relevant know-how and research results are licensed from Ramot. We intend to work with Ramot to protect and enhance our mutual intellectual property rights by filing continuations and new patent applications on any improvements and any new discoveries arising in the course of research and development.
Research and License Agreement with Ramot
On July 8, 2004, we entered into a Research and License Agreement (the “Original Ramot Agreement”) with Ramot, the technology licensing company of Tel Aviv University, which agreement was amended on March 30, 2006 by the Amended Research and License Agreement (described below). Under the terms of the Original Ramot Agreement, Ramot granted to us an exclusive license to (i) the know-how and patent applications on the above-mentioned stem cell technology developed by the team led by Prof. Melamed and Prof. 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 Prof. Offen pursuant to which all intellectual property developed by Prof. Melamed or Prof. Offen in the performance of services thereunder will be owned by Ramot and licensed to us under the Original Ramot Agreement.
On March 30, 2006, we entered into an Amended Research and License Agreement (the “Amended Research and License Agreement”) with Ramot. Under the Amended Research and License Agreement, the funding of further research relating to the licensed technology in an amount of $570,000 per year was reduced to $380,000 per year. Moreover, under the Amended Research and License Agreement, the initial period of time that we agreed to fund the research was extended from an initial period of two (2) years to an initial period of three (3) years. The Amended Research and License Agreement also extended the additional two-year period in the Original Ramot Agreement to an additional three-year period, if certain research milestones were met. In addition, the Amended Research and License Agreement reduced (i) certain royalties payments from five percent (5%) to three percent (3%) of all net sales in cases of third party royalties and (ii) potential payments concerning sublicenses from 30% to 20-25% of sublicense receipts.
We entered into a Second Amended and Restated Research and License Agreement with Ramot on July 26, 2007. Like the Original Ramot Agreement, the amended license agreement imposed on us development and commercialization obligations, milestone and royalty payment obligations and other obligations.
In addition, in the event that the “research period”, as defined in the amended license agreement, was extended for an additional three year period in accordance with the terms of the amended license agreement, then we had to make payments to Ramot during the first year of the extended research period in an aggregate amount of $380,000.
On December 24, 2009, we entered into a Letter Agreement (the “Letter Agreement”) with Ramot, pursuant to which, among other things, Ramot agreed to: (i) release us from our obligation to fund three years of additional research (which would have totaled $1,140,000); and (ii) accept 1,120,000 shares of our common stock in lieu of $272,000 in past-due amounts. Pursuant to the Letter Agreement, we agreed, among other things, to: (i) reimburse Ramot for outstanding patent-related expenses; and (ii) abandon our rights in certain patents of Ramot.
Through March 2011, Ramot sold the 1,120,000 shares of common stock of the Company for $235,000 and we paid the remaining $5,000 due to Ramot. There is no additional debt to Ramot.
On December 20, 2011, we entered into an Assignment Agreement with our Israeli Subsidiary (the “Assignment Agreement”). Under the Assignment Agreement, we assigned and transferred all of our rights, interests, titles, liabilities and obligations (the “Rights”) under the Second Amended and Restated Research and License Agreement with Ramot to our Israeli Subsidiary, effective as of January 1, 2007 and our Israeli Subsidiary agreed to assume all such Rights. We agreed to be a guarantor of all obligations of our Israeli Subsidiary under the Second Amended and Restated Research and License Agreement with Ramot and Ramot can look to us to demand compliance with the License Agreement.
Government Regulations and Supervision
Once fully developed, we intend to market our bone marrow derived differentiated neurothrophic-factor secreting cell products, NurOwn™, 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 NurOwn™ cell product, we have initiated the process of seeking regulatory approval from the FDA. 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 will request a pre-Investigational New Drug (“IND”) meeting with the FDA. We are also engaging a regulatory consultant to assist us with the regulatory authorities in Israel.
In February 2011, the FDA granted Orphan Drug designation to our NurOwn™ autologous adult stem cell product candidate for the treatment of ALS. Orphan Drug status entitles us to seven years of marketing exclusivity for NurOwn™ upon regulatory approval, as well as the opportunity to apply for grant funding from the FDA of up to $400,000 per year for four years to defray costs of clinical trial expenses, tax credits for clinical research expenses and potential exemption from the FDA's application user fee.
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 is regulated by the FDA, may take a number of years, and requires the expenditure of significant resources. The Orphan Drug designation we have recently been granted by the FDA will no doubt assist us through the regulatory process. However, there can be no assurance that our technology will ultimately receive regulatory approval. We summarize below our understanding of the regulatory approval requirements that may be applicable to us if we pursue the process of seeking an approval from the FDA.
The Federal Food, Drug, and Cosmetic Act and other federal statutes and regulations govern or influence the research, testing, manufacture, safety, labeling, storage, record-keeping, approval, distribution, use, reporting, advertising and promotion of our future products. Non-compliance with applicable requirements can result in civil penalties, recall, injunction or seizure of products, refusal of the government to approve or clear product approval applications or to allow us to enter into government supply contracts, withdrawal of previously approved applications and criminal prosecution.
The FDA has developed and is continuously updating the requirements with respect to cell and gene therapy products and has issued documents concerning the regulation of cellular and tissue-based products, as new biological products. In order to file for a BLA, we will be required to develop our stem cell product in accordance with the regulatory guidelines for cell therapy and manufacture the cell products under GMP. GMP, or Good Manufacturing Practice, is a standard set of guidelines for pharmaceutical and bio-pharmaceutical production operations and facilities by the FDA and other health regulatory authorities, which apply caution in allowing any biologically active material to be administered into the human body.
Although there can be no assurance that the FDA will not choose to change its regulations, current regulation proposes that cell products which are manipulated, allogeneic, or as in our case, autologous but intended for a different purpose than the natural source cells (NurOwn™ are bone marrow derived and are intended for transplantation into the spinal cord, 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 in effect prior to the initiation of human clinical studies; (iii) adequate and well-controlled clinical trials to establish the safety and efficacy of the product for its intended use; (iv) submission to the FDA of a BLA; and (v) review and approval of the BLA as well as inspections of the manufacturing facility for GMP compliance, prior to commercial marketing of the product.
Generally, in seeking an approval from the FDA for sale of a new medical product, an applicant must submit proof of safety and efficacy. Such proof entails extensive pre-clinical studies in the lab and in animals and, if approved by the agency, in humans. The testing, preparation of necessary applications and processing of those applications by the FDA is expensive and may take several years to complete. There can be no assurance that the FDA will act favorably or in a timely manner in reviewing submitted applications, and an applicant may encounter significant difficulties or costs in its efforts to obtain FDA approvals. This, in turn, could delay or preclude the applicant from marketing any products it may develop. The FDA may also require post-marketing testing and surveillance of approved products, or place other conditions on the approvals. These requirements could cause it to be more difficult or expensive to sell the products, and could therefore restrict the commercial applications of such products. Product approvals may be withdrawn if compliance with regulatory standards is not maintained or if problems occur following initial marketing. For patented technologies, delays imposed by the governmental approval process may materially reduce the period during which an applicant will have the exclusive right to exploit such technologies.
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 Good Tissue Practice (“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.
Compliance with Environmental, Health and Safety Laws
In addition to FDA regulations, we are also subject to evolving federal, state and local environmental, health and safety laws and regulations. In the past, compliance with environmental, health and safety laws and regulations has not had a material effect on our capital expenditures. We believe that we comply in all material respects with existing environmental, health and safety laws and regulations applicable to us. Compliance with environmental, health and safety laws and regulations in the future may require additional capital expenditures.
Competition
We face significant competition in our efforts to develop our products and services, including: (i) cell therapies competing with NurOwn™ and its applications and (ii) other treatments or procedures to cure or slow the effects of ALS, PD and other neurodegenerative diseases. There are a number of companies developing cell therapies for ALS, 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, NurOwn™ 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 14 scientific and administrative employees, 11 of whom are full-time. None of our employees is represented by a
labor union and we believe that we have good relationships with our employees.
PROPERTIES
Our executive offices are located in premises at 605 Third Avenue, 34th Floor, New York, NY 10158.
On
December 1, 2004, our Israeli subsidiary, Brainstorm Cell Therapeutics Ltd., entered into a lease agreement for the lease of premises
in 12 Basel Street, Petach Tikva, Israel, which include approximately 600 square meters of office and laboratory space. The original
term of the lease was 36 months, commencing on April 1, 2005, with two options to extend: one for an additional 24 months (the
“First Option”); and one for an additional 36 months (the “Second Option”). We are currently in the Second
Option period, which will expire on March 31, 2013, and rent is paid on a quarterly basis in the amount of NIS 32,200 per month.
We expanded our Petach Tikva facility in 2008 to include an animal research facility.
As part of the clinical trials with Hadassah, we pay $67,000 per month for rental and operation of two clean room facilities at Hadassah facilities in Jerusalem.
We
believe that the current office and laboratory space is adequate to meet our needs.
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 the Company improperly terminated its contract with CSC. The complaint seeks, among other things, the following relief: (i) 400,000 shares of the common stock of the Company and (ii) warrants to purchase 250,000 shares of the common stock of the Company at an exercise price of $0.30 per share. Further, the complaint alleges that CSC performed its obligations under the contract and has suffered compensatory damages in an amount up to approximately $672,500. CSC also seeks costs and attorneys’ fees. On June 5, 2008, the Company filed an answer with the Court. The Company believes that it has substantial defenses to the claims made by CSC and has vigorously defended this action over this period of time. 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.
MARKET FOR OUR COMMON EQUITY
Market Information
Our common stock is currently traded on the OTCQB under the symbol “BCLI”.The following table contains information about the range of high and low sales prices for our common stock based upon reports of transactions on the OTCQB.
Quarter
Ended | |
High | | |
Low | |
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June 30, 2012 | |
$ | 0.30 | | |
$ | 0.21 | |
March 31, 2012 | |
$ | 0.34 | | |
$ | 0.20 | |
December 31, 2011 | |
$ | 0.40 | | |
$ | 0.20 | |
September 30, 2011 | |
$ | 0.56 | | |
$ | 0.27 | |
June 30, 2011 | |
$ | 0.60 | | |
$ | 0.25 | |
March 31, 2011 | |
$ | 0.43 | | |
$ | 0.18 | |
December 31, 2010 | |
$ | 0.30 | | |
$ | 0.18 | |
September 30, 2010 | |
$ | 0.26 | | |
$ | 0.16 | |
June 30, 2010 | |
$ | 0.34 | | |
$ | 0.19 | |
March 31, 2010 | |
$ | 0.47 | | |
$ | 0.21 | |
The source of these high and low prices was the OTCQB. These quotations reflect inter-dealer prices, without retail mark-up, markdown or commissions and may not represent actual transactions. The high and low prices listed have been rounded up to the next highest two decimal places.
On July
9, 2012, the closing bid price of our common stock as reported by the OTCQB was $0.29 per share.
Trades in our common stock may be subject to Rule 15g-9 of the Exchange Act, which imposes requirements on broker/dealers who sell securities subject to the rule to persons other than established customers and accredited investors. For transactions covered by the rule, broker/dealers must make a special suitability determination for purchasers of the securities and receive the purchaser’s written agreement to the transaction before the sale.
The Securities and Exchange Commission also has rules that regulate broker/dealer practices in connection with transactions in “penny stocks.” Penny stocks generally are equity securities with a price of less than $5.00 (other than securities listed on certain national exchanges, provided that the current price and volume information with respect to transactions in that security is provided by the applicable exchange or system). The penny stock rules require a broker/dealer, before effecting a transaction in a penny stock not otherwise exempt from the rules, to deliver a standardized risk disclosure document prepared by the Securities and Exchange Commission that provides information about penny stocks and the nature and level of risks in the penny stock market. The broker/dealer also must provide the customer with current bid and offer quotations for the penny stock, the compensation of the broker/dealer and its salesperson in the transaction, and monthly account statements showing the market value of each penny stock held in the customer’s account. The bid and offer quotations, and the broker/dealer and salesperson compensation information, must be given to the customer orally or in writing before effecting the transaction, and must be given to the customer in writing before or with the customer’s confirmation. These disclosure requirements may have the effect of reducing the level of trading activity in the secondary market for shares of common stock of the Company. As a result of these rules, investors may find it difficult to sell their shares.
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. See “Dividend Policy.”
Record Holders
As
of June 15, 2012, there were approximately 66 holders of record of our common stock.
MANAGEMENT’S DISCUSSION AND ANALYSIS OF
FINANCIAL CONDITION AND RESULTS OF OPERATIONS
Company Overview
We are a biotechnology company developing innovative stem cell therapeutic products based on technologies enabling the in-vitro differentiation of bone marrow stem cells into neural-like cells. We aim to become a leader in adult stem cell transplantation for neurodegenerative diseases. Our technology entails exploiting the patient’s own bone marrow stem cells to generate glial-like cells that may provide an effective treatment for ALS, PD, MS and Spinal Cord Injury.
Our
core technology was developed in collaboration with 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 Prof. Daniel Offen, of the Felsenstein Medical Research Center of Tel Aviv University.
Our team demonstrated formation of neurotrophic-factor secreting cells (glial-like cells) from in-vitro differentiated bone marrow cells that produce NTF including GDNF, BDNF and additional factors. Moreover, in research conducted by our team, implantation of these differentiated cells into brains of animal models that had been induced to Parkinsonian behavior markedly improved their condition.
Our aim is to provide neural-supporting stem cell transplants that are expected to maintain, preserve and possibly restore the damaged neurons, protecting them from further degeneration.
Our
Israeli subsidiary holds exclusive worldwide rights to commercialize the technology, through a licensing agreement with Ramot,
the technology transfer company of Tel Aviv University, Israel.
As a result of limited cash resources and the desire to take a faster path to clinical trials, since the fourth quarter of 2008 we have focused all of our efforts on ALS, and are currently not allocating resources towards PD, MS or other neurodegenerative diseases. Other indications are currently being evaluated.
We
are currently in the clinical stage of development of our technology and we intend to begin the process of seeking regulatory
approval from regulatory agencies in the U.S.
In
June 2011, we initiated a Phase I/II clinical study for ALS patients using our autologous NurOwn™ stem cell therapy,
after receiving final approval from the Israel MOH. In June 2012, the Company completed a study of twelve
patients and an interim report is expected to be submitted to the Israel MOH in the third quarter of fiscal 2012.
Three ALS
patients have been treated on a compassionate use basis in Israel and no adverse events were reported in the six-month
post-transplant follow-up.
In February 2011, the FDA granted Orphan Drug designation to our NurOwn™ autologous adult stem cell product candidate for the treatment of ALS. Orphan Drug status entitles us to seven years of marketing exclusivity for NurOwn™ upon regulatory approval, as well as the opportunity to apply for grant funding from the FDA of up to $400,000 per year for four years to defray costs of clinical trial expenses, tax credits for clinical research expenses and potential exemption from the FDA's application user fee.
Our efforts are directed at:
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Operating a GMP compliant production process;
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Demonstrating Safety Tolerability and Therapeutic effect of transplantation of Autologous cultured Bone Marrow Stromal Cells secreting Neurothrophic factors (MSC-NTF) in a Phase I/II Clinical trial in human ALS patients;
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Setting up a centralized facility to provide the therapeutic products
and services for transplantation in patients in the US, as part of the clinical development program; and
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Submitting an IND to the FDA.
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Results of Operations
For the year ended December 31, 20l1
Research and Development, net:
Research and development expenses, net for the year
ended December 31, 2011 and 2010 were $1,689,000 and $1,045,000, respectively. In addition, our grant from The Office of the Chief
Scientist increased by $48,000 to $388,000 for the year ended December 31, 2011 from $340,000 for the year ended December 31,
2010.
The increase in research and development expenses,
net for the year ended December 31, 2011 is primarily due to: (i) in June 2011, the Company began clinical trials in ALS patients,
in Hadassah, under which the Company paid $350,000 in 2011; (ii) development and clinical trials conducted in GMP in Hadassah
in the amount of $370,000 in the year ended December 31, 2011 compared to $250,000 in the year ended December 31, 2010; and (iii)
an increase of $190,000 in payroll costs due to recruitment of four additional employees to conduct the clinical trials.
General and Administrative
General and administrative expenses for the years
ended December 31, 2011 and 2010 were $2,205,000 and $1,544,000, respectively. The increase in General and administrative expenses,
for the year ended December 31, 2011, is mainly due to: (i) an increase of $515,000 in stock-based compensation expenses, to $1,076,000
in the year ended December 31, 2011; and (ii) an increase of $140,000 in legal and audit expenses from $230,000 in the year ended
December 31, 2010 to $370,000 in the year ended December 31, 2011; this increase was partially offset by a reduction of $60,000
in public and investor relations expenses from $120,000 in the year ended December 31, 2010 to $60,000 in the year ended December
31, 2011.
Financial Expenses
Financial expense for the year ended December 31,
2011 was $151,000 compared to financial income of $189,000 for the year ended December 31, 2010.
The increase in financial expense for the year ended
December 31, 2011 is primarily due to $192,000 financial expense from conversion of debt to a subcontractor to our common stock. The
issuance of stock to the subcontractor was in an amount that was lower than the amount owed to the supplier. The value of the
amount issued was based on the per share price on the date of the grant. The above was balanced by financial income of $41,000
due to the conversion exchange rate.
Net Loss
Net loss for the year ended December 31, 2011 was
$3,918,000, as compared to a net loss of $2,419,000 for the year ended December 31, 2010. Net loss per share for the year ended
December 31, 2011 was $0.03, as it was for the year ended December 31, 2010.
The increase in the net loss for the year ended December
31, 2011 is due to (i) the beginning of clinical trials, (ii) development in GMP in Hadassah facilities, and (iii) stock-based
compensation expenses.
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, 2011 was 120,117,724, compared to 89,094,403
for the year ended December 31, 2010.
The increase in the weighted average number of shares
of common stock used in computing basic and diluted net loss per share for the year ended December 31, 2011 was due to (i) the
issuance of shares in a private placement, (ii) the exercise of warrants and (iii) the issuance of shares to service providers.
For the quarter ended March 31, 20l2
Research and Development, net:
Research and development expenses, net for the three months
ended March 31, 2012 and 2011 were $369,000 and $270,000, respectively. In addition, our grant from The Office of the Chief Scientist
increased by $140,000 to $240,000 for the three months ended March 31, 2012 from $100,000 for the three months ended March 31,
2011.
The increase in research and development expenses for the
three months ended March 31, 2012 is primarily due to: (i) in June 2011, the Company began clinical trials in ALS patients, in
Hadassah, under which the Company paid $340,000 in the three months ended March 31, 2012; (ii) an increase of $65,000 in payroll
costs due to recruitment of four additional employees to conduct the clinical trials.
General and Administrative:
General and administrative expenses for the three months
ended March 31, 2012 and 2011 were $510,000 and $258,000, respectively.
The increase in general and administrative expenses for
the three month period ended March 31, 2012 from the three month period ended March 31, 2011 is primarily due to: (i) an
increase of $170,000 in compensation expenses for stock granted to directors and employees; (ii) an increase of $70,000 in legal,
audit and public relations activity.
Financial Expenses:
Financial income for the three months ended March 31, 2012
was $11,000, compared to a financial expense of $177,000 for the three months ended March 31, 2011.
The financial income for the three months ended March 31,
2012 is mainly from conversion exchange rate and income on deposits in banks. The financial expense for the three months ended
March 31, 2011 is primarily attributable to $192,000 financial expense from conversion of debt to a subcontractor to our common
stock, balanced by financial income of $15,000 due to the conversion exchange rate.
Net Loss:
Net loss for the three months ended on March 31, 2012 was
$872,000, as compared to a net loss of $705,000 for the three months ended March 31, 2011. Net loss per share for the three months
ended March 31, 2012 was $0.01, as it also was for the three months ended March 31, 2011.
The weighted average number of shares of common stock used
in computing basic and diluted net loss per share for the three months ended March 31, 2012 was 126,591,262, compared to 108,895,199
for the three months ended March 31, 2011.
The increase in the weighted average number of shares of
common stock used in computing basic and diluted net loss per share for the three months ended March 31, 2012 was due to
(i) the issuance of shares in a private placement, (ii) the exercise of options and warrants and (iii) the issuance of shares
to service providers.
Liquidity and Capital Resources
The Company has financed its operations since inception primarily
through private sales of its common stock and warrants and the issuance of convertible promissory notes. At March 31, 2012, we
had $1,775,000 in total current assets and $1,290,000 in total current liabilities.
Net cash used in operating activities was $746,000 for the three
months ended March 31, 2012. Cash used for operating activities in the three months ended March 31, 2012 was primarily attributed
to clinical trial costs, payroll costs, rent, outside legal and audit fee expenses and public relations expenses.
Net cash used in investing activities was $52,000 for the three
months ended March 31, 2012.
Net cash provided by financing activities was $20,000 for
the three months ended March 31, 2012 is primarily attributable to exercise of options to common stock.
Our material cash needs for the next 12 months include the payments
due under an agreement with Hadassah to conduct clinical trials in ALS patients, under which we must pay to Hadassah an amount
of (i) up to $32,225 per patient (up to $773,400 in the aggregate) and (ii) $65,000 per month for rent and operation of the
GMP facilities in anticipation of Hadassah's clinical trials.
Our other material cash needs for the next 12 months will include
payments of (i) employee salaries, (ii) patents, (iii) construction fees for facilities to be used in our research and development
and (iv) fees to our consultants and legal advisors.
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.
CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE
We have not had any changes in or disagreements with accountants on accounting and financial disclosure during our two most recent fiscal years and the subsequent interim periods.
MANAGEMENT
Executive Officers and Directors
The following table lists our current executive officers and directors. Our executive officers are elected annually by our Board of Directors and serve at the discretion of the Board of Directors. Each current director is serving a term that will expire at our Company’s next annual meeting. There are no family relationships among any of our directors or executive officers.
Name
|
|
Age
|
|
Position
|
Adrian
Harel
|
|
55
|
|
Chief
Executive Officer and Director of Research and Development
|
Chaim
Lebovits
|
|
43
|
|
President
|
Liat
Sossover
|
|
44
|
|
Chief
Financial Officer
|
Dr.
Irit Arbel
|
|
52
|
|
Director
|
Mordechai
Friedman
|
|
59
|
|
Director
|
Dr.
Abraham Israeli
|
|
58
|
|
Chairman
and Director
|
Alon
Pinkas
|
|
50
|
|
Director
|
Chen
Schor
|
|
39
|
|
Director
|
Dr.
Robert Shorr
|
|
58
|
|
Director
|
Malcolm
Taub
|
|
66
|
|
Director
|
Adrian
Harel joined the Company on January 24, 2011 as our Chief Operating Officer and Acting Chief Executive Officer. On
June 11, 2012, Dr. Harel was appointed Chief Executive Officer and Director of Research and Development. From 2009 until 2010,
Dr. Harel set up Da-Ta Biotech Ltd, a consulting and advisory business focused on early stage biotech companies. Also
during 2010, Dr. Harel provided consulting services to KMBY LTD in connection with a medical device in the orthopedic field. From
2008 through 2010, Dr. Harel served as Chief Executive Officer of Meditor Pharmaceuticals Ltd. and Aminolab Technologies 2000
Ltd., which are focused on the production of new ethical drugs. From 2003 through 2007, Dr. Harel served as Chief Operating
Officer of Sepal Pharma Ltd. and Molecular Cytomics Ltd.
Chaim Lebovits joined the Company in July 2007 as our President. Mr. Lebovits controls ACC Holdings, a holding company which controls subsidiaries: (i) Shemen Oil and Gas Resources Ltd. ("Shemen"); (ii) ACC Resources; and (iii) ACCBT. ACC Holdings focuses on minerals exploration in West Africa and Israel. ACC Resources holds 10 permits for gold exploration in Burkina Faso. Shemen holds the Shemen License offshore Israel, which has contingent and prospective resources of over 250 million barrels of oil. 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.
Liat Sossover joined the Company in June 2010 as our Chief Financial Officer. From 2001 until June 2010, Ms. Sossover served as the Vice President of Finance of ForeScout Technologies, International. In such role, Ms. Sossover managed all financial and accounting aspects. Prior to that, Ms. Sossover served as VP of Finance and Secretary of Maximal Innovative Intelligence, which was acquired by Microsoft. She has held positions as Chief Financial Officer at RT Set, which is now part of Vizrt and Financial Controller for BVR Technologies, which later was acquired by Esterline Technologies. Ms. Sossover holds an MBA from Edinburgh University, and a Bachelor's degree in Accounting & Economics from Ben Gurion University.
Dr.
Irit Arbel has been an active Board Member of the Company since May 2004 and also served initially as President
for six months. From 2009 through 2011, Dr. Arbel served as Chairperson of Real Aesthetics Ltd., a company specializing in cellulite
ultrasound treatment, and BRH Medical, developer of medical devices for wound healing. She was also Director of M & A at RFB
Investment House, a private investment firm focusing on early stage technology related companies. Previously, Dr. Arbel was President
and CEO of Pluristem Life Systems, and prior to that, Israeli Sales Manager of Merck, Sharp & Dohme. 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.
Mordechai Friedman joined the Company on April 4, 2011 as a director and as Chairman of the Audit Committee of the Board. Since 2010, Mr. Friedman has served as Chief Executive Officer of Triple M Management and Investments Ltd. From 2007 through 2010, Mr. Friedman served as the Chairman of the Board of The Israel Electric Corp. From 2005 to 2007, Mr. Friedman served as Deputy Chairman and Chief Executive Officer of Brightman, Almagor & Zohar, Inc., a division of Deloitte Touche Tohmatsu. Mr. Friedman has been a partner and director in several business ventures and companies in Israel and abroad in the transportation, consumer business, telecommunication and energy industries. He has a B.A. in Economics and Accounting from the Tel Aviv University. Mr. Friedman currently serves as a director of the following private companies: (i) Electra Consumer Products; (ii) Tel-Hashomer-Medical Research; (iii) Triple M Management and Investments Ltd.; (iv) Mordechai Friedman Blue and White Management Services Ltd.; and (v) Double M Management and Investments Ltd.
Dr. Abraham Israeli joined the Company on April 13, 2010 as a director, as Chairman of the Board and as a consultant. Since November 2009, Dr. Israeli has served as Head of the Department of Health Policy, Health Care Management and Health Economics at the Hebrew University, Hadassah Faculty of Medicine. Since 1996, Dr. Israeli has held the Chair of Dr. Julien Rozan Professorship of Family Medicine and Health Promotion at the Hebrew University - Hadassah Medical School, Jerusalem. From November 2003 to October 2009, Dr. Israeli served as the Director General of the Israel Ministry of Health. Dr. Israeli holds a M.D. and M.P.H. from Hebrew University, Hadassah Medical School and a Master’s Degree from the Sloan School of Management at Massachusetts Institute of Technology. Dr. Israeli completed residencies in Internal Medicine and in Health-Care Management at Hadassah University Hospital and has certification in both specialties.
Alon Pinkas joined the Company on December 13, 2010 as a director. Mr. Pinkas served as the Israeli Consul General to New York from 2000 to 2004 and is an internationally respected foreign affairs analyst. Mr. Pinkas currently serves as an Adviser at Tigris Financial Group and the Rhodium Group. Mr. Pinkas currently serves as a director for Ormat Industries Limited, B.G.I. Investments (1961) Ltd. and Agri-Invest Ltd. Mr. Pinkas has a Bachelors Degree in Political Science from The Hebrew University of Jerusalem and a Masters Degree in Politics from Georgetown University.
Chen Schor joined the Company as a director on August 22, 2011. Mr. Schor is a global industry leader with vast experience in biotechnology, medical devices, business development and private equity. Mr. Schor led multiple licensing and M&A transactions valued at over $2 billion with companies such as GlaxoSmithKline, Amgen, Pfizer, Bayer, Merck-Serono and OncoGeneX Pharmaceuticals, and raised significant funds from reputable investors. Mr. Schor has a broad range of experience in multiple therapeutic areas including Neurology, Respiratory, Oncology, Auto-Immune, Genetic Diseases, and Women’s Health. In addition to leading the global business development at Teva Pharmaceuticals, Mr. Schor played a key role in building early stage companies to regulatory approvals, IPOs and M&As. From March 2009 until September 2011, Mr. Schor served as Vice President of Business Development, global branded products at Teva Pharmaceuticals. Prior to joining Teva, Mr. Schor was Chief Business Officer at Predix Pharmaceuticals from December 2003 until March 2009, leading the formation of more than $1.5 billion collaborations with GlaxoSmithKline, Amgen and additional pharmaceutical companies. Prior to joining Predix, Mr. Schor was a Partner at Yozma Venture Capital from September 1998 until December 2003, managing the fund’s investments in biotechnology and medical device companies. Mr. Schor previously held positions at Arthur Anderson and BDO consultants and holds an MBA, B.A. in biology, B.A. in economics and is a Certified Public Accountant (CPA).
Dr. Robert Shorr joined the Company as a director in March 2005. Since 1999, Dr. Shorr has served as Chief Executive Officer and Chief Science Officer of Cornerstone Pharmaceuticals, a bio technology company. Since 1998, he has also been a member of the Department of Biomedical Engineering at SUNY Stony Brook, where he also serves as Director of Business Development for the university’s Center for Advanced Technology. He has served as trustee at the Tissue Engineering Charities, Imperial College, London since 1999. From 1999 until 2005, Dr. Shorr was Vice-President of Science and Technology (CSO) of United Therapeutics, a NASDAQ listed company. 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 SUNY Buffalo.
Malcolm
Taub joined the Company as a director in March 2009. Since October 2010, Mr. Taub has been a Partner at
Davidoff Malito & Hutcher LLP, a full service law and government relations firm. From 2001 to September 30, 2010, Mr. Taub
was the Managing Member of Malcolm S. Taub LLP, a law firm which practiced in the areas of commercial litigation, among other
practice areas. Mr. Taub also works on art transactions, in the capacity as an attorney and a consultant. Mr.
Taub has also served as a principal of a firm which 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 formerly served on the Board of Directors of Safer Shot, Inc. (formerly known as Monumental Marketing Inc.), a company which
trades on the Pink Sheets.
Qualifications of Directors
The Board believes that each director has valuable individual skills and experiences that, taken together, provide the variety and depth of knowledge, judgment and vision necessary for the effective oversight of the Company. As indicated in the foregoing biographies, the directors have extensive experience in a variety of fields, including biotechnology (Drs. Arbel and Shorr and Mr. Schor), accounting (Mr. Friedman), health care and health policy (Dr. Israeli), foreign affairs (Mr. Pinkas) and law (Mr. Taub), each of which the Board believes provides valuable knowledge about important elements of our business. Most of our directors have leadership experience at major companies or firms with operations inside and outside the United States and/or experience on other companies’ boards, which provides an understanding of ways other companies address various business matters, strategies and issues. As indicated in the foregoing biographies, the directors have each demonstrated significant leadership skills, including as a chief executive officer (Drs. Arbel and Shorr and Mr. Friedman), as the consul general of Israel to New York and as chief of staff to Ministers of Foreign Affairs of Israel (Mr. Pinkas), as the director general of a governmental body (Dr. Israeli), as a managing member of a law firm (Mr. Taub) or as a partner of a venture capital firm (Mr. Schor). A number of the directors have extensive public policy, government or regulatory experience, including Consul General of Israel, New York (Mr. Pinkas) and Director General of Israel Ministry of Health (Dr. Israeli), which can provide valuable insight into issues faced by companies in regulated industries such as the Company. One of the directors (Dr. Arbel) has served as the President of the Company, which service has given her a deep knowledge of the Company and its business and directly relevant management experience. The Board believes that these skills and experiences qualify each individual to serve as a director of the Company.
Certain Arrangements
On
April 13, 2010, the Company, Dr. Israeli and Hadasit Medical Research Services and Development Ltd. (“Hadasit”) entered
into an Agreement, which was amended to clarify certain terms on December 31, 2011 (as amended, the “Agreement”)
pursuant to which Dr. Israeli agreed, during the term of the Agreement, to serve as (i) our Clinical Trials Advisor and (ii) a
member of our Board of Directors. Any party may terminate the Agreement upon 30 days prior notice to the other parties. In
consideration of the services to be provided by Dr. Israeli to us under the Agreement, we agreed to grant: (i) options to Dr.
Israeli annually during the term of the Agreement for the purchase of 166,666 shares of our common stock at an exercise price
equal to $0.00005 per share and (ii) warrants to Hadasit annually during the term of the Agreement for the purchase of 33,334
shares of our common stock at an exercise price equal to $0.00005 per share. Such options and warrants will vest and
become exercisable in twelve (12) consecutive equal monthly amounts. In addition, in December 2010 the Board granted
Dr. Israeli an option to purchase 200,000 shares of common stock at an exercise price equal to $0.15 in recognition of his service
as the Chairman of the Board and the number of hours Dr. Israeli devotes to fulfillment of his responsibilities of such role.
On August 22, 2011, we entered into an agreement with Chen Schor, which was amended and restated on November 11, 2011 to clarify vesting terms (as amended and restated, the “Executive Director Agreement”) pursuant to which we will pay $15,000 per quarter to Mr. Schor for his services as an Executive Board Member. In accordance with the terms of the Executive Director Agreement, the Company and Mr. Schor have also entered into an amended and restated Restricted Stock Agreement on November 11, 2011, pursuant to which Mr. Schor received 923,374 shares of our restricted common stock under our 2005 U.S. Stock Option and Incentive Plan. If we successfully raise $10,000,000 of proceeds through the issuance of equity securities in a private or public offering after August 22, 2011, or enter into a deal with a strategic partner that brings in at least $10,000,000 of gross proceeds after August 22, 2011, then 307,791 of the shares will vest upon such event, 307,791 of the shares will vest on August 22, 2012 and the remaining 307,792 shares will vest on August 22, 2013. If such capital is not raised by us prior to August 22, 2012, then the shares will vest over 3 years – 307,791 shares on August 22, 2012, 307,791 shares on August 22, 2013 and 307,792 shares on August 22, 2014. Mr. Schor is not entitled to any other compensation for his services as a director.
Involvement in certain legal proceedings
None of our directors or executive officers has during the past ten years:
|
·
|
been convicted in a criminal proceeding or been subject to a pending criminal proceeding (excluding traffic violations and other minor offences);
|
|
·
|
had any bankruptcy petition filed by or against the business or property of the person, or of any partnership, corporation or business association of which he was a general partner or executive officer, either at the time of the bankruptcy filing or within two years prior to that time;
|
|
·
|
been subject to any order, judgment, or decree, not subsequently reversed, suspended or vacated, of any court of competent jurisdiction or federal or state authority, permanently or temporarily enjoining, barring, suspending or otherwise limiting, his involvement in any type of business, securities, futures, commodities, investment, banking, savings and loan, or insurance activities, or to be associated with persons engaged in any such activity;
|
|
·
|
been found by a court of competent jurisdiction in a civil action or by the Securities and Exchange Commission or the Commodity Futures Trading Commission to have violated a federal or state securities or commodities law, and the judgment has not been reversed, suspended, or vacated;
|
|
·
|
been the subject of, or a party to, any federal or state judicial or administrative order, judgment, decree, or finding, not subsequently reversed, suspended or vacated (not including any settlement of a civil proceeding among private litigants), relating to an alleged violation of any federal or state securities or commodities law or regulation, any law or regulation respecting financial institutions or insurance companies including, but not limited to, a temporary or permanent injunction, order of disgorgement or restitution, civil money penalty or temporary or permanent cease-and-desist order, or removal or prohibition order, or any law or regulation prohibiting mail or wire fraud or fraud in connection with any business entity; or
|
|
·
|
been the subject of, or a party to, any sanction or order, not subsequently reversed, suspended or vacated, of any self-regulatory organization (as defined in Section 3(a)(26) of the Exchange Act, any registered entity (as defined in Section 1(a)(29) of the Commodity Exchange Act (7 U.S.C. 1(a)(29))), or any equivalent exchange, association, entity or organization that has disciplinary authority over its members or persons associated with a member.
|
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 our Code of Business Conduct and Ethics is posted on our website at www.brainstorm-cell.com.We intend to satisfy the disclosure requirement regarding any amendment to, or waiver of, a provision of the Code of Business Conduct and Ethics applicable to our principal executive officer or our senior financial officers (principal financial officer and controller or principal accounting officer, or persons performing similar functions) by posting such information on our website.
Committees of the Board of Directors
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
our 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 our outside auditors the financial information
developed by us, our systems of internal controls and our 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 management) to review and discuss various matters
pertaining to the audit, including our 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 us. The Audit Committee preapproves all audit services to be provided to us, whether provided by the principal auditor or other
firms, and all other services (review, attest and non-audit) to be provided to us by the independent auditor. The Audit Committee
coordinates the Board of Directors’ oversight of our 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 us 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 our website at www.brainstorm-cell.com.
The Audit Committee currently consists of Mr. Friedman (Chair), Dr. Arbel and Mr. Pinkas each of whom is independent as defined
under applicable Nasdaq listing standards. The Board of Directors has determined that Mordechai Friedman is an “audit
committee financial expert” as defined in Item 407(d)(5) of Regulation S-K. The Audit Committee held four meetings
during the fiscal year ended December 31, 2011.
GNC Committee
On
June 27, 2011, the Board of Directors established a standing Governance, Nominating and Compensation Committee (the “GNC
Committee”), which assists the Board in fulfilling its responsibilities relating to (i) compensation of the Company’s
executive officers, (ii) the director nomination process and (iii) reviewing the Company’s compliance with SEC corporate
governance requirements. The Board has adopted a written charter for the GNC Committee, which is available in the corporate governance
section of our website at www.brainstorm-cell.com. The GNC Committee currently consists of Dr. Arbel (Chair), Dr. Shorr
and Mr. Taub, each of whom is independent as defined under applicable Nasdaq listing standards. The GNC Committee
held two meetings during the fiscal year ended December 31, 2011.
The GNC Committee determines salaries, incentives and other forms of compensation for the Chief Executive Officer and the executive officers of the Company and reviews and makes recommendations to the Board with respect to director compensation. The GNC Committee annually reviews and approves the corporate goals and objectives relevant to the compensation of the Chief Executive Officer, evaluates the Chief Executive Officer’s performance in light of these goals and objectives, and sets the Chief Executive Officer’s compensation level based on this evaluation. The GNC Committee meets without the presence of executive officers when approving or deliberating on executive officer compensation, but may invite the Chief Executive Officer to be present during the approval of, or deliberations with respect to, other executive officer compensation. In addition, the GNC Committee administers the Company’s stock incentive compensation and equity-based plans.
The GNC Committee makes recommendations to the Board concerning all facets of the director nominee selection process. Generally, the GNC Committee identifies candidates for director nominees in consultation with management and the independent members of the Board, through the use of search firms or other advisers, through the recommendations submitted by stockholders or through such other methods as the GNC Committee deems to be helpful to identify candidates. Once candidates have been identified, the GNC Committee confirms that the candidates meet the independence requirements and qualifications for director nominees established by the Board. The GNC Committee may gather information about the candidates through interviews, questionnaires, background checks, or any other means that the GNC Committee deems to be helpful in the evaluation process. The GNC Committee meets to discuss and evaluate the qualities and skills of each candidate, both on an individual basis and taking into account the overall composition and needs of the Board. Upon selection of a qualified candidate, the GNC Committee would recommend the candidate for consideration by the full Board.
In considering whether to include any particular candidate in the Board’s slate of recommended director nominees, the Board will consider the candidate’s 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. The Board believes that experience as a leader of a business or institution, sound judgment, effective interpersonal and communication skills, strong character and integrity, and expertise in areas relevant to our business are important attributes in maintaining the effectiveness of the Board. As a matter of practice, the Board considers the diversity of the backgrounds and experience of prospective directors as well as their personal characteristics (e.g., gender, ethnicity, age) in evaluating, and making decisions regarding, Board composition, in order to facilitate Board deliberations that reflect a broad range of perspectives. The Board does not assign specific weights to particular criteria and no particular criterion is a prerequisite for each prospective nominee. The Company believes that the backgrounds and qualifications of its directors, considered as a group, should provide a significant breadth of experience, knowledge and abilities that will allow the Board to fulfill its responsibilities.
Stockholder Nominations
On June 27, 2011, the Board of Directors adopted the Brainstorm Cell Therapeutics Inc. Shareholder Nominations and Communications Policy (the “Policy”), pursuant to which procedures by which stockholders may recommend nominees to our Board of Directors were established. Previously, we had no formal policy by which a stockholder could recommend nominees to our Board of Directors.
Pursuant to the Policy, stockholders may recommend nominees for consideration by submitting the following information to our Secretary at our executive offices: (i) a current resume and curriculum vitae of the candidate; (ii) statement describing the candidate’s qualifications; and (iii) contact information for personal and professional references. In addition, submission must include the name and address of the stockholder making the nomination, the number of shares which are owned by such stockholder and a description of all arrangements or understandings between such stockholder and the candidate. Assuming that the required material has been provided on a timely basis, the GNC Committee will evaluate stockholder-recommended candidates by following substantially the same process, and applying substantially the same criteria, as it follows for candidates submitted by others.
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, 2011 and 2010 earned by the former Chief Executive Officer, our current Chief Executive Officer and our Chief Financial Officer
(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
($) (1)
(2)
|
|
All Other
Compensation
($)(3)
|
|
Total ($)
|
|
Adrian Harel(4) |
|
2011
|
|
117,000 |
|
|
203,026 |
|
65,000 |
|
|
385,026 |
|
Chief Executive Officer and Director of Research and Development |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liat Sossover(5) |
|
2011
|
|
98,000 |
|
|
- |
|
46,000 |
|
|
144,000 |
|
Chief Financial Officer |
|
2010 |
|
47,000 |
|
|
67,584 |
|
12,000 |
|
|
126,584 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Abraham
Efrati(6)
|
|
2011
|
|
264,000
|
|
|
30,481
|
|
25,000
|
|
|
319,481
|
|
Former
Chief Executive Officer and Director
|
|
2010 |
|
167,000 |
|
|
- |
|
13,000 |
|
|
180,000 |
|
(*) The Named Executive Officers were paid in 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 NIS as published by the Bank of Israel, the central bank of Israel.
(1) The amounts shown in the “Option Awards” column represent the aggregate grant date fair value of awards computed in accordance with ASC 718, not the actual amounts paid to or realized by the Named Executive Officer during fiscal 2011 and fiscal 2010. ASC 718 fair value amount as of the grant date for stock options generally is spread over the number of months of service required for the grant to vest.
(2) The
fair value of each stock option award is estimated as of the date of grant using the Black-Scholes valuation model. Additional
information regarding the assumptions used to estimate the fair value of all stock option awards is included in Note 11 to
Consolidated Financial Statements.
(3)
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.
(4) Dr.
Harel commenced employment with
the Company on January 23, 2011.
(5) Ms.
Sossover commenced employment with the Company on June 1, 2010.
(6)
Mr. Efrati resigned as Chief Executive Officer, effective as of February 28, 2011.
Executive
Employment Agreements and Termination of Employment and Change-in-Control Arrangements
Abraham Efrati. Pursuant to his employment agreement dated October 7, 2007, Mr. Efrati was entitled to an initial base salary of $14,000 per month. Mr. Efrati was also entitled to coverage under our Manager’s Insurance Policy and to an education fund and the use of a Company car.
Mr. Efrati resigned as Chief Executive Officer effective as of February 28, 2011.
Per the terms of his employment agreement, Mr. Efrati 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.
On
July 25, 2011, we entered into a Settlement and Waiver Agreement (the “Settlement Agreement”) with Mr. Efrati and
Pro Int. Ltd. (an entity believed to be controlled by Mr. Efrati) regarding the termination of Mr. Efrati’s position as
our Chief Executive Officer and certain unresolved compensatory matters relating thereto. Under the Settlement Agreement,
we agreed to pay to Mr. Efrati (i) NIS 543,077 on or before August 1, 2011, (ii) an additional NIS 200,000 on or before August
20, 2011 and (iii) an additional NIS 162,051 on or before September 15, 2011. We also agreed that 150,000 of Mr. Efrati’s
non-vested options to purchase our common stock were accelerated in full and that the exercise period for all vested
stock options held by Mr. Efrati was extended until April 30, 2012. The parties to the Settlement Agreement also agreed
to waive, and release the other parties from, all claims they may have had against each other.
Adrian Harel. Pursuant to his employment
agreement dated January 23, 2011, Dr. Harel is entitled to a monthly salary of 39,000 NIS (approximately $10,000) (including benefits
for monthly totals of approximately 60,300 NIS (approximately $15,900)). Dr. Harel also receives other benefits that
are generally made available to our employees. Dr. Harel is provided with a company car and a gross-up payment for
any taxes relating thereto.
Liat Sossover. Pursuant
to her employment agreement dated June 23, 2011, Ms. Sossover is entitled to a salary of 32,000 NIS (approximately $8,290) per
month. Ms. Sossover is also entitled to contributions on her behalf by the Company into a manager’s insurance
fund, disability insurance and an education fund.
Chaim Lebovits. Currently, we do not have an employment agreement and he is not entitled to receive any compensation from us at this time.
Terms of Option Awards
On
October 23, 2007, Mr. Efrati was granted, pursuant to our Global Plan, an option to purchase 1,000,000 shares of our common stock
at a price per share of $0.87 each, which options vested and became 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 was employed by or providing services to us on
each applicable vesting date. As of October 15, 2010, this option was fully vested and exercisable. On November 5,
2008, our 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. In addition, on June 29, 2009, Mr. Efrati was granted, pursuant to our Global
Plan, an option to purchase 1,000,000 shares of our common stock at a price per share of $0.067 each, which option would vest
and become exercisable with respect to 1/3 of the shares subject to the option on each anniversary of the date of grant, provided
Mr. Efrati is employed by or providing services to us on each applicable vesting date. Mr. Efrati resigned as Chief Executive
Officer, effective February 28, 2011, and did not stand for re-election to the Board at our last annual meeting. Pursuant
to the Settlement Agreement, 150,000 of Mr. Efrati’s non-vested options were accelerated in full and the exercise period
for all vested options was extended until April 30, 2012. As of April 30, 2012, Mr. Efrati had exercised all of
his outstanding options to purchase shares of our common stock.
On June 27, 2011, Dr. Harel was granted, pursuant
to our Global Plan, an option to purchase 450,000 shares of our common stock at a price per share of $0.20 each. One-third of
such option vested and became exercisable on January 23, 2012 and the remainder of the shares subject to the option will vest
and become exercisable over the following 24 months in equal installments. The option shall expire on the tenth anniversary of
the grant date.
On August 10, 2011, Dr. Harel was granted, pursuant
to our Global Plan, an option to purchase 70,000 shares of our common stock at a price per share of $0.20 each. Such option became
fully vested and exercisable upon our receipt of clean room approval in connection with the Hadassah trial. The option shall expire
on the tenth anniversary of the grant date.
On June 23, 2010, Ms. Sossover was granted, pursuant to our Global Plan, an option to purchase 400,000
shares of our common stock at a price per share of $0.18 each. One-third of such option vested and became exercisable on June
23, 2011 and the remainder of the shares subject to the option vest and become exercisable over the following 24 months in equal
installments. The option shall expire on the tenth anniversary of the grant date.
Outstanding Equity Awards
The following table sets forth information regarding equity awards granted to the Named Executive Officers that are outstanding as of December 31, 2011. In the table below, columns required by the regulations of the SEC have been omitted where no information was required to be disclosed under those columns.
Outstanding Equity Awards at December 31, 2011
|
|
Option Awards
|
Name
|
|
Number of
Securities
Underlying
Unexercised
Options
(#)
Exercisable
|
|
|
Number of
Securities
Underlying
Unexercised
Options
(#)
Unexercisable
|
|
|
Option
Exercise
Price
($)
|
|
|
Option Expiration Date
|
Adrian Harel |
|
|
— |
|
|
|
450,000 |
(1) |
|
|
0.20 |
|
|
6/26/2021 |
|
|
|
70,000 |
|
|
|
— |
|
|
|
0.20 |
|
|
8/9/2021 |
Liat Sossover |
|
|
200,000 |
|
|
|
200,000 |
(2) |
|
|
0.18 |
|
|
6/22/2020 |
Abraham
Efrati(3)
|
|
|
699,273 |
|
|
|
— |
|
|
|
0.15 |
|
|
4/30/2012
|
|
|
|
483,333 |
|
|
|
— |
|
|
|
0.067 |
|
|
|
(1) Options for the purchase of 150,000 shares vested and became exercisable
on January 23, 2012 and options for the purchase of 12,500 shares vested and became exercisable on each of February 23, March
23, April 23, May 23 and June 23, 2012. Options for the purchase of 12,500 shares will vest and become exercisable on the 23rd
of each month until the option is fully vested.
(2) Options for the purchase of 11,111 shares vested and became exercisable
on each of January 23, February 23, March 23, April 23, May 23 and June 23, 2012. Options for the purchase of 11,111 shares will
vest and become exercisable on the 23rd of each month until the option is fully vested.
(3) Mr. Efrati resigned as Chief Executive Officer effective as of February 28,
2011.
Stock Incentive Plans
In November 2004 and February 2005, our 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 our common stock for issuance thereunder. Our 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. Our stockholders approved the amendment and restatement of the Plans on June 5, 2008.
On April 21, 2011, the Board approved another 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 stockholders approved the amendment and restatement of the Plans on June 10, 2011.
On May 6, 2012, the Board approved another amendment and
restatement of the Plans to increase the number of shares available for issuance under the Plans by an additional 9,000,000 shares,
subject to the approval of the Company’s stockholders. Our stockholders approved the amendment and restatement of the Plans
on June 12, 2012.
Under
the Global Plan, we granted a total of 12,788,319 options with various exercise prices (a weighted average exercise price of $0.15295)
and expiration dates, to service providers, subcontractors, directors, officers, and employees. Under the U.S. Plan, we issued
an additional 4,530,040 shares of restricted stock and options to Scientific Advisory Board members, consultants, and directors.
As of June 6, 2012, there were 3,225,013 shares available for issuance under the Plans. As stated above, on June
12, 2012, the Plans were amended and restated to increase the number of shares available for issuance under the Plans by an additional
9,000,000 shares.
Compensation of Directors
The following table sets forth certain summary information with respect to the compensation paid during the fiscal year ended December 31, 2011 earned by each of the directors of the Company. In the table below, columns required by the regulations of the SEC have been omitted where no information was required to be disclosed under those columns.
Director Compensation Table for Fiscal 2011
Name
|
|
Stock
Awards
($) (1)
|
|
|
Option
Awards
($) (1)
|
|
|
Total
($)
|
|
Dr.
Irit Arbel
|
|
|
—
|
|
|
|
130,365
|
(2)
|
|
|
130,365
|
|
Mr.
Mordechai Friedman
|
|
|
—
|
|
|
|
75,355
|
(3) |
|
|
|
|
Dr.
Abraham Israeli
|
|
|
—
|
|
|
|
48,326
|
(4)
|
|
|
|
|
Mr.
Alon Pinkas
|
|
|
—
|
|
|
|
81,384
|
(5) |
|
|
|
|
Mr.
Chen Schor
|
|
|
443,220
|
(6) |
|
|
—
|
|
|
|
|
|
Dr.
Robert Shorr
|
|
|
114,400
|
(7) |
|
|
—
|
|
|
|
|
|
Mr.
Malcolm Taub
|
|
|
|
(8) |
|
|
—
|
|
|
|
|
|
(1) The amounts shown in the “Stock Awards” and “Option Awards” columns represent the aggregate grant date fair value of awards computed in accordance with ASC 718, not the actual amounts paid to or realized by the directors during fiscal 2011.
(2) At December 31, 2011, Dr. Arbel had options (vested and unvested) to purchase 988,333 shares of common stock.
(3) Mr. Friedman was elected to the Board of Directors on April 4, 2011. At December 31, 2011, he had options (vested and unvested) to purchase 166,666 shares of common stock.
(4)
At December 31, 2011, Dr. Israeli had options (vested and unvested) to purchase 533,332 shares of common stock.
(5) At December 31, 2011, Mr. Pinkas had options (vested and unvested) to purchase 180,000 shares of common stock.
(6) Mr.
Schor was elected to the Board of Directors on August 22, 2011. At December 31, 2011, he had 923,374 shares of restricted
common stock.
(7) At December 31, 2011, Dr. Shorr had 230,000 shares
of restricted common stock.
(8) At December 31, 2011, Mr. Taub had vested options to purchase 100,000 shares of common stock and
238,333 shares of restricted common stock.
We reimburse our non-employee directors for reasonable travel and other out-of-pocket expenses incurred in connection with attending board meetings.
On October 14, 2007, we implemented a compensation plan for non-employee directors. Under this compensation plan, each director was entitled to receive an option to purchase 100,000 shares of our common stock or 100,000 restricted shares of common stock. Dr. Israeli did not earn compensation in accordance with this compensation plan. In 2010, we issued an option to purchase 200,000 shares of common stock to Dr. Arbel under this compensation policy. In addition, in 2010, we approved the issuance of 200,000 restricted shares of common stock to Dr. Shorr and Mr. Taub under this compensation policy. The determination to grant equity awards in an amount greater than as set forth in the compensation plan was made at the discretion of the Board and as recognition for service on the Audit Committee by Drs. Arbel and Shorr and as recognition of service on the Board by Mr. Taub.
The Board also made the determination to issue an option to purchase 200,000 shares of common stock to Dr. Israeli in recognition of his service as the Chairman of the Board and the number of hours Dr. Israeli devotes to fulfillment of his responsibilities of such role.
On
June 27, 2011, we implemented a new Director Compensation Plan for non-employee directors (the “Director Compensation Plan”). Every
non-employee director of the Company, other than Dr. Israeli and Mr. Schor are eligible to participate in the Director Compensation
Plan. Under the Director Compensation Plan, each eligible director is granted an annual award immediately following
each annual meeting of shareholders beginning with the 2011 annual meeting. For non-U.S. directors, this annual award
consists of a nonqualified stock option to purchase 100,000 shares of common stock. For U.S. directors, at their option,
this annual award is either (i) a nonqualified stock option to purchase 100,000 shares of common stock or (ii) 100,000 shares
of restricted stock. Additionally, each member of the GNC Committee or Audit Committee receives (i) a nonqualified
stock option to purchase 30,000 shares of common stock or (ii) in the case of U.S. directors and at their option, 30,000 shares
of restricted stock. A chairperson of the GNC Committee or Audit Committee will instead of the above committee award
receive (i) a nonqualified stock option to purchase 50,000 shares of common stock or (ii) in the case of U.S. directors and at
their option, 50,000 shares of restricted stock. Any eligible participant who is serving as chairperson of the Board
of Directors of the Company shall also receive (i) a nonqualified stock option to purchase 100,000 shares of common stock or (ii)
in the case of U.S. directors and at their option, 100,000 shares of restricted stock. Awards are granted on a pro
rata basis for directors serving less than a year at the time of grant. The exercise price for options for U.S. directors
will be equal to the closing price per share of the common stock on the grant date as reported on the Over-the-Counter Bulletin
Board or the national securities exchange on which the common stock is then traded. The exercise price for options
for non-U.S. directors is $0.15. Every option and restricted stock award will vest monthly as to 1/12 the number of
shares subject to the award over a period of twelve months from the date of grant, provided that the recipient remains a director
of the Company on each such vesting date, or, in the case of a committee award, remains a member of the committee on each such
vesting date.
On June 27, 2011, the following grants were made under the Director Compensation Plan to the eligible directors: Dr. Arbel received a stock option to purchase 180,000 shares of common stock for her service as a director, chairperson of the GNC Committee and a member of the Audit Committee; Mr. Friedman received a stock option to purchase 150,000 shares of common stock for his service as a director and chairperson of the Audit Committee; Mr. Pinkas received a stock option to purchase 130,000 shares of common stock for his service as a director and a member of the GNC Committee; Mr. Shorr received 130,000 shares of restricted stock for his service as a director and a member of the Audit Committee; and Mr. Taub received 130,000 shares of restricted stock for his service as a director and a member of the GNC Committee.
Dr. Israeli receives an annual option for the purchase of 166,666 shares of common stock at an exercise price equal to $0.00005 per the terms of the Agreement, as described in detail in “Certain Arrangements” above and in “Certain Relationships and Related Transactions” below, which option is compensation for both his service as a director and as a clinical trials advisor. In addition, in December 2010 the Board granted Dr. Israeli an option to purchase 200,000 shares of common stock at an exercise price equal to $0.15 in recognition of his service as the Chairman of the Board and the number of hours Dr. Israeli devotes to fulfillment of his responsibilities of such role.
On August 22, 2011, Mr. Schor received a grant of 923,374 shares of restricted stock and will receive $15,000 per quarter for his services as a director and advisor of the Company pursuant to the terms of the Executive Director Agreement, as described in detail in “Certain Arrangements” above.
SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT
The
following table sets forth certain information as of June 15, 2012 with respect to the beneficial ownership of our common stock
by the following: (i) each of our current directors; (ii) the Named Executive Officers; (iii) all of the current executive officers
and directors as a group; and (iv) each person known by us to own beneficially more than five percent (5%) of the outstanding
shares of our common stock.
For
purposes of the following table, beneficial ownership is determined in accordance with the rules of 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, we believe that each person or entity named in the table has sole voting and investment power with respect to all shares
of our 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 our common stock issuable under options that are exercisable on or within 60 days after June
15, 2012 (“Presently Exercisable Options”) or under warrants that are exercisable on or within 60 days after June
15, 2012 (“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., 605 Third Avenue, 34th Floor, New York, New York 10158.
The
percentage of the common stock beneficially owned by each person or entity named in the following table is based on 128,586,644
shares of common stock outstanding as of June 15, 2012 plus any shares issuable upon exercise of Presently Exercisable Options
and Presently Exercisable Warrants held by such person or entity.
| |
Shares Beneficially Owned | |
Name of Beneficial Owner | |
Number of Shares | | |
Percentage of
Class | |
Directors and Named Executive Officers | |
| | | |
| | |
Adrian Harel | |
| 295,000 | (1) | |
| * | |
Liat Sossover | |
| 277,777 | (1) | |
| * | |
Abraham Efrati | |
| 483,333 | (2) | |
| * | |
Irit Arbel | |
| 3,255,000 | (3) | |
| 2.5 | % |
Mordechai Friedman | |
| 166,667 | (1) | |
| * | |
Abraham Israeli | |
| 588,888 | (1) | |
| * | |
Alon Pinkas | |
| 180,000 | (1) | |
| * | |
Chen Schor | |
| 923,374 | (4) | |
| * | |
Robert Shorr | |
| 230,000 | (5) | |
| * | |
Malcolm Taub | |
| 538,333 | (6) | |
| * | |
All current directors and officers as a group (10 persons) | |
| 66,011,963 | (7) | |
| 41.0 | % |
| |
| | | |
| | |
5% Shareholders | |
| | | |
| | |
| |
| | | |
| | |
ACCBT Corp. Morgan & Morgan Building Pasea Estate, Road Town Tortola British
Virgin Islands | |
| 59,556,924 (8) | | |
| 37.5 | % |
(1)
|
Consists of shares of common stock issuable upon the exercise of
Presently Exercisable Options.
|
(2)
|
Mr. Efrati resigned as Chief Executive Officer effective February 28, 2011.
|
(3)
|
Includes 955,000 shares of common stock issuable upon the
exercise of Presently Exercisable Options. Dr. Arbel’s address is 6 Hadishon Street, Jerusalem, Israel.
|
(4)
|
Consists of shares of restricted common stock. If the Company successfully raises $10,000,000 of proceeds through the issuance of equity securities in a private or public offering after August 22, 2011, or enters into a deal with a strategic partner that brings in at least $10,000,000 of gross proceeds after August 22, 2011, then 307,791 of the shares will vest upon such event, 307,791 of the shares will vest on August 22, 2012 and the remaining 307,792 shares will vest on August 22, 2013. If such capital is not raised by the Company prior to August 22, 2012, then 307,791 of the shares will vest on August 22, 2012, 307,791 of the shares will vest on August 22, 2013 and the remaining 307,792 shares will vest on August 22, 2014.
|
(5)
|
Consists of shares of restricted common stock. The shares
of restricted stock vest in 12 consecutive, equal monthly installments commencing on July 27, 2011 until fully vested on the first
anniversary of the date of grant, provided that Mr. Shorr remains a director of the Company on each vesting date.
|
(6)
|
Consists of 100,000 shares of common stock issuable upon the exercise of Presently Exercisable Options and 238,333 shares of restricted common stock. The shares of restricted stock vest in 12 consecutive, equal monthly installments commencing on July 27, 2011 until fully vested on the first anniversary of the date of grant, provided that Mr. Taub remains a director of the Company on each vesting date.
|
(7)
|
Includes (i) 29,006,924 shares of common stock owned by ACCBT
Corp. (Chaim Lebovits, our President, may be deemed to be the beneficial owner of these shares), (ii) 30,250,000 shares of
common stock issuable to ACCBT Corp. upon the exercise of Presently Exercisable Warrants, (iii) 300,000 shares of common stock
owned by ACC International Holdings Ltd. (Chaim Lebovits, our President, may be deemed to be the beneficial owner of these
shares) and (iv) 2,563,332 shares of common stock issuable upon the exercise of Presently Exercisable Options.
|
(8)
|
Consists of (i) 29,006,924 shares of common stock owned by ACCBT Corp., (ii) 30,250,000 shares of common stock issuable to ACCBT Corp. upon the exercise of Presently Exercisable Warrants and (iii) 300,000 shares of common stock owned by ACC International Holdings Ltd. ACC International Holdings Ltd. and Chaim Lebovits, our President, may each be deemed the beneficial owners of these shares.
|
RELATED PARTY TRANSACTIONS
Certain Relationships and Related Transactions
The
Audit Committee of our Board reviews and approves all related-party transactions. A “related-party transaction” is
a transaction that meets the minimum threshold for disclosure under the relevant SEC rules (transactions involving amounts exceeding
the lesser of $120,000 or one (1) percent of the average of the smaller reporting company's total assets at year end for the last
two fiscal years in which a “related person” or entity has a direct or indirect material interest). “Related
persons” include our executive officers, directors, 5% or more beneficial owners of our common stock, immediate family members
of these persons and entities in which one of these persons has a direct or indirect material interest. When a potential related-party
transaction is identified, management presents it to the Audit Committee to determine whether to approve or ratify it.
The Audit Committee reviews the material facts of any related-party transaction and either approves or disapproves of the entry into the transaction. If advance approval of a related-party transaction is not feasible, then the transaction will be considered and, if the Audit Committee determines it to be appropriate, ratified by the Audit Committee. No director may participate in the approval of a transaction for which he or she is a related party.
Research and License Agreement with Ramot
On July 8, 2004, we entered into a Research and License Agreement (the “Original Ramot Agreement”) with Ramot at Tel Aviv University Ltd. (“Ramot”), a former 5% stockholder of the Company, 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 stem cell technology developed by the team led by Prof. Melamed and Dr. Offen, and (ii) the results of further research to be performed by the same team on the development of the stem cell technology. Simultaneously with the execution of the Original Ramot Agreement, we entered into individual consulting agreements with Prof. Melamed and Dr. Offen pursuant to which all intellectual property developed by Prof. Melamed or Dr. Offen in the performance of services thereunder will be owned by Ramot and licensed to us under the Original Ramot Agreement.
Under the Original Ramot Agreement, we agreed to fund further research relating to the licensed technology in an amount of $570,000 per year for an initial period of two years, and for an additional two-year period if certain research milestones were met.
In consideration for the license, we originally agreed to pay Ramot:
|
·
|
An up-front license fee payment of $100,000;
|
|
·
|
An amount equal to 5% of all net sales of products; and
|
|
·
|
An amount equal to 30% of all sublicense receipts.
|
On March 30, 2006, we entered into an Amended Research and License Agreement (the “Amended Research and License Agreement”) with Ramot. Under the Amended Research and License Agreement, the funding of further research relating to the licensed technology in an amount of $570,000 per year was reduced to $380,000 per year. Moreover, under the Amended Research and License Agreement, the initial period of time that we agreed to fund the research was extended from an initial period of two (2) years to an initial period of three (3) years. The Amended Research and License Agreement also extended the additional two-year period in the Original Ramot Agreement to an additional three-year period, if certain research milestones were met. In addition, the Amended Research and License Agreement reduced (i) certain royalties payments from five percent (5%) to three percent (3%) of all net sales in cases of third party royalties and (ii) potential payments concerning sublicenses from 30% to 20-25% of sublicense receipts.
We entered into a Second Amended and Restated Research and License Agreement with Ramot on July 26, 2007 (the “Second Ramot Agreement”), which amended and replaced the Amended Research and License Agreement. Like the Original Ramot Agreement, the Second Ramot Agreement imposed on us development and commercialization obligations, milestone and royalty payment obligations and other obligations. As of June 30, 2007, we owed Ramot an aggregate of $513,249 in overdue payments and patent fees under the Amended Research and License Agreement. On August 1, 2007, we obtained a waiver and release from Ramot pursuant to which Ramot agreed to an amended payment schedule regarding our payment obligations under the Second Ramot Agreement and waived all claims against us resulting from our previous breaches, defaults and non-payment under the Amended Research and License Agreement.
In addition, in the event that the “research period”, as defined in the Second Ramot Agreement, was extended for an additional three year period in accordance with the terms of the Second Ramot Agreement, then we had to make payments to Ramot during the first year of the extended research period in an aggregate amount of $380,000.
On December 24, 2009, we entered into a Letter Agreement (the “Letter Agreement”) with Ramot, pursuant to which, among other things, Ramot agreed to: (i) release the Company from its obligation to fund three years of additional research (which would have totaled $1,140,000); and (ii) accept 1,120,000 shares of our common stock in lieu of $272,000 in past-due amounts. Pursuant to the Letter Agreement, we agreed, among other things, to: (i) reimburse Ramot for outstanding patent-related expenses; and (ii) abandon our rights in certain patents of Ramot.
Through March 2011, Ramot had sold the 1,120,000 shares of common stock of the Company for $235,000 and the Company paid the remaining $5,000 due to Ramot. There is no additional debt to Ramot.
On
December 20, 2011, we entered into an Assignment Agreement with our Israeli subsidiary (the “Assignment Agreement”). Under
the Assignment Agreement, we assigned and transferred all of our rights, interests, titles, liabilities and obligations (the “Rights”)
under the Second Ramot Agreement to our Israeli subsidiary, effective as of January 1, 2007 and our Israeli subsidiary agreed
to assume all such Rights. We agreed to be a guarantor of all obligations of our Israeli subsidiary under the Second
Ramot Agreement and Ramot can look to us to demand compliance with the Second Ramot Agreement.
Investment Agreement with ACCBT Corp.
On
July 2, 2007, we entered into a Subscription Agreement with ACCBT, a 37.6% stockholder and a company under the control of Mr.
Chaim Lebovits, our 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
were scheduled to take place from August 30, 2007 through November 15, 2008. The warrants originally had the following exercise
prices: (i) warrants for the first 10,083,333 shares of our common stock had an exercise price of $0.20; (ii) warrants for the
next 10,083,333 shares of our common stock had an exercise price of $0.29; and (iii) warrants for the final 10,083,334 shares
of our common stock had an exercise price of $0.36. Each warrant issued pursuant to the Subscription Agreement was to expire on
November 5, 2011.
Pursuant to the terms of the Subscription Agreement, as
amended, and a related registration rights agreement, ACCBT has the following rights for so long as
ACCBT or its affiliates hold at least 5% of our issued and outstanding share capital:
| · | Board
Appointment Right:
ACCBT has the
right to appoint
50.1% (any fractions
to be rounded
up to the nearest
whole number)
of the members
of our Board of
Directors and
any of our committees
and the Board
of Directors of
our subsidiary.
|
| · | Preemptive
Right:
ACCBT has the
right to receive
thirty day notice
of, and to purchase
a pro rata portion
(or greater under
certain circumstances
where offered
shares are not
purchased by other
subscribers) of,
securities issued
by us, including
options and rights
to purchase shares.
This preemptive
right does not
include issuances
under our equity
incentive plans. |
| · | Consent
Right:
ACCBT’s
written consent
is required for
certain corporate
actions, including
issuance of shares
(other than existing
warrants and issuances
under our incentive
plans), amendment
of our charter
or bylaws, repurchase
of shares, declaration
or payment of
dividends or distributions,
related party
transactions,
non-ordinary course
transactions involving
$25,000 or more,
liquidation or
dissolution, the
creation, acquisition
or disposition
of a subsidiary
or entry into
a joint venture
or strategic alliance,
a material change
to our business,
merger, change
of control, sale
of the company,
any acquisition,
and any payment
of cash compensation
over $60,000 per
year. |
In addition ACCBT is entitled to demand and piggyback registration
rights, whereby ACCBT may request, upon ten days written notice, that we file, or include within a registration statement to be
filed, with the Securities and Exchange Commission for ACCBT’s resale of the Subscription Shares, as adjusted, and the shares
of our common stock issuable upon exercise of the Warrants.
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 a $250,000 convertible promissory note, dated as of May 6, 2007, issued to ACCBT by us 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. On September 8, 2008, 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 August 18, 2009, we entered into an amendment to the Subscription Agreement (the “Amendment”), dated as of July 31, 2009, with ACCBT.
Under the terms of the Subscription Agreement, ACCBT was no longer obligated to invest any further amounts in the Company. Pursuant to the Amendment, ACCBT agreed to invest the remaining amount outstanding under the Subscription Agreement up to $5.0 million in the Company, and, in return, we agreed to amend the Subscription Agreement to, among other things: (i) decrease the purchase price per share of the up to 27,500,000 shares (the “Subscription Shares”) of our common stock that ACCBT previously purchased or will purchase pursuant to the terms of the Subscription Agreement, as amended, from $0.1818 to $0.12 (the “Repricing”); (ii) adjust the number of shares of common stock issuable under the Subscription Agreement in accordance with the Repricing; (iii) extend the expiration date of all Warrants (as described below); (iv) amend the exercise price of certain of the Warrants from $0.36 to $0.29; and (v) revise the investment schedule of the purchase and sale of the Subscription Shares. Pursuant to the Amendment, the Repricing retroactively applied to all Subscription Shares purchased by the Investor prior to the Amendment.
Pursuant to the Amendment, ACCBT agreed to purchase the remainder of the Subscription Shares, as adjusted, at an aggregate purchase price of $947,347 at a price per share of $0.12 in monthly installments of not less than $50,000 (with the last payment in an amount up to the maximum subscription price of $5.0 million) at closings to be held monthly beginning on August 1, 2009.
As described above, pursuant to the terms of the Subscription Agreement, we originally agreed to sell to ACCBT the Subscription Shares for an aggregate subscription price of up to $5.0 million and, for no additional consideration, if ACCBT purchased the Subscription Shares, warrants to purchase up to 30,250,000 shares of common stock (the “Warrants”). As of July 31, 2009, ACCBT had purchased an aggregate of 18,306,925 shares of common stock for an aggregate purchase price of $4,052,652, and the following Warrants (the “Issued Warrants”) had been issued to ACCBT: (i) 10,083,333 Warrants with an exercise price of $0.20; (ii) 10,083,333 Warrants with an exercise price of $0.29; and (iii) 1,008,334 Warrants (the “Last Warrant”) with an exercise price of $0.36. Pursuant to the Amendment, the exercise price of the Last Warrant decreased from $0.36 to $0.29. Pursuant to the Amendment, all of the Warrants, including the Issued Warrants, shall expire on November 5, 2013 instead of November 5, 2011.
Pursuant
to the Amendment and in connection with ACCBT’s completion of the investment of up to $5.0 million, we issued to ACCBT the
remainder of the Warrants.
In connection with the Repricing and the Amendment, we agreed to issue 9,916,667 shares of common stock to ACCBT for no additional consideration in order to retroactively apply the Repricing. On October 28, 2009, we issued the 9,916,667 shares of common stock to various designees of ACCBT, including 5,000,000 shares to Yosef Sternberg, a former 5% stockholder of the Company.
On May 10, 2012, we entered into a Warrant Amendment Agreement
with ACCBT pursuant to which we agreed, upon the effectiveness of a six month lock-up agreement entered into by ACCBT in connection
with this proposed offering, the then current expiration date of each Warrant shall be automatically extended by an additional
18 months.
As
of the date of this prospectus, ACCBT has purchased all of the Subscription Shares.
In sum, Warrants to purchase up to 30,250,000 shares of common stock were
issued to ACCBT, of which 30,250,000 Warrants are presently outstanding. The outstanding Warrants contain
full-ratchet anti-dilution provisions and cashless exercise provisions, which permit the cashless exercise of up to 50% of
the underlying shares of common stock, and 10,083,333 of such Warrants have an exercise price of $0.20 and the remainder have
an exercise price of $0.29. ACCBT has waived its participation rights, registration rights and anti-dilution rights solely in
connection with this offering and with respect to issuances that were made prior to the date hereof.
Agreement with Abraham Israeli
On
April 13, 2010, the Company, Dr. Israeli, a director of the Company, and Hadasit entered into an Agreement, which was amended
to claify certain terms on December 31, 2011, pursuant to which Dr. Israeli agreed, during the term of the Agreement,
to serve as (i) our Clinical Trials Advisor and (ii) a member of our Board of Directors. Any party may terminate the Agreement
upon 30 days prior notice to the other parties. In consideration of the services to be provided by Dr. Israeli to us under the
Agreement, we agreed to grant options and warrants annually during the term of the Agreement for the purchase of our common stock,
as follows:
|
·
|
an option for the purchase of 166,666 shares of common stock at an exercise price equal to $0.00005 per share to Dr. Israeli; and
|
|
·
|
warrants for the purchase of 33,334 shares of common stock at an
exercise price equal to $0.00005 per share to Hadasit,
|
Such options will vest and become exercisable in twelve (12) consecutive equal monthly amounts.
Agreement with Dr. Jonathan Javitt
On December 12, 2011, we entered into a Settlement Agreement with Dr. Jonathan Javitt, a former director of the Company, to settle certain disputed stock issuances. Under this agreement, we issued 350,000 shares of our common stock to Dr. Javitt to settle the disputed stock issuances. As part of this agreement, Dr. Javitt released the Company and related parties from all claims he may have had against the Company and its related parties.
Independence of the Board of Directors
The Board of Directors has determined that each of Dr. Arbel, Mr. Friedman, Dr. Israeli, Mr. Pinkas, Mr. Schor, 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. During the course of determining the independence of Dr. Israeli, the Board of Directors considered the Agreement entered into by and among the Company, Hadasit and Dr. Israeli described above in “Certain Arrangements” and “Certain Relationships and Related Transactions.”
The
Board of Directors is comprised of a substantial majority of independent directors and the Audit and GNC Committees are comprised
entirely of independent directors.
LEGAL MATTERS
Validity
of the securities offered by this prospectus will be passed upon for us by BRL Law Group LLC, Boston,
Massachusetts. As of March 31, 2012, Thomas B. Rosedale, the Managing Member of BRL Law Group LLC, beneficially
owned 180,000 shares of our common stock and may receive additonal shares as part of compensation for certain legal services
performed by BRL Law Group LLC in 2012.
EXPERTS
The financial statements included in this Prospectus of the Company have been audited by Brightman Almagor Zohar & Co., a member of Deloitte Touche Tohmatsu, an independent registered public accounting firm, as stated in their report appearing herein (which report expresses an unqualified opinion on the financial statements and includes an explanatory paragraph regarding the Company's ability to continue as a going concern). Such financial statements have been so included in reliance upon the report of such firm given upon their authority as experts in accounting and auditing.
INDEMNIFICATION UNDER OUR CERTIFICATE OF INCORPORATION AND BYLAWS
The Certificate of Incorporation of our Company provides that no director will be personally liable to our Company or its stockholders for monetary damages for breach of a fiduciary duty as a director, except to the extent such exemption or limitation of liability is not permitted under the Delaware General Corporation Law. The effect of this provision in the Certificate of Incorporation is to eliminate the rights of the Company and its stockholders, either directly or through stockholders’ derivative suits brought on behalf of our Company, to recover monetary damages from a director for breach of the fiduciary duty of care as a director except in those instances described under the Delaware General Corporation Law. Our Certificate of Incorporation and our Bylaws provide that the Company will indemnify its present and former directors and officers to the maximum extent permitted under the Delaware General Corporation Law. In addition, under our Bylaws the Company may purchase and maintain insurance on behalf of any person who is or was serving as a director, officer, employee or agent of the Company, or of another entity at the request of the Company.
Indemnification
may not apply in certain circumstances to actions arising under the federal securities laws. Insofar as indemnification for liabilities
arising under the Securities Act may be permitted to directors, officers or persons controlling our Company pursuant to the foregoing
provisions, our Company has been informed that in the opinion of the SEC such indemnification is against public policy as expressed
in the Securities Act and is therefore unenforceable.
WHERE YOU CAN FIND MORE INFORMATION
We
file annual, quarterly and special reports and other information
with the SEC. These filings contain important information that does not appear in this prospectus. For further information about
us, you may read and copy any reports, statements and other information filed by us at the SEC’s Public Reference Room at
100 F Street, N.E., Room 1580, Washington, D.C. 20549-0102. You may obtain further information on the operation of the Public
Reference Room by calling the SEC at 1-800-SEC-0330. Our SEC filings are also available on the SEC Internet site at http://www.sec.gov,
which contains reports, proxy and information statements, and other information regarding issuers that file electronically with
the SEC.
BRAINSTORM CELL THERAPEUTICS INC.
AND SUBSIDIARY
(A development stage company)
CONSOLIDATED FINANCIAL STATEMENTS
AS OF DECEMBER 31, 2011
U.S. DOLLARS IN THOUSANDS
(Except share data)
INDEX
|
Page |
|
|
Reports of Independent Registered Public Accounting Firms |
F-2 - F-3 |
|
|
Consolidated Financial Statements |
|
|
|
Consolidated Balance Sheets |
F-4 |
|
|
Consolidated Statements of Operations |
F-5 |
|
|
Statements of Changes in Stockholders' Equity (Deficiency) |
F-6 |
|
|
Consolidated Statements of Cash Flows |
F-15 |
|
|
Notes to Consolidated Financial Statements |
F-16 - F-47 |
|
|
Unaudited Consolidated Financial Statements |
|
|
|
Consolidated Balance Sheets as of March 31, 2012 and December 31, 2011 |
F-48 |
|
|
Consolidated Statements of Operations for the three months ended March 31, 2012 and 2011 |
F-49 |
|
|
Statements of Changes in Stockholders’ Equity (Deficiency) |
F-50 |
|
|
Consolidated Statements of Cash Flows for the three months ended March 31, 2012 and 2011 |
F-59 |
|
|
Notes to Consolidated Financial Statements (Unaudited) |
F-60 - F-78 |
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, 2011 and 2010, and the related consolidated statement of income, stockholders' deficiency, and cash flows for
each of the two years in the period ended December 31, 2011 and for the period from April 1, 2004 to December 31, 2011. 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 April 1, 2004 through December 31, 2007, were audited by other auditors. The consolidated financial statements for the period
from April 1, 2004 through December 31, 2007 included a net loss of $32,325,000. Our opinion on the consolidated statements of
operations, changes in stockholders' deficiency and cash flows for the period from April 1, 2004 through December 31, 2011, insofar
as it relates to amounts for prior periods through December 31, 2007, is based solely on the report of other auditors. The other
auditors report dated April 13, 2008 expressed an unqualified opinion, and included an explanatory paragraph concerning an uncertainty
about the Company's ability to continue as a going concern, and regarding the status of the Company research and development license
agreement with Ramot.
We conducted our audits in accordance
with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and
perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. The
Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. Our
audits included consideration of internal control over financial reporting as a basis for designing audit procedures that are
appropriate in the circumstances, but not for the purpose of expressing an opinion on the effectiveness of the Company's internal
control over financial reporting. Accordingly, we express no such opinion. An audit also includes examining, on a test basis,
evidence supporting the amounts and disclosures in the financial statements, assessing the accounting principles used and significant
estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our audits provide
a reasonable basis for our opinion.
In our opinion, based on our audits
and the report of other auditor, such consolidated financial statements present fairly, in all material respects, the financial
position of BRAINSTORM CELL THERAPEUTICS Inc. and subsidiary as of December 31, 2011 and 2010, and the results of their operations
and their cash flows for each of the two years in the period ended December 31, 2011 and for the period from April 1, 2004 to
December 31, 2011, 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 innovative stem cell therapeutic products based on technologies enabling the in-vitro differentiation of
bone marrow stem cells into neural-like cells, based on the acquired technology and research to be conducted and funded by the
Company as discussed in Note 1 to the financial statements. The Company's working capital deficiency and operating losses since
inception through December 31, 2011 raise substantial doubts about its ability to continue as a going concern. Management's plans
concerning these matters are also described in Note 1 to the financial statements. The financial statements do not include any
adjustments that might result from the outcome of' these uncertainties.
/s/ Brightman Almagor Zohar & Co.
Brightman Almagor Zohar & Co.
Certified Public Accountants
A Member Firm of Deloitte Touche Tohmatsu
Tel Aviv, Israel
March 13, 2012
Audit.Tax.Consulting.Financial
Advisory. |
Member of
Deloitte Touche Tohmatsu |
REPORT OF INDEPENDENT REGISTERED
PUBLIC ACCOUNTING FIRM
To the Stockholders and Board
of Directors of
BRAINSTORM CELL THERAPEUTICS
INC.
(A development stage company)
We have audited the accompanying
consolidated balance sheet of Brainstorm Cell Therapeutics Inc. (a development stage company) ("the Company") and its
subsidiary as of December 31, 2007, and the related consolidated statements of operations, statements of changes in stockholders'
equity (deficiency) and the consolidated statements of cash flows for the year ended December 31, 2007, for the nine months ended
December 31, 2006 and 2005 and for the period from March 31, 2004 through December 31, 2007. These financial statements
are the responsibility of the Company's management. Our responsibility is to express an opinion on these financial statements
based on our audits.
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. We
were not engaged to perform an audit of the Company's internal control over financial reporting. Our audit 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,
and evaluating the overall financial statement presentation. We believe that our audits and the report of the other auditors provide
a reasonable basis for our opinion.
In our opinion, based on our
audits, the consolidated financial statements referred to above present fairly, in all material respects, the consolidated financial
position of the Company and its subsidiary as of December 31, 2007, and the consolidated results of their operations and
cash flows for the year ended December 31, 2007, for the nine months ended December 31, 2006 and 2005 and for the period
from March 31, 2004 through December 31, 2007, in conformity with U.S generally accepted accounting principles.
As discussed in Note 2 to the
consolidated financial statements, in 2007, the Company adopted Financial Accounting Standard Board Statement No. 123(R), "Share-Based
Payment".
The accompanying financial statements
have been prepared assuming that the Company will continue as a going concern. As more fully described in Note 1h, the Company
has incurred operating losses and has a negative cash flow from operating activities and has a working capital deficiency. As
for the Company research and development license agreement with Ramot, see Note 3. These conditions raise substantial doubt about
the Company's ability to continue to operate as a going concern. The financial statements do not include any adjustments to reflect
the possible future effects on the recoverability and classification of assets or the amounts and classification of liabilities
that may result from the outcome of this uncertainty.
|
/s/ Kost Forer Gabbay & Kasierer |
Tel-Aviv, Israel |
KOST FORER GABBAY & KASIERER |
April 13, 2008 |
A Member of Ernst & Young Global |
BRAINSTORM CELL
THERAPEUTICS INC. AND SUBSIDIARY
(A development stage
company)
CONSOLIDATED BALANCE
SHEETS
U.S. dollars in thousands
(Except share data)
| |
December 31, | |
| |
2011 | | |
2010 | |
| |
U.S. $ in thousands | |
| |
| | |
| |
ASSETS | |
| | | |
| | |
| |
| | | |
| | |
Current Assets: | |
| | | |
| | |
Cash and cash equivalents | |
| 1,923 | | |
| 93 | |
Account receivable (Note 5) | |
| 312 | | |
| 427 | |
Prepaid expenses | |
| 69 | | |
| 59 | |
Total current assets | |
| 2,304 | | |
| 579 | |
| |
| | | |
| | |
Long-Term Investments: | |
| | | |
| | |
Prepaid expenses | |
| 17 | | |
| 1 | |
Severance payment fund | |
| 109 | | |
| 90 | |
Total long-term investments | |
| 126 | | |
| 91 | |
| |
| | | |
| | |
Property and Equipment,
Net (Note 6) | |
| 314 | | |
| 419 | |
| |
| | | |
| | |
Total
assets | |
| 2,744 | | |
| 1,089 | |
| |
| | | |
| | |
LIABILITIES
AND STOCKHOLDERS' DEFICIENCY | |
| | | |
| | |
| |
| | | |
| | |
Current Liabilities: | |
| | | |
| | |
Trade payables | |
| 244 | | |
| 307 | |
Accrued expenses | |
| 750 | | |
| 448 | |
Other accounts payable (Note 7) | |
| 141 | | |
| 531 | |
Short-term convertible note
(Note 8) | |
| - | | |
| 137 | |
Total current liabilities | |
| 1,135 | | |
| 1,423 | |
| |
| | | |
| | |
Accrued Severance Pay | |
| 121 | | |
| 125 | |
| |
| | | |
| | |
Total liabilities | |
| 1,256 | | |
| 1,548 | |
| |
| | | |
| | |
Stockholders' Equity (deficiency): | |
| | | |
| | |
Stock capital: (Note 11) | |
| 6 | | |
| 5 | |
Common stock $0.00005 par value - Authorized:
800,000,000 shares at December 31, 2011 and December 31, 2010; Issued and outstanding: 126,444,309 and 95,832,978 shares | |
| | | |
| | |
Additional paid-in-capital | |
| 45,560 | | |
| 39,696 | |
Deficit accumulated during
the development stage | |
| (44,078 | ) | |
| (40,160 | ) |
Total stockholders'
deficiency | |
| 1,488 | | |
| (459 | ) |
| |
| | | |
| | |
Total
liabilities and stockholders' Equity (deficiency) | |
| 2,744 | | |
| 1,089 | |
The accompanying notes are an integral
part of the consolidated financial statements.
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, | |
| |
2011 | | |
2010 | | |
2011(*) | |
| |
U.S. $ in thousands | |
| |
| | |
| | |
| |
Operating costs and expenses: | |
| | | |
| | | |
| | |
| |
| | | |
| | | |
| | |
Research and development, net (Note
12) | |
| 1,689 | | |
| 1,045 | | |
| 24,419 | |
General and administrative | |
| 2,205 | | |
| 1,544 | | |
| 17,003 | |
| |
| | | |
| | | |
| | |
Total operating costs and expenses | |
| 3,894 | | |
| 2,589 | | |
| 41,422 | |
| |
| | | |
| | | |
| | |
Financial expense (income), net | |
| 151 | | |
| (189 | ) | |
| 2,547 | |
Other income | |
| (132 | ) | |
| - | | |
| (132 | ) |
| |
| | | |
| | | |
| | |
Operating loss | |
| 3,913 | | |
| 2,400 | | |
| 43,837 | |
| |
| | | |
| | | |
| | |
Taxes on income (Note 13) | |
| 5 | | |
| 19 | | |
| 77 | |
| |
| | | |
| | | |
| | |
Loss from continuing operations | |
| 3,918 | | |
| 2,419 | | |
| 43,914 | |
| |
| | | |
| | | |
| | |
Net loss from discontinued
operations | |
| - | | |
| - | | |
| 164 | |
| |
| | | |
| | | |
| | |
Net loss | |
| 3,918 | | |
| 2,419 | | |
| 44,078 | |
| |
| | | |
| | | |
| | |
Basic and diluted net loss
per share from continuing operations | |
| 0.03 | | |
| 0.03 | | |
| | |
| |
| | | |
| | | |
| | |
Weighted average number of
shares outstanding used in computing basic and diluted net loss per share | |
| 120,117,724 | | |
| 89,094,403 | | |
| | |
(*)
Out of which, $163, relating to the period from inception to March 31, 2004, is unaudited.
The accompanying notes are an integral
part of the consolidated financial statements
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 | |
| |
Common stock | | |
Additional paid-in | | |
Deferred Stock - based | | |
during the
development | | |
stockholders'
equity | |
| |
Number | | |
Amount | | |
capital | | |
compensation | | |
stage | | |
(deficiency) | |
| |
| | |
| | |
| | |
| | |
| | |
| |
Balance
as of September 22, 2000 (date of inception) (unaudited) | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Stock issued
on September 22, 2000 for cash at $0.00188 per share | |
| 8,500,000 | | |
| 1 | | |
| 16 | | |
| - | | |
| - | | |
| 17 | |
Stock issued on June
30, 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 (unaudited) | |
| 10,100,000 | | |
| 1 | | |
| 84 | | |
| - | | |
| (17 | ) | |
| 68 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Contribution of capital | |
| - | | |
| - | | |
| 11 | | |
| - | | |
| - | | |
| 11 | |
Net
loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| (26 | ) | |
| (26 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Balance
as of March 31, 2002 (unaudited) | |
| 10,100,000 | | |
| 1 | | |
| 95 | | |
| - | | |
| (43 | ) | |
| 53 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Contribution of capital | |
| - | | |
| - | | |
| 15 | | |
| - | | |
| - | | |
| 15 | |
Net
loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| (47 | ) | |
| (47 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Balance
as of March 31, 2003 (unaudited) | |
| 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 President | |
| (10,062,000 | ) | |
| | * | |
| | * | |
| - | | |
| - | | |
| - | |
Contribution of capital | |
| - | | |
| | * | |
| 15 | | |
| - | | |
| - | | |
| 15 | |
Net
loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| (73 | ) | |
| (73 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Balance
as of March 31, 2004 (unaudited) | |
| 10,238,000 | | |
| 1 | | |
| 131 | | |
| - | | |
| (163 | ) | |
| (31 | ) |
* Represents an amount less than
$1.
The accompanying notes are an integral
part of the consolidated financial statements
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 | |
| |
Common stock | | |
Additional paid-in | | |
Deferred Stock - based | | |
during the development | | |
stockholders'
equity | |
| |
Number | | |
Amount | | |
capital | | |
compensation | | |
stage | | |
(deficiency) | |
| |
| | |
| | |
| | |
| | |
| | |
| |
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
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 | |
| |
Common stock | | |
Additional paid-in | | |
Deferred Stock - based | | |
during the development | | |
stockholders'
equity | |
| |
Number | | |
Amount | | |
capital | | |
compensation | | |
stage | | |
(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 $0.80 per share | |
| 186,875 | | |
| - | * | |
| 149 | | |
| - | | |
| - | | |
| 149 | |
Stock issued on July
27, 2005 for private placement at $0.60 per share | |
| 165,000 | | |
| - | * | |
| 99 | | |
| - | | |
| - | | |
| 99 | |
Stock issued on September
30, 2005 for private placement at $0.80 per share | |
| 312,500 | | |
| - | * | |
| 225 | | |
| - | | |
| - | | |
| 225 | |
Stock issued on December
7, 2005 for private placement at $0.80 per share | |
| 187,500 | | |
| - | * | |
| 135 | | |
| - | | |
| - | | |
| 135 | |
Forfeiture of options
granted to employees | |
| - | | |
| - | | |
| (3,363 | ) | |
| 3,363 | | |
| - | | |
| - | |
Deferred stock-based
compensation related to shares and options granted to directors and employees | |
| 200,000 | | |
| - | * | |
| 486 | | |
| (486 | ) | |
| - | | |
| - | |
Amortization of deferred
stock-based compensation related to options and shares granted to employees and directors | |
| - | | |
| - | | |
| 51 | | |
| 1,123 | | |
| - | | |
| 1,174 | |
Stock-based compensation
related to options and shares granted to service providers | |
| 934,904 | | |
| - | * | |
| 662 | | |
| - | | |
| - | | |
| 662 | |
Reclassification due
to application of ASC 815-40-25 (formerly EITF 00-19) | |
| - | | |
| - | | |
| (7,906 | ) | |
| | | |
| | | |
| (7,906 | ) |
Beneficial conversion
feature related to a convertible bridge loan | |
| - | | |
| - | | |
| 164 | | |
| - | | |
| - | | |
| 164 | |
Net
loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| (3,317 | ) | |
| (3,317 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Balance
as of March 31, 2006 | |
| 22,854,587 | | |
| 1 | | |
| 15,803 | | |
| (1,395 | ) | |
| (22,320 | ) | |
| (7,911 | ) |
* Represents an amount less than
$1.
The accompanying notes are an integral
part of the consolidated financial statements
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 | |
| |
Common stock | | |
Additional paid-in | | |
Deferred Stock - based | | |
during the development | | |
stockholders'
equity | |
| |
Number | | |
Amount | | |
capital | | |
compensation | | |
stage | | |
(deficiency) | |
| |
| | |
| | |
| | |
| | |
| | |
| |
Balance
as of March 31, 2006 | |
| 22,854,587 | | |
| 1 | | |
| 15,803 | | |
| (1,395 | ) | |
| (22,320 | ) | |
| (7,911 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Elimination of deferred
stock compensation due to implementation of ASC 718-10 (formerly SFAS 123(R)) | |
| - | | |
| - | | |
| (1,395 | ) | |
| 1,395 | | |
| - | | |
| - | |
Stock-based compensation
related to shares and options granted to directors and employees | |
| 200,000 | | |
| - | * | |
| 1,168 | | |
| - | | |
| - | | |
| 1,168 | |
Reclassification due
to application of ASC 815-40-25 (formerly EITF 00-19) | |
| - | | |
| - | | |
| 7,191 | | |
| - | | |
| - | | |
| 7,191 | |
Stock-based compensation
related to options and shares granted to service providers | |
| 1,147,225 | | |
| - | | |
| 453 | | |
| - | | |
| - | | |
| 453 | |
Warrants issued to
convertible note holder | |
| - | | |
| - | | |
| 11 | | |
| - | | |
| - | | |
| 11 | |
Warrants issued to
loan holder | |
| - | | |
| - | | |
| 110 | | |
| - | | |
| - | | |
| 110 | |
Beneficial conversion
feature related to convertible bridge loans | |
| - | | |
| - | | |
| 1,086 | | |
| - | | |
| - | | |
| 1,086 | |
Net
loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| (3,924 | ) | |
| (3,924 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Balance
as of December 31, 2006 | |
| 24,201,812 | | |
| 1 | | |
| 24,427 | | |
| - | | |
| (26,244 | ) | |
| (1,816 | ) |
* Represents an amount less than
$1.
The accompanying notes are an integral
part of the consolidated financial statements
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 | |
| |
Common stock | | |
Additional paid-in | | |
Deferred Stock - based | | |
during the development | | |
stockholders'
equity | |
| |
Number | | |
Amount | | |
capital | | |
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 | ) |
* Represents an amount less than
$1.
The accompanying notes are an integral
part of the consolidated financial statements
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 | |
| |
Common stock | | |
Additional paid-in | | |
Deferred Stock - based | | |
during the development | | |
stockholders'
equity | |
| |
Number | | |
Amount | | |
capital | | |
compensation | | |
stage | | |
(deficiency) | |
| |
| | |
| | |
| | |
| | |
| | |
| |
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
for private placement at $0.1818 per unit | |
| - | | |
| - | | |
| 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
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 | |
| |
Common stock | | |
Additional paid-in | | |
Deferred Stock - based | | |
during the development | | |
stockholders'
equity | |
| |
Number | | |
Amount | | |
capital | | |
compensation | | |
stage | | |
(deficiency) | |
| |
| | |
| | |
| | |
| | |
| | |
| |
Balance
as of December 31, 2008 | |
| 55,241,418 | | |
| 3 | | |
| 33,881 | | |
| - | | |
| (35,960 | ) | |
| (2,076 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Stock-based compensation
related to options and stock granted to service providers | |
| 5,284,284 | | |
| | * | |
| 775 | | |
| - | | |
| | | |
| 775 | |
Stock-based compensation
related to stock and options granted to directors and employees | |
| - | | |
| - | | |
| 409 | | |
| - | | |
| | | |
| 409 | |
Conversion of convertible
loans | |
| 2,500,000 | | |
| | * | |
| 200 | | |
| - | | |
| | | |
| 200 | |
Exercise of warrants | |
| 3,366,783 | | |
| | * | |
| - | | |
| - | | |
| | | |
| - | |
Stock issued for amendment
of private placement | |
| 9,916,667 | | |
| 1 | | |
| - | | |
| - | | |
| | | |
| 1 | |
Subscription of shares | |
| - | | |
| - | | |
| 729 | | |
| - | | |
| | | |
| 729 | |
Net
loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| (1,781 | ) | |
| (1,781 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Balance
as of December 31, 2009 | |
| 76,309,152 | | |
| 4 | | |
| 35,994 | | |
| - | | |
| (37,741 | ) | |
| (1,743 | ) |
* Represents an amount less than
$1.
The accompanying notes are an integral
part of the consolidated financial statements
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 | |
| |
Common stock | | |
Additional paid-in | | |
Deferred Stock - based | | |
during the development | | |
stockholders'
equity | |
| |
Number | | |
Amount | | |
capital | | |
compensation | | |
stage | | |
(deficiency) | |
| |
| | |
| | |
| | |
| | |
| | |
| |
Balance as of December 31, 2009 | |
| 76,309,152 | | |
| 4 | | |
| 35,994 | | |
| | | |
| (37,741 | ) | |
| (1,743 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Stock-based compensation related to options and stock granted
to service providers | |
| 443,333 | | |
| - | * | |
| 96 | | |
| - | | |
| - | | |
| 96 | |
Stock-based compensation related to stock and options granted
to directors and employees | |
| 466,667 | | |
| - | * | |
| 388 | | |
| - | | |
| - | | |
| 388 | |
Stock issued for amendment of private placement | |
| 7,250,000 | | |
| 1 | | |
| 1,750 | | |
| - | | |
| - | | |
| 1,751 | |
Conversion of convertible note | |
| 402,385 | | |
| - | * | |
| 135 | | |
| - | | |
| - | | |
| 135 | |
Conversion of convertible loans | |
| 1,016,109 | | |
| - | * | |
| 189 | | |
| - | | |
| - | | |
| 189 | |
Issuance of shares | |
| 2,475,000 | | |
| | | |
| 400 | | |
| | | |
| | | |
| 400 | |
Exercise of options | |
| 1,540,885 | | |
| - | * | |
| 77 | | |
| - | | |
| - | | |
| 77 | |
Exercise of warrants | |
| 3,929,446 | | |
| - | * | |
| 11 | | |
| - | | |
| - | | |
| 11 | |
Subscription of shares for private placement at $0.12 per
unit | |
| | | |
| | | |
| 455 | | |
| - | | |
| - | | |
| 455 | |
Conversion of trade payable to stock | |
| | | |
| | | |
| 201 | | |
| | | |
| | | |
| 201 | |
Issuance of shares on account of previously subscribed shares
(See also Note 11B.1.f) | |
| 2,000,001 | | |
| - | * | |
| - | | |
| - | | |
| - | | |
| - | |
Net loss | |
| | | |
| | | |
| | | |
| | | |
| (2,419 | ) | |
| (2,419 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Balance as of December
31, 2010 | |
| 95,832,978 | | |
| 5 | | |
| 39,696 | | |
| - | | |
| (40,160 | ) | |
| (459 | ) |
* Represents an amount less than
$1.
The accompanying notes are an
integral part of the consolidated financial statements.
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 | |
| |
Common stock | | |
Additional
paid-in | | |
Deferred
Stock - based | | |
during the
development | | |
stockholders'
equity | |
| |
Number | | |
Amount | | |
capital | | |
compensation | | |
stage | | |
(deficiency) | |
| |
| | |
| | |
| | |
| | |
| | |
| |
Balance
as of December 31, 2010 | |
| 95,832,978 | | |
$ | 5 | | |
$ | 39,696 | | |
$ | - | | |
$ | (40,160 | ) | |
$ | (459 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Stock-based
compensation related to options and stock granted to service providers | |
| 474,203 | | |
| - | | |
| 449 | | |
| - | | |
| - | | |
| 449 | |
Stock-based
compensation related to stock and options granted to directors and employees | |
| 2,025,040 | | |
| - | | |
| 1,135 | | |
| - | | |
| - | | |
| 1,135 | |
Conversion of convertible note | |
| 755,594 | | |
| - | | |
| 140 | | |
| - | | |
| - | | |
| 140 | |
Exercise of options | |
| 1,648,728 | | |
| - | | |
| 243 | | |
| - | | |
| - | | |
| 243 | |
Exercise of warrants | |
| 1,046,834 | | |
| - | | |
| 272 | | |
| - | | |
| - | | |
| 272 | |
Issuance
of shares for private placement | |
| 14,160,933 | | |
| 1 | | |
| 3,601 | | |
| - | | |
| - | | |
| 3,602 | |
Issuance
of shares on account of previously subscribed shares (See also Note 11B.1.f) | |
| 10,499,999 | | |
| - | | |
| 24 | | |
| - | | |
| - | | |
| 24 | |
Net loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| (3,918 | ) | |
| (3,918 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Balance
as of December 31, 2011 | |
| 126,444,309 | | |
$ | 6 | | |
$ | 45,560 | | |
$ | - | | |
$ | |