RISK FACTORS
An investment in our common stock involves significant risks, and should not be made by anyone who cannot afford to lose his or her entire investment. You should consider carefully the following risks, together with all other information contained in this prospectus, before deciding to invest in our common stock. If any of the following events or risks should occur, our business, operating results and financial condition would likely suffer materially and you could lose all or part of your investment.
Risks Relating to Our Business
Our auditors have expressed a going concern modification to their audit report.
Our independent auditors include a modification in their report to our financial statements expressing that certain matters regarding the company raise substantial doubt as to our ability to continue as a going concern. Note 2 to the December 31, 2012 financial statements states that we have not established an ongoing source of revenues sufficient to cover our operating costs and allow us to continue as a going concern. In order to continue as a going concern, we need, among other things, to secure additional capital resources to meet our operating expenses, which we plan to obtain from management and by seeking equity and/or debt financing. However management cannot provide any assurances that we will be successful in accomplishing any of our plans. If we are unable to obtain adequate capital, we could be forced to cease operations.
If we fail to maintain an effective system of internal controls over financial reporting, we may not be able to accurately report our financial results, which could have a material adverse effect on our share price.
Effective internal controls are necessary for us to provide accurate financial reports. We are in the process of documenting and testing our internal control procedures to satisfy the requirements of Section 404 of the Sarbanes-Oxley Act of 2002 and related SEC rules. These regulations require, among other things, management to assess annually the effectiveness of our internal control over financial reporting. During the course of this documentation and testing, we may identify significant deficiencies or material weaknesses that we may be unable to remediate before the deadline for those reports. If our controls fail or management or our independent auditors conclude in their reports that our internal control over financial reporting was not effective, investors could lose confidence in our reported financial information and negatively affect the value of our shares. Also, we could be subject to sanctions or investigations by the SEC or other regulatory authorities, which would require additional financial and management resources.
We have identified a lack of adequate segregation of duties and absence of an audit committee as a material weakness in our internal controls, which could cause stockholders and prospective investors to lose confidence in the reliability of our financial reporting.
We currently have limited segregation of duties among our officers and employees with respect to the preparation and review of financial statements, which is a material weakness in internal controls. If we fail to maintain an effective system of internal controls, we may not be able to accurately report financial results or prevent fraud. As a result, current and potential stockholders could lose confidence in the company's financial reporting which could harm the trading price of our shares.
The company and our independent public accounting firm have identified this as a material weakness in the company's internal controls. The company intends to remedy this material weakness by hiring additional employees and reallocating duties, including responsibilities for financial reporting, among the employees as soon as there are sufficient resources available. However, until such time, this material weakness will continue to exist.
We have a limited operating history and have not recorded revenues or operating profits since inception.
Although the company was formed in 1999, we have had only limited operations and no revenues since inception. We are deemed a development stage company, which is considered inherently more risky than established companies. Because we have no earnings history and there is no assurance that we will realize future revenues, there is substantial doubt as to whether we will achieve profitability. If we are unsuccessful in the development and commercialization of our proposed products and technology, the negative effect on our business would be substantial and our future would be questionable.
We anticipate needing additional financing in order to accomplish our business plan.
At July 23, 2013, we had cash on hand of $15,404 the result of a loan from our CEO. Management estimates that we will require approximately an additional $5,000,000 over the next twelve months to fully implement our current business plan. We expect to incur numerous expenses in our efforts to develop and eventually
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commercialize our proposed products. There is no assurance that we will be able to secure necessary financing, or that any financing available will be available on terms acceptable to us, or at all. Also, any additional offerings of our common stock will dilute the holdings of our then-current stockholders. If necessary, our directors or other stockholders may agree to loan funds to the company, although there are no formal agreements to do so. If we are unable to raise sufficient capital, we would not be able to continue our product development and we would likely have to curtail operations.
Our future success depends on our ability to develop products and technology and ultimately generate revenues from their commercialization, which may be subject to many factors.
Our operations to date have been limited to acquiring the Acquired Products and organizing and staffing our company. Our prospective products are in the early stageof development and we have not yet demonstrated the ability to successfully develop and market any products. The potential to generate future revenues and profits from our business depends on many factors, including, but not limited to the following:
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our ability to secure adequate funding to develop our proposed products and technology into commercially viable products and to obtain regulatory approval of our products;
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our ability to market those products;
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the cost and expenses associated with developing products and gaining regulatory approvals;
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the size and timing of future customer orders, product delivery and customer acceptance, if required;
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the costs of maintaining and expanding operations;
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our ability to compete with existing and new entities that offer the same or similar products; and
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our ability to attract and retain a qualified work force as business warrants.
There can be no assurance that we will be able to achieve any of the foregoing factors or realize revenues and profitability in the immediate future, or at any time.
Due to legal and factual uncertainties regarding the scope and protection afforded by patents and other proprietary rights, we may not have meaningful protection from competition.
Our long-term success will substantially depend upon our ability to protect our proprietary technologies from infringement, misappropriation, discovery and duplication and avoid infringing the proprietary rights of others. Our patent rights and the patent rights of biotechnology and pharmaceutical companies in general, are highly uncertain and include complex legal and factual issues. These uncertainties also mean that any patents that we own or will obtain in the future could be subject to challenge and, even if not challenged, may not provide us with meaningful protection from competition. Due to ongoing capital needs, we may not possess the financial resources necessary to enforce our patents. Patents already issued to us or our pending applications may become subject to dispute, and any dispute could be resolved against us.
If our patents are determined to be unenforceable or expire, or if we are unable to obtain new patents based on current patent applications or for future inventions, we may not be able to prevent others from using our intellectual property.
Our future success will depend in part on our ability to:
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obtain and maintain patent protection with respect to our products;
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prevent third parties from infringing upon our proprietary rights;
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maintain trade secrets;
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operate without infringing upon the patents and proprietary rights of others; and
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obtain appropriate licenses to patents or proprietary rights held by third parties if infringement would otherwise occur.
We have certain pending patent applications with the United States Patent and Trademark Office, specifically on our Nano E-dropsand Anticonvulsant oral spray. We may not be successful in securing final patents on these or other products or be able to maintain or extend the patents if necessary. There can be no assurance that any patents
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issued to us will not be challenged, invalidated, infringed on or circumvented, or that the rights granted thereunder will provide competitive advantages to us.
If we fail to obtain necessary regulatory approvals, we may not be allowed to commercialize our proposed products and we will not generate revenues.
Satisfaction of all regulatory requirements typically takes many years, is dependent upon the type, complexity and novelty of the product candidate, and requires the expenditure of substantial resources for research, development and testing. Our research and clinical approaches may not lead to products or drugs that the U.S. Food and Drug Administration (“FDA”) considers safe for humans and effective for indicated uses. The FDA may require us to conduct additional clinical testing, in which case we would have to expend additional time and resources. The approval process may also be delayed by changes in government regulation, future legislation or administrative action or changes in FDA policy that occur prior to or during our regulatory review. Delays in obtaining regulatory approvals may:
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delay commercialization of, and product revenues from, our product candidates;
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impose costly procedures on us; and
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diminish the competitive advantages that we would otherwise enjoy.
In foreign jurisdictions, we may have to receive marketing authorizations from the appropriate regulatory authorities before we can commercialize and market our proposed products. Foreign regulatory approval processes generally include all of the aforementioned requirements and risks associated with regulatory approval in the United States.
If we are unable to obtain requisite regulatory approvals, we would be unable to commercialize our products or to realize any future revenues. This would have a material adverse effect on our business and we may be forced to cease operations.
We may not be able to maintain necessary confidentiality of our technology and proprietary information.
Patent applications in the U.S. are confidential for a period of time until they are published. Publication of discoveries in scientific or patent literature typically lags actual discoveries by several months. As a result, we cannot be certain that the inventors listed in any patent or patent application owned by us were the first to conceive of the inventions covered by such patents and patent applications, or that such inventors were the first to file patent applications for such inventions.
We also may rely on unpatented trade secrets and know-how and continuing technological innovation to develop and maintain our competitive position, which we may seek to protect, in part, by confidentiality agreements. Presently, we do not have any such agreements. There can be no assurance, however, that future agreements will not be breached, that we will have adequate remedies for any breach, or that trade secrets will not otherwise become known or be independently discovered by competitors.
Our product development program may not be successful.
In addition to the development of the Acquired Products, we expect to pursue development of other potential products in the future. None of our potential pharmaceutical product candidates have commenced clinical trials and there are a number of FDA requirements that we must satisfy in order to commence clinical trials. These requirements will require substantial time, effort and financial resources. We may never satisfy these requirements. In addition, prior to commencing any trials of a drug candidate, we must evaluate whether a market exists for a particular candidate. This is costly and time consuming, and any market studies we rely on may not be accurate. We may expend significant capital and other resources on a candidate and find that no commercial market exists for the drug. Even if we are not required to obtain FDA pre-market approval for our potential product candidates, we will still be subject to a number of federal and state regulations, including regulation by the FDA and the Federal Trade Commission on any marketing claims we make and, we may be unable to satisfy these requirements. As a result, we may never successfully develop and obtain approval to market and sell any of our potential product candidates. Even if we do develop and obtain approval to market and sell such product candidates, we may be unable to compete against the many products and treatments currently being offered or under development by other established, well-known and well-financed cosmetic, health care and pharmaceutical companies.
If we are unable to rely upon the FDA’s accelerated approval process for certain pharmaceutical products, our plans to market some or all of our proposed pharmaceutical products may be jeopardizedseverely.
We intend to rely upon Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act to obtain approval for certain pharmaceutical products without conducting the full complement of safety and efficacy trials mandated by
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the FDA. Section 505(b)(2) is available for drugs that are similar or equivalent to ones already approved by the FDA. An applicant may use an original filer’s information and rely on published studies to demonstrate the safety and effectiveness of a new drug based on a known compound. This could possibly decrease requirements for preclinical investigations and clinical testing, accelerate the clinical approval process, shorten the time to market, and simplify the steps of the product development process. Initially, we intend to apply our technology only to known compounds previously approved by the FDA. Thus, we believe that Section 505(b)(2) could be available to us, which would likely decrease requirements for preclinical investigations and clinical testing and accelerate the overall approval process for our products. There can be no assurance that any of our proposed products will qualify for 505(b)(2) approval, or that we will be successful in completing the shortened approval process for any pharmaceutical product. Our inability to rely upon Section 505(b)(2) would significantly increase development expenses and approval time for our proposed products, which would negatively affect our business plan and our ability to ultimately market our proposed products.
Government agencies may establish and promulgate guidelines that directly apply to our products that may affect the use of our drugs.
Government agencies, professional societies, and other groups may establish guidelines that could apply to our potential future products and technologies. These guidelines could address such matters as usage and dose of our products, among other factors. Application of such guidelines could mitigate the potential use of our products.
Ifultimatelyapproved, there is no guarantee that themarketplace will acceptany ofour proposed products. If we are not successful in introducing products or if the market does not accept our products, our business, financial position, results of operations and stock price would be materially and adversely affected.
Even if weultimatelyobtain regulatory approvals for our proposed products, uncertainty exists as to whether the market will accept them. A number of factors may limit market acceptance, including timing of regulatory approvals and market entry relative to competitive products, availability of alternative products, pricing, availability of third party reimbursement and the extent of our marketing efforts. We cannot assure you thatany of our products will receive regulatory approval or that anyproducts willachieve market acceptance in a commercially viable period of time, if at all. We cannot be certain that any investment made in developing products will be recovered, even if we are successful in commercialization. To the extent that we expend significant resources on research and development efforts and are not able, ultimately, to introduce successful new products, our business will be materially and adversely affected and the market value of our common stock would decline.
We may not become or remain profitable even if our products are approved for sale.
Even if we obtain regulatory approval to market our pharmaceutical products or product candidates, many factors may prevent the products from ever being sold in commercial quantities. Some of these factors are beyond our control, such as:
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acceptance of the formulation or treatment by health care professionals and patients;
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the availability, effectiveness and relative cost of alternative treatments that may be developed by competitors; and
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the availability of third-party (i.e. insurer and governmental agency) reimbursements.
We must depend upon others for marketing and distribution of products. It may become necessary to enter into contracts that limit our potential benefits and control we have over our products. We intend to rely on collaborative arrangements with one or more other companies that possess strong marketing and distribution resources to perform these functions for us, although we have not finalized any such agreements to date. In addition, we will not have the same control over marketing and distribution that we would have if we conducted these functions ourselves.
We may not be able to compete with remedies now being marketed and developed, or which may be developed and marketed in the future by other companies.
Our products, upon development and commercialization will compete with existing and new therapies and treatments. Numerous pharmaceutical, biotechnology and drug delivery companies, hospitals, research organizations, individual scientists and non-profit organizations are engaged in the development of alternatives to our technologies. Most all of these companies have greater research and development capabilities, experience, manufacturing, marketing, financial and managerial resources than we do. Collaborations or mergers between large pharmaceutical or biotechnology companies with competing drug delivery technologies could enhance our competitors’ financial, marketing and other resources. Developments by other drug delivery companies could make our products or technologies uncompetitive or obsolete. Accordingly, our competitors may succeed in developing competing technologies, obtaining FDA approval for products or gaining market acceptance more rapidly than we can.
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If government programs and insurance companies do not agree to pay for or reimburse patients for our pharmaceutical productsfollowing their approval, our success will be negatively impacted.
Sales of our potential pharmaceutical products in U.S. and other markets,considering such products are approved, will depend in part on the availability of reimbursement by third-party payers such as government health administration authorities, private health insurers and other organizations. Third-party payers often challenge the price and cost-effectiveness of medical products and services. Governmental approval of health care products does not guarantee that these third-party payers will pay for the products. Even if third-party payers do accept ourfutureproduct, the amounts they pay may not be adequate to enable us to realize a profit. Legislation and regulations affecting the pricing of pharmaceuticals may change before our products are approved for marketing and any such changes could further limit reimbursement.
We face significant product liability risks, which may have a negative effect on our financial condition.
The administration of drugs or treatments to humans, whether in clinical trials or commercially, can result in product liability claims whether or not the drugs or treatments are actually at fault for causing an injury. Furthermore,if ultimately approvedour pharmaceutical products may cause, or may appear to have caused, serious adverse side effects (including death) or potentially dangerous drug interactions that we may not learn about or understand fully until the drug or treatment has been administered to patients for some time. Product liability claims can be expensive to defend and may result in large judgments or settlements against us, which could have a severe negative effect on our financial condition.
Developments by competitors may render our products or technologies obsolete or non-competitive.
Alternative technologies and products similar to ours are being developed by other companies. Some of these products may be in clinical trials or are awaiting approval from the FDA. In addition, companies that sell generic products represent substantial competition. Most competitors have greater capital resources, larger research and development staffs and facilities and more experience in drug development and in obtaining regulatory approvals. These organizations also compete with us to attract qualified personnel and partners for acquisitions, joint ventures or other collaborations. If we are unable to successfully compete with these other companies, our business will be negatively affected.
We are dependent upon our directors, officer and consultants, the loss of any of whom would negatively affect our business.
We are dependent upon the efforts of our directors, officers and consultants to operate our business. Should any of these persons leave or otherwise be unable to perform their duties, or should any consultant cease their activities for any reason before qualified replacements could be found, there could be material adverse effects on our business and prospects. We have not entered into employment agreements with any individuals and do not maintain key-man life insurance. Unless and until additional employees are hired, our attempt to manage our projects and meet our obligations with such a limited staff could have material adverse consequences, including without limitation, a possible failure to meet a contractual or SEC deadline or other business related obligation.
We may not be able to manage future growth effectively, which could adversely affect our operations and financial performance.
The ability to manage and operate our business as we execute our business plan will require effective planning. Significant future rapid growth could strain management and internal resources that would adversely affect financial performance.We are in the early phase of research and we may not be able to successfully formulate and commercialize any future products. If we do succeed in finalizing and marketing any of our proposed products, we anticipate that potential future growth could place a significant strain on personnel, management systems, infrastructure and other resources. Our ability to manage future growth effectively will also require attracting, training, motivating, retaining and managing new employees and continuing to update and improve operational, financial and management controls and procedures. If we do not manage growth effectively, our operations could be adversely affected resulting in slower growth and a failure to achieve or sustain profitability.
Being a public company involves increased administrative costs, which could result in lower net income and make it more difficult for us to attract and retain key personnel.
As a public company subject to the reporting requirements of the Securities Exchange Act of 1934 (the “Exchange Act,”) we incur significant legal, accounting and other expenses. The Sarbanes-Oxley Act of 2002, as well as new rules subsequently implemented by the SEC, require changes in corporate governance practices of public companies. We expect these new rules and regulations will increase our legal and financial compliance costs and make some activities more time consuming. For example, in connection with being a public company, we may have to create new board committees, implement additional internal controls and disclose controls and procedures,
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adopt an insider trading policy and incur costs relating to preparing and distributing periodic public reports. These rules and regulations could also make it more difficult for us to attract and retain qualified executive officers and members of our board of directors, particularly to serve on our audit committee.
The recently enacted JOBS Act reduces certain disclosure requirements for “emerging growth companies,” thereby decreasing related regulatory compliance costs. We qualify as an emerging growth company as of the date of this offering and may continue to qualify as an “emerging growth company” for up to five years. However, we would cease to qualify as an emerging growth company if:
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we have annual gross revenues of $1.0 billion or more in a fiscal year;
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we have, during the previous three-year period, issued more than $1.0 billion in non-convertible debt; or
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we become a “large accelerated filer”, defined by the SEC as a company with a word-wide public float of its common equity of $700 million or more.
Upon the occurrence of any of the above, we would not be able to take advantage of the reduced regulatory requirements and any associated cost savings.
Risks Relating to the Offering and Ownership of Our Common Stock
Currently, there is no public market for our common stock and there can be no assurance that any public market will ever develop or that our stock will be quoted for trading.
As of the date of this prospectus, there has not been any established trading market for our common stock and there is currently no public market whatsoever for our shares. We intend to contact a broker/dealer to make an initial application to FINRA to have our common shares quoted on the OTCBB. There can be no assurance that FINRA will approve the application or, if approved, that any market for our common stock will develop. If a trading market does develop, we cannot predict the extent to which investor interest will result in an active, liquid trading market.
We do not anticipate our common stock to be followed by any market analysts and, most likely, only a few institutions would act as market makers for our shares. Either of these factors could adversely affect the liquidity and trading price of our common stock. Until an orderly market develops, if ever, the price at which the shares trade will probably fluctuate significantly. Share price will likely be determined in the market and may be influenced by many factors including liquidity, business developments, investor perception and general economic and market conditions. No assurance can be given that an orderly or liquid market for our shares will be developed or maintained. Because of the anticipated low price of our common stock, many brokerage firms may not be willing to effect transactions in our common stock.
The stock price of our common stock in the public market may be volatile and subject to numerous factors.
There can be no assurance that our common stock will be accepted for quotation on the OTCBB or that an active trading market for our shares will ever develop or be maintained. Accordingly, even if a market is created it could be difficult for holders of our common stock to liquidate their shares. Any trading market for our shares will most likely be very volatile and subject to numerous factors, many beyond our control. Some factors that may influence the price of our shares are:
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our ability to develop our patents and technology into commercially viable products;
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our ability to achieve and maintain profitability;
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changes in earnings estimates and recommendations by financial analysts;
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actual or anticipated variations in our quarterly and annual results of operations;
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changes in market valuations of similar companies;
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announcements by us or our competitors of significant contracts, new products or drugs, acquisitions, commercial relationships, joint ventures or capital commitments; and
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general market, political and economic conditions.
In the past, following periods of extreme volatility in the market price of a particular company's securities, securities class action litigation has often been instituted. A securities class action suit against us could result in
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substantial costs and divert management's time and attention, which would otherwise be used to benefit our business.
Any trading market that may develop could be restricted because of state securities “Blue Sky” laws that prohibit trading absent compliance with individual state laws.
Transfer of our common stock may be restricted under the securities laws promulgated by various states and foreign jurisdictions, commonly referred to as Blue Sky laws. Individual state Blue Sky laws could make it difficult or impossible to sell our common stock in those states. A number of states require that an issuer’s securities be registered in their state, or appropriately exempted from registration, before the securities can trade in that state. We have no immediate plans to register our securities in any particular state. Absent compliance with such laws, our common stock may not be traded in such jurisdictions. Whether stockholders may trade their shares in a particular state is subject to various rules and regulations of that state.
Future operating results are difficult to predict.
We will likely experience significant quarter-to-quarter fluctuations in revenues, if any, and net income (loss) in the future. Until we are able to emerge from the development stage, we are not likely to realize any significant revenues and our quarter-to-quarter comparisons of historical operating results will not be a good indication of future performance. It is likely that in some future quarter, operating results may fall below the expectations of securities analysts and investors, which could have negative impact on the price of our common stock.
Effective voting control of our company is held by directors and certain principal stockholders.
Approximately 99% of our outstanding shares of common stock are held by directors and a small number of principal (5%) stockholders. These persons have the ability to exert significant control in matters requiring stockholder vote and may have interests that conflict with other stockholders. As a result, a relatively small number of stockholders acting together, have the ability to control all matters requiring stockholder approval, including the election of directors and approval of other significant corporate transactions. This concentration of ownership may have the effect of delaying, preventing or deterring a change in control of our company. It could also deprive our stockholders of an opportunity to receive a premium for their shares as part of a sale of our company and it may affect the market price of our common stock.
We do not expect to pay dividends in the foreseeable future, which could make our stock less attractive to potential investors.
We anticipate that we will retain any future earnings and other cash resources for operation and business development and do not intend to declare or pay any cash dividends in the foreseeable future. Any future payment of cash dividends will be at the discretion of our board of directors after taking into account many factors, including operating results, financial condition and capital requirements. Corporations that pay dividends may be viewed as a better investment than corporations that do not.
Future trading in our shares will most likely be subject to certain "penny stock” regulation, which could have a negative effect on the price of our shares in the marketplace.
In the event our common stock is approved for quotation of the OTCBB or other marketplace, of which there can be no assurance, trading will likely be subject to certain provisions and broker-dealer requirements, commonly referred to as penny stock rules, promulgated under the Exchange Act. A penny stock is generally defined to be any equity security that has a market price less than $5.00 per share, subject to certain exceptions. These sales practice provisions may require a broker dealer to:
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make a special suitability determination for purchasers of penny stocks;
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receive the purchaser's prior written consent to the transaction; and
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deliver to a prospective purchaser of a penny stock, prior to the first transaction, a risk disclosure document relating to the penny stock market.
Consequently, penny stock rules may restrict the ability of broker-dealers to trade and/or maintain a market in our common stock, which would affect the ability of stockholders to sell their shares. Broker-dealers may consider these requirements to be too cumbersome and impact their willingness to make a market in our shares. Also, many prospective investors may not want to get involved with the additional administrative requirements, which may have a material adverse effect on the trading of our shares.
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Future sales or the potential for sale of a substantial number of shares of our common stock could cause our market value to decline.
As of the date of this prospectus, we have 31,625,000 shares of common stock outstanding, of which 472,450, shares, or approximately 1.5% of the total outstanding, are being offered by selling stockholders under this prospectus. The shares offered by selling stockholders will be freely tradable without restriction upon the effectiveness of our registration statement.
Of the remaining shares outstanding, 31,152,550 shares are considered restricted securities and may be sold only pursuant to a registration statement or the availability of an appropriate exemption from registration, such as Rule 144. Our stockholders may not avail themselves to Rule 144 until May 29, 2013. Sales of a substantial number of these restricted shares in the public markets, or the perception that these sales may occur, could cause the market price of our common stock to decline and materially impair our ability to raise capital through the sale of additional equity securities.
In the event we issue additional common stock in the future, current stockholders could suffer immediate and significant dilution, which could have a negative effect on the value of their shares.
We are authorized to issue 100 million shares of common stock, of which 68,375,000 shares are unissued. Our board of directors has broad discretion for future issuances of common stock, which may be issued for cash, property, services rendered or to be rendered, or for several other reasons. We also could possibly issue shares to make it more difficult or to discourage an attempt to obtain control of the company by means of a merger, tender offer, proxy contest, or otherwise. For example, if in the due exercise of its fiduciary obligations the board determines that a takeover proposal was not in the company's best interests, unissued shares could be issued by the board without stockholder approval. This might prevent, or render more difficult or costly, completion of an expected takeover transaction.
We do not presently contemplate additional issuances of common stock in the immediate future, except to raise addition capital, although we presently do not have an agreement or understanding to sell additional shares. Our board of directors has authority, without action or vote of our stockholders, to issue all or part of the authorized but unissued shares. Any future issuance of shares will dilute the percentage ownership of existing stockholders and likely dilute the book value of the common stock, which could cause the price of our shares to decline and investors in the shares to lose all or a portion of their investment.
The existence of warrants, options, debentures or other convertible securities would likely dilute holdings of current stockholders and new investors.
As of the date of this prospectus, there are no options, warrants or other rights outstanding to purchase our common stock. If management decides to issue convertible securities, such as funding instruments or incentive options to key employees, the existence of these convertibles may hinder future equity offerings. The exercise of outstanding options or convertible securities would further dilute the interests of all of our existing stockholders. Future resale of common shares issuable on the exercise of convertible securities may have an adverse effect on the prevailing market price of our common stock. Furthermore, holders of convertible securities may have the ability to exercise them at a time when we would otherwise be able to obtain additional equity capital on terms more favourable to us.
As an “emerging growth company,” we cannot be certain if the reduced disclosure requirements applicable to emerging growth companies will make our common stock less attractive to investors.
We are an "emerging growth company," as defined in the JOBS Act. Accordingly, we are eligible to take advantage of certain exemptions from various reporting requirements applicable to other public companies that are not emerging growth companies. Additionally, Section 107 of the JOBS Act provides that an emerging growth company can take advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act for complying with new or revised accounting standards. An emerging growth company can therefore delay the adoption of certain accounting standards until those standards would otherwise apply to private companies. We have irrevocably elected not to take advantage of the benefits of this extended transition period and, therefore, will be subject to the same new or revised accounting standards as other public companies that are not emerging growth companies.
As long as we are an emerging growth company, we cannot predict if investors will find our common stock less attractive because we may rely on exemptions provided by the JOBS Act. If some investors find our common stock less attractive as a result, there may be a less active trading market for our common stock and our stock price may be more volatile.
FORWARD-LOOKING INFORMATION
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This prospectus contains certain forward-looking statements relating to future events or our future financial performance. In some cases, you can identify forward-looking statements by terminology such as “may,” “will” “should," “expect," "intend," "plan," anticipate," "believe," "estimate," "predict," "potential," "continue," or similar terms, variations of such terms or the negative of such terms. These statements are only predictions and involve known and unknown risks, uncertainties and other factors, including those risks discussed in the “Risk Factors” section beginning on page 6. Although forward-looking statements, and any assumptions upon which they are based, are made in good faith and reflect our current judgment, actual results could differ materially from those anticipated in such statements. Except as required by applicable law, including the securities laws of the United States, we do not intend to update any of the forward-looking statements to conform these statements to actual results.
DILUTION
We are not offering or selling any of the shares of common stock in this offering. All of the offered shares are held by selling stockholders and, accordingly, no dilution will result from the sale of the shares.
MARKET FOR OUR COMMON STOCK
There is not currently, nor has there ever been, a public trading market for our common stock. As of the date hereof, there are approximately 43 stockholders of record of our common stock. We are requesting a broker/dealer to make an initial application to FINRA to have our shares quoted on the OTCBB. The application consists of current corporate information, financial statements and other documents as required by Rule 15c2-11 of the Exchange Act.
Inclusion on the OTCBB will permit price quotations for our shares to be published by that service, although we do not anticipate a public trading market in our shares in the immediate future. Except for the application to the OTCBB, we have no plans, proposals, arrangements or understandings with any person concerning the development of a trading market in any of our securities. There can be no assurance that our shares will be accepted for quotation and trading on the OTCBB or any other recognized trading market. Also, there can be no assurance that a public trading market will develop following acceptance by the OTCBB or at any other time in the future or, that if such a market does develop, that it can be sustained.
The ability of individual stockholders to trade their shares in a particular state may be subject to various rules and regulations of that state. A number of states require that an issuer's securities be registered in their state or appropriately exempted from registration before the securities are permitted to trade in that state. Presently, we have no plans to register our securities in any particular state.
Penny Stock Rule
It is unlikely that our securities will be listed on any national or regional exchange or The Nasdaq Stock Market in the foreseeable future. Therefore our shares most likely will be subject to the provisions of Section 15(g) and Rule 15g-9 of the Exchange Act, commonly referred to as the "penny stock" rule. Section 15(g) sets forth certain requirements for broker-dealer transactions in penny stocks and Rule 15g-9(d)(1) incorporates the definition of penny stock as that used in Rule 3a51-1 of the Exchange Act.
The SEC generally defines a penny stock to be any equity security that has a market price less than $5.00 per share, subject to certain exceptions. Rule 3a51-1 provides that any equity security is considered to be a penny stock unless that security is:
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registered and traded on a national securities exchange meeting specified criteria set by the SEC;
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authorized for quotation on The Nasdaq Stock Market;
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issued by a registered investment company;
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excluded from the definition on the basis of price (at least $5.00 per share) or the issuer's net tangible assets; or
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exempted from the definition by the SEC.
Broker-dealers who sell penny stocks to persons other than established customers and accredited investors, are subject to additional sales practice requirements. An accredited investor is generally defined as a person with assets in excess of $1,000,000, excluding their principal residence, or annual income exceeding $200,000, or $300,000 together with their spouse.
For transactions covered by these rules, broker-dealers must make a special suitability determination for the purchase of such securities and receive the purchaser's written consent to the transaction prior to the purchase.
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Additionally, the rules require the delivery, prior to the first transaction, of a risk disclosure document relating to the penny stock market. A broker-dealer also must disclose the commissions payable to both the broker-dealer and the registered representative and current quotations for the securities. Finally, monthly statements must be sent to clients disclosing recent price information for the penny stocks held in the account and information on the limited market in penny stocks. Consequently, these rules may restrict the ability of broker-dealers to trade and/or maintain a market in our common stock and may affect the ability of stockholders to sell their shares.
These requirements may be considered cumbersome by broker-dealers and impact the willingness of a particular broker-dealer to make a market in our shares, or they could affect the value at which our shares trade. Classification of the shares as penny stocks increases the risk of an investment in our shares.
Rule 144
A total of 31,152,550 shares of our common stock presently outstanding and not being registered for resale under this prospectus, are deemed to be “restricted securities” as defined by Rule 144 under the Securities Act of 1933 (the “Securities Act”). Rule 144 is the common means for a stockholder to resell restricted securities and for affiliates, to sell their securities, either restricted or non-restricted control shares. The SEC amended Rule 144, effective February 15, 2008.
Under the amended Rule 144, an affiliate of a company filing reports under the Exchange Act who has held their shares for more than six months, may sell in any three-month period an amount of shares that does not exceed the greater of:
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the average weekly trading volume in the common stock, as reported through the automated quotation system of a registered securities association, during the four calendar weeks preceding such sale, or
● 1% of the shares then outstanding.
Sales by affiliates under Rule 144 are also subject to certain requirements as to the manner of sale, filing appropriate notice and the availability of current public information about the issuer.
A non-affiliate stockholder of a reporting company who has held their shares for more than six months, may make unlimited resales under Rule 144,provided only that the issuer has available current public information about itself. After a one-year holding period, a non-affiliate may make unlimited sales with no other requirements or limitations.
An important exception to the availability of the amended Rule 144 is that Rule 144 is not available for either a reporting or non-reporting shell company, unless the company:
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has ceased to be a shell company;
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is subject to the Exchange Act reporting obligations;
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has filed all required Exchange Act reports during the preceding twelve months; and
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at least one year has elapsed from the time the company filed with the SEC, current Form 10 type information reflecting its status as an entity that is not a shell company.
Because we were classified as a “shell” company, stockholders who currently hold restricted shares of common stock, will not be able to rely on Rule 144 until one year after we ceased to be a shell company and have filed with the SEC adequate information that we are no longer a shell company. On May 29, 2012, we filed a Form 8-K Current Report announcing that were completed the Acquisition Agreement and that we were no longer considered a shell company. The information included in the Form 8-K was intended to be adequate information that would otherwise be included in a registration statements. Accordingly, our stockholders, both affiliates and non affiliates, will be eligible to use Rule 144 after May 29, 2013, one year from the initial filing of the Form 8-K.
We cannot predict the effect any future sales under Rule 144 may have on the market price of our common stock, if a market for our shares develops, but such sales may have a substantial depressing effect on such market price.
DIVIDEND POLICY
We have never declared cash dividends on our common stock, nor do we anticipate paying any dividends on our common stock in the future.
THE OFFERING – PLAN OF DISTRIBUTION
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Commencing the date of this prospectus, selling stockholders identified herein may offer and sell up to 472,450 shares of our common stock. Selling stockholders will initially offer their shares at $0.10 per share until such time as the shares are approved for and quoted on the OTCBB. Thereafter, the shares will be offered at market prices, if a market develops, or at privately negotiated prices. There is currently no trading market or quoted price for our stock. The above offering price has been arbitrarily determined without any relation to factors such as a value determination, price earnings ratio, book value, or any other objective criteria.
Contemporaneously with the filing of the registration statement, to which this prospectus relates, we will request that a broker-dealer submit an application to have our shares quoted on the OTCBB. There can be no assurance that our shares will be accepted by the OTCBB, or that an active market for our shares will be established.
The term "selling stockholders" includes pledges, transferees or other successors-in-interest selling shares received from the selling stockholders as pledges, assignees, borrowers or in connection with other non-sale-related transfers. This prospectus may also be used by transferees of selling stockholders, including broker-dealers or other transferees who borrow or purchase the shares to settle or close out short sales. Selling stockholders will act independently of the company in making decisions with respect to the timing, manner and size of each sale or non-sale related transfer. We will not receive any of the proceeds from sales by the selling stockholders.
At such time when our shares are approved for quotation on the OTCBB, we expect selling stockholders will sell their shares primarily through the over-the-counter at prevailing market prices. Selling stockholders may sell, from time-to-time in, one or more transactions at or on any stock exchange, market or trading facility on which the shares are traded, or in private transactions. Sales may be made at fixed or negotiated prices, and may be affected by means of one or more of the following transactions, which may involve cross or block transactions:
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| ● | Ordinary brokerage transactions and transactions in which the broker-dealer solicits purchasers; |
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| ● | 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 to facilitate the transaction; |
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| ● | purchases by a broker-dealer as principal and resale by the broker-dealer for its account; |
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| ● | an exchange distribution in accordance with the rules of the applicable exchange; |
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| ● | Privately negotiated transactions; |
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| ● | settlement of short sales; |
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| ● | transactions in which broker-dealers may agree with one or more selling stockholders to sell a specified number of such shares at a stipulated price per share; |
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| ● | through the writing or settlement of options or other hedging transactions, whether through an options exchange or otherwise; or |
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| ● | a combination of any of the above or any other method permitted pursuant to applicable law. |
Selling stockholders may also sell shares under existing exemptions under the Securities Act, such as Rule 144 if available, rather than under this prospectus. Each selling stockholder has the sole discretion to not accept any purchase offer or make any sale if they deem the purchase price to be unsatisfactory at a particular time. To the extent required, this prospectus may be amended and supplemented from time to time to describe a specific plan of distribution.
Broker-dealers engaged by selling stockholders may arrange for other broker-dealers to participate in sales. Broker-dealers may receive commissions or discounts from the selling stockholders or, if any broker-dealer acts as agent for the purchase of shares, from the purchaser in amounts to be negotiated. Selling stockholders do not expect these commissions and discounts to exceed what is customary in the types of transactions involved.
In connection with sales of common stock or interests therein, selling stockholders may enter into hedging transactions with broker-dealers or other financial institutions, which may in turn engage in short sales in the course of hedging the positions they assume. Selling stockholders may engage in short sales, puts and calls or other transactions in our shares or derivatives of our securities, and may sell and deliver shares in connection with these transactions.
Selling stockholders and broker-dealers or agents involved in an arrangement to sell any of the offered shares may, under certain circumstances, will be deemed an "underwriter" within the meaning of the Securities Act. Any profit on such sales and any discount, commission, concession or other compensation received by any such
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underwriter, broker-dealer or agent, may be deemed an underwriting discount and commission under the Exchange Act. No selling stockholder has informed us that they have an agreement or understanding, directly or indirectly, with any person to distribute the common stock. If a selling stockholder notifies us that they have a material arrangement with a broker-dealer for the resale of their shares, we will be required to amend the registration statement, of which this prospectus is a part, and file a prospectus supplement to describe such arrangement.
We have agreed to pay all fees and expenses related to the registration of the common stock, including SEC filing fees. Each selling stockholder will be responsible for all costs and expenses in connection with the sale of their shares, including brokerage commissions or dealer discounts. We will indemnify selling stockholders against certain losses, claims, damages and liabilities, including certain liabilities under the Securities Act.
Common shares sold pursuant to this prospectus will be considered freely tradable in the hands of persons acquiring the shares, other than our affiliates.
Selling stockholders will be subject to applicable provisions of the Exchange Act and the rules and regulations thereunder, which provisions may limit the timing of purchases and sales of our common stock by them. The foregoing may affect the marketability of such securities. To comply with the securities laws of certain jurisdictions, if applicable, the common stock will be offered or sold in such jurisdictions only through registered or licensed brokers or dealers.
Selling stockholders and others participating in the sale or distribution of the shares offered hereby, are subject to Regulation M of the Exchange Act. With certain exceptions, Regulation M restricts certain activities of, and limits the timing of purchases and sales of shares by, selling stockholders, affiliated purchasers and any broker-dealer or other person participating in the sale or distribution. Under Regulation M, these persons are precluded from bidding for or purchasing, or attempting to induce any person to bid for or purchase, any security subject to the distribution until the distribution is complete. Regulation M also prohibits any bids or purchases made in order to stabilize the price of a security in connection with the distribution of that security. All of these limitations may affect the marketability of the shares offered by this prospectus.
No selling stockholder is a broker-dealer or an affiliate of a broker-dealer.
SELLING STOCKHOLDERS
We are registering the common stock offered for resale pursuant to this prospectus in order to afford stockholders the opportunity to sell their shares in a public transaction. Selling stockholders are offering up to 472,450 shares of our common stock. The following table provides information regarding the beneficial ownership of our common stock being offered by selling stockholders. Each selling stockholder’s percentage of ownership depicted below is based on 31,625,000 shares outstanding as of the date of this prospectus. The table includes the number of shares owned beneficially by each selling stockholder, the number of shares that may be offered for resale and the number of shares to be owned beneficially by each selling stockholder after the offering. The table has been prepared on the assumption that all the shares of common stock offered hereby will be sold.
Of the 472,450 shares offered, 350,000 shares (74.1%) are being offered by 9 stockholders considered to be affiliates, whether as an officer, director, promoter or principal (5%) stockholders. These stockholders are as follows:
Directors
Anna Gluskin
50,000 shares
Mirjana Hasanagic
25,000 shares
Brian Lukian
25,000 shares
Geoff Williams
50,000 shares
Officers
Joseph Schwarz
25,000 shares
Michael Weisspapir
25,000 shares
5% Stockholders
Edward Cowle
50,000 shares
TGT Investments
50,000 shares
H. Deworth Williams
50,000 shares
In computing the number of shares beneficially owned by a selling stockholder and the percentage ownership of that selling stockholder, we have included all shares of common stock owned or beneficially owned by that selling stockholder. Each selling stockholder may offer shares for sale, from time-to-time, in whole or in part. Except where otherwise noted, each selling stockholder named below has, to the best of our knowledge, sole voting and investment power with respect to the shares beneficially owned by them.
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Any or all of the securities listed below may be retained by any of the selling stockholders and, therefore, no accurate forecast can be made as to the number of securities that will be held by the selling stockholders upon termination of this offering. The selling stockholders are not making any representation that any shares covered by this prospectus will be offered for sale.
Common stock: 100,000,000 shares authorized,
| | | | |
| Par value of $0.00001; 31,625,000 shares issued and outstanding | 316 |
Additional paid-in capital | | 134,884 |
Deficit accumulated during development stage
(910,702)
| |
Total stockholders' deficit | $ (775,502) |
LEGAL PROCEEDINGS
From time-to-time, we may be involved in various claims, lawsuits, and disputes with third parties incidental to the normal operations of our business. As of the date of this prospectus, we are not aware of any material claims, lawsuits, disputes with third parties or regulatory proceedings that would have a material affect on our company.
BUSINESS
We are primarily engaged in the development ofnovel formulations of natural compounds and pharmaceutical products, which presently have perceived limitations in effective use for human consumption. We intend to accomplish this bydeveloping our proprietary self-emulsifying drug delivery systems, predominantly forming nanoemulsions.Although we have not finalized any products and are in the early stages of research, our goal is to be able to develop patentable formulations of pharmaceutical, nutraceutical dietary supplements and consumer health products that potentially can be used for various health conditions andsymptoms.
Our self-emulsifying drug delivery technology includes two different approaches that we believecould ultimately improvesolubility of poorly bioavailable compoundsand provide new methods of delivery. Theseperceived approachesconsist of (i) a self-nanoemulsifying vehicles for oral or topical use, and (ii) a technological approachintended to improve solubility of incorporated compounds. We believe that our technologies canbe applied forproducts based on natural and well-established compounds with known biological activities.
In developing our proposed products, we intend to use modern delivery technologies. Some examples are:
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nanoemulsification and nanoencapsulation;
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polymer-lipid mixed micelles;
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various fast dissolving / fast absorbing oral forms with enhanced sublingual transmucosal drug transport and absorption; and
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solubility improvement of poorly soluble compounds for molecules with known biological activity and well established safety profiles.
We believe that developing these delivery technologies using known compounds could possibly decrease requirements for preclinical investigations and clinical testing, accelerate the clinical approval process, shorten the time to market, and simplify the steps of the product development process. This can be possible for drugs that are similar or equivalent to ones already approved the Food and Drug Administration (“FDA”). Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act permits a company to obtain FDA approval of a New Drug Application (“NDA”) without conducting the full complement of safety and efficacy trials. An applicant under Section 505(b)(2) may use the original filer’s information and rely on published studies to demonstrate the safety and effectiveness of the new drug based on a known compound.
We are presently applying our technology only to knownpharmaceuticalcompounds that have been previously approved by the FDA. Thus, we believe that Section 505(b)(2) could possibly be available to us, which would likely decrease requirements for preclinical investigations and clinical testing and accelerate the overall approval time for our products, although there can be no assurance of this. Further, if we are able to use Section 505(b)(2) in the development of our products, we would expect that it would simplify the steps of the product development process and shorten the time required for our products to reach the market place.
Some of our proposed products beingdeveloped are based on existing naturalcompounds in the areas ofwellness, skin sanitizing, skin improvement, weight control andhealthy blood glucose management. Many of our proposed products are made of essential oils and extracts, whichwe believe may be useful in maintenance of a healthy urinary system. Additionally, some of proposed products use nanoemulsions technologies and solubilising delivery systems with enhanced transportation of included active compounds via transdermal and transmucosalways.
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Our technologies use excipients that we believe are safe and approved for human consumption and our proposed products can be manufactured using common equipment. We believe that these approaches are patentable and suitable for wide variety of active compounds. We further believe that the technologies can be applied to a variety of pharmaceuticals and natural components and may allow development of products for different applications and different routes of administration.
In October 2012, our CEO, Anna Gluskin, contributed to the company the corporate entity Eastgate Pharmaceuticals Inc., a Province of Ontario, Canada corporation, of which Ms. Gluskin was the sole shareholder, officer and director. Thus, Eastgate Pharmaceuticals became and will operate as our wholly owned subsidiary. Initially, we deposited into Eastgate Pharmaceuticals the $100,000 proceeds from a demand promissory note for use by the company. Subsequently in December 2012, Eastgate Pharmaceutical was the signing party to a distribution agreement with Mediq Dansmark A/S. We anticipate that we may conduct many of our future operations in Canada through thesubsidiary.
Glossary of Terms
To better understand the information discussed herein, we are including the following description of some of the terms used herein.
Bioavailability. A measurement of the rate and extent to which a drug is absorbed into the blood stream. An increase of bioavailability of 50% may allow for a decrease in the necessary dosage of the drug by 1.5 times, subsequently diminishing the side effects.
Bioadhesion. A property of a substance to adhere to body tissues and remain there for an extended period of time.
Chylomicrons. Chylomicrons are lipoprotein particles formed from digested food lipids, created by the absorptive cells of the small intestine. They transport required lipids to the liver, spleen, cardiac and skeletal muscle tissue, where their content is unloaded by the activity of the enzymes. Chylomicrons have a diameter of 75 to 1,200 nanometers (“nm”). They are released into lymphatic vessels in the small intestine and are then secreted into the bloodstream.
Emulsion. A mixture of two liquids that are normally not miscible (unblendable). In oil-in-water emulsion, for example, liquid oil is dispersed in the water with help of surfactant.
Excipient. Generally an inert or inactive material used as a carrier for an active ingredient or drug.
Hydrophobic compounds. Compounds that are repelled by water and are usually insoluble in water. Examples of hydrophobic compounds include oils, fats, waxes and greasy substances. The wordhydrophobic is constructed of two Greek words;hydro – water, andphobe – fear, which means something with a fear of water.
Homogeneous vehicle of water miscible non-irritating polar solvents and pharmaceutically acceptable surfactants. Relates to efficient vehicle for enhanced local and transdermal delivery of hydrophobic poorly soluble compounds.
In situ. Describes the process happening in the moment of combining of two different phases or components. Nanoemulsion forms“in situ” after combining of SNEDDS (defined below) and water media without use of any special equipment or application of additional force.
Micelles and polymer-lipid micelles. A micelle is an aggregate of surfactant molecules, having polar heads and non-polar tails. A typical micelle in aqueous solution forms an aggregate with the hydrophilic "head" regions in contact with while the hydrophobic tails form the micelle core. The driving force for spontaneous micelle formation is the hydrophobic interaction. Combination of some surfactants, lipidic components and polymeric molecules leads to formation of “polymer-lipid mixed micelles.” These mixed micelles demonstrate high drug loading and improved stability
Nanoemulsion. Nanoemulsion is thermodynamically stable emulsion where two immiscible liquids (water and oil phases) are mixed to form a biphasic system by means of an appropriate surfactants. Nanoemulsion droplet sizes fall typically in the narrow range of 10-200 nm and show narrow size distributions. The use of nanoemulsions as drug carriers show promise for the future of cosmetics, diagnostics, drug therapies, and biotechnology.
Nanoemulsification and self-nanoemulsifying drug delivery system (SNEDDS).Self-emulsifying microemulsions (SMEDDS) or self-emulsifying nanoemulsions (SNEDDS) are homogenous mixtures of natural or synthetic oils, surfactants and, sometimes, one or more pharmaceutical compounds. During combining of self-emulsifying composition with aqueous media, such as saliva, blood, gastrointestinal (GI) fluid and other, a fine oil-
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in-water (o/w) emulsion with average droplets size smaller than 300 nm, usually in range 10-100 nm forms immediately (“ in situ” nanoemulsification). Fine oil droplets are absorbed rapidly in the gastro-intestinal tract. In contrast to traditional submicron emulsions, SNEDDS are physically stable formulations that are easy to manufacture. Additionally, SNEDDS may improve the rate and extent of drug absorption and pharmacokinetics parameters of lipophilic drugs.
Surfactants. A surfactant is a compound that stabilizes mixtures of oil and water by reducing the surface tension at the interface between the oil and water phases. Because water and oil do not dissolve in each other, a surfactant has to be added to the mixture to keep droplets from merging and separating into layers.
Product Overview
Our fundamental strategy is to developnovel, patentable formulationsof pharmaceutical products that we believecould be useful in thetreatment of various diseases and symptoms.Although we are in the early stages of research, we believe that various dietary supplements, based on natural products incorporated into ourself-emulsifying drugdelivery systems, could prove to be beneficial formaintaining good health. Low solubility of many biologically active compounds remain a serious problem for modern drug development, with an estimated one-third of the drugs described as insoluble or poorly soluble in water. Many natural and synthetic compounds, herbal extracts and essential oils are insoluble in water. Further, traditional approaches used to overcome low solubility by using of organic solvents, pH variation or micronization, can result in clinical problems ranging from low and erratic bioavailability to serious side effects such as localirritation.
Self-Emulsifying vehicle for oral use
Our self-emulsifying vehicle is a delivery system built with a combination of scientifically selected, physiologically acceptable components in a predetermined ratio.Our preliminary research has shown that all active components are dissolved in the vehicle that provides an immediate formation of oil-in-water emulsion after contact with water media. The oil droplets of the formed emulsion are smaller than 300 nm, sometimes as small as 10-30 nm. Biologically active components remain associated with the oil droplets of the formed emulsion.
We believe that incorporation of active ingredients into the emulsion helps to improve bioavailability since small oil droplets are absorbed more easily in the gastro-intestinaltract. We also believe that the self-emulsifying vehiclemay exhibit taste-masking properties that can potentially hide the unpleasant taste of included components.
It is our intention to show that the self-nanoemulsifying technology couldprovide:
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Increased solubility of the active components (drugs, oils and herbal extracts) and total loading;
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“In situ” forming stable nanoemulsions without application of external force; and
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Active transport of fine drug-loaded oil droplets in gastro-intestinal tract active transportation pathways by mimicking usual behaviour of chylomicrons.
Our new proprietary formulations are built with safe, well-established components that have been previously approved for human use. Our goal forour proposed productsis to be stable,to have low irritation potential andso that theycould be manufactured with readily available industry-standard equipment.It is also our intention to establish that, once developed, our proposed products could be used for the systemic delivery of biologically active hydrophobic compounds, natural essential oils, lipophilicvitamins and other poorly soluble compounds.
We are developing potential topical products, based on a solubility-improved platform, that we believe can be ultimately implemented for delivery ofa poorly soluble antifungal compound. Additionally, we believe that we can develop natural health products, based on a combination of essential oils and poorly soluble herbal extracts in a proprietary penetration enhancedvehicle.
Business Strategy
Our primary business strategy capitalizes on the growing interest inthe followingareas:
1.
Developing innovative therapeutic products. Our goal is to discover, develop and commercialize innovative therapeuticproducts using our delivery technologies, and incorporate poorly soluble compounds having known biological activity and well established safety profiles into novel dosage forms.
2.
Alternative health care including dietary supplements and nutraceuticals. We believe that people are increasingly interested in alternative approaches to health care. Many people seek help with alternative forms of health care. An important component of alternative health care is the use of nutraceuticals and dietary supplements.
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Technology and Products
Our Technology
It is our belief and our research is focused on establishing that our technology can improve solubility of poorly soluble drugs andenhance the absorptionof incorporated components. Thiscould make it possible to increase efficacy of the medicines and could present an alternative delivery route. This technology is based on the formation of nanoemulsion with extremely small droplet size, usually smaller than 100 nm, upon contact of the formulation with body fluids or water media. Formed small droplets containing poorly soluble drug are actively absorbed to the blood stream.
Bioavailability Enhancement by Micro and Nano-Emulsification Technologies: Scientific Background
There are several scientific reviews describing the use of self-emulsifying formulations for improvement of solubility and bioavailability of poorly soluble compounds. Referencing a review by He C-X. et al, (2010), at least 40% of new pharmacologically active chemical entities identified by high-throughput screening have a problem with water solubility. Poor water solubility correlates with numerous issues such as impaired bioavailability and increased cost of drug products. Oral administration of poorly water-soluble drugs can result in low drug dissolution rate and poor absorption in the gastrointestinal tract, whereas intravenous administration of such compounds accompanied by adverse effects and toxic reactions as a result of the precipitation and aggregation of poorly soluble drugs. Therefore, efforts have been made to improve the solubility of the drug candidates. The usual formulation strategy is the conversion of a drug into a salt form by pH adjustment, if possible. If the drug is intrinsically insoluble, there are still various strategies available, such as the use of co-solvents, inclusion complexes, nanosuspensions, micelles, liposomes, polymeric nanoparticles, micro- and nanoemulsions or solid dispersions.1
Kohli K. et al. (2010) describes self-emulsifying drug delivery systems as a vital tool in solving low bioavailability issues of poorly soluble drugs. Hydrophobic drugs can be dissolved in these systems, designed for oral administration. When such system is released in the lumen of the gastrointestinal tract, it disperses to form a fine micro- or nanoemulsion with the aid of gastrointestinal fluid. This leads toin situ solubilization of drug that can subsequently be absorbed dominantly via the lymphatic pathway, bypassing the hepatic first-pass effect. This article presents a scientific body of various published reports on diverse types of self-emulsifying formulations with emphasis on their formulation, characterization and in vitro analysis, with examples of currently marketed preparations.2
Other published scientific articles outline significant increases in bioavailability of poorly soluble biologically active compounds, incorporated into a Self-Emulsifying Drug Delivery System (“SEDDS”). SEDDS is a broad term, typically related to technologies providing emulsions with a droplet size ranging from a few nanometers to several microns. Self-Microemulsifying Drug Delivery Systems (“SMEDDS”) characterize the formulations with oil droplets ranging between 100 and 250 nm. Self-Nanoemulsifying Drug Delivery Systems (“SNEDDS”) is a recent term construing the globule size range less than 100 nm.
Kohli K. et al. (2010) mentions examples of improvement in bioavailability for a variety of drugs using SEDDS: Indomethacin, Coenzyme Q10, Ontazolast, Simvastatin , Celecoxib, Carvedilol, Paclitaxel, Ramipril, Ibuprofen, Ketoprofen and Fenofibrate. Triretinoin, Cyclosporin, Saquinavir and some other drugs that are marketed in self-emulsified formulations.
Kotta S. et al. (2012) recently reviewed different methods of SEDDS preparation for various applications and delivery routes. In one of examples, the apparent permeability of the BCS class III compound Atenolol was enhanced 2.5-fold, of BCS class II compound Danazol – 3.2-fold and of BCS class I compound Metoprolol – 1.4-fold.3
Spernath A. et al., (2006) describes different types of self-emulsifying vehicles, allowing several folds of bioavailability increase for synthetic and natural compounds, included into such delivery systems.4
Chen H. et al., (2011) in the article “Nanonization strategies for poorly water-soluble drugs”, discusses the use of nanoemulsions for successful oral, topical and ophthalmic application.5
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According to Li W. et al. (2011), the AUC of Quercetin and Kaempferol, which represent the active flavonoids of Persimmon leaf extract (PLE), was increased by 1.5-fold and 1.6-fold respectively following oral administration of PLE-loaded SNEDDS in fasting beagle dogs. These results indicate that SNEDDS is a potential drug delivery system for increasing the oral bioavailability of different natural compounds.6
Hydrophobic herbal antioxidant and hepatoprotectant Silymarin (Parveen R. et al., 2011), incorporated into a self-emulsifying delivery system, demonstrated that the AUC and Cmax of Silymarin after oral administration were 4-fold and 6-fold higher than those of Silymarin suspension, respectively.7
Gupta M. et al. (2012) in a review article describes multiple examples of improvement of drug delivery for drugs included into topically applied nanoemulsions. According to reviewed data, skin-targeted topical delivery by means of nanosystems, in order to produce sustained release and maintain a localized effect, will result in an effective treatment of various difficult-to-treat dermatological conditions.8
We have relied uponestablishedpublished data, including the references set forth above, indicating that incorporation into a self-emulsifying vehicle can significantly (several folds) increases bioavailability (Cmax and AUC) of incorporated drugs, either in oral or in topicalformulations. Our nanoemulsion based delivery platform can be realized in several types of dosage forms:
1.
Liquid formulations for oral administration. Self-nanoemulsifying delivery system used for lorazepam oral spray, liquid forms of vitamins, nanoemulsion of essential oils(E-drops nano). Nanoemulsions, with oil droplets smaller than 100 nm, can penetrate through oral or other mucosal layers, stomach orintestine lining. Incorporation of essential oils into nanoemulsion formcould also provide taste maskingin our E-drops nano product.We also believe the technology could eliminate product loss due to adhesion to glass walls or metalsurfaces.
2.
Topical formulations containing polar solvents. This approach avoids drug precipitation and we believe can improve transdermal penetration of poorly soluble compounds. The technologywill be used inour antifungal composition.
3.
Oral-solid dosage forms. Self-microemulsifying compositions for incorporation of poorly soluble compounds, including plant extracts and natural components along with different lipids or essential oils, incorporated into gelatin capsules or compressed tablets. The capsule dissolves in the stomach and releases a fine emulsion with biologically active components incorporated in small oil droplets.We believe the active components are absorbed in the gastro-intestinal tract by active transport mechanism, similarly to chylomicrons. This can be used for enhanced delivery of corosolic acid,apoorly soluble active component from Banaba extract(GluCorrect™), and combination of ursolic and corosolic acid (Urban Power ™).
Proposed Products
Pharmaceutical prescriptions
Lorazepam oral spray for epilepsy/acute seizures emergency treatment
Control of acute severe seizures usually requires hospitalization and emergency treatment by means of intravenous anticonvulsant drugs. Lorazepam isan existing, popular drugbecause of its perceived anticonvulsant activity and relatively low level of side effects. Any delay in effective treatment of acute seizures increases the possibility of mortality and morbidity. Administration of anticonvulsants by more convenient routes (buccal, nasal) has been actively studied, butto the best of our knowledge, to date no medications in such form have been approved in North America. Accordingly, we believe there is an unmet need for a convenient, acute, and fast acting treatment of the acute seizures, particularly in out-of-hospital settings, which does not require parenteral administration.
The Lorazepam oral spray for transmucosal delivery is based on our waterless self-nanoemulsifying formula, which is designed to prevent precipitation of the active ingredient after contact with saliva. Although in the early stages of research, we believe that finalized spray could provide fast onset of actionand enhance drug absorption
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through the oral mucosa. Because the drug enters the blood stream directly,thus avoiding the first pass metabolism intheliver, we believe it will beefficiently and quickly delivered to the brain.
When fully developed, webelieve the oral spray formulation of Lorazepamwill be capable of providing a fast and effective treatment of acute seizures in the hospital, outpatient settings or in the home. This novel form of the anticonvulsantwould be a convenient alternative to injectable (especially intravenous) Lorazepam for efficient control of epilepsy emergencies. This spray can be used either by the patient or by any non-trained person even in the time of ongoing seizures.
Lorazepam oral spray is still in the research stage and our goal is to develop it withthe following features:
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Easy and fast non-invasive administration;
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Onset of action is comparable to injection;
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Suitable for self-administration;
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Can be administered in any setting;
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Easy and convenient control of delivered doses; and
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Can be applied to mucosa of lips or gums even when teeth clenched in a seizure.
We further believe the oral spray formulation of Lorazepamcould possess advantages over existing products,in terms of ease of administration and convenience to use. It can bepotentially self-administered or administered by a non-trained person, even if the patient is unconscious. Also, the productwill be easily titrated by varying the number of sprays. Because most epileptic seizures start in a community setting, rapid and effective treatment that can easily be administered by the patient, family members, caregivers or paramedics, is important. The oral spray of Lorazepamis intended tobe used during a seizure, when the patient is clenching his/her mouth, by applying the spray directly to the gum or lip mucosa.
Commercialization potential and development
Management believes that thelarge number ofannual incidence of epileptic seizures and acute repetitive seizures in the United States creates a potential for Lorazepamspray. Currently, patient with acute seizures must be transported to a hospital and treated with intravenous infusion of Lorazepam or intravenous injection of Midazolam along with constant breath monitoring. Due to delay of transportation and late beginning of the treatment, acute seizures can last for extended period, causing brain damage, disability and possibly death.
We believe Lorazepam oral spraycould ultimately be used in non-hospitalsettings shortly after a seizure begins. Thisearly-started treatment of acute seizures with the non-invasive spray could possibly result in a decrease in morbidity and mortality rates among seizure victims.
If pre-clinical investigations in animals and optimization of the formulation of transmucosal Lorazepam are successful, we believe the spray could be manufactured for toxicological, safety and pharmacokinetics investigations. Analytical development, product optimization and stability program for the selected dosage form will be carried out in accordance with good laboratory practice (GLP) and good manufacturing practice (GMP) requirements.
Required safety pharmacology and toxicology programs will be conducted using the optimal formulation in final dosage form and packaging in accordance with current regulations. Size and duration of toxicology and safety pharmacology program and clinical development program will be established after meeting withhealth regulators.
The estimated duration of product development is 24 to 36 months for pre-clinical studies, including toxicology and safety pharmacology in accordance with Canadian requirements, with an estimated cost of approximately $6.0 million. Clinical trials can start within three years after the start of the project. Because the proposed product is based on a long approved and well-known drug with good safety profile, and the proposed dosage is in the approved dosage range, we believe that a shortened clinical development could possibly be sufficient for marketing approval in Canada. We also believe that Lorazepam oral spray in the U.S. may satisfy development program requirements outlined in Section 505(b)(2) of Food and Drug Administration (“FDA”) New Drug Application.However, there is no assurance that we will be able to use the shortened approval process in Canada or that Section 505(b)(2) will be available in the U.S. We estimate the approximate cost of the clinical trials program to be around $13 million.
2% Ketoconazole antifungal ointment
Ketoconazole is a synthetic drug used to treat fungal infections. Structurally, Ketoconazole belongs to an Imidazole class of antifungals and works by slowing the growth of pathogenic fungi. Topical preparations of Ketoconazole are used to treat superficial fungal infections of the skin or nails that cannot be treated with other medications.
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Existing topical Ketoconazole preparations do not penetrate into the body in significant amounts and cannot cause any serious systemic adverse effects because concentration in the blood is extremely low. While these products deliver Ketoconazole only on the surface at site of application, the drug penetrates into the skin for only a few microns. Unfortunately, suchlimited penetrationrestricts antifungal efficacy of the drug to the upper layer of the skin. In the case when a fungal infection is located below the epidermis, topical application of Ketoconazole has low efficacy and the drug needs to be used orally.
Weare developing what we believe to bea novel topical formulation of 2% Ketoconazole ointment. Ketoconazole is a drug with very low solubility, but it completely dissolves in a proprietary vehicle of the water washable ointment. Thenovel solubilizing formulationprevents Ketoconazole from immediate precipitation on contact with body tissues and a combination of highly penetratable solvents transport the drug inanactive dissolvedstate. This could result in effectively treating fungal infections at site of application.Because Ketoconazole antifungal activity is well established and Ketoconazole is approved by the FDA for topical treatment of fungal infections, webelieve that the antifungal activity ofour formulation maycompare favourably with existing Ketoconazole formulations using traditional cream and ointment bases.
Commercialization potential and development
2% Ketoconazole gel (Xolegel® 2%)is intended for the topical treatment of seborrheic dermatitis andhas a retail price of approximately $300 for a 60 gram tube. The efficacy of this alcohol based formulation in treatment of superficial fungal infections is found to be about 25%. We expect that our proposed formulation of Ketoconazole, when developed,will demonstrateadequate antifungal activity for susceptible topical fungal strains. In addition,if our ultimate product will meet all our production design criteria,we expect an expansion of the current market for Ketoconazole because of additional indications that our preparation canpossiblybe used for the treatment of onychomycosis and fungal dermatitis of differentorigin.
Due tothewell-known active pharmaceutical ingredient and inactive components used in our formulation of Keteoconazole,we believe 2% Ketoconazole ointment may satisfy development program requirements outlined in Section 505(b)(2) of FDA New Drug Application. We estimate that product development cost in Canada will be approximately $4.5 million for pre-clinical studies, including toxicology and safety pharmacology and will take from 18 to 24 months. Clinical trials can start within 28 to 32 months after commencing the project and will cost approximately $10.0 million to $12.0 million. We have not commenced any preclinical investigations in animals or optimization of the formulation for this product.
Metformin Chewable Tablets (Taste Masked)
Metformin is a widely prescribed drug for treatment of type 2 diabetes. It is available in the United States and Canada by prescription in tablets of 500, 850 and 1000 mg and recommended dose can reach 3000 mg per day.Metformin use isoften associated with stomach disturbances such as diarrhea, nausea/vomiting, flatulence, asthena, indigestion and abdominal discomfort. The big Metformin tablet is difficult to swallow and the unpleasant taste preventspatients from chewing the tablets.
Our proposednovel taste-masked composition of Metformin isintended to be chewedor administered sublingually as lozenges. We believe this method of administration maybe more convenient for patients with difficulties in swallowing.
Our goal for this proposed product is that theformulation and processto be patentable andthat itcan be manufactured using standard pharmaceutical equipment. All ingredients are USP/NF or pharmaceutical grade and listed in FDA Inactive Ingredients Guide and/or Canadian List of Acceptable Non-Medicinal Ingredients.
Because Metformin is a well-known drug, we believe that Section 505(b)(2) requirements may be applicable and the timeline for the approval process of our lower dosage product could be shortened. We have not yet approached any agency regarding the Metformin product and estimate approximately 24 months and $2.0 million to complete formulation development of our proposed Metformin low dose tablets. We have not commenced any preclinical investigations in animals or optimization of the formulation for this product.
Natural health products
E-drops Nano – nanoemulsion of essential oils combinationfor urinary tract health
An innovative combination of essential oils for maintaining urinary system in healthy conditions was discovered by Dr. Enes Hasanagic, who originated a mixture of several essential oils, given orally to strengthen the urinary tract and helps kidney functions. Orally administered, essential oils and their metabolites support cleanliness of the urinary tract epithelium, which in turn may help to keep the system clean and healthy. E-drops developed by Dr. Hasanagic have become popular in Central and Eastern Europe.
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The primary limitation for wide use of thisproduct is a strong astringent taste and some stomach irritation resulting is consumer dissatisfaction. Using a proprietary technology, weare developing a process that can incorporate the essential oils into a self-nanoemulsifying composition, which forms nanoemulsion when added to water. We believe the resulting nanoemulsion will have a more pleasing taste andwillreduce the loss of active components due to adhesion to walls of the cup. We have determined that droplet size of the formed emulsion is around 100 to 200 nm, which we believe leads to faster oil absorption in the stomach without signs of irritation. Such small droplets can be absorbed more readily in the gastro-intestinaltract. We further believe that if fully developed, the nanoemulsion could result in stimulating kidney filtration and keeping the urinary tract in healthy conditions. The main active ingredient of the E-drops Nano is Juniper extract in form of steam distilled essential oil. The properties of Juniper extract are described in scientific literature as diuretic, carminative and digestive aid. 9
PURALENTM: Essential oils combination for relief of stomach disturbances
PURALEN is a combination of essential oils, similar to E-drops with activity focus shift from urinary tract to gastro-intestinal tract. Our research has shown that the proposed product has diuretic properties while providing a gentle colon cleansing. PURALEN forms a relatively coarse emulsion upon contact with water. Larger oil droplets get absorbed slower and remain in the gastro-intestinal tract longer than nanoemulsion particles of Nano E-Drops. The oil combination in PURALENcould possibly help to relieve stomach disturbances, and provides digesting aid and pronounced carminativeaction. We also believe the initiated bowel movement action is very delicate and does not cause any pain or irritation. During our research, we have not observed any habit formation related to PURALEN use of reasonable duration.
GluCorrectTM: Soft gelatin capsules with Banaba extract in self-emulsifying formulation formaintaining healthy blood sugar levels
We believe that naturalproducts could be ahelpful additive to diet and exercise in maintaining a normal level of blood glucose. Several medicinal plants have been studied for their potential anti-diabetic activity including Lagerstroemia speciosa (Banaba), Eriobotrya japonica (Loquat), Ternstroemia gymnanthera (Japanese Cleyera) and others. The major bioactive substance found in these plants is Corosolic acid, a sterol type molecule. A study reported in 2006 by Japanese researchers showed that Corosolic acid significantly affects glucose transport across cellmembranes.10 Corosolic acid has insulin-like properties and activates glucose passage through membranes, resulting in blood glucose reductions. A distinctive feature of Corosolic acid is not only the stimulation of glucose transport, but also possible inhibition of the growth of the fat cells. It has been shown that extracts ofLagersrtroemia speciosa activate glucose transport to adipocytes, similar toinsulin.11
Insulin resistance is an impaired response to the body’s own insulin resulting in active muscle cells not metabolizing glucose as easily as they should. Existing prescription drugs for the treatment of insulin resistance and hyperinsulinemia can cause significant negative side effects. We believe that Banaba leaf extract containing corosolic acid demonstrates a high degree of safety, minimal side effects, and presents a unique therapeutic opportunity. Recent industry research demonstrates that high strength corosolic acid (18%) from Banaba may offer significantadvantages.12 It may benefit those trying to overcome insulin resistance by helping to use glucose more effectively. It is our belief that administration of our self-emulsifying Banaba leaf extract with Corosolic acid for 30 consecutive days may decrease fasting blood glucose levels by 20-30%. The recent review of Stohs S.J., et al.describes current scientific findings regarding numerous beneficial effects of Banaba extract and its active components.13
Animal and human studies as well as in vitro systems indicates that Banaba leaf extracts exert antidiabetic and antiobesity effects. There is evidence to indicate that Corosolic acid as well as ellagitannins are responsible for these effects. A number of studies in animals and human subjects using highly purified Corosolic acid and Corosolic acid standardized preparations indicate that this component of Banaba exhibits properties that are beneficial in addressing various factors involved in glucose regulation and metabolism. These include enhanced cellular uptake of glucose,
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improved insulin sensitivity, decreased gluconeogenesis, and inhibited intestinal hydrolysis of sucrose, thereby lowering blood glucose levels. Furthermore, decreased serum cholesterol and triglycerides have been observed in response to Corosolic acid. Based on the studies conducted to date, no adverse effects have been reported in animals using either Corosolic acid or standardized Banaba extracts, nor have adverse events been observed or reported in controlled human clinicalstudies.14
A limitation to wide use of Banaba leaf extracts containing Corosolic acid is low solubility of this extremely hydrophobic component. We believe that bioavailability drawbackcould be overcome by the use of GluCorrect self-nanoemulsifying formulation. We are presently in the research phase of developing GluCorrect with the goal of eventually formulating a marketable capsule.
EachGluCorrect soft gelatine capsulewill contain 6mg of Banaba leaf (Lagerstroemia speciosa) extract, standardized by Corosolic acid (18%)and alpha-Lipoic acid in a proprietary self-emulsifying composition. This combinationwill be designed to form a nanoemulsion in the stomach when the swallowed capsule dissolves and biologically active compounds incorporated into droplets are released into the gastro-intestinal tract. We believe that the small size of the oil globules (less than 100 nm)will make absorbance fast and complete, which would increase the bioavailability and efficacy of the active components. We further believe Banaba leaf extractscould maintain blood glucose levels and may assist with overcoming insulinresistance.
Alpha-Lipoic acid is a potent antioxidant, synthesized in human body in small amounts and found in broccoli and spinach. This sulphur containing organic acid helps the body to utilize glucose, hence it plays an important role in improving blood sugar control. Alpha-Lipoic acid may reduce complications from a high sugar diet. It is readily absorbed from the developed self-nanoemulsifying composition.
We believe that alpha-Lipoic acid in combination with Banaba extract may increase glucose uptake in fat and muscle cells. Although alpha-Lipoic acid does not appear to bind to the insulin receptors, it can activate the insulin-signalling cascade in the cells.GluCorrect capsules would have to be taken 15 to 30 minutes before meals to support efficient carbohydrate metabolism and help retain the normal blood glucose level.
URBAN POWERTM: Ursolic acid and Banaba extract combination in soft gelatin capsule – for weightmanagement
Another product we are developing is URBAN POWER™ that we believe could ultimately be used for weight management.URBAN POWER™ soft gelatin capsuleswillcontain a highly bioavailable combination of Banaba extract (18% Corosolic acid), a natural glucose regulating factor, pure Ursolic acid extracted from Sage and alpha-Lipoic acid, a potent antioxidant. We believe that this combinationwill help to improve glucosemetabolism. All these components are poorly soluble and usually have a low absorption in gastro-intestinal tract. URBAN POWER™will be comprised of a self-nanoemulsifying delivery system, which increases solubility and should enhance bioavailability of active components.
Ursolic acid is a natural compound, present in apple peels and many edible plants. Recent studies indicate that Ursolic acid significantly reduced skeletal muscle atrophy, resulting from two important stress inducers, namely, starvation and muscle denervation. Animal experiments have shown that ursolic acid reduced adiposity and blood glucose in non-obese mice and also reduces total body weight, white fat, glucose intolerance and hepatic steatosis in high fat-fed mice. Additionally ursolic acid increases skeletal muscle, brown fat and energy expenditure in a mouse model of diet-induced obesity. These effects are associated with increased strength and exercise capacity, and reduced obesity, improved glucose tolerance and decreased hepatic steatosis. If ursolic acid has similar effects in humans, then ursolic acid and/or structural analogs might be useful therapeutic agents for a number of increasingly common metabolic disorders, including skeletal muscle atrophy, obesity, type 2 diabetes and non-alcoholic fatty liverdisease.15
Our research leads us to believe that the useof a self-emulsifying vehicle mayallow better absorption of the active components. Ursolic acid in this delivery system may be more efficient than traditional hard gelatin capsuleformulation.
We believe that a synergistic effect of combined Ursolic acid and Banana extract with alpha-Lipoic acid, may help in weightcontrol, diminish fat accumulation, facilitate muscle growingand improve glucosemetabolism.
Other Products
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In addition to the above product candidates, we believe that our technologies can be applied to additional products that could potentially compete with similar products already on the market. Using our existing technologies, weare researching with the goal of developing and commercializingthree new products:
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Vitamin D3, our formulation of Vitamin D in nanoemulsion;
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v-Clean, a vegetable wash with bactericidal components; and
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Cleaneeze, a hand sanitizercontaining essential oil.
None of the company’s natural health products contain any new dietary ingredients. All ingredients used in or natural health products are on the confirmed list of approved ingredients with the regulatory bodies. The FDA does not require any notification nor registration for natural health products.
In December 2012, we engaged Mediq Dansmark A/S to market these new natural productsonce development is finalized. We anticipate that we could commence marketing these products during thefirst half of 2014.
Government Regulation - Pharmaceutical products
Our research and development activities and the future manufacturing and marketing of our pharmaceutical products are subject to extensive regulation by the FDA in the United States, Health Canada in Canada and comparable designated regulatory authorities in other countries. Among other things, extensive regulations require us to satisfy numerous conditions before we can bring products to market. These regulations are not unique to us and they apply to all competitors in our industry.
The following discussion summarizes the principal features of food and drug regulation in the United States and other countries as they affect our business.
United States
All aspects of our research, development and foreseeable commercial activities relating to pharmaceutical products are subject to extensive regulation by the FDA and other regulatory authorities in the United States. United States federal and state statutes and regulations govern, among other things, the testing, manufacturing, safety, efficacy, labeling, storage, record keeping, approval, advertising and promotion of pharmaceutical products. The regulatory approval process, including clinical trials, usually takes several years and requires the expenditure of substantial resources.
The steps required before a pharmaceutical product may be marketed in the United States include:
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Preclinical Development
Preclinical development includes laboratory evaluation of product chemistry and formulation, as well as animal studies to assess the efficacy and potential safety of the product. Preclinical safety tests must be conducted by laboratories that comply with FDA regulations regarding Good Laboratory Practice, or GLP regulations. We plan to conduct and submit the results of preclinical development to the FDA as part of our Investigational New Drug Application (“IND”) prior to commencing clinical trials. We may be required to conduct extensive toxicology studies as part of preclinical development.
The results of these evaluations and tests are then submitted to the FDA, together with manufacturing information, analytical data, and protocols for clinical studies, in an IND, to receive an approval from the FDA that the clinical studies proposed under the IND are allowed to proceed.
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Clinical trials
Based on preclinical testing, an IND is filed with the FDA to begin human testing of the drug. The IND becomes effective, if not rejected by the FDA, within 30 days. The IND must indicate the results of previous experiments, how, where and by whom the new studies will be conducted, the chemical structure of the compound, the possible mechanism of action, any toxic effects of the compound found in the animal studies and how the product is manufactured. All clinical trials must be conducted in accordance with good clinical practice (“GCP”), regulations. In addition, an Institutional Review Board (“IRB”), generally comprised of physicians at the hospital or clinic where the proposed studies will be conducted, must review and approve the IND. The IRB also continues to monitor the study. We must submit progress reports detailing the results of the clinical trials to the FDA at least annually. In addition, the FDA may, at any time during the 30-day period or at any time thereafter, impose a clinical hold on proposed or ongoing clinical trials. If the FDA imposes a clinical hold, clinical trials cannot commence or recommence without FDA authorization and then only under terms authorized by the FDA. In some instances, the IND application process can result in substantial delay and expense.
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Clinical trials involve the administration of a new drug to humans, under the supervision of qualified investigators using the protocol approved by the FDA and IRB, to establish the safety and efficacy of the product candidate for the intended use.
Clinical trials are typically conducted in three sequential phases (Phase I, Phase II, and Phase III), but the phases may overlap. Phase I clinical trials test the drug on healthy human subjects for safety and other aspects, but usually not effectiveness. Phase II clinical trials are conducted in a limited patient population to gather evidence about the efficacy of the drug for specific purposes, to determine dosage tolerance and optimal dosages, and to identify possible adverse effects and safety risks. When a product has shown evidence of efficacy and acceptable safety in Phase II evaluations, Phase III clinical trials are undertaken to evaluate and confirm clinical efficacy and to test for safety in an expanded patient population at several clinical trial sites in different geographical locations. Clinical trials need to be conducted in compliance with the FDA’s Good Clinical Practice requirements.
After the completion of clinical trials, if there is substantial evidence that the drug is safe and effective, a New Drug Application (“NDA”) is filed with the FDA. The NDA must contain all of the information on the drug gathered to that date, including data from the clinical trials. NDAs are often over 100,000 pages in length.
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NDA Submission
The results of pre-clinical studies, clinical studies, and adequate data on chemistry, manufacturing and control information to ensure reproducible product quality batch after batch, are submitted to FDA in an NDA to seek approval to market and commercialize the drug product for a specified use. The FDA reviews all submitted NDAs and is governed by the Prescription Drug User Fee Act (“PDUFA”) regarding response time to the application, which is generally 12 months (and shorter for a priority application). It may deny a NDA if it believes that applicable regulatory criteria are not satisfied. The FDA also may require additional clarifications on the existing application or even additional testing for safety and efficacy of the drug.
In such an event, the NDA must be resubmitted with the additional information and, again, is subject to review before filing. Once the submission is accepted for filing, the FDA begins an in-depth review of the NDA. Under the Federal Food, Drug and Cosmetic Act, the FDA has 365 days in which to review the NDA and respond to the applicant. The review process is often significantly extended by FDA requests for additional information or clarification regarding information already provided in the submission. The FDA may refer the application to an appropriate advisory committee, typically a panel of clinicians, for review, evaluation and a recommendation as to whether the application should be approved.
The FDA is not bound by the recommendation of an advisory committee. If FDA evaluations of the NDA and the manufacturing facilities are favorable, the FDA may issue either an approval letter, or an approvable letter that will likely contain a number of conditions that must be met in order to secure final approval of the NDA. When and if those conditions have been met to the FDA’s satisfaction, the FDA will issue an approval letter, authorizing commercial marketing of the drug for certain indications. If the FDA’s evaluation of the NDA submission or manufacturing facilities is not favorable, the FDA may refuse to approve the NDA or issue a not approvable letter.
If the FDA approves the NDA, the drug becomes available for physicians to prescribe. Periodic reports must be submitted to the FDA, including descriptions of any adverse reactions reported. The FDA may request additional post marketing studies, or Phase IV studies, to evaluate long-term effects of the approved drug.
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Section 505(b)(2)
An application under section 505(b)(2) of Federal Food, Drug and Cosmetic Actcontains full safety and effectiveness reports, but allows at least some of the information required for approval to come from studies not conducted by or for the applicant. This application can only be used for drugs that are similar or equivalent to the ones already approved by the FDA in an NDA for another company. The applicant does not need to get permission from the original filer to use their information and it allows the applicant to rely onstudies published in the scientific literature to demonstrate the safety and effectiveness of new drug. The 505(b)(2) application is intended to encourage sponsors to develop innovative medicines using currently available products by significantly reducing the time and money to bring new application of an old drug to market. There is no assurance that any of our proposed products will satisfy the requirements for Section 505(b)(2) approval, or that we will be successful in completing the shortened approval process for any OTC product. If we are unable to use the 505(b)(2) processor the shortened approval process for OTC products, we will experience a significant increase in development expenses and approval time will be considerably longer. This could ultimately preclude the marketing of our proposed products, which could have a serious negative affect to our business plan and potential for futurerevenues.
Foreign Countries
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Canadian regulatory procedure is substantially similar to that of the United States. Before we are permitted to market any of our pharmaceutical products outside of the United States and Canada, those products will be subject to regulatory approval by foreign government agencies similar to the FDA or Therapeutic Products Directorate in Canada (“TPD”). These requirements vary widely from country to country. Generally, however, no action can be taken to market any drug product in a country until an appropriate application has been submitted by a sponsor and approved by the regulatory authorities in that country. Again, similar to the FDA and TPD, each country will mandate a specific financial consideration for the Marketing Application dossiers being submitted. Although an important consideration, FDA or TPD approval does not assure approval by other regulatory authorities. The current approval process varies from country to country, and the time spent in gaining approval varies from that required for FDA or TPD approval.
Natural Health Products
Manufacturing of natural health products for human consumption requires registration of the composition in Health CanadaNatural Health Products Directorate in accordance with current regulations and obtaining a Natural Product Number (“NPN”). We have applied for an NPN for each of our proposed nutraceuticals formulations. Currently we have NPN number for our nanoemulsion formulation for cystitis aid, Nano E-drops (NPN 80030783), Vitamin D3 nanoemulsion (NPN 80037273), Hand sanitizer Cleanezze (NPN 80041150), Wart remover Wartzz-off (NPN 80041153) and vitamin complex Shield-X (NPN 80041141). An application for GluCorrect has been accepted and we expect to receive NPN for Glucorrect and our other proposed products in the foreseeable future.
In the United States, FDA regulates both finished dietary supplement products and dietary ingredients under a different set of regulations than those covering "conventional" foods and drug products (prescription and Over-the-Counter). Under the Dietary Supplement Health and Education Act of 1994 (“DSHEA”), the dietary supplement or dietary ingredient manufacturer is responsible for ensuring that a dietary supplement or ingredient is safe before it is marketed. FDA is responsible for taking action against any unsafe dietary supplement product after it reaches the market. Generally, manufacturers do not need to register their products with FDA nor get FDA approval before producing or selling dietary supplements.
The Federal Food, Drug and Cosmetic Act (the “Act”) requires manufacturers and distributors who wish to market dietary supplements containing "new dietary ingredients", to notify the Food and Drug Administration about these ingredients. (See Section 413b of the act (21 U.S.C. 350b).) The notification generally includes information on which manufacturers/distributors base their conclusion that a dietary supplement, containing a new dietary ingredient, will reasonably be expected to be safe under the conditions of use recommended or suggested in the labeling.
For European Union (“EU”) countries, Natural Health Products usually can be registered as “food supplements”. Essential oils nanoemulsion for help with cystitis and urinary tract infections (Nano E-drops) was successfully registered as food supplement in Latvia (registration No. 10352) and placed into the EU database of registered food supplements. It simplifies and accelerates registration and approval of the product in other EU countries. We also have received an import license in Uzbekistan to sell Nano E-Drops in that country.
Marketing and Distribution
We plan to market our completed products through collaborative arrangements with companies that have well-established pharmaceutical and nutraceutical health products marketing and distribution capabilities, including expertise in the regulatory approval processes in their respective jurisdictions.
Currently we have several NPNs in Canada and registration as food supplement in Latvia (EU) for Nano E-Drops as well as import license for Nano E-Drops in Uzbekistan.
Nutraceuticals have become an important part of mainstream health care. We believe the market for nutraceuticals is growing. Although public awareness of nutraceuticals is increasing, only a small percentage of North Americans actually use nutraceuticals on a regular basis. Thus we believe there is a potential new market for these products for the following reasons:
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Increased use of nutraceutical products for the over-50 population segment, whose numbers are increasing;
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Increased awareness that nutraceuticals is an important part of mainstream health care; and
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Price increases.
Marketing Strategies
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We have formulated a strategy that we believe will differentiate us as a company by:
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focusing on science;
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developing unique nutraceuticals and related products;
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securing a proprietary position for our products;
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advertising aggressively and market through all appropriate distribution channels using all professional means; and
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providing information by a company website to be developed.
Following this strategy, we believe we can gain access to many revenue generating channels through classic pharmaceuticals and other health care products. We further believe there are greater consumer demands, market growth potential and both real and perceived usefulness. We can increase market share by reducing market share of competitors. This strategy will capitalize on the market development to date and capture a share of markets held by existing nutraceuticals. The key benefit is that we have carefully chosen products for the pipeline with the intent to maximize the therapeutic value of their discoveries and technology. This strategy requires extensive advertising in mainstream media, including infomercial, interactive TV, direct mail, independent sales reps and educational inserts/newsletters. Product studies will support this marketing strategy. In this context, the company will pursue preliminary inquiries from favored vendors.
Management plans to explore new markets for products through strategic positioning. This future strategy will involve developing specialty catalogues, placement on retail shelves of health food stores, educational product inserts/newsletters, media appearances discussing product, and independent sales reps.
We also intend to engage multi-level marketing companies. This strategy would likely involve creating private labels for a large customer. A major component of this strategy is the effect of product identity. This channel of distribution usually requires more price mark-up than the product would tolerate. As of the date hereof, we have not entered into any agreement or understanding with any prospective marketing company.
We further intend to keep capital outlay at a minimum by licensing and/or franchising our products to a brand-name company. This strategy would add value to the product in the form of brand name loyalty, manufacturing strength, and a strong sales/service force already in place.
Marketing Plan
In moving from the start-up stage into the first growth stage, we must identify and match market segments with appropriate distribution channels. Our goal is to expand regionally, both in Canada and the U.S., based on existing markets and consumer profiles. Once we realize regional sales growth and product recognition, we plan to implement a national and international marketing strategy. At such time as we reach this level, management anticipates it will employ a major marketing communications agency.
Our marketing and sales outline is as follows.
Marketing Function
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A complete review and analysis of the proposed product’s market.
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Use of groups conducted with the professional community and general consumers to identify professional and consumer preferences.
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Based on research results, create a product identity.
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Form product identity, establish professional and consumer strategic directions, which would affect product design, packaging, advertising, consumer promotion, and product publicity.
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Develop and launch a marketing plan with all elements and budget for both professional and consumer.
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Actual implementation of the plan to include product design changes, packaging, advertising, consumer promotion, display, and product publicity.
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Consider using a sales organization for retail sales and a broker for the remainder of sales.
Initially, we intend to focus on marketing our proposed natural health products and on establishing distribution networks. We intend to market products as they become ready for sale, including satisfaction of any regulatory requirements. Initially during the next twelve months, we plan to market only natural products and hope to add new natural products during the next three years.Presently, we do not completed development of any proposed products
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for commercial marketing. Those products that we believe may be marketable in the next twelve months include the following:
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E-drops Nano
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Vitamin D3
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Cleanezze
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V-Clean
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Warrtz-off
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GluCorrectTM
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URBAN POWERTM
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PURALENTM
Our plan is to provide either a finished product or product in bulk to distributors with regulatory support in order to register the product within specific jurisdictions. In December 2012, through our wholly owned subsidiary Eastgate Pharmaceuticals Inc., we engaged Mediq Dansmark A/S to market four of our natural products, Vitamin D3, V-Clean, Cleaneeze and Wartzz-Off. Mediq distributes throughout Scandinavia and approximately 14 countries throughout Europe. The agreement provides that delivery of product will be made against purchase orders issued by Mediq. The company shall acknowledge Mediq’s purchase orders within ten business days after receipt, including the requested deliver date. Mediq will endeavour to place orders in minimum volume of 5,000 units per order. Mediq will reimburse the company for 80% of the invoiced amount for any cancelled orders.
During the next three-year period, we intend to continue development of our proposed pharmaceutical products and carry on our research to satisfy the more stringent requisite pre-clinical and clinical requirements of the regulatory agencies. Because of the uncertainty in regards to funding and uncertainty in regards to regulatory approval, we are unable to precisely estimate when proposed pharmaceutical products will be available for sale. We currently have the development of Lorazepam Oral spray as our top priority, with the development of Metformin and Ketoconazole following shortly thereafter. Because we intend to pursue co-development partners for all our pharmaceutical products to help with funding, product development priorities may change. It is not possible to indicate at this time which pharmaceutical product will be able to be available on the market first.
We are presently in discussions with other potential distributors in the United States and Canada. We also intend to introduce products using e-commerce and through our Internet website. We intend to consider other marketing and licensing opportunities with respect to our prospective pharmaceutical products once initial development milestones have been met.
Manufacturing
We intend to use third party manufacturers for our products. Currently we have a signed agreement with Nutralab Ltd. (Markham, Ontario) to manufacture several of our products, such as Nano E-Drops, PURALEN, vitamin D3, GluCorrect in soft gelatin capsules and URBAN POWER soft gelatin capsules. The initial batch of 9,000 bottles of Nano E-drops was successfully manufactured, packaged and labelled at Nutralab Ltd. in full compliance with GMP requirements. The agreement was assigned to us by NanoEssential Ltd. as part of the Acquired Products.
We have also selected Vesta Pharmaceuticals Ltd. of Indianapolis, Indiana as the manufacturer of chewable tablets, such as GluCorrect (Banaba extract), although we do not have a definitive agreement.
Raw Material Supplies
Excipients used in our formulations are available from numerous sources in sufficient quantities for manufacturing purposes. We believe raw materials will be available in sufficient quantities for commercial purposes when required.
We also believe future development and marketing partners under licensing and development agreements, if any, will provide, or assist in obtaining, pharmaceutical compounds that are used in products covered under such agreements.
Components used in the production of our consumer products are available from a number of potential suppliers. We have not secured commercial supply agreements with any supplier referenced below as the components are readily available in the commercial quantities.
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We have selected Citrus and Allied Essences Ltd. of Lake Success, New York as a supplier of Natural essential oils, suitable for oral human consumption (FCC and USP/NF grades). American Lecithin will be the supplier of Lecithin.
Compendial high purity oils, acetylated glycerides and pharmaceutically acceptable surfactants are being supplied by Kerry Bio-Science by way of Nealanders International, Inc., Mississauga, Ontario.
Grain alcohol is supplied by Commercial Alcohols Inc., Toronto, Ontario.
OptiPure (Chemco International/Kenco group), Los Angeles, California and Sabinsa Corp., East Windsor, New Jersey, are suppliers of active natural ingredients.
Intellectual Property
Patents are a key determinant of market exclusivity for most branded pharmaceutical products. Protection for individual products or technologies extends for varying periods, in accordance with the expiration dates of patents in the various countries. The protection afforded, which may also vary from country to country, depends upon the type of patent, its scope of coverage and the availability of meaningful legal remedies in the country.
We have one US patent application for nanoemulsion for oral administration of essential oils (application # 2013/0029978 A1Medicinal Compositions And Method For Treatment Of Urinary Tract Infections). Several patent applications are in preparation and will be filed in 2013 or 2014 after obtaining of supporting animal experimental data, provided we have sufficient funding.
We also have developed brand names and trademarks for products in all areas. We consider the overall protection of our patent, trademark and other intellectual property rights to be of material value and acts to protect these rights from infringement.
Our long-term success will substantially depend upon our ability to obtain patent protection for our technology and our ability to protect our technology from infringement, misappropriation, discovery and duplication. We cannot be sure that any future patent applications will be granted, or that any patents which we own or obtain in the future will fully protect our position.
Our patent rights and the patent rights of biotechnology and pharmaceutical companies in general, are highly uncertain and include complex legal and factual issues. We believe that our existing technology and the patents that we hold or for which we have applied do not infringe anyone else's patent rights. We believe our patent rights will provide meaningful protection against others duplicating our proprietary technologies. We cannot be sure of this, however, because of the complexity of the legal and scientific issues that could arise in litigation over these issues.
We also rely on technological know-how’s, composition’s trade secrets and other unpatented proprietary information. We will seek to protect this information, in part, by confidentiality agreements with our employees, consultants, advisors and collaborators.
Competition
Our future success depends, in part, upon our ability to develop products and achieve market share at the expense of existing and more established and future products in the relevant target markets. Existing and future products, therapies, technological approaches or delivery systems will compete directly with our products that are used to treat the same medical conditions. Competing products may provide greater therapeutic benefits for a specific indication, or may offer comparable performance at a lower cost.
Management recognizes that competition in the development of novel drug delivery methods and formulations is intense. Several companies work in the field of use of colloidal delivery systems, including nano-and microemulsions. Most competitors have significantly longer operating histories, more advanced technology and greater financial resources. Additionally, most of our competitors have significantly greater experience in
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developing drugs;
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undertaking preclinical testing and human clinical trials;
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obtaining FDA and other regulatory approvals of drugs;
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formulating and manufacturing drugs; and
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launching, marketing, distributing and selling drugs.
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Companies that we are in competition with include, but are not limited to Pfizer, Wyeth, Upsher-Smith Laboratories, Stiefel Laboratories, Merck, BMS, Boston Therapeutics, Biovail and others. We believe that we could possibly compete with these companies because we have several unique methods and novel technological approaches that could potentially allow us to reach proposed targets and develop formulations with improved properties.
Our scientific team is experienced in the field of developing novel types of delivery systems. This experience includes technical transfer and products launch and manufacturing along with patents and patent applications for multiple compositions.
Developments by competitors may render our products or technologies obsolete or non-competitive. Alternatively, competitors may challenge our patents and prevail in a court of law rendering our products unmarketable, even if they are successfully developed, tested and approved.
Lorazepam spray
We believe that currently there are no oral sprays containing lorazepam or other benzodiazepines that could treat severe epileptic seizures and be suitable for use in non-hospital settings.
Pfizer/Wyeth markets an injectable drug branded ATIVAN® that is used to treat serious seizures (status epilepticus). It is also used before surgeries or procedures to cause drowsiness, decrease anxiety, and cause forgetfulness about the procedure or surgery. This drug may also be used to cause drowsiness in patients who need a tube and machine to help with breathing (intubated), to prevent nausea and vomiting in patients on chemotherapy, and to treat a mental/mood disorder (delirium). This medication is also available in tablet form and form of oral solution to relieve anxiety and promote sleep.
Several companies are developing novel, non-injectable, fast acting medicines for treatment of acute seizures. These companies include large and medium size pharmaceutical companies, as well as universities, government agencies and other private and public research organizations. Examples include Upsher-Smith Laboratories, ViroPharma, Valeant Pharmaceuticals International, Medir Pharmaceuticals (The Netherlands). In particular, Upsher-Smith Laboratories, has successfully advanced an Midazolam Intranasal Spray through several Phase I and Phase II trials, demonstrating improved control of partial and generalized seizures over placebo. In 2011, Upsher-Smith initiated a global double-blind placebo-controlled Phase III study under a special protocol assessment agreement with FDA.
Currently Diazepam rectal gel 5 mg/ml (Diastat®, Valeant Pharmaceuticals International) is the only non-injectable product, approved in the United States and Canada for treatment of cluster seizures. Due to obvious limitations and inconvenience, it is highly desirable to have an alternative non-invasive anti-seizure preparation. We believe that our proposed oral spray of Lorazepam, when fully development and marketed, could satisfy the need in emergency treatment of status epilepticus and acute seizures.
2% Ketoconazole ointment
There are a number of preparations currently on the market containingKetoconazole, including tablets (200 mg), shampoo (1% and 2%), cream (2%), gel (2%) and foam (2%). We consider our direct competition to be 2% Ketoconazole gel from Barrier Therapeutics, Inc. / Stiefel Laboratories, Inc., marketed under the brand name Xolegel™, 2% Ketoconazole cream from JSJ Pharmaceuticals marketed under the brand name Kuric™, and 2% Ketoconazole foam marketed by Stiefel Laboratories, Inc. under the brand name Extina® Foam. Ketoconazole tablets are available in generic form and are marketed by a number of generic drug manufacturers.
Topical formulations of Ketoconazole can be used for treatment of seborrheic dermatitis. Topical Ketoconazole is used also for treating ringworm, jock itch, athlete's foot, dandruff, tinea versicolor and other skin fungal infections, susceptible toKetoconazole. We believe that our proposed Ketoconazole formulation when finalized, could provide efficient relief and an acceptable cure rate in the treatment of susceptible infections than existing creams and gels.
Metformin
Metformin hydrochloride oral dosage forms are manufactured by many pharmaceutical companies, such as Merck, BMS, Boston Therapeutics, Biovail, Ranbaxy, Alphapharm, Shionogi and Teva Pharmaceuticals. Recently Boston Therapeutics filed an Abbreviated New Drug Application (ANDA) with FDA for chewable dosage form of Metformin.
Existing oral dosage forms for Metformin (Glucofage®) and generics include tablets (500, 850 and 1000 mg) and oral solution 500 mg/5ml (Riomet®). We believe that there is no sublingual or chewable tablet or lozenge of Metformin available. We further believe thatour proposed Metformin sublingual / chewable tabletcould possibly
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improve patient compliancedue to masking the unpleasant taste of the drug. There is no assurance that we will be able to obtainFDA approval for the proposed chewable Metformin tablet.
Dietary Supplements
E-drops Nano
Naturalaids for urinary tracthealth include various cranberry based compositions, manufactured by numerous companies and natural plant sugar D-mannose, launched recently in theUnited Kingdom. We believe that upon finalizing development of the proposed E-drops Nano, the product could be used in maintaining urinary system healthy status.
GluCorrectTM
We believe that incorporating Corosolic acid(18%) herbal extract intoaproprietary self-emulsifying composition could result in a naturalproduct that could be helpful in retaining normal blood glucose levels. The available products containing Banaba extract are marketed by Shaklee (Glucose Regulating Complex), Swanson (GlucoHelp), American BioSciences Inc. (SugarSolve 24/7) and others, although, to the best of our knowledge, not one manufacturer offers a self-emulsifying composition.
Research and Development
Following the acquisition of the Acquired Products in 2012, we expended $105,422 during 2012 on research and development and $37,995 during the first three months of 2013. It is our goal to conduct our research programs as necessary funds are available. The specific requirements for our various product candidates are as follows:
Pharmaceutical prescriptions
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Lorazepam oral spray for epilepsy/acute seizures emergency treatment.
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2% Ketoconazole ointment fortreatment of succeptable skin fungal infections.
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Metformin Chewable Tablets.
Our three proposed products above are all pharmaceutical prescription products and require the FDA approval process as discussed above. The pre-clinical process could take three years or more and require up to $20 million for each product. We anticipate that we will proceed with the research process as funds are available. We will most likely seek approval first in the U.S. and Canada.
Natural health products (nutraceuticals)
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E-drops Nano
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PURALEN
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VitaminD3 nanoemulsion
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Cleanezze
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V-Clean
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GluCorrect
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Urban Power
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Wartzz
We believe that the eight proposed products above are all natural health products and do not require FDA approval as discussed above. Generally, manufacturers do not need to register their products with FDA nor get FDA approval before producing or selling dietary supplements. We anticipate that all the above productswill be available to be marketed in the current year.
Our business plan is to market only natural products in the first fiscal year and add additional new natural products each fiscal year for at least the first three years. The estimated cost of development using our self-emulsifying vehicle delivery system is approximately $200,000 to $500,000 for each product. Our plan is to first complete development ofNano E-drops and PURALEN, followed by Vitamin D3, GluCorrect, Wartzz, Clanezze, V-Clean and Urban Power. We have not made a determination as to the next natural products that we will concentrate efforts, although future development will depend primarily on available funds.
The pharmaceutical prescription products program will commence when we are able to secure funding that is adequate to complete the more comprehensive and costly approval process required for pharmaceutical products. We currently intend to focus on developing and marketing of Lorazepam Oral spray as our top priority. Subsequently, we plan to focus on finalizing development of Metformin and Ketoconazole.
We presently do not have any firm agreement or understanding that will provide adequate funding to execute our business plan, although management continues to explore possible funding opportunities. However, anticipate
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having products available for sale during 2013 that could provide some cash flow, although there is no assurance that we will realize any proceeds from sales or, that any proceeds realized will be sufficient to execute our business plan. If we are unsuccessful in raising sufficient capital, our timetable for completing development, gaining necessary regulatory approval and marketing our products would be significantly lengthened.
Employees
Currently, we do not have any employees. Our directors and officers are devoting their time to the company in developing our products. Management is presently reviewing the near term possibility of engaging qualified, full-time personnel to assist in developing and marketing our products. We may use non-employee consultants to assist us in formulating a research and development strategy, preparing regulatory submissions, developing protocols for clinical trials, for designing, equipping and staffing future manufacturing facilities and for business development. We may find it necessary to periodically hire part-time clerical help on an as-needed basis.
Consultants and advisors usually have the right to terminate their relationships on short notice. Loss of some of these key consultants or advisors could interrupt or delay development of one or more of our products or otherwise adversely affect our business plans.
We expect to continue to need qualified scientific personnel and personnel with experience in clinical testing, government regulation and manufacturing. We may have difficulty in obtaining qualified scientific and technical personnel as there is strong competition for such personnel from other pharmaceutical and biotechnology companies, as well as universities and research institutions. Our business could be materially harmed if we are unable to recruit and retain qualified scientific, administrative and executive personnel to support our expanding activities, or if one or more members of our limited scientific and management staff were unable or unwilling to continue their association with us.
Properties.
We currently use as our principal place of business the business office of our director, Geoff Williams, in Salt Lake City, Utah. We have no written agreement and currently pay no rent for the use of the facilities. We are presently in the process of locating commercial office space from which to conduct our business.
On October 1, 2012 we entered into a lease agreement for laboratory facility and office space. The lease has a term of 32 months with an expiration date of May 31, 2015. The lease specifies a monthly rate of $4,988 for 2012, $5,344 for 2013, and $5,700 for 2014 and 2015. The lease requires minimum lease payments of $175,988 over the term of the lease.
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION
AND RESULTS OF OPERATIONS
The following discussion and analysis of our financial condition and results of operations should be read in conjunction with the financial statements and notes thereto appearing elsewhere in this prospectus.
The following selected comparative financial information has been derived from and should be read in conjunction with the company’s financial statements for the years ended December 31, 2012 and 2011 and for the three months ended March 31, 2013 and 2012.
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| | | | | | |
| | | Year Ended | | | Year Ended |
| | | December 31, 2012 | | | December 31, 2011 |
| | | | | | |
Revenues | | $ | - | | $ | - |
| | | | | | |
Operating expenses | | | | | | |
Professional fees | | | 116,874 | | | - |
Research and development | | | 105,422 | | | - |
General and administrative | | | 383,501 | | | 23,943 |
| | | | | | |
Total operating expenses | | | 605,797 | | | 23,943 |
| | | | | | |
Loss from operations | | | (605,797) | | | (23,943) |
Interest expense | | | 17,023 | | | 5,977 |
| | | | | | |
Net loss | | $ | (622,820) | | $ | (29,920) |
| | | | | | |
Total assets | | $ | 104,500 | | $ | - |
Working capital | | $ | (609,008) | | $ | (89,188) |
| | | | | | | | | | | |
| | | | | From inception on September 8, 1999 Through March 31, 2013 |
| | | | For the Three Months Ended |
| | | | March 31, |
| | | | 2013 | | | 2012 |
Revenues | $ | - | | $ | - | |
$ |
- |
| | | | | | | | | |
Operating Expenses | | | | | | | |
| Professional fees | | 3,586 | | | - | |
120,462 |
| Research and development | | 37,995 | | | - | |
143,417 |
| General and administrative | | 113,689 | | | 5,750 | |
601,388 |
| | | | | | | | | |
| | Total operating expenses | | (155,270) | | | (5,750) | |
(865,267) |
| | | | | | | | | |
Loss from Operations | | (155,270) | | | (5,750) | |
(865,267) |
| | | | | | | | | |
| Interest expense | | (11,222) | | | (1,487) | |
(45,435) |
| | | | | | | | | |
Net loss | $ | (166,492) | | $ | ( 7,237) | $ | (910,702) |
Results of Operations
Year ended December 31, 2012 compared to year ended December 31, 2011.
We have not reported any revenues since inception and incurred a net loss of $622,820 for the year ended December 31, 2012, compared to a loss of $29,920 for the year ended December 31, 2011. We anticipate commencing sales in the second half of 2013 as a result of developing certain intellectual property acquired pursuant to the Acquisition Agreement. We have also reported a cumulative net loss of $744,210 since inception through December 31, 2012. The increase in net loss for 2012 is attributed primarily to the increase in general and administrative expenses from $23,943 in 2011 to $383,501 in 2012, directly due to the acquisition of the Acquired Products. Additionally, we had professional fees of $116,874 in 2012 compared to $0 for 2011, which mainly related to the Acquisition Agreement and requisite SEC reporting requirements, and also incurred research and development expenses of $105,422 in 2012 compared to $0 in 2011, in connection with the Acquired Products. Interest expense increased to $17,203 for 2012 from $5,977 for 2011, representing the increased amount of interest on payables to related parties.
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Management believes that the company will realize revenues during 2013 as products are fully developed and marketed. We anticipate that expenses will increase as sales commence and future funding becomes available so that additional research and development becomes possible. However, there is no assurance that we will realize revenues during 2013 or that we will secure necessary funding to complete development and ultimately market our products.
Currently, we do not have any firm agreement or understanding that will provide the funds necessary to assure completion of any of our proposed products. We are presently investigating possible funding opportunities to arrange for additional funds. However, if we are unable secure adequate funding, it is unlikely that we will be able to complete development and market any of our proposed products. If we cannot market any products without additional funding, we will not realize revenues and our ability to continue our business will be greatly jeopardized.
Three months ended March 31, 2013 compared to the three months ended March 31, 2012.
During the three month period ended March 31, 2013 (“first quarter”), we incurred a net loss of $166,492, an increase of $159,255 when compared to our net loss of $7,237 for the first quarter of 2012. The increased net loss is primarily attributed to the increase in general and administrative expenses, from $5,750 in the first quarter of 2012 to $113,689 for the first quarter of 2013, and $37,995 in research and development expenses in the first quarter of 2013 compared to $0 for the 2012 period. These increased expenses are due to beginning operations and development of products following the acquisition of intellectual property in May 2012. Also, interest expense increased from $1,487 for the first quarter of 2012 to $11,222 for the first quarter of 2013, due to an increase in loans from stockholders.
Liquidity and Capital Resources
At March 31, 2013 we had a working capital deficit of $825,617, which is an additional deficit of $216,609 from the December 31, 2012 deficit balance of $609,008. Our working capital deficit at December 31, 2011 was $89,188. The increased deficit is a result of the start of operations in 2012, which was financed by advances from a related party.
During the first three months of 2013, ongoing expenses were paid by principal stockholders. At March 31, 2013 and December 31, 2012, we had cash on hand of 10,873 and $100,000, respectively. On October 23, 2012, the company entered into a demand promissory note agreement whereby we received $100,000 from a related party. The note accrues interest at an annual rate of 5%, is unsecured and is payable on demand. At March 31, 2013 we had a note payable - related party of $482,332, compared to $449,103 at December 31, 2012 and $59,590 at December 31, 2011. The increase represents additional payment of ongoing expenses by related parties during the first three months of 2013 and during 2012. Accrued interest – related party at March 31, 2013 was $45,405 compared to $35,155 at December 31, 2012 and $17,190 at December 31, 2011, which increases reflect the added interest on the payable – related party. Accounts payable increased from $12,408 at December 31, 2011 and $229,250 at December 31, 2012, to $273,523 at March 31, 2013, reflecting an increase in unpaid obligations due to increased operations since finalizing the Acquisition Agreement.
At March 31, 2013, we had a stockholders’ deficit of $775,702 compared to a stockholders' deficit of $609,008 at December 31, 2012 and $89,188 at December 31, 2011. The increase in stockholders' deficit is primarily attributed to ongoing general and administrative expenses and additional professional fees, principally legal and accounting costs, and research and development expenses.
As of July 23, 2013, we had cash on hand of $15,404. We believe that our available cash will be sufficient to carry on general corporate functions for the next three months, although we will need to limit cash outlays for research and product development until we can secure additional fund. We are presently investigating possible funding opportunities to arrange for additional funds, although we do not have any definitive agreement or arrangement for such funds. We expect that additional funding to proceed with development of the Acquired Products will most likely be from the sale of securities or from stockholder loans. We may not be successful in our efforts to obtain equity financing to carry out our business plan and there is doubt regarding our ability to complete our planned development program. We estimate that cash requirements for the next twelve months will be approximately $5,000,000. In the past year, we have relied on advances from related parties for financing our operations. We continue to explore potential funding opportunities, which may be in the form of debt or the sale of equity securities. In the event we are unsuccessful in arranging for outside funding, we will most likely continue to rely on related parties to provide funding, although there are no firm commitments or agreements with any related party to provide funds in the future.
Inflation
In the opinion of management, inflation has not and will not have a material effect on our operations in the immediate future. Management will continue to monitor inflation and evaluate the possible future effects of inflation on our business and operations.
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Recent Accounting Pronouncements
The company has evaluated recent accounting pronouncements and their adoption has not had nor is not expected to have a material impact on the company’s financial position or statements.
Off-balance Sheet Arrangements
We have no off-balance sheet arrangements.
Critical Accounting Policies
JOBS Act
The JOBS Act provides that, so long as a company qualifies as an “emerging growth company,” it will, among other things:
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Be exempt from the provisions of Section 404(b) of the Sarbanes-Oxley Act requiring that its independent registered public accounting firm provide an attestation report on the effectiveness of its internal control over financial reporting;
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Be exempt from the “say on pay” and “say on golden parachute” advisory vote requirements of the Dodd-Frank Wall Street Reform and Customer Protection Act (the “Dodd-Frank Act”), and certain disclosure requirements of the Dodd-Frank Act relating to compensation of its chief executive officer and be permitted to omit the detailed compensation discussion and analysis from proxy statements and reports filed under the Exchange Act; and
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Instead provide a reduced level of disclosure concerning executive compensation and be exempt from any rules that may be adopted by the Public Company Accounting Oversight Board requiring mandatory audit firm rotations or a supplement to the auditor’s report on the financial statements.
It should be noted that notwithstanding our status as an emerging growth company, we would be eligible for these exemptions as a result of our status as a “smaller reporting company” as defined by the Exchange Act.
Section 107 of the JOBS Act provides that an emerging growth company can take advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act for complying with new or revised accounting standards. An emerging growth company can therefore delay the adoption of certain accounting standards until those standards would otherwise apply to private companies. We have irrevocably elected not to take advantage of the benefits of this extended transition period and, therefore, will be subject to the same new or revised accounting standards as other public companies that are not emerging growth companies.
Plan of Operation
Following the closing of the Acquisition Agreement we have become engaged in the development and ultimate formulation of other novel formulations of natural compounds and pharmaceutical products that have limitations in effective use for human consumption. We believe our self-emulsifying drug delivery technology can improve the efficacy of existing products and formulations based on natural or well-established compounds and known biologically active compounds. We intend to conduct our research and development through collaborative programs. We anticipate relying on arrangements with third party drug developers such as contract research organizations and clinical research sites for a significant portion of our product development efforts.
The Acquisition Agreement enabled us to acquire certain products, formulas, processes, proprietary technology and/or patents and patent applications related to pharmaceutical, nutraceutical, food supplements and consumer health products. We have not formulated any final products or receive approvals from any regulatory agencies or generated any revenues from product sales. We have not been profitable since our inception through the current date.
We expect to incur significant operating losses for the next several years and until we are able to formulate a commercially viable product. We also expect to continue to incur significant operating and capital expenditures and anticipate that our expenses will increase substantially in the foreseeable future as we:
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Continue to undertake formulation of novel products and subsequent preclinical and clinical trials for our product candidates;
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Seek regulatory approvals for our product candidates;
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Develop, formulate, manufacture and commercialize our products;
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Implement additional internal systems and develop new infrastructure;
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Acquire or in-license additional products or technologies, or expand the use of our technology;
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Maintain, defend and expand the scope of our intellectual property; and
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Hire qualified personnel.
Future product revenue will depend on our ability to develops, receive regulatory approvals for, and successfully market, our product candidates. In the event that our development efforts result in regulatory approval and successful commercialization of our product candidates, we will generate revenue from direct sales of our products and/or, if we license our products to future collaborators, from the receipt of license fees and royalties from licensed products.
Management estimates that our research and development expenses for the next 12 months will be approximately $3.0 million, primarily for research and pilot studies. We also estimate that other expenses, including personnel, general and administrative and miscellaneous expenses could be as much as $2.0 million during the same time period. Because we currently have no revenues, most likely the only source of funding these expenses will be through the private sale of our securities, either equity or debt. We are currently exploring possible funding sources, but we have not entered into any arrangements or agreements for funding as of this time. If we are unable to raise the necessary funding, our research and development plans will be delayed indefinitely. There can be no assurance that we will be able to raise the funds necessary to carry out our business plan on terms favorable to the company, or at all.
MANAGEMENT
Directors and Executive Officers
The following table sets forth the name, age and position of our present directors and executive officers.
| | | | |
Name | | Age | | Position Held with Eastgate |
Anna Gluskin | | 60 | | CEO and Director |
Mirjana Hasanagic | | 47 | | President and Director |
Brian Lukian | | 63 | | CFO and Director |
Joseph Schwarz | | 57 | | Chief Scientific Officer |
Michael Weisspapir | | 55 | | Chief Medical Officer |
Geoff Williams | | 42 | | Director |
Nancy Ah Chong | | 44 | | Secretary/Treasurer and Director |
All directors serve for a one-year term until their successors are elected or they are re-elected at an annual stockholders' meeting. Officers hold their positions at the pleasure of the board of directors, absent any employment agreement, of which none currently exists or is contemplated.
There is no arrangement, agreement or understanding between any of the directors or officers and any other person pursuant to which any director or officer was or is to be selected as a director or officer. Also, there is no arrangement, agreement or understanding between management and non-management stockholders under which non-management stockholders may directly or indirectly participate in or influence the management of our affairs.
There are no agreements or understandings for any officer or director to resign at the request of another person and none of the current offers or directors of are acting on behalf of, or will act at the direction of any other person. However, two directors, Geoff Williams and Nancy Ah Chong, have agreed to tender their resignations as directors and officers at such time as the balance of $50,000 due to Williams Investment Company under the Acquisition Agreement is paid.
The business experience of each of the persons listed above during the past five years is as follows:
Anna Gluskinbecame a director and CEO on May 22, 2012. Ms. Gluskin has over 30 years’ experience in discovering and developing opportunities in the area of biotechnology pharmaceutical and consumer health products. She is currently managing her own investments related to consumer health products and drug delivery. From October 1997 to September 2010, Ms. Gluskin served as director, Chief Executive Officer and President of Generex Biotechnology Corporation, a company that has developed a proprietary alternative (non-invasive; non-injectable) drug delivery system. Ms. Gluskin was a Founder of Generex and was instrumental in raising capital for
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the company. Generex has developed an oral (buccal delivery insulin spray, Oral-lyn) and a platform from which a number of applications have been tested and others identified. An over-the-counter spray product pipeline was also developed and was marketed in a number of markets around the globe. From September 2010 to May 2012, Ms. Gluskin was exploring new business opportunities, which included examining new products and technologies and preliminarily organizing a scientific team. These efforts eventually led to the assignment of the products and technology representing the Acquired Products that Eastgate acquired from her in May 2012.
Prior to her position at Generex Biotechnology, Ms. Gluskin served as a director of Interlock Consolidated Corporation, a Canadian public company, engaged in the sale and fabrication of pharmaceutical manufacturing facilities. Ms. Gluskin successfully participated in the set-up of pharmaceutical facilities in Russia and other countries in Eastern Europe. Ms. Gluskin has a number of patents for innovative pharmaceutical drugs in her name. She holds a Master’s Degree in Microbiology and Genetics from Moscow State University. She holds an equivalent degree from the University of Toronto. Ms. Gluskin also serves as CEO of our wholly owned subsidiary, Eastgate Pharmaceuticals Inc. We believe that Ms. Gluskin’s education, expertise and extensive experience in the pharmaceutical industry and with public companies qualify her as a member of our board of directors.
Mirjana Hasanagicbecame a director and President on May 22, 2012. Ms. Hasanagic has over 20 years of managerial experience including marketing, budgeting and accounting, purchasing and inventory control and staff supervision. She has held various executive positions within pharmaceuticals and healthcare industries. From 2009 to 2012, she has served as President of Nano Essentials, Inc., a Toronto, Canada company developing products containing nano-sized delivery vectors.
From 2000 to 2008, Ms. Hasanagic was president of Go Laser Inc., a Waterloo based company engaged in herbalism and alternative medicine to treat infections, skin ailments and viral diseases. Her interest and experience in natural health products and diagnostics has led her to develop formulations that provide better absorption and delivery with the goal of attaining long term recovery and/prevention. Ms. Hasanagic holds Medical Doctor (Alternative Medicine), Herbalism degree from Indian Board of Alternative Medicine and B.A., Philosophy, Linguistics & Literature from University of Sarajevo, Bosnia. On May 27, 2009, Ms. Hasanagic filed for protection under the bankruptcy laws in the District Court of the City of Waterloo, Ontario, Canada. The bankruptcy was discharged by the Court on February 28, 2010. Ms. Hasanagic also serves as President of our wholly owned subsidiary, Eastgate Pharmaceuticals Inc. We believe that Ms. Hasanagic’s education, expertise and extensive experience in the natural health products industry qualify her as a member of our board of directors.
Brian Lukianbecame a director and CFO on May 22, 2012. Mr. Lukianhas Over 30 years of financial, strategic and business leadership experience in various industries and countries. Mr. Lukian served as Chief Financial Officer for Enhance Skin products of Denver, Colorado from August 2008 to May 2012, and for Quantum Materials Corp. of Phoenix, Arizona from November 2008 to June 2011. Both are reporting pubic companies with the SEC. Since January 2007, he has provided consulting services in regards to mergers and acquisitions, turnarounds, financings as well as business and industry analysis. From 2000 through 2006, he was employed as Chief Financial Officer and Chief Operating Officer for several public companies in Canada, for which he was responsible for public reporting requirements in Canada.
Mr. Lukian earned his certificate as a Chartered CPA, McGill University, while employed by Ernst & Young, Montreal, Canada and is a member of the Order of Certified Professional Accountants of Quebec. Mr. Lukian also held a United States Investment Bankers license, Series Seven. He received a Bachelor of Commerce from Loyola College, Montreal, Canada. Mr. Lukian also serves as CFO of our wholly owned subsidiary, Eastgate Pharmaceuticals Inc. We believe that Mr. Lukian’s education, expertise and accounting experience with public companies qualify him as a member of our board of directors.
Geoff Williams.Mr. Williams has served as a director and President and CEO of our company since its inception in September 1999. He resigned as President and CEO on May 22, 2012. From 1994 to the present, Mr. Williams has been a representative of Williams Investments Company, a Salt Lake City, Utah financial consulting firm involved in facilitating mergers, acquisitions, business consolidations and financings. Mr. Williams attended the University of Utah and California Institute of the Arts. Mr. Williams also previously served as our principal financial officer and principal accounting officer until May 2012.
Mr. Williams is currently a director, President and CEO of Westgate Acquisitions Corp. and, until he resigned in February 2010, he was a director, President and CEO of Greyhound Commissary, Inc., now known as Tanke Biosciences Corp. Mr. Williams served as a director of U.S. Rare Earths, Inc., a rare earths mining company from November 2011 to August 2012. He has also served as President and a director of Protect Pharmaceutical Corporation, a drug development company, from February 14, 2012 to the present. We believe that Mr. Williams’ relationship with the company since its inception and his expertise and extensive experience with public companies qualify him as a member of our board of directors.
Nancy Ah Chong. Ms. Ah Chong became a director and Secretary / Treasurer of our company in September 2006. From August 2004 to the present, she has been an office manager for Williams Investment Company, a Salt
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Lake City, Utah financial consulting firm involved in facilitating mergers, acquisitions, business consolidations and financings. Previously, Mrs. Ah Chong was an administrative assistant for Forsgren Associates in Salt Lake City from March 2004 to August 2004. She has also worked as a customer service representative for Overstock.com from November 2003 to January 2004 and O’Currance from February 2001 to November 2003, and as a marketing and travel coordinator for MGIS from February 2000 to August 2001. Mrs. Ah Chong attended and graduated from the Omaha Institute of Art and Design in Omaha, Nebraska.
Ms. Ah Chong is currently a director and Secretary / Treasurer of Westgate Acquisitions Corp. and, until she resigned in February 2010, she was a director and Secretary / Treasurer of Greyhound Commissary, Inc., now known as Tanke Biosciences Corp. Ms. Ah Chong also became a director and Secretary of Protect Pharmaceutical Corporation on February 14, 2012 and was named a director of U.S. Rare Earths, Inc. in May 2013. We believe that Ms. Ah Chong’s relationship with the company since 2006 and her past experience with public companies qualify her as a member of our board of directors.
Joseph Schwarz becameChief Scientific Officer on May 22, 2012. Mr. Schwarz has a graduate degree in Polymer Chemistry from Moscow State University, and a PhD in Organic Chemistry from Zelinsky Organic Chemistry Institute (Academy of Science, Moscow), Laboratory of polynitrocompounds. He has more than 40 publications 8 issued US patents and approximately 20 US patent applications. He has more than 20 years in pharmaceutical R&D Experience. Mr. Schwarz is a pharmaceutical technology and formulation expert in sustained release formulations for oral, topical, transmucosal, ophthalmic and parenteral application; biodegradable nano- and micro particles for controlled drug delivery of small molecules, peptides and proteins; colloidal drug delivery systems – nanoemulsions, micelles, hybrid nanoparticles; development and manufacturing of generic and brand pharmaceutical and cosmetic products. Mr. Schwarz served as Chief Scientist position (CS) at AlphaRx Canada from 2004 to 2011 and was Senior Manager/Formulation Development at Novopharm Pharmaceuticals LTD from 2003 to 2004. Mr. Schwarz also serves as Chief Scientific Officer of our wholly owned subsidiary, Eastgate Pharmaceuticals Inc. We believe that Mr. Schwarz’s education, expertise and extensive experience in the pharmaceutical industry qualify him to serve as our Chief Scientific Officer.
Michael Weisspapir became Chief Medical Officer on May 22, 2012 and has over 25 years’ experience in pharmacology and drug development. His knowledge spans all stages of drug development including pharmacology, toxicology, pharmaceutical science and neuroscience. He is also experienced in immunomodulators, anti-inflammatory drugs, anticonvulsant, anticancer agents as well as different methods of administration including parenteral, oral, transdermal and topical applications.
Mr. Weisspapir’s has experience with new drug evaluation for efficacy and safety (immunomodulators, chemotherapeutic agents, NSAID, anticonvulsants, antioxidants). This includes design and implementation of animal models of different indications, implementation ofin vivo andin vitro experimental protocols as well as with controlled drug delivery systems, submicron emulsion, nanoemulsions, biodegradable nanoparticulate systems (NSAID, SAID, tranquilizers, anticonvulsants, peptides, antibiotics). His most recent past work experience includes Chief Medical Scientist position (CMS) at AlphaRx Canada (2004 -2011).
Mr. Weisspapir currently holds three patents, has 20 patent applications and has been published in over 20 pharmacological and toxicological journals. Mr. Weisspapir holds a Medical Doctor degree and Ph.D. degree in Pharmacology- both from Chelyabinsk State Medical Institute, Russia. Mr. Weisspapir also serves as Chief Medical Officer of our wholly owned subsidiary, Eastgate Pharmaceuticals Inc. We believe that Mr. Weisspapir’s education, expertise and extensive experience in the pharmaceutical industry qualify him to serve as our Chief Medical Officer.
Currently, each officer, except for Mr. Williams and Ms. Ah Chong, devotes approximately 40 hours per week to the company, which is approximately 100% of their business time, except for Ms. Gluskin that devotes approximately 90% of her time to the company. Mr. Williams and Ms. Ah Chong will devote only minimal time to the company on an as-needed basis.
Committees of the Board of Directors
No director is deemed to be an independent director. Currently we do not have any standing committees of the board of directors. Until formal committees are established, our board of directors will perform some of the functions associated with a nominating committee and a compensation committee, including reviewing all forms of compensation provided to our executive officers, directors, consultants and employees, including stock compensation. The board will also perform the functions of an audit committee until we establish a formal committee.
Relationships and Related Party Transactions
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Except as set forth below, we have not entered into any other material transactions with any officer, director, nominee for election as director, or any stockholder owning greater than five percent (5%) of our outstanding shares, nor any member of the above referenced individuals' immediate family.
On May 22, 2012, we acquired the Acquired Products from Anna Gluskin, our current President and CEO, pursuant to the Acquisition Agreement. In exchange for the Acquired Products, we issued 10 million shares of common stock to the following persons who subsequently became directors and/or executive officers of the company:
●
Anna Gluskin (Director and Chief Executive Officer)
3,500,000 shares
●
Mirjana Hasanagic (Director and President)
2,000,000 shares
●
Joseph Schwarz (Chief Scientific Officer)
2,000,000 shares
●
Michael Weisspapir (Chief Medical Officer)
2,000,000 shares
●
Brian Lukian (Director and Chief Financial Officer)
500,000 shares
The 10 million shares issued for the Acquired Products were valued at $0 for the assets and $50,000 for services ($0.005 per share). In connection with the Acquisition Agreement, we also issued 10 million shares of common stock (valued at $50,000 or $0.005 per share) to TGT Investment Management Inc. in exchange for services and/or monies advanced. TGT Investment Management Inc. is privately held investment holding company controlled by Rose Perri, and which became a principal stockholder of the company.
As a provision of the Acquisition Agreement, Williams Investment Company was to be paid $100,000 for services rendered in connection with the execution of the agreement and the transactions contemplated thereby. Of that amount $50,000 was paid at the closing and $50,000 is to be paid at such time as the company realizes additional financing in the minimum amount of $300,000. H. Deworth Williams is a principal stockholder of the company and is the principal owner of Williams Investment Company. Two current directors, Geoff Williams and Nancy Ah Chong, are employees of Williams Investment Company and have agreed to resign as directors when the final $50,000 payment is paid to Williams Investment Company.
On October 23, 2012,our President and CEOMs. Gluskin loaned $100,000 to the company pursuant to the terms of a demand promissory note agreement. The note is unsecured, carries interest at the rate of 5% per annum and is payable on demand. The company will use the proceeds from the loan to conduct its general business operations until additional funding can be arranged, of which there can be no assurance. The largest principal amount outstanding during 2012 and as of the period ended March 31, 2013 was $100,000 and no payment of principal or interest has been made on the note. As of March 31, 2013, accrued interest on the note was $2,493.
From the year ended December 31, 2010 through March 31, 2013, the company recorded loans from shareholders, amounts due to shareholders for expenses paid on its behalf by shareholders, as notes payable - related parties on its balance sheet.The notes bear interest of 10% per annum, are unsecured and due and payable upon demand. As of March 31, 2013 the notes payable - related parties was $482,332, including the $100,000 note to Ms. Gluskin and the following:
●
$9,590, plus $19,364 of accrued interest, payable to William Investment Company, controlled by H. Deworth Williams a principal stockholder;
●
$4,600, plus $479 of accrued interest, payable to Anna Gluskin our CEO;
●
$46,164, plus $3,626 of accrued interest, payable to Angara Enterprises – a private corporation controlled by Anna Gluskin a principal stockholder;
●
$246,512, plus $14,345 of accrued interest, payable to Nano Essential, Inc., a private corporation deemed to be controlled by our PresidentMirjana Hasanagic and Ms. Gluskin; and
●
$75,466, plus $5,098 of accrued interest, payable toTGT Investment Management Inc., a private corporation controlled by Rose Perri, a principal stockholdershareholder and Ms. Gluskin.
At December 31, 2012,the notes payable - related party balance due was $449,103, with accrued interest of $35,155and as set forth below:
●
$100,000, plus $1,260 of accrued interest, payable to Anna Gluskin per the October 23, 2012 note;
●
$9,590, plus $19,128 of accrued interest, payable to William Investment Company;
●
$4,600, plus $366 of accrued interest, payable to Anna Gluskin;
●
$46,164, plus $2,488 of accrued interest, payable to Angara Enterprises;
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●
$220,302, plus $8,589 of accrued interest, payable to Nano Essential; and
●
$68,447, plus $3,324 of accrued interest, payable toTGT Investment Management Inc..
At December 31, 2011, the only payable to a related party was $59,590, with accrued interest of $17,190, and at December 31, 2010, the related party payable was $53,035 plus accrued interest of $11,213, each payable to Williams Investment Company. No payments have been made on the related party debts since they were incurred, except for the $50,000 payment made to Williams Investment Company on the closing of the Acquisition Agreement.
On October 1, 2012, the company entered into a lease agreement for laboratory and office space through the assignment of an existing lease by NanoEssential, Inc. The lease has a term of 32 months, with an expiration date of May 31, 2015, and specifies a monthly rate of $4,988 for 2012, $5,344 for 2013, and $5,700 for 2014 and 2015. The lease requires minimum lease payments of $175,988 over the term of the lease. At December 31, 2012 and March 31, 2013, the Companypaid $14,963 and $0, respectively, in connection with the lease.Mirjana Hasanagic, President and a director of Eastgate, previously served as President of NanoEssential, Inc. from 2009 to 2012and Ms. Gluskin our CEO is deemed in control of NanoEssential.
Contributed Capital
During the year ended December 31, 2011, Geoff Williams, a director, contributed various administrative services to the Company. These services include basic management and accounting services, and utilization of office space and equipment. The services have been valued at $3,000 for the year ended December 31, 2011.
During the year ended December 31, 2012, Anna Gluskin contributed various administrative services to the Company. These services include basic management and accounting services, and utilization of office space and equipment. The services have been valued at $6,000 for the years ended December 31, 2012.
Executive Compensation
We have not had a bonus, profit sharing, or deferred compensation plan for the benefit of employees, officers or directors. We have not paid any salaries or other compensation to officers, directors or employees for the years ended December 31, 2012, 2011 and 2010. Further, we have not entered into an employment agreement with any of our officers, directors or any other persons and no such agreements are anticipated in the immediate future. We expect that directors will defer any compensation until such time as the company is in a better financial position and will strive to have the business opportunity provide their remuneration. As of the date hereof, no person has accrued any compensation.
STOCK OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT
The following table sets forth information as ofJuly 23, 2013, to the best of our knowledge, with respect to each person believed to be the beneficial owner of more than 5% of our outstanding common stock, each director and executive officer and by all directors and executive officers as a group. For purposes of disclosure, a person is deemed to be the beneficial owner of any shares of common stock (i) over which the person has or shares, directly or indirectly, voting or investment power, or (ii) of which the person has a right to acquire beneficial ownership at any time within 60 days after the date of this prospectus. “Voting power” is the power to vote or direct the voting of shares and “investment power” includes the power to dispose or direct the disposition of shares.
Unless otherwise noted, the address of each person below will be c/o Eastgate Acquisitions Corporation, 2681 East Parleys Way, Suite 204, Salt Lake City, Utah 84109.
| | | | | | |
Name of Beneficial Owner | | Number of Shares | | Percent of Class(1) | |
Directors and Officers | | | | | |
Anna Gluskin* | | 3,500,000 | | | 11.1% | |
Mirjana Hasanagic* | | 2,000,000 | | | 6.3% | |
Brian Lukian* | | 500,000 | | | 1.6% | |
Joseph Schwarz* | | 2,000,000 | | | 6.3% | |
Michael Weisspapir* | | 2,000,000 | | | 6.3% | |
Geoff Williams * | | 4,635,000 | | | 14.7% | |
Nancy Ah Chong * | | 0 | | | 0% | |
5% Stockholders | | | | | | |
TGT Investment Management Inc.(2) | | 10,000,000 | | | 31.6% | |
Edward F. Cowle* | | 4,635,000 | | | 14.7% | |
H. Deworth Williams | | 2,195,445 | | | 6.9% | |
All Directors and Officers as a group (7 persons) | | 14,635,000 | | | 46.3% | |
|
* Director and/or executive officer |
Note: Unless otherwise indicated, we have been advised that each person above has sole voting power over the shares indicated above.
(1)
Based upon 31,625,000 shares of common stock outstanding onJuly 23, 2013.
(2)
TGT Investment Management Inc. is privately held investment holding company, of which investment and voting control are held by Rose Perriand Anna Gluskin.
DESCRIPTION OF SECURITIES
Common Stock
Authorized and Outstanding
We are authorized to issue up to 100 million shares of common stock, par value $0.0001 per share, of which 31,625,000 shares are outstanding as of the date of this prospectus.
Voting Rights
Each holders of our common stock has the right to cast one vote for each share of stock in their name on the books of our company, whether represented in person or by proxy, on all matters submitted to a vote of holders of common stock, including election of directors. There is no right to cumulative voting in election of directors. Except where a greater requirement is provided by statute, by our articles of incorporation or bylaws, the presence, in
person or by proxy duly authorized, of one or more holders of a majority of the outstanding shares of our common stock constitutes a quorum for the transaction of business. The vote by the holders of a majority of outstanding shares is required to effect certain fundamental corporate changes such as liquidation, merger, or amendment of our articles of incorporation.
Dividends
There are no restrictions in our articles of incorporation or bylaws that prevent us from declaring dividends. We have not declared any dividends and we do not plan to declare any dividends in the foreseeable future.
Preemptive Rights
Holders of our common stock are not entitled to preemptive rights, and no redemption or sinking fund provisions are applicable to our common stock.
Transfer Agent
We have designated as our transfer agent Interstate Transfer Company, 6076 South 900 East, Suite 101, Salt Lake City, Utah 84121.
DISCLOSURE OF COMMISSION POSITION OF INDEMNIFICATION FOR SECURITIES ACT LIABILITIES
Our bylaws provide that directors, officers and persons acting at our request as an officer or director, will be indemnified by us to the fullest extent authorized by the general corporate laws of Nevada. This indemnification applies to all expenses and liabilities reasonably incurred in connection with services for us or on our behalf if:
●
such person acted in good faith with a view to our best interests; and
●
in the case of a monetary penalty in connection with a criminal or administrative action or proceeding, such person had reasonable grounds to believe that his or her conduct was lawful.
Insofar as indemnification for liabilities arising under the Securities Act might be permitted to directors, officers or persons controlling our company under the provisions described above, we have been informed that in the opinion of the SEC such indemnification is against public policy as expressed in the Securities Act and is therefore unenforceable.
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LEGAL MATTERS
Leonard E. Neilson, Attorney at Law, 8160 South Highland Drive, Suite 104, Sandy, Utah 84093, telephone (801) 733-0800, has acted as our special legal counsel.
EXPERTS
Our financial statements for the fiscal years ended December 31, 2012 and 2011 appearing in this prospectus have been audited by Sadler, Gibb & Associates, L.L.C, independent certified public accountants, Salt Lake City, Utah. Their report is given upon their authority as experts in accounting and auditing. Our unaudited financial statements for the three-month period ended March 31, 2013 have been prepared by the company.
INTEREST OF NAMED EXPERTS AND COUNSEL
No expert or counsel named in this prospectus was hired on a contingent basis, will receive a direct or indirect interest in Eastgate or has acted or will act as a promoter, underwriter, voting trustee, director, officer, or employee of our company.
WHERE YOU CAN FIND MORE INFORMATION
This prospectus is part of a registration statement that we filed with the SEC in accordance with its rules and regulations. This prospectus does not contain all of the information in the registration statement. For further information regarding both our company and the securities in this offering, we refer you to the registration statement, including all exhibits and schedules. You may inspect our registration statement, without charge, at the public reference facilities of the SEC’s Washington, D.C. office, 100 F Street, NE, Washington, D.C. 20549 and on its Internet site athttp://www.sec.gov. Please call the SEC at 1-800-SEC-0330 for further information about the public reference room.
You also may request a copy of the registration statement and these filings by contacting us electronically atinformation@eastgatepharmaceuticals.com.
We are subject to the informational requirements of the Securities Exchange Act of 1934 and required to file annual, quarterly and current reports and other information with the SEC. These reports and other information may also be inspected and copied at the SEC’s public reference facilities or its web site.
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EASTGATE ACQUISITIONS CORPORATION
(A Development Stage Company)
FINANCIAL STATEMENTS
December 31, 2012 and 2011
F-1
Eastgate Acquisitions Corporation
(A Development Stage Company)
Index to Financial Statements
Report of Independent Registered Public Accounting Firm
F-3
Balance Sheets as of December 31, 2012 and 2011
F-4
Statements of Operations for the Years Ended December 31, 2012 and 2011 and
from inception on September 8, 1999 through December 31, 2012
F-5
Statements of Stockholders’ Deficit from inception on September 8, 1999 through
December 31, 2012
F-6
Statements of Cash Flows for the Years Ended December 31, 2012 and 2011 and
from inception on September 8, 1999 through December 31, 2012
F-7
Notes to Financial Statements
F-8
F-2
![[forms1amend4edgar3redline001.jpg]](https://capedge.com/proxy/S-1A/0001099574-13-000018/forms1amend4edgar3redline001.jpg)
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Board of Directors
Eastgate Acquisitions Corporation and subsidiary
We have audited the accompanying consolidated balance sheets of Eastgate Acquisitions Corporation and subsidiary (the “Company”) as of December 31, 2012 and 2011 and the related consolidated statements of operations, stockholders’ (deficit) and cash flows for the years then ended and for the cumulative period from September 8, 1999 (date of inception) through December 31, 2012. 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 audit.
We conducted our audits in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and perform the audits to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. Our audits included consideration of internal control over financial reporting as a basis for designing audit procedures that are appropriate in the circumstances, but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion. An audit also includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements, assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for our opinion.
In our opinion the consolidated financial statements referred to above present fairly, in all material respects, the financial position of Eastgate Acquisitions Corporation and subsidiary as of December 31, 2012 and 2011, and the results of their operations and cash flows for the years then ended and for the cumulative period from September 8, 1999 (date of inception) through December 31, 2012, 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 2 to the financial statements, the Company had accumulated losses of $744,208 for the period from inception through December 31, 2012 which raises substantial doubt about its ability to continue as a going concern. Management’s plans concerning these matters are also described in Note 2. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.
/s/ Sadler, Gibb & Associates, LLC![[forms1amend4edgar3redline002.jpg]](https://capedge.com/proxy/S-1A/0001099574-13-000018/forms1amend4edgar3redline002.jpg)
Salt Lake City, UT
April 15, 2013
F-3