UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM S-1
Amendment #2
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933
OWC PHARMACEUTICAL RESEARCH CORP.
(Exact Name of Registrant in its Charter)
Delaware | 3841 | 98-0573566 |
(State or other Jurisdiction of Incorporation) | (Primary Standard Industrial Classification Code) | (IRS Employer Identification No.) |
22 Shacham Steet, P.O. Box 8324, Petach Tikva, 4918103, Israel, Phone: +
972
(0) 3-758-2657
(Address and Telephone Number of Registrants Principal Executive Offices and Principal Place of Business)
Approximate date of commencement of proposed sale to the public: As soon as practicable after this Registration Statement becomes effective. If any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933, check the following box.
xIf this Form is filed to register additional securities for an Offering pursuant to Rule 462(b) under the Securities Act of 1933, please check the following box and list the Securities Act registration Statement number of the earlier effective registration statement for the same Offering.
¨If this Form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act of 1933, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same Offering.
¨If delivery of the Prospectus is expected to be made pursuant to Rule 434, please check the following box.
¨Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of large accelerated filer, accelerated filer and smaller reporting company in Rule 12b-2 of the Exchange Act.
Large accelerated filer | ¨ | Accelerated filer | ¨ |
Non-accelerated filer | ¨ | Smaller reporting company | x |
The Registrant hereby amends this Registration Statement on such date or dates as may be necessary to delay its effective date until the Registrant shall file a further amendment which specifically states that this Registration Statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933, as amended, or until the Registration Statement shall become effective on such date as the Commission, acting pursuant to said Section 8(a), may determine.
The information in this Prospectus is not complete and may be changed. We may not sell these securities until the registration statement filed with the Securities and Exchange Commission becomes effective. This Prospectus is not an offer to sell these securities and we are not soliciting offers to buy these securities in any state where the offer or sale is not permitted.
PRELIMINARY PROSPECTUS
SUBJECT TO COMPLETION ON AUGUST __, 2015
OWC PHARMACEUTICAL RESEARCH CORP.
9,101,373 SHARES OF COMMON STOCK
The selling shareholders (the "Selling Shareholders") named in this prospectus (the "Prospectus") are offering shares of common stock, par value $0.00001 per share (the "Common Stock") of OWC Pharmaceutical Research Corp., a Delaware corporation f/k/a Dynamic Applications Corp. offered through this Prospectus. We are filing this registration statement (the "Registration Statement"), of which this Prospectus forms a part, in order to permit the Selling Shareholders to sell a portion of their restricted shares of Common Stock that they acquired in a series of transactions exempt from registration under the Securities Act of 1933, as amended (the "Act") pursuant to the provisions of Regulation D and Regulation S promulgated by the United States Securities and Exchange Commission (the "SEC") under the Act. The shares of Common Stock to be offered and sold by the Selling Shareholders, as disclosed in the section under the caption "Selling Shareholders" of this Prospectus, have already been issued and are currently issued and outstanding Common Stock of the Company. We will not receive any proceeds from the sale of the Common Stock by the Selling Shareholders covered by this Prospectus in connection with the offering (the "Offering").
Our Common Stock is subject to quotation on OTCQB Market under the symbol OWCP. On August 12, 2015, the last reported sale price for our Common Stock was $0.18 per share. We urge prospective purchasers of our Common Stock to obtain current information about the market prices of our Common Stock. The prices at which the Selling Shareholders may sell the shares of Common Stock in this Offering will be determined by the prevailing market price for the shares of Common Stock on the date(s) of their respective sales and/or in negotiated transactions from time-to-time.
Our independent registered public accounting firm has expressed substantial doubt as to our ability to continue as a going concern.
Investing in our Common Stock involves a high degree of risk. See "Risk Factors" beginning on page 9 to read about factors you should consider before buying shares of our Common Stock.
NEITHER THE SECURITIES AND EXCHANGE COMMISSION NOR ANY STATE SECURITIES COMMISSION HAS APPROVED OR DISAPPROVED OF THESE SECURITIES OR DETERMINED IF THIS PROSPECTUS IS TRUTHFUL OR COMPLETE. ANY REPRESENTATION TO THE CONTRARY IS A CRIMINAL OFFENSE.
The Date of This Prospectus is: August __, 2015
Please read this Prospectus carefully and in its entirety. This Prospectus contains disclosure regarding our business, our financial condition and results of operations and risk factors related to our business and our Common Stock, among other material disclosure. We have prepared this Prospectus so that you will have the information necessary to make an informed investment decision in determining whether to purchase shares of Common Stock offered by our Selling Shareholders.
You should rely only on information contained in this Prospectus. We have not authorized any other person to provide you with different information. This Prospectus is not an offer to sell, nor is it seeking an offer to buy, these securities in any state where the offer or sale is not permitted. The information in this Prospectus is complete and accurate as of the date on the front cover, but the information may have changed since that date.
This summary highlights selected information contained elsewhere in this Prospectus. This summary does not contain all the information that you should consider before investing in the Common Stock. You should carefully read the entire Prospectus, including the disclosure contained under the captions "Risk Factors," "Description of Business," "Management's Discussion and Analysis of Financial Condition and Results of Operations" and the Financial Statements, before making an investment decision. In this Prospectus, the terms "OWCP," "Company," "Registrant," "we," "us" and "our" refer to OWC Pharmaceutical Research Corp., a Delaware corporation f/k/a Dynamic Applications Corp.
Business Plan
We are engaged in three distinct business sectors and we may require additional capital to implement our business plan and fund our operations.
Our three distinct business operations are:
(i) continuing to work with GUMI to commercialize and market the Company's
Electromagnetic Percussion Device (the "Device"); and
(ii) research and
development of cannabis-based medical products for the treatment of a variety of
medical conditions, such as multiple myeloma, psoriasis, fibromyalgia, migraine
and PTSD (post-traumatic stress disorder);
(iii) consulting services to third
parties with respect to compliance with applicable medical cannabis protocols
and regulations.
We have not yet commenced any significant activities related to our consulting services.
We were incorporated in Delaware on March 7, 2008 under the name Dynamic Applications Corp. In 2008, we acquired a patent for our Device from an unaffiliated third party. On May 5, 2008, we filed a registration statement on Form S-1 pursuant to which we offered and sold to the public 2,000,000 shares of our Common Stock at $0.04 per share, resulting in gross proceeds of $80,000 and net proceeds of approximately $60,000. Notwithstanding our successful IPO and a subsequent raise of approximately $200,000 in December 2008, the Company's cash resources were applied to a significant extent to executive compensation and consulting fees, without devoting resources to the development of our Device. Due to our limited financial and personnel resources and following the acquisition of the patent, we were dependent upon our ability to identify potential third parties to develop a prototype of our Device and thereafter to contract for the manufacture and marketing of commercial models.
During 2011, we began discussions with several of our shareholders as part of our plan to raise funds privately from investors in order to pursue the development of our Device. During 2011 and 2012, we had preliminary internal discussions with several of our shareholders and new investors related to renewing our efforts related to our Device. To that end, we entered into a manufacturing and distribution agreement with GUMI, a technology company engaged in the manufacture and sale of industrial equipment, to develop a Device prototype. GUMI completed the prototype and the manufacture of several commercial models of the Device and has commenced efforts to market the Device. To date, we have not yet derived any revenues from GUMI's marketing efforts and we continue to be dependent upon the ability of GUMI to successfully market our Device.
In early 2014, several of our shareholders conferred with management and expressed their interest in having the Company expand the scope of its business beyond efforts related to the exploitation of our Device in collaboration with GUMI.
During the first six months of 2014 and in connection with the appointment of a new chief executive officer, we raised capital from investors largely as a result of our determination to expand our business focus. We were introduced by shareholders and others in Israel to several leading scientists and physicians in both Israel and the United States who were engaged in conducting research and development of cannabis-based products for potential use in the treatment of a variety of medical illnesses and who expressed interest in conducting these activities as part of a public company.
To that end and based, in part, by our ability to raise capital from investors who supported our new direction, we began discussions with the group of scientists and physicians about the goal of commencing clinical trials working in collaboration with leading academic medical centers and scientific institutions in Israel. In connection with this new focus, we organized a wholly-owned subsidiary, One World Cannabis Ltd. (sometimes referred to as "OWC") under the laws of the State of Israel on July 6, 2014, to facilitate these new research and development activities.
We will utilize the capital that we have raised during 2014 to fund OWC's research and development of cannabis-based products and treatments ("Prospect Products").
The Company plans to collaborate with leading medical experts, major Israeli hospitals and research institutions in drug development and clinical research to develop and commercialize new therapeutic approaches for the treatment of certain medical conditions and diseases as well as the symptoms of disease, through the use of planet-derived cannabinoids.
Page 4
We made this determination for, among others, the following reasons: (i) the State of Israel issues licenses that permit medical research related to the medical use of cannabis and its active compounds; (ii) the presence of and access in Israel to leading institutions of higher learning and highly trained medical and scientific personnel engaged in such cannabis-based research; (iii) the introduction to OWC of several leading professors and physicians both in Israel and the United States expressing interest in working with us; and (iv) our ability to raise capital from existing shareholders and new investors for the purpose of funding our new efforts.
One World Cannabis Ltd., our wholly owned Israeli subsidiary, is focused on discovering, developing and commercializing cannabis-based novel therapeutics products and treatments specifically designed for several medical conditions, with our current focus starting with multiple myeloma, psoriasis, fibromyalgia, migraine, and PTSD (post-traumatic stress disorder).
One World Cannabis aims to produce pharmaceutical-grade cannabis-based treatments, that will be standardized in composition, formulation and dose, administered by means of an appropriate and efficient delivery system, and tested in properly controlled pre-clinical and clinical studies.
The main active ingredients of the Company's medical cannabis products, THC and CBD, are extracted from the cannabis plant. In addition to THC and CBD, the products contain additional cannabinoid and non-cannabinoid plant-derived components. In order to achieve a fully standardized formulation of these complex extracts, we plan to employ analytical technologies to demonstrate batch-to-batch uniformity.
Our research and development activities are focused primarily on exploring several formulations containing active compounds from the cannabis plant, including (but not exclusive to) the cannabinoids CBD and THC, and identifying potential therapeutic applications of the synergistic effects of these active compounds. The synergistic contributions of our formulations have only recently begun to be scientifically researched and demonstrated. We aim to standardize the formulations across the extracts as a whole, not simply by reference to their key active components (CBD or THC).
The Company has identified and prioritized several conditions that it believes will respond positively to cannabis-based therapies.
To date, OWC has signed three research collaboration and license agreements with Sheba Academic Medical Center, Tel Hashomer, Israel ("Sheba"). Sheba is a university-affiliated hospital that serves as Israel's national medical center and the most comprehensive medical center in the Middle East. Within the framework of the agreements with Sheba, OWC will initiate three studies at the Sheba facilities to explore the effect of three formulations, all based on active ingredients in the cannabis extracts, on multiple myeloma, psoriasis and fibromyalgia (a specific formulation to each indication).
At present, OWC is negotiating with two other Israeli leading medical centers for the collaboration in the research of migraine and PTSD (post-traumatic stress disorder). The Company expects these agreements to be finalized during the fourth quarter of 2015.
In addition, OWC signed an R&D service agreement with G.C. Group Ltd. - an Israeli pharmaceutical R&D company, to provide formulation development services for OWC's new delivery system in the form of a cannabis soluble tablet. The cannabis soluble tablet could provide physicians with the ability to control and administrate optimal dosage, to replace the most common usage/delivery method of medical cannabis today, which is not acceptable by scientists and physicians, such as smoking, edibles and oil extracts with no adequate means of dosage control. The Company expects to start developing other delivery system, designed for different indications, during the fourth quarter of 2015.
The Company has recently signed a Memorandum of Understanding with Emilia Cosmetics Ltd., a large Israeli-based private label manufacturer located in Yerucham, Israel ("Emilia") for the purpose of developing, manufacturing and marketing a cannabinoid-based topical cream to treat psoriasis. The Company expects that Emilia will commence the research and development of the topical cream by the end of the third quarter of 2015. After the completion of the topical cream formulation, which we anticipate during the fourth quarter of 2015, the Company will initiate a phase I study at the Sheba facilities to explore the effect of topical cream on psoriasis.
The Company also expects to start research and development of other delivery systems, designed for different indications, during the fourth quarter of 2015 or in early 2016. However, we may experience delays for a variety of reasons or that costs of such research and development may exceed those we anticipate, which could have an adverse affect on our business operations.
There can be no assurance that we will be successful in meeting our aims or that any success will be achieved in a timely manner within our budget.
Page 5
Our Filing Status as a "Smaller Reporting Company
We are a "smaller reporting company," meaning that we are not an investment company, an asset-backed issuer, or a majority-owned subsidiary of a parent company that is not a smaller reporting company and have a public float of less than $75 million and annual revenues of less than $50 million during the most recently completed fiscal year. As a "smaller reporting company," the disclosure we will be required to provide in our SEC filings are less than it would be if we were not considered a "smaller reporting company." Specifically, "smaller reporting companies" are able to provide simplified executive compensation disclosures in their filings; are exempt from the provisions of Section 404(b) of the Sarbanes-Oxley Act of 2002 requiring that independent registered public accounting firms provide an attestation report on the effectiveness of internal control over financial reporting; are not required to conduct say-on-pay and frequency votes until annual meetings occurring on or after January 21, 2013; and have certain other decreased disclosure obligations in their SEC filings, including, among other things, being permitted to provide two years of audited financial statements in annual reports rather than three years. Decreased disclosures in our SEC filings due to our status as a "smaller reporting company" may make it harder for investors to analyze the Company's results of operations and financial prospects.
Summary of Risk Factors
This offering involves substantial risk. Our ability to execute our business plan and strategy is also subject to certain risks. The risks described under the heading "Risk Factors" included elsewhere in this prospectus may cause us not to realize the full benefits of our business plan and strategy or may cause us to be unable to successfully execute all or part of our strategy. Some of the most significant challenges and risks include the following:
Our Independent Registered Public Accounting Firm has expressed substantial doubt as to our ability to continue as a going concern.
We have no operating history in the field of medical research and face many of the risks and difficulties frequently encountered by early stage companies.
Our research and development success depends on laws, mainly in Israel, pertaining to Cannabis.
We will rely to a great extend on research collaboration with third-party institutions. Clinical trials of cannabis-based medical products and treatments are novel terrain with very limited or non-existing clinical trials history, and we face a significant risk that the trials will not result in commercially viable products.
You will experience dilution of your ownership interest because of possible future issuances of additional shares of our common stock or preferred stock.
Before you invest in our Common Stock, you should carefully consider all the information in this prospectus, including matters set forth under the heading "Risk Factors."
Where You Can Find Us
We presently maintain our principal offices at 22 Shacham Street, Box 8324, Petach Tikva, 4918103, Israel, Phone: +972 (3) 758-2657/9.
Page 6
Common Stock offered by Selling Shareholders | 9,101,373 shares of Common Stock representing 11.29% of our current outstanding Common Stock. (1) |
Common Stock outstanding before and after the Offering | 80,592,403 |
Terms of the Offering | The Selling Shareholders will determine when and how they will sell the Common Stock offered in this Prospectus. The prices at which the Selling Shareholders may sell the shares of Common Stock in this Offering will be determined by the prevailing market price for the shares of Common Stock or in negotiated transactions. |
Termination of the Offering | The Offering will conclude upon such time as all of the Common Stock has been sold pursuant to the Registration Statement. |
Trading Market | Our Common Stock is subject to quotation on the OTCQB Market under the symbol OWPC. |
Use of proceeds | The Company is not selling any shares of the Common Stock covered by this Prospectus. As such, we will not receive any of the Offering proceeds from the registration of the shares of Common Stock covered by this Prospectus. |
Risk Factors | The Common Stock offered hereby involves a high degree of risk and should not be purchased by investors who cannot afford the loss of his/her/its entire investment. See Risk Factors. |
(1) Based on 80,592,403 shares of Common Stock outstanding as of May 31, 2015.
Page 7
The following summary financial data should be read in conjunction with Managements Discussion and Analysis, Plan of Operation and the Financial Statements and Notes thereto, included elsewhere in this Prospectus. The balance sheet and the statement of operations data are derived from our unaudited interim financial statements for the period ended March 31, 2015 and our audited financial statements for the years ended December 31, 2014.
Statement of Operations Data:
For the Period | Year Ended | |||
Ended Mach 31, 2015 | December 31, 2014 | |||
Revenues | $ | - | $ | - |
Total general and administrative | 305,479 | 4,873,223 | ||
Research and development | 99,124 | 160,325 | ||
Total other (expense) | - | (37,125 ) | ||
Total cost and expense | (404,603) | (5,070,673) | ||
Net loss | $ | (404,603) | $ | (5,070,673) |
Net Loss Per Share Basic and Diluted | $ | (0.01) | $ | (0.10) |
Weighted Average Number of Common Shares Outstanding - Basic and Diluted | 79,729,241 | 52,209,962 |
Balance Sheet Data:
March 31, 2015 | ||
Cash and cash equivalents | $ | 1,165,638 |
Total assets | 1,194,541 | |
Total current liabilities | 40,258 | |
Total liabilities | 40,258 | |
Total stockholders' equity | $ | 1,154,283 |
Total liabilities and shareholders' equity | $ | 1,194,541 |
Special Note Regarding Forward-Looking Statements
The information contained in this Prospectus, including in the documents incorporated by reference into this Prospectus, includes some statements that are not purely historical and that are "forward-looking statements." Such forward-looking statements include, but are not limited to, statements regarding our management's expectations, hopes, beliefs, intentions and/or strategies regarding the future, including our financial condition and results of operations. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. The words "anticipates," "believes," "continue," "could," "estimates," "expects," "intends," "may," "might," "plans," "possible," "potential," "predicts," "projects," "seeks," "should," "would" and similar expressions, or the negatives of such terms, may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking.
The forward-looking statements contained in this Prospectus are based on current expectations and beliefs concerning future developments and the potential effects on the parties and the transaction. There can be no assurance that future developments actually affecting us will be those anticipated. These that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements, including the following forward-looking statements involve a number of risks, uncertainties (some of which are beyond the parties' control) or other assumptions.
Page 8
The shares of our Common Stock being offered for resale by the Selling Shareholders are highly speculative in nature, involve a high degree of risk and should be purchased only by persons who can afford to lose their entire amount invested in the Common Stock. Accordingly, prospective investors should carefully consider, along with other matters referred to herein, the following risk factors in evaluating our business before purchasing any shares of Common Stocks. If any of the following risks actually occurs, our business, financial condition or operating results could be materially adversely affected. In such case, you may lose all or part of your investment. You should carefully consider the risks described below and the other information in this Prospectus before investing in our Common Stock.
Risks Related to Our Business
Our Independent Registered Public Accounting Firm has expressed substantial doubt as to our ability to continue as a going concern.
The audited financial statements included in this registration statement
have been prepared assuming that we will continue as a going concern and do not
include any adjustments that might result if we cease to continue as a going
concern. We believe that in order to continue as a going concern, including the
costs of being a public company, we will need approximately $65,000 per year
simply to cover the administrative, legal and accounting fees. We have incurred
significant losses since our inception. We have funded these losses primarily
through the sale of restricted shares of our Common Stock and the issuance of
convertible notes, which have subsequently been converted into restricted shares
of Common Stock.
Based on our financial history, in their report on the financial statements
for the year ended December 31, 2014, our independent registered public
accounting firm has expressed substantial doubt as to our ability to continue as
a going concern. To date we have not generated any revenues and we do not
anticipate generating any revenues through the remainder of 2015 or early 2016.
Notwithstanding our success in raising over $2.1 million from the sale of our
securities, principally during 2014, there can be no assurance that we will be
able to continue to raise equity and/or debt capital from investors at terms and
conditions satisfactory to the Company, or otherwise, and/or have adequate
capital resources required by us to fund our current and future planned
operations. If we are unable to obtain adequate capital resources to fund
operations, we may be required to delay, scale back or eliminate some or all of
our plan of operations, which may have a material adverse effect on our
business, results of operations and ability to operate as a going concern.
We face many of the risks and difficulties frequently encountered by
relatively new companies with respect to our operations.
ThThe Company's business involves three distinct operations: (i) the
development, manufacture and sale of our Electronic Percussion Device, relying
on the services and expertise of GUMI; (ii) on conducting scientific research in
collaboration with leading universities and institutions in Israel on cannabis
for medical treatment; and (iii) consulting services. We have not yet generated
any revenues from any of our three distinct business operations. Notwithstanding
the significant scientific and medical experience of OWC's management and
advisory team, neither the Company nor OWC have any operating history as a
medical research company engaged in cannabis research or any other related field
upon which an evaluation of the Company and its prospects could be based. There
can be no assurance that our management will be successful in being able to
commercially exploit the results, if any, from our medical and scientific
research projects or that we will be able to develop products and treatments
that will enable us to generate sufficient revenues to meet our expenses or to
achieve and/or maintain profitability.
If we are unable to raise sufficient capital as needed, we may be required to
reduce the scope of our research and development activities, which could harm
our business plans, financial condition and operating results, or cease our
operations entirely, in which case, you will lose all your investment.
We rely on GUMI Tel-Aviv to develop, manufacture and market commercial
models of our Electromagnetic Percussion Device.
We are dependent upon the ability of GUMI Tel-Aviv to develop, manufacture
and market commercial models of our Electromagnetic Percussion Device. While
GUMI has completed development of our Device and produced several commercial
models, to date there have been no sales revenues from our Device and there can
be no assurance that GUMI will be successful generating sufficient revenues or
profits from the sale and marketing of our Device.
We are a small company with limited resources compared to some of our
potential competitors engaged in the manufacture and sale of electromagnetic
percussion devices may not be able to compete effectively in this market.
The electromagnetic percussion industry is very competitive and although we
believe our technology offers unique development opportunities, there can be no
assurance that the perceived advantages and features of our Device are enough to
effectively capture a significant enough market share to successfully launch and
sustain our product. Most of our current and potential competitors have longer
operating histories, significantly greater resources and name recognition, and a
larger base of distributors and customers than we have.
Page 9
Changes in consumer preferences and acceptance of cannabis-based medical
products and treatments and any negative trends will adversely affect our
business.
We are substantially dependent on continued market acceptance and
proliferation of cannabis-based medical products and treatments. We believe that
as cannabis-based products and treatments become more widely accepted by the
medical/scientific communities and the public at large, the stigma associated
with cannabis-based medical products and treatments will moderate and, as a
result, consumer demand will likely continue to grow. However, we cannot predict
the future growth rate and size of the market, assuming that the regulatory
climate permits, of which there can be no assurance. Any negative outlook on
cannabis-based medical products will adversely affect our business prospects.
In addition, we believe that large, well-funded pharmaceutical and other
related businesses and industries may have a strong economic reasons to be in
strong opposition to cannabis-based medical products. We believe that the
pharmaceutical industry may not easily surrender control of any product, such as
cannabis-based products, that could generate significant revenue. The
pharmaceutical industry is well-funded with a strong and experienced lobby
presence at both the federal and state levels as well as internationally, that
surpasses financial resources of the current group of medical cannabis research
and development companies. Any effort the pharmaceutical lobby could or might
undertake to halt or delay the newly developing medical cannabis industry could
have a detrimental impact on our business.
These pressures could also limit or restrict the introduction and marketing
of any such product. Adverse publicity from cannabis misuse or adverse side
effects from cannabis or other cannabinoid products may adversely affect the
commercial success or marketability. The nature of our business attracts and may
be expected to continue to attract a high level of public and media interest
and, in the event of any related adverse publicity, we may not succeed in
monetizing our products.
Our involvement in the cannabis industry may make it difficult to obtain
insurance coverage.
In the event that we decide to commence business operations in the U.S., of
which there can be no assurance, obtaining and maintaining necessary insurance
coverage, for such things as workers compensation, general liability, product
liability and directors and officers insurance, may be more difficult and/or
expensive for us to find because we are involved in the cannabis industry. There
can be no assurance that we will be able to find such insurance in the near
future, if needed, or that the cost of coverage will be affordable or
cost-effective. If, either because of unavailability or cost prohibitive
reasons, we are compelled to operate without insurance coverage, we may be
prevented from entering certain business sectors, experience inhibited growth
potential and/or expose us to additional risks and financial liabilities.
We are entering a potentially highly competitive market.
Demand for medical cannabis-based products is dependent on a number of
social, political and economic factors that are beyond our control. While we
believe that demand for such medical products will continue to grow, there is no
assurance that such increase in demand will happen, that we will benefit from
any demand increase or that our business, in fact, will ever become profitable.
The emerging markets for cannabis-related medical research and development is
and will likely remain both competitive and evolve into becoming even more so.
In particular, we face strong competition from larger and better funded
companies that may be in the process of offering similar products and treatments
that we intend to offer. Many of our current and potential competitors have
longer operating histories, significantly greater financial, marketing and other
resources than we may be expected to have for the foreseeable future,
notwithstanding our belief in the strength of our management team.
These competitors may be able to react to market changes, respond more
rapidly to new regulations and/or allocate greater resources to the development
and promotion of their products than we can. Furthermore, some of these
competitors may make acquisitions or establish collaborative relationships among
themselves or with third parties to increase their ability to rapidly gain
market share.
Given the rapid changes affecting the cannabis-related medical research and
development industry, we may not be able to create and maintain a competitive
advantage in the marketplace. Our success will depend on our ability to develop
innovative cannabis-related products and treatments working with our university
and institutional partners that will be accepted, especially with ever-changing
legal and regulatory environment. Our success will depend on our ability to
respond to, among other things, changes in the economy, market conditions, and
competitive pressures. Any failure by us to anticipate or respond adequately to
such changes could have a material adverse effect on our financial condition,
operating results, liquidity, cash flow and our operational performance.
Changes in legislation or regulation in the health care systems in the
United States and foreign jurisdictions may affect us.
Our ability to successfully commercialize our cannabis-based medical products
and treatments may depend on how Israel, the US and other respective governments
and/or health administrations provide coverage and/or reimbursements for our
cannabis-based prospect products and treatments. The ongoing efforts of
governments, insurance companies, and other participants in the health care
services industry to trim health care costs may adversely affect our ability to
achieve profitability.
Page 10
In certain foreign markets, including major markets in the European Union,
pricing of prescription pharmaceuticals is subject to governmental control.
Price negotiations with governmental authorities may range from 6 to 12 months
or longer after the receipt of regulatory marketing approval for a product. Our
business could be detrimentally effected if reimbursements of our cannabis-based
products is unavailable or limited if pricing is set at unacceptable levels.
Our failure to comply with existing and potential future laws and
regulations could harm our plan of operations.
Our business is, and will be, subject to wide-ranging, existing laws and
regulations of the State of Israel, the U.S. (federal and states), and other
governments in each of the countries we may develop and market our prospect
products. We must comply to all regulatory requirements if we expect to be
successful.
If any of our cannabis-based prospect products and treatments is approved in
the United States, it will be subject to ongoing regulatory requirements
including federal and state requirements. As a result, we and our collaborators
and/or joint venture partners must continue to expend time, money and effort in
all areas of regulatory compliance, including, if applicable, manufacturing,
production, quality control and assurance and, of upmost importance, clinical
trials. We will also be required to report certain adverse reactions and
production problems, if any and applicable, to the FDA, and to comply with
advertising and promotion requirements for our cannabis-based prospect products
and treatments.
Any failure to comply with ongoing regulatory requirements may significantly
and adversely affect our ability to conduct clinical trials which are
prerequisite to our ability to commercialize our cannabis-based medical products
and related treatments. If regulatory sanctions are applied or if regulatory
approval, once obtained, is for any reason withdrawn, the value of our business
and our operating results could be materially adversely affected.
We depend substantially on collaboration with our research and development
partners
We do not have in-house research facilities and, as a consequence, we must
rely on collaboration agreements with industry partners, as well as leading
academic medical centers, in order to develop, research, produce and
commercialize our novel cannabinoid-based therapies targeting a variety of
different indications and effectively help patients in need.
Dr. Yehuda Baruch, One World Cannabis Director of Research and Regulatory
Affairs, is highly qualified by both training and experience, is monitoring the
progress of the investigation and research of our medical cannabis development.
In addition, Alon Sinai, COO of One World Cannabis, serves as our key liaison
with our collaboration partners at the major Israeli hospitals and medical
centers. See the disclosure under "Directors, Executive Officers, Promoters and
Control Persons - Key Medical Personnel of One World Cannabis" below.
To date, OWC has signed three research collaboration and license agreements
with Sheba Academic Medical Center, Tel Hashomer, Israel ("Sheba"). Sheba is a
university-affiliated hospital that serves as Israel's national medical center
and the most comprehensive medical center in the Middle East. Within the
framework of the agreements with Sheba, OWC will initiate three studies at the
Sheba facilities to explore the effect of three formulations, all based on
active ingredients in the cannabis extracts, on multiple myeloma, psoriasis and
fibromyalgia (a specific formulation to each indication).
At present, OWC is negotiating with two other Israeli leading medical centers
for the collaboration in the research of migraine and PTSD (post-traumatic
stress disorder). The Company expects these agreements to be finalized during
the fourth quarter of 2015.
In addition, OWC signed an R&D service agreement with G.C. Group Ltd. - an
Israeli pharmaceutical R&D company, to provide formulation development services
for OWC's new delivery system in the form of a cannabis soluble tablet. The
cannabis soluble tablet could provide physicians with the ability to control
and administrate optimal dosage, to replace the most common usage/delivery
method of medical cannabis today, which is not acceptable by scientists and
physicians, such as smoking, edibles and oil extracts with no adequate means of
dosage control. The Company expects to start developing other delivery system,
designed for different indications, during the fourth quarter of 2015.
The Company has recently signed a Memorandum of Understanding (MoU) with
Emilia Cosmetics Ltd. - a large Israeli private label manufacturer, for the
developing, manufacturing and marketing of a cannabinoid-based topical cream to
treat psoriasis. The Company will initiate the research and development of the
topical cream by the end of the third quarter of 2015, at Emilia Cosmetics labs
located in Yerucham, Israel. After the completion of the formulation
development, during the fourth quarter of 2015, the Company will initiate a
phase I study at the Sheba facilities to explore the effect of topical cream on
psoriasis.
Our collaborating partners have the right, under certain circumstances, to
terminate their agreements with us. In the event that our partners, for any
reason, terminate their agreements with us or fail to complete any research upon
which we are dependent, it will have a material adverse effect on our business,
our results of operations and financial condition.
Page 11
While we retain full ownership on our intellectual property, or other
proprietary rights and trade secrets that were conceived prior to the signing of
the agreements with Sheba Academic Medical Center, the psoriasis and
fibromyalgia research agreements with Sheba provide that all intellectual
property and other rights that are conceived during the course of the
collaboration will be jointly owned by Sheba and One World Cannabis.
Intellectual rights related to the multiple myeloma are being negotiated and we
expect to finalize an agreement with Sheba during the fourth quarter of 2015.
Collaboration agreements that we may enter into in the future may not be
successful, which could adversely affect our ability to develop and
commercialize cannabis-based medical products.
We may also enter into collaboration agreements with pharmaceutical companies
and/or biotechnology institutions for the development or commercialization of
our cannabis-based prospect products and treatments, which agreements may
contain provisions based upon, among other things, the merits of retaining
certain rights. We will face significant competition in seeking appropriate
collaborators and in negotiating agreements at acceptable terms, if at all. We
may not be successful in our efforts to enter, implement and maintain
collaboration agreements. Disagreements stemming from collaboration agreements
concerning development, intellectual property, regulatory or commercialization
matters can lead to delays and, in some cases, termination of our collaboration
agreements or otherwise result in the potentially significant costs and fees in
seeking to enforce or protect our rights, if any. Any such disagreements can be
difficult if, in fact, neither of the parties has final decision making
authority. The resulting outcome of any disputes and/or disagreements would in
all likelihood adversely affect our business.
Clinical trials of cannabis-based medical products and treatments are
novel terrain with very limited or non-existing clinical trials history; we face
a significant risk that the trials will not result in commercially viable
products and treatments.
At present, there is no documented history of clinical trials from which we
can derive any scientific conclusions, or prove that our present assumptions for
the current and planned research are scientifically compelling.
While we are encouraged by the results of the limited in vitro tests, there
can be no assurance that any clinical trial will result in commercially viable
products or treatments.
Clinical trials are expensive, time consuming and difficult to design and
implement. We, as well as the regulatory authorities in Israel and elsewhere,
such as an IRB (Helsinki committee), IMCU - Israel Medical Cannabis Unit, or the
FDA, may suspend, delay or terminate our clinical trials at any time, may
require us, for various reasons, to conduct additional clinical trials, or may
require a particular clinical trial to continue for a longer duration than
originally planned, including, among others:
lack
of effectiveness of any formulation or delivery system during clinical trials;
Any of the foregoing could have a material adverse effect on our business,
results of operations and financial condition.
If we are unable to hire and retain key personnel, we may not be able to
implement our business plan and our business may fail.
Our future success depends, to a significant extent, on our ability to
attract, train and retain capable scientists and physicians, enter into
collaboration agreements for our research and managerial personnel. Recruiting
and retaining capable personnel, particularly those with expertise with medical
research, is vital to our success. If we are unable to attract and retain
qualified employees, our business may fail and our investors could lose their
entire investment.
At present, we believe to have the necessary key personal to carry out our
business plans but there can be no assurance that our beliefs prove unfounded.
If we are unable to protect our intellectual property, our business will be
materially adversely affected.
Page 12
Our Future Success Is Dependent, In Part, On The Performance And Continued
Service Of Dr. Yehuda Baruch, OWC's Director of Research and Regulatory Affairs
and Alon Sinai, OWC's COO.
The Company is dependent to a great deal on Dr. Yehuda Baruch, OWC's Director
of Research and Regulatory Affairs, to conduct and oversee our clinical studies.
We are also dependent on the services of Alon Sinai, OWC's COO, in negotiating
and serving as our liaison with our collaboration partners at the major Israeli
medical centers. The loss of Dr. Baruch's services and those of Mr. Sinai could
have a material adverse effect on the operations and prospects of the Company.
Dr. Baruch is expected to handle all aspects of our Research and Regulatory
Affairs related to developing our Prospect Products. At this time, the Company
does not currently have "key man" life insurance on Dr. Baruch or Mr. Sinai.
We may become subject to frequent and costly litigation regarding patent
and other intellectual property rights. It is possible that our prospect
products and treatments may not withstand challenges made by others or that any
patents protecting our rights are inadequate or inadequately defended.
Our success depends in large part on our ability to secure and maintain
effective patent protection for our products and treatments in the United States
and internationally. To date, we have filed eight provisional patent
applications with the U.S. Patent and Trademark Office and expect to continue to
file patent applications for various aspects of our prospect products and
related treatments. However, we face the risks that:
we may fail to secure
necessary patents on our prospect products pending prior to or after obtaining
regulatory clearances, thereby permitting competitors to market competing
products using our perceived proprietary rights and intellectual property; and
If we are unable to protect our intellectual property adequately, our
business and commercial prospects will suffer.
Other parties may claim that our cannabis-based medical products infringe on
their proprietary and perhaps patent protected rights. We may be subject to
claims and costly legal proceedings regarding alleged infringement by us of the
intellectual property rights and patents of third parties. Such claims, whether
or not meritorious, may result in the expenditure of significant financial and
managerial resources, legal fees, result in injunctions, temporary restraining
orders and/or require the payment of damages. In the event that our patents do
not fully protect us, we may need to obtain licenses from third parties who
allege that we have infringed on their lawful rights. However, such licenses may
not be available on terms acceptable to us or at all. In addition, we may not be
able to obtain or utilize on terms that are favorable to us, or at all, licenses
or other rights with respect to intellectual property we do not own.
Our by-laws provide for indemnification of our directors and the purchase
of D&O insurance at our expense and limit their potential or actual liability
which may result in a significant cost to us and damage the interests of our
shareholders.
The Company's By-Laws include provisions that eliminate the personal
liability of the directors of the Company for monetary damages to the fullest
extent possible under the laws of the State of Delaware as well as other
applicable laws. These provisions eliminate the liability of directors to the
Company and its shareholders for monetary damages arising out of any violation
of a director of his fiduciary duty of due care. Under Delaware law, however,
such provisions do not eliminate the personal liability of a director for: (i)
breach of the director's duty of loyalty; (ii) acts or omissions not in good
faith or involving intentional misconduct or knowing violation of law; (iii)
payment of dividends or repurchases of stock other than from lawfully available
funds; or (iv) any transaction from which the director derived an improper
benefit. These provisions do not affect a director's liabilities under the
federal securities laws or the recovery of damages by third parties.
Reporting requirements under the Exchange Act and compliance with the
Sarbanes-Oxley Act of 2002, including establishing and maintaining acceptable
internal controls over financial reporting, are costly and may increase
substantially.
The rules and regulations of the SEC require a public company to prepare and
file periodic reports under the Exchange Act, which will require that the
Company engage legal, accounting, auditing and other professional service
providers. The engagement of such services is costly and continuing.
Additionally, the Sarbanes-Oxley Act of 2002 (the "Sarbanes-Oxley Act")
requires, among other things, that we design, implement and maintain adequate
internal controls and procedures over financial reporting. The costs of
complying with the Sarbanes-Oxley Act and the limited technically qualified
personnel we have may make it difficult for us to design, implement and maintain
adequate internal controls over financial reporting. We expect these costs to be
approximately $25,000 per year or perhaps more as our operations increase in
scope and magnitude. In the event that we fail to maintain an effective system
of internal controls or discover material weaknesses in our internal controls,
we may not be able to produce reliable financial reports and/or discover and
report fraud, which may harm our overall financial condition and result in loss
of investor confidence and a decline in our share price.
As a public company, we will be subject to the reporting requirements of the
Exchange Act, the Sarbanes-Oxley Act, the Dodd-Frank Act of 2010 and other
applicable securities rules and regulations. Our legal and financial compliance
costs related to these rules and regulations may increase, make some activities
more difficult, time-consuming or costly and increase demand on our systems and
resources. The Exchange Act requires, among other things, that we file annual
and quarterly, and, from time-to-time, current reports with respect to our
business and operating results.
Page 13
We are working with our legal, independent accounting and financial advisors
to identify those areas in which changes should or could be made to improve our
financial and management control systems in order to manage our growth and our
legal obligations as a public company. These areas include corporate governance,
corporate control, disclosure controls and procedures and financial reporting
and accounting systems. We have made, and will continue to make, changes in
these and other areas, if and when any perceived deficiencies are discovered.
However, we anticipate that the expenses associated with being a reporting
public company are expected to be both material and continuing. We estimate that
the aggregate cost of increased legal services; accounting and audit functions;
personnel, such as a chief financial officer familiar with the obligations of
public company reporting; consultants to design and implement internal controls
could be material. In addition, if and when we retain independent directors
and/or additional members of senior management, we may incur additional expenses
related to director compensation and/or premiums for directors' and officers'
liability insurance ("D&O Insurance"), the costs of which we cannot estimate at
this time. We may also incur additional expenses associated with investor
relations and similar functions, the cost of which we also cannot estimate at
this time. However, these additional expenses individually, or in the aggregate,
may also be expected to be material.
In addition, being a public company could make it more difficult or more
costly for us to obtain certain types of insurance, including D&O Insurance, and
we may be forced to accept reduced policy limits and coverage or incur
substantially higher costs to obtain the same or similar coverage. The impact of
these events could also make it more difficult for us to attract and retain
qualified persons to serve on our board of directors, our board committees or as
executive officers.
The increased costs associated with operating as a public company may
decrease our net income or increase our net loss, and may cause us to reduce
costs in other areas of our business or increase the prices of our product to
offset the effect of such increased costs. Additionally, if these requirements
divert our management's attention from other business concerns, they could have
a material adverse effect on our business, financial condition and results of
operations.
Page 14
Risks Related to the Cannabis Industry
Risks Related to Controlled Substances
(Cannabis)
Controlled substance legislation differs between countries and legislation in
certain countries may restrict or limit our ability to research, manufacture and
develop a commercial market for our products.
Approximately 250 substances, including cannabis, are listed in the Schedules
annexed to the United Nations Single Convention on Narcotic Drugs (New York,
1961, amended 1972), the Convention on Psychotropic Substances (Vienna, 1971)
and the Convention against Illicit Traffic in Narcotic Drugs and Psychotropic
Substances (introducing control on precursors) (Vienna, 1988). The purpose of
these listings is to control and limit the use of these drugs according to a
classification of their therapeutic value, risk of abuse and health dangers, and
to minimize the diversion of precursor chemicals to illegal drug manufacturers.
The 1961 UN Single Convention on Narcotic Drugs, as amended in 1972
classifies cannabis as Schedule I ("substances with addictive properties,
presenting a serious risk of abuse") and as Schedule IV ("the most dangerous
substances, already listed in Schedule I, which are particularly harmful and of
extremely limited medical or therapeutic value") narcotic drug.
The 1971 UN Convention on Psychotropic Substances classifies
tetrahydrocannabinol (THC) - the principal psychoactive cannabinoid of cannabis
- as schedule I psychotropic substance (Substances presenting a high risk of
abuse, posing a particularly, serious threat to public health which are of very
little or no therapeutic value).
Most countries are parties to these conventions, which governs international
trade and domestic control of these substances, including cannabis. Countries
may interpret and implement their obligations in a way that creates a legal
obstacle to our obtaining manufacturing and/or marketing approval for our
products in those countries. These countries may not be willing or able to amend
or otherwise modify their laws and regulations to permit our products to be
manufactured and/or marketed, or achieving such amendments to the laws and
regulations may take a prolonged period of time.
To date, we are only conducting our research in Israel and, in fact, have
limited our activities to Israel. The medical products we are developing contain
the controlled substance - cannabis - as defined in the Israeli Dangerous Drugs
Ordinance [New Version], 5733 - 1973. In Israel, licenses to cultivate, possess
and to use cannabis for medical research are granted by the Ministry of Health, IMCU - Israel Medical Cannabis Unit, on ad-hoc basis. One World Cannabis is
acquiring the cannabis needed for its research activities from G.K. Medical
Cannabis - a government-licensed Israeli medical cannabis grower. One World
Cannabis obtained necessary IMCU licenses in order to carry out the research in
collaboration with Sheba Academic Medical Center and with G.C. Group. Because
One World Cannabis does not have a license to possess cannabis, the cannabis is
transported from the grower directly to the labs at Sheba and at G.C. Group, in
accordance with our license to use cannabis for medical research. We have
applied for further licenses in order to continue our activities. Although we
have an established track record of successfully obtaining the requisite
licenses as required, there can be no assurance that we will continue to be able
to secure licenses in the future.
Currently we do not conduct any product-related activity (such as research,
development, manufacturing, distribution or sale) outside of Israel.
In the event that we seek to conduct any product-related activity in the
United States in the future, the manufacturing, distribution and sale of our
products will become subject to the United States' Federal Controlled Substances
Act of 1970 and regulations promulgated thereunder. While cannabis is a Schedule
I controlled substance, products approved for medical use in the United States
that contain cannabis or cannabis extracts must be placed in Schedules II-V,
since approval by the FDA satisfies the "accepted medical use" requirement. If
approved by the FDA, we expect the products to be listed by the DEA as a
Schedule II or III controlled substance. Consequently, the manufacture,
importation, exportation, domestic distribution, storage, sale and legitimate
use of our cannabis-based products will be subject to a significant degree of
regulation by the DEA. In addition, individual states in the United States have
also established controlled substance laws and regulations. Though
state-controlled substances laws often mirror federal law, because the states
are separate jurisdictions, they may separately schedule our products.
In the event that we seek to conduct any product-related activity in Europe,
the manufacturing, distribution and sell of our products will also become
subject to the European Union regulations and Council decisions, as well as the
member states domestic legislation on the matter.
Failure to comply with these laws and regulations, in Israel, the United
States, Europe and elsewhere, or the cost of compliance with these laws and
regulations, may adversely affect the results of our business operations, during
pre-clinical and clinical research and development, as well as post-approval,
and our financial condition.
Page 15
While continuing with scientific investigations into medical effects and
benefits of cannabis, the Company anticipates that it will begin generating
revenue through our planned consulting services. For example, the consulting
division of One World Cannabis plans to offer guidance to policy-makers and to
businesses through the regulatory framework and operating infrastructure of
medical cannabis programs, as well as training and educational modules for
patients, physicians, caregivers and researchers. One World Cannabis offered its
services to several applicants for NY medical marijuana program, but the parties
did not agree on the partnership terms. We believe our ability to develop our
consulting services business will be dependent on the success we experience, if
any, in our core business of developing cannabis-based products accepted by the
medical community and the public. There can be no assurance that we will be
successful in securing any clients for our consulting services or, if
successful, that we will generate significant revenues, if any, from such
services.
Laws and regulations affecting our business are constantly evolving.
The constant evolution of laws and regulations affecting the research and
development of cannabis-based medical products and treatments could
detrimentally affect our business. Laws and regulations related to the
therapeutic uses of marijuana are subject to changing interpretations. These
changes may require us to incur substantial costs associated with legal and
compliance fees and ultimately require us to alter our business plan.
Furthermore, violations or alleged violation of these laws could disrupt our
business and result in a material adverse effect on our operations. In addition,
we cannot predict the nature of any future laws, regulations, interpretations or
applications of laws and regulations and it is possible that new laws and
regulations may be enacted in the future that will be directly applicable to our
business.
The FDA has not approved cannabis as a safe and effective drug for any
indication
The FDA has not approved the whole-plant extract of Cannabis as a safe and
effective drug for any indication. It has, however, approved one drug containing
a synthetic version of a substance that is present in the cannabis plant and one
other drug containing a synthetic substance that acts similarly to compounds
from cannabis but is not present in cannabis.
Although the FDA has not approved any drug product containing or derived from
botanical cannabis, the FDA is aware that there is considerable interest in its
use to attempt to treat a number of medical conditions.
Before conducting testing in humans of a drug that has not been approved by
the FDA, one needs to submit an investigational new drug (IND) application,
which is reviewed by the FDA.
Failure to comply with applicable U.S. requirements may subject a company to
a variety of administrative or judicial sanctions, such as FDA refusal to
approve pending NDAs, warning letters, product recalls, product seizures, total
or partial suspension of production or distribution, injunctions, fines, civil
penalties and criminal prosecution.
Risks Related to Our Common Stock
The Company has warrants outstanding, the exercise of which may be expected
to dilute the value of our shares.
The Company has granted warrants and if those are exercised, the issuance of up to 33,144,490 shares of Common Stock of the Company may dilute the value of shares held by existing shareholders.
There can be no assurance of a liquid public trading market for our common
stock or whether investors will be able to readily be able to sell their shares
of common stock.
At present, our Common Stock is subject to quotation on the OTCQB market
under the symbol OWCP. There is only a limited, liquid public trading market for
our Common Stock and there can be no assurance that a more liquid market will
ever develop or be sustained. Market liquidity will depend on the perception of
our business and any steps that our management might take to bring public
awareness of our business to the investing public within the parameters of the
federal securities laws. There can be given no assurance that there will be any
awareness generated or sustained. Consequently, investors may not be able to
liquidate their investment or liquidate it at a price paid by investors equal to
or greater than their initial investment in our Common Stock. As a result,
holders of our Common Stock may not find purchasers for their shares should they
to decide to sell the Common Stock held by them at any particular time if ever.
Consequently, our Common Stock should be purchased only by investors who have no
immediate need for liquidity in their investment and who can hold our Common
Stock, possibly for a prolonged period of time.
In the event an active trading market develops for our common stock, the
market price may, from time-to-time, be volatile.
In the event an active trading market develops for our Common Stock, the
market price of our Common Stock may be highly volatile, as is the market for
securities subject to quotation on OTC Markets in particular. Some of the
factors that may materially affect the market price of our Common Stock are
beyond our control, such as changes in conditions or trends in the industry in
which we operate, general market and economic conditions in the United States
and world-wide as well as the number of our shares of Common Stock being
purchased and sold at any particular time. These factors may materially
adversely affect the market price of our Common Stock, regardless of our
historic business performance or future prospects. In addition, the public stock
markets have experienced and may be expected to experience extreme price and
trading volume volatility.
Page 16
This volatility has significantly affected the market
prices of securities of many companies for reasons frequently unrelated to their
operating performance. These market fluctuations
may adversely affect the market price of our Common Stock.
A large number of additional shares will be available for resale into the
public market pursuant to this offering as well as in the near future, which may
cause the market price of our common stock to decline significantly.
Sales of a substantial number of shares of our Common Stock in the public
market will become available pursuant to Rule 144 promulgated by the SEC under
the Act, could adversely affect the market price of our Common Stock. As of
March 31, 2015, we had 79,729,241 shares of Common Stock outstanding, of which
46,903,410 shares of Common Stock are restricted as a result of applicable
federal securities laws. As restrictions on resale of other shares of Common
Stock expire, pursuant to the provisions of Rule 144 or otherwise, the market
price could drop significantly if the holders of these restricted shares sell
them or are perceived by the market as intending to sell them at any given date
or over any particular period of time. For a more detailed description of the
risks associated with this Risk Factor, see the disclosure under the caption
"Shares Eligible for Future Sale" contained in this Prospectus.
If holders of restricted securities sell a large number of shares pursuant to
Rule 144 under the Act, they could adversely affect the market price for our
Common Stock, which adverse affect could be sustained and over which we have no
control.
You will experience dilution of your ownership interest because of the
future issuance of additional shares of our common stock or our preferred stock.
In the future, we may issue our authorized but previously unissued equity
securities, including shares of our Common Stock, resulting in the dilution of
the ownership interests of our present shareholders. We are authorized to issue
an aggregate of 500,000,000 shares of Common Stock, par value $0.00001 per
share, of which 79,729,241 shares are currently outstanding.
We may also issue additional shares of our Common Stock, warrants or other
securities that are convertible into or exercisable for the purchase of shares
of our Common Stock in connection with hiring and/or retaining employees or
consultants, future acquisitions, future sales of our securities for capital
raising purposes, or for other business purposes. The future issuance of any
such additional shares of our Common Stock or other securities, for any reason
including those stated above, may have a negative impact on the market price of
our Common Stock. There can be no assurance that the issuance of any additional
shares of Common Stock, warrants or other convertible securities may not be at a
price (or exercise prices) below the then prevailing price at which shares of
our Common Stock will be quoted on the OTCQB Market.
We may never pay any dividends to our shareholders.
We currently intend to retain any future earnings for use in the operation
and expansion of our business. Accordingly, we do not expect to pay any
dividends in the foreseeable future, but will review this policy as
circumstances dictate. The declaration and payment of all future dividends, if
any, will be at the sole discretion of our board of directors, which retains the
right to change our dividend policy at any time. Consequently, shareholders must
rely on sales of their Common Stock after price appreciation, which may never
occur, as the only way to realize any future gains on their investment.
Insiders will continue to have substantial control over us after this
offering and will be able to influence corporate matters.
Our directors and executive officers and present shareholders holding more
than 5% of our Common Stock ("Affiliated Persons") will continue to own of
record and beneficially, in the aggregate, approximately 26.3% of our
outstanding Common Stock. As a result, if these shareholders were to choose to
act together, they would be able to exercise significant influence over all
matters requiring shareholder approval, including the election of directors and
approval of significant corporate transactions, such as a merger or other sale
of our Company or all or a significant percentage of our assets. This
concentration of ownership could limit your ability to influence corporate
matters and may have the effect of delaying or preventing a third party from
acquiring control over us. For information regarding the ownership of our
outstanding stock by our executive officers and directors and their affiliates,
see the disclosure under the caption "Security Ownership of Certain Beneficial
Owners and Management."
We cannot assure you that the interests of our management and Affiliated
Persons will coincide with the interests of the investors. So long as our
management and Affiliated Persons collectively controls a significant portion of
our Common Stock, these individuals and/or entities controlled by them, will
continue to collectively be able to strongly influence or effectively control
our decisions.
Anti-takeover provisions of the Delaware General Corporation Law may
discourage or prevent a change of control, even if an acquisition would be
beneficial to our shareholders, which could reduce our stock price.
We are subject to the provisions of Section 203 of the Delaware General
Corporation Law, which may prohibit certain business combinations with
shareholders owning 15% or more of our outstanding voting stock. These and other
provisions in our amended and restated certificate of incorporation, amended and
restated bylaws and Delaware law could make it more difficult for shareholders
or potential acquirers to obtain control of our board of directors or initiate
actions that are opposed by our then-current board of directors, including a
merger, tender offer or proxy contest involving our Company. Any delay or
prevention of a change of control transaction or changes in our board of
directors could cause the market price of our Common Stock to decline.
Page 17
State Blue Sky registration, potential limitations on resale of our common
stock.
The holders of our shares of Common Stock and those persons, who desire to
purchase our Common Stock in any trading market that might develop, should be
aware that there may be state blue-sky law restrictions upon the ability of
investors to resell our securities. Accordingly, investors should consider the
secondary market our securities to be a limited one.
It is the present intention of management after the active commencement of
operations in to seek coverage and publication of information regarding the
Company in an accepted publication manual, which permits a manual exemption. The
manual exemption permits a security to be distributed in a particular state
without being registered if the Registrant issuing the security has a listing
for that security in a securities manual recognized by the state.
However, it is not enough for the security to be listed in a recognized
manual. The listing entry must contain (1) the names of issuer's officers, and
directors, (2) an issuer's balance sheet, and (3) a profit and loss statement
for either the fiscal year preceding the balance sheet or for the most recent
fiscal year of operations. Furthermore, the manual exemption is a non-issuer
exemption restricted to secondary trading transactions, making it unavailable
for issuers selling newly issued securities.
Most of the accepted manuals are those published in Standard and Poor's,
Moody's Investor Service, Fitch's Investment Service, and Best's Insurance
Reports, and many states expressly recognize these manuals. A smaller number of
states declare that they "recognize securities manuals" but do not specify the
recognized manuals. The following states do not have any provisions and
therefore do not expressly recognize the manual exemption: Alabama, Georgia,
Illinois, Kentucky, Louisiana, Montana, South Dakota, Tennessee, Vermont and
Wisconsin.
Our common stock is considered a Penny Stock, which may be subject to
restrictions on marketability, so you may not be able to sell your shares.
We may be subject now and in the future to the Penny Stock rules if our
shares of Common Stock sell below $5.00 per share. Penny stocks generally are
equity securities with a price of less than $5.00. The penny stock rules require
broker-dealers to deliver a standardized risk disclosure document prepared by
the SEC which provides information about penny stocks and the nature and level
of risks in the penny stock market. The broker-dealer must also provide the
customer with current bid and offer quotations for the penny stock, the
compensation of the broker-dealer and its salesperson, 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
prior to completing the transaction and must be given to the customer in writing
before or with the customer's confirmation.
In addition, the penny stock rules require that prior to a transaction, the
broker dealer must make a special written determination that the penny stock is
a suitable investment for the purchaser and receive the purchaser's written
agreement to the transaction. The penny stock rules are burdensome and may
reduce purchases of any Offerings and reduce the trading activity for shares of
our Common Stock. As long as our shares of Common Stock are subject to the penny
stock rules, the holders of such shares of Common Stock may find it more
difficult to sell their securities.
The control deficiencies in our internal control over financial reporting
may until remedied cause errors in our financial statements or cause our filings
with the SEC to not be timely.
We have identified control deficiencies in our internal control over
financial reporting as of the evaluation done by management as of March 31,
2015, including those related to (i) absent or inadequate segregation of duties
within a significant account or process, (ii) inadequate documentation of the
components of internal control, and (iii) inadequate design of information
technology general and application controls that prevent the information system
from providing complete and accurate information consistent with financial
reporting objectives and current needs. If our internal control over financial
reporting or disclosure controls and procedures are not effective, there may be
errors in our financial statements that could require a restatement or our
filings may not be timely made with the SEC. Based on the work undertaken and
performed by us, however, we believe the financial statements contained in our
reports filed with the SEC are fairly stated in all material respects in
accordance with GAAP for each of the periods presented. We intend to implement
additional corporate governance and control measures to strengthen our control
environment as we are able, but we may not achieve our desired objectives. We
may identify material weaknesses and control deficiencies in our internal
control over financial reporting in the future that may require remediation and
could lead investors losing confidence in our reported financial information,
which could lead to a decline in our stock price.
Page 18
OuOur in vitro
tests results on multiple myeloma cells studied outside their normal biological
context, on which we announced on June 17, 2015, led us to proceed with further
pre-clinical study (safety and toxicity, PK, PD) of our formulation and whether
it has scientific merit for further development as an investigational new drug.
discovery of serious or
unexpected toxicities or side effects experienced by trial participants or other
safety issues;
slower than
expected rates of subject recruitment and enrollment rates in clinical trials;
delays or inability in
manufacturing or obtaining sufficient quantities of materials for use in
clinical trials due to regulatory and manufacturing constraints;
delays
in obtaining regulatory authorization to commence a trial, including IRB
approvals, licenses required for obtaining and using cannabis for research,
either before or after a trial is commenced;
unfavorable
results from ongoing pre-clinical studies and clinical trials.
patients
or investigators failing to comply with study protocols;
patients
failing to return for post-treatment follow-up at the expected rate;
sites
participating in an ongoing clinical study withdraw, requiring us to engage new
sites;
third-party
clinical investigators decline to participate in our clinical studies, do not
perform the clinical studies on the anticipated schedule, or act in ways
inconsistent with the established investigator agreement, clinical study
protocol, good clinical practices, and other Institutional Review Board
requirements;
third-party
entities do not perform data collection and analysis in a timely or accurate
manner or at all;
regulatory
inspections of our clinical studies require us to undertake corrective action or
suspend or terminate our clinical studies;
previously granted patents
may be re-examined, invalidated or not extended.
We will not receive any proceeds from the sale of Common Stock by the Selling Shareholders. All proceeds from the sale of our Common Stock by Selling Shareholders will go to the Selling Shareholders as described more fully below in the sections entitled "Selling Security Holders" and "Plan of Distribution." We have agreed to bear the expenses relating to the registration of the Common Stock for the Selling Shareholders.
The Selling Shareholders may sell their shares on the OTCQB market or otherwise, at market prices prevailing at the time of sale, at prices related to the prevailing market price, or at negotiated prices. We will not receive any proceeds from the sale of Common Stock by the Selling Shareholders.
The Common Stock to be sold by the Selling Shareholders as provided in the "Selling Security Holders" section is Common Stock that is currently issued. Accordingly, there will be no dilution to our existing shareholders due to this offering.
The shares of Common Stock being offered for resale by the Selling Shareholders consist of
9,101,373 shares of our Common Stock held by 36 shareholders. Such Selling Shareholders include the holders of shares that we sold at offering prices ranging from $0.005 to $0.15 per share from February 2014 through November 2014. These private offerings were made in reliance on and pursuant to the provisions Regulation S and, to a lesser extent, Regulation D, both promulgated by the SEC under the Act. In addition, several Selling Shareholders will be selling shares of Common Stock acquired upon the conversion of notes at varying prices, which notes were converted during February 2014.
The following table sets forth the names of the Selling Shareholders and the number of shares of Common Stock beneficially owned by
them as of the date of our Registration Statement, of which this Prospectus is a part, and the number of shares of Common Stock being offered by the Selling Shareholders. The shares being offered hereby are being registered to permit public secondary trading. The Selling Shareholders may offer all or part of the shares for resale from time to time. However, the Selling Shareholders are under no obligation to sell all or any portion of their shares subject to this Registration Statement, nor are the Selling Shareholders obligated to sell any shares immediately upon effectiveness of this
Registration Statement.
Shares Beneficially Owned
Shares to
Shares Beneficially Owned
Percent Beneficially
Last Name
First Name
Prior to Offering
Be Offered
After Offering
Owned
After (a)
Avdinco Ltd.
(1)
444,444
222,222
222,222
0.28%
Benhamu
David
55,555
27,778
27,777
0.03%
Chordekar
Nuriel
55,555
27,778
27,777
0.03%
Cohen
Eran
222,222
111,111
111,111
0.14%
Cohen
Gil
500,000
250,000
250,000
0.31%
Asaf
David
111,111
55,556
55,555
0.07%
H. Leigh Severance Inc.
(2)
834,000
417,000
417,000
0.52%
H. Leigh Severance Inc.
(2)
834,000
417,000
417,000
0.52%
Invita Pharma LLC.
(3)
1,322,222
661,111
661,111
0.82%
Falach
Masha Lea
555,555
277,778
277,777
0.34%
NE Solutions Ltd.
(4)
1,360,000
680,000
680,000
0.84%
Nir
Ben Nissan
111,111
55,556
55,555
0.07%
Prop Trade Ltd.
(5)
3,333,333
1,666,667
1,666,666
2.07%
R. P. Holdings (1992) Ltd.
(6)
444,444
222,222
222,222
0.28%
Senator
Ron
222,222
111,111
111,111
0.14%
Pasternak
Shmuel
450,000
225,000
225,000
0.28%
Short Trade Ltd.
(7)
2,762,633
1,381,317
1,381,316
1.71%
Shrem
David
222,222
111,111
111,111
0.14%
Teperberg, Tal & Graf, Gal
111,111
55,556
55,555
0.07%
Talesnick
Alan
166,666
83,334
83,333
0.10%
Tenenbaum
Boruj
444,444
222,222
222,222
0.28%
Cohen
Tomer
166,667
83,334
83,333
0.10%
Yogev
Yoel
1,500,000
750,000
750,000
0.93%
Cohen
Yosef
220,000
110,000
110,000
0.14%
Zetouny
Judith
111,111
55,556
55,555
0.07%
Kahlon
Shay
43,859
14,620
29,239
0.04%
Ashkenazi
Moshe
350,877
116,959
233,918
0.29%
Calvo
Shem-Tov
1,030,000
343,333
686,667
0.85%
Farjun
Rafi
333,333
111,111
222,222
0.28%
Abraham
Guy
43,426
14,475
28,951
0.04%
Elad
Guy
61,666
20,555
41,111
0.05%
Glazer
Ido
66,667
22,222
44,445
0.06%
Atias
Nissim
166,667
55,556
111,111
0.14%
Leibovitz
Sarah
66,667
22,222
44,445
0.06%
Heiden
Ivo
200,000
50,000
150,000
0.18%
Securities Compliance Corp.
(8)
200,000
50,000
150,000
0.18%
Total
19,123,790
9,101,373
10,022,418
12.43%
(a) Based on 80,592,403 shares outstanding as of May 31, 2015.
(1(1) Advinco Ltd. Mr. Avner Cohen, a resident of Israel, exercises the sole voting and dispositive powers with respect to the shares offered.
(2) H. Leigh Severance Inc. and H. Leigh Severance Pension Plan & Trust. Mr. H. Leigh Severance, a resident of Colorado exercises the sole voting and dispositive powers with respect to the shares offered.
(3) Invita Pharma LLC. Mr. Richard S. Greenberg, a resident of Colorado, exercises the sole voting and dispositive powers with respect to the shares offered.
(4) NE Solutions Ltd. Mr. Roy Group Ltd. Mr. Lee Yit Tong, a resident of Singapore, exercises the sole voting and dispositive powers with respect to the shares offered.
(5) Prop Trade Ltd. Ltd. Mrs. Charlotte Eilin Tay, a resident of Singapore, exercises the sole voting and dispositive powers with respect to the shares offered.
(6) R.P. Holding Ltd. Mr. Rubin Zimerman, a resident of Israel, exercises the sole voting and dispositive powers with respect to the shares offered.
(7) Short Trade Ltd. Mr. Shlomo Noyman,
a resident of Israel, exercises the sole voting and dispositive powers with respect to the shares offered.
(8) Securities Compliance Corp. is controlled by Richard Rubin.
None of the selling shareholders has any material relationship with any of the Company's affiliates such as officers, directors and significant shareholders, other than Ido Glazer who is the brother of Uri Glazer, the VP of the Company's wholly-owned subsidiary OWC.
To the best of the Company's knowledge, none of the other Selling Shareholders or their beneficial owners:
- has had a material relationship with us other than as a shareholder at any time within the past three years; or
- has ever been one of our officers or directors or an officer or director of our predecessors or affiliates;
- are broker-dealers or affiliated with broker-dealers.
This Prospectus relates to the resale of up to 9,101,373 shares of our Common Stock by the Selling Shareholders.
The Selling Shareholders and any of its pledgees, donees, assignees and other successors-in-interest may, from time to time sell any or all of their shares of Common Stock on any market or trading facility on which the shares are traded or in private transactions. These sales may be at fixed or negotiated prices. The Selling Shareholders may use any one or more of the following methods when selling shares:
| ordinary brokerage transactions and transactions in which the broker-dealer solicits the purchaser; |
| block trades in which the broker-dealer will attempt to sell the shares as agent but may position and resell a portion of the block as principal; |
| facilitate the transaction; |
| purchases by a broker-dealer as principal and resale by the broker-dealer for its account; |
| an exchange distribution in accordance with the rules of the applicable exchange; |
| privately negotiated transactions; |
| broker-dealers may agree with the Selling Shareholders to sell a specified number of such shares at a stipulated price per share; |
| through the writing of options on the shares |
| a combination of any such methods of sale; and |
| any other method permitted pursuant to applicable law. |
The Selling Shareholders shall have the sole and absolute discretion not to accept any purchase offer or make any sale of shares if it deems the purchase price to be unsatisfactory at any particular time.
The Selling Shareholders may also sell the shares directly to market makers acting as principals and/or broker-dealers acting as agents for themselves or their customers. Such broker-dealers may receive compensation in the form of discounts, concessions or commissions from the Selling Shareholders and/or the purchasers of shares for whom such broker-dealers may act as agents or to whom they sell as principal or both, which compensation as to a particular broker-dealer might be in excess of customary commissions. Market makers and block purchasers purchasing the shares will do so for their own account and at their own risk. It is possible that the Selling Shareholders will attempt to sell shares of Common Stock in block transactions to market makers or other purchasers at a price per share which may be below the then existing market price. We cannot assure that all or any of the shares offered in this Prospectus will be issued to, or sold by, the Selling Shareholders. The Selling Shareholders and any broker-dealers or agents, upon completing the sale of any of the shares offered in this Prospectus, may be deemed to be "underwriters" as that term is defined under the Act, the Exchange Act and the rules and regulations of such acts. In such event, any commissions received by such broker-dealers or agents and any profit on the resale of the shares purchased by them may be deemed to be underwriting commissions or discounts under the Act.
The Selling Shareholders, alternatively, may sell all or any part of the shares offered in this Prospectus through an underwriter. The Selling Shareholders have not entered into any agreement with a prospective underwriter and there is no assurance that any such agreement will be entered into.
We know of no existing arrangements between the Selling Shareholders and any other shareholder, broker, dealer or agent relating to the sale or distribution of the shares. We will not receive any proceeds from the sale of the shares of the Selling Shareholders pursuant to this Prospectus. We have agreed to bear the expenses of the registration of the shares, including legal and accounting fees, and such expenses are estimated to be approximately $30,000.
Page 20
A Selling Shareholder may pledge his/her/its shares to their respective brokers under the margin provisions of customer agreements. If a Selling Shareholder defaults on a margin loan, the broker may, from time to time, offer and sell the pledged shares of Common Stock. The Selling Shareholders and any other persons participating in the sale or distribution of the shares will be subject to applicable provisions of the Exchange Act, and the rules and regulations under such act, including, without limitation, Regulation M. These provisions may restrict certain activities of, and limit the timing of purchases and sales of any of the shares by, the Selling Shareholders or any other such person. The Selling Shareholders is not permitted to engage in short sales of Common Stock. Furthermore, under Regulation M, persons engaged in a distribution of securities are prohibited from simultaneously engaging in market making and certain other activities with respect to such securities for a specified period of time prior to the commencement of such distributions, subject to specified exceptions or exemptions. All of these limitations may affect the marketability of the shares.
General
We are authorized to issue an aggregate number of 520,000,000 shares of capital stock, $0.00001 par value per share, consisting of 20,000,000 shares of Preferred Stock and 500,000,000 shares of Common Stock.
Preferred Stock
We are authorized to issue 20,000,000 shares of Preferred Stock, $0.00001 par value per share. As of May 31, 2015, no preferred shares were issued and outstanding. The Board of Directors has the authority to establish one or more series of Preferred Stock and fix relative rights and preferences of any series of Preferred Stock, without any further action or approval of our shareholders.
Common Stock
We are authorized to issue 500,000,000 shares of Common Stock, $0.00001 par value per share. As of May 31, 2015, we had 79,729,241 shares of Common Stock issued and outstanding.
Each share of Common Stock shall have one (1) vote per share for all purpose. Our Common Stock does not provide a preemptive, subscription or conversion rights and there are no redemption or sinking fund provisions or rights. Our Common Stock holders are not entitled to cumulative voting for election of Board of Directors.
Dividends
We have not paid any cash dividends to our shareholders. The declaration of any future cash dividends is at the discretion of our board of directors and depends upon our earnings, if any, our capital requirements and financial position, our general economic conditions, and other pertinent conditions. It is our present intention not to pay any cash dividends in the foreseeable future, but rather to reinvest earnings, if any, in our business operations.
Warrants
In connection with our private placements during 2014, we issued a total of 33,144,490 warrants in connection with unit offerings each unit consisting of one share of Common Stock and one warrant exercisable to purchase one additional share of Common Stock at prices ranging from $0.14 to $0.25 per share.
During 2013, the Company granted 600,000 warrants to GUMI and 550,000 warrants to L&L Holdings Ltd. both are vested and L&L Holdings exercised all 550,000 warrants.
Options
During 2014, the Company signed advisory services agreements with officers of its subsidiary pursuant to which the officers are entitled to 51,785,417 options to be granted if and when our subsidiary achieves 3 milestones. As of the date of this prospectus, none of the milestones has been achieved and therefore no options have vested.
Transfer Agent and Registrar
The transfer agent of our Common Stock is VStock Transfer LLC, 18 Lafayette Place, Woodmere, NY 11598, Phone: (212) 828-8436.
Page 21
No expert or counsel named in this Prospectus as having prepared or certified any part of this Prospectus or having given an opinion upon the validity of the securities being registered or upon other legal matters in connection with the registration or Offering of the Common Stock was employed on a contingency basis, or had, or is to receive, in connection with the Offering, a substantial interest, direct or indirect, in the registrant. Nor was any such person connected with the registrant as a promoter, managing or principal underwriter, voting trustee, director, officer, or employee.
Thomas J. Craft, Jr., Esq., 5420 North Ocean Drive, Suite 2102, Singer Island, FL 33404, will pass on the validity of the Common Stock being offered pursuant to this Registration Statement.
The audited financial statements for the years ended December 31, 2014 and 2013 included in this Prospectus and the Registration Statement have been audited by M&K CPAS, PLLC, an independent registered public accounting firm, to the extent and for the periods set forth in their report appearing elsewhere herein and in the Registration Statement, and are included in reliance upon such report given upon the authority of said firm as experts in auditing and accounting.
We filed this Registration Statement on Form S-1 with the SEC under the Act with respect to the Common Stock offered by Selling Shareholders in this Prospectus. This Prospectus, which constitutes a part of the Registration Statement, does not contain all of the information set forth in the Registration Statement or the exhibits and schedules filed therewith. For further information with respect to us and our Common Stock, please see the Registration Statement and the exhibits and schedules filed with the Registration Statement. Statements contained in this Prospectus regarding the contents of any contract or any other document that is filed as an exhibit to the Registration Statement are not necessarily complete, and each such statement is qualified in all respects by reference to the full text of such contract or other document filed as an exhibit to the Registration Statement. The Registration Statement, including its exhibits and schedules, may be inspected without charge at the public reference room maintained by the SEC, located at 100 F Street, N.E., Room 1580, Washington, D.C. 20549, and copies of all or any part of the Registration Statement may be obtained from such offices upon the payment of the fees prescribed by the SEC. Please call the SEC at 1-800-SEC-0330 for further information about the public reference room. The SEC also maintains an Internet website that contains reports, proxy and information statements and other information regarding registrants that file electronically with the SEC. The address of the site is
www.sec.gov
.
We also maintain a website at http://www.owcpharma.com. Upon completion of this Offering, you may access these materials on our website free of charge as soon as reasonably practicable after they are electronically filed with, or furnished to, the SEC. Information contained on our website is not a part of this Prospectus and the inclusion of our website address in this Prospectus is an inactive textual reference only.
Overview
We are engaged in two distinct business sectors and we may require additional capital to implement our business plan and fund our operations.
Our three distinct business operations are:
(i) continuing to work with GUMI to commercialize and market the Company's Electromagnetic Percussion Device (the "Device"); and
Background
We were incorporated in Delaware on March 7, 2008 under the name Dynamic Applications Corp. In 2008, we acquired a patent for our Device from an unaffiliated third party. On May 5, 2008, we filed a registration statement on Form S-1 pursuant to which we offered and sold to the public 2,000,000 shares of our Common Stock at $0.04 per share, resulting in gross proceeds of $80,000 and net proceeds of approximately $60,000. Notwithstanding our successful IPO and a subsequent raise of approximately $200,000 in December 2008, the Company's cash resources were applied to a significant extent to executive compensation and consulting fees, without devoting resources to the development of our Device. Due to our limited financial and personnel resources and following the acquisition of the patent, we were dependent upon our ability to identify potential third parties to develop a prototype of our Device and thereafter to contract for the manufacture and marketing of commercial models. However, our management did not actively pursue the commercial development of the Device.
Page 22
During 2011, we began discussions with several of our shareholders as part of our plan to raise funds privately from investors in order to pursue the development of our Device. During 2011 and 2012, we had preliminary internal discussions with several of our shareholders and our new investors to renew our efforts related to our Device. We entered into a manufacturing and distribution agreement with GUMI, a technology company engaged in the manufacture and sale of industrial equipment, to develop a Device prototype. GUMI completed the prototype and the manufacture of several commercial models of the Device and has commenced efforts to market the Device. To date, we have not yet derived any revenues from GUMI's marketing efforts and we continue to be dependent upon the ability of GUMI to successfully market our Device.
Our Business Operations
In early 2014, several of our shareholders conferred with management and
expressed their interest in having the Company expand the scope of its business
beyond our Device. During the first half of 2014 and in connection with the
appointment of a new chief executive officer, we raised capital from investors
largely as a result of our determination to expand our business focus. We were
introduced by shareholders and others in Israel to several leading scientists
and physicians in both Israel and the United States who were engaged in
conducting research and development of cannabis-based products for potential use
in the treatment of a variety of medical illnesses and who expressed interest in
conducting these activities as part of a public company.
Based on our ability to raise capital from investors who supported our new
direction, we began discussions with the group of scientists and physicians
about the goal of commencing clinical trials working in collaboration with
leading universities and scientific institutions in Israel. In connection with
this new focus, we organized a wholly-owned subsidiary, One World Cannabis Ltd.,
under the laws of the State of Israel on July 6, 2014, to facilitate these new
research and development activities.
One World Cannabis aims to produce pharmaceutical-grade cannabis-based
products and treatments that will be standardized in composition, formulation
and dose, administered by means of an appropriate and efficient delivery system,
and tested in properly controlled pre-clinical and clinical studies. The Company
plans to collaborate with leading medical experts, major Israeli hospitals and
research organizations in drug development and clinical research.
We made this determination for, among others, the following reasons: (i) the
laws of the State of Israel that permit research activities related to the
medical use of cannabis and its active compounds; (ii) the presence of and
access in Israel to leading institutions of higher learning and highly trained
medical and scientific personnel engaged in such cannabis-based research; (iii)
the introduction to OWC of several leading professors and physicians both in
Israel, the United States and elsewhere expressing interest in working with us;
and (iv) our ability to raise capital from existing shareholders and new
investors for the purpose of funding our new efforts.
We will utilize the capital that we have raised during 2014 and through the
first quarter of 2015, to fund OWC's business focus on research and development
of cannabis-based medical products and treatments ("Prospect Products").
Cannabis Overview
The raw cannabis plant, which contains nearly 400 different chemical
compounds, including over 70 active compounds - cannabinoids. The cannabinoids
have not yet been subjected to rigorous clinical trials and scientific scrutiny
that governmental agencies, such as the Food and Drug Administration (FDA) in
the United States, apply to all other new medications - a comprehensive process
designed to ensure the highest standards of safety and efficacy.
Initial academic research in the field of cannabinoid science focused almost
exclusively on THC (delta-9-tetrahydrocannabinol). It has been widely published
in scientific literature that THC has pain suppression, anti-spasmodic,
anti-tremor, anti-inflammatory, appetite stimulant and anti-nausea properties.
CBD (cannabidiol), the second most common cannabinoid, is considered to have a
wider scope of medical applications. THC and CBD are believed to have
synergistic effect, meaning that when they are both present at therapeutic
levels they are more effective together than they are alone. While THC is widely
known for its psychoactive properties, pre-clinical research published by Zuardi,
et al. in the Journal of Psychopharmacology 1982 and clinical research published
by Karniol, et al. in the European Journal of Pharmacology 1974, suggests that
the presence of CBD may mitigate some of the side-effects of THC.
Our research and development, however, is focused primarily on exploring
several formulations containing active compounds from the cannabis plant,
including (but not exclusive to) the cannabinoids CBD and THC, and identifying
potential therapeutic applications of the synergistic effects of these active
compounds. The synergistic contributions of our formulations have not yet been
scientifically researched and demonstrated. We aim to standardize the
formulations across the extracts as a whole, not simply by reference to their
key active components (CBD or THC).
Although there are reports and studies on CBD and THC, our formulations that
contain several active compounds from the cannabis plant, need to be researched
further in order to verify its effectiveness to indications, at what doses and
which method of administration will be the most appropriate and effective.
One World Cannabis' intention is to produce pharmaceutical-grade
cannabinoid-based products and treatments that will be standardized in
composition, formulation and dose, administered by means of an appropriate and
efficient delivery system, and tested in properly controlled pre-clinical and
clinical studies.
Page 23
Our Business Strategy
Based on collaboration agreements with leading Israeli hospitals and
institutions, we plan to conduct studies and clinical trials designed to develop
cannabis-based products for the treatment of various diseases and medical
conditions.
To date, OWC has signed three research collaboration and license agreements
with Sheba Academic Medical Center, Tel Hashomer, Israel ("Sheba"). Sheba is a
university-affiliated hospital that serves as Israel's national medical center
and the most comprehensive medical center in the Middle East. Within the
framework of the agreements with Sheba, OWC will initiate three studies at the
Sheba facilities to explore the effect of three formulations, all based on
active ingredients in the cannabis extracts, on multiple myeloma, psoriasis and
fibromyalgia (a specific formulation to each indication).
At present, OWC is negotiating with two other Israeli leading medical centers
for the collaboration in the research of migraine and PTSD (post-traumatic
stress disorder).
The Company expects these agreements to be finalized during the fourth
quarter of 2015.
In addition, OWC signed an R&D service agreement with G.C. Group Ltd. - an
Israeli pharmaceutical R&D company, to provide formulation development services
for OWC's new delivery system in the form of a cannabis soluble tablet. The
Company expects to start developing other delivery system, designed for
different indications, during the fourth quarter of 2015.
The Company has recently signed a Memorandum of Understanding (MoU) with
Emilia Cosmetics Ltd. - a large Israeli private label manufacturer, for the
developing, manufacturing and marketing of a cannabinoid-based topical cream to
treat psoriasis. The Company will initiate the research and development of the
topical cream by the end of the third quarter of 2015, at Emilia Cosmetics labs
located in Yerucham, Israel. After the completion of the formulation
development, during the fourth quarter of 2015, the Company will initiate a
phase I study at the Sheba facilities to explore the effect of topical cream on
psoriasis.
To date, One World Cannabis has filed eight provisional patents with the
United States Patent and Regulatory Office (USPTO), all related to its line of
activity related to cannabis-based medical products. Assuming the successful
completion of the clinical trials, of which there can be no assurance, the
Company believes that it will be able to retain the intellectual rights and
secure patent protections.
Research and Development
Our research and development is focused primarily on exploring several
formulations containing active compounds from the cannabis plant, including (but
not exclusive to) the cannabinoids CBD and THC, and identifying potential
therapeutic applications of the synergistic effects of these active compounds.
The synergistic contributions of our formulations have not yet been
scientifically researched and demonstrated. We aim to standardize the
formulations across the extracts as a whole, not simply by reference to their
key active components (CBD and/or THC).
Although there are existing reports and studies on CBD and THC, our
formulations will contain several active compounds from the cannabis plant, that
must be fully researched and documented in order to verify its effectiveness to
indications, at what doses and which method of administration will be the most
appropriate and effective.
One World Cannabis plans to produce pharmaceutical-grade cannabinoid-based
products and treatments, that will be standardized in composition, formulation
and dose, administered by means of an appropriate and efficient delivery system,
and tested in properly controlled pre-clinical and clinical studies. OWC plans
to conduct its researches, led by internationally renowned investigators, at the
facilities of leading Israeli hospitals and scientific institutions. The Company
will adhere to legislation, rules and guidelines regarding the investigations.
Dr. Baruch, OWC's Director of Research and Regulatory Affairs, and Alon Sinai,
OWC's Chief Operating Officer, will monitor the investigations and researches.
To date, OWC has signed three research collaboration and license agreements
with Sheba Academic Medical Center, Tel Hashomer, Israel ("Sheba"). Sheba is a
university-affiliated hospital that serves as Israel's national medical center
and the most comprehensive medical center in the Middle East. Within the
framework of the agreements with Sheba, OWC will initiate three studies at the
Sheba facilities to explore the effect of three formulations, all based on
active ingredients in the cannabis extracts, on multiple myeloma, psoriasis and
fibromyalgia (a specific formulation to each indication).
At present, OWC is negotiating with two other Israeli leading medical centers
for the collaboration in the research of migraine and PTSD (post-traumatic
stress disorder). The Company expects these agreements to be finalized during
the fourth quarter of 2015. Of course, there can be no assurance that we be able
to successfully negotiate these agreements before the end of 2015, if at all.
In addition, OWC signed an R&D service agreement with G.C. Group Ltd. - an
Israeli pharmaceutical R&D company, to provide formulation development services
for OWC's new delivery system in the form of a cannabis soluble tablet. The
cannabis soluble tablet could provide physicians with the ability to control
and administrate optimal dosage, to replace the most common usage/delivery
method of medical cannabis today, which is not acceptable by scientists and
physicians, such as smoking, edibles and oil extracts with no adequate means of
dosage control.
Page 24
Use of cannabis to treat Psoriasis
The Company expects to start developing other delivery system, designed for
different indications, during the fourth quarter of 2015.
The Company has recently signed a Memorandum of Understanding (MoU) with
Emilia Cosmetics Ltd. - a large Israeli private label manufacturer, for the
developing, manufacturing and marketing of a cannabinoid-based topical cream to
treat psoriasis. The Company will initiate the research and development of the
topical cream by the end of the third quarter of 2015, at Emilia Cosmetics labs
located in Yerucham, Israel. After the completion of the formulation
development, during the fourth quarter of 2015, the Company will initiate a
phase I study at the Sheba facilities to explore the effect of topical cream on
psoriasis. However, we do not know if our expectations will be fulfilled in a
timely manner, if at all, or that the costs of development will exceed our
anticipation.
To date, One World Cannabis has filed eight provisional patents with the
United States Patent and Regulatory Office (USPTO), all related to its line of
activity related to cannabis-based medical products. Assuming the successful
completion of the clinical trials, of which there can be no assurance, the
Company believes that it will be able to retain the intellectual rights and
secure patent protections.
While we retain full ownership on our intellectual property rights that we
conceived prior to the signing of the research collaboration and license
agreements with Sheba Academic Medical Center, the psoriasis and fibromyalgia
agreements with Sheba provide that all intellectual property rights that is
conceived during the course of the research is to be jointly owned by Sheba and
One World Cannabis Intellectual rights related to the multiple myeloma are being
negotiated and the Company expects to finalized an agreement during the 4th
quarter of 2015.
Pursuant to the collaboration agreements, we are obliged to pay Sheba
$330,000 for conducting the multiple myeloma trial between the 3rd quarter of
2015 and the second quarter of 2016. In addition, we expect to commence
pre-clinical studies on fibromyalgia and psoriasis during 3rd quarter of 2015.
Pursuant to the collaboration agreements, we are obliged to pay Sheba $300,000
during the 1st quarter of 2016 for conducting the psoriasis research, and
$100,000 for the fibromyalgia research during the two years of the study. We
currently have the financial resources to fund these studies, but anticipate
that we will require additional funding during the next 12 months for our
continuing and planned expanded operations.
Our Development Programs
The following table summarizes the stages of
development for each of our current Prospect Products.
OWC's Investigation on Multiple Myeloma
Dr. Merav Leiba, Head of Multiple Myeloma Outpatient
Clinic and Multiple Myeloma Research Lab at Sheba's Hematology Institute, led
the in vitro tests on multiple myeloma. Dr. Leiba, a specialist in Internal
Medicine and Hematology, was a postdoctoral fellow at the Jerome Lipper Multiple
Myeloma Center at Dana Farber Cancer Institute, Boston, Massachusetts
(2006-2008). Dr. Leiba has participated in numerous clinical and investigational
studies aimed at developing novel drugs for multiple myeloma.
Page 25
Our in vitro tests results on multiple myeloma cells
studied outside their normal biological context, on which we announced on June
17, 2015, led us to proceed with further pre-clinical study (safety and
toxicity, PK, PD) of our formulation, to find out whether it has scientific
merit for further development as an investigational new drug. While we are
encouraged by the results of the limited in vitro tests, there can be no
assurance that any clinical trial will result in commercially viable products or
treatments.
Clinical trials are expensive, time consuming and
difficult to design and implement. We, as well as the regulatory authorities in
Israel and elsewhere, such as an IRB (Helsinki committee), IMCU - Israel Medical
Cannabis Unit, or the FDA, may suspend, delay or terminate our clinical trials
at any time, may require us, for various reasons, to conduct additional clinical
trials, or may require a particular clinical trial to continue for a longer
duration than originally planned, including, among others:
lack
of effectiveness of any formulation or delivery system during clinical trials;
Any of the foregoing could have a material adverse
effect on our business, results of operations and financial condition.
Consulting Services
One World Cannabis Ltd. believes that the complexity of
the medical cannabis programs has created a demand for consulting and advisory
services in different aspects of the medical cannabis industry. The Company's
services are designed to help government officials, policy-makers and regulatory
agencies develop and implement tailor-made comprehensive medical cannabis
programs. In addition, One World Cannabis offers medical cannabis regulatory
compliance services and patient-care consultancy services.
Our initial activities to secure consulting contracts will be
in member states of the European Union and states of the United States that does
not allow for comprehensive public medical cannabis programs.
One World Cannabis Ltd. management has the expertise in
designing training programs for physicians, caregivers, and researches that are
essential to the establishment of a successful, patient-focused medical cannabis
program. By working with policy-makers, government officials, public agencies,
and privately owned businesses, we believe we can also raise the public's
awareness of the benefits of cannabis-based treatments and products.
In furtherance of our plans, we may, in the future, consider
strategic acquisitions and joint ventures as well as other projects to grow our
business activities including but not limited to: product licensing and royalty
agreements, consulting, and strategic alliances to support our Prospect Product
development. However, there can be no assurance that this strategy will be
successful in generating any revenues or growing out business.
Our Strengths
Notwithstanding the fact that we have only commenced our
cannabis-based medical research, we believe that we offer the following key
characteristics in our approach to develop our cannabis-based Prospect Products:
Our
leading medical professionals are recognized leaders in medical cannabis
treatments;
Page 26
Market and Competition
According to the 2014 edition of the Marijuana Business
Factbook, U.S. retail sales of medical cannabis are expected to rise
significantly over the next five years from an estimated $2.2 billion in 2014 to
$8.2 billion in 2018.
Controlled substance legislation differs between
countries and legislation in certain countries may restrict or limit our ability
to distribute or sell our products. Reference is being made to Risk Factor
"Risks Related to Controlled Substances (Cannabis).
We believe that the United States will represent a major
market for our cannabis-based Prospect Products due to, in large part, to state
level legislation allowing comprehensive public medical cannabis programs. A
total of 23 states, the District of Columbia and Guam now allow for
comprehensive public medical cannabis programs. Recently approved efforts in
16 states allow use of "low THC, high cannabidiol (CBD)" products for medical
reasons in limited situations.
In Europe, medical cannabis programs regulatory frameworks
exist in several countries, such as the Netherlands, Italy, Germany, Finland and
the Czech Republic. It can also be expected that there will be policy changes in
the member countries of the European Union concerning the medical use of
cannabis and cannabis-based products.
We believe that there will be rising demand for cannabis
derived medical products and that future growth is expected to be driven by
favorable changes in legislation and demographic factors.
We face competition from larger companies that are or may be
in the process of offering similar products to ours. Many of our current and
potential competitors have longer operating histories, significantly greater
financial, marketing and other resources than we may be expected to have.
Competitors may include major pharmaceutical and
biotechnology companies and public and private research institutions. However,
we believe that our own Prospect Products will be able to compete with existing
therapies and new therapies that may become available in the future.
Management cannot be certain that we will be able to compete
against current or future competitors or that competitive pressure will not
seriously harm our business prospects. These competitors may be able to react to
market changes, respond more rapidly to new regulations or allocate greater
resources to the development and promotion of their products than we can.
Furthermore, some of these competitors may make acquisitions
or establish collaborative relationships among themselves to increase their
ability to rapidly gain market share. Large pharmaceutical companies may
eventually enter the market.
Given the rapid changes affecting the global, national, and
regional economies in general and cannabis-related medical research and
development in particular, we may not be able to create and maintain a
competitive advantage in the marketplace. Time-to-Market is an important factor
and our success will depend on our ability to develop innovative products that
will be accepted by patients.
Our success will also depend on our ability to respond
quickly to, among other things, changes in the economy, market conditions, and
competitive pressures. Any failure to anticipate or respond adequately to such
changes could have a material effect on our financial condition, operating
results, liquidity, cash flow and our operational performance.
There can be given no assurance that any of our on
cannabis-based medical products will obtain regulatory approval in the US or in
other markets that we intent to market such products.
Intellectual Property
Proprietary Information-Know-How
Our success depends in significant part on our ability to
protect the proprietary nature of our prospect products, technology and
know-how, to operate without infringing on the proprietary rights of others, and
to defend challenges and oppositions from others and prevent others from
infringing on our proprietary rights, including our provisional patents
described below. We have not acquired any intellectual property from Dr. Yehuda
Baruch, OWC's Director of Research and Regulatory Affairs, nor from Alon Sinai,
OWC's Chief Operating Officer. Rather, they have brought to the Company their
wealth of know-how in all matters related to medical cannabis, based upon their
many years of experience in the IDF's Mental Health Department as well as Dr.
Baruch's service as Director of the Medical Cannabis Program of the Israeli
Ministry of Health.
We plan to continue to seek patent protection in the United
States and other countries for our proprietary technologies. To date, our
intellectual property portfolio includes eight provisional patents, filed with
the United States Patent and Regulatory Office (USPTO), all related to our line
of activity (pharmaceutical formulations; drug delivery; therapeutic uses of
cannabinoids and other cannabis compounds), as well as know-how and trade
secrets.
Page 27
We anticipate additional patent applications in conjunction
with our research, testing, and development of our cannabis-based prospect
products.
Our policy is to seek patent protection for the technology,
inventions and improvements that we consider important to the development of our
business, but only in those cases where we believe that the costs of obtaining
patent protection is justified by the commercial potential of the technology,
and typically only in those jurisdictions that we believe present significant
commercial opportunities.
FDA Approval Process in the United States
The United States extensively regulate the pre-clinical and clinical testing,
manufacturing, labeling, storage, record-keeping, advertising, promotion,
export, marketing and distribution of drugs. The FDA regulates pharmaceutical
products under the Federal Food, Drug, and Cosmetic Act, the Public Health
Service Act and other federal statutes and regulations.
To obtain approval of our future product candidates from the FDA, we must,
among other requirements, submit data supporting safety and efficacy for the
intended indication as well as detailed information on the manufacture and
composition of the product candidate. In most cases, this will require extensive
laboratory tests and preclinical and clinical trials. The collection of these
data, as well as the preparation of applications for review by the FDA involve
significant time and expense. The FDA also may require post-marketing testing to
monitor the safety and efficacy of approved products or place conditions on any
approvals that could restrict the therapeutic claims and commercial applications
of these products. Regulatory authorities may withdraw product approvals if we
fail to comply with regulatory standards or if we encounter problems at any time
following initial marketing of our products.
The first stage of the FDA approval process for a new drug involves
completion of pre-clinical studies and the submission of the results of these
studies to the FDA. These data, together with proposed clinical protocols,
manufacturing information, analytical data and other information submitted to
the FDA in an IND application, must become effective before human clinical
trials may commence. Preclinical studies generally involve FDA regulated
laboratory evaluation of product characteristics and animal studies to assess
the efficacy and safety of the product candidate.
After the IND becomes effective, a company may commence human clinical
trials. These are typically conducted in three sequential phases, but the phases
may overlap. Phase 1 trials consist of testing the product candidate in a small
number of patients or healthy volunteers, primarily for safety at one or more
doses. Phase 2 trials, in addition to safety, evaluate the efficacy of the
product candidate in a patient population somewhat larger than Phase 1 trials.
Phase 3 trials typically involve additional testing for safety and clinical
efficacy in an expanded population at multiple test sites. A company must submit
to the FDA a clinical protocol, accompanied by the approval of the Institutional
Review Board ("IRB") at the institutions participating in the trials, prior to
commencement of each clinical trial.
To obtain FDA marketing authorization, a company must submit to the FDA the
results of the preclinical and clinical testing, together with, among other
things, detailed information on the manufacture and composition of the product
candidate, in the form of a new drug application (an "NDA").
The amount of time taken by the FDA for approval of an NDA will depend upon a
number of factors, including whether the product candidate has received priority
review, the quality of the submission and studies presented, the potential
contribution that the compound will make in improving the treatment of the
disease in question and the workload at the FDA.
The FDA may, in some cases, confer upon an investigational product the status
of a fast track product. A fast track product is defined as a new drug or
biologic intended for the treatment of a serious or life threatening condition
that demonstrates the potential to address unmet medical needs for this
condition. The FDA can base approval of an NDA for a fast track product on an
effect on a surrogate endpoint, or on another endpoint that is reasonably likely
to predict clinical benefit. If a preliminary review of clinical data suggests
that a fast track product may be effective, the FDA may initiate review of
entire sections of a marketing application for a fast track product before the
sponsor completes the application.
Page 28
We anticipate that any of our future products will be manufactured by
strategic partners, licensees or other third parties. Before approving an NDA,
the FDA will inspect the facilities at which the product is manufactured and
will not approve the product unless the manufacturing facilities are in
compliance with the FDA's current good manufacturing practices ("cGMP"), which
are regulations that govern the manufacture, holding and distribution of a
product. Our manufacturers also will be subject to regulation under the
Occupational Safety and Health Act, the Nuclear Energy and Radiation Control
Act, the Toxic Substance Control Act and the Resource Conservation and Recovery
Act and other applicable environmental statutes. Following approval, the FDA
periodically inspects drug manufacturing facilities to ensure continued
compliance with the cGMP. Our manufacturers will have to continue to comply with
those requirements. Failure to comply with these requirements subjects the
manufacturer to possible legal or regulatory action, such as suspension of
manufacturing or recall or seizure of product. Adverse patient experiences with
the product must be reported to the FDA and could result in the imposition of
marketing restrictions through labeling changes or market removal. Product
approvals may be withdrawn if compliance with regulatory requirements is not
maintained or if problems concerning safety or efficacy of the product occur
following approval.
The labeling, advertising, promotion, marketing and distribution of a drug
must also be in compliance with FDA and Federal Trade Commission requirements
which include, among others, standards and regulations for off-label promotion,
industry sponsored scientific and educational activities, promotional activities
involving the internet, and direct-to-consumer advertising. We also will be
subject to a variety of federal, state and local regulations relating to the
use, handling, storage and disposal of hazardous materials, including chemicals
and radioactive and biological materials. In addition, we will be subject to
various laws and regulations governing laboratory practices and the experimental
use of animals. In each of these areas, as above, the FDA has broad regulatory
and enforcement powers, including the ability to levy fines and civil penalties,
suspend or delay issuance of product approvals, seize or recall products and
deny or withdraw approvals.
We will also be subject to a variety of regulations governing clinical trials
and sales of our products outside the United States. Whether or not FDA approval
has been obtained, approval of a product candidate by the comparable regulatory
authorities of foreign countries and regions must be obtained prior to the
commencement of marketing the product in those countries. The approval process
varies from one regulatory authority to another and the time may be longer or
shorter than that required for FDA approval.
Government Laws and
Regulations
To date, our research and development activities have been
conducted in and limited to Israel. The cannabis-based products we are
developing contain controlled substance (cannabis) as defined in the Israeli
Dangerous Drugs Ordinance [New Version], 5733 - 1973. In Israel, licenses to
cultivate, possess and to use cannabis for medical research are granted by the
Ministry of Health, IMCU - Israel Medical Cannabis Unit, on ad-hoc basis. One
World Cannabis Ltd. obtained necessary IMCU licenses in order to carry out the
research in collaboration with Sheba Academic Medical Center and with G.C.
Group. One World Cannabis is acquiring the cannabis needed for its research
activities from G.K. Medical Cannabis, a government-licensed Israeli medical
cannabis grower. Because we do not have a license to possess cannabis, the
cannabis that is required for the studies must be transported from the licensed
grower directly to Sheba's laboratories, in compliance with our license to use
cannabis for medical research. We have applied for additional licenses in order
to continue our activities in collaboration with Sheba Academic Medical Center
and with G.C. Group.
Although we have been successful in obtaining the licenses to
acquire as needed, there can be no assurance that we will be able to continue to
acquire cannabis, as needed, in the future.
Currently we do not conduct any product-related activities
such as research, development, manufacturing or marketing activities outside of
Israel, nor do we expect to for the foreseeable future.
In the event that we seek to conduct any product-related
activities in the United States in the future, the research and development,
manufacturing, distribution and sale of our products will become subject to the
United States' Federal Controlled Substances Act of 1970 and regulations
promulgated thereunder. While cannabis is a Schedule I controlled substance,
products approved for medical use in the United States that contain cannabis or
cannabis extracts must be placed in Schedules II-V, since approval by the FDA
satisfies the "accepted medical use" requirement. If approved by the FDA, we
expect the products to be listed by the DEA as a Schedule II or III controlled
substance. Consequently, its manufacture, importation, exportation, domestic
distribution, storage, sale and legitimate use will be subject to a significant
degree of regulation by the DEA. In addition, individual states in the United
States have also established controlled substance laws and regulations. Though
state-controlled substances laws often mirror federal law, because the states
are separate jurisdictions, they may separately schedule our products. To date,
a total of 23 states, the District of Columbia and Guam allow for comprehensive
public medical cannabis programs. In addition, 16 states allow use of "low THC,
high cannabidiol (CBD)" products for medical reasons in limited situations.
Similarly, in the event that seek to conduct any
product-related activities in Europe, the research and development,
manufacturing, distribution and sale of our products will become subject to the
European Union regulations and Council decisions, as well as the member states
domestic legislation on the matter.
In the event we seek to conduct our activities in, Latin
America or Asia, the research and development, manufacturing, distribution and
sale of our products will also be subject to the laws and regulations on the
matter.
Page 29
Failure to comply with these laws and regulations in Israel,
the United States, Europe and elsewhere, or the cost of compliance with their
respective laws and regulations, may adversely affect the results of our
business operations, during pre-clinical and clinical research and development
as well as post approval, and our financial condition.
Employees
We presently have no full-time employees. Our CEO and CFO are employed under services agreements with the
Company. Our officers and directors are expected to dedicate approximately 60% of their professional time to our business development until such time that we receive regulatory approval of any prospect product.
OWC has currently 8 employees. We conduct our medical research through collaboration agreements.
Our principal executive office is located at 22 Shacham Street, P.O. Box 8324, Petach Tikva, 4918103, Israel. Our telephone number in Israel is +972 (0)3-758-2657/9. Our executive office is a rented suite located in the Beit Dvir building. The Company pays $1,650 per month for 461 square foot of office space.
We believe that this space is adequate for our current and immediately
foreseeable operating needs.
From time to time, we may become involved in various lawsuits and legal proceedings, which arise, in the ordinary course of business. We are currently not aware of any legal proceedings or claims that we believe will have a material adverse effect on our business, financial condition or operating results.
Market Information
The Company's Common Stock is subject to quotation on the OTCQB Market under the symbol
OWCP. There can be no assurance that there will be an active trading market for the Common Stock. In the event that an active trading market commences, there can be no assurance as to the market price of the shares of Common Stock, whether any trading market will provide liquidity to investors, or whether any trading market will be sustained.
For the periods indicated, the following table sets forth the high and low bid prices per share of Common Stock. The below prices represent inter-dealer quotations without retail markup, markdown, or commission and may not necessarily represent actual transactions.
As of March 31, 2014, our shares of common stock were held by approximately 120 stockholders of record. This does not include
shares held in "street name." The transfer agent of our common stock is VStock Transfer LLC, 18 Lafayette Place, Woodmere, NY 11598, Phone (212) 828-8436. VStock Transfer is registered under the Exchange Act.
Rule 144 Shares:
As of March 31, 2015, there were 25,717,482 shares currently available for sale to the public in accordance with the volume and trading limitations of Rule 144.
Stock Option Grants
: We do not have a stock option plan (ESOP) in place in 2014 and have not granted any stock options at this time. We contemplate adopting an ESOP during the
third quarter of 2015.
Securities Authorized for Issuance Under Equity Compensation Plans:
No equity compensation plan or agreements under which our Common Stock is authorized for issuance has been adopted during the fiscal year ended December 31, 2014 and 2013.
Dividends
Holders of common stock are entitled to dividends when, as, and if
declared by the Board of Directors, out of funds legally available therefore. We
have never declared cash dividends on its common stock and our Board of
Directors does not anticipate paying cash dividends in the foreseeable future as
it intends to retain future earnings to finance the growth of our businesses.
Page 30
Sale of Unregistered Securities
(a) The units include warrants exercisable at $0.16 per share.
The sales of these securities were exempt under either Section 4(2) of the Securities Act of 1933, as amended (the "Act") and the rules and regulations promulgated by the SEC thereunder, including Regulation S. The investors represented to the Company that they have sufficient knowledge and experience in financial and business matters to evaluate the risks and merits of the investment (the "sophisticated investor"), or be able to bear the investment's economic risk, have access to the type of information normally provided in a prospectus; and agreed not to resell or distribute the securities to the public other than in compliance with the Act. In addition, the Company did not use any form of public solicitation or general advertising in connection with the offerings.
Page 32
Penny Stock Considerations
Our Common Stock will be deemed to be "penny stock" as that term is generally defined in the Securities Exchange Act of 1934 to mean equity securities with a price of less than $5.00. Our shares thus will be subject to rules that impose sales practice and disclosure requirements on broker-dealers who engage in certain transactions involving a penny stock.
Under the penny stock regulations, a broker-dealer selling a penny stock to anyone other than an established customer or accredited investor must make a special suitability determination regarding the purchaser and must receive the purchaser's written consent to the transaction prior to the sale, unless the broker-dealer is otherwise exempt. Generally, an individual with a net worth in excess of $1,000,000 or annual income exceeding $100,000 individually or $300,000 together with his or her spouse is considered an accredited investor. In addition, under the penny stock regulations the broker-dealer is required to:
(ii)
research and development of cannabis-based medical products for the treatment of
a variety of medical conditions such as multiple myeloma, psoriasis,
fibromyalgia, post-traumatic stress disorder (PTSD) and migraine, and
(iii)
consulting services to companies and governmental agencies with respect to
complex international medical cannabis protocols and regulations.
Targeted Medical Condition
Collaborator
Status
Use of cannabis to treat
multiple Myeloma
Sheba Academic
Medical Center
Basic Science
Research Agreement - signed;
Clinical Research Agreement - in
negotiation;
Pre-clinical study: Approved by Ethics Committee (IRB);
In vitro tests - completed.
Next: Pre-clinical study: Safety and
Toxicity, PK, PD
Clinical trial protocol synopsis - draft completed.
Use of cannabis to treat
Psoriasis
(1) Sheba
Academic Medical Center
Research
Collaboration and License Agreement - signed;
Protocol of A Phase I,
double blind, randomized, placebo controlled, multiple escalating dose
study to determine the safety, tolerability and pharmacokinetic profile
of medical grade cannabis in healthy volunteers - draft completed.
Use of cannabis to treat
Psoriasis
(2)
Emilia Cosmetics Ltd.
Memorandum of
Understanding (MoU) for the developing, manufacturing and marketing of a
cannabinoid-based topical cream to treat psoriasis - signed;
Received
license to purchase and use of cannabis for R&D purposes;
Formulation
development will be initiated during third quarter of 2015.
Use of cannabis to treat
Fibromyalgia
Sheba
Academic Medical Center
Research
Collaboration and License Agreement - signed;
Clinical trial protocol
synopsis - initial draft completed.
New delivery system - cannabis
soluble tablet
G.C. Group Ltd.
Formulation
development;
Received license to purchase and use of cannabis for R&D
purposed.
Use of cannabis to treat PTSD
In
Negotiations
Clinical trial
documents - submitted; Awaiting for Ethics Committee (IRB) final
approval.
Use of cannabis to treat Migraine
In
Negotiations
Clinical trial
protocol synopsis - initial draft completed.
discovery of serious or
unexpected toxicities or side effects experienced by trial participants or other
safety issues;
slower than
expected rates of subject recruitment and enrollment rates in clinical trials;
delays or inability in
manufacturing or obtaining sufficient quantities of materials for use in
clinical trials due to regulatory and manufacturing constraints;
delays
in obtaining regulatory authorization to commence a trial, including IRB
approvals, licenses required for obtaining and using cannabis for research,
either before or after a trial is commenced;
unfavorable
results from ongoing pre-clinical studies and clinical trials.
patients
or investigators failing to comply with study protocols;
patients
failing to return for post-treatment follow-up at the expected rate;
sites
participating in an ongoing clinical study withdraw, requiring us to engage new
sites;
third-party
clinical investigators decline to participate in our clinical studies, do not
perform the clinical studies on the anticipated schedule, or act in ways
inconsistent with the established investigator agreement, clinical study
protocol, good clinical practices, and other Institutional Review Board
requirements;
third-party
entities do not perform data collection and analysis in a timely or accurate
manner or at all;
regulatory
inspections of our clinical studies require us to undertake corrective action or
suspend or terminate our clinical studies;
We received
Ethics Committee approval (IRB - internal review board approval) to the in vitro
tests on the multiple myeloma study. We have applied for an Ethics Committee
approval (IRB - internal review board approval) to the PTSD study;
We have already filed eight
provisional patent applications with the USPTO;
We have entered into three
research and license agreements with Sheba Academic Medical Center to conduct
research on multiple myeloma, psoriasis and fibromyalgia;
Strong competitive position in
a highly specialized and regulated field. Understanding Government regulation is
a prerequisite. The team has substantial knowledge and experience in this field,
both regulatory and scientifically related, in Israel and across the world.
OWC's expert team delivers
years of proven practices in diverse disciplines, including medical science and
regulatory affairs, as well as extensive cannabis-related issues experience.
Fiscal 2014
Fiscal 2013
Fiscal 2012
High
Low
High
Low
High
Low
First Quarter ended March 31
$
0.30
$
0.01
$
0.18
$
0.08
$
0.35
$
0.13
Second Quarter ended June 30
$
0.30
$
0.17
$
0.33
$
0.11
$
0.35
$
0.13
Third Quarter ended September 30
$
0.49
$
0.21
$
0.32
$
0.06
$
0.24
$
0.13
Fourth Quarter ended December 31
$
0.27
$
0.10
$
0.15
$
0.01
$
0.21
$
0.08
Date
Title
Shares Issued
Persons
Consideration Per Share
02/28/14
Common Stock
913,000
Amir Uziel
Conversion of debt into equity at $0.01 per share pursuant to Section
4(2)
02/28/14
Common Stock
349,300
Tena Holdings GmbH (1)
Conversion of debt into equity at $0.01 per share pursuant to Section
4(2)
02/28/14
Common Stock
688,500
Lavi Krasney
Conversion of debt into equity at $0.01 per share pursuant to Section
4(2)
02/28/14
Common Stock
366,500
Akiva Shonfeld
Conversion of debt into equity at $0.01 per share pursuant to Section
4(2)
02/28/14
Common Stock
592,900
Amita S.A. (2)
Conversion of debt into equity at $0.01 per share pursuant to Section
4(2)
02/28/14
Common Stock
2,383,100
L&L Holdings (3)
Conversion of debt into equity at $0.01 per share pursuant to Section
4(2)
02/28/14
Common Stock
2,947,000
Asher G. Mediouni
Conversion of debt into equity at $0.01 per share pursuant to Section
4(2)
02/28/14
Common Stock
3,657,100
Ofliam L.L.C. (4)
Conversion of debt into equity at $0.01 per share pursuant to Section
4(2)
02/28/14
Common Stock
295,200
Kfir Silbrman
Conversion of debt into equity at $0.01 per share pursuant to Section
4(2)
03/11/14
Common Stock
2,000,000
IMWT Holdings Ltd. (5)
For Services provided valued at $20,000 pursuant to Section 4(2)
03/11/14
Common Stock
2,000,000
KE Zurich Capital (6)
For Services provided valued at $20,000 pursuant to Section 4(2)
03/11/14
Common Stock
1,000,000
Tzvika Borodizki
For Services provided valued at $10,000 pursuant to Section 4(2)
03/11/14
Common Stock
1,000,000
Asaf Itschaik
For Services provided valued at $10,000 pursuant to Section 4(2)
03/31/14
Common Stock
529,400
L&L Holdings (3)
Conversion of debt into equity at $0.01 per share pursuant to Section
4(2)
03/31/14
Common Stock
1,470,000
L&L Holdings (3)
For Services provided valued at $14,700 pursuant to Section 4(2)
03/31/14
Common Stock
362,000
Bransville Investment Ltd. (7)
Conversion of debt into equity at $0.01 per share pursuant to Section
4(2)
03/31/14
Common Stock
1,638,000
Bransville Investment Ltd. (7)
For Services provided valued at $16,380 pursuant to Section 4(2)
04/15/14
Common Stock
500,000
Short Trade Ltd. (8)
$0.005 per share in cash pursuant to Section 4(2)
04/15/14
Common Stock
1,250,000
Ben-Zion Weiner
$0.005 per share in cash pursuant to Section 4(2)
04/15/14
Common Stock
500,000
Yoel Yogev
$0.005 per share in cash pursuant to Section 4(2)
04/15/14
Common Stock
2,000,000
Ariela Krasney
$0.005 per share in cash pursuant to Section 4(2)
04/15/14
Common Stock
150,000
Oded Gilboa
$0.005 per share in cash pursuant to Section 4(2)
04/15/14
Common Stock
300,000
David Massas
$0.005 per share in cash pursuant to Section 4(2)
06/24/14
Units (a)
111,111
David Asaf
$0.09 per share in cash pursuant to Reg S exemption
06/29/14
Units (a)
444,444
Avdinco Ltd. (9)
$0.09 per share in cash pursuant to Reg S exemption
06/24/14
Units (a)
55,555
David Benhamu
$0.09 per share in cash pursuant to Reg S exemption)
06/05/14
Units (a)
222,222
David Shrem
$0.09 per share in cash pursuant to Reg S exemption
06/24/14
Units (a)
222,222
Eran Cohan
$0.09 per share in cash pursuant to Reg S exemption
07/01/14
Units (a)
111,111
Judith Zetouny
$0.09 per share in cash pursuant to Reg S exemption
06/23/14
Units (a)
555,555
Falash Masha Lea
$0.09 per share in cash pursuant to Reg S exemption
06/18/14
Units (a)
111,111
Nir Ben Nissan
$0.09 per share in cash pursuant to Reg S exemption
06/20/14
Units (a)
55,555
Nuriel Chordekar
$0.09 per share in cash pursuant to Reg S exemption
06/19/14
Units (a)
2,222,222
Prop Trade Ltd. (10)
$0.09 per share in cash pursuant to Reg S exemption
06/19/14
Units (a)
444,444
R.P. Holdings Ltd. (11)
$0.09 per share in cash pursuant to Reg S exemption
06/18/14
Units (a)
222,222
Ron Senator
$0.09 per share in cash pursuant to Reg S exemption
06/24/14
Units (a)
450,000
Shmuel Pasternak
$0.09 per share in cash pursuant to Reg S exemption
06/13/14
Units (a)
2,222,222
Short Trade Ltd. (12)
$0.09 per share in cash pursuant to Reg S exemption)
06/24/14
Units (a)
111,111
Tal Taperberg & Gal Graf
$0.09 per share in cash pursuant to Reg S exemption
06/11/14
Units (a)
444,444
Boruj Tenenbaum
$0.09 per share in cash pursuant to Reg S exemption
06/18/14
Units (a)
166,667
Tomer Cohan
$0.09 per share in cash pursuant to Reg S exemption
06/11/14
Units (a)
1,000,000
Yoel Yogev
$0.09 per share in cash pursuant to Reg S exemption
06/10/14
Units (a)
220,000
Yosef Cohan
$0.09 per share in cash pursuant to Reg S exemption
08/14/14
Common Stock
150,000
Ivo Heiden
For Services provided valued at $0.25 per share pursuant to Section 4(2)
08/14/14
Common Stock
150,000
Securities Compliance Corp. (13)
For Services provided valued at $0.25 per share pursuant to Section 4(2)
07/14/14
Common Stock
179,300
Activa Shonenfeld
Conversion of debt into equity at $0.01 per share pursuant to Section
4(2)
07/15/14
Common Stock
150,000
Gonen, Eli - former Chairman
For Services provided valued at $0.28 per share pursuant to Section 4(2)
07/15/14
Common Stock
250,000
Goore, Ori - former CEO and Director
For Services provided valued at $0.28 per share pursuant to Section 4(2)
07/15/14
Warrants
200,000
Gonen, Eli - former Chairman
Exercisable at $0.14 per share pursuant to Section 4(2)
07/15/14
Warrants
150,000
Goore, Ori - former CEO and Director
Exercisable at $0.14 per share pursuant to Section 4(2)
08/04/14
Warrants
3,500,000
Amir Uziel
For services provided, exercisable at $0.14 per share pursuant to
Section 4(2)
08/04/14
Warrants
700,000
Eli Yorsh
For services provided, exercisable at $0.14 per share pursuant to
Section 4(2)
08/04/14
Warrants
3,500,000
Capitallink Ltd. (14)
For services provided, exercisable at $0.14 per share pursuant to
Section 4(2)
08/04/14
Warrants
2,800,000
L.I.A. Pure Capital Ltd. (15)
For services provided, exercisable at $0.14 per share pursuant to
Section 4(2)
08/04/14
Warrants
3,500,000
Yaad Ltd. (16)
For services provided, exercisable at $0.14 per share pursuant to
Section 4(2)
08/17/14
Units (a)
1,322,222
Invita Pharmaceuticals LLC. (17)
$0.09 per share in cash pursuant to Section 4(2)
07/12/14
Units (b)
166,666
Alan L. Talesnick
$0.15 per share in cash pursuant to Reg S exemption
07/12/14
Units (b)
500,000
Gil Cohan
$0.15 per share in cash pursuant to Reg S exemption
07/08/14
Units (b)
834,000
H. Leigh Severance Inc. (18)
$0.15 per share in cash pursuant to Section 4(2)
07/08/14
Units (b)
834,000
H. Leigh Severance Inc. Pension Plan & Trust (19)
$0.15 per share in cash pursuant to Section 4(2)
08/18/14
Units (b)
1,360,000
NE Solutions Ltd. (20)
$0.15 per share in cash pursuant to Reg S exemption
09/23/14
Units (a)
1,111,111
Prop Trade Ltd. (21)
$0.09 per share in cash pursuant to Reg S exemption
09/23/14
Units (a)
1,111,111
Short Trade Ltd. (22)
$0.09 per share in cash pursuant to Reg S exemption
11/07/14
Common Stock
5,134,375
Dr. Alan Shackelford, CTO of OWC (23)
$0.05 per share in cash pursuant to Section 4(2)
11/07/14
Common Stock
2,104,480
Ziv Turner
$0.05 per share in cash pursuant to Reg S exemption
11/07/14
Common Stock
2,114,480
Uri Glazer
$0.05 per share in cash pursuant to Reg S exemption
11/07/14
Common Stock
861,250
Alon Sinai
$0.05 per share in cash pursuant to Reg S exemption
11/07/14
Common Stock
132,500
Shmuel De-Saban, CFO
$0.05 per share in cash pursuant to Reg S exemption
11/17/14
Unit (b)
166,667
Nissim Atias
$0.15 per share in cash pursuant to Reg S exemption
11/17/14
Unit (b)
66,667
Ido Glazer
$0.15 per share in cash pursuant to Reg S exemption
11/17/14
Unit (b)
43,426
Guy Abraham
$0.15 per share in cash pursuant to Reg S exemption
11/17/14
Unit (b)
61,666
Guy Elad
$0.15 per share in cash pursuant to Reg S exemption
11/17/14
Unit (b)
66,667
Sara Leibovitz
$0.15 per share in cash pursuant to Reg S exemption
11/17/14
Unit (b)
1,030,000
Shem Tov and Claudia Calvo
$0.15 per share in cash pursuant to Reg S exemption
11/17/14
Unit (b)
333,333
Michal and Rafi Farjun
$0.15 per share in cash pursuant to Reg S exemption
11/17/14
Unit (b)
43,859
Shay Kahlon
$0.15 per share in cash pursuant to Reg S exemption
11/17/14
Unit (b)
350,877
Moshe Ashkenazi
$0.15 per share in cash pursuant to Reg S exemption
12/22/2014
Common Stock
200,000
Uri Glazer
$0.05 per share in cash pursuant to Section 4(2)
12/22/2014
Common Stock
150,000
Alon Sinai
$0.05 per share in cash pursuant to Section 4(2)
12/22/2014
Common Stock
2,120,000
Yehuda Baruch
$0.05 per share in cash pursuant to Section 4(2)
12/22/2014
Common Stock
100,000
Mirabelle Gazit
$0.05 per share in cash pursuant to Section 4(2)
12/22/2014
Common Stock
250,000
Dubi Kohva
$0.05 per share in cash pursuant to Section 4(2)
12/22/2014
Common Stock
62,916
Shmuel De-Saban, CFO
$0.05 per share in cash pursuant to Section 4(2)
06/16/2014
Common Stock
100,000
Ten West Holding Ltd. (24)
$0.09 per share in cash pursuant to Section 4(2)
(b) The units include warrants exercisable at $0.25 per share.
(1) Tena Holdings is controlled by Daren Bitan, a resident of Israel.
(2) Amit SA is controlled by Haem Arusi, a resident of Israel.
(3) L&L Holdings is controlled by Ruiz Diaz Rolon Rosa, a resident of Argentina.
(4) Ofliam LLC is controlled by Patric Sasun Resident of Luxembourg
(5) IMWT is controlled by John Shafat, a resident of Austria
(6) KE Zurich
Capital Ltd. is controlled by Tal Yoresh, a resident of Australia.
(7) Branseville Investments is controlled by Albert Oliverio, a resident of Gibraltar.
(8) Short Trade Ltd is controlled by Shlomo Noyman, a resident of Israel.
(9) Avdinco Ltd. is controlled by Avner Cohen, a resident of Israel.
(10) Prop Trade Ltd. is controlled by Charlote Eilin Tay, a resident of Singapore.
(11) R.P. Holdings (1992) Ltd is controlled by Rubin Zimerman, a resident of Israel.
(12) Short Trade Ltd. is controlled by Shlomo Noyman, a resident of Israel.
(13) Securities Compliance Corp. is controlled by Richard Rubin.
(14) Capitallink Ltd. is controlled by Levi Krasney, a resident of Israel.
(15) L.I.A. Pure Capital Ltd. is controlled by Kfir Silberman, a resident of
Israel.
(16) Yaad Ltd.
is controlled by Isaac Shrem, a resident of Israel.
(17) Invita Pharmaceuticals LLC is controlled by Richard S. Greenberg, a resident of the State of Colorado.
(18) H. Leigh Severance Inc. Pension Plan and Trust is controlled by H. Leigh Severance, a resident of the State of Colorado.
(19) H. Leigh Severance Inc. is controlled by H. Leigh Severance, a resident of the State of Colorado.
(20) NE Solutions Ltd. is controlled by Lee Yit Tong, a resident of Singapore.
(21) Prop Trade Ltd. is controlled by Charlote Eilin Tay, a resident of Singapore
(22) Short Trade Ltd. is controlled by Shlomo Noyman, a resident of Israel.
(23) Dr. Alan Shackelford is a US resident and CSO of our wholly-owned subsidiary, One World
cannabis Ltd.
(24) Ten West Holding Ltd. is controlled by Marc Sitzer, a US resident.
Disclose commissions payable to the broker-dealer and our registered representatives and current bid and offer quotations for the securities;
Send monthly statements disclosing recent price information pertaining to the penny stock held in a customer's account, the account's value and information regarding the limited market in penny stocks; and
Make a special written determination that the penny stock is a suitable investment for the purchaser and receive the purchaser's written agreement to the transaction, prior to conducting any penny stock transaction in the customer's account.
Because of these regulations, broker-dealers may encounter difficulties in their attempt to buy or sell shares of our Common Stock, which may affect the ability of Selling Shareholders or other holders to sell their shares in the secondary market and have the effect of reducing the level of trading activity in the secondary market. These additional sales practice and disclosure requirements could impede the sale of our Common Stock even if our Common Stock becomes publicly traded. In addition, the liquidity for our Common Stock may be decreased, with a corresponding decrease in the price of our Common Stock. Our shares are likely to be subject to such penny stock rules for the foreseeable future.
Page 33
Page 34
Page 35
Revenues
$
-
$
-
305,479
472,142
99,124
-
-
(34,034)
-
-
$
(404,603)
$
(509,013)
$
(0.01)
$
(0.02)
79,729,241
29,358,306
Page 36
Page 37
Cash
flows from operating activities:
$
(404,603)
$
(509,013)
(40,697)
2,837
(387,040)
(16,712)
(1,630)
-
90,000
23,250
(303,628)
6,538
1,469,266
2,469
$
1,165,638
$
9,007
Page 38
OWC Pharmaceutical Research Corp.
1. The Company and Significant Accounting Policies
Organizational Background:
OWC Pharmaceutical
Research Corp. ("OWCP" or the "Company") was incorporated in Delaware, on
March 7, 2008, under the name Dynamic applications Corp.
We are engaged in three distinct business sectors and we may require additional capital to implement our business plan and fund our operations. Our
three distinct business operations are:
(i) continuing to work with GUMI to commercialize and market the Company's Electromagnetic Percussion Device (the "Device"); and
The accompanying financial
statements of OWCP were prepared from the accounts of the Company under the
accrual basis of accounting.
Basis of Presentation:
The accompanying financial
statements have been prepared in conformity with accounting principles
generally accepted in the United States of America, which contemplate
continuation of the Company as a going concern. The Company has not
established any source of revenue to cover its operating costs, and as such,
has incurred an operating loss since inception. These and other factors
raise substantial doubt about the Company's ability to continue as a going
concern. The accompanying 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 possible inability of the Company to continue as a
going concern.
Principles of Consolidation:
The financial statements
include the accounts of
OWC Pharmaceutical Research Corp
. and its wholly owned
subsidiary One World Cannabis Ltd. All significant inter-company
balances and transactions have been eliminated.
Significant Accounting Policies
Use of Estimates:
The preparation of financial
statements in conformity with generally accepted accounting principles
requires management to make estimates and assumptions that affect reported
amounts of assets and liabilities and disclosure of contingent assets and
liabilities at the date of the financial statement and the reported amounts
of revenues and expenses during the reporting period. Actual results could
differ from the estimates.
Cash and Cash Equivalents:
For financial statement
presentation purposes, the Company considers those short-term, highly liquid
investments with original maturities of three months or less to be cash or
cash equivalents. There were no cash equivalents at March 31, 2015 and
December 31, 2014.
Property and Equipment:
New property and equipment are
recorded at cost. Property and equipment included in the bankruptcy
proceedings and transferred to the Trustee had been valued at liquidation
value. Depreciation is computed using the straight-line method over the
estimated useful lives of the assets, generally 5 years. Expenditures for
renewals and betterments are capitalized. Expenditures for minor items,
repairs and maintenance are charged to operations as incurred. Gain or loss
upon sale or retirement due to obsolescence is reflected in the operating
results in the period the event takes place.
Valuation of Long-Lived Assets:
We review the
recoverability of our long-lived assets including equipment, goodwill and
other intangible assets, when events or changes in circumstances occur that
indicate that the carrying value of the asset may not be recoverable. The
assessment of possible impairment is based on our ability to recover the
carrying value of the asset from the expected future pre-tax cash flows
(undiscounted and without interest charges) of the related operations. If
these cash flows are less than the carrying value of such asset, an
impairment loss is recognized for the difference between estimated fair
value and carrying value. Our primary measure of fair value is based on
discounted cash flows. The measurement of impairment requires management to
make estimates of these cash flows related to long-lived assets, as well as
other fair value determinations.
Foreign Currency:
Non-U.S. entity operations are
recorded in the functional currency of each entity. Results of operations
for non-U.S. dollar functional currency entities are translated into U.S.
dollars using average currency rates. Assets and liabilities are translated
using currency rates at period end. Foreign currency translation adjustments
are recorded as a component of other comprehensive income (loss) within
stockholders' equity.
Stock Based Compensation:
Stock-based awards are
accounted for using the fair value method in accordance with ASC 718,
Share-Based Payments. Our primary type of share-based compensation consists
of stock options. We use the Black-Scholes option pricing model in valuing
options. The inputs for the valuation analysis of the options include the
market value of the Company's common stock, the estimated volatility of the
Company's common stock, the exercise price of the warrants and the risk free
interest rate.
Accounting For Obligations And Instruments Potentially To Be Settled
In The Company's Own Stock:
We account for obligations and
instruments potentially to be settled in the Company's stock in accordance
with FASB ASC 815, Accounting for Derivative Financial Instruments. This
issue addresses the initial balance sheet classification and measurement of
contracts that are indexed to, and potentially settled in, the Company's own
stock.
Fair Value of Financial Instruments:
FASB ASC 825,
"Financial Instruments," requires entities to disclose the fair value of
financial instruments, both assets and liabilities recognized and not
recognized on the balance sheet, for which it is practicable to estimate
fair value. FASB ASC 825 defines fair value of a financial instrument as the
amount at which the instrument could be exchanged in a current transaction
between willing parties. At March 31, 2015 and December 31, 2014, the
carrying value of certain financial instruments (cash and cash equivalents,
accounts payable and accrued expenses.) approximates fair value due to the
short-term nature of the instruments or interest rates, which are comparable
with current rates.
Fair Value Measurements:
The Company measures fair
value under a framework that utilizes a fair value hierarchy that
prioritizes the inputs to valuation techniques used to measure fair value.
The hierarchy gives the highest priority to unadjusted quoted prices in
active markets for identical assets or liabilities (level 1 measurements)
and the lowest priority to unobservable inputs (level 3 measurements). The
three levels of inputs which prioritize the inputs used in measuring fair
value are:
Level 1:
Inputs to the valuation methodology are unadjusted quoted prices for
identical assets or liabilities in active markets that the Company has the ability to
access.
Level 2:
Inputs to the valuation methodology include:
- Quoted prices for similar assets or liabilities in active markets;
If the asset or liability has a specified (contractual) term, the level 2 input must be
observable for substantially the full term of the asset or liability.
Level 3:
Inputs to the valuation methodology are unobservable and significant to
the fair value measurement.
The assets or liabilitys fair value measurement level within the fair value
hierarchy is based on the lowest level of any input that is significant to the fair value
measurement. Valuation techniques used need to maximize the use of observable inputs and
minimize the use of unobservable inputs. The following table presents assets that were
measured and recognize at fair value on March 31, 2015 and December 31, 2014 and the year
then ended on a recurring basis:
When the Company changes its valuation inputs for measuring financial
assets and liabilities at fair value, either due to changes in current
market conditions or other factors, it may need to transfer those assets or
liabilities to another level in the hierarchy based on the new inputs used.
The Company recognizes these transfers at the end of the reporting period
that the transfers occur. For the fiscal periods ended March 31, 2015 and
December 31, 2014, there were no significant transfers of financial assets
or financial liabilities between the hierarchy levels.
Earnings per Common Share:
We compute net income
(loss) per share in accordance with ASC 260, Earning per Share. ASC 260
requires presentation of both basic and diluted earnings per share (EPS) on
the face of the income statement. Basic EPS is computed by dividing net
income (loss) available to common shareholders (numerator) by the weighted
average number of shares outstanding (denominator) during the period.
Diluted EPS gives effect to all dilutive potential common shares outstanding
during the period using the treasury stock method and convertible preferred
stock using the if-converted method. In computing Diluted EPS, the average
stock price for the period is used in determining the number of shares
assumed to be purchased from the exercise of stock options or warrants.
Diluted EPS excludes all dilutive potential shares if their effect is
anti-dilutive. All per share disclosures retroactively reflect shares
outstanding or issuable as though the reverse split had occurred January 1,
2010.
Income Taxes:
We have adopted ASC 740, Accounting for
Income Taxes. Pursuant to ASC 740, we are required to compute tax asset
benefits for net operating losses carried forward. The potential benefits of
net operating losses have not been recognized in these financial statements
because the Company cannot be assured it is more likely than not it will
utilize the net operating losses carried forward in future years.
We must make certain estimates and judgments in determining income tax
expense for financial statement purposes. These estimates and judgments
occur in the calculation of certain tax assets and liabilities, which arise
from differences in the timing of recognition of revenue and expense for tax
and financial statement purposes.
Deferred tax assets and liabilities are determined based on the
differences between financial reporting and the tax basis of assets and
liabilities using the tax rates and laws in effect when the differences are
expected to reverse. ASC 740 provides for the recognition of deferred tax
assets if realization of such assets is more likely than not to occur.
Realization of our net deferred tax assets is dependent upon our generating
sufficient taxable income in future years in appropriate tax jurisdictions
to realize benefit from the reversal of temporary differences and from net
operating loss, or NOL, carryforwards. We have determined it more likely
than not that these timing differences will not materialize and have
provided a valuation allowance against substantially all of our net deferred
tax asset.
Management will continue to evaluate the realizability of the deferred
tax asset and its related valuation allowance. If our assessment of the
deferred tax assets or the corresponding valuation allowance were to change,
we would record the related adjustment to income during the period in which
we make the determination. Our tax rate may also vary based on our results
and the mix of income or loss in domestic and foreign tax jurisdictions in
which we operate.
In addition, the calculation of our tax liabilities involves dealing with
uncertainties in the application of complex tax regulations. We recognize
liabilities for anticipated tax audit issues in the U.S. and other tax
jurisdictions based on our estimate of whether, and to the extent to which,
additional taxes will be due. If we ultimately determine that payment of
these amounts is unnecessary, we will reverse the liability and recognize a
tax benefit during the period in which we determine that the liability is no
longer necessary. We will record an additional charge in our provision for
taxes in the period in which we determine that the recorded tax liability is
less than we expect the ultimate assessment to be.
ASC 740 which requires recognition of estimated income taxes payable or
refundable on income tax returns for the current year and for the estimated
future tax effect attributable to temporary differences and carry-forwards.
Measurement of deferred income tax is based on enacted tax laws including
tax rates, with the measurement of deferred income tax assets being reduced
by available tax benefits not expected to be realized.
Uncertain Tax Positions:
When tax returns are filed,
it is highly certain that some positions taken would be sustained upon
examination by the taxing authorities, while others are subject to
uncertainty about the merits of the position taken or the amount of the
position that would be ultimately sustained. In accordance with the guidance
of FASB ASC 740-10, Accounting for Uncertain Income Tax Positions, the
benefit of a tax position is recognized in the financial statements in the
period during which, based on all available evidence, management believes it
is more likely than not that the position will be sustained upon
examination, including the resolution of appeals or litigation processes, if
any. Tax positions taken are not offset or aggregated with other positions.
Tax positions that meet the more-likely-than-not recognition threshold are
measured as the largest amount of tax benefit that is more than 50 percent
likely of being realized upon settlement with the applicable taxing
authority. The portion of the benefits associated with tax positions taken
that exceeds the amount measured as described above should be reflected as a
liability for unrecognized tax benefits in the accompanying consolidated
balance sheets along with any associated interest and penalties that would
be payable to the taxing authorities upon examination.
Our federal and state income tax returns are open for fiscal years ending
on or after December 31, 2010. We are not under examination by any
jurisdiction for any tax year. At March 31, 2015 we had no material
unrecognized tax benefits and no adjustments to liabilities or operations
were required under FASB ASC 740-10.
Recent Accounting Pronouncements
In August 2014, the FASB issued ASU 2014-15, Presentation of Financial
Statements - Going Concern . The new standard requires management of public
and private companies to evaluate whether there is substantial doubt about
the entity's ability to continue as a going concern and, if so, disclose
that fact. Management will also be required to evaluate and disclose whether
its plans alleviate that doubt. The standard requires management to
evaluate, for each reporting period, whether there are conditions or events
that raise substantial doubt about a company's ability to continue as a
going concern within one year from the date the financial statements are
issued. The new standard is effective for annual periods ending after
December 15, 2016, and interim periods within annual periods beginning after
December 15, 2016. Early adoption is permitted. We do not expect the
adoption of the ASU to have a significant impact on our consolidated
financial statements.
On November 2014, The Financial Accounting Standards Board (FASB) issued
Accounting Standard Update No. 2014-16 - Derivatives and Hedging (Topic
815): Determining Whether the Host Contract in a Hybrid Financial Instrument
Issued in the Form of a Share Is More Akin to Debt or to Equity (a consensus
of the FASB Emerging Issues Task Force). The amendments in this Update do
not change the current criteria in GAAP for determining when separation of
certain embedded derivative features in a hybrid financial instrument is
required. That is, an entity will continue to evaluate whether the economic
characteristics and risks of the embedded derivative feature are clearly and
closely related to those of the host contract, among other relevant
criteria. The amendments clarify how current GAAP should be interpreted in
evaluating the economic characteristics and risks of a host contract in a
hybrid financial instrument that is issued in the form of a share. The
effects of initially adopting the amendments in this Update should be
applied on a modified retrospective basis to existing hybrid financial
instruments issued in the form of a share as of the beginning of the fiscal
year for which the amendments are effective. Retrospective application is
permitted to all relevant prior periods.
On November 2014, The Financial Accounting Standards Board (FASB) issued
Accounting Standard Update No. 2014-17 - Business Combinations (Topic 805):
Pushdown Accounting (a consensus of the FASB Emerging Issues Task Force).
The amendments in this Update provide an acquired entity with an option to
apply pushdown accounting in its separate financial statements upon
occurrence of an event in which an acquirer obtains control of the acquired
entity. The amendments in this Update are effective on November 18, 2014.
After the effective date, an acquired entity can make an election to apply
the guidance to future change-in-control events or to its most recent
change-in-control event. However, if the financial statements for the period
in which the most recent change-in-control event occurred already have been
issued or made available to be issued, the application of this guidance
would be a change in accounting principle.
Management does not anticipate that the adoption of these standards will
have a material impact on the financial statements.
The Financial Statements presented herein have been prepared by us in
accordance with the accounting policies described in our December 31, 2014
Annual Report and should be read in conjunction with the Notes to Financial
Statements which appear in that report.
The preparation of these financial statements in conformity with
accounting principles generally accepted in the United States requires us to
make estimates and judgments that affect the reported amounts of assets,
liabilities, revenues and expenses, and related disclosure of contingent
assets and liabilities. On an on-going basis, we evaluate our estimates,
including those related intangible assets, income taxes, insurance
obligations and contingencies and litigation. We base our estimates on
historical experience and on various other assumptions that are believed to
be reasonable under the circumstances, the results of which form the basis
for making judgments about the carrying values of assets and liabilities
that are not readily apparent from other resources. Actual results may
differ from these estimates under different assumptions or conditions.
In the opinion of management, the information furnished in these interim
financial statements reflects all adjustments necessary for a fair statement
of the financial position and results of operations and cash flows as of and
for the three-month periods ended March 31, 2015 and 2014. All such
adjustments are of a normal recurring nature. The Financial Statements do
not include some information and notes necessary to conform to annual
reporting requirements.
2. Stockholders' Equity
Common Stock
Recent Issuances of Common Stock - for the Period Ended March 31, 2015:
Stock Issued for cash:
In February of 2015, we sold 800,000 shares
to one investor for the offering price of $0.05 per share that resulted in
total proceeds of $40,000. During 2015 we also received $50,000 through a
placement of common stock units. Those units were sold at $0.15 per unit.
Each unit consisted of one share of common stock and one warrant to purchase
common stock.
Historical Activity in 2014:
Stock Issued upon conversion of debt- On July 1, 2014 we issued 179,300
shares of our common stock in settlement of $1,500 in convertible note
payable plus associated accrued interest of $293. The conversion occurred
within the terms of the promissory note and no gain or loss resulted. On
February 28, 2014 we issued 13,084,000 shares of our common stock in
settlement of $114,414 in convertible note payable plus associated accrued
interest of $16,435. The conversion occurred within the terms of the
promissory note and no gain or loss resulted.
Stock Issued for Services:
During the interim period ended
September 30, 2014 we issued 300,000 shares of our common stock to an
unrelated party as payment for services. We also issued 400,000 shares to
two former officers and directors of the company as part of a severance
agreement. The shares were valued at the closing price as of the date of the
agreements ($0.25 and $0.28, respectively) and resulted in full recognition
of $187,000 in consulting services expense. During the interim periods
ended on or before June 30, 2014 we issued 9,208,600 shares of our common
stock to seven unrelated parties as payment for services. The shares were
valued at the closing price as of the date of the agreement ($0.05) and
resulted in full recognition of $481,430 in consulting services expense. In
June we cancelled 3,108,600 of these shares valued at $155,430 resulting in
$305,000 in consulting expense through September 30, 2014.
Options Issued for Services:
During the interim period ended
September 30, 2014 we issued 14,350,000 common stock options. 350,000 of
those options valued at $82,640 were granted to former related parties while
14,000,000 options valued at $3,774,496 were granted for services provided
by unrelated parties.
The fair value of the options was estimated at the date of grant using
the Black-Sholes-Merton pricing model. The Black-Sholes-Merton pricing model
assumptions used are as follows: expected dividend yield of 0%; risk-free
interest rate of 0.47% to 0.49%; expected volatility of 241%, and warrant
term of two years.
Stock Issued for cash:
In connection with a private placement of
10,000,000 shares of common stock in March and April of 2014 we sold
4,700,000 shares to six investors for the offering price of $0.005 per share
that resulted in total proceeds of $23,500. During 2014 we received
$1,164,300 through a placement of common stock units. Those units were sold
at $0.09 per unit. Each unit consisted of one share of common stock and one
warrant to purchase common stock. We issued 12,936,662 shares through
September 30th to 22 investors of this offering. The warrants are
exercisable at $0.16 and expire in June, 2015. During 2014 we received
$554,200 through a placement of common stock units. Those units were sold at
$0.15 per unit. Each unit consisted of one share of common stock and one
warrant to purchase common stock. We issued 3,694,666 shares through
September 30th to 4 investors of this offering. The warrants are exercisable
at $0.16 and expire in June, 2015.
Warrants
In February, 2015 we issued 64,935 warrants for services. The warrants
are exercisable at $0.25 and expire February 23, 2016. We used the
Black-Scholes-Merton pricing model and inputs described below to estimate
the fair value of $10,839. The Black-Sholes-Merton pricing model assumptions used are as follows:
expected dividend yield of 0%; risk-free interest rate of 0.10%-.0.11%;
expected volatility of 242%, and warrant term of one year.
3. Related Party Transactions Not Disclosed Elsewhere
Due Related Parties: Amounts due related parties consist of corporate
reinstatement and regulatory compliance expenses paid directly by a director
of the company and unpaid compensation. Such items totaled $28,436 at
September 30, 2014 and December 31, 2013, respectively. The advances are not
formalized by a written agreement and do not carry a specific date of
payment and are non-interest bearing.
4. Notes Payable
Unsecured Notes Payable With No Conversion Rights
During 2014 the Company signed a series of three new unsecured promissory
notes with unrelated parties for an aggregate of $14,500. The notes bear
interest at 1% per annum and are due one year from the date of issuance. The
notes were paid in full in 2014.
Unsecured Notes Payable With Conversion Rights
In February 28, 2014 eleven holders of convertible notes with an
aggregate principal balance of $114,414 and accrued interest of $16,435
converted their notes and accrued interest into 13,084,000 shares of common
stock. Upon conversion, $34,034 of unamortized discount arising from the
previously recorded beneficial conversion feature was recognized as
additional interest expense. The conversion occurred within the terms of the
promissory note and no gain or loss resulted.
5. Future Commitment and Issuance of Warrants
On March 5, 2013, the Company and GUMI Tel Aviv Ltd, a major,
privately-held Israeli technology company ("GUMI"), entered into
development/manufacturing/marketing agreement ("GUMI Agreement"). GUMI is
engaged in the manufacture, import/export, marketing and install industrial
equipment and designing technical solutions.
Pursuant to the GUMI Agreement, GUMI agreed to: (i) complete the
development of the Prototype of the Patented Device; (ii) manufacture the
commercial model(s) of the Patented device; and (iii) market the commercial
model(s) of the Patented Device.
In consideration for developing the Prototype and manufacturing and
marketing/distributing commercial models of the Patented Device as well as
incurring all related costs and expenses in connection therewith, the
Company shall compensate GUMI as follows: (i) upon the execution of the GUMI
Agreement, the Company granted GUMI warrants (the "Warrants") exercisable to
purchase 200,000 shares of the Company's common stock ("Warrant Shares") at
an exercise price of USD$0.05 per share (the "Exercise Price"); (ii) upon
completion of the Prototype, granting GUMI additional Warrants to purchase
200,000 additional Warrant Shares at the Exercise Price; and (iii) upon
completion of a Commercial Device ready for manufacture and sale, granting
GUMI additional Warrants to purchase 200,000 additional Warrant Shares at
the Exercise Price. The Warrants shall expire 3 years from the date of each
grant and shall be subject to adjustment in the event of any
recapitalization of the Company's capital stock.
In addition to the consideration represented by the grant of Warrants,
the Agreement further provides that following commencement of sale of the
Commercial Device and until such time that GUMI has recouped all costs and
expenses that it has incurred and paid in connection with the completion of
development of the Prototype and the manufacture of the Commercial Device
("Date of Recoupment"), one hundred (100%) percent of the net sales revenues
shall be paid and distributed to GUMI. On and after the Date of Recoupment,
net sales revenues shall be paid sixty-five (65%) percent to GUMI and
thirty-five (35%) percent to the Company.
The Company recorded $107,074 in fiscal year 2013 in expenses related to
600,000 vested warrants previously granted to GUMI Tel Aviv Ltd. The
warrants were valued using the Black-Scholes option pricing model. The
inputs for the valuation analysis of the warrants include the market value
of the Company's common stock were as follows: the estimated volatility of
the Company's common stock used in the Black-Scholes option pricing model
was 318%, the exercise price and the risk free interest rate used were $0.05
and 0.36%, respectively. All warrants are fully vested.
6. Going Concern
The accompanying financial statements have been prepared in conformity
with accounting principles generally accepted in the United States of
America, which contemplate continuation of the Company as a going concern.
The Company has not established any source of revenue to cover its operating
costs, and as such, has incurred an operating loss since inception. Further,
as of March 31, 2015, the cash resources of the Company were insufficient to
meet its current business plan. These and other factors raise substantial
doubt about the Company's ability to continue as a going concern. The
accompanying financial statements do not include any adjustments to reflect
the possible future effects on the recoverability and classification of
asset or the amounts and classification of liabilities that may result from
the possible inability of the Company to continue as a going concern.
7. Subsequent Events
There were no subsequent events following the period ended March 31, 2015
and throughout the date of the filing of Form 10-Q.
Page 44
REPORT OF INDEPENDENT
REGISTERED PUBLIC ACCOUNTING FIRM
Petach Tikva, Israel
We have audited the accompanying consolidated balance sheets of OWC Pharmaceutical
Research Corp. (the
"Company") as of December 31, 2014 and 2013 and the related
consolidated statements of
operations, consolidated statements of comprehensive loss, consolidated
statement of changes in stockholders equity (deficit) and consolidated
statements of cash flows for the years then ended. 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 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 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 includes examining,
on a test basis, evidence supporting the amounts and disclosures in the financial
statements. An audit also includes 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, the financial statements referred to above present fairly, in all
material respects, the financial position of OWC Pharmaceutical Research Corp. as of December 31,
2014 and 2013 and the results of its operations and cash flows for the periods described above 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. As discussed in Note 6 to the financial statements, the
Company suffered a net loss from operations and has no source of revenue, which raises
substantial doubt about its ability to continue as a going concern. Managements
plans regarding those matters are also described in Note 6. The financial statements do
not include any adjustments that might result from the outcome of this uncertainty.
/s/ M&K CPAS, PLLC
www.mkacpas.com
Houston, Texas
Page 45
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Cash
flows from operating activities:
Page 50
OWC Pharmaceutical Research Corp.
Note 1. The Company and Significant Accounting Policies
Organizational Background:
OWC Pharmaceutical
Research Corp. ("OWCP" or the "Company") was incorporated in Delaware, on
March 7, 2008, under the name Dynamic applications Corp.
We are engaged in three distinct business sectors and we may require additional capital to implement our business plan and fund our operations. Our
three distinct business operations are:
(i) continuing to work with GUMI to commercialize and market the Company's Electromagnetic Percussion Device (the "Device"); and
Basis of Presentation:
The accompanying financial
statements have been prepared in conformity with accounting principles
generally accepted in the United States of America, which contemplate
continuation of the Company as a going concern. The Company has not
established any source of revenue to cover its operating costs, and as such,
has incurred an operating loss since inception. These and other factors
raise substantial doubt about the Company's ability to continue as a going
concern. The accompanying 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 possible inability of the Company to continue as a
going concern.
Development Stage
On June 10, 2014, the FASB issued
Accounting Standards Update ("ASU") No. 2014-10, which eliminates
development stage reporting requirements under FASB ASC 915, as well as
amends provisions of existing variable interest entity guidance under ASC
810. Additionally, the ASU indicates that the lack of commencement of
principal operations represents a risk and uncertainty and, accordingly, is
subject to the disclosure requirements of FASB ASC 275. As a result of the
changes, existing development stage entity presentation and disclosure
requirements are eliminated. The presentation and disclosure changes to FASB
ASC 915 are effective for public entities for annual periods beginning after
December 15, 2014, and the revisions to the consolidation standards are
effective for annual periods beginning after December 15, 2015. The Company
has adopted these provisions and enhanced disclosure of risks and
uncertainties as required.
Principles of Consolidation:
The 2014
financial statements include the accounts of OWC Pharmaceutical Research
Corp. and its wholly owned subsidiary One World Cannabis Ltd. All
significant inter-company balances and transactions have been eliminated.
Significant Accounting Policies
Use of Estimates:
The preparation of
financial statements in conformity with generally accepted accounting
principles requires management to make estimates and assumptions that affect
reported amounts of assets and liabilities and disclosure of contingent
assets and liabilities at the date of the financial statement and the
reported amounts of revenues and expenses during the reporting period.
Actual results could differ from the estimates.
Cash and Cash
Equivalents:
For financial statement presentation purposes, the Company
considers those short-term, highly liquid investments with original
maturities of three months or less to be cash or cash equivalents. There
were no cash equivalents at December 31, 2014 or December 31, 2013.
Property and Equipment:
New property and equipment are recorded at cost.
Property and equipment included in the bankruptcy proceedings and
transferred to the Trustee had been valued at liquidation value.
Depreciation is computed using the straight-line method over the estimated
useful lives of the assets, generally 5 years. Expenditures for renewals and
betterments are capitalized. Expenditures for minor items, repairs and
maintenance are charged to operations as incurred. Gain or loss upon sale or
retirement due to obsolescence is reflected in the operating results in the
period the event takes place.
Valuation of Long-Lived Assets:
We
review the recoverability of our long-lived assets including equipment,
goodwill and other intangible assets, when events or changes in
circumstances occur that indicate that the carrying value of the asset may
not be recoverable. The assessment of possible impairment is based on our
ability to recover the carrying value of the asset from the expected future
pre-tax cash flows (undiscounted and without interest charges) of the
related operations. If these cash flows are less than the carrying value of
such asset, an impairment loss is recognized for the difference between
estimated fair value and carrying value. Our primary measure of fair value
is based on discounted cash flows. The measurement of impairment requires
management to make estimates of these cash flows related to long-lived
assets, as well as other fair value determinations.
Foreign Currency:
Non-U.S. entity operations are recorded in the functional currency of each
entity. Results of operations for non-U.S. dollar functional currency
entities are translated into U.S. dollars using average currency rates.
Assets and liabilities are translated using currency rates at period end.
Foreign currency translation adjustments are recorded as a component of
other comprehensive income (loss) within stockholders' equity.
Stock
Based Compensation:
Stock-based awards are accounted for using the fair
value method in accordance with ASC 718, Share-Based Payments. Our primary
type of share-based compensation consists of stock options. We use the
Black-Scholes option pricing model in valuing options. The inputs for the
valuation analysis of the options include the market value of the Company's
common stock, the estimated volatility of the Company's common stock, the
exercise price of the warrants and the risk free interest rate.
Accounting For Obligations And Instruments Potentially To Be Settled In The
Company's Own Stock:
We account for obligations and instruments potentially
to be settled in the Company's stock in accordance with FASB ASC 815,
Accounting for Derivative Financial Instruments. This issue addresses the
initial balance sheet classification and measurement of contracts that are
indexed to, and potentially settled in, the Company's own stock.
Fair
Value of Financial Instruments:
FASB ASC 825, "Financial Instruments,"
requires entities to disclose the fair value of financial instruments, both
assets and liabilities recognized and not recognized on the balance sheet,
for which it is practicable to estimate fair value. FASB ASC 825 defines
fair value of a financial instrument as the amount at which the instrument
could be exchanged in a current transaction between willing parties. At
December 31, 2014 and December 31, 2013, the carrying value of certain
financial instruments (cash and cash equivalents, accounts payable and
accrued expenses.) approximates fair value due to the short-term nature of
the instruments or interest rates, which are comparable with current rates.
Fair Value Measurements:
The Company measures fair value under a
framework that utilizes a fair value hierarchy that prioritizes the inputs
to valuation techniques used to measure fair value. The hierarchy gives the
highest priority to unadjusted quoted prices in active markets for identical
assets or liabilities (level 1 measurements) and the lowest priority to
unobservable inputs (level 3 measurements). The three levels of inputs which
prioritize the inputs used in measuring fair value are:
Level 1:
Inputs to the valuation methodology are unadjusted quoted prices for
identical assets or liabilities in active markets that the Company has the
ability to access.
Level 2: Inputs to the valuation methodology
include:
Level 3: Inputs to the valuation
methodology are unobservable and significant to the fair value measurement.
The assets or liability's fair value measurement level within the fair
value hierarchy is based on the lowest level of any input that is
significant to the fair value measurement. Valuation techniques used need to
maximize the use of observable inputs and minimize the use of unobservable
inputs. The following table presents assets that were measured and recognize
at fair value on December 31, 2014 and December 31, 2013 and the year then
ended on a recurring basis:
When the Company changes its valuation inputs for measuring financial assets and
liabilities at fair value, either due to changes in current market
conditions or other factors, it may need to transfer those assets or
liabilities to another level in the hierarchy based on the new inputs used.
The Company recognizes these transfers at the end of the reporting period
that the transfers occur. For the fiscal periods ended December 31, 2014 and
December 31, 2013, there were no significant transfers of financial assets
or financial liabilities between the hierarchy levels.
Earnings per
Common Share:
We compute net income (loss) per share in accordance with ASC
260, Earning per Share. ASC 260 requires presentation of both basic and
diluted earnings per share (EPS) on the face of the income statement. Basic
EPS is computed by dividing net income (loss) available to common
shareholders (numerator) by the weighted average number of shares
outstanding (denominator) during the period. Diluted EPS gives effect to all
dilutive potential common shares outstanding during the period using the
treasury stock method and convertible preferred stock using the if-converted
method. In computing Diluted EPS, the average stock price for the period is
used in determining the number of shares assumed to be purchased from the
exercise of stock options or warrants. Diluted EPS excludes all dilutive
potential shares if their effect is anti-dilutive.
Income Taxes:
We have
adopted ASC 740, Accounting for Income Taxes. Pursuant to ASC 740, we are
required to compute tax asset benefits for net operating losses carried
forward. The potential benefits of net operating losses have not been
recognized in these financial statements because the Company cannot be
assured it is more likely than not it will utilize the net operating losses
carried forward in future years.
We must make certain estimates and
judgments in determining income tax expense for financial statement
purposes. These estimates and judgments occur in the calculation of certain
tax assets and liabilities, which arise from differences in the timing of
recognition of revenue and expense for tax and financial statement purposes.
Deferred tax assets and liabilities are determined based on the
differences between financial reporting and the tax basis of assets and
liabilities using the tax rates and laws in effect when the differences are
expected to reverse. ASC 740 provides for the recognition of deferred tax
assets if realization of such assets is more likely than not to occur.
Realization of our net deferred tax assets is dependent upon our generating
sufficient taxable income in future years in appropriate tax jurisdictions
to realize benefit from the reversal of temporary differences and from net
operating loss, or NOL, carryforwards. We have determined it more likely
than not that these timing differences will not materialize and have
provided a valuation allowance against substantially all of our net deferred
tax asset.
Management will continue to evaluate the realizability of the
deferred tax asset and its related valuation allowance. If our assessment of
the deferred tax assets or the corresponding valuation allowance were to
change, we would record the related adjustment to income during the period
in which we make the determination. Our tax rate may also vary based on our
results and the mix of income or loss in domestic and foreign tax
jurisdictions in which we operate.
In addition, the calculation of our
tax liabilities involves dealing with uncertainties in the application of
complex tax regulations. We recognize liabilities for anticipated tax audit
issues in the U.S. and other tax jurisdictions based on our estimate of
whether, and to the extent to which, additional taxes will be due. If we
ultimately determine that payment of these amounts is unnecessary, we will
reverse the liability and recognize a tax benefit during the period in which
we determine that the liability is no longer necessary. We will record an
additional charge in our provision for taxes in the period in which we
determine that the recorded tax liability is less than we expect the
ultimate assessment to be.
ASC 740 which requires recognition of
estimated income taxes payable or refundable on income tax returns for the
current year and for the estimated future tax effect attributable to
temporary differences and carry-forwards. Measurement of deferred income tax
is based on enacted tax laws including tax rates, with the measurement of
deferred income tax assets being reduced by available tax benefits not
expected to be realized.
Uncertain Tax Positions:
When tax returns are
filed, it is highly certain that some positions taken would be sustained
upon examination by the taxing authorities, while others are subject to
uncertainty about the merits of the position taken or the amount of the
position that would be ultimately sustained. In accordance with the guidance
of FASB ASC 740-10, Accounting for Uncertain Income Tax Positions, the
benefit of a tax position is recognized in the financial statements in the
period during which, based on all available evidence, management believes it
is more likely than not that the position will be sustained upon
examination, including the resolution of appeals or litigation processes, if
any. Tax positions taken are not offset or aggregated with other positions.
Tax positions that meet the more-likely-than-not recognition threshold are
measured as the largest amount of tax benefit that is more than 50 percent
likely of being realized upon settlement with the applicable taxing
authority. The portion of the benefits associated with tax positions taken
that exceeds the amount measured as described above should be reflected as a
liability for unrecognized tax benefits in the accompanying consolidated
balance sheets along with any associated interest and penalties that would
be payable to the taxing authorities upon examination.
Our federal
and state income tax returns are open for fiscal years ending on or after
December 31, 2011. We are not under examination by any jurisdiction for any
tax year. At December 31, 2014 we had no material unrecognized tax benefits
and no adjustments to liabilities or operations were required under FASB ASC
740-10.
Recent Accounting Pronouncements
On June 10, 2014, the
FASB issued Accounting Standards Update ("ASU") No. 2014-10 , which
eliminates development stage reporting requirements under FASB ASC 915, as
well as amends provisions of existing variable interest entity guidance
under ASC 810. Additionally, the ASU indicates that the lack of commencement
of principal operations represents a risk and uncertainty and, accordingly,
is subject to the disclosure requirements of FASB ASC 275. As a result of
the changes, existing development stage entity presentation and disclosure
requirements are eliminated. The presentation and disclosure changes to FASB
ASC 915 are effective for public entities for annual periods beginning after
December 15, 2014, and the revisions to the consolidation standards are
effective for annual periods beginning after December 15, 2015. The Company
has adopted these provisions and enhanced disclosure of risks and
uncertainties as required.
In April 2014, the FASB issued ASU
2014-08,
Presentation of Financial Statements (Topic 205) and Property,
Plant, and Equipment (Topic 360): Reporting Discontinued Operations and
Disclosures of Disposals of Components of an Entity.
The amendments in this
ASU change the criteria for reporting discontinued operations while
enhancing disclosures in this area. Under the new guidance, only disposals
representing a strategic shift in operations should be presented as
discontinued operations. Those strategic shifts should have a major effect
on the organization's operations and financial results and include disposals
of a major geographic area, a major line of business, or a major equity
method investment. The new guidance requires expanded disclosures about
discontinued operations that will provide financial statement users with
more information about the assets, liabilities, income, and expenses of
discontinued operations. Additionally, the new guidance requires disclosure
of the pre-tax income attributable to a disposal of a significant part of an
organization that does not qualify for discontinued operations reporting.
The amendments in the ASU are effective for public business entities for
annual periods, and interim periods within those annual periods, beginning
after December 15, 2014. Early adoption is permitted. The Company is
currently evaluating the impact of this pronouncement.
In August
2014, the FASB issued ASU 2014-15,
Presentation of Financial Statements -
Going Concern
. The new standard requires management of public and private
companies to evaluate whether there is substantial doubt about the entity's
ability to continue as a going concern and, if so, disclose that fact.
Management will also be required to evaluate and disclose whether its plans
alleviate that doubt. The standard requires management to evaluate, for each
reporting period, whether there are conditions or events that raise
substantial doubt about a company's ability to continue as a going concern
within one year from the date the financial statements are issued. The new
standard is effective for annual periods ending after December 15, 2016, and
interim periods within annual periods beginning after December 15, 2016.
Early adoption is permitted. We do not expect the adoption of the ASU to
have a significant impact on our consolidated financial statements.
Management does not anticipate that the adoption of these standards will
have a material impact on the financial statements.
Note 2. Stockholders'
Equity
Transactions in our Common Stock
Stock Issued upon
conversion of debt:
On February
28, 2014 we issued 13,084,000 shares of our common stock in settlement of
$114,414 in convertible note payable plus associated accrued interest of
$16,435. The conversion occurred within the terms of the promissory note and
no gain or loss resulted.
On July 1, 2014 we issued 179,300 shares of our common stock in settlement
of $1,500 in convertible note payable plus associated accrued interest of
$293. The conversion occurred within the terms of the promissory note and no
gain or loss resulted.
On June 19, 2013 we issued 5,162,000 shares of our common stock in
settlement of $40,000 due to a former related party plus associated accrued
interest of $11,620. The conversion occurred within the terms of the
promissory note and no gain or loss resulted.
Stock Issued for services:
During the year ended December 31, 2014 we
issued 595,416 shares of our common stock to two unrelated parties (400,000
shares) and to the Company's CFO (195,416 shares) as payment for services.
We also issued 400,000 shares to two former officers and directors of the
company as part of a severance agreement. The shares were valued at the
closing price as of the date of the agreements (ranging from $0.25 to $0.28)
and resulted in full recognition of $155,716 and $112,000, respectively, in
consulting services expense. We also issued 6,000,000 shares of our common
stock to six unrelated parties as payment for services. The shares were
valued at the closing price as of the date of the agreement ($0.05) and
resulted in full recognition of $300,000 in consulting services expense.
On June 3, 2013 we issued 100,000 shares of our common stock as payment for
services. The share were valued at the closing price as of the date of the
agreement and resulted in recognition of $28,000 in consulting services
expense for the year ended December 31, 2013.
Stock Issued for cash:
We raised
capital through four different private placements of common stock in 2014.
- We sold 4,700,000 shares to six investors for the offering price
of $0.005 per share that resulted in total proceeds of $23,500.
- We
sold 13,034,585 shares through a placement of common stock. Those shares
were sold to nine investors for the offering price of $0.05 per share
resulting in proceeds of $651,730. As of December 31, 2014,the proceeds of
this offering are carried as subscriptions receivable.
- We sold 12,936,662 common
shares through a placement of common stock units. Those units were sold to
twenty-two investors for the offering price of $0.09 per share resulting in
proceeds of $1,164,300. Each unit consisted of one share of common stock and
one warrant to purchase common stock. The warrants are exercisable at $0.16
and expire one year from the date of issuance. The relative fair value of
the common stock component and warrants (based on the Black-Scholes option
pricing model) was estimated $340,758 and $823,542, respectively. The
Black-Sholes-Merton pricing model assumptions used are as follows: expected
dividend yield of 0%; risk-free interest rate of 0.10% - 0.11%; expected
volatility of 249%, and warrant term of one year.
- We sold 5,857,828
common shares through a placement of common stock units. Those units were
sold to fifteen investors for the offering price of $0.15 per share
resulting in proceeds of $878,676. Each unit consisted of one share of
common stock and one warrant to purchase common stock. The warrants are
exercisable at $0.25 and expire one year from the date of issuance. The
relative fair value of the common stock component and warrants (based on the
Black-Scholes option pricing model) was estimated to be $373,706 and
$504,970, respectively. The Black-Sholes-Merton pricing model assumptions
used are as follows: expected dividend yield of 0%; risk-free interest rate
of 0.10%-.0.11%; expected volatility of 249%, and warrant term of one year.
A summary of the offerings is as follows:
Warrants
Warrants Issued for services:
During the year ended December 31,
2014 we issued 14,350,000 common stock warrants. 350,000 of those warrants
valued at $82,640 were granted to former related parties while 14,000,000
warrants valued at $3,774,496 were granted for services provided by
unrelated parties. The fair value of the warrants was estimated at the date
of grant using the Black-Sholes-Merton pricing model. The
Black-Sholes-Merton pricing model assumptions used are as follows: expected
dividend yield of 0%; risk-free interest rate of 0.47% to 0.49%; expected
volatility of 241%, and warrant term of two years. In conjunction with the
2014 unit offerings the Company issued a total of 18,794,490 warrants to
purchase up to 18,794,490 shares of common stock at $0.16 - $0.25 per share.
In 2013, the Company recorded $107,074 in
expenses related to 600,000 vested warrants previously granted to GUMI Tel
Aviv Ltd. The warrants were valued using the Black-Scholes option pricing
model. The inputs for the valuation analysis of the warrants include the
market value of the Company's common stock were as follows: the estimated
volatility of the Company's common stock used in the Black-Scholes option
pricing model was 318%, the exercise price and the risk free interest rate
used were $0.05 and 0.36%, respectively. All warrants were fully vested at
December 31, 2013.
In 2013, we issued one promissory note for $20,000
that was accompanied by 550,000 detachable warrants (the L&L warrants). The
warrants were valued using the Black-Scholes option pricing model. The
inputs for the valuation analysis of the warrants include the market value
of the Company's common stock on the date of grant, the estimated volatility
of the Company's common stock (194%), the exercise price of $0.00001 and the
risk free interest rate of .11%. On May 9, 2013 all 550,000 L&L warrants
were exercised for total cash proceed of $55.
Note 3. Related Party Transactions not Disclosed Elsewhere.
Due Related Parties:
Amounts due related parties consist of
corporate reinstatement and regulatory compliance expenses paid directly by
a director of the company and unpaid compensation. Such items totaled
$28,436 at December 31, 2013. In 2014 these advance were forgiven and
resulted in a $28,436 addition to paid-in capital.
Note 4. Notes Payable.
Unsecured Notes Payable with no Conversion Rights
During 2014 the Company
signed a series of three new unsecured promissory notes with unrelated
parties for an aggregate of $14,500. The notes bear interest at 1% per annum
and are due one year from the date of issuance. The notes were paid in full
in 2014.
Unsecured Notes Payable with Conversion Rights
On February 28, 2014 eleven holders of convertible notes with an
aggregate principal balance of $114,414 and accrued interest of $16,435
converted their notes and accrued interest into 13,084,000 shares of common
stock. Upon conversion, $20,495 of unamortized discount arising from the
previously recorded beneficial conversion feature was recognized as
additional interest expense. The conversion occurred within the terms of the
promissory note and no gain or loss resulted.
For the year ended December 31, 2014 the Company has
recognized $2,923 in accrued interest expense related to all notes and has
amortized $34,034 of the beneficial conversion feature. In addition to which
has also been recorded as interest expense. As of December 31, 2014 all
notes and related accrued interest have been paid through the issuance of
13,263,300 shares of common stock.
During 2013 the Company signed a
series of thirteen new unsecured promissory notes with unrelated parties for
an aggregate of $86,114. The notes bear interest at 12%-15% per annum and
are due approximately one year from the date of issuance. The maturity dates
range from February 6, 2014 to December 6, 2014 with all amounts recorded as
current liabilities. The notes have conversion rights that allow the holder
of the note to convert the principal balance into the Company's common stock
at the lender's sole discretion at $0.01 per share. One note for $20,000 was
accompanied by 550,000 detachable warrants (the L&L warrants). The warrants
were valued using the Black-Scholes option pricing model. The inputs for the
valuation analysis of the warrants include the market value of the Company's
common stock on the date of grant, the estimated volatility of the Company's
common stock (194%), the exercise price of $0.00001 and the risk free
interest rate of 0.11%.
In accordance with ASC 470, the Company has
analyzed the beneficial nature of the conversion terms and determined that a
beneficial conversion feature (BCF) exists. The Company calculated the value
of the BCF using the intrinsic method as stipulated in ASC 470. The BCF has
been recorded as a discount to the notes payable and to Additional Paid-in
Capital. As of December 31, 2013, the aggregate balance of convertible notes
payable was $81,880 net of unamortized discounts of $34,034.
Note 5. Future Commitment and Issuance of Warrants.
During 2014, the Company signed advisory services agreements with officers of its
subsidiary pursuant to which the officers are entitled to 51,785,417 options
to be granted if and when our subsidiary achieves 3 milestones. As of March
31, 2015, none of the milestones has been achieved and therefore no options
have vested.
On March 5, 2013, the Company and
GUMI Tel Aviv Ltd, a major, privately-held Israeli technology company
("GUMI"), entered into development/manufacturing/marketing agreement ("GUMI
Agreement"). GUMI is engaged in the manufacture, import/export, marketing
and install industrial equipment and designing technical solutions.
Pursuant to the GUMI Agreement, GUMI agreed to: (i) complete the development
of the Prototype of the Patented Device; (ii) manufacture the commercial
model(s) of the Patented device; and (iii) market the commercial model(s) of
the Patented Device.
In consideration for developing the Prototype and
manufacturing and marketing/distributing commercial models of the Patented
Device as well as incurring all related costs and expenses in connection
therewith, the Company shall compensate GUMI as follows: (i) upon the
execution of the GUMI Agreement, the Company granted GUMI warrants (the
"Warrants") exercisable to purchase 200,000 shares of the Company's common
stock ("Warrant Shares") at an exercise price of USD$0.05 per share (the
"Exercise Price"); (ii) upon completion of the Prototype, granting GUMI
additional Warrants to purchase 200,000 additional Warrant Shares at the
Exercise Price; and (iii) upon completion of a Commercial Device ready for
manufacture and sale, granting GUMI additional Warrants to purchase 200,000
additional Warrant Shares at the Exercise Price. The Warrants shall expire 3
years from the date of each grant and shall be subject to adjustment in the
event of any recapitalization of the Company's capital stock.
In addition
to the consideration represented by the grant of Warrants, the Agreement
further provides that following commencement of sale of the Commercial
Device and until such time that GUMI has recouped all costs and expenses
that it has incurred and paid in connection with the completion of
development of the Prototype and the manufacture of the Commercial Device
("Date of Recoupment"), one hundred (100%) percent of the net sales revenues
shall be paid and distributed to GUMI. On and after the Date of Recoupment,
net sales revenues shall be paid sixty-five (65%) percent to GUMI and
thirty-five (35%) percent to the Company.
Note 6. Going Concern.
The accompanying financial
statements have been prepared in conformity with accounting principles
generally accepted in the United States of America, which contemplate
continuation of the Company as a going concern. The Company has not
established any source of revenue to cover its operating costs, and as such,
has incurred an operating loss since inception. Further, as of December 31,
2014, the cash resources of the Company were insufficient to meet its
current business plan. These and other factors raise substantial doubt about
the Company's ability to continue as a going concern. The accompanying
financial statements do not include any adjustments to reflect the possible
future effects on the recoverability and classification of asset or the
amounts and classification of liabilities that may result from the possible
inability of the Company to continue as a going concern.
Page 56
MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND PLAN OF OPERATIONS
The following plan of operation provides information which management believes is relevant to an assessment and understanding of our results of operations and financial condition. The discussion should be read along with our financial statements and notes thereto. This section includes a number of forward-looking statements that reflect our current views with respect to future events and financial performance. Forward-looking statements are often identified by words like believe, expect, estimate, anticipate, intend, project and similar expressions, or words which, by their nature, refer to future events. You should not place undue certainty on these forward-looking statements. These forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially from our predictions.
Plan of Operations
We are engaged in three distinct business sectors and we may require
additional capital to implement our business plan and fund our operations.
We have not yet commenced any significant activities related to our
consulting services.
In 2008, we acquired the patent for our Device and from 2008 until 2011, we
devoted our limited resources and efforts to the development of our Device.
During late 2011 and into 2012, we renewed our interest in pursuing development
of our Device and, subsequent to our year ended December 31, 2012, we entered
into an agreement with GUMI to develop a Device prototype, which was
successfully completed. GUMI has completed the manufacture of several commercial
models of the Device that GUMI is presently devoting resources to market under
the terms of our agreement. We continue to be dependent upon the ability of GUMI
to successfully market our Device, which process has started. However, we have
not yet derived any revenues from GUMI's on-going marketing efforts, which
commenced in late 2013 and are continuing in 2015.
We will utilize the capital we recently raised to fund OWC's business
including the assembly of a professional team of highly-qualified medical and
scientific experts together with experienced management and marketing executives
to develop OWC's business.
Our goal is to become a leader in the research and development of
cannabis-based medical drugs and treatments. To achieve our goal, we plan to
focus our activities on the following areas:
Research and Development
Our research and development is focused primarily on exploring several
formulations containing active compounds from the cannabis plant, including (but
not exclusive to) the cannabinoids CBD and THC, and identifying potential
therapeutic applications of the synergistic effects of these active compounds.
The synergistic contributions of our formulations have not yet been
scientifically researched and demonstrated. We aim to standardize the
formulations across the extracts as a whole, not simply by reference to their
key active components (CBD and/or THC).
Although there are existing reports and studies on CBD and THC, our
formulations will contain several active compounds from the cannabis plant, that
must be fully researched and documented in order to verify its effectiveness to
indications, at what doses and which method of administration will be the most
appropriate and effective.
One World Cannabis plans to produce pharmaceutical-grade cannabinoid-based
products and treatments, that will be standardized in composition, formulation
and dose, administered by means of an appropriate and efficient delivery system,
and tested in properly controlled pre-clinical and clinical studies. OWC plans
to conduct its researches, led by internationally renowned investigators, at the
facilities of leading Israeli hospitals and scientific institutions. The Company
will adhere to legislation, rules and guidelines regarding the investigations.
Dr. Baruch, OWC's Director of Research and Regulatory Affairs, and Alon Sinai,
OWC's Chief Operating Officer, will monitor the investigations and researches.
To date, OWC has signed three research collaboration and license agreements
with Sheba Academic Medical Center, Tel Hashomer, Israel ("Sheba"). Sheba is a
university-affiliated hospital that serves as Israel's national medical center
and the most comprehensive medical center in the Middle East. Within the
framework of the agreements with Sheba, OWC will initiate three studies at the
Sheba facilities to explore the effect of three formulations, all based on
active ingredients in the cannabis extracts, on multiple myeloma, psoriasis and
fibromyalgia (a specific formulation to each indication).
Page 57
At present, OWC is negotiating with two other Israeli leading medical centers
for the collaboration in the research of migraine and PTSD (post-traumatic
stress disorder). The Company expects these agreements to be finalized during
the fourth quarter of 2015. Of course, there can be no assurance that we be able
to successfully negotiate these agreements before the end of 2015, if at all.
In addition, OWC signed an R&D service agreement with G.C. Group Ltd. - an
Israeli pharmaceutical R&D company, to provide formulation development services
for OWC's new delivery system in the form of a cannabis soluble tablet. The
cannabis soluble tablet could provide physicians with the ability to control
and administrate optimal dosage, to replace the most common usage/delivery
method of medical cannabis today, which is not acceptable by scientists and
physicians, such as smoking, edibles and oil extracts with no adequate means of
dosage control.
The Company expects to start developing other delivery system, designed for
different indications, during the fourth quarter of 2015.
The Company has recently signed a Memorandum of Understanding (MoU) with
Emilia Cosmetics Ltd. - a large Israeli private label manufacturer, for the
developing, manufacturing and marketing of a cannabinoid-based topical cream to
treat psoriasis. The Company will initiate the research and development of the
topical cream by the end of the third quarter of 2015, at Emilia Cosmetics labs
located in Yerucham, Israel. After the completion of the formulation
development, during the fourth quarter of 2015, the Company will initiate a
phase I study at the Sheba facilities to explore the effect of topical cream on
psoriasis. However, we do not know if our expectations will be fulfilled in a
timely manner, if at all, or that the costs of development will exceed our
anticipation.
To date, One World Cannabis has filed eight provisional patents with the
United States Patent and Regulatory Office (USPTO), all related to its line of
activity related to cannabis-based medical products. Assuming the successful
completion of the clinical trials, of which there can be no assurance, the
Company believes that it will be able to retain the intellectual rights and
secure patent protections.
While we retain full ownership on our intellectual property rights that we
conceived prior to the signing of the research collaboration and license
agreements with Sheba Academic Medical Center, the psoriasis and fibromyalgia
agreements with Sheba provide that all intellectual property rights that is
conceived during the course of the research is to be jointly owned by Sheba and
One World Cannabis Intellectual rights related to the multiple myeloma are being
negotiated and the Company expects to finalized an agreement during the 4th
quarter of 2015.
Pursuant to the collaboration agreements, we are obliged to pay Sheba
$330,000 for conducting the multiple myeloma trial between the 3rd quarter of
2015 and the second quarter of 2016. In addition, we expect to commence
pre-clinical studies on fibromyalgia and psoriasis during 3rd quarter of 2015.
Pursuant to the collaboration agreements, we are obliged to pay Sheba $300,000
during the 1st quarter of 2016 for conducting the psoriasis research, and
$100,000 for the fibromyalgia research during the two years of the study. We
currently have the financial resources to fund these studies, but anticipate
that we will require additional funding during the next 12 months for our
continuing and planned expanded operations.
Research and Development Status
The following table summarizes the stages of
development for each of our current Prospect Products.
Page 58
OWC's Investigation on Multiple Myeloma
Dr. Merav Leiba, Head of Multiple Myeloma Outpatient
Clinic and Multiple Myeloma Research Lab at Sheba's Hematology Institute, led
the in vitro tests on multiple myeloma. Dr. Leiba, a specialist in Internal
Medicine and Hematology, was a postdoctoral fellow at the Jerome Lipper Multiple
Myeloma Center at Dana Farber Cancer Institute, Boston, Massachusetts
(2006-2008). Dr. Leiba has participated in numerous clinical and investigational
studies aimed at developing novel drugs for multiple myeloma.
Our in vitro tests results on multiple myeloma cells
studied outside their normal biological context, on which we announced on June
17, 2015, led us to proceed with further pre-clinical study (safety and
toxicity, PK, PD) of our formulation, to find out whether it has scientific
merit for further development as an investigational new drug. While we are
encouraged by the results of the limited in vitro tests, there can be no
assurance that any clinical trial will result in commercially viable products or
treatments.
Clinical trials are expensive, time consuming and
difficult to design and implement. We, as well as the regulatory authorities in
Israel and elsewhere, such as an IRB (Helsinki committee), IMCU - Israel Medical
Cannabis Unit, or the FDA, may suspend, delay or terminate our clinical trials
at any time, may require us, for various reasons, to conduct additional clinical
trials, or may require a particular clinical trial to continue for a longer
duration than originally planned, including, among others:
lack
of effectiveness of any formulation or delivery system during clinical trials;
Any of the foregoing could have a material adverse
effect on our business, results of operations and financial condition.
Consulting Services
OWC believes that the complexity of the
medical cannabis programs has created a demand for consulting and advisory
services in different aspects of the medical cannabis industry. The Company's
services are designed to help government officials, policy-makers and regulatory
agencies develop and implement tailor-made comprehensive medical cannabis
programs. In addition, One World Cannabis offers medical cannabis regulatory
compliance services and patient-care consultancy services.
Our initial activities to secure consulting contracts will be
in member states of the European Union and states of the United States that does
not allow for comprehensive public medical cannabis programs.
OWC management has the expertise in
designing training programs for physicians, caregivers, and researches that are
essential to the establishment of a successful, patient-focused medical cannabis
program. By working with policy-makers, government officials, public agencies,
and privately owned businesses, we believe we can also raise the public's
awareness of the benefits of cannabis-based treatments and products.
In furtherance of our plans, we may, in the future, consider
strategic acquisitions and joint ventures as well as other projects to grow our
business activities including but not limited to: product licensing and royalty
agreements, consulting, and strategic alliances to support our Prospect Product
development. However, there can be no assurance that this strategy will be
successful in generating any revenues or growing out business.
Results of Operations during the three months ended March 31, 2015 as compared to the
three months ended March 31, 2014
We have not generated any revenue during the three months ended March 31,
2015 and 2014. We have operating expenses related to general and administrative
expenses and research and development expenses. During the three months ended
March 31, 2015, we incurred a net loss of $404,603 due to general and
administrative expenses of $305,479 and research and development expenses of
$99,124 compared to a net loss of $509,013 due to general and administrative
expenses of $472,142 and amortization of debt discount of $34,034 during the same
period in the prior year.
Page 59
Our general and administrative expenses decreased
by $166,663 or 35% during the three month-period ended March 31, 2015 as
compared to the same period in the prior year. During the three month-period
ended March 31, 2015, we incurred $99,124 in research and development expenses
as compared to no such expenses in the same period in the prior year. During the
three month-period ended March 31, 2015, we had no amortization of debt discount
expenses as compared to $34,034 during the three months ended March 31, 2014.
Our comprehensive net loss during the three months ended March 31, 2015 was
$409,561, adjusted by $4,958 due to foreign currency translation adjustments as
compared to $509,013 in the same period in the prior year with no adjustments.
Results of Operations during the year ended December 31, 2014 as compared to the year ended December 31, 2013
We have not generated any revenues during the years ended December 31,
2014 and 2013. We have operating expenses related to general and administrative
expenses being a public company and interest expenses. During 2014, we incurred
a net loss of $5,070,673 due to expenses consisting of general and
administrative expenses of $4,873,223, research and development expenses of
$160,325, interest expenses of $3,185, interest income of $94 and amortization
of debt discount of $34,034 compared to a net loss of $318,310 due to general
and administrative expenses of $231,336, interest expenses of $15,941 and
amortization of debt discount of $71,033 during the year ended December 31,
2013.
Our general and administrative expenses increased by $4,641,887 during the
year ended December 31, 2014 as compared to the same period in the prior year
mainly due to $3,857,136 in expenses related to warrant valuations. During the
year ended 2014, we incurred $160,325 in research and development expenses as
compared to no such expenses in 2013. During the twelve months ended December
31, 2014, our interest expense was $3,185 as compared to $15,941 in the same
period in the prior year, which decrease by $12,756 or 80% was mainly due to the
conversion of convertible notes during the year 2014. We received $94 in
interest income during 2014 compared to no interest income in 2013. During the
year 2014, our amortization of debt discount expenses decreased by 52% from
$71,033 in 2013 to $34,034 or by $36,999 due to the conversion of convertible
notes into equity during the year 2014.
Our net loss during the year ended December 31, 2014 was $5,070,673 as
compared to a net loss of $318,310 in the same period in the prior year.
Liquidity and Capital Resources
On March 31, 2015, we had total
assets of $1,194,541 consisting of $1,165,638 in cash and equipment valued at
$28,903. We had total assets of $1,522,812 as of December 31, 2014, consisting
of $1,469,267 in cash, $24,091 in other assets and equipment valued at $29,454.
On March 31, 2015, we had $40,258 in liabilities consisting of $37,309 in
accounts payable and $2,949 in accrued expenses. On December 31, 2014, we had
total liabilities of $60,304 consisting of $16,523 in accounts payable, $43,643
in accrued expenses and $138 in advances and accounts payable to related
parties.
We had positive working capital of $1,125,380 at March 31, 2015 and
$1,433,054 at December 31, 2014. Our accumulated deficits as of March 31, 2015
and December 31, 2014 were $6,298,486 and $5,893,878, respectively.
We used $387,040 in our operating activities during the three months ended
March 31, 2015, which was due to a net loss of $404,603 offset by depreciation
expenses of $2,181, shares issued for services valued at $500, warrants issued
for services valued at $10,839, decrease in current assets of $24,090, increase
in accounts payable of $20,788, an increase of accrued expenses of $40,697 and a
decrease in accounts payable to related party of $138.
We used $16,712 in our operating activities during the three month ended
March 31, 2014, which was due to a net loss of $509,013 offset by increases in
amortization of debt discount of $34,034, non-cash compensation expenses valued
at $455,430 and an increase in accrued expenses of $2,837.
We used $1,630 during the three months ended March 31, 2015 to purchase
property and equipment. We had no investing activities in the same period in the
prior year.
Our financing activities during the three months ended March 31, 2015
provided us with $90,000 related to proceeds from the issuance of 800,000 shares
of common stock and 333,333 warrants.
We financed our negative cash flow from operations during the three months
ended March 31, 2014 through proceeds from issuance of common stock in the
amount of $8,750 and proceeds from the issuance of convertible notes of $14,500,
representing total cash generated by financing activities of $23,250.
Page 60
On December 31, 2014, we had total assets of $1,522,812 consisting of
$1,469,267 in cash, $24,091 in other assets and property and equipment valued at
$29,454 compared to total assets of $2,469 as of December 31, 2013, all of which
was in cash. On December 31, 2014, we had total liabilities of $60,304
consisting of $16,523 in accounts payable, $43,643 in accrued expenses and $138
in advances and accounts payable to related parties.
On December 31, 2013, we had total liabilities of $128,179 consisting of
$4,000 in accrued expenses, accrued interest of $13,863, $28,436 in advances and
accounts payable to related parties and $81,880 in convertible notes.
We had positive working capital of $1,433,054 at December 31, 2104 as
compared to negative working capital of $125,710 at December 31, 2013. Our
accumulated deficits as of December 31, 2014 and 2013 were $5,893,878 and
$823,205, respectively.
We used $602,404 in our operating activities during the year 2014, which was
due to a net loss of $5,070,673 offset by increases in amortization of debt
discount of $34,034, depreciation expenses of $2,740, non-cash compensation
expenses valued at $567,716, warrants issued for services valued at $3,857,136,
increase in accounts payable to related party of $138, increase in accounts
payable of $16,519, increase of accrued expenses of $14,076 and decrease in
other current assets of $24,090.
We used $91,801 in our operating activities during the year 2013, which was
mainly due to a net loss of $318,310 offset by increases in amortization of debt
discount of $71,033, non-cash compensation expenses valued at $28,000, warrants
issued for services valued at $107,074 and an increase in accounts payable and
accrued liabilities by $20,402.
We used $32,194 in the year 2014 to purchase property and equipment. We had
no investing activities in 2013.
Our financing activities in 2014 provided us with $2,094,912 due to
$2,066,476 in proceeds from issuance of common stock and proceeds of $14,500
from debt borrowings. We repaid $14,500 in debt during 2014 and had debt
forgives of $28,436.
We financed our negative cash flow from operations in 2013 through proceeds
from issuance of common stock in the amount of $55 and proceeds from the
issuance of convertible notes of $86,114, representing total cash generated by
financing activities of $86,169.
During the year 2014, the Company issued 13,263,300 shares of common stock in
connection with the conversion of $81,880 in debt outstanding.
Based upon our cash position of $1,165,638 at March 31, 2015, we believe that
we may need to raise additional capital, either equity or debt prior to the end
of fiscal 2015 in order to fund our plan of operations including our research
and development initiatives for the next twelve months. There can be no
assurance, however, that additional capital will be sufficient to fund our
currently anticipated expenditure requirements for the next twelve-month period
nor can there be any assurance that financing will be available at satisfactory
terms and conditions or at all, for that matter.
Our auditors have issued an opinion on our financial statements which
includes a statement describing our going concern status. This means that there
is substantial doubt that we can continue as an on-going business for the next
twelve months unless we obtain additional capital to pay our bills and meet our
other financial obligations. This is because we have not generated any revenues
and no revenues are anticipated until we begin marketing the product.
Accordingly, we must raise capital from sources other than the actual sale of
the product. We must raise capital to implement our project and stay in
business. Even if we raise the maximum amount of money in this offering, we do
not know how long the money will last, however, we do believe it will last at
least twelve months.
Our
lack of operating history may make it difficult to raise capital. Our inability to borrow funds or raise
equity capital to facilitate our business plan may have a material adverse
effect on our financial condition and future prospects.
Funding of Our Research Programs
On October 22, 2014, we have entered into a collaboration agreement with
Sheba Academic Medical Center, a hospital in Tel-Aviv, Israel, relating to the
use of cannabis to treat Myeloma. Within the framework of this collaboration
agreement, the Company currently conducts pre-clinical studies on multiple
myeloma, which have commenced in April 2015 and we expect to commence
pre-clinical studies on fibromyalgia in the third quarter of 2015. Pursuant to
the agreement, we are obligated to pay Sheba $330,000 between the third quarter
of 2015 and second quarter of 2016.
We are obligated to provide $300,000 in funding in the first quarter of 2016
related to the Psoriasis research conducted at Sheba. We have funding
obligations of $100,000 related to the Fibromyalgia research due during two
years of the studies.
Our capital expenditures allocated to our corporate activities conducted
through our facilities in Petach Tikva are expected to be around $606,000 during
2015.
At present, we use our available working capital to fund these studies.
However, we may need to raise additional funding prior to or if clinical studies
are to commence.
Page 61
Off-Balance Sheet Arrangements
As of March 31, 2015, December 31, 2014 and 2013, we did not have any off-balance sheet arrangements as defined in Item 303(a)(4)(ii) of Regulation S-K promulgated under the Securities Act of 1934.
Contractual Obligations and Commitments
As of March 31, 2015, December 31, 2014 and 2013, we did not have any contractual obligations.
Critical Accounting Policies
Our significant accounting policies are described in the notes to our financial statements for the years ended December 31, 2014 and 2013, and are included elsewhere in this registration statement.
CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE
There have been no changes in or disagreements with accountants on accounting or financial disclosure matters.
DIRECTORS, EXECUTIVE OFFICERS, PROMOTERS AND CONTROL PERSONS
Our directors was elected to serve until the next annual meeting of shareholders and
until his respective successors will have been elected and will have qualified. The
following table sets forth the name, age and position held with respect to our present
director and executive officer:
Age
Mordechai Bignitz, age 64,
Chief Executive Officer and Chairman. Mr.
Bignitz has over 30 years of experience in investment banking specializing in
all aspects of the planning, negotiation and execution of both domestic and
international transactions. Over the same period, Mr. Bignitz has had extensive
experience in the management of investments and financial systems, accounting
and taxation. During the past five years, he has served as a director of the
following public companies: Arad Investment & Industrial Development Ltd since
February 2014, traded on the Tel-Aviv Stock Exchange ("TASE"); Globe Exploration
Limited Partnership since July 2013, traded on the TASE; Ellomay Capital Limited
since 2011, engaged in investments in energy and infrastructures and traded on
the NASDAQ and TASE; Israel Financial Levers Ltd, since 2012, engaged in the
real estate business and traded on the TASE; Ablon Group Ltd from 2011 to 2013,
engaged in the real estate business and traded on the London Stock Exchange;
Leader Holdings & Investments Ltd from 2007 to 2010, an investment company
traded on the TASE; and Leader Capital Markets, from 2006 to 2010, an
underwriter and brokerage firm traded on the TASE.
The Registrant believes that Mr. Bignitz's many years of experience as a
senior executive officer and director of several successful public companies
in a variety in industries, all of which have had far greater resources and
operating history than the Registrant, and renders him highly qualified to
serve on the Registrant's CEO and Chairman.
Shmuel De-Saban, age 49,
Chief Financial Officer. During the past
five years, Mr. De-Saban, a CPA, has operated his own accounting firm
providing complete accounting services to clients including the
establishment of internal management reports, examining all corporate
systems such as: (i) purchase management (inventory and procurement
planning); (ii) cash flow, work plans, annual budgets, and monthly analysis
of performance against budget; and (iii) establishment of working
procedures, among other related accounting services. Mr. De-Saban's firm has
represented both Israeli and international clients engaged in manufacturing,
services, retail, food industry services, construction professionals,
hi-tech research and development, programming, importers, exporters, foreign
and domestic residents, real estate, financial services and healthcare.
Mr. De-Saban has a Bachelor's Degree in Economics from Tel-Aviv
University and a degree as a CPA from Bar Ilan University, Israel.
The Registrant believes that Mr. De-Saban's many years of experience in
the accounting in a variety in industries, all of which have had far greater
resources and operating history than the Registrant, and renders him highly
qualified to serve on the Registrant's CFO.
Key Medical Personnel of One World Cannabis Ltd.
Dr. Yehuda Baruch, Director of Research and Regulatory Affairs of One World
Cannabis Ltd
Dr. Yehuda Baruch
, Director of Research and Regulatory Affairs since
January 2015. Dr. Baruch served as Head of the Israeli Ministry of Health's
Medical Marijuana Program from 2003 through 2013, directing their efforts on
regulation, chaired the indication committee, secured Helsinki Approvals for
medical research, and managed regulation of patient licensing and dosage. Dr.
Baruch has extensive experience in researching medical cannabis, most notably
for its effect on PTSD. From 2004 until 2014, Dr. Baruch also served as CEO of
Abarbanel Mental Health Center in Bat Yam, Israel, prior to which, he was the
director of Israel's Ministry of Health medical management division, and
director general of Be'er Yakov Mental Health Center.
Page 62
He has taught at
Ben-Gurion University of the Negev and Tel Aviv University's Sackler School of
Medicine. Management Team As Colonel in IDF's Medical Corps, Dr. Baruch was the
director of the Israeli field hospital to India following the 2001 earthquake
and was the director of the joint USA-Israel Mental Health Team operation in Sri
Lanka post tsunami. Dr. Barch was the director of the Health Administration
Division in the Israel Ministry of Health for 5 years from 1999 to 2004 and for
the past 6 years has has been the director of Abarbanel Mental Health Center and
lecturer at Ben Gurion and Bar Ilan Universities. Dr. Yehuda Baruch is MD and
MHA both from Tel Aviv University.
Alon Sinai,
Chief Operating Officer of One World Cannabis Ltd.
Mr. Alon Sinai, OWC's COO, serves as our liaison with the major Israeli
medical institutions in negotiating our collaboration agreements. He is a
retired Lieutenant-Colonel who served in the Medical Corps of IDF from 1987 to
2013. Mr. Sinai successfully completed the NATO School Oberammergau Program,
NATO's premier individual training and education facility at the operational
level. Mr. Sinai recently served as Head of the Doctrine, Instruction and
Training Department of the IDF, where he was responsible for commanding and
developing emergency medical facilities, writing professional doctrine and
literature for the IDF Medical Corps and working with foreign militaries. Mr.
Sinai is currently pursuing his Ph.D. in Health Systems Management at Ben-Gurion
University of the Negev, where he previously earned an MA in Health Systems
Management and a B.EMS in Emergency Medicine.
Director Independence.
In determining whether or not our directors are considered independent,
the Company used the definition of independence as defined in NASDAQ Rule
4200. Based on that definition we believe that our sole director, Mr.
Bignitz is not independent.
NASDAQ Rule 4200.
The NASDAQ Rule 4200, which sets forth several tests to determine whether
a director of a listed company is independent. Rule 4200 provides that a
director would not be considered independent if the director or an immediate
family member accepted any compensation from the listed company in excess of
$120,000 during any period of 12 consecutive months within the three years
preceding the determination of independence (excluding compensation for
board or board committee service, compensation paid to an immediate family
member as a non-executive employee, benefits paid under a tax-qualified
retirement plan and non-discretionary compensation).
Directors' Term of Office.
Our directors are elected to serve until the next annual meeting of
shareholders and until their respective successors will have been elected
and will have qualified.
Audit Committee and Financial Expert, Compensation Committee,
Nominations Committee.
We do not have any of the above mentioned standing committees because our
corporate financial affairs and corporate governance are simple in nature at
this stage of development and each financial transaction is approved by our
sole officer or director.
Code of Ethics.
We do not currently have a Code of Ethics applicable to our principal
executive officers; however, the Company plans to implement such a code in
the fourth quarter of 2014.
Potential Conflicts of Interest.
Since we do not have an audit or compensation committee comprised of
independent Directors, the functions that would have been performed by such
committees are performed by our Board of Directors. Thus, there is a
potential conflict of interest in that our Directors have the authority to
determine issues concerning management compensation, in essence their own,
and audit issues that may affect management decisions. We are not aware of
any other conflicts of interest with any of our Executives or Directors.
Board's Role in Risk Oversight.
The Board assesses on an ongoing basis the risks faced by the Company.
These risks include financial, technological, competitive, and operational
risks. In addition, since the Company does not have an Audit Committee, the
Board is also responsible for the assessment and oversight of the Company's
financial risk exposures.
Involvement in Certain Legal Proceedings.
We are not aware of any material legal proceedings that have occurred
within the past ten years concerning any Director or control person which
involved a criminal conviction, a pending criminal proceeding, a pending or
concluded administrative or civil proceeding limiting one's participation in
the securities or banking industries, or a finding of securities or
commodities law violations.
Section 16(a) Compliance.
Section 16(a) of the Securities and Exchange Act of 1934 requires the
Registrant's directors and executive officers, and persons who own
beneficially more than ten percent (10%) of the Registrant's Common Stock,
to file reports of ownership and changes of ownership with the Securities
and Exchange Commission. Copies of all filed reports are required to be
furnished to the Registrant pursuant to Section 16(a). Based solely on the
reports received by the Registrant and on written representations from
reporting persons, the Registrant was informed that its CEO and CTO and ten
percent (10%) shareholders have filed reports required to be filed under
Section 16(a).
Page 64
The following table sets forth information concerning the total compensation that we have paid or that has accrued on behalf of our chief executive officer and other executive officers during the fiscal years ending December 31, 2014, 2013 and 2012.
(1) Mr. Bignitz was appointed the CEO and
Chairman on July 15, 2014 and receives compensation of $1,000 per month
commencing November 1, 2014 pursuant to his services agreement.
Option Grants
In connection with Mr. De-Saban's, services
agreement, as supplemented on October 2, 2014, the Company agreed to grant
Mr. De-Saban options to purchase 662,500 shares at an exercise price of
$0.01, which options expire on October 1, 2018. These options will vest only
if the Company's wholly-owned subsidiary OWC achieves certain milestones. As of
March 31 2015, no milestone has been achieved and no options have
vested.
In connection with the resignation and signing of a mutual
release and separation agreement by Mr. Goore, he was granted 150,000
options at an exercise price of $0.14 per shares with an expiration date of
July 15, 2016.
In connection with the resignation and signing of a mutual
release separation agreement by Mr. Gonen, he was granted 200,000 options at
an exercise price of $0.14 per shares with an expiration date of July 15,
2016.
Aggregated Option Exercises and Fiscal Year-End Option
Value
There were no stock options exercised during the year ended
December 31, 2014 by the executive officers named in the Summary
Compensation Table.
Long-Term Incentive Plan ("LTIP") Awards
There were no awards made to a named executive officers in
the last completed fiscal year under any LTIP.
Compensation of Directors
Directors are permitted to receive fixed fees and other
compensation for their services as directors. The Board of Directors has the
authority to fix the compensation of directors. No amounts have been paid
to, or accrued to, directors in such capacity.
Employment Agreements
Currently, we have services/employment agreements with our
CEO and CFO. Our CEO also serves as the sole director for no additional
compensation.
Page 65
OWC Pharmaceutical Research Corp.
Consolidated Balance Sheets
At
March 31, 2015 and December 31, 2014
Back to Table of Contents
March 31, 2015
(Unaudited)
December 31,
2014
ASSETS
Current assets:
Cash
$
1,165,638
$
1,469,267
Other current assets
-
24,091
Total current assets
1,165,638
1,493,358
Property and equipment, net
28,903
29,454
Total Assets
$
1,194,541
$
1,522,812
LIABILITIES
AND STOCKHOLDERS' EQUITY (DEFICIT)
Current liabilities:
Accounts
payable - trade
$
37,309
$
16,523
Accrued
expenses
2,949
43,643
Advances and accounts payable to
related parties
-
138
Total current liabilities
40,258
60,304
Total liabilities
40,258
60,304
Stockholders'
equity:
Preferred stock,
$0.00001 par value; 20,000,000 shares authorized; no shares issued and outstanding
-
-
Common stock,
$0.00001 par value; 500,000,000 shares authorized; and
79,729,241 and 78,429,241 issued and outstanding at March 31, 2015 and December 31, 2014,
respectively
797
784
Additional paid in
capital
8,052,175
8,000,847
Common stock subscription receivable
(651,730)
(651,730)
Subscription payable
50,000
0
Accumulated
deficit
(6,298,486)
(5,893,878)
Accumulated
other comprehensive income
1,527
6,485
Total
stockholders' equity
1,154,283
1,462,508
Total liabilities and stockholders' equity
$
1,194,541
$
1,522,812
See notes to unaudited interim consolidated financial statements.
OWC Pharmaceutical Research Corp.
Consolidated Statements of Operations
For
the Three Months Ended March 31, 2015 and 2014
(Unaudited)
Back to Table of Contents
For the three
months
For the three
months
ended March 31, 2015
ended March 31, 2014
Expenses
General and
administrative
Research and
development
Loss from operations
(404,603)
(472,142)
Other income
(expense):
Amortization
of debt discount
Total other expense
-
(36,871)
Total costs
and expenses
(404,603)
(509,013)
Net loss before income
taxes
(404,603)
(509,013)
Income tax
Net loss
Basic and diluted
per share amounts:
Basic and diluted net
loss
Weighted average
shares outstanding (basic and diluted)
See notes to
unaudited interim consolidated financial statements.
OWC Pharmaceutical Research Corp.
Consolidated Statements Comprehensive Loss
For
the Three Months Ended March 31, 2015 and 2014
(Unaudited)
Back to Table of Contents
For the three months
For the three months
ended March 31, 2015
ended March 31, 2014
Net loss
$
(404,603)
$
(509,013)
Other comprehensive income, net of tax:
Foreign currency translation adjustments
(4,958)
-
Total other comprehensive income, net of tax
(4,958)
-
Comprehensive loss
$
(409,561)
$
(509,013)
See notes to
unaudited interim consolidated financial statements.
OWC Pharmaceutical Research Corp.
Consolidated Statements of
Cash Flows
For
the Three Months Ended March 31, 2015 and 2014
(Unaudited)
Back to Table of Contents
For the three
months
For the three
months
ended March 31, 2015
ended March 31, 2014
Net loss
Adjustments to reconcile
net loss to net cash used in operating activities:
Amortization
of debt discount
-
34,034
Depreciation
2,181
-
Common stock
issued for services
500
455,430
Fair value
of warrants issued for services
10,839
-
Changes in net assets and
liabilities:
(Increase) decrease in current assets
24,090
-
Accounts payable - related party
(138)
-
Increase (decrease) in accounts payable
20,788
-
Increase
(decrease) in accrued expenses
Cash used in operating
activities
Cash flow from
investing activities:
Purchase of equipment
(1,630)
-
Cash
used in investing activities
Cash flow from
financing activities:
Proceeds
from issuance of common stock
90,000
8,750
Proceeds of debt borrowings
-
14,500
Cash provided by
financing activities
Change in cash
Cash - beginning of
period
Cash - end of period
Supplement cash flow
information:
Non-cash transactions:
Debt
discount arising from beneficial conversion feature
$
-
$
-
Debt and
accrued interest converted to equity
$
-
$
130,849
See notes to
unaudited interim consolidated financial statements.
Back to Table of Contents
(ii)
research and development of cannabis-based medical products for the treatment of
a variety of medical conditions such as multiple myeloma, psoriasis,
fibromyalgia, post-traumatic stress disorder (PTSD) and migraine, and
(iii)
consulting services to companies and governmental agencies with respect to
complex international medical cannabis protocols and regulations.
- Quoted prices for identical or similar assets or liabilities in inactive markets;
- Inputs other than quoted prices that are observable for the asset or liability;
- Inputs that are derived principally from or corroborated by observable market data by
correlation or other means.
Back to Table of Contents
OWC Pharmaceutical Research Corp.
March 31, 2015
OWC Pharmaceutical Research Corp.
(formerly
Dynamic Applications Corp.)
Consolidated Balance Sheets
At
December 31, 2014 and 2013
Back to Table of Contents
December 31, 2014
December 31,
2013
ASSETS
Current assets:
Cash
$
1,469,267
$
2,469
Other current assets
24,091
-
Total current assets
1,493,358
2,469
Property and equipment, net
29,454
Total Assets
$
1,522,812
$
2,469
LIABILITIES
AND STOCKHOLDERS' EQUITY (DEFICIT)
Current liabilities:
Accounts
payable - trade
$
16,523
$
-
Accrued
expenses
43,643
4,000
Accrued interest
-
13,863
Advances
and accounts payable to
related parties
138
28,436
Convertible notes payable, net of discount
-
81,880
Total current liabilities
60,304
128,179
Total liabilities
60,304
128,179
Stockholders'
equity (deficit):
Preferred stock,
$0.00001 par value; 20,000,000 shares authorized; no shares issued and outstanding
-
-
Common stock,
$0.00001 par value; 500,000,000 shares authorized; and
78,429,241 and 21,641,450 issued and outstanding at December 31, 2014 and 2013,
respectively
784
217
Additional paid in
capital
8,000,847
697,278
Common stock subscription receivable
(651,730)
-
Accumulated
deficit
(5,893,878)
(823,205)
Accumulated
other comprehensive income
6,485
-
Total
stockholders' equity (deficit)
1,462,508
(125,710)
Total Liabilities and Stockholders' equity (deficit)
$
1,522,812
$
2,469
The
accompanying notes to the consolidated financial statements are an integral part of these financial
statements.
OWC Pharmaceutical Research Corp.
(formerly
Dynamic Applications Corp.)
Consolidated Statements of Operations
For
the Years Ended December 31, 2014 and 2013
Back to Table of Contents
For the year ended
For the year ended
December 31, 2014
December 31, 2013
Revenues
$
-
$
-
Expenses:
General and administrative
4,873,223
231,336
Research and development
160,325
-
Loss from operations
(5,033,548)
(231,336)
Other income (expense):
Interest expense
(3,185)
(15,941)
Interest income
94
-
Amortization of debt discount
(34,034)
(71,033)
Total other (expense)
(37,125)
(86,974)
Total costs and expenses
(5,070,673)
(318,310)
Net loss before income taxes
(5,070,673)
(318,310)
Income tax
-
-
Net loss
$
(5,070,673)
$
(318,310)
Basic and diluted per share amounts:
Basic and diluted net
loss
$
(0.10)
$
(0.02)
Weighted average shares outstanding (basic and diluted)
52,209,962
18,981,066
The accompanying notes to the
consolidated financial statements are an integral part of these financial
statements.
OWC Pharmaceutical Research Corp.
(formerly
Dynamic Applications Corp.)
Consolidated Statements Comprehensive Loss
For
the Years Ended December 31, 2014 and 2013
Back to Table of Contents
For the year ended
For the year ended
December 31, 2014
December 31, 2013
Net loss
$
(5,070,673)
$
(318,310)
Other comprehensive income, net of tax:
Foreign currency translation adjustments
6,485
-
Total other comprehensive income, net of tax
6,485
-
Comprehensive loss
$
(5,064,188)
$
(318,310)
The
accompanying notes to the consolidated financial statements are an integral part of these financial
statements.
OWC Pharmaceutical Research Corp.
(formerly Dynamic Applications
Corp.)
Consolidated Statement
of Changes in Stockholders' Equity (Deficit)
For the Years Ended December 31, 2014 and
2013
Back to Table of Contents
Accumulated
Total
Common
Additional
Subscription
Accumulated
Other
Stockholders'
Shares
Amount
Paid-in Capital
Receivable
Deficit
Comprehensive
Deficit
Balance at December 31, 2012
15,829,450
$
157
$
424,474
$
-
$
(504,895)
$
-
$
(80,263)
Fair value of warrants
issued for services
-
-
107,074
-
-
-
107,074
Impact of beneficial conversion feature
-
-
86,114
-
-
-
86,114
Stock issued upon conversion of debt and accrued interest
5,162,000
52
51,568
-
-
-
51,620
Stock issued for services
100,000
1
27,999
-
-
-
28,000
Stock issued due to exercise of warrants for cash
550,000
6
49
-
-
-
55
Net loss
-
-
-
-
(318,310)
-
(318,310)
Balance at
December 31, 2013
21,641,450
$
217
$
697,278
$
-
$
(823,205)
$
-
$
(125,710)
Fair value of warrants
issued for services
-
-
3,857,136
-
-
-
3,857,136
Stock issued upon conversion of debt and accrued interest
13,263,300
133
132,509
-
-
-
132,642
Forgiveness of indebtedness to former related party
-
-
28,436
-
-
-
28,436
Stock issued for services
6,995,416
70
567,647
-
-
-
567,716
Stock issued for cash at $0.005
4,700,000
47
23,453
-
-
-
23,500
Stock issued for cash at $0.05
13,034,585
130
651,600
(651,730)
-
-
-
Stock issued for cash at $0.09
12,936,662
129
1,164,171
-
-
-
1,164,300
Stock issued for cash at $0.15
5,857,828
59
878,617
-
-
-
878,676
Other comprehensive income
-
-
-
-
-
6,485
6,485
Net loss
-
-
-
-
(5,070,673)
-
(5,070,673)
Balance
at December 31, 2014
78,429,241
$
784
$
8,000,847
$
(651,730)
$
(5,893,878)
$
6,485
$
1,462,508
The accompanying notes to the consolidated financial statements are integral part of these
financial statements.
OWC Pharmaceutical Research Corp.
(Formerly Dynamic Application Corp.)
Consolidated Statements of Cash Flows
For the Years Ended December 31, 2014 and 2013
Back to Table of Contents
For the year
ended
For the year
ended
December 31, 2014
December 31, 2013
Net loss
$
(5,070,673)
$
(318,310)
Adjustments to reconcile
net loss to net cash used in operating activities:
Amortization
of debt discount
34,034
71,033
Depreciation
2,740
-
Common stock
issued for services
567,716
28,000
Fair value of warrants
issued for services
3,857,136
107,074
Changes in net assets and
liabilities:
(Increase) decrease in current assets
(24,090)
-
Accounts payable - related party
138
-
Increase (decrease) in accounts payable
16,519
-
Increase
(decrease) in accrued expenses
14,076
20,402
Cash used in operating
activities
(602,404)
(91,801)
Cash flow from
investing activities:
Purchase of equipment
(32,194)
-
Cash used
in investing activities
(32,194)
-
Cash flow from
financing activities:
Contributed capital - debt forgiven
28,436
-
Proceeds
from issuance of common stock
2,066,476
55
Proceeds of
debt borrowings
14,500
86,114
Principal payments
(14,500)
-
Cash provided by
financing activities
2,094,912
86
,169
Foreign currency translations
6,485
-
Change in cash
1,466,798
(5,632)
Cash - beginning of
period
2,469
8,101
Cash - end of period
$
1,469,267
$
2,469
Supplement cash flow
information:
Non-cash transactions:
Debt discount
arising from beneficial conversion feature
$
-
$
82,614
Debt and
accrued interest converted into equity
$
132,642
$
51,620
The
accompanying notes to the consolidated financial statements are an integral part of these financial
statements.
(Formerly Dynamic Applications Corp.)
Notes to
Consolidated Financial Statements
December 31, 2014
Back to Table of Contents
(ii)
research and development of cannabis-based medical products for the treatment of
a variety of medical conditions such as multiple myeloma, psoriasis,
fibromyalgia, post-traumatic stress disorder (PTSD) and migraine, and
(iii)
consulting services to companies and governmental agencies with respect to
complex international medical cannabis protocols and regulations.
- Quoted prices for similar assets or liabilities in active
markets;
- Quoted prices for identical or similar assets or liabilities
in inactive markets;
- Inputs other than quoted prices that are
observable for the asset or liability;
- Inputs that are derived
principally from or corroborated by observable market data by correlation or
other means.
If the asset or liability has a specified (contractual)
term, the level 2 input must be observable for substantially the full term
of the asset or liability.
Offering:
Common Stock
Subscribed
Proceeds
Warrants
Exercise
Price
Term
$0.005 per share
4,700,000
23,500
-
-
-
$0.05 per share
13,034,585
651,730
-
-
-
$0.09 per unit
12,936,662
1,164,300
12,936,662
0.16
1 year
$0.15 per unit
5,857,828
878,676
5,857,828
0.25
1 year
The Company recorded $107,074
in fiscal year 2013 in expenses related to 600,000 vested warrants
previously granted to GUMI Tel Aviv Ltd. The warrants were valued using the
Black-Scholes option pricing model. The inputs for the valuation analysis of
the warrants include the market value of the Company's common stock were as
follows: the estimated volatility of the Company's common stock used in the
Black-Scholes option pricing model was 318%, the exercise price and the risk
free interest rate used were $0.05 and 0.36%, respectively. All warrants are
fully vested.
Our three distinct business operations are:
(i) continuing to work with GUMI
to commercialize and market the Company's Electromagnetic Percussion Device (the
"Device"); and
(ii) research and development of cannabis-based medical
products for the treatment of a variety of medical conditions such as multiple
myeloma, psoriasis, fibromyalgia, post-traumatic stress disorder (PTSD) and
migraine, and
(iii)
consulting services to companies and governmental agencies with respect to
complex international medical cannabis protocols and regulations.
Targeted Medical Condition
Collaborator
Status
Use of cannabis to treat
multiple Myeloma
Sheba Academic
Medical Center
Basic Science
Research Agreement - signed;
Clinical Research Agreement - in
negotiation;
Pre-clinical study: Approved by Ethics Committee (IRB);
In vitro tests - completed.
Next: Pre-clinical study: Safety and
Toxicity, PK, PD
Clinical trial protocol synopsis - draft completed.
Use of cannabis to treat
Psoriasis
(1) Sheba
Academic Medical Center
Research
Collaboration and License Agreement - signed;
Protocol of A Phase I,
double blind, randomized, placebo controlled, multiple escalating dose
study to determine the safety, tolerability and pharmacokinetic profile
of medical grade cannabis in healthy volunteers - draft completed.
Use of cannabis to treat
Psoriasis
(2)
Emilia Cosmetics Ltd.
Memorandum of
Understanding (MoU) for the developing, manufacturing and marketing of a
cannabinoid-based topical cream to treat psoriasis - signed;
Received
license to purchase and use of cannabis for R&D purposes;
Formulation
development will be initiated during third quarter of 2015.
Use of cannabis to treat
Fibromyalgia
Sheba
Academic Medical Center
Research
Collaboration and License Agreement - signed;
Clinical trial protocol
synopsis - initial draft completed.
New delivery system - cannabis
soluble tablet
G.C. Group Ltd.
Formulation
development;
Received license to purchase and use of cannabis for R&D
purposed.
Use of cannabis to treat PTSD
In
Negotiations
Clinical trial
documents - submitted; Awaiting for Ethics Committee (IRB) final
approval.
Use of cannabis to treat Migraine
In
Negotiations
Clinical trial
protocol synopsis - initial draft completed.
discovery of serious or
unexpected toxicities or side effects experienced by trial participants or other
safety issues;
slower than
expected rates of subject recruitment and enrollment rates in clinical trials;
delays or inability in
manufacturing or obtaining sufficient quantities of materials for use in
clinical trials due to regulatory and manufacturing constraints;
delays
in obtaining regulatory authorization to commence a trial, including IRB
approvals, licenses required for obtaining and using cannabis for research,
either before or after a trial is commenced;
unfavorable
results from ongoing pre-clinical studies and clinical trials.
patients
or investigators failing to comply with study protocols;
patients
failing to return for post-treatment follow-up at the expected rate;
sites
participating in an ongoing clinical study withdraw, requiring us to engage new
sites;
third-party
clinical investigators decline to participate in our clinical studies, do not
perform the clinical studies on the anticipated schedule, or act in ways
inconsistent with the established investigator agreement, clinical study
protocol, good clinical practices, and other Institutional Review Board
requirements;
third-party
entities do not perform data collection and analysis in a timely or accurate
manner or at all;
regulatory
inspections of our clinical studies require us to undertake corrective action or
suspend or terminate our clinical studies;
Our
comprehensive net loss in 2014 was $5,064,188, adjusted by $6,485 due to foreign
currency translation adjustments as compared to $318,310 in 2013 and no
adjustments.
Name
Title
Date Became Executive
Officer
Mordechai Bignitz
64
Chief Executive
Officer and Chairman
07/2014
Shmuel
De-Saban
49
Chief Financial
Officer
06/2014
Long
Term
Annual
Compensation
Compensation
Awards
Other
Restricted
Securities
Annual
Stock
Underlying
All Other
Salary
Bonus
Compensation
Award(s)
Options
Compensation
Name and
Principal Position
Year
($)
($)
($)
(#) (5)
(#)
($)
Mordechai Bignitz,
CEO and Chairman (1)
2014
3,000
---
---
---
---
---
Shmuel De-Saban, CFO
(2)
2014
---
---
---
195,416
662,500
---
Ori Goore, former CEO
and CFO (3)
2014
---
---
---
250,000
150,000
---
2013
---
---
---
---
---
---
2012
---
---
---
---
---
---
Eli Gonen, former
Chairman (4)
2014
---
---
---
150,000
200,000
---
2013
---
---
---
---
---
---
2012
---
---
---
---
---
---
(2) Mr. De-Saban
was appointed the CFO on June 16, 2014. Mr. De-Saban signed a services
agreement pursuant to which he was issued 195,416 restricted shares upon
signing the agreement and 662,500 options, which will vest if OWC achieves
certain milestones. As of March 31
2015, none of the milestones has been achieved and therefore no options have
vested.
(3) Mr. Goore became the Company's CEO and director in February
2009 and received no compensation for serving as CEO and director. Mr. Goore
resigned as CEO on July 15, 2015 to pursue other business opportunities. In
connection with his resignation and signing of a mutual release, Mr. Goore
received 250,000 restricted shares and was granted 150,000 options at an
exercise price of $0.14 per shares with an expiration date of July 15, 2016.
(4) Mr. Gonen became the Company's Chairman February 2009 and received no
compensation for serving as Chairman. Mr. Gonen resigned as Chairman July
15, 2015 to pursue other business opportunities. In connection with his
resignation and signing of a mutual release, Mr. Gonen received 150,000
restricted shares and was granted 200,000 options at an exercise price of
$0.14 per shares with an expiration date of July 15, 2016.
(5) The restricted stock awards were granted in connection
with services agreements with our current management and separation agreements
with former management.
The following tables set forth certain information concerning the number of shares of the Corporation's Common Stock owned beneficially as of May 31, 2015 by: (i) each person (including any group) known to us to own more than five (5%) percent of any class of its voting securities; (ii) each of the Corporation's directors and each of its named executive officers, including directors and officers of OWC, the Corporation's wholly-owned Israeli subsidiary; and (iii) officers and directors as a group. Unless otherwise indicated, the shareholders listed possess sole voting and investment power with respect to the shares shown.
As of May 31, 2015, the Registrant had 80,592,403 shares of Common Stock issued and outstanding.
Name of Beneficial Owner | Common Stock Beneficially Owned | Percentage of Common Stock Owned (1) | ||
Mordechai Bignitz, CEO and Chairman | 0 | 0.00% | ||
7 Jacobtinsky Street, Ramat Gan 52520, Israel | ||||
Shmuel De-Saban, CFO | 195,416 | 0.24% | ||
215 Jaffa Street, Jerusalem, Israel | ||||
Ziv Turner, CEO of OWC | 2,104,480 | 2.60% | ||
Shaham 22 Street, Petach Tikva 49181, Israel | ||||
Dr. Alan Shackelford, CSO of OWC | 5,134,375 | 6.36% | ||
2257 South Broadway, Denver, CO 80210 | ||||
Jacky Shenker | 8,000,000 | 9.92% | ||
78 Uziel Street, Jerusalem, Israel | ||||
Director and Officer (4 person) (2) | 7,434,271 | 9.21% |
All Directors and Officers as a group (4 persons), including those of the Registrant's wholly-owned subsidiary, One World cannabis Ltd own 7,434,271shares.
(1) Applicable percentage ownership is based on 80,592,403 shares of Common Stock outstanding as of
May 31, 2015. Beneficial ownership is determined in accordance with the rules of the Securities and Exchange Commission and generally includes voting or investment power with respect to securities. Shares of Common Stock that are currently exercisable or exercisable within 60 days are deemed to be beneficially owned by the person holding such securities for the purpose of computing the percentage of ownership of such person, but are not treated as outstanding for the purpose of computing the percentage ownership of any other person.
(2) Includes officers of the Registrant's wholly-owned Israeli subsidiary, One Word
cannabis Ltd.
TRANSACTIONS WITH RELATED PERSONS, PROMOTERS AND CERTAIN CONTROL PERSONS
Related Party Transactions in 2014 and 2013: Amounts due related parties consist of corporate reinstatement and regulatory compliance expenses paid directly by a director of the company and unpaid compensation. Such items totaled $28,436 at December 31, 2013. The advances are not formalized by a written agreement and do not carry a specific date of payment and are non-interest bearing. As of December 31, 2014, we owed $138 to a related party.
Indebtedness of Management
No officer, director or security holder known to us to own of record or beneficially more than 5% of our Common Stock or any member of the immediate family or sharing the household (other than a tenant or employee) of any of the foregoing persons is indebted to us.
Disclosure of Commission Position on Indemnification of Securities Act Liabilities
Our directors and officers are indemnified as provided by the Delaware corporate law and our Bylaws. We have agreed to indemnify each of our directors and certain officers against certain liabilities, including liabilities under the Securities Act of 1933, as amended. Insofar as indemnification for liabilities arising under the Securities Act of 1933, as amended may be permitted to our directors, officers and controlling persons pursuant to the provisions described above, or otherwise, we have been advised that in the opinion of the Securities and Exchange Commission such indemnification is against public policy as expressed in the Securities Act of 1933, as amended and is, therefore, unenforceable. In the event that a claim for indemnification against such liabilities (other than our payment of expenses incurred or paid by our director, officer or controlling person in the successful defense of any action, suit or proceeding) is asserted by such director, officer or controlling person in connection with the securities being registered, we will, unless in the opinion of our counsel the matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction the question whether such indemnification by it is against public policy as expressed in the Act and will be governed by the final adjudication of such issue.
We have been advised that in the opinion of the Securities and Exchange Commission indemnification for liabilities arising under the Act is against public policy as expressed in the Act, and is, therefore, unenforceable. In the event that a claim for indemnification against such liabilities is asserted by one of our directors, officers, or controlling persons in connection with the securities being registered, we will, unless in the opinion of our legal counsel the matter has been settled by controlling precedent, submit the question of whether such indemnification is against public policy to a court of appropriate jurisdiction. We will then be governed by the court's decision.
Page 66
OWC PHARMACEUTICAL RESEARCH CORP.
9,101,373 SHARES OF COMMON STOCK
PROSPECTUS
YOU SHOULD RELY ONLY ON THE INFORMATION CONTAINED IN THIS DOCUMENT OR THAT WE HAVE REFERRED YOU TO. WE HAVE NOT AUTHORIZED ANYONE TO PROVIDE YOU WITH INFORMATION THAT IS DIFFERENT. THIS PROSPECTUS IS NOT AN OFFER TO SELL COMMON STOCK AND IS NOT SOLICITING AN OFFER TO BUY COMMON STOCK IN ANY STATE WHERE THE OFFER OR SALE IS NOT PERMITTED.
Until _____________, all dealers that effect transactions in these securities whether or not participating in this Offering may be required to deliver a Prospectus. This is in addition to the dealer's obligation to deliver a Prospectus when acting as underwriters.
The Date of This Prospectus is June __, 2015
PART II
INFORMATION NOT REQUIRED IN THE PROSPECTUS
Item 13. Other Expenses of Issuance and Distribution
All amounts are estimates other than the Commission's registration fee. We are paying all expenses of the Offering listed above. No portion of these expenses will be borne by the Selling Shareholders. The Selling Shareholders, however, will pay any other expenses incurred in selling their Common Stock, including any brokerage commissions or costs of sale.
Item 14. Indemnification of Directors and Officers
Our directors and officers are indemnified as provided by the Delaware corporate law and our Bylaws. We have agreed to indemnify each of our directors and certain officers against certain liabilities, including liabilities under the Act. Insofar as indemnification for liabilities arising under the Act may be permitted to our directors, officers and controlling persons pursuant to the provisions described above, or otherwise, we have been advised that in the opinion of the Securities and Exchange Commission such indemnification is against public policy as expressed in the Act and is, therefore, unenforceable. In the event that a claim for indemnification against such liabilities (other than our payment of expenses incurred or paid by our director, officer or controlling person in the successful defense of any action, suit or proceeding) is asserted by such director, officer or controlling person in connection with the securities being registered, we will, unless in the opinion of our counsel the matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction the question whether such indemnification by it is against public policy as expressed in the Act and will be governed by the final adjudication of such issue.
We have been advised that in the opinion of the Securities and Exchange Commission indemnification for liabilities arising under the Act is against public policy as expressed in the Act, and is, therefore, unenforceable. In the event that a claim for indemnification against such liabilities is asserted by one of our directors, officers, or controlling persons in connection with the securities being registered, we will, unless in the opinion of our legal counsel the matter has been settled by controlling precedent, submit the question of whether such indemnification is against public policy to a court of appropriate jurisdiction. We will then be governed by the court's decision.
Section 102 of the Delaware General Corporation Law permits a corporation to eliminate the personal liability of its directors or its shareholders for monetary damages for a breach of fiduciary duty as a director, except where the director breached his or her duty of loyalty, failed to act in good faith, engaged in intentional misconduct or knowingly violated a law, authorized the payment of a dividend or approved a stock repurchase in violation of Delaware corporate law or obtained an improper personal benefit. Our by-laws provides that no director shall be personally liable to us or our shareholders for monetary damages for any breach of fiduciary duty as a director, notwithstanding any provision of law imposing such liability, except to the extent that the Delaware General Corporation Law prohibits the elimination or limitation of liability of directors for breaches of fiduciary duty.
Section 145 of the Delaware General Corporation Law provides that a corporation has the power to indemnify a director, officer, employee or agent of the corporation and certain other persons serving at the request of the corporation in related capacities against expenses (including attorneys' fees), judgments, fines and amounts paid in settlements actually and reasonably incurred by the person in connection with an action, suit or proceeding to which he or she is party or is threatened to be made a party by reason of such position, if such person acted in good faith and in a manner he or she reasonably believed to be in or not opposed to the best interests of the corporation, and, in any criminal action or proceeding, had no reasonable cause to believe his or her conduct was unlawful, except that, in the case of actions brought by or in the right of the corporation, no indemnification shall be made with respect to any claim, issue or matter as to which such person shall have been adjudged to be liable to the corporation unless and only to the extent that the Court of Chancery or other adjudicating court determines that, despite the adjudication of liability but in view of all of the circumstances of the case, such person is fairly and reasonably entitled to indemnification for such expenses which the Court of Chancery or such other court shall deem proper.
Item 15. Recent Sales of Unregistered Securities
Sale of Unregistered Securities
(a) The units include warrants exercisable at $0.16 per share.
The sales of these securities were exempt under either Section 4(2) of the Securities Act of 1933, as amended (the "Act") and the rules and regulations promulgated by the SEC thereunder, including Regulation S. The investors represented to the Company that they have sufficient knowledge and experience in financial and business matters to evaluate the risks and merits of the investment (the "sophisticated investor"), or be able to bear the investment's economic risk, have access to the type of information normally provided in a prospectus; and agreed not to resell or distribute the securities to the public other than in compliance with the Act. In addition, the Company did not use any form of public solicitation or general advertising in connection with the offerings.
Item 16. Exhibits and Financial Statement Schedules
Item 17. Undertakings
(a) The undersigned registrant hereby undertakes:
SIGNATURES
Securities and Exchange Commission registration fee
$
275
Transfer Agent Fees
$
0
Accounting fees and expenses
$
1,000
Legal fees and expense
$
25,000
Total
$
26,275
Date
Title
Shares Issued
Persons
Consideration Per Share
02/28/14
Common Stock
913,000
Amir Uziel
Conversion of debt into equity at $0.01 per share pursuant to Section
4(2)
02/28/14
Common Stock
349,300
Tena Holdings GmbH (1)
Conversion of debt into equity at $0.01 per share pursuant to Section
4(2)
02/28/14
Common Stock
688,500
Lavi Krasney
Conversion of debt into equity at $0.01 per share pursuant to Section
4(2)
02/28/14
Common Stock
366,500
Akiva Shonfeld
Conversion of debt into equity at $0.01 per share pursuant to Section
4(2)
02/28/14
Common Stock
592,900
Amita S.A. (2)
Conversion of debt into equity at $0.01 per share pursuant to Section
4(2)
02/28/14
Common Stock
2,383,100
L&L Holdings (3)
Conversion of debt into equity at $0.01 per share pursuant to Section
4(2)
02/28/14
Common Stock
2,947,000
Asher G. Mediouni
Conversion of debt into equity at $0.01 per share pursuant to Section
4(2)
02/28/14
Common Stock
3,657,100
Ofliam L.L.C. (4)
Conversion of debt into equity at $0.01 per share pursuant to Section
4(2)
02/28/14
Common Stock
295,200
Kfir Silbrman
Conversion of debt into equity at $0.01 per share pursuant to Section
4(2)
03/11/14
Common Stock
2,000,000
IMWT Holdings Ltd. (5)
For Services provided valued at $20,000 pursuant to Section 4(2)
03/11/14
Common Stock
2,000,000
KE Zurich Capital (6)
For Services provided valued at $20,000 pursuant to Section 4(2)
03/11/14
Common Stock
1,000,000
Tzvika Borodizki
For Services provided valued at $10,000 pursuant to Section 4(2)
03/11/14
Common Stock
1,000,000
Asaf Itschaik
For Services provided valued at $10,000 pursuant to Section 4(2)
03/31/14
Common Stock
529,400
L&L Holdings (3)
Conversion of debt into equity at $0.01 per share pursuant to Section
4(2)
03/31/14
Common Stock
1,470,000
L&L Holdings (3)
For Services provided valued at $14,700 pursuant to Section 4(2)
03/31/14
Common Stock
362,000
Bransville Investment Ltd. (7)
Conversion of debt into equity at $0.01 per share pursuant to Section
4(2)
03/31/14
Common Stock
1,638,000
Bransville Investment Ltd. (7)
For Services provided valued at $16,380 pursuant to Section 4(2)
04/15/14
Common Stock
500,000
Short Trade Ltd. (8)
$0.005 per share in cash pursuant to Section 4(2)
04/15/14
Common Stock
1,250,000
Ben-Zion Weiner
$0.005 per share in cash pursuant to Section 4(2)
04/15/14
Common Stock
500,000
Yoel Yogev
$0.005 per share in cash pursuant to Section 4(2)
04/15/14
Common Stock
2,000,000
Ariela Krasney
$0.005 per share in cash pursuant to Section 4(2)
04/15/14
Common Stock
150,000
Oded Gilboa
$0.005 per share in cash pursuant to Section 4(2)
04/15/14
Common Stock
300,000
David Massas
$0.005 per share in cash pursuant to Section 4(2)
06/24/14
Units (a)
111,111
David Asaf
$0.09 per share in cash pursuant to Reg S exemption
06/29/14
Units (a)
444,444
Avdinco Ltd. (9)
$0.09 per share in cash pursuant to Reg S exemption
06/24/14
Units (a)
55,555
David Benhamu
$0.09 per share in cash pursuant to Reg S exemption)
06/05/14
Units (a)
222,222
David Shrem
$0.09 per share in cash pursuant to Reg S exemption
06/24/14
Units (a)
222,222
Eran Cohan
$0.09 per share in cash pursuant to Reg S exemption
07/01/14
Units (a)
111,111
Judith Zetouny
$0.09 per share in cash pursuant to Reg S exemption
06/23/14
Units (a)
555,555
Falash Masha Lea
$0.09 per share in cash pursuant to Reg S exemption
06/18/14
Units (a)
111,111
Nir Ben Nissan
$0.09 per share in cash pursuant to Reg S exemption
06/20/14
Units (a)
55,555
Nuriel Chordekar
$0.09 per share in cash pursuant to Reg S exemption
06/19/14
Units (a)
2,222,222
Prop Trade Ltd. (10)
$0.09 per share in cash pursuant to Reg S exemption
06/19/14
Units (a)
444,444
R.P. Holdings Ltd. (11)
$0.09 per share in cash pursuant to Reg S exemption
06/18/14
Units (a)
222,222
Ron Senator
$0.09 per share in cash pursuant to Reg S exemption
06/24/14
Units (a)
450,000
Shmuel Pasternak
$0.09 per share in cash pursuant to Reg S exemption
06/13/14
Units (a)
2,222,222
Short Trade Ltd. (12)
$0.09 per share in cash pursuant to Reg S exemption)
06/24/14
Units (a)
111,111
Tal Taperberg & Gal Graf
$0.09 per share in cash pursuant to Reg S exemption
06/11/14
Units (a)
444,444
Boruj Tenenbaum
$0.09 per share in cash pursuant to Reg S exemption
06/18/14
Units (a)
166,667
Tomer Cohan
$0.09 per share in cash pursuant to Reg S exemption
06/11/14
Units (a)
1,000,000
Yoel Yogev
$0.09 per share in cash pursuant to Reg S exemption
06/10/14
Units (a)
220,000
Yosef Cohan
$0.09 per share in cash pursuant to Reg S exemption
08/14/14
Common Stock
150,000
Ivo Heiden
For Services provided valued at $0.25 per share pursuant to Section 4(2)
08/14/14
Common Stock
150,000
Securities Compliance Corp. (13)
For Services provided valued at $0.25 per share pursuant to Section 4(2)
07/14/14
Common Stock
179,300
Activa Shonenfeld
Conversion of debt into equity at $0.01 per share pursuant to Section
4(2)
07/15/14
Common Stock
150,000
Gonen, Eli - former Chairman
For Services provided valued at $0.28 per share pursuant to Section 4(2)
07/15/14
Common Stock
250,000
Goore, Ori - former CEO and Director
For Services provided valued at $0.28 per share pursuant to Section 4(2)
07/15/14
Warrants
200,000
Gonen, Eli - former Chairman
Exercisable at $0.14 per share pursuant to Section 4(2)
07/15/14
Warrants
150,000
Goore, Ori - former CEO and Director
Exercisable at $0.14 per share pursuant to Section 4(2)
08/04/14
Warrants
3,500,000
Amir Uziel
For services provided, exercisable at $0.14 per share pursuant to
Section 4(2)
08/04/14
Warrants
700,000
Eli Yorsh
For services provided, exercisable at $0.14 per share pursuant to
Section 4(2)
08/04/14
Warrants
3,500,000
Capitallink Ltd. (14)
For services provided, exercisable at $0.14 per share pursuant to
Section 4(2)
08/04/14
Warrants
2,800,000
L.I.A. Pure Capital Ltd. (15)
For services provided, exercisable at $0.14 per share pursuant to
Section 4(2)
08/04/14
Warrants
3,500,000
Yaad Ltd. (16)
For services provided, exercisable at $0.14 per share pursuant to
Section 4(2)
08/17/14
Units (a)
1,322,222
Invita Pharmaceuticals LLC. (17)
$0.09 per share in cash pursuant to Section 4(2)
07/12/14
Units (b)
166,666
Alan L. Talesnick
$0.15 per share in cash pursuant to Reg S exemption
07/12/14
Units (b)
500,000
Gil Cohan
$0.15 per share in cash pursuant to Reg S exemption
07/08/14
Units (b)
834,000
H. Leigh Severance Inc. (18)
$0.15 per share in cash pursuant to Section 4(2)
07/08/14
Units (b)
834,000
H. Leigh Severance Inc. Pension Plan & Trust (19)
$0.15 per share in cash pursuant to Section 4(2)
08/18/14
Units (b)
1,360,000
NE Solutions Ltd. (20)
$0.15 per share in cash pursuant to Reg S exemption
09/23/14
Units (a)
1,111,111
Prop Trade Ltd. (21)
$0.09 per share in cash pursuant to Reg S exemption
09/23/14
Units (a)
1,111,111
Short Trade Ltd. (22)
$0.09 per share in cash pursuant to Reg S exemption
11/07/14
Common Stock
5,134,375
Dr. Alan Shackelford, CTO of OWC (23)
$0.05 per share in cash pursuant to Section 4(2)
11/07/14
Common Stock
2,104,480
Ziv Turner
$0.05 per share in cash pursuant to Reg S exemption
11/07/14
Common Stock
2,114,480
Uri Glazer
$0.05 per share in cash pursuant to Reg S exemption
11/07/14
Common Stock
861,250
Alon Sinai
$0.05 per share in cash pursuant to Reg S exemption
11/07/14
Common Stock
132,500
Shmuel De-Saban, CFO
$0.05 per share in cash pursuant to Reg S exemption
11/17/14
Unit (b)
166,667
Nissim Atias
$0.15 per share in cash pursuant to Reg S exemption
11/17/14
Unit (b)
66,667
Ido Glazer
$0.15 per share in cash pursuant to Reg S exemption
11/17/14
Unit (b)
43,426
Guy Abraham
$0.15 per share in cash pursuant to Reg S exemption
11/17/14
Unit (b)
61,666
Guy Elad
$0.15 per share in cash pursuant to Reg S exemption
11/17/14
Unit (b)
66,667
Sara Leibovitz
$0.15 per share in cash pursuant to Reg S exemption
11/17/14
Unit (b)
1,030,000
Shem Tov and Claudia Calvo
$0.15 per share in cash pursuant to Reg S exemption
11/17/14
Unit (b)
333,333
Michal and Rafi Farjun
$0.15 per share in cash pursuant to Reg S exemption
11/17/14
Unit (b)
43,859
Shay Kahlon
$0.15 per share in cash pursuant to Reg S exemption
11/17/14
Unit (b)
350,877
Moshe Ashkenazi
$0.15 per share in cash pursuant to Reg S exemption
12/22/2014
Common Stock
200,000
Uri Glazer
$0.05 per share in cash pursuant to Section 4(2)
12/22/2014
Common Stock
150,000
Alon Sinai
$0.05 per share in cash pursuant to Section 4(2)
12/22/2014
Common Stock
2,120,000
Yehuda Baruch
$0.05 per share in cash pursuant to Section 4(2)
12/22/2014
Common Stock
100,000
Mirabelle Gazit
$0.05 per share in cash pursuant to Section 4(2)
12/22/2014
Common Stock
250,000
Dubi Kohva
$0.05 per share in cash pursuant to Section 4(2)
12/22/2014
Common Stock
62,916
Shmuel De-Saban, CFO
$0.05 per share in cash pursuant to Section 4(2)
06/16/2014
Common Stock
100,000
Ten West Holding Ltd. (24)
$0.09 per share in cash pursuant to Section 4(2)
(b) The units include warrants exercisable at $0.25 per share.
(1) Tena Holdings is controlled by Daren Bitan, a resident of Israel.
(2) Amit SA is controlled by Haem Arusi, a resident of Israel.
(3) L&L Holdings is controlled by Ruiz Diaz Rolon Rosa, a resident of Argentina.
(4) Ofliam LLC is controlled by Patric Sasun Resident of Luxembourg
(5) IMWT is controlled by John Shafat, a resident of Austria
(6) KE Zurich
Capital Ltd. is controlled by Tal Yoresh, a resident of Australia.
(7) Branseville Investments is controlled by Albert Oliverio, a resident of Gibraltar.
(8) Short Trade Ltd is controlled by Shlomo Noyman, a resident of Israel.
(9) Avdinco Ltd. is controlled by Avner Cohen, a resident of Israel.
(10) Prop Trade Ltd. is controlled by Charlote Eilin Tay, a resident of Singapore.
(11) R.P. Holdings (1992) Ltd is controlled by Rubin Zimerman, a resident of Israel.
(12) Short Trade Ltd. is controlled by Shlomo Noyman, a resident of Israel.
(13) Securities Compliance Corp. is controlled by Richard Rubin.
(14) Capitallink Ltd. is controlled by Levi Krasney, a resident of Israel.
(15) L.I.A. Pure Capital Ltd. is controlled by Kfir Silberman, a resident of
Israel.
(16) Yaad Ltd.
is controlled by Isaac Shrem, a resident of Israel.
(17) Invita Pharmaceuticals LLC is controlled by Richard S. Greenberg, a resident of the State of Colorado.
(18) H. Leigh Severance Inc. Pension Plan and Trust is controlled by H. Leigh Severance, a resident of the State of Colorado.
(19) H. Leigh Severance Inc. is controlled by H. Leigh Severance, a resident of the State of Colorado.
(20) NE Solutions Ltd. is controlled by Lee Yit Tong, a resident of Singapore.
(21) Prop Trade Ltd. is controlled by Charlote Eilin Tay, a resident of Singapore
(22) Short Trade Ltd. is controlled by Shlomo Noyman, a resident of Israel.
(23 Dr. Alan Shackelford is a US resident and CSO of our wholly-owned subsidiary, One World
cannabis Ltd.
(24) Ten West Holding Ltd. is controlled by Marc Sitzer, a US resident.
(1) To file, during any period in which offers or sales are being made, a post-effective amendment to this registration statement:
(i) To include any prospectus required by Section 10(a)(3) of the Securities Act of 1933;
(ii) To reflect in the prospectus any facts or events arising after the effective date of the registration statement (or the most recent post-effective amendment thereof) which, individually or in the aggregate, represent a fundamental change in the information set forth in the registration statement. Notwithstanding the foregoing, any increase or decrease in volume of securities offered (if the total dollar value of securities offered would not exceed that which was registered) and any deviation from the low or high end of the estimated maximum offering range may be reflected in the form of prospectus filed with the Commission pursuant to Rule 424(b) if, in the aggregate, the changes in volume and price represent no more than 20% change in the maximum aggregate offering price set forth in the "Calculation of Registration Fee" table in the effective registration statement.
(iii) To include any material information with respect to the plan of distribution not previously disclosed in the registration statement or any material change to such information in the registration statement;
(2) That, for the purpose of determining any liability under the Securities Act of 1933, each such post-effective amendment shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof.
(3) To remove from registration by means of a post-effective amendment any of the securities being registered which remain unsold at the termination of the offering.
(4) That, for the purpose of determining liability under the Securities Act of 1933 to any purchaser, each prospectus filed pursuant to Rule 424(b) as part of a registration statement relating to an offering, other than registration statements relying on Rule 430B or other than prospectuses filed in reliance on Rule 430A, shall be deemed to be part of and included in the registration statement as of the date it is first used after effectiveness. Provided, however, that no statement made in a registration statement or prospectus that is part of the registration statement or made in a document incorporated or deemed incorporated by reference into the registration statement or prospectus that is part of the registration statement will, as to a purchaser with a time of contract of sale prior to such first use, supersede or modify any statement that was made in the registration statement or prospectus that was part of the registration statement or made in any such document immediately prior to such date of first use.
(b) Insofar as indemnification for liabilities arising under the Securities Act
may be permitted to directors, officers and controlling persons of the
registrant pursuant to the foregoing provisions, or otherwise, the registrant
has been advised that in the opinion of the SEC such indemnification is against
public policy as expressed in the Securities Act and is, therefore,
unenforceable. In the event that a claim for indemnification against such
liabilities (other than the payment by the registrant of expenses incurred or
paid by a director, officer or controlling person of the registrant in the
successful defense of any action, suit or proceeding) is asserted by such
director, officer or controlling person in connection with the securities being
registered, the registrant will, unless in the opinion of its counsel the matter
has been settled by controlling precedent, submit to a court of appropriate
jurisdiction the question whether such indemnification by it is against public
policy as expressed in the Securities Act and will be governed by the final
adjudication of such issue.
Pursuant to the requirement of the Securities Act of 1933, as amended, the registrant has duly caused this registration statement on Form S-1/A to be signed on its behalf by the undersigned, thereunto duly authorized in the City of Petach Tikva, State of Israel, on August 13, 2015.
OWC PHARMACEUTICAL RESEARCH CORP.
By: /s/ Mordechai Bignitz
Mordechai Bignitz
Chief Executive Officer (Principal Executive Officer)
Pursuant to the requirements of the Securities Act of 1933, this registration statement has been signed by the following persons in the capacities and on the dates indicated.
Signature | Title | Date |
/s/ Mordechai Bignitz | Chairman of the Board | August 13, 2015 |
Mordechai Bignitz | ||
/s/ Mordechai Bignitz | Chief Executive Officer (Principal Executive Officer) | August 13, 2015 |
Mordechai Bignitz | ||
/s/ Shmuel De-Saban | Chief Financial Officer (Principal Financial and Principal Accounting Officer) | August 13, 2015 |
Shmuel De-Saban | ||
CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
We hereby consent
to the inclusion in this Registration Statement on Form S-1 Amendment #2 of our
report dated August 13, 2015, of OWC Pharmaceutical Research relating to
the audit of the financial statements as of December 31, 2014 and 2013 and the
reference to our firm under the caption "Experts" in the Registration Statement.
/s/ M&K CPAS, PLLC
www.mkacpas.com
Houston, Texas
August 13, 2015
ADDENDUM
As of July 27, 2015
to
SERVICE AGREEMENT
As of October 22, 2014
Between
Medical Research Infrastructure Development and Health Services Fund by the
Chaim
Sheba Medical Center
(hereinafter: "the Fund")
And
One World Cannabis Ltd.
(hereinafter: "Client")
Whereas The Parties signed a Service Agreement dated October 22, 2014 ("the Agreement"); and
Whereas The Parties wish to amend the second paragraph of the preamble of the Agreement;
The Parties hereby agree as follows:
1. The preamble to this Addendum constitutes an integral part of the Agreement. Capitalized terms herein shall have the meanings attributed to each such term in the Agreement or any relevant schedule attached to the Agreement.
2. The second paragraph of the preamble to the Agreement shall be replaced with the following wording: "and One World Cannabis Ltd., a private company incorporated under the laws of the state of Israel, having its registered office at 22 Shacham Street (Beit Dvir), Petach Tikva, Israel 4918103, PO Box 8324".
3. The remaining provisions of the Agreement which were not altered in this Addendum shall remain in full force and effect.
4. The Agreement, this Addendum and any Schedules and Exhibits thereto and hereto constitute the entire understanding between the Parties concerning the subject matter hereof and supersedes any prior agreements or understanding whether written or oral. The combined Agreement including this Addendum and any Schedules and Exhibits thereto and hereto shall not be amended except in a writing signed by the Parties hereto.
IN WITNESS WHEREOF, the Parties hereto have executed this Addendum on the date
first set forth above.
Sheba Academic Medical Center One World Cannabis Ltd.
Medical Research Infrastructure
/s/: Ziv Turner
Development and Health Services Fund
Ziv Turner, CEO
/s/: Professor Shlomo Noy
Professor Shlomo Noy, M.D. Ph.D