As filed with the Securities and Exchange Commission on December 16, 2013
Registration No. [______]
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM S-1
REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933
GENSPERA, INC.
(Exact name of registrant as specified in its charter)
Delaware | 2834 | 20-0438951 | ||
(State or jurisdiction of incorporation or organization) |
(Primary Standard Industrial Classification Code Number) |
(I.R.S. Employer Identification No.) |
2511 N Loop 1604 W, Suite 204
San Antonio, TX 78258
(210) 479-8112
FAX (210) 479-8113
(Address, including zip code, and telephone number,
including area code, of registrant’s principal executive offices)
Agent for Service:
National Corporate Research
800 Brazos St., Suite 400
Austin, TX 78701
800-345-4647
(Name, address, including zip code, and telephone number,
including area code, of agent for service)
Copy to:
Raul Silvestre
Silvestre Law Group, P.C.
31200 Via Colinas, Suite 200
Westlake Village, CA 91362
(818) 597-7552
Fax (818) 597-7551
Approximate date of commencement of proposed sale to the public: From time to time after this registration statement becomes effective.
If any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933 check the following box. x
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. ¨
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. ¨
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. ¨
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer | ¨ | Accelerated filer | ¨ | |||
Non-accelerated filer | ¨ (Do not check if smaller reporting company) | Smaller reporting company | x |
CALCULATION OF REGISTRATION FEE
Amount | Proposed | Proposed | Amount | |||||||||||||
Title of Each Class of | to be | Offering Price | Aggregate | of | ||||||||||||
Securities to be Registered | Registered (1) | Per Share | Offering Price | Registration Fee (3) | ||||||||||||
Common Stock Underlying $2.03 Warrants | 50,000 | $ | 2.03 | (2) | $ | 101,500 | $ | 13.84 | ||||||||
Total | 50,000 | $ | 101,500 | $ | 13.84 |
(1) | Pursuant to SEC Rule 416, also covers additional common shares that may be offered to prevent dilution as a result of stock splits or stock dividends. |
(2) | Fee based on exercise price applicable to shares issuable upon exercise of warrants in accordance with Rule 457(g). |
(3) | Fee previously paid with regard to 5,509,874 common shares previously registered on registration statement no. 333-175248, filed by the registrant on Form S-1 and declared effective on November 14, 2012 |
THE REGISTRANT HEREBY AMENDS THIS REGISTRATION STATEMENT ON SUCH DATE OR DATES AS MAY BE NECESSARY TO DELAY ITS EFFECTIVE DATE UNTIL THE REGISTRANT SHALL FILE A FURTHER AMENDMENT WHICH SPECIFICALLY STATES THAT THIS REGISTRATION STATEMENT SHALL THEREAFTER BECOME EFFECTIVE IN ACCORDANCE WITH SECTION 8(a) OF THE SECURITIES ACT OF 1933, AS AMENDED, OR UNTIL THE REGISTRATION STATEMENT SHALL BECOME EFFECTIVE ON SUCH DATE AS THE COMMISSION, ACTING PURSUANT TO SUCH SECTION 8(a), MAY DETERMINE.
Explanatory Note
Pursuant to Rule 429 under the Securities Act of 1933, the prospectus included in this registration statement is a combined prospectus relating to:
(i) the resale of 50,000 common shares underlying warrants being initially registered herein;
(ii) the resale of 5,509,874 common shares previously registered on registration statement no. 333-175248, filed by the registrant on Form S-1 and declared effective on November 14, 2012.
This registration statement, which is a new registration statement, also constitutes post-effective amendment no. 5 to the above referenced registration statements, and such post-effective amendment shall hereafter become effective concurrently with the effectiveness of this registration statement and in accordance with Section 8(c) of the Securities Act of 1933.
SUBJECT TO COMPLETION, DATED DECEMBER 16, 2013
The information in this preliminary prospectus is not complete and may be changed. These securities may not be sold until the registration statement filed with the Securities and Exchange Commission is effective. This preliminary prospectus is not an offer to sell nor does it seek an offer to buy these securities in any jurisdiction where the offer or sale is not permitted.
PROSPECTUS
GenSpera, Inc.
5,559,874 Shares
Common Stock
This prospectus relates to the resale of 5,559,874 shares of our common stock, by the selling stockholders identified in the selling stockholders tables beginning on page 13 of this prospectus (“Selling Stockholders”). We will not receive any proceeds from the sale of these shares by the Selling Stockholders.
The prices at which the Selling Stockholders may sell their shares will be determined by the prevailing market price for the shares or in privately negotiated transactions or in any other manner as described in the “ Plan of Distribution ” section of this prospectus. Information regarding the Selling Stockholders is provided under the “ Selling Stockholders ” section of this prospectus.
Our common stock is quoted on the OTCQB tier of the OTC Markets Group Inc., under the symbol “GNSZ”. On December 9, 2013, the closing price of our common stock was $1.28 per share. You are urged to obtain current market quotations of our common stock before purchasing any of the shares being offered for sale pursuant to this prospectus.
Our principal executive offices are located at 2511 N Loop 1604 W, Suite 204, San Antonio, Texas, 78258, telephone number 210-479-8112.
Investing in our common stock is highly speculative and involves a high degree of risk. You should consider carefully the risks and uncertainties in the section entitled “Risk Factors” beginning on page 2 of this prospectus before investing in our common stock.
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.
The date of this Prospectus is __________, 2013.
TABLE OF CONTENTS
Page | |
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS | 1 |
RISK FACTORS | 2 |
USE OF PROCEEDS | 15 |
DETERMINATION OF OFFERING PRICE | 16 |
SELLING STOCKHOLDERS | 16 |
PLAN OF DISTRIBUTION | 29 |
DESCRIPTION OF SECURITIES | 30 |
DESCRIPTION OF BUSINESS | 33 |
DESCRIPTION OF PROPERTY | 40 |
LEGAL PROCEEDINGS | 40 |
MARKET FOR COMMON EQUITY & RELATED STOCKHOLDER MATTERS | 41 |
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS | 41 |
MANAGEMENT | 47 |
CORPORATE GOVERNANCE | 48 |
EXECUTIVE COMPENSATION | 51 |
DIRECTOR COMPENSATION | 57 |
CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS | 57 |
PRINCIPAL STOCKHOLDERS | 60 |
INDEMNIFICATION OF DIRECTORS AND OFFICERS | 61 |
EXPERTS | 61 |
INTERESTS OF NAMED EXPERTS AND COUNSEL | 62 |
WHERE YOU CAN FIND MORE INFORMATION | 62 |
FINANCIAL STATEMENTS | F-1 |
Please read this prospectus carefully. It describes our business, our financial condition and our results of operations. We have prepared this prospectus so that you will have the information necessary to make an informed investment decision.
You may rely only on the information contained in this prospectus. We have not, and the underwriters have not, authorized anyone to provide information or to make representations not contained in this prospectus. This prospectus is neither an offer to sell, nor a solicitation of an offer to buy, these securities in any jurisdiction where an offer or solicitation would be unlawful. Neither the delivery of this prospectus, nor any sale made under this prospectus, means that the information contained in this prospectus is correct as of any time after the date of this prospectus. This prospectus may be used only where it is legal to offer and sell these securities.
USE OF MARKET AND INDUSTRY DATA
This prospectus includes market and industry data that has been obtained from third party sources, including industry publications, as well as industry data prepared by our management on the basis of its knowledge of and experience in the industries in which we operate (including our management’s estimates and assumptions relating to such industries based on that knowledge). Management’s knowledge of such industries has been developed through its experience and participation in these industries. While our management believes the third party sources referred to in this prospectus are reliable, neither we nor our management have independently verified any of the data from such sources referred to in this prospectus or ascertained the underlying economic assumptions relied upon by such sources. Internally prepared and third party market forecasts, in particular, are estimates only and may be inaccurate, especially over long periods of time. In addition, the underwriters have not independently verified any of the industry data prepared by management or ascertained the underlying estimates and assumptions relied upon by management. Furthermore, references in this prospectus to any publications, reports, surveys or articles prepared by third parties should not be construed as depicting the complete findings of the entire publication, report, survey or article. The information in any such publication, report, survey or article is not incorporated by reference in this prospectus.
ADVISEMENT
We urge you to read this entire prospectus carefully, including the” Risk Factors” section and the financial statements and related notes included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2012, filed with the Securities and Exchange Commission (“SEC”) as well as our Quarterly Reports on Form 10-Q for the nine months ended September 30, 2013, and all subsequent reports we file with the SEC. As used in this prospectus, unless the context otherwise requires, the words “we,” “us,” “our,” “the Company,” “GenSpera” and “Registrant” refer to GenSpera, Inc. Also, any reference to “common stock” or “common shares” refers to our $0.0001 par value common stock. The information contained herein is current as of the date of this prospectus, unless another date is specified.
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
This prospectus includes “forward-looking” statements within the meaning of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act. These statements relate to our business development plans, clinical trials, regulatory reviews, timing, strategies, expectations, anticipated expenses levels, business prospects and positioning with respect to the market, business outlook, technology spending and various other matters (including contingent liabilities and obligations and changes in accounting policies, standards and interpretations) and express our current intentions, beliefs, expectations, strategies or predictions, as well as historical information. Such forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements, or industry results, to be materially different from anticipated results, performance or achievements expressed or implied by such forward-looking statements. When used in this prospectus, statements that are not statements of current or historical fact may be deemed to be forward-looking statements. Without limiting the foregoing, the words “plan,” “intend,” “may,” “will,” “expect,” “believe,” “could,” “anticipate,” “estimate,” or “continue” or similar expressions or other variations or comparable terminology are intended to identify such forward-looking statements. Although we believe that the assumptions on which the forward-looking statements contained herein are based are reasonable, any of those assumptions could prove to be inaccurate given the inherent uncertainties as to the occurrence or nonoccurrence of future events. These statements are not guarantees of future performance and involve risks and uncertainties that are difficult to predict. Our future operating results are dependent upon many factors, and our further development is highly dependent on market acceptance, which is outside its control. You should not place undue reliance on forward-looking statements. Forward-looking statements may not be realized due to a variety of factors, including, without limitation:
· | our ability to manage the business despite continuing operating losses and cash outflows; |
· | our ability to obtain sufficient capital or a strategic business arrangement to fund our operations and expansion plans; |
· | our ability to build the management and human resources and infrastructure necessary to support the growth of our business; |
· | competitive factors and developments beyond our control; |
· | scientific and medical developments beyond our control; |
· | government regulation of our business; |
· | whether any of our current or future patent applications result in issued patents and our ability to obtain and maintain other rights to technology required or desirable for the conduct of our business; |
· | whether any potential strategic benefits of licensing transactions will be realized and whether any potential benefits from the acquisition of newly licensed technologies, if any, will be realized; and |
· | the other factors discussed in the “Risk Factors” section and elsewhere in this prospectus. |
All forward-looking statements attributable to us are expressly qualified in their entirety by these and other factors. In addition to the foregoing, other factors may influence our future performance including those factors discussed in the “Risk Factors” section included in our 2012 Annual Report on Form 10-K as well as those discussed in our Quarterly Reports on Form 10-Q under the heading “Risk Factors”. All forward-looking statements attributable to us are expressly qualified in their entirety by these and other factors. We undertake no obligation to update or revise these forward-looking statements, whether to reflect events or circumstances after the date initially filed, to reflect the occurrence of unanticipated events or otherwise, except to the extent required by federal securities laws. The risks discussed in this report should be considered in evaluating our business and future financial performance.
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RISK FACTORS
Investing in our common stock involves a high degree of risk. You should carefully consider the following risk factors and all other information contained in this prospectus in evaluating our common stock. If any of the following events were to occur, our business, financial condition or results of operations could be materially and adversely affected. In these circumstances, the market price of our common stock could decline, and you could lose your entire investment.
Risks Related to our Financial Position and Need to Raise Additional Capital
We may not be able to continue as a going concern if we do not obtain additional financing by December 2014.
Our cash and cash equivalents balance at September 30, 2013 was $4.9 million. Based on our current expected level of operating expenditures, we expect to be able to fund our operations for the next twelve to fifteen months. Our ability to continue as a going concern is wholly dependent upon obtaining sufficient financing to fund our operations. We have no committed sources of additional capital and our access to capital funding is always uncertain. Accordingly, despite our ability to secure capital in the past, there is no assurance that additional equity or debt financing will be available to us when needed, on acceptable terms or even at all. In the event that we are not able to secure financing, we may be forced to curtail operations, delay or stop ongoing clinical trials, or cease operations altogether or file for bankruptcy. Any such change may materially harm our business, financial condition, and operations.
Our auditors have expressed substantial doubt about our ability to continue as a going concern.
Our auditors’ report on our December 31, 2012 financial statements expressed an opinion that our Company’s capital resources as of the date of their Audit Report are not sufficient to sustain operations or complete our planned activities for the upcoming year unless we raise additional funds. These conditions raise substantial doubt about our ability to continue as a going concern. If we do not obtain additional funds there is the distinct possibility that we will no longer be a going concern and will cease operation which means that our shareholders will lose their entire investment in our Company.
Risks Relating to Our Stage of Development and Business
We are an early development stage company, have no product revenues, are not profitable and may never be profitable.
Since inception through September 30, 2013, we have raised approximately $24.3 million through the sale of our securities. During this same period, we have recorded accumulated deficit totaling approximately $30.3 million. Our net losses for the two most recent fiscal years ended December 31, 2012 and 2011 were $6.9 million and $5.7 million, respectively. None of our products in development have received approval from the FDA or other regulatory authorities; we have no sales and have never generated product revenues nor expect to for years, if at all. Currently, our only product candidate in development is G-202 which is being tested in a Phase II clinical trial. We expect to incur significant operating losses for the foreseeable future as we continue research and clinical development of our product candidates. Accordingly, we need additional capital to fund our continuing operations. Since we do not generate any revenue, the most likely sources of such additional capital include the sale of our securities or funds from a potential strategic licensing or collaboration transaction involving the rights to one or more of our product candidates, or from grants. To the extent that we raise additional capital by issuing equity securities, our stockholders are likely to experience dilution, which may be significant. If we raise additional funds through collaborations and licensing arrangements, it may be necessary to relinquish some rights to our technologies, product candidates or products, or grant licenses on terms that are not favorable to us. If we raise additional funds by incurring debt, we could incur significant interest expense and become subject to covenants in the related transaction documentation that could affect the manner in which we conduct our business.
All of our product candidates are in an early stage of development and we may never succeed in developing and/or commercializing them. If we are unable to commercialize G-202 or any of our other product candidates, or if we experience significant delays in doing so, our business may fail.
Our product candidates are in various stages of early development and significant financial resources are required to develop commercially viable products and obtain regulatory approval. We have invested a significant portion of our efforts and financial resources in the development of G-202 and depend heavily on its success. We will need to devote significant additional research and development efforts, financial resources and personnel to develop commercially viable products and obtain regulatory approvals. We may encounter hurdles and unexpected issues as we proceed in the development of G-202 and our other product candidates. Although initial data from the trials appear promising, the outcome of the trials is uncertain and these trials or future trials may ultimately be unsuccessful. There are many reasons that we may not succeed in our efforts to develop our product candidates, including the possibility that:
· | we may be unable to enroll sufficient subjects to complete our clinical studies in a timely manner; |
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· | unexpected safety issues may occur and additional studies or analyses may be required to characterize and understand those issues, or our studies may be terminated by the institutional review boards or the FDA; |
· | our product candidates may be deemed ineffective, unsafe or will not receive regulatory approvals; |
· | our product candidates may be too expensive to manufacture or market or will not achieve broad market acceptance; |
· | others may claim proprietary rights that may prevent us from marketing our product candidates; or |
· | our competitors may market products that are perceived as equivalent or superior. |
If we fail to develop and commercialize our product candidates, our business would be materially harmed and could fail.
We have only two full-time employees and a limited operating history and may not be able to effectively operate our business.
Our limited staff and operating history means that there is a high degree of uncertainty in our ability to:
· | develop and commercialize our technologies and proposed products; |
· | obtain regulatory approval to commence marketing our products; |
· | identify, hire and retain any needed additional management or scientific personnel to develop and implement our product development plans and conduct pre-clinical and clinical testing; |
· | manage potential rapid growth with our current limited managerial, operational and financial resources; |
· | achieve market acceptance or insurance reimbursement for any of our proposed products, if successfully developed; |
· | respond to competition; or |
· | operate the business, as management has not previously undertaken such actions as a company. |
No assurances can be given as to exactly when, if at all, we would be able to fully develop, and take the necessary steps to derive any revenues from our proposed products candidates.
Raising capital may be difficult as a result of our history of losses and limited operating history.
When making investment decisions, investors typically look at a company’s earnings and historical performance in evaluating the risks and operations of the business and the business’s future prospects. Our history of losses and limited operating history makes such evaluation, as well as any estimation of our future performance, substantially more difficult. As a result, investors may be unwilling to invest in us or on terms or conditions which are acceptable. If we are unable to secure additional financing, we may need to materially scale back our business plan and/or operations or cease operations altogether.
Risks Related to Commercialization
The market for our proposed products is rapidly changing and competitive, and new drugs and new treatments, which may be developed by others, could impair our ability to maintain and grow our business and remain competitive.
The pharmaceutical and biotechnology industries are subject to rapid and substantial technological change. Developments by others may render our proposed products noncompetitive or obsolete, or we may be unable to keep pace with technological developments and other market factors. Technological competition from pharmaceutical and biotechnology companies, universities, governmental entities and others diversifying into the field is intense and is expected to increase.
As a pre-revenue development stage company, our resources are limited and we may experience technical challenges inherent in the early development of novel therapeutics. Competitors have developed or are in the process of developing technologies that are, or in the future may be, the basis for competition. Some of these technologies may have an entirely different approach or means of accomplishing similar therapeutic efforts compared to our proposed products. Our competitors may develop drugs that are safer, more effective and less costly than our proposed products and, therefore, present a serious competitive threat to us.
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The potential widespread acceptance of therapies that are alternatives to ours may limit market acceptance of our proposed products, even if commercialized. Many of our targeted diseases and conditions can also be treated by other medications and treatments. These treatments may be widely accepted in medical communities and have a longer history of use. The established use of other competing drugs may limit the potential for our proposed products, even if commercialized.
Our proposed products may not be accepted by the health care community.
Our proposed products, if approved for marketing, may not achieve market acceptance since hospitals, physicians, patients or the medical community in general may decide not to utilize them. We are attempting to develop products that are likely to be first approved for marketing as a treatment for late stage cancer where there is no truly effective standard of care. If approved for use in late stage cancer, our proposed products might then be evaluated in earlier stages where they could represent a substantial departure from established treatment methods and would most likely compete with a number of more conventional drugs and therapies manufactured and marketed by major pharmaceutical companies. It is too early in the development cycle of our proposed products for us to accurately predict our major competitors.
The degree of market acceptance of any of our products, if developed, will depend on a number of factors, including but not limited to:
· | our ability to demonstrate the clinical efficacy and safety of our proposed products to the medical community; |
· | our ability to create products that are superior to alternatives currently on the market; |
· | our ability to establish in the medical community the potential advantage of our treatments over alternative treatment methods; and |
· | the reimbursement policies of government and third-party payors. |
There can be no assurance that such reimbursement would be available at all or without substantial delay, or if such reimbursement is provided, that the approved reimbursement amounts would be sufficient to support demand for our proposed products at a level that would be profitable. If the health care community does not accept our products, our business could be materially harmed.
Our competitors in the biotechnology and pharmaceutical industries have significantly greater operating histories and financial resources than we have.
We compete against numerous companies, many of which have substantially greater financial and other resources than we have. Several such competitors have research programs and/or efforts to treat the same diseases we target. Companies such as Merck & Co., Inc., Ipsen, Johnson & Johnson, and Sanofi S.A., as well as others, have substantially greater financial and other resources, larger research and development staffs and more effective marketing and manufacturing operations than we have and are better situated to compete with us. As a result, our competitors may bring competing products to market that would result in a decrease in demand for our product, if developed, which could have a materially adverse effect on the viability of the company.
Risks Related to Manufacturing Our Product Candidates
We intend to rely exclusively upon third-party FDA-regulated manufacturers and suppliers for our proposed products.
We currently have no internal manufacturing capability, and intend to rely exclusively on FDA-approved licensees, strategic partners or third party contract manufacturers or suppliers for the foreseeable future. Because manufacturing facilities are subject to regulatory oversight and inspection, the failure of any of our third-party FDA regulated manufactures or suppliers to comply with regulatory requirements could result in material manufacturing delays and product shortages, which could delay or otherwise negatively impact our clinical trials and product development. Should we be forced to manufacture our proposed products, we cannot give any assurance that we would be able to develop internal manufacturing capabilities or procure third party suppliers for raw materials. In the event we seek third party suppliers or alternative manufacturers, they may require us to purchase a minimum amount of materials or could require other unfavorable terms. Any such event would materially impact our business prospects and could delay the development of our proposed products. Moreover, we cannot give any assurance that any contract manufacturers or suppliers that we select would be able to supply our products in a timely or cost effective manner or in accordance with applicable regulatory requirements or our specifications.
We may not be able to establish or maintain the third-party relationships that are necessary to develop or potentially commercialize some or all of our product candidates.
Our business plan relies heavily on third party collaborators, partners, licensees, clinical research organizations or other third parties to support our discovery efforts, and to conduct clinical trials for all or some of our product candidates. We cannot guarantee that we are able to successfully negotiate agreements for or maintain relationships with collaborators, partners, licensees, clinical investigators, vendors or other third parties on a commercially reasonable basis, if at all. Additionally, to commercialize our proposed products, we intend to rely on third party licensees or the outright sale of our proposed products to a major pharmaceutical partner. Our ability to successfully negotiate such agreements depends on, among other things, potential partners’ evaluation of our technology over competing technologies and the quality of the pre-clinical and clinical data that we have generated, and the perceived risks specific to generating our product candidates. If we fail to establish such third-party relationships as anticipated, we could experience delays in the commercialization of our products.
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Our business is dependent upon securing and importing sufficient quantities of seeds from the plant, Thapsia garganica, which currently grows in very specific locations outside of the United States.
The therapeutic component of our products, including our lead compound G-202, is referred to as 12ADT. 12ADT is derived from a material called thapsigargin. Thapsigargin is derived from the seeds of a plant referred to as Thapsia garganica, which grows along the coastal regions of the Mediterranean Sea. We currently secure the seeds from Thapsibiza, SL, a third-party supplier. There can be no assurances that Thapsia garganica would continue to grow in sufficient quantities to produce an adequate supply of seeds for the production of sufficient quantities of thapsigargin, or that the countries from which we can secure Thapsia garganica continue to allow Thapsibiza, SL, to collect such seeds and/or export the seeds derived from Thapsia garganica to the United States. The process of importing Thapsia garganica seeds is subject to U.S. import and export laws and controls. Our supply agreement with Thapsibiza, SL (our sole supplier) expires on April 6, 2017. The agreement also provides that either party may extend the agreement for an additional 5 years by providing the other party 30 days’ written notice prior to its expiration. In the event we are no longer able to obtain these seeds in the future, we may not be able to produce our proposed drug and our business could be adversely affected.
We may be required to locate, secure and finance land for cultivation and harvesting of Thapsia garganica to satisfy our needs for clinical development of our therapies.
We believe that we can satisfy our needs for the clinical development of G-202, through completion of Phase III clinical studies, from Thapsia garganica that grows naturally in the wild. In the event G-202 is approved for commercial marketing, our current supply of Thapsia garganica may not be sufficient for the anticipated demand. In order to secure sufficient quantities of Thapsia garganica for the commercialization of a product comprising G-202, we would need to secure adequate acreage of land to cultivate and grow Thapsia garganica. We have not yet fully assessed the amount of land or other costs that would be associated with a full-scale farming operation. There can be no assurances that we would be able to secure adequate acres of land, or that even if we are able to do so, that we could grow sufficient quantities of Thapsia garganica to satisfy any commercial objectives that involve G-202. Our inability to secure adequate seeds will result in us not being able to develop and manufacture our proposed drug candidates and could adversely impact our business. Additionally, due to the toxic nature of the plant, our harvesting of Thapsia garganica could be subject to various environmental and/or zoning laws, the violation of which could materially impact our product development.
The synthesis of 12ADT must be conducted in special facilities.
We are required to manufacture the 12ADT that is to be used in our clinical trials in FDA approved facilities. There are a limited number of manufacturing facilities qualified to handle and manufacture toxic therapeutic agents and compounds. This limits the potential number of possible manufacturing sites for our therapeutic compounds derived from Thapsia garganica. No assurances can be provided that these facilities would be available for the manufacture of our therapeutic compounds under our time schedules or within the parameters of our manufacturing budget. In the event facilities are not available for the manufacturing of our therapeutic compounds, we may not be able to complete our clinical trials and our business and future prospects would be adversely affected.
Our current manufacturing process requires acetonitrile, which in the past has been in short supply.
The current manufacturing process for our compounds requires the common solvent acetonitrile. From late 2008 through 2009 there was a worldwide shortage of acetonitrile for a variety of reasons. We observed during that time that the available supply of acetonitrile was of variable quality, some of which was not suitable for our purposes. If we are unable to successfully change our manufacturing methods to avoid the reliance upon acetonitrile, we may incur longer production timelines and increased production costs in the future if such shortage reoccurs, which would harm our financial results. In an extreme case this situation could adversely affect our ability to manufacture our compounds altogether, thus adversely impacting our future operations.
Our therapeutic compounds have not been subjected to large scale manufacturing procedures and may not be able to be manufactured profitably on a large enough scale to support late stage clinical trials or commercialization.
To date, our proposed products have only been manufactured at a scale which is adequate to supply our research activities and early stage clinical trials. There can be no assurance that the current procedures used to manufacture our proposed products would work at a scale which is adequate for commercial needs. In the event our therapeutic compounds cannot be manufactured in sufficient commercial quantities, our future prospects could be significantly impacted and our financial prospects would be materially harmed.
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Risks Relating to our Intellectual Property
Our competitive position is dependent on our intellectual property and we may not be able to withstand challenges to our intellectual property rights.
We rely on our intellectual property, including our issued and applied for U.S. and foreign patents as well as our licenses, as the foundation of our business. If our intellectual property rights are challenged, no assurances can be given that our patents or licenses would survive claims alleging invalidity or infringement on other patents and/or licenses. In addition, disputes may arise regarding inventorship of our intellectual property. It is possible that our products may be infringing upon existing patents that we are currently unaware of. As the number of participants in the market place grows, the possibility of patent infringement claims against us increases. It is difficult, if not impossible, to determine how such disputes would be resolved. Furthermore, because of the substantial amount of discovery required in connection with patent litigation, there is a risk that some of our confidential information could be required to be publicly disclosed. In addition, during the course of patent litigation, there could be public announcements of the results of hearings, motions or other interim proceedings or developments in the litigation. Any litigation claims against us may cause us to incur substantial costs and could place a significant strain upon our financial resources, divert the attention of management or restrict our core business or result in the public disclosure of confidential information. The occurrence of any of the foregoing could materially impact our business.
We are the subject of litigation related to our intellectual property.
We instituted a declaratory judgment action in the United States District Court of Maryland on March 12, 2012. We, as the licensee, are seeking a declaratory judgment that the current named inventors on U.S. Patent Nos. 7,468,354 and 7,767,648 are the only inventors of the underlying inventions. On November 1, 2012, the defendant in the case filed a complaint in the State Circuit Court for Baltimore County, Maryland, naming GenSpera as a defendant along with Dr. Samuel Denmeade and Dr. John Isaacs (the named inventors on the ‘354 patent and the ‘648 patent). The complaint, alleges certain common-law torts by conspiring to exclude her wrongly from inventorship on a valid patent. The outcome of the above mentioned litigation could materially and adversely affect our business. However, because this litigation is in its early stages, and due to the inherent uncertainty surrounding the litigation process, we are unable to reasonably estimate the ultimate outcome or the impact of such outcome at this time. See the section of this prospectus entitled “Legal Proceedings”.
We may incur substantial costs as a result of litigation or other proceedings relating to patent and other intellectual property rights and we may be unable to protect our rights to, or use of, our technology.
Some or all of our patent applications may not issue as patents, or the claims of any issued patents may not afford meaningful protection for our technologies or products. In addition, patents issued to us or our licensors, if any, may be challenged and subsequently narrowed, invalidated or circumvented. Patent litigation is widespread in the biotechnology industry and could harm our business. Litigation might be necessary to protect our patent position or to determine the scope and validity of third-party proprietary rights. If we choose to go to court to stop someone else from using the inventions claimed in our patents, that individual or company would have the right to ask the court to rule that such patents are invalid and/or should not be enforced against that third party. These lawsuits are expensive and we may not have the required resources to pursue such litigation or to protect our patent rights. In addition, there is a risk that the court might decide that these patents are not valid and that we do not have the right to stop the other party from using the inventions. There is also the risk that, even if the validity of these patents is upheld, the court refuses to stop the other party on the ground that such other party’s activities do not infringe our rights in these patents.
Furthermore, a third party may claim that we are using inventions covered by the third party’s patent rights and may go to court to stop us from engaging in our normal operations and activities, including making or selling our product candidates. These lawsuits are costly and could affect our results of operations and divert the attention of managerial and technical personnel. There is a risk that a court would decide that we are infringing the third party’s patents and would order us to stop the activities covered by the patents. In addition, there is a risk that a court would order us to pay the other party treble damages for having violated the other party’s patents. The biotechnology industry has produced a proliferation of patents, and it is not always clear to industry participants, including us, which patents cover various types of products or methods of use. The coverage of patents is subject to interpretation by the courts, and the interpretation is not always uniform.
If we are sued for patent infringement, we would need to demonstrate that our products or methods of use either do not infringe the claims of the relevant patent and/or that the patent claims are invalid, and we may not be able to do this. Proving invalidity in the United Sates, in particular, is difficult since it requires a showing of clear and convincing evidence to overcome the presumption of validity enjoyed by issued patents.
Because some patent applications in the United States may be maintained in secrecy until the patents are issued, patent applications in the United States and many foreign jurisdictions are typically not published until eighteen months after filing, and publications in the scientific literature often lag behind actual discoveries, we cannot be certain that others have not filed patent applications for technology covered by our issued patents or our pending applications or that we were the first to invent the technology. Our competitors may have filed, and may in the future file, patent applications covering technology similar to ours. Any such patent application may have priority over our patent applications and could further require us to obtain rights to issued patents covering such technologies.
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If another party has filed a United States patent application on inventions similar to ours, we may have to participate in an interference or other proceeding in the U.S. Patent and Trademark Office, or the PTO, or a court to determine priority of invention in the United States. The costs of these proceedings could be substantial, and it is possible that such efforts would be unsuccessful, resulting in a loss of our United States patent position with respect to such inventions.
Some of our competitors may be able to sustain the costs of complex patent litigation more effectively than we can because they have substantially greater resources. In addition, any uncertainties resulting from the initiation and continuation of any litigation could have a material adverse effect on our ability to raise the funds necessary to continue our operations.
Obtaining and maintaining our patent protection depends upon compliance with various procedural, documentary, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
The PTO and various foreign governmental patent agencies require compliance with a number of procedural, documentary, fee payment and other provisions during the patent process. There are situations in which noncompliance can result in abandonment or lapse of a patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction. In such an event, competitors might be able to enter the market earlier than would otherwise have been the case.
Our failure to secure trademark registration could adversely affect our ability to market our product candidates and our business.
Our trademark applications in the United States, when filed, and any other jurisdictions where we may file, may not be allowed for registration, and our registered trademarks may not be maintained or enforced. During trademark registration proceedings, we may receive rejections. Although we are given an opportunity to respond to those rejections, we may be unable to overcome such rejections. In addition, in the PTO and in comparable agencies in many foreign jurisdictions, third parties are given an opportunity to oppose pending trademark applications and to seek to cancel registered trademarks. Opposition or cancellation proceedings may be filed against our applications and/or registrations, and our applications and/or registrations may not survive such proceedings. Failure to secure such trademark registrations in the United States and in foreign jurisdictions could adversely affect our ability to market our product candidates and our business.
Confidentiality agreements with employees and others may not adequately prevent disclosure of our trade secrets and other proprietary information and may not adequately protect our intellectual property, which could impede our ability to compete.
We rely in part on trade secret protection in order to protect our proprietary trade secrets and unpatented know-how. However, trade secrets are difficult to protect, and we cannot be certain that others do not develop the same or similar technologies on their own. We have taken steps, including entering into confidentiality agreements with our employees, consultants, service providers, and potential strategic partners to protect our trade secrets and unpatented know-how. These agreements generally require that the other party keep confidential and not disclose to third parties all confidential information developed by the party or made known to the party by us during the course of the party’s relationship with us. We also typically obtain agreements from these parties which provide that inventions conceived by the party in the course of rendering services to us are our property. However, these agreements may not be honored and may not effectively assign intellectual property rights to us. Enforcing a claim that a party illegally obtained and is using our trade secrets or know-how is difficult, expensive and time consuming, and the outcome is unpredictable. In addition, courts outside the United States may be less willing to protect trade secrets or know-how. The failure to obtain or maintain trade secret protection could adversely affect our competitive position.
We may be subject to claims that our employees or consultants have wrongfully used or disclosed alleged trade secrets of their former employers.
As is common in the biotechnology and pharmaceutical industry, we employ and hire individuals and/or entities who were previously employed at other biotechnology or pharmaceutical companies, including our competitors or potential competitors. Although no claims against us are currently pending, we may be subject to claims that these individuals, entities or us have inadvertently or otherwise used or disclosed trade secrets or other proprietary information of their former employers. Litigation may be necessary to defend against these claims. Even if we are successful in defending against these claims, litigation could result in substantial costs and be a distraction to management.
We may not be able to adequately protect our intellectual property.
Considerable research with regard to our technologies has been performed in countries outside of the United States. The laws in some of those countries may not provide protection for our trade secrets and intellectual property. If our trade secrets or intellectual property are misappropriated in those countries, we may be without adequate remedies to address the issue. Additionally, we also rely on confidentiality and assignment of invention agreements to protect our intellectual property. These agreements provide for contractual remedies in the event of misappropriation. We do not know to what extent, if any, these agreements and any remedies for their breach would be enforced by a foreign or domestic court. In the event our intellectual property is misappropriated or infringed upon and an adequate remedy is not available, our future prospects would greatly diminish.
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Additionally, prosecuting and maintaining intellectual property (particularly patent) rights are very costly endeavors. We do not know whether legal and government fees would increase substantially and therefore are unable to predict whether cost may factor into our intellectual property strategy.
Risks Relating to Marketing Approval and Government Regulations
Thapsia garganica and thapsigargin are highly toxic and we may be liable for any contamination or injury we may cause or any environmental and safety law we may violate.
The therapeutic component of our products, including our lead product G-202, is derived from the natural product, thapsigargin, which is isolated from the seeds of the plant Thapsia garganica. Both thapsigargin, as well as seeds of Thapsia garganica, are highly toxic. As a consequence, we are subject to numerous environmental and safety laws and regulations, including those governing laboratory procedures and the handling of toxic materials. We may be required to incur significant costs to comply with current or future environmental laws and regulations and may be adversely affected by the cost of compliance with these laws and regulations. Although we believe that our safety procedures for using, handling, storing and disposing of hazardous materials comply with the standards prescribed by state and federal regulations, the risk of accidental contamination or injury from these materials cannot be eliminated. In the event of such an accident, state or federal authorities could curtail our use of these materials and we could be liable for any civil damages that result, the cost of which could be substantial. Further, any failure by us to control the use, disposal, removal or storage, or to adequately restrict the discharge, or assist in the clean-up of toxic substances could subject us to significant liabilities, including joint and several liabilities under certain statutes. Although we feel this risk may be minimized through our use of third parties, it is possible that the employees of such contractors could suffer medical issues related to the handling of these toxic agents and subsequently seek compensation from us via, for example, litigation. Any such liability could exceed our resources and could have a material adverse effect on our business, financial condition and results of operations. No assurances can be given, despite our contractual relationship with the third-party contractor, that we would not be the subject of litigation related to the handling of Thapsia garganica and the natural product thapsigargin. Additional federal, state and local laws and regulations affecting us may be adopted in the future. We may incur substantial costs to comply with these laws and regulations and substantial fines or penalties if we violate any of these laws or regulations, which would adversely affect our business.
We are dependent upon third parties to develop our product candidates, and such parties are, to some extent, outside of our control.
We depend upon independent contract research organizations, investigators and collaborators, such as universities and medical institutions, to conduct our pre-clinical and clinical trials under agreements with us. These individuals and/or entities are not our employees and we cannot control the amount or timing of resources that they devote to our programs. These third parties may not assign as great a priority to our programs or pursue them as diligently as we would if we were undertaking such programs ourselves. If these third parties fail to devote sufficient time and resources to our programs, or if their performance is substandard, the development of our drug candidates and corresponding FDA approval could be delayed or fail entirely.
Data obtained from clinical trials are susceptible to varying interpretations and may not be sufficient to support approval by the FDA, which could delay, limit or prevent regulatory clearances.
The design of our clinical trials is based on many assumptions about the expected effect of our product candidate and if those assumptions are incorrect, the clinical trials may not produce statistically significant results. Preliminary results may not be confirmed on full analysis of the detailed results of early clinical trials. Data already obtained, or in the future obtained, from pre-clinical studies and clinical trials do not necessarily predict the results that may be obtained from later pre-clinical studies and clinical trials. Moreover, pre-clinical and clinical data are susceptible to varying interpretations, which could delay, limit or prevent regulatory approval. A number of companies in the pharmaceutical industry have suffered significant setbacks in advanced clinical trials, even after promising results in earlier trials. The failure to adequately demonstrate the safety and effectiveness of a proposed formulation or product under development could delay or prevent regulatory clearance of the potential drug. Our products may not prove to be safe and effective in clinical trials and may not meet all regulatory requirements needed to receive regulatory approval. The resulting delays to commercialization could materially harm our business. Our clinical trials may not demonstrate sufficient levels of safety and efficacy necessary to obtain the requisite regulatory approvals for our drugs, and thus our proposed drugs may not be approved for marketing.
Changes in regulatory requirements and guidance or unanticipated events during our clinical trials may occur, which may result in necessary changes to clinical trial protocols, informed consents and study budgets, which could result in increased costs to us, delay our development timeline or reduce the likelihood of successful completion of the clinical trial or product development.
Changes in regulatory requirements and guidance or unanticipated events during our clinical trials may occur, as a result of which, we may need to amend clinical trial protocols, informed consents and study budgets. If we experience delays in initiation, conduct or completion of, or if we terminate, any clinical trials due to changes in regulatory requirements/guidance or other unanticipated events, we may incur additional costs, have difficulty enrolling subjects or achieving medical investigator or institutional review board acceptance of the changes and the successful completion of the trial and, ultimately, the commercial prospects for our products may be harmed and our ability to generate product revenue could be delayed, possibly materially.
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The process to obtain FDA approval for a new drug is very costly and time consuming and if we cannot complete our clinical trials in a timely or cost-effective manner, our results of operations may be adversely affected.
The costs of clinical trials may vary significantly over the life of a project owing, but not limited to the following:
• | the duration of the clinical trials; |
• | the number of sites included in the trials; |
• | the countries in which the trials are conducted; |
• | the length of time required to enroll eligible patients; |
• | the number of patients that participate in the trials; |
• | the number of doses that patients receive; |
• | the drop-out or discontinuation rates of patients; |
• | potential additional safety monitoring or other studies requested by regulatory agencies; |
• | the duration of patient follow-up; |
• | the efficacy and safety profile of the product candidate; and |
• | the costs and timing of obtaining regulatory approvals. |
If we are unable to control the costs of our clinical trials and conduct our trials in a cost-effective manner, our results of operations may be adversely affected.
Our proposed products may not receive FDA or other regulatory approvals.
The FDA and comparable government agencies in foreign countries impose substantial regulations on the manufacture and marketing of pharmaceutical products through lengthy and detailed laboratory, pre-clinical and clinical testing procedures, sampling activities and other costly and time-consuming procedures. Satisfaction of these regulations typically takes several years or more and varies substantially based upon the type, complexity and novelty of the proposed product. Our proposed products are subject to extensive regulation and/or acceptance by numerous governmental authorities in the United States, including the FDA, and authorities in other countries. Most of our proposed products require governmental approval before they can be commercialized. If we are unable to obtain regulatory approvals for our products at all or in a timely manner, we may not be able to grow as quickly as expected, or at all, and the loss of anticipated revenues could reduce our ability to fully fund our operations and to otherwise execute our business plan. Our failure to receive the regulatory approvals in the United States would likely cause us to cease operations and go out of business.
As we develop additional new products, we are required to determine what regulatory requirements, if any, we must comply with in order to market and sell such proposed products in the United States and worldwide. The process of obtaining regulatory approval could take years and be very costly, if approval can be obtained at all. If we fail to comply with these requirements, we could be subjected to enforcement actions such as an injunction to stop us from marketing the product at issue or a possible seizure of our assets. We intend to work diligently to assure compliance with all applicable regulations that impact our business. We can give no assurance, however, that we will be able to obtain regulatory approval for our products. We also cannot assure that additional regulations will not be enacted in the future that would be costly or difficult to satisfy. Our failure to receive regulatory approvals in the United States in a timely manner or comply with newly enacted additional regulation could cause us to cease operations and go out of business. Because our products are in various stages of development, we expect that significant research and development, financial resources, and personnel would be required to develop commercially-viable products that can obtain regulatory approval.
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The regulatory process, which includes clinical validation of many of our proposed products to establish their safety and effectiveness, can take many years and require the expenditure of substantial financial and other resources. Data obtained from clinical validation activities are susceptible to varying interpretations that could delay, limit or prevent regulatory approval. In addition, delays or rejection may be encountered based upon changes in, or additions to, regulatory policies for device marketing authorization during the period of product development and regulatory review. Delays in obtaining such approvals could adversely affect our marketing of products developed and our ability to generate commercial product revenues.
In addition, if we desire to commercialize our proposed products worldwide, we are required to meet regulatory requirements in countries outside the United States, which can change rapidly with relatively short notice, resulting in our products being banned in certain countries and an associated loss of revenues and income. Foreign regulatory agencies can also introduce test format changes which, if we do not quickly address, can result in restrictions on sales of our products. Such changes are not uncommon due to advances in basic research.
Our proposed products may not have favorable results in clinical trials or receive regulatory approval.
Positive results from pre-clinical studies and our Phase I trials of G-202 should not be relied upon as evidence that our clinical trials will succeed. Even if our proposed product achieves positive results in pre-clinical studies or during our Phase I studies, we will be required to demonstrate through further clinical trials that our product candidates are safe and effective for use in a diverse population before we can seek regulatory approvals for their commercial sale. There is typically an extremely high rate of attrition from the failure of product candidates as they proceed through clinical trials. If any product candidate fails to demonstrate sufficient safety and efficacy in any clinical trial, then we would experience potentially significant delays in, or be required to abandon, development of that product candidate. Although initial data from the trials appear promising, the outcome of the trials is uncertain and these trials or future trials may ultimately be unsuccessful. If we delay or abandon the development efforts of any of our product candidates, we may not be able to generate revenues.
We may be unable to complete our Phase II clinical trials of G-202 if we do not have adequate enrollment or capital to finance the studies.
In February 2013, we initiated a Phase II clinical trial in liver cancer. The continuation and completion of this trial is dependent on a number of factors, including adequate capital to fund the clinical trials and patient enrollment at the trial sites. At present, we have limited capital resources and require significant additional capital to complete any ongoing or future clinical trials that we may initiate. Additionally, we are initially targeting liver cancer in these trials which has historically had a lower occurrence in the United States, which is where our trial is being conducted. Our failure to gain required regulatory approval or to be able to initiate our clinical trials could materially harm our business.
Even if we complete clinical development, successfully submit applications for marketing and obtain regulatory approvals, our marketed drugs are subject to ongoing regulatory review and oversight. If we fail to comply with ongoing regulatory requirements, we could be subject to potential enforcement actions such as fines, seizures, operating restrictions, suspension or lose our approvals to market drugs and our business would be materially and adversely affected.
Following regulatory approval of any drugs or therapies we may develop, we remain subject to continuing regulatory review, including the review of adverse drug experiences and clinical results that are reported after our drug products are made available to patients. This would include results from any post marketing tests or vigilance required as a condition of approval. The manufacturer or manufacturing facilities we use to make any of our drug products are also be subject to periodic review and inspection by the FDA. The discovery of any new or previously unknown problems with the product, manufacturer or facility may result in restrictions on the drug or manufacturer facility, including withdrawal of the drug from the market. We would continue to be subject to the FDA requirements governing the labeling, packaging, storage, advertising, promotion, recordkeeping, and submission of safety and other post-market information for all of our product candidates, even those that the FDA has approved. If we fail to comply with the applicable continuing regulatory requirements, we may be subject to fines, suspension or withdrawal of regulatory approval, product recalls and seizures, operating restrictions and other adverse consequences.
Even if we receive regulatory approval to market our proposed product candidates, they may not be accepted commercially, or be eligible for reimbursement under governmental or third-party payor insurance programs, which would prevent us from becoming profitable.
We have concentrated our research and development on our prodrug technologies. Our ability to generate revenue and operate profitably depends on us being able to develop these technologies for human applications. Our technologies are primarily directed toward the development of cancer therapeutic agents. We cannot guarantee that the results obtained in the pre-clinical and clinical evaluation of our therapeutic agents would be sufficient to warrant approval by the FDA. Even if our therapeutic agents are approved for use by the FDA, there is no guarantee that they exhibit an enhanced efficacy relative to competing therapeutic modalities such that they would be adopted by the medical community. Without significant adoption by the medical community, our agents will have limited commercial potential which could harm our ability to generate revenues, operate profitably or remain a viable business.
Additional factors that we believe could materially affect market acceptance of our therapeutic agents are:
• | timing of our receipt of any marketing approvals, the terms of any approvals and the countries in which approvals are obtained; |
• | safety, efficacy and ease of administration of our therapeutic agents; |
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• | advantages of our therapeutic agents over those of our competitors; |
• | willingness of patients to accept new therapies; |
• | success of our physician education programs; |
• | availability of government and third-party payor reimbursement; |
• | pricing of our products, particularly as compared to alternative treatments; and |
• | availability of effective alternative treatments and the relative risks and/or benefits of the treatments. |
If users of our proposed products are unable to obtain adequate reimbursement from third-party payors, market acceptance of our proposed products may be limited and we may not achieve revenues or profits.
The continuing efforts of governments, insurance companies, health maintenance organizations and other payers of healthcare costs to contain or reduce costs of health care may affect our future revenues and profitability as well as the future revenues and profitability of our potential customers, suppliers and collaborative partners in addition to the availability of capital. In other words, our ability to commercialize our proposed products depends in large part on the extent to which appropriate reimbursement levels for the cost of our proposed formulations, products and related treatments are obtained by the health care providers of these products and treatments. At this time we cannot predict the precise impact of the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Affordability Act of 2010, the comprehensive health care reform legislation passed by Congress in March 2010.
We need to obtain FDA approval of any proposed product brand names, and any failure or delay associated with such approval may adversely impact our business.
A pharmaceutical product cannot be marketed in the United States or other countries until it has completed rigorous and extensive regulatory review processes, including approval of a brand name. Any brand names we intend to use for our product candidates requires approval from the FDA regardless of whether we have secured a formal trademark registration from the PTO. The FDA typically conducts a review of proposed product brand names, including an evaluation of potential for confusion with other product names. The FDA may also object to a product brand name if it believes the name inappropriately implies medical claims. If the FDA objects to any of our proposed product brand names, we may be required to adopt an alternative brand name for our product.
If we are unable to successfully complete clinical trials, we will be unable to seek regulatory approval to commercialize our proposed products which could significantly impair our viability.
The Phase II trial of G-202 in liver cancer patients is ongoing and we plan to initiate additional Phase II trials with G-202 when financial resources permit. Although one Phase II clinical trial is underway, the outcome of this and future clinical trials is uncertain and, if we are unable to satisfactorily complete such trials, or if such trials yield unsatisfactory results, we would not be able to commercialize our proposed products. The failure of our trials could delay or prevent regulatory approval and could harm our ability to generate revenues, operate profitably or remain a viable business.
We may be unable to comply with our reporting and other requirements under federal securities laws.
The Sarbanes-Oxley Act of 2002, as well as related new rules and regulations implemented by the United States Securities and Exchange Commission, or SEC, and the Public Company Accounting Oversight Board, require changes in the corporate governance practices and financial reporting standards for public companies. These laws, rules and regulations, including compliance with Section 404 of the Sarbanes-Oxley Act of 2002 relating to internal control over financial reporting, would be expected to materially increase the Company’s legal and financial compliance costs and make some activities more time-consuming and more burdensome. Presently we qualify as a non-accelerated filer and, accordingly, are exempt from the requirements of Section 404(b) and our independent registered public accounting firm is not required to audit the design and operating effectiveness of our internal controls and management’s assessment of the design and the operating effectiveness of such internal controls. In the event we become an accelerated filer, we would be required to expend substantial capital in connection with compliance.
We do not have effective internal controls over our financial reporting, and if we cannot provide reliable financial and other information, investors may lose confidence in us and in our SEC reports.
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Because of our limited resources, management has concluded that our internal control over financial reporting may not be effective in providing reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with U.S. generally accepted accounting principles. To mitigate the current limited resources and limited number of employees, we rely heavily on direct management oversight of transactions, along with the use of legal and accounting professionals. As we expand, we expect to increase our number of employees, which would enable us to implement adequate segregation of duties within the Committee of Sponsoring Organizations of the Treadway Commission internal control framework.
Effective internal controls over financial reporting and disclosure controls and procedures are necessary for us to provide reliable financial and other reports and effectively prevent fraud. If we cannot provide reliable financial or SEC reports or prevent fraud, investors may lose confidence in our SEC reports, our operating results and the trading price of our common stock could suffer materially and we may become subject to litigation.
Compliance with changing regulation of corporate governance and public disclosure may result in additional expenses and will divert time and attention away from revenue generating activities.
Changing laws, regulations and standards relating to corporate governance and public disclosure, including the Sarbanes-Oxley Act of 2002 and related SEC regulations, have created uncertainty for public companies and significantly increased the costs and risks associated with accessing the public markets and public reporting. Our management team invests significant time and financial resources to comply with both existing and evolving standards for public companies, which will lead to increased general and administrative expenses and a diversion of management time and attention from developing our business to compliance activities which could have an adverse effect on our business.
Risks Relating to our Securities
Our common stock price may be particularly volatile because of our stage of development and business and may be adversely affected by several factors.
The market prices for securities of biotechnology and pharmaceutical companies in general, and early-stage drug development companies in particular, have been highly volatile and may continue to be highly volatile in the future. The following may have a significant impact on the market price of our common stock:
• | the development status of our drug candidates, particularly the results of our clinical trials of G-202; |
• | market conditions or trends related to the biotechnology and pharmaceutical industries, or the market in general; |
• | announcements of technological innovations, new commercial products, or other material events by our competitors or us; |
• | disputes or other developments concerning our proprietary rights; |
• | changes in, or failure to meet, securities analysts’ or investors’ expectations of our financial and developmental performance; |
• | additions or departures of key personnel; |
• | loss of any strategic relationship; |
• | discussions of our business, products, financial performance, prospects, or stock price by the financial and scientific press and online investor communities such as chat rooms; |
• | industry developments, including, without limitation, changes in healthcare policies or practices or third-party reimbursement policies; |
• | public concern as to, and legislative action with respect to, testing or other research areas of biopharmaceutical and pharmaceutical companies, the pricing and availability of prescription drugs, or the safety of drugs; |
• | regulatory developments in the United States or foreign countries; and |
• | economic, political and other external factors. |
In addition, the market price for securities of pharmaceutical and biotechnology companies historically has been volatile, and the securities markets have from time to time experienced significant price and volume fluctuations that are unrelated to the operating performance of particular companies. These broad market fluctuations may cause the market price of our common stock to decline substantially. In the past, following periods of volatility in the market price of a particular company’s securities, securities class action litigation has often been brought against that company. We may become subject to this type of litigation, which is often extremely expensive and diverts management’s attention. Additionally, fluctuations in the trading price or liquidity of our common stock may materially and adversely affect, among other things, the interest of investors to purchase our common stock on the open market and, generally, our ability to raise capital.
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We may issue additional common stock, which might dilute the net tangible book value per share of our common stock for existing stockholders.
We are authorized to issue up to 150,000,000 shares of common stock and 30,000,000 shares of “blank check” preferred stock, although these amounts may change in the future subject to shareholder approval. Any stock issuances could be made at a price that reflects a discount to, or a premium from, the then-current market price of our common stock. In addition, in order to raise capital, we may need to issue securities that are convertible into or exchangeable for a significant amount of our common stock. These issuances would dilute the percentage ownership interest, which would have the effect of reducing your influence on matters on which our stockholders vote, and might dilute the net tangible book value per share of our common stock.
Our board of directors has broad discretion to issue additional securities.
We are authorized under our certificate of incorporation to issue up to 150,000,000 shares of common stock and 30,000,000 “blank check” shares of preferred stock. Shares of our blank check preferred stock provide the board of directors’ broad authority to determine voting, dividend, conversion, and other rights. As of November 30, 2013 we have issued and outstanding 27,252,966 shares of common stock and we have 22,250,205 shares of common stock reserved for future grants under our equity compensation plans and for issuances upon the exercise or conversion of currently outstanding options, warrants and convertible securities. As of November 30, 2013, we had no shares of preferred stock issued and outstanding.
Accordingly, we are entitled to issue up to 100,496,829 additional shares of common stock and 30,000,000 additional shares of “blank check” preferred stock. Our board may generally issue those common and preferred shares, or convertible securities to purchase those shares, without further approval by our shareholders. Any preferred shares we may issue could have such rights, preferences, privileges and restrictions as may be designated from time-to-time by our board, including preferential dividend rights, voting rights, conversion rights, redemption rights and liquidation provisions. It is likely that we would issue a large amount of additional securities to raise capital in order to further our development and marketing plans. It is also likely that would issue a large amount of additional securities to directors, officers, employees and consultants as compensatory grants in connection with their services, both in the form of stand-alone grants or under our various stock plans. The issuance of additional securities may cause substantial dilution to our shareholders.
Future sales of our common stock could cause our stock price to fall.
Transactions that result in a large amount of newly issued shares become readily tradable, or other events that cause current stockholders to sell shares, could place downward pressure on the trading price of our common stock. In addition, the lack of a robust trading market may require a stockholder who desires to sell a large number of shares of common stock to sell the shares in increments over time to mitigate any adverse impact of the sales on the market price of our stock. If our stockholders sell, or the market perceives that our stockholders intend to sell for various reasons, substantial amounts of our common stock in the public market, including shares issued upon the exercise of outstanding options or warrants, the market price of our common stock could fall. Sales of a substantial number of shares of our common stock may make it more difficult for us to sell equity or equity-related securities in the future at a time and price that we deem reasonable or appropriate. We may become involved in securities class action litigation that could divert management’s attention and harm our business.
As of November 30, 2013, we had 27,252,966 shares of common stock issued and outstanding. Substantially all of these shares are available for public sale, subject in some cases to volume and other limitations or delivery of a prospectus. As of November 30, 2013, we had reserved for issuance (i) 260,771 shares of our common stock issuable upon the conversion of outstanding convertible notes; (ii) 10,216,597 shares of our common stock issuable upon exercise of outstanding warrants at a weighted average exercise price of $2.56 per share; and (iii) 6,011,023 shares of our common stock issuable upon exercise of outstanding stock options under our equity compensation plans at a weighted average exercise price of $1.83 per share. Subject to applicable vesting requirements, upon conversion or exercise of the outstanding convertible notes, warrants and options, the underlying shares may be resold into the public market. We cannot predict if future issuances or sales of our common stock, or the availability of our common stock for sale, would harm the market price of our common stock or our ability to raise capital.
The market for our common stock has been illiquid.
Our common stock trades with limited volume on the OTCQB tier of the OTC Markets Group Inc. Accordingly, although a limited public market for our common stock exists, it is still relatively illiquid compared to that of a seasoned issuer. Any prospective investor in our securities should consider the limited market of our common stock when making an investment decision. No assurances can be given that the trading volume of our common stock will increase or that a liquid public market for our securities will ever materialize.
We have not paid cash dividends in the past and do not expect to pay cash dividends in the foreseeable future. Any return on your investment may be limited to increases in the market price of our common stock.
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We have never paid cash dividends on our common stock and do not anticipate paying cash dividends on our common stock in the foreseeable future. If we do not pay dividends, our common stock may be less valuable because a return on your investment will only occur if the market price of our common stock appreciates.
Our officers and scientific advisors, by virtue of their ownership of our securities, may be able to control the Company.
As of November 30, 2013, our officers and scientific advisors owned approximately 23% of our issued and outstanding common stock. As a consequence of their level of stock ownership, the group retains substantial ability to influence the election or removal of members of our board of directors, and thereby control our management. This group of shareholders has the ability to significantly control the outcome of corporate actions requiring shareholder approval, including amending our certificate of incorporation and bylaws, approving mergers or other changes of corporate control, and approving going private transactions and other extraordinary transactions, any of which may be in opposition to the best interest of the other shareholders and may negatively impact the value of your investment.
Provisions of Delaware law and executive employment agreements may prevent or delay a change of control, which could depress the trading price of our common stock.
We are subject to the Delaware anti-takeover laws regulating corporate takeovers. These anti-takeover laws prevent Delaware corporations from engaging in a merger or sale of more than 10% of its assets with any stockholder, including all affiliates and associates of the stockholder, who owns 15% or more of the corporation’s outstanding voting stock, for three years following the date that the stockholder acquired 15% or more of the corporation’s assets unless:
• | the Board of Directors approved the transaction in which the stockholder acquired 15% or more of the corporation’s assets; |
• | after the transaction in which the stockholder acquired 15% or more of the corporation’s assets, the stockholder owned at least 85% of the corporation’s outstanding voting stock, excluding shares owned by directors, officers and employee stock plans in which employee participants do not have the right to determine confidentially whether shares held under the plan will be tendered in a tender or exchange offer; or |
• | on or after this date, the merger or sale is approved by the Board of Directors and the holders of at least two-thirds of the outstanding voting stock that is not owned by the stockholder. |
A Delaware corporation may opt out of the Delaware anti-takeover laws if its certificate of incorporation or bylaws so provides. We have not opted out of the provisions of the anti-takeover laws. As such, these laws could prohibit or delay mergers or other takeover or change of control of GenSpera and may discourage attempts by other companies to acquire us.
In addition, employment agreements with certain executive officers provide for the payment of severance and accelerated vesting of options and restricted stock in the event of termination following a change of control. These provisions could have the effect of discouraging potential takeover attempts even if it would be beneficial to shareholders.
Our certificate of incorporation and bylaws contain provisions that could discourage a third-party from acquiring us.
Our certificate of incorporation and bylaws, as applicable, among other things,(i) provide our board with the ability to alter the bylaws without stockholder approval, and (ii) provide that vacancies on our board of directors may be filled by a majority of directors in office. These provisions, while designed to reduce vulnerability to an unsolicited acquisition proposal, and to discourage certain tactics used in proxy fights, may negatively impact a third-party’s decision to acquire us even if it would be beneficial to shareholders.
If securities or industry analysts do not publish research or reports or if they publish unfavorable research or reports, the price of our common stock could decline.
The trading market for our common stock depends in part on the research and reports that securities or industry analysts publish about us or our business. We currently have limited research coverage by securities and industry analysts. We are a small company which is relatively unknown to stock analysts, stock brokers, institutional investors and others in the investment community that generate or influence sales volume. Even if we come to the attention of such persons, they may be reluctant to follow or recommend an unproven company such as ours until such time as we became more seasoned and viable. As a consequence, there may be periods of several days, weeks or months when trading activity in our shares is minimal or non-existent, as compared to a seasoned issuer which has a large and steady volume of trading activity that generally supports continuous sales without an adverse effect on share price. We cannot give you any assurance that a broader or more active public trading market for our common stock will develop or if developed, will be sustained, or that current trading levels could be sustained or not diminish. In addition, in the event any analysts downgrades our securities, the price of our shares would likely decline. If one or more of these analysts ceases to cover us or fails to publish regular reports on us, interest in the purchase of our securities could decrease, which could cause the price of our common stock and its trading volume, if any, to decline.
14 |
Our common stock is considered a “penny stock,” and is subject to additional sale and trading regulations that may make it more difficult to sell.
Our common stock is considered a “penny stock.” The principal result or effect of being designated a penny stock is that securities broker-dealers participating in sales of our common stock may be subject to the penny stock regulations set forth in Rules 15g-2 through 15g-9 promulgated under the Exchange Act. For example, Rule 15g-2 requires broker-dealers dealing in penny stocks to provide potential investors with a document disclosing the risks of penny stocks and to obtain a manually signed and dated written receipt of the document at least two business days before effecting any transaction in a penny stock for the investor’s account. Moreover, Rule 15g-9 requires broker-dealers in penny stocks to approve the account of any investor for transactions in such stocks before selling any penny stock to that investor. This procedure requires the broker-dealer to (i) obtain from the investor information concerning his or her financial situation, investment experience and investment objectives; (ii) reasonably determine, based on that information, that transactions in penny stocks are suitable for the investor and that the investor has sufficient knowledge and experience as to be reasonably capable of evaluating the risks of penny stock transactions; (iii) provide the investor with a written statement setting forth the basis on which the broker-dealer made the determination in (ii) above; and (iv) receive a signed and dated copy of such statement from the investor, confirming that it accurately reflects the investor’s financial situation, investment experience and investment objectives. Compliance with these requirements may make it more difficult and time consuming for holders of our common stock to resell their shares to third parties or to otherwise dispose of them in the market or otherwise.
Other Risks
We depend on Craig A. Dionne, PhD, our Chief Executive Officer, to manage and drive the execution of our business plans, develop our products and core technologies and pursue collaborative relationships; the loss of Dr. Dionne would materially and adversely affect our business.
Although we have entered into an employment agreement with Dr. Dionne, there can be no assurance that he will continue to provide services to us. A voluntary or involuntary termination of employment by Dr. Dionne could have a materially adverse effect on our business.
We may be required to make significant payments to members of our management in the event their employment with us is terminated or if we experience a change of control.
We are a party to employment agreements with members of management. In the event we terminate the employment of any of these executives, we experience a change in control or, in certain cases, if such executive terminates their employment with us, such executive will be entitled to receive certain severance and related payments. Additionally, in such instance, certain securities held by members of management shall become immediately vested and exercisable. Upon the occurrence of any such event, our obligation to make such payments could significantly impact our working capital and, accordingly, our ability to execute our business plan which could have a materially adverse effect to our business. Also, these provisions may discourage potential takeover attempts that could be beneficial to our stockholders.
If our management team is not effective or if we fail to attract, hire or retain qualified personnel, we may not be able to design, develop or commercialize our products successfully or manage our business.
Our anticipated growth and expansion may require the addition of new personnel and the development of additional expertise by existing management. There is intense competition for qualified personnel in such areas. Accordingly, there can be no assurances that we would be able to attract and retain the qualified personnel necessary for the successful development of our business.
We are exposed to product liability risks, which could place a financial burden upon us, should we be sued.
We have obtained limited product liability insurance coverage for our clinical trials. However, we may not be able to secure or maintain insurance coverage at a reasonable cost or in sufficient amounts to protect us against all losses we may incur. If a successful product liability claim or series of claims is brought against us for uninsured liabilities or in excess of insured liabilities, our assets may not be sufficient to cover such claims and our business, financial condition and results of operations could be materially adversely affected.
USE OF PROCEEDS
We will not receive any of the proceeds from the sale of the shares by any of the selling stockholders, but we will receive up to $15,890,643 upon the exercise of warrants in the event they are all exercised for cash. We will use the proceeds received from the exercise of warrants, if any, for working capital.
15 |
DETERMINATION OF OFFERING PRICE
The Selling Stockholders will offer their shares at the prevailing market prices, privately negotiated prices, or in any other fashion and manner as described in the section of this Prospectus entitled “Plan of Distribution.”
SELLING STOCKHOLDERS
This prospectus relates to the offering and sale, from time to time, of up to 5,559,874 shares of our common stock by the stockholders named in the table below (“Selling Stockholders”). Except for 50,000 common shares underlying warrants as described in footnote 69, the shares being registered have been previously registered and this prospectus constitutes a post-effective amendment to the prior registration statement. The shares relate to: (i) shares underlying warrants issued in our April 2011 offering (“April 2011 Offering”); (ii) shares underlying warrants issued in our January and February 2011 offering (“January / February 2011 Offering”); (iii) shares underlying warrants issued in our May 2010 offering (“ May 2010 Offering”); (iv) shares underlying warrants issued in our January and March 2010 offering (“January / March 2010 Offering”); (v) shares underlying warrants issued in our September 2009 offering (“September 2009 Offering”); (vi) shares underlying warrants issued in our June and July 2009 offering (“June / July 2009 Offering”); (vii) shares underlying warrants issued in our February and April 2009 offering (“February 2009 Offering”); (viii); shares issued pursuant to the exercise of warrants issued in our July and August 2008 offering (“July / August 2008 Offering”), and (ix) shares underlying warrants issued to consultants for services provided and shares issued pursuant to the exercise of consultant warrants (“Consultant Warrants & Shares”)
The Selling Stockholders may exercise their warrants at any time in their sole discretion. Set forth below is information, to the extent known to us, the name of each Selling Stockholders and the amount and percentage of common stock owned by each (including shares that can be acquired on the exercise of outstanding warrants) prior to the offering, the shares to be sold in the offering, and the amount and percentage of common stock to be owned by each (including shares that can be acquired on the exercise of outstanding warrants) after the offering assuming all the shares being registered are sold. The footnotes provide information about persons who have investment and voting power for the Selling Stockholders and about transactions between the Selling Stockholders and the Company.
The Selling Stockholders may sell all or some of the shares of common stock they are offering, and may sell shares of our common stock otherwise than pursuant to this prospectus. The tables below assumes that each Selling Stockholder exercises all of its warrants and sells all of the shares issued upon exercise thereof, and that each Selling Stockholder sells all of the shares offered by it in offerings pursuant to this prospectus, and does not acquire any additional shares. We are unable to determine the exact number of shares that will actually be sold or when or if these sales will occur.
The Selling Stockholders may sell all, some or none of their shares in this offering. See “Plan of Distribution.”
The total number of common shares sold under this prospectus may be adjusted to reflect adjustments due to stock dividends, stock distributions, splits, combinations or recapitalizations with regard to the common stock and warrants. Unless otherwise stated below in the footnotes, to our knowledge, no Selling Stockholder nor any affiliate of such stockholder: (i) has held any position or office with us during the three years prior to the date of this prospectus; or (ii) is a broker-dealer, or an affiliate of a broker-dealer. Additionally, unless stated in the footnotes, to our knowledge, any Selling Shareholder who is an associated or affiliated person of a broker-dealer, as identified herein, purchased the securities in the ordinary course of business and at the time of purchase, had no agreement or understandings, directly or indirectly, with any person, to distribute the securities. We may amend or supplement this prospectus from time to time in the future to update or change this list and shares which may be resold.
April 2011 Offering
Included herein are 718,175 previously registered common shares underlying warrants issued in connection with our April 2011 Offering. The warrants have a term of five years and entitle the holders to purchase the common shares at a price per share of $3.15. In the event the shares underlying the warrants are not subject to a registration statement, the warrants may be exercised on a cashless basis after 12 months from the issuance date. The warrants also contain provisions providing for an adjustment in the underlying number of shares and exercise price in the event of stock splits or dividends and fundamental transactions. The warrants do not contain any price protection provisions. The warrants are callable assuming the following: (i) our common stock trades above $6.50 for ten (10) consecutive days; (ii) the daily average minimum volume over such ten (10) days is 15,000 or greater; and (iii) there is an effective registration statement covering the underlying shares. We also granted the investors certain piggy-back registration rights.
January / February 2011 Offering
Included herein are 1,218,610 previously registered common shares underlying warrants issued in connection with our January/February 2011 Offering. The shares consist of: (i) 1,120,805 common shares underlying warrants issued to investors and (ii) 97,805 common shares underlying warrants issued to placement agents and/or finders. The investor warrants have a term of five years and entitle the holders to purchase the common shares at a price per share of $3.30. In the event the shares underlying the warrants are not subject to a registration statement, the warrants may be exercised on a cashless basis after 12 months from the issuance date. The warrants also contain provisions providing for an adjustment in the underlying number of shares and exercise price in the event of stock splits or dividends and fundamental transactions. The warrants do not contain any price protection provisions. The warrants are callable assuming the following: (i) our common stock trades above $5.50 for ten (10) consecutive days; (ii) the daily average minimum volume over such ten (10) days is 15,000 or greater; and (iii) there is an effective registration statement covering the underlying shares. We also granted the investors certain piggy-back registration rights. The placement agent and finder’s warrants are substantially similar to the investor warrants except for having an average exercise price of $3.20.
16 |
May 2010 Offering
Included herein are 713,566 previously registered common shares underlying warrants issued in connection with our May 2010 Offering. The warrants have a term of five years and an exercise price of $3.50. The warrants also contain provisions providing for an adjustment in the underlying number of shares and exercise price in the event of stock splits or dividends and fundamental transactions. The warrants are callable assuming the following: (i) our common stock trades above $6.50 for twenty (20) consecutive days; (ii) the daily average minimum volume over such 20 days is 50,000 or greater; and (iii) there is an effective registration statement covering the underlying shares. We also granted the investors certain piggy-back registration rights.
January / March 2010 Offering
Included herein are 309,377 previously registered common shares underlying warrants issued in connection with our January / March, 2010 Offering. The shares consist of: (i) 266,704 common shares underlying warrants issued to investors and (ii) 42,673 common shares underlying warrants issued to placement agents and/or finders. The warrants have a term of five years and allow the investors to purchase our common stock at a price per share of $3.10. The warrants also contain anti-dilution protection in the event of stock splits, stock dividends and other similar transactions. The warrants are callable assuming the following: (i) our common stock trades above $5.00 for twenty (20) consecutive days; (ii) the daily average minimum volume over such 20 days is 75,000 or greater; and (iii) there is an effective registration statement covering the underlying shares. The placement agent and finder’s warrants are substantially similar to the investor warrants except for having an average exercise price of $2.73.
September 2009 Offering
Included herein are 92,269 previously registered common shares underlying warrants issued in connection with our September 2009 Offering. The shares consist of: (i) 80,000 common shares underlying warrants issued to investors and (ii) 12,267 common shares underlying warrants issued to finders. The warrants have a term of five years and allow the holder to purchase our common shares at a price per share of $3.00. The warrants also contain anti-dilution protection in the event of stock splits, stock dividends and other similar transactions. The warrants are callable by us in the event our shares are publically traded and certain price and volume conditions are met.
June / July 2009 Offering
Included herein are 1,113,241 previously registered common shares underlying warrants issued in connection with our June/July 2009 Offering. The shares consist of: (i) 1,012,679 common shares underlying warrants issued to investors and (ii) 100,562 common shares underlying warrants issued to finders. The warrants have a term of five years and allow the investors to purchase our common shares at a price per share of $3.00. The warrants also contain anti-dilution protection in the event of stock splits, stock dividends and other similar transactions. The warrants are callable by us in the event the Company’s shares are publically traded and certain price and volume conditions are met.
February 2009 Offering
Included herein are 250,006 previously registered common shares underlying warrants issued in connection with our February 2009 Offering. The warrants have a term of five years and allow the investors to purchase our common shares at a price per share of $3.00. The warrants also contain anti-dilution protection in the event of stock splits, stock dividends and other similar transactions. The warrants are callable by us in the event our shares are publically traded and certain price and volume conditions are met.
July / August 2008 Offering
Included herein are 358,338 previously registered common shares that were issued upon the exercise of warrants issued in connection with our July/August 2008 Offering.
17 |
Consultant Warrants & Shares
Included herein are 786,292 common shares and common shares underlying warrants issued to consultants. The shares consist of: (i) 702,292 previously registered common shares underlying warrants (ii) 84,000 previously registered common shares issued upon exercise of consulting warrant, and (iii) 50,000 common shares underlying warrants which have not previously been registered.
The Selling Stockholders may exercise their warrants at any time in their sole discretion. All of the Selling Stockholders named below acquired their common stock and warrants directly from us in private transactions.
Common Shares Owned Before Sale (1) | Common Shares Owned After Sale (2) | |||||||||||||||||||||||||||
Held Outright | Warrants/ Options | Amount | % of class | Shares being registered | Amount | % of Class | ||||||||||||||||||||||
Bristol Investment Fund, Ltd.(3) | 133,334 | 183,334 | 316,668 | 1.16 | % | 50,000 | 266,668 | 0.98 | % | |||||||||||||||||||
IRA FBO J. Steven Emerson Rollover II Pershing LLC as Custodian (4) | 381,000 | 443,500 | 824,500 | 3.03 | % | 62,500 | 762,000 | 2.80 | % | |||||||||||||||||||
T.R. Winston & Company, LLC (5) | 56,987 | 275,705 | 332,692 | 1.22 | % | 18,000 | 314,692 | 1.15 | % | |||||||||||||||||||
Steven Michell Sack PSP U/A DTD 01/01/1994 (6) | 66,667 | 25,000 | 91,667 | 0.34 | % | 91,667 | - | 0.00 | % | |||||||||||||||||||
Robert O'Mara (7) | 190,001 | 16,667 | 206,668 | 0.76 | % | 43,334 | 163,334 | 0.60 | % | |||||||||||||||||||
Subhash C. Gulati (8) | 6,667 | 12,500 | 19,167 | 0.07 | % | 19,167 | - | 0.00 | % | |||||||||||||||||||
Steven Mitchell Sack (9) | 15,000 | 40,000 | 55,000 | 0.20 | % | 55,000 | - | 0.00 | % | |||||||||||||||||||
Samax Family Limited Partnership (10) | 50,000 | 25,000 | 75,000 | 0.28 | % | 75,000 | - | 0.00 | % | |||||||||||||||||||
Jay R. Solan (11) | - | 12,500 | 12,500 | 0.05 | % | 12,500 | - | 0.00 | % | |||||||||||||||||||
Thomas E. Genna (12) | - | 25,000 | 25,000 | 0.09 | % | 25,000 | - | 0.00 | % | |||||||||||||||||||
D. Carl Lustig, III (13) | 50,000 | - | 50,000 | 0.18 | % | 50,000 | - | 0.00 | % | |||||||||||||||||||
The Verrazano Group, LLC (14) | 84,000 | 289,625 | 373,625 | 1.37 | % | 233,625 | 140,000 | 0.51 | % | |||||||||||||||||||
Christopher Miglino (15) | 10,000 | - | 10,000 | 0.04 | % | 10,000 | - | 0.00 | % | |||||||||||||||||||
Mitchell J. Sassower (16) | 33,334 | - | 33,334 | 0.12 | % | 33,334 | - | 0.00 | % | |||||||||||||||||||
Faith Griffin & John A. Lenhart JTWROS (17) | 16,667 | - | 16,667 | 0.06 | % | 16,667 | - | 0.00 | % | |||||||||||||||||||
Patrick Hund (18) | 25,001 | - | 25,001 | 0.09 | % | 25,001 | - | 0.00 | % | |||||||||||||||||||
Rhonda Wesolak Individual Retirement Account Merrill Lynch Wealth Management Cust (19) | 16,667 | 16,667 | 0.06 | % | 16,667 | - | 0.00 | % | ||||||||||||||||||||
John G. Korman (20) | 16,667 | 16,667 | 0.06 | % | 16,667 | - | 0.00 | % | ||||||||||||||||||||
A.C. Providenti (21) | 16,667 | 16,667 | 0.06 | % | 16,667 | - | 0.00 | % | ||||||||||||||||||||
Benjamin Hill (22) | 21,667 | 26,973 | 48,640 | 0.18 | % | 5,834 | 42,806 | 0.16 | % | |||||||||||||||||||
Gary J. Faden (23) | 8,334 | - | 8,334 | 0.03 | % | 8,334 | - | 0.00 | % | |||||||||||||||||||
Peter Nejes (24) | - | 30,000 | 30,000 | 0.11 | % | 30,000 | - | 0.00 | % | |||||||||||||||||||
Dennis Powers (25) | - | 30,000 | 30,000 | 0.11 | % | 30,000 | - | 0.00 | % | |||||||||||||||||||
Karen Kemmerer (26) | - | 90,000 | 90,000 | 0.33 | % | 90,000 | - | 0.00 | % | |||||||||||||||||||
John L. Kemmere JR 1957 Trust (27) | 690,000 | 345,000 | 1,035,000 | 3.80 | % | 345,000 | 690,000 | 2.53 | % | |||||||||||||||||||
Photon Global Ltd. (28) | - | 229,167 | 229,167 | 0.84 | % | 229,167 | - | 0.00 | % | |||||||||||||||||||
Gregory P. Zeller (29) | 166,667 | 83,334 | 250,001 | 0.92 | % | 83,334 | 166,667 | 0.61 | % | |||||||||||||||||||
Far Hills Capital, LLC (30) | 183,334 | 91,667 | 275,001 | 1.01 | % | 91,667 | 183,334 | 0.67 | % | |||||||||||||||||||
Cynthia P. Stafford Trust (31) | 133,334 | 66,667 | 200,001 | 0.73 | % | 66,667 | 133,334 | 0.49 | % | |||||||||||||||||||
Jonathan Meyers (32) | 66,667 | 33,334 | 100,001 | 0.37 | % | 33,334 | 66,667 | 0.24 | % | |||||||||||||||||||
Gene Mulvihill (33) | - | 33,334 | 33,334 | 0.12 | % | 33,334 | - | 0.00 | % | |||||||||||||||||||
Robert L. and Natacha Stafford (34) | 66,667 | 33,334 | 100,001 | 0.37 | % | 33,334 | 66,667 | 0.24 | % | |||||||||||||||||||
Horemheb Investments, LLC (35) | 66,667 | 33,334 | 100,001 | 0.37 | % | 33,334 | 66,667 | 0.24 | % | |||||||||||||||||||
Robert L. Stafford Jr. Trust (36) | 30,000 | 48,334 | 78,334 | 0.29 | % | 48,334 | 30,000 | 0.11 | % | |||||||||||||||||||
Equity Trust Company, d.b.a. Sterling Trust, Custodian FBO: John Sanderford (37) | 46,667 | 23,334 | 70,001 | 0.26 | % | 23,334 | 46,667 | 0.17 | % | |||||||||||||||||||
Peter Cunningham (38) | - | 39,167 | 39,167 | 0.14 | % | 39,167 | - | 0.00 | % | |||||||||||||||||||
Gordon W. Clark, Jr. (39) | - | 16,667 | 16,667 | 0.06 | % | 16,667 | - | 0.00 | % | |||||||||||||||||||
Edward J. Foley, III (40) | 33,334 | 16,667 | 50,001 | 0.18 | % | 16,667 | 33,334 | 0.12 | % | |||||||||||||||||||
Held Under Will of Joan P. Foley FBO Edward J. Foley, III - Lifetime Trust (41) | 45,834 | 22,917 | 68,751 | 0.25 | % | 22,917 | 45,834 | 0.17 | % |
18 |
Common Shares Owned Before Sale (1) | Common Shares Owned After Sale (2) | |||||||||||||||||||||||||||
Held Outright | Warrants/ Options | Amount | % of class | Shares
being registered | Amount | % of Class | ||||||||||||||||||||||
Edward J. Foley, III, 2009 GRAT (42) | 33,334 | 16,667 | 50,001 | 0.18 | % | 16,667 | 33,334 | 0.12 | % | |||||||||||||||||||
Francis O'Connor (43) | - | 16,667 | 16,667 | 0.06 | % | 16,667 | - | 0.00 | % | |||||||||||||||||||
Frank E. Walsh, III (44) | 33,334 | 16,667 | 50,001 | 0.18 | % | 16,667 | 33,334 | 0.12 | % | |||||||||||||||||||
James M. Bass (45) | - | 5,834 | 5,834 | 0.02 | % | 5,834 | - | 0.00 | % | |||||||||||||||||||
Brian Thebault (46) | 33,334 | 16,667 | 50,001 | 0.18 | % | 16,667 | 33,334 | 0.12 | % | |||||||||||||||||||
Voiceified Technologies, LLC (47) | - | 16,667 | 16,667 | 0.06 | % | 16,667 | - | 0.00 | % | |||||||||||||||||||
Kihong Kwon, M.D. (48) | 33,334 | 16,667 | 50,001 | 0.18 | % | 16,667 | 33,334 | 0.12 | % | |||||||||||||||||||
Iroquois Master Fund, Ltd. (49) | 33,334 | 16,667 | 50,001 | 0.18 | % | 16,667 | 33,334 | 0.12 | % | |||||||||||||||||||
Roxy Transportation Co., Inc. (50) | - | 12,500 | 12,500 | 0.05 | % | 12,500 | - | 0.00 | % | |||||||||||||||||||
William Stewart (51) | - | 21,112 | 21,112 | 0.08 | % | 21,112 | - | 0.00 | % | |||||||||||||||||||
Bernard B. Markey (52) | - | 26,112 | 26,112 | 0.10 | % | 26,112 | - | 0.00 | % | |||||||||||||||||||
Diamond II Investments, LLC (53) | - | 11,112 | 11,112 | 0.04 | % | 11,112 | - | 0.00 | % | |||||||||||||||||||
Ravenwood Partners, LLC (54) | 19,741 | 74,381 | 94,122 | 0.35 | % | 54,640 | 39,482 | 0.14 | % | |||||||||||||||||||
John Sanderford (55) | - | 10,000 | 10,000 | 0.04 | % | 10,000 | - | 0.00 | % | |||||||||||||||||||
Terry Sholty Strada (56) | 16,667 | 8,334 | 25,001 | 0.09 | % | 8,334 | 16,667 | 0.06 | % | |||||||||||||||||||
John Amorosa (57) | - | 8,334 | 8,334 | 0.03 | % | 8,334 | - | 0.00 | % | |||||||||||||||||||
Glen Bliwise (58) | - | 8,334 | 8,334 | 0.03 | % | 8,334 | - | 0.00 | % | |||||||||||||||||||
Joseph C. Roselle (59) | - | 8,334 | 8,334 | 0.03 | % | 8,334 | - | 0.00 | % | |||||||||||||||||||
Schuyler L. Merrihew (60) | 44,445 | 22,223 | 66,668 | 0.24 | % | 22,223 | - | 0.00 | % | |||||||||||||||||||
Kihong Kwon, M.D., Custodian, UGMA for Connor Merrihew (61) | 54,069 | 28,347 | 82,416 | 0.30 | % | 28,347 | 54,069 | 0.20 | % | |||||||||||||||||||
Kihong Kwon, M.D., Custodian, UGMA for Mason Kwon (62) | 97,109 | 41,222 | 138,331 | 0.51 | % | 41,222 | 97,109 | 0.36 | % | |||||||||||||||||||
Timothy V. O'Connor (63) | 10,000 | 5,000 | 15,000 | 0.06 | % | 5,000 | 10,000 | 0.04 | % | |||||||||||||||||||
Jarmila Cunningham (64) | - | 4,167 | 4,167 | 0.02 | % | 4,167 | - | 0.00 | % | |||||||||||||||||||
Bernard B. Markey, Individual 401(K) ETRADE Custodian (65) | - | 3,334 | 3,334 | 0.01 | % | 3,334 | - | 0.00 | % | |||||||||||||||||||
Timothy V. O'Connor Roth IRA (66) | 6,667 | 3,334 | 10,001 | 0.04 | % | 3,334 | 6,667 | 0.02 | % | |||||||||||||||||||
Brandon Hill (67) | 19,001 | 23,972 | 42,973 | 0.16 | % | 6,167 | 36,806 | 0.14 | % | |||||||||||||||||||
Sequoia Global Partners, LLC (68) | - | 83,228 | 83,228 | 0.31 | % | 83,228 | - | 0.00 | % | |||||||||||||||||||
Walter H. Bass, LLC (69) | 238,434 | 499,028 | 737,462 | 2.71 | % | 499,028 | 238,434 | 0.87 | % | |||||||||||||||||||
Robert Scherne (70) | 3,334 | 91,667 | 95,001 | 0.35 | % | 1,667 | 93,334 | 0.34 | % | |||||||||||||||||||
Craig Petralia (71) | 1,667 | 834 | 2,501 | 0.01 | % | 834 | 1,667 | 0.01 | % | |||||||||||||||||||
Todd Shapiro (72) | 1,667 | 834 | 2,501 | 0.01 | % | 834 | 1,667 | 0.01 | % | |||||||||||||||||||
The Alec and Evelyn Sabo Trust (73) | 233,334 | 116,667 | 350,001 | 1.28 | % | 116,667 | 233,334 | 0.86 | % | |||||||||||||||||||
Cataracta Aps (74) | 312,500 | 80,000 | 392,500 | 1.44 | % | 60,000 | 332,500 | 1.22 | % | |||||||||||||||||||
Galt Financial (75) | - | 48,231 | 48,231 | 0.18 | % | 48,231 | - | 0.00 | % | |||||||||||||||||||
MKM Opportunity Master Fund, LLC (76) | - | 76,000 | 76,000 | 0.28 | % | 76,000 | - | 0.00 | % | |||||||||||||||||||
A. & C. Edwards, Trustees, A. E. Edwards III & C. A. Edwards Trust (77) | - | 3,000 | 3,000 | 0.01 | % | 3,000 | - | 0.00 | % | |||||||||||||||||||
A. Whitley & D. Whitley, Trustees, Whitley Family Trust (78) | - | 3,000 | 3,000 | 0.01 | % | 3,000 | - | 0.00 | % | |||||||||||||||||||
Akinobu Yorihiro (79) | - | 3,000 | 3,000 | 0.01 | % | 3,000 | - | 0.00 | % |
19 |
Common Shares Owned Before Sale (1) | Common Shares Owned After Sale (2) | |||||||||||||||||||||||||||
Held Outright | Warrants/ Options | Amount | % of class | Shares
being registered | Amount | % of Class | ||||||||||||||||||||||
Brian Bock & Suzanne Bock, Trustees of The Bock Family Trust U/A dtd 7/20/2001 (80) | - | 3,000 | 3,000 | 0.01 | % | 3,000 | - | 0.00 | % | |||||||||||||||||||
Cesar & Lydia Giraldo, Trustees, Giraldo Family Trust (81) | - | 15,150 | 15,150 | 0.06 | % | 15,150 | - | 0.00 | % | |||||||||||||||||||
Clarence Colby (82) | 20,000 | 10,000 | 30,000 | 0.11 | % | 10,000 | 20,000 | 0.07 | % | |||||||||||||||||||
Craig Rosato (83) | 6,000 | 3,000 | 9,000 | 0.03 | % | 3,000 | 6,000 | 0.02 | % | |||||||||||||||||||
Dan Moses (84) | - | 3,000 | 3,000 | 0.01 | % | 3,000 | - | 0.00 | % | |||||||||||||||||||
Equity Trust Co dba Sterling Trust FBO Brad Starkey (85) | 10,000 | 5,000 | 15,000 | 0.06 | % | 5,000 | 10,000 | 0.04 | % | |||||||||||||||||||
Equity Trust Co., DBA Sterling Trust, Custodian FBO Edward Bracken (86) | 6,000 | 3,000 | 9,000 | 0.03 | % | 3,000 | 6,000 | 0.02 | % | |||||||||||||||||||
Hershcel Katchen & Phyllis Katchen, Revocable Trust (87) | - | 3,000 | 3,000 | 0.01 | % | 3,000 | - | 0.00 | % | |||||||||||||||||||
Jon D. Katch (88) | 3,000 | 3,000 | 0.01 | % | 3,000 | - | 0.00 | % | ||||||||||||||||||||
John Dokken (89) | 3,000 | 3,000 | 0.01 | % | 3,000 | - | 0.00 | % | ||||||||||||||||||||
Jon Tamiyasu (90) | 6,000 | 3,000 | 9,000 | 0.03 | % | 3,000 | 6,000 | 0.02 | % | |||||||||||||||||||
Keith A. Fink Agreement of Trust (91) | - | 30,304 | 30,304 | 0.11 | % | 30,304 | - | 0.00 | % | |||||||||||||||||||
Kurtwood & Joan Smith, Trustees, KJ Smith Family Trust (92) | 28,201 | 43,201 | 71,402 | 0.26 | % | 15,000 | 56,402 | 0.21 | % | |||||||||||||||||||
L. Katch & R. Katch, Trustees, Katch Family Trust (93) | - | 3,000 | 3,000 | 0.01 | % | 3,000 | - | 0.00 | % | |||||||||||||||||||
Lawrence & Susan Mayle (94) | - | 12,100 | 12,100 | 0.04 | % | 12,100 | - | 0.00 | % | |||||||||||||||||||
Marie Tillman (95) | 6,000 | 3,000 | 9,000 | 0.03 | % | 3,000 | 6,000 | 0.02 | % | |||||||||||||||||||
Marlo Morra (96) | 10,000 | 5,000 | 15,000 | 0.06 | % | 5,000 | 10,000 | 0.04 | % | |||||||||||||||||||
Marvin Rosato (97) | - | 1,500 | 1,500 | 0.01 | % | 1,500 | - | 0.00 | % | |||||||||||||||||||
Michael and Sandra Raydo, Trustees, Raydo Trust (98) | - | 3,000 | 3,000 | 0.01 | % | 3,000 | - | 0.00 | % | |||||||||||||||||||
Philip Ehrlich (99) | - | 3,000 | 3,000 | 0.01 | % | 3,000 | - | 0.00 | % | |||||||||||||||||||
R. Gaffuri & P. Gaffuri, Trustees, Gaffuri Trust (100) | - | 3,000 | 3,000 | 0.01 | % | 3,000 | - | 0.00 | % | |||||||||||||||||||
R. Katch & A. Hopkins, Trustees, Manchester Financial PSP FBO A. Hopkins (101) | - | 3,000 | 3,000 | 0.01 | % | 3,000 | - | 0.00 | % | |||||||||||||||||||
R. Katch & A. Hopkins, Trustees, Manchester Financial PSP FBO R. Katch (102) | - | 5,000 | 5,000 | 0.02 | % | 5,000 | - | 0.00 | % | |||||||||||||||||||
Robert Maraist (103) | - | 3,000 | 3,000 | 0.01 | % | 3,000 | - | 0.00 | % | |||||||||||||||||||
S & C Warford Family Trust (104) | - | 3,050 | 3,050 | 0.01 | % | 3,050 | - | 0.00 | % | |||||||||||||||||||
S. Davar & L. Davar, Trustees, Davar Family Rev Liv U/A dtd 06/25/1990 (105) | - | 3,000 | 3,000 | 0.01 | % | 3,000 | - | 0.00 | % | |||||||||||||||||||
Sue S Barham TTEE Margaret S Lake (106) | - | 7,550 | 7,550 | 0.03 | % | 7,550 | - | 0.00 | % | |||||||||||||||||||
Sue S. Barham, Trustee, the Sue S. Barham Trust (107) | - | 3,000 | 3,000 | 0.01 | % | 3,000 | - | 0.00 | % | |||||||||||||||||||
Timothy & Deborah Triplett Family Trust (108) | - | 7,550 | 7,550 | 0.03 | % | 7,550 | - | 0.00 | % | |||||||||||||||||||
William & Kerry Bryan TTEEs Bryan 2002 Living Trust (109) | - | 6,500 | 6,500 | 0.02 | % | 6,500 | - | 0.00 | % | |||||||||||||||||||
Anthony Silverman (110) | - | 6,250 | 6,250 | 0.02 | % | 6,250 | - | 0.00 | % | |||||||||||||||||||
Bradley C. Nordheimer (111) | 12,500 | 6,250 | 18,750 | 0.07 | % | 6,250 | 12,500 | 0.05 | % | |||||||||||||||||||
Chaim Solomiuc (112) | 15,000 | 7,500 | 22,500 | 0.08 | % | 7,500 | 15,000 | 0.06 | % | |||||||||||||||||||
Fink Family Trust (113) | 10,000 | 5,000 | 15,000 | 0.05 | % | 5,000 | 10,000 | 0.04 | % | |||||||||||||||||||
Hamilton C. Davis, III (114) | - | 7,500 | 7,500 | 0.03 | % | 7,500 | - | 0.00 | % | |||||||||||||||||||
Hormoz Lashkari (115) | - | 3,750 | 3,750 | 0.01 | % | 3,750 | - | 0.00 | % | |||||||||||||||||||
Von J. Sanderford, LLC (116) | - | 5,000 | 5,000 | 0.02 | % | 5,000 | - | 0.00 | % |
20 |
Common Shares Owned Before Sale (1) | Common Shares Owned After Sale (2) | |||||||||||||||||||||||||||
Held Outright | Warrants/ Options | Amount | % of class | Shares
being registered | Amount | % of Class | ||||||||||||||||||||||
Kwon Family Trust (117) | 1,478,789 | 739,395 | 2,218,184 | 8.14 | % | 739,395 | 1,478,789 | 5.43 | % | |||||||||||||||||||
Lapp Libra 401K Plan FBO William Lapp (118) | - | 20,000 | 20,000 | 0.07 | % | 20,000 | - | 0.00 | % | |||||||||||||||||||
Lawrence Chimerine (119) | - | 5,000 | 5,000 | 0.02 | % | 5,000 | - | 0.00 | % | |||||||||||||||||||
Michael Lawroski (120) | - | 7,500 | 7,500 | 0.03 | % | 7,500 | - | 0.00 | % | |||||||||||||||||||
Michael Kren (121) | - | 7,500 | 7,500 | 0.03 | % | 7,500 | - | 0.00 | % | |||||||||||||||||||
Rodney A. Nordheimer (122) | 12,500 | 6,250 | 18,750 | 0.07 | % | 6,250 | 12,500 | 0.05 | % | |||||||||||||||||||
Stephen Howard (123) | - | 20,000 | 20,000 | 0.07 | % | 20,000 | - | 0.00 | % | |||||||||||||||||||
William S. Lapp (124) | - | 45,000 | 45,000 | 0.17 | % | 45,000 | - | 0.00 | % | |||||||||||||||||||
Willie and Patsy Mosley (125) | 284,205 | 226,705 | 510,910 | 1.87 | % | 57,500 | 453,410 | 1.66 | % | |||||||||||||||||||
Brandon Luke Mills, A Minor, UGMA, Becky Bass, Custodian (126) | - | 4,000 | 4,000 | 0.01 | % | 4,000 | - | 0.00 | % | |||||||||||||||||||
Courtney Pittman, A Minor, UGMA, Eric L Pittman, Custodian (127) | - | 3,000 | 3,000 | 0.01 | % | 3,000 | - | 0.00 | % | |||||||||||||||||||
Guadalupe M. Sanchez (128) | 11,112 | 5,556 | 16,668 | 0.06 | % | 5,556 | 11,112 | 0.04 | % | |||||||||||||||||||
Kevin Kwon Alaska Asset Conservation Trust (129) | 121,415 | 48,889 | 170,304 | 0.62 | % | 48,889 | 121,415 | 0.45 | % | |||||||||||||||||||
Kevin Kwon Alaska Asset Preservation Trust (130) | 20,136 | 7,222 | 27,358 | 0.10 | % | 7,222 | 20,136 | 0.07 | % | |||||||||||||||||||
Kwon Family Foundation (131) | 555,555 | 277,778 | 833,333 | 3.06 | % | 277,778 | 555,555 | 2.04 | % | |||||||||||||||||||
Mary Ann Carter (132) | - | 5,556 | 5,556 | 0.02 | % | 5,556 | - | 0.00 | % | |||||||||||||||||||
Michael Tong & Lida Tong JTWROS (133) | 13,888 | 6,944 | 20,832 | 0.08 | % | 6,944 | 13,888 | 0.05 | % | |||||||||||||||||||
MLPF&S Custodian Kihong Kwon IRA (134) | - | 472,222 | 472,222 | 1.73 | % | 472,222 | - | 0.00 | % | |||||||||||||||||||
Schuyler L. Merrihew and Nancy M. Kwon - Community Property (135) | 69,445 | 34,723 | 104,168 | 0.38 | % | 34,723 | 69,445 | 0.25 | % | |||||||||||||||||||
The Nancy M. Kwon Separate Property Trust DTD 11/7/05 (136) | 79,192 | 27,777 | 106,969 | 0.39 | % | 27,777 | 79,192 | 0.29 | % | |||||||||||||||||||
Wendy L Semkus (137) | 2,000 | 8,000 | 10,000 | 0.04 | % | 8,000 | 2,000 | 0.01 | % | |||||||||||||||||||
Richard and Diana Landry (138) | - | 1,000 | 1,000 | 0.00 | % | 1,000 | - | 0.00 | % | |||||||||||||||||||
Donna Hines (139) | - | 1,000 | 1,000 | 0.00 | % | 1,000 | - | 0.00 | % | |||||||||||||||||||
Bull Dog Trust-Trustee Eric J Byrnes (140) | 56,001 | 13,900 | 69,901 | 0.26 | % | 13,900 | 56,001 | 0.21 | % | |||||||||||||||||||
Burton Weinstein (141) | - | 6,945 | 6,945 | 0.03 | % | 6,945 | - | 0.00 | % | |||||||||||||||||||
Cedarview Opportunities Master Funds, LP (142) | - | 27,778 | 27,778 | 0.10 | % | 27,778 | - | 0.00 | % | |||||||||||||||||||
The Trapp Family Trust U/A/D 10/06/04, Eric G. Trapp and Jacqueline M. Trapp, Trustees (143) | 16,666 | 8,333 | 24,999 | 0.09 | % | 8,333 | 16,666 | 0.06 | % | |||||||||||||||||||
Walter H. Bass (144) | 112,804 | 5,834 | 118,638 | 0.44 | % | 5,834 | 112,804 | 0.41 | % | |||||||||||||||||||
Thomas W. Bass (145) | - | 5,833 | 5,833 | 0.02 | % | 5,833 | - | 0.00 | % | |||||||||||||||||||
Robert A. Bass (146) | - | 5,833 | 5,833 | 0.02 | % | 5,833 | - | 0.00 | % | |||||||||||||||||||
Julie Bass Adkins (147) | - | 5,833 | 5,833 | 0.02 | % | 5,833 | - | 0.00 | % | |||||||||||||||||||
6,916,545 | 6,395,666 | 13,312,211 | 48.85 | % | 5,559,874 | 7,707,892 | 28.28 | % |
21 |
* Represents less than 1%
**Unless otherwise stated, the individual(s) with voting and dispositive control of securities offered on behalf of trusts or custodial accounts is the individual or entity referenced in the name of such accounts.
(1) | Pursuant to Rules 13d-3 and 13d-5 of the Exchange Act, beneficial ownership includes any common shares as to which a shareholder has sole or shared voting power or investment power, and also any common shares which the shareholder has the right to acquire within 60 days, including upon exercise of common shares purchase options or warrants. There were 27,252,966 common shares outstanding as of November 30, 2013. |
(2) | Includes the sale of all common shares registered herein. |
(3) | The shares being registered include 50,000 shares underlying warrants issued pursuant to our May 2010 Offering. Bristol Capital Advisors, LLC (“BCA”) is the investment advisor to Bristol Investment Fund, Ltd. (“Bristol”). Paul Kessler is the manager of BCA and as such has voting and investment control over the securities held by Bristol. Mr. Kessler disclaims beneficial ownership of these securities. |
(4) | The shares being registered include 62,500 shares underlying warrants issued pursuant to our May 2010 Offering. |
(5) | The shares being registered include 18,000 shares underlying warrants issued as compensation for placement agent services in connection with our May 2010 Offering. G. Tyler Runnels, as President, has voting and dispositive control with respect to the securities being offered. Mr. Runnels is an associated person of TR Winston & Company, LLC, a registered broker-dealer. |
(6) | The shares being registered include (i) 25,000 shares underlying warrants issued in our May 2010 Offering and (ii) 66,667 shares issued upon the exercise of July / August 2008 Offering warrants. |
(7) | The shares being registered include (i) 26,667 shares issued upon the exercises of July / August 2008 Offering warrants, and (ii) 16,667 shares underlying warrants issued in our June / July 2009 Offering. |
(8) | The shares being registered include (i) 6,667 shares issued upon the exercises of July / August 2008 Offering warrants, and (ii) 12,500 shares underlying warrants issued in our May 2010 Offering. |
(9) | The shares being registered include (i) 15,000 shares issued upon the exercises of July / August 2008 Offering warrants, and (ii) 40,000 shares underlying warrants issued in our May 2010 Offering. |
(10) | The shares being registered include (i) 50,000 shares issued upon the exercises of July / August 2008 Offering warrants, and (ii) 25,000 shares underlying warrants issued in our May 2010 Offering. Andrew Margulies, General Partner, has voting and dispositive control with respect to the securities being offered. |
(11) | The shares being registered include 12,500 shares underlying warrants issued in our May 2010 Offering. |
(12) | The shares being registered include 25,000 shares underlying warrants issued in our May 2010 Offering. |
(13) | The shares being registered include 50,000 shares issued upon exercises of July / August 2008 Offering warrants. |
(14) | The shares being registered include (i) 149,625 shares underlying warrants issued as compensation for consulting services, and (ii) 84,000 shares issued upon the exercise of warrants. Stephen Chizzik has voting and dispositive control with respect to the securities being offered. |
(15) | The shares being registered include 10,000 shares issued upon the exercises of July / August 2008 Offering warrants. |
22 |
(16) | The shares being registered include 33,334 shares issued upon the exercises of July / August 2008 Offering warrants. |
(17) | The shares being registered 16,667 shares issued upon the exercises of July / August 2008 Offering warrants. |
(18) | The shares being registered include 25,001 shares issued upon the exercises of July / August 2008 Offering warrants. |
(19) | The shares being registered include 16,667 shares issued upon the exercises of July / August 2008 Offering warrants. |
(20) | The shares being registered include 16,667 shares issued upon the exercises of July / August 2008 Offering warrants. |
(21) | The shares being registered include 16,667 shares issued upon the exercises of July / August 2008 Offering warrants. |
(22) | The shares being registered include (i) 3,334 shares issued upon the exercises of July / August 2008 Offering warrants, and (ii) 2,500 shares underlying warrants issued in our January / March 2010 Offering. |
(23) | The shares being registered include 8,334 shares issued upon the exercises of July / August 2008 Offering warrants. |
(24) | The shares being registered include 30,000 shares underlying warrants issued as partial compensation for consulting services and expense reimbursement. |
(25) | The shares being registered include 30,000 shares underlying warrants issued as compensation for consulting services and expense reimbursement. |
(26) | The shares being registered include 90,000 shares underlying warrants issued as compensation for consulting services and expense reimbursement. |
(27) | The shares being registered include 345,000 shares underlying warrants issued in our June / July 2009 Offering. John L. Kemmerer, III has voting and dispositive control with respect to the securities being offered. |
(28) | The shares being reg |