REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933
MEDICAL DISCOVERIES, INC.
Utah | 2834 | 87-0407858 | ||
(State or Jurisdiction of | (Primary Standard | (I.R.S. Employer | ||
Incorporation or | Industrial | Identification No.) | ||
Organization) | Classification Code | |||
Number) |
1338 S. Foothill Drive, #266
Salt Lake City, Utah 84108
Telephone: (801) 582-9583
Judy M. Robinett
President and Chief Executive Officer
Medical Discoveries, Inc.
1338 S. Foothill Drive, #266
Salt Lake City, Utah 84108
Telephone: (801) 582-9583
Copies to:
Stephen R. Drake, Esq.
Approximate date of commencement of proposed sale to the public: As soon as practicable after this Registration Statement becomes effective.
If this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, please check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. o
If this Form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. o
If this Form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. o
If any of the securities being registered on this form are to be offered on a delayed or continuing basis pursuant to Rule 415 under the Securities Act of 1933, check the following box. þ
If delivery of the prospectus is expected to be made pursuant to Rule 434, please check the following box. o
The Registrant hereby amends this Registration Statement on such date or dates as may be necessary to delay its effective date until the registrant shall file a further amendment which specifically states that this Registration Statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act or until the Registration Statement shall become effective on such date as the Commission, acting pursuant to said Section 8(a), may determine.
SUBJECT TO COMPLETION DATED MAY 24, 2006
The information in this prospectus is not complete and may be changed. We may not sell these securities until the registration statement filed with the Securities and Exchange Commission is effective. This prospectus is not an offer to sell these securities, and it is not soliciting an offer to buy these securities in any state where the offer or sale is not permitted.
Medical Discoveries, Inc.
113,511,158 shares of common stock
This prospectus relates to the offering and sale of 113,511,158 shares of common stock offered for resale by the selling security holders identified on page 10 of this prospectus.
We will not receive any of the proceeds from the sale of the shares offered hereunder. Our common stock is traded on the NASD OTC Bulletin Board under the symbol MLSC. On May 23, 2006, the closing sales price of our common stock, as reported by the OTC Bulletin Board, was $0.11 per share.
Consider carefully the risk factors beginning on page 2 of this prospectus before investing in the offered shares being sold with this prospectus.
This prospectus shall not constitute an offer to sell, or the solicitation of an offer to buy, in any state in which such offer or sale would be unlawful before or absent qualification under the securities laws of such state.
Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or passed upon the adequacy or accuracy of this prospectus. Any representation to the contrary is a criminal offense.
Dated May 24, 2006
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EXHIBIT 5.1 | ||||||||
EXHIBIT 23.1 | ||||||||
EXHIBIT 23.2 | ||||||||
EXHIBIT 23.3 |
ABOUT THIS PROSPECTUS
This prospectus provides you with a description of our company, certain risk factors associated with investment in our common shares, a description of the contemplated offering and certain financial information. Fuzeon is a registered trademark of Roche Laboratories, Inc. and Timeris Inc. Tobramycin is a registered trademark of Chiron Corporation or its subsidiaries. Pulmozyme is a registered trademark of Genetech, Inc. Advair is a registered trademark of GlaxoSmithKline. Singulair is a registered trademark of Merck & Co., Inc. Herceptin is a registered trademark of Genetech, Inc. Femara is a registered trademark of Novartis Pharma AG. Arimidex is a registered trademark of AstraZeneca Pharmaceuticals LP. Aromasin is a registered trademark of Pfizer, Inc.
PROSPECTUS SUMMARY
The following is a summary that highlights what we believe to be the most important information regarding Medical Discoveries, Inc. and the securities being offered herein. Because it is a summary, however, it may not contain all of the information that is important to you. To understand our business and this offering fully, you should read carefully this entire prospectus, including our financial statements and related notes and the risks of investing in our common stock discussed under Risk Factors.
Our Company
Medical Discoveries, Inc. was incorporated on November 20, 1991 as a Utah corporation and maintains its principal offices at 1338 S. Foothill Drive, #266, Salt Lake City, Utah 84108. Our telephone number is (801) 582-9583 and our web address is www.medicaldiscoveries.com. We are a developmental-stage bio-pharmaceutical company engaged in the research, validation, development and ultimate commercialization of two drugs: MDI-P and SaveCream. MDI-P is an anti-infective drug that we believe will be a useful and well tolerated treatment for bacterial infections, viral infections and fungal infections, and we believe may be a useful therapy for the treatment of cystic fibrosis and HIV infection, among other conditions. SaveCream is a breast cancer medication that is applied topically to reduce breast cancer tumors. Neither of these drugs has been approved by the U. S. Food and Drug Administration (FDA). We filed an Investigational New Drug Application (IND) for MDI-P for the treatment of cystic fibrosis with the FDA on November 10, 2004. FDA placed the proposed Phase I clinical trials in humans on clinical hold, pending the outcome of additional preclinical research. We completed that research and filed an amended IND with the FDA on March 16, 2006. The FDA responded to that amendment on April 21, 2006 and continued the clinical hold until additional preclinical trials are conducted. Save Cream is currently in preclinical development.
The Offering
Securities offered by the Selling Stockholders
|
350,000 shares restricted common stock | |
84,000,000(1) shares of common stock issuable upon conversion of Series A convertible preferred stock | ||
29,161,158 shares of common stock issuable upon exercise of warrants | ||
Shares of our common stock outstanding prior
to this offering
|
107,992,148(2) | |
Shares of common stock outstanding following
this offering, if all registered shares are sold
|
221,153,306 | |
Use of Proceeds
|
All net proceeds of this offering will be received by the Selling Stockholders. | |
Risk Factors
|
You should read the Risk Factors beginning on page 2 as well as other cautionary statements throughout this prospectus before investing in any shares offered hereunder. |
(1) | This registration statement covers, in part, shares of common stock that may be issued upon conversion of two issuances of Series A convertible preferred stock. While we are required to register an aggregate of only 84,000,000 shares of common stock pursuant to those issuances, the actual number of shares into which the Series A stock could be converted could be much greater. On March 14, 2005, we issued 30,000 shares of Series A Stock to Mercator Momentum Fund, LP and Mercator Momentum Fund III, LP. There is no minimum conversion price per share for that issuance. Therefore, the number of shares of common stock into which the Series A stock could be converted is theoretically unlimited. See the sections of this prospectus entitled Prospectus Summary Selling Security Holders and Selling Security Holders for a detailed analysis of the Series A conversion feature. Before making an investment decision in Medical Discoveries, you should consider the risks associated with the Series A conversion feature. See Risk Factors: Obtaining Additional Capital Through The Sale Of Common Stock Will Result In Dilution Of Stockholder Interests. |
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(2) | Excludes up to 19,983,000 shares of common stock authorized for issuance upon exercise of outstanding options granted pursuant to our stock option plans, 3,500,000 shares of our common stock reserved for the future grant of stock options under such plans, and 40,923,861 shares of our common stock issuable upon exercise of warrants (which 40,923,861 includes the 29,161,158 shares of common stock subject to outstanding warrants being registered in this offering). | |||
In addition, pursuant to Rule 416 of the Securities Act, this prospectus, and the registration statement of which it is a part, covers a presently indeterminate number of shares of stock issuable upon the occurrence of a stock split, stock dividend or other similar transaction.
Selling Security Holders
All of the offered shares are to be sold by existing security holders. The selling shareholders acquired the rights to their shares and warrants (i) in a private placement of Series A Convertible Preferred Stock and warrants in October 2004; (ii) in a private placement of Series A Convertible Preferred Stock and warrants in March 2005; and (iii) in exchange for placement agent services and consulting in connection with the foregoing financings.
Of the shares of our common stock offered hereby, 350,000 shares consist of restricted common stock, 84,000,000 shares may be issuable upon the conversion of Series A Convertible Preferred Stock and 29,161,158 shares are issuable upon the exercise of outstanding warrants to purchase our common stock.
In addition, pursuant to Rule 416 of the Securities Act, this prospectus and the registration statement of which it is a part cover a presently indeterminate number of shares of common stock issuable upon the occurrence of a stock split, stock dividend, or other similar transaction.
The 84,000,000 shares potentially issuable upon conversion of the Series A stock are issuable upon conversion of two issuances of such Series A stock. While we are required to register an aggregate of only 84,000,000 shares of common stock pursuant to those issuances, the actual number of shares into which the Series A stock could be converted could be much greater. Specifically, on October 18, 2004 we issued 12,000 shares of Series A stock to Monarch Pointe Fund, Ltd. Under the terms of that issuance, each share of Series A stock entitles the holder to convert the share into the number of shares of common stock resulting from dividing $100 (which is the purchase price per share of Series A stock) by the conversion price. The conversion price is 75% of the average of the lowest three intra-day trading prices for our common stock during the 10 trading days immediately preceding the conversion date, but the conversion price may not exceed $0.1967 or be lower than $0.05. We are registering 24,000,000 shares of common stock in connection with that issuance (which is based on the floor conversion price of $0.05 per share and is the number of shares required to be registered pursuant to the applicable registration rights agreement with Monarch Pointe Fund, Ltd.). On March 14, 2005 we issued 30,000 shares of Series A stock to Mercator Momentum Fund, LP and Mercator Momentum Fund III, LP. Under the terms of that issuance, each share of Series A stock entitles the holder to convert the share into the number of shares of common stock resulting from dividing $100 (which is the purchase price per share of Series A stock) by the conversion price. The conversion price is 75% of the average of the lowest three intra-day trading prices for our common stock during the 10 trading days immediately preceding the conversion date, but the conversion price may not exceed $0.1967. There is no minimum conversion price per share for that issuance. We are registering 60,000,000 shares of common stock in connection with that issuance (which is based on an assumed conversion price of $0.05 per share and is the number of shares required to be registered pursuant to the applicable registration rights agreement with Mercator Momentum Fund, LP and Mercator Momentum Fund III, LP).
Notwithstanding our obligation to register 84,000,000 shares of common stock upon conversion of the Series A stock, the actual minimum and maximum number of shares of common stock into which the outstanding Series A stock could be converted is as follows:
Shares of Common Stock Into Which | ||||||||
Series A May Be Converted | ||||||||
Minimum | Maximum | |||||||
12,000 Shares of Series A issued 10/18/04 |
6,100,661 | 24,000,000 | ||||||
30,000 Shares of Series A issued 03/14/05 |
15,251,652 | Theoretically unlimited(1) | ||||||
Total |
21,352,313 | Theoretically unlimited(1) |
(1) | Because the conversion price has no floor, it theoretically could be infinitely small, resulting in conversion into an infinitely large number of shares of common stock. See the sections of this prospectus entitled Selling Security Holders and Security Ownership Of Certain Beneficial Owners And Management. | |
RISK FACTORS
An investment in our common stock involves a high degree of risk. You should consider the following discussion of risks in addition to the other information in this prospectus before making an investment in Medical Discoveries. If any of the following risks actually occurs, our business, financial condition or results of operations could be materially adversely affected. In such a case, you may lose all or part of your investment. The risks below address some of the factors that may affect our future operating results and financial performance.
Risks Relating to Our Business
We Are A Development-Stage Company That Has Not Yet Commercialized A Product. We have not commercialized MDI-P, SaveCream or any other product and our failure to commercialize our drugs would likely cause us to cease operations. While we believe MDI-P and SaveCream may have very broad commercial applications, we do not have any other products under development, nor do we have scientific personnel on staff to develop any further technologies. The results of our preclinical and anecdotal clinical studies may not be indicative of future clinical trials. Moreover, unacceptable side effects could occur at any time in the course of human trials or, if our drugs are approved for sale, during commercial use. Even if our drugs do prove to be safe and effective and receive regulatory approvals, we may be unable to successfully commercialize them.
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We Have Incurred Substantial Losses Since Our Inception And May Continue To Operate At A Loss. We have experienced net losses in each twelve-month period since inception, with a retained deficit of approximately $23,811,757 as of March 31, 2006. Our net losses were $1,486,781 for the fiscal year ended December 31, 2005, $1,571,466 for the quarter ended March 31, 2006, and $22,412,180 from inception through March 31, 2006. We will likely continue to experience a net loss until, and if, we can fully commercialize our technologies, which may not be for several years. We are presently investing all of our resources in the testing, development and commercialization of MDI-P and Save-Cream. If MDI-P and SaveCream do not generate revenues or if the revenues do not exceed the costs of research, development, testing, regulatory approval and other costs, then we may never realize a profit from operations.
We May Not Be Able To Raise Sufficient Capital To Meet Present And Future Obligations. As of April 30, 2006 we had $74,340 in cash and a working capital deficit of $3,513,022. We are in immediate need of additional capital in order to satisfy our current liabilities.
In addition, we are unable to progress to our next developmental milestone entering Phase I clinical trials on MDI-P as a treatment for cystic fibrosis without additional capital. Our cystic fibrosis Phase I IND has been placed on clinical hold by the FDA pending our completion of additional preclinical trials. We estimate those additional tests will cost $700,000 and take six to nine months to complete. Taking into account our overhead expense during that time, we estimate we will need between $1,100,000 and $1,300,000 in funding to resubmit our IND to the FDA. Even if we fund those additional tests, the FDA may require further testing and expenditures by us. Without sufficient capital to progress any of our products to some stage of clinical development, our ability to commercialize any product, even by license to third parties, will be severely limited.
We have insufficient capital to file our IND for HIV. In addition, once an IND application for HIV is submitted, and assuming it is approved, we will need additional capital to initiate Phase I clinical trials.
We estimate the cost to complete Phase I and Phase II clinical trials to be several million dollars per indication and the cost to complete Phase III testing and obtain approval of a New Drug Application to be in the tens of millions of dollars per indication. While our ability to obtain financing may improve in the event our IND application is approved, we cannot give assurances that we will have access to the significant capital required to take a drug through regulatory approvals and to market.
We do not currently have revenues that could be used to satisfy our capital requirements. We may seek to obtain revenues at any time, however, by partnering with another company to help us co-develop, license, or even purchase some or all of our technologies. Most likely, we will seek to raise additional capital through equity and/or debt financings.
The timing and amount of our future capital requirements will depend on many factors, including, without limitation the following:
| our ability to raise additional funding and the amounts raised, if any; | |||
| the time and costs involved in obtaining regulatory approvals; | |||
| the results of pre-clinical studies and clinical trials; | |||
| the cost of manufacturing scale-up; | |||
| competing technological and market developments; | |||
| the costs of filing, prosecuting and enforcing patent claims; and | |||
| the effectiveness of our commercialization activities. |
Factors affecting the availability and price of capital may include, without limitation, the following:
| market factors affecting the availability and cost of capital generally; | |||
| our performance; | |||
| the size of our capital needs; | |||
| the markets perception and acceptance of our technologies; and | |||
| the price, volatility and trading volume of our common shares. | |||
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If we are unable to obtain sufficient capital or are forced to pay a high price for capital, we may be unable to complete testing, regulatory approval and commercialization of our technologies and may never achieve consistent revenues or profitability. In addition, because of their size, resources and other factors, our competitors may have better access to capital than we do and, as a result, may be able to exploit opportunities more rapidly, easily or thoroughly than we can.
Obtaining Additional Capital Though The Sale Of Common Stock Will Result In Dilution Of Stockholder Interests. We plan to raise additional funds in the future by issuing additional shares of common stock, or securities such as convertible notes, options, warrants or preferred stock that are convertible into common stock. Any such sale of common stock or other securities will lead to further dilution of the equity ownership of existing holders of our common stock. Additionally, the existing options, warrants and conversion rights, detailed in the Dilution section of this prospectus, may hinder future equity offerings, and the exercise of those options, warrants and conversion rights may have an adverse effect on the value of our stock. In particular, we have 19,983,000 options outstanding with exercise prices ranging from $0.01 to $0.50 and a weighted average exercise price of $0.04 per share; 40,923,861 warrants outstanding with exercise prices ranging from $0.09 to $1.00 and a weighted average exercise price of $0.23 per share; and 41,800 shares of Series A convertible preferred stock outstanding, 11,800 of which can be exercised into as many as 23,600,000 shares of common stock at the exercise price of $0.05 per share and 30,000 of which can be exercised into a theoretically unlimited number of shares of common stock without a floor on the exercise price. If any such options, warrants or conversion rights are exercised at a price below the current market price of our shares, then the market as a whole will experience dilution. Further, if any such options, warrants or conversion rights are exercised at a price below the price at which any particular shareholder purchased shares, then that particular shareholder will experience dilution in his or her investment.
Selling Pressure From Our Series A Convertible Preferred Shareholders May Negatively Impact Our Stock Price, Our Market Value, And Our Ability To Raise Additional Capital. Because the conversion price of much of the Series A convertible preferred stock held by the selling shareholders in this prospectus has no floor, coupled with the fact that the conversion price is at a discount to market, the selling shareholders could realize a profit on selling common stock no matter what price our common stock is trading at in the market at the time. Because our trading volume is limited and our stock price is subject to fluctuation, the market price of our stock could decrease dramatically if the selling shareholders decide to liquidate all or even some of their position. Even if the selling stockholders liquidate their position slowly over time, because the overall number of shares into which they could exercise is so large as a proportion to our shares outstanding, the result could be a sustained market price for our stock that is much lower than it would otherwise be without such sustained selling pressure. If our stock price does suffer due to this type of selling pressure, our market value will be lower and our ability to raise much needed additional capital will be negatively impacted. If the selling shareholders decide to liquidate their position in a market with very little purchaser demand, the result could be to eliminate substantially all of our market value, resulting in no meaningful opportunity whatsoever to obtain additional financing that we need to continue to develop our development-stage products.
Our Independent Auditors Have Expressed Substantial Doubt As To Our Ability To Continue As A Going Concern. Our auditors have expressed substantial doubt about our ability to continue as a going concern because of our recurring losses from our development-stage activities in current and prior years. We have not generated any significant revenues to date. We expect to continue to incur substantial net operating losses over the next several years. We may not be able to generate sufficient revenues to become profitable and do not expect to generate any revenues for several years. We struggle with operating and liquidity issues due to our negative cash flows from operations and we have had difficulty in the past with raising capital. As a result of these and other factors, our independent auditors have expressed substantial doubt about our ability to continue as a going concern. The financial statements do not include any adjustments that might be necessary if the Company is unable to continue as a going concern.
Our Operations Are And Will Be Subject To Extensive Regulation. Our use of MDI-P and SaveCream in the treatment of humans is subject to extensive regulation by United States and foreign governmental authorities. In particular, pharmaceutical treatments are subject to rigorous pre-clinical and clinical testing and other approval requirements by the FDA in the United States under the federal Food, Drug and Cosmetic Act and by comparable agencies in most foreign countries. Various federal, state and foreign statutes also govern or influence the manufacture, labeling, storage, record keeping, and marketing of such products. Pharmaceutical manufacturing facilities are also regulated by state, local, and other authorities. Obtaining approval from the FDA and other regulatory authorities for a new drug or treatment may take several years and involve substantial expenditures. Moreover, ongoing compliance with these requirements can require the expenditure of substantial resources. Difficulties or unanticipated costs may be encountered by us in our efforts to secure necessary governmental approvals, which could delay or preclude us from marketing our products.
4
Our Products Will Be Exposed To Pricing And Reimbursement Risks. Our ability to earn revenue will depend in part on the extent to which reimbursement for the costs of the products and related treatments will be available from government health administration authorities, private health coverage and managed care organizations. Third-party payers are increasingly challenging the prices of drugs and medical services. If purchasers or users of MDI-P or SaveCream are not able to obtain adequate reimbursement, they may forego or reduce their use.
5
We Face Intense Competition And Competing Products. Competition in the markets for MDI-P and SaveCream is intense and will likely further intensify. The biotechnology and pharmaceutical industries are characterized by rapidly evolving technologies and intense competition. Our competitors include major pharmaceutical, and specialized biotechnology companies, many of which have financial, technical, and marketing resources significantly greater than ours. Fully integrated pharmaceutical companies, due to their expertise in research and development, manufacturing, testing, obtaining regulatory approvals, and marketing, as well as their substantially greater financial and other resources, may be our most formidable competitors. In addition, acquisitions by such pharmaceutical companies could enhance the financial and marketing resources of smaller competitors. Furthermore, colleges, universities, governmental agencies, and other public and private research organizations will continue to conduct research and possibly market competitive commercial products on their own or through joint ventures. These institutions are becoming more active in seeking patent protection and licensing arrangements to collect royalties for use of technology that they have developed. These institutions also will compete with us in recruiting and retaining highly qualified scientific personnel.
In particular, we face competition from the manufacturers of products that would compete with MDI-P and SaveCream should they be commercialized. Manufacturers of products currently available for the treatment of HIV and cystic fibrosis would be among our most significant competitors in the market for MDI-P. While there are 24 HIV therapies currently on the market (commonly used in three- or four-drug combinations), the primary therapies currently in use are produced by Pfizer, Bristol-Myers Squibb, Boehringer Ingelheim, GlaxoSmithKline, Gilead Sciences, Hoffman-La Roche, Merck, Abbott Laboratories, Agouron Pharmaceuticals, and Trimeris. Currently available anti-infectives commonly used in the treatment of cystic fibrosis are manufactured by Bayer Corporation, the maker of Cipro; Pfizer, the maker of Zithromax; and Chiron, the maker of tobramycin solution (TOBI). Bayer and Pfizer would compete with us in the cystic fibrosis market, while MDI-P is being studied as an adjunct to treatment with TOBI; thus we would be unlikely to compete directly with Chiron. Producers of aromatase inhibitors and other breast cancer treatments would compete with SaveCream should we able to commercialize this product. These companies include Astra-Zeneca, the maker of both Tamoxifen and Arimidex; Novartis, the maker of Femara; and Pfizer, the maker of Aromasin.
If and when we obtain regulatory approval for any of the potential uses of our technology which require them, we must then compete for acceptance in the marketplace. None of our products may prove to fulfill an unmet need in the marketplace or to produce any competitive advantage. Additionally, given that regulatory approval, especially in the United States, may take a number of years, the timing of the introduction of our technology and other products to the market is critical. Other safe and effective drugs and treatments may be introduced into the market prior to the time that we are able to obtain approval for the commercialization of our technology. In addition, even after such regulatory approval is obtained, competition among products approved for sale may be affected by, among other things, product efficacy, safety, reliability, availability, price, and patent position.
The extensive financial and other resources of the major pharmaceutical manufacturers who are our most likely competitors may make it unlikely that we can successfully compete in the HIV, cystic fibrosis or breast cancer markets on our own. As a result, we may seek a development partner or pursue licensing opportunities for these technologies.
Our Intellectual Property May Not Be Adequately Protected. We rely heavily on our patent protection to prevent others from using the human therapeutic applications of our technology. It is our policy to protect our intellectual property and proprietary technologies by, among other means, filing patent applications to protect technology that we consider important to the development of our business.
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We also rely on trade secrets and improvements, unpatented know how, and continuing technological innovation to develop and maintain our competitive position. Despite our policy to seek patent protection wherever appropriate, we cannot be sure that our patent applications will result in further patents being issued or that, if issued, the patents will afford protection against competitors with similar technology. We are unaware of any current or past infringement of our patented technologies; however, if such infringement were to occur, sufficient funds may not be available to adequately pursue an action for infringement. While we have obtained several United States patents, persons in jurisdictions outside of the United States in which no application has been filed or which do not honor United States patents may develop and market infringing technologies. Also, the cost of enforcing patents outside North America as well as other obstacles, may limit our ability to enforce any patents outside of the United States. Finally, our products and processes may infringe on patents of others. If relevant claims of third-party patents are upheld as valid and enforceable, we could be prevented from practicing the subject matter claimed in the claims, or be required to obtain licenses or redesign our products or processes to avoid infringement.
We currently hold eight U.S. patents, two Japanese patents and one Mexican patent related to MDI-P. These patents, detailed in the Description of Business section of this prospectus, cover a specific solution, methods of using this solution as an anti-infective, and the equipment and processes necessary to produce it. The durations of these patents range from May 2010 to August 2014. We also have three pending U.S. patent applications relating to methods of using MDI-P to treat cystic fibrosis, sepsis and asthma. The intellectual property assets purchased from Savetherapeutics include the intellectual property rights in four patent families related to SaveCream. These patents and the related international patents and patent applications are detailed in the Description of Business section.
We May Need to Litigate to Secure Our Rights to SaveCream And Related Assets. At the time we purchased SaveCream and the other intellectual property assets from Savetherapeutics A.G. (SaveT), SaveT had not yet obtained and filed with the appropriate patent offices assignments of the inventors rights to the underlying inventions. As a result, at the time the SaveT assets were obtained, the two inventors of SaveCream, Heinrich Wieland and Alfred Schmidt, were the record holders of the U.S. patent rights related to this product. Each of those inventors has agreed and is contractually bound to assign such rights to SaveT. As of September 25, 2005, Heinrich Wieland has executed assignments of his interests in the SaveCream patents to Savetherapeutics and has provided us with a declaration to the U.S. Patent and Trademark Office detailing the agreements by which he and Mr. Schmidt, upon receipt of consideration from SaveT, agreed and intended to transfer these rights to SaveT. Those assignments, along with assignments of Savetherapeutics rights in the patents to us, have been filed with the U.S. Patent and Trademark Office.
Despite his prior written agreements to do so, Mr. Schmidt has refused to execute assignments of his rights in the SaveCream patents. To our knowledge, Mr. Schmidts refusal to undertake his contractual obligation to assign the SaveCream patents has no basis in law. It may be necessary, however, to litigate against Mr. Schmidt in all countries in which patents are filed in order to obtain the assignment of these rights. These countries include the U.S., Germany, Canada, France, Great Britain, Italy, the Netherlands, Switzerland and Spain. We may not have the funds necessary to effectively pursue these claims.
Should we fail to obtain the assignment of Mr. Schmidts rights in the SaveCream patents, it may be more difficult to commercialize SaveCream should FDA approval for such commercialization be granted. While the product would remain subject to patent protection and we could pursue our development and commercialization activities based upon Dr. Wielands assignment, Mr. Schmidt, as a co-inventor, may be able to independently exploit his rights in the SaveCream patents and could enter into competition with us or license his rights to third parties. This would effectively preclude us from pursing an exclusive licensing or co-development opportunity, and would, therefore substantially reduce the value of this intellectual property to us.
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We Face Significant Product Liability. We face an inherent business risk of exposure to product liability and other claims in the event our products result in or are alleged to result in harmful effects. We may not be able to avoid significant liability exposure. We may not have or be able to obtain or maintain sufficient insurance coverage at a reasonable cost. An inability to obtain sufficient insurance coverage at a reasonable cost could prevent or inhibit the commercialization of our technology. Even if we avoid liability exposure, we could incur significant costs that hurt our financial performance. We currently do not have and have not applied for product liability insurance. We intend to purchase product liability insurance prior to commencing clinical trials, and have incorporated the costs of insurance coverage into our budget for the trials.
Risks Specific to the Purchase of Common Stock in This Offering
The Market For Our Stock Is Thin And Subject To Manipulation. Our common stock is traded on the NASD OTC Bulletin Board under the symbol MLSC. Since our inception, trading in our stock has been sporadic. During the three months ended April 30, 2006, the daily trading volume of our stock averaged 70,325 shares per day. This thin trading market increases the volatility of our stock price and allows trades of even small blocks of stock to have a significant impact on our stock price. Our thin trading market also increases the risk of illegal naked short selling which may cause the stock price to decrease to as low as $0.001 and shareholders to lose essentially all value in their stock. The following table sets forth the range of bid quotations for our common stock for the quarters indicated according to data provided by The NASDAQ Stock Market, Inc. Such quotations reflect inter-dealer prices, without retail mark-ups, markdowns or commissions, and may not represent actual transactions.
PERIOD | HIGH BID | LOW BID | ||||||
Quarter
ended March 31, 2006 |
$ | 0.185 | $ | 0.090 | ||||
Quarter ended December 31,
2005 |
0.135 | 0.090 | ||||||
Quarter ended September 30, 2005 |
0.180 | 0.080 | ||||||
Quarter ended June 30, 2005 |
0.170 | 0.082 |
The Market Price For Our Common Stock Will Likely Be Volatile And May Change Dramatically At Any Time. The market price of our common stock, like that of the securities of other early-stage companies, may be highly volatile. Our stock price may change dramatically as the result of announcements of our quarterly results, the execution or termination of significant customer contracts, significant litigation or other factors or events that would be expected to affect our business or financial condition, results of operations and other factors specific to our business and future prospects. In addition, the market price for our common stock may be affected by various factors not directly related to our business, including the following:
| intentional manipulation of our stock price by existing or future stockholders; | |||
| short selling of our common stock or related derivative securities; | |||
| the interest, or lack of interest, of the market in our business sector, without regard to our financial condition or results of operations; | |||
| the adoption of governmental regulations and similar developments in the United States or abroad that may affect our ability to develop our products or affect our cost structure; and | |||
| economic and other external market factors, such as poor economic indicators or investor distrust. |
Penny stock rules may make buying or selling our securities difficult which may make our stock less liquid and make it harder for investors to buy and sell our shares. Trading in our securities is subject to the SECs penny stock rules and it is anticipated that trading in our securities will continue to be subject to the penny stock rules for the foreseeable future. The SEC has adopted regulations that generally define a penny stock to be any equity security that has a market price of less than $4.00 per share, subject to certain exceptions. These rules require that any broker-dealer who recommends our securities to persons other than prior customers and accredited investors must, prior to the sale, make a special written suitability determination for the purchaser and receive the purchasers written agreement to execute the transaction. Unless an exception is available, the regulations require the delivery, prior to any transaction involving a penny stock, of a disclosure schedule explaining the penny stock market and the risks associated with trading in the penny stock market. In addition, broker-dealers must disclose commissions payable to both the broker-dealer and the registered representative and current quotations for the securities they offer. The additional burdens imposed upon broker-dealers by these requirements may discourage broker-dealers from recommending transactions in our securities, which could severely limit the liquidity of our securities and consequently adversely affect the market price for our securities.
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We Are Unlikely To Pay Dividends On Our Common Stock In the Foreseeable Future. We have never declared or paid dividends on our stock. We currently intend to retain all available funds and any future earnings for use in the operation and expansion of our business. We do not anticipate paying any cash dividends in the foreseeable future, and it is unlikely that investors will derive any current income from ownership of our stock. This means that your potential for economic gain from ownership of our stock depends on appreciation of our stock price and will only be realized by a sale of the stock at a price higher than your purchase price.
FORWARD-LOOKING STATEMENTS
This prospectus, any supplement to this prospectus and the documents incorporated by reference contains statements that constitute forward-looking statements within the meaning of section 27A of the Securities Act and section 21E of the Securities Exchange Act. To the extent that the information presented in this prospectus discusses financial projections, information or expectations about our business plans, results of operations, products or markets, or otherwise makes statements about future events, such statement are forward-looking. Such statements can be identified by the use of the forward-looking words such as intends, anticipates, believes, estimates, projects, forecasts, expects, plans, and proposes and variations of such words or similar expressions. Additional forward-looking statements may be made by us from time to time.
Although we believe that the expectations reflected in these forward-looking statements are based on reasonable assumptions, expressed in good faith and have a reasonable basis, including without limitation, our examination of historical operating trends, data contained in our records and other data available from third parties, there can be no assurance that our expectations, beliefs and projections will result or be achieved or accomplished. There are a number of risks and uncertainties that could cause actual results to differ materially from such forward-looking statements. These include, among others, the cautionary statements in the Risk Factors and Managements Discussion and Analysis of Financial Condition and Results of Operations sections of this prospectus. When considering forward-looking statements in this prospectus, you should keep in mind the cautionary statements in the Risk Factors and Managements Discussion and Analysis of Financial Condition and Results of Operations and other sections of this prospectus.
In addition, these forward-looking statements speak only as of the date of this prospectus. We undertake no obligation to publicly update or revise forward-looking statements which may be made to reflect events or circumstances after the date made or to reflect the occurrence of unanticipated events.
9
USE OF PROCEEDS
The aggregate proceeds to the selling stockholders from the sale of the common stock offered by them will be the purchase price of the common stock, less any applicable discounts or commissions. We will not receive any of the proceeds from this offering. Upon any exercise of the warrants by payment of cash, however, we will receive the exercise price of the warrants.
DETERMINATION OF OFFERING PRICE
The offering price of the shares of common stock offered by this prospectus is being determined by each of the selling stockholders on a transaction-by-transaction basis based upon factors that such selling stockholder considers appropriate. The offering prices determined by the selling stockholders may, or may not, relate to a current market price but should not, in any case, be considered an indication of the actual value of the shares of common stock. We do not have any influence over the price at which selling stockholders offer or sell the shares of common stock offered by this prospectus.
DILUTION
Our net tangible book value (tangible assets less total liabilities) at March 31, 2006 was $(7,020,508) or approximately $(0.065) per each of the 107,922,148 shares of common stock then outstanding. Accordingly, new investors who purchase shares will suffer an immediate, total dilution of their investment.
As of May 24, 2006, there were outstanding options to purchase up to 19,983,000 shares of our common stock as well as warrants to purchase up to 40,923,861 shares of our common stock (including the 29,161,158 shares of common stock subject to outstanding warrants being registered in this offering). The existence of those options and conversion rights may hinder future equity offerings by us, and the exercise of those options and conversion rights may have an adverse effect on the value of shares of our common stock. Furthermore, the holders of those options and conversion rights may exercise them at a time when we would otherwise be able to obtain additional equity capital on terms more favorable to us.
SELLING SECURITY HOLDERS
All of the offered shares are to be sold by existing security holders. The selling stockholders acquired the rights to their shares and warrants (i) in a private placement of Series A Convertible Preferred Stock and warrants in October 2004; (ii) in a private placement of Series A Convertible Preferred Stock and warrants in March 2005; and (iii) in exchange for placement agent services and consulting in connection with the foregoing financings.
Of the shares of our common stock offered hereby, 350,000 shares consist of restricted common stock, 84,000,000 shares are issuable upon the conversion of Series A Convertible Preferred Stock, and 29,161,158 shares are issuable upon the exercise of outstanding warrants to purchase our common stock.
In addition, pursuant to Rule 416 of the Securities Act, this prospectus and the registration statement of which it is a part cover a presently indeterminate number of shares of common stock issuable upon the occurrence of a stock split, stock dividend, or other similar transaction.
For purposes of this prospectus, we have assumed that the number of shares issuable upon exercise of each of the warrants is the number stated on the face thereof. The number of shares issuable upon exercise of the warrants, and available for resale
10
hereunder, is subject to adjustment and could materially differ from the estimated amount depending on the occurrence of a stock split, consolidation stock dividend, or similar transaction resulting in an adjustment in the number of shares subject to the warrants.
The 84,000,000 shares potentially issuable upon conversion of the Series A stock are issuable upon conversion of two issuances of such Series A stock. While we are required to register an aggregate of only 84,000,000 shares of common stock pursuant to those issuances, the actual number of shares into which the Series A stock could be converted could be much greater. Specifically, on October 18, 2004 we issued 12,000 shares of Series A stock to Monarch Pointe Fund, Ltd. Under the terms of that issuance, each share of Series A stock entitles the holder to convert the share into the number of shares of common stock resulting from dividing $100 (which is the purchase price per share of Series A stock) by the conversion price. The conversion price is 75% of the average of the lowest three intra-day trading prices for our common stock during the 10 trading days immediately preceding the conversion date, but the conversion price may not exceed $0.1967 or be lower than $0.05. We are registering 24,000,000 shares of common stock in connection with that issuance (which is based on the floor conversion price of $0.05 per share and is the number of shares required to be registered pursuant to the applicable registration rights agreement with Monarch Pointe Fund, Ltd.). On March 14, 2005 we issued 30,000 shares of Series A stock to Mercator Momentum Fund, LP and Mercator Momentum Fund III, LP. Under the terms of that issuance, each share of Series A stock entitles the holder to convert the share into the number of shares of common stock resulting from dividing $100 (which is the purchase price per share of Series A stock) by the conversion price. The conversion price is 75% of the average of the lowest three intra-day trading prices for our common stock during the 10 trading days immediately preceding the conversion date, but the conversion price may not exceed $0.1967. There is no minimum conversion price per share for that issuance. We are registering 60,000,000 shares of common stock in connection with that issuance (which is based on an assumed conversion price of $0.05 per share and is the number of shares required to be registered pursuant to the applicable registration rights agreement with Mercator Momentum Fund, LP and Mercator Momentum Fund III, LP).
Notwithstanding our obligation to register 84,000,000 shares of common stock upon conversion of the Series A stock, the actual minimum and maximum number of shares of common stock into which the outstanding Series A stock could be converted is as follows:
Shares of Common Stock Into Which | ||||||||
Series A May Be Converted | ||||||||
Minimum | Maximum | |||||||
12,000 Shares of Series A issued 10/18/04 |
6,100,661 | 24,000,000 | ||||||
30,000 Shares of Series A issued 03/14/05 |
15,251,652 | Theoretically unlimited(1) | ||||||
Total |
21,352,313 | Theoretically unlimited(1) |
(1) | Because the conversion price has no floor, it theoretically could be infinitely small, resulting in conversion into an infinitely large number of shares of common stock. See the sections of this prospectus entitled Selling Security Holders and Security Ownership Of Certain Beneficial Owners And Management. |
The table below sets forth, as of May 24, 2006:
| the name of each selling stockholder; | |||
| certain beneficial ownership information with respect to the selling stockholders; | |||
| the number of shares that may be sold from time to time by each selling stockholder pursuant to this prospectus; and | |||
| the amount (and, if 1% or more, the percentage) of shares of common stock to be owned by each selling stockholder if all offered shares are sold. |
Beneficial ownership is determined in accordance with SEC rules and generally includes voting or investment power with respect to securities. Shares of common stock that are issuable upon the
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conversion of Preferred stock or exercise of outstanding warrants held by a selling stockholder, to the extent exercisable within 60 days of May 24, 2006, are treated as outstanding for purposes of computing each selling stockholders ownership of outstanding shares of common stock and percentage ownership (but not the percentage ownership of other selling stockholders). The number of shares of common stock into which Series A convertible preferred stock is convertible is based on the applicable conversion prices as of May 24, 2006.
Beneficial Ownership | Beneficial Ownership upon | |||||||||||||||||||
Before Offering | Number of Shares | Completion of the Offering | ||||||||||||||||||
Beneficial Owner | Number of Shares | Percent | Being Offered | Number of Shares | Percent | |||||||||||||||
Monarch Pointe Fund, Ltd. |
21,759,944 | (1) | 16.77 | (5) | 21,759,944 | | | |||||||||||||
Mercator Momentum Fund, LP |
33,521,103 | (2) | 23.69 | (5) | 33,521,103 | | | |||||||||||||
Mercator Momentum Fund III, LP |
23,166,504 | (3) | 17.66 | (5) | 23,166,504 | | | |||||||||||||
Mercator Advisory Group, LLC |
90,801,389 | (4) | 45.68 | (5) | 90,801,389 | | | |||||||||||||
Ascendiant Securities, LLC |
1,708,184 | (6) | 1.56 | 1,708,184 | | | ||||||||||||||
Ascendiant Capital Group, LLC |
350,000 | (7) | * | 350,000 | | |
* | Less than 1% | |
(1) | Includes 3,660,396 shares that may be acquired upon exercise of currently exercisable warrants and includes 18,099,548 shares of common stock issuable upon conversion of 12,000 shares of Series A convertible preferred stock based on an assumed conversion price of $0.0663. Mercator Advisory Group, LLC controls the investments of Monarch Pointe Fund, Ltd. and David F. Firestone is the managing member of Mercator Advisory Group, LLC. | |
(2) | Includes 6,748,856 shares that may be acquired upon exercise of currently exercisable warrants and includes 26,772,247 shares of common stock issuable upon conversion of 17,750 shares of Series A convertible preferred stock based on an assumed conversion price of $0.0663. Mercator Advisory Group, LLC is the general partner of this partnership and David F. Firestone is the managing member of Mercator Advisory Group, LLC. | |
(3) | Includes 4,689,883 shares that may be acquired upon exercise of currently exercisable warrants and includes 18,476,621 shares of common stock issuable upon conversion of 12,250 shares of Series A convertible preferred stock based on an assumed conversion price of $0.0663. Mercator Advisory Group, LLC is the general partner of this partnership and David F. Firestone is the managing member of Mercator Advisory Group, LLC. | |
(4) | Includes 12,353,838 shares that may be acquired upon exercise of currently exercisable warrants and includes shares beneficially owned by Monarch Pointe Fund, Ltd., Mercator Momentum Fund, LP, and Mercator Momentum Fund III, LP. David F. Firestone is the managing member of this LLC. | |
(5) | Notwithstanding these percentages, each of these entities individually is and all of them in the aggregate are limited by the terms of the Series A Preferred Stock and by the applicable warrants to owning no more than 9.99% of our outstanding common stock at any given time. | |
(6) | Represents shares that may be acquired upon exercise of currently exercisable warrants. Ascendiant Securities, LLC is a wholly-owned subsidiary of Ascendiant Capital Group, LLC. The beneficial owners of Ascendiant Capital Group, LLC are Bradley Wilhite and Mark Bergendahl. Messrs. Wilhite and Bergendahl are registered principals of Ascendiant Securities, LLC, a registered broker-dealer. | |
(7) | Represents restricted common stock. The beneficial owners of Ascendiant Capital Group, LLC are Bradley Wilhite and Mark Bergendahl. Messrs. Wilhite and Bergendahl are registered principals of Ascendiant Securities, LLC, a registered broker-dealer. | |
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PLAN OF DISTRIBUTION
The selling stockholders, which as used herein includes donees, pledgees, transferees or other successors-in-interest selling shares of common stock or interests in shares of common stock received after the date of this prospectus from a selling stockholder as a gift, pledge, partnership distribution or other transfer, may, from time to time, sell, transfer or otherwise dispose of any or all of their shares of common stock or interests in shares of common stock on any stock exchange, market or trading facility on which the shares are traded or in private transactions. These dispositions may be at fixed prices, at prevailing market prices at the time of sale, at prices related to the prevailing market price, at varying prices determined at the time of sale, or at negotiated prices.
The selling stockholders may use any one or more of the following methods when disposing of shares or interests therein:
| ordinary brokerage transactions and transactions in which the broker-dealer solicits purchasers; | |||
| 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; | |||
| purchases by a broker-dealer as principal and resale by the broker-dealer for its account; | |||
| an exchange distribution in accordance with the rules of the applicable exchange; | |||
| privately negotiated transactions; | |||
| through the writing or settlement of options or other hedging transactions, whether through an options exchange or otherwise; | |||
| broker-dealers may agree with the selling stockholders to sell a specified number of such shares at a stipulated price per share; | |||
| a combination of any such methods of sale; and | |||
| any other method permitted pursuant to applicable law. |
The selling stockholders may, from time to time, pledge or grant a security interest in some or all of the shares of common stock owned by them and, if they default in the performance of their secured obligations, the pledgees or secured parties may offer and sell the shares of common stock, from time to time, under this prospectus, or under an amendment to this prospectus under Rule 424(b)(3) or other applicable provision of the Securities Act amending the list of selling stockholders to include the pledgee, transferee or other successors in interest as selling stockholders under this prospectus. The selling stockholders may also transfer the shares of common stock in other circumstances, in which case the transferees, pledgees or other successors in interest will be the selling beneficial owners for purposes of this prospectus.
The selling stockholders may also sell shares by means of short sales to the extent permitted by United States securities laws. Short sales involve the sale by a selling shareholder, usually with a future delivery date, of shares of common stock that the seller does not own. Covered short sales are sales made in an amount not greater than the number of shares subject to the short sellers warrant, exchange right or other right to acquire shares of common stock. A selling shareholder may close out any covered short position by either exercising its warrants or exchange rights to acquire shares of common stock or purchasing shares in the open market. In determining the source of shares to
13
close out the covered short position, a selling shareholder will likely consider, among other things, the price of shares of common stock available for purchase in the open market as compared to the price at which it may purchase shares of common stock pursuant to its warrants or exchange rights.
Naked short sales are any sales in excess of the number of shares subject to the short sellers warrant, exchange right or other right to acquire shares of common stock. A selling shareholder must close out any naked position by purchasing shares. A naked short position is more likely to be created if a selling shareholder is concerned that there may be downward pressure on the price of the shares of common stock in the open market.
The existence of a significant number of short sales generally causes the price of the shares of common stock to decline, in part because it indicates that a number of market participants are taking a position that will be profitable only if the price of the shares of common stock declines. Purchases to cover naked short sales may, however, increase the demand for the shares of common stock and have the effect of raising or maintaining the price of the shares of common stock.
The selling stockholders may also enter into option or other transactions with broker-dealers or other financial institutions or the creation of one or more derivative securities that require the delivery to such broker-dealer or other financial institution of shares offered by this prospectus, which shares such broker-dealer or other financial institution may resell pursuant to this prospectus (as supplemented or amended to reflect such transaction).
The selling stockholders also may resell all or a portion of the shares in open market transactions in reliance upon Rule 144 under the Securities Act, provided that they meet the criteria and conform to the requirements of that rule.
The selling stockholders and any underwriters, broker-dealers or agents that participate in the sale of the common stock or interests therein may be underwriters within the meaning of Section 2(11) of the Securities Act. Any discounts, commissions, concessions or profit they earn on any resale of the shares may be underwriting discounts and commissions under the Securities Act. Selling stockholders who are underwriters within the meaning of Section 2(11) of the Securities Act will be subject to the prospectus delivery requirements of the Securities Act.
To the extent required, the shares of our common stock to be sold, the names of the selling stockholders, the respective purchase prices and public offering prices, the names of any agents, dealers or underwriters, and any applicable commissions or discounts with respect to a particular offer will be set forth in an accompanying prospectus supplement or, if appropriate, a post-effective amendment to the registration statement that includes this prospectus.
Expenses, Indemnification and Registration Obligations. We are paying the expenses incurred in connection with preparing and filing this prospectus and the registration statement to which it relates, other than selling commissions. We have not retained any underwriter, broker or dealer to facilitate the offer or sale of the shares offered hereby. We will pay no underwriting commissions or discounts in connection therewith.
We have agreed to indemnify the selling stockholders against liabilities, including liabilities under the Securities Act and state securities laws, relating to the registration of the shares offered by this prospectus. The selling stockholders may indemnify any broker-dealers that participate in transactions involving the sale of the shares against certain liabilities, including liabilities arising under the Securities Act.
14
We have agreed with the selling stockholders to keep the registration statement of which this prospectus constitutes a part effective until the earlier of (i) such time as all of the shares covered by this prospectus have been disposed of pursuant to and in accordance with the registration statement or (ii) the date on which the shares may be sold pursuant to Rule 144(k) of the Securities Act.
Passive Market Making. We have advised the selling stockholders that while they are engaged in a distribution of the shares offered pursuant to this prospectus, they are required to comply with Regulation M promulgated under the Securities Exchange Act of 1934, as amended. With certain exceptions, Regulation M precludes the selling stockholders, any affiliate purchasers and any broker-dealers or other persons who participate in the distribution from bidding for or purchasing, or attempting to induce any person to bid for or purchase, any security that is subject to the distribution until the entire distribution is complete. Regulation M also restricts bids or purchases made in order to stabilize the price of a security in connection with the distribution of that security. We do not intend to engage in any passive market making or stabilization transactions during the course of the distribution described in this prospectus. All of the foregoing may affect the marketability of the shares offered pursuant to this prospectus.
Limitations. We have advised the selling stockholders that, to the extent necessary to comply with governing state securities laws, the offered securities should be offered and sold in such jurisdictions only through registered or licensed brokers or dealers. In addition, we have advised the selling stockholders that the offered securities may not be offered or sold in any state unless they have been registered or qualified for sale in the applicable state or an exemption from the registration or qualification requirement is available with respect to such offers or sales.
LEGAL PROCEEDINGS
We are not aware of any legal proceedings against us. We may however be involved, from time to time, in various legal proceedings and claims incident to the normal conduct of our business.
DIRECTORS, EXECUTIVE OFFICERS, PROMOTERS AND CONTROL PERSONS
The following table sets forth certain information regarding the executive officers and directors of Medical Discoveries, Inc. as of May 24, 2006.
Name | Age | Title | Term of | |||||
David R. Walker
|
60 | Chairman of the Board of Directors | 7 Years | |||||
Judy Robinett
|
52 | President and Chief Executive Officer, | 5 Years | |||||
Director | ||||||||
Larry Anderson
|
55 | Director | 1 Year | |||||
Stephen R. Drake
|
37 | Secretary | 2 Years |
David R. Walker
David R. Walker joined the Board of Directors on May 2, 1996, and was appointed Chairman of the Board of Directors on May 10, 1998. He has served as Chairman of the Audit Committee since its inception in 2001. For over 20 years, Mr. Walker has held the office of General Manager of Sunheaven Farms, the largest onion growing and packing entity in the State of Washington with annual revenues in excess of $50 million. In the capacity of General Manager, Mr. Walker performs the functions of a traditional chief financial officer. Mr. Walker holds a Bachelor of Arts degree in economics from Brigham Young University with minors in accounting and finance.
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Judy Robinett
Judy M. Robinett has held the office of President and Chief Executive Officer since November, 2000, and joined the Board of Directors on February 9, 2001. Since 1994, she has owned and operated an international consulting company focused on strategic planning, finance, marketing, and distribution for entrepreneurs and established companies. Prior to that, Ms. Robinetts employment positions included Vice President for Quality Improvement for a regional hospital, Division Manager for Universal Foods, Group Manager for EG&Gs Nuclear Training Facility in Idaho, and a Planner for the State of Idaho. Ms. Robinett has published more than 50 articles on business finance and operations and is a recognized authority on quality control. Ms. Robinett holds a Bachelors of Sciences degree in psychology and a Masters degree in labor economics from Utah State University.
Larry Anderson
Larry Anderson has a wide range of investment banking, sales and entrepreneurial experience. He has held investment banking and stock broker positions with Merrill Lynch (1984 to 1987), Oppenheimer (1987) and Kidder Peabody (1992), managing up to $300 million in accounts. Mr. Anderson has significant sales experience including holding national sales leader awards while at Automatic Data Processing and Qantel Computer Corporation. Mr. Anderson is an entrepreneur with numerous start-ups and turn-arounds to his credit. Within the last 5 years he has owned and operated or currently owns and operates, among other companies, C Innovation Inc, a 36-employee K-12 educational software company located in Claremont, California; Success Finance, a small contract financing company based in Utah; Complete Nursing Services a 28-employee terminally ill child care company in the State of Washington; All Home Care, a 65-employee aged home care company in California; and Future Now Enterprises, LLC in Utah. The combined yearly payroll of his businesses is over $6 million. Anderson currently lives in Salt Lake City, Utah.
Stephen R. Drake
Stephen R. Drake was elected Secretary of the Company effective as of April 1, 2004. He has served as legal counsel to the Company since November 2000. Mr. Drake is an attorney in private practice with Epstein Becker and Green, P.C. in Chicago, Illinois, where he practices corporate and securities law. Mr. Drake received a Bachelors of Arts degree, cum laude, from Albertson College in 1991 and a Juris Doctor degree, cum laude, from Willamette University College of Law in 1996.
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SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT
The following table sets forth information regarding persons known by the Company to beneficially own, as defined by Rule 13d-3 under the Securities Exchange Act of 1934, more than 5% of Common Stock as of May 24, 2006, based solely on information regarding such ownership available to the Company in filings by such beneficial owners with the SEC on Schedules 13D and 13G. The following table also sets forth information regarding beneficial ownership of Common Stock as of May 24, 2006, by the Directors and the Named Executive Officer and by the Directors and Named Executive Officer as a group.
Number of Shares | ||||||||
and Nature of | Percent | |||||||
Beneficial | of | |||||||
Name and Address of Beneficial Owner(a) | Ownership (b) | Class | ||||||
Certain Beneficial Owners: |
||||||||
Monarch Pointe Fund, Ltd. |
21,759,944 | (c) | 16.77 | (k) | ||||
555 S. Flower St., Suite 4500 Los Angeles, CA 90071 |
||||||||
Mercator Momentum Fund, LP |
33,521,103 | (d) | 23.69 | (k) | ||||
555 S. Flower St., Suite 4500 Los Angeles, CA 90071 |
||||||||
Mercator Momentum Fund III, LP |
23,166,504 | (e) | 17.66 | (k) | ||||
555 S. Flower St., Suite 4500 Los Angeles, CA 90071 |
||||||||
Mercator Advisory Group, LLC |
90,801,389 | (f) | 45.68 | (k) | ||||
555 S. Flower St., Suite 4500 Los Angeles, CA 90071 |
||||||||
David F.
Firestone(g) |
90,801,389 | (g) | 45.68 | (k) | ||||
555 S. Flower
St., Suite 4500 Los Angeles, CA 90071 |
||||||||
Judy M. Robinett |
16,030,000 | (h) | 12.94 | |||||
Directors/Named Executive Officer: |
||||||||
David R. Walker |
1,153,539 | (i) | 1.06 | |||||
Judy M. Robinett |
16,030,000 | (h) | 12.94 | |||||
Larry Anderson |
250,000 | * | ||||||
All Directors and Executive Officers as a Group (3 persons) |
17,433,539 | (j) | 13.98 |
* | Less than 1% | |
(a) | Unless otherwise indicated, the business address of each person listed is c/o Medical Discoveries, Inc., 1338 S. Foothill Drive, #266, Salt Lake City, Utah 84108. | |
(b) | For purposes of this table, shares are considered to be beneficially owned if the person directly or indirectly has the sole or shared power to vote or direct the voting of the securities or the sole or shared power to dispose of or direct the disposition of the securities. Shares are also considered beneficially owned if a person has the right | |
17
to acquire the beneficial ownership of the shares within 60 days of May 24, 2006. Unless otherwise indicated in these footnotes, each shareholder has sole voting and investment power with respect to the shares beneficially owned. | ||
(c) | Includes 3,660,396 shares that may be acquired upon exercise of currently exercisable warrants and includes 18,099,548 shares of common stock issuable upon conversion of 12,000 shares of Series A convertible preferred stock based on an assumed conversion price of $.0.0688, which would have been the applicable conversion price as of May 24, 2006. | |
(d) | Includes 6,748,856 shares that may be acquired upon exercise of currently exercisable warrants and includes 26,772,247 shares of common stock issuable upon conversion of 17,750 shares of Series A convertible preferred stock based on an assumed conversion price of $.0.0688, which would have been the applicable conversion price as of May 24, 2006. | |
(e) | Includes 4,689,883 shares that may be acquired upon exercise of currently exercisable warrants and includes 18,476,621 shares of common stock issuable upon conversion of 12,250 shares of Series A convertible preferred stock based on an assumed conversion price of $.0.0688, which would have been the applicable conversion price as of May 24, 2006. | |
(f) | Includes 12,353,838 shares that may be acquired upon exercise of currently exercisable warrants and includes shares beneficially owned by Monarch Pointe Fund, Ltd., Mercator Momentum Fund, LP, and Mercator Momentum fund III, LP. | |
(g) | Represents shares beneficially owned by Mercator Advisory Group, LLC. | |
(h) | Includes 16,000,000 shares that may be acquired upon the exercise of currently exercisable stock options. | |
(i) | Includes 750,000 shares that may be acquired upon the exercise of currently exercisable stock options. | |
(j) | Includes 16,750,000 shares that may be acquired upon the exercise of currently exercisable stock options. | |
(k) | Notwithstanding these percentages, each of these entities individually is and all of them in the aggregate are limited by the terms of the Series A Preferred Stock and by the applicable warrants to owning no more than 9.99% of our outstanding common stock at any given time. | |
DESCRIPTION OF SECURITIES
The following description of our authorized capital stock is subject to the detailed provisions of our Articles of Incorporation. Our Articles of Incorporation are included as Exhibit 2.1 to the registration statement.
The aggregate number of shares of capital stock authorized for issuance by our Articles of Incorporation is 300,000,000, of which 250,000,000 are shares of common stock, no par value, and 50,000,000 are shares of preferred stock, no par value.
18
Common Stock.
As of May 24, 2006, there were 107,992,148 shares of common stock issued and outstanding and 1,500 stockholders of record.
Dividend Rights. We have never declared or paid any cash dividends on our voting ordinary shares. Any future payment of dividends will be made at the discretion of our Board of Directors based upon conditions then existing, including earnings, financial condition and capital requirements as well as such economic and other conditions as our Board of Directors may deem relevant. Our Bylaws provide that the Board of Directors may, from time to time declare, and we may pay dividends on our outstanding shares in the manner and upon the terms and conditions provided by law.
Voting. Holders of our common stock are entitled to cast one vote in person or by proxy for each share of such common stock standing in his name on the stock transfer records of the Corporation. No shareholder has the right to cumulate votes in the election of directors. Currently, there are three members on our Board of Directors.
Dissolution Rights. In the event of any liquidation, dissolution or winding up of the affairs of the Company, after any preferential amount with respect to the Preferred Stock has been paid or reserved, the holders of Common Stock and the holders of any series of Preferred Stock entitled to participate in the distribution of assets are entitled to receive the net assets of the Company.
Preemptive Rights. There are no preemptive rights authorized by our Articles of Incorporation or our Bylaws.
Redemption. There are no redemption provisions applicable to our common stock.
Certain Provisions of the Articles of Incorporation. Our Articles of Incorporation provide that we may indemnify and advance expenses to its directors, officers, employees, fiduciaries or agents and to any person who is or was serving at the Corporations request as a director, officer, partner, trustee, employee, fiduciary or agent of another domestic or foreign corporation or other person or of an employee benefit plan (and their respective estates or personal representatives) to the fullest extent as from time to time permitted by Utah law.
Preferred Stock.
As of May 24, 2006, there were 41,800 shares of Series A Convertible Preferred Stock issued and outstanding.
Dividend Rights. The holders of Series A Preferred Stock shall be entitled to receive, when, as and if declared by the Board of Directors, out of any assets of the Company legally available therefore, such dividends as may be declared from time to time by the Board of Directors.
Voting. The Series A Preferred Stock is non-voting.
Dissolution Rights. In the event of any liquidation, dissolution or winding up of the Company, the holders of Series A Preferred Stock are entitled to be paid first out of the assets of the Company available for distribution to shareholders an amount equal to the $100.00 per share purchase price of each share of Series A Preferred Stock held, plus any declared but unpaid dividends on such share, before payment is to be made to the holders of the Common Stock.
Other Preferred Stock. Our Articles of Incorporation authorize the issuance of Preferred Stock in one or more series, from time to time, by the Board of Directors without further vote of the shareholders, except as may be provided for under applicable law or the rules of any stock exchange or other market system on
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which the preferred stock may then be listed or traded. The rights of the Board of Directors to designate and issue specific series of Preferred Stock will include, without limitation, the right to determine or designate the following with respect to each series:
| The distinctive designation and number of shares comprising such series, which number may (except where otherwise provided by the Board of Directors in creating such series) be increased or decreased (but not below the number of shares then outstanding) from time to time by like action of the Board of Directors; | |||
| The dividend rate of such series, the conditions and times upon which such dividends shall be payable, the relation which such dividends shall bear to the dividends payable on any other class or classes of stock or series thereof, or on the other series of the same class, and whether dividends shall be cumulative or non-cumulative; | |||
| The conditions upon which the shares of such series shall be subject to redemption by the Company and the times, prices and other terms and provisions upon which the shares of the series may be redeemed; | |||
| Whether or not the shares of the series shall be subject to the operation of retirement or sinking fund provisions to be applied to the purchase or redemption of such shares and, if such retirement or sinking fund be established, the annual amount thereof and the terms and provisions relative to the operation thereof; | |||
| Whether or not the shares of the series shall be convertible into or exchangeable for shares of any other class or classes, with or without par value, or of any other series of the same class and, if provision is made for conversion or exchange, the times, prices, rates, adjustments and other terms and conditions of such conversion or exchange; | |||
| Whether or not the shares of the series shall have voting rights, in addition to the voting rights provided by law, and, if so, the terms of such voting rights; | |||
| The rights of the shares of the series in the event of voluntary or involuntary liquidation, dissolution or upon distribution of assets of the Company; and | |||
| Any other designations, preferences, limitations and relative rights of the shares of such series, as the Board of Directors may deem advisable. |
INTEREST OF NAMED EXPERTS AND COUNSEL
The validity of the common stock offered hereby will be passed upon for us by Epstein Becker & Green, P.C. Our Secretary, Stephen R. Drake, is a member of Epstein Becker & Green, P.C. As of the date of this prospectus, a member of Epstein Becker & Green, P.C. holds an aggregate of 33,000 shares of our common stock and an option to purchase 300,000 shares of our common stock at $0.05 per share.
LIMITATION OF LIABILITY AND INDEMNIFICATION
Our Articles of Incorporation provide that we will indemnify and advance expenses to our directors, officers, employees, fiduciaries or agents and to any person who is or was serving at our request as a director, officer, partner, trustee, employee, fiduciary or agent
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of another domestic or foreign corporation or other person or of an employee benefit plan (and their respective estates or personal representatives) to the fullest extent as from time to time permitted by Utah law. The personal liability of our directors and officers to us or our shareholders, or to any third person, will be eliminated or limited to the fullest extent as from time to time permitted by Utah law.
Our Bylaws provide that we shall indemnify any director or officer if a determination has been made that the director or officer acted in good faith, he or she reasonably believed that his or her conduct was in, or not opposed to, the Companys best interests. The Bylaws provide that we shall not indemnify a director or officer if the director or officer, in connection with any proceeding by or in the right of the Company in which he or she was adjudged liable to the Company or any other proceeding he or she was adjudged liable on the basis that he or she derived an improper benefit.
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Insofar as indemnification for liabilities arising under the Securities Act of 1933 (the Act) may be permitted to directors, officers and controlling persons of the small business issuer pursuant to the foregoing provisions, or otherwise, the small business issuer has been advised that in the opinion of the Securities and Exchange Commission such indemnification is against public policy as expressed in the Act and is, therefore, unenforceable.
DESCRIPTION OF BUSINESS
Medical Discoveries, Inc. was incorporated on November 20, 1991 as a Utah corporation and maintains its principal offices at 1338 S. Foothill Drive, #266, Salt Lake City, Utah 84108. Our telephone number is (801) 582-9583 and our web address is www.medicaldiscoveries.com. We are a developmental-stage bio-pharmaceutical company engaged in the research, validation, development and ultimate commercialization of two drugs: MDI-P and SaveCream. MDI-P is an anti-infective drug that we believe will be a useful and well-tolerated treatment for bacterial infections, viral infections and fungal infections. We further believe that MDI-P will be a useful therapy for the treatment of cystic fibrosis. SaveCream is a breast cancer medication that is applied topically to reduce breast cancer tumors. Both of these drugs are still in development and have not been approved by the U. S. Food and Drug Administration (FDA).
Our initial target indications for MDI-P are cystic fibrosis and HIV. On November 10, 2004, we filed an Investigational New Drug application (IND) with the FDA seeking permission to begin Phase I human clinical trials of MDI-P as a treatment for cystic fibrosis. The FDA placed the proposed Phase I clinical trials on clinical hold pending additional preclinical testing. We completed that preclinical testing and no significant toxicities were noted. We submitted that data to the FDA on March 16, 2006. On April 21, 2006 the FDA responded and continued the clinical hold pending the outcome of yet another battery of preclinical trials. We intend to complete those additional tests and resubmit our IND within the next 6 months. If the FDA lifts the clinical hold upon receipt of the amended IND and allows us to proceed with Phase I studies, we will begin human trials at St. Lukes Regional Medical Center in Boise, Idaho using a protocol designed by Dr. Henry Thompson. We hope to commence recruitment for this study in 2007. If our Phase I IND for cystic fibrosis is successful, we intend to file an IND for Phase I testing of MDI-P as a treatment for HIV at Harvard School of Medicine using a protocol designed by Dr. Bruce Dezube. We also expect to add additional indications for the use of MDI- P in the future as we further our preclinical development.
We recently purchased SaveCream from a German biotechnology company. We are in the process of developing a global commercialization strategy for SaveCream.
To date, we have not generated significant revenues from operations or realized a profit. Through March 31, 2006, we had incurred cumulative net losses since inception of $22,412,180.
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Recent Developments.
Cystic Fibrosis IND. We are continuing to pursue our IND for cystic fibrosis with the FDA. In 2005 we concluded large animal model testing to establish pharmacological safety with relation to cardiovascular and central nervous system toxicity as well as in-vitro work on genotoxicity for this IND. That preclinical testing was completed with positive results and on March 16, 2006, we submitted the data to the FDA in hopes of being permitted to proceed with Phase I testing.
| Use of the same mode of nebulization administration of MDI-P in small and large mammals as proposed for the Phase I cystic fibrosis clinical trial, to develop: |
| Satisfactory safety pharmacology data from frank toxicity to minimal toxicity for periods mimicking the proposed clinical trial term; | |
| Mouse safety pharmacology on potential central nervous system involvement; and | |
| Dog safety pharmacology on potential cardiovascular system involvement; |
| A battery of genotoxicity studies; and | |
| Data to support the safety of the maximum expected human exposure to listed extractables in our prior IND submission. |
On April 21, 2006, the FDA responded to our submission by continuing to maintain the clinical hold until additional preclinical trials can be conducted. Specifically, the FDA is requiring us to conduct two additional toxicity studies (dose response and acute toxicity) in a third mammal species, the rat. Data from those studies will help establish safe dosing in humans. In addition, the FDA has asked for additional data on the extractable components of MDI-P.
We estimate these tests will cost between $1,100,000 and 1,300,000 (including overhead expenses) and take six to nine months to complete. We do not have any funds for this purpose and will need to raise additional capital.
SaveCream. On March 16, 2005, Medical Discoveries, Inc. (the Company) completed the purchase of the intellectual property assets (the Assets) of Savetherapeutics AG, a German corporation in liquidation in Hamburg, Germany (SaveT). The Assets consist primarily of patents, patent applications, pre-clinical study data and anecdotal clinical trial data concerning SaveCream, SaveTs developmental topical aromatase inhibitor treatment for breast cancer. The purchase price of the Assets is 2,350,000 (approximately $2.8 million under current exchange rates) payable as follows: 500,000 at closing, 500,000 upon conclusion of certain pending transfers of patent and patent application rights from SaveTs inventors to the Company, and 1,350,000 upon successful commercialization of the Assets. The Companys source of funds for the acquisition is a $3 million equity investment by Mercator Momentum Fund LP and Mercator Momentum Fund III LP. Neither SaveT nor any employee of SaveT has a material relationship with the Company or any of its affiliates, any director or officer of the Company or any associate of any such director or officer.
Before it ceased business in 2004, Savetherapeutics (SaveT) had been developing SaveCream, a topical steroidal form of aromatase inhibitor (AI) for breast cancer that never generated revenues for SaveT. This cancer therapeutic product has been tested in the European Union under a unique German regulatory scheme that allows patients with limited treatment options to receive novel treatments. In the study, over 100 women diagnosed with breast cancer received special permission to be treated with SaveCream. The study subjects had all elected surgery to remove their tumors and were treated with SaveCream for 2-3 weeks prior to surgery. Mamograms prior to treatment and just prior to surgery as well as pathological tests on the surgically removed tumors demonstrated that a significant number of those women experienced a significant reduction in tumor size of fifty percent. No follow up data was collected to permit assessment of adverse events or benefits of treatment occurring after the treatment period. This study is of limited benefit and will need to be repeated under FDA guidelines before the FDA would allow the drug to be marketed. Specifically, a study acceptable to the FDA would need to include, at a minimum, controls against placebos and competing treatments as well as dose dependency analysis. We are in the process of developing a global commercialization strategy for SaveCream, to include certain preclinical studies including toxicology and pharmacokinetics, as well as the development of future clinical protocols.
M.A.G. Capital, LLC (formerly Mercator Advisory Group, LLC), through its designated funds, Mercator Momentum Fund, L.P., and Mercator Momentum Fund III, L.P., provided us with $3 million for the purchase, pursuant to terms described below.
We would like to initiate a preclinical development program for SaveCream, however we do not currently have the funds to do so. Should we be unable to fund preclinical testing necessary to file an IND, we may instead seek a co-development partner or out-licensing opportunities for this product.
We analyzed whether the intellectual property purchased was a business within the contemplation of Regulation S-X, and concluded that no such business had been acquired.
Series A Preferred Stock Financings. On or about March 14, 2005, we closed the second of two rounds of Series A Preferred Stock financing with M.A.G. Capital, LLC (formerly Mercator Advisory Group, LLC). In this round, we sold 30,000 shares of Preferred Stock and warrants to purchase 22,877,478 shares of common stock for a total offering price of $3 million. Each share of Preferred Stock entitles the holder to convert the share of Preferred Stock into the number of shares of common stock resulting from dividing $100 by the conversion price. The conversion price for this round is 75% of the average of the lowest three intra-day trading prices for our common stock during the 10 trading days immediately preceding the conversion date, but the conversion price may not exceed $0.1967. The number of shares of common stock subject to the warrants and the exercise price are subject to equitable adjustment in connection with a stock split, stock dividend or similar transaction. The warrants entitle the holder to purchase up to 22,877,478 shares of our common stock on or before the third anniversary of the issuance date of the warrants at $0.1967 per share. The number of shares of common stock subject to the warrants and the exercise price are subject to equitable adjustment in connection with a stock split, stock dividend or similar transaction. In connection with this financing, we issued to a placement agent warrants that entitle the holder to purchase up to 1,220,132 shares of our common stock on or before the third anniversary of the issuance date of the warrants at $0.1967 per share.
On or about October 18, 2004, we closed the first of two rounds of Series A Preferred Stock financing with M.A.G. Capital, LLC (formerly Mercator Advisory Group, LLC). In this round, we sold 12,000 shares of Preferred Stock and warrants to purchase 4,575,496 shares of common stock for a total offering price of $1.2 million. Each share of Preferred Stock entitles the holder to convert the share of Preferred Stock into the number of shares of common stock resulting from dividing $100 by the conversion price. The conversion price for this round is 85% of the average of the lowest three intra-day trading prices for our common stock during the 10 trading days immediately preceding the conversion date, but the conversion price may not exceed $0.1967 or be lower than $0.05. The number of shares of common stock subject to the warrants and the exercise price are subject to equitable adjustment in connection with a stock split, stock dividend or similar transaction. The warrants entitle the holder to purchase up to 4,575,496 shares of our common stock on or before the third anniversary of the issuance date of the warrants at $0.1967 per share. The number of shares of common stock subject to the warrants and the exercise price are subject to equitable adjustment in connection with a stock split, stock dividend or similar transaction. In connection with this financing, we issued to a placement agent 350,000 shares of restricted common stock and warrants that entitle the holder to purchase up to 488,052 shares of our common stock on or before the third anniversary of the issuance date of the warrants at $0.1967 per share.
In connection with the Series A Preferred Stock financings, we agreed with the investors to register the shares of common stock into which the Preferred Stock is convertible and the warrants are exercisable. This prospectus relates to our registration of those shares.
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Business Strategy. Our highest priorities are to:
| commence human clinical trials of MDI-P for cystic fibrosis; | |||
| file an IND for HIV; and | |||
| develop a commercialization strategy for SaveCream. | |||
Our second priorities are the completion of a longer-range strategic business plan in which we utilize the intellectual property that has been developed over the last decade and determine an appropriate direction for future development of the business over the next five to ten years. Some of the issues we will be dealing with will include:
| listing the Companys common stock on a stock exchange or NASDAQ; | |||
| how to provide shareholders with liquidity, transparency and a return on investment; | |||
| a decision on whether or when to relocate the Company or maintain its current location; | |||
| a decision as to what staffing requirements the Company will have, when to bring additional permanent staff on board and the best route for recruiting those staff members; | |||
| additional target indications and the formulation and development process required for those target indications; | |||
| a comprehensive intellectual property strategy; | |||
| a potential partnering strategy; and | |||
| projected long-term financing requirements. | |||
MDI-P: Novel Anti-Infective Technology. MDI-P is an anti-infective drug that we believe will be useful treatment for bacterial infections, viral infections and fungal infections. MDI-P appears to work by virtue of the direct virus-, bacteria- and fungus-killing effect of several of the powerful oxidants present in the MDI-P solution. The MDI-P solution contains oxidants such as various hypochlorous acid chains, ozone and dilute hydrogen peroxide. These oxidants, traditionally believed to have a very short half-life in their natural state, seem to exhibit stability of one month or longer in MDI-P.
During the past nine years, we have conducted a variety of cell line testing at the following university and medical research institutions, among others:
Stratton V.A. Medical Center, Albany, New York
Albany Medical College, Albany, New York
Indiana University School Of Medicine And Dentistry
University of California, Los Angeles
Baylor College of Medicine and Dentistry, Dallas, Texas
Dana-Farber Cancer Institute, Boston, Massachusetts
University of Washington Medical School
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Highlights from those tests include the following:
| In 1998, we initiated in vitro testing, conducted at the Dana-Farber Cancer Institute in Boston, Massachusetts, a major teaching affiliate of the Harvard Medical School. The results of this independent testing confirmed that MDI-P achieved destruction of more than 90% of the HIV virus in cell cultures, with no toxicity to the cells. | |||
| In 2000, data and results published by Dr. Aldonna Baltch, M.D., of the Stratton V.A. Medical Center and Albany Medical College, Albany NY, indicated that MDI-P is a potent antibacterial and anti-fungal agent. Dr. Baltchs work demonstrated that MDI-P was effective in destroying the fungi Candida albicans and Legionella pneumophillia (Legionnaires Disease) within 60 seconds of exposure to the fungi with no evidence of cell toxicity. This work was published in The American Journal of Infection Control in 2000 and as abstracts of the American Society of Microbiology meetings in 1997 and 1998. | |||
| Toxicity tests completed in 2001 by WIL Research Laboratories demonstrated that various strengths of MDI-P (up to a 50% solution strength) produced no systemic toxicity in laboratory animal tests used to assess potential problems for human application. These preclinical studies were conducted following FDA guidelines and have helped establish that MDI-P is reasonably safe for human clinical trials. | |||
| In 2004, Dr. Emil Chi, Chairman of the Department of Histopathology at the University of Washington Medical School, conducted a mouse study focused on MDI-P as a potential therapeutic agent for the treatment of sepsis. The results reaffirmed the anti-infective strength and low toxicity profile in preclinical models of MDI-P. | |||
| In 2004, we also commissioned a mouse study by Dr. Chi focused on MDI-P as a potential therapeutic agent for the treatment of the symptoms of asthma. In the study, 36 female mice were examined in a chronic asthma model, using various doses of MDI-P as a therapeutic agent as measured against a saline control. Samples of bronchial lavage lung fluid and tissue were taken from all mice, with assays performed in airway mucus build-up and eosinophil infiltration, a prime blood cell measure of asthmatic attacks. More than 70% of the MDI-P treated mice exhibited no increase in mucus secretions, comparable with saline control animals, with a marked reduction in eosinophil infiltration. Untreated asthmatic mice, in contrast, had more than a nine-fold increase in mucus build-up as compared with saline controls. Further, no toxicity was found in the MDI-P treated mice. | |||
| On July 15, 2004, we announced our receipt from Clagett Consulting of a large mammal toxicity report for MDI-P. The study found no sign of any toxicity from MDI-P in the anatomy, behavior, clinical chemical, hematological, or histopathological measures of adverse events. The study was conducted in a rabbit species (New Zealand white rabbits) because of their acknowledged hyper-reactivity to toxicity in drugs. These results, when combined with our prior toxicological work, suggest that MDI-P should not cause toxic events in humans. Also included in the Clagett Consulting report was a further genomic analysis for toxicology of MDI-P. This genomics analysis indicated that MDI-P had no effect on any of the following: bone marrow function, hematocrit levels in peripheral blood, serum levels for alanine aminotransferase levels and aspartate aminotransferase levels, both of which provide sensitive measures of hepatic toxicity, serum protein and albumin levels, bound urinary nitrogen levels, serum calcium levels or blood glucose levels. In addition, this genomics analysis provided confirmation that various measures of impact on the hundreds of genes controlling toxicity as well as the immuno-regulatory system were neither up-or-down regulated by MDI-P. | |||
| In 2004 Dr. Chi also studied MDI-P as a potential therapeutic agent for the treatment of the symptoms of cystic fibrosis. In this study of 48 mice, it was found that MDI-P is a useful agent to reduce primary measures of disease in cystic fibrosis, including bacterial infection, mucus secretion, cellular infiltration, lung edema (swelling with excess fluid), lung hemorrhage, and lung infiltration by neutrophils and eosinophils, the principal white blood cells responding to allergic and infectious pathogens. Excessive presence of neutrophils and eosinophils can lead to cell death in surrounding tissues, causing serious health problems from their over-expression. No overt signs of toxicity were found in the primary organs (lungs, liver, spleen, kidneys, brain) of mice treated with MDI-P. | |||
| In 2004 we conducted a chronic toxicity study of MDI-P. The study involved the weekly injection of MDI-P into the body cavity of test mice for six-months. No statistically relevant changes in body weight, or morphometry or histopathology of vital organs were observed, when compared with mice receiving saline control injections or with untreated animals. The study resulted in no dose-dependency and no toxic effects. | |||
| In 2005 and 2006 we conducted a battery of tests in response to the FDAs clinical hold items for our cystic fibrosis IND. Those studies included a mouse central nervous system toxicity study conducted by Ascentia Bio-Medical Technologies, a dog cardiovascular toxicity study conducted by MPI Research, and the following genotoxicity studies conducted by NAMSA: Mouse Peripheral Blood Micronucleus Study, Dose Range Study in Mouse Peripheral Blood Micronucleus, In-Vitro Chromosomal Aberration Study in Mammalian Cells, and Bacterial Reverse Mutation Study. No adverse events were discovered in these studies. |
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MDIs Commercialization Program for SaveCream. MDI believes that the existing chemistry, manufacturing and control (CMC) data supporting SaveCream will be sufficient, however additional preclinical data will need to be obtained, including toxicology and pharmacokinetic testing. While the Company plans to undertake a program to expand SaveCreams preclinical data and expand the clinical trial program, including revised protocols, additional funds will need to be raised before this work can proceed. The preclinical testing will likely take an additional three to six months once it has begun, and expanded clinical trials will likely take an additional year or more of work.
Patents: MDI-P and Related Technologies. We hold eight United States Patents, two Japanese patents and a Mexican patent covering various applications for MDI-P, the machinery that manufactures it and the method by which it is manufactured. We believe that these patents, in combination with our pending applications for patents covering additional uses of MDI-P are sufficient to protect our proposed indications for use, however additional patents may be sought if we pursue additional uses for this product. The U.S. Patents are as follows:
| Patent No. 5,334,383: Electrically Hydrolyzed Salines as In Vivo Microbicides for the Treatment of Cardiomyopathy and Multiple Sclerosis | |||
This patent covers a method of treating antigen related infections related to cardiomyopathy and multiple sclerosis in humans and other warm blooded animals. It does not cover the MDI-P Substance itself, but covers a particular use of the substance. This method of treatment includes the use of an electrolyzed saline solution in conjunction with one or more modulating agents such as ascorbic acid (Vitamin C), with or without concurrent colchicine, to mimic or enhance the bodys naturally occurring immune response to bacterial, viral or fungal infection. The duration of this patent is until August 2, 2011, subject to patent term extension for clinical trial time. | ||||
| Patent No. 5,507,932: Apparatus for Electrolyzing Fluids | |||
This patent covers equipment that exposes a liquid solution to an electrical current, creating an electrolyzed solution. This equipment may be used to produce an electrolyzed saline solution, capable of killing bacterial, viral and fungal agents, for use in medical applications such as the treatment of antigen related infections in humans and other warm blooded animals. This patent covers the equipment used to produce MDI-P, not the substance itself. The duration of this patent is until August 26, 2014. | ||||
| Patent No. 5,560,816: Method for Electrolyzing Fluids | |||
This patent covers a method for electrolyzing fluids, by using specialized equipment to expose liquid solutions to an electrical current. Saline, for example, may be treated by this process to yield an electrolyzed saline solution, capable of killing bacterial, viral and fungal agents, for the treatment of antigen related infection in humans and other warm blooded animals. This patent covers the method by which MDI-P is produced, not the substance itself. The duration of this patent is until August 26, 2014, subject to patent term extension for clinical trial time. | ||||
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| Patent No. 5,622,848: Electrically Hydrolyzed Saline Solution as Microbicides for In Vitro Treatment of Contaminated Fluids Containing Blood | |||
This patent covers a method of treating whole blood and other blood products with an electrolyzed saline solution to reduce infection with bacterial, viral and fungal agents. This patent covers a particular use of MDI-P, not substance itself. The duration of this patent is until April 22, 2014, subject to patent term extension for clinical trial time. | ||||
| Patent No. 5,674,537: An Electrolyzed Saline Solution Containing Concentrated Amount of Ozone and Chlorine Species | |||
This patent covers a specific electrolyzed saline solution containing a regulated amount of microbicidal agents including ozone and active chlorine species. This solution is intended for use in the treatment of infections in the body of humans and other warm blooded animals, or in blood or blood products. This patent covers the MDI-P substance. The duration of this patent is until October 7, 2014, subject to patent term extension for clinical trial time. | ||||
| Patent No. 5,731,008: Electrically Hydrolyzed Salines as Microbicides | |||
This patent covers a method of using a specific electrolyzed saline solution containing a regulated amount of microbicidal agents including ozone and active chlorine species for the treatment of microbial infections, including HIV infection. The method includes intravenous administration of the solution along with one or more modulating agents such ascorbic acid (Vitamin C), with or without concurrent colchicine. This patent covers a method for using MDI-P, not the substance itself. The duration of this patent is until May 23, 2010, subject to patent term extension for clinical trial time. | ||||
| Patent No. 6,007,686: System for Electrolyzing Fluids for Use as Antimicrobial Agents | |||
This patent covers a system for electrolyzing fluids, such as a saline solution, for use in sterilizing dental and medical instruments and other health care equipment. The patent covers the necessary equipment for generating and circulating the electrolyzed saline solution around the instruments to be sterilized, and includes specific claims for equipment designed for use with dental drill handpieces and flexible tubing. This patent covers a process by which MDI-P may be made for a particular use, not the substance itself. The duration of this patent is until August 26, 2014. | ||||
| Patent No. 6,117,285: System for Carrying Out Sterilization of Equipment | |||
This patent covers a system for cleaning and sterilizing medical and dental instruments to prevent the spread of infection from one patient to another. The covered system bathes the instrument in an electrolyzed saline solution and causes the solution to flow into and sterilize any openings in the equipment. It includes specific claims for systems designed specifically for the sterilization of dental drills and flexible tubing. This patent covers a particular use of MDI-P, not the substance itself. The duration of this patent is until August 26, 2014. |
The Japanese and Mexican patents provide coverage in those countries for various of the U.S. patents. We also have pending applications with the US Patent and Trademark Office for patents on MDI-P as a pharmaceutical treatment for cystic fibrosis, sepsis and asthma. These include:
| A patent application for the use of MDI-P in the treatment of sepsis. This patent, if it is ultimately granted, would cover a particular use of the MDI-P substance, not the substance itself. |
| A provisional patent application for the use of MDI-P in the treatment of sepsis. A provisional patent application is an abbreviated application intended to establish a priority filing date for this technology. A full patent application will be required before this patent application is reviewed by the U.S. Patent and Trademark Office. This patent, if it is ultimately granted, would cover a particular use of the MDI-P substance, not the substance itself. |
| A provisional patent application for the use of MDI-P in the treatment of asthma. A provisional patent application is an abbreviated application intended to establish a priority filing date for this technology. A full patent application will be required before this patent application is reviewed by the U.S. Patent and Trademark Office. This patent, if it is ultimately granted, would cover a particular use of the MDI-P substance, not the substance itself. |
As existing patents and pending patent applications are method patents covering the use of MDI-P for particular indications, we believe they are adequate to protect the proposed indications for use.
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Patents: SaveCream and Related Technologies. The intellectual property assets we purchased from the liquidation estate of Savetherapeutics A.G. include the following four patent families:
| Substances and Agents for Positively Influencing Collagen. This includes an EU patent application and a Canadian patent. This patent covers the use of a substance such as an aromatase inhibitor to inhibit the local formation of estrogen to stabilize, multiply and/or restore collagen in the skin for cosmetic purposes. It does not cover the SaveCream substance itself. | ||
| Topical Treatment for Mastalgia. This includes U.S. patent application 10/416,096 filed October 30, 2001. A European Union patent application has been filed as well. This patent application seeks to cover a substance containing an aromatase inhibitor for topical administration for medicinal treatment, including prevention and treatment of mastalgia. | ||
| Medicament for Preventing and/or Treating a Mammary Carcinoma Containing a Steroidal Aromatase Inhibitor. This includes a U.S. patent application, No. 09/646,355, filed November 16, 2000 and divisional and continuation applications based upon the initial application. These applications seek to cover a method or prevention or treatment of breast cancer involving the local, topical application of an aromatase inhibitor. These applications seek to cover a particular use of the SaveCream substance, not the substance itself. | ||
| Aromatase Marking. This includes a U.S. Patent application, No. 10/487,953, filed August 28, 2002, as well as a European Union patent application. These patents seek to cover a group of compounds that exhibit an inhibitory action toward the enzyme aromatase, permitting them to be used for the medical diagnosis and treatment of tumor diseases including breast cancer. | ||
We believe that these patents, if granted, will sufficiently protect our proposed indications for use. We may, however, seek additional patents to cover new uses of SaveCream that may be discovered during the products development.
We are in the process of transferring the patents and applications to MDIs subsidiary. At the time we purchased SaveCream and the other intellectual property assets from SaveT, SaveT had not yet obtained and filed with the appropriate patent offices assignments of the various inventors rights to the underlying inventions. Each of those inventors has agreed and is contractually bound to assign such rights. We are currently in the process of securing the applicable assignments. However, we may need to initiate litigation against the inventors to secure such assignments. See Risk Factors We May Need to Litigate to Secure Our Rights to SaveCream and Related Assets.
Competition. The biotechnology and pharmaceutical industries are characterized by rapidly evolving technologies and intense competition. Our competitors include major pharmaceutical, and specialized biotechnology companies, many of which have financial, technical, and marketing resources significantly greater than ours. Fully integrated pharmaceutical companies, due to their expertise in research and development, manufacturing, testing, obtaining regulatory approvals, and marketing, as well as their substantially greater financial and other resources, may be our most formidable competitors. In addition, acquisitions by such pharmaceutical companies could enhance the financial and marketing resources of smaller competitors. Furthermore, colleges, universities, governmental agencies, and other public and private research organizations will continue to conduct research and possibly market competitive commercial products on their own or through joint ventures. These institutions are becoming more active in seeking patent protection and licensing arrangements to collect royalties for use of technology that they have developed. These institutions also will compete with us in recruiting and retaining highly qualified scientific personnel.
In particular, we face competition from the manufacturers of products that would compete with MDI-P and SaveCream should they be commercialized. Manufacturers of products currently available for the treatment of HIV and cystic fibrosis would be among our most significant competitors in the market for MDI-P. While there are 24 HIV therapies currently on the market (commonly used in three- or four-drug combinations), the primary therapies currently in use are produced by Pfizer, Bristol-Myers Squibb, Boehringer Ingelheim, GlaxoSmithKline, Gilead Sciences, Hoffman-La Roche, Merck, Abbott Laboratories, Agouron Pharmaceuticals, and Trimeris. Currently available anti-infectives commonly used in the treatment of cystic fibrosis are manufactured by Bayer Corporation, the maker of Cipro; Pfizer, the maker of Zithromax; and Chiron, the maker of tobramycin solution (TOBI); Bayer and Pfizer would compete with us in the cystic fibrosis market, while MDI-P is being studied as an adjunct to treatment with TOBI; thus we would be unlikely to compete directly with Chiron. Producers of aromatase inhibitors and other breast cancer treatments would compete with SaveCream should we able to commercialize this product. These companies include Astra-Zeneca, the maker of both Tamoxifen and Arimidex; Novartis, the maker of Femara; and Pfizer, the maker of Aromasin.
If and when we obtain regulatory approval for any of the potential uses of our technology which require them, we must then compete for acceptance in the marketplace. Given that such regulatory approval, especially in the United States, may take a number of years, the timing of the introduction of our technology and other products to the market is critical. Other safe and effective drugs and treatments may be introduced into the market prior to the time that we are able to obtain approval for the commercialization of our technology. In addition, even after such regulatory approval is obtained, competition among products approved for sale may be affected by, among other things, product efficacy, safety, reliability, availability, price, and patent position. There can be no assurance that our technology will be competitive if and when introduced into the marketplace for any of its possible uses.
Government Regulations. Our use of MDI-P and SaveCream as pharmaceuticals is subject to extensive regulation by United States and foreign governmental authorities. In particular, pharmaceutical treatments are subject to rigorous preclinical and clinical testing and other approval requirements by the FDA in the United States under the federal Food, Drug and Cosmetic Act and by comparable agencies in most foreign countries. Various federal, state and foreign statutes also govern or influence the manufacture, labeling, storage, record keeping, and marketing of such products. Pharmaceutical manufacturing facilities are also regulated by state, local, and other authorities. Obtaining approval from the FDA and other regulatory authorities for a new drug or treatment may take several years and involve substantial expenditures. Moreover, ongoing compliance with these requirements can require the expenditure of substantial resources. Difficulties or unanticipated costs may be encountered by us in our efforts to secure necessary governmental approvals, which could delay or preclude us from marketing MDI-P or SaveCream.
33
The FDA imposes substantial requirements upon and conditions precedent to the introduction of therapeutic drug products, such as MDI-P or SaveCream, through lengthy and detailed laboratory and clinical testing procedures, sampling activities and other costly and time consuming procedures to demonstrate that such products are both safe and effective in treating the indications for which approval is sought. After testing in animals, an Investigational New Drug, or IND, application must be filed with the FDA to obtain authorization for human testing. When the clinical testing has been completed and analyzed, final manufacturing processes and procedures are in place, and certain other required information is available to the manufacturer, a manufacturer may submit a new drug application, or NDA, to the FDA. No action can be taken to market any therapeutic drug product in the United States until an NDA has been approved by the FDA.
The IND process in the United States is governed by regulations established by the FDA which strictly control the use and distribution of investigational drugs in the United States. The guidelines require that an application contain sufficient information to justify administering the drug to humans, that the application include relevant information on the chemistry, pharmacology and toxicology of the drug derived from chemical, laboratory and animal or in vitro testing, and that a protocol be provided for the initial study of the new drug to be conducted on humans.
In order to conduct a clinical trial of a new drug in humans, a sponsor must prepare and submit to the FDA a comprehensive IND. The focal point of the IND is a description of the overall plan for investigating the drug product and a comprehensive protocol for each planned study. The plan is carried out in three phases: Phase I clinical trials, which involve the administration of the drug to a small number of healthy subjects to determine safety, tolerance, absorption and metabolism characteristics; Phase II clinical trials, which involve the administration of the drug to a limited number of patients for a specific disease to determine dose response, efficacy and safety; and Phase III clinical trials, which involve the study of the drug to gain confirmatory evidence of efficacy and safety from a wide base of investigators and patients.
Phase I testing typically takes at least one year, Phase II trials typically take from 1-1/2 to 2-1/2 years, and Phase III trials generally take from 2 to 5 years to complete. Should the FDA grant fast-track status to MDI-P based upon its safety profile and early signs of efficacy in Phase I clinical trials, the overall timeline for completion of Phase II-III clinical trials can be compacted to as little as 2-3 years. We can give no assurance that Phase I, Phase II or Phase III testing for MDI-P or SaveCream will be completed successfully within any specified time period, if at all. While we are hopeful that fast-track status might be provided MDI-P, there is no assurance that such status will, in fact, be provided. Furthermore, the FDA may suspend clinical trials at any time if the patients are believed to be exposed to a significant health risk.
An investigators brochure must be included in the IND and the IND must commit the sponsor to obtain initial and continual review and approval of the clinical investigation. A section describing the composition, manufacture and control of the drug substance and the drug product is included in the IND. Sufficient information is required to be submitted to assure the proper identification, quality, purity and strength of the investigational drug. A description of the drug substance, including its physical, chemical, and biological characteristics, must also be included in the IND. The general method of preparation of the drug substance must be included. A list of all components including inactive ingredients must also be submitted. There must be adequate information about pharmacological and toxicological studies of the drug involving laboratory animals and in vitro tests on the basis of which the sponsor has concluded that it is reasonably safe to conduct the proposed clinical investigation. Where there has been widespread use of the drug outside of the United States or otherwise, it is possible in some limited circumstances to use well documented clinical experience as a substitute for other pre-clinical work.
The FDA typically takes several months to consider and act on an IND application. We can give no assurance that our IND application will be approved or, if approved following comments or subject to modifications, the length of FDA approval time.
After the FDA approves the IND, the investigation is permitted to proceed, during which the sponsor must keep the FDA informed of new studies, including animal studies, make progress reports on the study or studies covered by the IND, and also be responsible for alerting FDA and clinical investigators immediately of unforeseen serious side effects or injuries.
34
When all clinical testing has been completed and analyzed, final manufacturing processes and procedures are in place, and certain other required information is available to the manufacturer, a manufacturer may submit an NDA to the FDA. An NDA must be approved by the FDA covering the drug before its manufacturer can commence commercial distribution of the drug. The NDA contains a section describing the clinical investigations of the drug which section includes, among other things, the following: a description and analysis of each clinical pharmacology study of the drug; a description and analysis of each controlled clinical study pertinent to a proposed use of the drug; a description of each uncontrolled clinical study including a summary of the results and a brief statement explaining why the study is classified as uncontrolled; and a description and analysis of any other data or information relevant to an evaluation of the safety and effectiveness of the drug product obtained or otherwise received by the applicant from any source foreign or domestic. The NDA also includes an integrated summary of all available information about the safety of the drug product including pertinent animal and other laboratory data, demonstrated or potential adverse effects of the drug, including clinically significant potential adverse effects of administration of the drug contemporaneously with the administration of other drugs and other related drugs. A section is included describing the statistical controlled clinical study and the documentation and supporting statistical analysis used in evaluating the controlled clinical studies.
Another section of the NDA describes the data concerning the action of a drug in the human body over a period of time and data concerning the extent of drug absorption in the human body or information supporting a waiver of the submission of such data. Also included in the NDA is a section describing the composition, manufacture and specification of the drug substance including the following: a full description of the drug substance, its physical and chemical characteristics; its stability; the process controls used during manufacture and packaging; and such specifications and analytical methods as are necessary to assure the identity, strength, quality and purity of the drug substance as well as the availability of the drug products made from the substance. NDAs contain lists of all components used in the manufacture of the drug product and a statement of the specifications and analytical methods for each component. Also included are studies of the toxicological actions of the drug as they relate to the drugs intended uses.
The data in the NDA must establish that the drug has been shown to be safe for use under its proposed labeling conditions and that there is substantial evidence that the drug is effective for its proposed use(s). Substantial evidence is defined by statute and FDA regulation to mean evidence consisting of adequate and well-controlled investigations, including clinical investigations by experts qualified by scientific training and experience, to evaluate the effectiveness of the drug involved. We can give no assurance that even if we complete clinical testing that our NDA will be approved.
Raw Materials. The components of both MDI-P and SaveCream are readily available from a number of sources. Therefore, once we are in the production stage with respect to these drugs, we do not anticipate raw materials acquisition difficulties or supplier identification or relations problems.
Research and Development Expenditures. Our research and development efforts to date have consisted primarily of pre-clinical development of and preparing applications for regulatory approvals for MDI-P for our initial target indications, HIV and cystic fibrosis. Our research and development is accomplished by outside scientific researchers under the coordination of Craig Palmer, Ph.D. During the fiscal year ended December 31, 2005, we spent $2,172,461 on research and development of MDI-P. During fiscal year 2004, we spent $550,093 on research and development. From inception through March 31, 2006, we have recorded $5,813,782 in research and development expenses including expenditures relating to the purchase of the SaveCream intellectual property. We are actively pursuing our research efforts of MDI-P and are in the process of establishing a commercialization plan for SaveCream.
Employees. We currently have two employees, our President and CEO, Judy M. Robinett, and our controller. We have engagements with a number of consultants for communications, investor relations, website development, accounting and other services. Over the past several years, our priority has been the advancement of our therapeutic technology through preclinical development and all capital resources have been devoted in that direction. At such time as capital resources permit, we will hire a full-time staff of employees.
35
Scientific Advisory Board. We have a scientific advisory board consisting of the following individuals:
Bruce I. Dezube, M.D.
Director of AIDS Oncology, Beth Israel Deaconess Medical Center, Boston
Associate Professor of Medicine, Harvard Medical School
We retained Dr. Dezube to oversee medical testing, FDA protocol alignment and approvals planning
for MDI-P. Dr. Dezube will be the principal investigator for our IND in HIV. Dr. Dezube is a
member of the AIDS Clinical Trial Group (ACTG) where he is principal investigator in more than
seven studies involving the testing and evaluation of interferon and newer anti-HIV agents.
Additionally, Dr. Dezube has been involved in industry-sponsored studies of other anti-HIV agents,
assisting with required FDA approvals. Dr. Dezube received his M.A. from Harvard University and his M.D. from
Tufts University. Dr. Dezube was a research fellow in hematology and oncology and is board
certified in internal medicine, hematology, and oncology.
Robert A. Mastico, Ph.D.
Physical Chemist, Independent Consultant
Dr. Mastico specializes in the chemistry, manufacturing and control of new drug substances required
for FDA approval. He has experience submitting INDs to the FDA, handling the manufacturing and
analytical data (CMC section) for investigational therapeutics. We have retained Dr. Mastico to
determine the chemical characterization requirements for MDI-P, and for planning and compliance
with all FDA and other required certifications involving chemical analyses. Dr. Mastico received
his Ph.D. from the University of Leeds in genetic biochemistry and has fifteen years experience in
the fields of biotherapeutics and pharmaceutical production.
Craig R. Palmer, Ph.D.
Principal, Palmer Consulting Group
Dr. Palmer has served over the past twenty years as a strategic financial advisor to a wide variety
of technology platform and biotech companies in their capital formation, management and product
licensing arenas. We have retained Dr. Palmer to assist us in managing the pre-clinical and
clinical development of MDI-P as well as commercialization. He serves as a director on several
biotech and biomedical companies, and has successfully licensed major ethical drugs and biomedical
devices. Prior to his involvement as a Principal in Palmer Capital Group LLC, and its predecessor
The Palmer Group, he served as a manager and principal in the consulting operations of Ernst &
Young (10 years), followed by a brief stint as a VP of Investments for a regional bank and its
SBIC. Dr. Palmer has assisted a number of his clients in securing underwriters for their IPOs or
secondary offerings. He has also assisted several clients in establishing major strategic
partnerships for product development. Dr. Palmer received his Ph.D. from the University of
Washington.
Dr. Henry R. Thompson, M.D.
Director, Cystic Fibrosis Program Therapeutics Center, St. Lukes Health Center, Boise, Idaho
Organizational History. Medical Discoveries, Inc. was incorporated under the laws of the State of Utah on November 20, 1991. Effective as of August 6, 1992, the Company merged with and into WPI Pharmaceutical, Inc., a Utah corporation (WPI), pursuant to which WPI was the surviving corporation. Pursuant to the MDI-WPI merger, the name of the surviving corporation was changed to Medical Discoveries, Inc. WPI was incorporated under the laws of the State of Utah on February 22, 1984 under the name Westport Pharmaceutical, Inc. Effective as of May 8, 1984, Westport Pharmaceutical, Inc. merged with and into Euripides Technology, Inc., a Utah corporation (Euripides), pursuant to which Euripides was the surviving corporation. Pursuant to the Westport-Euripides merger, the name of the surviving corporation was changed to Westport Pharmaceutical, Inc. Westport Pharmaceutical, Inc. subsequently changed its name to WPI Pharmaceutical, Inc. Euripides was incorporated under the laws of the State of Utah on November 9, 1983.
On July 6, 1998, we incorporated a wholly-owned subsidiary, Regenere, Inc., in the State of Nevada. On October 2, 1998, we incorporated another wholly-owned subsidiary, MDI Healthcare Systems, Inc., in the State of Nevada. Both subsidiaries were incorporated to undertake special purposes, neither of which were pursued by us in recent years. As of December 31, 2003, we dissolved those subsidiaries.
On March 22, 2005, we formed MDI Oncology, Inc., a Delaware corporation, as a wholly-owned subsidiary to acquire certain intellectual property assets from the liquidation estate of Savetherapeutics, A.G.
36
Reports to Security Holders. We have filed with the Securities and Exchange Commission, a Registration Statement on Form SB-2 under the Securities Act of 1933 with respect to the common stock offered by this prospectus. This prospectus does not contain all of the information set forth in the registration statement and the exhibits and schedules to the registration statement. For further information with respect to us and the common stock offered by this prospectus, reference is made to the registration statement and the exhibits and schedules filed as a part of the registration statement. Additionally, we file annual, quarterly and current reports, proxy statements and other documents with the Securities and Exchange Commission. You may read and copy any materials we file with the Securities and Exchange Commission at the Securities and Exchange Commissions Public Reference Room at 450 Fifth Street, N.W., Washington, D.C. 20549. You may obtain information on the operation of the Public Reference Room by calling the Securities and Exchange Commission at 1-800-SEC-0330. The Securities and Exchange Commission also maintains a World Wide Web site that contains reports, proxy and information statements and other information regarding registrants that file electronically with the Securities and Exchange Commission. The address of the Securities and Exchange Commissions Web site is http://www.sec.gov. You may also find more information about us, and any recent developments at our Web site at http://medicaldiscoveries.com.
MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.
The purpose of this section is to discuss and analyze our consolidated financial condition, liquidity and capital resources, and results of operations. This analysis should be read in conjunction with the financial statements and notes thereto at pages F-1 through F-29.
This section contains certain forward-looking statements that involve risks and uncertainties, including statements regarding our plans, objectives, goals, strategies and financial performance. Our actual results could differ materially from the results anticipated in these forward-looking statements as a result of factors set forth under Forward-Looking Statements above and elsewhere in this prospectus.
37
38
Off-Balance Sheet Arrangements. We have no off-balance sheet arrangements as defined in Item 303(c) of Regulation S-B.
Foreign Currency Risk. We bear foreign currency exchange risk because our remaining purchase price obligation for the Savetherapeutics assets is stated in Euros.
DESCRIPTION OF PROPERTY
We do not currently own or lease any real property. Currently, we operate out of the President and CEOs home office. We do not pay any rent to the President and CEO. Over the past several years, our priority has been the advancement of our therapeutic technology through pre-clinical development and all capital resources have been devoted in that direction. At such time as capital resources permit, we will lease dedicated office and laboratory space.
39
RELATED PARTY TRANSACTIONS
At December 31, 2005 we had accounts payable to our President and CEO totaling $877,636 for services performed on behalf of the Company. Also at December 31, 2005, we had an account payable to our controller of $73,000. These accounts payable represent accrued but unpaid compensation for the period June 2000 through June 2005. The executed employment agreement between the Company and our President and CEO is attached as Exhibit 10.4.
MARKET FOR COMMON EQUITY AND RELATED STOCKHOLDER MATTERS
Market Information. Our common stock is traded on the NASD OTC Bulletin Board under the symbol MLSC. The following table sets forth the range of bid quotations for our common stock for the quarters indicated according to data provided by The NASDAQ Stock Market, Inc. Such quotations reflect inter-dealer prices, without retail mark-ups, markdowns or commissions, and may not represent actual transactions.
FISCAL YEAR ENDED DECEMBER 31, 2006 | HIGH BID | LOW BID | ||||||
First Quarter |
$ | 0.185 | $ | 0.090 |
FISCAL YEAR ENDED DECEMBER 31, 2005 | HIGH BID | LOW BID | ||||||
First Quarter |
$ | 0.220 | $ | 0.130 | ||||
Second Quarter |
0.180 | 0.080 | ||||||
Third Quarter |
0.170 | 0.082 | ||||||
Fourth Quarter |
0.135 | 0.090 |
FISCAL YEAR ENDED DECEMBER 31, 2004 | HIGH BID | LOW BID | ||||||
First Quarter |
$ | 0.170 | $ | 0.100 | ||||
Second Quarter |
0.300 | 0.115 | ||||||
Third Quarter |
0.301 | 0.150 | ||||||
Fourth Quarter |
0.260 | 0.180 |
40
Shareholders. The approximate number of shareholders of record of our common stock as of May 24, 2006 was 1,500. This number does not include shareholders whose shares are held in securities position listings.
Dividends. We have never paid any cash dividends on our common stock and do not anticipate paying dividends in the foreseeable future. We presently intend to retain any future earnings for financing our growth and expansion.
Securities Authorized for Issuance Under Equity Compensation Plans. The following table contains information regarding our equity compensation plans as of December 31, 2005.
Number of | ||||||||||||
Securities | ||||||||||||
Remaining | ||||||||||||
Available for | ||||||||||||
Number of | Weighted- | Future Issuance | ||||||||||
Securities to be | Average Exercise | under Equity | ||||||||||
Issued upon | Price of | Compensation | ||||||||||
Exercise of | Outstanding | Plans (Excluding | ||||||||||
Outstanding | Options, | Securities | ||||||||||
Options, Warrants | Warrants and | Reflected in the | ||||||||||
Plan Category | and Rights | Rights | First Column) | |||||||||
Equity compensation plans approved
by security holders |
||||||||||||
1993 Incentive Plan |
3,483,000 | $ | 0.14 | -0- | ||||||||
2002 Stock Incentive Plan |
16,000,000 | $ | 0.02 | 4,000,000 | ||||||||
Equity compensation plans not
approved by security holders |
| | | |||||||||
Total |
19,483,000 | $ | 0.04 | 4,000,000 |
41
EXECUTIVE COMPENSATION
Director Compensation. Directors who are not officers of the Company do not receive any regular compensation for their service on the board of directors, and directors who are officers of the Company receive no additional compensation for their service as a director of the Company. Directors are entitled to receive compensation for services unrelated to their service as a director to the extent that they provide such unrelated services to the Company. See Related Party Transactions above.
Directors of the Company and its subsidiaries are entitled to participate in our 2002 Stock Incentive Plan. During the year ended December 31, 2005, we did not grant any options to directors.
Summary Compensation Table. The following table sets forth certain summary information concerning compensation paid by the Company to the President and Chief Executive Officer (the Named Executive Officer) for the years ended December 31, 2005, 2004, and 2003. No other executive officer of the Company received a total annual salary and bonus in excess of $100,000 during the year ended December 31, 2005. As of April 1, 2005, we increased Ms. Robinetts salary to $350,000 per year pursuant to a new employment agreement. Under the employment agreement, the Company agreed to adopt a formal annual bonus plan under which the Named Executive Officer will be eligible for an annual bonus, as a percentage of the annual salary, upon the achievement of specified financial, operational and managerial goals. The agreement has a three-year term and is terminable by either partly with six months written notice. In case of termination without cause, the Named Executive Officer will be eligible for severance pay in the amount of two years annual salary.
Securities | ||||||||||||||||
Underlying | ||||||||||||||||
Salary | Options | |||||||||||||||
Name and Principal Position(s) | Year | ($) | Bonus ($) | (#) | ||||||||||||
2005 | 322,500 | | | |||||||||||||
Judy M. Robinett |
2004 | 220,000 | (a) | | | |||||||||||
President and Chief |
2003 | 220,000 | (a) | | 14,500,000 | |||||||||||
Executive Officer |
(a) | Represents total amounts accrued for the period, whether or not actually paid. As of December 31, 2005, the Company had a total payable to Ms. Robinett of $877,636. |
The Named Executive Officer was not granted options during the year ended December 31, 2005.
42
The following table sets forth certain summary information concerning options exercised by the Named Executive Officer during 2005, and the value of options held by such person at December 31, 2005 measured in terms of the average sale price reported for Common Stock on December 30, 2005 ($.1125, as reported by OTC Bulletin Board).
Aggregate Option Exercises in 2005 and Option Values at 12/31/2005
Number of | ||||||||||||||||
Securities | Value of Unexercised | |||||||||||||||
Underlying | In-the-Money | |||||||||||||||
Unexercised Options | Options at | |||||||||||||||
Shares | at December 31, | December 31, | ||||||||||||||
Acquired on | Value | 2005 (#) | 2005 ($) | |||||||||||||
Name | Exercise (#) | Realized ($) | Exercisable/Unexercisable | Exercisable/Unexercisable | ||||||||||||
Judy M. Robinett |
| | 16,000,000/0 | 1,500,000 |
The Company has never granted any freestanding stock appreciation rights.
EXPERTS
Our financial statements included in this prospectus as of December 31, 2005 and 2004 and for each of the two years then ended and for the period from inception (November 20, 1991) through December 31, 2005 have been audited by Hansen Barnett and Maxwell; Eide Bailly LLP (formerly Balukoff Lindstrom & Co. P.A. joined Eide Bailly November 1, 2004); and Tanner LC; as stated in their reports appearing elsewhere in this prospectus and in the registration statement, and are included in reliance upon those reports given upon the authority of those firms as experts in accounting and auditing.
43
Page No. | ||||||
F-2 | ||||||
F-3 | ||||||
F-4 | ||||||
FINANCIAL STATEMENTS
|
||||||
F-5 | ||||||
F-6 | ||||||
F-7 | ||||||
F-11 | ||||||
F-12 | ||||||
F-23 | ||||||
F-24 | ||||||
F-25 | ||||||
F-27 |
F-1
/s/ HANSEN, BARNETT & MAXWELL | |
|
F-2
/s/ EIDE BAILLY LLP (formerly BALUKOFF, LINDSTROM & CO. P.A. joined Eide Bailly November 1, 2004) |
F-3
F-4
December 31, | December 31, | |||||||||
2005 | 2004 | |||||||||
ASSETS | ||||||||||
CURRENT ASSETS
|
||||||||||
Cash
|
$ | 654,438 | $ | 1,455,397 | ||||||
Deposits
|
| 51,100 | ||||||||
Total Current Assets
|
654,438 | 1,506,497 | ||||||||
Note receivable
|
296,050 | | ||||||||
Property and equipment, net
|
80,635 | | ||||||||
TOTAL ASSETS
|
$ | 1,031,123 | $ | 1,506,497 | ||||||
LIABILITIES AND STOCKHOLDERS DEFICIT | ||||||||||
CURRENT LIABILITIES
|
||||||||||
Accounts payable
|
$ | 2,608,783 | $ | 2,448,454 | ||||||
Accrued interest payable
|
237,836 | 415,262 | ||||||||
Notes payable
|
56,000 | 336,717 | ||||||||
Convertible notes payable
|
193,200 | 193,200 | ||||||||
Research and development obligation
|
592,100 | | ||||||||
Financial instrument
|
2,859,596 | | ||||||||
Total Current Liabilities
|
6,547,515 | 3,393,633 | ||||||||
TOTAL LIABILITIES
|
6,547,515 | 3,393,633 | ||||||||
STOCKHOLDERS DEFICIT
|
||||||||||
Preferred Stock Series A,
convertible; no par value; 42,000 shares authorized; 42,000
and 12,000 shares issued and outstanding, respectively;
(aggregate liquidation preference of $4,200,000 and $1,200,000,
respectively)
|
523,334 | 523,334 | ||||||||
Common stock, no par value; 250,000,000 shares authorized;
107,679,724 and 105,653,335 shares issued and outstanding,
respectively
|
15,211,895 | 14,918,657 | ||||||||
Additional paid-in capital
|
988,670 | 3,424,383 | ||||||||
Deficit accumulated prior to the development stage
|
(1,399,577 | ) | (1,399,577 | ) | ||||||
Deficit accumulated during the development stage
|
(20,840,714 | ) | (19,353,933 | ) | ||||||
Total Stockholders Deficit
|
(5,516,392 | ) | (1,887,136 | ) | ||||||
TOTAL LIABILITIES AND STOCKHOLDERS DEFICIT
|
$ | 1,031,123 | $ | 1,506,497 | ||||||
F-5
From Inception of the | ||||||||||||||
For the Years Ended | Development Stage | |||||||||||||
December 31, | on November 20, 1991 | |||||||||||||
through December 31, | ||||||||||||||
2005 | 2004 | 2005 | ||||||||||||
REVENUES
|
$ | | $ | | $ | 157,044 | ||||||||
COST OF GOODS SOLD
|
| | 14,564 | |||||||||||
GROSS PROFIT
|
| | 142,480 | |||||||||||
OPERATING EXPENSES
|
||||||||||||||
General and administrative
|
1,878,027 | 3,057,429 | 17,054,997 | |||||||||||
Research and development
|
2,172,461 | 550,093 | 5,721,199 | |||||||||||
Inventory write-down
|
| | 96,859 | |||||||||||
Impairment loss
|
| | 9,709 | |||||||||||
License fees
|
| | 1,001,500 | |||||||||||
Total Expenses
|
4,050,488 | 3,607,522 | 23,884,264 | |||||||||||
LOSS FROM OPERATIONS
|
(4,050,488 | ) | (3,607,522 | ) | (23,741,784 | ) | ||||||||
OTHER INCOME (EXPENSES)
|
||||||||||||||
Unrealized gain on financial instrument
|
2,300,191 | | 2,300,191 | |||||||||||
Interest income
|
25,727 | 6,165 | 55,298 | |||||||||||
Interest expense
|
(38,264 | ) | (131,526 | ) | (1,155,701 | ) | ||||||||
Foreign currency transaction gain
|
56,480 | | 56,480 | |||||||||||
Gain on forgiveness of debt
|
196,353 | | 1,431,889 | |||||||||||
Other income
|
23,220 | 1,408 | 905,112 | |||||||||||
Total Other Income (Expenses)
|
2,563,707 | (123,953 | ) | 3,593,269 | ||||||||||
NET LOSS
|
(1,486,781 | ) | (3,731,475 | ) | (20,148,515 | ) | ||||||||
Preferred stock dividend from beneficial conversion feature
|
| (692,199 | ) | (692,199 | ) | |||||||||
NET LOSS APPLICABLE TO COMMON SHAREHOLDERS
|
$ | (1,486,781 | ) | $ | (4,423,674 | ) | $ | (20,840,714 | ) | |||||
BASIC AND DILUTED LOSS PER COMMON SHARE
|
$ | (0.01 | ) | $ | (0.05 | ) | ||||||||
WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING
|
107,398,164 | 93,947,646 | ||||||||||||
F-6
Accumulated | Deficit | |||||||||||||||||||||||||||||||||||||
Deficit Prior | Accumulated | |||||||||||||||||||||||||||||||||||||
Preferred Stock | Common Stock | Additional | to | During the | Escrow/ | |||||||||||||||||||||||||||||||||
Paid in | Development | Development | Subscription | |||||||||||||||||||||||||||||||||||
Shares | Amount | Shares | Amount | Capital | Stage | Stage | Receivables | Total | ||||||||||||||||||||||||||||||
Balance at October 31,1991
|
1,750,000 | $ | 252,997 | $ | | $ | (1,482,514 | ) | $ | | $ | | $ | (1,229,517 | ) | |||||||||||||||||||||||
Restatement for reverse acquisition of WPI Pharmaceutical, Inc.
by Medical Discoveries, Inc.
|
| | | (252,997 | ) | | 252,997 | | | | ||||||||||||||||||||||||||||
Shares issued in merger of WPI Pharmaceutical, Inc. Medical
Discoveries, Inc., $0.01 per share
|
| | 10,000,000 | 135,000 | | (170,060 | ) | | | (35,060 | ) | |||||||||||||||||||||||||||
Balance at November 20,1991
(Date of Inception of Development Stage) |
| | 11,750,000 | 135,000 | | (1,399,577 | ) | | | (1,264,577 | ) | |||||||||||||||||||||||||||
Issuance of common stock for:
|
||||||||||||||||||||||||||||||||||||||
Cash
|
||||||||||||||||||||||||||||||||||||||
1992 $0.50 per share
|
| | 200,000 | 100,000 | | | | | 100,000 | |||||||||||||||||||||||||||||
1992 $1.50 per share
|
| | 40,000 | 60,000 | | | | | 60,000 | |||||||||||||||||||||||||||||
1993 $0.97 per share
|
| | 542,917 | 528,500 | | | | | 528,500 | |||||||||||||||||||||||||||||
1994 $1.20 per share
|
| | 617,237 | 739,500 | | | | | 739,500 | |||||||||||||||||||||||||||||
1995 $0.67 per share
|
| | 424,732 | 283,200 | | | | | 283,200 | |||||||||||||||||||||||||||||
1996 $0.66 per share
|
| | 962,868 | 635,000 | | | | (60,000 | ) | 575,000 | ||||||||||||||||||||||||||||
1997 $0.43 per share
|
| | 311,538 | 135,000 | | | | 60,000 | 195,000 | |||||||||||||||||||||||||||||
1998 $0.29 per share
|
| | 2,236,928 | 650,000 | | | | | 650,000 | |||||||||||||||||||||||||||||
1999 $0.15 per share
|
| | 13,334 | 2,000 | | | | | 2,000 | |||||||||||||||||||||||||||||
2001 $0.15 per share
|
| | 660,000 | 99,000 | | | | | 99,000 | |||||||||||||||||||||||||||||
2003 $0.04 per share
|
| | 20,162,500 | 790,300 | | | | | 790,300 | |||||||||||||||||||||||||||||
Services and Interest
|
||||||||||||||||||||||||||||||||||||||
1992 $0.50 per share
|
| | 500,000 | 250,000 | | | | | 250,000 | |||||||||||||||||||||||||||||
1993 $0.51 per share
|
| | 251,450 | 127,900 | | | | | 127,900 | |||||||||||||||||||||||||||||
1993 $0.50 per share
|
| | 800,000 | 400,000 | | | | | 400,000 | |||||||||||||||||||||||||||||
1994 $1.00 per share
|
| | 239,675 | 239,675 | | | | | 239,675 |
F-7
Accumulated | Deficit | ||||||||||||||||||||||||||||||||||||
Deficit Prior | Accumulated | ||||||||||||||||||||||||||||||||||||
Preferred Stock | Common Stock | Additional | to | During the | Escrow/ | ||||||||||||||||||||||||||||||||
Paid in | Development | Development | Subscription | ||||||||||||||||||||||||||||||||||
Shares | Amount | Shares | Amount | Capital | Stage | Stage | Receivables | Total | |||||||||||||||||||||||||||||
1995 $0.39 per share
|
| | 4,333,547 | 1,683,846 | | | | (584,860 | ) | 1,098,986 | |||||||||||||||||||||||||||
1996 $0.65 per share
|
| | 156,539 | 101,550 | | | | | 101,550 | ||||||||||||||||||||||||||||
1997 $0.29 per share
|
| | 12,500 | 3,625 | | | | | 3,625 | ||||||||||||||||||||||||||||
1998 $0.16 per share
|
| | 683,000 | 110,750 | | | | | 110,750 | ||||||||||||||||||||||||||||
1999 $0.30 per share
|
| | 100,000 | 30,000 | | | | | 30,000 | ||||||||||||||||||||||||||||
2001 $0.14 per share
|
| | 1,971,496 | 284,689 | | | | | 284,689 | ||||||||||||||||||||||||||||
2002 $0.11 per share
|
| | 2,956,733 | 332,236 | | | | | 332,236 | ||||||||||||||||||||||||||||
2003 $0.06 per share
|
| | 694,739 | 43,395 | | | | | 43,395 | ||||||||||||||||||||||||||||
Conversion of Debt
|
|||||||||||||||||||||||||||||||||||||
1996 $0.78 per share
|
239,458 | 186,958 | | | | | 186,958 | ||||||||||||||||||||||||||||||
1997 $0.25 per share
|
| | 100,000 | 25,000 | | | | | 25,000 | ||||||||||||||||||||||||||||
1998 $0.20 per share
|
| | 283,400 | 56,680 | | | | | 56,680 | ||||||||||||||||||||||||||||
2002 Debt $0.03 per share
|
| | 17,935,206 | 583,500 | | | | | 583,500 | ||||||||||||||||||||||||||||
Other Issuances
|
|||||||||||||||||||||||||||||||||||||
1993 License $0.50 share
|
| | 2,000,000 | 1,000,000 | | | | | 1,000,000 | ||||||||||||||||||||||||||||
1997 Settlement of contract
|
| | 800,000 | 200,000 | | | | | 200,000 | ||||||||||||||||||||||||||||
1998 Issuance of common stock from exercise of
warrants, $0.001 per share
|
| | 200,000 | 200 | | | | | 200 | ||||||||||||||||||||||||||||
2000 Reversal of shares issued
|
| | (81,538 | ) | | | | | | | |||||||||||||||||||||||||||
Escrow and Subscription Receivables
|
|||||||||||||||||||||||||||||||||||||
1996 Common stock canceled $.34 per
share
|
| | (1,400,000 | ) | (472,360 | ) | | | | 472,360 | | ||||||||||||||||||||||||||
2000 Issuance for escrow receivable $0.09 per
share
|
| | 5,500,000 | 500,000 | | | | (500,000 | ) | | |||||||||||||||||||||||||||
2000 Write-off of subscription receivable
|
| | | | | | | 112,500 | 112,500 | ||||||||||||||||||||||||||||
2000 Research and development costs
|
| | | | | | | 115,400 | 115,400 |
F-8
Accumulated | Deficit | |||||||||||||||||||||||||||||||||||||
Deficit Prior | Accumulated | |||||||||||||||||||||||||||||||||||||
Preferred Stock | Common Stock | Additional | to | During the | Escrow/ | |||||||||||||||||||||||||||||||||
Paid in | Development | Development | Subscription | |||||||||||||||||||||||||||||||||||
Shares | Amount | Shares | Amount | Capital | Stage | Stage | Receivables | Total | ||||||||||||||||||||||||||||||
2001 Research and development costs
|
| | | | | | | 132,300 | 132,300 | |||||||||||||||||||||||||||||
2001 Operating expenses
|
| | | | | | | 25,000 | 25,000 | |||||||||||||||||||||||||||||
Exercise of Options and Warrants
|
||||||||||||||||||||||||||||||||||||||
1997 $0.25 per share
|
| | 87,836 | 21,959 | | | | | 21,959 | |||||||||||||||||||||||||||||
1999 Waived option price $0.14 per share
|
| | 170,000 | 24,000 | | | | | 24,000 | |||||||||||||||||||||||||||||
Value of Issued for Services
|
||||||||||||||||||||||||||||||||||||||
1998
|
| | | 2,336,303 | | | | | 2,336,303 | |||||||||||||||||||||||||||||
1999
|
| | | 196,587 | | | | | 196,587 | |||||||||||||||||||||||||||||
2001
|
| | | | 159,405 | | | | 159,405 | |||||||||||||||||||||||||||||
2002
|
| | | | 124,958 | | | | 124,958 | |||||||||||||||||||||||||||||
2003
|
| | | | 295,000 | | | | 295,000 | |||||||||||||||||||||||||||||
Other
|
||||||||||||||||||||||||||||||||||||||
1994 Cash contributed
|
| | | 102,964 | | | | | 102,964 | |||||||||||||||||||||||||||||
1995 Issuance of common stock option to satisfy debt
restructuring
|
| | | 20,000 | | | | | 20,000 | |||||||||||||||||||||||||||||
Net loss from inception through December 31, 2003
|
| | | | | | (14,930,259 | ) | | (14,930,259 | ) | |||||||||||||||||||||||||||
Balance at December 31, 2003
|
| | 76,456,095 | 12,546,957 | 579,363 | (1,399,577 | ) | (14,930,259 | ) | (227,300 | ) | (3,430,816 | ) | |||||||||||||||||||||||||
Extension of options for services
|
| | | | 1,675,000 | | | | 1,675,000 | |||||||||||||||||||||||||||||
Termination of escrow agreement
|
| | (2,356,200 | ) | (227,300 | ) | | | | 227,300 | | |||||||||||||||||||||||||||
Issuance of preferred stock and warrants for cash
|
||||||||||||||||||||||||||||||||||||||
(net $130,000, common stock and warrants issued to placement agent) | 12,000 | 523,334 | 350,000 | 68,845 | 477,821 | | | | 1,070,000 | |||||||||||||||||||||||||||||
Convertible preferred stock beneficial conversion dividend
|
| | | | 692,199 | | (692,199 | ) | | |||||||||||||||||||||||||||||
Issuance of common stock for:
|
||||||||||||||||||||||||||||||||||||||
Cash $0.09 per share
|
| | 20,138,024 | 1,813,186 | | | | | 1,813,186 | |||||||||||||||||||||||||||||
Debt and interest $0.07 per share
|
| | 9,875,951 | 650,468 | | | | | 650,468 | |||||||||||||||||||||||||||||
Services $0.06 per share
|
| | 1,189,465 | 66,501 | | | | | 66,501 | |||||||||||||||||||||||||||||
Net loss for the year ended December 31, 2004
|
| | | | | | (3,731,475 | ) | | (3,731,475 | ) | |||||||||||||||||||||||||||
Accumulated | Deficit | ||||||||||||||||||||||||||||||||||||
Deficit Prior | Accumulated | ||||||||||||||||||||||||||||||||||||
Preferred Stock | Common Stock | Additional | to | During the | Escrow/ | ||||||||||||||||||||||||||||||||
Paid in | Development | Development | Subscription | ||||||||||||||||||||||||||||||||||
Shares | Amount | Shares | Amount | Capital | Stage | Stage | Receivables | Total | |||||||||||||||||||||||||||||
Balance at December 31, 2004
|
12,000 | 523,334 | 105,653,335 | 14,918,657 | 3,424,383 | (1,399,577 | ) | (19,353,933 | ) | | (1,887,136 | ) | |||||||||||||||||||||||||
Issuance of common stock for services
|
| | 104,167 | 11,312 | | | | | 11,312 | ||||||||||||||||||||||||||||
Issuance of common stock for cash at $0.18 per share
|
| | 1,922,222 | 281,926 | | | | | 281,926 | ||||||||||||||||||||||||||||
Issuance of preferred stock and warrants for cash (net $340,000,
entire amount was reclassified to financial instrument liability)
|
30,000 | | | | | | | | | ||||||||||||||||||||||||||||
Reclassification of warrants to a financial instrument liability
|
| | | | (2,435,713 | ) | | | | (2,435,713 | ) | ||||||||||||||||||||||||||
Net loss for the year ended December 31, 2005
|
| | | | | | (1,486,781 | ) | | (1,486,781 | ) | ||||||||||||||||||||||||||
Balance at December 31, 2005
|
42,000 | $ | 523,334 | 107,679,724 | $ | 15,211,895 | $ | 988,670 | $ | (1,399,577 | ) | $ | (20,840,714 | ) | $ | | $ | (5,516,392 | ) | ||||||||||||||||||
From Inception of the | ||||||||||||||
For the Year Ended | Development Stage on | |||||||||||||
December 31, | November 20, 1991 | |||||||||||||
through Dec. 30, | ||||||||||||||
2005 | 2004 | 2005 | ||||||||||||
CASH FLOWS FROM OPERATING ACTIVITIES
|
||||||||||||||
Net Loss
|
$ | (1,486,781 | ) | $ | (3,731,475 | ) | $ | (20,148,515 | ) | |||||
Adjustments to reconcile net loss to net cash used by operating
activities:
|
||||||||||||||
Foreign currency transaction gain
|
(56,480 | ) | | (56,480 | ) | |||||||||
Gain on debt restructuring
|
(196,353 | ) | | (1,431,889 | ) | |||||||||
Common stock issued for services, expenses, and litigation
|
| 66,501 | 4,267,717 | |||||||||||
Commitment for research and development obligation
|
665,700 | | 665,700 | |||||||||||
Depreciation
|
8,515 | | 108,786 | |||||||||||
Reduction of escrow receivable from research and development
|
| | 272,700 | |||||||||||
Unrealized gain on financial instrument
|
(2,300,191 | ) | | (2,300,191 | ) | |||||||||
Stock options and warrants granted for services
|
| 1,675,000 | 4,811,253 | |||||||||||
Reduction of legal costs
|
| | (130,000 | ) | ||||||||||
Write-off of subscriptions receivable
|
| | 112,500 | |||||||||||
Impairment of loss on assets
|
| | 9,709 | |||||||||||
Loss on disposal of equipment
|
| | 30,364 | |||||||||||
Write-off of receivable
|
51,100 | | 245,065 | |||||||||||
Note payable issued for litigation
|
| | 385,000 | |||||||||||
Changes in operating assets and liabilities
|
||||||||||||||
Increase in accounts receivable
|
| | (7,529 | ) | ||||||||||
Decrease in prepaid expenses
|
| 11,331 | | |||||||||||
Decrease in deferred charges
|
| 12,077 | | |||||||||||
Increase in accounts payable
|
171,641 | 381,727 | 2,464,186 | |||||||||||
Increase in accrued expenses
|
38,210 | 53,934 | 637,919 | |||||||||||
Net Cash Used by Operating Activities
|
(3,104,639 | ) | (1,530,905 | ) | (10,063,705 | ) | ||||||||
CASH FLOWS FROM INVESTING ACTIVITIES
|
||||||||||||||
Increase in deposits
|
| (51,100 | ) | (51,100 | ) | |||||||||
Purchase of equipment
|
(89,150 | ) | | (221,334 | ) | |||||||||
Issuance of note receivable
|
(313,170 | ) | | (313,170 | ) | |||||||||
Payments received on note receivable
|
| | 130,000 | |||||||||||
Net Cash Used by Investing Activities
|
(402,320 | ) | (51,100 | ) | (455,604 | ) | ||||||||
CASH FLOWS FROM FINANCING ACTIVITIES
|
||||||||||||||
Issuance of common stock, preferred stock and warrants for cash
|
3,006,000 | 2,883,186 | 10,033,845 | |||||||||||
Contributed equity
|
| | 131,374 | |||||||||||
Proceeds from notes payable
|
| | 1,336,613 | |||||||||||
Payments on notes payable
|
(300,000 | ) | (270,000 | ) | (801,287 | ) | ||||||||
Proceeds from convertible notes payable
|
| | 571,702 | |||||||||||
Payments on convertible notes payable
|
| | (98,500 | ) | ||||||||||
Net Cash Provided by Financing Activities
|
2,706,000 | 2,613,186 | 11,173,747 | |||||||||||
NET INCREASE (DECREASE) IN CASH
|
(800,959 | ) | 1,031,181 | 654,438 | ||||||||||
CASH AT BEGINNING OF PERIOD
|
1,455,397 | 424,216 | | |||||||||||
CASH AT END OF PERIOD
|
$ | 654,438 | $ | 1,455,397 | $ | 654,438 | ||||||||
SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION
|
||||||||||||||
Interest paid
|
$ | 19,283 | $ | 77,592 | ||||||||||
NONCASH INVESTING AND FINANCING ACTIVITIES
|
||||||||||||||
Retirement of notes payable and interest through issuance of
common stock
|
$ | | $ | 650,468 | ||||||||||
Release of shares as part of Perrigrine settlement
|
$ | | $ | 227,300 | ||||||||||
Common stock and warrants issued to placement agent
|
$ | 11,312 | $ | 162,746 | ||||||||||
Preferred stock dividend as part of beneficial conversion feature
|
$ | | $ | 692,199 |
F-11
Principles of Consolidation |
Development Stage Company |
Cash and Cash Equivalents |
Property and Equipment |
Income Taxes |
F-12
Research and Development |
Fair Value of Financial Instruments |
Estimates |
Basic and Diluted Loss per Share |
Concentration of Credit |
Stock Based Compensation |
F-13
Fiscal Year Ended December 31, | ||||||||
2005 | 2004 | |||||||
Net loss applicable to common stockholders, as reported
|
$ | (1,486,781 | ) | $ | (4,423,674 | ) | ||
Add: Stock-based employee compensation expense included in
reported net loss
|
| 1,675,000 | ||||||
Deduct: Total stock based employee compensation expense
determined under fair value based method for all awards
|
| (1,979,237 | ) | |||||
Pro forma net loss applicable to common shareholders
|
$ | (1,486,781 | ) | $ | (4,727,911 | ) | ||
Basic and diluted loss per share, as reported
|
$ | (0.01 | ) | $ | (0.05 | ) | ||
Basic and diluted loss per share, pro forma
|
$ | (0.01 | ) | $ | (0.05 | ) | ||
Recently Issued Accounting Statements |
F-14
2005 | 2004 | |||||||
Equipment
|
$ | 168,468 | $ | 79,318 | ||||
Accumulated depreciation
|
(87,833 | ) | (79,318 | ) | ||||
$ | 80,635 | $ | | |||||
Years Ended December 31, | ||||||||
2005 | 2004 | |||||||
Federal income tax benefit at statutory rate (34%)
|
$ | 506,000 | $ | 1,268,000 | ||||
State income tax, net of federal benefit
|
89,000 | 224,000 | ||||||
Unrealized gain on financial instrument
|
920,000 | | ||||||
Revaluation and expiration of options
|
| (631,000 | ) | |||||
Change in valuation allowance
|
(1,515,000 | ) | (861,000 | ) | ||||
$ | | $ | | |||||
December 31, | ||||||||
2005 | 2004 | |||||||
Net operating loss carryforward
|
$ | 6,663,000 | $ | 5,132,000 | ||||
Research and development credits
|
80,000 | 80,000 | ||||||
Stock options
|
646,000 | 646,000 | ||||||
Accrued compensation
|
380,000 | 396,000 | ||||||
Valuation allowance
|
(7,769,000 | ) | (6,254,000 | ) | ||||
Net deferred tax asset
|
$ | | $ | | ||||
F-15
2005 | 2004 | |||||||
Notes payable to shareholders, which are currently due and in
default. Interest is at 12%
|
$ | 56,000 | $ | 336,717 |
2005 | 2004 | |||||||
Convertible notes payable to a trust, which is currently due and
in default. Interest is at 12%. Each $1,000 note is convertible
into 667 shares of Companys common stock
|
$ | 193,200 | $ | 193,200 |
Common Stock |
F-16
Preferred Stock and Warrants |
F-17
Financial Instrument |
Commitment Regarding Peregrine Stock |
F-18
2005 | 2004 | |||||||||||||||
Weighted- | Weighted- | |||||||||||||||
Average | Average | |||||||||||||||
Options | Exercise Price | Options | Exercise Price | |||||||||||||
Outstanding at beginning of year
|
19,483,000 | $ | 0.04 | 18,783,000 | $ | 0.04 | ||||||||||
Issued
|
| | 700,000 | 0.05 | ||||||||||||
Forfeited
|
| | | | ||||||||||||
Outstanding at end of year
|
19,483,000 | 0.04 | 19,483,000 | 0.04 | ||||||||||||
Exercisable at end of year
|
19,483,000 | $ | 0.04 | 19,483,000 | $ | 0.04 | ||||||||||
Weighed average fair value of options granted during the year
|
$ | | $ | 0.14 | ||||||||||||
Options Outstanding | Options Exercisable | |||||||||||||||||||
Weighted | ||||||||||||||||||||
Average | ||||||||||||||||||||
Remaining | Weighted | Weighted | ||||||||||||||||||
Contractual | Average | Average | ||||||||||||||||||
Number | Life | Exercise | Number | Exercise | ||||||||||||||||
Range of Exercise Prices | Outstanding | (Years) | Price | Exercisable | Price | |||||||||||||||
$0.01 to 0.02
|
16,000,000 | 7.6 | $ | 0.02 | 16,000,000 | $ | 0.02 | |||||||||||||
$0.05
|
1,500,000 | 6.1 | $ | 0.05 | 1,500,000 | $ | 0.05 | |||||||||||||
$0.15 to 0.50
|
1,983,000 | 6.1 | $ | 0.02 | 1,983,000 | $ | 0.02 | |||||||||||||
19,483,000 | 19,483,000 | |||||||||||||||||||
F-19
2005 | 2004 | |||||||
Expected dividend yield
|
| | ||||||
Risk free interest rate
|
| 3.8 | % | |||||
Expected volatility
|
| 220 | % | |||||
Expected life
|
| 7 years | ||||||
Weighted average fair value per share
|
$ | | $ | 0.10 |
Stock Warrants |
2005 | 2004 | |||||||||||||||
Weighted- | Weighted- | |||||||||||||||
Average | Average | |||||||||||||||
Warrants | Exercise Price | Warrants | Exercise Price | |||||||||||||
Outstanding at beginning of year
|
14,904,029 | $ | 0.28 | 3,616,005 | $ | 0.61 | ||||||||||
Issued
|
26,019,832 | 0.20 | 12,954,029 | 0.17 | ||||||||||||
Expired
|
| | (1,666,005 | ) | 0.16 | |||||||||||
Exercised
|
| | | | ||||||||||||
Outstanding at end of year
|
40,923,861 | $ | 0.23 | 14,904,029 | $ | 0.28 | ||||||||||
Weighted | ||||||||||||
Average | ||||||||||||
Remaining | Weighted | |||||||||||
Contractual | Average | |||||||||||
Number | Life | Exercise | ||||||||||
Range of Exercise Price | Outstanding | (Years) | Price | |||||||||
$0.09
|
2,356,700 | 1.5 | $ | 0.09 | ||||||||
$0.18 to 0.20
|
36,617,161 | 2.1 | 0.19 | |||||||||
$1.00
|
1,950,000 | 1.0 | 1.00 | |||||||||
40,923,861 | 2.0 | $ | 0.23 | |||||||||
F-20
SaveCream Asset Purchase |
Formation of MDI Oncology, Inc. |
F-21
Exercise of Series A Convertible Preferred Stock |
Re-Grant of Stock Option |
F-22
March 31, | December 31, | |||||||
2006 | 2005 | |||||||
ASSETS |
||||||||
CURRENT ASSETS |
||||||||
Cash |
$ | 106,589 | $ | 654,438 | ||||
Total Current Assets |
106,589 | 654,438 | ||||||
Note receivable |
303,475 | 296,050 | ||||||
Property and equipment, net |
75,621 | 80,635 | ||||||
TOTAL ASSETS |
$ | 485,685 | $ | 1,031,123 | ||||
LIABILITIES AND STOCKHOLDERS DEFICIT |
||||||||
CURRENT LIABILITIES |
||||||||
Accounts payable |
$ | 2,425,462 | $ | 2,608,783 | ||||
Accrued interest payable |
245,208 | 237,836 | ||||||
Notes payable |
56,000 | 56,000 | ||||||
Convertible notes payable |
193,200 | 193,200 | ||||||
Research and development obligation |
606,950 | 592,100 | ||||||
Financial instrument |
3,979,373 | 2,859,596 | ||||||
Total Current Liabilities |
7,506,193 | 6,547,515 | ||||||
TOTAL LIABILITIES |
7,506,193 | 6,547,515 | ||||||
STOCKHOLDERS DEFICIT |
||||||||
Preferred stock, Series A,
convertible; no par value; 42,000 shares authorized; 41,800 and
42,000 shares issued and outstanding, respectively; (aggregate liquidation preference of
$4,180,000 and $4,200,000, respectively) |
514,612 | 523,334 | ||||||
Common stock, no par value; 250,000,000 shares authorized; 107,922,148 and 107,679,724
shares issued and outstanding, respectively |
15,220,617 | 15,211,895 | ||||||
Additional paid-in capital |
1,056,020 | 988,670 | ||||||
Deficit accumulated prior to the development stage |
(1,399,577 | ) | (1,399,577 | ) | ||||
Deficit accumulated during the development stage |
(22,412,180 | ) | (20,840,714 | ) | ||||
Total Stockholders Deficit |
(7,020,508 | ) | (5,516,392 | ) | ||||
TOTAL LIABILITIES AND STOCKHOLDERS DEFICIT |
$ | 485,685 | $ | 1,031,123 | ||||
F-23
From Inception | ||||||||||||
of the | ||||||||||||
Development Stage | ||||||||||||
For the Three | on November 20, 1991 | |||||||||||
Months Ended | Through | |||||||||||
March 31, | March 31, | |||||||||||
2006 | 2005 | 2006 | ||||||||||
REVENUES |
$ | | $ | | $ | 157,044 | ||||||
COST OF GOODS SOLD |
| | 14,564 | |||||||||
GROSS PROFIT |
| | 142,480 | |||||||||
OPERATING EXPENSES |
||||||||||||
General and administrative |
345,520 | 251,996 | 17,400,517 | |||||||||
Research and development |
92,583 | 1,551,986 | 5,813,782 | |||||||||
Inventory write-down |
| | 96,859 | |||||||||
Impairment loss |
| | 9,709 | |||||||||
License fees |
| | 1,001,500 | |||||||||
Total Expenses |
438,103 | 1,803,982 | 24,322,367 | |||||||||
LOSS FROM OPERATIONS |
(438,103 | ) | (1,803,982 | ) | (24,179,887 | ) | ||||||
OTHER INCOME (EXPENSES) |
||||||||||||
Unrealized gain (loss) on financial instrument |
(1,119,777 | ) | (142,262 | ) | 1,180,414 | |||||||
Interest income |
1,211 | 5,564 | 56,509 | |||||||||
Interest expense |
(7,372 | ) | (15,898 | ) | (1,163,073 | ) | ||||||
Foreign currency transaction gain (loss) |
(7,425 | ) | 19,900 | 49,055 | ||||||||
Gain on forgiveness of debt |
| | 1,431,889 | |||||||||
Other income |
| | 905,112 | |||||||||
Total Other Income (Expenses) |
(1,133,363 | ) | (132,696 | ) | 2,459,906 | |||||||
NET LOSS |
(1,571,466 | ) | (1,936,678 | ) | (21,719,981 | ) | ||||||
Preferred stock dividend from
beneficial conversion feature |
| | (692,199 | ) | ||||||||
NET LOSS APPLICABLE TO
COMMON SHAREHOLDERS |
$ | (1,571,466 | ) | $ | (1,936,678 | ) | $ | (22,412,180 | ) | |||
BASIC AND DILUTED LOSS PER
COMMON SHARE |
$ | (0.01 | ) | $ | (0.02 | ) | ||||||
WEIGHTED AVERAGE NUMBER OF
SHARES OUTSTANDING |
107,895,212 | 106,506,793 | ||||||||||
F-24
From Inception | ||||||||||||
For the Three | of the | |||||||||||
Months Ended | Development Stage | |||||||||||
March 31, | on November 20, 1991 | |||||||||||
2006 | 2005 | Through March 31, 2006 | ||||||||||
CASH FLOWS FROM OPERATING ACTIVITIES |
||||||||||||
Net Loss |
$ | (1,571,466 | ) | $ | (1,936,678 | ) | $ | (21,719,981 | ) | |||
Adjustments to reconcile net loss to net cash used by operating activities: |
||||||||||||
Foreign currency transaction (gain) loss |
7,425 | (19,900 | ) | (49,055 | ) | |||||||
Gain on debt restructuring |
| | (1,431,889 | ) | ||||||||
Common stock issued for services |
| 18,750 | 4,267,717 | |||||||||
Commitment for research and development obligation |
| 665,700 | 665,700 | |||||||||
Unrealized (gain) loss on financial instrument |
1,119,777 | 142,262 | (1,180,414 | ) | ||||||||
Depreciation |
5,014 | | 113,800 | |||||||||
Reduction of escrow receivable from
research and development |
| | 272,700 | |||||||||
Stock options and warrants granted for services |
67,350 | | 4,878,603 | |||||||||
Reduction of legal costs |
| | (130,000 | ) | ||||||||
Write-off of subscriptions receivable |
| | 112,500 | |||||||||
Impairment of loss on assets |
| | 9,709 | |||||||||
Loss on disposal of equipment |
| | 30,364 | |||||||||
Write-off of receivable |
| | 245,065 | |||||||||
Note payable issued for litigation |
| | 385,000 | |||||||||
Changes in operating assets and liabilities
|
||||||||||||
Increase in accounts receivable |
| | (7,529 | ) | ||||||||
Increase (decrease) in accounts payable |
(183,321 | ) | (84,904 | ) | 2,280,865 | |||||||
Increase in accrued expenses |
7,372 | 15,898 | 645,291 | |||||||||
Net Cash Used by Operating Activities |
(547,849 | ) | (1,198,872 | ) | (10,611,554 | ) | ||||||
CASH FLOWS FROM INVESTING ACTIVITIES |
||||||||||||
Increase in deposits |
| | (51,100 | ) | ||||||||
Purchase of equipment |
| | (221,334 | ) | ||||||||
Issuance of note receivable |
| | (313,170 | ) | ||||||||
Payments received on note receivable |
| | 130,000 | |||||||||
Net Cash Used by Investing Activities |
| | (455,604 | ) | ||||||||
CASH FLOWS FROM FINANCING ACTIVITIES |
||||||||||||
Issuance of common stock, preferred stock and warrants for cash |
| 2,902,000 | 10,033,845 | |||||||||
Contributed equity |
| | 131,374 | |||||||||
Proceeds from notes payable |
| | 1,336,613 | |||||||||
Payments on notes payable |
| | (801,287 | ) | ||||||||
Proceeds from convertible notes payable |
| | 571,702 | |||||||||
Payments on convertible notes payable |
| | (98,500 | ) | ||||||||
Net Cash Provided by Financing Activities |
| 2,902,000 | 11,173,747 | |||||||||
NET INCREASE (DECREASE) IN CASH |
(547,849 | ) | 1,703,128 | 106,589 | ||||||||
CASH AT BEGINNING OF PERIOD |
654,438 | 1,455,397 | | |||||||||
CASH AT END OF PERIOD |
$ | 106,589 | $ | 3,158,525 | $ | 106,589 | ||||||
F-25
For the Three | ||||||||
Months Ended | ||||||||
March 31, | ||||||||
2006 | 2005 | |||||||
SUPPLEMENTAL DISCLOSURES OF
CASH FLOW INFORMATION |
||||||||
Initial valuation of financial instrument |
$ | | $ | 6,279,829 | ||||
Conversion of preferred stock to common stock |
$ | 8,722 | $ | |
F-26
F-27
F-28
F-29
No dealer, salesman or other person is authorized to give any information or to make any representations not contained in this prospectus in connection with the offer made hereby, and, if given or made, such information or representations must not be relied upon as having been made by us.
This prospectus does not offer to sell or buy any securities in any jurisdiction where it is unlawful.
The information in this prospectus is current as of the date hereof. Neither the delivery of this prospectus nor any sale made hereunder shall create any implication that the information contained herein is correct as of any time subsequent to the date hereof.
113,511,158 shares common
stock
Medical Discoveries, Inc.
Prospectus
May 24, 2006
PART II
INFORMATION NOT REQUIRED IN THE PROSPECTUS
Item 24. Indemnification of Officers and Directors
Part 9 of the Utah Business Corporation Act empowers a corporation to indemnify its directors and officers, advance or reimburse expenses to its directors and officers, and to purchase insurance with respect to liability arising out of their capacity or status as directors and officers. Such indemnification is permissible in certain situations and mandatory in other situations. In cases where indemnification or advancing or reimbursing of expenses is permissible, authorization and a determination of qualification must be made in each specific case. The Registrants articles of incorporation and bylaws provide for the indemnification of its directors and officers to the fullest extent permitted by law.
Item 25. Other Expenses of Issuance and Distribution
The following table sets forth the various expenses of the offering, sale and distribution of the offered securities being registered pursuant to this registration statement (the Registration Statement). We will bear all of the expenses listed below. All of the amounts shown are estimates except the SEC registration fees.
Item | Amount | |||
SEC registration fees |
$ | 2,760 | ||
Accounting and legal fees and expenses |
$ | 115,000 | ||
Printing expenses |
$ | 10,000 | ||
Miscellaneous expenses |
$ | 1,000 | ||
Total: |
$ | 128,760 | ||
Item 26. Recent Sales of Unregistered Securities
We sold the following unregistered securities in the past three years. None of the sales involved an underwriter. We believe these sales were exempt from registration pursuant to Section 4(2) of the Securities Act of 1933 because the sales did not involve a public offering.
| On August 31, 2005, we sold the following number of shares of restricted common stock to the following investors for cash of $0.18 per share. Each sale included a warrant to purchase an equal number of shares of restricted common stock at a price of $0.18 per share, exercisable for a period of three years following the date of investment. These securities were issued in a private placement that we believe qualified for the exemption form registration under Section 4(2) of the Securities Act of 1933 and the safe harbor provided thereunder pursuant to Rule 506 because the sales did not involve a public offering, were made without general solicitation, were made primarily to accredited investors (plus no more than 35 non-accredited investors), and were made upon delivery of a private placement memorandum satisfying the information requirements of Rule 502. |
Name | Shares | |||
Kristie B. Pederson Trust |
555,556 | |||
Seattle Sacs, LLC |
555,556 | |||
Enternet Development Corp. |
444,444 | |||
James I. Lytton |
150,000 | |||
Brooke B. Medicine Eagle |
83,333 | |||
Alberto Villoldo |
83,333 | |||
Mark Savage |
50,000 |
| On or about March 14, 2005, we sold to Mercator Momentum Fund I, L.P., Mercator Momentum Fund III, L.P. and Mercator Advisory Group, LLC 30,000 shares of Preferred Stock and warrants to purchase 22,877,478 shares of common stock for a total offering price of $3 million. Each share of Preferred Stock entitles the holder to convert the share of Preferred Stock into the number of shares of common stock resulting from dividing $100 by the conversion price. The conversion price is 75% of the average of the lowest three intra-day trading prices for the Companys common stock during the 10 trading days immediately preceding the conversion date, but the conversion price may not exceed $0.1967. The number of shares of common stock subject to the warrants and the exercise price are subject to equitable adjustment in connection with a stock split, stock dividend or similar transaction. The warrants entitle the holder to purchase up to 22,877,478 shares of common stock of the Company on or before the third anniversary of the issuance date of the warrants at $0.1967 per share. The number of shares of common stock subject to the warrants and the exercise price are subject to equitable adjustment in connection with a stock split, stock dividend or similar transaction. In connection with this financing, we issued to a placement agent Ascendiant Securities, LLC warrants that entitle the holder to purchase up to 1,220,132 shares of common stock of the Company on or before the third anniversary of the issuance date of the warrants at $0.1967 per share. | |||
| On or about October 18, 2004, we sold to Monarch Pointe Fund, Ltd. and Mercator Advisory Group, LLC 12,000 shares of Preferred Stock and warrants to purchase 4,575,496 shares of common stock for a total offering price of $1.2 million. Each share of Preferred Stock entitles the holder to convert the share of Preferred Stock into the number of shares of common stock resulting from dividing $100 by the conversion price. The conversion price is 75% of the average of the lowest three intra-day trading prices for the Companys common stock during the 10 trading days immediately preceding the conversion date, but the conversion price may not exceed $0.1967 or be lower than $0.05. The number of shares of common stock subject to the warrants and the exercise price are subject to equitable adjustment in connection with a stock split, stock dividend or similar transaction. The warrants entitle the holder to purchase up to 4,575,496 shares of common stock of the Company on or before the third anniversary of the issuance date of the warrants at $0.1967 per share. The number of shares of common stock subject to the warrants and the exercise price are subject to equitable adjustment in connection with a stock split, stock dividend or similar transaction. In connection with this financing, we issued to a placement agent, Ascendiant Securities, LLC and its affiliate Ascendiant Capital Group, LLC, 350,000 shares of restricted common stock and warrants that entitle the holder to purchase up to 488,052 shares of common stock of the Company on or before the third anniversary of the issuance date of the warrants at $0.1967 per share. | |||
II-1
| On November 4, 2004, we sold the following number of shares of restricted common stock to the following investors for cash of $0.18 per share. Each sale included a warrant to purchase an equal number of shares of restricted common stock at a price of $0.18 per share, exercisable for a period of three years following the date of investment. These securities were issued in a private placement that we believe qualified for the exemption form registration under Section 4(2) of the Securities Act of 1933 and the safe harbor provided thereunder pursuant to Rule 506 because the sales did not involve a public offering, were made without general solicitation, were made primarily to accredited investors (plus no more than 35 non-accredited investors), and were made upon delivery of a private placement memorandum satisfying the information requirements of Rule 502. | |||
Name | Shares | |||
John Aksamit Foundation, Inc. |
833,334 | |||
HIP Investments |
555,567 | |||
Norman Cohn |
555,556 | |||
Earl Kaplan |
555,556 | |||
Neil Wood |
305,000 | |||
Marty Kaplan |
194,444 | |||
James B. Peek |
138,889 | |||
Scott Smith |
138,889 | |||
George E. Van, Jr. |
138,889 | |||
Dietrich Klinghardt |
138,889 | |||
Marcia D. Julian |
138,889 | |||
Steven Lyons |
138,889 | |||
Todd Seeholzer |
138,889 | |||
Sound Current Wisdom |
138,889 | |||
Blievernicht Trust |
138,889 | |||
Frona L. Toney |
138,889 | |||
Michael Rodgers |
138,889 | |||
Natalie Hastings OShea |
138,889 | |||
R. Arthur Jenkins |
122,222 | |||
Lyman Jensen |
101,000 | |||
Stephen Zahn |
100,000 | |||
James Laufenberg |
83,333 | |||
Richard Morrisey-Paine |
77,778 | |||
Mary Lou Mellinger Trust |
69,445 | |||
ABC Trust |
69,444 | |||
Mark Savage |
65,000 | |||
Isaac Shapiro |
61,110 | |||
Farmilion Investments Ltd. |
55,556 | |||
Alan Bolotin |
50,000 | |||
Stephen Richardson |
30,000 |
| On July 14, 2004, we sold 714,286 shares of restricted common stock to Scott Smith, M.D. for cash of $0.14 per share. These securities were issued in a private placement that we believe qualified for the exemption from registration under Section 4(2) of the Securities Act of 1933 and the safe harbor provided thereunder pursuant to Rule 506 because the sales did not involve a public offering and was made to an accredited investor. |
| On June 18, 2004, we sold 2,272,727 shares of restricted common stock to John Aksamit Revocable Trust for cash of $0.11 per share. These securities were issued in a private placement that we believe qualified for the exemption from registration under Section 4(2) of the Securities Act of 1933 and the safe harbor provided thereunder pursuant to Rule 506 because the sales did not involve a public offering and was made to an accredited investor. |
| On April 9, 2004, we sold the following number of shares of restricted common stock to the following investors for cash of $0.04 per share. These securities were issued in a private placement that we believe qualified for the exemption form registration under Section 4(2) of the Securities Act of 1933 and the safe harbor provided thereunder pursuant to Rule 506 because the sales did not involve a public offering, were made without general solicitation, were made primarily to accredited investors (plus no more than 35 non-accredited investors), and were made upon delivery of a private placement memorandum satisfying the information requirements of Rule 502. |
Name | Shares | |||
Robert Kenneth Yukes |
500,000 | |||
Bruce O. Hoffman |
250,000 | |||
Richard Frires |
250,000 | |||
David Bolotin |
250,000 | |||
Stephen J. Rogers |
125,000 | |||
Stephen J. Rogers |
175,000 | |||
Bob Palmer |
750,000 | |||
Isaac Shapiro |
175,000 | |||
Kenneth West |
250,000 | |||
Richard John Morrisey Paine |
250,000 | |||
Michael Gurevich |
250,000 | |||
David Belz |
250,000 | |||
Marie-Louise Knaupp |
300,000 | |||
Janet R. Prado |
250,000 | |||
Belle B. Wolkoff |
250,000 | |||
Lynn Bruton |
250,000 | |||
Pie In The Sky |
250,000 | |||
ABC Trust |
250,000 |
| On January 26, 2004, we sold the following number of shares of restricted common stock to the following investors for cash of $0.04 per share. These securities were issued in a private placement that we believe qualified for the exemption form registration under Section 4(2) of the Securities Act of 1933 and the safe harbor provided thereunder pursuant to Rule 506 because the sales did not involve a public offering, were made without general solicitation, were made primarily to accredited investors (plus no more than 35 non-accredited investors), and were made upon delivery of a private placement memorandum satisfying the information requirements of Rule 502. |
II-2
Name | Shares | |||
Gary R. Stone |
125,000 | |||
Raymond C. Cooper |
500,000 | |||
Brent W. Davis |
375,000 | |||
Sharon M. Gillette & Associates Money Purchase Plan |
1,700,000 | |||
Sharon M. Gillette IRA Rollover Plan |
800,000 | |||
Dan Dwayne Pounds |
250,000 | |||
Peter S. Levin |
375,000 | |||
Stephen Peltier |
250,000 | |||
H. Howard Wills |
125,000 | |||
Louise B. Simmons Trust |
250,000 | |||
Thomas Manning |
125,000 | |||
Gary S. Kraftsow |
250,000 | |||
Kelvin Buneman |
125,000 | |||
H. Larry Spilker |
125,000 | |||
Stephen F. Richardson |
250,000 | |||
Stephen Zahn |
250,000 | |||
Mary Lou Mellinger Trust |
250,000 | |||
Pershing LLC |
450,000 |
| During 2004 we issued an aggregate of 9,875,951 shares of common stock to Martha Cooper Lang, Nick Garnero and Richard W. Smith upon conversion of certain promissory notes with an aggregate outstanding principal and interest amount of $650,468. | |||
| During 2004 we issued 1,189,465 shares of restricted common stock in lieu of cash finders fees in connection with equity financings. | |||
| On October 28, 2003, we sold the following number of shares of restricted common stock to the following investors for cash of $0.04 per share. These securities were issued in a private placement that we believe qualified for the exemption form registration under Section 4(2) of the Securities Act of 1933 and the safe harbor provided thereunder pursuant to Rule 506 because the sales did not involve a public offering, were made without general solicitation, were made primarily to accredited investors (plus no more than 35 non-accredited investors), and were made upon delivery of a private placement memorandum satisfying the information requirements of Rule 502. |
Name | Share | |||
Ross Durrant |
150,000 | |||
Shu Na Wan |
500,000 | |||
Martha Cooper Lang |
1,250,000 | |||
Gary L. Perry |
312,500 | |||
Larry S. Anderson |
250,000 | |||
Suzanne M. Sommer |
250,000 | |||
Alan L. Daniels |
250,000 | |||
Dorin S. Daniels TR 1/15/93 Daniels Family |
250,000 | |||
Shields Family Living Trust |
250,000 | |||
Kenneth D. Perry |
312,500 | |||
Mark Savage |
650,000 | |||
Greg E. Groom |
125,000 | |||
David Lewis |
125,000 | |||
John Plocher |
250,000 | |||
David R. Lucas |
375,000 | |||
Institute of Facial Surgery St. Paul PR |
250,000 | |||
Thomas D. Madison |
1,250,000 | |||
Robin V. Smith |
500,000 | |||
Vernon C. Mortensen |
250,000 | |||
Micah J. Richins |
250,000 | |||
R. Arthur Jenkins |
362,500 | |||
Summit Insurance Planning, Inc. |
250,000 | |||
Lyman Jensen |
1,250,000 | |||
Kenneth A. Wolkoff |
375,000 | |||
The Chris Sanders Trust |
250,000 | |||
Charles E. Krpata |
250,000 | |||
Micah J. Richins |
250,000 | |||
Rulon N. Richins |
250,000 | |||
Alan Bolotin |
250,000 | |||
Joseph S. Hood |
300,000 | |||
Justin Y. Shimada |
500,000 | |||
Ross Durrant |
500,000 | |||
James Laufenberg |
250,000 | |||
Gregory H. Von Gehr |
250,000 | |||
Alan Chin |
125,000 | |||
James B. Peek |
250,000 | |||
David R. Lucas |
300,000 | |||
David R. Lucas |
150,000 | |||
David R. Walker |
250,000 | |||
The Kurtz Family Trust |
2,500,000 | |||
Lyman Jensen |
1,250,000 | |||
Lyman Jensen |
1,250,000 | |||
Lyman Jensen |
250,000 | |||
Alan Sagatelyan |
250,000 |
II-3
Item 27. Exhibits
The following exhibits required by Item 601 of Regulation S-B promulgated under the Securities Act have been included with the Registration Statement as indicated below.
EXHIBIT INDEX
Exhibit No. | Exhibit | |
2.1
|
Sale and Purchase Agreement between Attorney Hinnerk-Joachim Müller as liquidator of Savetherapeutics AG i.L and Medical Discoveries, Inc. regarding the purchase of essential assets of Savetherapeutics AG i.L.+ | |
3.1
|
Amended and Restated Articles of Incorporation of the Company (filed as Exhibit 3.1 to the Companys Annual Report on Form 10-KSB for the fiscal year ended December 31, 1994, and incorporated herein by reference). | |
3.2
|
Amended Bylaws of the Company (filed as Exhibit 3.2 to the Companys Annual Report on Form 10-KSB for the fiscal year ended December 31, 1994, and incorporated herein by reference). | |
4.1
|
Certificate of Designations of Preferences and Rights of Series A Convertible Preferred Stock of Medical Discoveries, Inc.+ | |
4.2
|
Amendment to Certificate of Designations of Preferences and Rights of Series A Convertible Preferred Stock of Medical Discoveries, Inc.+ | |
4.3
|
Registration Rights Agreement dated October 18, 2004 among Monarch Pointe Fund, Ltd, Mercator Advisory Group, LLC and Medical Discoveries, Inc.+ | |
4.4
|
Registration Rights Agreement dated December 3, 2004 among Mercator Momentum Fund, LP, Mercator Momentum Fund III, LP, Mercator Advisory Group, LLC and Medical Discoveries, Inc.+ | |
5.1
|
Opinion of Epstein Becker & Green, P.C.* | |
10.1
|
2002 Stock Incentive Plan adopted by the Board of Directors as of July 11, 2002 (filed as Exhibit 10.5 to the Companys Quarterly Report on Form 10-QSB for the quarter ended June 30, 2002, and incorporated herein by reference). | |
10.2
|
Subscription Agreement dated October 18, 2004 among Monarch Pointe Fund, Ltd., Mercator Advisory Group, LLC, and Medical Discoveries, Inc.+ | |
10.3
|
Subscription Agreement dated December 3, 2004 among Mercator Momentum Fund, LP, Mercator Momentum Fund III, LP, Mercator Advisory Group, LLC, and Medical Discoveries, Inc.+ | |
10.4
|
Employment Agreement dated March 1, 2005 between Medical Discoveries, Inc. and Judy M. Robinett.+ | |
21
|
Subsidiaries+ | |
23.1
|
Consent of Hansen, Barnett & Maxwell* | |
23.2
|
Consent Eide Bailly LLP* | |
23.3
|
Consent of Tanner LC* | |
23.4
|
Consent of Epstein Becker & Green, P.C.++ |
* | Filed herewith | |
+ | Previously filed | |
++ | Included in Item 5.1 |
II-4
Item 28. Undertakings
The Registrant hereby undertakes:
(1) To file during any period in which offers or sales are being made, a post-effective amendment to this registration statement to:
(i) Include any prospectus required by Section 10(a)(3) of the Securities Act.
(ii) Reflect in the prospectus any facts or events that, individually or together, represent a fundamental change in the information. Notwithstanding the foregoing, any increase or decrease in volume of securities offered (if the total dollar value of securities offered would not exceed that which was registered) and any deviation from the low or high end of the estimated maximum offering range may be reflected in the form of prospectus filed with the Commission pursuant to Rule 424(b) if, in the aggregate, the changes in volume and price represent no more than a 20% change in the maximum aggregate offering price set forth in the Calculation of Registration Fee table in the effective registration statement.
(iii) Include any additional or changed material information on the plan of distribution.
(2) That for determining liability under the Securities Act, to treat each post-effective amendment as a new registration statement of the securities offered, and the offering of the securities at that time to be the initial bona fide offering.
(3) To file a post-effective amendment to remove from registration any of the securities that remain unsold at the end of the offering.
Insofar as indemnification for liabilities arising under the Securities Act may be permitted to directors, officers and controlling persons of the Registrant pursuant to the foregoing provisions or otherwise, the Registrant has been advised that in the opinion of the Securities and Exchange Commission such indemnification is against public policy as expressed in the Securities Act and is, therefore, unenforceable.
II-5
SIGNATURES
In accordance with the requirements of the Securities Act, the registrant certifies that it has reasonable grounds to believe that it meets all of the requirements for filing on Form SB-2 and authorized this registration statement to be signed on its behalf by the undersigned, in Salt Lake City, Utah, on May 24, 2006.
Medical Discoveries, Inc. | ||||
By: | /s/ Judy M. Robinett | |||
Judy M. Robinett | ||||
President and Chief Executive Officer |
KNOW ALL MEN BY THESE PRESENTS, that each person whose signature appears below hereby constitutes and appoints Judy M. Robinett his or her attorney-in-fact and agent, with full power of substitution, for him or her and in his or her name, place and stead, in any and all capacities, to sign any or all amendments to this Registration Statement on Form SB-2, and to file the same, with all exhibits thereto and other documents in connection therewith, with the Securities and Exchange Commission, granting unto said attorney-in-fact and agent full power and authority to do and perform each and every act and thing requisite and necessary to be done in connection with this Registration Statement, as fully to all intents and purposes as he or she might or could do in person, hereby ratifying and confirming all that any of said attorney-in-fact and agent, or his or her substitute or substitutes, may lawfully do or cause to be done by virtue hereof.
In accordance with the requirements of the Securities Act, this registration Statement was signed by the following persons in the capacities and on the dates stated:
/s/ Judy M. Robinett
|
President and Chief Executive | May 24, 2006 | ||
Officer | ||||
Judy M. Robinett
|
||||
/s/
Deirdra J. Burgess
|
Controller | May 24, 2006 | ||
Deirdra J. Burgess |
||||
/s/ David R. Walker
|
Chairman of the Board of Directors | May 24, 2006 | ||
David R. Walker |
||||
/s/ Larry Anderson
|
Director | May 24, 2006 | ||
Larry Anderson |
II-6
EXHIBIT INDEX
Exhibit No. | Exhibit | |
2.1
|
Sale and Purchase Agreement between Attorney Hinnerk-Joachim Müller as liquidator of Savetherapeutics AG i.L and Medical Discoveries, Inc. regarding the purchase of essential assets of Savetherapeutics AG i.L.+ | |
3.1
|
Amended and Restated Articles of Incorporation of the Company (filed as Exhibit 3.1 to the Companys Annual Report on Form 10-KSB for the fiscal year ended December 31, 1994, and incorporated herein by reference). | |
3.2
|
Amended Bylaws of the Company (filed as Exhibit 3.2 to the Companys Annual Report on Form 10-KSB for the fiscal year ended December 31, 1994, and incorporated herein by reference). | |
4.1
|
Certificate of Designations of Preferences and Rights of Series A Convertible Preferred Stock of Medical Discoveries, Inc.+ | |
4.2
|
Amendment to Certificate of Designations of Preferences and Rights of Series A Convertible Preferred Stock of Medical Discoveries, Inc.+ | |
4.3
|
Registration Rights Agreement dated October 18, 2004 among Monarch Pointe Fund, Ltd, Mercator Advisory Group, LLC and Medical Discoveries, Inc.+ | |
4.4
|
Registration Rights Agreement dated December 3, 2004 among Mercator Momentum Fund, LP, Mercator Momentum Fund III, LP, Mercator Advisory Group, LLC and Medical Discoveries, Inc.+ | |
5.1
|
Opinion of Epstein Becker & Green, P.C.* | |
10.1
|
2002 Stock Incentive Plan adopted by the Board of Directors as of July 11, 2002 (filed as Exhibit 10.5 to the Companys Quarterly Report on Form 10-QSB for the quarter ended June 30, 2002, and incorporated herein by reference). | |
10.2
|
Subscription Agreement dated October 18, 2004 among Monarch Pointe Fund, Ltd., Mercator Advisory Group, LLC, and Medical Discoveries, Inc.+ | |
10.3
|
Subscription Agreement dated December 3, 2004 among Mercator Momentum Fund, LP, Mercator Momentum Fund III, LP, Mercator Advisory Group, LLC, and Medical Discoveries, Inc.+ | |
10.4
|
Employment Agreement dated March 1, 2005 between Medical Discoveries, Inc. and Judy M. Robinett.+ | |
21
|
Subsidiaries+ | |
23.1
|
Consent of Hansen, Barnett & Maxwell* | |
23.2
|
Consent Eide Bailly LLP* | |
23.3
|
Consent of Tanner LC* | |
23.4
|
Consent of Epstein Becker & Green, P.C.++ |
* | Filed herewith | |
+ | Previously filed | |
++ | Included in Item 5.1 |
II-7